# COMAR Title 10 — Maryland Department of Health ## Subtitle 07 — Hospitals ### Chapter 01 — Acute General Hospitals and Special Hospitals **Authority:** Health-General Article, §§19-307.2, 19-308, 19-308.6, 19-308.8, 19-318—19-320, 19-323, 19-342, 19-349.1, and 19-380—19-385; Insurance Article, Title 4, Subtitle 4; Public Safety Article, §14-110.1; Annotated Code of Maryland **Administrative History:** Effective date: December 19, 1946 **Administrative History:** Amended effective March 20, 1959 **Administrative History:** Amended effective September 1, 1964 **Administrative History:** Regulations .03C, G, I, K; .04B, D; .05A, B; .06C; .07B, E; .08A, B; .09B, C; .10F; .11A, B; .12F amended effective February 24, 1978 (5:4 Md. R. 226) **Administrative History:** Regulations .01—.13 repealed and new Regulations .01—.10 adopted effective August 1, 1983 (10:15 Md. R. 1350) **Administrative History:** Regulation .01 amended as an emergency provision effective August 12, 1985 (12:18 Md. R. 1756), emergency status expired December 10, 1985; adopted permanently effective December 16, 1985 (12:25 Md. R. 2471) **Administrative History:** Regulation .01 amended effective May 23, 1994 (21:10 Md. R. 844) **Administrative History:** Regulations .01, .02B, .04A, .05A, .07, .08B amended; .02C, .09D, and new .10 and .11 adopted; existing .10—.20 recodified as .12—.22 as an emergency provision effective July 1, 1986 (13:15 Md. R. 1726); adopted permanently effective December 1, 1986 (13:24 Md. R. 2558) **Administrative History:** Regulation .01B amended effective December 28, 1987 (14:26 Md. R. 2746); August 6, 1990 (17:15 Md. R. 1858) **Administrative History:** Regulation .01B amended as an emergency provision effective July 1, 2000 (27:15 Md. R. 1396); amended permanently effective October 30, 2000 (27:21 Md. R. 1975) **Administrative History:** Regulation .01B amended effective November 11, 2002 (29:22 Md. R. 1721); April 21, 2008 (35:8 Md. R. 804); June 28, 2010 (37:13 Md. R. 852); April 16, 2012 (39:7 Md. R. 491); March 31, 2014 (41:6 Md. R. 378); March 27, 2017 (44:6 Md. R. 325); April 23, 2018 (45:8 Md. R. 420) **Administrative History:** Regulation .02 recodified to be Regulation .03 and new Regulation .02 adopted effective July 4, 2016 (43:13 Md. R. 712) **Administrative History:** Regulation .02 amended effective April 13, 2026 (53:7 Md. R. 328) **Administrative History:** Regulation .02D adopted effective November 11, 2002 (29:22 Md. R. 1721) **Administrative History:** Regulation .02D repealed effective June 28, 2010 (37:13 Md. R. 852) **Administrative History:** Regulation .03 repealed and Regulation .02 recodified to be Regulation .03 effective July 4, 2016 (43:13 Md. R. 712) **Administrative History:** Regulation .03 amended effective June 24, 1991 (18:12 Md. R. 1338) **Administrative History:** Regulation .03A amended effective November 11, 2002 (29:22 Md. R. 1721); June 28, 2010 (37:13 Md. R. 852) **Administrative History:** Regulation .04 amended effective June 28, 2010 (37:13 Md. R. 852) **Administrative History:** Regulation .04A amended effective November 11, 2002 (29:22 Md. R. 1721) **Administrative History:** Regulation .04A, C amended effective March 13, 2017 (44:5 Md. R. 292) **Administrative History:** Regulation .04D amended effective February 26, 2007 (34:4 Md. R. 400) **Administrative History:** Regulation .05 amended effective November 11, 2002 (29:22 Md. R. 1721) **Administrative History:** Regulation .05A amended effective June 28, 2010 (37:13 Md. R. 852) **Administrative History:** Regulation .06A amended as an emergency provision effective November 20, 2019 (46:26 Md. R. 1162); emergency status expired May 18, 2020 **Administrative History:** Regulation .06C adopted as an emergency provision effective November 20, 2019 (46:26 Md. R. 1162); emergency status expired May 18, 2020 **Administrative History:** Regulation .06-1 adopted as an emergency provision effective July 1, 2000 (27:15 Md. R. 1396); adopted permanently effective October 30, 2000 (27:21 Md. R. 1975) **Administrative History:** Regulation .07 amended effective December 28, 1987 (14:26 Md. R. 2746); June 28, 2010 (37:13 Md. R. 852) **Administrative History:** Regulation .07A amended effective November 11, 2002 (29:22 Md. R. 1721) **Administrative History:** Regulation .08 amended effective November 11, 2002 (29:22 Md. R. 1721) **Administrative History:** Regulation .08B adopted effective June 28, 2010 (37:13 Md. R. 852) **Administrative History:** Regulation .08B amended effective April 13, 2026 (53:7 Md. R. 328) **Administrative History:** Regulation .09 amended effective June 24, 1991 (18:12 Md. R. 1338); November 11, 2002 (29:22 Md. R. 1721); June 28, 2010 (37:13 Md. R. 852) **Administrative History:** Regulation .09A amended effective February 26, 2007 (34:4 Md. R. 400); March 31, 2014 (41:6 Md. R. 378); April 13, 2026 (53:7 Md. R. 328) **Administrative History:** Regulation .10A amended effective June 24, 1991 (18:12 Md. R. 1338); November 11, 2002 (29:22 Md. R. 1721) **Administrative History:** Regulations .11—.20 adopted as an emergency provision effective August 12, 1985 (12:18 Md. R. 1756), emergency status expired December 10, 1985; adopted permanently effective December 16, 1985 (12:25 Md. R. 2471) **Administrative History:** Regulation .13 amended effective May 23, 1994 (21:10 Md. R. 844) **Administrative History:** Regulation .20 amended effective December 28, 1987 (14:26 Md. R. 2746) **Administrative History:** Regulation .21 repealed effective March 13, 2017 (44:5 Md. R. 292) **Administrative History:** Regulation .22 repealed effective May 23, 1994 (21:10 Md. R. 844) **Administrative History:** Regulation .22 adopted effective April 16, 2012 (39:7 Md. R. 491) **Administrative History:** Regulation .23 adopted effective February 22, 1988 (15:4 Md. R. 473) **Administrative History:** Regulation .23A and C amended as an emergency provision effective June 9, 1988 (15:14 Md. R. 1653); emergency status expired December 9, 1988; adopted permanently effective December 26, 1988 (15:26 Md. R. 2982) **Administrative History:** Regulations .24—.26 adopted effective December 28, 1987 (14:26 Md. R. 2746) **Administrative History:** Regulation .24 amended effective March 1, 2004 (31:4 Md. R. 315); March 31, 2014 (41:6 Md. R. 378) **Administrative History:** Regulation .24C amended as an emergency provision effective May 6, 2025 (52:11 Md. R. 531); adopted permanently effective October 13, 2025 (52:20 Md. R. 1001) **Administrative History:** Regulation .24E amended effective April 16, 2012 (39:7 Md. R. 491) **Administrative History:** Regulation .25 repealed effective March 15, 2004 (31:5 Md. R. 448) **Administrative History:** Regulation .25 adopted effective February 25, 2008 (35:4 Md. R. 514) **Administrative History:** Regulation .26 recodified to Regulation .27, and new Regulation .26 adopted effective March 20, 1989 (16:5 Md. R. 629) **Administrative History:** Regulation .26 amended effective April 2, 1990 (17:6 Md. R. 741) **Administrative History:** Regulations .27—.31 adopted effective August 6, 1990 (17:15 Md. R. 1858) **Administrative History:** Regulation .27 recodified to Regulation .32 effective August 6, 1990 (17:15 Md. R. 1858) **Administrative History:** Regulations .27—.31 repealed effective May 23, 1994 (21:10 Md. R. 844) **Administrative History:** Regulation .27 adopted effective March 13, 2006 (33:5 Md. R. 520) **Administrative History:** Regulation .28 adopted effective June 28, 2010 (37:13 Md. R. 852) **Administrative History:** Regulation .28A amended effective April 13, 2026 (53:7 Md. R. 328) **Administrative History:** Regulation .29 adopted effective March 31, 2014 (41:6 Md. R. 378) **Administrative History:** Regulation .29F adopted effective April 23, 2018 (45:8 Md. R. 420) **Administrative History:** Regulation .30 adopted effective July 4, 2016 (43:13 Md. R. 712) **Administrative History:** Regulation .30A amended effective April 13, 2026 (53:7 Md. R. 328) **Administrative History:** Regulation .31 adopted effective March 27, 2017 (44:6 Md. R. 325) **Administrative History:** Regulation .32D amended effective November 11, 2002 (29:22 Md. R. 1721); June 28, 2010 (37:13 Md. R. 852) **Administrative History:** Regulation .32-1 adopted effective March 13, 2006 (33:5 Md. R. 520) **Administrative History:** Regulation .32-2 adopted effective March 13, 2006 (33:5 Md. R. 520) **Administrative History:** Regulation .32-3 adopted effective March 13, 2006 (33:5 Md. R. 520) **Administrative History:** Regulation .33 adopted effective November 11, 2002 (29:22 Md. R. 1721) **Administrative History:** Regulation .33A amended effective March 2, 2015 (42:4 Md. R. 433) **Administrative History:** Regulation .34 adopted effective April 21, 2008 (35:8 Md. R. 804) **Administrative History:** Regulation .35 adopted effective April 23, 2018 (45:8 Md. R. 420) **Administrative History:** Regulation .36 adopted effective April 23, 2018 (45:8 Md. R. 420) **Administrative History:** Regulation .37 adopted effective April 23, 2018 (45:8 Md. R. 420) #### Regulation .01 Definitions. *COMAR 10.07.01.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Accredited hospital” means a hospital accredited by The Joint Commission or other accreditation organization approved by the Department. (2) “Accredited special rehabilitation hospital” means a hospital that is accredited by the Commission on Accreditation of Rehabilitation Facilities for providing comprehensive physical rehabilitation services. (2-1) “Accreditation organization” means a private entity that conducts inspections and surveys of health care facilities based on nationally recognized and developed standards. (3) “Administrative day” means a day of care rendered to a patient who no longer requires the level of care the hospital is licensed to provide. (4) “Admission” means the formal acceptance by a hospital of a patient who is to be provided with room, board, and medical services. (4-1) Aftercare. (a) “Aftercare” means any assistance provided by a lay caregiver to a patient after discharge of the patient. (b) “Aftercare” includes tasks that are limited to the patient’s condition at the time of discharge that do not require a licensed professional. (5) “Agent” means the individual or individuals, or organization that shall conduct utilization review activities in fulfillment of a hospital's responsibilities under these regulations. The agent may be a hospital employee or employees, or it may be an independent group or organization. (6) “Appointment” means designation of a physician to have staff privileges at the hospital. (7) “Authorized decision maker” means the health care agent, guardian of the person, or surrogate decision maker who is making health care decisions on behalf of a patient in accordance with the Health Care Decisions Act, Health-General Article, §§5-601—5-618, Annotated Code of Maryland. (8) “Calculated licensed bed capacity” means the total number of inpatient beds recalculated annually as 140 percent of a general hospital's average daily census as determined by the Health Services Cost Review Commission for the most recent 12-month period. (9) “Claim” means a written demand for damages as a result of alleged professional malpractice. (10) “Commission on Accreditation of Rehabilitation Facilities” means the private, nonprofit organization formed in 1966 which has established standards of quality for rehabilitation services and accredits those who provide the services. (11) “Comprehensive physical rehabilitation services” has the same meaning as defined in Health-General Article, §19-1201(b), Annotated Code of Maryland. (12) “Credentialing process” means the process by which a hospital: (a) Verifies qualifications of a physician; (b) Delineates clinical privileges of a physician; and (c) Monitors performance of a physician. (13) “Department” means the Maryland Department of Health. (14) “Elective”, when applied to admission or to a health care service, means an admission or service that can be delayed without substantial risk to the health of the individual. (15) “Healthcare-associated infection” means an infection that: (a) Develops in a patient who is cared for in any setting where healthcare is delivered; and (b) Was not incubating or present at the time the healthcare was provided. (16) “Hospital” means an institution that: (a) Has a group of at least five physicians who are organized as a medical staff for the institution; (b) Maintains facilities to provide, under the supervision of the medical staff, diagnostic and treatment services for two or more unrelated individuals; and (c) Admits or retains the individuals for overnight care. (17) “Incident” means any circumstance or occurrence that may be injurious to a patient or that may result in an adverse outcome to a patient. (18) “The Joint Commission” means the voluntary national healthcare accreditation service recognized for Medicare certification purposes by Public Law 89-97 and for Maryland State licensure purposes by Health-General Article, §19-2302, Annotated Code of Maryland. (18-1) “Lay caregiver” means an individual who: (a) Is an adult; (b) Is designated as a lay caregiver by a patient or the legal guardian of a patient; and (c) Performs aftercare for the patient at the residence of the patient. (19) “License” means a license issued by the Secretary to operate a hospital in this State. (20) “Long-term care” means, for the purpose of this chapter, care provided in a hospital, but is designed to treat conditions requiring treatment at a level below that of acute hospital care. (21) “Maryland Medical Assistance Program” means the program administered by the State under Title XIX of the Social Security Act which provides comprehensive medical and other health-related care for eligible categorically and medically needy persons. For the purpose of this chapter, this shall include those persons provided care under the program administered and financed by the State for eligible needy persons who do not meet the technical requirements of federally funded Medical Assistance. (22) “Medical Orders for Life Sustaining Treatment (MOLST) form” means the form required to be developed pursuant to Health-General Article, §5-608.1, Annotated Code of Maryland. (23) “Medicare Program” means the federal program of health insurance for the aged and disabled established pursuant to 42 U.S.C. §1395 et seq. (24) “Nonaccredited hospital” means a: (a) Hospital not accredited by The Joint Commission or other accreditation organization approved by the Department; or (b) Special rehabilitation hospital not accredited by The Joint Commission. (25) “Nonelective”, when applied to admission or to a health care service, means an admission or service that cannot be delayed without substantial risk to the health of the individual. (26) “Palliative care” means specialized medical care for individuals with serious illnesses or conditions that: (a) Is focused on providing patients with relief from the symptoms, pain, and stress of a serious illness or condition, whatever the diagnosis; (b) Has the goal of improving quality of life for the patient, the patient’s family, and other caregivers; (c) Is provided at any age and at any stage in a serious illness or condition; and (d) Can be provided along with curative treatment. (27) “Palliative care program” means an interdisciplinary team that provides palliative care services. (28) “Physician” has the meaning stated under Health Occupations Article, §14-101(j), Annotated Code of Maryland. (29) “Plan” means a thorough written specification of how the elements of review required by these regulations shall be performed. (30) “Privilege” means the authority granted to a physician by a hospital to: (a) Admit patients to the hospital; or (b) Perform specific procedures or treatments on patients at the hospital. (30-1) Residence. (a) “Residence” means a dwelling that a patient considers to be home. (b) “Residence” does not include: (i) A rehabilitation facility; (ii) A hospital; (iii) A nursing home; (iv) An assisted living; or (v) A group home licensed by the State. (31) “Secretary” means the Secretary of Health. (32) “Specialized rehabilitation program” has the meaning stated in Health-General Article, §19-1201(e), Annotated Code of Maryland. (33) Telemedicine. (a) “Telemedicine” means the use of interactive audio, video, or other telecommunications or electronic technology by a physician in the practice of medicine outside the physical presence of the patient. (b) “Telemedicine” does not include: (i) An audio only telephone conversation between the physician and patient; (ii) An electronic mail message between a physician and a patient; or (iii) A facsimile transmission between a physician and a patient. (34) “Unexpected adverse outcomes” means unanticipated negative outcomes related to a patient’s medical treatment and not related to the natural course of the patient’s illness or underlying disease condition. (35) “Uniform standard credentialing form” means: (a) The form designated by the Department through COMAR 10.07.01.24C(6) for credentialing physicians who seek to be employed by or have staff privileges at a hospital; or (b) The uniform credentialing form that the Insurance Commissioner designates under Insurance Article, §15–112.1, Annotated Code of Maryland. (36) “Utilization review” means a system for reviewing the appropriate and efficient allocation of hospital resources and services given or proposed to be given to a patient or group of patients. (37) “Utilization review plan” means a description of the standards governing utilization review activities performed by a private review agent or hospital utilization review agent. #### Regulation .02 Incorporation by Reference. *COMAR 10.07.01.02* The following documents are incorporated by reference: A. Guidelines for Design and Construction of Hospitals, The Facilities Guidelines Institute (2022 Edition); and B. 2025 Hospital Accreditation Standards, Elements of Performance, The Joint Commission, (December 15, 2024). #### Regulation .03 Hospital Classification. *COMAR 10.07.01.03* A. General Hospital. A hospital shall be classified as a general hospital if the hospital at least has the facilities and provides the services that are necessary for the general medical and surgical care of patients. B. Special Hospital. A hospital shall be classified as a special hospital if the hospital: (1) Defines a program of specialized services, such as obstetrics, mental health, tuberculosis, orthopedy, chronic disease, or communicable disease; (2) Admits only patients with medical or surgical needs within the program; and (3) Has the facilities for and provides those specialized services. C. Special Rehabilitation Hospital. A hospital shall be classified as a special rehabilitation hospital if the hospital provides or holds itself out as providing comprehensive physical rehabilitation services. #### Regulation .04 Licensure Application Procedure. *COMAR 10.07.01.04* A. A person desiring to open a hospital, to continue the operation of an existing hospital, or to change the classification of an existing hospital shall file an application with the Secretary, on a written or electronic form provided by the Secretary. An application shall state the classification of hospital for which a license is sought. B. Applications on behalf of a corporation, association, or governmental unit or agency shall be made by two officers of the corporation, association, or governmental unit or agency and names of their Board members shall be submitted. Ownership of property, real estate, and equipment shall be disclosed if it is other than the licensee's. The names of persons holding 2 percent or more of the stock or assets shall be disclosed. C. License Renewal. An application for the renewal of the license on a written or electronic form provided by the Secretary shall be made: (1) By a nonaccredited hospital at least 60 days before expiration of the issued license; or (2) By an accredited hospital within 30 calendar days of the exit date of the triennial survey conducted by an accreditation organization approved by the Department. D. License Fees. (1) All applications shall be accompanied by the fee established by the Secretary. (2) Accredited hospitals shall submit a $3,000 nonrefundable license fee per accreditation period, payable to the Department. (3) Nonaccredited hospitals shall submit a $1,000 nonrefundable annual license fee, payable to the Department. E. In order to ensure that the hospital's licensure information is current, the hospital shall immediately notify the Department in writing of any change in the hospital's: (1) Name; (2) Administrator; or (3) Contact information such as mailing address and telephone number. F. In order to ensure the completion of any review or inspection by the Department of any major renovations, construction of patient care areas, or the establishment of a medical service as defined under Health-General Article, §19-120, Annotated Code of Maryland, and not previously provided by the hospital, the hospital shall notify the Department 60 days before its occupancy or operation. #### Regulation .05 Duration of License. *COMAR 10.07.01.05* A. The Secretary shall issue a license to an accredited hospital or special rehabilitation hospital for the term of the facility's accreditation. B. The Secretary shall issue a license to a nonaccredited hospital for a term not to exceed 1 year. #### Regulation .06 Separate License Required. *COMAR 10.07.01.06* A. Separate licenses are required for institutions maintained on separate premises, even though both institutions are operated under the same management. B. Separate licenses are not required for separate buildings on the same grounds. #### Regulation .06-1 Licensed Bed Capacity. *COMAR 10.07.01.06-1* A. On or before July 1, 2000, and each July 1 thereafter, the Secretary shall determine the authorized licensed bed capacity for each hospital classified as a general hospital. B. Methodology for Calculating Total Authorized Licensed Bed Capacity. (1) The average daily census for each general hospital shall be obtained from the most current Health Services Cost Review Commission inpatient utilization data for a 12-month period. (2) The calculation of average daily census shall include the utilization of inpatient medical-surgical, gynecology, obstetric, pediatric, and acute psychiatric service beds. Newborn services are excluded from the calculation of average daily census. (3) The total licensed bed capacity for each general hospital shall equal 140 percent of the calculated average daily census for all inpatient acute care hospital services. C. Application for Designation of Licensed Bed Capacity by Service. (1) The Secretary shall annually forward to each general hospital its calculated total licensed bed capacity for the next licensure period and the current allocation of beds by major service category. (2) In a format specified by the Secretary, each general hospital shall notify the Department of its designation of total beds by major service category for the next licensure period. (3) The Maryland Health Care Commission shall review and approve the designation of total beds by major service category. (4) This section does not permit a general hospital to reallocate bed capacity in a manner inconsistent with applicable statute and regulations. D. On or before July 1, 2000, and each July 1 thereafter, the Secretary shall delicense any licensed hospital beds determined to be excess bed capacity under Regulation .07B of this chapter. E. Temporary Adjustments to Calculated Licensed Bed Capacity. (1) If necessary to adequately meet demand for services, a general hospital may exceed its calculated licensed bed capacity if: (a) On average for the 12-month period, the hospital does not exceed its licensed bed capacity based on the annual calculation; and (b) The hospital includes in its monthly report to the Health Services Cost Review Commission the following information: (i) The number of days in the month the hospital exceeded its licensed bed capacity, and (ii) The number of beds that were in excess on each of those days. (2) A hospital exceeding its calculated licensed bed capacity shall notify the Department within 5 business days of the effective dates of the change in a format specified by the Secretary. #### Regulation .07 Inspections. *COMAR 10.07.01.07* A. New Hospitals. A hospital that began initial operation on or after July 1, 1982, shall be inspected for compliance with the safety and sanitation components of the regulations promulgated by the Department until the hospital receives accreditation by an accreditation organization approved by the Department. If the hospital has not applied for accreditation by an accreditation organization approved by the Department within 1 year after beginning operation or has had its application for accreditation rejected, the Department shall inspect the hospital for compliance with the standards adopted under this subtitle. B. Accredited Hospitals and Accredited Special Rehabilitation Hospitals. An accredited hospital and an accredited special rehabilitation hospital shall be subject to inspection under this chapter by the Department to: (1) Determine compliance with a quality requirement; (2) Follow up on any serious problem identified by an accreditation organization approved by the Department; (3) Investigate a complaint; or (4) Validate the findings of an accreditation organization approved by the Department. C. Nonaccredited Hospitals. Nonaccredited hospitals shall be subject to at least two inspections per year by the Department. D. Inspection by Secretary. The Secretary may inspect any: (1) Hospital record or record of any utilization review agent of a hospital pertaining to review activities under the utilization review plan of the hospital to enforce the provisions of Regulations .13—.22 of this chapter; (2) Physician credentialing record to enforce the provisions of Regulation .24 of this chapter; and (3) Hospital patient safety record, patient complaint record, or hospital patient record pertaining to review activities under a hospital's patient safety program to enforce the provisions of COMAR 10.07.06. #### Regulation .08 Complaint Investigations. *COMAR 10.07.01.08* A. Notwithstanding any other provisions of this subtitle, each hospital and residential treatment center shall be open to inspections by the Department to investigate and resolve any complaint concerning patient care, safety, medical and nursing supervision, physical environment, sanitation, or dietary matters. B. Complaints. (1) To resolve expeditiously a complaint that alleges the existence of any non-life-threatening deficiency, the Department shall refer the complaint directly to the hospital. (2) If appropriate, issues relating to the practice of medicine or the licensure or conduct of a health professional shall be referred to the hospital and may be referred to the appropriate licensure Board for resolution. (3) If the Department determines that the hospital has not satisfactorily addressed the referred complaint or if the complaint alleges the existence of a life-threatening deficiency, the Department shall conduct an independent investigation. When conducting its independent investigation, the Department shall use the standards adopted by the Secretary under this subtitle and: (a) For an accredited hospital, the hospital accreditation standards of the accreditation organization that accredits the hospital; (b) For an accredited special rehabilitation hospital, the service standards adopted by the Secretary in Regulation .10 of this chapter; or (c) For a nonaccredited hospital, the standards adopted by the Secretary in Regulation .09 of this chapter. #### Regulation .09 Service Standards — Nonaccredited Hospitals. *COMAR 10.07.01.09* A. Acute General Hospitals and Special Hospitals. Nonaccredited acute general and special hospitals shall comply with The Joint Commission’s Hospital Accreditation Standards. B. Waiver Authority. The Secretary may, for good cause, waive compliance with the incorporated Joint Commission standards. The hospital shall justify the need for the waiver in the manner prescribed by the Department. #### Regulation .10 Service Standards — Special Rehabilitation Hospitals. *COMAR 10.07.01.10* A. Before a special rehabilitation hospital can provide or hold itself out as providing comprehensive physical rehabilitation services, the special rehabilitation hospital shall: (1) Except as otherwise provided in this regulation, be accredited by the Commission on Accreditation of Rehabilitation Facilities; and (2) Meet the standards of the Commission on Accreditation of Rehabilitation Facilities as set forth in the Medical Rehabilitation Standards Manual, which is incorporated by reference under COMAR 10.07.18.05. B. Waiver of Accreditation. (1) To allow a special rehabilitation hospital to achieve accreditation by the Commission on Accreditation of Rehabilitation Facilities as required under this regulation, the accreditation requirement shall be waived for any special rehabilitation hospital that has submitted an appropriate application for accreditation. (2) The waiver under this section shall be effective for not more than 2 years from the later of: (a) July 1, 1986; or (b) The date on which the facility begins operations. #### Regulation .11 Special Rehabilitation Programs — Hospitals. *COMAR 10.07.01.11* A. Except as otherwise provided in this regulation, before a hospital can provide or hold itself out as providing any specialized rehabilitation program, the hospital shall be accredited by the Commission on Accreditation of Rehabilitation Facilities to provide the program. B. The requirement that a hospital be accredited by the Commission on Accreditation of Rehabilitation Facilities before the hospital can provide any specialized rehabilitation program shall be waived if the hospital has applied for accreditation for the program, for not more than 2 years from the later of: (1) July 1, 1986; or (2) The date on which the hospital begins operation of the specialized rehabilitation program. #### Regulation .12 Records and Reports — Inspection. *COMAR 10.07.01.12* Licensees shall keep such records and make reports in the manner and form as the Secretary shall prescribe by regulation, and all these records shall be open to inspection by the Secretary. #### Regulation .13 Utilization Review Plan. *COMAR 10.07.01.13* A. Before October 1, 1985, each hospital shall submit a proposed utilization review plan to the Secretary. B. Effective October 1, 1985, each hospital shall have in effect a utilization review plan approved by the Secretary pursuant to this chapter. C. The purpose of the hospital's utilization review program, as defined by the plan, shall be to determine for patients included in the hospital's review responsibilities the: (1) Reasonableness and medical necessity of care given or proposed to be given at the hospital; (2) Quality of care given at the hospital; and (3) Appropriateness of the level of care proposed or given, including whether the care could be or could have been provided appropriately and more economically on an outpatient basis or in a facility that provides a lower level of care. D. A utilization review plan shall: (1) Identify the designated utilization review agent; (2) Describe the criteria to be used in evaluating proposed or delivered hospital care; (3) Delineate the types and kinds of cases that the agent will review and the circumstances under which either some or all patients in the hospital, or within specific diagnostic groups, will be selected; (4) Make provisions for the collecting, storing, and reporting of data; (5) Define measures by which the agent can evaluate the effectiveness of its program; (6) Make provisions for screening medical records pertaining to patients for which the agent has review responsibility in order to identify and verify problems in the quality of care; (7) Establish a mechanism through which patients, physicians, or third-party payers may seek reconsideration of decisions made by the utilization review agent; (8) Detail how each of the following elements is to be performed by the agent: (a) Pre-admission review of elective admissions; (b) Post-admission review of nonelective admissions; (c) Concurrent or retrospective review of admissions; (d) Pre-authorization of certain selected procedures proposed to be performed on an inpatient basis; (e) Institution of an objective second surgical opinion protocol to evaluate the desirability of performing selected surgical procedures on an elective basis; (f) Discharge planning review; (g) Continued stay review; and (h) Re-admission review; (9) Meet all other requirements for utilization review promulgated by the Secretary. #### Regulation .14 Utilization Review Agent. *COMAR 10.07.01.14* A. Each hospital shall appoint a utilization review agent to carry out the requirements of the utilization review plan. When the agent is composed of hospital related personnel the hospital's plan shall expressly designate the positions and the organizational structure within the hospital that constitute the utilization review agent for that institution. B. Each utilization review plan shall set forth the manner in which the agent: (1) Utilizes the services of doctors of medicine or osteopathy and other practitioners capable of admitting patients, who are representative of practicing physicians in the area in which the hospital is located. (2) Has available the services of sufficient numbers of physicians and dentists to assure the adequate review of medical specialty and subspecialty cases. (3) Utilizes the services of registered nurses, medical records technicians, or similarly qualified persons supported and supervised by physicians in carrying out its review activities. (4) Uses only a doctor of medicine, osteopathy, or dentistry to make a final determination that care rendered or to be rendered was, is, or may be medically inappropriate. (5) Makes direct comparisons with professionally developed, objective criteria to determine the appropriateness of admission and continued stay. The criteria should: (a) Be nationally recognized and accepted, unless a special exception is granted by the Secretary; (b) Be capable of being utilized to define the type and extent of services which are to be considered as within the range of appropriate diagnosis and treatment for a given condition; (c) Identify the level of care at which the services can appropriately and economically be rendered; and (d) Recognize that for many conditions more than one mode or site of treatment or diagnosis may be medically acceptable. (6) Collects information relevant to its function, maintains records, and reports to the Department as required. The hospital's utilization review plan shall outline the method by which patient confidentiality shall be maintained. C. A member of the agent's staff, or any person that the agent may delegate or employ, may not review or make a determination of appropriateness for care that that person was directly responsible for providing, or which was provided by or to a member of that person's family. #### Regulation .15 Performance Standards for Utilization Review. *COMAR 10.07.01.15* The hospital's program shall apply to all patients with the exceptions of those noted in Regulation .17, below. Except when noted for certain types of review, the program may delineate certain types and kinds of cases to be reviewed, so as to most efficiently carry out the purposes of these regulations. As a minimum, the hospital utilization review program shall satisfy the following performance standards: A. Pre-admission Review. (1) A review of those elective admissions identified under the plan shall be performed by the agent in advance of the proposed admission. (2) The purpose of this review shall be to determine the reasonableness and medical necessity of the admission, and the appropriateness of the level of proposed care. (3) In conducting the review, the agent may supplement the information provided by the hospital through discussion with the patient's physician. (4) The agent, using specific medical criteria, shall render a decision as to whether the admission is medically appropriate within 3 working days of the time it receives the case, except in those circumstances when responding within this period would not permit sufficient consultation or discussion to render a responsible opinion. B. Post-admission Review. (1) For those categories of emergency admissions identified for review in the hospital's plan, the agent shall carry out a review to ascertain the: (a) Reasonableness and medical necessity of the admission; (b) Appropriateness of the level of care provided; and (c) Justification for the non-elective nature of the admission. (2) The agent shall be notified by the hospital within 24 working hours of the admission and the agent shall carry out the review within 3 working days of notification, except in cases when appropriate consultation cannot be carried out in this period of time. C. Concurrent or Retrospective Review. (1) For patients included in the plan the agent shall determine whether each day of the patient's hospitalization was medically necessary and appropriate based upon nationally recognized criteria. The agent shall also designate those days of hospitalization caused by administrative requirements including days on which patients await appropriate placement or equipment needed after discharge. (2) The review may be concurrent with the patient's stay or take place after the patient is discharged. (3) Days designated as administrative shall be found appropriate only if approved under discharge planning review, as discussed in §F. D. Pre-authorization Review. (1) The agent shall review prospectively all elective admissions in which one or more of the plan designated procedures is the principal procedure being performed for that admission. (2) The procedures for which pre-authorization is required are set forth in Regulation .21. (3) The agent may approve inpatient treatment for the listed procedures only if there is documentation that equivalent outpatient treatment would not be medically appropriate for the patient. (4) All non-elective admissions that have not been pre-authorized and that subsequently involve performance of one or more of the plan designated procedures shall be reviewed concurrently or retrospectively by the agent. E. Objective Second Opinion. (1) Before an elective admission for a surgical procedure designated below, the patient shall obtain an objective second opinion. (2) The procedures for which a second opinion is required are set forth in Regulation .22. (3) The second opinion may be rendered by any physician of the patient's choosing except a physician having any financial relationship with the patient's original physician. (4) Should a voluntary admission not take place within 6 months of the rendering of the second opinion, then another opinion shall be sought before admission. (5) The agent may waive the requirement for obtaining a second opinion because: (a) Obtaining the second opinion would impose a hardship on the patient; or (b) The patient's medical insurance does not cover second opinions, and was: (i) Issued and delivered in another state, and (ii) Not intended to cover persons living or working in Maryland. F. Discharge Planning. (1) The utilization review plan shall set forth the hospital's discharge planning procedures. (2) The agent shall review the effectiveness of the hospital's discharge planning. (3) The agent shall review those days of care which have been designated to be administrative as a result of the agent's concurrent or retrospective review. (4) Administrative days may be approved as necessary and appropriate only if evidence can be found that the hospital has developed and implemented a discharge plan at the earliest possible time and there is evidence that appropriate placement efforts have been made. G. Continued Stay Review. For patients in beds licensed for long term care, the agent shall periodically review and certify as appropriate the level of care and placement, and the medical necessity of treatment prescribed. H. Re-admission Review. The agent shall review the appropriateness of the previous discharge and the indications for admission for hospitalizations occurring shortly after a previous discharge. #### Regulation .16 Protection of Patients — Patient Liability. *COMAR 10.07.01.16* A. Charges for any days disallowed as a result of retrospective review by the agent or by a payer conducting utilization review under these regulations shall be deducted from the gross charges in the bill to the patient as a contractual allowance unless the patient refuses or has refused to leave the hospital when it is medically appropriate to do so, and the disallowed days occur: (1) After the hospital has notified the patient in writing of the potential disallowance; or (2) As a direct result of the noncompliance by the patient to treatment or hospital regulations. B. If a bill is generated before the receipt of the results of retrospective review, a subsequent adjustment to the bill, if required under Sec. A, above, shall be issued by the hospital. The final bill shall demonstrate all procedures, services, or days of care found to be inappropriate. C. In cases when a form of review other than retrospective review was performed, each patient bill generated by the hospital shall clearly demonstrate all procedures, services, or days of care which have been found to be inappropriate or have been disallowed by the hospital's utilization review agent or any other reviewer or payer conducting utilization review. D. The utilization review agent shall be responsible for establishing a process by which physicians and patients may request clarification and reconsideration of review decisions. These clarifications or reconsiderations shall be carried out in a timely fashion, and patients shall be granted full access to any medical records maintained by the agent pertaining to their care to the extent permitted under Health-General Article, § 4-302, Annotated Code of Maryland. #### Regulation .17 Exemptions from Hospital Utilization Review. *COMAR 10.07.01.17* A. A hospital shall be exempt from carrying out utilization review procedures for a given patient if the: (1) Person, corporate entity, or insurance plan paying for the patient's hospitalization has a utilization review program that is determined by the Insurance Commissioner and the Secretary to substantially meet the minimum standards described in these regulations, including the reporting requirements detailed in Regulation .19 of this chapter, those programs and amendments to them having been submitted to the Commissioner for approval; (2) Patient is a subscriber or a member of a health maintenance organization as defined in Health-General Article, §19-701, Annotated Code of Maryland; or (3) Patient is a Medicare or Maryland Medical Assistance Program beneficiary, and the services rendered at the hospital are within the scope of coverage provided by the relevant program. B. The Secretary will issue yearly lists of third-party payers known to have utilization review plans that qualify for the exemption described in this regulation. #### Regulation .18 Record Maintenance by Utilization Review Agents. *COMAR 10.07.01.18* A. The plan shall describe how, in addition to maintaining documents which describe its utilization review procedures, the agent shall maintain the following records for each individual patient for whom any aspect of the utilization review procedure has been applied: (1) The patient's name, hospital history number, source of payment, and other demographic information capable of identifying the patient. (2) The principal diagnosis or diagnoses (with corresponding codes listed in the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) as defined in COMAR 10.09.06.01P), and the particular category of patient chosen for review in accordance with the hospital's utilization review plan. (3) The date or dates on which review activities were requested and the date or dates on which opinions were rendered. (4) The type of review carried out, the nature of the criteria applied, and the results of the review. In the case of disallowed services, the reasons for disallowance shall be stated, as well as the name of the physician member of the agent's staff making the final disallowance determination. (5) In the case of objective second opinions, documentation shall include the name of the physician rendering the second opinion, the physician's specialty, and the nature of the opinion. B. Each agent shall maintain a listing of all reviewed cases suitable for the selection of a sample of all cases reviewed within each 2-year certification period. #### Regulation .19 Reports to the Secretary. *COMAR 10.07.01.19* A. Each hospital shall report annually to the Secretary the following summary statistics on the activity of its utilization review program: (1) The number of discharges and total patient days reviewed under the program; (2) For each of the procedures requiring pre-authorization for inpatient treatment, the number of patients: (a) Reviewed; and (b) Approved for inpatient treatment; (3) For each of the procedures requiring an objective second opinion, the number of patients: (a) Undergoing the procedure at the hospital; (b) Admitted non-electively for the procedure; (c) Admitted electively after the patient had obtained a second opinion; and (d) Admitted electively but for whom the requirement of a second opinion was waived, including a tabulation of the reasons for waivers; (4) For admissions reviewed concurrently or retrospectively, the number of all reviewed admissions disapproved, and reasons for disapproval; (5) The number of all reviewed days of hospitalization disapproved, by reason for disapproval; (6) A summary of the findings of re-admission review, including the frequency and proportion of these cases, the diagnoses or treatments involved, and the reasons found; (7) A listing and description of quality care problems found by the agent in the course of reviewing patient records in furtherance of its duties under the utilization review plan. B. The Secretary shall be allowed access to hospital patient records and to the records of the hospital's utilization review agent pertaining to review activities under the plan for the purpose of enforcing these regulations. #### Regulation .20 Penalties. *COMAR 10.07.01.20* If a hospital fails to submit a utilization review plan or fails, after adequate discussion with the Department, to develop an approvable plan, or fails to operate a plan which has been approved, then the Secretary may impose upon the hospital the following penalties: A. Delicensure of the hospital; or B. A fine of $500 for each day that the hospital is in violation of these regulations. #### Regulation .21 Procedures for Which Preauthorization is Required — Repealed. *COMAR 10.07.01.21* #### Regulation .22 Practitioner Performance Evaluation. *COMAR 10.07.01.22* A. Consistent with the standards of the Joint Commission for focused and ongoing professional performance evaluations, the hospital shall establish a practitioner performance evaluation process that objectively evaluates the performance of each member of the medical staff. B. The hospital’s practitioner performance evaluation process shall include a review of care which shall: (1) Be undertaken for cases: (a) Chosen at random; and (b) With unexpected adverse outcomes; (2) Be based on objective review standards; (3) Include a review of the appropriateness of the plan of care for the patient, particularly any medical procedures performed on the patient, in relation to the patient’s condition; and (4) Be conducted by members of the medical staff, or at the discretion of the hospital, by external reviewers, who: (a) Are of the same specialty as the member of the medical staff under review; (b) Have been trained to perform practitioner performance evaluation; and (c) Are not otherwise associated with the case under review. C. A hospital shall take into account the results of the practitioner performance evaluation process for a member of the medical staff in the reappointment process. #### Regulation .23 Guidelines Governing the Transfer of Patients Between Hospitals. *COMAR 10.07.01.23* A. If a hospital is able to provide adequate care to a patient, the hospital may not transfer the patient to another hospital unless: (1) One or more of the following circumstances is present: (a) The patient does not have a physician with privileges at the hospital and the patient refuses treatment by any physician with privileges at the hospital; (b) The patient or a legally authorized representative of the patient requests the transfer; (c) The transfer is in compliance with relevant sections of Health-General Article, Title 10, Subtitle 8, Annotated Code of Maryland; (d) The transfer is in compliance with the Interstate Compact on Mental Health as adopted in Health-General Article, Title 11, Annotated Code of Maryland; or (e) The transfer is in compliance with any agreement entered into between the Department and a hospital for the provision of acute inpatient psychiatric care in State hospital conversion beds; (2) These circumstances are documented in the patient's medical record; and (3) The provisions of this regulation are met. B. A hospital may not use the inability of a patient to pay or the source of payment for a patient as a reason to transfer the patient to another hospital. C. Before moving a patient, the transferring hospital shall: (1) Determine that the patient can be transferred without causing harm to the patient; (2) Notify the receiving hospital of the transfer; and (3) Unless otherwise provided for in an agreement with the Department for State hospital conversion beds, obtain from the receiving hospital confirmation that: (a) The receiving hospital consents to accept the patient; and (b) The patient meets any criteria that the receiving hospital has established for admission regarding: (i) The patient's required level of care; (ii) Physician services available; and (iii) Other services necessary to treat the patient. D. Explanation of Transfer. (1) Except as otherwise provided in §C(2),, of this regulation, before moving a patient, the transferring hospital shall provide explanation of the reasons for the transfer and any alternative to the transfer to the patient or to a legally authorized representative of the patient. (2) If the transferring hospital can document that the necessity to move the patient to the receiving hospital is immediate to protect the health, safety, or welfare of the patient, the transferring hospital may give the explanation required in §C(1), of this regulation, concurrently with the transfer. E. In effecting a transfer, the transferring hospital shall provide that: (1) Medically appropriate life-support measures that a reasonable and prudent physician exercising ordinary care would use are used to stabilize the patient before transfer and sustain the patient during transfer; (2) Appropriate personnel and equipment that a reasonable and prudent physician exercising ordinary care would use are provided and used in the transfer; and (3) All records necessary for continuing the patient's care are transferred with the patient. F. The Department shall inspect hospitals for compliance with this regulation as provided in Regulations .07 and .08 of this chapter. G. Penalties. (1) The Secretary may impose a penalty not exceeding $1,000 per violation on any hospital that violates this regulation. (2) In determining the amount of the penalty, the Secretary shall consider: (a) The hospital's history of previous violations; (b) The seriousness of the violation; (c) Whether the hospital demonstrated good faith in attempting to comply with this regulation; and (d) Whether the violation threatened the health or safety of: (i) A patient; or (ii) The public. #### Regulation .24 Physician Credentialing Process. *COMAR 10.07.01.24* A. General. In accordance with this regulation, a hospital shall have in effect a credentialing process. B. Scope of Credentialing Process. The credentialing process shall apply to any physician who shall admit or treat patients in the hospital. C. Specific Standard — Appointment and Employment Process. (1) In accordance with this section, a hospital shall establish a formal written process for the appointment or employment of a physician by the hospital. (2) The term of an appointment may not exceed the term established by the standards of the accreditation organization that accredits the hospital. (3) The formal written appointment or employment process shall provide for a probationary period that shall be successfully completed before the finalization of the appointment or employment of the physician. (4) As part of the formal written appointment and employment process, the hospital shall collect, verify, review, and document the following information about the physician: (a) The physician's education; (b) The clinical expertise of the physician; (c) The professional experience of the physician including: (i) Any board certification or specialty training of the physician; (ii) The internship of the physician; and (iii) The residencies of the physician; (d) Any license or registration to practice a health occupation ever held by the physician, including: (i) A license to practice medicine; and (ii) DEA registration; (e) Whether any license or registration to practice a health occupation ever held by the physician has been: (i) Suspended; (ii) Revoked; (iii) Voluntarily surrendered or not renewed; (f) Concerning any hospital where the physician was appointed or employed: (i) The name of the hospital; (ii) The term of appointment or employment; (iii) Privileges held and any disciplinary action taken on the privileges, including suspension, revocation, limitation, or voluntary surrender; (g) Concerning the physician's professional liability insurance: (i) The physician's present carrier; (ii) The physician's current limits of coverage; (iii) The physician's current types of coverage; (iv) Restrictions on the physician's coverage; and (v) Whether or not the physician has maintained continuous malpractice coverage since first obtaining professional insurance; (h) Any claim that has been made against the physician in the practice of any health occupation and the status of the claim; (i) The physician's medical history including the physician's current mental and physical health status; (j) A complaint or report filed with: (i) The Board of Physicians or any other state medical discipline agency; (ii) A state medical society; (iii) A state disciplinary body; or (iv) A professional or specialty association. (5) The formal written process shall provide for the documentation of any action taken by the hospital regarding the appointment or employment of the physician. (6) Uniform Standard Credentialing Form. (a) A hospital shall use the uniform standard credentialing form approved by the Department for the initial credentialing of a physician seeking appointment or employment. (b) Use of the uniform standard credentialing form does not preclude a hospital from requiring additional information, attestations, or supplemental documentation as required by that hospital's credentialing process. (c) A physician seeking hospital privileges shall submit an updated and complete uniform standard credentialing form at the time of application to each hospital. D. Specific Standard — Granting of Delineated Clinical Privileges. (1) In accordance with this section, a hospital shall establish a formal written process for the granting of delineated clinical privileges. (2) The formal written process shall include: (a) Criteria for determining whether a physician shall be granted privileges by the hospital to provide specific services; (b) Criteria for ongoing evaluation of the performance of the services for which privileges have been granted; (c) Procedures for altering, suspending, or revoking the delineated privileges. (3) The formal written process shall provide for documentation of any actions taken regarding delineated privileges. E. Specific Standard — Reappointment. (1) In accordance with this section, a hospital shall establish a formal written process for the reappointment of a physician who has been appointed to the hospital. (2) The term of reappointment shall be 2 years or less. (3) As part of the formal written appointment process, a hospital shall collect, verify, review, and document the following information about the physician: (a) An update of the information regarding appointment under §C of this regulation; (b) Concerning the physician's pattern of performance based on an analysis of the following: (i) Claims filed against the physician; (ii) Utilization, quality and risk data; (iii) A review of clinical skills; (iv) Adherence to hospital bylaws, policies, and procedures; (v) Compliance with continuing medical education requirements; (vi) An assessment of current mental and physical health status; (vii) Attitudes, cooperation, and the ability to work with others; and (viii) The results of the Practitioner Performance Evaluation process as described in Health-General Article, §§19-3B-01—19-3B-09, Annotated Code of Maryland. F. Specific Standard — Record Maintenance. (1) In accordance with this section, a hospital shall maintain a separate credentialing file for each physician. (2) The credentialing file for each physician shall contain documentation relating to the credentialing process required under this regulation. G. Disaster Privileges. (1) During an emergency or disaster in which the hospital's disaster or emergency management plan has been activated, when the Governor has declared that a state of emergency exists, or when the Secretary has issued an order pursuant to Health-General Article, §18-905, Annotated Code of Maryland, the chief executive officer, medical staff president, or designee may grant temporary disaster privileges to licensed physicians who have not been appointed to the hospital's medical staff. (2) The hospital shall develop a medical staff plan for the granting of disaster privileges that identifies: (a) The individual responsible for granting disaster privileges; (b) The responsibilities of that individual; (c) A system to manage, assign, and supervise the physicians who have been granted disaster privileges; and (d) The process by which credentials and privileges are verified as soon as the situation allows, ensuring that the process complies with §C of this regulation. (3) Physicians granted disaster privileges by a hospital shall: (a) Be registered and trained by the Department as part of the Department's Maryland Physician Volunteer Corps and possess the Department issued photo identification; or (b) Comply with the hospital's medical staff plan for granting privileges in a disaster, which shall require at least one of the following: (i) Presentation of a current Maryland license to practice medicine and a valid identification picture (ID) issued by a state, federal, or regulatory agency; (ii) Presentation of a license to practice medicine from another state if a state of emergency has been declared by the Governor and the assistance of the physician has been requested by Maryland pursuant to the Emergency Management Assistance Compact, Public Safety Article, §14-702, Annotated Code of Maryland; (iii) Presentation of a current photo identification card from another Maryland hospital where the physician is a member of the medical staff; or (iv) Verification by a current member of the hospital's medical staff who has personal knowledge regarding the practitioner's identity and current Maryland medical licensure. (4) Disaster privileges shall be discontinued when the hospital's chief executive officer, medical staff president, or designee determines that the emergency condition no longer exists and that the hospital has adequate resources to meet the patient's needs. (5) The hospital shall maintain records that include: (a) The number of hours worked by each physician; (b) The type of service provided by each physician; (c) The location where these services were provided; and (d) Any additional information required by the Department for federal and State reimbursement. H. Telemedicine. Notwithstanding any other provision of COMAR 10.07.01.24, in its credentialing and privileging process for a physician who provides medical services to the patients at the hospital only through telemedicine from a distant-site hospital or distant-site telemedicine entity, a hospital may rely on the credentialing and privileging decisions made for the physician by the distant-site hospital or distant-site telemedicine entity as authorized under 42 C.F.R. Part 482, if: (1) The physician who provides medical services through telemedicine holds a license to practice medicine in the State under Health Occupations Article, Title 14, Annotated Code of Maryland; and (2) The credentialing and privileging decisions with respect to the physician who provides medical services through telemedicine are: (a) Approved by the medical staff of the hospital; and (b) Recommended by the medical staff of the hospital to the hospital’s governing body. I. Request for Documentation by Department. On request from the Department, a hospital shall provide documentation that before: (1) Appointment or employment of a physician or granting delineated privileges, the hospital has complied with the requirements of this regulation; and (2) Reappointment or renewing of employment or specific privileges, the hospital has complied with the requirements of this regulation. J. Penalties. If a hospital fails to have in effect a credentialing process in accordance with these regulations, the Secretary may impose upon the hospital the following penalties: (1) Delicensure of the hospital; or (2) A fine of $500 for each day that the hospital is in violation of these regulations. #### Regulation .25 Medical Professional Liability Closed Claim Form. *COMAR 10.07.01.25* A. A hospital shall complete and submit to the Department the approved Medical Professional Liability Closed Claim form, for each medical liability claim filed regarding the care or services received by a patient under the care of that hospital. B. Regardless of the result of a closed claim, the hospital shall submit the Medical Professional Liability Closed Claim form to the Department within 90 days after the end of the quarter during which the final judgment, settlement, or final disposition of the claim was made. #### Regulation .26 Anatomical Donations. *COMAR 10.07.01.26* A. This regulation does not: (1) Limit the right of an individual to make a gift under the Anatomical Gift Act, Estates and Trusts Article, Title 4, Subtitle 5, Annotated Code of Maryland; or (2) Interfere with the duties of the office of the Chief Medical Examiner. B. A hospital shall develop and follow a protocol in accordance with this regulation for the procurement of organs and tissues. C. Requests for Donation on Death of Patient. (1) In accordance with this regulation, whenever a patient of a hospital meets the following criteria, the administrator of the hospital shall designate a person to request that the representative of the patient consent to the donation of the organs and tissues of the patient: (a) The patient may be pronounced dead in accordance with Health-General Article, §5-202, Annotated Code of Maryland; (b) The patient has not given actual notice of an objection to the donation of his or her organs and tissues; and (c) The patient has not made a gift of all or part of his or her body under the Anatomical Gift Act, Estates and Trusts Article, Title 4, Subtitle 5, Annotated Code of Maryland. (2) A hospital may not make a request for consent to a donation if the use of all of the organs or tissues of the patient is medically contraindicated. (3) In making a request required in §C(1), of this regulation, the hospital designee shall: (a) Make a reasonable effort to locate and contact the appropriate person set forth in §D, of this regulation, as the representative of the deceased patient; and (b) Request that the representative consent to a donation of any organ or tissue of the patient which is suitable for donation. D. Determination of Patient Representative for Consent to Donation. (1) The representative of a deceased patient shall be: (a) The spouse of the patient, but, if the spouse is not competent; then (b) Any adult son or daughter of the patient, but, if no adult child of the patient is competent; then (c) Either parent of the patient, but, if neither is competent; then (d) Any adult brother or sister of the patient, but, if no adult sibling of the patient is competent; then (e) Any guardian of the person of the patient, but, if the patient has no guardian of his or her person; then (f) Any other person authorized or obligated by law to dispose of the body of the patient. (2) If the death of a patient occurs suddenly and the patient was in apparent good health or unattended by a physician, the hospital shall notify and cooperate with the office of the Chief Medical Examiner before the removal of any organ or tissue. E. Discretion and Sensitivity in Making Requests. In making a request for donation, the hospital designee shall show reasonable discretion and sensitivity to the: (1) Circumstances of the family of the patient; (2) Religious beliefs of the patient; and (3) Suitability of the organs or tissues for donation. F. Documentation. The designee shall document in the medical record of the patient: (1) Any request made for donation of organs or tissues; (2) Any consent to donate organs or tissues; (3) Whether a donation is made and accepted; (4) Any objection to the donation made by: (a) The patient, or (b) An appropriate representative of a patient as set forth in §D of this regulation; and (5) The reason for electing not to make a request for organ or tissue donation. #### Regulation .27 Discharge Planning Requirements. *COMAR 10.07.01.27* A. Discharge Options. A hospital may discharge a patient: (1) Entirely; (2) To another level of care, treatment, or services; (3) To different health care professionals; or (4) To settings for continued services. B. A hospital's process for transfer or discharge shall be based on a patient's assessed needs at the time of discharge. C. To facilitate discharge or transfer, the hospital shall: (1) Assess the patient's needs beginning at an early stage of the patient's hospitalization and as the patient's needs change throughout the hospitalization; (2) Develop plans for the patient's discharge or transfer with input, if appropriate, from the patient, the family, or other interested party; (3) Identify appropriately qualified staff, such as registered nurses or licensed social workers, who have the knowledge and experience necessary to determine what services or type of providers can best meet the patient's discharge needs; (4) Arrange or help to arrange for services needed to meet the patient's needs after discharge; and (5) Provide the patient, or the provider who is responsible for providing continuing care to the patient, with written discharge instructions and other necessary medical information in a form the patient or provider can understand. #### Regulation .28 Emergency and Disaster Plan. *COMAR 10.07.01.28* A. A licensed acute general hospital or special hospital shall comply with the Emergency Management standards outlined in The Joint Commission’s Hospital Accreditation Standards. B. A licensee shall prepare an executive summary of the hospital's evacuation procedures to provide to a patient, family member, or legal representative upon request. The summary shall: (1) Describe the hospital's Emergency Operation Plan (EOP), which is discussed throughout the Emergency Management standards cited in §A(1) of this regulation; and (2) Describe the role and responsibilities of a patient, family member, or legal representative in the event of an emergency situation. C. A licensee shall have a tracking system to assist the hospital, family members, government representatives, and other authorized stakeholders, to locate and identify patients in the event of displacement due to an emergency or disaster. #### Regulation .29 Notice to Patients of Outpatient on Observation Status. *COMAR 10.07.01.29* A. A hospital shall provide both an oral and written notice to a patient of: (1) The patient’s outpatient on observation status; (2) The billing implications of the outpatient on observation status; and (3) The impact of the outpatient on observation status on the patient’s eligibility for Medicare rehabilitation services if: (a) The patient received on-site services from the hospital for more than 23 consecutive hours; (b) The on-site services received by the patient include a hospital bed and meals that have been provided in an area of the hospital other than the Emergency Department; and (c) The patient is classified as an outpatient at the hospital for observation rather than as an admitted inpatient. B. The written notice shall include: (1) That the patient is considered to be on observation as an outpatient and is not admitted as an inpatient; (2) The reason or rationale that the patient has not been admitted for inpatient services; (3) That the patient, if needed upon discharge, may not qualify for Medicare Part A reimbursement for rehabilitation services, including such services provided under Medicare Part A in a skilled nursing facility; (4) That there may be billing implications based on their outpatient status that may increase the patient’s out-of-pocket costs for their stay; (5) The name and title of the staff who provided the oral notice stating the date and time of the oral notice; and (6) The signature of the patient to verify an understanding and receipt of the written notice. C. Once the patient has received onsite services for more than 23 hours, the hospital shall provide written and oral notice to the patient that the physician has ordered services be provided as outpatient on observation status. D. The oral and written notice shall be provided in a manner that is understood by the patient. E. If the patient lacks capacity to understand the medical or financial implications of his or her outpatient on observation status, the oral and written notice shall be provided to a person authorized to make medical or financial decisions for the patient, including: (1) A guardian of the person under Estates and Trusts Article, §13-705, Annotated Code of Maryland; (2) A guardian of the property under Estates and Trusts Article, §13-201, Annotated Code of Maryland; (3) An agent appointed under an advance directive that meets the requirements of Health-General Article, §5-602, Annotated Code of Maryland; (4) A surrogate decision maker with authority under Health-General Article, §5-605, Annotated Code of Maryland; (5) An agent appointed under a power of attorney that meets the requirements of Estates and Trusts Article, Title 17, Annotated Code of Maryland; (6) A representative payee or other similar fiduciary; or (7) Any other person, if that person was designated by the patient who was competent at the time of designation, and the patient or representative has provided the hospital with documentation of the designation. F. For Medicare patients only, a hospital has the option to provide only the notice required by Medicare under 42 CFR §489.20(y). Hospitals that elect to use that option shall be considered compliant with this regulation if the notice is provided to patients that receive on-site services for more than 23 hours. #### Regulation .30 Physical Environment. *COMAR 10.07.01.30* A. The facility shall be in compliance with: (1) The Facilities Guidelines Institute's Guidelines for Design and Construction of Hospitals; and (2) All applicable State and local governing laws, regulations, standards, ordinances, and codes for fire safety, building, and zoning requirements. B. Any waiver or other modification of these requirements shall be addressed by the appropriate State or local authority having jurisdiction in accordance with established procedures. #### Regulation .31 Hospital Palliative Care Programs. *COMAR 10.07.01.31* A. Acute general hospitals and special hospitals-chronic care with 50 or more beds shall establish an active hospitalwide palliative care program that provides consultation services to patients suffering from pain and symptoms due to serious illnesses or conditions. B. The hospital shall: (1) Promote the palliative care program; (2) Provide information and referrals to patients and families when appropriate regarding the availability of palliative care services; and (3) Inform patients of the patient’s right to request a palliative care consultation. C. Staffing. (1) The hospital shall designate a qualified interdisciplinary care team with training in palliative care to staff the palliative care program. (2) The hospital shall ensure that: (a) A qualified health care professional coordinates the activities of the palliative care program with the palliative care patient’s interdisciplinary care team; (b) Staff is appropriately trained, credentialed, or certified in the staff’s area of expertise; (c) Staff receives continuing training and education; and (d) Written policies and procedures for the hospital palliative care program are established, implemented, maintained, and updated periodically. D. Palliative Care Education and Training. The hospital shall provide and document training to medical and other clinical staff as determined by the hospital regarding: (1) Services provided by the palliative care program; (2) Domains of palliative care; and (3) Legal requirements for: (a) Health care decisions; and (b) MOLST as referenced in COMAR 10.01.21. E. Interdisciplinary Plan of Care. (1) The hospital shall incorporate the recommendations of the palliative care program into the palliative care patient’s interdisciplinary care plan. (2) The hospital shall review the interdisciplinary plan of care and revise it as necessary to meet the needs of the palliative care patient. (3) The palliative care program shall conduct care conferences as appropriate to review the plan of care with: (a) The palliative care patient; (b) The palliative care patient’s family; (c) The health care professionals; and (d) Other interdisciplinary team members. (4) Contents. The hospital shall ensure that the palliative care patient’s plan of care includes at a minimum: (a) Initial assessments conducted by the interdisciplinary palliative care team; (b) Psychological needs assessment; (c) Treatment goals; (d) Choice of treatment options; (e) Preferred care setting; (f) Availability of hospice services; (g) Preferred site of death and after-death arrangements, as appropriate; (h) Grief and bereavement plan, as appropriate; (i) Assessment of cultural needs; (j) Assessment of legal needs; and (k) Assessment of discharge needs. (5) Collaboration. The hospital shall document and provide palliative care services in collaboration with: (a) The attending physician; and (b) Any other health care provider managing the patient’s care. (6) Continuity of Care. The hospital shall coordinate services to ensure continuity of care for the palliative care patient. The hospital shall: (a) Transfer the pertinent parts of the medical record, medical orders, and plan of care with the palliative care patient upon transfer to post-acute care; (b) Ensure that MOLST forms are completed in accordance with COMAR 10.01.21; (c) Convert a palliative care patient’s treatment goals into medical orders, as appropriate; and (d) Have reporting mechanisms to keep all staff informed and updated about care changes and treatment goals. F. Palliative Care Services. (1) The hospital or palliative care program shall counsel the palliative care patient or the patient’s authorized decision maker regarding: (a) Health options; (b) Pain management options; (c) Prognosis; (d) Risks and benefits of treatment; (e) Availability of grief and bereavement services, as appropriate; (f) Psychological services; (g) Availability of spiritual care counseling through the hospital or outpatient providers; and (h) Hospice services, as appropriate. (2) Referrals. (a) As appropriate and upon request by the patient or authorized decision maker, the hospital may make timely referrals. (b) The hospital shall document any referrals made to: (i) Inpatient or outpatient bereavement providers; (ii) Psychological services for the palliative care patient and the patient’s family; (iii) Inpatient or outpatient spiritual care services; and (iv) Hospice. (3) Pain and Symptom Management. The hospital shall: (a) Conduct and document pain and symptom assessments using available standardized scales to appropriately manage a palliative care patient’s symptoms; (b) Provide adequate and appropriate dosage of analgesics and sedatives to meet the needs of the palliative care patient; and (c) Educate the patient and the patient’s family about the use of opioids during end-of-life care. (4) Other Services. The hospital shall provide culturally and linguistically appropriate education and support about how to safely care for the patient at home or in an alternate residential setting as appropriate. (5) Imminent Death. The palliative care program shall document and counsel the patient, the authorized decision maker, the patient’s family, and the interdisciplinary care team about the active dying phase and imminent death as appropriate. (6) MOLST. The hospital shall comply with the procedures and requirements of the Medical Orders for Life-Sustaining Treatment Form, which is incorporated by reference at COMAR 10.07.21. (7) Interpreter Services. The hospital shall ensure interpreter services are available and accessible to the palliative care program. G. Advance Directives. (1) The hospital shall recognize the authority of: (a) An advance directive established in compliance with Health-General Article, §5-602, Annotated Code of Maryland; and (b) An authorized decision maker. (2) The hospital shall ensure that any provided advance directive and authorized decision maker designation are in the patient’s medical record, including the electronic medical record. (3) The hospital shall promote advance care planning and the completion of advance directives through community outreach activities. H. Ethics Committee. The hospital shall allow staff, patients, and the patient’s family in the palliative care program access to an ethics committee to address ethical conflicts at the end of life. I. Quality Improvement. The palliative care program shall take part in the hospital’s quality improvement and performance improvement activities to the extent required by State and federal statute. J. Departmental Oversight. The Department shall have access to all data maintained through the hospital’s palliative care program to determine the hospital’s compliance with State and federal regulations. #### Regulation .32 Penalties — General. *COMAR 10.07.01.32* A. The Secretary shall deny a license to a person who has been convicted of a felony that relates to Medicaid or to a nursing home. B. The Secretary shall revoke the license of any licensee convicted of a felony that relates to Medicaid or to a nursing home. C. The Secretary may deny or revoke a license if the hospital does not meet the requirements of: (1) Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland; (2) Any regulation adopted under Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, including this chapter. D. A hospital subject to a fine or a penalty, or to delicensure, denial, or revocation of license under these regulations, may request a hearing as set forth under State Government Article, §10-201 et seq., Annotated Code of Maryland, and COMAR 10.01.03. #### Regulation .32-1 Civil Money Penalties — Imposition. *COMAR 10.07.01.32-1* A. The Department may impose a civil money penalty not to exceed $10,000 for each failure of a hospital to comply with the requirements of Regulation .27 of this chapter. B. In determining whether to impose a civil money penalty, the Department may consider the following factors: (1) The number of failures to comply; (2) The nature and seriousness of the failure to comply; (3) The degree of risk to the health, life, or safety of the patient being discharged that is caused by the failure to comply; (4) A hospital's prior history to comply with discharge requirements; and (5) Such other factors as justice may require. #### Regulation .32-2 Civil Money Penalties — Payment of Penalty. *COMAR 10.07.01.32-2* A. If a hospital owes a civil money penalty to the Department, the hospital shall adhere to the procedures of this regulation. B. A civil money penalty payment is due to the Department 15 calendar days after: (1) The time period for requesting a hearing has expired if a request for hearing is not received; or (2) Receipt of a written request from the hospital to waive its right to a hearing and reduce the amount of the civil penalty by 40 percent, if the written request is received by the Department within 30 calendar days of the Department's order imposing the civil money penalty. #### Regulation .32-3 Civil Money Penalties — Hearings. *COMAR 10.07.01.32-3* A. A hospital aggrieved by the imposition of a civil money penalty may appeal the action by filing a request for a hearing in accordance with State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland. B. The Secretary has the burden of proof with respect to the imposition of civil money penalties. #### Regulation .33 Uniform Emergency Codes. *COMAR 10.07.01.33* A. Each hospital shall adopt and implement the following set of uniform codes for the identified emergency situations as part of its emergency or disaster plans: (1) Fire — Code Red; (2) Infant or Child Abduction — Code Pink; (3) Cardiac Respiratory Arrest — Code Blue — Adult; (4) Cardiac Respiratory Arrest — Code Blue — Child; (5) Cardiac Respiratory Arrest — Code Blue — Infant; (6) Combative Person — Code Green; (7) Bomb Threat — Code Gold; (8) Hazardous Material Spill or Release — Code Orange; (9) Elopement — Code Gray; (10) Security Only Response — Code Purple; (11) Emergency or Disaster — Code Yellow; and (12) Armed Assailant — Code Silver. B. A hospital may adapt the uniform codes referenced in §A of this regulation to meet the specific needs of the hospital by adding a suffix or additional words after that code. C. For emergency situations not addressed by the codes in §A of this regulation, a hospital may establish its own identifying code. D. A hospital shall adopt only those uniform color codes that are consistent with the services or needs of the hospital. E. As part of its emergency or disaster plan, the hospital shall establish its own protocol for each of the uniform codes. F. A hospital shall provide orientation and training to all staff regarding the uniform emergency codes and the hospital's emergency or disaster plan. G. A hospital seeking exceptions to the requirements of this regulation shall submit its plan for emergency codes to the Department for review and approval: (1) Within 90 days after the effective date of this regulation; or (2) Before implementation of changes in its emergency code that would not comply with §§A—F of this regulation. #### Regulation .34 Infection Prevention and Control Program. *COMAR 10.07.01.34* A. The hospital shall have an active hospital-wide program for the prevention, control, and investigation of communicable diseases and infections. B. Staffing. (1) The hospital shall designate qualified staff with training in infection prevention and control to be responsible for the implementation of the infection prevention and control program. (2) Additional clinical and support staff shall be provided for the infection prevention and control program based on the size and complexity of the hospital's services. C. Infection Prevention and Control Program. (1) The infection prevention and control program shall be based on nationally recognized, evidence-based standards. (2) The infection prevention and control program shall be developed using an interdisciplinary approach with input from: (a) Administrative staff; (b) Medical staff; (c) Pharmacy staff; (d) Laboratory personnel; (e) Nursing staff; (f) Physical plant personnel; (g) Employee health personnel; (h) Patient safety officer; and (i) Staff from other departments whose knowledge and experience would contribute to improved infection prevention and control. (3) Written policies and procedures for the infection prevention and control program shall be established, implemented, maintained, and updated periodically. D. Surveillance. (1) The hospital shall: (a) Have a process for the identification and surveillance of healthcare- associated infections; (b) Analyze and utilize surveillance data to monitor and improve infection control and healthcare outcomes; and (c) Maintain a log of the identified infections. (2) The infection prevention and control program shall include: (a) Processes for the monitoring and control of patients who have a communicable disease or infection to prevent its spread to other patients and staff; (b) A process to identify and investigate the occurrence of outbreaks of communicable diseases or clusters of infections; and (c) Reporting of infections, communicable diseases, and outbreaks to the local or State health department, as required by COMAR 10.06.01. (3) When an outbreak occurs, the infection control staff shall have adequate resources and authority to ensure comprehensive and timely investigation and to implement control measures. E. Education. (1) The hospital shall provide education to all staff and, if appropriate, to the patient and visitors regarding the prevention and control of communicable diseases and infections. Educational activities shall address problems identified by the infection prevention and control program. (2) Nonclinical staff shall be included in infection prevention and control training consistent with their assigned responsibilities. (3) Attendance or participation in an educational program shall be recorded. Educational programs shall be evaluated not less than annually for effectiveness. (4) Education related to infection prevention and control shall be included in the hospital's orientation program for all new employees, including appropriate contractual personnel. (5) Physicians who are employed or who have privileges and who do not receive training through the hospital's new employee training program shall receive alternative orientation education on infection prevention and control practices and the hospital's infection prevention and control program. (6) Outside agency staff shall receive sufficient training in the hospital's infection prevention and control policies and procedures to provide safe care to the patients. F. Prevention. (1) The hospital shall establish processes and programs to prevent the spread of communicable diseases and infections. (2) A hospital's processes and programs to prevent the spread of communicable diseases and infections shall include at least the items listed in §F(3) of this regulation. (3) Required Processes and Programs. (a) Hand Hygiene. (i) The infection prevention and control program shall include activities to educate staff on the need for hand hygiene prior to and after any patient contact and as directed by accepted professional practice. (ii) Hand hygiene compliance by staff shall be monitored through the infection prevention and control program. (iii) The infection prevention and control program shall maintain documentation of audits for compliance with this requirement. (iv) Facilities and supplies to facilitate hand hygiene shall be provided and be accessible in all locations of the hospital where patient care is provided. (b) Sanitation. (i) The hospital shall maintain a sanitary environment to prevent the spread of communicable diseases and infections. (ii) The hospital shall have systems to maintain the environment in a clean and sanitary condition. (iii) Systems shall be provided to ensure that housekeeping, linen handling, waste disposal including medical waste, food handling, ventilation systems, water systems, and pest control meet acceptable federal and State standards and guidelines. (c) Aseptic Technique. The hospital shall use aseptic techniques to prevent infections, including surgical site infections and device-associated infections. (d) Immunocompromised Patients. The hospital shall use professionally accepted procedures to protect immunocompromised patients from infection. (e) Standard Precautions. The hospital staff shall use standard precautions and other categories of isolation or precautions consistent with current Center for Disease Control (CDC) recommendations. (f) Equipment and Supplies. (i) The hospital shall have personal protective equipment, such as gloves, gowns, respirators, and masks or other facial protection for staff readily available. (ii) Supplies and equipment needed to prevent the spread of communicable diseases and infections shall be available in all patient care areas. (4) Employee Health Program. The infection prevention and control program shall work in conjunction with the employee health program and include monitoring and identification of employee health concerns such as immunity to measles, mumps, rubella, and varicella (chicken pox). (5) Immunizations for influenza shall be offered to staff and licensed independent practitioners. Reasons for refusal of the influenza vaccine by an employee shall be documented by the infection control or employee health program. G. Performance Improvement. (1) The infection prevention and control program shall include performance improvement and quality assurance measures to address the problems identified through the surveillance, control, and investigation of infections. (2) The hospital shall develop and implement interventions to address identified problems and monitor the effectiveness of interventions to control and prevent infections. (3) The infection prevention and control program shall be incorporated into the hospital's performance improvement program. H. Patient Safety. The infection prevention and control program shall share data regarding healthcare-associated infections with the hospital's designated patient safety officer. Health care associated infections that meet the definition of a Level 1 adverse event shall be reported to the Department, and a root cause analysis submitted as required by COMAR 10.07.06. I. Reports to the Governing Body. (1) Infection control data including reports on the numbers and types of healthcare-associated infections shall be reported to the hospital's medical staff and governing body on an ongoing basis. (2) The hospital leadership shall support infection prevention and control activities, including the provision of adequate resources for the program. J. Department Oversight. (1) The hospital shall comply with all data reporting requirements of the Maryland Health Care Commission related to the prevention and acquisition of infections in accordance with Health-General Article, §19-134(e), Annotated Code of Maryland. (2) The Department shall have access to all data maintained through the hospital's infection prevention and control program to determine the hospital's compliance with State and federal regulations. #### Regulation .35 Designation of Lay Caregivers. *COMAR 10.07.01.35* A. A hospital shall provide a patient or legal guardian of a patient with an opportunity to designate one lay caregiver before the discharge of the patient to their residence. B. The hospital’s discharge planning shall include the designation of the lay caregiver as soon as practicable in the discharge planning process. C. If a patient or legal guardian of a patient declines to designate a lay caregiver, the hospital shall: (1) Document the decision in the patient’s medical record; and (2) Be deemed to be in compliance with this regulation. D. If a patient or legal guardian of a patient designates a lay caregiver the hospital shall record in the patient’s medical record: (1) The designation of the lay caregiver; (2) The relationship of the lay caregiver to the patient; and (3) The name, telephone number, and address of the lay caregiver. E. Release of Medical Information. (1) If the patient designates a lay caregiver, the hospital shall request the patient or legal guardian to consent in writing to release medical information to the lay caregiver. The release of records shall be in accordance with: (a) The hospital’s procedures for releasing personal health information; and (b) All applicable federal and State laws. (2) If a patient or legal guardian of a patient declines to consent to the release of medical information to the lay caregiver, the hospital is not required to: (a) Provide to the lay caregiver the notice required under Health-General Article, §19-382, Annotated Code of Maryland; or (b) Consult with the lay caregiver or provide to the lay caregiver information contained in the discharge plan issued under Health-General Article, §19-383, Annotated Code of Maryland. F. A patient or a legal guardian of the patient may change the designation of a lay caregiver in the event the lay caregiver becomes incapacitated. G. Regardless of the desire of the patient or legal guardian of the patient, the designated lay caregiver is not obligated to perform any aftercare for the patient. H. A patient or legal guardian is not required to designate a lay caregiver. I. Hospital Obligations. (1) If a patient or legal guardian of a patient designates a lay caregiver, the hospital shall notify the lay caregiver as soon as practicable of the discharge of the patient or the patient’s transfer to another hospital, licensed health care facility or other residential facility. (2) As soon as practicable before the discharge of a patient, the hospital shall attempt to: (a) Consult with the patient’s lay caregiver to prepare the lay caregiver for the patient’s aftercare; and (b) Issue a discharge plan that describes the aftercare needs of the patient. (3) The hospital shall make reasonable attempts to consult with the lay caregiver. (4) The inability of the hospital to consult with a lay caregiver may not interfere with, delay, or otherwise affect the medical care provided to the patient or the patient’s planned discharge. (5) The hospital shall document successful or unsuccessful attempts to contact the lay caregiver. J. Discharge Planning Requirements. Regardless of the request for the designation of a lay caregiver, the hospital shall comply with all discharge planning requirements in: (1) Regulation .27 of this chapter; (2) The standards imposed under the hospital’s accreditation by a State-approved accreditation organization; and (3) 42 CFR §482.43. K. The designation of a lay caregiver may not: (1) Interfere with the rights of an agent to make health care decisions under Health-General Article, Title 5, Subtitle 6, Annotated Code of Maryland; or (2) Create a private right of action against a hospital, a hospital employee, or a duly authorized agent of a hospital or otherwise supersede or replace existing rights or remedies under any other State or federal law. #### Regulation .36 Patient Rights. *COMAR 10.07.01.36* A. A hospital shall develop a listing of the rights of patients that is consistent with the requirements of: (1) The Joint Commission; (2) Health-General Article, §19-342, Annotated Code of Maryland; and (3) 42 CFR §482.13. B. The hospital’s patient rights shall at minimum address: (1) Patient privacy and confidentiality; (2) Informed decision making and informed consent; (3) Visitation; (4) Advance directives; (5) Access to patient medical records; (6) Complaint and grievance process; (7) Freedom from: (a) Physical or mental abuse; (b) Neglect; (c) Harassment; or (d) Mistreatment; (8) A patient’s right to expect and receive appropriate assessment, management, and treatment of pain as an integral component of the patient’s care; and (9) Communication in a manner the patient can understand. C. All patients receiving services at the hospital, have the right to receive written copies of the hospital’s patient rights upon request. D. The hospital’s patient rights shall be easily accessible to patients and visitors. E. Hospital staff who are responsible for patient care shall: (1) Receive training regarding the hospital’s patient rights; and (2) Be able to assist patients and their families to: (a) Access the services of the hospital’s patient advocacy staff; (b) File a complaint or grievance; or (c) Obtain a written copy of the hospital’s patient rights documents. #### Regulation .37 Maryland Health Care Decisions Act. *COMAR 10.07.01.37* A hospital shall comply with the requirements of Health-General Article, Title 5, Subtitle 6, Annotated Code of Maryland. ### Chapter 02 — Nursing Homes **Authority:** Health-General Article, §§19-308, 19-308.1, 19-323, and 19-1401 et seq.;Public Safety Article, §14-110.1; Annotated Code of Maryland **Administrative History:** Effective date: June 30, 1978 (5:13 Md. R. 1053) **Administrative History:** This chapter is a compilation and revision of prior regulations contained in COMAR 10.07.02, Nursing Homes—Extended Care, and COMAR 10.07.05, Intermediate Care Facilities—Long-term Care (Type A). COMAR 10.07.02 was effective January 1, 1967; amended effective March 27, 1973 and April 16, 1975 (2:8 Md. R. 565). COMAR 10.07.05 was effective July 1, 1969 and amended effective March 27, 1973. **Administrative History:** Regulation .01B amended effective January 7, 1991 (17:26 Md. R. 2975); June 22, 1992 (19:12 Md. R. 1134); January 17, 1994 (21:1 Md. R. 33); August 15, 1994 (21:16 Md. R. 1383); June 30, 1997 (24:13 Md. R. 931); June 1, 1998 (25:11 Md. R. 821) **Administrative History:** Regulation .01B amended as an emergency provision effective January 1, 2001 (28:4 Md. R. 414); amended permanently effective May 14, 2001 (28:9 Md. R. 885) **Administrative History:** Regulation .01B amended effective September 16, 2002 (29:18 Md. R. 1442); March 3, 2003 (30:4 Md. R. 316); September 13, 2004 (31:18 Md. R. 1350) **Administrative History:** Regulation .01I-1, L-1, O-1, GG-1 adopted effective January 13, 1986 (13:1 Md. R. 16) **Administrative History:** Regulation .01GG-1, KK-1 adopted effective August 3, 1981 (8:15 Md. R. 1306) **Administrative History:** Regulation .01II-1 adopted effective January 26, 1987 (14:2 Md. R. 128) **Administrative History:** Regulation .01-1 adopted effective June 1, 1998 (25:11 Md. R. 821) **Administrative History:** Regulation .01-1 amended effective January 6, 2005 (31:26 Md. R. 1862) **Administrative History:** Regulation .02 amended effective January 14, 1988 (15:1 Md. R. 20) **Administrative History:** Regulation .02 repealed and new Regulation .02 adopted effective May 10, 1993 (20:9 Md. R. 778) **Administrative History:** Regulation .02 amended effective August 24, 2009 (36:17 Md. R. 1312) **Administrative History:** Regulation .02F amended effective April 8, 1996 (23:7 Md. R. 551) **Administrative History:** Regulation .02G adopted effective September 16, 2002 (29:18 Md. R. 1442) **Administrative History:** Regulation .03 amended effective May 10, 1993 (20:9 Md. R. 778); August 27, 2007 (34:17 Md. R. 1507); August 24, 2009 (36:17 Md. R. 1312); August 29, 2016 (43:17 Md. R. 953) **Administrative History:** Regulation .03A amended effective May 24, 1982 (9:10 Md. R. 1021); June 22, 1992 (19:12 Md. R. 1134) **Administrative History:** Regulation .03B amended effective August 1, 1994 (21:15 Md. R. 1304) **Administrative History:** Regulation .03-1 adopted effective May 10, 1993 (20:9 Md. R. 778) **Administrative History:** Regulation .04B amended effective December 7, 1992 (19:24 Md. R. 2125) **Administrative History:** Regulation .05 amended effective August 1, 2016 (43:15 Md. R. 864) **Administrative History:** Regulation .05B amended effective January 17, 1994 (21:1 Md. R. 33) **Administrative History:** Regulation .05C amended effective January 25, 1980 (7:2 Md. R. 115) **Administrative History:** Regulation .07 amended effective January 26, 1987 (14:2 Md. R. 128); May 20, 1996 (23:10 Md. R. 731); August 24, 2009 (36:17 Md. R. 1312) **Administrative History:** Regulation .07A amended effective August 3, 1981 (8:15 Md. R. 1306) **Administrative History:** Regulation .07G amended effective May 24, 1982 (9:10 Md. R. 1021); January 26, 1987 (14:2 Md. R. 128); March 3, 2003 (30:4 Md. R. 316) **Administrative History:** Regulation .07-1 adopted effective January 1, 2007 (33:26 Md. R. 1996) **Administrative History:** Regulation .08 amended effective June 22, 1992 (19:12 Md. R. 1134) **Administrative History:** Regulation .08A, B, D amended effective January 26, 1987 (14:2 Md. R. 128) **Administrative History:** Regulation .08A, E amended effective January 13, 1986 (13:1 Md. R. 16) **Administrative History:** Regulation .08-1 adopted effective September 16, 2002 (29:18 Md. R. 1442) **Administrative History:** Regulation .09A amended effective November 8, 1982 (9:22 Md. R. 2196); January 13, 1986 (13:1 Md. R. 16); January 17, 1994 (21:1 Md. R. 33) **Administrative History:** Regulation .09B-1 adopted effective August 3, 1981 (8:15 Md. R. 1306) **Administrative History:** Regulation .09C, D amended effective August 24, 2009 (36:17 Md. R. 1312) **Administrative History:** Regulation .10 amended effective January 26, 1987 (14:2 Md. R. 128); June 30, 1997 (24:13 Md. R. 931) **Administrative History:** Regulation .10E amended effective November 8, 1982 (9:22 Md. R. 2196) **Administrative History:** Regulation .10H amended effective May 24, 1982 (9:10 Md. R. 1021) **Administrative History:** Regulation .10 repealed and new Regulation .10 adopted effective August 6, 2001 (28:15 Md. R. 1396) **Administrative History:** Regulation .11 amended effective January 26, 1987 (14:2 Md. R. 128) **Administrative History:** Regulation .11O amended effective November 8, 1982 (9:22 Md. R. 2196) **Administrative History:** Regulation .11 repealed and new Regulation .11 adopted effective August 6, 2001 (28:15 Md. R. 1396) **Administrative History:** Regulation .11-1 adopted effective August 6, 2001 (28:15 Md. R. 1396) **Administrative History:** Regulation .11-2 adopted effective August 6, 2001 (28:15 Md. R. 1396) **Administrative History:** Regulations .12, .13, .18—.21 amended effective January 13, 1986 (13:1 Md. R. 16) **Administrative History:** Regulation .12 amended effective January 26, 1987 (14:2 Md. R. 128) **Administrative History:** Regulation .13 amended effective January 26, 1987 (14:2 Md. R. 128) **Administrative History:** Regulation .14-1 adopted effective August 15, 1994 (21:16 Md. R. 1383) **Administrative History:** Regulation .14-2 adopted effective August 15, 1994 (21:16 Md. R. 1383) **Administrative History:** Regulation .15 amended effective January 26, 1987 (14:2 Md. R. 128); September 22, 2008 (35:19 Md. R. 1716) **Administrative History:** Regulation .15B amended effective March 16, 1992 (19:5 Md. R. 577); June 5, 1995 (22:11 Md. R. 820) **Administrative History:** Regulation .17 amended effective January 26, 1987 (14:2 Md. R. 128) **Administrative History:** Regulation .18B amended effective January 26, 1987 (14:2 Md. R. 128) **Administrative History:** Regulation .19A, B amended effective January 26, 1987 (14:2 Md. R. 128) **Administrative History:** Regulation .20 amended effective January 26, 1987 (14:2 Md. R. 128) **Administrative History:** Regulation .21 amended effective June 1, 1998 (25:11 Md. R. 821) **Administrative History:** Regulation .21 repealed and new Regulation .21 adopted effective January 6, 2005 (31:26 Md. R. 1862) **Administrative History:** Regulation .21E amended effective November 8, 1982 (9:22 Md. R. 2196) **Administrative History:** Regulation .21-1 adopted effective January 17, 1994 (21:1 Md. R. 33) **Administrative History:** Regulation .21-1 repealed and new Regulation .21-1 adopted effective January 6, 2005 (31:26 Md. R. 1862) **Administrative History:** Regulation .21-2 adopted effective January 6, 2005 (31:26 Md. R. 1862) **Administrative History:** Regulation .21-3 adopted effective January 6, 2005 (31:26 Md. R. 1862) **Administrative History:** Regulation .21-4 adopted effective January 6, 2005 (31:26 Md. R. 1862) **Administrative History:** Regulation .22B amended effective August 3, 1981 (8:15 Md. R. 1306) **Administrative History:** Regulation .24 repealed and new Regulation .24 adopted effective April 21, 2008 (35:8 Md. R. 805) **Administrative History:** Regulation .26F amended and .26G—H repealed effective January 17, 1983 (10:1 Md. R. 28) **Administrative History:** Regulation .26EE amended effective October 25, 1982 (9:21 Md. R. 2106); September 16, 2002 (29:18 Md. R. 1442) **Administrative History:** Regulation .27A, B amended effective March 3, 2003 (30:4 Md. R. 316) **Administrative History:** Regulation .27B amended effective January 26, 1987 (14:2 Md. R. 128) **Administrative History:** Regulation .28 amended effective January 26, 1987 (14:2 Md. R. 128); January 17, 1994 (21:1 Md. R. 33) **Administrative History:** Regulation .28C amended effective January 14, 1988 (15:1 Md. R. 20) **Administrative History:** Regulation .31A amended effective September 16, 2002 (29:18 Md. R. 1442) **Administrative History:** Regulation .32F amended effective January 17, 1994 (21:1 Md. R. 33) **Administrative History:** Regulation .32G amended effective January 26, 1987 (14:2 Md. R. 128) **Administrative History:** Regulation .33E amended effective January 26, 1987 (14:2 Md. R. 128) **Administrative History:** Regulations .35—.41 adopted effective January 13, 1986 (13:1 Md. R. 16) **Administrative History:** Regulation .35 amended effective December 16, 1996 (23:25 Md. R. 1785) **Administrative History:** Regulation .36 amended effective December 16, 1996 (23:25 Md. R. 1785); September 16, 2002 (29:18 Md. R. 1442) **Administrative History:** Regulation .36C amended effective March 3, 2003 (30:4 Md. R. 316) **Administrative History:** Regulation .37 amended effective December 16, 1996 (23:25 Md. R. 1785); September 16, 2002 (29:18 Md. R. 1442) **Administrative History:** Regulation .38 amended effective December 16, 1996 (23:25 Md. R. 1785) **Administrative History:** Regulation .39A and B amended effective October 1, 1990 (17:19 Md. R. 2320) **Administrative History:** Regulation .39C and D repealed effective October 1, 1990 (17:19 Md. R. 2320) **Administrative History:** Regulation .39G amended effective June 30, 1986 (13:13 Md. R. 1491) **Administrative History:** Regulation .40A amended effective June 30, 1986 (13:13 Md. R. 1491) **Administrative History:** Regulations .40 and .41 recodified to Regulations .43 and .44, respectively, Appendix recodified as Regulation .40 and amended, and new Regulations .41 and .42 adopted effective October 1, 1990 (17:19 Md. R. 2320) **Administrative History:** Regulation .41 repealed and new Regulation .41 adopted effective September 13, 2004 (31:18 Md. R. 1350) **Administrative History:** Regulation .41A amended effective August 1, 1994 (21:15 Md. R. 1304) **Administrative History:** Regulation .41D amended effective June 30, 1986 (13:13 Md. R. 1491) **Administrative History:** Regulation .43C adopted effective October 1, 1990 (17:19 Md. R. 2320) **Administrative History:** Regulations .45—.51 adopted effective January 7, 1991 (17:26 Md. R. 2975) **Administrative History:** Regulations .45—.51 repealed as an emergency provision effective January 1, 2001 (28:4 Md. R. 414); repealed permanently effective May 14, 2001 (28:9 Md. R. 885) **Administrative History:** Regulations .45—.60 adopted as an emergency provision effective January 1, 2001 (28:4 Md. R. 414); adopted permanently effective May 14, 2001 (28:9 Md. R. 885) **Administrative History:** Regulation .49D amended effective September 16, 2002 (29:18 Md. R. 1442) **Administrative History:** Regulation .54D adopted effective March 3, 2003 (30:4 Md. R. 316) **Administrative History:** Regulation .61 adopted effective August 24, 2009 (36:17 Md. R. 1312) **Administrative History:** Chapter revised effective June 17, 2019 (46:12 Md. R. 536) #### Regulation .01 Definitions. *COMAR 10.07.02.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Administrator” means the individual licensed by the Board of Examiners of Nursing Home Administrators who is responsible for the operation of the nursing home. (2) “Attending physician” means an individual licensed to practice medicine in the State who: (a) Admits residents to the nursing home; and (b) Is responsible for the overall care of a resident. (3) “Audiologist” means an individual who holds a Maryland license issued by the State Board of Audiologists, Hearing Aid Dealers, and Speech-Language Pathologists. (4) “Authorized prescriber” has the meaning stated in Health Occupations Article, §12-101, Annotated Code of Maryland. (5) “Certified medicine aide” means an individual who meets the requirements as stated in COMAR 10.39.01 and 10.39.03. (6) “Certified social worker” means an individual licensed to practice as a certified social worker in this State. (7) “Charge nurse” means the registered or licensed practical nurse who is responsible for day-to-day operations of a unit in the nursing home on which residents live. (8) “Chemical restraint” means the administration of any drug that is used for discipline or convenience and not required to treat medical symptoms. (9) “Comprehensive care facility” means a nursing home that admits residents requiring medical services and nursing services rendered by or under the supervision of a registered nurse, who: (a) Are advanced in age; or (b) Have a disease or a disability. (10) “Concurrent review” means daily rounds by a licensed nurse which include: (a) Appraisal and observation of all residents by the licensed nurse to determine any change in each resident’s physical or mental status; (b) If there is a change in the resident’s physical or mental status, an evaluation by the licensed nurse of the resident’s medications, laboratory values relating to the resident, and clinical data relating to the resident, including the resident’s: (i) Hydration and nutritional needs; (ii) Skin integrity; (iii) Noted weight changes; and (iv) Appetite; (c) Evaluation of injuries sustained by the resident that result from an accident or incident involving the resident; and (d) Any other relevant parameters affecting or reflecting the resident’s physical and mental status. (11) “Culture change facility” means a nursing home where physical environment and operational changes have been made to establish person-valued and person-directed care activities and services. (12) “Deficiency” means a condition existing in a nursing home or an action or inaction by the nursing home staff that results in potential for more than minimal harm, actual harm, or serious and immediate threat to one or more residents. (13) “Dentist” means an individual licensed to practice dentistry in this State. (14) “Department” means the Maryland Department of Health. (15) “Dietetic service supervisor” means a person who: (a) Is a qualified dietitian; (b) Is a graduate of a dietetic technician program approved by the American Dietetic Association; (c) Is a certified dietary manager who has successfully completed the required course and maintains certification as required by the certifying board for the Dietary Managers Association; (d) Is a graduate of a State-approved course that provided 90 or more hours of classroom instruction in food service supervision and has experience as a supervisor in a health care institution with consultation from a dietitian; or (e) Has training and experience in food service supervision and management in a military service equivalent in content to §B(15)(b) and (d) of this regulation. (16) “Dietitian-nutritionist” means an individual who: (a) Is licensed by the Maryland Board of Dietetic Practice to practice dietetics; (b) Has met the certifying requirements for registration as a dietitian as administered by the Commission on Dietetic Registration; and (c) Maintains the continuing education requirements of registration. (17) “Discharge” means the removal of a resident from a nursing home when the releasing nursing home is no longer responsible for the resident’s care. (18) “Discipline” means the medical, rehabilitative, nursing, dietetic, activities and social service components affiliated with the operation of a nursing home. (19) “Distinct part extended care facility” means a portion of a nursing home that is licensed as an extended care facility. (20) “Extended care facility” means a nursing home that offers sub-acute care and provides medical treatment services for residents who require inpatient care but who do not currently require continuous hospital services. (21) “Facility” means a nursing home. (22) “Fire authorities” means the official fire safety agency including the State Fire Marshal or local fire marshals or fire departments as appropriate. (23) “Full time” means 40 hours per week or the standard work week adopted by the nursing home. (24) “Geriatric nursing assistant” means a CNA who has successfully completed the requirements for a GNA set forth in 42 CFR §§483.151—483.156 and COMAR 10.39.01. (25) “Grant” means the award of money to an individual or an organization to: (a) Study an aspect for the geriatric population; or (b) Provide a service to nursing home residents or their families. (26) “Health officer” means the health officer or the designated representative in each of the 23 counties and the Commissioner of Health in Baltimore City. (27) “HVAC” means heating, ventilation and air conditioning. (28) “Infection preventionist” means a licensed healthcare worker who: (a) Manages the infection prevention and control program in the nursing home; and (b) Has completed a minimum of 15 contact hours of infection prevention and control training that is approved by the: (i) Department’s Office of Infectious Disease Epidemiology and Outbreak Response; and (ii) Office of Health Care Quality. (29) “Licensed bachelor social worker (LBSW)” means an individual authorized to practice bachelor social work under Health Occupations Article, Title 19, Annotated Code of Maryland. (30) “Licensed certified social worker (LCSW)” means an individual authorized to practice certified social work under Health Occupations Article, Title 19, Annotated Code of Maryland. (31) “Licensed certified social worker–clinical (LCSW-C)” means an individual authorized to practice clinical social work under Health Occupations Article, Title 19, Annotated Code of Maryland. (32) “Licensed master social worker” means an individual authorized to practice master social work under Health Occupations Article, Title 19, Annotated Code of Maryland. (33) “Licensed or certified professional health care practitioner” means a nurse practitioner, physician assistant, or other practitioner licensed or certified under the Health Occupations Article, Annotated Code of Maryland. (34) “Licensed pharmacist” means an individual who is licensed by the Board to practice pharmacy as defined in Health Occupations Article, §12-101(l), Annotated Code of Maryland. (35) “Licensed practical nurse” means an individual authorized to practice licensed practical nursing under Health Occupations Article, Title 8, Annotated Code of Maryland. (36) “Management firm” means an organization, under contract with an applicant for a license or a current licensee, that is intended to have or has full responsibility and control for the day-to-day operations of the nursing home. (37) “MDS Care Area Assessment” means the investigation of triggered care areas, to determine if the care area or areas require interventions and care planning. (38) “Medical director” means an individual licensed to practice medicine in this State who, pursuant to a written agreement, is responsible for the overall coordination of the medical care in the nursing home to ensure the adequacy and appropriateness of the medical services provided to residents and to maintain surveillance of the health status of employees. (39) “Minimum Data Set (MDS)” means a core set of screening, clinical, and functional status elements, including common definitions and coding categories, which: (a) Forms the foundation of a comprehensive assessment for all nursing home and swing bed residents; and (b) Standardize communication about resident problems and conditions: (i) Within these facilities; (ii) Between these facilities; and (iii) Between these facilities and outside agencies. (40) “New nursing home” means a nursing home that does not yet have plans approved by the Department at the time of the adoption of this chapter. (41) “NFPA” means National Fire Protection Association. (42) “Nurse” means a licensed practical nurse or registered nurse licensed in the State as defined in Health Occupations Article, §8-101, Annotated Code of Maryland. (43) “Nurse practitioner” has the meaning stated in Health Occupations Article, §8-101(k), Annotated Code of Maryland. (44) “Nursing care” has the meaning stated in Health-General Article, §19-301(k), Annotated Code of Maryland. (45) “Nursing home” means a comprehensive care facility or extended care facility which offers nonacute inpatient care to residents: (a) Who have a disease, chronic illness, condition, disability of advanced age, or terminal disease requiring maximal nursing care without continuous hospital services; and (b) Who require medical services and nursing services rendered by or under the supervision of a licensed nurse together with convalescent, restorative, or rehabilitative services. (46) “Nursing service personnel” means staff licensed or certified by the Maryland Board of Nursing. (47) “Occupational therapist” means an individual who is licensed by the State Board of Occupational Therapy Practice to practice occupational therapy. (48) “Occupational therapy assistant” means an individual who is currently licensed by the State Board of Occupational Therapy Practice as an occupational therapy assistant. (49) “Ongoing pattern” means the occurrence of any potential for more than minimal harm or greater deficiency on two consecutive on-site visits as a result of: (a) Annual surveys; (b) Follow-up visits and unscheduled visits; or (c) Complaint investigations. (50) “Paid feeding assistant” means an individual who: (a) Meets the requirements of Regulation .63 of this chapter; and (b) Is paid by a nursing home to feed residents who are unable to perform the task themselves. (51) “Physical restraint” means any manual method or physical or mechanical device, material, or equipment attached or adjacent to the resident’s body that the individual cannot remove easily which restricts freedom of movement or normal access to one’s body including but not limited to: (a) Leg restraints; (b) Arm restraints; (c) Hand mitts; (d) Soft ties or vests; (e) Lap cushions; and (f) Lap trays. (52) “Physical therapist” means an individual licensed to practice physical therapy by the State Board of Physical Therapy Examiners. (53) “Physician” means an individual licensed to practice medicine in this State. (54) “Physician assistant” has the meaning stated in Health Occupations Article, §15-101(o), Annotated Code of Maryland. (55) “Plan of correction” means a written response from the nursing home addressing each deficiency cited as a result of an inspection by the Department. (56) “Positive tuberculin skin test” means a test provided as authorized by the Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings. (57) “Principal physician” means an individual licensed to practice medicine in this State who agrees to perform certain medical services under contract with a nursing home, consistent with the policies of the nursing home. (58) “Protective device” means any device or equipment: (a) That is prescribed by a physician; (b) That limits, but does not eliminate the movement of the resident’s head, body, or limbs; and (c) That: (i) Shields a resident from self-injury; (ii) Prevents a resident from aggravating an existing physical problem; or (iii) Prevents a resident from precipitating a potential physical problem. (59) “Qualified medical record practitioner” means an individual who: (a) Has: (i) Received a baccalaureate degree from an accredited college or university including or supplemented by a successful completion of a course in health record administration approved by the Council on Medical Education of the American Medical Association; and (ii) Passed the national registration examination for registered record administrators; or (b) Has: (i) Received an associate of arts degree in health record technology from a college or university approved by the American Medical Association Council on Medical Education or an equivalent approved health record technology correspondence course of the American Medical Record Association; and (ii) Passed the national accreditation examination for accredited record technicians. (60) “Qualified social work consultant” means an individual who: (a) Is a licensed certified social worker; and (b) Has a minimum of 3 years’ experience in social work programs in a long-term care setting within the last 5 years. (61) “Quality Improvement and Evaluation System (QIES) Assessment Submission and Processing (ASAP) system” means the standard nationwide system to which several types of health care providers submit CMS required resident information to the National Submissions Database. (62) “Registered nurse” means an individual licensed to practice as a registered nurse in this State. (63) Relocation. (a) “Relocation” means the movement of a resident from one room to another within: (i) The same Medicare-certified nursing home; (ii) A Medicaid-only certified nursing home; or (iii) A licensed-only nursing home. (b) “Relocation” does not mean the movement of a resident if the effect of the movement is to move the resident from: (i) The distinct part of the nursing home that is a skilled nursing facility to a distinct part of the nursing home that is not a skilled nursing facility; or (ii) A bed that is certified for Medicaid to a distinct part of the nursing home that is a skilled nursing facility. (64) “Resident” means an individual who: (a) Resides in the nursing home; and (b) Receives nursing services rendered by or under the supervision of a registered nurse. (65) “Resident activities coordinator” means an individual who: (a) Is a: (i) Certified therapeutic recreation specialist; (ii) Licensed occupational therapist; or (iii) Licensed occupational therapy assistant; or (b) Has 2 years of experience in a social or recreational program in a licensed health care setting within the last 5 years, 1 year of which was full time in a resident activities program with guidance from an individual identified in §B(73)(a) of this regulation. (66) Resident Assessment Instrument (RAI). (a) “Resident Assessment Instrument (RAI)” means a standardized and reproducible resident assessment process based on completion of Minimum Data Set (MDS) screening items, and including the MDS Care Area Assessment process, and related process for care planning and evaluation. (b) “Resident Assessment Instrument (RAI)” includes: (i) Minimum Data Set; (ii) MDS Care Area Assessment Process; and (iii) RAI utilization guidelines. (67) “Resident’s representative” means a person with the authority to act on the resident’s behalf regarding the matter at issue. (68) “Restraint” means any physical or chemical restraint as defined in this chapter. (69) “Secretary” means the Secretary of Health. (70) “Serious and immediate threat” means a situation in which immediate corrective action is necessary because a deficiency has caused or is likely to cause serious injury, harm, impairment to, or death of a resident receiving care in the nursing home. (71) “Special care unit” means a nursing home unit that provides intensive specialized care, such as respiratory, rehabilitative, dementia, or dialysis care, continuously on a 24-hour basis. (72) “Speech-language pathologist” means an individual licensed by the State Board of Audiologists, Hearing Aid Dispensers, and Speech-Language Pathologists. (73) “Support personnel” means an aide who: (a) Is assigned to a particular service such as: (i) Nursing; (ii) Dietary; (iii) Physical therapy; or (iv) Occupational therapy; and (b) Has been approved by the manager of the services as having sufficient training and experience to perform the assigned duties. (74) “Tuberculin skin test” means a test to diagnose tuberculosis infection using purified protein derivative (PPD) that is injected intradermally and read within 48—72 hours with results recorded in millimeters of induration. (75) Tuberculosis in a Communicable Form. (a) “Tuberculosis in a communicable form” means that an individual: (i) Is presumed to have active pulmonary or laryngeal tuberculosis as evidenced by positive X-ray findings with or without positive acid-fast bacilli (AFB) sputum smear or positive AFB sputum culture; and (ii) Has received chemotherapy for less than 14 days. (b) “Tuberculosis in a communicable form” does not include: (i) When the individual who has presumptive or confirmed active disease, has had three negative AFB smears, collected 8—24 hours apart, shows clinical improvement, and has received chemotherapy to which the strain is susceptible for at least 14 days; or (ii) The individual who has inactive pulmonary scarring, calcification, or a normal chest X-ray. (76) “Two-step tuberculin skin testing” means the administration of a second tuberculin skin test 1 to 3 weeks after the initial skin test is negative, to identify individuals with a past TB infection who may now have reduced skin reactivity. #### Regulation .02 Incorporation by Reference. *COMAR 10.07.02.02* A. In this chapter, the following documents are incorporated by reference. B. Documents Incorporated. (1) CMS Long-term Care Facility Resident Assessment Instrument 3.0 User’s Manual, (Version 1.14, October 2016). (2) CMS Manual System, Pub. 100-07 State Operations Provider Certification, (Transmittal 127, November 26, 2014, U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services). (3) Guidelines for Design and Construction of Residential Health, Care, and Support Facilities. (2014) Facility Guidelines Institute, which is incorporated in COMAR 10.07.01.02. (4) 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings (Centers for Disease Control and Prevention (CDC), Healthcare Infection Control Practices Advisory Committee (HIPAC), 2007). (5) Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005 (MMWR2005; 54, No. RR-17, Centers for Disease Control and Prevention (CDC), Atlanta, GA). (6) Immunization of Health-Care Personnel: Recommendations of the Advisory Committee on Immunization Practices (ACIP), (MMWR2011; 60 No. SS-07, Centers for Disease Control and Prevention (CDC), Atlanta, GA). (7) National Fire Protection Association, NFPA 99 Health Care Facilities Code (2015 Edition). (8) National Fire Protection Association, NFPA 101 “Life Safety Code”, which is incorporated by reference at COMAR 29.06.01.06. (9) Recommended Dietary Allowances, (10th Edition, Food and Nutritional Board, Commission on Life Sciences, and National Research Council, 1989). #### Regulation .03 License Required. *COMAR 10.07.02.03* A. A person may not establish, operate, or continue the operation of an existing comprehensive care facility or extended care facility without first obtaining a license from the Secretary. A license is valid for 2 years from the date of issuance, unless revoked by the Secretary. B. Separate License Required. Separate licenses are required for facilities maintained on separate premises, even though they are operated under the same management. Separate licenses may be required for separate buildings on the same grounds. C. Other License Required. A facility having a dual function, including care of the sick requiring hospital facilities in addition to rendering other care services, is required to be licensed for each level of health care rendered. D. Posting of License Application and Instructions for Written Comment. (1) At least 50 days before the anticipated date of the new license or relicensure, a facility shall conspicuously post: (a) Its application for initial license or license renewal; or (b) A notice describing where in the facility the application for licensure or relicensure may be found. (2) The posting shall be near the entrance, in a manner which is plainly visible and easily read by the public. (3) The posting shall include instructions for filing written comments to the Department. E. Posting of License. A facility shall conspicuously post its license on the premises, at or near the entrance, in a manner which is plainly visible and easily read by the public. F. Provisional License. (1) The Secretary may issue a license to a nursing home or an extended care facility for less than a 24-month period under any of the following conditions: (a) A facility has substantial deficiencies which in the opinion of the Department do not constitute a serious or immediate threat to the health, life, or safety of the residents and the facility has submitted a plan of correction to the Department which satisfactorily addresses the correction of each deficiency within a time frame acceptable to the Department; (b) A facility has substantial deficiencies which in the opinion of the Department have no immediate adverse effect on the life, safety, or health status of residents but require construction or remodeling to correct, and the facility has made a bona fide commitment to correct the deficiencies by a required date; (c) Departmental administrative delays have occurred which are beyond the control of the facility; (d) If new construction is completed to the point of being able to provide all necessary services to its residents but certain substantial items of equipment for optional services are temporarily lacking, which in the opinion of the Department will have no immediate adverse effect on the safety or health of its residents; or (e) Licensing revocation proceedings are pending against the facility. (2) A provisional license shall be based upon the facility's written plan of correction addressing every deficiency existing at the time of licensure, including specific corrective action with the anticipated date of correction for each deficiency. The Department's decision to issue a provisional license shall be based upon the reasonableness of the plan and the facility's compliance history. (3) The Secretary shall issue only one license of less than 24 months during a given licensure period unless the facility can demonstrate that extenuating circumstances exist which are beyond the control of the facility in meeting a required deadline or, where necessary, to allow the Department to coordinate and unify its annual licensing dates with federal certification dates. G. Waiver of Provisions. If a facility experiences practical difficulties or unnecessary hardships in complying with the provisions of this chapter, and can demonstrate that granting a waiver will not adversely affect the health and safety of its residents, the Secretary may waive any provision of this chapter. A waiver granted to a facility is effective for the period specified in the waiver. A waiver may be revoked at any time if a facility violates a condition of the waiver or if it appears to the Secretary that the health or safety of residents residing in the facility would be adversely affected by the continuation of the waiver. H. Plan of Correction Required. (1) A facility shall submit a written plan of correction to the Department within 10 working days of the date that a facility receives written notice of deficiencies from the Department. (2) The Department may not issue a license to a facility until the facility submits a plan of correction that is acceptable to the Department. #### Regulation .04 Licensing Procedure. *COMAR 10.07.02.04* A. Application for License. (1) An applicant desiring to open a comprehensive care facility or an extended care facility shall file an application with the Secretary, on a written or electronic form provided by the Secretary. (2) An application for a license shall be filed with the Department at least 60 days before the anticipated issuance of the license. (3) Applications on behalf of a legal entity shall be made by the senior officer or other senior official and a second official, if any. (4) All members of the governing body shall be disclosed, with their business addresses. (5) The applicant shall complete all disclosure required by the Secretary, including: (a) Ownership of real property; (b) The identity of any management company that will operate or contract with the applicant to operate the facility; (c) Ownership of equipment; and (d) The names of persons holding 5 percent or greater of stocks or assets. (6) The applicant for a license to operate a comprehensive care facility or an extended care facility is the licensee. Responsibility for conformance with licensing standards and regulations rests upon the licensee. Those licensees requesting participation in the Maryland Medicaid program shall comply with the Medicaid contract. (7) Additional Requirements. (a) The Secretary shall require an applicant for licensure to submit to the Secretary the following information concerning the applicant’s: (i) Past or current operation of a nursing home, other health care facility as defined in Health-General Article, §19-114, Annotated Code of Maryland, assisted living program, residential service agency or other licensed in-home care service, or licensed community program for individuals with developmental disabilities, substance abuse, or mental health needs, located within or outside this State; (ii) Ability to comply with the applicable standards of medical and nursing care and applicable State or federal laws and regulations by disclosing the identities of its medical director, director of nursing, and administrator, and by providing the nursing home’s quality assurance plan, as required in Regulation .66 of this chapter; and (iii) Financial and administrative ability to maintain a nursing home in compliance with these regulations, including submission of an audited financial statement, whether or not the applicant ever operated a nursing home, related institution, or other health care facility. (b) The Secretary shall: (i) Approve the application unconditionally; (ii) Approve the application with conditions, such as requiring the applicant to use the services of a management firm, requiring a staffing pattern, or limiting admissions to the facility; or (iii) Deny the application. (c) A person who disagrees with the decision of the Secretary to deny a license application under this section may appeal the Secretary’s action by filing a request for a hearing in accordance with Regulation .78 of this chapter. B. Restrictions of License. (1) Nomenclature. A nursing home licensed under this regulation may not use the word “hospital” in its title. (2) Zoning. If a proposed facility is to be located in a political subdivision requiring zoning approval, the zoning authority's written approval shall be submitted to the Department before the Department's approval of the first drawings which are submitted. (3) Local Law or Ordinance, Where Applicable. A nursing home located in a political subdivision which requires it to meet certain standards shall submit proof to the Secretary that the nursing home meets local laws, regulations, or ordinances at the time application for license is submitted. (4) Transfer or Assignment of License. (a) If the sale, transfer, assignment, or lease of a nursing home causes a change in the person or persons who control or operate the nursing home, the nursing home shall be considered a “new nursing home” and the licensee shall conform to all regulations applicable at the time of transfer of operations. (b) The transfer of any stock which results in a change of the person or persons who control the nursing home, or a 25 percent or greater change in any form of ownership interest, constitutes a sale. (c) For purposes of Life Safety Code enforcement, the nursing home is considered to be an existing nursing home if it has been in continuous use as a nursing home. Waivers may be granted under Regulation .03F of this chapter. (5) Return of License to the Secretary of Health. The current license shall immediately become void and shall be returned to the Secretary if the: (a) Nursing home is sold, leased, or discontinued; (b) Operation moved to a new location; or (c) License is revoked. #### Regulation .05 Licensed Bed Capacity. *COMAR 10.07.02.05* A. A facility may exceed its licensed bed capacity only if the Department: (1) Requests that the facility exceed its licensed bed capacity; or (2) Approves a request from a facility to exceed its licensed bed capacity. B. Departmental Request of Facility to Exceed Capacity. If the Department requests a facility to exceed its licensed bed capacity, the written request is to include the: (1) Circumstances that prompted the Department to make the request; (2) Conditions under which the licensed bed capacity may be exceeded; and (3) Number of residents by which the facility's licensed capacity may be exceeded. C. Request for Departmental Permission to Exceed Capacity. (1) If an emergency situation exists, a facility may request permission from the Department to exceed its licensed bed capacity to help resolve the emergency situation. (2) The written request shall include the: (a) Circumstances or reasons for the request; (b) Identity of any resident involved; (c) Beginning and ending dates for which the request is made; and (d) Documentation of any objection by a resident affected by the request, or by the resident's personal representative. (3) The nursing home shall: (a) Submit the written request to the Office of Licensing and Certification Programs; and (b) Make the request for a term not to exceed 30 days. (4) Before reaching its decision on the request, the Department shall consider the: (a) Needs of the resident whose admission is proposed; (b) Ability of the facility to care for the resident properly; (c) Likely effect of the admission on the comfort and care of the other residents in the facility; and (d) Evidence that exceeding licensed capacity would help resolve the emergency situation. (5) Required Resident Accommodations. Before a facility may admit a resident that causes the facility to exceed its licensed bed capacity, the facility shall: (a) Provide the following equipment for the exclusive use of the resident: (i) Electronic nurses call system or hand bell, (ii) Privacy curtain or screen, (iii) Storage space for belongings, and (iv) A bed, at least 36 inches wide, sturdy and in good repair; (b) Meet any square footage requirements under this chapter for a room; and (c) Meet any other condition that the Department may require. (6) Admission. When a facility is permitted to exceed its licensed bed capacity under this section, the facility may not admit a resident to the facility until each resident admitted under permission granted under this section has: (a) Been placed in the facility as part of the facility's permanent resident population; or (b) Found other placement that is acceptable to the resident. #### Regulation .06 Rights of Applicant if License Denied or Revoked. *COMAR 10.07.02.06* A. Denial of License — Proposed Facility. The Secretary shall inform the applicant of the reasons for refusal to issue a license. B. Revocation of License. (1) The Secretary may, for cause shown, revoke or refuse to reissue any license issued by the Secretary. The Secretary shall consider the following factors in deciding whether a facility's license should be revoked: (a) The number, nature, and seriousness of the deficiencies; (b) The degree of risk to the residents posed by the deficiencies; (c) The compliance history of the facility; and (d) Background of the owner and management, including the owner's and management's experience in operating facilities and other businesses. (2) The licensee shall have the right to a hearing before revocation of the facility's license. The hearing shall be held after 10 days notice to the licensee, and the licensee shall have an opportunity to be represented by counsel at the hearing. #### Regulation .07 Inspection by Secretary. *COMAR 10.07.02.07* A. Open at all Times for Inspection. Licensed nursing homes and any premises that an applicant for a license proposes to operate shall be open at all times to inspection by the Secretary and by any agency designated by the Secretary. B. Site Visits and Surveys. (1) The Department shall make a site visit and conduct a full survey of each licensed nursing home at least once per calendar year. (2) All surveys shall be unannounced. C. Records and Reports. Licensees shall keep such records and make reports in the manner and form as the Secretary shall prescribe and all these records and reports shall be open to inspection by the Secretary. Upon the written request of the Secretary or the Secretary's designee, the licensee shall provide immediately to the Secretary, photocopies of records and reports, including the clinical records of residents. The Department, upon request, shall reimburse the licensee for the cost of photocopying all records and reports requested under this section. D. The Secretary shall have the authority to immediately restrict admissions in accordance with the provisions of Health-General Article, §19-328, Annotated Code of Maryland. E. The Department shall make a site visit and conduct a full survey of each licensed nursing home at least once per calendar year. #### Regulation .08 New Construction, Conversion, Alteration, or Addition. *COMAR 10.07.02.08* A. Submission of Plans. (1) The architect or professional engineer of record shall submit stamped and sealed final construction drawings to the Department. (2) The architect or professional engineer of record shall submit a letter certifying that the project has been designed in accordance with all applicable federal, State, and local codes, laws, ordinances, and regulations for construction. B. Plan Approval. (1) A system of water supply, plumbing, sewerage, electrical power, garbage or refuse disposal may not be installed or extended until the architect or professional engineer of record submits stamped and sealed final construction drawings for Department record and provisional approval in accordance with §A of this regulation. (2) The architect or professional engineer of record shall also submit a letter certifying that the project has been designed in accordance with all applicable federal, State, and local codes, laws, ordinances, and regulations. C. New Construction. (1) A new nursing home shall satisfy the review of the Maryland Health Care Commission for the: (a) Establishment of a new nursing home; and (b) Increase or decrease in capacity of an existing nursing home. (2) After obtaining approval by the Maryland Health Care Commission, the nursing home shall provide written verification of the approval to the Office of Health Care Quality. (3) Verification shall include: (a) Details of the proposed nursing home changes; and (b) Written plans that describe how all residents, staff, and the general public will be kept safe for the duration of the project. D. Conversion, Alteration, and Additions. (1) An existing nursing home that wishes to convert, alter, modify, or add to the existing infrastructure shall notify the Office of Health Care Quality in writing. (2) The nursing home shall provide the Office of Health Care Quality with the documentation that verifies that the applicable local and State governmental authorities have approved work that was done. (3) The nursing home shall provide additional information upon request. #### Regulation .09 Administration and Resident Care. *COMAR 10.07.02.09* A. Responsibility. (1) The licensee shall be responsible for the overall conduct of the comprehensive care facility or extended care facility and for compliance with applicable laws and regulations. (2) The administrator shall be responsible for the implementation and enforcement of all provisions of the Patient's Bill of Rights Regulations under COMAR 10.07.09. B. Delegation to Administrator. (1) The licensee, if not acting as an administrator, shall appoint as administrator a responsible person who is: (a) Qualified by training and experience; and (b) Licensed by the Board of Examiners of Nursing Home Administrators for the State. (2) The administrator shall: (a) Be responsible for the control of the operation on a 24-hour basis; and (b) With the exception of §B(3) of this regulation, serve full-time. (3) With the Department’s approval, an administrator may serve on a less than full-time basis for a maximum of two nursing facilities, one of which shall have a licensed capacity of 35 beds or fewer. (4) The Department shall consider the following factors when deciding whether to approve an administrator to serve on a less than full-time basis: (a) Geographic location of the facilities; (b) Ownership of the facilities; (c) Organizational structure of the facilities; (d) Size of the facilities; and (e) Background and experience of the administrator. C. Absence of Administrator. (1) In the absence of the administrator, the nursing home at all times shall be under the direct and personal supervision of an experienced, trained, competent employee. (2) When serving as relief for the administrator, the director of nursing shall designate an experienced, qualified registered nurse to direct the nursing service. (3) The relief director of nursing shall be freed from other responsibilities. D. Excessive Absenteeism of Administrator. (1) If the director of nursing’s absence while covering for the administrator is having an adverse effect on resident care, the Department may require the designation of a specific registered nurse who shall be named the assistant director of nursing. (2) The Department shall be notified of the name of the assistant director of nursing. (3) When the designee is replaced, the Department shall be notified of the name of the registered nurse filling the vacancy. E. Character. The administrator shall: (1) Be of good moral character; (2) Be in good physical and mental health; and (3) Demonstrate a genuine interest in the well-being and welfare of residents in the nursing home. F. Staffing. (1) The administrator shall employ sufficient and satisfactory personnel as specified in this chapter to: (a) Provide maintenance, cleaning, and housekeeping; (b) Assist residents with eating; and (c) Give adequate resident care. (2) Voluntary Admissions Ceiling. (a) A nursing home may request a voluntary admissions ceiling by submitting a written request to the Department to authorize a temporary restriction on resident admissions based upon anticipated bed usage. (b) When the nursing home wishes to request that the restriction be removed, the request shall include the specific effective date and a statement that personnel staffing is sufficient to meet the State’s requirements at the designated census level. (c) The Department shall approve the increase in beds within 72 hours following receipt of the nursing home’s documentation that the required additional staff is in position to serve the increased number of beds. (d) Management of the nursing home may not permit the resident census to exceed the admissions ceiling without prior approval from the Department. G. Educational Program. (1) The administrator shall plan an ongoing educational program to develop and improve the skills of all the nursing home’s personnel, including training related to problems and needs of the aged, ill, and disabled. (2) The administrator shall maintain records reflecting attendance, by name and title, and training content. (3) In-service training shall include at least: (a) Prevention and control of infections; (b) Fire prevention programs and resident related safety procedures in emergency situations or conditions; (c) Accident prevention; (d) Confidentiality of resident information; (e) Preservation of resident dignity, including protection of the resident’s privacy and personal and property rights; (f) Physical, functional, and psychosocial needs of the aged ill individuals; (g) Receipt by each employee of appropriate orientation to the facility and its policies, and to the employee's position and duties; (h) Approval by the Department of the orientation and training programs. H. Employment Records. A written application shall be on file for each employee and shall contain at least the: (1) Employee’s Social Security number; (2) Home address; (3) Educational background; (4) Past employment documentation with references; (5) Past nursing home employment documentation, including any past instances of abuse of residents, theft, and fires; (6) Verified licensure of personnel employed; and (7) Proof of criminal background check. I. Support Personnel. (1) To support placement in a specific position, there shall be sufficient documentation in the employee’s record reflecting training and experience. (2) In instances when an aide is to be assigned to a particular service such as dietary, physical therapy, or occupational therapy, the person in charge of the service shall be responsible for evaluating and approving or disapproving the qualifications. J. New Support Personnel. (1) New support personnel shall be credited for 50 percent of their working time until the employee’s orientation program, as approved by the Department, is completed. (2) Employee Orientation Program. (a) New support personnel shall have an employee orientation program. (b) The person in charge of the service to which the employee is assigned shall: (i) Have input into the contents of the orientation program; (ii) Determine the number of hours of orientation required for the various levels of support personnel; and (iii) Following the period of orientation, indicate whether the employee satisfactorily completed the orientation program. (3) The responsible department’s approval shall be in writing, signed by the appropriate department head whose license number, if applicable, shall be recorded in the record. (4) In new facilities, the director of nursing and supervisors of dietary services, housekeeping, rehabilitation services, and social services shall be responsible for orienting the new support personnel to the nursing home policies and procedures and to the physical plant. (5) There shall be a complete orientation for all the employees in life safety and disaster preparedness. (6) The number of daily admissions of residents shall be controlled to allow sufficient time for on-the-job training. (7) Before the opening of the nursing home, support personnel shall have a minimum of 2 days of orientation training. K. Relief Personnel. Provision shall be made for qualified relief personnel during vacations or other relief periods. L. Availability of Information. The administrator shall make available to the Secretary such information as may be requested to insure that the facility is meeting the requirements of these and other applicable regulations. M. Except where inappropriate for safety reasons, an employee and any other individual who provides a health care service within or on the premises of the nursing home shall wear a personal identification tag that: (1) States the name of the individual; (2) States the profession or other title of the individual; and (3) Is in a readily visible type font and size. #### Regulation .10 Employee Training on Cognitive Impairment and Mental Illness. *COMAR 10.07.02.10* A. The following employees shall receive a minimum of 8 hours of training on cognitive impairment and mental illness within the first 90 days of employment: (1) Any employee who is licensed, certified, or registered under the Health Occupations Article, Annotated Code of Maryland; and (2) Any employee whose job duties include assisting residents with activities of daily living. B. The training on cognitive impairment and mental illness shall be designed to meet the specific needs of the nursing home’s population as determined by the staff trainer, including the following as appropriate: (1) An overview of the following: (a) A description of normal aging and conditions causing cognitive impairment; (b) A description of normal aging and conditions causing mental illness; (c) Risk factors for cognitive impairment; (d) Risk factors for mental illness; (e) Health conditions that affect cognitive impairment; (f) Health conditions that affect mental illness; (g) Early identification and intervention for cognitive impairment; (h) Early identification and intervention for mental illness; and (i) Procedures for reporting cognitive, behavioral, and mood changes; (2) Effective communication including: (a) The effect of cognitive impairment on expressive and receptive communication; (b) The effect of mental illness on expressive and receptive communication; (c) Effective verbal, non-verbal, tone and volume of voice, and word choice techniques; and (d) Environmental stimuli and influences on communication; (3) Behavioral interventions including: (a) Identifying and interpreting behavioral symptoms; (b) Problem solving for appropriate intervention; (c) Risk factors and safety precautions to protect the individual and other residents; and (d) De-escalation techniques; (4) Making activities meaningful including: (a) Understanding the therapeutic role of activities; (b) Creating opportunities for productive, leisure, and self-care activities; and (c) Structuring the day; (5) Staff and family interaction including: (a) Building a partnership for goal-directed care; (b) Understanding families' needs; and (c) Effective communication between family and staff; (6) End-of-life care including: (a) Pain management; (b) Providing comfort and dignity; and (c) Supporting the family; and (7) Managing staff stress including: (a) Understanding the impact of stress on job performance, staff relations, and overall facility environment; (b) Identification of stress triggers; (c) Self-care skills; (d) De-escalation techniques; and (e) Devising support systems and action plans. C. Employees who are not licensed, certified, or registered or who do not assist residents with activities of daily living shall receive a minimum of 2 hours of training on cognitive impairment and mental illness within the first 90 days of employment. The training shall include: (1) An overview of the following: (a) A description of normal aging and conditions causing cognitive impairment; (b) A description of normal aging and conditions causing mental illness; (c) Risk factors for cognitive impairment; (d) Risk factors for mental illness; (e) Health conditions that affect cognitive impairment; (f) Health conditions that affect mental illness; (g) Early identification and intervention for cognitive impairment; (h) Early identification and intervention for mental illness; and (i) Procedures for reporting cognitive, behavioral, and mood changes; (2) Effective communication including: (a) The effect of cognitive impairment on expressive and receptive communication; (b) The effect of mental illness on expressive and receptive communication; (c) Effective verbal, non-verbal, tone and volume of voice, and word choice techniques; and (d) Environmental stimuli and influences on communication; and (3) Behavioral intervention including risk factors and safety precautions to protect the individual and other residents. D. Ongoing training in cognitive impairment and mental illness shall be provided annually and consist of, at a minimum: (1) 2 hours for employees who are licensed, certified, or registered under the Health Occupations Article, Annotated Code of Maryland, or who assist residents with activities of daily living; and (2) 1 hour for all other employees. E. The training that is described in this chapter may be provided through various means including: (1) Classroom instruction; (2) In-service training; (3) Internet courses; (4) Correspondence courses; (5) Pre-recorded training; or (6) Other training methods. F. When the training method does not involve direct interaction between faculty and the participant, the facility shall make available to the participant during the training a trained individual to answer questions and respond to issues raised by the training. #### Regulation .11 Admission and Discharge. *COMAR 10.07.02.11* A. Written Policy. The nursing home shall develop written policies, consistent with this chapter and COMAR 10.07.09, to govern the nursing care, related medical, and other services that the nursing home provides regarding: (1) Admissions, transfers, and discharges; (2) Acceptable payment sources; and (3) Medical Assistance program information. B. The nursing home shall make its admission and discharge policies available for review by residents, the resident’s representative, and the long-term care ombudsman. C. Discrimination Prohibited. A nursing home licensed under this chapter may not discriminate in admitting or providing care to an individual because of the individual’s: (1) Race; (2) Color; (3) National origin; (4) Sexual orientation; (5) Gender identity; (6) Religion; (7) Physical disability; or (8) Mental disability. D. Contract. Before or at admission, a contract shall be executed by the administrator and resident, guardian, or responsible agency which is consistent with the requirements of Health-General Article, §19-344, Annotated Code of Maryland, “Rights of Individuals”. E. Registry. A nursing home shall maintain a permanent resident registry in which the name of each resident is entered in chronological order with the date and number of entry. F. Admission Record. A copy of the clinical record, identification, and summary sheet described in Regulation .32 shall be used as an admission record. G. Before discharge the nursing home shall: (1) Verify that the transfer and discharge is to a licensed assisted living facility and appropriate to meet the needs of the resident; and (2) Document the verification in the resident’s medical record. H. Notification of Responsible Persons When Resident Moves. When the resident is transferred from the nursing home for any reason or at time of death, the administrator or the administrator’s designee shall notify the attending physician and the: (1) Private agency; (2) Public agency; or (3) Responsible party designated by the resident. I. Restrictions on Admission and Retention of Residents. Residents may not be admitted or retained if, in the judgment of the attending physician, they are: (1) Acutely ill and require medical, surgical, or nursing care beyond the capabilities of the facility; or (2) Dangerous to themselves or others. #### Regulation .12 Resident's Representative. *COMAR 10.07.02.12* A. A nursing home shall recognize the authority of: (1) A guardian of the person under Estates and Trusts Article, §13-705, Annotated Code of Maryland; (2) A guardian of the property under Estates and Trusts Article, §13-201, Annotated Code of Maryland; (3) An advance directive that meets the requirements of Health-General Article, §5-602, Annotated Code of Maryland; (4) A surrogate decision maker with authority under Health-General Article, §5-605, Annotated Code of Maryland; (5) A power of attorney that meets the requirements of Estates and Trusts Article, §13-601, Annotated Code of Maryland; (6) A representative payee or other similar fiduciary; or (7) To the extent permitted by Maryland law, any other individual, if that individual was designated by a resident who was competent at the time of designation. B. A facility shall require documentation or other appropriate verification of the authority of a resident's representative. A facility may not recognize the authority of a resident's representative if the representative attempts to exceed the authority: (1) Stated in the instrument that grants the representative authority; or (2) Established by State law. C. A facility shall: (1) Document in the resident's record the name of the individual, if any, with authority identified in §A of this regulation; or (2) Include the documentation in the record. #### Regulation .13 Resident Care Policies. *COMAR 10.07.02.13* A. A nursing home shall develop written policies consistent with Regulation .11 of this chapter pertaining to: (1) Physician services; (2) Residents’ rights; (3) Nursing services; (4) Dietetic services; (5) Specialized rehabilitative services including occupational therapy, physical therapy, speech pathology and audiology services; (6) Pharmaceutical services; (7) Laboratory and radiologic services; (8) Dental services; (9) Social services; (10) Resident activities; (11) Clinical records; (12) Reports and action required in unusual circumstances; (13) Utilization review; (14) Infection control; (15) Tuberculosis surveillance; (16) Disaster plan; (17) Housekeeping services, pest control, and laundry; and (18) Resident care management. B. Resident Care Policy. (1) A nursing home shall develop resident care policies with the advice of: (a) The principal physician or medical staff or medical director, if applicable; and (b) At least one registered nurse. (2) A group of professional personnel including one or more physicians and one or more registered nurses shall review the policies at least annually. (3) Written policies shall be kept current with the policies used to administer the nursing home. (4) For reference purposes, copies of the resident care policies shall be readily available to all personnel responsible for resident care. (5) The nursing home shall make its resident care policies available for review by residents, the resident’s representative, and the ombudsman. C. Policies and Procedures. (1) Upon the request of the Secretary or the Secretary's designee, the facility's policies and procedures shall be made available to the Secretary for onsite review. (2) The licensee shall submit to the Department any significant substantive changes to the policies and procedures which have occurred since review of the policies and procedures within 2 weeks of implementation of the changes. D. Use of Protective Device or Devices. (1) A written physician's order is required for the use of a protective device or devices. This order shall be in effect for a maximum of 60 days. If continuation of the use of a protective device or devices beyond 60 days is necessary, a new order shall be written by the physician and rewritten every 60 days. (2) The physician's order shall contain the specific type of protective device or devices to be used. (3) The physician's order shall reflect his or her reason for ordering a protective device or devices. (4) A resident in a protective device or devices shall be observed periodically by personnel, to ensure that the resident’s health and personal care needs are met. (5) A resident who is in a protective device or devices may not be left in the same postural position for more than 2 consecutive hours. #### Regulation .14 Physician Services. *COMAR 10.07.02.14* A. Responsibility for the Resident's Care. The attending physician shall: (1) Assess a new admission in a timely manner, based on a facility-developed protocol, depending on: (a) The individual's medical stability; (b) Recent and previous medical history; (c) Presence of significant or previously unidentified medical conditions; or (d) Problems that cannot be handled readily by phone; (2) Seek, provide, and analyze needed information regarding a resident's current status, recent history, and medications and treatments, to enable safe, effective continuing care and appropriate regulatory compliance; (3) Provide appropriate information and documentation to support a facility-determined level of care for a new admission; (4) Provide for the authorization of admission orders in a timely manner, based on a facility-developed protocol, to enable the nursing facility to provide safe, appropriate, and timely care; and (5) For a resident who is to be transferred to the care of another attending physician, continue to provide all necessary medical care and services pending transfer until another attending physician has accepted responsibility for the resident. B. Support Resident Discharges and Transfers. The attending physician shall: (1) Follow-up as needed with a physician or another health care practitioner at a receiving hospital within 24 hours of the transfer of an acutely ill or unstable resident; (2) Provide whatever summary or documentation may be needed at the time of transfer to enable care continuity at a receiving facility and to allow the nursing facility to meet its legal, regulatory, and clinical responsibilities for a discharged individual; and (3) Provide a pertinent medical discharge summary within 30 days of discharge or transfer of the resident. C. Periodic, Pertinent On-site Visits to Residents. The attending physician or licensed or certified professional health care practitioner shall: (1) Visit a resident as frequently as the resident's condition requires, consistent with reasonable facility policies; (2) Determine the progress of each resident's condition at the time of a visit by evaluating the resident, talking with staff as needed, and reviewing relevant information, as needed; (3) Review and respond to issues requiring a physician's expertise, including: (a) The resident's current condition; (b) The status of any acute episodes of illness since the last visit; (c) Test results; (d) Other actual or high-risk potential medical problems that may affect the individual's functional, physical, or cognitive status; and (e) Staff, resident, or family questions regarding the individual's care and treatments; and (4) At each visit, provide a legible progress note in a timely manner for placement on the chart, which includes relevant information about significant ongoing, active, or potential problems, including: (a) Reasons for changing or maintaining current treatments or medications; and (b) A plan to address relevant medical issues. D. Timeliness of Visits and Progress Notes. (1) Within 30 days of admission, a physician shall visit a resident, assess the resident's needs, and prescribe a regimen of medical care. After that, a physician, nurse practitioner, or physician assistant shall visit a resident every 30 days, except that a physician shall visit a resident at least every 120 days. (2) The timeliness of visits shall be based on a facility-developed protocol, depending on: (a) The resident's medical stability; (b) Recent and previous medical history; (c) The presence of significant or previously unidentified medical conditions; or (d) Problems that cannot be handled readily by phone. (3) The physician or licensed or certified professional health care practitioner shall maintain progress notes and make appropriate revisions to the resident's total program of care. The progress notes and revisions to the program of care shall cover, at a minimum, prognosis and changes in rehabilitation and other appropriate goals. The physician shall review and approve each program of care. E. Alternate Schedule. If the physician determines that the resident's condition requires less frequent visits than described in §D of this regulation, the physician may order an alternate schedule in the resident's medical record. An alternate schedule may not be ordered for the resident's first 90 days of stay. The alternate schedule may not exceed 60 days between visits. If there is no alternate schedule approved by the physician, visits may not exceed 30-day intervals. F. Adequate Ongoing Coverage. The attending physician shall: (1) Designate an alternate physician or physicians who shall respond in an appropriate, timely manner if the attending physician is unavailable; (2) Update the facility about the attending physician's current office address, phone, fax, and pager numbers to enable appropriate, timely communications, as well as the current office address, phone, fax, and pager numbers of designated alternate physicians; (3) Help ensure that alternate physicians provide adequate, timely support while covering and intervene with alternate physicians when informed of problems regarding coverage; and (4) Adequately inform alternate physicians about residents with active acute conditions or potential problems that may need medical follow-up during their on-call time. G. Appropriate Care of Residents. The attending physician shall: (1) Perform accurate, timely, and relevant medical assessments; (2) Properly define and describe resident symptoms and problems, clarify and verify diagnoses, relate diagnoses to resident problems, and help establish a realistic prognosis and care goals; (3) In consultation with the facility's staff: (a) Determine appropriate services and programs for a resident, consistent with diagnoses, condition, prognosis, and resident wishes; (b) Ensure that treatments are medically necessary and appropriate in accordance with nursing facility regulatory requirements; and (c) Manage and document ethics issues consistent with relevant laws and regulations and with residents' wishes, including advising residents and families about formulating advance directives or other care instructions and helping identify individuals for whom aggressive medical interventions may not be indicated; (4) Respond in an appropriate time frame, based on a facility-developed protocol, to emergency and routine notification, to enable the facility to meet its clinical and regulatory obligations; (5) Respond to notification of laboratory and other diagnostic test results in a timely manner, based on the resident's condition and clinical significance of the results; (6) Analyze the significance of abnormal test results that may reflect important changes in the resident's status and explain the medical rationale for interventions or decisions not to intervene based on those results; (7) Respond promptly to notification of, and assess and manage adequately, reported acute and other significant clinical condition changes in residents; (8) Ensure that individuals receiving palliative care have appropriate comfort and supportive care measures; and (9) Properly refer residents to specialty services and providers when the care needs of the resident exceed the scope of the attending physician’s knowledge and skill. H. Appropriate, Timely Medical Orders. The attending physician shall: (1) Provide timely medical orders based on an appropriate resident assessment, review of relevant pre-admission and post-admission information, and age-related and other pertinent risks of various medications and treatments; (2) Provide sufficiently clear, legible written medication orders to avoid misinterpretation and potential medication errors, including: (a) Medication strength and formulation, if alternate forms are available; (b) Route of administration; (c) Frequency and, if applicable, timing of administration; and (d) Reason for which the medication is being given; and (3) Institute safeguards to ensure the accuracy of verbal orders at the time the verbal orders are given and cosign the verbal orders in a timely fashion, but not later than the next visit to the resident. I. Appropriate, Timely, and Pertinent Documentation. The attending physician shall: (1) Provide documentation required to explain medical decisions, that promote effective care and allow a nursing facility to comply with relevant legal and regulatory requirements; and (2) Complete death certificates in a timely fashion, including all information required of a physician. #### Regulation .15 Medical Director — Qualifications. *COMAR 10.07.02.15* A. Medical Director Qualifications. The nursing home shall: (1) Designate a medical director who has at least the following qualifications: (a) A current license as a physician in this State; (b) At least 2 years of experience or specialized training in the medical care of geriatric or chronically ill and impaired residents; and (c) Successful completion of a curriculum in physician management or administration from: (i) AMDA: The Society for Post-Acute and Long-Term Care Medicine; or (ii) A curriculum approved by the Department or its designee; (2) Have a written agreement with a medical director that specifies the medical director's duties and roles and the authority to adequately discharge those responsibilities; and (3) Submit a copy of the medical director’s credentials to the Department upon a change in the medical director. B. The requirement specified in §A(1)(c) of this regulation becomes effective 3 years after the effective date of this regulation, but the medical director shall begin the educational process in physician management or administration within the first year from the date of employment as a medical director. #### Regulation .16 Medical Director — Responsibilities. *COMAR 10.07.02.16* A. General Responsibilities. The medical director is responsible for: (1) Overall coordination, execution, and monitoring of physician services; (2) Monitoring and evaluating the health care services and outcomes, including clinical and physician services provided to the nursing home’s residents; and (3) Designating an alternate medical director with sufficient training and experience to perform the responsibilities of the medical director as described in the regulations of this chapter. B. Practitioner Oversight. The medical director shall: (1) Oversee all physicians and other licensed or certified professional health care practitioners who provide health care to the facility's residents; (2) Ensure that there is a procedure for the review of the practitioners' credentials and the granting of privileges for licensed or certified professional health care practitioners who treat residents of the nursing facility; and (3) Recommend rules governing the performance of physicians and other licensed or certified professional health care practitioners who admit residents to the facility. C. Defining the Scope of Medical Services. (1) The medical director, in collaboration with the facility, shall recommend written policies and procedures that are approved by the licensee, delineating the scope of physician services and medical care. (2) The facility shall make these policies and procedures available to a resident or resident's representative upon admission and whenever a substantive change is made. D. Ensuring Physician Accountability. The medical director, in collaboration with the facility, shall recommend policies and procedures that cover essential physician responsibilities to the residents and the facility, including: (1) Accepting responsibility for the care of residents; (2) Supporting resident discharges and transfers; (3) Making periodic, pertinent resident visits in the facility; (4) Providing adequate ongoing medical coverage; (5) Providing appropriate resident care; (6) Providing appropriate, timely medical orders; (7) Providing appropriate, timely, and pertinent documentation; (8) Advising residents and families about formulating advance directives; and (9) Any other responsibilities as determined by the facility and the medical director. E. Quality Assurance. The medical director shall actively participate in the nursing home’s quality improvement process. Participation shall include: (1) Regular reports and attendance at the nursing home’s quality improvement committee meetings; and (2) Routine participation in ongoing facility efforts to improve the overall quality of the clinical care, including facility efforts to evaluate and address the causes of various care-related problems and deficiencies cited by the Office of Health Care Quality. F. Employee Health Oversight. The nursing home, in consultation with the medical director and other physicians, if necessary, shall establish and maintain surveillance of the health status of employees, including: (1) Advising on the development and execution of an employee health program, which shall include provisions for determining that employees are free of communicable diseases according to current accepted standards of practice; and (2) Ensuring that the facility plans and implements required immunization programs. G. Other Related Duties. The medical director shall perform other essential duties related to clinical care and physician practices, including: (1) Advising the administrator and the director of nursing on clinical issues, including the criteria for residents to be admitted, transferred, or discharged from the nursing facility; (2) Working with the nursing facility to establish appropriate relationships with area hospitals and other pertinent institutions to improve care of the residents; (3) Advising and consulting with the nursing facility staff regarding communicable diseases, infection control, and isolation procedures, and serving as a liaison with local health officials and public health agencies that have policies and programs that may affect the nursing facility's care and services to residents; (4) Providing or arranging for temporary physician services as needed to ensure that each resident has continuous physician coverage; (5) Participating as appropriate in facility committee projects and meetings concerning clinical care and quality improvement that require physician input; and (6) Educating or overseeing the education of, and informing, all attending physicians about their roles, responsibilities, and applicable rules and regulations. H. Medical Director Oversight Plan. (1) Based upon physician and medical director responsibilities in nursing facilities, as described in this chapter, the medical director shall develop and implement a plan describing how the medical director will carry out the responsibilities for the: (a) Overall monitoring, coordination, and execution of physician services and medical care to residents of the nursing facility; and (b) Systematic review of the quality of health care, including medical and physician services, provided to the facility's residents. (2) Minimum Requirements of the Plan. The medical director oversight plan shall include, at least, a plan to ensure that physicians: (a) Accept appropriate responsibility for residents under the physicians' care in the nursing facility; (b) Provide appropriate, timely medical care consistent with widely identified medical principles relevant to the facility's population; and (c) Provide appropriate, timely, and pertinent medical documentation and orders. (3) Documentation Regarding Medical Director Activities. (a) The medical director shall keep documentation regarding the medical director's activities in relation to designated responsibilities. (b) The documentation required in this subsection may include: (i) Notes; (ii) Minutes; (iii) Copies of faxes, letters, and telephone communications with attending physicians, other facility staff and departments, the administration, the governing body, and others regarding concerns, inquiries, and interventions. (c) The documentation required in this subsection shall show evidence of the medical director's interventions and follow-up of the effectiveness of those interventions. I. Quality Assurance Committee Minutes. Committee minutes shall reflect monthly input from the medical director regarding physician issues and general facility clinical care issues. #### Regulation .17 Nursing Home’s Responsibilities in Relation to the Nursing Home’s Medical Director. *COMAR 10.07.02.17* A. The nursing facility shall: (1) Be responsible for working with the medical director to ensure adequate resident care and practitioner performance; (2) Inform the physician of explicit requirements as a medical director and assist the medical director in gaining the necessary information and tools to properly execute those responsibilities; and (3) Ensure that the medical director has the necessary support and authority to perform medical director duties effectively and to hold practitioners accountable. B. When the attending physician and medical director document a resident’s medical need for a particular treatment, assistive device, or equipment, the nursing home shall provide that treatment, assistive device, or equipment unless the nursing home documents in the quality assurance committee minutes the reason or reasons why the treatment, assistive device, or equipment should not be provided. C. When the attending physician and medical director agree that a particular nursing home developed protocol is required to ensure that quality medical care is delivered to the nursing home’s residents, that protocol shall be implemented unless the nursing home documents in the nursing home’s resident care committee minutes the reason or reasons why the protocol should not be implemented. D. Evaluation of Medical Director's Performance. (1) The facility shall have a mechanism for evaluating the medical director's performance and for providing the medical director with feedback about that performance. (2) The criteria for evaluation shall be based on explicit medical director responsibilities and shall facilitate the medical director's improvement and performance of functions and duties. #### Regulation .18 Nursing Services. *COMAR 10.07.02.18* A. Organization, Policies, and Procedures. (1) Nursing service personnel shall provide care appropriate to the residents’ needs with the organizational plan, authority, functions, and duties clearly defined. (2) Nurses and support personnel shall be chosen for their training, experience, and ability. (3) Policies and procedures shall be adopted and made available to all nursing service personnel. B. Signed Agreement. (1) A signed copy of the agreement between the nursing home and the director of nursing, showing the license number of the nurse, shall be filed with the Department upon: (a) Application for an initial nursing home license; and (b) A change of director of nursing. (2) The agreement shall specify the duties of the director of nursing. C. Nursing Care 24 Hours a Day. The administrator shall employ sufficient and satisfactory licensed nursing service personnel and support personnel to: (1) Be on duty 24 hours a day; (2) Provide appropriate bedside care; and (3) Ensure that a resident: (a) Receives treatments, medications, and diet as prescribed; (b) Receives rehabilitative nursing care as needed; (c) Receives proper care to prevent pressure ulcers and deformities; (d) Is kept comfortable, clean, and well-groomed; (e) Is protected from accident, injury, and infection; (f) Is encouraged, assisted, and trained in self-care and group activities; and (g) Receives prompt and appropriate responses to requests for assistance. D. Assistance by Nursing Service Personnel. Nursing service personnel shall help the resident perform daily routine dental hygiene. E. Charge Nurse. (1) At least one licensed nurse shall be: (a) On duty at all times; and (b) Be designated by the director of nursing to be in charge of the nursing activities during each tour of duty. (2) The charge nurse or nurses shall have the ability to recognize significant changes in the condition of residents and to take necessary action. F. Charge Nurses’ Daily Rounds. The charge nurse or nurses shall make daily rounds on all nursing units for which they are responsible, performing such functions as: (1) Visiting each resident; (2) Reviewing clinical records, medication orders, resident care plans, and staff assignments; and (3) To the degree possible, accompanying physicians when visiting residents. G. Program of Restorative Nursing Care. There shall be an active program of restorative nursing care aimed at assisting each resident to achieve and maintain the individual’s highest level of independent function, including activities of daily living. This program shall include: (1) Ambulation and range of motion; (2) Maintaining good body alignment and proper positioning of bedfast residents; (3) Encouraging and assisting residents to change positions at least every 2 hours to stimulate circulation and prevent pressure ulcers and deformities; (4) Encouraging and assisting residents to keep active and out of bed for reasonable periods of time, within the limitations permitted by physicians’ orders; (5) Encouraging residents to engage in resident-chosen community and independent activities and achieve independence; and (6) Assisting residents to adjust to their disabilities and ensuring availability and use of their prosthetic and assistive devices. H. Coordination of Nursing and Dietetic Services. Nursing and dietetic services shall establish an effective policy to ensure that: (1) Nursing service personnel are aware of the nutritional needs and food and fluid intake of residents; (2) Nursing service personnel provide special meals and nourishment when required; (3) Residents’ food choices and preferences are honored as much as practical; (4) Nursing service personnel promptly aid residents when necessary in eating; (5) The dietetic service is informed of physicians’ diet orders and of residents’ nutrition-related issues; and (6) Food and fluid intake of residents is observed, and deviations from normal are recorded and reported to the: (a) Charge nurse; (b) Physician; and (c) Dietetic service. I. In-Service Education Program. (1) The director of nursing shall: (a) Provide a continuing in-service education program for all nursing service personnel; (b) Provide a thorough job orientation for new personnel; and (c) Document the content of the continuing in-service education program and include the names and titles of participants. (2) The director of nursing shall obtain approval from the Department. J. Responsibility to Report Care that Is Considered Questionable. (1) If a nurse questions the care provided to any resident or believes that appropriate consultation is needed and has not been obtained, the nurse shall inform the supervisor. (2) If indicated, the supervisor shall refer the matter to the director of nursing. (3) If warranted, the director of nursing shall report the matter to the medical director or principal physician. #### Regulation .19 Nursing Services — Staffing. *COMAR 10.07.02.19* A. Supervisory Personnel — Nursing Homes. (1) Nursing homes shall provide at least the following supervisory personnel: (2) The director of nursing’s time is included in §A(1) of this regulation. B. Hours of Bedside Care — Nursing Home. (1) A nursing home shall employ supervisory personnel and a sufficient number of support personnel to provide a minimum of 3 hours of bedside care per occupied bed per day, 7 days per week. (2) Bedside hours include the care provided by: (a) Registered nurses; (b) Licensed practical nurses; and (c) Support personnel. (3) Only those hours which the director of nursing spends in bedside care may be counted in the 3-hour minimum requirement. (4) The director of nursing’s time counted in bedside care shall be documented. C. Staffing in Nursing Home. (1) A nursing home shall be staffed with at least one registered nurse, 24 hours per day and 7 days per week. (2) Additional registered nurses, licensed practical nurses, and support personnel shall be employed to meet the needs of all the residents admitted. The nursing home shall be staffed as referenced in §§A and B of this regulation. D. Nursing Service Personnel on Duty. The ratio of nursing service personnel on duty providing bedside care to residents may not at any time be less than one to 15. #### Regulation .20 Nursing Services — Director of Nursing. *COMAR 10.07.02.20* A. Director of Nursing. The nursing home shall provide for an organized nursing service, under the direction of a full-time registered nurse. B. Termination of Services of Director of Nursing. (1) If the nursing home terminates the services of the director of nursing, the nursing home immediately shall notify the Department of the termination. (2) The name and license number of the replacement director of nursing shall be supplied to the Department as soon as employment begins. (3) A copy of the agreement between the nursing home and the replacement shall be sent to the Department. C. Director of Nursing’s Vacancy Exceeding 30 Days. If the position of director of nursing remains vacant for a period exceeding 30 days, the nursing home’s license may be revoked unless the administrator and the governing body are able to demonstrate that they have made every effort to obtain a replacement. D. Relief for Director of Nursing. (1) When the director of nursing is absent, the individual shall designate an experienced, qualified registered nurse to direct the nursing service. (2) In a nursing home in which the director of nursing serves as relief for the administrator, the director of nursing shall designate a specific registered nurse who shall be in charge of the nursing service while the director of nursing covers for the administrator. E. Responsibilities of the Director of Nursing. The responsibilities of the director of nursing shall include: (1) Assisting in the development and updating of statements of nursing philosophy and objectives to define the type of nursing care the nursing home shall provide; (2) Preparation of written job descriptions for nursing service personnel; (3) Planning to meet the total nursing needs of residents to be met and recommending the assignment of a sufficient number of supervisory and support personnel for each tour of duty; (4) Development and maintenance of nursing service policies and procedures to implement the program of care; (5) Participation in the coordination of resident services through appropriate staff committee meetings on issues relating to: (a) Pharmacy; (b) Infection control; (c) Resident care policies; (d) Quality assurance programs; and (e) Departmental meetings; (6) Cooperation with administration in planning the orientation program and the staff development program to upgrade the competency of personnel; (7) Ensuring that nursing personnel understand the philosophy and meet the objectives; (8) Participation in planning and budgeting for nursing services; (9) Establishment of a procedure to ensure that nursing service personnel, including private duty nurses, have valid and current Maryland licenses; (10) Execution of resident care policies unless delegated to the principal physician or medical director; (11) Participation in the selection of prospective admissions to ensure that the nursing home’s staff is capable of meeting the needs of all residents admitted; (12) Coordination of the interdisciplinary resident care management efforts; and (13) Supervision of certified medicine aides to ensure that the aides act within the limitations and restrictions placed on them. F. Delegation of Responsibilities. The director of nursing shall make clear any authority delegated to another staff member. G. Daily Rounds — Director of Nursing. (1) Although daily rounds are primarily the responsibility of the charge nurse or nurses, the director or assistant director of nursing shall periodically make clinical rounds to nursing units, randomly reviewing clinical records, medication orders, resident care plans, and staff assignments and visiting residents. (2) Upon request, the director or assistant director of nursing may accompany physicians visiting residents. H. Director of Nursing’s Continuing Education. The director of nursing shall assume responsibility for maintaining professional competence of staff through their participation in education programs. #### Regulation .21 Dietetic Services. *COMAR 10.07.02.21* A. Services Provided. Services may be provided directly by the facility or the facility may contract with a food management company, a caterer, or another facility. The facility and the food management company (or caterer or facility providing service) shall comply with these regulations. Food service personnel shall comply with COMAR 10.15.03 Food Service Facilities. B. Supervision. (1) In a nursing home with more than 50 beds, overall supervisory responsibilities for the food service department and food production shall be assigned to a full-time qualified dietetic service supervisor. It shall be the responsibility of the supervisor to delegate relief duties to an individual qualified to serve as relief as stated in Regulation .09I of this chapter. (2) In a nursing home with 50 or fewer beds, exceptions may be made by the Department to allow the supervisor to share cooking responsibilities with the full-time cook. C. Consultation. (1) If the supervisor is not a licensed registered dietitian, the individual shall receive regularly scheduled consultation from a licensed registered dietitian. In all instances sufficient consultation shall be provided to fulfill all required responsibilities. (2) There shall be a signed agreement between the facility and the consultant dietitian specifying hours and frequency of service responsibilities, and registration number if applicable. (3) Consultation services shall be documented by written reports. D. Staffing. (1) A sufficient number of food service personnel shall be employed to perform efficiently the functions of the food and nutrition service and meet the dietary needs of the residents. (2) Working hours shall be scheduled to ensure that the nutritional needs of the residents are met. (3) Nursing, housekeeping, laundry, or other personnel may not be used as food service staff. Exceptions, such as in a culture change setting, shall be based on the written approval of the Department. The kitchen may not be used for any purpose other than the preparation of food. E. Adequacy of Diet. (1) The food and nutritional needs of residents shall be met in accordance with physicians’ orders. (2) To the extent medically possible, the “Recommended Dietary Allowances” of the Food and Nutrition Board, Commission on Life Sciences, and National Research Council, adjusted for age, sex, and activity, shall be observed. (3) The “Diet Manual for Long-Term Care Residents”, as published by the Department, or any other similar reference material that contains food allowances and guides for regular and therapeutic diets, shall be used. F. Therapeutic Diets. Therapeutic diets shall be planned, prepared, and served as prescribed by the attending physician: (1) Therapeutic diets shall be planned by a licensed registered dietitian; (2) Preparation and serving shall be supervised by a qualified dietetic supervisor; and (3) A current diet manual shall be available to medical, nursing, and dietetic staff. G. Frequency and Quality of Meals. (1) At least three meals or their equivalent shall be offered daily, at regular times, with not more than 14-hour intervals between the substantial evening meal and breakfast. (2) A substantial evening meal is an offering of three or more menu items at one time, one of which includes a high quality protein such as meat, fish, eggs, or cheese. This meal represents at least 20 percent of the day’s total nutritional requirements. (3) To the extent medical orders permit, bedtime nourishments shall be offered routinely to all residents. (4) If a four or five meal a day plan is used, the meal pattern to provide this plan shall be approved by the Department. H. Advance Planning and Posting of Menus. (1) Residents shall be given the opportunity to participate in planning menus. Menus shall be written at least 1 week in advance. (2) The current week’s basic menu shall be posted in one or more easily accessible places in the food services department and in the common areas. (3) Menus shall include alternatives of similar nutritive value that give residents the opportunity to choose meals that they prefer. The dietary preferences of a resident shall be ascertained, including preferences arising from a resident’s religious, cultural, and ethnic heritage, and efforts shall be made to meet those preferences. I. Menus Served as Planned. Food sufficient to meet the nutritional needs of patients shall be prepared as planned for each meal. When menu changes are necessary, substitutions shall provide equal nutritional value. J. Retention of Records. Menus as served and records of food purchased for consumption by patients shall be filed on the premises for a period of 30 days. K. Preparation of Food. (1) Foods shall be prepared by methods that conserve nutritive value, flavor, and appearance, and shall be served at proper temperatures, in a form to meet individual needs. (2) Standardized recipes adjusted to appropriate yield shall be followed. Standardized recipes are those recipes which have been tested by the nursing home or another source and that ensure consistent quality and quantity. L. Resident-Directed Meal Pattern. If a resident-directed meal pattern is provided, the following is required: (1) Counseling the residents regarding the risks and benefits of a resident-selected diet which is documented within the medical record; and (2) Approval of the pattern by both the resident’s physician and a licensed registered dietitian. #### Regulation .22 Specialized Rehabilitative Services — Occupational Therapy Services, Physical Therapy Services, Speech Pathology and Audiology Services. *COMAR 10.07.02.22* A. Rehabilitative Services — Admission Policies. In a nursing home which does not accept residents in need of specialized rehabilitative services, the minimal acceptable restorative service shall be the restorative nursing care plan designed to maintain function or improve the resident’s ability to carry out activities of daily living as set forth in Regulation .18G, of this chapter. B. Arrangements for Services. (1) If a nursing home’s admission policies include the admission of residents requiring rehabilitative services, the nursing home shall provide, or arrange for under written agreement, specialized rehabilitative services by qualified personnel, such as a physical therapist, speech-language pathologist and audiologist, and occupational therapist. (2) Initiation of services to meet the rehabilitative needs of the resident shall occur within 48 hours, excluding Saturday, Sunday, and State and federal holidays, of the physician’s order for the specialized service. (3) The resident may not be accepted for admission if at least one service to meet the rehabilitative needs of the resident cannot be initiated within the 48-hour period, excluding Saturday, Sunday, and State and federal holidays. C. Policies and Procedures. (1) Written administrative and resident care policies and procedures shall be developed for rehabilitative services by appropriate rehabilitation team members and representatives of the medical, administrative, and nursing staff. (2) Policies shall provide for the coordination of rehabilitative services and the rehabilitative aspects of nursing. (3) The nursing home shall make its administrative and resident care policies available for review by residents and the resident’s representative. D. Written Plan of Care. Rehabilitative services shall be provided under a written plan of care, initiated by the attending physician, and developed in consultation with appropriate rehabilitation team members and the nursing service. E. Physician’s Orders. (1) Specialized rehabilitative services shall be provided only on written orders of the attending physician. (2) Orders shall include modalities to be used, frequency, and anticipated goals and shall be made a part of the resident care plan. (3) The physician shall review with the resident or the family or resident’s representative the goals and the treatment program. The frequency of communications between the physician and the rehabilitation team members shall depend on changes in the resident and the resident’s medical status. F. Progress Notes. (1) Within 2 weeks of referral to specialized rehabilitative services, the rehabilitation team members shall provide the attending physician with a written report of the evaluation, including goals and progress of the resident. (2) Progress notes related to rehabilitative services shall be written at least every 2 weeks. G. Reevaluation of Resident’s Progress. (1) The physician and the rehabilitation team members shall reevaluate the resident’s progress as necessary, but at least every 30 days. (2) The physician may document on the record that the reevaluation may be less frequent but in no case may the reevaluation exceed 60 days. H. Resident’s Record. (1) The physician’s orders, the initial evaluations, the plan of rehabilitative care, goals, services rendered, evaluations of progress, and other pertinent information shall be: (a) Recorded in the resident’s medical record; and (b) Dated and signed by the: (i) Physician ordering the service; and (ii) Those disciplines who provided the service. (2) The record and progress notes concerning the resident shall reflect at all times the most recent and current status of the resident, including current short-term and long-term goals. I. Proof of Licensure. The facility shall maintain a file which includes proof of current licensure of all the rehabilitative services' personnel. J. Job Descriptions. Current job descriptions for all rehabilitative services personnel shall be readily available in the facility. #### Regulation .23 Special Care Units — General. *COMAR 10.07.02.23* A. A nursing home which holds a current and valid operating license may establish special care units with the approval of the: (1) Office of Health Care Quality; and (2) Department’s Office of Capital Planning, Budgeting and Engineering Services. B. A facility may notify the Department of its intention to establish a special care unit before developing and submitting the required documents for approval as described in §C of this regulation. C. The nursing home shall obtain Departmental approval of the following pertaining to the special care unit: (1) A description and scope of services to be provided; (2) An organization chart of the special care unit and its relationship to the rest of the nursing home; (3) A description of staffing patterns; (4) Qualifications, duties, and responsibilities of personnel; (5) A quality assurance plan which includes: (a) Assignment of responsibility for monitoring and evaluation activities; (b) Identification of the predominant aspects of care provided; (c) Identification of indicators and appropriate clinical criteria for monitoring the most important aspects of care; (d) Establishment of thresholds (levels or trends) for the indicators that will trigger evaluation of care; (e) Monitoring of the important aspects of care by collecting and organizing data for each indicator; (f) Evaluation of care when thresholds are reached in order to identify opportunities to improve either care or problems; (g) Taking actions to improve care or to correct the problems; (h) Assessing the effectiveness of the actions, documenting the improvement in care, and assessing the quality assurance process; and (i) Communication of the results of the monitoring and evaluation process to relevant individuals or services; (6) Policies and procedures, including: (a) The transfer or referral of residents who require services that are not provided by the special care unit; (b) The administration of medications that are relevant to the special care residents in the special care units; (c) Infection control measures to minimize the transfer of infection in the special care unit; (d) Pertinent safety practices, including the control of fire and mechanical hazards; and (e) Preventive maintenance for equipment in the special care unit; (7) Protocols for obtaining specialized services, such as arterial blood gases or other STAT services; (8) Protocols for emergency situations; and (9) An inventory of any specialized equipment to be housed on the unit to provide services in the special care unit. D. A facility that has been approved to establish a special care unit shall meet all applicable requirements of this chapter. E. Physician Coordinator. (1) If the facility's medical director does not have special training and experience in the discipline of the assigned special care unit, the facility shall hire a physician who is appropriately trained and experienced to provide: (a) Overall medical supervision of the special care unit; and (b) Coordination of all services for the assigned special care unit. (2) The facility shall verify the candidate's credentials before employment as physician coordinator. (3) The physician coordinator, or a designee who meets the requirements of §E(1) of this regulation, shall: (a) Respond personally or arrange for another qualified physician to respond to situations warranting medical intervention; and (b) Be available to provide any required consultation. F. Staffing. The nursing home shall ensure that each unit is sufficiently staffed with qualified personnel to provide appropriate treatment and meet the care needs of the residents. G. Nursing Services. (1) The director of nursing shall designate a registered nurse who has education, training, and experience in caring for the needs of the special care residents to coordinate all nursing care within the special care unit. (2) Nursing staff shall be: (a) Knowledgeable about the emotional and rehabilitative aspects of the special care unit residents; and (b) Capable of initiating appropriate therapeutic interventions when needed. H. Design. (1) A special care unit shall meet the general construction requirements of Regulations .08, .42, and .41 of this chapter, and the requirements in this regulation. (2) The nursing home shall ensure that floor space allocated to each bed meets minimum requirements listed in Regulation .49 of this chapter, and is sufficient to accommodate the special equipment necessary to meet the needs of residents. I. Radiologic and Laboratory Services. The facility shall ensure that diagnostic radiologic and clinical laboratory services are available 24 hours a day. The services may be provided through contractual arrangements with providers that meet applicable federal and State laws and regulations. J. Quality Assurance Program. The facility shall: (1) Develop a quality assurance plan to monitor and evaluate the care provided in each special care unit; and (2) Monitor and evaluate the quality and appropriateness of care provided by the special care unit as part of the facility's overall quality assurance program. #### Regulation .24 Special Care Units — Respiratory Care Unit. *COMAR 10.07.02.24* A. A respiratory care unit shall meet the: (1) General requirements established for all special care units as outlined in Regulation .23 of this chapter; and (2) Requirements of this regulation. B. The nursing home shall submit to the Department and obtain approval of the following: (1) All documents required in Regulation .23 of this chapter; (2) Policies and procedures for all aspects of care as outlined in Regulation .23 of this chapter, and the following: (a) Qualifications, duties, and responsibilities of staff, including the staff who are permitted to perform the following procedures: (i) Cardiopulmonary resuscitation; (ii) Obtaining arterial blood gas samples and their analyses; (iii) Pulmonary function testing; (iv) Therapeutic chest percussion and vibration; (v) Bronchopulmonary drainage; (vi) Coughing and breathing exercises; (vii) Mechanical ventilatory and oxygenation support for residents; and (viii) Aerosol, humidification, and medical gas administration; (b) Weaning from mechanical ventilatory support and discharge planning for residents of the respiratory care unit; and (c) The procurement, handling, storage, and dispensing of medical gases. C. Physician Coordinator. If the nursing home’s medical director does not have special training and experience in diagnosing, treating, and assessing respiratory problems, the nursing home shall employ or contract with a Board-certified pulmonologist who has the special knowledge and experience to provide: (1) Overall medical supervision of the respiratory care unit; and (2) Coordination of all services for the respiratory care unit. D. Staffing. The nursing home shall ensure that: (1) The nurse manager or the director of nursing of vent units has a background in ventilator care or is qualified in ventilator management; (2) Respiratory care services are provided by a sufficient number of qualified personnel; and (3) Respiratory care personnel provide respiratory care services commensurate with their documented training, experience, and competence. E. Design. (1) Emergency Power. The nursing home unit shall meet all applicable requirements in Regulation .46 of this chapter for emergency electrical power, including the provision of: (a) Emergency lighting in the respiratory care unit where life support equipment is used; and (b) Duplex receptacles connected to the facility's emergency generator to provide emergency power to operate life support equipment and nonflammable medical gas systems in the respiratory care unit. (2) Ventilator Alarms. The facility shall ensure that each ventilator is equipped with an alarm on both the pressure valve and the volume valve for safety. (3) Piped Medical Gas Systems. (a) To service the medical gas systems, a vendor or staff shall be trained and accredited in accordance with NFPA 99 Health Care Facilities Code. (b) The vendor or staff may provide the following services: (i) Installation; (ii) Inspection; or (iii) Testing. (c) The nursing home shall ensure that all piped medical gas systems adhere to the following standards: (i) NFPA 99 Health Care Facilities Code; and (ii) NFPA 101 Life Safety Code. F. The nursing home shall provide pulmonary function testing and blood gas or pulse analysis capability on-site or through contractual arrangements with providers who meet applicable State and federal laws and regulations. G. Contractual Services. When any respiratory care services are provided by an outside contractor, the facility shall: (1) Approve the contractor based on the contractor's credentials, training, and experience; (2) Ensure that all contractors: (a) Provide services 24 hours a day; (b) Meet all safety requirements; (c) Abide by all pertinent policies and procedures of the facility; (d) Provide services in accordance with all laws and regulations governing the facility; and (e) Participate in the monitoring and evaluation of the appropriateness of services provided as required by the facility's quality assurance program; and (3) Ensure that all contractual services receive overall medical supervision and coordination by the facility's physician coordinator of the respiratory care unit. #### Regulation .25 Special Care Units — Dementia Care Unit. *COMAR 10.07.02.25* A. A dementia care unit shall meet the: (1) General requirements established for all special care units as outlined in Regulation .24 of this chapter; and (2) Requirements of this regulation. B. Dementia Unit Disclosure. (1) The disclosure shall be made to the Department and to any person seeking placement or receiving care in a Dementia special care unit or program of a nursing home. (2) The information disclosed shall explain the additional care provided in each of the following areas: (a) The Dementia special care unit’s written statement of its overall philosophy and mission, which reflects the needs of residents with dementia; (b) The process and criteria for placement, transfer, or discharge from the unit; (c) The process used for individualized assessment and establishing the resident-centered plan of care and its implementation, including the method by which the plan of care evolves and is responsive to changes in the individual’s condition; (d) Staff training and continuing education practices; (e) The physical environment and design features appropriate to support the functioning of cognitively impaired adult residents; (f) The frequency and types of resident activities; (g) The involvement of families and family support programs; and (h) The cost of care and any additional fees. C. Secured units shall meet the established standards applicable to nursing home set forth in NFPA 99 Health Care Facilities Code and NFPA 101 Life Safety Code. #### Regulation .26 Pharmaceutical Services. *COMAR 10.07.02.26* A. Definition. In this regulation, the term “committee” means the pharmaceutical services committee. B. Duties of the Nursing Home. (1) The nursing home shall provide appropriate methods and procedures for administering drugs and biologicals to the nursing home’s residents. (2) The nursing home shall provide pharmaceutical services in accordance with accepted professional standards and related federal, State, and local laws. C. Duties of the Pharmaceutical Services Committee. (1) A pharmaceutical services committee, or its equivalent, shall develop written policies and procedures for safe and effective drug therapy, distribution, control, and use. (2) The composition of the committee shall include at least: (a) The licensed pharmacist; (b) The director of nursing; (c) The consultant dietitian-nutritionist; (d) One physician; and (e) The administrator. (3) The committee shall meet at least quarterly to establish policies and procedures. (4) There shall be an agenda to guide meeting participants. (5) All members of the committee shall review revisions of policies and procedures before implementing any changes. (6) The pharmaceutical services committee may not develop policies and procedures that prohibit or restrict a resident from receiving medications from the pharmacy of the resident’s choice. (7) In cases where the cost of any medication obtained from the pharmacy selected by the resident exceeds the cost of the same or equivalent medication available through a pharmacy that the nursing home has contracted with to provide pharmaceutical services, the resident shall be responsible for the additional amount. (8) The committee may not require the pharmacy to provide drugs by way of a specific drug distribution system such as unit dose or use of a particular packaging system. (9) The committee shall establish the contents of sealed emergency drug kits. (10) The committee shall oversee the accuracy and adequacy of pharmaceutical services to the nursing home. (11) The committee shall make recommendations for improvements to pharmaceutical services. (12) The committee shall document its actions and recommendations. D. Labeling. (1) Medications shall be accurately and plainly labeled. Except for those over-the-counter medications that the Department may list as suitable for purchasing in bulk and dispensing as needed, the labels for all medications shall bear at least: (a) The resident’s full name; (b) The name of the drug; (c) Strength; (d) Original filling date and date refilled, if applicable; (e) Name of authorized prescriber; (f) Expiration date of medication (month, year); (g) Any special handling and storage instructions; (h) Name and address of dispensing pharmacy; (i) Prescription number; (j) Number of tablets or capsules; and (k) Accessory federal labels. (2) A nurse may not package, repackage, bottle, or label any medication, in whole or in part, or alter any labeled medication in any way. E. Storage. (1) The nursing home shall store medications in a locked medication storage area that: (a) Is well lighted; (b) Is located where personnel preparing drugs for administration will not be interrupted; (c) Is spacious enough to allow separate storage of external and internal medications; (d) Is kept in a clean, orderly and uncluttered manner; and (e) Contains a refrigerator to be used for medication storage only. (2) The nursing home shall keep poisons and medications marked “for external use only” separate from general medications and Schedule II drugs. F. Schedule II—IV Drugs. (1) Schedule II drugs shall be kept in separately locked, securely fixed boxes or drawers in the storage area, under two locks. The lock on the door of a medication room shall be counted as one of the two locks. (2) A nurse and a second staff member who is a nurse or an administrator may destroy controlled dangerous substances in Schedules II—V on the premises of the nursing home. (3) If a controlled dangerous substance is destroyed on the nursing home premises in accordance with §F(2) of this regulation: (a) A record of the disposal, in addition to any other required records, shall be maintained in the nursing home; and (b) A copy of the record of disposal shall be forwarded to the Office of Controlled Substances Administration. (4) A nursing home, whether or not operating a licensed pharmacy, shall maintain a signed record of a Schedule II count at each change of shift. (5) A nursing home that administers Schedule II drugs shall maintain a drug record that documents: (a) The name of the resident; (b) The date, time, kind, dosage, and method of administration of all Schedule II drugs; and (c) The name of the authorized prescriber who prescribed the medication. #### Regulation .27 Pharmaceutical Management. *COMAR 10.07.02.27* A. Administration Procedures. (1) Medications, legend and non-legend, administered to residents shall be ordered in writing by the resident’s physician. (2) Medications shall be administered by: (a) Appropriately licensed personnel in accordance with laws and regulations governing these acts; or (b) Certified graduates of a State-approved medicine aide course. (3) The individual who prepares medications shall give and record them. (4) Medicine may not be returned to the container. If the resident refuses the drug or if a mistake occurs: (a) The drug shall be discarded; and (b) The occurrence shall be documented in the resident’s chart. (5) Before invoking stop order policies, the resident’s attending physician shall be contacted for instructions so that continuity of the resident’s therapeutic regimen is not interrupted. If the attending physician cannot be reached, the medical director shall be contacted for instructions. B. Pharmaceutical Services. (1) The nursing home shall arrange for pharmacies that provide medications for residents in the nursing home. The pharmacy shall agree in writing to maintain at the pharmacy a resident profile record system for each resident in the nursing home for whom prescriptions are dispensed. (2) If the nursing home does not employ a licensed pharmacist, the nursing home shall arrange by written contract for a pharmacy to provide consultation on administering the pharmacy services in accordance with the policies and procedures established by the pharmaceutical services committee. Pharmaceutical services shall be under the general supervision of a licensed pharmacist who shall: (a) With the advice of the pharmaceutical services committee, be responsible for developing, coordinating, and supervising pharmaceutical services and provide in-service training at least twice yearly; (b) Visit the nursing home frequently enough to ensure that policies and procedures established by the pharmaceutical services committee are enforced; (c) Notify the attending physician of any potential drug problems found during the drug regimen review; and (d) At least quarterly, submit a report to the pharmaceutical services committee on the status of the nursing home’s pharmaceutical services and staff adherence to policies and procedures. C. Resident-Designated Pharmacy. (1) The nursing home shall inform a resident’s designated pharmacy about the nursing home’s written policies concerning the provision of drugs. (2) To provide services to the resident, a designated pharmacy shall agree to comply with the nursing home’s policies. (3) If the pharmacy fails to comply with the policies, a representative of the nursing home shall discuss the situation with the pharmacy and the resident, and if the pharmacy subsequently refuses to follow the policies, the resident shall select another pharmacy that agrees to comply. (4) The pharmacy shall have access to a copy of the written pharmaceutical care policies. (5) The pharmacy shall be responsible for delivering medications to the nursing home. Members of the resident’s family or the responsible party for the resident may not deliver medications to the resident or to the nursing home. D. Medication Return and Disposal. (1) The nursing home shall return all prescribed medications, for residents who have been discharged or otherwise departed, to the pharmacy in accordance with the nursing home’s policy. (2) The nursing home shall destroy adulterated, deteriorated, or outdated medications in the following manner: (a) Disposal shall occur in the presence of two witnesses who are authorized by the nursing home; and (b) The witnesses shall document the disposal in the resident’s chart. (3) The nursing home shall only release prescribed medications to residents at the time of discharge based on the written authorization of the resident’s authorized prescriber. (4) Each month, the nursing home shall perform a drug regimen review on each resident’s records at the nursing home and document the findings in the resident’s medical record. E. Administration of Medications for Leave of Absence of 24 Hours or Less. (1) A nursing home shall develop policies and procedures to ensure that a resident or, if the resident lacks the capacity, the resident’s family or other individual accompanying the resident is informed, both orally and in writing, on how the resident shall safely and correctly take the resident’s medications during a short-term leave of absence of 24 hours or less. (2) In accordance with a nursing home-developed procedure, a licensed nurse shall prepare medications to be sent with a resident during a short-term leave of absence of 24 hours or less. #### Regulation .28 Laboratory and Radiologic Services. *COMAR 10.07.02.28* A. Approved Source. Laboratory services provided by the facility shall meet the applicable conditions established under COMAR 10.10.01 Medical Laboratories in Maryland. B. Provisions of Services. If the facility does not provide laboratory and radiologic services, arrangements shall be made for obtaining these services from a physician's office, a licensed laboratory in a hospital or nursing facility, a licensed independent laboratory, or a State-approved portable X-ray supplier. C. Physician's Order Required. All services shall be provided only on the orders of the attending physician. D. Reports of Findings. The nursing home shall notify the attending physician promptly of the findings. The nursing home shall file signed and dated reports of diagnostic services in the resident’s medical record. E. Transportation. The nursing home shall assist the resident, if necessary, in arranging transportation to and from the source of service. F. Blood and Blood Products — Blood Handling and Storage. Blood handling and storage facilities shall be safe, adequate, and properly supervised. G. Storage and Transfusion. If the facility provides for maintaining and transfusing blood and blood products, it shall meet the standards in COMAR 10.10.02 Blood Banks. H. Transfusion Services. If the nursing home only provides transfusion services, it shall meet at least the requirements established under COMAR 10.10.02. #### Regulation .29 Dental Services. *COMAR 10.07.02.29* A. Provision for Dental Care. Residents shall be assisted to obtain routine and emergency dental care. B. Advisory Dentist. There shall be an advisory dentist who shall: (1) Recommend oral hygiene policies and practices for the care of the residents and for arrangements for emergency treatment; (2) Assist in the formulation of dental health policies; (3) Provide direction for in-service training to give the nursing staff an understanding of residents’ dental problems. C. Assistance by Nursing Personnel. Nursing personnel shall assist the resident in carrying out routine dental hygiene. D. Arrangements for Dental Service. If dental services are not provided on the premises, there shall be a cooperative agreement with a dental service. E. Transportation. Arrangements shall be made, when necessary, for the resident to be transported to the dentist’s office. #### Regulation .30 Social Work Services. *COMAR 10.07.02.30* A. Services Provided. The nursing home shall provide or make arrangements for services to identify and meet the resident’s medically related physical, social, and behavioral health needs. B. Social Work Staff Responsibility. (1) Social services responsibilities in the nursing home shall be assigned to a: (a) Licensed bachelor social worker; (b) Licensed graduate social worker; (c) Licensed certified social worker; or (d) Licensed certified social worker–clinical. (2) If the social worker is not a licensed certified social worker (LCSW) or a licensed certified social worker-clinical (LCSW-C), the nursing home shall arrange for an LCSW or LCSW-C to provide sufficient hours of supervision. (3) As of January 1, 2021, a license is required for an employee to provide social services except if: (a) On the effective date of these regulations, the employee was assigned responsibility for social services; and (b) The nursing home has an agreement with a qualified social work consultant that provides for sufficient hours of supervision to assure that the employee’s services meet the medically related physical, social, and behavioral health needs of the residents. C. Social History. Within 7 days after admission, the social worker shall initiate a written social history, which shall be as complete as possible and shall include: (1) Social data about personal and family background to provide understanding of the resident and how the resident functions; (2) Information regarding current personal and family circumstances and attitudes as they relate to the resident’s illness and care; and (3) Information regarding the resident’s and family’s plans regarding discharge. D. Records. Records shall include the information required in §C of this regulation. E. Space. A nursing home shall provide: (1) Space for social work personnel, accessible to residents, medical, and other staff; and (2) Privacy for interviews. #### Regulation .31 Resident Activities. *COMAR 10.07.02.31* A. Activities Program. The nursing home shall provide: (1) A program of structured and unstructured activities; and (2) Activities designed and monitored appropriately to meet the day-to-day needs and interests of each resident and encourage: (a) Self-care; (b) Engagement in resident-selected activities; and (c) Maintenance of an optimal level of psychosocial functioning. B. Staffing. A staff member who is qualified by experience or training shall be appointed to be responsible for the activities program. If the designee is not a qualified resident activities coordinator as defined in Regulation .01 of this chapter, the Department may approve the designee based on the person’s education, performance, and experience. C. If the Department determines that an effective program is not maintained consultation may be required as specified by the Department. D. Restrictions on Participation Documented on Chart. The physician shall document in the resident’s chart any restrictions applicable to the resident’s participation in the activities program. E. Objective. The activities shall be designed to promote the general health and physical, social, and mental well-being of the residents. F. Space, Supplies. The nursing home shall provide adequate space and a variety of supplies and equipment to satisfy the appropriate individual activity needs of residents. #### Regulation .32 Clinical Records. *COMAR 10.07.02.32* A. Records for all Residents. Records for all residents shall be maintained in accordance with accepted professional standards and practices. B. Contents of Record. Contents of record shall include: (1) Identification and summary sheet or sheets including: (a) Resident’s name; (b) Social Security number; (c) Armed forces status; (d) Citizenship; (e) Marital status; (f) Age; (g) Sex; (h) Home address; and (i) Religion; (2) Names, addresses, and telephone numbers of referral agencies, including: (a) Hospital from which admitted; (b) Personal physician; (c) Dentist; (d) Parents’ names or next of kin; and (e) Resident’s representative; (3) Documentation of the: (a) Needs of the resident; (b) Establishment of an appropriate initial and ongoing treatment plan; and (c) Care and services provided; (4) Authentication of hospital diagnoses, based on a: (a) Discharge summary; (b) Report from the resident’s attending physician; or (c) Transfer form; (5) Consent forms when required, such as: (a) Administration of investigational drugs; (b) Burial arrangements made in advance; (c) Release of medical record information; and (d) Handling of finances; (6) Medical and social history of the resident; (7) Report of physical examination; (8) Diagnostic and therapeutic orders; (9) Consultation reports; (10) Observations and progress notes; (11) Reports of medication administration, treatments, and clinical findings; (12) Discharge summary including final diagnosis and prognosis; (13) Assessments done by various disciplines; and (14) Interdisciplinary care plan. C. Staffing. An employee of the nursing home shall be designated as the person responsible for the overall supervision of the medical records service. There shall be sufficient support staff to accomplish all medical records functions. D. Consultation. If the medical records supervisor is not a qualified medical record practitioner, the Department may require that the supervisor receive consultation from a qualified person. E. Completion of Records and Centralization of Reports. (1) Current medical records and those of discharged residents shall be completed promptly. (2) All clinical information pertaining to a resident’s stay shall be centralized in the resident’s medical record. F. Retention and Preservation of Records. (1) Medical records shall be retained for a period of at least 5 years from the date of discharge or, in the case of a minor, 3 years after the resident becomes of age or 5 years, whichever is longer. (2) The nursing home shall maintain and dispose of a resident’s medical records in accordance with Health-General Article, Title 4, Subtitles 3 and 4, Annotated Code of Maryland. G. Current Records — Location and Facilities. The nursing home shall maintain adequate space and equipment, conveniently located, to provide for efficient processing, reviewing, indexing, filing, and prompt retrieval of medical records. H. Closed or Inactive Records. Closed or inactive records shall be filed and stored in a safe place, free from fire hazards, which provides for confidentiality and, when necessary, retrieval. I. Electronic Health Records. (1) A nursing home that uses electronic health records exclusively or along with a paper-based medical record shall comply with this chapter and all applicable State and federal laws, including laws governing privacy and security of records. (2) Staff and nursing home-approved practitioners shall be trained in the use of electronic health records. (3) A nursing home that uses electronic health records shall: (a) Ensure access to residents as specified in COMAR 10.07.09.08C(13) and (14); and (b) On request, provide the resident with copies of the resident’s medical records at a reasonable cost and in the resident’s preferred format. (4) A nursing home shall provide full access to electronic health records in accordance with all applicable laws and regulations to: (a) Representatives of the Department as set forth in COMAR 10.07.02.07; (b) An ombudsman as set forth in Human Services Article, §10-905, Annotated Code of Maryland; and (c) Other legal representatives as set forth in COMAR 10.07.09.08 and authorized by law to obtain access. (5) A nursing home shall develop a system to ensure that nursing home staff have access to residents’ health records in the event of a failure of the nursing home’s electronic medical record system. #### Regulation .33 Infection Prevention and Control Program. *COMAR 10.07.02.33* A. Infection Prevention and Control Program. The nursing home shall establish, implement, and maintain an effective infection prevention and control program that: (1) Investigates, controls, and prevents infections in a timely manner through a system that enables the facility to: (a) Analyze patterns of infected individuals; (b) Analyze changes in prevalent organisms; (c) Analyze increases in the rate of infection; and (d) Obtain surveillance data for the prevention and control of additional cases; (2) Determines the procedures, such as appropriate precautions, that are to be applied to an individual resident; (3) Maintains a record of infections in the nursing home and the corrective actions that were taken related to infections; and (4) Monitors and evaluates the: (a) Effectiveness of the infection prevention and control program by surveying rates of infection, especially infection rates that are significantly higher than usual; and (b) Effective implementation of the policies and procedures that are outlined in §E(1) of this regulation. B. Infection Preventionist. (1) The nursing home shall assign at least one infection preventionist that has attended training in infection surveillance, prevention, and control to actively manage the nursing home’s infection prevention and control program. (2) The infection preventionist shall attend or have attended a basic infection prevention and control training course that is approved by the: (a) Office of Health Care Quality; and (b) Office of Infectious Disease Epidemiology and Outbreak Response for the Department. (3) This position shall be staffed at a ratio of 1.0 Full Time Equivalents for every 200 beds. C. The nursing home shall have mechanisms for communicating the results of infection control activities to employees and to the individual or individuals who are responsible for improving the nursing home’s performance. D. The nursing home’s communication mechanism shall ensure that the administrator, director of nursing, and the medical director receive and address reports of infection prevention and control findings and recommendations in a timely manner. E. Infection Prevention and Control Policies and Procedures. (1) The infection prevention and control program shall establish written policies and procedures to identify, investigate, control, and prevent infections in the nursing home, including policies and procedures to: (a) Identify health care-associated infections and communicable diseases in accordance with COMAR 10.06.01; (b) Report occurrences of certain infectious diseases and outbreaks of infectious diseases to the local health department in a timely manner in accordance with COMAR 10.06.01 and Health-General Article, §18-202, Annotated Code of Maryland; (c) Institute appropriate control measures when an infection or outbreak of infections is suspected or identified in order to control infection and prevent spread to other residents; (d) Perform surveillance for health care-associated and community-associated infections of residents and employees using definitions and methods approved by the infection prevention and control oversight committee to monitor and investigate causes of infection, and the manner in which the infection is spread; (e) Train employees about infection prevention and control, including: (i) Standard precautions and hand hygiene; (ii) Respiratory hygiene and cough etiquette; (iii) Soiled laundry and linen processing; (iv) Safe handling of needles and sharps and safe injection techniques; (v) Special medical waste handling and disposal; (vi) Appropriate use of antiseptics and disinfectants; (vii) Blood-borne pathogens, including hepatitis B and C and human immunodeficiency virus; (viii) Tuberculosis exposure; and (ix) Proper use and wearing of personal protective equipment, such as gloves, gowns, and eye protection; (f) Train and perform compliance monitoring of employee application of infection prevention and control activities, such as hand hygiene and personal protective equipment used for isolation precautions; (g) Review the infection prevention and control program elements at least annually and revise as necessary; and (h) Obtain annual approval of infection prevention and control program activities by the infection prevention and control oversight committee. (2) The nursing home shall provide information concerning the infectious disease status of any resident being transferred or discharged to any other nursing home, including a funeral home. (3) The nursing home shall obtain information concerning the infectious disease status of any resident being transferred or admitted to the nursing home from elsewhere. F. Preventing Spread of Infection. (1) The facility shall assess any residents with signs and symptoms of an infectious illness for the possibility of transmission to another resident or employee. (2) The nursing home shall take appropriate infection prevention and control measures to prevent the transmission of an infectious disease to residents, employees, and visitors as outlined in the following guidelines: (a) 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings; and (b) Guideline for Infection Control in Health Care Personnel. (3) The nursing home shall prohibit employees with an infectious disease or with infected skin lesions from having direct contact with residents or their food if direct contact could transmit the disease. (4) The nursing home shall require employees to perform hand hygiene before and after each direct resident contact for which hand hygiene is indicated by accepted professional practice. (5) The facility shall handle, store, process, and transport linens so as to prevent the spread of infection. #### Regulation .34 Employee Health Program. *COMAR 10.07.02.34* A. The nursing home’s infection prevention and control program shall monitor the relevant health status of all employees, as it relates to infection prevention and control. The nursing home shall refer to the following guidelines in implementing its employee health program: (1) Guideline for Infection Control in Health Care Personnel; (2) Immunization of Health Care Personnel: Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the Hospital Infection Control Practices Advisory Committee (HICPAC); and (3) COMAR 09.12.31. B. Tuberculosis Exposure Control. (1) The infection control program shall include a risk assessment program, including monitoring for tuberculosis infection for employees that is in accordance with the Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings. (2) The nursing home shall ensure that employees may not provide services that require direct access to residents without documented evidence that the employee is free from communicable tuberculosis. (3) A new employee shall be assessed for risk of tuberculosis through: (a) A two-step tuberculin skin testing at the time of hire following guidelines referenced in the Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings; or (b) An interferon-gamma release assay (IGRA) blood test. (4) The nursing home shall maintain written documentation of the following: (a) Results of tuberculin skin tests, recorded in millimeters of induration with dates of administration, dates of reading, results of test, and the manufacturer and lot number of the purified protein derivative (PPD) solution used; and (b) Any previous tuberculin skin tests, chest x-ray, or blood test results, chemotherapy, and chemoprophylaxis that are the basis for certifying that the individual is free from tuberculosis in a communicable form. C. Measles, Mumps, Rubella, and Varicella. (1) The nursing home shall screen and maintain written documentation of each employee’s proof of immunity to common childhood infections including measles, mumps, rubella, and chickenpox (varicella). Proof of immunity to these diseases shall be verified by: (a) Documented evidence of administration of vaccine; or (b) Laboratory evidence of immunity. (2) The nursing home shall require that employees who are not immune to measles, mumps, rubella, and varicella receive immunization for measles, mumps, rubella, or varicella, unless medically contraindicated or against the employee’s religious beliefs. If the employee refuses to be immunized, the nursing home shall document the refusal and the reason for it. D. Hepatitis B. The nursing home shall require that all new employees receive immunization for Hepatitis B, unless medically contraindicated, against the employee’s religious beliefs, or after being fully informed of the health risks of not being immunized. The nursing home shall inform all new and current employees of the health risks of not being immunized. If the employee refuses to be immunized, the nursing home shall document the refusal and the reason for the refusal. E. Influenza. (1) The nursing home shall require that all employees receive annual immunization for influenza, unless: (a) Medically contraindicated; (b) Against the employee’s religious beliefs; or (c) After being fully informed of the health risks associated with not receiving a vaccine, the employee refuses the immunization. (2) The nursing home shall: (a) Comply with Health-General Article, §18-404, Annotated Code of Maryland, regarding immunizations of employees; (b) Inform all new and current employees of the health risks of not being immunized; (c) Document refusals; and (d) Require that any employee who is not vaccinated with the current influenza vaccine wear a mask when: (i) Within 6 feet of a resident; and (ii) During the influenza season as specified by the State’s Prevention and Health Promotion Administration, based on influenza activity in Maryland. F. Pertussis. The nursing home shall: (1) Require that each new employee receive a one-dose booster immunization for pertussis, unless medically contraindicated or against the employee’s religious beliefs; (2) Inform all new and current employees of the health risks of not being immunized; (3) Document any refusals of immunization; and (4) Ensure that the immunization is given in the form of Tdap (tetanus, diphtheria, acellular pertussis) vaccine, in accordance with the guidelines prescribed in Immunization of Health-Care Personnel: Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the Health Care Infection Control Practices Advisory Committee (HICPAC). #### Regulation .35 Resident Health Program. *COMAR 10.07.02.35* A. Immunization. (1) The nursing home shall offer influenza and pneumococcal immunization to each resident. (2) The nursing home shall obtain written consent to administer the immunization from: (a) The resident; or (b) The resident's representative. (3) A resident is not required to receive the influenza and pneumococcal immunization if it is: (a) Medically contraindicated; (b) Against the resident’s religious beliefs; or (c) After being fully informed of the health risks associated with not receiving a vaccine, the resident refuses the immunization. (4) If the resident refuses to be immunized, the nursing home shall document the refusal and the reason for the refusal. (5) The nursing home shall notify each prospective resident of the immunization requirements and request that the resident agree to be immunized. (6) The nursing home shall make available to residents educational and informational materials relating to immunization against influenza virus and immunization against pneumococcal disease. B. Tuberculosis Assessment. (1) The nursing home shall assess residents for tuberculosis according to the Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health Care Settings. (2) A new resident shall receive a two-step tuberculin skin test within 10 days of admission to the nursing home unless the resident has had: (a) A documented negative tuberculin skin test within the previous 12 months; (b) A previous positive tuberculin skin test; (c) A history of preventive therapy treatment; (d) A latent infection; or (e) The treatment of active tuberculosis. (3) The nursing home shall continue to monitor residents for signs and symptoms of tuberculosis by performing a yearly symptom review. When a resident has signs and symptoms of tuberculosis, a physician shall be notified to: (a) Evaluate the resident for possible tuberculosis in a communicable form; (b) Notify the health officer within 24 hours if the physician suspects tuberculosis; and (c) Coordinate management of the resident and the resident’s contacts with the local health officer. (4) The nursing home shall assess and manage a resident with a history of a previous positive tuberculin skin test, a history of latent infection, or a previous history of active tuberculosis, in accordance with Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings. #### Regulation .36 Volunteer Health Program. *COMAR 10.07.02.36* A. The nursing home shall urge that volunteers, defined as individuals who spend an average of 8 hours per week or more in the resident care areas and who receive no pay or benefits, receive annual influenza vaccination and tuberculin skin testing as considered necessary by the nursing home. B. The nursing home shall give appropriate health care information to such volunteers to provide maximum protection to residents. C. The nursing home shall maintain documentation of the discussion between the nursing home and the volunteer concerning influenza vaccine and tuberculin skin testing. #### Regulation .37 Infection Control — Standard Precautions. *COMAR 10.07.02.37* A. Standard Precautions. All employees shall routinely use appropriate barrier precautions to prevent skin and mucous membrane exposure when contact with blood or the body fluids of any resident is anticipated as outlined in: (1) 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings; and (2) COMAR 09.12.31. B. The infection prevention and control program shall include the handling of special medical waste as defined in COMAR 10.06.06. C. A nursing home shall maintain, at all times, the capability to physically isolate any resident who may contract a communicable disease from the remaining resident population. To provide for this, a nursing home shall have at least one private bedroom with an attached private bathroom that includes a: (1) Toilet; (2) Hand-washing sink; and (3) Bathtub, shower, or other bathing device. #### Regulation .38 Reports and Action Required in Unusual Circumstances. *COMAR 10.07.02.38* A. Serious Emotional Disturbances. A facility may not accept or keep patients who destroy property or are dangerous to themselves or others, or who have acute symptoms of mental illness. B. Action to Be Taken if a Patient Becomes Actively Disturbed. The following action shall be taken: (1) If a patient becomes actively disturbed, the personal physician shall be notified immediately. (2) A restraint may be used only if all of the following conditions are met: (a) Failure to use a restraint or restraints is likely to endanger the health or safety of the patient or others; (b) There is a written physician's order for the use of the restraint or restraints, which shall comply with the following requirements: (i) The physician's written order for the restraint or restraints shall be for a specified maximum period of time, not to exceed 24 hours. (ii) The necessity for the use of the restraint or restraints shall be documented, and (iii) The frequency of patient observations by licensed personnel on not less than an hourly basis during the period of time that the restraint or restraints or the effects of the restraint or restraints are present shall be indicated; (c) Appropriate documentation by licensed personnel shall be recorded in the clinical record; (d) The facility may not re-impose a restraint or restraints except upon the written order of a physician who has personally observed the patient since the previous restraint or restraints order was imposed. (3) A restraint or restraints may not be ordered PRN. (4) If a physician is not immediately available, a registered nurse may authorize the use of a physical restraint or restraints for a period not to exceed 4 hours in any 30-day period. Licensed personnel shall observe the patient hourly. The patient shall be seen by a physician if the restraint or restraints are to be applied for more than the initial 4-hour period. C. Unusual Occurrences. (1) The administrator of the nursing home shall immediately report to the local health department and the Department the occurrence of: (a) Infectious disease; (b) Poisoning; (c) Internal emergency or disaster; (d) External emergency or disaster, (e) Any symptomatic condition of importance to public health that affects the nursing home; or (f) Any other serious occurrence that threatens the welfare, safety, or health of any resident. (2) The administrator of the nursing home shall be responsible for ensuring that appropriate procedures and reporting are carried out for all reportable infections. An occurrence of a confirmed or suspected infection shall be reported and acted on in accordance with COMAR 10.06.01 and COMAR 10.15.03. #### Regulation .39 Transfer Agreement. *COMAR 10.07.02.39* A. Written Agreement. A written agreement with at least one acute hospital shall be effected which shall provide for the following actions: (1) Planning to ensure that all services required for the continuity of resident care will be made available promptly; (2) Advance discussion with the resident regarding the reason for the transfer and any available alternatives; (3) Notification to the next of kin or responsible person regarding the anticipated transfer; (4) Interchange of medical and other information necessary in the care and treatment of residents transferred between facilities, including notification of the licensed pharmacist of resident transfer; (5) Safe and timely transportation and care of the resident during transfer; (6) Security and accountability for the resident’s personal effects; (7) Prompt readmission to the nursing home at the end of the hospital stay; (8) Annual review of transfer arrangements by a utilization review committee or other designated group to ensure that each party is fulfilling the needs of the residents, the providers, the hospital, and the nursing home; (9) If needs are not being met, the administrator of the nursing home shall act on recommendations of the reviewing group to effect compliance; (10) Before licensure, the comprehensive care facility or the extended care facility shall submit to the Department a copy of the written agreement, signed by persons authorized to execute the agreement on behalf of the facilities; (11) Each facility shall maintain a signed copy of the agreement. B. Facilities Under Common Control. If two facilities are under common control, a written agreement is not required; policies and procedures of both facilities shall provide assurance that §A(1)—(12) will be the practice of the facilities. C. Human remains shall be transported pursuant to COMAR 10.29.21. #### Regulation .40 Emergency and Disaster Plan. *COMAR 10.07.02.40* A. Emergency and Disaster Plan. (1) The licensee shall develop an emergency and disaster plan that includes procedures that shall be followed before, during, and after an emergency or disaster, including: (a) Evacuation, transportation, or shelter in place of residents; (b) Notification of families and staff regarding the action that will be taken concerning the safety and well-being of the residents; (c) Staff coverage, organization, and assignment of responsibilities for ongoing shelter in place or evacuation, including identification of staff members available to report to work or remain for extended periods; and (d) The continuity of services, including: (i) Operations, planning, and financial and logistical arrangements; (ii) Procuring essential goods, equipment, and services to sustain operations for at least 72 hours; (iii) Relocation to alternate facilities or other locations; and (iv) Reasonable efforts to continue care. (2) The licensee shall have a tracking system to locate and identify residents in the event of displacement due to an emergency or disaster that includes at a minimum the: (a) Resident's name; (b) Time that the resident was sent to the initial alternative facility or location; and (c) Name of the initial alternative facility or location where the resident was sent. (3) When the nursing home relocates residents, the nursing home shall send a medical fact sheet and any medically related information with each resident that includes at a minimum the resident’s: (a) Name; (b) Medical condition or diagnosis; (c) Medications; (d) Allergies; (e) Special diets or dietary restrictions; (f) Family or legal representative contact information; and (g) Advance directives, living will, or a copy of the resident’s Maryland’s Medical Orders for Life-Sustaining Treatment (MOLST) form. (4) The brief medical fact sheet for each resident described in §A(3) of this regulation shall be: (a) Updated upon the occurrence of any change of information on the medical fact sheet; (b) Reviewed at least monthly; and (c) Maintained in a written, electronic, or printed form in a central location readily accessible and available to accompany residents in case of an emergency evacuation. (5) The licensee shall review the emergency and disaster plan at least annually and update the plan as necessary. (6) The licensee shall: (a) Identify a facility, facilities, alternate location, or alternate locations that have agreed to house the licensee's residents during an emergency evacuation; and (b) Document an agreement with each facility or location. (7) The licensee shall: (a) Identify a source or sources of transportation that have agreed to safely transport residents during an emergency evacuation; and (b) Document an agreement with each transportation source. (8) Upon request, a licensee shall provide a copy of the facility's emergency and disaster plan to the local emergency management organization for the purposes of coordinating local emergency planning. The licensee shall provide the emergency and disaster plan in a format that is mutually agreeable to the local emergency management organization. (9) The licensee shall identify an emergency and disaster planning liaison for the facility and shall provide the liaison's contact information to the local emergency management organization. (10) The licensee shall prepare an executive summary of its evacuation procedures to provide to a resident, family member, or legal representative upon request. The summary shall, at a minimum: (a) List means of potential transportation to be used in the event of evacuation; (b) List potential alternative facilities or locations to be used in the event of evacuation; (c) Describe means of communication with family members and legal representatives; (d) Describe the role and responsibilities of the resident, family member, or legal representative in the event of an emergency situation; and (e) Notify families that the information provided may change depending upon the nature or scope of the emergency or disaster. (11) Maryland Health Alert Network. (a) A nursing home shall register with the Maryland Health Alert Network. (b) A nursing home shall register at least four representatives, including the administrator and the director of nursing. (c) Following any changes in the initial registration of the four representatives, a nursing home shall update the information within 5 business days of the change. (12) The licensee shall: (a) Identify an emergency and disaster planning liaison for the nursing home; and (b) Provide the liaison’s contact information to the local emergency management organization. (13) The licensee shall prepare an executive summary of the nursing home’s evacuation procedures to provide to a resident, family member, or resident’s representative upon request. The summary shall, at a minimum: (a) List potential means of transportation to be used in the event of evacuation; (b) List potential alternative facilities or locations to be used in the event of evacuation; (c) Describe means of communication with family members and resident’s representatives; (d) Describe the role and responsibilities of the resident, family member, or resident’s representative in the event of an emergency situation; and (e) Notify families that the information provided may change depending on the nature or scope of the emergency or disaster. B. Evacuation Plans. The facility shall conspicuously post individual floor plans with designated evacuation routes on each floor. C. Orientation and Drills. (1) The licensee shall: (a) Orient staff to the emergency and disaster plan and to their individual responsibilities in relation to the plan within 24 hours of the commencement of job duties; (b) Document completion of the orientation in the staff member’s personnel file through the signature of the employee; and (c) Within 24 hours of admission, notify and direct residents to the nursing home’s emergency plans and maps, including evacuation procedures. (2) Fire Drills. (a) The licensee shall conduct fire drills at least quarterly on all shifts. (b) The licensee shall: (i) Document completion of each drill; (ii) Have all staff who participated in the drill sign the document; and (iii) Maintain the documentation on file for a minimum of 2 years. (3) Semiannual Emergency and Disaster Drill. (a) The licensee shall conduct a semiannual emergency and disaster drill on all shifts during which the facility practices evacuating residents or sheltering in place so that each is practiced at least one time a year. (b) The drills may be conducted via a table-top exercise if the licensee can demonstrate that moving residents will be harmful to the residents. (c) Documentation. The licensee shall: (i) Document completion of each drill or training session; (ii) Have all staff who participated in the drill or training sign the document; (iii) Document any opportunities for improvement as identified as a result of the drill; and (iv) Keep the documentation on file for a minimum of 2 years. (4) The licensee shall cooperate with the local emergency management agency in emergency planning, training, and drills and in the event of an actual emergency. #### Regulation .41 Physical Plant — New and Existing Construction Requirements. *COMAR 10.07.02.41* A. Construction of a New Nursing Home. (1) A new nursing home shall be constructed, equipped, and maintained to protect the health and safety of residents, personnel, and the public. (2) A nursing home desiring to provide services other than those for which it is already licensed shall obtain prior approval from the Department. (3) The nursing home shall obtain prior approval from the Department for any part of the premises to be used for tenant occupancy or for unrelated business purposes. (4) A nursing home shall be constructed in accordance with the provisions of the NFPA 101 Life Safety Code. B. Construction in an Existing Structure. In existing structures, the Department shall entertain requests for waivers on items that: (1) Will not endanger the health and safety of residents, visitors, employees, and other individuals using the nursing home; and (2) If corrected, will result in an unreasonable, substantial financial burden on the nursing home. C. Conversion of an Existing Structure. When an owner plans to convert an existing structure that has not been licensed as a nursing or care home to a nursing home, the owner shall be required to meet all conditions set forth in this chapter. D. Preventative Maintenance Program. A nursing home shall have a documented preventative maintenance program. This program shall include: (1) Periodic service and testing of items as recommended by manufacturers of at least the following: (a) Building systems; (b) Building components; (c) Resident care equipment; (d) Resident therapy equipment; (e) Resident bathing and shower equipment; (f) Furniture and furnishings; (g) Wheelchairs; (h) Walkers; (i) Body lifts; (j) Scales; (k) Electronics; and (l) Electrical switches and outlets; (2) Ongoing staff monitoring for evidence of malfunction or deterioration; and (3) A centralized system for reporting and monitoring repairs. #### Regulation .42 Physical Plant — General Requirements. *COMAR 10.07.02.42* A. Unless otherwise indicated, all general requirements apply to both new construction and an existing nursing home. B. A nursing home shall comply with all applicable federal, State, and local governing laws, regulations, standards, ordinances, and codes. C. A nursing home shall be constructed to comply with the provisions of the NFPA 101 Life Safety Code, as promulgated by the State Fire Prevention Commission, that are applicable to nursing homes. D. Securely anchored handrails: (1) Shall be provided on each side of all corridors in resident areas; and (2) May not be more than 36 inches high as measured from the floor to the top of the handrail. E. Elevators. (1) New Construction. Elevators shall meet the requirements for elevators in a long-term care nursing home as set forth in the Guidelines for Design and Construction of Residential, Health, Care, and Support Facilities. (2) Existing Facilities. An existing nursing home shall meet all local codes and standards for safety and maintenance of institutional elevators. F. Lighting. (1) A resident’s room shall: (a) Be lighted by outside windows; and (b) Have artificial light adequate for reading and other uses as required. (2) In order to prevent accidents and promote efficiency of service, the nursing home shall ensure that the following areas have sufficient artificial lighting: (a) Entrances; (b) Hallways; (c) Stairways; (d) Inclines; (e) Ramps; (f) Basements; (g) Attics; (h) Storerooms; (i) Kitchens; (j) Laundries; and (k) Service units. G. Minimally Maintained Lighting Levels. The following table lists the minimum lighting requirements in the following given areas: H. Night Lights. (1) A nursing home shall have sufficient lighting at night in the following areas: (a) Hallways; (b) Stairs; and (c) Designated toilets of the nursing home for the safety of the resident who gets up during the night. (2) There shall be at least one night light in each bedroom for residents. (3) In new construction, the night light shall be located at the resident room door and be capable of being switched on and off. I. Screens. (1) A nursing home shall ensure that screened doors and windows are installed and maintained in accordance with applicable fire and safety codes and COMAR 10.15.03 Food Service Facilities. (2) Maintenance and installation may not conflict with other applicable laws, regulations, codes, or ordinances. (3) A nursing home shall equip all screened doors with self-closing devices, to provide for the normal flow of ingress and egress of traffic. (4) A nursing home shall screen with wire screen or its equivalent, not less than 16 meshes per linear inch for doors and windows that provide ventilation. J. Garbage Disposal. (1) Garbage shall be: (a) Stored in water-tight containers with tight-fitting covers; and (b) Emptied at frequent intervals. (2) Soiled containers shall be thoroughly scoured and aired before using again. K. Garbage Storage Space. Storage space shall be provided for garbage and trash awaiting pickup. L. Burning. A nursing home may not burn or incinerate garbage at the nursing home. M. Special Medical Wastes. The nursing home shall meet the requirements for handling, treatment, and disposal of special medical wastes as provided in COMAR 10.06.06. N. Smoking. (1) Resident Smoking Requirements. (a) A resident who smokes shall be assessed for safe smoking behaviors at admission and on significant changes in condition. (b) A resident assessed to exhibit unsafe behaviors shall have a care plan to ensure the resident is safe when smoking. (2) Nursing Home Smoking Requirements. (a) Smoking areas shall be designated. (b) Smoking shall be prohibited at the main entrance to all facilities. (c) All tobacco products shall be extinguished and disposed of in noncombustible containers with self-closing lids in accordance with the provisions of NFPA 101 Life Safety Code. O. A nursing home shall be protected throughout the entire building by an automatic fire extinguishing system. #### Regulation .43 Physical Plant — Plumbing. *COMAR 10.07.02.43* A. Unless otherwise indicated, all general requirements apply to both new construction and an existing nursing home. B. Plumbing. (1) Plumbing shall be installed in conformance with all applicable federal, State, and local codes and ordinances. (2) Plumbing and water supplies shall be protected against backflow within a nursing home. (3) Prevention of backflow shall be ensured by proper installation of: (a) Plumbing cross-connections; (b) Submerged inlets; and (c) Back siphonage. C. Sewage. The nursing home shall be serviced by a public sewage disposal system if available. D. Private Sewage Disposal Approval. (1) If no approved public sewerage system is available, a private sewage disposal may be used, if it is approved by the Department. (2) Private sewage disposal systems shall comply with COMAR 26.04.02. E. Water Supply. A nursing home shall be served by water from a safe public water supply, if available, as determined by the Department. F. Approval of Private Water Supply. (1) If a safe public water supply is not available, a private water supply may be used if it is approved by the Department. (2) Private water systems shall comply with all federal, State, and local requirements. G. Emergency Procedures. Emergency procedures shall be established and documented that enable the nursing home to provide water in all essential areas in the event of the loss of the normal water supply or if the nursing home would have to shelter in place during an emergency or disaster. These written procedures shall: (1) Be a part of the nursing home’s Emergency and Disaster Plan, in conformance with Regulation .40 of this chapter; and (2) Describe the nursing home’s plan to ensure that there is an adequate amount of safe drinking water for all residents and staff for a minimum of 72 hours. H. Adequacy of Pressure. (1) The water supply shall be adequate in quantity and delivered under sufficient pressure to satisfactorily serve equipment in the nursing home. (2) A minimum pressure of 15 psi during demand period is required at top floor equipment. I. Temperature. The water heating equipment shall supply adequate amounts of heated water according to the following temperature guidelines for: (1) Resident use, the water temperature shall be between 100°F (38°C) and 120°F (49°C): (a) Washing; (b) Bathing; and (c) Other personal use; (2) Food preparation use, as referenced in COMAR 10.15.03; and (3) Laundry use, as referenced in the 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings. #### Regulation .44 Physical Plant — Heating and Cooling. *COMAR 10.07.02.44* A. Unless otherwise indicated, all general requirements apply to both new construction and an existing nursing home. B. Temperatures. A nursing home shall maintain a minimum design temperature of 75°F or 24°C for all occupied areas. C. Heating System. A nursing home shall be equipped with a properly maintained and operational central heating system. The heating system shall be: (1) Capable of maintaining 75°F or 24°C throughout the residents’ section of the building with the outside temperature as prescribed in the Guidelines for Design and Construction of Residential Health, Care, and Support Facilities; and (2) In compliance with NFPA 101 Life Safety Code, NFPA 99 Health Care Facilities Code, and other applicable codes, and all federal, State, and local codes. D. Humidity. The humidity shall be controlled according to the guidelines prescribed in the Guidelines for Design and Construction of Residential Health, Care, and Support Facilities. E. Auxiliary Heat. Appropriate provisions shall be made for emergency auxiliary heat by means of alternative sources of electric power, alternative fuels, or standby equipment. F. Space Heaters. Space heaters and portable heaters may not be used. G. Boiler rooms. Boiler rooms shall be provided with sufficient outdoor air to maintain combustion rates of equipment and to limit temperatures in working stations to 97°F or 36°C. H. Air Conditioning. (1) A nursing home shall be equipped with a properly maintained air conditioning system. (2) The air conditioning system shall be in compliance with NFPA 101 Life Safety Code, NFPA 99 Health Care Facilities Code, and all federal, State, and local codes. (3) In an existing structure, the nursing home shall comply with the regulations and building codes effective at the date of construction. (4) In new construction or renovation, the nursing home shall comply with the regulations and building codes effective at the date of construction or renovation. #### Regulation .45 Physical Plant — Ventilation. *COMAR 10.07.02.45* A. Unless otherwise indicated, all general requirements apply to both new construction and an existing nursing home. B. An existing nursing home shall provide for adequate ventilation through windows or mechanical means or a combination of both. C. A new nursing home shall adhere to the requirements of this chapter. D. Ventilation System Details. (1) All air-supply and air-exhaust systems shall be mechanically operated. (2) The ventilation rates shown in Table 1 under §D(10) of this regulation shall be considered the minimum acceptable rates and may not be construed as precluding the use of higher ventilation rates. (3) All fans serving exhaust systems shall be located at the discharge end of the system. (4) Outdoor air intakes shall be located: (a) As far as practical but not less than 25 feet from: (i) Exhaust outlets of ventilating systems; (ii) Combustion equipment stacks; (iii) Medical-surgical vacuum systems; (iv) Plumbing vent stacks; or (v) Areas that may collect vehicular exhaust and other noxious fumes; and (b) As high as practical, so that the bottom of the outdoor air intake is: (i) At least 6 feet above ground level; or (ii) At least 3 feet above roof level. (5) The ventilation systems shall be designed and balanced to provide the pressure relationships as shown in Table 1 under §D(10) of this regulation. (6) The bottoms of ventilation openings may not be not less than 3 inches above the floor of any room. (7) Corridors may not be used to supply air to or exhaust air from any room, except that air from corridors may be used to ventilate bathrooms, toilet rooms, janitors’ closets, and small electrical or telephone closets opening directly on corridors. (8) Filters. (a) A central ventilation or air conditioning system shall be equipped with filters having efficiencies no less than those specified in Table 2 under §D(11) of this regulation. (b) The filter bed shall be located upstream of the air conditioning equipment, unless a prefilter is employed. (c) If a prefilter is employed, the prefilter shall be upstream of the equipment and the main filter bed may be located further downstream. (d) A filter or filter efficiency shall comply with the standards of the Guidelines for Design and Construction of Residential Health, Care, and Support Facilities. (e) A filter frame shall be durable and carefully dimensioned and shall have an airtight fit with the enclosing duct work. (f) A joint between filter segments and the enclosing duct work shall be gasketed or sealed to provide a positive seal against air leakage. (g) A manometer shall be installed across each filter bed serving central air systems. (9) Air Ducts. (a) Air-handling duct systems shall meet the requirements applicable to nursing homes cited in NFPA 99 Health Care Facilities Code. (b) Fire and smoke dampers shall be constructed, located, and installed in accordance with the requirements of NFPA 101 Life Safety Code. (c) Air ducts that pass through a required smoke barrier shall be provided with a smoke damper at the barrier. (d) Smoke dampers shall activate by smoke detectors located in the ducts at the smoke barrier, or by the smoke detectors used to close smoke barrier doors. (e) Smoke dampers shall be controlled to close automatically to prevent flow of smoke-laden air in either direction. (f) Smoke dampers shall be equipped with automatic remote control reset devices, except that manual reopening will be permitted if smoke dampers are accessible. (g) All devices shall be interlocked with the fire alarm system. (10) Table 1. This table refers to the pressure relationships and ventilation of certain areas of a nursing home other than chronic disease hospitals. (11) Table 2. This table refers to the filter efficiencies for central ventilation and air conditioning systems in a nursing home other than chronic disease hospitals. (12) Exhaust Hoods. All hoods over cooking surfaces shall comply with the requirements as provided in COMAR 10.15.03. #### Regulation .46 Physical Plant — Emergency Power. *COMAR 10.07.02.46* A. Unless otherwise indicated, all general requirements apply to both new construction and an existing nursing home. B. Emergency Electrical Power. (1) The nursing home shall provide emergency electrical power. (2) Emergency power for the purpose of egress lighting and protection shall be as required by NFPA 101 Life Safety Code. (3) Other emergency lighting shall be as follows: (a) Nursing station; (b) Drug distribution station or unit dose storage; (c) A lighted area for emergency telephone use; (d) Boiler or mechanical room; (e) Kitchen; (f) Generator set location and switch gear location; (g) Elevator, if operable on emergency power; (h) Areas where life support equipment is used; (i) If applicable, lighting for the common area of refuge; and (j) If applicable, lighting in toilet rooms of the common area of refuge. (4) Emergency power shall be provided for the: (a) Nurses’ call system; (b) Duplex receptacles installed 50 feet apart in all corridors in resident areas or appropriately located duplex receptacles in the common area of refuge; (c) Telephone service with at least one telephone available for incoming and outgoing calls; (d) Fire pump; (e) Sewerage pump and sump pump; (f) Elevator, if required, for evacuation as referenced in NFPA 101 Life Safety Code; (g) Heating equipment, if applicable, to maintain a minimum temperature of 71°F or 22°C in the common areas of refuge; (h) Life support equipment; (i) Nonflammable medical gas systems; (j) Computer system, if applicable, to enable use of electronic medical records system; and (k) Refrigerated medication storage. (5) Common Area or Areas of Refuge. (a) The nursing home shall provide a common area or areas of refuge in an emergency situation if all resident rooms, day rooms, and toilet rooms are not tied into the emergency generator to provide heat and cooling. (b) The common area or areas of refuge: (i) Shall be at least 30 square feet per bed, not including corridors; (ii) May not include toilet rooms in the 30 square feet per bed; and (iii) Shall maintain a minimum temperature of 71°F or 22°C and a maximum temperature of 81°F or 27°C. (c) The nursing home shall provide heated toilet rooms adjacent to the common areas of refuge. (d) The nursing home shall provide a Department-approved written plan that: (i) Defines the specified area of refuge; (ii) Outlines paths of egress from the common areas of refuge; and (iii) Describes provisions for light, heat, food service, washing, and toileting residents. (6) Emergency Power Source. (a) The emergency power source shall be a generating set and prime mover located on the premises with automatic transfer. (b) The emergency generator shall: (i) In the event of failure of the normal electrical service, be activated immediately; (ii) Come to full speed and load acceptance within 10 seconds; (iii) Have a capacity of 48 hours of operation from fuel stored on-site; and (iv) Be tested once a month, for at least 30 minutes under normal emergency nursing home connected load, and the test recorded in a permanent log book maintained for that purpose. #### Regulation .47 Nursing Care Unit. *COMAR 10.07.02.47* A. Size. Nursing care units may not exceed 60 beds. The Department may specify the numbers and types of personnel for each unit which exceeds 40 beds. B. Common Space. The nursing home shall provide a living room for residents’ use with a sufficient number of reading lamps, tables, and comfortable chairs or sofas. C. Service Areas Required. (1) Nurses’ Work Area. (a) The nurses’ work area shall be located on the unit and within easy view of corridors outside of residents’ rooms. (b) The Department may specify the location and size of a nurses’ work area which serves a nursing care unit exceeding 40 beds. (2) Nursing Care Unit. (a) A nursing care unit, regardless of size, including special care units, shall be equipped as described in this regulation. (b) A nursing care unit bathroom shall include: (i) A toilet, within the care unit, for the use of personnel; and (ii) A hand-washing sink equipped with goose-neck spout, separate soap dispenser, and disposable paper towel dispenser. (c) A nursing care unit’s medicine shall be stored in accordance with the following procedures: (i) Shall be stored in a cabinet with locks; (ii) Schedule II drugs shall be kept in a separately locked, securely fixed box or drawer in the medicine storage cabinet under two locks, keyed differently; (iii) The medicine storage and preparation area shall be illuminated with at least 100 foot-candles at the work counter; (iv) The preparation area shall include a small sink set into the counter or with drain boards and a biological refrigerator; and (v) The medicine storage cabinet, medicine preparation area, and biological refrigerator shall be under the direct visual control of the nursing or pharmacy staff. (d) Nurses' call system. (e) Charting desk and supplies. (f) Storage space for miscellaneous medical supplies which shall be protected from contamination. (g) A nursing care unit shall have sufficient space and equipment for medical records so that personnel can function effectively and maintain easily accessible records for all residents. (3) Medication Storage in Nursing Home. (a) The storage facility shall provide for the conditions listed in §C(3)(b)—(g) of this regulation when prescribed. (b) Cold — Any temperature at or below 46°F or 8°C. A refrigerator is a cold place in which the temperature is maintained thermostatically between 46°F and 59°F or 8°C and 15°C. A freezer is a cold place in which the temperature is maintained thermostatically between -4°F and -14°F or -20°C and -26°C. (c) Cool — Any temperature between 46°F and 59°F or 8°C and 15°. An article for which storage in a cool place is directed may, alternatively, be stored in a refrigerator, unless otherwise specified in the individual monograph. (d) Room Temperature — The temperature prevailing in a working area. Controlled room temperature is a temperature maintained thermostatically between 59°F and 86° F or 15°C and 30°C. (e) Warm — Any temperature between 86°F and 104°F or 30°C and 40°C. (f) Excessive Heat — Any temperature above 104°F or 40°C. (g) Protection from Freezing. The container label bears appropriate instructions to protect the product from freezing when freezing it may subject a product to: (i) Loss of strength or potency; (ii) Risk of breakage of the container; or (iii) Destructive alteration of the dosage form. (h) Storage under Non-specific Conditions. When no specific storage directions or limitations are provided in the individual monograph, the storage conditions shall include protection from moisture, freezing, and excessive heat. (4) Space for Storage of Linen. Capacity shall be provided for storing of at least two complete linen changes per bed. Clean linen shall be stored separately from unclean items. (5) Janitor Closet — New Construction. (a) A nursing unit shall contain at least one janitor closet containing a floor receptor or service sink and storage space for housekeeping equipment and supplies. (b) The janitor closet shall be equipped for hand washing. (c) The janitor closet shall be connected to mechanically operated exhaust ventilation. (d) The plumbing fixture for the utility or service sink within a janitor closet shall be provided with a back-flow prevention device. (6) Utility Rooms. (a) There shall be separate clean and soiled utility rooms in each nursing unit: (i) Accessible to the resident area; (ii) Each having separate entrances; and (iii) No more than 120 feet to the most remote resident bedroom. (b) The clean utility room shall contain: (i) A small sink equipped with gooseneck spout and wrist blades; (ii) Soap and individual paper towels in a dispenser; (iii) Adequate storage and work counter space for storage and assembly of supplies for nursing procedures; and (iv) Clean linen stored and transported in covered containers, closed linen carts, or rooms exclusively provided for this purpose. (c) The soiled utility room shall contain: (i) Work counter with sink, gooseneck faucet, and wrist blades; (ii) A small sink equipped with soap and individual paper towels in a dispenser; (iii) Space for waste receptacles and soiled linen receptacles; provision for storing and transporting soiled linen in covered leakproof containers; (iv) Equipment to clean and sanitize bedpans, urinals, and basins; and (v) Equipment for the disposal of liquid and semi-solid wastes and bodily fluids via the nursing home’s sanitary sewer connection or on-site sewage disposal system. (7) Culture Change Nursing Home. In a culture change nursing home, service areas shall be provided for resident care needs as approved by the Department. The culture change nursing home shall be required to have service areas that meet the specifications in this chapter for: (a) Clean storage; (b) Soiled holding; (c) Laundry; (d) Janitorial services; and (e) Medication storage. D. Drinking Fountains. One public drinking fountain or comparable equipment as preapproved by the Department shall be provided on each floor, usable from a wheelchair. Alternative means to provide drinking water to residents, staff, and the general public may be used as approved by the Department. E. Automated External Defibrillator. (1) A nursing home shall possess a functioning automated external defibrillator (AED). (2) As of July 1, 2020, a nursing home shall install a functioning AED unit. #### Regulation .48 Call Systems. *COMAR 10.07.02.48* A. Call System. (1) A nurse call system shall be installed and maintained in operating order in all nursing units. (2) A call system shall be maintained in a manner that will provide visible and audible signal communication between nursing service personnel and residents. (3) A call station shall provide readily accessible and detachable extension cords to each resident’s bed in the residents’ rooms at all times. (4) A call system shall have a visible signal above the door of each resident’s bedroom that shall be visible from all parts of the corridor. (5) A call system shall provide visual lights at corridor intersections, in multi-corridor nursing units. (6) A call system shall be provided in each resident’s bathroom and bathing area in locations accessible to the residents. (7) The call system shall enable residents in the rehabilitation area to summon rehabilitation staff. (8) The nurses’ call system shall require resetting at the station where the call originates. B. Wireless Call Systems. (1) A call system that uses wireless pagers or other wireless communication devices may be used as an alternative system. (2) A wireless device shall: (a) Be issued to all assigned direct care staff; and (b) Receive signals originating from residents’ bedrooms, bathrooms, bathing areas, and therapy areas. (3) The use of an approved wireless call system shall eliminate the need to install call light indicators outside the residents’ bedrooms, bathrooms, bathing areas, and therapy areas. (4) A computer system with a monitor or other electronic display device may be installed to replace the call system annunciator, as long as it reveals the location where the signal originated and sounds an audible alert tone. Otherwise, a dedicated annunciator connected to the wireless call system will be needed. (5) An electrically powered call system shall be connected to the emergency power supply. (6) The sounding of the audible signal shall be continuous or intermittent until answered. (7) The audible signal may not be turned off at the nursing station. (8) The audible signal shall be loud enough to be heard at the nurses’ station. #### Regulation .49 Resident Bedroom in Nursing Home. *COMAR 10.07.02.49* A. Unless otherwise indicated, all general requirements apply to both new construction and an existing nursing home unless a waiver has been granted by the Office of Health Care Quality in accordance with Regulation .03G of this chapter. B. Bedroom Accommodations. (1) Bedroom. (a) A resident’s room shall have direct access to an exit in accordance with the requirements applicable to nursing homes specified in NFPA 101 Life Safety Code. (b) A room that opens into the kitchen may not be used as a resident bedroom. (c) A room may not be used as a resident bedroom if it can only be reached by passing through a kitchen. (d) Residents may not occupy rooms extending below the ground level. (e) No more than four individuals may occupy a multiple occupancy bedroom. (f) Residents’ beds may not be located near radiators, registers, or sources of draft. (g) Adequate storage space shall be provided in each bedroom to allow each resident to keep necessary items of clothing, including items that need to be hung. Adequate storage space shall be provided for residents’ personal possessions, including the storage of seasonal clothing. (h) All occupants of any bedroom shall be of the same sex, except in the case of a two-bed room occupied by: (i) Siblings; (ii) A parent and child; (iii) A married couple; or (iv) Consenting residents. (2) Bedroom — New Construction. A nursing home shall provide cubicle curtains and tracks in multiple occupancy bedrooms between beds to ensure privacy of residents. (3) Bedroom — Existing Construction. In an existing nursing home, curtains or screens shall be acceptable. C. Floor and Window Space. (1) Floors. (a) A distance of at least 3 feet shall be maintained between each bed. Beds are to be placed so that all sides of the bed are at least 18 inches from heating units. (b) The following shall be considered a minimum allowance of floor space: (i) 100 square feet, single-bed room; and (ii) 80 square feet, per bed, for multiple-bed rooms. (c) The following floor areas may not be included in the calculation of floor space: (i) Toilet rooms and bathing facilities; (ii) Closets; (iii) The floor area occupied by wardrobes, bureaus, or lockers, when permanently installed as part of walls or ceilings and as a permanent component of a bedroom; (iv) HVAC equipment, including any steam, water, or electrical supply or return lines that may run parallel to the floor or interrupt the floor surface; (v) Support columns, pipe chases, or other structures, whether free-standing or as an integral part of a wall; and (vi) The arc of any doors that open into the room, excluding closet doors. (d) The minimum horizontal dimensions of a bedroom shall be 10 feet to: (i) Facilitate the placement of beds as required in Regulation .44 of this chapter; and (ii) Maintain a minimum clearance of 3 feet at the foot of the bed. (e) In an existing nursing home, the usable floor area for rooms having a bedroom shall have a finished ceiling height of 8 feet. For a bedroom that has sloping walls, only 50 percent of the floor area with a ceiling height between 4 feet and 7 feet, 6 inches, shall be credited, provided that at least 50 percent of the total area of the bedroom has a ceiling height of 8 feet. (2) Windows. (a) The window area within each bedroom shall be at least 10 square feet per bed. The window opening shall be at least 28 inches so that the total area equals 10 square feet per bed. This is to allow entry of fire fighters, removal of smoke, and emergency evacuation. (b) The maximum height from the floor to the top of a window sill shall be 44 inches above the finished floor. (c) A portable window air-conditioning unit may not block window space. The installation of a portable air-conditioning unit shall be approved by the: (i) Local fire authorities; and (ii) Department. (d) If windows cannot be opened for ventilation, a central HVAC system shall be provided and maintained. (e) If windows can be opened, but the nursing home has concern over the window being opened due to resident safety issues and elopement, the window sash may be restricted by hardware as approved by the Department. D. Furnishings. (1) Furnishings. (a) The nursing home shall provide residents with their own bed. The bed shall be at least 36 inches wide and be substantially constructed. Rollaway type beds, cots, or folding beds may not be used. (b) Bed. (i) Each bed provided shall be in good repair, with a clean and comfortable standard size mattress and foundation. (ii) To avoid injury to the resident, the mattress and foundation shall fit the bed. (iii) Clean linen and a clean, comfortable pillow shall be provided. Extra pillows shall be available. (c) Bedroom Furniture. A resident shall be provided with the following furnishings, which shall be convenient to the resident: (i) Bedside stand with a drawer; (ii) Towel hanger; (iii) A comfortable chair; (iv) A chest of drawers with at least one locking drawer; (v) Enclosed space for hanging clothing; (vi) A wall mirror in each room, unless contraindicated by physician’s order; and (vii) A bedside lamp, over-bed lamp, or other directional light source for resident reading and bedside care. (d) Resident’s Personal Furnishings. (i) A nursing home shall develop policies and procedures to give residents the opportunity to use the resident’s own furnishings as detailed in this chapter. (ii) The nursing home shall make its resident’s personal furnishing policies available for review by residents and the resident’s representative. (iii) These policies shall address the condition of the personal furnishings, presence of insects or vermin, and overall safety to ensure that the use of the resident’s belongings does not create any safety or health issues. (iv) Personal furnishings that are allowed shall be appropriate for the resident’s use. (e) Windows shall be provided with shades or draperies adequate to control glare and maintain privacy. (f) Each living room for residents’ use shall be provided with a sufficient number of reading lamps, tables, and comfortable chairs or sofas. (2) Furnishings — New Construction. A bedroom shall be provided with a hand-washing sink with both hot and cold running water unless a toilet or bathroom facility with a sink is connected to the bedroom. (3) Medication Storage Cabinets. (a) Medication storage cabinets with locks shall be permitted for the storage of resident medications that do not require refrigeration within a resident bedroom. (b) Controlled medications to be stored within medication storage cabinets in a resident’s room shall be held within a separate compartment that is locked and inside of the larger medication storage cabinet in that room. #### Regulation .50 Body-Holding Room. *COMAR 10.07.02.50* A. Body-Holding Room — New Construction and Existing Nursing Home. (1) A body-holding room shall be equipped with ventilation by mechanical means at the same rate and specifications as designed for soiled linen sorting and storage areas. (2) A nursing home shall develop and implement a method for body-holding that minimizes the psychological effects on other residents. B. Body-Holding Room — New Construction. A body-holding room shall be located to facilitate quiet and unobtrusive ingress and egress of bodies, convenient to the elevator and with an isolated exit. C. Body-Holding Room — Existing Nursing Home. If a body-holding room is not provided, a holding area shall be designated that approximates the above conditions. #### Regulation .51 Resident Bathroom Amenities. *COMAR 10.07.02.51* A. Bathing. (1) There shall be at least one separate room or compartment with a bathtub, shower, or other bathing device, as approved by the Department, for every 15 licensed beds. (2) The compartment shall be large enough to accommodate: (a) The resident; (b) A caregiver; and (c) A wheelchair, shower chair, or shower bed. B. Toilets. (1) For every eight beds, there shall be at least one toilet enclosed in a separate room or stall. (2) Each floor shall have at least one toilet room large enough to: (a) Accommodate: (i) The resident; (ii) A wheelchair; and (iii) A caregiver; and (b) Permit toilet assistance or training. C. Sinks. (1) For every four licensed beds, there shall be at least one hand-washing sink. (2) For hand-washing purposes, there shall be a towel dispenser and a supply of paper towels and soap dispenser adjacent to each sink. #### Regulation .52 Equipment and Supplies for Bedside Care and Therapy. *COMAR 10.07.02.52* A. Needs of Residents. (1) There shall be sufficient equipment to meet the needs of the residents admitted. (2) The administrator shall obtain specific items required for individual cases where requested by the attending physician or medical director. (3) The Department may require that the nursing home have specific types of equipment based on the needs of the residents. (4) A nursing home shall establish and enforce a written preventive maintenance program to ensure that all resident care and therapy equipment is maintained in safe operating condition. B. Use of Hot Packs, Ice Packs, and Other Therapeutic Medical Devices. (1) Covers shall be placed on hot packs, ice packs and other temperature-related therapeutic medical devices before they are placed in a bed or on a resident. (2) The temperatures in the building, hot packs, and therapeutic equipment may not exceed 120°F or 49°C. (3) The use of hot and cold medical devices shall be: (a) Consistent with manufacturer’ guidelines and nursing home policies; and (b) Maintained and applied by trained staff. #### Regulation .53 Rehabilitation Facilities — Space and Equipment. *COMAR 10.07.02.53* A. Unless otherwise indicated, all general requirements apply to both new construction and an existing nursing home. B. General Requirements. (1) Space. (a) A nursing home shall provide adequate space to: (i) Receive, examine, and treat residents; (ii) Store supplies and equipment, including wheelchairs and stretchers; and (iii) Provide office space for the employed personnel to work. (b) A nursing home shall allot 75 square feet for treatment area per resident, based on peak treatment schedules. (c) A nursing home shall plan and arrange space for shared use by physical therapy and occupational therapy staff and residents, if scheduling permits. (d) A nursing home may distribute space in the following manner: (i) Storage space shall comprise at least 10 percent of the area designated for exercise and rehabilitation; and (ii) Office space shall be at least 110 square feet for one therapist, or 85 square feet per therapist if there are two or more. (2) Equipment. (a) Equipment shall allow for providing safe and effective resident care. (b) All electrical equipment shall be calibrated according to the manufacturer's guidelines and shall be serviced periodically as part of a preventive maintenance program. A sticker bearing the date of the most current inspection shall be affixed on each piece of equipment. (c) All electrical equipment shall be tested periodically for proper grounding, current leakage, and calibration where appropriate. (d) The operator’s instruction manual shall be available in a designated location or accessible electronically at all times. (e) All flammables shall be stored in compliance with NFPA 99 Health Care Facilities. (f) Adequate exhaust ventilation shall be provided when using vaporous materials or pollutants. (3) Toilet Facilities in Rehabilitation Area — New Construction. (a) A nursing home with rehabilitation areas shall provide a hand-washing sink and toilet which meet Guidelines for Design and Construction of Residential Health, Care, and Support Facilities standards for residents who use a wheelchair. (b) The nursing home shall be readily accessible to the residents receiving rehabilitative services. (c) Toilets and bathing rooms within a rehabilitation area shall be equipped with a nurse call system. #### Regulation .54 Dayroom and Dining Area. *COMAR 10.07.02.54* A. General Requirements. Resident Dining, Occupational Therapy, and Activities Program. The nursing home shall provide one or more attractively furnished areas of adequate size for resident dining, occupational therapy, and social activities. Activities space shall be of adequate size to meet the needs of the residents and shall be located on each floor occupied by residents. B. Dining Area. (1) A nursing home shall provide dining areas large enough to accommodate all residents who eat there at the same time. (2) There shall be an allowance of at least 12 square feet per resident. This allowance shall be substantially increased proportionate to the number of residents who use a wheelchair. (3) The height of tables provided in dining areas shall accommodate each resident using a wheelchair. C. Dayroom Area. Dayroom areas shall be provided that are: (1) Adequate for the residents located on each nursing care unit; and (2) Located convenient to the residents’ bedrooms. D. Multi-purpose Room. (1) The nursing home shall provide a multi-purpose room for dining, occupational therapy, physical therapy, and social activities. There shall be sufficient space to accommodate all activities without interfering with each other. (2) The nursing home shall set aside areas for residents’ dining and recreation that total at least 30 square feet per licensed bed for the first 100 beds, plus 27 square feet per licensed bed for all beds in excess of 100. (3) Areas that meet this requirement may include: (a) Reception areas; (b) Lobbies, portion not required for egress per NFPA 101 Life Safety Code, as are applicable to nursing homes; (c) Hair care; (d) Salon rooms; (e) Resident gift shops; (f) Theater; (g) Auditorium; (h) Spiritual worship; (i) Meditation areas; (j) Dayrooms; (k) Dining areas; (l) Libraries; and (m) No more than 50 percent of the floor area of all occupational therapy and physical therapy areas, and other areas as approved by the Department. #### Regulation .55 Dietetic Service Area. *COMAR 10.07.02.55* A. General Requirements. Unless otherwise indicated, all general requirements apply to both new construction and an existing nursing home. B. Food Service Department. (1) The size and location of the food service area shall comply with COMAR 10.15.03. (2) A catered or satellite system shall be covered by a contract approved by the Department. (3) The vendor providing the food shall have a valid food service permit. C. Outside Service Entrance. A convenient outside service entrance shall exist to facilitate receiving food supplies and the disposal of waste. D. Restriction — Entry to Kitchen or Serving Pantry. A toilet room or sleeping room may not open directly into any kitchen or serving pantry. E. Limitations on Use of Kitchen. The kitchen may not be used as a passageway. It shall be used for no other purpose than activities connected with food service. F. Janitor Closet or Service Area. (1) Janitor Closet — New Construction. A janitor closet or service alcove for the exclusive use of food service areas shall be provided in, or adjacent to, the dietetic service department. (2) The janitor closet or service alcove shall be: (a) Equipped with: (i) A utility sink; (ii) Storage shelves; and (iii) A rack for hanging brooms and mops; and (b) Connected to mechanically operated exhaust ventilation. (3) The plumbing fixture for the utility sink within a janitor’s closet shall be provided with an approved back-flow prevention device. G. Space. (1) There shall be sufficient floor space in the food service department to permit all activities to function efficiently without overcrowding or increasing the risk for cross-contamination of food or equipment from soiled surfaces. (2) Minimum Space Requirements — New Construction. (3) Space — Existing Nursing Home. (a) A nursing home that holds full licensure as of the adoption date of these regulations shall be considered to have an adequate size dietetic service department. (b) Renovations of all kitchens shall be approved by the Department, which will consider modification of the minimum space requirement based on space available, costs, and type of service. (4) Aisle space between working areas shall be at least 3 feet, and aisle space for main traffic shall be at least 5 feet wide. (5) Ceiling height shall be at least 9 feet. (6) If the licensed capacity of a nursing home is increased, or if meals are provided to anyone outside of the nursing home from the food service area of the nursing home, the nursing home shall provide an additional food service area in accordance with this chapter. The additional food service area required when meals are provided to anyone outside of the nursing home is to be calculated by using the total number of individuals to whom meals are provided. (7) The kitchen space requirement as described in this regulation does not apply to occasional special functions such as picnics or dinners for residents, volunteers, families, or community groups as long as the nursing home certifies to the Department that providing meals for a special function will not adversely affect or detract from the timely provision of meals to the nursing home’s residents. H. Floor Pantries — New Construction. (1) There shall be at least one food service floor pantry per nursing care unit. (2) This area shall be of sufficient size to accommodate the equipment required for food preparation and service. (3) The equipment provided in food service floor pantries shall comply with the requirements of the local health department. (4) A food service floor pantry shall include the following: (a) Refrigerator; (b) Cabinets for dry storage and supplies; (c) Work space; (d) Sink for purposes other than hand-washing; (e) Hand-washing sink with soap dispenser and disposable paper towel dispenser; and (f) Except for trays that are assembled in the main kitchen and then distributed to the nursing care units, equipment to hold hot food if bulk foods are plated and served to the residents on the nursing care unit. (5) A food service floor pantry shall include the following additional equipment: (a) Toaster; (b) Ice-making machine or ice-storage container; (c) Work space for tray preparation; (d) Equipment to deliver completed trays; (e) Three-compartment sanitizing sink or dishwasher; (f) Cabinet for dry storage, supplies, and kitchenware; and (g) Storage for trays, tableware, flatware, and utensils. I. Equipment for Food Preparation and Distributions. (1) Adequate equipment for preparation, serving, and distribution of food shall be provided. (2) A dumbwaiter, elevator, or ramp shall be provided in a nursing home of more than one story where more than eight residents above or below the kitchen level receive bedside tray service. (3) Equipment to protect food from dust or contamination and to maintain food at proper temperature shall be provided to transport food to the residents. J. Dry Food Storage. (1) Food Storage Space. (a) Adequate space shall be provided to store food supplies. (b) The amount of storage space needed to store food depends on the frequency of deliveries. (c) It is recommended that 2 square feet per resident be provided and that the dry food storage area be located within easy access to the receiving area and the kitchen. (2) The storeroom shall be cool and well-ventilated. (3) All food supplies shall be stored off the floor and away from the wall to allow for cleaning. K. Refrigerated Storage. (1) Adequate refrigerated storage, refrigerators, and frozen food storage cabinets shall be provided and regulated to maintain temperatures prescribed in COMAR 10.15.03. (2) Food in storage shall be arranged so that new food items are stored behind old food items. (3) The oldest foods shall be used first, known as the first in, first out method. L. Mobile Food Carts. (1) All policies and procedures for the mobile food cart shall be approved by the Department and the nursing home’s local health department before implementation. (2) Policies and procedures shall address, at a minimum the following: (a) Identify how many staff members will assist with serving food items, pushing the mobile cart, and delivering meals to the residents; (b) Ensure proper food protection on three sides to protect the food; (c) Maintain proper temperature control, hot food at a minimum of 135°F and cold food maintained at a maximum of 41°F; (d) Record of temperatures before serving meals on each individual unit; (e) Ensure proper food temperatures; and (f) Hand washing. (3) The hand washing policy and procedures referenced in §L(2)(f) of this regulation shall include the following: (a) Use of a hand sanitizer in lieu of proper hand washing is not permitted; (b) Bare hands may not have direct contact with ready-to-eat food; (c) Hand washing shall be done before starting meal service on each individual unit; (d) When and at what location hand washing will be done; (e) Hand washing may not be done in resident rooms; (f) Access to a hand washing sink may not require the opening of a door; (g) The hand washing sink shall be in a central, unobstructed location; (h) Mobile hand sinks are acceptable as long as a written procedure to meet sanitation requirements is developed; (i) The hand sink shall be supplied with hot and cold water under pressure; (j) The unit shall be supplied with adequate waste containers to hold dirty water until dumping is done; and (k) The written procedure shall include the disposal of the dirty water. #### Regulation .56 Administrative Areas. *COMAR 10.07.02.56* A. Unless otherwise indicated, all general requirements apply to both new construction and an existing nursing home. B. Administrative Areas — New Construction. (1) A nursing home shall provide a separate room or rooms for the administrator and administrative support staff. Sufficient areas shall be provided to accommodate all necessary office furniture, files, and other equipment and enable the safe storage of residents’ valuables. (2) In new construction, separate locker rooms and a toilet facility shall be provided for male and female employees in each nursing home. C. Administrative Areas — Existing Nursing Homes. (1) The nursing home shall provide an administrative area that is suitable for conducting business or discussing problems privately with the resident’s representative. (2) The nursing home shall provide a sufficient number of lockers that can be locked securely for all employees working at any one time, and shall provide for the employee use of toilet facilities. D. Lobby Area — New Nursing Home. A nursing home shall provide a lobby area that shall have: (1) Public toilets for both sexes, either separate or unisex, located conveniently to this area; (2) Access to telephone; and (3) Drinking fountains or other drinking water dispensers that meet Guidelines for Design and Construction of Residential Health, Care, and Support Facilities. E. Employee Facilities — New Construction. In new construction, separate locker rooms and toilet facilities shall be provided for male and female employees in each facility. F. Employee Facilities — Existing Facilities. An existing nursing home shall: (1) Have a sufficient number of lockers that can be locked securely for all employees working at any one time; and (2) Provide for the employee use of toilet facilities at a convenient location. #### Regulation .57 Housekeeping Services, Pest Control, and Laundry. *COMAR 10.07.02.57* A. General Requirements. Unless otherwise indicated, all general requirements apply to both new construction and an existing nursing home. B. Staff. Sufficient housekeeping and maintenance personnel shall be employed to maintain the interior and exterior of the facility in a safe, clean, orderly, and attractive manner. C. Cleanliness and Maintenance. (1) The building and all its parts and facilities shall be kept in good repair, neat, and attractive. The safety and comfort of the residents shall be the primary consideration. (2) All walls, floors, ceilings, windows, and fixtures shall be kept clean. Interior walls and floors shall be of a type to allow frequent and easy cleaning. (3) The nursing home shall be kept free of unnecessary accumulations of personal possessions, boxes, trunks, suitcases, papers, unused furniture, bed clothing, linens, bric-a-brac, and similar items. (4) Storage areas shall be: (a) Kept clean and orderly; and (b) Readily accessible for: (i) Housekeeping; (ii) Maintenance; and (iii) Pest control servicing. (5) The grounds shall be kept clean, neat, attractive, and free of hazards. (6) Pest Control. The nursing home shall: (a) Be maintained free of insects and rodents by operation of an active pest-control program, either by use of maintenance personnel or by contract with a pest-control company; (b) Use and store toxic and flammable insecticides and rodenticides with care; (c) Ensure that usage of toxic and flammable insecticides and rodenticides conforms to the U.S. Environmental Protection Administration and Maryland Department of Agriculture requirements; (d) Be protected to prevent the entry and harborage of rodents and insects; (e) Install and effectively maintain: (i) Screen doors that fit tightly when closed; (ii) Easily adjusted closely fitted window screens; (iii) Rat-proofing devices; or (iv) Other approved deterrents; and (f) Effectively protect all openings to the outside against the entry of insects by: (i) Closed doors; (ii) Closed windows; or (iii) Other means. (7) Laundry Services. (a) A nursing home shall provide laundry service, whether on-site or off-site. (b) Laundry service shall be provided to meet the residents’ needs. (c) All laundry shall be processed and handled in a manner that prevents the spread of infections. Staff working in laundry shall be given personal protective equipment, including: (i) Disposable gloves; (ii) Masks; and (iii) Body coverings. (d) All laundry shall be processed through the use of sufficiently hot water, chemical agents, or a combination of the both, to remove or destroy infectious biological materials. (e) Clean and Soiled Areas. (i) There shall be a physical separation between the clean and soiled areas. (ii) The soiled area shall allow for sorting and washing soiled laundry. (iii) The clean area shall allow for drying and folding of clean laundry. (iv) All soiled areas within a laundry shall be connected to mechanically operated exhaust ventilation. (f) The system provided in laundries may not allow the spread of airborne contaminants to other parts of the nursing home that are occupied by residents, staff not working in the laundry, and the general public. (g) The plumbing fixtures for all water supply connections to washing machines and the plumbing fixtures for all utility sinks shall have an integrated atmospheric vacuum breaker or other approved back-flow prevention devices. #### Regulation .58 Resident Care Management System. *COMAR 10.07.02.58* A. Each comprehensive care facility and extended care facility shall establish and maintain a resident care management system. B. The resident care management system shall consist of three related components: (1) Resident status assessment and data gathering; (2) Care planning; and (3) Actions in response to care plan approaches. #### Regulation .59 Resident Status Assessment. *COMAR 10.07.02.59* A. A nursing home shall use the following forms and procedures for resident assessment as described in the CMS Manual System, Pub. 100-07 State Operations Provider Certification and in the CMS Long-term Care Facility Resident Assessment Instrument 3.0 User’s Manual: (1) The Minimum Data Set (MDS) version as determined by the U.S. Department of Health and Human Services, Centers for Medicare and Medicaid Services, in Transmittal No. 22, referenced in §B of this regulation. (2) MDS Care Area Assessment process; and (3) Care plans. B. The nursing home shall complete all assessments in accordance with the provisions of 42 CFR §483.20, as amended. C. A nursing home certified for participation in Medicare or Medicaid shall complete and electronically submit the assessment to the Quality Improvement and Evaluation System (QIES) Assessment Submission and Processing (ASAP) system. The assessment shall: (1) Use a standard record layout format; (2) Use a data dictionary as identified by the automated data processing requirements; and (3) Pass standardized edits as defined by CMS and the State. D. A federally certified nursing home shall: (1) Encode assessment data as specified in the CMS Long-term Care Facility Resident Assessment Instrument 3.0 User’s Manual; and (2) Transmit assessment data as specified in the CMS Long-term Care Facility Resident Assessment Instrument 3.0 User’s Manual except as excluded in §E of this regulation. E. A nursing home licensed as a nursing home but not certified for participation in the Medicare or Medicaid Program shall comply with the CMS Manual System, Pub. 100-07 State Operations Provider Certification, and with RAI instructions in the CMS Long-term Care Facility Resident Assessment Instrument 3.0 User’s Manual, except that data may not be submitted electronically to the Department. #### Regulation .60 Care Planning. *COMAR 10.07.02.60* A. An interdisciplinary team shall complete or revise as necessary a resident-specific care plan for each resident within 7 calendar days following completion of assessments, including: (1) Admission assessment; (2) Annual assessment; (3) Quarterly assessment; and (4) Significant change in the resident’s condition. B. Care Plan Meeting. The nursing home shall, with the resident’s consent: (1) Give an interested and appropriate family member or resident’s representative 7 calendar days advance notice, in writing, of the location, date, and time of a care planning conference for a resident; (2) Strive to accommodate the schedules of invited family members and resident’s representatives when scheduling care plan meetings; and (3) Include an invitation for the family member or resident’s representative to attend the conference. C. The nursing home shall hold the care planning conference not later than 7 calendar days after completing the assessment, but may hold the conference sooner if agreed to by the resident, a family member, or a resident’s representative. D. Organization of Care Plan. (1) Resident’s problems and needs shall be identified, based upon the interdisciplinary assessment. The care plan shall address all of the resident’s special care requirements necessary to improve or maintain the resident’s status. The interdisciplinary team shall incorporate resident input into the care plan. (2) The team shall establish goals for each problem or need identified, or a combination thereof. The goals shall be realistic, practical, and tailored to the resident’s needs. Goal outcomes shall be measurable in time or degree, or both. (3) Approaches to accomplishing each goal shall be established. Approaches shall indicate the work to be done, who is to do it, and how frequently it is to be done. E. Disciplines shall update the care plans as the resident's assessment warrants, but not less than quarterly. F. Availability of Resident Care Plan. Resident care plans shall be readily available for use by all health care personnel. #### Regulation .61 Skin Record. *COMAR 10.07.02.61* A. The facility shall establish a skin care record documenting skin, hair, and nail condition on admission, if any abnormal conditions exist. B. The staff shall document progress of the condition or conditions weekly until the condition or conditions have healed. C. At any time that a skin condition persists for more than 7 days, staff shall add the condition to the skin record. #### Regulation .62 Geriatric Nursing Assistant Training Program. *COMAR 10.07.02.62* A. Nursing Home Responsibilities. (1) A nursing home shall conduct or arrange a geriatric nursing assistant training program for unlicensed personnel assigned to direct resident care duties. The Maryland Board of Nursing shall approve the geriatric nursing assistant training program curriculum. (2) A nursing home may not employ an individual as a geriatric nursing assistant until the individual has successfully completed a competency evaluation approved by the Maryland Board of Nursing. (3) A geriatric nursing assistant is deemed to satisfy the requirements of this chapter if that individual has successfully completed a training program approved by the State before July 1, 1990, or has been “grandfathered” under previous regulations. (4) Other persons hired as geriatric nursing assistants shall complete an approved geriatric nursing assistant training program within 120 days of employment. (5) The nursing home shall: (a) Record the satisfactory completion of the program in each employee’s personnel record; and (b) Give the employee a certificate signed by the program’s teacher or trainer as evidence of completion of the program. B. Course Structure. (1) The geriatric nursing assistant training program shall consist of 75 hours or more, and include at least 37.5 hours of classroom instruction and at least 37.5 hours of supervised clinical experience in long-term care. (2) The course content shall adhere to the geriatric nursing assistant training program curriculum approved by the Maryland Board of Nursing. #### Regulation .63 Paid Feeding Assistants. *COMAR 10.07.02.63* A. A facility may use a paid feeding assistant who has successfully completed a State-approved training course as described in §E of this regulation. B. Supervision. (1) A paid feeding assistant shall work under the supervision of a licensed nurse. (2) In an emergency, when the resident is fed in the resident's room, a paid feeding assistant shall use the resident call system to call a supervisory nurse for help. C. A nursing home that uses a paid feeding assistant shall ensure that the paid feeding assistant feeds only residents who do not have complicated feeding conditions including, but not limited to: (1) Difficulty swallowing; (2) Choking; (3) Recurrent lung aspiration; or (4) Tube or parenteral intravenous feedings. D. Protocol. The nursing home shall develop a protocol for selecting residents who are appropriate for feeding by a paid feeding assistant. The nursing home shall select eligible residents based on the: (1) Charge nurse's current assessment of the resident; (2) The resident's latest Minimum Data Set (MDS) assessment; and (3) The resident's plan of care. E. State-Approved Training. A State-approved training course for paid feeding assistants shall consist of at least 8 hours of training that includes: (1) Feeding techniques; (2) Assistance with feeding and hydration; (3) Communication and interpersonal skills; (4) Appropriate responses to resident behavior; (5) Safety and emergency procedures, including the Heimlich maneuver; (6) Infection control; (7) Resident rights; (8) Recognizing changes in a resident's behavior that are inconsistent with the resident's normal behavior and the importance of reporting these changes to a supervisory nurse; and (9) Successful completion of a two-part test that includes a: (a) Written test with a passing score of 80 percent; and (b) Demonstration of proper feeding skills performed on a resident while being observed. F. The feeding assistant training may be taught by a: (1) Registered nurse and supplementary professional instructors; (2) Licensed dietitian-nutritionist; (3) Licensed physical therapist; (4) Licensed speech therapist; or (5) Licensed occupational therapist. G. The facility shall maintain a record of all paid feeding assistants who have successfully completed a feeding assistance course. #### Regulation .64 Quality Assurance Program. *COMAR 10.07.02.64* A. A nursing home shall establish an effective quality assurance program that includes components described in this regulation and Regulation .65 of this chapter. B. The nursing home shall appoint a qualified individual to manage quality assurance activities within the nursing facility. C. The nursing home shall establish a quality assurance committee that includes at least: (1) The nursing home director of nursing; (2) The nursing home administrator; (3) A social worker; (4) The nursing home medical director; (5) A dietitian-nutritionist; and (6) A geriatric nursing assistant at the nursing home. D. The Quality Assurance Committee. The quality assurance committee shall: (1) Designate an individual to oversee committee activities; (2) Meet monthly to carry out quality assurance activities; (3) Help develop and approve the nursing home’s quality assurance plan; (4) Submit the quality assurance plan to the Department’s Office of Health Care Quality at the time of initial application for licensure; (5) Submit any changes to the quality assurance plan to the Office of Health Care Quality within 30 days of the changes; (6) Review and approve the facility's quality assurance plan at least yearly; and (7) Prepare monthly reports for the ombudsman, family council, and residents' council. E. Quality Assurance Records. For the purposes of ensuring implementation and effectiveness of the quality assurance program, the facility shall make quality assurance records and documents available to the Office of Health Care Quality. F. Quality Assurance Committee — Non-members. Anyone not on the committee shall be informed of how to present and submit concerns to: (1) The committee; (2) A member of the resident council; or (3) A member of the family council if one exists. #### Regulation .65 Quality Assurance Plan. *COMAR 10.07.02.65* A. The nursing home’s quality assurance committee shall develop and implement a quality assurance plan that includes procedures for: (1) Concurrent review; (2) Ongoing monitoring; (3) Resident complaints; (4) Accidents and incidents; and (5) Abuse and neglect. B. Concurrent Review. The quality assurance plan shall include: (1) The procedures for conducting concurrent review of each resident including: (a) Criteria to determine any change in a resident's condition; (b) A method to document the concurrent review; and (c) Identification of the licensed nurse or nurses conducting the concurrent review; (2) The procedures to evaluate clinical data for any resident with a change in condition including at least: (a) Medications; (b) Laboratory values; (c) Intake and output; (d) Skin breakdown; (e) Noted weights; (f) Appetite; (g) Injuries resulting from accidents or incidents; and (h) Any other relevant parameters that may affect the resident's physical or mental status; (3) Procedures to take action when there is a change in the resident’s condition, including: (a) Communicating changes to the director of nursing or the resident’s attending physician; and (b) Changing the resident’s plan of care as necessary; and (4) Procedure for referring data to the quality assurance committee, when appropriate. C. Ongoing Monitoring. The quality assurance plan shall include: (1) A description of the measurable criteria for ongoing monitoring of all aspects of resident care including: (a) Medication administration; (b) Prevention of pressure ulcers, dehydration, and malnutrition; (c) Nutritional status and weight loss or weight gain; (d) Accidents and injuries; (e) Unexpected death; and (f) Changes in physical or mental status; (2) The methodology for collecting data; (3) The methodology for evaluating and analyzing data to determine trends and patterns; (4) A description of the thresholds and performance parameters that represent acceptable care for the measured criteria; (5) Time frames for referral to the quality assurance committee; (6) A description of the plan for follow-up to determine effectiveness of the recommendations; and (7) A description of how the quality assurance activities will be documented. D. Resident Complaints. The quality assurance plan shall include: (1) A description of a complaint process that effectively addresses resident and family concerns including: (a) The designated person or persons and their phone numbers to receive complaints and concerns; (b) The method to be used to acknowledge complaints received; and (c) The time frames for investigating complaints, depending on the nature or seriousness of the complaint; (2) A description of a logging system that will be used including the: (a) Name of the complainant; (b) Date the complaint was received; (c) Nature of the complaint; and (d) Date that the complainant was notified of the disposition or resolution of the complaint; and (3) The procedures for: (a) Notifying residents of their right to file a complaint with the Office of Health Care Quality; (b) Informing residents, families, or guardians of the complaint process upon admission; and (c) Posting the complaint process or making it available without the need to request it. E. Accidents and Injuries. The quality assurance plan shall include: (1) A definition of accident and injury that is appropriate to the type of resident served by the nursing home; (2) A description of the process for reporting accidents and injuries including: (a) Who shall report incidents; (b) The time frame for reporting incidents; and (c) The procedure for reporting incidents; (3) A policy statement that ensures that incidents can be reported without fear of reprisal; (4) A description of how internal investigations of accidents and injuries will be handled including: (a) Assessment of any injury; (b) Interview of the resident, staff, and any witnesses; (c) Review of any relevant records including the resident's medical records, discharge summary, hospital records, etc.; and (d) Time frames for conducting the investigation; (5) A description of the process for notifying a family or guardian about the incident; (6) A description of the process for the ongoing evaluation of patterns and trends in accidents and injuries; and (7) A description of how relevant information will be referred to the quality assurance committee. F. Abuse and Neglect. The quality assurance plan shall include: (1) The process for implementing COMAR 10.07.09.15 concerning abuse of residents; (2) A description of the process for providing immediate notification to the family, guardian, or responsible party about the incident; (3) A description of the process for the ongoing evaluation of validated incidents of abuse and neglect to determine patterns and trends; and (4) A description of how relevant information will be referred to the quality assurance committee. #### Regulation .66 Relocation of Residents. *COMAR 10.07.02.66* A. The facility shall develop and implement a written plan to provide for the smooth and orderly transfer of residents if the facility closes. B. The plan for relocation shall include: (1) A description of how residents, families, or guardians will be notified and by whom; (2) Sample letters and other documents that will be used during a closure; (3) Procedures for notifying Medicaid and other payment sources; (4) Procedures for notifying the Office of Health Care Quality; and (5) A mechanism to ensure the safe and orderly transfer of residents that takes into account: (a) Roommates, medical care, religious affiliation, geographical location and payer source; (b) Proper assessment and identification of any special needs; (c) Transfer of medical information and records; and (d) Transfer of personal property. #### Regulation .67 Posting of Staffing. *COMAR 10.07.02.67* A. A nursing home shall post a notice on each floor or unit of the nursing home, for each shift, a notice that gives the ratio of licensed and unlicensed staff to residents. B. The posting on each floor shall include: (1) Names of the staff members on duty and the room numbers of the residents to whom each is assigned; (2) Name of the charge nurse or person who is in charge of the unit; (3) If the person in charge is not a registered nurse, the name of the registered nurse responsible for the unit; and (4) Name of the medicine aide or person responsible for medication administration. C. The posting shall be on a form provided or approved by the Department. D. A record of the posting shall be retained for 1 year. #### Regulation .68 Sanctions. *COMAR 10.07.02.68* A. If a deficiency exists, the Department, in addition to the sanctions set forth in this regulation and Regulations .67—.74 of this chapter, may: (1) Restrict the number of residents the nursing facility may admit in accordance with Health-General Article, §19-328, Annotated Code of Maryland; (2) Require the establishment of an escrow account in accordance with Health-General Article, §19-362, Annotated Code of Maryland; (3) Direct the licensee to correct the deficiencies in a specific manner or within a specific time frame, or both, to protect the health and welfare of residents; (4) Enter into an agreement with the licensee establishing certain conditions for continued operation, including time limits for compliance; and (5) In accordance with Health-General Article, §19-1405, Annotated Code of Maryland, appoint an independent State monitor who is qualified on the basis of education and experience to oversee correction of the deficiencies. B. State Monitor. (1) The duties of the State monitor shall be specified in a written agreement between the Department and the State monitor and shall include but are not limited to: (a) Conducting periodic on-site inspections to assess a nursing facility's compliance with State and federal regulations; (b) Making recommendations to achieve compliance with State and federal regulations; and (c) Issuing written reports to the Department and the nursing home, detailing the findings of the on-site inspections and the status of requirements and recommendations for the nursing home to achieve compliance. (2) The State monitor shall function for a period of time specified by the Department. The facility may request rescission or modification of the duration of the State monitor's appointment at intervals of not less than 120 days from the date of appointment. (3) The State monitor may not be an employee of the Department. (4) The State monitor's salary shall be: (a) Paid directly by the nursing facility; and (b) At least equivalent to the prevailing salary paid by nursing facilities for an individual with similar education and experience. C. If the Secretary determines that the licensee has violated a condition or requirement of an imposed sanction, the Secretary may revoke the license as permitted by applicable law. D. A licensee that disagrees with the imposition of a sanction under §A(1) or (5) of this regulation may appeal the Secretary’s action by filing a request for a hearing in accordance with Regulation .78 of this chapter. A licensee that disagrees with the imposition of a sanction under §A(2) of this regulation may appeal the Secretary’s action in accordance with Health-General Article, §§19-364 and 19-367, Annotated Code of Maryland. #### Regulation .69 Mandated Staffing Pattern. *COMAR 10.07.02.69* A. When the Department determines that a deficiency or deficiencies exist, the Department shall notify the nursing facility of the deficiency or deficiencies and may either: (1) Mandate a staffing pattern which specifies the number of personnel or personnel qualifications, or both; or (2) Permit the facility the opportunity to correct the deficiencies by a specific date. B. If the facility does not correct the deficiency or deficiencies, the Department has the authority to specify the number of personnel or personnel qualifications, or both. C. The facility shall comply with the Department's mandated staffing pattern and notify the Department, in writing, when the staffing pattern has been implemented. D. A mandated staffing pattern shall be in effect for the period of time specified by the Department. A facility may request rescission or modification of the staffing pattern at intervals of not less than 60 days from the date of imposition of the staffing pattern. E. A facility has the right to appeal a mandated staffing pattern in accordance with State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland. However, the mandated staffing pattern shall be maintained during the pendency of the appeal. #### Regulation .70 Civil Money Penalties — Imposition. *COMAR 10.07.02.70* A. A civil money penalty may be imposed when: (1) A deficiency exists; or (2) An ongoing pattern of deficiencies exist in a nursing facility. B. In determining whether a civil money penalty is to be imposed, the Department shall consider the following factors: (1) The number, nature, and seriousness of the deficiencies; (2) The extent to which the deficiency or deficiencies are part of an ongoing pattern during the preceding 24 months; (3) The degree of risk to the health, life, or safety of the residents of the nursing facility caused by the deficiency or deficiencies; (4) The efforts made by, and the ability of, the nursing facility to correct the deficiency or deficiencies; (5) A nursing facility's prior history of compliance in general and specifically with reference to the cited deficiencies; and (6) Such other factors as justice may require. C. When the Department determines that a deficiency or an ongoing pattern of deficiencies exists, the Department shall notify the nursing facility of the deficiency or deficiencies and may: (1) Impose a per day civil money penalty until sustained compliance has been achieved; (2) Permit the facility the opportunity to correct the deficiencies by a specific date; or (3) Impose a per instance civil money penalty for each instance of violation. D. When the Department permits a facility the opportunity to correct the deficiencies by a specific date, and the facility fails to comply with this requirement, the Department may impose a per day civil money penalty for each day of violation until correction of the deficiency or deficiencies has been verified and sustained compliance has been maintained. E. When a civil money penalty is imposed, the Department shall issue an order which includes the: (1) Deficiency or deficiencies on which the order was based; (2) Amount of civil money penalty to be imposed; and (3) Manner in which the amount of civil money penalty was calculated. F. An order issued pursuant to §E of this regulation is void unless issued within 60 days of the inspection or reinspection at which the deficiency or deficiencies are identified. #### Regulation .71 Civil Money Penalties — Amount of Penalty. *COMAR 10.07.02.71* A. A civil money penalty imposed under this chapter for potential for more than minimal harm deficiencies may not exceed: (1) $10,000 per instance; or (2) $1,000 per day for an ongoing pattern of deficiencies until correction of the deficiencies has been verified and sustained compliance has been maintained. B. A civil money penalty imposed under this chapter for actual harm deficiencies may not exceed: (1) $10,000 per instance; or (2) $5,000 per day for an ongoing pattern of deficiencies until correction of the deficiencies has been verified and sustained compliance has been maintained. C. A civil money penalty imposed under this chapter for a serious and immediate threat may not exceed: (1) $10,000 per instance; or (2) $10,000 per day for an ongoing pattern of deficiencies until correction of the deficiencies has been verified and sustained compliance has been maintained. D. In setting the amount of a civil money penalty, the Department shall consider the following factors: (1) The number, nature, and seriousness of the deficiencies; (2) The degree of risk to the health, life, or safety of the residents of the nursing facility caused by the deficiency or deficiencies; (3) The efforts made by, and the ability of, the nursing facility to correct the deficiency or deficiencies; (4) Current federal guidelines for civil money penalties; (5) Whether the amount of the proposed civil money penalty will jeopardize the financial ability of the nursing facility to continue operating as a nursing facility; (6) A nursing facility's prior history of compliance; and (7) Such other factors as justice may require. #### Regulation .72 Civil Money Penalties — Effective Date and Duration of Penalty. *COMAR 10.07.02.72* A. Per Instance Civil Money Penalty. The effective date may be as early as the date that the deficiency or deficiencies upon which the civil money penalty is based first occurred. B. Per Day Civil Money Penalty. (1) The daily civil money penalty starts to accrue as of the date of the visit that identifies the deficiency or deficiencies upon which the civil money penalty is based. (2) The accrual of the daily civil money penalty ceases when correction of the deficiency or deficiencies upon which the civil money penalty was based has been verified and the facility has maintained sustained compliance. #### Regulation .73 Civil Money Penalties — Payment of Penalty/Establishment of Escrow Account. *COMAR 10.07.02.73* A. A civil money penalty payment is due 15 calendar days after: (1) The time period for requesting a hearing has expired and a request for hearing was not received; or (2) Receipt of a written request from the facility to waive its right to a hearing and reduce the amount of the civil money penalty by 40 percent provided the written request is received by the Department within 30 calendar days of the Department's order imposing the civil money penalty. B. Within 15 days of the request for an appeal by a nursing facility, the nursing facility shall deposit the amount of the civil money penalty in an interest-bearing escrow account. If a per day civil money penalty is in effect at the time the escrow account is established, the amount owed on that date shall be deposited into the escrow account. The nursing facility shall bear any cost associated with establishing the escrow account, and the account shall be titled in the name of the nursing facility and the Maryland Department of Health as joint owners. C. When the Secretary issues the final decision of the Department: (1) If the decision upholds the imposition of the full civil money penalty, the escrow funds, in addition to the amount of any per day civil money penalty that has accrued after the initial deposit into the escrow account, shall be released to the Department within 15 days from the date of the decision; (2) If the decision upholds the imposition of a civil money penalty, but reduces the amount of the civil money penalty, the amount due the Department shall be released to the Department with accrued interest within 15 days of the date of the decision and the balance will be released to the nursing facility within 15 days of the date of the decision; or (3) If the decision reverses the imposition of the civil penalty, the escrow funds shall be released to the nursing facility with accrued interest within 15 days of the decision. D. If a facility does not release or pay the civil money penalty to the Department after the Secretary has issued a final decision upholding the civil money penalty and after notice to the facility, the State may deduct the amount of the civil money penalty from any sum that is then or later owed by the State to the facility, pursuant to State Finance and Procurement Article, §7-222, Annotated Code of Maryland. #### Regulation .74 Civil Money Penalties — Hearings. *COMAR 10.07.02.74* A. A licensee aggrieved by the imposition of a civil money penalty may appeal the action by filing a request for a hearing in accordance with State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland. B. The Secretary has the burden of proof with respect to the imposition of civil money penalties. C. The Office of Administrative Hearings shall render a decision within 10 working days of the hearing. #### Regulation .75 Criminal Penalties. *COMAR 10.07.02.75* A. A person maintaining or operating a nursing home without a license is guilty of a misdemeanor, and, on conviction, is liable for a fine of not more than $1,000 for the first offense and not more than $10,000 for each subsequent conviction in accordance with Health-General Article, §19-358, Annotated Code of Maryland. B. Each day that the nursing home continues to operate without a license after the first conviction is a subsequent offense and may subject the operator to further criminal prosecution. C. A person maintaining and operating a nursing home that is in violation of this chapter is guilty of a misdemeanor, and, on conviction, shall be fined not more than $1,000 under the authority of Health-General Article, §19-359, Annotated Code of Maryland. D. Each day that the nursing home operates after the first conviction, without correction of the cited violation, is considered a subsequent offense and may subject the operator to further prosecution. #### Regulation .76 Emergency Suspension. *COMAR 10.07.02.76* A. The Secretary may immediately suspend a license on finding that the public health, safety, or welfare imperatively requires emergency action pursuant to State Government Article, §10-405(b), Annotated Code of Maryland. B. The Department shall deliver a written notice to the nursing facility: (1) Informing the nursing facility of the emergency suspension; (2) Giving the reasons for the action and the regulation or regulations with which the licensee has failed to comply that forms the basis for the emergency suspension; and (3) Notifying the nursing facility of its right to request a hearing and to be represented by counsel. C. The filing of a hearing request does not stay the emergency action. D. When a license is suspended by emergency action: (1) The nursing facility shall immediately return the license to the Department; and (2) The licensee shall notify the residents or representatives of the residents of the suspension and make every reasonable effort to assist them in making arrangements for transfer to other appropriate living arrangements. E. In the event of an emergency suspension, the Department may assist in the relocation of residents. F. A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .59 of this chapter. G. The Office of Administrative Hearings shall conduct a hearing as provided in Regulation .59 of this chapter and issue a proposed decision within 10 business days of the close of the hearing record. Exceptions may be filed by an aggrieved person pursuant to COMAR 10.01.03. The Secretary shall make a final decision pursuant to COMAR 10.01.03. H. If the Secretary's final decision does not uphold the emergency suspension, the nursing facility may resume operation. #### Regulation .77 Denial or Revocation of License. *COMAR 10.07.02.77* A. Denial or Revocation of License. The Secretary, for cause shown, may notify the nursing facility of the decision to revoke or deny the nursing facility's license. The denial or revocation shall be stayed if a hearing is requested. B. The Department shall notify the nursing facility in writing of the following: (1) The effective date of the denial or revocation; (2) The reason for the denial or revocation; (3) The regulations with which the licensee has failed to comply that form the basis for the denial or revocation; (4) That the nursing facility is entitled to a hearing if requested, and to be represented by counsel; (5) That the nursing facility shall stop providing services on the effective date of the denial or revocation if the nursing facility does not request a hearing; (6) That the denial or revocation shall be stayed if a hearing is requested; and (7) That the nursing facility is required to surrender its license to the Department if the denial or revocation is upheld. C. The licensee shall notify the residents or residents' representatives of any final denial or revocation and make every reasonable effort to assist them in making other living arrangements. The Department may assist in the relocation of residents. D. A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .59 of this chapter. #### Regulation .78 Hearings. *COMAR 10.07.02.78* A. A request for a hearing shall be filed with the Office of Administrative Hearings, with a copy to the Office of Health Care Quality of the Department, not later than 30 days after receipt of notice of the Secretary's action. This request shall include a copy of the Secretary's action. B. A hearing requested under this chapter shall be conducted in accordance with: (1) State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland; (2) COMAR 28.02.01; and (3) COMAR 10.01.03. C. The burden of proof is as provided in COMAR 10.01.03.28. D. Unless otherwise stated in this chapter, the Office of Administrative Hearings shall issue a proposed decision within the time frames set forth in COMAR 28.02.01. E. The aggrieved person may file exceptions as provided in COMAR 10.01.03.35. F. A final decision by the Secretary shall be issued in accordance with COMAR 10.01.03.35. #### Regulation .79 Health Care Quality Account. *COMAR 10.07.02.79* A. The Department shall establish a health care quality account in the Department. B. The health care quality account shall be funded by civil money penalties paid by nursing homes. C. The Department shall use funds from the health care quality account to improve the quality of care in nursing facilities. D. Expenditure of funds may include, but are not limited to the following: (1) Funding for the establishment and operation of a demonstration project; (2) A grant award; (3) Relocation of residents in crisis situations; (4) Provision of educational programs to nursing facilities, the Office of Health Care Quality, other government, professional, or advocacy agencies, and consumers; and (5) Any other purpose that will directly improve quality of care. E. Suggestions for the use of funds may be submitted to the Department from: (1) Members of the public; (2) Advocacy organizations; (3) Government agencies; (4) Professional organizations including trade associations; (5) Nursing homes; and (6) Nursing home associations. F. Decision on Expenditure of Funds. (1) The Department, in its sole discretion, shall decide how to spend funds from the health care quality account. (2) The Department's decision to spend funds or not to spend funds for a specific project or purpose is not a contested case as defined in State Government Article, §10-202(d), Annotated Code of Maryland, and therefore is not subject to appeal. #### Regulation .80 Financial Disclosure. *COMAR 10.07.02.80* A. A licensee shall have financial resources in accordance with this regulation in order to: (1) Satisfy obligations; and (2) Ensure at all times the delivery of essential care and services, such as nursing, dietary services, or utilities. B. A licensee shall notify the Secretary of significant adverse changes in financial condition which reasonably could be anticipated to adversely affect the delivery of essential care and services. These adverse changes include, but are not limited to, the following situations: (1) The facility fails to maintain the facility's utilities or a quantity of supplies, including nursing, dietary, pharmaceutical, or other care and service supplies, sufficient to meet the needs of the residents; (2) The facility is unable to meet its employee payroll or benefits obligations; (3) The license holder or entity legally authorized to act on behalf of the license holder receives notice that a judgment or tax lien of at least $5,000 has been filed, recorded, or levied against the facility or any of the assets of the facility or the license holder and the judgment or tax lien is not satisfied, or an appropriate extension has not been obtained, within 30 days after receipt of the notice; (4) A financial institution refuses to honor facility-operation-related checks or other financial instruments issued by the license holder or entity legally authorized to act on behalf of the license holder, and: (a) The cumulative amount of the checks or financial instruments is $5,000 or more; and (b) The checks or financial instruments are not honored or replaced to the satisfaction of the holders of the instruments within 10 working days after the holders have notified the license holder, operator, administrator, manager, or the person authorized to issue the instrument of the dishonored items; (5) The license holder, or entity legally authorized to act on behalf of the license holder fails to make timely payments of any facility-related tax of at least $1,000, and fails to satisfy the tax within 30 working days after the date the tax becomes delinquent; (6) The license holder, owner of 25 percent of the license holder's assets, or facility management company files a voluntary bankruptcy petition, or a creditor files an involuntary bankruptcy petition against the facility management company, license holder, or owner of 25 percent or greater of the license holder's assets; (7) A court appoints a bankruptcy trustee for the facility; (8) A person seeking appointment of a receiver for the facility files a petition for the appointment of a receiver for the facility in any jurisdiction; (9) The license holder, or person legally authorized to act on behalf of the license holder is unable to meet conditions of a facility-operation-related loan or material debt covenant unless the loan or material debt covenant has been waived or cured, and that inability has led to a recall by the issuing entity; or (10) The license holder, or entity legally authorized to act on behalf of the license holder, is delinquent on more than $5,000 of facility-related contractual obligations or vendor contracts that affect essential care and services for residents and has not cured the delinquency within 10 working days after receipt of notice from the creditor or creditors to pay the debt. C. The license holder shall notify the Secretary in writing of a significant adverse change in its financial condition as required by §B of this regulation within 72 hours after the license holder becomes aware of, or reasonably should have become aware of, the change in its financial condition. D. The license holder's notice required by §B of this regulation shall include a description of: (1) The specific significant adverse change in financial condition; (2) How the significant adverse change in financial condition affects or may affect the license holder's ability to deliver essential care and services; and (3) The actions the license holder has taken to address the significant adverse change in financial condition. E. The license holder shall fax, email, or hand-deliver the notice required in §B of this regulation to the Department's Office of Health Care Quality, and the notice shall be kept on file with a copy of the delivery confirmation. F. The license holder shall provide any other information, unless prohibited under applicable laws, requested by the Office of Health Care Quality to substantiate continued compliance with the requirements of this regulation within 30 days after the request. Failure to comply with the requirements of this regulation may result in the Secretary imposing one or more sanctions, as appropriate, from Regulations .51—.58 of this chapter against the facility. G. The information submitted pursuant to §D of this regulation is confidential and may not be disclosed without the consent of the licensee. H. Unless disclosure of the information is otherwise prohibited by applicable law, the provisions of §G of this regulation do not apply to: (1) The holder of a license that has been suspended or revoked; or (2) The use of information in: (a) An administrative proceeding initiated by the Department; or (b) A judicial proceeding. ### Chapter 03 — Health Care Staff Agencies **Authority:** Health-General Article, §2-104 and Title 19, Subtitle 20, Annotated Code of Maryland **Administrative History:** Effective date: December 17, 2007 (34:25 Md. R. 2211) **Administrative History:** Chapter revised effective September 15, 2014 (41:18 Md. R. 1009) **Administrative History:** Regulation .05A, D amended effective December 21, 2015 (42:25 Md. R. 1542); August 29, 2016 (43:17 Md. R. 953); March 13, 2017 (44:5 Md. R. 292) **Administrative History:** Regulation .05D amended effective June 5, 2017 (44:11 Md. R. 524) **Administrative History:** Regulation .06B amended effective August 29, 2016 (43:17 Md. R. 953) #### Regulation .01 Purpose. *COMAR 10.07.03.01* A. The purpose of this chapter is to set minimum standards for licensure of health care staff agencies providing services in Maryland. B. The regulations of this chapter do not preclude a health care staff agency from operating with independent contractors. #### Regulation .02 Definitions. *COMAR 10.07.03.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) Abuse. (a) “Abuse” means: (i) The nontherapeutic infliction upon a resident of physical pain or injury; or (ii) A persistent course of conduct intended to produce, or resulting in, mental or emotional distress to a resident, for example, verbal intimidation of a resident. (b) “Abuse” does not mean the performance of an accepted medical procedure ordered by a physician or administered by another health care professional practicing within the scope of the physician's or health care professional's license. (2) “Agency” means a health care staff agency. (3) Allied Health Care Field. (a) “Allied health care field” means a healthcare profession subject to licensure under Health Occupations Article, Annotated Code of Maryland. (b) “Allied health care field” does not include the healthcare profession of physician assistant. (4) “Board” means a health occupation licensing board authorized to license, certify, and discipline a health care practitioner in accordance with the Health Occupations Article. (5) “Client facility” means a health care facility that contracts with a health care staff agency for the referral of health care practitioners. (6) “Deficiency” means any failure of the health care staff agency to meet the requirements of Health-General Article, Title 19, Subtitle 20, Annotated Code of Maryland, or any rule or regulation that the Secretary adopts under that subtitle. (7) “Department” means the Department of Health. (8) “Health care facility” means a hospital or related institution as defined in Health-General Article, §19-301, Annotated Code of Maryland. (9) Health Care Practitioner. (a) Except as provided in §B(9)(b) of this regulation, “health care practitioner” means any individual licensed or certified under Health Occupations Article, Annotated Code of Maryland, who practices in an allied health care field. (b) “Health care practitioner” does not include: (i) An acupuncturist; (ii) A dentist; (iii) A nurse anesthetist; (iv) A nurse midwife; (v) A nurse practitioner; (vi) A pharmacist; (vii) A physician; or (viii) A podiatrist. (10) “Initially providing or referring” means the first time a health care staff agency provides or refers a particular health care practitioner to a health care facility. (11) “Licensee” means the person, association, partnership, corporation, limited-liability company, or other entity to which a license is issued. (12) “Neglect” means failure to provide goods and services necessary to avoid physical harm, mental anguish, or mental illness. (13) Health Care Staff Agency. (a) “Health care staff agency” means any person, firm, corporation, partnership, or other business entity engaged in the business of referring health care practitioners as employees or independent contractors to render temporary health care services at a health care facility in the State. (b) “Health care staff agency” does not include: (i) A health care staff agency operated by a health care facility or its affiliates solely for the purpose of procuring, furnishing, or referring temporary or permanent health care practitioners for employment at that health care facility or its affiliates; (ii) A home health agency regulated under Health-General Article, Title 19, Subtitle 4, Annotated Code of Maryland; or (iii) Any health care practitioner procuring, furnishing, or referring their own services to a health care facility without the direct or indirect assistance of a health care staff agency. (14) “Office” means the Office of Health Care Quality in the Department. (15) “Responsible party” means the individual at a health care staff agency who controls the day-to-day operation of the health care staff agency. (16) “Secretary” means the Secretary of Health. #### Regulation .03 License Required. *COMAR 10.07.03.03* A. A person, firm, corporation, partnership, or other business entity may not maintain or operate a health care staff agency in this State without first obtaining a license from the Secretary and complying with the regulations of this chapter. B. An agency shall post its license conspicuously onsite so that it is clearly visible to the general public. C. An out-of-State agency providing services in this State shall have a current Maryland license conspicuously posted at the: (1) Office in this State where the agency conducts its day-to-day operations, if the agency operates an in-State office; or (2) Agency's records repository that is located in this State, if the agency utilizes a records repository. #### Regulation .04 Restrictions of License. *COMAR 10.07.03.04* A. A person operating an agency may not use the term “health care staff agency” in its advertising without first obtaining a license from the Secretary. B. A license is valid only in the name of the licensee to whom the license is issued and is not subject to sale, assignment, or other transfer. C. If the agency ceases to operate for any reason, the license is void and the licensee shall immediately return the license to the Department. #### Regulation .05 Licensing Procedure. *COMAR 10.07.03.05* A. Application for Licensure. (1) A person desiring to refer a health care practitioner to a health care facility to render temporary health care services in this State shall file an application with the Secretary, on a written or electronic form provided by the Secretary. (2) The application for licensure shall contain the agency's business name, address, telephone number, and responsible party. (3) Along with the application, the applicant shall submit a copy of the agency’s policies and procedures as specified in Regulation .08 of this chapter. B. Additional Requirements. (1) The applicant shall: (a) Demonstrate compliance with all applicable federal, State, and local laws and regulations; and (b) Submit all documentation requested by the Department that is relevant to the applicant's ability to operate an agency in compliance with this chapter, including documentation of any: (i) Past or current operation of a health-related facility or an agency; (ii) Prior denial, suspension, or revocation of a license of certification to provide care to third parties; and (iii) Felony conviction of the applicant or anyone with direct or indirect ownership interest in the agency. (2) The Secretary may require an applicant to submit information to demonstrate the applicant's financial ability to operate an agency in compliance with this chapter. C. Duration of License. An agency's annual license shall expire on the annual anniversary of the date the license was originally issued unless the license is renewed for a 1-year term. D. License Renewal. (1) At least 1 month before the current license expires, the Office shall send to the agency, by first-class mail to the last known address of the agency, a renewal notice that states: (a) The date on which the current license expires; (b) The date by which the renewal application shall be received by the Office for the renewal to be issued and mailed before the license expires; and (c) That no renewal fee is required. (2) Before a license expires, the agency may renew its license for an additional term by submitting a renewal application on a written or electronic form provided by the Secretary, if the agency: (a) Otherwise is entitled to be licensed; and (b) Provides updates, if any, to the agency's policies and procedures as specified in Regulation .09 of this chapter. (3) Failure to Renew License. When an agency fails to renew its license, the agency shall: (a) Immediately stop referring personnel to health care facilities; and (b) Notify health care facilities where personnel are currently referred that the agency no longer has a valid operating license. E. Based on information provided to the Department by the applicant and the Department's own investigation, the Secretary shall: (1) Approve the application unconditionally; (2) Approve the application conditionally, which may include, among other conditions, requiring the applicant to use the services of a management firm approved by the Secretary; or (3) Deny the application. F. Nursing Staff Agency Licensees. (1) Effective September 15, 2014, a person holding a nursing staff agency license who is in good standing and refers only nursing personnel shall be deemed to meet the requirements for issuance of a health care staff agency license. (2) A person holding a nursing staff agency license who wishes to expand their referrals to other health care practitioners in addition to nursing personnel shall first obtain a new health care staff agency license. G. Rights of Applicant if License is Revoked or Denied. (1) Denial of License. The Secretary shall inform the applicant of the reasons for refusal to issue a license. (2) Revocation of License. The Secretary may, for cause shown, revoke or refuse to reissue any license. (3) A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary’s action by filing a request for a hearing consistent with Regulation .17 of this chapter. #### Regulation .06 Changes to Licensure Information. *COMAR 10.07.03.06* A. A licensee shall notify the Department of any change in agency ownership, name, or address within 30 calendar days of the change. B. Any change in agency ownership, name, or address requires the issuance of a new license. If the sale, transfer, assignment, or lease of an agency causes a change in the person or persons who control or operate the agency, the agency shall be considered a “new agency” and the new owner shall comply with all regulations of this chapter when applying for a new license. C. If the licensee fails to notify the Office of the changes in §A of this regulation, the Office may impose a fine of $100. #### Regulation .07 Inspections by the Department. *COMAR 10.07.03.07* A. The Department or its designee may conduct announced or unannounced licensure or complaint inspection visits to the agency's office or records repository, if utilized by an out-of-State agency, to ensure compliance with the requirements of this chapter. B. The agency's office or records repository, if utilized by an out-of-State agency, shall be available during normal business hours for announced or unannounced inspections by the Department or its designee. C. An agency with offices out-of-State shall comply with the regulations of this chapter and shall reimburse the Department for reasonable travel expenses incurred in conducting out-of-State inspections. D. An agency shall maintain records to support compliance with the regulations of this chapter. The responsible party of the agency shall provide all records requested by the Office not later than 24 hours after the request. #### Regulation .08 Administration. *COMAR 10.07.03.08* A. The agency shall develop, document, and implement policies and procedures. B. Policies and procedures shall include, but are not limited to: (1) Selecting and verifying the credentials of a health care practitioner referred by the agency; (2) Validating the experience of a health care practitioner prior to referral by the agency; (3) Tracking and acting on serious or life-threatening complaints received by a client, facility, or the client facility's agent; (4) Reporting of an action or condition performed by a health care practitioner as required under Regulation .09C of this chapter; (5) Verifying the following: (a) A health care practitioner referred by the agency is of satisfactory health status and has received the necessary testing and immunization as required or requested by the client facility; (b) Drug screening of a health care practitioner is performed before referral by the agency, if the client facility requires drug screening for facility employees; (c) Drug testing of a health care practitioner referred by the agency is performed, if there is probable cause to perform a drug test or if a client facility requests a drug test; (d) Criminal background checks of a health care practitioner are performed before referral by the agency, if the client facility requires criminal background checks for facility employees; (e) The references of a health care practitioner referred by the agency; (f) A health care practitioner referred by the agency has I-9 status that permits them to legally work in the United States; and (g) A health care practitioner has active licensure or certification with the Board; and (6) Investigating a complaint or grievance presented to an agency by the client facility, an individual receiving services, a representative of the individual receiving services, or any concerned individual that includes a: (a) Description of how and to whom to file a complaint within the agency; (b) Description of how and to whom to file a complaint with the Office; (c) Commitment to conduct a thorough investigation into any allegation against individuals referred by the agency; and (d) Mechanism for making completed investigation reports available to the Department immediately upon request during inspections. #### Regulation .09 Referral and Reporting Health Care Practitioners. *COMAR 10.07.03.09* A. An agency may not knowingly provide or refer a heath care practitioner to render temporary services who is not authorized under Health Occupations Article, Annotated Code of Maryland, to practice their profession in Maryland. B. An agency and client facility shall ensure that the scope of practice of the referred health care practitioner is consistent with Health Occupations Article, Annotated Code of Maryland. C. If an agency is aware of an action or inaction by a health care practitioner who is provided or referred by the agency that may be grounds for action under Health Occupations Article, Annotated Code of Maryland, the agency shall report the action or condition to the appropriate Board and the Office immediately when the action or condition is known by the agency. D. An individual shall have immunity from liability described in the Courts and Judicial Proceedings Article, §5-709, Annotated Code of Maryland, for making a report as required under §C of this regulation. E. Personnel Qualifications and Duties. (1) The agency shall maintain the following from client facilities: (a) Job descriptions for referred individuals; and (b) A documented procedure for the agency and client facility to determine that an individual's qualifications are consistent with the assignments to which the individual is being referred. (2) The agency shall maintain documentation indicating that individuals providing services in any health care facility within the State have been educated by the agency or the facility about: (a) The facility's policies and procedures related to the individuals' scope of practice and responsibilities in the referred assignment; and (b) The individuals' obligations under Maryland law to report abuse and neglect. (3) An agency shall attest on a form developed by the Department that the agency is in compliance with the federal: (a) Civil Rights Act of 1964; (b) Rehabilitation Act of 1973; (c) Americans with Disabilities Act of 1990; and (d) Drug Free Workplace Act of 1988, if applicable. #### Regulation .10 Civil Money Penalties — Imposition. *COMAR 10.07.03.10* A. The Department may impose a civil money penalty if a deficiency exists. B. In determining whether a civil money penalty is to be imposed, the Department shall consider the following factors: (1) The number, nature, and seriousness of the deficiencies; (2) The extent to which the deficiencies are part of a pattern; (3) The degree of risk to the health, life, or safety of the residents of the client facility caused by the deficiency or deficiencies; (4) The efforts made by, and the ability of the agency to correct the deficiency or deficiencies; (5) An agency's prior history of compliance in general and specifically with reference to the cited deficiencies; and (6) Other factors as justice may require. C. If the Department determines that a deficiency or a pattern of deficiencies exists, the Department shall notify the agency of the deficiency or deficiencies and may: (1) Impose a per-day civil money penalty until compliance has been achieved; (2) Permit the agency the opportunity to correct the deficiencies by a specific date; or (3) Impose a per-instance civil money penalty for each deficiency. D. If the Department permits an agency the opportunity to correct the deficiencies by a specific date and the agency fails to comply with this requirement, the Department may impose a per-day civil money penalty for each day of violation until correction of the deficiency or deficiencies has been verified and compliance has been maintained. E. When a civil money penalty is imposed, the Department shall issue an order that includes the: (1) Deficiency or deficiencies on which the order was based; and (2) Amount of civil money penalty to be imposed. #### Regulation .11 Civil Money Penalties — Amount of Penalty. *COMAR 10.07.03.11* A. A civil money penalty imposed under this chapter for a first offense may not exceed: (1) $2,500 for each instance of violation; or (2) $2,500 per day until correction of the deficiency or deficiencies has been verified and compliance has been maintained. B. A civil money penalty imposed under this chapter for a second offense may not exceed: (1) $5,000 for each instance of violation; or (2) $5,000 per day until correction of the deficiency or deficiencies has been verified and compliance has been maintained. C. A civil money penalty imposed under this chapter for a third or subsequent offense may not exceed: (1) $10,000 for each instance of violation; or (2) $10,000 per day until correction of the deficiency or deficiencies has been verified and compliance has been maintained. #### Regulation .12 Civil Money Penalties — Effective Date and Duration of Penalty. *COMAR 10.07.03.12* A. Per-Instance Civil Money Penalty. The effective date may be as early as the date that the deficiency or deficiencies on which the civil money penalty is based first occurred. B. Per-Day Civil Money Penalty. (1) The daily civil money penalty starts to accrue as of the date of the inspection, survey, or interview by the Department that identifies the deficiency or deficiencies on which the civil money penalty is based. (2) The accrual of the daily civil money penalty ceases when correction of the deficiency or deficiencies on which the civil money penalty was based has been verified. #### Regulation .13 Civil Money Penalties — Payment of Penalty/Establishment of Escrow Account. *COMAR 10.07.03.13* A. A civil money penalty payment is due 15 calendar days after: (1) The time period for requesting a hearing has expired, if a request for a hearing has not been received; or (2) Receipt of a written request from the agency to waive its right to a hearing and reduce the amount of the civil money penalty by 40 percent, if the written request is received by the Department within 30 calendar days of the Department's order imposing the civil money penalty. B. The amount of the civil money penalty, when determined, may be deducted from any sum owed by the State to the agency. #### Regulation .14 Civil Money Penalties — Hearings. *COMAR 10.07.03.14* A licensee aggrieved by the imposition of a civil money penalty may appeal the action by filing a request for a hearing in accordance with State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland. #### Regulation .15 Emergency Suspensions. *COMAR 10.07.03.15* A. The Secretary may immediately suspend a license on finding that the public health, safety, or welfare imperatively requires emergency action pursuant to State Government Article, §10-226(c), Annotated Code of Maryland. B. The Department shall deliver a written notice to the agency: (1) Informing the agency of the emergency suspension; (2) Giving the reasons for the action and the regulation or regulations with which the licensee has failed to comply that form the basis for the emergency suspension; and (3) Notifying the agency of its right to request a hearing and to be represented by counsel. C. The filing of a hearing request does not stay the emergency action. D. Suspended License. If a license is suspended by emergency action, the agency shall: (1) Immediately return the license to the Department; and (2) Cease making referrals. E. A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary’s action by filing a request for a hearing in accordance with Regulation .17 of this chapter. F. The Office of Administrative Hearings shall conduct a hearing as provided in Regulation .17 of this chapter and issue a proposed decision within 10 business days of the close of the hearing record. Exceptions may be filed by an aggrieved person pursuant to COMAR 10.01.03. The Secretary shall make a final decision pursuant to COMAR 10.01.03. G. If the Secretary's final decision does not uphold the emergency suspension, the agency may resume operation. #### Regulation .16 Denial or Revocation of License. *COMAR 10.07.03.16* A. Denial or Revocation of License. The Secretary, for cause shown, may notify the agency of the decision to revoke or deny the license. Except as provided in Regulation .15 of this chapter, the denial or revocation shall be stayed if a hearing is requested. B. Criteria for Denial or Revocation. The Department shall notify the agency in writing of the following: (1) The effective date of the denial or revocation; (2) The reason for the denial or revocation; (3) The regulations with which the licensee has failed to comply that form the basis for the denial or revocation; (4) That the agency is entitled to a hearing if requested, and to be represented by counsel; (5) That the agency shall stop providing services on the effective date of the denial or revocation if the agency does not request a hearing; (6) That the denial or revocation shall be stayed if a hearing is requested; and (7) That the agency is required to surrender its license to the Department if the denial or revocation is upheld. C. A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary’s action by filing a request for a hearing in accordance with Regulation .17 of this chapter. #### Regulation .17 Hearings. *COMAR 10.07.03.17* A. An agency shall file a request for a hearing with the Office of Administrative Hearings, with a copy to the Office of Health Care Quality of the Department, not later than 30 calendar days after receipt of notice of the Secretary's action. This request shall include a copy of the Secretary's action. B. A hearing requested under this chapter shall be conducted in accordance with: (1) State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland; (2) COMAR 28.02.01; and (3) COMAR 10.01.03. C. The burden of proof is as provided in COMAR 10.01.03.28. D. Unless otherwise stated in this chapter, the Office of Administrative Hearings shall issue a proposed decision within the time frames set forth in COMAR 28.02.01. E. The aggrieved person may file exceptions as provided in COMAR 10.01.03.35. F. A final decision by the Secretary shall be issued in accordance with COMAR 10.01.03.35. ### Chapter 04 — Residential Treatment Centers for Emotionally Disturbed Children and Adolescents **Authority:** Health-General Article, §§19-301, 19-305, 19-308, 19-309, 19-320, 19-323, and 19-360, Annotated Code of Maryland **Administrative History:** Effective date: April 17, 1967 **Administrative History:** Amended effective March 27, 1973 **Administrative History:** Amended effective March 22, 1974 **Administrative History:** Regulation .02C amended effective January 20, 2014 (41:1 Md. R. 13) **Administrative History:** Regulation .03 amended effective March 13, 2017 (44:5 Md. R. 292) **Administrative History:** Regulation .03A amended effective August 29, 2016 (43:17 Md. R. 953) **Administrative History:** Regulation .11B amended effective February 15, 2016 (43:3 Md. R. 272) **Administrative History:** Chapter revised effective May 22, 2017 (44:10 Md. R. 472) **Administrative History:** Regulation .02B amended effective June 8, 2026 (53:11 Md. R. 484) **Administrative History:** Regulation .04A, D amended effective June 8, 2026 (53:11 Md. R. 484) **Administrative History:** Regulation .17B amended effective June 8, 2026 (53:11 Md. R. 484) **Administrative History:** Annotation: COMAR 10.07.04 cited in Attorney General Opinion No. 82-034 (November 18, 1982) #### Regulation .01 Scope. *COMAR 10.07.04.01* A. The treatment and care of emotionally disturbed children and adolescents are of great concern to various State agencies including the Maryland Department of Health, Department of Human Services, Maryland State Department of Education and Department of Juvenile Justice. B. The Maryland Department of Health, Department of Human Services, Maryland State Department of Education, and Department of Juvenile Services, by statute, are responsible to ascertain that applicants for licenses conform to the regulations promulgated under the legal authority vested in the respective departments. #### Regulation .02 Definitions. *COMAR 10.07.04.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Accreditation organization” means a private entity that conducts inspections and surveys of health care facilities based on nationally recognized and developed standards. (2) “Accredited residential treatment center” means a residential treatment center that is accredited by: (a) The Joint Commission on Accreditation of Healthcare Organizations; (b) The Commission on Accreditation of Rehabilitation Facilities; or (c) The Council on Accreditation. (3) “Adverse event” means an unexpected occurrence that: (a) Is related to a resident’s medical or behavioral treatment; and (b) Is not related to the natural course of the resident’s illness or underlying disease condition. (4) “Center” means a residential treatment center. (5) “Change in condition” means a significant change in a resident’s physical, mental, or psychological status including: (a) Life-threatening conditions; (b) Clinical complications, including significant somatic symptoms that require the assessment or treatment by qualified medical personnel; (c) The need to discontinue a medication or treatment because of: (i) An adverse consequence; or (ii) The need to begin a new form of treatment; (d) Evaluation at or admission to a hospital; (e) Injuries that require the assessment of or treatment by qualified medical personnel; (f) The use of restraint or seclusion; and (g) Suicide attempts. (6) “Department” means the Maryland Department of Health. (7) “Fire authorities” means the official fire safety agency including the State Fire Marshal and local fire departments or fire marshals as appropriate. (8) “Governing body” means the organizational structure that is responsible for all center operations, including: (a) Establishing policy; (b) Maintaining quality care; and (c) Providing management and planning for the center. (9) “Joint Commission” means the voluntary national healthcare accreditation service recognized for: (a) Medicare certification purposes by Public Law 89-97; and (b) Maryland State licensure purposes by Health-General Article, §19-2302, Annotated Code of Maryland. (10) “Licensee” means the individual, partnership, association, or corporation to which a license is issued. (11) “Nonaccredited residential treatment center” means a residential treatment center that is not accredited by: (a) The Joint Commission on Accreditation of Healthcare Organizations; (b) The Commission on Accreditation of Rehabilitation Facilities; or (c) The Council on Accreditation. (12) “Person” means an individual, receiver, trustee, guardian, personal representative, fiduciary, or representative of any kind and any partnership, firm, association, corporation, or other entity. (13) “Resident” means any child or adolescent domiciled in a center for the purpose of receiving the services offered by a residential treatment center. (14) “Residential treatment center” means a psychiatric institution that provides campus-based intensive and extensive evaluation and treatment of children and adolescents with severe and chronic emotional disturbances who require a self-contained therapeutic, educational, and recreational program in a residential setting. (15) “Secretary" means the Secretary of Health. #### Regulation .03 License Requirements. *COMAR 10.07.04.03* A. License Required. A person may not establish, conduct, maintain, or operate in the State a center without first obtaining a license from the Secretary. B. Separate License Required. Centers maintained on separate premises shall obtain separate licenses, even though operated under the same management. C. License Not Required Under This Chapter. The following facilities are not deemed to be within the purview of these licensing requirements and are not required to obtain a license under these provisions: (1) Any institution for well children, including day nurseries, child care centers, foster boarding homes, and institutions for intellectually disabled children; and (2) Institutions operated by the Federal Government. D. Posting of License. The license shall be posted conspicuously on the premises. E. Other Licensing Requirements. Before issuing a license the Secretary shall receive written notification that the center meets the following requirements: (1) Clinical services and treatment program shall be approved by the Department; (2) Child care services and program shall be approved by the Department of Human Services in accordance with its published regulations; (3) The educational program shall be approved by the State Department of Education. F. Licensed Capacity. A center may not admit residents in excess of the number authorized and shown on the current license. #### Regulation .04 Licensing Procedure. *COMAR 10.07.04.04* A. Application. Applicants shall conform to the following: (1) An applicant desiring to open or to continue the operation of an existing center shall file with the Secretary, on a written or electronic form provided by the Secretary: (a) The name of the applicant desiring the license; and (b) The location of the center, the name of the person in charge, and any additional documents and information that the Secretary may require. (2) Application on behalf of a corporation or association or a governmental unit or agency shall be made by two of its officers, and the names of their board members shall be submitted. (3) All licenses shall expire 3 years from the date of issuance unless revoked. (4) The applicant for an original license shall submit the following, and insure that current copies are on file with the Department: (a) Written permission from local zoning authority for an original license in municipalities which have established zoning; (b) Written approval from the appropriate fire authorities; (c) A current food service permit; and (d) Copy of signed agreement between the center and the principal somatic physician and psychiatrist. (5) Renewal. Application for the renewal of the license shall be made each year at least 30 days before expiration of issued license, submitted on written or electronic forms provided by the Secretary. (6) License renewal shall be based on accreditation by the Joint Commission, the Commission on Accreditation of Rehabilitation Facilities, or the Council on Accreditation. (7) The center shall be required to submit evidence of current accreditation that shall include: (a) A copy of the current accreditation letter issued to the center; (b) A copy of the standards determined not to be in compliance, or with recommendations for improvement issued to the center; and (c) The evidence of the action taken to correct noncompliance which was submitted to the accreditation organization. B. Restrictions. (1) Centers licensed under these regulations may not use in their title words “Hospital”, “Sanitarium”, “Nursing”, “Convalescent”, or “Rest”. (2) A license shall be valid only in the hands of the licensee to whom it is issued and may not be subject to sale, assignment, or other transfer, voluntary or involuntary, nor may a license be valid for any premises other than those for which originally issued. C. Duration of License. Licenses are valid for 1 year from the date of issuance unless revoked. D. Licenses for Less Than 12 Months for the Operation of Hospitals and Related Institutions. The Secretary may issue a provisional license to a nonaccredited residential treatment center if: (1) The nonaccredited residential treatment center is pending accreditation by The Joint Commission, the Commission on Accreditation of Rehabilitation Facilities, or the Council on Accreditation; and (2) The provision license is valid for a period not to exceed 12 months. #### Regulation .05 Denial or Revocation of License. *COMAR 10.07.04.05* A. The Secretary shall deny a license to a person who has been convicted of a felony that relates to Medicaid or to a nursing home. B. The Secretary shall revoke the license of any licensee convicted of a felony that relates to Medicaid or to a nursing home. C. The Secretary may deny or revoke a license if the center does not meet the requirements of: (1) Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland; and (2) Any regulation adopted under Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, including this chapter. D. A center subject to denial or revocation of license under this chapter, may request a hearing as set forth in accordance with Regulation .20 of this chapter. #### Regulation .06 Inspection. *COMAR 10.07.04.06* Open to Inspection. A center licensed under this chapter and any premises proposed to be operated by an applicant for a license shall be open at all reasonable times to inspection by: A. The Secretary or designee; B. The Department of Human Services; C. The Maryland State Department of Education; D. The Department of Juvenile Services; or E. Any other agency authorized by the Secretary. #### Regulation .07 New Construction or Alteration. *COMAR 10.07.04.07* A. Submission of Plans. Plans shall be submitted to the Secretary before construction or alterations begin affecting its functional structure or normal bed capacity. These plans shall have the prior approval of local zoning authorities and the appropriate fire authorities. The Secretary shall review promptly the plans and shall notify the applicant or licensee within 30 days that the building, alteration, additions, or changes, are approved or disapproved with the recommendations that the Secretary may make. If an application is disapproved, the applicant or licensee shall be informed of the reasons at the time of notification. B. Application to Service Facilities. A system of water supply, plumbing, sewerage, electrical power, garbage or refuse disposal may not be installed or extended until complete plans and specifications have been submitted and approved in accordance with §A, of this regulation. #### Regulation .08 Physical Plant. *COMAR 10.07.04.08* A. Construction. A new building designated as a residential treatment center and any existing building proposed for conversion for this use shall meet the following: (1) The construction of the building shall prevent the entrance and harborage of rats and other rodents; (2) The center shall comply with all other applicable governing laws or ordinances; and (3) The center shall be constructed to comply with the requirements of the Americans with Disabilities Act. B. Heating. A center shall be equipped with a central heating system capable of maintaining a minimum temperature of 68°F throughout the residential section of the building when the temperature falls to 0°F or below. Alternate modern types of heating systems may be accepted if approved by the fire authorities. Space heaters and portable heaters are not acceptable. C. Lighting. (1) Lighting shall be adequate for the activities conducted in the various areas. (2) Bedrooms and dormitories shall be lighted by outside windows and shall also have artificial light adequate for reading and other uses. (3) All entrances, hallways, stairways, inclines, ramps, cellars, attics, storerooms, kitchens, laundries, and service units shall have sufficient artificial lighting to prevent accidents and promote efficiency of service. D. Bathrooms. A center shall provide the following minimum bathroom facilities: (1) One hand sink and one toilet for each six residents of the same sex on each floor; (2) One bathtub or shower for each 12 beds on each floor; (3) The number of beds for which the center is licensed shall be used in determining the number of bathroom fixtures required even if some of the beds are not occupied; (4) There shall be one complete bathroom on each floor used by the residents, regardless of the number of beds; (5) All bath and toilet rooms shall be easily accessible, conveniently located and well lighted with a night light burning all night and have mechanical exhaust ventilation; (6) A lavatory or toilet facility may not: (a) Open directly into a kitchen, pantry or food preparation room; or (b) Be located so that a resident is required to pass through another resident's room to enter it; and (7) Bathrooms shall be constructed using anti-ligature fixtures and designed for the safety of the residents. E. Plumbing. (1) All plumbing within the building shall be installed in conformance with existing building and sanitary regulations. (2) All sewage disposal shall be in accordance with existing regulations. F. Water Supply. (1) Centers shall be served by water from a safe public water supply, if available, as determined by the Department. If a safe public water supply is not available, a private water supply approved by the Department may be used. (2) Adequacy. The supply shall be adequate in quantity and delivered under sufficient pressure to satisfactorily serve fixtures in the center. (3) Temperature. The hot water heating equipment shall be of sufficient capacity to supply an adequate amount of water not in excess of 125°F for bathing and showering. The center shall install mixing valves or other anti-scalding devices. (4) Hot water for kitchen and laundry use shall be at least 160°F. G. Seclusion and Restraint. (1) Seclusion and restraint rooms shall be constructed and maintained free of hazards to ensure the safety of the residents. (2) The rooms shall allow for the unobstructed view of the resident. (3) The rooms shall be equipped with adequate lighting for the staff to view the resident. (4) Locking mechanisms on doors shall allow for prompt access in the event of an emergency. (5) The rooms shall be adequate in size for staff to safely restrain residents or provide emergency care and treatment. #### Regulation .09 Fire Regulations. *COMAR 10.07.04.09* A center shall be free from fire hazards and shall comply with all applicable local fire and building codes and the safety requirements of the National Fire Protection Association, NFPA 101 “Life Safety Code”, which is incorporated by reference at COMAR 29.06.01.06. #### Regulation .10 General Requirements. *COMAR 10.07.04.10* A. Cleanliness and Maintenance. The following shall be observed: (1) The building and all its parts and facilities shall be kept in good repair, neat, and attractive. The safety and comfort of the residents shall be the first consideration. (2) All walls, floors, ceilings, windows, and fixtures shall be kept clean. Interior walls and floors shall be easily cleanable. (3) Adequate storage space shall be provided for excess supplies, personal possessions of residents and staff, linens, and similar items. This storage space may not constitute a fire or accident hazard, and may not be in the way of residents or staff. All supplies shall be stored 10 inches off the floor and away from the wall to allow for cleaning and pest control. (4) The grounds shall be kept clean, neat, reasonably attractive, and free of hazards. (5) The center shall be maintained free from insects and rodents. (6) Bathtubs and hand sinks may not be used for laundering or storing soiled linens. (7) Bathtubs and shower stalls may not be used for storage. B. The center shall provide adequate furnishings and equipment to meet the needs of the residents, including but not limited to: (1) Beds and mattresses in good repair; (2) A storage area for each resident within their room; (3) A desk and chair for each resident room; and (4) Adequate furnishings in dayrooms and lounge areas to allow for recreational and relaxation purposes. #### Regulation .11 Food Services. *COMAR 10.07.04.11* A. Dietary Requirements. The following minimum requirements shall be observed: (1) A minimum of three meals in each 24 hour period shall be served. In addition, nutritious between meal and bedtime snacks should be offered to all residents no less than 1-1/2 to 2 hours before the next meal. (2) There may not be an interval longer than 12 hours from the evening meal or substantial bedtime snack to breakfast. The diet shall consist of simply prepared, appropriately served, palatable foods including a minimum of the following daily: (b) Meat, fish, poultry, eggs: Two servings per day; (c) Vegetables and fruits: Four servings per day, including one serving of citrus fruit or tomato daily and one serving of a dark green or deep yellow vegetable or fruit five times weekly; (d) Breads and Cereals: Four servings daily. (3) Size of servings and consistency or texture of food will be regulated by the age and condition of the residents. (4) A record of the current week's menu plan shall be posted and kept on file for the following 2 weeks. A time schedule for service of meals to residents and personnel should be established and it is recommenced that meals be served approximately 4 hours apart for breakfast, lunch and dinner. (5) Special diets or any variation of these requirements ordered by the resident's physician shall be provided for residents as ordered. (6) Meals shall be served in a dining or community room equipped with furniture and utensils appropriate to the age and development of the residents. A resident with a temporary illness shall be served privately. B. Sanitation and Personal Hygiene. All applicable requirements of COMAR 10.15.03 shall be observed. #### Regulation .12 Management Requirements. *COMAR 10.07.04.12* A. Responsibility. The licensee is responsible for conformance with licensing regulations. B. Responsible Person. The licensee or administrator appointed by the licensee and all persons in supervisory or other responsible positions shall be 21 years old or older. The licensee shall ensure 24-hour coverage by an administrator or designee. C. Qualifications of Administrator. (1) The administrator of the center shall be a psychiatrist, psychologist, social worker, registered nurse, or any other person trained in the behavioral sciences or in administration. (2) The administrator shall be capable by experience and training of directing and supervising persons working in the center. D. Financial Responsibility. The licensee shall provide to the Secretary assurance of financial responsibility to meet the minimum needs for services offered, safety, maintenance, food, and comfort of the residents of the center. E. Compliance with Regulations. (1) The licensee shall charge the administrator to be familiar with this chapter. (2) The licensee or administrator shall also familiarize employees with those standards related to their work. (3) The center’s governing body shall be responsible for the center’s compliance with all applicable federal and State regulations. F. Availability of Information. The licensee or administrator shall make available to the Secretary such information as may be requested to ensure that the institution is meeting requirements of this chapter. #### Regulation .13 Health Services. *COMAR 10.07.04.13* A. Supervision of Treatment Program. Treatment at any center shall be under the direction of a qualified psychiatrist who is responsible for the adequacy, quality, and appropriateness of the treatment program for each resident. There shall be sufficient professional personnel to ensure the implementation of the treatment program for each resident. B. Medical Supervision. A resident shall be under the medical care of a physician licensed in the State. Each resident shall have a complete physical examination done within 30 days before admission, and updated within 72 hours after admission, and at appropriate, regularly scheduled intervals thereafter. C. Principal Physician. The center shall arrange for a physician to serve as principal physician and a qualified relief to cover periods when their services are not available. The medical director or assigned on call physician shall respond at times of emergency and be available as needed to advise the administrator and nursing staff on medical questions. D. Restrictions on Medication. Medication may not be given without the written order of a physician, nurse practitioner, or physician assistant except in an emergency when medication or treatment may be given on the verbal or telephone order of the prescriber. These orders shall be entered on the doctor's order sheet and shall be confirmed by the prescriber at the next visit. E. Medication Handling. The center shall comply with all applicable Federal, State, and local laws and ordinances, standards, and codes regulating the purchasing, handling, storage, administration, and recording of medications, including controlled substances. #### Regulation .14 Staffing Requirements. *COMAR 10.07.04.14* A. The administrator shall employ sufficient and qualified personnel to ensure adequate treatment and care of the residents and the maintenance, cleaning, and housekeeping. B. The staff shall be sufficient in number so that the individual needs of residents are met. C. Provision shall be made for relief personnel during vacations or other relief periods. The relief personnel shall have qualifications equivalent to those of the person being relieved. D. Clinical staff shall, at a minimum, have current training in: (1) CPR; (2) The Heimlich maneuver; and (3) First aid. E. The center shall ensure that one or more competent trained individuals are present 24 hours a day with the required skills to address medical and behavioral emergencies. F. The center shall maintain personnel records on each employee, including: (1) The initial application; (2) Current professional license and certification; (3) Criminal background checks; and (4) Performance appraisals and annual competency evaluations. G. Each staff member shall have a pre-employment examination for tuberculosis and additional testing when known TB exposure occurs. H. There shall be personnel policies which define staff jobs, qualifications, hours, vacation, sick leave, and retirement. #### Regulation .15 Accommodations. *COMAR 10.07.04.15* A. Usable Living Space Needed. (1) Each center shall provide at least 35 square feet of usable floor space per resident, in addition to bedroom space, in order to meet minimal requirements for dining, living, and recreational facilities. (2) A minimum of 80 square feet is required for single occupancy bedrooms, and 60 square feet per bed for multiple occupancy bedrooms. (3) Usable space excludes service areas, entrance ways, door swing areas, closets, dormers, and other breaks in floor areas. B. Closet Space. Adequate closet space, conveniently located, shall be provided to allow each resident to keep necessary items of clothing and other personal belongings. C. Areas Devoted to Educational Programs. Provision of space for classrooms and other educational activities shall be made in accordance with the needs of the center as approved by the Department of Education. #### Regulation .16 Restraints and Seclusion. *COMAR 10.07.04.16* The use of restraints and seclusion shall be in compliance with 42 CFR §§483.352—483.376 Condition of Participation for the Use of Seclusion and Restraint in Psychiatric Residential Treatment Facilities Providing Inpatient Psychiatric Services For Individuals Under Age 21. #### Regulation .17 Complaint Investigations. *COMAR 10.07.04.17* A. Notwithstanding any other provision of this chapter, residential treatment centers shall be open to inspections by the Department to investigate and resolve any complaint concerning: (1) Resident care; (2) Safety; (3) Medical and nursing supervision; (4) Physical environment; (5) Sanitation; or (6) Dietary matters. B. Complaints. (1) To expeditiously resolve a complaint that alleges the existence of any non-life-threatening deficiency, the Department may refer the complaint directly to the residential treatment center. (2) If appropriate, issues relating to the practice of medicine or the licensure or conduct of a health professional may be referred to the residential treatment center and to the appropriate health occupation licensing board for resolution. (3) If the Department determines that the center has not satisfactorily addressed the referred complaint or if the complaint alleges the existence of a potentially serious or life-threatening deficiency, the Department shall conduct an independent investigation. (4) When conducting its independent investigation of an accredited residential treatment center, the Department shall use the standards of the accreditation organization that accredits the residential treatment center and this chapter. #### Regulation .18 Reports. *COMAR 10.07.04.18* A. The center shall furnish to the Secretary reports covering the following: (1) Deaths, serious injuries, or unusual incidents, including suicide attempts, by no later than the close of business of the next business day following the event; and (2) Any occurrences which threaten the welfare, safety, or health of any resident of the center such as fire, infectious disease outbreaks, or poisoning. B. The center shall comply with the reporting requirements of the Department of Juvenile Services, the Department of Human Services, the Maryland State Department of Education, or other placement agencies. C. The center shall comply with the reporting requirements of 42 CFR §483.374(b) and (c). D. Serious Occurrence Notification. (1) Staff shall report any serious occurrence described in 42 CFR §483.374(b) involving a resident to both the State Medicaid agency and the State-designated Protection and Advocacy System by not later than close of business the next business day after a serious occurrence. (2) The report shall include: (a) The name of the resident involved in the serious occurrence; and (b) A description of the occurrence. (3) In the case of a minor, the center shall notify the resident’s parent or parents or legal guardian or legal guardians: (a) As soon as possible; or (b) No later than 24 hours after the serious occurrence. (4) Staff shall document in the resident’s record that the serious occurrence was reported to both the State Medicaid agency and the State-designated Protection and Advocacy System, including the name of the individual to whom the incident was reported. (5) A copy of the report shall be maintained in the resident’s record, as well as in the incident and accident report logs kept by the center. #### Regulation .19 Civil Money Penalties. *COMAR 10.07.04.19* A. Civil Money Penalties. The Secretary may impose a civil money penalty on a person if: (1) The person maintains or operates an unlicensed center; or (2) A serious or life-threatening patient care deficiency exists and the center fails to correct the deficiency through immediate corrective action. B. In determining whether a civil money penalty is to be imposed, the Secretary shall consider the following factors: (1) Number, nature, and seriousness of the patient care deficiencies; (2) The extent to which the patient care deficiency or deficiencies are part of an ongoing pattern during the preceding 24 months; (3) The degree of risk to the health, life, or safety of the residents of the center that is caused by the patient care deficiency or deficiencies; (4) The efforts made by, and the ability of the center to correct, the patient care deficiency or deficiencies through implementation of immediate corrective action; and (5) The center’s prior history of compliance. C. If the Department determines that a person has been operating an unlicensed center, the Department may impose a civil money penalty not to exceed $10,000. D. If the Department determines that a serious or life-threatening deficiency or an ongoing pattern of deficiencies exists, the Department shall notify the center of the deficiency or deficiencies and may: (1) Impose a per-day civil money penalty not to exceed $10,000 until sustained compliance has been achieved; (2) Permit the center the opportunity to correct the deficiencies by a specific date; or (3) Impose a per-instance civil money penalty not to exceed $10,000 for each instance of violation. E. If the Department permits a center the opportunity to correct the deficiencies by a specific date, and the center fails to comply with this requirement, the Department may impose a per-day civil money penalty for each day of violation until correction of the deficiency or deficiencies has been verified and sustained compliance has been maintained. F. If the Department proposes to impose a civil money penalty, the Secretary shall issue an order which shall state the: (1) Deficiency or deficiencies on which the order is based; (2) Amount of civil money penalties to be imposed; and (3) Manner in which the amount of civil money penalties imposed was calculated. G. A center subject to a civil money penalty under this regulation may request a hearing as set forth in accordance with Regulation .20 of this chapter. #### Regulation .20 Hearings. *COMAR 10.07.04.20* A. A request for a hearing shall be filed with the Office of Administrative Hearings, with a copy to the Office of Health Care Quality of the Department, not later than 30 days after receipt of notice of the Secretary's action. This request shall include a copy of the Secretary's action. B. A hearing requested under this chapter shall be conducted in accordance with: (1) State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland; (2) COMAR 28.02.01; and (3) COMAR 10.01.03. C. The burden of proof is as provided in COMAR 10.01.03.16. D. Unless otherwise stated in this chapter, the Office of Administrative Hearings shall issue a proposed decision within the time frames set forth in COMAR 28.02.01. E. The aggrieved person may file exceptions as provided in COMAR 10.01.03.18. F. A final decision by the Secretary shall be issued in accordance with COMAR 10.01.03.20. #### Regulation .21 Notifications. *COMAR 10.07.04.21* A. Within 24 hours of an event or change in condition and in accordance with State and federal confidentiality laws, a center shall attempt to notify a resident and a resident’s representative, family member, legal guardian, or custodian of: (1) A change in the resident’s condition; (2) An adverse event that affected the resident; and (3) If appropriate, the corrective action taken. B. The notification may be waived by the individual identified under Regulation .19A of this chapter if the individual sends a written response instructing the center that the individual: (1) Waives the required notifications; or (2) Requests that the notification be provided only under the circumstances identified in the written response. C. All written responses waiving some or all notifications shall be maintained in the resident’s medical record. D. The center shall document in the medical records that the required notification were completed. The documentation shall include: (1) The nature of the event or change in condition; (2) The names of the individuals who received notification; (3) The dates and times of the notifications; and (4) The name of the staff who made the notifications. E. If a center has made reasonable attempts to notify the required individuals and has been unable to make contact, the failure to reach the individuals shall be documented in the medical records. F. If the Department determines that the center has failed to provide the required notification, the Department shall require the center as part of its plan of correction to provide notification as soon as possible. #### Regulation .22 Resident Rights. *COMAR 10.07.04.22* A. The center shall post the list of resident rights in areas of the center where the residents can read the posting. A resident of a residential treatment center has the right to: (1) Be treated with respect; (2) Have their cultural spiritual, personal beliefs, values, and preferences respected; (3) Personal privacy; (4) Practice their religious beliefs; (5) Receive information about care and treatment in a manner that he or she understands; (6) Be free from neglect, exploitation, and verbal, sexual, physical, and mental abuse; (7) Access protection and advocacy services; (8) Receive care in a safe setting; (9) File a complaint and have it investigated without fear of retribution; (10) Have visitors in accordance with the center’s visitation policy; (11) Send and receive mail; (12) Consult with their attorney, advocate, or social worker in private; and (13) Make and receive telephone calls in accordance with the center’s policy. B. The resident’s parents or guardians or, if the resident is age 18 or older, the resident shall have the right to: (1) Be involved in the treatment planning process; (2) Consent to treatment and medication; (3) Be informed of changes in the treatment plan and medication regimen; (4) Withhold consent for treatment; and (5) Have complaints investigated in a timely manner. C. A resident’s rights shall only be restricted if the provision of that right poses a threat to the therapeutic needs of the resident or places the resident’s or other residents’ safety and security at risk. D. Restrictions on a resident’s rights shall be documented in the treatment plan and reviewed and approved by the treatment team. E. Restrictions on a resident’s rights shall be removed as soon as possible when the restriction is not therapeutically indicated. ### Chapter 05 — Residential Service Agencies **Authority:** Health-General Article, Title 19, Subtitle 4A, Annotated Code of Maryland **Administrative History:** Effective date: January 17, 1994 (21:1 Md. R. 33) **Administrative History:** Regulation .01B amended effective June 2, 1997 (24:11 Md. R. 793) **Administrative History:** Regulation .02 amended effective June 2, 1997 (24:11 Md. R. 793) **Administrative History:** Regulation .03C repealed effective June 2, 1997 (24:11 Md. R. 793) **Administrative History:** Regulation .05-1 adopted effective June 2, 1997 (24:11 Md. R. 793) **Administrative History:** Regulations .01—.08 repealed and new Regulations .01—.28 adopted effective May 1, 2012 (38:21 Md. R. 1277) **Administrative History:** Regulation .04A amended effective December 21, 2015 (42:25 Md. R. 1543); March 28, 2016 (43:6 Md. R. 406) **Administrative History:** Regulation .04A, I amended effective August 19, 2013 (40:16 Md. R. 1343); January 6, 2014 (40:26 Md. R. 2162); March 13, 2017 (44:5 Md. R. 292) **Administrative History:** Regulation .04H amended effective January 6, 2014 (40:26 Md. R. 2162) **Administrative History:** Regulation .04H, I amended effective July 4, 2016 (43:13 Md. R. 712) **Administrative History:** Regulation .12E amended as an emergency provision effective June 1, 2012 (39:13 Md. R. 784); amended permanently effective September 3, 2012 (39:17 Md. R. 1148) #### Regulation .01 Purpose. *COMAR 10.07.05.01* The purpose of this chapter is to establish minimum standards for licensure of residential service agencies that conduct business in Maryland. #### Regulation .02 Definitions. *COMAR 10.07.05.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Activities of daily living” means normal daily activities including: (a) Eating or being fed; (b) Grooming, bathing, oral hygiene including brushing teeth, shaving, and combing hair; (c) Mobility, transferring, ambulation, and access to the outdoors, when appropriate; (d) Toileting; and (e) Dressing in clean, weather-appropriate clothing. (2) “Agency” means a residential service agency as defined in §B(25) of this regulation. (3) “Branch office” means a satellite office of a residential service agency that: (a) Is operated by the same person, corporation, or other business entity that manages the parent residential service agency; and (b) Along with the parent residential service agency has the same: (i) Ownership tax identification number as the parent residential service agency; (ii) Upper-level management; (iii) Policies and procedures; and (iv) Services within the same geographic area as the parent residential service agency. (4) “Certified care” means a service or services that: (a) May be performed for compensation only by an individual who is certified by the Board of Nursing, including a certified medication technician, a certified medicine aide, or a certified nursing assistant; and (b) Include nursing functions that are routinely delegated by a registered nurse. (5) “Certified medication technician” means an individual who: (a) Has completed a Board-approved medication technician training program; and (b) Is certified by the Board as a medication technician. (6) “Certified medicine aide” means an individual who is: (a) A certified nursing assistant who has completed a Board-approved course in medication administration; and (b) Certified by the Board as a certified medicine aide. (7) “Certified nursing assistant” means an individual, regardless of title, who: (a) Routinely performs for compensation delegated nursing tasks which were delegated by a registered nurse or licensed practical nurse; and (b) Is certified by the Maryland Board of Nursing as a certified nursing assistant. (8) “Client representative” means an individual with legal authority to make decisions on behalf of the client as set forth in Regulation .13 of this chapter. (9) “Clinical record” means a written account of all services provided to a client by the agency as well as all pertinent medical information necessary to provide care. (10) “Department” means the Maryland Department of Health. (11) “Governing authority” means the individual, partnership, agency, group, corporation, or other entity that is designated to assume full responsibility for the policy determination, management, operation, and financial liability of the agency. (12) “Home health care” includes any of the following services: (a) Audiology and speech pathology; (b) Dietary and nutritional services; (c) Drug services; (d) Home health aide; (e) Laboratory; (f) Medical social services; (g) Nursing; (h) Occupational therapy; (i) Physical therapy; (j) Provision of invasive medical equipment; and (k) Home medical equipment services. (13) “Home medical equipment services” means the delivery, installation, maintenance, or replacement of, or instruction in the use of, medical equipment used by a sick or disabled individual to allow the individual to be maintained in a noninstitutional environment. (14) “Household or family support services” means performance of tasks necessary to supplement an individual’s ability to perform: (a) Child care for children who require no medical attention; or (b) Instrumental activities of daily living. (15) “Informal dispute resolution conference (IDR)” means an informal meeting that provides a licensee the opportunity to question the Department about deficiencies cited on a recent inspection. (16) “Informed consent” means the willing, uncoerced acceptance of medical intervention by a client or a client representative with legal authority to make health care decisions after adequate disclosure of the nature of the intervention, and its risks and benefits, as well as alternatives with their risks and benefits. (17) “Instrumental activities of daily living” means: (a) Light housekeeping and home management; (b) Meal planning and preparation; or (c) Shopping and errands. (18) “Intravenous therapy” means the provision of services and monitoring and instruction related to substances that are administered intravenously, including but not limited to: (a) Total parenteral nutrition (TPN); (b) Hydration therapy; (c) Chemotherapy; (d) Antibiotic therapy; and (e) Blood and blood products. (19) “Invasive medical equipment” means a device that invades tissue or a body cavity for the purpose of maintaining treatment modalities, including but not limited to: (a) Intravenous lines, whether enteral or parenteral; (b) Catheters; (c) Ventilators; (d) Gastric or nasogastric tubes; (e) Tracheostomy; and (f) Ostomies. (20) “Law enforcement agencies” mean the Maryland State Police or a police agency of a county or municipal corporation. (21) “License” means a document issued by the Secretary to a person to operate a residential service agency in this State. (22) “Medical equipment” means technologically sophisticated medical devices including but not limited to: (a) Oxygen and oxygen delivery systems; (b) Ventilators; (c) Respiratory disease management devices; (d) Electronic and computer-driven wheelchairs and seating systems; (e) Apnea monitors; (f) Transcutaneous electrical nerve stimulator (T.E.N.S.) units; (g) Low air loss cutaneous pressure management devices; (h) Sequential compression devices; (i) Neonatal home phototherapy devices; (j) Feeding pumps; and (k) Electrically powered hospital beds. (23) “Personal care provider under the Medical Assistance Personal Care Program” means an individual or personal care agency that has been approved by the Department as meeting requirements set forth in COMAR 10.09.20 and 10.09.36 to provide personal care services to individuals who are certified for and receiving Medical Assistance benefits. (24) “Plan of correction” means a written response from the residential service agency that addresses each deficiency cited as a result of an inspection by the Department. (25) Residential Service Agency. (a) “Residential service agency” means: (i) An individual, partnership, firm, association, corporation, or other entity of any kind that is engaged in a nongovernmental business of employing or contracting with individuals to provide at least one home health care service for compensation to an unrelated sick or disabled individual in the residence of that individual; or (ii) An agency that employs or contracts with individuals directly for hire as home health care providers. (b) “Residential service agency” does not include: (i) A home health agency that is licensed under Health-General Article, Title 19, Subtitle 4, Annotated Code of Maryland; (ii) An individual, partnership, firm, association, corporation, or other entity of any kind that is required to be licensed as a home health agency under Health-General Article, Title 19, Subtitle 4, Annotated Code of Maryland; (iii) A home-based hospice care program that is licensed under Health-General Article, Title 19, Subtitle 9, Annotated Code of Maryland; (iv) A hospital that is licensed under Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland; (v) A related institution that is licensed under Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland; (vi) A nursing referral service agency that is licensed under Health-General Article, Title 19, Subtitle 4B, Annotated Code of Maryland, that screens or refers individuals for a client’s selection or rejection as its sole business operation, and does not itself provide any home health care service; (vii) A personal care provider under the Medical Assistance Personal Care Program; (viii) An individual practicing in a health occupation for which the individual is authorized to practice under Health Occupations Article, Annotated Code of Maryland; (ix) A business entity consisting of a group of individuals licensed under the same title of Health Occupations Article, Annotated Code of Maryland, which provides only that same, single, licensed health care service to its clients; or (x) A residential rehabilitation services provider approved under regulations adopted under Health-General Article, §10-901, Annotated Code of Maryland. (26) “Secretary” means the Secretary of Health. (27) Significant Change of Condition. (a) “Significant change of condition” means a change in a client’s health, functional, or psychosocial condition that causes either an improvement or a deterioration in a client’s condition. (b) “Significant change of condition” does not include any ordinary, day-to-day fluctuations in health status, function, or behavior or an acute short-term illness, such as a cold, unless these fluctuations continue to reoccur. (28) “Skilled care” means a service or services that may be provided only by an individual who: (a) Is licensed under Health Occupations Article, Annotated Code of Maryland; and (b) Exercises specialized knowledge, judgment, and skill. (29) “Skilled services” means services provided by or under the supervision of a registered nurse and in accordance with the plan of treatment. (30) “Waiver of services” means an informed agreement by a competent adult client to receive certified care or skilled services that are less than the level of care that is recommended by the licensee or a representative of the licensee. #### Regulation .03 License Required. *COMAR 10.07.05.03* A. A person, partnership, corporation, association, or other entity may not conduct or operate an agency in this State without first obtaining a license from the Secretary and complying with the regulations of this chapter. B. An agency that provides only household or family support services as defined in Regulation .02B(14) of this chapter does not require licensure. C. Separate License Required. (1) Except as provided in §C(2) of this regulation, a separate license is required for each agency. (2) A branch office may operate under the same license of the agency. D. Posting of a License. The licensee shall display the agency’s current license in a conspicuous place, at or near the entrance of the agency’s office. E. This chapter does not preclude an agency from operating with independent contractors. #### Regulation .04 Licensing Procedures. *COMAR 10.07.05.04* A. Application for License. (1) To obtain and maintain a license, an applicant shall meet all of the requirements of: (a) This chapter; and (b) Other applicable federal, State, and local laws and regulations. (2) An applicant shall submit: (a) An application on a written or electronic form developed by the Department; (b) Verification that the applicant or corporate representative is 21 years old or older; (c) Documentation of any prior denial, suspension, or revocation of a license or certification to provide care to third parties; (d) Identification of any individual or corporate owner of a 25 percent or more interest in the agency; (e) Ownership information as specified on an addendum to the application; (f) Information concerning any license or certification held by the applicant under Health Occupations Article or Health-General Article, Annotated Code of Maryland, including prior or current operation of a similar health care program by the applicant; (g) Disclosure of any criminal charges or convictions, and disclosure of any findings of violation of: (i) Medicare and Medicaid laws and regulations; (ii) Health-General Article, Annotated Code of Maryland; or (iii) Health Occupations Article, Annotated Code of Maryland; (h) Information demonstrating the financial or administrative ability to operate an agency in compliance with this chapter, which shall include at a minimum a business plan that contains a: (i) 1-year operating budget; (ii) Marketing plan that identifies the populations to be served; and (iii) Detailed and specific description of agency services; (i) Copies of the agency’s policies and procedures as specified in Regulation .08B of this chapter; (j) Proof of Workers’ Compensation for all employees as required by the Maryland Workers’ Compensation Commission; and (k) A nonrefundable license fee of $1,000 made payable to the Department for a 3-year licensing fee. B. Additional Requirements for Initial Licensure. (1) If the applicant, owner, or person identified in §A(2)(d) of this regulation has had their license suspended or revoked by the Department that person may not own, operate, or manage another agency for 10 years without good cause shown. After 10 years, the applicant shall submit evidence to the Department that the applicant is capable of owning, managing, or operating an agency within the laws and regulations. (2) If an applicant, owner, or person identified in §A(2)(d) of this regulation operates or manages an agency, that applicant, owner, or individual may not apply to open additional agencies, if the agency: (a) Has had sanctions imposed within the last 2 years; and (b) Has not achieved compliance with the regulations at the time of application for licensure. (3) The Department reserves the right to deny licensure for a residential service agency to an applicant, an owner, or an individual identified in §A(2)(d) of this regulation, based on that person’s prior: (a) History of violations of residential service agency regulations; or (b) Criminal history that the Department determines may be potentially harmful to clients. C. The Department shall review all applications for licensure to determine whether the applicant: (1) Can provide appropriate services to sick or disabled individuals who require care in the individuals’ residence; and (2) Meets the regulatory requirements of this chapter. D. In addition to any other rights of inspection, before approving or denying an application for licensure, the Department may conduct an announced or unannounced on-site inspection of the agency. E. Based on information provided to the Department by the applicant, the Secretary shall: (1) Approve the application unconditionally; (2) Approve the application conditionally, which may include, among other conditions, requiring: (a) The applicant to use the services of a management firm approved by the Secretary; or (b) A licensure term of less than 1 year; or (3) Deny the application. F. The Secretary may not require the use of a management firm for a period in excess of 24 months. G. A person aggrieved by a decision of the Secretary under this regulation to deny a license application may appeal the Secretary’s action by filing a request for a hearing consistent with Regulation .28 of this chapter. H. Duration of License. A license is valid for 3 years from the date of issuance, unless: (1) Surrendered, suspended, or revoked; or (2) It is a provisional license as described in §J of this regulation. I. License Renewal. A licensee shall submit to the Department: (1) An application for license renewal on a written or electronic form developed by the Department; (2) A nonrefundable license renewal fee of $1,000 made payable to the Department for a 3-year licensing fee; (3) Copies of any policies and procedures that have changed substantively since they were previously reviewed by the Department, including those relevant to: (a) Handling of complaints made to the agency; and (b) Evaluation and assessment of clients; (4) Valid professional licenses and certificates for all current employees; and (5) An annual data collection survey in the form and manner prescribed by the Secretary with each application for license renewal. J. Licenses for Less than 1 Year. (1) The Department may issue a provisional license if: (a) The agency intends to provide services limited to skilled nursing and home health aid services; or (b) The residential service agency is not in full compliance with this chapter, but, in the opinion of the Department, the: (i) Noncompliance does not constitute a safety or health hazard; and (ii) Applicant or licensee has submitted a plan of correction that is acceptable to the Department which satisfactorily addresses the correction of each deficiency within a timeframe acceptable to the Department. (2) A provisional license may not be extended beyond its expiration date. K. If an agency fails to comply with the regulations of this chapter and the Department needs to conduct more than one on-site prelicensure visit, the Department may: (1) Charge $250 per additional on-site visit; or (2) Deny the license. #### Regulation .05 Changes in an Agency That Affect the Operating License. *COMAR 10.07.05.05* A. Change of Services or Name. (1) During the licensure period, a licensee may not: (a) Provide services for which it has not been approved to provide; or (b) Change the name under which the program is doing business without the Department’s approval. (2) When the licensee wants to provide additional services which require a license under this chapter, before offering the services, the licensee shall submit to the Department: (a) A new application and written request for a new license citing the additional services the agency wants to provide; (b) Policies and procedures pertaining to the additional services the agency wants to provide; and (c) An application fee as required by Health-General Article, §19-4A-03(c), Annotated Code of Maryland. (3) When there is a change in name or address of the licensee, but no change of ownership, an amended license is required and the licensee shall pay $50 for the issuance of an amended license. (4) Sale or Transfer of an Agency. (a) If a sale or transfer of an agency causes a change in the person or persons who control or operate the agency, the agency is considered a new agency and the licensee shall apply for a new license and conform to all regulations applicable at the time of the transfer of operations. (b) The transfer of any stock which results in a change of the person or persons who control the agency or the transfer of any stock in excess of 25 percent of the outstanding stock constitutes a sale. B. Voluntary Closure or Change of Residential Service Agency Ownership. (1) A licensee shall notify the Department in writing at least 45 days in advance of any intention to: (a) Voluntarily close; (b) Change ownership; or (c) Sell its agency. (2) The licensee shall include the following information in the notice to the Department: (a) The method for informing clients or client representatives, if applicable, of its intent to close, change ownership, or sell its agency; and (b) The actions the licensee will take to assist clients in securing comparable services and assistance, if necessary. (3) A licensee shall notify clients or client representatives, if applicable, of any proposed changes set forth in §B(1) of this regulation, in writing, at least 45 days before the effective date of the proposed change. (4) Whenever ownership of an agency is transferred from the person or organization named on the license to another person or organization, the future owner shall apply for a new license. The future owner shall file an application for a license at least 45 days before the transfer. (5) The Department shall issue a new license to a new owner who meets the requirements for licensure under this chapter. The former licensee shall return its license to the Department by certified mail. (6) A licensee named in the original license remains responsible for the operation of the agency until a new license is issued to the new owner. The current licensee remains responsible for correction of all outstanding deficiencies and impending sanctions until a new license is issued to the new owner. After a new license is issued, the new owner shall become responsible for correction of all outstanding deficiencies and impending sanctions. (7) In addition to the notice to the Department required by §B(1) and (2) of this regulation, after an agency closes, the licensee shall: (a) Notify the Department of the date of closure; and (b) Return all licenses, past and present, to the Department by certified mail. C. Changes to Licensure Information. A licensee shall immediately notify the Department of any change in the information the licensee had submitted with the most recent application. D. License — Sale, Assignment, or Transfer. The license is valid in the name of the licensee to whom it is issued, and is not subject to sale, assignment, or other transfer. E. If an agency fails to comply with §§A—D of this regulation, the Department may impose a fine of up to $500 for each violation.. F. A license is void if the agency ceases to operate. #### Regulation .05-1 Special Requirements for the Provision of Home Medical Equipment Services. *COMAR 10.07.05.05-1* A. A provider of home medical equipment services shall meet the requirements of this regulation in addition to meeting the requirements of Regulations .02—.03 of this chapter. B. An agency shall: (1) Ensure that personnel demonstrate competency in delivering and installing the equipment; (2) Provide education, training, and written instructions to the patient and his or her caregivers on the use of the equipment before the equipment is used, and provide retraining as needed; (3) Provide the patient and caregivers with the telephone number of persons who can deliver critical care on an emergency basis; (4) Provide the prescribing physician with a copy of the: (a) Qualifications, duties, and responsibilities of agency personnel who deliver the services, and (b) Instructions given to the patient and the patient's caregivers; (5) Maintain a clinical record for each patient receiving home medical equipment services; and (6) Ensure that the installation, maintenance, repair, and storage of home medical equipment meet with manufacturer's specifications. #### Regulation .06 Public Representation. *COMAR 10.07.05.06* A. An agency shall include the following information in all of the agency’s advertising and marketing materials: (1) The agency’s license number; and (2) The statement “Licensed as a residential service agency by the Maryland Department of Health, Office of Health Care Quality”. B. Misleading or False Advertising. (1) A person may not advertise, represent, or imply to the public that an agency is authorized to provide a service that the agency is not licensed, certified, or otherwise authorized by the Department to provide under this chapter. (2) A person may not advertise an agency in a misleading or fraudulent manner. (3) A person licensed as an agency may not advertise that it is licensed as a hospice, home health agency, or nursing referral service agency unless it is separately licensed with the Department as such. C. A person who violates this regulation is subject to referral for criminal prosecution and imposition of civil money penalties in accordance with Regulations .21—.23 of this chapter. #### Regulation .07 Inspection by the Department. *COMAR 10.07.05.07* A. Residential Service Agency to be Open for Inspection. (1) The Department or its designee may conduct announced or unannounced licensure inspections or complaint investigations to ensure compliance with the requirements of this chapter. (2) The agency shall be open for inspection by the Department during all hours identified in the agency’s application as routine business hours. B. Access to Agency and Sites Where Services Are Offered. Upon the request of the Department, an agency shall: (1) Make its offices available for inspection during other than its routine business hours; (2) Assist the Department in gaining access to sites where services are provided for the purpose of conducting inspections to: (a) Ensure that the agency is in compliance with the regulations of this chapter; and (b) Enable the Department to investigate and resolve complaints filed against the agency. C. Records and Reports. (1) Inspection. (a) A licensee shall maintain records and reports to support compliance with the regulations of this chapter. All records and reports shall be open to inspection by the Department. (b) Except for the records permitted to be stored off site, a licensee or licensee’s designee shall immediately, upon request, provide copies of records and reports, including medical records of clients, to the Department. The Department shall, if requested, reimburse the licensee for the cost of copying records and reports. (2) Maintenance. (a) The residential service agency shall maintain files on site pertaining to: (i) Current clients; (ii) Clients that have been discharged within the last 12 months; (iii) Current staff; (iv) Staff that have been discharged within the last year; and (v) Quality assurance activities. (b) All other records may be stored off site, but shall be available for inspection within 24 hours of the Department’s request. D. An agency shall make available upon request to clients, client representatives, potential clients, or federal, State, or local regulatory or law enforcement agencies any statements of deficiencies, reports, and plans of corrections. E. Notice of Violations. (1) If a complaint investigation or survey inspection identifies a regulatory violation, the Secretary shall issue a notice: (a) Citing the violation or deficiency; (b) Requiring the residential service agency to submit an acceptable plan of correction within 10 calendar days of receipt of the notice of violation or deficiency; (c) Advising the residential service agency that failure to correct cited violations or deficiencies may result in sanctions; and (d) Offering the residential service agency the opportunity for an informal dispute resolution conference (IDR). (2) The plan of correction referred to in §E(1)(b) of this regulation shall include the date by which the licensee shall complete the correction of each deficiency. Failure to return an acceptable plan of correction within the allotted timeframe may result in a sanction. (3) When a licensee requests an IDR as provided in §F of this regulation, the licensee shall file a plan of correction within the required time, except to the extent that the licensee contests specific findings. If the licensee contests specific findings, absent the Department’s directive, a licensee may delay submitting its plan of correction with respect to those specific findings until 5 days after the licensee is provided oral or written notice of the outcome of the IDR. F. Informal Dispute Resolution (IDR). (1) A licensee may request an informal dispute resolution conference (IDR) to question violations or deficiencies within 10 days of receiving the statement of deficiencies. The written request for an IDR shall fully describe the disagreement with the statement of deficiencies and be accompanied by any supporting documentation. (2) At the discretion of the Office of Health Care Quality, the IDR may be held in person, by telephone, or in writing. In-person IDRs are informal in nature and are not attended by counsel. (3) The IDR process may not delay the effective date of any enforcement action. #### Regulation .08 Administration. *COMAR 10.07.05.08* A. Governing Authority. (1) The agency shall have a governing authority. (2) The governing authority shall: (a) Convene at least annually with management staff to review and advise the agency on policies; and (b) Keep minutes, including: (i) The participants of any meeting; (ii) Agenda items considered; and (iii) Actions taken. B. Policies and Procedures. (1) An agency shall develop and implement policies and procedures, including but not limited to: (a) Administration, including: (i) Scope of services; (ii) Delineation of services provided by the agency when the agency coordinates care within the agency or with another provider; (iii) Notification to the client or client representative with legal authority to make health care decisions of the agency’s responsibilities to coordinate care when appropriate; (iv) Admission criteria; (v) Assessment of potential clients before their acceptance into the program; (vi) Billing and service records, maintenance of charges, and similar items, except for those clients receiving services through a managed-care health benefits plan or third party payor, in which case records are maintained as required by the third party payor; (vii) Quality assurance program; and (viii) Clinical management, including assessment, plans, delegation, and supervision; (b) Personnel, including: (i) Job descriptions and educational qualifications for all employees and contractors; (ii) Skill assessments of all employees and contractors; and (iii) Health requirements for employees and contractors; (c) Patient care, including: (i) Provision of home health care services and criteria for determining the need for skilled services; (ii) Administration of drugs; (iii) Enteral and parenteral nutrition procedures; (iv) Frequency of client monitoring; and (v) Training and retraining of clients or their family members, when indicated; (d) Informed consent when: (i) A client or client representative with legal authority to make legal decisions, signs an informed consent form consenting to changes to the agency’s recommended plan of care; or (ii) A client signs an informed consent form consenting to assistance by a nonlicensed individual with treatments of a routine nature, or with the self-administration of medications; and (e) Environment and safety, including: (i) Preparation and storage of enteral formulas, intravenous therapies, other supplies, equipment, and similar items; (ii) Infection control procedures; (iii) Disposal of biomedical waste; (iv) Maintenance of equipment; and (v) Emergency procedures. (2) The Department may waive the requirement of a policy and procedure that is required in §B of this regulation upon the agency’s written explanation as to why the policy and procedure is inappropriate or unnecessary to the agency’s specific operation. (3) An agency that provides invasive equipment or supplies, such as intravenous therapy, shall arrange for 24-hour-a-day equipment maintenance service in case of equipment failure. #### Regulation .09 Complaint Process. *COMAR 10.07.05.09* A. Internal Complaint Process. An agency shall institute an internal client complaint process that includes: (1) Notice to the client or the client representative of the complaint process; (2) Protocols to investigate complaints; and (3) A mechanism for the receipt and timely investigation of written complaints that ensures that the client’s services will not be disrupted due to the filing of a complaint. B. Internal Complaint Investigations. (1) All investigation reports shall include: (a) Time, date, place, and individuals involved; (b) Complete description of the complaint; (c) Disposition of the complaint; and (d) Follow-up activities and steps taken to prevent its reoccurrence. (2) If the agency does not conduct a complaint investigation, the agency shall document in the complaint record the reason for not conducting an investigation. (3) An agency shall provide notice to the following persons regarding the disposition of a complaint: (a) Client, or if the client is incompetent, the client representative; (b) Client’s physician, if needed; and (c) Licensing or law enforcement agencies, when required by law. (4) An agency shall maintain records to support its internal complaint investigation process. C. An agency shall provide notice to clients of the Department’s complaint hotline number for complaints about services provided by the agency or services that the agency failed to provide. D. Availability of Internal Investigation Reports. (1) The agency shall make investigation reports available to the Department immediately upon request. (2) An agency shall provide a summary report of any complaint investigation for public inspection, upon request, to the extent permitted by law. #### Regulation .10 Employee, Independent Contractor, and Contractual Employee Requirements. *COMAR 10.07.05.10* A. An agency shall develop and implement policies and procedures to screen a prospective employee, independent contractor, or contractual employee who will provide services to clients. B. Screening. (1) Screening shall include: (a) A State criminal history records check or a private agency background check as required under Health-General Article, Title 19, Subtitle 19, Annotated Code of Maryland; (b) Verification of current professional licensure or certification under Health Occupations Article, Annotated Code of Maryland; (c) A basic health screening, including tuberculosis screening; (d) Verification of references; (e) Verification of employment history; (f) Completion of I-9 forms for employment; (g) Verification of identity and employment eligibility of an employee, independent contractor, or contractual employee; (h) An in-person interview of an employee, independent contractor, or contractual employee before the individual is referred to clients; and (i) Completion of a skills assessment and demonstration before client referral. (2) An agency shall retain records of training in the personnel file. C. An agency shall maintain records of information described in §B of this regulation for each employee, independent contractor, or contractual employee and retain the information in the agency’s business office. D. An agency may not knowingly provide or refer a caregiver who is not certified to provide services to a client unless the client: (1) Does not require the caregiver to provide assistance with activities of daily living; (2) Only requires assistance with activities of daily living and in the judgment of the supervising nurse, there are no predictable adverse health consequences; or (3) Signs a waiver of skilled services form as required under Regulation .12D of this chapter. E. An agency shall provide or refer a certified caregiver to a client who requires: (1) A certified caregiver to perform activities of daily living; or (2) Administration of medication. F. If an agency is aware of an action or inaction by an individual who is provided or referred by the agency that may be grounds for action under Health Occupations Article, §§8-316 and 8-6A-10, Annotated Code of Maryland, the agency shall report the action or condition to the Board of Nursing and the Office of Health Care Quality immediately when the action or condition is known by the agency. G. A nursing administrator, a registered nurse, a licensed practical nurse, and a certified nursing assistant shall have immunity from liability as described in Courts and Judicial Proceedings Article, §5-709, Annotated Code of Maryland, for making a report to the Board of Nursing as required under §F of this regulation. Other persons are entitled to the immunity from liability as described in the Courts and Judicial Proceedings Article, §5-708, Annotated Code of Maryland, for making a report to the Board of Nursing as required under §F of this regulation. H. Use of Subcontract Agencies. If an agency subcontracts with another licensed agency to provide services, the subcontracting agency shall: (1) Verify personnel information outlined in §B of this regulation; and (2) Submit evidence to the contracting agency that verification has occurred. #### Regulation .11 Training. *COMAR 10.07.05.11* A. An agency shall ensure that individuals that are referred are trained appropriately to provide care that is needed by the agency’s clients. B. Sources other than the agency may provide training, as approved in writing by the Office of Health Care Quality. C. At a minimum, training for individuals providing care in clients’ homes shall include: (1) Instruction and supervised practice in relevant personal care services of the sick or disabled at home; (2) Identification of situations that require referral to a registered nurse, including significant changes in a client’s condition; (3) Record keeping; (4) Ethical behavior and confidentiality of information; (5) CPR; (6) Standard precautions for infection control; and (7) Prevention of abuse and neglect. #### Regulation .12 Services Provided. *COMAR 10.07.05.12* A. An agency shall take reasonable measures to ensure that all individuals who are referred to provide services to clients do so in accordance with Maryland laws and regulations, including but not limited to the Health Occupations Article, Annotated Code of Maryland. B. Provision of Services. (1) A registered nurse shall assess each new client who requires skilled services and assistance with the activities of daily living. (2) The registered nurse shall also: (a) Participate in developing the client’s plan of care and in assigning appropriate personnel; (b) Determine whether the client requires the services of a certified nursing assistant, or whether services may be provided by an individual who is not certified; and (c) Participate in training and retraining the individuals who will provide the care, when indicated. C. Plan of Care. (1) A client’s plan of care shall be based on assessments of the client’s health, function, and psychosocial condition. (2) An assessment of a client shall be completed: (a) When the client is requesting or requiring services regulated by this chapter; (b) Before the client receives services from the agency unless: (i) The client does not request skilled care or skilled services; and (ii) There is no reason to believe that the client requires skilled care or skilled services, such as discharge instructions requiring skilled care; (c) Within 48 hours of when the client begins services when the client requires, including but not limited to: (i) Wound and catheter care; (ii) Treatment of stage three or stage four skin ulcers; (iii) Ventilator services; (iv) Skilled monitoring, testing, and aggressive adjustment of medications and treatments where there is the presence of, or risk for, a fluctuating acute condition; (v) Monitoring of a chronic medical condition that is not readily controllable through available medications and treatments; (vi) Infusion therapy; (vii) Specialized intravenous therapies or nutrition support; (viii) Monitoring for being at high risk for health or safety complications which cannot be adequately managed; or (ix) A different level of care after notification of a significant change of condition; (d) At the request of the client or the client representative; (e) At least annually; and (f) Except in the following circumstances: (i) Weather-related emergencies; (ii) Natural disasters; or (iii) Federal, state, or local declaration of an emergency. (3) When a registered nurse determines in the nurse’s clinical judgment that the client does not require an assessment within 48 hours of a significant change of condition as provided in §C(2)(c) of this regulation, the registered nurse shall: (a) Document the determination in the client’s record; and (b) Ensure that an assessment of the client is conducted within 7 calendar days. (4) The agency shall ensure that the care plan developed for the client at a minimum addresses: (a) The services to be provided to the client, which are based on the assessment of the client; (b) When and how often the services are to be provided; (c) How and by whom the services are to be provided; (d) Long-range and short-range goals for the client; and (e) Physical needs, including safety measures to protect against injury. (5) Client care plans shall be reviewed by a registered nurse or another health care practitioner who is authorized to do so under Health Occupations Article, Annotated Code of Maryland, when appropriate. D. Informed Consent. (1) An adult client who is competent to make decisions or a client representative with legal authority to make health care decisions may consent to make changes to the agency’s recommended plan of care. (2) A cognitively capable adult client, but not a client representative with legal authority to make health care decisions, may waive the licensee’s recommendation of certified care services to be provided in the adult client’s home to assist with treatments of a routine nature, or with the self-administration of medications. (3) A cognitively capable adult client may waive the licensee’s recommended skilled care. (4) Consents. (a) The consent given under §D(1)—(3) of this regulation may be granted only after a discussion of the risks and benefits with the client or, if appropriate, the client representative with legal authority to make health care decisions. This discussion shall be reflected in an informed consent form. (b) The informed consent form shall be: (i) Signed and dated by the client, or the client representative with legal authority over health care decisions; and (ii) Documented in the client’s records. (c) A form confirming a waiver of skilled services shall be signed by a cognitively capable adult client and maintained in the client’s record. (5) Client medications shall be administered in accordance with §F of this regulation. E. Nursing Supervision. (1) For clients who require skilled services or assistance with the activities of daily living, an agency shall have a registered nurse to provide oversight for: (a) Implementation of the care plan; (b) Delegation; (c) Supervision; and (d) Training. (2) The registered nurse shall provide periodic, on-site supervision of care: (a) At least every 45 days if the staff administers medications to the client; (b) At least every 3 months if the staff assists the client with self-administration of medications; (c) At least every 4 months if the staff does not administer medications or assist the client with medication self-administration; or (d) At a greater frequency established by the registered nurse due to the client's medical condition or clinical status. (3) The agency shall maintain accurate documentation of the supervision that is provided by the registered nurse. F. Medication Administration. If agency employees, independent contractors, or contractual employees administer medications, the agency shall: (1) Provide for administration of drugs and treatments by licensed or certified staff consistent with Maryland law and the client’s plan of care, unless the client has executed an informed consent form under §D of this regulation; (2) Provide for drugs and treatments to be administered only as ordered by the physician; and (3) Document in the client’s clinical record: (a) Medications administered or taken; (b) Medication errors; and (c) Adverse drug reactions and corrective action. G. On-Call Services. The agency shall: (1) Establish a procedure by which current clients or their representatives may contact a representative of the agency by communication device at any time, 24 hours a day and 7 days a week; (2) Recognize and respond to emergency inquiries in a manner that is consistent with medical and nursing standards; (3) Ensure that the inquiry is directed to an individual for response as required by medical and nursing standards; (4) Ensure that the individual responds to an inquiry not later than 1 hour after the inquiry is received by the agency or sooner as necessitated by medical standards; (5) Maintain a log of inquiries that includes the identity of the response personnel, content of the inquiry, and the time of each inquiry; and (6) Provide clients or the client representatives with written procedures and the phone number for on-call service. #### Regulation .13 Client Representative. *COMAR 10.07.05.13* A. An agency shall recognize the authority of: (1) A guardian of the person under Estates and Trusts Article, §13-705, Annotated Code of Maryland; (2) A guardian of the property under Estates and Trusts Article, §13-201, Annotated Code of Maryland; (3) An advanced directive that meets the requirements of Health-General Article, §5-602, Annotated Code of Maryland; (4) A surrogate decision maker with the authority under Health-General Article, §5-605, Annotated Code of Maryland; (5) A power of attorney that meets the requirements of Estates and Trusts Article, Title 17, Annotated Code of Maryland; (6) A representative payee or other similar fiduciary; or (7) Any other person, if that person was designated by a client who was competent at the time of designation, and the client or client representative has provided the agency with documentation of the designation. B. An agency may not recognize the authority of a client representative if the representative attempts to exceed the authority: (1) Stated in the instrument that grants the representative authority; or (2) Established by State law. C. An agency shall: (1) Document in the client’s record the name of the person, if any, with the authority identified in §A of this regulation; or (2) Include the documentation creating the authority in the record. #### Regulation .14 Clinical Records. *COMAR 10.07.05.14* A. With the exception of §B of this regulation, an agency shall ensure that a clinical record is maintained for each client in a manner that ensures security and confidentiality, and includes at a minimum: (1) The documentation required by §D of this regulation; (2) Any currently effective health care orders; (3) Nurse’s assessment (4) Rehabilitation plans, if appropriate; (5) The care plan; (6) Medications administered or taken, including: (a) Dosage; (b) Route of administration; and (c) Frequency; (7) History of sensitivities or allergic reactions; (8) Nutritional requirements, including specific dietary plans; (9) Medically necessary supplies and equipment; (10) Care notes; (11) The name, address, and telephone number of: (a) The client’s physicians; and (b) The client representative; and (12) The following documents for each client upon discharge: (a) Directions for the safe continuation of care after discharge; and (b) If skilled services have been provided, a discharge summary that includes the reason for discharge. B. An agency that provides care to clients who are assessed as not requiring certified caregivers or skilled services shall maintain a client record, including but not limited to: (1) Nursing assessment; (2) Plan of care; (3) Services provided; (4) Any significant change of condition; and (5) Any other pertinent information regarding the client being served. C. An agency shall develop policies and procedures to ensure that all information relating to a client’s condition or preferences, including any significant change of condition as defined in Regulation .02B(27) of this chapter, is documented in the client’s record and communicated in a timely manner to: (1) The client; (2) The client representative, if appropriate; and (3) All appropriate health care professionals and staff who are involved in the development and implementation of the client’s care plan. D. Care Notes. (1) Appropriate staff shall write care notes for each client, at a minimum: (a) On admission and at least weekly; (b) Upon any significant changes in the client’s condition; and (c) When the care plan is modified. (2) The agency shall ensure that all notes and reports that are entered in the clinical record, which may include an electronic record, are detailed, legible, chronological, dated, and signed with the name and title of the individual rendering the service. E. The agency may accept orders for care with an electronic signature. Orders may be received by, but not limited to, mail, hand delivery, or facsimile transmission. #### Regulation .15 Maintenance of Records. *COMAR 10.07.05.15* A. The agency shall maintain a client’s record for 5 years after the client is discharged. For a client younger than 18 years old, the agency shall maintain the client’s record after discharge until the resident is 21 years old, or for 5 years after the record is made, whichever is later, except as otherwise provided in Health-General Article, §4-403, Annotated Code of Maryland. B. If an agency ceases operation, the agency shall make arrangements to return the records to the client or client representative with legal authority to make health care decisions, or retain the records as required by §A of this regulation. C. An agency shall: (1) Maintain the privacy and confidentiality of a client’s medical records; (2) Release medical records or medical information about a client only with the written consent of the client or client representative, or as permitted by Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland; and (3) Maintain and dispose of a client’s medical records in accordance with Health-General Article, Title 4, Subtitle 3 and 4, Annotated Code of Maryland. D. In addition to the provisions of §§A—C of this regulation, the agency shall establish and implement procedures that ensure that: (1) Records of discharged clients are completed no later than 30 days after the date of discharge; and (2) Safeguards are in place to protect clinical record information against loss, destruction, or illegal or unauthorized use. #### Regulation .16 Client’s Rights and Responsibilities. *COMAR 10.07.05.16* A. The agency shall ensure that agency staff develops and implements written policies and procedures concerning clients’ rights and responsibilities. B. The agency shall make the policies and procedures available to clients or client representatives. C. The policies and procedures shall ensure that the agency provides the client or client representative with: (1) An estimate of costs associated with the services requested by the client; (2) A statement clarifying the costs that the client or client representative will be responsible for if services are not covered by third-party payors; (3) Fully itemized billing statements, including dates of services and unit charge, to be made available on request of the client or client representative; (4) The name of the caregiver or caregivers referred by the agency to provide the service or services; (5) The name and contact information for the individual who is responsible for supervising the client’s care; (6) The telephone number where a client or the client representative can contact the agency 24 hours a day, 7 days a week regarding care; and (7) Disclosure of any subcontractual relationship with any individual or agency to be assigned or referred to provide care to the client. D. Rights. (1) A client of an agency or, if appropriate, the client representative with legal authority to make health care decisions has the right to: (a) Be treated with consideration, respect, and full recognition of the client’s human dignity and individuality; (b) Receive treatment, care, and services that are adequate, appropriate, and in compliance with relevant State, local, and federal laws and regulations; (c) Participate in the development of the client’s care plan and medical treatment; (d) Refuse treatment after the possible consequences of refusing treatment have been fully explained; (e) Privacy; (f) Be free from mental, verbal, sexual, and physical abuse, neglect, involuntary seclusion, and exploitation; and (g) Confidentiality. (2) A client or client representative has the right to: (a) Make suggestions or complaints, or present grievances on behalf of the client to the agency, government agencies, or other persons without the threat or fear of retaliation; (b) Receive a prompt response, through an established complaint or grievance procedure, to any complaints, suggestions, or grievances the participant may have; and (c) Have access to the procedures for making a complaint to the Office of Health Care Quality, and to: (i) The Adult Protective Services Program of the local department of social services, if the client is an adult; or (ii) The Child Protective Services Program of the local department of social services, if the client is a minor. E. Advanced Directives. With the exception of durable medical equipment agencies, an agency shall: (1) Provide information to a client about advance directives and the right to have an advance directive; and (2) Obtain information regarding the client’s advance directives to determine whether the advance directive information has an impact on care provided. F. Client Directed Care. The agency shall honor the right of: (1) A cognitively capable adult client, or a client representative with legal authority to make health care decisions, to refuse any portion of planned treatment or other portions of the treatment plan, except where medical contraindications to partial treatment exist; and (2) A cognitively capable adult client to have an individual who is not certified to provide assistance with activities of daily living and treatments of a routine nature if the client signs a waiver of skilled services detailing the potential risks and benefits of waiver as required under Regulation .12D of this chapter. G. Informed Consent. The agency shall provide sufficient information to the client or the client representative to allow the client or the client representative to make an informed decision regarding treatment as required under Regulation .12D of this chapter, including: (1) The purpose and nature of an evaluation or treatment regimen; (2) Alternatives to treatment; (3) Side effects and benefits of a proposed treatment regimen and the alternatives to the treatment; (4) The estimated cost of the treatment and the alternatives; and (5) The right to withdraw from treatment at any time, including the risks associated with withdrawing from treatment. H. Client Participation. The agency shall allow a client, or client representative with legal authority to make health care decisions, to accept or reject, at the client’s or client representative’s discretion without fear of retaliation from the agency, any employee, independent contractor, or contractual employee that is referred by the agency. #### Regulation .17 Special Requirements for the Provision of Intravenous or Related Therapies. *COMAR 10.07.05.17* A. This regulation applies to intravenous or related therapy provided in the home. B. A provider of intravenous or related therapies shall meet the requirements of this regulation in addition to meeting the requirements of Regulations .01—.16 of this chapter. C. Specialized intravenous therapies and nutritional support services administered enterally or parenterally shall be considered skilled nursing functions. D. Medications. (1) Medications and preparations used in the provision of intravenous or nutritional support shall be obtained from a licensed pharmacy. (2) The agency shall document any adverse reactions associated with the therapy and notify the client’s physician. E. Education and Training. When an agency provides intravenous or related therapies, the agency shall provide: (1) Education, training, and written instructions to the client, client representative, or the individual caring for the client before the initiation of treatment, which includes: (a) Feeding formulation or medication preparation; (b) Administration of the therapy; (c) Accessing private care; (d) Equipment maintenance; (e) Recognition of complications of therapy, adverse medication reactions, and equipment malfunctions; and (f) Mechanisms for accessing a clinician during business hours and at any time after hours for questions related to drug therapy, drug administration, or equipment troubleshooting or malfunctions; and (2) Retraining and a review to the client, client representative, or the individual caring for the client as needed or requested. F. The agency shall maintain a clinical record for a client receiving intravenous or related therapies, which, in addition to the documents required to be maintained in accordance with the provisions set forth in Regulations .14 and .15 of this chapter, includes the following: (1) Results of training or retraining of the client, client representative, or the individual caring for the client; (2) Composition, indication for use, role, and mode of administration of feeding formulas or medications; and (3) Summary statement at termination of the intravenous or related therapy which includes the results of therapy, complications, outcome, and disposition of the client. #### Regulation .18 Special Requirements for the Provision of Ventilator Services. *COMAR 10.07.05.18* A. A provider of ventilator services shall meet the requirements of this regulation in addition to meeting the requirements of Regulations .01—.16 of this chapter. B. This regulation applies to ventilator services provided in the home, including: (1) Volume ventilation; (2) Pressure ventilation; (3) Emergency back-up power systems; (4) Alarms and troubleshooting equipment; (5) Emergency resuscitation; and (6) All related medical equipment used with the provision of ventilator services, including but not limited to: (a) Nebulizers; (b) Suction equipment; and (c) Oxygen. C. Education and Training. When an agency provides ventilator services, the agency shall: (1) Use either a licensed registered nurse or a licensed respiratory care practitioner to supervise the provision of education and training and written instruction to the client, client representative, or individual caring for the client; and (2) Provide retraining and review on a monthly basis, and as frequently as necessary. D. Client Record. For a client receiving ventilator services, the agency shall maintain a clinical record, in addition to the documents required to be maintained in accordance with the provisions set forth in Regulations .14 and .15 of this chapter, that includes the following: (1) An evaluation of use of the ventilator and all related medical equipment by the client, client representative, or individual caring for the client that includes: (a) Training at least monthly on the provision of ventilator services; and (b) Retraining, more frequently as needed, on the provision of ventilator services; (2) A prescription that includes the mode, frequency, and ventilator settings; (3) Respiratory and all specialized services, including the results, complications, and outcomes; (4) Physician orders and pharmacy-dispensed respiratory medications; (5) Evidence that the client, client representative, or individual caring for the client was instructed that medications are to be obtained from a licensed pharmacy; and (6) A discharge summary when a client is no longer receiving ventilator-related services. #### Regulation .19 Special Requirements for the Provision of Home Medical Equipment Services. *COMAR 10.07.05.19* A. An agency that provides home medical equipment services shall meet the requirements of this regulation in addition to meeting the requirements of Regulations .01—.16 of this chapter. B. Education and Training. When an agency provides home medical equipment services, the agency shall: (1) Ensure that its personnel demonstrate competency in delivering and installing the equipment; (2) Provide education, training, and written instructions to the client, the client representative, or the individual caring for the client on the use of the equipment at the time of installation; and (3) Provide the client, client representative, or the individual caring for the client the telephone number of the agency in the event of equipment failure or emergency. C. Upon request, an agency shall provide the prescribing physician with a copy of the: (1) Qualifications, duties, and responsibilities of agency personnel who deliver the home medical equipment services; and (2) Instructions given to the client and the client’s caregivers. D. Client Records. The agency shall maintain a client record for each client receiving home medical equipment services in accordance with industry standards, including but not limited to: (1) Physician order for the provision of home medical equipment services; (2) Any significant change of condition; (3) Services provided; and (4) Any other pertinent information regarding the client being served. E. An agency shall ensure that the installation, maintenance, repair, and storage of home medical equipment comply with the manufacturer’s specifications. #### Regulation .20 Sanctions. *COMAR 10.07.05.20* A. If the Secretary determines that an agency has violated this chapter, the Secretary, in addition to the sanctions set forth in Regulations .21—.27 of this chapter may: (1) Restrict the number of clients the agency may serve; (2) Limit the types of clients an agency may serve; (3) Require the licensee, and any of its staff, to receive remedial instruction in a specific area; (4) Require the agency to use the services of a management firm that is approved by the Department; (5) Mandate staffing patterns that specify the number of personnel or personnel qualifications, or both; (6) Direct the licensee to correct the violations in a specific manner or within a specified timeframe; (7) Notify, or require the agency to notify, the client, the client representative, or the family of any client who is affected by the noncompliance; (8) Increase the frequency of monitoring visits during a specified period of time; or (9) Establish certain conditions for continued operation, including time limits for continued operation and for compliance. B. If the Secretary determines that the licensee has violated a condition or requirement of an imposed sanction, the Secretary may suspend or revoke the license. C. A licensee aggrieved by the imposition of a sanction under §A(1) or (2) or B of this regulation may appeal the Secretary’s action by filing a request for a hearing in accordance with Regulation .28 of this chapter. #### Regulation .21 Civil Money Penalties. *COMAR 10.07.05.21* A. The Secretary may impose a civil money penalty on an agency if a deficiency or continuing pattern of deficiencies exists in the residential service agency. B. In determining whether a civil money penalty will be imposed, the Secretary shall consider the following factors: (1) Nature, number, and seriousness of the deficiencies; (2) The extent to which the deficiency or deficiencies are part of a continuing pattern during the preceding 24 months; (3) The degree of risk to the health, life, or safety of the clients of the agency that is caused by the deficiency or deficiencies; (4) The efforts made by, and the ability of, the agency to correct the deficiency or deficiencies; and (5) An agency’s prior history of compliance. C. If the Department determines that a deficiency or a continuing pattern of deficiencies exists, the Department shall notify the agency of the deficiency or deficiencies and may: (1) Permit the agency the opportunity to correct the deficiencies by a specified date; (2) Impose a civil money penalty of up to $1,000 per day until sustained compliance is achieved; or (3) Impose a civil money penalty for each instance of violation. D. If the Department permits an agency the opportunity to correct the deficiencies by a specific date, and the agency fails to comply with this requirement, the Department may impose a civil penalty of up to $1,000 for each day of violation until correction of the deficiency or deficiencies has been verified and sustained compliance has been maintained. E. If the Department proposes to impose a civil money penalty, the Secretary shall issue an order which shall state the: (1) Deficiency or deficiencies on which the order is based; (2) Amount of the civil money penalties to be imposed; (3) Manner in which the amount of the civil money penalty was calculated; and (4) Appeal rights. #### Regulation .22 Amount of Civil Money Penalties. *COMAR 10.07.05.22* A. A civil money penalty imposed on a person under this chapter may not exceed $10,000 per instance or, as provided in Regulation .21 of this chapter, $1,000 per day. B. In setting the amount of the civil money penalty under this chapter, the Secretary shall consider the following factors: (1) Nature, number, and seriousness of the deficiencies; (2) The degree of risk to the health, life, or safety of the clients of the agency that is caused by the deficiency or deficiencies; (3) The efforts made by, and ability of, the agency to correct the deficiency or deficiencies; (4) Whether the amount of the civil money penalty will jeopardize the financial ability of the agency to continue operation as an agency; (5) Prior history of compliance by the agency; and (6) Other factors as justice may require. C. A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary’s action by filing a request for a hearing in accordance with Regulation .28 of this chapter. #### Regulation .23 Civil Money Penalties — Hearings. *COMAR 10.07.05.23* A. A hearing on the appeal shall be held consistent with State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland. B. The Secretary shall have the burden of proof with respect to the imposition of the civil money penalties under this chapter. #### Regulation .24 Emergency Suspension. *COMAR 10.07.05.24* A. The Secretary may immediately suspend a license on finding that the public health, safety, or welfare imperatively requires emergency action B. The Department shall deliver a written notice to the licensee: (1) Informing the licensee of the emergency suspension; (2) Giving the reasons for the action, and the regulation or regulations with which the licensee has failed to comply that forms the basis for the emergency suspension; and (3) Notifying the licensee of its right to request a hearing and to be represented by counsel. C. The filing of a hearing request does not stay the emergency action. D. When a license is suspended by emergency action: (1) The agency shall immediately return the license to the Department; (2) The agency shall immediately stop providing services; and (3) The agency shall notify competent clients and client representatives about the suspension and make every reasonable effort to assist them in making other arrangements for services. E. A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary’s action by filing a request for a hearing in accordance with Regulation .28 of this chapter. F. Show Cause Hearing. (1) In addition to the right to request an evidentiary hearing in accordance with Regulation .28 of this chapter, a person aggrieved by the action of the Secretary under this regulation shall be provided with the opportunity for a hearing to show cause why the Department should lift the summary suspension before the evidentiary hearing. (2) The show cause hearing shall be held promptly. (3) The show cause hearing shall be a nonevidentiary hearing to provide the parties with an opportunity for oral argument on the summary suspension. (4) The show cause hearing shall be conducted before the Secretary, or a designee of the Secretary, who: (a) Shall determine procedural issues; (b) May impose reasonable time limits on each party’s oral argument; and (c) Shall make rulings reasonably necessary to facilitate the effective and efficient operation of the show cause hearing. (5) At the conclusion of the show cause hearing, the Secretary or the Secretary’s designee may: (a) Affirm the order of summary suspension; (b) Rescind the order of summary suspension; (c) Enter into a consent order; or (d) Enter into an interim order warranted by the circumstances of the case, including one providing for a stay of the summary suspension subject to certain conditions. (6) After the show cause hearing, if the Secretary or the Secretary’s designee decides to continue the summary suspension, the person aggrieved by the decision may request an evidentiary hearing before the Office of Administrative Hearings in accordance with Regulation .28 of this chapter. G. If the Secretary’s final decision does not uphold the emergency suspension, the agency may resume operation. #### Regulation .25 Denial or Revocation of a License. *COMAR 10.07.05.25* The Secretary, for cause shown, may deny, revoke, or refuse to reissue any license issued for inability or failure to comply with the regulations of this chapter. This action is subject to the provisions of the Administrative Procedure Act, State Government Article, §10-201 et seq., Annotated Code of Maryland. #### Regulation .26 Notice to Clients. *COMAR 10.07.05.26* Unless otherwise ordered by the Secretary, the agency shall notify each competent client and each client representative within at least 30 days of: A. Any significant change of licensure status; B. A voluntary surrender of its agency license; or C. Denial, revocation, or suspension of the license. #### Regulation .27 Penalty for Unlicensed Operation. *COMAR 10.07.05.27* A person that operates a residential service agency without a license may be assessed a civil money penalty by the Department not to exceed $10,000 per violation and, additionally, is guilty of a misdemeanor and, on conviction, is subject to a criminal fine not exceeding $1,000 for the first offense and $10,000 for each subsequent offense. Each day that a violation is continued after the first conviction is a separate offense. #### Regulation .28 Hearings. *COMAR 10.07.05.28* A. An agency shall file a request for a hearing with the Office of Administrative Hearings, with a copy to the Office of Health Care Quality, not later than 30 days after receipt of notice of the Secretary’s action. The request shall include a copy of the Secretary’s action. B. A hearing requested under this chapter shall be conducted in accordance with State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, and COMAR 10.01.03 and 28.02.01. C. The burden of proof is as provided in COMAR 10.01.03.28. D. Unless otherwise stated in this chapter, the Office of Administrative Hearings shall issue a proposed decision within the time frames set forth in State Government Article, §10-205, Annotated Code of Maryland. E. An aggrieved party may file exceptions as provided in COMAR 10.01.03.35. F. A final decision by the Secretary shall be issued in accordance with COMAR 10.01.03.35. ### Chapter 06 — Hospital Patient Safety Program **Authority:** Health-General Article, §§19-308 and 19-319, Annotated Code of Maryland **Administrative History:** Effective date: March 15, 2004 (31:5 Md. R. 448) **Administrative History:** Regulation .15B amended effective February 26, 2018 (45:4 Md. R. 206) **Administrative History:** Regulation .17 adopted effective February 26, 2018 (45:4 Md. R. 206) #### Regulation .01 Purpose. *COMAR 10.07.06.01* The purpose of this chapter is to provide a safe environment for patients by requiring hospitals to: A. Identify adverse events; B. Encourage reporting of near-misses; C. Assess and prioritize near-misses and adverse events based on level of disability or potential disability to patients; D. Determine the appropriate hospital response based on level of disability or potential disability; E. Conduct a root cause analysis of: (1) All level 1 events; (2) All level 2 events; and (3) If warranted, any near-miss or other adverse event; F. Conduct an appropriate investigation of adverse events and near-misses that do not require or warrant a root cause analysis; G. Provide a process by which the concerns of patients can be addressed; and H. Provide a process to notify a patient or, if appropriate, a patient's family, whenever an outcome of care differs significantly from an anticipated outcome. #### Regulation .02 Definitions. *COMAR 10.07.06.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Action plan” means a written document that includes: (a) Specific measures to correct problems or areas of concerns; (b) Specific measures to address areas of system improvement; (c) Time frames for implementation of any specific measures; and (d) Title of responsible individual to monitor implementation and effectiveness. (2) “Adverse event” means an unexpected occurrence related to an individual's medical treatment and not related to the natural course of the patient's illness or underlying disease condition. (3) “Department” means the Maryland Department of Health. (4) “Level 1 adverse event” means an adverse event that results in death or serious disability. (5) “Level 2 adverse event” means an adverse event that requires a medical intervention to prevent death or serious disability. (6) “Level 3 adverse event” means an adverse event that does not result in death or serious disability and does not require any medical intervention to prevent death or serious disability. (7) “Medical review committee” has the meaning stated in Health Occupations Article, §1-401, Annotated Code of Maryland. (8) “Near-miss” means a situation that could have resulted in an adverse event but did not, either by chance or through timely intervention. (9) “Patient safety program” means an ongoing, proactive program for identifying risks to patient safety and reducing medical errors which is one component of the hospital-wide risk management program. (10) “Root cause analysis” means a medical review committee process as defined under Health Occupations Article, §1-401, Annotated Code of Maryland, for identifying the basic or contributing causal factors that underlie variations in performance associated with adverse events or near-misses. (11) “Serious disability” means a physical or mental impairment that substantially limits one or more of the major life activities of an individual lasting more than 7 days or still is present at the time of discharge. #### Regulation .03 Patient Safety Program. *COMAR 10.07.06.03* A. General. On or before March 15, 2004, a hospital shall have in effect a patient safety program that meets the requirements of this chapter. B. Duties of the Hospital. (1) The hospital shall identify an individual as patient safety coordinator who shall: (a) Coordinate patient safety activities; (b) Facilitate assessment and determination of the appropriate response to reported near-misses and adverse events related to patient care; (c) Monitor root cause analyses and any actions resulting from a root cause analysis; and (d) Provide for flow of information among quality assurance, credentialing, peer review, and any patient safety committee. (2) The hospital shall establish: (a) Patient safety education programs for all staff; and (b) An internal staff committee structure in accordance with Health Occupations Article, §1-401, Annotated Code of Maryland to conduct a review and evaluation of patient safety activities in accordance with this chapter. (3) The governing board of a hospital shall develop a process to review the hospital's patient safety program and to determine the effectiveness of the hospital's patient safety program. (4) Before a committee may operate or review patient safety activities under this chapter, a hospital shall require that the committee meet the requirements for a medical review committee under Health Occupations Article, §1-401, Annotated Code of Maryland. #### Regulation .04 Near-Miss and Adverse Event Reporting and Determination of Appropriate Response. *COMAR 10.07.06.04* A. The hospital shall develop and encourage a supportive environment that permits spontaneous identification, open discussion, and timely and accurate reporting of near-misses and adverse events. B. The hospital shall establish a clear and well-defined near-miss and adverse event identification and reporting process that shall: (1) Encourage reporting of near-misses and require reporting of adverse events; (2) List and describe examples of adverse events that shall be reported; (3) Designate a hospital representative to whom a near-miss is encouraged to be reported or to whom an adverse event shall be reported; (4) Provide a time frame within which the near-miss is encouraged to be reported or within which an adverse event shall be reported; (5) Require that an individual employed by the hospital or appointed to the medical staff and who is aware of an adverse event shall report the adverse event in accordance with this chapter; (6) Develop a procedure to coordinate receipt of all adverse events and near-misses and to prioritize adverse events and near-misses based on level of disability or potential disability; and (7) Develop a procedure to assign an appropriate response to level 1 and level 2 adverse events, other adverse events, and near-misses. #### Regulation .05 Procedures for Level 1 and 2 Adverse Events and Certain Near-Misses. *COMAR 10.07.06.05* A. When a level 1 or 2 adverse event, or a near-miss that warrants a root cause analysis occurs, the hospital shall: (1) Provide immediate care to the patient; (2) Identify any immediate corrective action to prevent reoccurrence; (3) Identify and report the event in accordance with the hospital's reporting process; (4) Complete a root cause analysis within 60 days of the time that the hospital has knowledge of the occurrence; (5) Develop and implement an action plan to correct any systems problems; (6) Share any pertinent information with quality assurance or other medical review committees; and (7) Aggregate data to determine patterns or trends. B. All patient safety activities shall be conducted by a medical review committee established under Health Occupations Article, §1-401, Annotated Code of Maryland. #### Regulation .06 Root Cause Analysis. *COMAR 10.07.06.06* A. The hospital shall appoint an interdisciplinary root cause analysis team that shall include: (1) Individuals who have knowledge of the event or near-miss; (2) Representatives of hospital leadership; and (3) Individuals with expertise in the subject matter of the event. B. The root cause analysis team shall interview and permit participation of individuals who were directly involved in the event or near-miss and allow the individual to participate in the root cause analysis as appropriate. C. The root cause analysis shall examine the cause and effect of the event through an impartial process by: (1) Analysis of human and other factors; (2) Analysis of related processes and systems; (3) Analysis of underlying cause and effect systems through a series of “why” questions; (4) Identification of risks and possible contributing factors; and (5) Determination of improvement in processes or systems. D. A root cause analysis shall: (1) Be internally consistent; and (2) Include consideration of relevant literature and best practices. E. The hospital shall provide feedback including changes to hospital policy or procedure resulting from the root cause analysis to hospital employees and staff who were involved in the event or near-miss and to other employees or staff who would benefit from the feedback. #### Regulation .07 Procedures for Level 3 Adverse Events and Certain Near-Misses. *COMAR 10.07.06.07* A. If the event is not a level 1 or 2 event or a near-miss that warrants a root cause analysis, the hospital shall conduct an evaluation of the event to determine any problem area and corrective action. B. All events shall be aggregated by type and level to determine any patterns or trends. C. The hospital is encouraged to evaluate and trend all near-misses to determine any system problems. D. The hospital shall monitor the results and effectiveness of all action plans. #### Regulation .08 Information Sharing. *COMAR 10.07.06.08* The patient safety program shall require that the quality assurance and other medical review committees share information and take any appropriate action concerning near-misses and adverse events. #### Regulation .09 Reports to the Department. *COMAR 10.07.06.09* A. A hospital shall report any level 1 adverse event to the Department within 5 days of the hospital's knowledge that the event occurred. B. A hospital shall submit the root cause analysis and action plan for the level 1 adverse event to the Department within 60 days of the hospital's knowledge of the occurrence. C. Any root cause analysis and any other medical review committee information submitted to the Department and the identity of individuals appointed to the interdisciplinary root cause analysis team are confidential under Health Occupations Article, §1-401, Annotated Code of Maryland and are not discoverable, disclosable, or admissible as evidence in any civil action or available under the Maryland Public Information Act. D. If the Department receives a complaint alleging a level 1 adverse event, the Department may accept the root cause analysis as a hospital's internal investigation under Health-General Article, §19-309(b), Annotated Code of Maryland. #### Regulation .10 Documentation. *COMAR 10.07.06.10* Actions taken by the quality assurance and medical staff credentialing and peer review committees shall be documented in committee minutes. #### Regulation .11 Patient Complaint Program. *COMAR 10.07.06.11* A. In accordance with this regulation, the patient safety program shall include a formal written program for addressing patient complaints. B. The hospital shall provide patients with information regarding the hospital's patient complaint program including: (1) The name of the hospital's representative that the patient may contact if the patient wishes to make a complaint; and (2) The hospital representative's phone number or address. C. The hospital's representative shall treat the complainant with dignity and courtesy and due regard for the individual's privacy. D. The hospital's representative shall provide the complainant with information about the complaint including: (1) The hospital representative that the patient may contact for information regarding the complaint; (2) The procedure for investigating the complaint; (3) The length of time in which the complainant can expect a response or resolution to the complaint; and (4) Notice that the patient may contact the Department at a specified telephone number or address with any complaint. E. The hospital's representative shall document the complaint and any action taken concerning the complaint or the hospital function complained about. F. Patient Safety Program Requirement—Notice to Patients and Families of Unanticipated Outcomes. The hospital shall inform the patient and, if appropriate, the patient's family whenever a final outcome of care differs significantly from an anticipated outcome. #### Regulation .12 Interhospital Notification Of Level 1 or Level 2 Adverse Events. *COMAR 10.07.06.12* A. A hospital that admits a patient with a condition resulting from a level 1 or level 2 adverse event that the hospital perceives may be related to care that was provided at another Maryland hospital and that appears to be unknown to the other hospital at the time of discharge shall notify and provide any necessary information to the appropriate medical review committee at the hospital where the adverse event allegedly occurred. B. The hospital where the event allegedly occurred shall conduct a root cause analysis and provide notice to the Department in accordance with this chapter. C. The hospital where the event allegedly occurred shall notify the patient or the patient's family in accordance with this chapter. D. All communication that occurs in accordance with §§A—B of this regulation is confidential under Health Occupations Article, §1-401, Annotated Code of Maryland. #### Regulation .13 Records. *COMAR 10.07.06.13* The hospital shall maintain records that document the operation of its patient safety program. #### Regulation .14 Documentation. *COMAR 10.07.06.14* A. On or before March 15, 2004, the hospital shall send to the Secretary a written description of its patient safety program that includes: (1) The name of the patient safety coordinator; (2) The board policy statement relevant to patient safety activities including the process to review the hospital's patient safety program and to determine the effectiveness of the hospital's patient safety program; (3) A description of the near-miss and adverse event identification and reporting process; (4) A list of examples of adverse events that shall be reported; (5) A description of the process for determining which near-misses warrant a root cause analysis to be conducted; (6) A description of the near-miss and adverse event review, prioritization, evaluation, and root cause analysis process; (7) A description of the process used to provide notification to a patient, and, if appropriate, to a patient's family whenever an outcome of care differs from an anticipated outcome; and (8) A description of the formal written patient complaint process. B. The hospital shall notify the Secretary of any change in its patient safety program related to the description required by this regulation within 30 days of the effective date of the change. #### Regulation .15 Plan of Correction. *COMAR 10.07.06.15* A. If the Department notifies a hospital that the patient safety program of the hospital does not meet the requirements of this chapter, the hospital shall submit a plan indicating the steps the hospital shall take to meet the requirements of this chapter. B. The plan shall be sent to the Secretary within 10 days after the Department notifies the hospital that the hospital does not meet the requirements of this chapter. #### Regulation .16 Penalties. *COMAR 10.07.06.16* If a hospital fails to have in effect a patient safety program in accordance with this chapter, then the Secretary may impose on the hospital the following penalties: A. Revocation of the hospital's license; or B. A fine of $500 for each day that the hospital is in violation of this chapter. #### Regulation .17 Departmental Obligations. *COMAR 10.07.06.17* The Department shall: A. Provide feedback to hospitals regarding submitted root cause analyses within 60 days of receipt; and B. Release an annual public report containing a compilation of de-identified data regarding the type and outcomes of reported adverse events. ### Chapter 07 — Nursing Referral Service Agencies **Authority:** Health-General Article, Subtitle 19-4B, Annotated Code of Maryland **Administrative History:** Effective date: November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .04A, E amended effective March 13, 2017 (44:5 Md. R. 292) #### Regulation .01 Purpose. *COMAR 10.07.07.01* The purpose of this chapter is to set minimum standards for licensure of nursing referral service agencies in Maryland. This chapter does not preclude a nursing referral service agency from operating with independent contractors. #### Regulation .02 Definitions. *COMAR 10.07.07.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Activities of daily living” means normal daily activities including: (a) Bathing, toileting, and personal hygiene; (b) Dressing; (c) Meal preparation and eating; (d) Companionship; and (e) Assistance with physical transfer and ambulation. (2) “Agency” means a licensed nursing referral service agency as defined in §B(8) of this regulation. (3) “Care provider” means an individual who provides health care services and assistance to a client in the activities of daily living including: (a) Bathing, toileting, and personal hygiene; (b) Dressing; (c) Meal preparation and eating; (d) Companionship; and (e) Assistance in physical transfer and ambulation. (4) “Department” means the Maryland Department of Health. (5) “Home health aid services” means personal and health care services delivered to a client by a care provider. (6) “License” means a document issued by the Secretary to a person to operate a nursing referral service agency in Maryland. (7) “Licensed or certified health professional” means an individual who is licensed or certified under the Health Occupations Article, Annotated Code of Maryland, to provide health care services in this State. (8) “Licensee” means a person to whom a license is issued by the Secretary to operate a nursing referral service agency. (9) “Nursing referral service agency” means one or more individuals engaged in the business of screening and referring, directly or in accordance with contractual arrangements that may include independent contractors, licensed health professionals or care providers to clients for the provision of nursing services, home health aid services, or other home health care services at the request of the client. (10) “Residence” means a place where an individual resides and may include a private home, a nursing facility, an assisted living program, or other type of residential unit. (11) “Secretary” means the Secretary of Health. #### Regulation .03 License Required. *COMAR 10.07.07.03* A. A person, partnership, corporation, association, or other business entity may not conduct, operate, or maintain a nursing referral service agency in this State before being licensed by the Secretary. B. This chapter does not limit the right of any person who holds a license issued under Health-General Article or Health Occupations Article, Annotated Code of Maryland, to act as authorized by that license. #### Regulation .04 Licensing Procedures. *COMAR 10.07.07.04* A. Application for License. (1) A person desiring to conduct, operate, or maintain a nursing referral service agency in this State shall file an application with the Secretary, on the written or electronic form provided by the Secretary. (2) The application for licensure shall contain the name and address of each officer and the director of the nursing referral service agency. (3) Along with the application, the applicant shall submit a: (a) Nonrefundable 3-year license fee of $1,000 payable to the Department; and (b) Copy of the agency's policies and procedures as specified in Regulation .08B(1) of this chapter. B. Additional Requirements. The applicant shall: (1) Demonstrate compliance with all applicable federal, State, and local laws and regulations; and (2) Maintain records to support compliance with the regulations of this chapter and make the records available to the Department upon request. C. After reviewing the application for licensure, the Secretary shall: (1) Approve the application and issue a 3-year license to the applicant if the applicant complies with all requirements of this chapter; or (2) Deny the application if the applicant does not comply with the requirements of this chapter. D. A 3-year license expires 3 years from the date of its issuance, unless it is otherwise revoked or suspended by the Department. E. License Renewal. (1) The agency shall file an application for relicensure on the written or electronic form provided by the Secretary at least 60 days before the expiration of its current license. (2) A licensee shall submit to the Department: (a) An application for license renewal; (b) A nonrefundable license renewal fee of $1,000 payable to the Department; and (c) Updates, if any, to the agency's policies and procedures as specified in Regulation .08B(1) of this chapter. #### Regulation .05 Posting Of License. *COMAR 10.07.07.05* A nursing referral service agency shall post its license conspicuously onsite so that it is clearly visible to the general public. #### Regulation .06 Restrictions on a License. *COMAR 10.07.07.06* A. A licensee may not, under any circumstances, transfer or reassign its nursing referral service agency license to another person. B. If the agency ceases to operate for any reason, the license is void and the licensee shall immediately return the license to the Department. #### Regulation .07 Inspections by the Secretary of Health. *COMAR 10.07.07.07* A. An applicant or a licensee shall maintain records to support compliance with this chapter and ensure that all records are open to inspection by the Department. B. An applicant or a licensee shall assist the Department in conducting an inspection if the Department determines that the assistance is necessary to enable the Department to conduct the inspection. C. If the Department issues deficiencies after an inspection, an agency shall submit a written plan of correction to the Department within 10 business days of receiving the Department's notice of deficiencies. #### Regulation .08 Administration. *COMAR 10.07.07.08* A. Contractual Arrangements. The regulations of this chapter do not preclude a nursing referral service agency from operating with independent contractors. B. Agency Referrals. An agency shall: (1) Develop and implement policies and procedures to screen licensed or certified health professionals and care providers that include the following: (a) A State criminal history records check or a private agency background check in accordance with Health-General Article, §19-4B-03(c), Annotated Code of Maryland; (b) Verification of current professional licensure or certification under the Health Occupations Article, Annotated Code of Maryland; (c) A basic health screening including tuberculosis screening; (d) Verification of references; (e) Verification of employment history; (f) Completion of I-9 forms; and (g) An in-person interview of a licensed or certified health professional and care provider before any referral of the individual is made to a client; and (2) Disclose to the client or the client's representative whether or not the agency has made a determination that the referral is appropriate to the needs of a client and is in compliance with applicable titles of Health Occupations Article, Annotated Code of Maryland. C. Complaint Process. (1) An agency shall institute an internal client complaint investigation process that includes: (a) Notice to the client or the client's representative of the complaint process; and (b) Protocols to investigate complaints. (2) An agency shall provide notice to clients of the Department's complaint hotline number for complaints about services provided by an individual that is referred by the agency. D. Client Participation. An agency shall allow clients to accept or reject, at their discretion, any licensed or certified health professional or care provider that is referred by the agency. #### Regulation .09 Sanctions. *COMAR 10.07.07.09* A. The Secretary may deny, suspend, revoke, or refuse to reissue any license for inability or failure to comply with this chapter. Any action taken to deny, suspend, or refuse to issue a license is subject to provisions of the Administrative Procedure Act, State Government Article, §10-201 et seq., Annotated Code of Maryland. B. The Secretary, in addition to or instead of the sanctions set forth in §A of this regulation may direct the licensee to establish certain conditions for continued operation, including time limits for compliance. #### Regulation .10 Penalty for Unlicensed Operation. *COMAR 10.07.07.10* A person that operates a nursing referral services agency without a license is guilty of a misdemeanor, and on conviction is subject to a fine not exceeding $1,000 for the first offense and $10,000 for each subsequent offense. Each day that a violation is continued after the first conviction is a separate offense. ### Chapter 08 — Freestanding Medical Facilities **Authority:** Health-General Article, §2-104 and Title 19, Subtitle 3A, Annotated Code of Maryland **Administrative History:** Effective date: February 12, 2007 (34:3 Md. R. 297) **Administrative History:** Regulation .04B amended effective March 13, 2017 (44:5 Md. R. 292) **Administrative History:** Regulation .05A amended effective March 13, 2017 (44:5 Md. R. 292) **Administrative History:** Regulation .05C amended effective August 29, 2016 (43:17 Md. R. 953) #### Regulation .01 Definitions. *COMAR 10.07.08.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Accredited hospital” means a hospital accredited by the Joint Commission on Accreditation of Healthcare Organizations. (2) “ACEP” means the American College of Emergency Physicians. (3) “Affiliated hospital” means a hospital that operates and provides ancillary and support services to the freestanding medical facility. (4) “Certified medical radiation technologist” means an individual who is certified by the Board of Physicians to practice medical radiation technology in this State. (5) “Credentialing process” means the process by which a hospital: (a) Verifies qualifications of a physician; (b) Delineates clinical privileges of a physician; and (c) Monitors performance of a physician. (6) “Department” means the Maryland Department of Health. (7) “Emergency medical condition” means a medical condition manifesting itself by acute symptoms of sufficient severity including severe pain, psychiatric disturbances, and symptoms of substance abuse such that the absence of immediate medical attention could result in: (a) Placing the health of the individual in serious jeopardy; (b) Placing the health of a pregnant woman or unborn child in serious jeopardy; (c) Serious impairment to any bodily function; (d) Serious dysfunction of any bodily organ or part; or (e) With respect to a pregnant woman who is having contractions: (i) Inadequate time to effect a safe transfer to another hospital before delivery; or (ii) The transfer posing a threat to the health or safety of the woman or the unborn child. (8) “Freestanding medical facility” means a facility: (a) In which medical and health services are provided; (b) That is physically separated from a hospital or hospital grounds; and (c) That is an administrative part of a hospital or related institution. (9) “Hospital” means an institution that: (a) Has a group of at least five physicians who are organized as a medical staff for the institution; (b) Maintains facilities to provide, under the supervision of the medical staff, diagnostic and treatment services for two or more unrelated individuals; and (c) Admits or retains the individuals for overnight care. (10) “Joint Commission on Accreditation of Healthcare Organizations” means the voluntary national healthcare accreditation service recognized for Medicare certification purposes by Public Law 89-97. (11) “License” means a document issued by the Secretary to operate a freestanding emergency medical facility in this State. (12) “Licensed independent practitioner” means any individual permitted by law and by the facility to provide care and services without direction or supervision within the scope of the individual's license and consistent with individually granted clinical privileges. (13) “Physician” means an individual who is licensed by the Board of Physicians to practice medicine in this State. (14) “Registered nurse” means an individual who is licensed by the Board of Nursing to practice registered nursing in this State. (15) “Related institution” means a facility as defined under Health-General Article, §19-301(o), Annotated Code of Maryland. (16) “Secretary” means the Secretary of Health. #### Regulation .02 Incorporation by Reference. *COMAR 10.07.08.02* A. In this chapter, the following documents are incorporated by reference. B. Documents Incorporated. (1) Interhospital Transfer Guidelines Manual; Maryland Institute for Emergency Medical Services Systems, Baltimore, Maryland (January 2002). (2) ACEP Policy Statement: Emergency Department Planning and Resources Guidelines (June 2004), American College of Emergency Physicians, PO Box 619911, Dallas, Texas 75261-9911. (3) Guidelines for Design and Construction of Hospital and Healthcare Facilities, 2001 Edition, American Institute of Architects, 1735 New York Avenue, N.W., Washington D.C. 20006, which is incorporated in COMAR 10.07.01.03. (4) Hospital Accreditation Standards, 2006 Edition, Joint Commission on Accreditation of Healthcare Organizations, One Renaissance Blvd, Oakbrook Terrace, Illinois 60181, which is incorporated in COMAR 10.07.01.09. (5) U.S. Centers for Disease Control and Prevention Guidelines for Standard Precautions and the federal Occupational Safety and Health Administration/Maryland Occupational Safety and Health, Bloodborne Pathogen Standard 29 CFR §1910.1030 which is incorporated by reference in COMAR 09.12.31. (6) The Maryland State Fire Prevention Code, which is incorporated by reference in COMAR 29.06.01. #### Regulation .03 Restrictions. *COMAR 10.07.08.03* A freestanding medical facility may not use the name “emergency room”, “emergency department”, or “hospital” in its title or advertisements or on any signage. #### Regulation .04 Licensure Application Procedure. *COMAR 10.07.08.04* A. A hospital may not establish, operate, or continue to operate an existing freestanding medical facility without first obtaining a license from the Secretary. B. A hospital desiring to establish a freestanding medical facility shall apply to the Department for initial licensure on a written or electronic form provided by the Secretary. C. The application shall state the name of the affiliated accredited hospital. D. The application shall be accompanied by a nonrefundable 3-year license fee of $3,000. E. The Secretary shall issue a license to a freestanding medical facility for a term of 3 years if the facility complies with all licensing requirements. #### Regulation .05 Renewal of License. *COMAR 10.07.08.05* A. A licensee shall file an application for license renewal with the Secretary on a written or electronic form provided by the Secretary. B. A licensed freestanding medical facility shall apply for licensure within 60 days of the expiration date of its current license. C. The application fee for license renewal shall be accompanied by a nonrefundable 3-year license renewal fee of $2,000. #### Regulation .06 Inspections. *COMAR 10.07.08.06* A. A freestanding medical facility shall be open to inspection at all times by the Department for annual licensure surveys, revisit surveys, and complaint investigations. B. Licensure Standards. When conducting a licensure or complaint survey, the Department shall use this chapter as well as the: (1) Joint Commission on Accreditation of Healthcare Organization, 2006 Hospital Accreditation Standards; (2) COMAR 10.07.06; (3) COMAR 10.07.01.24, .26 and .33; and (4) ACEP Policy Statement: Emergency Department Planning and Resources Guidelines. C. Responsibility of the Freestanding Medical Facility. The facility shall make the following documents available for review by the Department: (1) Policies and procedures; (2) Minutes of committee meetings; and (3) Data and documentation related to oversight of the freestanding medical facility at the affiliated hospital. #### Regulation .07 Waiver. *COMAR 10.07.08.07* A. Facilities that are providing services on or before February 12, 2007, but do not meet all requirements of this chapter, may request a waiver of specific requirements from the Department. B. All other freestanding medical facilities seeking a waiver from this chapter shall submit a request to the Department including the rationale for the waiver and alternatives to the requirement based on clinical and technical advances. C. In its request, the facility shall demonstrate that a waiver of the requirement would: (1) Not pose a threat to patients or the provision of services; and (2) Be a financial hardship for the facility to comply with that requirement. D. The Department shall review the request for a waiver and notify the freestanding medical facility of its determination. #### Regulation .08 Affiliated Hospitals. *COMAR 10.07.08.08* A. The freestanding medical facility shall be reviewed under the affiliated hospital's accreditation by the Joint Commission on Accreditation of Healthcare Organizations. B. The governing body of the affiliated hospital shall provide administrative and clinical oversight for the care and services provided by the freestanding medical facility. Services of the facility shall be reviewed and monitored consistent with the hospital's bylaws, including but not limited to: (1) Patient safety; (2) Peer review; (3) Medical staff; (4) Risk management; and (5) Quality improvement. C. The Department may issue a waiver for the requirement for accreditation if the affiliated hospital is not accredited or if the hospital is actively seeking accreditation. #### Regulation .09 Treatment of Patients. *COMAR 10.07.08.09* Regardless of a patient's medical condition, insurance status, or ability to pay, the freestanding medical facility shall provide stabilizing treatment to a patient presenting with an emergency medical condition. #### Regulation .10 Personnel. *COMAR 10.07.08.10* A. Administrative Director. The freestanding medical facility shall have a full-time administrative director who: (1) Acts as a liaison with the affiliated hospital; (2) Directs the daily operation of the facility; and (3) Ensures that employees are capable of providing: (a) Resuscitation; (b) Stabilization; (c) Timely triage; and (d) Appropriate transfer of all patients; and (4) Ensures that there is an organized and structured patient safety and quality improvement program to monitor and improve patient care. B. Medical Director. The facility shall have a Medical Director who is: (1) A licensed physician; and (2) Board certified or Board eligible in Emergency Medicine by the: (a) American College of Emergency Physicians; (b) American Board of Emergency Medicine; or (c) American Osteopathic Board of Emergency Medicine. C. The Medical Director shall provide clinical oversight of the freestanding medical facility. D. Other Personnel. The freestanding medical facility shall be staffed at all times with a: (1) Minimum of one physician who is trained in emergency medicine; (2) Sufficient number of registered nurses and other professionals to provide advanced life support; (3) Certified medical radiation technologist; and (4) Laboratory technician. E. A freestanding medical facility shall be staffed during all hours of operation by licensed independent practitioners, nurses, and ancillary health care professionals with the certification, experience, competencies, and skills necessary for providing basic and advanced life support for children and adults. F. Credentialing. Physicians and other licensed independent practitioners shall be credentialed consistent with COMAR 10.07.01.24. G. The facility shall assess its staffing pattern on a regular basis. Staffing patterns shall accommodate the potential for the unexpected arrival of additional patients. The facility shall have a plan for the provision of additional licensed independent practitioners and nurses in times of acute overload. #### Regulation .11 Quality Assurance. *COMAR 10.07.08.11* A. The freestanding medical facility shall develop and implement a quality assurance program. B. The quality assurance program shall have a quality management process that: (1) Is multidisciplinary; (2) Is integrated into the hospital's overall quality management program that is reported to the hospital's governing body; (3) Has a structure to ensure that defined program outcomes and performance measures are developed and monitored regularly; (4) Maintains sufficient documentation to: (a) Verify problems; (b) Identify opportunities for improvement; and (c) Show corrective actions taken and resolution of problems; (5) Includes review of morbidity and mortality; and (6) Evaluates medical care, nursing care, utilization review, tissue review, and pre-hospital care. #### Regulation .12 Laboratory Services. *COMAR 10.07.08.12* A. The freestanding medical facility shall have on-site laboratory services that are available during the facility's hours of operation. B. Laboratory Licensure Standards. The facility's laboratory services shall be licensed consistent with: (1) COMAR 10.10.01; (2) COMAR 10.10.02; (3) COMAR 10.10.03; (4) COMAR 10.10.04; (5) COMAR 10.10.05; (6) COMAR 10.10.06; (7) COMAR 10.10.07; and (8) COMAR 10.10.08. C. Laboratory services shall include the “Suggested Laboratory Capabilities”, ACEP Policy Statement: Emergency Department Planning and Resources Guidelines, Page 13. #### Regulation .13 Radiology Services. *COMAR 10.07.08.13* A. The freestanding medical facility's radiology services shall comply with all State and federal requirements for licensure. B. Radiology services shall be available on site at all times that the facility is open for business consistent with “Radiological, Imaging, and Other Diagnostic Services”, ACEP Policy Statement: Emergency Department Planning and Resources Guidelines, Page 12, except for the sections related to Nuclear Medicine, Radiographic Services, and Vascular/flow Studies including impedance plethysmography. #### Regulation .14 Pharmacy Services. *COMAR 10.07.08.14* A. Pharmacy services for freestanding medical facility patients may be provided by: (1) The facility's affiliated hospital; or (2) A contracted pharmacy. B. The freestanding medical facility that does not have 24-hour a day, 7-day a week outpatient pharmacy services, shall provide its patients with a list of community pharmacies that offer service 24-hours per day. C. The facility's pharmacy services shall be provided and operated consistent with all applicable State and federal laws. D. The freestanding medical facility shall maintain a supply of medications consistent with the “Suggested Pharmacological and Therapeutic Drugs for Emergency Departments”, ACEP Policy Statement Emergency Department Planning and Resources Guidelines, Page 11. E. The facility shall ensure that all drugs and pharmaceuticals are stored securely and maintained within the acceptable level of humidity and temperature. F. Data and other information about quality oversight of the pharmacy services shall be available to the Department for review and monitoring. #### Regulation .15 Access to Emergency Medical Services. *COMAR 10.07.08.15* An emergency medical facility shall meet the requirements of the Maryland Institute for Emergency Medical Services Systems to be eligible to accept patients through the Emergency Medical System. #### Regulation .16 Transfer of Patients. *COMAR 10.07.08.16* A. The freestanding medical facility shall have pre-arranged transfer agreements with facilities that are capable of providing definitive care appropriate for the nature and severity of the patient's illness or injury. B. Patient transfers shall be consistent with the Interhospital Transfer Guidelines published by the Maryland Institute for Emergency Medical Services System. C. When transfer by ambulance is medically necessary the facility shall transfer the patient via: (1) A hospital owned and operated ambulance service; (2) A contracted ambulance service; or (3) An ambulance service through an agreement with the local emergency medical system (EMS) jurisdictional program. D. The level of care and medical interventions provided by an ambulance during transfer shall be appropriate for the patient's condition. E. Before transfer, the patient shall: (1) Be assessed by a physician or licensed independent practitioner; and (2) Receive stabilizing medical treatment consistent with that of the freestanding medical facility's ability to treat. F. The freestanding medical facility shall provide the emergency medical system and the receiving facility with the patient's medical records necessary for ongoing care, including: (1) All treatment provided to the patient; (2) Medications administered to the patient; (3) Diagnostic procedures performed for the patient; and (4) The patient's response to the care at the time of transfer. #### Regulation .17 Medical Records. *COMAR 10.07.08.17* A. The freestanding medical facility shall ensure that staff members develop a legible and appropriate medical record for each patient who visits the facility for treatment. B. Security and Disclosure of Medical Information. The freestanding medical facility shall: (1) Maintain records in a secure manner that protects the confidentiality of patient information at all times; (2) Develop and implement policies and procedures for disclosure of patient medical records and patient access to their medical records, including the costs for retrieving and copying records as defined in Health-General Article, §§4-301— 4-309, Annotated Code of Maryland; and (3) Make medical records available to emergency medical services agencies for outcome data as directed by the Maryland Institute for Emergency Medical Services System. C. Retention. The medical record shall be retained as required by all federal and State laws and regulations and shall be made available promptly to the freestanding medical facility staff. #### Regulation .18 Nourishing Snacks. *COMAR 10.07.08.18* A freestanding medical facility shall maintain a supply of nourishing snacks for patients who may require them. The facility shall provide appropriate storage facilities, including refrigeration for the nourishing snacks. #### Regulation .19 Infection Control. *COMAR 10.07.08.19* The freestanding medical facility shall comply with the U.S. Centers for Disease Control and Prevention guidelines for standard precautions and the federal Occupational Safety and Health Administration/Maryland Occupational Safety and Health, Bloodborne Pathogen Standard, except in a life-threatening emergency in which compliance is not feasible or practicable. #### Regulation .20 Equipment and Supplies. *COMAR 10.07.08.20* The freestanding medical facility shall have equipment and supplies available consistent with the “Suggested Equipment and Supplies for Emergency Departments,” ACEP Policy Statement: Emergency Department Planning and Resources Guidelines, pages 7—10. #### Regulation .21 Physical Environment. *COMAR 10.07.08.21* A. Construction and Zoning. The freestanding medical facility shall comply with the following construction and zoning requirements: (1) All federal, State, and local building, construction and zoning laws; and (2) “Guidelines for Design and Construction of Hospital and Healthcare Facilities, (2001 Edition),” Section 9.6 Freestanding Emergency Facility and other applicable sections. B. Fire Safety. (1) The facility shall comply with the Maryland State Fire Prevention Code and applicable local fire prevention codes that are in effect at the time of plans review and construction. (2) The local fire authority for the proposed facility shall review construction plans and conduct an initial inspection to verify compliance with fire safety requirements before use and occupancy. (3) An annual fire inspection of the facility is required for license renewal. C. Housekeeping. (1) The freestanding medical facility shall be clean and maintained in good repair at all times. (2) The facility shall employ sufficient staff to provide housekeeping and maintenance services, or the services may be provided under a contractual arrangement. (3) The facility shall be maintained in a manner that is safe and free of pests or other hazards. D. Equipment Maintenance. (1) The freestanding medical facility shall have a preventive maintenance program for all facility systems and equipment. (2) The facility shall maintain records of preventive maintenance performed and of all service repairs. (3) Appropriately trained staff employed by the facility or under contractual arrangements shall perform maintenance of clinical equipment. E. All entrances, including ambulance entrances, shall be clearly marked and accessible at all times. F. There shall be a sheltered area for off-loading patients from ambulances. G. The facility shall store and dispose of trash and medical waste consistent with all federal and State laws and regulations. #### Regulation .22 Emergency Preparedness. *COMAR 10.07.08.22* The freestanding medical facility shall develop an emergency preparedness plan to address internal and external emergencies. The emergency plan shall identify the manner by which the facility will interface with local emergency services and the affiliated hospital in the event of a major disaster. #### Regulation .23 Emergency Suspension. *COMAR 10.07.08.23* A. The Secretary may immediately suspend a license on finding that the public health, safety, or welfare imperatively requires emergency action. B. Notice of Emergency Suspension. The Department shall deliver a written notice to the licensee: (1) Informing the licensee of the emergency suspension; (2) Giving the reasons for the action and the regulation or regulations with which the licensee has failed to comply that forms the basis for the emergency suspension; and (3) Notifying the licensee of its right to request a hearing and to be represented by counsel. C. The filing of a hearing request does not stay the emergency action. D. Suspension of License. When a license is suspended by emergency action, the licensee shall: (1) Immediately return the license to the Department; (2) Stop providing services immediately; and (3) Notify patients or the patients' representatives about the suspension and make every reasonable effort to assist them in making other arrangements for services. E. A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing consistent with Regulation .25 this chapter. F. Show Cause Hearing. (1) In addition to the right to request a hearing consistent with Regulation .25 of this chapter, a person aggrieved by the action of the Secretary under this regulation shall be given the opportunity for a hearing to show cause why the Department should lift the summary suspension. (2) The show cause hearing shall be a nonevidentiary hearing to provide the parties with an opportunity for oral argument on the summary suspension. (3) Show Cause Hearing Procedures. The show cause hearing shall be conducted before the Secretary or a designee of the Secretary, who: (a) Shall determine procedural issues; (b) May impose reasonable time limits on each party's oral argument; and (c) Shall make rulings reasonably necessary to facilitate the effective and efficient operation of the show cause hearing. (4) Results of a Show Cause Hearing. At the conclusion of the show cause hearing, the Secretary or the Secretary's designee may: (a) Affirm the order of summary suspension; (b) Rescind the order of summary suspension; (c) Enter into a consent order; or (d) Enter into an interim order warranted by the circumstances of the case, including one providing for a stay of the summary suspension subject to certain conditions. (5) After the show cause hearing, if the Secretary or the Secretary's designee decides to continue the summary suspension, the person aggrieved by the decision may request an evidentiary hearing before the Office of Administrative Hearings consistent with Regulation .25 of this chapter. #### Regulation .24 Sanctions. *COMAR 10.07.08.24* A. In addition to other penalties available under State law, the Department may impose sanctions against a freestanding medical facility that fails to comply with Health-General Article, Subtitle 3A, Annotated Code of Maryland, or the regulations of this chapter. The sanctions include: (1) A civil penalty not to exceed $10,000; (2) Restrictions on the operation of the freestanding medical facility; (3) A directed plan of correction; and (4) Suspension or revocation of the freestanding medical facility's license. B. Except as otherwise provided under the Administrative Procedure Act, State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, before the Department may impose any sanctions under §A of this regulation, the Department shall provide the freestanding medical facility notice and an opportunity for a hearing and judicial review under the Administrative Procedure Act. C. Before the Department imposes a directed plan of correction, the Department shall give the freestanding medical facility notice and the opportunity for a prompt informal hearing with the Director of the Office of Health Care Quality. #### Regulation .25 Hearings. *COMAR 10.07.08.25* A. The licensee shall file a request for a hearing with the Office of Administrative Hearings, with a copy to the Office of Health Care Quality of the Department, not later than 30 days after receipt of notice of the Secretary's action. The request shall include a copy of the Secretary's action. B. A hearing requested under this chapter shall be conducted consistent with State Government Article, §10-201 et seq., Annotated Code of Maryland, and COMAR 28.02.01 and 10.01.03. C. The burden of proof is as set forth in COMAR 10.01.03.28. D. Unless otherwise stated in this chapter, the Office of Administrative Hearings shall issue a proposed decision within the time frames set forth in COMAR 28.02.01. E. The aggrieved person may file exceptions as set forth in COMAR 10.01.03.35. F. The Secretary shall issue a final decision consistent with COMAR 10.01.03.35. ### Chapter 09 — Residents' Bill of Rights: Comprehensive Care Facilities and Extended Care Facilities **Authority:** Health-General Article, §§19-343—19-347 and 19-349—19-352, Annotated Code of Maryland **Administrative History:** Effective date: December 30, 1977 (4:27 Md. R. 2107) **Administrative History:** Regulations .01—.03 amended effective December 16, 1985 (12:25 Md. R. 2472) **Administrative History:** Regulation .02K and .03K adopted effective August 30, 1982 (9:17 Md. R. 1708) **Administrative History:** Regulation .03C amended effective August 30, 1982 (9:17 Md. R. 1708) **Administrative History:** Regulations .01—.03 under COMAR 10.07.09 Patients' Bill of Rights: Comprehensive Care Facilities and Extended Care Facilities repealed and new Regulations .01—.20 under COMAR 10.07.09 Residents' Bill of Rights: Comprehensive Care Facilities and Extended Care Facilities adopted effective April 22, 1996 (23:8 Md. R. 605) **Administrative History:** Regulation .02B amended effective January 5, 2004 (30:26 Md. R. 1914) **Administrative History:** Regulation .08C amended effective March 13, 2017 (44:5 Md. R. 292) **Administrative History:** Regulation .09 amended effective January 5, 2004 (30:26 Md. R. 1914) **Administrative History:** Regulation .12A amended effective August 24, 2009 (36:17 Md. R. 1312) #### Regulation .01 Scope. *COMAR 10.07.09.01* The provisions of this chapter apply to a health care facility which is licensed as a comprehensive or extended care facility under COMAR 10.07.02. These facilities are generally known as “nursing facilities”. Failure to comply with the regulations of this chapter is ground for licensure enforcement actions. #### Regulation .02 Definitions. *COMAR 10.07.09.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) Abuse of a Resident. (a) “Abuse of a resident” means: (i) The nontherapeutic infliction upon a resident of physical pain or injury, for example, striking a resident; or (ii) A persistent course of conduct intended to produce, or resulting in, mental or emotional distress to a resident, for example, verbal intimidation of a resident. (b) “Abuse of a resident” does not mean the performance of an accepted medical procedure ordered by a physician or administered by another licensed health care professional practicing within the scope of the physician's or health care professional's license. (2) “Abuse of funds” means the misappropriation of a resident's assets or income. Misappropriation includes spending the resident's assets or income: (a) Against or without the resident's consent, or, if the resident is incapable of giving consent and has no agent with authority to give consent, when the expenditure is not necessary for the direct and immediate benefit and welfare of the resident; or (b) For the use and benefit of a person other than the resident, if the resident or agent has not consented to the expense. (3) “Agent” means a person who manages, uses, or controls the funds or assets that legally may be used to pay an applicant's or resident's share of costs or other charges for the facility's services. (4) “Certified” means the designation attached to a nursing facility that has met the requirements for participation as a skilled nursing facility in the Medicare Program or as a nursing facility in the Medicaid Program. (4-1) “Change in condition” means a significant change in the resident's physical, mental, or psychological status including, but not limited to: (a) Life-threatening conditions such as heart attack or stroke; (b) Clinical complications such as the: (i) Development of a pressure sore; (ii) Onset or recurrent periods of delirium; (iii) Onset of recurrent urinary tract infection; (iv) Onset of depression; and (v) Onset of aggressive or inappropriate behavior; (c) The need to discontinue a medication or treatment because of: (i) Adverse consequences; or (ii) The need to begin a new form of treatment; (d) Evaluation at or admission to a hospital; or (e) Accidents that result in injury having the potential for requiring a physician's intervention. (5) “Chemical restraint” means use of a psychopharmacologic drug to control behavior and not otherwise required to treat medical symptoms. (6) “Comprehensive care facility” means a nursing facility that admits residents suffering from disease or disabilities or advanced age, who require medical and nursing services rendered by or under the supervision of a registered nurse. (7) “Consent” means an express agreement by a resident who is capable of making an informed decision or, in cases when the resident is not capable, by the resident's representative. (8) “Department” means the Maryland Department of Health. (9) “Director” means the Director of the Office on Aging. (10) “Disabled resident” means a nursing facility resident who lacks sufficient understanding or capacity to make or communicate a responsible or informed decision on health care or personal finances because of a physical or mental disability, or because of substance abuse. (11) “Discharge” means the: (a) Removal of a resident from a nursing facility when the releasing nursing facility is no longer responsible for the resident's care; (b) Movement of a resident from a certified bed to a noncertified bed; (c) Movement of a resident from a skilled nursing facility bed under the Medicare Program to a bed not certified under that Program; or (d) Movement of a resident from a bed certified only for Medicaid to a distinct part of the facility that is a skilled nursing facility under the Medicare Program. (12) “Emergency” means a situation in which the life, health, or safety of an individual is in imminent and serious jeopardy. (13) “Extended care facility” means a nursing facility that: (a) Provides treatment services for residents requiring inpatient care but who do not currently require continuous hospital services; and (b) Admits residents who: (i) Require extensive restorative or rehabilitative services, or (ii) Have a terminal disease requiring extensive nursing care. (14) Involuntary Transfer or Discharge. (a) “Involuntary transfer or discharge” means a transfer or discharge of a resident that is initiated by a nursing facility without the consent of the resident or, when applicable, the resident's representative. (b) “Involuntary discharge” includes a discharge as described in Regulation .12E of this chapter. (15) “Licensee” means a person licensed by the Department to operate a comprehensive care facility or an extended care facility. (16) “Licensing and Certification Administration” means the survey and licensing agency, a unit of the Department of Health. (17) “Neglect” means failure to provide goods and services necessary to avoid physical harm, mental anguish, or mental illness. (18) “Nursing facility” means a comprehensive care or extended care facility. (19) “Office” means the Office on Aging. (20) “Physical restraint” means a device, including material or equipment, attached or adjacent to a resident's body, that the resident cannot remove easily and that restricts the resident's freedom of movement. (21) Private Pay. (a) “Private pay” means a nursing facility's acceptance of payment from a source other than the Medical Assistance Program. (b) “Private pay” includes reimbursement by the Medicare Program or other third-party insurer. (22) Relocation. (a) “Relocation” means the movement of a resident from one room to another within: (i) The same Medicare-certified facility; (ii) A Medicaid-only certified nursing facility; or (iii) A licensed-only nursing facility. (b) “Relocation” does not mean the movement of a resident if the effect of the movement is to move the resident from: (i) The distinct part of the nursing facility that is a skilled nursing facility to a distinct part of the nursing facility that is not a skilled nursing facility; or (ii) A bed that is certified for Medicaid to a distinct part of the nursing facility that is a skilled nursing facility. (23) “Representative” means a person referenced in Regulation .03 of this chapter. (24) “Resident” means an individual who is admitted or remains in residence for overnight care in a nursing facility. (25) “Resident funds” means the assets and income of a resident or nursing home applicant that are under the use, ownership, management, or control of the resident or resident's agent. (26) “Residents' Bill of Rights” means the statement of basic rights of each resident of a nursing facility as set forth in: (a) Health-General Article, §§19-343—19-347 and 19-349—19-352, Annotated Code of Maryland; (b) Title XIX of the Social Security Act, 42 U.S.C. §1396(5)(c); (c) 42 CFR §483.10 et seq.; and (d) The regulations in this chapter. (27) “Transfer” has the meaning as described in §B(11) of this regulation. #### Regulation .03 Resident's Representative. *COMAR 10.07.09.03* A. A nursing facility or nursing facility's agent shall recognize the authority of: (1) A guardian of the person under Estates and Trusts Article, §13-705, Annotated Code of Maryland; (2) A guardian of the property under the Estates and Trusts Article, §13-201, Annotated Code of Maryland; (3) An advance directive established in compliance with Health-General Article, §5-602, Annotated Code of Maryland; (4) A surrogate decision maker with authority under Health-General Article, §5-605, Annotated Code of Maryland; (5) A power of attorney established in compliance with Estates and Trusts Article, §13-601, Annotated Code of Maryland; (6) An individual exercising a resident's rights pursuant to Health-General Article, §19-344(r), Annotated Code of Maryland, but not for purposes of medical care or treatment; (7) A representative payee or other similar fiduciary; (8) An agent as defined in Health-General Article, §19-344(c), Annotated Code of Maryland; or (9) A person if that person was designated by a resident who was not disabled at the time the designation was made and if the resident or representative has provided the nursing facility with documentation of the designation. B. A nursing facility may not recognize the authority of a resident's representative if the representative attempts to exceed the authority: (1) Stated in the instrument that grants the representative authority; or (2) Established by State law. C. A facility shall document in the resident's record the name of a representative listed in this regulation, including a copy, when applicable, of the designation. #### Regulation .04 Admission Procedures and Requirements. *COMAR 10.07.09.04* A. At the time of admission of a resident, and whenever information changes during the resident's stay, the nursing facility shall notify the resident and, when applicable, a representative or interested family member, in writing and orally, in a language that is easily understood of all terms of admission including, but not limited to the: (1) Residents' Bill of Rights; (2) Nursing facility's policies and procedures that implement the Residents' Bill of Rights; (3) Rules of resident responsibility; (4) Nursing facility's complaint procedure; (5) Nursing facility's visitation rules; (6) Procedures for obtaining a determination from the Medical Assistance Program of the amount of the resident's funds available to pay for the cost of the resident's care; (7) Procedures for establishing eligibility for Medicaid and for receiving refunds for previous private payments covered by these benefits, including the right to request an assessment under 42 U.S.C. §1396r(5)(c) for the purpose of determining the: (a) Extent of a couple's nonexempt resources at the time of institutionalization; and (b) Amount of a couple's resources to be attributed to the community spouse as the spouse's equitable share of resources which are not considered available for payment toward the cost of the institutionalized spouse's medical care or for determining Medicaid eligibility for the institutionalized spouse; and (8) Resident's rights under State law to formulate advance directives. B. Upon admission of a resident, a nursing facility shall: (1) Document in the resident's clinical record whether the resident has executed an advance directive and, if an advance directive exists, keep a copy of the advance directive in: (a) The resident's clinical record; or (b) A location within the nursing facility which is accessible to appropriate administrative, nursing, and medical personnel on a 24-hour a day basis; (2) Prepare an inventory of all property that the resident is bringing into the nursing facility; (3) Request the resident or representative to identify: (a) Those items with a value of $100 or more; (b) Any damage to an item existing before admission of the resident; and (c) Whether the resident is retaining possession of each item or is entrusting the item to the nursing facility for safekeeping on behalf of the resident; (4) Give to the resident and, when applicable, the resident's representative or interested family member, a copy of the inventory prepared under §B(2) of this regulation; and (5) Advise the resident and, when applicable, a representative or interested family member: (a) Whether the nursing facility has purchased insurance to cover a resident's tangible personal property for loss or damage due to the facility's negligence; and (b) Of the limits of insurance coverage. C. With information provided by the resident or representative, a nursing facility shall periodically update the inventory of the resident's personal property with respect to items having a value of $100 or more. D. Required Notification. A nursing facility shall notify in writing: (1) A resident who is entitled to Medicaid benefits at the time of admission, or when the resident becomes eligible for benefits, of: (a) Items and services that are included in the per diem rate under Medicaid, and for which the resident may not be charged; (b) Other items and services that the nursing facility offers and for which the resident may be charged, and the current range of charges for each item and service; (c) The nursing facility's obligation following admission to notify the resident and, when applicable, the agent or interested family member, of any changes made to the items and services for which the resident may or may not be charged; (d) The fact that the resident may not be required to pay for an item or service not covered by Medicaid unless the: (i) Resident or, when applicable, the agent, knowingly requests the item or service; and (ii) Resident receives the item or service; and (e) The resident's right, within 90 days of receiving an item or service, to request an itemized statement of charges that: (i) Briefly and clearly describes each item or service, the amount charged for it, and the identity of the payer billed for the service; and (ii) Contains a statement in bold and conspicuous print as to when interest may be assessed consistent with Regulation .05B(8) of this chapter; (2) A private-pay resident, or the resident's agent, of: (a) The items and services included in the nursing facility's basic per diem rate; (b) The items and services that are covered by Medicare, and of the amount of any copayments or deductibles; (c) Other services that the nursing facility offers and for which the resident may be charged, and the current range of charges for the services, including but not limited to charges related to a resident's monthly drug regimen review and other non-drug-related pharmacy costs; (d) Whether the costs for supplies used in the performance of a service are included in the service charge and the costs of these supplies, within 24 hours of request, when the costs are not included in the service charge; and (e) The resident's right, within 90 days of receiving an item or service or within 30 days of payment, to request an itemized statement of charges that: (i) Briefly and clearly describes each item or service, the amount charged for it, and the identity of the payer billed for the service; and (ii) Contains a statement in bold and conspicuous print as to when interest may be assessed consistent with Regulation .05B(8) of this chapter; and (3) A resident of changes to be made to the items and services specified in §D(1) and (2) of this regulation, and increases in any fee or charge, or a new fee or charge, or a change in billing procedures, at least 45 days before the increase, new charge, or change becomes effective. E. A nursing facility shall: (1) Give the resident a copy of the statement of items, services, and charges provided by the facility; (2) Provide information regarding services to be rendered by other health care providers, including: (a) The cost to the resident; (b) Transportation arrangements; and (c) Direct or indirect financial interests that the nursing facility has in the provider. #### Regulation .05 Admission Prohibitions. *COMAR 10.07.09.05* A. The acts in §B of this regulation are admission prohibitions. B. A nursing facility may not: (1) Require or solicit, as a condition of admission into the nursing facility, the signature of an individual other than the applicant on the application or contract for admission to the nursing facility, unless the: (a) Applicant is adjudicated disabled in accordance with Estates and Trusts Article, §13-701, Annotated Code of Maryland; or (b) Applicant's physician determines that the applicant is incapable of understanding or exercising the applicant's rights and responsibilities and records, in the applicant's nursing facility record, the specific reasons for the determination; (2) Require an individual, including an agent, to incur personal financial liability by signing the contract, although the nursing facility may require the individual to pay for nursing facility care for the resident to the extent of the resident's available income and assets; (3) Charge, solicit, accept, or receive, in addition to any amount otherwise required to be paid under Medicaid, a gift, money, donation, or other consideration as a precondition of admission or expedited admission to, or continued stay in, the nursing facility; (4) Require residents or applicants to waive their rights to Medicare or Medicaid; (5) Require oral or written assurances that residents or applicants are not eligible for, or will not apply for, Medicare or Medicaid benefits; (6) Charge individuals who are eligible for Medicaid more than the rates established by the Medical Assistance Program for these services; (7) Increase any charge and make the resident liable for the increase until the 46th day after the facility notifies the resident in writing; (8) Impose an interest penalty on charges for items and services provided to a resident until the later of the following: (a) 45 days after the nursing facility mails an itemized statement of charges to the resident or the resident's agent; or (b) 30 days after the end of the period covered by the itemized statement of charges; (9) Condition providing care or otherwise discriminate against a resident based on whether the resident has or has not executed an advance directive; (10) Except for contributions toward cost of care as determined by the Medical Assistance Program, charge a resident who is eligible for Medicaid for services, unless the resident or the resident's agent knowingly has requested and received noncovered services, and the nursing facility: (a) Has given proper notice of the availability and cost of the services to residents; and (b) Does not condition the resident's admission or continued stay on the request for and receipt of additional services; and (11) Solicit, accept, or receive a charitable, religious, or philanthropic contribution from an organization or an individual related to the resident or applicant unless the nursing facility makes clear that the contribution is not a condition of admission to, expedited admission to, or continued stay in the nursing facility. #### Regulation .06 Admission Contract Required. *COMAR 10.07.09.06* A. Before or upon admission, a nursing facility and applicant or, when applicable, the applicant's agent, shall execute an admission contract which has been approved by the Department. B. If the Department has approved a model contract, a nursing facility shall include within its contract, at a minimum, all of the provisions of the model contract. C. The nursing facility shall carefully explain all clauses of the contract and answer all questions that the applicant, the applicant's agent, and any interested family member may have. D. Except as required in §B of this regulation, the applicant and, when applicable, an agent, have the right to delete clauses or sections of the contract with which they do not agree, or to add clauses or sections, subject to the nursing facility's concurrence. Substantive changes require the Department's approval. E. An admission contract shall include a statement regarding the nursing facility's policies if private funds are exhausted during the resident's stay, including, in clear and concise language, any restrictions with respect to the acceptance of third-party payments. F. An admission contract used by a certified Medicaid provider shall clearly state that if private funds are exhausted during the resident's stay, and Medicaid payment is available, the nursing facility shall accept Medicaid payments on behalf of the resident. G. An admission contract used by a certified Medicaid provider shall inform the applicant, through a form established by the Department, that medical eligibility is a requirement for Medical Assistance, and that the applicant should learn if the applicant meets the Medicaid eligibility requirement at the time of admission. #### Regulation .07 Third-Party Signature on Admission Contract. *COMAR 10.07.09.07* A. If a facility requires an individual, other than the applicant or resident, to sign the admission contract, the conditions of Regulation .05B(1) of this chapter shall be met. B. If an agent, as defined in Regulation .02B(3) of this chapter, signs the contract, the agent accepts responsibility to pay for the cost of the resident's care only to the extent of the resident's available funds and assets. C. If an agent, as defined in Regulation .02B(3) of this chapter, signs the contract, the agent is not, by signing the contract, accepting any responsibility for making payments from the agent's own personal funds, unless the agent does so voluntarily. The facility shall list separately in the contract any obligations voluntarily entered into by the agent, and the agent shall initial these obligations on the contract. D. An agent who has not paid a current obligation for the resident's care may apply to the Medical Assistance Program for a determination of the funds available to pay for the cost of the resident's care. E. An agent shall distribute any funds, including income or assets of the applicant or resident that the Medical Assistance Program has determined to be available, to pay for the cost of the resident's care in the facility. F. An agent shall seek, on behalf of the applicant or resident, all assistance from the Medical Assistance Program that may be available to the applicant or resident. G. The Attorney General may impose civil money penalties against an agent who wilfully or with gross negligence violates the requirements of this regulation as follows: (1) An agent who wilfully or with gross negligence violates §E of this regulation is subject to a civil money penalty not less than the amount of funds subject to the violation; and (2) An agent who wilfully or with gross negligence violates §F of this regulation is subject to a civil money penalty not exceeding $10,000. #### Regulation .08 Resident's Rights and Services. *COMAR 10.07.09.08* A. A nursing facility shall provide care for residents in a manner and in an environment that maintains or enhances each resident's dignity and respect, and in full recognition of the resident's individuality. B. A nursing facility may not interfere with a resident's exercise of rights guaranteed under the Constitution or laws of the United States and Maryland. C. A resident has the right to: (1) Reside and receive services in a nursing facility with reasonable accommodations of individual needs and preferences, except when accommodations would endanger the health or safety of the resident or other residents; (2) Receive treatment, care, and services that are in an environment that promotes maintenance or enhancement of each resident's quality of life; (3) A dignified existence, self-determination, and communication with and access to individuals and services inside and outside the nursing facility; (4) Be free of interference, coercion, discrimination, or reprisal from the nursing facility when exercising the resident's rights; (5) Be free from: (a) Physical abuse; (b) Verbal abuse; (c) Sexual abuse; (d) Physical or chemical restraints imposed for purposes of discipline or convenience; (e) Mental abuse; and (f) Involuntary seclusion; (6) Choose an attending physician, if the physician agrees to abide by nursing facility policies and procedures, and the regulations in this chapter; (7) Choose a pharmacy to obtain medications as set forth in COMAR 10.07.02.15B(3) and D(3); (8) Be fully informed in advance about care and treatment, and of proposed changes in that care or treatment; (9) Participate in planning care and treatment, or changes in care or treatment; (10) Seek advice from the resident care advisory committee concerning the options for medical care and treatment for an individual with a life-threatening condition in accordance with Health-General Article, §19-370 et seq., Annotated Code of Maryland; (11) Consent to or refuse treatment, including the right to accept or reject artificially administered sustenance in accordance with State law; (12) Self-administer drugs if the interdisciplinary team determines that the practice is safe; (13) Access the resident's records within 24 hours, excluding weekends and holidays, upon an oral or written request; (14) Purchase copies of all or part of the resident's records upon request by giving 2 working days advance notice to the nursing facility; (15) Approve or refuse the release of personal and clinical records to an individual outside the nursing facility unless: (a) Otherwise provided by Health-General Article, §4-301 et seq., Annotated Code of Maryland; or (b) The release is required by law; (16) Personal privacy, including: (a) Confidentiality of personal records; and (b) Privacy in: (i) Medical treatment, and (ii) Personal care; (17) Privacy in the resident's room, including the right to have nursing facility staff knock before entering the resident's room; (18) Privacy in written communication, including the right to: (a) Send and receive mail promptly without it being opened by anyone other than the resident, except when the resident requests assistance; and (b) Have access to stationery, postage, and writing implements at the resident's own expense; (19) Reasonable access to the private use of a telephone; (20) Meet or visit privately with any individual the resident chooses, subject to reasonable restrictions by the nursing facility on visiting hours and places; (21) Visit or meet privately with the following, to whom the nursing facility shall provide reasonable access: (a) A representative of the Secretary of the U.S. Department of Health and Human Services; (b) A representative of the Department; (c) The resident's personal physician; (d) A representative of the State Long-Term Care Ombudsman Program; (e) The agency responsible for advocacy and protection of developmentally disabled and mentally ill individuals in Maryland; or (f) Any other legal representative; (22) Visit privately with the resident’s spouse or domestic partner; (23) Consent or deny consent to all visits, and may deny or withdraw consent at any time; (24) Examine the results of the most recent federal and State surveys, including the annual survey and any subsequent complaint investigations, not otherwise prohibited by law, of the nursing facility and any plans of correction prompted by these surveys; (25) Receive notice before the resident's roommate is changed and, to the extent possible, have input into the choice of roommate; (26) Voice grievances, including those about treatment or care that is or fails to be furnished, and recommend changes in policies and services, to the staff or administrator of the nursing facility, the Licensing and Certification Administration, the Office on Aging, or any other person, without fear of reprisal, restraint, interference, coercion, or discrimination; (27) Prompt efforts by the nursing facility to resolve grievances the resident may have, including those with respect to the behavior of other residents; (28) Contact and receive information from agencies acting as client advocates; (29) Refuse to perform services for the nursing facility; (30) Perform services for the nursing facility if the resident chooses, only if: (a) The nursing facility has documented the need or desire for work in the plan of care; (b) The plan specifies the nature of the services to be performed and whether the services are voluntary or paid; (c) Compensation for paid services is at or above prevailing rates; and (d) The resident agrees in writing to the work arrangement described in the plan of care, and the contract is part of the resident's record; (31) Share a room with the resident's spouse if both spouses consent and it is not medically contraindicated; and (32) Participate in social, religious, and community activities if the activities do not interfere with the rights of other residents in the nursing facility. D. A resident has the right to participate or refuse to participate in experimental research. When the resident is incapable of making this decision, the resident's appropriate representative may consent for participation in therapeutic experimental research only. E. The resident or, when applicable, the resident's health care representative, has the right to be fully informed, in a language that the resident or representative can reasonably be expected to understand, of complete and current information about the resident's diagnosis, treatment, and prognosis, unless it would be medically inadvisable as documented by the resident's attending health care provider. If this determination has been made, the health care provider shall, upon written request: (1) Make a summary of the undisclosed portion of the medical record available to the resident or health care representative; (2) Insert a copy of the summary in the medical record of the resident; (3) Permit examination and copying of the medical record by another health care provider; and (4) Inform the resident or health care representative of the resident's or health care representative's right to select another health care provider. F. Resident and Family Groups. (1) A resident has the right to organize and participate in resident groups in the nursing facility. (2) A resident's family has the right to meet in the nursing facility with the families of other residents. (3) Staff or other visitors may attend meetings only at the group's invitation. #### Regulation .09 Implementation of Residents' Bill of Rights. *COMAR 10.07.09.09* A nursing facility shall: A. Ensure that: (1) The rights of residents as set forth in the Residents' Bill of Rights are protected, including but not limited to informing each resident of the resident's right to select a physician and pharmacy of the resident's choice; (2) Employees of the nursing facility are trained to: (a) Respect and enforce the Residents' Bill of Rights and the nursing facility's policies and procedures that implement the Residents' Bill of Rights; and (b) Protect the rights of residents; (3) The nursing facility's policies and procedures implement all rights of the residents as set forth in: (a) Health-General Article, §§19-343—19-347 and 19-349—19-352, Annotated Code of Maryland; (b) Title XIX of the Social Security Act; (c) 42 CFR §483.10 et seq.; and (d) The regulations of this chapter; and (4) The nursing facility's policies comply with the requirements of federal and State law concerning advance directives, including but not limited to: (a) If an applicant is incapacitated or is incapable of informing the nursing facility whether the applicant has executed an advance directive, the facility may provide advance directive information to the resident's health care representative; and (b) Once the resident is no longer incapacitated, the facility shall provide the advance directive information to the resident directly at the appropriate time; B. Post conspicuously in a public place accessible to residents: (1) The Residents' Bill of Rights in large, clearly readable type; (2) The nursing facility's complaint procedures in large, clearly readable type; (3) The nursing facility's statement of deficiencies for the most recent survey and any subsequent complaint investigations conducted by federal or State surveyors and any plans of correction in effect with respect to the survey or complaint investigation findings; and (4) Signs provided by the Department to notify the visiting public and residents: (a) That complaints may be made to the Department or to the Office; (b) How to report an instance of abuse of a resident to the Department, the Office, or law enforcement agencies; and (c) How to file a complaint with State agencies and client advocacy agencies, such as the Licensing and Certification Administration, the Office on Aging, the Older Americans Act Legal Services providers, the Maryland Disabilities Law Center, State Medicaid Fraud Unit, and the Legal Aid Bureau, Inc.; C. Establish and maintain identical policies and practices regarding transfer, discharge, and the provision of services under the State plan for all individuals, regardless of source of payment; D. Provide each resident and, if applicable, the resident's appropriate representative or interested family member, with a written description of the resident's legal rights, including a: (1) Description of the manner of protecting resident funds; and (2) Statement that the resident may file a complaint with the Department or the Office concerning resident abuse, neglect, misappropriation of resident property in the nursing facility, and noncompliance with advance directive requirements; E. Place the name, address, and telephone number of the physician who is responsible for the resident's care within easy access of the resident; F. Inform the resident and the appropriate legal representative, or interested family member, and promptly consult with the resident's physician if any of the following incidents occur: (1) An accident involving the resident which results in injury; (2) A significant change in the resident's physical, mental, or psychosocial status; (3) A need to alter treatment significantly; or (4) A decision to transfer or discharge the resident from the nursing facility; G. Consistent with State and federal confidentiality laws and, in a timely manner, notify a resident and, if applicable, the resident's representative or interested family member, of any: (1) Change in condition; (2) Adverse event that may result in a change in condition; (3) Outcome of care that results in an unanticipated consequence; and (4) Corrective action, if any; H. Notify the resident and, when applicable, the appropriate representative, or interested family member, when there is a change in: (1) Room or roommate assignment; (2) The Residents' Bill of Rights; or (3) Federal or State law and regulations relating to residents' rights; I. Record and update the address and phone number of the resident's representatives and interested family members; J. Permit representatives of the State Long-Term Care Ombudsman Program to accomplish their responsibilities, as set forth in 42 U.S.C. §3058g, the State Long-Term Care Ombudsman Program; K. Encourage the activities of resident and family groups by: (1) Providing the residents and their families with private space for meetings; (2) Designating a staff person to provide assistance and respond to written requests from residents and their families; (3) Listening to the views of residents and their families; (4) Acting upon the grievances and recommendations of residents and their families concerning proposed policy and operational decisions affecting resident care and life in the nursing facility; and (5) Advising resident and family groups of the disposition of their grievances and recommendations; L. Educate staff, residents, representatives, and interested family members on advance directives; M. When applicable, promptly provide the Medical Assistance Program with all required information in its possession; and N. Provide copies of clinical records upon request, based on the following charges: (1) A fee for copying and mailing not exceeding 50 cents per page; (2) A discretionary fee not to exceed $15 for record retrieval and preparation; (3) The actual cost of postage and handling of the copies; and (4) A discretionary annual adjustment in the fees described in §M(1)—(3) of this regulation based on the current Consumer Price Index. #### Regulation .10 Resident Transfers and Discharges. *COMAR 10.07.09.10* A. A nursing facility may not involuntarily transfer or discharge a resident from the nursing facility unless the: (1) Transfer or discharge is necessary for the resident's welfare and the resident's needs cannot be met in the nursing facility; (2) Transfer or discharge is appropriate because the resident's health has improved sufficiently so that the resident no longer needs the health care or services provided by the nursing facility; (3) Resident's presence endangers the health or safety of other individuals in the nursing facility; (4) Resident has failed, after reasonable and appropriate notice, to pay, or to have paid under third-party payers, for a stay at the nursing facility; or (5) Nursing facility ceases to operate or, in the case of a resident who receives Medicare or Medicaid services, when the nursing facility has been decertified or has withdrawn from the Medicare or Medicaid Program. B. A resident has a right to request a hearing on the proposed transfer or discharge, except when the transfer or discharge is being taken pursuant to §A(5) of this regulation. C. Notice. (1) Transfer and Discharge. Except in emergency situations such as a hospitalization, or if the resident has not resided in the facility for 30 days, the nursing facility shall notify the resident, representative, or interested family member, the State Long-Term Care Ombudsman, and the Department at least: (a) 30 days before any proposed transfer or discharge if the nursing facility is not part of a continuing care retirement community as defined in Article 70B, Annotated Code of Maryland; or (b) 60 days before any proposed transfer or discharge if the nursing facility is part of a continuing care retirement community. (2) Emergency Transfers, Discharges, and Relocations. In an emergency situation, a nursing facility shall notify the resident, representative, or interested family member of a transfer as soon as possible. D. Contents of Notice. The required notice to a resident under this regulation shall be on a form developed by the Department and shall include: (1) Each reason for the proposed transfer or discharge; (2) A statement that the resident has the right to request a hearing on a proposed transfer or discharge, and how to request a hearing pursuant to Regulation .13 of this chapter, except in the case of a discharge made pursuant to §A(5) of this regulation; (3) The name, address, and telephone number of the State's Office on Aging and local office on aging long-term care ombudsman; (4) The right of a resident to consult with any lawyer the resident chooses; (5) The name, address, and telephone number of the Legal Aid Bureau, The Older American Act Senior Legal Assistance Programs, and other agencies that may provide assistance to individuals who need legal counsel; (6) For nursing facility residents with developmental disabilities, the mailing address and telephone number of the agency responsible for the protection and advocacy of developmentally disabled individuals; (7) For nursing facility residents who are mentally ill, the mailing address and telephone number of the agency responsible for the protection and advocacy of mentally ill individuals; (8) The effective date of the proposed transfer or discharge which, except as set forth in §C of this regulation, is at least 30 days after receiving the notice and at least 60 days after receipt of the notice if the nursing facility is part of a continuing care retirement center; and (9) The resident's rights concerning discharge, as set forth in Regulation .11 of this chapter. E. Documentation. (1) In the event of a discharge or transfer of a resident, a nursing facility shall ensure that the following appears in the resident record: (a) The circumstances surrounding the discharge or transfer, including interventions initiated by the facility before proposing the discharge; (b) The notice described in §§C and D of this regulation; and (c) If applicable, any express consent given by the resident or, when applicable, the resident's representative. (2) When a resident is transferred or discharged pursuant to §A(1) and (2) of this regulation, the resident's physician shall document in the resident's clinical records the reason or reasons why the transfer or discharge is necessary. (3) When a resident is transferred or discharged pursuant to §A(3) of this regulation, a physician shall document in the resident's clinical records the reason or reasons why the transfer or discharge is necessary. #### Regulation .11 Involuntary Discharge or Transfer of a Resident. *COMAR 10.07.09.11* A. In addition to the provisions of Regulation .10 of this chapter, a facility may not involuntarily discharge or transfer a resident unless, within 48 hours before the discharge or transfer, the facility has: (1) Provided or obtained: (a) A comprehensive medical assessment and evaluation of the resident, including a physical examination, that is documented in the resident's medical record; (b) A post-discharge plan of care for the resident that is developed, if possible, with the participation of the resident's representative; and (c) Written documentation from the resident's attending physician indicating that the transfer or discharge is in accordance with the post-discharge plan of care and is not contraindicated by the resident's medical condition; and (2) Provided information to the resident concerning the resident's rights to make decisions concerning health care, including the right to: (a) Accept or refuse medical treatment; (b) Make an advance directive, including the right to make a living will and the right to appoint an agent to make health care decisions; and (c) Revoke an advance directive. B. With the exception of residents of a certified continuing care facility as set forth in §D of this regulation, at the time of transfer or discharge, the facility shall provide the resident and, when appropriate, the representative or interested family member with: (1) A written statement of the medical assessment and evaluation and post-discharge plan of care required under §A of this regulation; (2) A written statement itemizing the medications currently being taken by the resident; (3) To the extent permitted under federal and State law, at least a 3-day supply of the medications currently being taken by the resident; (4) Information necessary to assist the resident or the resident's representative in obtaining additional prescriptions for necessary medication through consultation with the resident's attending physician; and (5) A written statement containing the date, time, method, mode, and destination of the resident's discharge. C. A facility may not discharge or transfer a resident: (1) Unless the resident or appropriate representative consented in writing to the discharge or transfer; or (2) Except when the discharge or transfer: (a) Is in accordance with a post-discharge plan of care developed under §A of this regulation; (b) Is to a safe and secure environment where the resident will be under the care of a: (i) Licensed, certified, or registered care provider; or (ii) Person who has agreed in writing to provide a safe and secure environment. D. A continuing care facility certified under Article 70B, Annotated Code of Maryland, is not subject to §B of this regulation if the: (1) Facility transfers a resident to a lesser level of care within the same facility in accordance with a contract between the facility and the resident; and (2) Transfer is approved by the resident's attending physician. E. If the requirements of §§A—D of this regulation have been met, the resident's representative, in conjunction with the facility, shall cooperate and assist in the resident's discharge planning, including: (1) Contacting, cooperating with, and assisting other health care facilities considering admitting the resident; and (2) Cooperating with government agencies, including applying for Medical Assistance for the resident. F. If requested by a person during the process of transferring or discharging a resident, or on its own initiative, the Office of the Attorney General may investigate whether an abuse of a resident's funds contributed to the decision to transfer or discharge the resident, and may make appropriate referrals of the matter to other government agencies. G. The Secretary may impose a civil money penalty not to exceed $10,000 for each: (1) Violation by a facility of its obligations under this regulation and Regulation .10 of this chapter; or (2) Willfully or grossly negligent violation by a resident's representative of the representative's obligations under this regulation and Regulation .10 of this chapter. H. If a civil money penalty is imposed under §G of this regulation, the facility or representative has the right to request a hearing on the proposed civil money penalty in accordance with State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, and COMAR 10.01.04. I. A resident, resident's representative, resident's attorney, or the Attorney General, on behalf of a resident who believes that an involuntary discharge or transfer that violates this regulation is imminent or has taken place, may request appropriate injunctive relief from the appropriate circuit court. #### Regulation .12 Resident Relocation and Bed Hold. *COMAR 10.07.09.12* A. Notification of Resident Relocation Within a Facility. (1) Except in emergency situations or when it is documented in the resident's record that a resident's physical, clinical, or psychological well-being would be jeopardized, a nursing facility shall notify a resident or, when applicable, the resident's representative or interested family member, if available, in writing at least 30 days before the resident is relocated within a facility or to a different part of a facility, unless the resident or, if the resident is incapacitated, the resident's legally authorized representative, agrees to the relocation and this is documented in the resident's record. (2) Under the limited conditions set forth in §A(1) of this regulation where 30-days notice cannot be provided in advance of a relocation, the facility shall document that it has provided notice of the relocation as soon as practicable. (3) When a resident is relocated, the facility shall elicit and make reasonable efforts to comply with the resident's request of location and, if applicable, assignment of roommate. B. A resident's right to refuse a change in room assignment under §A of this regulation does not affect the resident's eligibility or entitlement to Medicaid benefits. C. Notice. (1) Notice of Bed-Hold Policy at the Time of Admission. At the time of admission, a nursing facility shall provide written information to a resident or, when applicable, the resident's representative or interested family member, describing the facility's bed-hold policy, including the period of time during which the resident is permitted to return and resume residence in the nursing facility. (2) Notice of Bed-Hold Policy at Time of Transfer. At the time of transfer of a resident to a hospital or for therapeutic leave, a nursing facility shall provide a written notice to the resident, or when applicable, the resident's representative or interested family member, which specifies the duration of the bed-hold policy described in §C of this regulation. D. Permitting a Resident to Return to the Nursing Facility. When a resident's hospitalization or therapeutic leave exceeds the bed-hold period under the State Medicaid plan, the resident has a right to be readmitted to the nursing facility immediately upon the first availability of a bed in a semiprivate room if the resident: (1) Requires the services provided by the nursing facility; and (2) Is eligible for Medicaid coverage for the nursing facility's services. E. Unless the bed hold has expired, for purposes of this regulation, transfer includes the refusal of a nursing facility to accept the return of a resident who was previously transferred from the nursing facility: (1) Whose bed at the nursing facility was continuously reserved or required to be reserved through payment to the nursing facility from any source; or (2) Who had an application for medical assistance pending at the time of the transfer if there is no reason to believe that the application will not be approved. F. Transfer and Discharge Planning. In addition to the requirements of Regulation .11 of this chapter, a nursing facility shall provide, in all cases, orientation and planning to residents to ensure safe and orderly transfer of discharge from the nursing facility. #### Regulation .13 Hearings for Transfers and Discharges, and Establishment of an Escrow Account. *COMAR 10.07.09.13* A. A resident may request a hearing within 30 days of receiving a notice of an intended involuntary transfer or discharge as provided in Regulation .10C of this chapter. B. Except in an emergency or when the resident has resided in a facility for less than 30 days, after a request for a hearing has been filed, a nursing facility may not discharge or transfer the resident until: (1) A final decision is issued after the hearing and all requirements of Regulation .11 of this chapter are met; or (2) The resident consents to the discharge or transfer and withdraws the request for a hearing. C. Procedure. (1) The resident shall send a written request for a hearing to the Office of Administrative Hearings by the 30th calendar day after the resident receives the nursing facility's notice of the proposed transfer or discharge. (2) After receiving the written request, the Office of Administrative Hearings shall schedule a hearing. (3) The Office of Administrative Hearings shall conduct the hearing in accordance with COMAR 10.01.04 and 28.02.01. (4) The Department is not a party to a hearing conducted pursuant to this regulation. The parties are the nursing facility and the resident. Therefore, a hearing conducted pursuant to this regulation is not a contested case as defined in the Administrative Procedure Act, State Government Article, §10-202, Annotated Code of Maryland. D. A facility may require that an escrow account be established when the: (1) Basis for a resident's discharge is nonpayment; and (2) Resident continues to reside in the facility pending a final decision. E. If an escrow account is required under §D of this regulation, the facility shall develop a policy and procedure that is acceptable to the Department concerning the establishment and disposition of funds from the escrow account. #### Regulation .14 Physical and Chemical Restraints. *COMAR 10.07.09.14* A. Physical restraints may be used only: (1) As an integral part of an individual medical treatment plan; (2) If absolutely necessary to protect the resident or others from injury; (3) If prescribed by a physician or administered by another health care professional practicing within the scope of their license; and (4) If less restrictive alternatives were considered and appropriately ruled out by the physician. B. Use of Physical Restraints. (1) When a facility uses physical restraints, personnel: (a) Trained in the use of restraints shall check a resident in restraint at least every 2 hours, and maintain a record of the checks and usage; and (b) Shall provide opportunities for motion and exercise during each 2-hour period in which physical restraint is used, and shall monitor the use of the restraint use and maintain a record of it. (2) The attending physician shall ensure that treatment plans include provisions for the progressive elimination of physical restraints. C. Use of Psychopharmacologic Drugs. When a physician prescribes psychopharmacologic drugs for a resident, the resident's clinical records shall contain all of the following documentation: (1) A physician's indication that the dosage, duration, indication, and monitoring are clinically appropriate and the reasons why they are clinically appropriate; (2) Indication that the resident is being monitored for adverse complications of the drug therapy; (3) Confirmation that previous attempts at dosage reduction have been unsuccessful, if applicable; (4) Evidence of the resident's subjective or objective improvement, or maintenance or function, while taking the medication; (5) Evidence that the resident's decline or deterioration, if applicable, has been evaluated by the interdisciplinary team to determine whether a particular drug, a particular dosage, or duration of therapy may be the cause; (6) Evidence of why the resident's age, weight, or other factors would require a unique drug dose, drug duration, indication, or monitoring; or (7) Other evidence that substantiates the use of the restraint. #### Regulation .15 Abuse of Residents. *COMAR 10.07.09.15* A. A nursing facility shall develop and implement policies and procedures prohibiting abuse and neglect of residents. B. A nursing facility may not knowingly employ an individual who has been convicted of abusing or neglecting a resident or who has had a finding entered into the State Nurse Aide Registry concerning abuse or neglect of a resident or misappropriation of a resident's property. C. Reports of Abuse. (1) A person who believes that a resident has been abused shall promptly report the alleged abuse to the: (a) Appropriate law enforcement agency; (b) Licensing and Certification Administration within the Department; or (c) The Office on Aging. (2) An employee of a nursing facility who believes that a resident has been abused: (a) Shall report the alleged abuse as set forth in §C(1) of this regulation within 3 days after learning of the alleged abuse; (b) May be subject to a penalty imposed by the Secretary of up to $1,000 for failing to report an alleged abuse within 3 days after learning of the alleged abuse. (3) An individual on whom a penalty has been imposed may request a hearing on the penalty by submitting a written request for a hearing to the Department on or before the 30th calendar day after the individual received notice of the imposition of the penalty. (4) Upon receiving a request for a hearing under this section, the Secretary shall conduct a hearing in accordance with COMAR 10.01.03. D. Investigations. A nursing facility shall: (1) Thoroughly investigate all allegations of abuse; and (2) Take appropriate action to prevent further incidents of abuse while the investigation is in progress, and after that. E. Immunity from Civil Liability. An individual who, acting in good faith, makes a report under this regulation has immunity from liability described in Health-General Article, §19-347(g), Annotated Code of Maryland. #### Regulation .16 Complaint Procedure. *COMAR 10.07.09.16* A. A resident, the resident's representative, or an interested individual has the right to: (1) Make a complaint about the nursing facility; (2) Recommend a change in facility policy and procedure; and (3) Be free from reprisal, restraint, interference, coercion, or discrimination by the nursing facility or its employees as a result of making a complaint or recommending a change in policy. B. A nursing facility shall develop and implement the following complaint procedures: (1) A resident, the resident's representative, or an interested individual may present complaints to: (a) The nursing facility administration; (b) The nursing facility's staff; (c) The Office; (d) The Department; or (e) Other persons or groups; (2) A complaint may be made to the nursing facility in person, orally or in writing, by telephone or by mail, and may be reported anonymously; (3) A nursing facility may not require the signature of the resident or, when applicable, the resident's representative or an interested individual on a complaint; (4) If a complaint is presented to a nursing facility, the nursing facility shall investigate within 30 days the allegations made in the complaint and advise the complainant of the action the nursing facility is taking to resolve the complaint; (5) A nursing facility shall send to the Office and the Department a copy of any complaint that a complainant indicates has not been resolved to the satisfaction of the complainant; (6) A nursing facility shall maintain a permanent record for inspection by the Office or the Department of all complaints concerning the nursing facility; and (7) A complainant may request a hearing from the Department within 30 days of receiving the facility's response to the complaint or within 60 days of filing the complaint, whichever is earlier. C. A complaint which has not been resolved to the satisfaction of the complainant may be resolved through a hearing as follows: (1) After receiving a written request for a hearing, the Department shall forward a copy of the request to the Office and schedule a hearing; (2) The nursing facility may be represented by the nursing facility administrator, designee, or counsel; (3) The complainant may be represented by: (a) The complainant; (b) The Office; (c) Counsel; or (d) Any other individual; (4) The Department's Director of Licensing and Certification, or a designee of the Director, shall conduct the hearing; (5) The Director or the Director's designee may: (a) Receive testimony from both parties; (b) If appropriate, issue deficiencies and require the nursing facility to submit a plan of correction; (c) Attempt to assist the parties in reaching a satisfactory resolution; (d) Notify the complainant of the results of the findings and any actions taken; and (e) Notify the appropriate State's attorney if there is evidence of criminal conduct. D. A hearing conducted under §C of this regulation is not a contested case as defined in State Government Article, §10-202, Annotated Code of Maryland. #### Regulation .17 Personal Property of Residents. *COMAR 10.07.09.17* A. Personal Possessions. (1) A resident has the right to retain and use personal possessions, including furnishings and appropriate clothing as space permits, unless to do so would be detrimental to the rights or health and safety of other residents. (2) A facility shall take reasonable steps to ensure the safety and security of the personal belongings of its residents. (3) A facility shall provide a reasonable amount of locked storage space for personal property upon the request of a resident. B. A nursing facility may not limit the amount of funds it keeps on behalf of a resident, but may limit the amount of other property that it retains on behalf of the resident. C. A nursing facility shall establish written procedures to prevent loss or damage to, and protect, property. D. A nursing facility shall establish written procedures for investigating an incident of loss or damage to the property of a resident, including: (1) A procedure by which an individual, including a resident or representative of a resident, may report loss or damage; (2) The designation of an employee of the nursing facility to: (a) Receive reports of loss or damage; (b) Conduct an investigation; and (c) Inform the resident, or when applicable, a representative or interested family member, of the results of the investigation. E. Release of Personal Property. A nursing facility shall release the property of a resident to: (1) The resident or a representative upon the: (a) Request of the resident; or (b) Transfer or discharge of the resident from the nursing facility; or (2) A government agency acting pursuant to legal authority. F. Disposition of Personal Property Upon the Death of a Resident. (1) Immediately upon but not later than 30 business days after the death of a resident, a nursing facility shall provide notice of the resident's property being held by the facility to: (a) The resident's representative or interested family member; and (b) Government agencies which have paid any part of the nursing facility charges for the resident. (2) Upon the death of a resident, the nursing facility shall release: (a) The resident's wearing apparel other than furs and jewels to a representative or immediate family member; and (b) Other personal property only to an individual who presents certified letters of administration that designate the individual as “Representative of the Estate of _______________________________________________”. (3) Personal property or income derived from the cash conversion of personal property that a facility holds for a discharged or deceased resident is presumed abandoned in accordance with Commercial Law Article, Title 17, Annotated Code of Maryland, when the property or income from cash conversion is not claimed within 1 year. (4) When a nursing facility is still holding a resident's personal property 1 year after the resident's death, the nursing facility shall notify the Unclaimed Property Section, Comptroller of the Treasury, for appropriate direction. #### Regulation .18 Protection of a Resident's Personal Funds. *COMAR 10.07.09.18* A. A resident has the right to: (1) Manage the resident's financial affairs; or (2) Choose any person who is willing to handle the resident's financial affairs. B. Except as authorized by being appointed representative payee, a nursing facility may not manage a resident's funds without an express written request from: (1) The resident; or (2) An agent who has legal authority to make decisions regarding the resident's funds. C. Management of Personal Funds. Upon written authorization of a resident or agent, a nursing facility shall hold, safeguard, manage, and account for the resident's personal funds that are deposited with the nursing facility as specified in this regulation. D. Personal Funds in Excess of $50. A nursing facility shall: (1) Deposit a resident's personal funds in excess of $50 in an interest-bearing account that is: (a) Established and maintained by the facility under one of the following terms: (i) In the name of the resident only; (ii) In the name of the facility “in trust for” or as the “trustee” for the individual resident; or (iii) In a residents' pooled account, with a separate accounting for each resident's share; and (b) Located in a financial institution whose accounts are insured by the: (i) Federal Deposit Insurance Corporation (FDIC); (ii) Federal Savings and Loan Insurance Corporation (FSLIC); or (iii) Other insurer approved by the Department; and (c) Separate from any of the nursing facility's operating accounts; and (2) Credit all interest earned to the resident's account at least quarterly. E. Personal Funds Less Than $50. A nursing facility may maintain a resident's personal funds that do not exceed $50 in a petty cash fund or a non-interest-bearing account that is identified as a residents' account. F. Establishment of Resident Accounts. When a nursing facility manages a resident's financial affairs, the nursing facility shall establish and maintain a system that: (1) Ensures a full, complete, and separate accounting, according to generally accepted accounting principles, of each resident's personal funds entrusted to the nursing facility; and (2) Precludes any commingling of resident funds with the nursing facility funds. G. For all resident funds entrusted to a nursing facility, the facility shall: (1) Establish and maintain adequate fire and theft coverage to protect a resident's funds that are on the premises of the nursing facility; and (2) Otherwise ensure the security of all residents' personal funds deposited with the nursing facility by purchasing a surety bond with the State as obligee on behalf of the nursing facility residents. H. Limitation on Charges to Personal Funds. A nursing facility may not: (1) Impose a charge against a resident's personal funds for: (a) An item or service for which payment is made under Medicare or Medicaid; and (b) A cost or fee incurred by the facility for establishing and servicing the resident's accounts; or (2) Use a Medicaid resident's personal funds to offset a contribution of care debt unless authorized by the resident, the resident's agent, or a court. #### Regulation .19 Records of Resident Personal Funds. *COMAR 10.07.09.19* A. Records. For all resident funds entrusted to a nursing facility, the facility shall: (1) Maintain an individual record for the funds of each resident, which includes the following information regarding each fund transaction: (a) The date of the transaction; (b) The type of transaction, whether it is a deposit, withdrawal, or any other transaction; (c) When the transaction is a withdrawal or deposit, reference to a numbered receipt; and (d) The balance of funds after the completion of the transaction; (2) At least weekly, post to the record of the funds all deposits, withdrawals, and other transactions; (3) Furnish each resident or, when applicable, the resident's agent or interested family member, with a quarterly statement of the resident's individual account not later than 30 days after the end of each quarter; (4) Make available for inspection by the resident or, when applicable, the resident's agent or interested family member, a monthly statement of the resident's account; and (5) Make available at the nursing facility, for audit by the Department and the Office, records pertaining to each resident's funds. B. Receipts of Transactions. (1) If a transaction involves a transfer of funds between a resident and a second party, or between the nursing facility and the institution in which the resident's account is located, the nursing facility or financial institution shall: (a) Provide a receipt or copy of a receipt to the resident, or retain the resident's copy of the receipt as part of the resident's individual financial record; and (b) Maintain the original receipt and make it available for audit. (2) Except as provided in §B(3) of this regulation, a nursing facility shall require that each receipt for withdrawal of funds from a resident's account be signed by the resident or, when applicable, the resident's agent. (3) A nursing facility may allow a resident to withdraw money from the resident's account without signing a receipt only if the nursing facility documents that the resident is not disabled but is incapable of signing due to a physical disability. (4) Except as set forth in Regulation .18H(2) of this chapter, a nursing facility may withdraw money from a resident's account without written authorization of the resident or, when applicable, the resident's agent, if the: (a) Nursing facility documents that the resident is incapable of understanding the resident's rights and responsibilities regarding finances; (b) Resident's agent is unavailable; and (c) Withdrawal of funds is for an item or service needed for the resident's direct and immediate benefit and the facility maintains documentation that the withdrawal was used for that purpose. (5) A withdrawal under §B(4) of this regulation requires witness signatures of two facility employees authorized by the facility administrator. C. Availability of Funds. (1) A resident has the right to access funds entrusted to the nursing facility: (a) During normal business hours, if the funds are held within the facility; or (b) Within 3 banking days, if a bank, the State treasurer, or a county or municipal treasurer holds the money. (2) When a nursing facility transfers or discharges a resident, the nursing facility shall either: (a) Request and follow the resident's written instructions for transferring the money; (b) Return, upon the resident's or, when applicable, the resident's agent's demand, the resident's money that the nursing facility has in its possession and have the resident or agent sign a receipt for the money; or (c) Make available to the resident or the resident's agent, within 3 banking days, the resident's money which is in an account with a bank, the State treasurer, or county or municipal treasurer. D. Notice of Balances. A nursing facility shall provide written notification to a resident who receives Medicaid benefits: (1) As specified in §1611(a)(3)(B) of the Social Security Act when the amount in the resident's account reaches $200 less than the Supplemental Security Income (SSI) resource limit for one individual; and (2) That, when the amount in the account, in addition to the value of the resident's other nonexempt resources, reaches the SSI resource limit for one individual, the resident may lose eligibility for Medicaid or SSI. E. Death of a Resident. Upon the death of a resident for whom a nursing facility is holding funds, the nursing facility shall notify the resident's agent or interested family member and: (1) Convey within 30 days a final accounting of the resident's personal funds which are deposited with the nursing facility; (2) Transfer, pursuant to the resident's preexisting burial contract, an amount not to exceed the outstanding unpaid balance of the contract, or the total of the resident's funds entrusted to the nursing facility, whichever is less; (3) Release the resident's funds only to an individual who presents certified letters of administration that designate the person as “Representative of the Estate of _______________________________________”; and (4) When the nursing facility is still in possession of a resident's funds 1 year after the resident's death, the facility shall report all money it holds for the former resident to the Unclaimed Property Section, Comptroller of the Treasury. #### Regulation .20 Misuse of Resident's Funds. *COMAR 10.07.09.20* A. A person may not misappropriate a resident's assets or income, including spending the resident's assets or income against or without the resident or resident's agent's consent, except as permitted by Regulation .19B(4) of this chapter. B. A person who believes that there has been an abuse of a resident's funds may make a complaint to the: (1) Local department of social services; (2) Director of the Office on Aging if the resident is 65 years old or older; or (3) Director of the Licensing and Certification Administration, regardless of the resident's age. ### Chapter 10 — Home Health Agencies **Authority:** Health-General Article, §19-404, Annotated Code of Maryland **Administrative History:** Effective date: June 2, 1978 (5:11 Md. R. 884) **Administrative History:** Regulation .03B amended effective June 29, 1979 (6:13 Md. R. 1126); June 13, 1980 (7:12 Md. R. 1147); May 24, 1982 (9:10 Md. R. 1022) **Administrative History:** Regulation .09E amended effective May 24, 1982 (9:10 Md. R. 1022) **Administrative History:** Chapter revised effective December 14, 1987 (14:25 Md. R. 2660) **Administrative History:** Regulation .02B amended effective April 11, 1994 (21:7 Md. R. 530) **Administrative History:** Regulation .04 amended effective April 11, 1994 (21:7 Md. R. 530) **Administrative History:** Regulation .04B amended effective May 1, 1989 (16:8 Md. R. 909); August 19, 1991 (18:16 Md. R. 1811) **Administrative History:** Chapter revised effective June 6, 2016 (43:11 Md. R. 634) **Administrative History:** Regulation .04B, C amended effective August 29, 2016 (43:17 Md. R. 953); March 13, 2017 (44:5 Md. R. 292) #### Regulation .01 Purpose. *COMAR 10.07.10.01* The purpose of these regulations is: A. To promote the interests and general well-being of all patients of home health agencies providing service within the State; B. To protect those interests by a public declaration of support for a patient's bill of rights; and C. To assure that the treatment of patients is, at all times, fully consistent with the provisions of this Act. #### Regulation .02 Definitions. *COMAR 10.07.10.02* A. All terms used in these regulations shall have the same meaning as those used in the Act. B. Terms Defined. (1) “Administrator” means an individual who has had: (a) Formal education in health services or administration, as evidenced by being a: (i) Physician, (ii) Registered nurse, or (iii) College graduate with a bachelor's or higher degree in a health-related field; and (b) At least 1 year of supervisory experience in: (i) Hospital management, (ii) Home health management, or (iii) Public health program management. (2) “Clinical note” means a dated and signed notation, with service designation by a member of the health team, of a contact with a patient. (3) “Clinical record” means a written account of all services provided a patient within the authorities of the home health agency, as well as other pertinent information necessary to provide care. (4) “Consumer” means a resident of the geographic area served who has demonstrated an interest in health care. The consumer representative may not personally, or through direct family ties, have any financial or active professional interest in the operation of the agency and shall be free of the existence of or appearance of conflict of interest. (5) “Department” means the Maryland Department of Health. (6) “Governing authority” means the individual, partnership, agency, group, or corporation designated to assume full legal responsibility for the policy determination, management, operation, and financial liability of the home health agency. (7) “Home health agency” means a health-related institution, organization, or a part of an institution that: (a) Is owned or operated by one or more persons, whether or not for profit and whether as a public or private enterprise; and (b) Directly or through a contractual arrangement, provides to a sick or disabled individual in the residence of that individual skilled nursing services, home health aid services, and at least one other home health care service, that are centrally administered. (8) “Home health aide” means a nonlicensed person who: (a) Has: (i) At least 1 year of practical experience in a hospital, nursing home, home care program; or (ii) Satisfactorily completed the Maryland Red Cross Home Care Course or an equivalent program; and (b) Provides personal and health care services to an individual in the place of residence, under supervision of the appropriate health professional. (9) “In-home service” means a program provided by a home health agency which makes available personal care, homemaker, chore, or respite services to disabled or elderly persons in the place of residence. The services are designed to enable these persons to remain in their own residence consistent with their desires, abilities, and safety. (10) “Maintenance health care” means a program provided by a home health agency for patients who are medically stable or have attained a satisfactory level of rehabilitation. These patients require only periodic monitoring by a health care professional in order to maintain their health care status and do not require the renewal of physician orders at least every 60 days. (11) “Parent agency” means the agency that develops and maintains administrative and professional control of the delivery of services either directly or through branch offices. (12) “Physician” means a person who is currently authorized to practice medicine under Health Occupations Article, §1-101, Annotated Code of Maryland. (13) “Professional advisory group” means a committee which includes: (a) One currently licensed physician; (b) One registered nurse; (c) One representative providing input from each allied discipline utilized by the agency; and (d) One consumer representative. (14) “Progress note” means a dated written notation by a member of the health team summarizing facts about the care given and the patient's response during a given period of time. (15) “Secretary” means the Secretary of Health. (16) “Skilled care” means a service or services which can only be safely and effectively provided by a person licensed under Health Occupations Article, Annotated Code of Maryland, and exercising specialized knowledge, judgment, and skill. (17) “Skilled nursing services” means services provided by or under the supervision of a registered nurse and in accordance with the plan of treatment. (18) “Utilization review” means a medical record review procedure designed to evaluate: (a) The appropriateness of admissions; (b) The efficiency and adequacy of provided services; and (c) Length of stay and discharge practices. #### Regulation .03 Application for a License. *COMAR 10.07.10.03* A. The applicant shall file an application for a license to operate a home health agency on forms provided by the Department. B. The application for licensure shall contain the name and address of each officer and director of the home health agency. Those corporations having more than 100 owners shall name those having an interest of 2 percent or more. Persons related by marriage or blood to the third degree of consanguinity shall each be named if the sum of their separate holdings exceeds 2 percent. #### Regulation .04 General Licensure Provisions. *COMAR 10.07.10.04* A. A person, partnership, corporation, or association, or any State or local government or agency thereof, may not conduct, operate, or maintain a home health agency in the State without being licensed by the Department. A license is valid for 1 year from the date of issuance, unless revoked by the Secretary. B. Application for License. An agency desiring to conduct, operate, or maintain a home health agency in the State shall file an application with the Secretary, on a written or electronic form provided by the Secretary. C. Renewal of License. An agency shall file an application on the written or electronic form provided by the Secretary for renewal of the license at least 60 days before expiration of the issued license and submit it on forms provided by the Secretary. D. The home health agency shall: (1) Demonstrate compliance with all applicable federal, State, and local laws and regulations, including the requirement of Health-General Article, Title 19, Subtitle 1, Annotated Code of Maryland. (2) Provide liability insurance to cover all employees. The agency shall also ensure that its contractual persons possess appropriate liability protection. (3) Maintain records as determined by the Department and make the records available to the Department upon request. (4) Accept patients for skilled care only on the signed order of a physician, obtained within 28 days after acceptance. (5) Contact a physician to obtain a signed order as soon as possible, but not later than 10 days after acceptance of a patient for skilled care, and record all efforts to contact the physician. (6) Adopt procedures for the administration of drugs and biologicals which shall include: (a) The administration of treatment modalities, including any intravenous procedures, chemotherapy, parenteral feedings, and injections; (b) The assurance of 24-hour-a-day availability of care for the hours during the administration of intravenous medications and nutritional support; (c) The administration of drugs and treatments only by the following licensed agency staff: (i) Physician, (ii) Registered nurse, or (iii) Licensed practical nurse if the drugs or treatments are administered under the supervision of a registered nurse in accordance with the physician's plan of treatment, and in accordance with a plan of care developed by a registered nurse; (d) Minimum training in keeping with applicable law for staff who administer drugs and treatments; (e) Drugs and treatments to be administered only as ordered by the physician; (f) Documentation in the patient's medical record of medications administered and any medication errors, adverse drug reactions, and corrective actions; (g) If the agency provides to any patient controlled drugs as described in Criminal Law Article, Title 5, Subtitle 4, Annotated Code of Maryland, written policies and procedures governing the disposal of controlled drugs in accordance with applicable federal and State laws and regulations. (7) Have services available at least 8 hours a day, 5 days a week, and available on an emergency basis 24 hours a day, 7 days a week by: (a) Establishing a procedure by which any patient may contact a representative of the agency at any time by telephone; (b) Ensuring that the person receiving patient calls is able to contact a registered nurse immediately, but not later than 1/2 hour after receipt of a patient's call; and (c) Ensuring that the registered nurse: (i) Assesses the patient's needs; and (ii) In emergency situations, renders immediate care to the patient, or causes the patient to be treated by an appropriate health care provider. E. The Department shall: (1) Issue its operating license only to the home health agency named in the application. The license may not be transferred or reassigned. The license shall be immediately void if the home health agency ceases to operate and shall be returned to the Department. (2) Issue licenses which expire 1 year from the date of its issuance or, in the case of a provisional license, on the date specified at the time of issuance, unless otherwise revoked or suspended by the Department. (3) Make inspections and surveys at least annually to determine compliance with the regulations. (4) Conduct its inspections, surveys, and investigations at all reasonable times and at all geographical locations considered necessary for the proper conduct of its business. (5) Prepare a written report detailing its determination of compliance with those regulations. A copy of this report shall be forwarded to the applicant within 30 days of the inspection. F. If a parent agency is located outside the State, the Department shall issue a license if: (1) At least one branch office is located within the State; or (2) The parent agency is located in a state bordering Maryland and either the: (a) Bordering state has a reciprocal agreement for home health licensure, under which the agency may be inspected at the discretion of the Department; or (b) Agency agrees to be inspected by the Department. G. Investigation of complaints shall be conducted by the Department as necessary. #### Regulation .05 Inspections. *COMAR 10.07.10.05* A licensed home health agency or an entity proposing to operate such a facility shall be open during normal business hours, or any other times that the facility is serving residents, for inspection by the Department or by any other agency designated by the Department to: A. Survey home health agencies at least every 3 years; B. Verify compliance with licensing regulations; or C. Investigate complaints. #### Regulation .06 Administrative Enforcement. *COMAR 10.07.10.06* A. When a home health agency fails to comply with these regulations, the Department may: (1) Deny any application for a license; (2) Suspend or revoke a license; or (3) Issue a provisional license. B. Revocation, suspension, denial, or issuance of a provisional license shall occur in accordance with State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland. C. The Department may issue a provisional license for a period of less than 1 year in instances where: (1) The home health agency is in existence in Maryland at the time of promulgation of these regulations, and, therefore, requires a reasonable time period during which it may come into compliance with these regulations; (2) The home health agency has failed to demonstrate substantial compliance with the regulations but has indicated, in writing, its willingness to take the necessary corrective action to achieve substantial compliance. D. The Department shall designate the conditions and the time period under which a provisional license is being issued. E. A provisional license may not be renewed unless the deficiencies have been substantially corrected or a satisfactory POC implemented. A provisional license may not be issued for more than 2 consecutive years. #### Regulation .07 Notice to Patients. *COMAR 10.07.10.07* The home health agency shall notify each patient or the patient's authorized representative, the patient's attending physician, and any third-party payers at least 30 days before the voluntary surrender of its license, or as directed under an order of denial, revocation, or suspension of license issued by the Department. #### Regulation .08 Posting of License. *COMAR 10.07.10.08* A. The home health agency shall conspicuously post its license in its office and in each of its branch offices. The license shall be posted as to be viewable by the general public. B. In branch offices, the license shall be accompanied by a Departmental statement affirming the authority of the branch office to conduct its activities under the licensure authority of its parent agency. #### Regulation .09 Governing Authority. *COMAR 10.07.10.09* A. The home health agency shall have a duly constituted governing body, or designated persons so functioning, with full legal authority, responsibility, and accountability for its operation. B. Adoption of By-laws. (1) The governing body shall adopt written by-laws, in accordance with applicable legal requirements, for the conduct of business by the home health agency. (2) These by-laws shall include, at least the following: (a) A statement of objectives; and (b) An organizational structure by which agency policies and procedures are implemented. (3) These by-laws shall be reviewed annually and revised as necessary. C. The governing body shall appoint a home health agency administrator who shall be responsible for the overall management and fiscal operations of the agency. D. The governing body shall designate a “professional advisory group” whose functions shall include, at least: (1) To regularly review and advise on agency policies covering professional issues, including: (a) Scope of services offered; (b) Criteria for acceptance, discharge and/or rejection of patients; (c) Appropriateness of medical supervision; (d) Emergency care services to patients; (e) Adequacy of system for maintaining clinical records; (f) Adequacy of agency's review and evaluation program; and (g) Mechanism for referrals and continuity of care with allied health care providers; (2) To participate in the annual evaluation of the agency's programs. E. The Professional Advisory Group shall meet at least three times each calendar year and shall keep documented minutes. F. The governing body shall take appropriate actions on recommendations made by the professional advisory group. Complete documentation of recommendations made and actions taken shall be maintained. G. The governing body shall assure that all services offered by the home health agency, whether directly or indirectly, are: (1) Monitored and supervised by the parent agency; and (2) When stipulated by a physician's order, provided to an individual within 24 hours after the physician refers the individual to the agency. H. The home health agency shall establish a written contractual arrangement for the provision of all services which are not provided directly by the agency. At a minimum, the written contract shall: (1) Designate the services which are to be provided, the setting and the geographical area served (services provided are to be within the scope and limitations set forth in the plan of treatment and may not be altered in type, amount, frequency, or duration, except in the case of adverse reaction, by the individual under contract); (2) Describe how the contracted personnel are to be administratively or professionally supervised, or both; (3) Describe how services will be controlled, coordinated, and evaluated by the parent agency; (4) Describe the procedure for submitting clinical and progress notes, scheduling of visits, and periodic patient evaluations; (5) Specify the charges for specific services provided under contract; (6) Specify that only the parent agency shall bill for service and collect the applicable deductible or co-insurance payments; (7) Specify the period of time that the contract shall be in effect and how frequently it shall be reviewed; the contract shall be reviewed at least annually and renewed when necessary; (8) Insure that personnel and services contracted meet the requirements specified in these regulations for home health agency personnel and services, including licensure, personnel qualifications, physical examinations, functions, supervision, orientation, in-service education, and attendance at case conferences; (9) Provide for the acceptance of patients for home health services only by the parent agency. Patients may not be admitted for home health service by a contracted individual without prior review of the case and acceptance of the patient by the home health agency in accordance with agency policies. #### Regulation .10 Personnel. *COMAR 10.07.10.10* A. All professional personnel employed by or conducting business with a home health agency shall be licensed or duly authorized to conduct the business under the laws and regulations of the State. B. The home health agency shall have written policies on qualifications, responsibilities, and requirements for employment for each classification of personnel, including licensure where required. C. The policies of the home health agency shall, at a minimum, provide for: (1) Wage and salary schedules; (2) Eligibility for vacation, sick leave, and other fringe benefits; (3) In-service training and orientation of all personnel in the objectives, policies, and functions of the agency, including grievance procedures; and (4) Job descriptions for each classification of personnel. D. The policies of the home health agency shall be reviewed annually and revised as necessary. E. The home health agency shall maintain a complete and current personnel record for each employee and volunteer, which, at a minimum, shall include: (1) A certification that the employee is free from tuberculosis in a communicable form as provided in Regulation .14, of this chapter, only if the employee or volunteer: (a) Will be involved in the direct care of tuberculosis patients, or (b) Is an immigrant from Africa, Asia, or Latin America; (2) Evidence of current licensure, certification, or registration, as appropriate; (3) Evidence of the individual's qualifications for the position; and (4) Periodic performance evaluations. #### Regulation .11 Staff Supervision and Training. *COMAR 10.07.10.11* A. The Administrator shall appoint a full-time employee as a “service director” to provide general supervision and direction of the professional services offered by the home health agency. The service director, who shall be a physician, registered nurse, or an alternate professional, who is sufficiently qualified by advance training to supervise this service, shall be available at all times during operating hours of the home health agency and shall participate in all activities related to the professional services provided, including the qualifications of personnel as related to their assigned duties. In his absence, he shall appoint a similarly qualified designee. B. The nursing services of the home health agencies shall be provided under the supervision and direction of a registered nurse who is qualified by having 2 to 3 years experience or education in community health nursing. C. There shall be periodic, on-site supervision of services provided by home health aides, with complete and accurate documentation maintained. D. Training Requirements for Home Health Aides. Aides shall receive a periodic, structured program of training and orientation which includes, at a minimum: (1) The role of the home health aide as a member of the professional health services team; (2) Instruction and supervised practice in personal care services of the sick at home, with major attention being given to personal hygiene and activities of daily living; (3) Instruction in how to assist patients to achieve maximum self-reliance through re-learning and modifying activities of daily living; (4) Principles of good nutrition; (5) Meal planning, food purchasing, and preparation of meals, including special diets; (6) General information on the processes of growth, development, and aging; (7) Information on the emotional and physical problems accompanying illness; (8) Principles and practices in maintaining a clean, health, and safe environment as well as a pleasant one that encourages morale building and self-help; (9) Items requiring referral to the nurse supervisor in the home health agency, including changes in the patient's condition or family situation; (10) Record-keeping, when applicable; (11) Policies and objectives of the agency; (12) Information concerning the duties and responsibilities of a home health aide; and (13) Ethical behavior and confidentiality of information. E. Inservice education is required for all professionals including home health aides, on a quarterly basis. The subject matter, content, and attendance shall be documented for review during the survey process. #### Regulation .12 Clinical Records. *COMAR 10.07.10.12* A. A clinical record shall be maintained for each patient in accordance with accepted professional standards, including, at a minimum: (1) All pertinent diagnoses; (2) Name, address, and telephone number of physicians; (3) Physician's orders, including specific instructions for services to be rendered, activities and limitations, and medically-necessary supplies and equipment; (4) Drug information, including type, dosage, route of administration, frequency, and history of sensitivities or allergic reactions; (5) Nutritional requirements, including specific dietary plans; (6) Prognosis, including rehabilitation potential; (7) Patient care plans, which should include: (a) Long and short-range goals; (b) Physical needs, including safety measures to protect against injury; (c) Psycho-social needs; (d) Actions taken by individual disciplines; and (e) Evidence of periodic reappraisal of the needs of the patient; (8) Progress notes and modifications to the treatment plan; and (9) Discharge summary. B. The home health agency should maintain a unit record for all patients receiving multi-disciplinary care. C. All notes and reports entered in the clinic record shall be typewritten or written in ink, legible, dated and signed with the name and title of the person rendering service. D. The home health agency shall establish and implement policies concerning clinical records which assure: (1) That records of discharged patients are completed no later than 30 days after the date of discharge; (2) The proper operation of a system for identifying, filing, and retrieving clinical records; (3) Proper mechanisms for the timely transfer of clinical record information upon request from duly-authorized persons and organizations; (4) Proper safeguards for clinical record information against loss, destruction, or illegal or unauthorized use; (5) That clinical records are preserved for at least 5 years from the date of discharge; (6) That, with the approval of the Department, provisions are made for retention of clinical records when it ceases operation; and (7) That progress notes are recorded within 5 working days after service is delivered. The treatment plan shall be modified accordingly. E. A home health agency which provides maintenance health care or in-home services, or both, may not be required to maintain the same level of supervisory and record-keeping requirements of these regulations for those patients who only receive the maintenance health or in-home services. In these cases, the agency shall develop performance criteria, supervisory and record-keeping requirements for these patients. #### Regulation .13 Program Review and Evaluation. *COMAR 10.07.10.13* A. The home health agency shall establish policies and procedures for self-evaluation of its programs. These should include, at a minimum: (1) Evaluations of staffing patterns to assure adequacy and appropriateness of service delivered; (2) An annual review of programs to determine: (a) Trends in service needs and activities; (b) Problems and unmet needs of patients; (c) Anticipated changes in delivery of service; (d) Linkages with related community services. B. The home health agency shall review its written policies at least annually, and revise them as necessary. The results of this review shall be presented, in writing, to the professional advisory group and to the governing body. C. Utilization Review. (1) The home health agency shall establish a program of utilization review which, at a minimum, includes a utilization review committee to review clinical records at least quarterly. The committee members shall represent the scope of services offered by the agency. The clinical record review shall consist of a minimal sampling of 10 percent of unduplicated caseload records per annum or 40 records, whichever is less. All services offered shall be included in the sample. (2) Sixty Day Continuous Care Review. Each active record shall be reviewed at least every 60 days to determine the adequacy of the plan of treatment and appropriateness of continued service, including renewal of physician orders. D. The home health agency shall maintain a documented statistical reporting system for each county and the City of Baltimore, if served, which includes, at a minimum: (1) Number of patients by age, sex, and race receiving each service; (2) Number of patient visits conducted by each discipline; (3) Diagnostic categories; (4) Source of referrals; (5) Reason for discharge; and (6) Sources of reimbursement for all services. E. The home health agency shall: (1) Prepare a report annually of its documented statistics within 90 days after the close of its fiscal year; and (2) Beginning with the next fiscal year after adoption of this regulation, submit the report to the Department in the form and manner prescribed by the Secretary with each application for license renewal. #### Regulation .14 Patient's Bill of Rights. *COMAR 10.07.10.14* A. The home health agency shall provide each patient, client, or designated representative with a written statement affirming the agency's representatives support of a patient's bill of rights, including: (1) Upon request, a written statement of services offered, including frequency and unit charge; (2) Fully itemized, billing statements, including date of service and unit charge, to be made available on request of the patient; (3) Written disclosure of its policy on uncompensated care; (4) Upon request, information as to the identity of other health care providers with which the agency has contractual relationships, insofar as the patient's home health care is concerned; (5) The name of the responsible person supervising the patient's home health care and the manner in which that person may be contacted during regular working hours; B. To the extent reasonably possible, the home health agency shall provide for the patient's being consulted in the implementation of the home health care plan, including its likely outcome; C. The home health agency shall provide for the right of the patient to refuse any portion of planned treatment without relinquishing other portions of the treatment plan, except where medical contraindications to partial treatment exist; D. The home health agency shall provide a mechanism for the receipt and timely investigation of written complaints in which: (1) Disruption in service may not result from the filing of a complaint; (2) Complete files are maintained on the source, category, and disposition of the complaint; (3) A summary report is presented to the professional advisory group at its regular meetings; (4) A summary report is made available to the Department at least annually; and (5) A summary report is made available for public inspection, upon request. #### Regulation .15 Tuberculosis Screening. *COMAR 10.07.10.15* A. Certification of paid and unpaid personnel under Regulation .09E shall occur not later than 10 days after the beginning of service. Certification shall be accomplished in one of the following four ways as specified in §A(1)—(4), of this regulation: (1) If the individual has documentation of a negative tuberculin test by the Mantoux method within the past 24 months and has, by history, no contact with a person with tuberculosis in a communicable form following this documentation or no symptoms consistent with tuberculosis, the individual shall be considered to be a negative tuberculin reactor and to be free from tuberculosis in a communicable form. Further skin testing is not necessary, except for epidemiologic diagnostic purposes which may be required by the local health officer or the Department. (2) If the individual does not have documentation of a negative tuberculin test by the Mantoux method within the past 24 months and does not have a history of having had a positive tuberculin test by the Mantoux method, the following procedure shall be done: (a) Five tuberculin units (TU) of purified protein derivative (PPD) shall be administered intradermally and the results read 48—72 hours following the administration of the test; (b) An individual with induration of 5—9 millimeters and no history of contact with a person with tuberculosis in a communicable form or an individual with induration of 0—4 millimeters shall be considered to be a negative tuberculin reactor and to be free from tuberculosis in a communicable form; (c) An individual with induration of 5—9 millimeters and a history of contact with a person with tuberculosis in a communicable form or an individual with induration of 10 millimeters or more shall be considered to be a positive tuberculin reactor and shall be handled as described in §A(3)(a)—(c), of this regulation. (3) If the individual is a positive tuberculin reactor as defined in §A(2)(c), of this regulation, or if the individual has a history of a positive tuberculin test by the Mantoux method without documentation of having received an adequate course of therapy, as defined by the local health officer, for tuberculosis disease or received adequate prophylaxis, as defined by the local health officer, for tuberculosis infection, the following procedure shall be done: (a) If the individual does not have documentation of a negative chest X-ray within the past 12 months, the individual shall be evaluated by a chest X-ray. If the chest X-ray is negative, the individual shall be considered to be free from tuberculosis in a communicable form and shall have a repeat chest X-ray in 12 months, unless isoniazid therapy is instituted, in which case the second chest X-ray is unnecessary. (b) If the individual has documentation of a negative chest X-ray within the past 12 months, the individual shall be considered to be free from tuberculosis in a communicable form and shall have a repeat chest X-ray 12 months after the individual's most recent documented chest X-ray unless isoniazid therapy has been instituted, in which case the second chest X-ray is unnecessary. (c) If the individual has had two successive negative chest X-rays 12 months apart, no further chest X-rays are necessary and the individual shall be considered to be free from tuberculosis in a communicable form unless the individual has symptoms consistent with tuberculosis. (4) If the individual has documentation of an adequate course of therapy, approved by the local health officer, for tuberculosis disease or adequate prophylaxis, approved by the local health officer, for tuberculosis infection, further chest X-rays are not necessary and the individual shall be considered to be free from tuberculosis in a communicable form unless the individual has symptoms consistent with tuberculosis. B. The agency shall instruct each employee and volunteer in the signs and symptoms of active tuberculosis and advise the individual to seek immediate medical care should the individual detect these signs or symptoms. C. If the individual meets any of the following criteria in this section, the agency shall have written policies and procedures, acceptable to the Department, for the evaluation, management, and surveillance of this individual. The criteria include: (1) A history of tuberculosis or tuberculosis infection without documentation of adequate treatment as defined and determined by the local health officer; (2) Current treatment for tuberculosis disease or tuberculosis infection; (3) Chest X-rays consistent with tuberculosis without documentation of adequate treatment as defined and determined by the local health officer; or (4) Symptoms consistent with tuberculosis or a history of contact with a person with tuberculosis in a communicable form within the past 12 months. D. The following records shall be maintained by the agency: (1) Results of Mantoux tests, recorded in millimeters of induration with dates of administration, dates of reading, and results of tests; (2) Results of X-rays required in §A(3)(a)—(c), of this regulation; and (3) Documentation of any Mantoux test, chest X-ray, chemotherapy, and chemoprophylaxis which is the basis for the certification that the individual is free from tuberculosis in a communicable form. #### Regulation .16 Rehabilitation Services. *COMAR 10.07.10.16* A home health agency that holds itself out to the public as providing a complete array of physical rehabilitation services shall: A. Provide a program of coordinated interdisciplinary rehabilitative care that shall include: (1) Physical and occupational therapy, (2) Speech and language therapy, (3) Audiology therapy, (4) Psychotherapy, and (5) Social work services; B. Hold interdisciplinary meetings with the involvement of a physician to plan and monitor patient care; and C. Meet any other applicable standard required by law. ### Chapter 11 — Health Maintenance Organizations **Authority:** Health-General Article, §19-701 et seq.; Insurance Article, §2-109(a)—(c); Annotated Code of Maryland **Administrative History:** Effective date: June 16, 1978 (5:12 Md. R. 967) **Administrative History:** Regulations .01E, .02, .03. .04B. .05D, .07E, .09B, .10B, .11A, .12B and C amended effective June 29, 1987 (14:13 Md. R. 1472) **Administrative History:** Regulation .01 amended effective June 22, 1992 (19:12 Md. R. 1134) **Administrative History:** Regulation .01 recodified to Regulation .01-1 and the Scope paragraph codified as Regulation .01 in May, 1993 **Administrative History:** Regulation .01-1B amended effective December 9, 2004 (31:24 Md. R. 1726) **Administrative History:** Regulation .04A amended effective June 22, 1992 (19:12 Md. R. 1134) **Administrative History:** Regulation .04B amended effective February 15, 2016 (43:3 Md. R. 272) **Administrative History:** Regulation .05B amended effective December 9, 2004 (31:24 Md. R. 1726) **Administrative History:** Regulation .07 amended effective June 22, 1992 (19:12 Md. R. 1134); December 9, 2004 (31:24 Md. R. 1726) **Administrative History:** Regulation .09A amended effective March 13, 2017 (44:5 Md. R. 292) **Administrative History:** Regulation .10 amended effective March 13, 2017 (44:5 Md. R. 292) **Administrative History:** Regulation .11 repealed and new Regulation .11 adopted as an emergency provision effective March 3, 1999 (26:7 Md. R. 535); emergency status expired September 3, 1999; adopted permanently effective September 6, 1999 (26:18 Md. R. 1376) **Administrative History:** Regulation .11D and E adopted effective June 22, 1992 (19:12 Md. R. 1134) **Administrative History:** Regulation .13 repealed effective June 22, 1992 (19:12 Md. R. 1134) #### Regulation .01 Scope. *COMAR 10.07.11.01* The purpose of these regulations is to regulate various phases of the operations of health maintenance organizations in accordance with the mandates of Health-General Article, §§19-701—19-734, Annotated Code of Maryland. #### Regulation .01-1 Definitions. *COMAR 10.07.11.01-1* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Board” means the Board of Physicians. (1-1) “Certified nurse practitioner” has the meaning stated in Health Occupations Article, Title 8, Annotated Code of Maryland. (2) “Commissioner” means the Insurance Commissioner of Maryland. (3) “Department” means the Maryland Department of Health. (4) “Enrollee” means a person who has entered into a health care services contract or on whose behalf a contractual arrangement has been entered into with a health maintenance organization (HMO). (5) “Governing authority” means the person or persons designated in the bylaws with the responsibility for operating the HMO. (6) “Grievance” means any complaint by an enrollee: (a) That the enrollee has not received any benefit or other right to which the enrollee is contractually entitled or that the enrollee has been treated unprofessionally or otherwise improperly by the HMO, or a provider engaged by the HMO; (b) Which is not resolved formally to the satisfaction of the enrollee. (7) “Operating year” means the consecutive 12-month period, or part thereof, during which the HMO makes available health services as delineated in its Certificate of Authority (as issued by the Insurance Commissioner), and beginning on the issuance date of this Certificate. (8) “Out-of-area coverage” means contractual benefits provided by the HMO to its enrollees with respect to emergency health care services received by enrollees outside the primary geographical area served by the HMO. (9) “Physician” means an individual authorized by law to practice medicine in the State. (10) “Preventive services” means those services designed to prevent the occurrence of disease or injury or to arrest disease at an early stage before complications and serious disabilities develop. (11) “Quality of health care” means that level of health care delivered which reflects the general health care standards and practices in the geographical area served by the HMO. (12) “Secretary” means the Secretary of Health. #### Regulation .02 Service Requirements. *COMAR 10.07.11.02* A. The HMO shall provide the services required by the Maryland Health Maintenance Organization Act of 1975, Health-General Article, §19-701(d), Annotated Code of Maryland. B. The HMO shall make available and encourage appropriate history and baseline examinations for each enrollee within a reasonable time of enrollment set by the HMO. Medical problems that are a potential hazard to the person's health shall be identified and a course of action to alleviate these problems outlined. Progress notes indicating success or failure of the course of action shall be recorded. C. The HMO shall offer or arrange for preventive services that include health education and counseling, early disease detection, and immunization. The HMO shall develop or arrange for periodic health education on subjects which impact on the health status of the enrollee population and shall notify every enrollee in writing of the availability of these and other preventive services. D. Services to prevent a disease shall be offered if all of the following conditions exist: (1) The disease produces death or disability and exists in the enrolled population; (2) The etiology of the disease is known or the disease can be detected at an early stage; (3) Elimination of factors leading to the disease or immunization has been proven to prevent its occurrence, or early disease detection followed by behavior modification, environmental modification, or medical intervention has been proven to prevent death or disability. E. An HMO shall offer services through a licensed health care practitioner who is not a physician if the: (1) Services are within the scope of practice for both: (a) A physician; and (b) Another licensed health care practitioner; and (2) HMO considers the offering of the practitioner's services appropriate. #### Regulation .03 Quality Assurance Requirements — Program Planning and Evaluation. *COMAR 10.07.11.03* A. The HMO shall have a written program plan that is updated and reviewed at least every 3 years. B. The plan shall include the following information: (1) Statistics on age, sex, and other general demographic data used to determine the health care needs of its population; (2) Identification of the major health problems in the enrolled population; (3) Identification of enrolled special groups that have unique health problems such as the poor, the elderly, the mentally ill, and educationally disadvantaged; (4) A description of community health resources and how they will be used. C. Priorities and Objectives. The HMO shall state its priorities and objectives in writing, describing how the priorities and objectives relating to the health problems and needs of the enrolled population will be provided for. D. Services. At the time membership is solicited, the HMO shall provide a general description of services available to enrollees including: (1) Benefit limitations and exclusions; (2) Location of facilities or providers; and (3) Procedures by which a member would obtain medical services. E. On each enrollment card or application, the HMO shall: (1) Place the following statement in bold print: “If you have any questions concerning the benefits and services that are provided by or excluded under this agreement, please contact a membership services representative before signing this application or card”; and (2) Provide information on how a prospective member may contact a membership services representative. F. The plan shall contain evidence that: (1) Programs and services offered are based on the health problems of, and the community health services available to, the enrolled population; (2) There is an active program for preventing illness, disability, and hospitalization among enrollees; (3) Services designed to prevent the major health problems identified among child and adult enrollees and to improve their general health are provided by the HMO. #### Regulation .04 Peer Review. *COMAR 10.07.11.04* A. Internal Review. The HMO shall have an internal peer review system that will evaluate the utilization of services and the quality of health care provided enrollees. The review system shall: (1) Provide for review by appropriate health professionals of the process followed in the provision of health services; (2) Use systematic data collection of performances and patient results; (3) Provide interpretation of this data to the practitioners; (4) Review and update continuing education programs for health professionals providing services to enrollees; (5) Identify needed change and proposed modifications to implement; (6) Maintain written records of the internal peer review process; (7) Conduct focused studies directly related to major health problems and preventive health needs identified in Regulation .03B and C of this chapter; and (8) Assure that at least three focused studies related to the HMO specific plan under Regulation .03 of this chapter are conducted each year. B. External Review. (1) The Department shall conduct an external review of the quality of health care services of the HMO when and in a manner the Department considers appropriate. (2) The external review shall be conducted by: (a) A panel of physicians and other health professionals consisting of persons who: (i) Have been approved by the Department; (ii) Have substantial experience in the delivery of health care in an HMO setting but who are not members of the HMO staff or performing professional services for the HMO concerned; (iii) Reside outside the area serviced by the HMO; or (b) The Department. (3) The final decision on which type of external review is to be employed rests solely with the Department. (4) The external review shall consist of a review and evaluation of the following: (a) Internal peer review system and reports; (b) The HMO program plan to determine if it is adequate and being followed; (c) The professional standards and practices of the HMO in every area of services provided; (d) The grievances relating specifically to the delivery of medical care, including their final disposition; (e) The physical facilities and equipment; and (f) A statistically representative sample of enrollee records. (5) A health maintenance organization accredited by an accreditation organization approved by the Secretary in accordance with Health-General Article, §19—2302, Annotated Code of Maryland, shall be exempt from the external review. #### Regulation .05 Medical Records. *COMAR 10.07.11.05* A. The HMO shall maintain an individual record for each patient according to accepted professional principles and the provisions of these regulations, with entries kept current, dated, and signed by a physician or other medical professional. B. All information contained in the medical records and information received from physicians, surgeons, certified nurse practitioners, or hospitals, incident to the health care practitioner-patient or hospital-patient relationship, shall be kept confidential, and, except for use incident to bona fide medical research and education, or for the Department's review under these regulations, or as reasonably necessary in connection with the administration of the member's contract, may not be disclosed without the consent of the patient. C. Contents and Procedures. The medical record shall contain at least the following information and be maintained under the following procedures: (1) Identification and summary sheets; (2) Prior medical findings and referral information; (3) Information necessary to support the diagnosis and justify the treatment given as shown in the individual written plan of treatment; (4) Progress notes by a medical staff member, as appropriate; a physician shall review and approve the progress notes within 24 hours of entry; (5) Dated record of all treatments, medications, laboratory tests, X-rays, operative reports, anesthesia records, and measurements; (6) Consultation report, if appropriate; (7) Record of any emergency care treatment rendered to patient; and (8) Discharge summary of inpatient hospitalization to include condition at time of discharge and post operative instructions given to the patient. D. It is the responsibility of each attending clinical staff member to complete and sign the medical records of each ambulatory patient the staff member treats, within 72 hours of treatment. E. The HMO shall maintain a system for identifying and filing records which provides for: (1) A universal identifier; and (2) Adequate space and equipment for filing and prompt retrieval of medical records. F. The HMO shall have established policies assuring that medical records of current enrollees and enrollees who leave the HMO plan are completed, promptly filed, and retained in safekeeping according to acceptable professional practices and State statutes. G. When the HMO provides services directly to its enrollees at several locations, it shall ensure, through the coordination of medical records and the use of other appropriate operating procedures, that the services it furnishes at those various locations are organized in this manner as to facilitate continuity of care. A central patient record keeping system shall be maintained as required by the Department. H. The HMO shall designate a member of the staff qualified by reason of training or experience, or both, who is responsible for the implementation of medical record policies and for the maintenance of the medical record system. #### Regulation .06 Statistics. *COMAR 10.07.11.06* The HMO shall provide the Department with full access to all operational and statistical data to enable the Department to verify the HMO's compliance and to enable the Department to conduct specific statistical studies with respect to current status of various segments of the enrolled population. #### Regulation .07 Personnel. *COMAR 10.07.11.07* A. When applicable, each staff member of the HMO shall be licensed as required by State and local law, and meet acceptable professional qualifications or have qualified by means of an occupational proficiency examination or through acceptable training. Provider staff patterns shall be designed to meet enrollee needs. B. The HMO shall provide orientation for all new employees and require continuing education of all professional and supportive personnel which reflects advances in medical knowledge and enrollee health education. C. The HMO shall establish a formal written process for: (1) Appointment of a physician or certified nurse practitioner to the clinical staff of the HMO; (2) Employment of a physician or certified nurse practitioner by the HMO; or (3) Selection of a physician or certified nurse practitioner to provide services to the enrollees under contract with the HMO. D. Information Concerning a Physician's or Certified Nurse Practitioner's Background and Training. (1) As part of the formal written process in §C of this regulation, the HMO shall collect, review, and verify the information concerning a physician's or certified nurse practitioner's background and training in §D(2) and (3) of this regulation. (2) Information that shall be collected, reviewed, and verified for a physician or certified nurse practitioner includes: (a) Evidence of education; (b) Evidence of current license to practice in the State; (c) Evidence of internship, residency training, or other pertinent training; (d) Evidence of specialty certification; (e) Evidence of Drug Enforcement Administration or Controlled Dangerous Substances registration; (f) Evidence of malpractice insurance coverage; (g) Physical and mental status; (h) List of all hospitals where the physician or certified nurse practitioner has current privileges or is employed; (i) Evidence of any adverse action or restriction of privileges imposed by any hospital or Board; (j) Delineation of services to be provided to patients at the HMO; (k) Past malpractice claims history; (l) Verification of status through the federal National Practitioner Data Bank; and (m) Cooperative arrangement with a physician for each certified nurse practitioner. (3) For a physician who has privileges in a licensed Maryland hospital, the HMO may verify, through the hospital, the credentials described in §D(2)(a)—(f) of this regulation. E. Reevaluation of Physicians or Certified Nurse Practitioners. (1) The HMO shall establish a formal written process for the reevaluation of appointment, employment, or selection of a physician or certified nurse practitioner. (2) The reevaluation shall include an ongoing process for verifying: (a) Current State Licensure; (b) Current Controlled Dangerous Substances or Drug Enforcement Administration registration; and (c) Evidence of current malpractice insurance. (3) Every 3 years, the reevaluation also shall include the following for all physicians and certified nurse practitioners: (a) An update of the requirements of §D of this regulation; (b) An assessment of the performance pattern based on an analysis of: (i) Complaints filed through the grievance system; (ii) Malpractice claims filed; (iii) Utilization, quality, and risk data; (iv) Adherence to policies, bylaws, and procedures; and (v) Physician and certified nurse practitioner practice patterns as reviewed through the HMO's quality assurance program. F. Administrator. (1) At least one administrator shall be appointed by the governing body and delegated the responsibility for the internal operation of the HMO according to established policies. The administrator's responsibility for procurement and direction of personnel shall be clearly defined. An individual competent and authorized to act in the absence of the administrator shall be designated. (2) The HMO shall notify the Department of the name of the person appointed administrator and of any change in the appointment. G. Medical Director. The HMO shall have a medical director who is licensed to practice medicine in the State. A physician authorized to act in the absence of the medical director shall be designated. The medical director shall oversee the quality of care provided to the HMO's patients. If the medical director becomes aware of unethical or unprofessional conduct on the part of any health provider, the medical director shall take appropriate action to prevent future occurrences of this conduct. H. The HMO shall have a licensed registered nurse present to perform nursing services at all times that these services are required. #### Regulation .08 Policy Formulation. *COMAR 10.07.11.08* A. The HMO shall have written policies governing the provision of the HMO services according to stated objectives of the HMO. The policies shall be developed in consultation with the executive officer, representative professionals, including one or more physicians, nursing service personnel associated with the service, and one or more enrollee representative or representatives. Policies shall be approved by the governing authority and reviewed and revised annually as required. These approvals shall be affirmed in writing and dated by an authorized representative of the governing authority. B. Patient Care Policies. The policies shall cover at least the following: (1) Inpatient admission and discharge policies; (2) Physician (Independent Practice Association) services, including medical staff organization; (3) Provision of or arrangements for other services not directly provided by the HMO; (4) Continuity and availability of care through an established referral mechanism and ongoing contract with other health services providers. #### Regulation .09 Access and Availability of Services. *COMAR 10.07.11.09* A. Regular Hours. (1) With respect to all services it furnishes, whether direct or through contractual arrangements, an HMO shall provide for regular hours during which an enrollee may receive services. (2) An HMO that provides services directly to its enrollees through its staff members shall have an orderly system for scheduling the provision of services to enrollees in a timely manner, taking into account the immediacy of need for services. (3) An HMO that provides services to its enrollees through independent licensed health care providers under contract with the HMO shall ensure that the providers have an orderly system for scheduling the provision of services to enrollees in a timely manner, taking into account the immediacy of need for services. B. Outside of Regular Hours. The HMO shall have a system for providing the enrollee with 24-hour access to a physician in cases where there is an immediate need for medical services. To meet this requirement, the HMO's arrangements for off-hour services may provide for access to physicians who do not have a contract with the HMO and facilities such as hospital emergency rooms. When a physician who does not have a contract with the HMO is used, the HMO shall develop and publicize procedures assuring that the HMO is notified of the services and receives adequate documentation from the physician or facility within a reasonable period of time. #### Regulation .10 Physician Availability. *COMAR 10.07.11.10* A. The HMO shall have a physician available at all times to provide diagnostic and treatment services. The HMO shall assure that every enrollee seen for a medical complaint is evaluated under the direction of a physician and that every enrollee receiving diagnostic evaluation or treatment is under the direct medical management of an HMO physician who provides continuing medical management. B. Each enrollee shall have an opportunity to select a primary physician or certified nurse practitioner from among those available to the HMO. #### Regulation .11 Complaint System for Quality of Care Issues. *COMAR 10.07.11.11* A. The HMO shall have a: (1) Written procedure to assist and respond to enrollees, families, and providers on complaints concerning quality of care issues; and (2) Designated department to handle complaints. B. Quality of care issues include, but are not necessarily limited to: (1) Bad outcomes related to poor care; (2) Failure to follow-up on diagnostic procedures; (3) Failure to provide treatment for presenting complaints consistent with standard of care; (4) Failure to appropriately document medical records; (5) Confidentiality and privacy issues related to medical records or provision of care; (6) General dissatisfaction with care; (7) Qualifications of individuals who are: (a) Employees of the HMO; or (b) Under contract with the HMO to provide services to enrollees; (8) Misdiagnosis; (9) Inappropriate referral to meet enrollees' needs; (10) Environmental issues related to infection control and hazardous medical waste; (11) Failure of a provider to perform adequate medical screening, assessments, or timely care in emergency situations; (12) Failure to provide an adequate internal enrollee complaint process concerning quality of care issues; (13) Failure to comply with policies and procedures concerning delivery of care; or (14) Inadequate credentialing and performance appraisal for physicians. C. The HMO shall: (1) Submit the written procedure to the Department for approval before distributing to enrollees; (2) Obtain Departmental approval of any revision to the written procedure before implementing the proposed change; and (3) Distribute the approved written procedure to all enrollees. D. The written complaint procedure shall include, at a minimum, the: (1) Department of the HMO that the enrollee or family member may contact if the enrollee wishes to make a complaint or obtain information concerning a complaint; (2) Complaint department's address and telephone number; (3) Procedure for investigating the complaint; (4) Time frame in which the HMO shall provide a final response to or resolve the enrollee's complaint, not to exceed 60 days; and (5) Telephone number of the Maryland Insurance Administration if the enrollee wishes to pursue a complaint regarding quality of care issues outside of the HMO's complaint system. E. The HMO shall treat the enrollee with dignity, courtesy, and due regard for the individual's privacy. F. The HMO shall maintain a written record of complaints and responses for at least 5 years following the date the complaint was received by the HMO. G. Investigation by the Department. (1) The Maryland Insurance Administration is the single point of entry for all complaints to State government filed by an HMO enrollee. The Maryland Insurance Administration shall refer all quality of care complaints, as defined in §B of this regulation, to the Department for investigation. (2) The Department may: (a) Refer a complaint directly to an HMO for resolution; or (b) Conduct an independent investigation. (3) If the Department refers the complaint to an HMO, the HMO shall provide the following information in writing to the Department within 30 days of receipt of the complaint: (a) The results of the investigation; (b) Any change or proposed change to HMO policies or procedures as a result of the investigation; and (c) The HMO's method to prevent recurrence of the problem. (4) If the HMO has not completed the investigation within 30 days, the HMO shall send the Department an interim report with a summary of the investigation to date and the expected date of completion. The expected date of completion may not be longer than 60 days from receipt of the complaint. #### Regulation .12 Inspections. *COMAR 10.07.11.12* A. HMO to Be Open for Inspection. An HMO shall be open to inspection by representatives of the Department and by any agency designated by the Department. B. Frequency of Inspection. (1) The Department shall inspect each HMO periodically at reasonable times. (2) The Department shall monitor continuously the health care services of an HMO: (a) From the time of notice by the Commissioner that the HMO is not operating in a fiscally sound manner; and (b) Until: (i) The Commissioner notifies the Department that the HMO is operating in a fiscally sound manner; and (ii) The Secretary determines that further continuous monitoring is not warranted. C. Records and Reports. HMO's shall keep records and shall make reports as the Department shall prescribe. All records shall be open to inspection by representatives of the Department. #### Regulation .13 Repealed. *COMAR 10.07.11.13* #### Regulation .14 Waiver Authority. *COMAR 10.07.11.14* The Department may grant waivers to the provisions of these regulations when this action is demonstrated to be in the best interests of the general public. Waivers may be granted for a 1-year period, are renewable, and are subject to reconsideration at any time. ### Chapter 12 — Health Care Facilities Within Correctional Institutions **Authority:** Health-General Article, §§19-307, 19-308, 19-320, and 19-323, Annotated Code of Maryland **Administrative History:** Effective date: June 16, 1978 (5:12 Md. R. 967) **Administrative History:** Regulation .04A amended effective March 13, 2017 (44:5 Md. R. 292) **Administrative History:** Regulation .20A amended effective March 13, 2017 (44:5 Md. R. 292) #### Regulation .01 Scope. *COMAR 10.07.12.01* These regulations are applicable to all health care facilities within correctional institutions and include those services provided inmates who report to the health care facility on an out-patient basis. These regulations do not include infirmaries which do not house patients overnight. #### Regulation .02 Definitions. *COMAR 10.07.12.02* A. “Communicable disease programs” means the provision of services that will assist in the prevention of communicable disease. B. “Department” means the Maryland Department of Health. C. “Health care facility” means a specified area within the correctional institution in which general and clinical health care services are provided to inmates in the custody of the Division of Corrections. D. “Health care program” means a document prepared by the facility and approved by the Department which lists the following: (1) The number of beds; (2) Organizational structure; (3) A description of the care, treatment, and services provided for inmates; (4) Admission policies; (5) Discharge and referral policies and procedures; (6) The staffing pattern by shifts; (7) The job classification and job descriptions of each employee. E. “Inpatient” means an inmate not requiring acute hospital care but requiring services of licensed nursing personnel or supportive services which he cannot perform for himself. F. “Referred services” means those appropriate services provided to inmates based on individual medical needs in the area of psychiatric services, dental care, or emergency care. G. “Sick call” means the medical care provided to inmates not classified as inpatients but who have expressed a need for medical attention or who have been referred to the health care facility by the appropriate personnel in the correctional institution. #### Regulation .03 Compliance with State and Local Laws, Ordinances, Regulations, or Orders. *COMAR 10.07.12.03* A. Each correctional facility shall demonstrate to the Department its compliance with applicable State and local ordinances, laws, regulations, and orders as they apply to the use of facilities for health, welfare and safety. B. Fire code requirements shall be: (1) In accordance with the NFPA 101 Life Safety Code as adopted as part of the State Fire Prevention Code of Maryland; (2) Annual inspection and approval by the State fire authority. #### Regulation .04 License Procedure. *COMAR 10.07.12.04* Applicants for licensure shall conform to the following: A. Any person desiring to open and operate a health care facility within a correctional institution or to continue the operation of an existing health care facility, shall file a written or electronic application with the Department giving the information required by the Office of Health Care Quality; B. The applicant shall submit a synopsis of the health care program to be offered with the application; each subsequent application shall include a list of changes in the original program. #### Regulation .05 Transfer or Assignment of License. *COMAR 10.07.12.05* A. Transfer or assignment of the license is prohibited. B. A separate license shall be required for each health care facility operated within the correctional institution. #### Regulation .06 Inspections. *COMAR 10.07.12.06* A. Health Care Facility to be Open for Inspection. Health care facilities, and any premise proposed to be operated by an applicant for a license, shall be open at all reasonable times to inspection by the Secretary of Health and by any agency designated by the Secretary of Health. B. Frequency of Inspection. Health care facilities shall be inspected by the Secretary of Health at least once during each 1-year period for which a license is granted to determine whether the health care facility is complying with the minimum standards established pursuant to these regulations. C. Records and Reports. All records shall be open to inspection by authorized representatives of the Department. Except where authentication may be required, the disclosure of patient names to the Division of Licensing and Certification surveyor may not be required. The representatives of the Department shall maintain confidentiality of all the data disclosed to them. #### Regulation .07 Policies and Procedures. *COMAR 10.07.12.07* Written policies and procedures shall be established for the following services: A. Physician services; B. Health care services; C. Staffing; D. Emergency care; E. Medical research; F. Communicable diseases; G. Medical examinations and evaluation process; H. Pharmacy services; I. Dietary services; J. Nursing Services. #### Regulation .08 Communication. *COMAR 10.07.12.08* There shall be a telephone in the health unit and additional telephones or extensions or communication systems as required by the Department to summon help in case of fire or other emergency. #### Regulation .09 Physician Services. *COMAR 10.07.12.09* A. Medical Examination. Each newly received inmate to the health facility shall be examined within 2 working days after his admission as to his medical condition. A record of each examination shall be kept as part of the permanent medical record. B. Availability. A licensed physician shall be readily available to take care of the medical needs of the inmates. Physician services may be provided through the following arrangements: (1) A contract with a local physician to provide coverage on specified hours and for emergencies; or (2) Affiliation with a local hospital to provide medical services required by the health care facility. #### Regulation .10 Psychiatric Services. *COMAR 10.07.12.10* Psychiatric services shall be provided according to the needs of the patients. #### Regulation .11 Surgical Services. *COMAR 10.07.12.11* Each health care facility desiring to perform surgical procedures shall first obtain approval from the Department. #### Regulation .12 Health Care Services. *COMAR 10.07.12.12* A. Health care services shall be provided according to the needs of the inmates and shall be designed to maintain the highest possible degree of function, self-care, and independence. B. A health care program shall be developed to insure prompt treatment of injury or illness. C. The health care facility shall provide equipment necessary for medical care according to the needs of the patients. D. An individual medical record shall be maintained for each patient. The record shall indicate their condition at the time of admission, reports of illness and injury, medical treatment provided, results of treatment, and their condition at the time of discharge. #### Regulation .13 Staffing. *COMAR 10.07.12.13* A. The health facility shall provide the number and level of personnel sufficient to meet the total needs of the patient. B. Health facilities shall employ licensed personnel to provide medical services when applicable. C. The facility shall provide personnel who are qualified by both training and experience in the handling of health emergencies. #### Regulation .14 Emergency Care. *COMAR 10.07.12.14* Each health facility in cooperation with the facility physician shall set forth in writing, to all personnel, the routine procedure for summoning appropriate medical care personnel. #### Regulation .15 Medical Research. *COMAR 10.07.12.15* Each health facility involved in medical research shall follow standards developed by the American Correctional Association for the safety and well-being of the inmate population. #### Regulation .16 Communicable Disease. *COMAR 10.07.12.16* A. Cross-infection shall be guarded against by prompt isolation of diagnosed and suspected cases of communicable disease. Room furnishings, equipment, and supplies shall be kept clean at all times, properly cleaned after use, and disinfected. B. Reports of Disease. The occurrence of an infectious disease, food poisoning, or dysentery, shall be reported immediately by the examining physician to the local health department and to the Division of Licensing and Certification. #### Regulation .17 Medical Examination and Evaluation Process. *COMAR 10.07.12.17* A. Written policies and procedures shall be developed and maintained in consultation with representatives of the medical staff, nursing service, and administration governing the provisions for the control of the sick call process and referral services. They shall address the following: (1) Screening Procedures. (a) Routine handling of patient complaints; (b) Non-routine handling of patient complaints. (2) Reporting Procedure. A responsible staff member to whom an inmate can report injuries, symptoms of illness, and emergencies shall be on duty at all times and be immediately accessible. (3) Complaint Procedure. Complaints of illness or injury shall be recorded in the inmate's clinical record together with the treatment prescribed. (4) Examination Procedure. The procedure shall specify where the examination area is located as well as who is to perform the examination. (5) Procedures to be followed by the correctional officer in attendance. #### Regulation .18 Staff Development. *COMAR 10.07.12.18* A. There shall be a combined orientation and continuing education program at least every 2 months for all personnel. Documentation shall be available to include date, time, topic discussed, speaker, and members present. A coordinated training program with a local hospital is encouraged. B. There shall be health care orientation and training for correctional officers assigned to medical facilities. Assignments and activities of correctional officers in medical areas shall be established. #### Regulation .19 Pharmacy Services. *COMAR 10.07.12.19* A. Procedures for Administration of Pharmaceutical Services. Each facility shall comply with all federal, State, and local laws, ordinances, standards and codes regulating the purchasing, storage, dispensing, administration, and recording of drugs. Each health care facility shall: (1) Ensure that pharmaceutical services are provided; (2) Make provision for prompt and convenient acquisition of prescribed drugs; (3) Record all supplies and drugs requisitioned and received from the pharmacy; (4) Record all prescriptions dispensed; (5) Obtain a permit to operate a pharmacy from the Board of Pharmacy in the State if the pharmacy is located within the correctional facility; (6) If the facility has no pharmacy, there shall be a written agreement for qualified pharmacy services, including provision for emergency service and consultation. B. Staff Requirements. (1) Pharmaceutical service, when provided within the health care facility, shall be under the direction and supervision of a pharmacist licensed to practice pharmacy in the State. (2) The staff or consultant pharmacist at each correctional facility shall participate in planned inservice education programs for the facility on topics related to pharmaceutical services. (3) The consultant pharmacist shall be available to assist in formulating the procedures, rules, and regulations for the acceptable distribution of drugs throughout the correctional system and shall visit the facility on a regular basis to review all aspects of the services provided and to ensure that proper controls are maintained. C. Formulary. There shall be a formulary system, approved by the institutional physician and pharmacist and by other appropriate facility staff. Copies of the formulary shall be located and available as appropriate to the institution. D. Space and Equipment. If the pharmacy is located within the health care facility there shall be adequate space and equipment to house the drugs and supplies. The pharmacist and pharmacy personnel, under the direct supervision of the pharmacist, may not dispense medications, make label changes, or transfer medications on other than the original containers. Documentation of the qualifications of the pharmacy personnel shall be available. E. Emergency Kit. There shall be an emergency drug kit immediately available at each nursing or service area for use by medical personnel. Written policies and procedures establishing the contents of the supply and procedures establishing the contents of the supply and procedures for use, restocking, and sealing of the emergency drug supply shall be available. A list of drugs shall be signed by the pharmacist and physician and attached to the kit. F. Stop Order Policy. Automatic stop orders on all drugs shall be maintained by the medical and pharmacy staff. These orders may not apply when the physician indicates a specific period of time a drug is to be used, or a specific number of dosages. G. Medication Release. All medications to be released to the patient shall be approved in writing by the physician. A notation concerning their disposition shall be made on the patient's clinical record. H. Administration of Medications. (1) All medications shall be administered by licensed medical or nursing personnel or by personnel who possess written documentation of training in theory and practice in the administration of medications. This written documentation shall be available for review by the Department. (2) The person assigned the responsibility of administering medications to inpatients shall complete the procedure by: (a) Personally preparing the dose; (b) Observing the act of swallowing the oral medications; (c) Recording the act of administration. (3) In the case of unit dose medications the person administering medication shall: (a) Open the unit dose package; (b) Observe the taking and swallowing of the medication; (c) Record the administration of the medication. (4) Medication shall be given only to the individual patient for whom the prescription was issued and shall be given according to directions as prescribed. (5) Medication cards and lists, or acceptable substitutes, shall be used and checked against the physician's orders when administering medications to inpatients. (6) Self-administration of medications by patients shall be permitted only when specifically ordered by the attending physician. (7) Medication errors and drug reactions shall be reported to the physician responsible for the resident. An entry of the medication error or the drug reaction or a combination of both, shall be recorded in the patient's record. (8) Current pharmaceutical reference materials shall be provided in order to furnish the medical, pharmacy, and nursing staffs with current information concerning the drugs used in the hospital. I. Investigational Drugs. Investigational drugs, properly labeled according to federal regulations, may be used only under the direct supervision of the principal investigator and after written consent is obtained from the patient. The drugs shall be approved by an appropriate medical staff committee acting according to established policies and procedures. Only physicians and nurses may administer investigative drugs after they have been made aware of the essential pharmacologic information necessary for them to discharge their professional responsibilities. A central location shall be established where information on investigational drugs being used is maintained. J. Labeling and Storing of Medication. (1) All medications shall be properly labeled and stored in a locked cabinet at the medical unit. The key to this cabinet shall be in the possession of authorized personnel. The labels shall bear the name and strength of the drug, expiration date of all time-dated drugs, name of the pharmacy issuing the drug, name of patient, and federal and State cautionary statements. Necessary labels shall be affixed to the labeled container. (2) Medications requiring refrigeration shall be kept in a locked refrigerator. Poisons and medication for “external use only”, including rubbing alcohol, shall be kept in a locked cabinet or compartment separate and apart from internal medications. (3) Discontinued and outdated drugs, and containers with worn, illegible, or missing labels, shall be returned to the pharmacy for proper disposition. (4) A drug recall procedure shall be established that can be readily implemented. (5) Drug cabinets on the medical units shall be checked by the pharmacist at least every 2 months. K. Control of Schedule II and Legend Drugs. (1) All Schedule II drugs shall be kept in a separately locked, securely fastened compartment within the locked medicine cabinet. (2) All Schedule II drugs retained on each nursing unit shall be counted at the termination of each tour of duty. This record shall be signed by both the outgoing and incoming professional nurse or authorized person. Schedule II drugs which are outdated and no longer in use shall be disposed of according to federal regulations. All other discontinued or outdated drugs shall be disposed of according to State regulations. #### Regulation .20 Dietary Services. *COMAR 10.07.12.20* A. Adequacy of Diet. The food and nutritional needs of patients shall be met according to physician's orders. B. Therapeutic Diets. (1) The therapeutic diet prescribed by the attending physician shall be prepared and served as part of the course of treatment of the patient. If the dietary requirement is beyond the capability of the facility, other arrangements for the nutritional needs shall be made by the health care facility physician. (2) A diet manual approved by the physician or dietitian shall be available. C. Frequency and Quality of Meals. At least three meals or their equivalent shall be served daily, at regular times, with not more than a 14-hour interval between the evening meal and breakfast. D. Planning of Menus. Menus shall be planned in advance and food sufficient to meet the nutritional needs of residents shall be prepared as planned for each meal. When menu changes are necessary, substitutions shall provide equal nutritional value. E. Preparation of Food. Food shall be prepared by methods that conserve nutritive value, flavor, and appearance, and shall be served at proper temperature. F. Compliance with COMAR 10.15.03 Food Service Facilities. Food service personnel shall comply with Maryland Department of Health COMAR 10.15.03 Food Service Facilities. #### Regulation .21 Housekeeping Services and Pest Control. *COMAR 10.07.12.21* The following shall be observed: A. The building and all its parts shall be kept in good repair, neat, clean, attractive, and safe. Housekeeping shall meet the highest possible standards of hygiene and cleanliness. B. All walls, floors, ceilings, windows, and fixtures shall be kept clean. Interior walls and floors shall be of a character to permit frequent and easy cleaning. C. The facility shall be kept free of unnecessary accumulations of unused furniture, equipment, linen, clothing, and similar items. D. The facility shall be maintained free of insects, rodents, and harborages, by operation of an active pest-control program, either by use of facility personnel or by contract with a pest-control company. Care shall be exercised in the usage and storage of toxic and flammable insecticides and rodenticides. E. All outside doors, windows, and other outside openings shall be screened with wire screen or its equal of at least 16 meshes per linear inch. ### Chapter 13 — Forensic Residential Centers (FRCs) **Authority:** Health-General Article, §§2-102 and 7-904; Criminal Procedure Article, §3-102; Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.06 adopted as an emergency provision effective July 10, 2008 (35:16 Md. R. 1388); emergency status extended at 36:2 Md. R. 96; adopted permanently effective January 26, 2009 (36:2 Md. R. 100) **Administrative History:** Regulation .02B amended effective January 20, 2014 (41:1 Md. R. 13) **Administrative History:** Regulation .04G amended effective January 20, 2014 (41:1 Md. R. 13) #### Regulation .01 Scope. *COMAR 10.07.13.01* This chapter sets forth requirements for a facility to be licensed as a forensic residential center. #### Regulation .02 Definitions. *COMAR 10.07.13.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Confined” means an order by the court pursuant to Criminal Procedure Article, §3-106(d)(2), Annotated Code of Maryland. (2) “Court-ordered evaluation” means an evaluation ordered by the court under Criminal Procedure Article, §§3-105 and 3-111, Annotated Code of Maryland, to assist the court to determine if an individual is incompetent to stand trial or is not criminally responsible because of mental retardation. (3) “Department” means the Maryland Department of Health. (4) “Evaluation unit” means a part of the forensic residential center dedicated to performing court-ordered evaluations pursuant to Criminal Procedure Article, Title 3, Annotated Code of Maryland. (5) “Forensic residential center (FRC)” means a facility that is: (a) Licensed to provide a continuum of integrative services to individuals with an intellectual disability: (i) Ordered by the court for an evaluation or to be confined; (ii) Court-committed for care or treatment to the Department as incompetent to stand trial or not criminally responsible, who are dangerous as a result of mental retardation; or (iii) On conditional release and returned to the facility either voluntarily or on hospital warrant; (b) A related institution as defined in Health-General Article, §19-301(o), Annotated Code of Maryland; and (c) Not an extended care or comprehensive rehabilitation facility. (6) “Incompetent to stand trial (IST)” has the meaning set forth in Criminal Procedure Article, §3-101(f), Annotated Code of Maryland. (7) “Not criminally responsible (NCR)” means a verdict of not criminally responsible as set forth in Criminal Procedure Article, §3-109, Annotated Code of Maryland. (8) “Qualified developmental disabilities professional (QDDP)” means an individual who coordinates and monitors the delivery of services for individuals with an intellectual disability. (9) “Therapeutic care unit” means an FRC or part of an FRC dedicated to providing care or treatment to individuals who are court-committed or confined. #### Regulation .03 Licensing Procedure. *COMAR 10.07.13.03* A. The Secretary shall license an FRC that meets the requirements of this chapter. B. The license for an FRC shall be effective for 1 year. C. The Secretary may renew the license of an FRC if it continues to meet the requirements of this chapter. D. Approval, Denial, Revocation, and Sanctions. (1) The Secretary may deny an application, suspend, revoke, or impose disciplinary sanctions on the license of an FRC if it fails to comply with the requirements of this chapter. (2) Any action to deny an application, suspend, revoke, or impose sanctions on a license shall be governed by COMAR 10.22.03. #### Regulation .04 Administrative Requirements. *COMAR 10.07.13.04* A. In addition to the requirements of this chapter, an FRC shall comply with the applicable requirements of COMAR 10.22.02. B. Safety and Sanitation. (1) An FRC's grounds, fixtures, and equipment shall: (a) Be maintained in good repair and be clean and attractive; (b) Be free of unnecessary accumulations of personal property or debris; (c) Be free of hazards, insects, and rodents; and (d) Be free from fire hazards. (2) An FRC shall comply with all applicable local fire and building codes and the Maryland State Fire Prevention Code, which is incorporated by reference in COMAR 29.06.01. C. Living Space. An FRC shall: (1) Have bedrooms that: (a) Have at least one outside wall; (b) Are equipped with or located near toilet and bathing facilities; (c) Accommodate no more than two individuals, provided such arrangement is clinically appropriate; and (d) Measure at least: (i) 60 square feet per individual in multiple individuals' bedrooms; and (ii) 80 square feet in single individual's bedrooms; (2) Have adequate bathroom facilities and maintain water temperature that does not exceed 110 degrees Fahrenheit in areas where individuals do not demonstrate the capability to regulate water temperature; (3) Provide adequate space and equipment for dining, living, health and therapeutic services, recreation, and other program activities; and (4) Provide that the above described living space be: (a) Dedicated to the sole use of individuals committed for court evaluation or committed or confined pursuant to Criminal Procedure Article, Title 3, Annotated Code of Maryland; and (b) Separate from areas used, frequented, or occupied by individuals committed or admitted pursuant to Health-General Article, Title 10, Annotated Code of Maryland. D. Infection Control. The FRC shall: (1) Establish policies and procedures to investigate, control, and prevent infections in the facility; (2) Ensure that facility staff follows these policies and procedures; and (3) Maintain records of actions taken to address and prevent infections. E. Food Services. The FRC shall employ a qualified dietitian either full-time or part-time, or on a consultant basis at the facility's discretion, who shall: (1) Provide adequate food and nutrition services; (2) Provide individuals with a nourishing, well-balanced diet including modified and specially prescribed diets; (3) Ensure the diet is prepared in accordance with current clinical dietary standards; (4) Ensure individuals receive at least three meals a day, at regular normal meal times; (5) Ensure foods are served in variety, appropriate consistency, texture, quantity, in season, and at appropriate temperatures; and (6) Prepare menus in advance and keep them on file a minimum 30 days. F. Health Care Services. As clinically appropriate, an FRC shall provide health services for all residents including, but not limited to: (1) Physician services, 24 hours a day; (2) Annual physical examinations which include: (a) Vision evaluations; and (b) Hearing evaluations; (3) Immunizations; (4) Laboratory services; (5) Nursing services and delegated nursing services in compliance with COMAR 10.27.11; (6) Medical care or nursing care plans for each individual and reviews of each plan; (7) Dental care; (8) Pharmacy services; and (9) Training or supervision of individuals to: (a) Self administer medications; (b) Perform routine treatments; and (c) Provide for their health care. G. Personnel and Staffing. (1) The administrator of an FRC shall: (a) Ensure appropriate employee health screenings; and (b) Obtain certification that an employee or volunteer is free from tuberculosis in a communicable form only if the employee or volunteer will be involved in the direct care of tuberculosis patients. (2) An FRC shall provide an adequate staffing plan in accordance with COMAR 10.22.02.11 to meet the needs of individuals served. (3) An FRC shall employ a Maryland licensed psychologist as the supervising psychologist who shall: (a) Supervise the evaluation and therapeutic treatment of individuals; (b) Use clinical best practices for the FRC population; (c) Have relevant work experiences and training in conducting and completing functional analyses, assessments, and behavior plans including experience working with individuals with co-occurring diagnoses of mental illness, substance abuse, and an intellectual disability; (d) Train direct care staff to collect data, and implement behavior plans and other programs in the individual's plan; (e) Ensure all services provided are documented appropriately in the individual's record; and (f) Ensure all behavior plans are developed in accordance with COMAR 10.22.10. (4) An FRC shall employ a Maryland licensed physician who: (a) Is certified in psychiatry by the American Board of Psychiatry and Neurology or who has completed the minimum educational and training requirements to be qualified to take the Board examination; and (b) Has the relevant work experience in providing psychiatric services to individuals with an intellectual disability and co-occurring disorders including mental disorders and addiction diseases. (5) An FRC shall employ direct care staff who develop and implement an activity schedule for the individual that includes at a minimum: (a) The individual's preferred activities; (b) Opportunities for recreation and social activities; (c) Times for meals; (d) Training as indicated in the individual's plan; and (e) The individual's waking and bedtime hours. (6) An FRC shall employ a Maryland licensed registered nurse to: (a) Train direct care staff on an individual's nursing care needs and any delegated nursing services; and (b) Ensure all services provided are documented in the individual's plan. (7) The FRC shall have a clinical team that shall include, at a minimum: (a) A Maryland licensed psychologist; (b) A Maryland licensed certified social worker—clinical (LCSW-C); (c) A QDDP; (d) Direct care staff; (e) A Maryland licensed registered nurse; and (f) As necessary: (i) A psychiatrist; (ii) A physician; or (iii) Other licensed staff. H. Security and Restrictions. (1) A resident may have access to personal electronic devices according to the resident's individual plan. (2) A resident may not have access to or possess: (a) Illegal products; (b) Cigarettes, alcohol, or pornography; or (c) Items or objects that the supervising psychologist documents in the individual's record as contraindicated or designates as dangerous to the individual or others. (3) The administrator of an FRC shall ensure a safe and secure setting for individuals by providing: (a) Adequate staffing; (b) Adequate supervision of individuals; (c) Appropriate training for staff to perform their job duties competently; and (d) Designated visitors' rooms with appropriate supervision of individuals during visits as needed. (4) The administrator of an FRC may utilize the following environmental security measures: (a) Security doors and windows; (b) Security screens; (c) Appropriate locks; (d) Alarm systems; (e) Electronic monitoring devices; (f) Video monitoring systems; (g) Outdoor gates and fences with locks; and (h) Enclosed or locked patios. (5) A resident's rights to communications and restrictions of communications are set forth in Health-General Article, §10-702, Annotated Code of Maryland, and adopted herein. I. Emergency Management Plans. The administrator of an FRC shall develop an emergency plan for all types of emergencies and disasters in accordance with COMAR 10.07.20.05E. J. Standing Committee Approval. An FRC shall assure that the quality assurance standing committee reviews all behavioral plans in accordance with COMAR 10.22.02.14E. #### Regulation .05 Enrollment, Release, and Discharge. *COMAR 10.07.13.05* A. All individuals in an FRC are ordered or committed by the court to the Department, or under the court's jurisdiction pursuant to an order of conditional release as set forth in Criminal Procedure Article, Title 3, Annotated Code of Maryland. B. An individual on conditional release who voluntarily agrees to admission to a therapeutic care unit shall be admitted as set forth in the conditional release order. C. Release From an FRC. (1) Individuals court ordered for evaluation shall be released from the evaluation unit as set forth in Criminal Procedure Article, §3-105 or 3-111, Annotated Code of Maryland. (2) Individuals committed as IST or NCR shall be released as set forth in Criminal Procedure Article, Title 3, Annotated Code of Maryland. D. Confined individuals shall be discharged as set forth in Health-General Article, §7-503(e), Annotated Code of Maryland. E. Individuals admitted pursuant to a hospital warrant shall be discharged as set forth in Criminal Procedure Article, §3-121, Annotated Code of Maryland. F. Individuals who voluntarily admit themselves pursuant to a conditional release order shall be discharged as set forth in the conditional release order. #### Regulation .06 Services. *COMAR 10.07.13.06* A. Services provided by an FRC shall include: (1) As set forth in Criminal Procedure, Title 3, Annotated Code of Maryland, all required evaluations and reports; and (2) Therapeutic services designed to prepare the individual for productive community living, that address issues of dangerousness, and are based on an interdisciplinary team assessment considering least restrictive interventions, include but are not limited to: (a) For individuals committed as IST, competency attainment services; and (b) For all individuals, services as set forth in the Individual Plan and, as clinically appropriate, therapeutic services include, but are not limited to: (i) Behavioral and mental health plans and services; (ii) Physical, speech, and occupational therapies; (iii) Habilitation services including vocational, educational, and life skills training; or (iv) Development of an aftercare or services plan. B. Therapeutic services for all individuals shall be conducted in space not simultaneously shared or used with individuals who are not residents of the FRC. ### Chapter 14 — Assisted Living Programs **Authority:** Health-General Article, Title 19, Subtitle 18, Annotated Code of Maryland **Administrative History:** Effective date: January 1, 1999 (25:26 Md. R. 1923) **Administrative History:** Regulation .02B amended effective November 1, 1999 (26:22 Md. R. 1692); July 22, 2002 (29:14 Md. R. 1074) **Administrative History:** Regulation .02B amended effective March 29, 2004 (31:6 Md. R. 508) **Administrative History:** Regulation .03 amended effective August 21, 2000 (27:16 Md. R. 1523) **Administrative History:** Regulation .04 amended effective March 29, 2004 (31:6 Md. R. 508) **Administrative History:** Regulation .06 amended as an emergency provision effective August 15, 2000 (27:18 Md. R. 1664); amended permanently effective November 27, 2000 (27:23 Md. R. 2147) **Administrative History:** Regulation .06E adopted effective March 29, 2004 (31:6 Md. R. 508) **Administrative History:** Regulation .09B, C amended effective March 29, 2004 (31:6 Md. R. 508) **Administrative History:** Regulation .12D, E amended effective March 29, 2004 (31:6 Md. R. 508) **Administrative History:** Regulation .15-1 adopted effective October 10, 2005 (32:20 Md. R. 1655) **Administrative History:** Regulation .15-2 adopted effective October 10, 2005 (32:20 Md. R. 1655) **Administrative History:** Regulation .17B amended effective March 29, 2004 (31:6 Md. R. 508) **Administrative History:** Regulation .17E—G adopted effective October 10, 2005 (32:20 Md. R. 1655) **Administrative History:** Regulation .21F, K amended effective March 29, 2004 (31:6 Md. R. 508) **Administrative History:** Regulation .21P adopted effective March 29, 2004 (31:6 Md. R. 508) **Administrative History:** Regulation .26A amended effective March 29, 2004 (31:6 Md. R. 508) **Administrative History:** Regulation .27C, E amended effective March 29, 2004 (31:6 Md. R. 508) **Administrative History:** Regulation .28D amended, and E—K adopted, effective November 1, 1999 (26:22 Md. R. 1692) **Administrative History:** Regulation .29B amended effective March 29, 2004 (31:6 Md. R. 508) **Administrative History:** Regulation .36A amended effective March 29, 2004 (31:6 Md. R. 508); December 19, 2005 (32:25 Md. R. 1941) **Administrative History:** Regulation .46 amended effective March 29, 2004 (31:6 Md. R. 508) **Administrative History:** Regulation .49B amended effective July 22, 2002 (29:14 Md. R. 1074) **Administrative History:** Regulations .01—.53 repealed and new Regulations .01—.64 adopted effective December 29, 2008 (35:26 Md. R. 2249) **Administrative History:** Regulation .07A amended effective August 19, 2013 (40:16 Md. R. 1344); August 29, 2016 (43:17 Md. R. 953); March 13, 2017 (44:5 Md. R. 292) **Administrative History:** Regulation .07C amended effective March 13, 2017 (44:5 Md. R. 292) **Administrative History:** Regulation .13A amended effective June 25, 2012 (39:12 Md. R. 745) **Administrative History:** Regulation .24D amended effective June 25, 2012 (39:12 Md. R. 745) **Administrative History:** Regulation .29 amended effective June 25, 2012 (39:12 Md. R. 745) **Administrative History:** Chapter revised effective April 28, 2025 (52:8 Md. R. 357) #### Regulation .01 Purpose. *COMAR 10.07.14.01* The purpose of this chapter is to set minimum, reasonable standards for licensure of assisted living programs in Maryland. This chapter is intended to maximize independence and promote the principles of individuality, personal dignity, freedom of choice, and fairness for all individuals residing in assisted living programs while establishing reasonable standards to promote individuals’ health and safety. #### Regulation .02 Definitions. *COMAR 10.07.14.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) Abuse of a Resident. (a) “Abuse of a resident” means physical, sexual, mental, or verbal abuse, or the improper use of a physical or chemical restraint or involuntary seclusion as those terms are defined in this regulation. (b) “Abuse of a resident” does not include: (i) The performance of an accepted medical procedure ordered by a health care practitioner practicing within the scope of their license; (ii) Compliance with a valid advance directive; or (iii) Honoring a resident’s known wishes regarding medical care. (2) Activities of Daily Living. (a) “Activities of daily living” means normal daily activities. (b) “Activities of daily living” includes: (i) Eating or being fed; (ii) Grooming, bathing, and oral hygiene, including brushing teeth, shaving, and combing hair; (iii) Mobility, transfer, ambulation, and access to the outdoors, when appropriate; (iv) Toileting; and (v) Dressing in clean, weather-appropriate clothing. (3) Administration of Medication. (a) “Administration of medication” means the act of preparing and giving a medication to a resident. (b) “Administration of medication” includes: (i) Identifying the time to administer the medication; (ii) Opening the medication container; (iii) Removing the medication from the container; (iv) Giving the medication to the resident. (c) “Administration of medication” does not include residents who have the cognitive ability to recognize their medications but only require assistance such as: (i) A reminder to take the medication; (ii) Physical assistance with opening a medication container; or (iii) Assistance with removing medication from the container. (4) “Adult medical day care” has the meaning stated in Health-General Article, 14-301, Annotated Code of Maryland. (5) “Advance directive” means: (a) A written or electronic document, voluntarily executed by the declarant consistent with the requirements of Health-General Article, Title 5, Subtitle 6, Annotated Code of Maryland; or (b) A witnessed oral statement, made by the declarant consistent with the provisions of the Health-General Article, Title 5, Subtitle 6, Annotated Code of Maryland. (6) “Alzheimer’s Special Care Unit” means a secured or separated special unit specifically designed for individuals with any type of dementia, including a probable or confirmed diagnosis of Alzheimer’s disease and related dementias. (7) “Assessment” means a process of evaluating an individual’s health, functional and psychosocial history, and condition using the Resident Assessment Tool. (8) “Assist rail” means a hand rail or other similar, substantially constructed device that is installed to enable residents to move safely from one point or position to another. (9) “Assisted living manager” means the individual who is: (a) Designated by an assisted living program to oversee the overall and day-to-day operation of the assisted living program; and (b) Responsible for the duties set forth in Regulation .15 of this chapter. (10) Assisted Living Program. (a) “Assisted living program” means a residential or facility-based program for two or more residents that provides housing and supportive services, supervision, personalized assistance, health-related services, or a combination of these services to meet the needs of individuals who are unable to perform, or who need assistance in performing, the activities of daily living or instrumental activities of daily living, in a way that promotes optimum dignity and independence for the individuals. (b) “Assisted living program” does not include: (i) A nursing facility, as defined under Health-General Article, §19-301, Annotated Code of Maryland; (ii) A State facility, as defined under Health-General Article, §10-101, Annotated Code of Maryland; (iii) A program licensed or approved by the Department under Health-General Article, Title 7 or Title 10, Annotated Code of Maryland; (iv) A hospice care program licensed by the Department under Health-General Article, Title 19, Annotated Code of Maryland; (v) Services provided by family members; (vi) Services provided by a licensed residential service agency or licensed home health agency in an individual’s own home; or (vii) A Certified Adult Residential Environment Program that is certified by the Department of Human Services under Human Services Article, §§6-508—6-513, Annotated Code of Maryland. (11) “Authorized prescriber” means an individual who is authorized to prescribe medications under Health Occupations Article, Annotated Code of Maryland. (12) “Background check” means a check of court and other records by a private agency. (13) “Bank” means a bank, trust company, savings bank, savings and loan association, or financial institution that is: (a) Authorized to do business in this State; and (b) Insured by the Federal Deposit Insurance Corporation. (14) “Certified medication technician” means an individual who is certified as a medication technician by the Maryland Board of Nursing under COMAR 10.39.04. (15) “Chemical restraint” means controlling behavior by use of a drug that is not otherwise required to treat medical symptoms. (16) Cognitive Impairment. (a) “Cognitive impairment” means the loss of those thought processes that orchestrate relatively simple ideas, movements, or actions into goal-directed behavior. (b) “Cognitive impairment” includes lack of judgment, planning, organization, self-control, and the persistence needed to manage normal demands of the individual’s environment. (17) “Common ownership community” means: (a) A condominium organized under Real Property Article, Title 11, Annotated Code of Maryland; (b) A homeowners association organized under Real Property Article, Title 11B, Annotated Code of Maryland; or (c) A cooperative housing corporation organized under Corporations and Associations Article, Title 5, Subtitle 6B, Annotated Code of Maryland. (18) “Common-use telephone” means a telephone that is: (a) Within the facility; (b) Accessible to residents; (c) Located so that residents can have private conversations; and (d) Available to residents to make free local calls. (19) “Consultant” means an individual or organization, under contract with a licensee, that may: (a) Have partial or full responsibility and control over one or more areas of operations of the assisted living provider; and (b) Provide expertise related to: (i) One or more licensure requirements; or (ii) Standards of care. (20) “Contact precautions” means the use of a private room, if available, and appropriate personal protective equipment, such as gowns, gloves, or masks to prevent the transmission of certain organisms between an infected individual and others. (21) “Controlled dangerous substance (CDS)” means a medication or substance listed in Schedule I through Schedule V as defined in Criminal Law Article, §5-101, Annotated Code of Maryland. (22) “Criminal history records check” means a check of criminal history information, as defined in Criminal Procedure Article, §10-201, Annotated Code of Maryland, by the Department of Public Safety and Correctional Services. (23) “Delegating nurse” means a nurse who: (a) Is licensed to practice registered nursing in this State as defined in Health Occupations Article, Title 8, Annotated Code of Maryland; and (b) Has successfully completed the Board of Nursing’s approved training program for registered nurses, delegating nurses, and case managers in assisted living. (24) “Delegation of nursing tasks” means the formal process approved by the Maryland Board of Nursing which permits a professional nurse to assign nursing tasks to an unlicensed individual, a certified nursing assistant, or a medication technician, in accordance with COMAR 10.27.11.03, through: (a) A nursing assessment of the patient’s nursing care needs prior to delegation of tasks; (b) Instructing the unlicensed individual, certified nursing assistant, or medication technician, or verifying their competency; (c) Supervising of the delegated task in accordance with COMAR 10.27.11.04; (d) Retaining accountability and responsibility for the delegated task; (e) Evaluating the performance of the delegated task; and (f) Assuring accurate documentation of outcomes on the nursing record. (25) “Department” means the Maryland Department of Health. (26) “Discharge” means releasing a resident from an assisted living program, after which the releasing program no longer is responsible for the resident’s care. (27) “Emergency admission” means the temporary admittance of an individual in an assisted living program when the individual’s health and safety would be jeopardized by not permitting immediate admittance. (28) “Emergency Medical Services form” means a form issued by the Maryland Institute for Emergency Medical Services Systems for the purpose of documenting emergency medical services and do not resuscitate orders as defined in Health-General Article, §5-601(k), Annotated Code of Maryland, including a Maryland Medical Orders for Life-Sustaining Treatment (MOLST) form. (29) Facilitating Access. (a) “Facilitating access” means: (i) Making appropriate referrals for care and treatment; (ii) Arranging for the appointment and involvement of appropriate health care decision makers, when necessary; and (iii) Facilitating contact between the resident, the resident representative, the health care or social service professional, and needed services. (b) “Facilitating access” does not mean guaranteeing payment for services that are not: (i) Covered by the resident agreement; or (ii) Paid for by the resident or the resident agent. (30) “Facility” means the physical plant in which an assisted living program is operated. (31) “Family” means a group of two or more individuals related by legal status or affection who consider themselves a family. (32) “Family council” means a group of individuals who work together to protect the rights of and improve the quality of life for residents of an assisted living program. (33) “Financial exploitation” means the misappropriation of a resident’s assets or income, including: (a) Spending the resident’s assets or income against the will of or without the consent of the resident or the resident agent; (b) Spending the resident’s assets or income for the use and benefit of a person other than the resident, if the resident or resident agent has not consented to the expenditure; or (c) The resident agent’s misappropriation of the resident funds. (34) “Frequent” means occurring or appearing quite often or at close intervals, but not continuously. (35) “Health care practitioner” means a physician, a certified nurse practitioner, or a physician assistant who provides health care services and is licensed under Health Occupations Article, Annotated Code of Maryland. (36) “Health condition” means the status of a resident’s physical, mental, and psychosocial well-being. (37) “Home health services” means those services provided as defined in Health-General Article, §§19-401—19-410 or §§19-4A-01—19-4A-10, Annotated Code of Maryland. (38) “Household member” means an individual living in an assisted living program who is not a resident or staff member. (39) “Incident” means: (a) The death of a resident from other than natural causes; (b) The disappearance or elopement of a resident; (c) An assault on a resident resulting in injury; (d) An injury to a resident which may require treatment by a health care practitioner, or an event such as a fall which could subsequently require treatment; (e) Abuse, neglect, or financial exploitation of a resident; (f) An error or omission in medication or treatment which may result in harm to the resident; (g) An emergency situation or natural disaster; or (h) Any other event that results in death, permanent harm, or severe temporary harm. (40) “Informal dispute resolution (IDR)” means an informal process that provides an assisted living program the opportunity to dispute one or more deficiencies cited in a written statement of deficiencies issued by the Department or the Department’s designee related to a recent survey. (41) “Instrumental activities of daily living” means home management skills, such as shopping for food and personal items, preparing meals, or handling money. (42) “Intensive” means highly concentrated. (43) “Intermittent nursing care” means nursing care which is provided episodically, irregularly, or for a limited time period. (44) Involuntary Seclusion. (a) “Involuntary seclusion” means the separation of a resident from others or from the resident’s room or confinement to the resident’s room with or without roommates, against the resident’s will or the will of the resident representative. (b) “Involuntary seclusion” does not mean separating a resident from other residents on a temporary and monitored basis. (45) “Lavatory” means a basin used to maintain personal cleanliness that has hot and cold running water and sanitary drainage. (46) “Law enforcement agency” means the Maryland State Police or a police agency of a county or municipal corporation. (47) “License” means a document issued by the Secretary to operate an assisted living program in the State. (48) “Licensed pharmacist” means an individual who is authorized to practice pharmacy under Health Occupations Article, Title 12, Annotated Code of Maryland. (49) “Licensed physician” means an individual who is authorized to practice medicine under Health Occupation Article, Title 14, Annotated Code of Maryland. (50) “Licensee” means the person to whom a license is issued. (51) “Management firm” means an organization, under contract with an applicant for a license or a current licensee, that is intended to have or has full responsibility and control over the day-to-day operations of the assisted living program. (52) “Medical Orders for Life-Sustaining Treatment (MOLST) form” means the form required to be developed pursuant to Health-General Article, §5-608.1, Annotated Code of Maryland. (53) “Medical record” has the meaning stated in Health-General Article, §4-301, Annotated Code of Maryland. (54) Mental Abuse. (a) “Mental abuse” means an intentional course of conduct resulting in or intended to produce emotional harm. (b) “Mental abuse” does not include the performance of an accepted clinical or medical procedure. (55) “Minimal” means the least amount required to produce the desired result. (56) “Neglect” means depriving a resident of adequate food, clothing, shelter, supervision, essential medical treatment, or essential rehabilitative therapy. (57) Nursing Overview. (a) “Nursing overview” means a process by which a registered nurse assures that the health and psychosocial needs of the resident are met. (b) “Nursing overview” includes: (i) Observation; (ii) Assessment; (iii) Staff education; and (iv) The development, implementation, and evaluation of a resident’s service plan. (58) “Occasional” means occurring from time to time, on an infrequent or irregular basis, with no particular pattern. (59) “Office of Health Care Quality (OHCQ)” means the Office of Health Care Quality of the Maryland Department of Health. (60) “Ongoing” means continuing over an extended period of time. (61) “Person” means an individual, receiver, trustee, guardian, personal representative, fiduciary, or representative of any kind and any partnership, firm, association, corporation, or other entity. (62) “Personal representative” means an individual appointed by the court with the duties and authority to settle and distribute the estate of the decedent consistent with Estates and Trusts Article, §7-401, Annotated Code of Maryland. (63) “Physical abuse” means the sustaining of any physical injury or pain to a resident as a result of cruel or inhumane treatment, or as a result of a malicious act by any individual. (64) Physical Restraint. (a) “Physical restraint” means the use of a device or physical action to prevent, suppress, or control head, body, or limb movement that cannot be readily and easily removed by the resident. (b) “Physical restraint” does not mean a protective device as defined in this regulation. (65) “Plan of correction” means a written response from the assisted living program that addresses how each deficiency cited as a result of a survey by the Department or the Department’s designee will be corrected. (66) “Protective device” means any device or equipment, except bedside rails: (a) That: (i) Shields a resident from self-injury; (ii) Prevents a resident from aggravating an existing physical problem; or (iii) Prevents a resident from precipitating a potential physical problem; (b) That may limit, but does not eliminate, the movement of the resident’s head, body, or limbs; and (c) That is prescribed by a health care practitioner. (67) “Quality assurance” means a system for maintaining professionally acceptable standards of care by: (a) Identifying opportunities to improve; (b) Studying problems, if any, and their root causes; and (c) Implementing and monitoring interventions to ensure the intended improvement is achieved and sustained. (68) “Relief personnel” means qualified individuals who have been hired to substitute for certain staff members: (a) In emergency situations; or (b) When the assisted living manager or other staff is absent from the assisted living program for extended hours. (69) “Resident” means an individual 18 years old or older who requires assisted living services. (70) “Resident agent” means a person who manages, uses, or controls the funds or assets that legally may be used to pay an applicant’s or resident’s share of the costs or other charges for assisted living services. (71) “Resident agreement” means a document signed by both the resident or the resident agent and the assisted living manager, or designee, stating the terms that the parties agree to, including, at a minimum, the provisions set forth in Regulations .26 and .27 of this chapter. (72) “Resident Assessment Tool” means Maryland’s Assisted Living Resident Assessment and Level of Care Scoring Tool that is: (a) Developed by the OHCQ with input from assisted living program staff; and (b) Used by assisted living programs to assess the current health, physical, and psychosocial status of prospective and current residents. (73) Resident Representative. (a) “Resident representative” means a person referenced in Regulation .35 of this chapter. (b) “Resident representative” does not include an assisted living program owner or employee that has been designated as a representative payee for a resident. (74) Restraint. (a) “Restraint” means any chemical restraint or physical restraint as defined in §B(15) and (64) of this regulation. (b) “Restraint” does not include a protective device. (75) “Sanction” means a disciplinary penalty imposed for a violation of statutes or regulations relating to the operation of an assisted living program, including, but not limited to, those penalties referenced in Regulations .58, .59, .61, .63, and .64 of this chapter. (76) “Secretary” means the Secretary of Health or the Secretary’s designee. (77) “Self-administration of medication” means a resident having the cognitive and physical ability to take medication as prescribed by an authorized prescriber: (a) At the correct time; (b) By the correct route; and (c) In the correct dosage. (78) “Service plan” means a written plan developed by an assisted living program in conjunction with the resident and the resident representative, if appropriate, which identifies, among other things, services that the assisted living program will provide to the resident based upon the resident’s needs as determined by the Resident Assessment Tool. (79) “Sexual abuse” means a crime listed in Criminal Law Article, Title 3, Subtitle 3, Annotated Code of Maryland. (80) “Short-term residential care” means a stay, either continuous or intermittent, in an assisted living program of not more than 30 consecutive days from the date of initial admission, which cannot exceed 180 days per year. (81) Significant Change of Condition. (a) “Significant change of condition” means a shift in a resident’s health, functional, cognitive, behavioral, or psychosocial conditions that either causes an improvement or deterioration in a resident’s condition as described in the Resident Assessment Tool. (b) “Significant change of condition” does not include any ordinary, day-to-day fluctuations in health status, function, or behavior, or an acute short-term illness, such as a cold, unless these fluctuations continue to recur. (82) “Staff” means supervisors, assistants, aides, or other employees, including independent contractors retained by an assisted living program, to provide the care and services required by this chapter. (83) “Standard precautions” means a set of infection control practices used to prevent transmission of diseases that can be acquired by contact with blood, body fluids, non-intact skin (including rashes), and mucous membranes. (84) “Substantial” means considerable in importance, degree, amount, frequency, or extent. (85) “Trauma-informed approach” means an approach to care delivery that: (a) Recognizes the widespread impact and signs and symptoms of trauma in residents; and (b) Incorporates knowledge about trauma into care plans, policies, procedures, and practices to avoid re-traumatization. (86) “Trauma-informed care” means an approach to delivering care that involves understanding, recognizing and responding to the effects of all types of trauma. (87) “Treatment” means medical or psychological management to cure, slow the progression of, maintain, or improve a disease or condition. (88) “Unclaimed deceased resident” means a resident of an assisted living program: (a) Who has not prearranged and prepaid for the disposal of the resident’s body; or (b) For whom no individual has claimed the body and assumed funeral or burial responsibility. (89) “Verbal abuse” means the use of any oral or gestured language that includes disparaging or derogatory terms, which is directed to a resident, or within a resident’s hearing distance, regardless of the resident’s age, ability to comprehend, or disability. #### Regulation .03 Incorporation by Reference. *COMAR 10.07.14.03* In this chapter, the following documents are incorporated by reference: A. Centers for Disease Control and Prevention (CDC) Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Facilities, 2005, which is incorporated by reference in COMAR 10.07.02.02; B. National Fire Protection Association (NFPA) 101 Life Safety Code (2018 Edition), which is incorporated by reference in COMAR 29.06.01.06; and C. The State Fire Prevention Code, which is incorporated by reference in COMAR 29.06.01. #### Regulation .04 License Required. *COMAR 10.07.14.04* A. A person may not operate an assisted living program in the State without obtaining a license from the Secretary and complying with the requirements of this chapter. B. Providing housing under a landlord-tenant arrangement does not, in and of itself, exclude a person from the licensure requirements of this chapter. C. Separate licenses are required for assisted living programs that are maintained on the same or separate premises, even though the programs are operated by the same person. D. The Secretary shall issue a license for a specified number of beds and a specified level of care. E. An assisted living program may not provide services beyond its licensed authority by: (1) Providing care to more residents than the total number of licensed beds; or (2) Providing care beyond the specified level of care without first obtaining written approval of a resident-specific waiver request from the Department. F. The number of residents, as stated in §E of this regulation, includes: (1) Residents in the facility; (2) Individuals admitted to the assisted living program for short-term residential care; (3) Family members who are cared for by assisted living program staff; and (4) Individuals who are transitioning to the assisted living program. G. An assisted living program shall conspicuously post its license in a common-use area at the facility. H. A person who falsifies or alters an assisted living program license shall be subject to referral for a criminal prosecution and imposition of civil fines, as specified in Regulations .57—.65 of this chapter. #### Regulation .05 Levels of Care. *COMAR 10.07.14.05* A. An assisted living program may provide: (1) The level of care for which the assisted living program has been approved; and (2) Any lower level of care. B. At the time of initial licensure, an applicant shall: (1) Request approval to provide services at one of the three levels of care set forth in §G of this regulation; and (2) Demonstrate that the assisted living program has the capacity to provide the level of care requested either directly or through the coordination of community services. C. If, at any time, an assisted living program wants to provide a higher level of care than that for which it is licensed, the assisted living program shall request authority from the Department to change its licensed level of care. D. The Department shall determine if an applicant or the assisted living program has the capacity to provide and ensure the requested level of care. E. The Department may approve or deny the request. F. If an applicant or an assisted living program is aggrieved by the Department’s decision, the applicant or the assisted living program may appeal by filing a request for a hearing consistent with Regulation .65 of this chapter. G. Levels of Care. (1) The applicant or assisted living program shall: (a) Request one of the levels of care listed below; and (b) Have sufficient staff and the abilities necessary to provide the level of care selected. (2) Level 1: Low Level of Care. (a) Health and Wellness. Staff shall have the ability to: (i) Recognize the causes and risks associated with a resident’s current health condition once these factors are identified by a health care practitioner; and (ii) Provide occasional assistance in accessing and coordinating health services and interventions. (b) Functional Condition. Staff shall have the ability to provide occasional supervision, assistance, support, setup, or reminders with two or more activities of daily living. (c) Medication and Treatment. Staff shall have the ability to assist a resident with taking medication or to coordinate access to necessary medication and treatment. (d) Behavioral Condition. Staff shall have the ability to monitor and provide uncomplicated intervention to manage occasional behaviors that are likely to disrupt or harm the resident or others. (e) Psychological or Psychiatric Condition. Staff shall have the ability to monitor and manage occasional psychological or psychiatric episodes or fluctuations that require uncomplicated intervention or support. (f) Social and Recreational Interests. Staff shall have the ability to provide occasional assistance in accessing social and recreational services. (3) Level 2: Moderate Level of Care. (a) Health and Wellness. Staff shall have the ability to: (i) Recognize and accurately describe and define a resident’s health condition and identify likely causes and risks associated with the resident’s condition; and (ii) Provide or ensure access to necessary health services and interventions. (b) Functional Condition. Staff shall have the ability to provide or ensure: (i) Substantial support with two or more activities of daily living; or (ii) Minimal support with any number of activities of daily living. (c) Medication and Treatment. Staff shall have the ability to: (i) Provide or ensure assistance with taking medication; or (ii) Administer necessary medication and treatment, including monitoring the effects of the medication and treatment. (d) Behavioral Condition. Staff shall have the ability to monitor and provide or ensure intervention to manage frequent behaviors which are likely to disrupt or harm the resident or others. (e) Psychological or Psychiatric Condition. Staff shall have the ability to monitor and manage frequent psychological or psychiatric episodes that may require limited skilled interpretation, or prompt intervention or support. (f) Social and Recreational Interests. Staff shall have the ability to provide or ensure ongoing assistance in accessing social and recreational services. (4) Level 3: High Level of Care. (a) Health and Wellness. Staff shall have the ability to: (i) Recognize and accurately describe and define a resident’s health condition and identify likely causes and risks associated with the residents’ condition; and (ii) Provide or ensure ongoing access to and coordination of comprehensive health services and interventions, including nursing overview. (b) Functional Condition. Staff shall have the ability to provide or ensure comprehensive support as frequently as needed to compensate for any number of activities of daily living deficits. (c) Medication and Treatment. Staff shall have the ability to: (i) Provide or ensure assistance with taking medication; and (ii) Administer necessary medication and treatment, including monitoring or arranging for monitoring of the effects of complex medication and treatment regimens. (d) Behavioral Condition. Staff shall have the ability to monitor and provide or ensure ongoing therapeutic intervention or intensive supervision to manage chronic behaviors which are likely to disrupt or harm the resident or others. (e) Psychological or Psychiatric Condition. Staff shall have the ability to monitor and manage a variety of psychological or psychiatric episodes involving active symptoms, condition changes, or significant risks that may require skilled interpretation or immediate interventions. (f) Social and Recreational Interests. Staff shall have the ability to provide or ensure ongoing access to comprehensive social and recreational services. #### Regulation .06 Restrictions. *COMAR 10.07.14.06* A. Restricted Nomenclature. An assisted living program licensed under this chapter may not use in its title or advertising the words “hospital”, “sanitarium”, “nursing”, “convalescent”, “rehabilitative”, “sub-acute”, or “hospice”. B. Advertising an Assisted Living Program. (1) Prohibited Terms. A person operating an assisted living program may not use the term “assisted living” in its advertising without being licensed as an assisted living program by the Department. (2) Misleading or False Advertising. (a) A person may not advertise, represent, or imply to the public that an assisted living program is authorized to provide a service that the program is not licensed, certified, or otherwise authorized by the Department to provide when the license, certificate, or authorization is required under this chapter. (b) A person may not advertise an assisted living program in a misleading or fraudulent manner. (c) The Department shall report misleading or false advertising to the Office of the Attorney General, Division of Consumer Protection. C. Drop-In or Day Services. (1) An assisted living program may not provide day, partial, or hourly adult day care services without appropriate adult medical day care licensure. (2) An individual who has applied for admission or who has been admitted to the assisted living program may, for a reasonable period of time not to exceed 30 calendar days, transition to the program in increments of partial days before becoming a resident. (3) All regulations of this chapter apply to services and care provided during this transition period. (4) An individual who has applied for admission or who has been admitted to the licensee who is transitioning to the assisted living program is counted as a resident. D. Dual Licensure. An assisted living program dually licensed as an adult medical day care program or any other licensed program shall meet all requirements for both programs. E. A person who falsifies or alters an assisted living license shall be subject to referral for criminal prosecution and imposition of civil fines. F. Disclosure of Ownership. An assisted living owner shall disclose any ownership of an adult medical day care center to an assisted living resident prior to referring the resident to the center. #### Regulation .07 Licensing Procedure. *COMAR 10.07.14.07* A. Application for License. (1) To obtain and maintain a license, an applicant shall meet all of the requirements of: (a) This chapter; (b) Other applicable federal, State, and local laws and regulations; and (c) Health-General Article, §19-311, Annotated Code of Maryland, if the program provides services to 17 or more residents. (2) An applicant shall submit: (a) An application on a written or electronic form developed by the Department; (b) The completed Uniform Disclosure Statement on a form developed by the Department; and (c) All other reasonable documents as required by the Department. (3) At a minimum, the applicant shall provide: (a) Verification that the applicant or corporate representative is 21 years old or older; (b) Documentation of any prior denial, suspension, or revocation of a license or certification to provide care to third parties; (c) Identification of any individual or corporate owner of 25 percent or more interest in the assisted living program; (d) Documentation of any conviction and current background check or criminal history records check of the owner, the applicant, the assisted living manager, the alternate assisted living manager, other staff, and any household member; (e) Ownership information as specified on an addendum to the application; (f) Verification that the facility is owned, leased, or otherwise under the control of the applicant; (g) The level of care to be provided by the assisted living program, its location, and the name of the proposed assisted living manager; (h) Documentation of zoning approval, if zoning approval is required by the local jurisdiction in which the assisted living program will be located; and (i) Where applicable, approvals from the local health department, local or State fire authority, and local area agency on aging. B. Additional Requirements for Initial Licensure. The Secretary shall require an applicant for initial licensure to submit: (1) Information concerning any license or certification held by the applicant under Health Occupations Article or Health-General Article, Annotated Code of Maryland, including the prior or current operation by the applicant of a health care facility or similar health care program; (2) Information demonstrating financial or administrative ability to operate an assisted living program in compliance with this chapter, which shall include a business plan and 1-year operating budget; (3) Policies and procedures to be implemented as designated in the application for licensure; and (4) Other reasonably relevant information, if required by law or local jurisdiction, such as: (a) Verification of Workers’ Compensation insurance; (b) Facility plan review documentation; (c) Food service permit; and (d) Rental license. C. License Suspension or Revocation. (1) The owner, assisted living manager, alternate assisted living manager, or board member of an assisted living program that has had its license suspended or revoked by the Department may not own, operate, lease, or manage another assisted living program for 10 years from the date the license was suspended or revoked without good cause shown. (2) After 10 years, the applicant shall submit evidence to the Department that the applicant is capable of owning, managing, or operating an assisted living program. D. Sanctions and Uncorrected Deficiencies. (1) If an owner, assisted living manager, or alternate assisted living manager of an assisted living program operates, leases, or manages an assisted living program that has had sanctions imposed or deficiencies cited within the past 3 years and has not corrected the deficiencies which present a risk to the health or safety of residents for a currently licensed assisted living program, that owner, assisted living manager, or alternate assisted living manager may not apply to open an additional assisted living program until those deficiencies have been corrected as approved by the Department. (2) The Department may not approve a license application for an assisted living program if the owner, assisted living manager, or alternate assisted living manager operates, leases, or manages a licensed assisted living program that has uncorrected deficiencies. (3) In making a determination about a pending assisted living program license application, the Department may consider any sanctions or uncorrected deficiencies that were imposed before or after the application submission which present a risk to the health or safety of residents for a currently licensed assisted living program that is operated, leased, or managed by an owner, assisted living manager, or alternate assisted living manager in the pending license application. E. Violations and Criminal Convictions. (1) The Department reserves the right to deny licensure to an applicant based on the owner’s, assisted living manager’s, or alternate assisted living manager’s prior: (a) History of violations of assisted living regulations; (b) Criminal history that the Department determines may be potentially harmful to residents; (c) Convictions as described in 42 U.S.C. §1320a–7(a) or Criminal Law Article, §14-101, Annotated Code of Maryland; and (d) History of final actions of a Health Occupations Board. (2) In making a determination about a license application, the Department shall consider the following factors related to a criminal conviction: (a) The age at which the crime was committed; (b) The circumstances surrounding the crime; (c) The length of time that has passed since the crime; and (d) Subsequent work history. (3) In making a determination about a license application, the Department shall consider the following factors related to a violation of assisted living regulations: (a) The circumstances surrounding the violation; (b) The length of time since the violation occurred; (c) The scope of the violation; (d) The severity of the violation; and (e) The implementation of a plan of correction. (4) The Department shall consider other evidence that demonstrates whether the applicant poses a threat to the health or safety of residents in an assisted living program. F. Determination of License Application. (1) Based on information provided to the Department by the applicant and the Department’s own investigation, the Secretary shall: (a) Approve the application unconditionally; (b) Approve the application conditionally, which may include, among other conditions, requiring the applicant to use the services of a management firm approved by the Secretary; or (c) Deny the application. (2) The Secretary may not require use of a management firm for a period in excess of 24 months. (3) A person may not: (a) Operate an assisted living program until a provisional license or license has been issued; or (b) Operate multiple sites until each site has been inspected and approved by the Department. (4) A person aggrieved by a decision of the Secretary under this section to deny a license application may appeal the Secretary’s action by filing a request for a hearing consistent with Regulation .65 of this chapter. G. Provisional Licenses for Less than 1 Year. The Department may issue a provisional license if: (1) An assisted living program is not in full compliance with this chapter; (2) The Department determines that the noncompliance does not constitute a safety or health hazard; and (3) The applicant or assisted living program has submitted a plan of correction acceptable to the Department which satisfactorily addresses the correction of each deficiency within a time frame acceptable to the Department. H. License Application Administratively Closed. (1) An application is not complete until the Department has received the completed license application and all required documents. (2) After 180 calendar days from the date of initial receipt, the Department may deem an incomplete license application inactive and administratively close the application. (3) An applicant whose application is administratively closed may reapply for a license by submitting a new application. #### Regulation .08 Changes in an Assisted Living Program that Affect the Operating License. *COMAR 10.07.14.08* A. General Information Related to Licensure. (1) A licensee shall immediately notify the Department of any change in the information the licensee had submitted with the most recent application. (2) A license is valid only in the name of the licensee to whom it is issued, and is not subject to sale, assignment, or other transfer. (3) A license is valid only for the premises for which it was originally issued. (4) A licensee shall forward to the Department a copy of any report or citation of a violation of any applicable building codes, sanitary codes, fire safety codes, or other regulations affecting the health, safety, or welfare of residents within 7 calendar days of receipt of the report or citation. An assisted living program’s failure to notify the Department may result in the imposition of a sanction. B. Increase in Licensed Beds. (1) An assisted living program may not provide assisted living services to more residents than the number of beds approved in writing by the Department. (2) To request an increase in the number of beds, a licensed assisted living program shall: (a) Submit the request for an increase in licensed beds on the form developed by and in the manner established by the Department; and (b) Attach the required documents, including, at a minimum, proof of compliance with all local requirements for fire safety, use and occupancy, and zoning permits. (3) If approved, the Department shall issue a new license to the assisted living program that includes the approved number of beds. (4) Upon receipt of a new license, all use of the previously issued assisted living program license shall cease. C. Increase in Level of Care. (1) An assisted living program may not provide a higher level of care for residents than is approved by the Department unless a specific resident has a waiver to receive a higher level of care. (2) To request an increase in the level of care, an assisted living program shall: (a) Submit the request for an increase in the level of care on the form developed by and in the manner established by the Department; and (b) Attach supporting documentation, including any changes in staffing, training, or policies and procedures. (3) If approved, the Department shall issue a new license to the assisted living program that includes the approved level of care. (4) Upon receipt of a new license, all use of the previously issued assisted living program license shall cease. D. Name Change. (1) An assisted living program shall have a revised license from the Department to change its name or the name under which the program is doing business. (2) To request a name change, an assisted living program shall: (a) Submit the request for a name change on the form developed by and in the manner established by the Department; and (b) Attach the required attachments, including a letter of good standing from the Maryland State Department of Assessments and Taxation (SDAT) Business Express. (3) Upon processing, the Department shall issue a new license to the assisted living program that includes the new name of the licensee. (4) Upon receipt of a new license, all use of the previously issued assisted living program license shall cease. E. Change of Location. (1) Prior to operating an assisted living program at a new location, the applicant shall have an assisted living program license issued by the Department. (2) To request an assisted living program license for a new location, an applicant shall: (a) Submit an application for an assisted living program license on the form developed by and in the manner established by the Department; and (b) Submit all required attachments. (3) An assisted living program shall notify the Department in writing of a relocation: (a) Within 60 calendar days in advance of the effective date if licensed for 49 or fewer beds; or (b) Within 75 calendar days in advance of the effective date if licensed for 50 or more beds. (4) An assisted living program shall notify residents and resident representatives in writing of a relocation: (a) Within 60 calendar days in advance of the effective date if licensed for 49 or fewer beds; or (b) Within 75 calendar days in advance of the effective date if licensed for 50 or more beds. (5) If approved, the Department shall issue a license to the assisted living program at the new location. (6) Upon receipt of a new license, all use of the previously issued assisted living program license shall cease. F. Change of Ownership — Sale, Transfer, or Lease of a Facility. (1) If a sale, transfer, or lease of a facility causes a change in the person or persons who control or operate the assisted living program, the assisted living program shall be considered a new program and the new owner shall apply for a license and conform to all regulations applicable at the time of transfer of operations. (2) The transfer of any stock which results in a change of the person or persons who control the program or the transfer of any stock in excess of 25 percent of the outstanding stock, constitutes a sale. (3) For the purposes of Life Safety Code enforcement, the program is considered an existing facility if it has been in continuous use as an assisted living program. (4) An assisted living program shall notify the Department in writing of a change of ownership, sale, transfer, or lease of a facility: (a) Within 60 calendar days in advance of the effective date if licensed for 49 or fewer beds; or (b) Within 75 calendar days in advance of the effective date if licensed for 50 or more beds. (5) An assisted living program shall notify residents and resident representatives in writing of a change of ownership, sale, transfer, or lease of a facility: (a) Within 60 calendar days in advance of the effective date if licensed for 49 or fewer beds; or (b) Within 75 calendar days in advance of the effective date if licensed for 50 or more beds. (6) If a change of ownership of the assisted living program is occurring, the new owner shall: (a) Submit an application for an assisted living program license on the form developed by and in the manner established by the Department; and (b) Submit all required attachments. (7) If approved, the Department shall issue a license to the assisted living program. (8) Upon receipt of a new license, all use of the previously issued assisted living licensee shall immediately cease. (9) A licensee named in the original license shall remain responsible for the operation of the assisted living program until a new license is issued to the new owner, and the current licensee shall remain responsible for correction of all outstanding deficiencies or impending sanctions until a new license is issued to the new owner. G. Voluntary Closure. (1) An assisted living program shall notify the Department of any intention to voluntarily close: (a) Within 60 calendar days in advance of the closure if licensed for 49 or fewer beds; or (b) Within 75 calendar days in advance of the closure if licensed for 50 or more beds. (2) The assisted living program shall include the following information in the notice to the Department: (a) The method for informing residents and resident representatives of its intent to close, change ownership, change location, or sell its assisted living program; and (b) The actions the assisted living program will take to assist residents in securing comparable housing and assistance, if necessary. (3) An assisted living program shall notify residents and resident representatives of a voluntary closure, in writing: (a) Within 60 calendar days in advance of the closure if licensed for 49 or fewer beds; or (b) Within 75 calendar days in advance of the closure if licensed for 50 or more beds. (4) The assisted living program shall provide at least weekly updates to the OHCQ, including: (a) Number of residents remaining in the facility; (b) Number of residents with plans for relocation; and (c) Number of residents with no plans for relocation. (5) In addition to the notice to the Department required by §B of this regulation, after a program closes, the assisted living program shall: (a) Notify the Department of the date of closure and the place of relocation of each resident; and (b) Cease all use of the previously issued assisted living program license. H. Voiding of License. (1) Maryland State Department of Assessments and Taxation (SDAT). (a) A licensed assisted living program shall remain in good standing with (SDAT). (b) If the assisted living program fails to return to good standing 60 calendar days after receipt of notification of noncompliance from SDAT or another government agency, the Department may void the assisted living program’s license. (2) Ceases the Provision of Services. (a) A license is void if the assisted living program ceases to provide services to residents for a period of 180 consecutive days. (b) The owner shall immediately cease all use of the previously issued assisted living program license when the license is voided. I. Surrender of License. (1) Unless the Department agrees to accept the surrender of a license, an assisted living program may not surrender a license to operate an assisted living program nor may the license lapse by operation of law while the licensee is under investigation or while charges are pending against the licensee. (2) The Department may set conditions on its agreement with the licensee under investigation or against which charges are pending to accept surrender of the license. #### Regulation .09 Licensure Standards Waiver. *COMAR 10.07.14.09* A. The Department may grant an assisted living program a waiver from the licensure requirements of this chapter with or without conditions. B. The Department may not, however, grant a waiver from the requirements of Regulation .23A of this chapter. If, however, two individuals having a long-term or otherwise significant relationship wish to be admitted to a program in order to reside in the program together, and one of the individuals requires care as defined in Regulation .23A of this chapter, the Department may grant a waiver consistent with the process established in Regulation .24 of this chapter. C. Application for Licensure Standards Waiver. (1) An assisted living program shall submit a request for a waiver under this regulation on a form developed and in the manner established by the Department. (2) The requestor shall provide in writing the: (a) Regulation from which a waiver is sought; (b) Reason the assisted living program is unable to comply with the regulation; (c) Reason that compliance with the regulation will impose a substantial hardship; and (d) Reason that a waiver will not adversely affect residents. D. Evaluation of Application for Licensure Standards Waiver. In evaluating a waiver request submitted under this regulation, the Department shall review the statements in the application, and may: (1) Inspect the assisted living program; (2) Confer with the assisted living manager or designee; or (3) Discuss the request with residents or their representatives to determine whether they believe a waiver is in the residents’ best interest. E. Grant or Denial of Licensure Standards Waiver. (1) The Department may grant a waiver request if it determines that: (a) Compliance with the regulation from which the waiver is sought cannot be accomplished without substantial hardship; and (b) A waiver will not adversely affect residents. (2) If the Department determines that the conditions of §E(1) of this regulation are not met, the Department shall deny the request for a waiver. The denial of a waiver may not be appealed. F. Written Decision. (1) The Department shall issue and mail to the applicant a final written decision on a waiver request submitted under §A of this regulation within 45 calendar days from receipt of the request and all appropriate supporting information. (2) If the Department grants the waiver, the written decision shall include the waiver’s duration and any conditions imposed by the Department. G. If an assisted living program violates any condition of the waiver, or if it appears to the Secretary that the health or safety of residents residing in the assisted living program will be adversely affected by the continuation of the waiver, a waiver may be revoked. The revocation of a waiver may not be appealed. #### Regulation .10 Uniform Disclosure Statement. *COMAR 10.07.14.10* A. When an assisted living program changes the services reported on its Uniform Disclosure Statement filed with the Department under Regulation .07A(2)(b) of this chapter, the program shall file an amended Uniform Disclosure Statement with the Department within 30 calendar days of the change in services. B. If an individual requests a copy of an assisted living program’s Uniform Disclosure Statement, the assisted living program shall provide a copy of the Uniform Disclosure Statement on a form provided by the Department without cost to the individual making the request. C. An assisted living program shall provide a copy of the current Uniform Disclosure Statement to individuals as part of the program’s marketing materials. #### Regulation .11 Investigation by Department. *COMAR 10.07.14.11* A. Assisted Living Program to Be Open for Inspection. (1) An assisted living program operated by a licensee, and any premises proposed to be operated as an assisted living program, shall be open at all times to announced or unannounced inspections by the Department and by any agency designated by the Department. (2) Any part of the facility, and any surrounding accessory buildings which may be entered by staff or residents, are considered part of the facility and are subject to inspection. (3) An assisted living program and any premises proposed to be operated as an assisted living program may not deny access to the Department or any agency designated by the Department. (4) At all times, the staff on duty at an assisted living program shall know how to contact the assisted living manager, alternate assisted living manager, delegating nurse, and alternate delegating nurse. B. Records and Reports. (1) Inspection. (a) An assisted living program shall maintain records and reports. (b) The records and reports may be paper or electronic documents. (c) The records and reports shall be open to inspection by the Department or its designee. (d) Except for the records permitted to be stored off-site, an assisted living program shall immediately, upon request, provide copies of records and reports, including medical records of residents, to the Department or its designee. (2) Maintenance. (a) The assisted living program shall maintain files on-site pertaining to: (i) Current residents; (ii) Residents who have been discharged within the last 6 months; (iii) Staff; and (iv) Quality assurance activities. (b) The files listed in §B(2)(a) of this regulation shall be maintained on-site at the licensed assisted living program where residents receive assisted living services. (c) All other records may be stored off-site but shall be available for inspection within 24 hours of a request from the Department or the Department’s designee. C. Posting of Documents. An assisted living program shall post the following documents in a conspicuous place that is visible to residents, potential residents, and other interested parties: (1) All of the following: (a) The notice of compliance or the statement of deficiencies and the plan of correction for the most recent annual licensure survey; and (b) The notice of compliance or the statement of deficiencies and the plan of correction for all surveys conducted since the last annual licensure survey; or (2) A notice describing where in the facility the items listed in §C(1) of this regulation may be found. D. Notice of Deficiencies. (1) If a survey identifies noncompliance with a requirement, the Secretary shall issue a notice: (a) Citing each deficiency; (b) Requiring the assisted living program to submit an acceptable plan of correction within 10 calendar days of receipt of the statement of deficiencies; (c) Notifying the assisted living program of sanctions or that failure to correct the violation may result in sanctions; and (d) Offering the assisted living program the opportunity for informal dispute resolution (IDR). (2) The plan of correction referred to in §D(1)(b) of this regulation shall include: (a) How the assisted living program will correct each deficiency; (b) The date by which each deficient practice will be corrected; (c) How the assisted living program will prevent the deficient practice from recurring; and (d) Who will be responsible for ensuring the deficiency will not reoccur. (3) Failure to return an acceptable plan of correction within the allotted time frame may result in a sanction. (4) A request for an IDR does not change the assisted living program’s requirement to submit a plan of correction for all deficiencies within 10 calendar days after receipt of the notice of deficiency. E. Informal Dispute Resolution (IDR). (1) An assisted living program may request an IDR to dispute one or more deficiencies in a statement of deficiencies. (2) The assisted living program shall submit the request for an IDR to the Department within 10 calendar days of receiving the statement of deficiencies. (3) The written request for an IDR shall fully describe the disagreement with the statement of deficiencies and be accompanied by all evidence for the Department’s consideration. (4) At the discretion of the Department, the IDR may be held in person, by telephone, by video conference, or in writing. (5) IDRs are informal in nature and are not attended by legal counsel representing the assisted living program or the Department. (6) The IDR process may not delay the effective date of any enforcement action. (7) In the event an assisted living program requests an IDR of a deficiency written by a designee of the Department, the Department shall request the designee to participate in the IDR process. (8) There is no appeal of the Department’s decision in an IDR. #### Regulation .12 Compliance Monitoring. *COMAR 10.07.14.12* A. The Department shall be responsible for monitoring and inspecting assisted living programs to determine compliance with the requirements of this chapter. B. Consistent with an interagency agreement, the Department may delegate certain aspects of its monitoring, inspection, or waiver responsibilities to the Department of Aging or a local health department. C. The Department or its designee may conduct announced or unannounced surveys. D. An assisted living program shall be surveyed on-site, at least annually. The Department may extend the time between surveys to up to 18 months if the assisted living program has: (1) No outstanding plan of correction; (2) No complaints or facility-reported incidents pending investigation; (3) No settlement agreement in effect; (4) No outstanding civil money penalty; and (5) No sanctions in effect. E. The Department, or those agencies delegated responsibility under this regulation, may inspect an assisted living program more frequently than annually if it is considered necessary to determine compliance with this chapter. #### Regulation .13 Administration. *COMAR 10.07.14.13* A. Quality Assurance. (1) The assisted living program manager or their designee shall develop and implement a quality assurance plan. (2) Quality Assurance Plan. (a) The quality assurance plan shall include an annual facility risk assessment for tuberculosis, in accordance with the CDC Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005. (b) The assisted living manager and the delegating nurse shall meet at least every 6 months to review the: (i) Change in status of the assisted living program’s residents; (ii) Service plan requirements; and (iii) Written recommendations, findings, and outcomes of pharmacy reviews, as required by Regulation .31I of this chapter. (c) The assisted living manager shall document the proceedings of the meeting referred to in §A(2)(b) of this regulation. B. Family Council. (1) If assisted living program residents have a family council, the assisted living program shall make reasonable attempts to support and cooperate with the family council. (2) The family council for an assisted living program may include the following members: (a) Members of a current resident’s family; (b) An individual appointed by a current resident who has the capacity to appoint an individual; (c) A resident representative; or (d) An individual appointed by a resident representative. (3) The assisted living program shall provide the family council the right to privacy for meetings and, if possible, the space to meet privately. (4) Staff members may attend a meeting only if requested by the family council. (5) The assisted living program shall consider the family council’s recommendations and grievances and attempt to accommodate those recommendations and grievances that affect residents’ quality of life. (6) The assisted living program shall respond in writing within 30 calendar days to the family council when it has received written requests or grievances from the council. C. Resident Council. (1) If an assisted living program has a resident council, the assisted living program shall make reasonable attempts to support and cooperate with the resident council. (2) A resident council includes current residents of the assisted living program. (3) The assisted living program shall provide the resident council the right to privacy for meetings and, if possible, the space to meet privately. (4) Staff members may attend a meeting only if requested by the resident council. (5) The assisted living program shall consider the council’s recommendations and grievances and attempt to accommodate those recommendations and grievances that affect the residents’ quality of life. (6) The assisted living program shall respond in writing within 30 calendar days to the resident council when it has received written requests or grievances from the council. #### Regulation .14 Staffing Plan. *COMAR 10.07.14.14* A. Following an analysis of the number of residents that the assisted living program intends to serve and the individual needs of each resident, the assisted living program shall develop a staffing plan that identifies the type and number of staff needed to provide the services required by this chapter. B. The assisted living program shall employ or contract with sufficient numbers of staff to comply with the: (1) Requirements of this chapter; (2) Standards of care for the specific conditions of the residents the assisted living program serves; and (3) All other applicable laws and regulations. C. Resident Care Needs. (1) The resident’s care needs shall determine the: (a) Need, amount, and frequency of nursing overview by the registered nurse; (b) Need for on-site nursing services; and (c) Need for awake overnight staff. (2) The Department may approve a waiver of the requirement for awake overnight staff when the assisted living program has demonstrated to the Department its use of an effective electronic monitoring system. (3) The Department may not approve a waiver for awake overnight staff on an Alzheimer’s Special Care Unit. (4) The assisted living program shall comply with applicable requirements of COMAR 10.27.09. D. On-Site Staff. (1) The staffing plan shall include on-site staff sufficient in number and qualifications to meet the 24-hour scheduled and unscheduled needs of the residents. (2) When a resident is in the facility, a staff member shall be present. (3) When a resident is expected to return to the assisted living program, a staff member shall be present. (4) A staffing schedule shall: (a) Be maintained on-site; (b) Include the date, shift hours, and identifying name of all staff members scheduled to work; and (c) Be kept on file for 18 months. E. Awake Overnight Staff. (1) An assisted living program shall provide awake overnight staff when a resident’s assessment using the Resident Assessment Tool indicates that awake overnight staff is required according to instructions on that tool. (2) If a health care practitioner or assessing registered nurse, in the health care practitioner’s or registered nurse’s clinical judgment, does not believe that a resident requires awake overnight staff, the health care practitioner or assessing registered nurse shall document the reasons in the area provided in the Resident Assessment Tool. (3) The assisted living program shall retain this documentation in the resident’s record. (4) Awake overnight staff are required on an approved Alzheimer’s Special Care Unit. F. Electronic Monitoring Systems. (1) Upon the written recommendation of the resident’s health care practitioner, the assisted living program may apply to the Department for a waiver in accordance with Regulation .09 of this chapter to use an electronic monitoring system instead of awake overnight staff. (2) If an electronic monitoring system is approved by the Department for the assisted living program to use, the licensee shall document the approval of the electronic monitoring system in the area provided on the Resident Assessment Tool. (3) When a resident is assessed or reassessed using the Resident Assessment Tool, the health care practitioner shall review and document the: (a) Need for awake overnight staff if the resident’s previous assessment or review of an assessment indicated awake overnight staff was not necessary at the time; and (b) Continued appropriateness of a waiver to use an approved electronic monitoring system instead of awake overnight staff. (4) The assisted living program shall comply with applicable requirements of COMAR 10.27.09. (5) The Department may not approve a waiver for awake overnight staff on an Alzheimer’s Special Care Unit. G. On-Site Nursing Requirements. (1) An assisted living program shall provide on-site nursing when a delegating nurse or health care practitioner, based upon the needs of a resident, issues a nursing or clinical order for that service. (2) If an assisted living manager determines that a nursing or clinical order should not or cannot be implemented, the assisted living manager, delegating nurse, and resident’s health care practitioner shall discuss any alternatives that could safely address the resident’s needs. (3) The assisted living manager shall document in the resident’s record this discussion and all individuals who participated in the discussion. (4) If there are alternatives that could safely address the resident’s needs, the assisted living manager shall notify the resident and, if appropriate, the resident’s legal representative, the delegating nurse, and resident’s health care practitioner of the change to the order. (5) The assisted living manager shall document in the resident’s record this change and the date of notification. (6) If an assisted living manager fails to implement a nursing or clinical order without identifying and providing alternatives to the care or service order, the delegating nurse shall notify the resident’s health care practitioner, the OHCQ, and the resident or, if appropriate, the legal representative of the resident. (7) Failure to implement a nursing or clinical order, without demonstrating why the order should not be followed or without identifying alternatives to care, may result in sanctions against the assisted living program and referral of a licensed or certified staff to the appropriate health occupations licensing board. H. On-site nursing personnel shall work in partnership with the delegating nurse and assisted living program staff to ensure: (1) Adequate assessment of residents; (2) Planning of medical services; and (3) Oversight of nursing activities. #### Regulation .15 Assisted Living Manager. *COMAR 10.07.14.15* A. Qualifications. (1) An individual shall be licensed as required by Health Occupations Article, §9-3A-01, Annotated Code of Maryland, before the individual may practice as an assisted living manager in Maryland. (2) The assisted living manager shall at a minimum: (a) Be 21 years old or older; (b) Possess a high school diploma, a high school equivalency diploma, or other appropriate education and have experience to conduct the responsibilities specified in §C of this regulation; (c) For level 3 licensed programs, have: (i) A 4-year, college-level degree; or (ii) 2 years experience in a health care related field and 1 year of experience as an assisted living program manager or alternate assisted living manager; or (iii) 2 years experience in a health care related field and successful completion of an 80-hour assisted living manager training course approved by the Department; (d) Be free from tuberculosis in a communicable form in accordance with Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Facilities; (e) Be immune to measles, mumps, rubella, and varicella as evidenced by history of disease or vaccination; (f) Have no criminal convictions or other criminal history that indicates behavior that is potentially harmful to residents, documented through either a criminal history records check or a background check, completed within 1 month before employment; (g) Have sufficient skills, training, and experience to serve the residents in a manner that is consistent with the philosophy of assisted living; (h) Have verifiable knowledge in: (i) The health and psychosocial needs of the population being served; (ii) The resident assessment process; (iii) Use of service plans; (iv) Cuing, coaching, and monitoring residents who self-administer medications, with or without assistance; (v) Providing assistance with ambulation, personal hygiene, dressing, toileting, and feeding; and (vi) Resident rights; (i) Receive initial and annual training in: (i) Fire and life safety; (ii) Infection control, including standard precautions; (iii) Emergency disaster plans; and (iv) Basic food safety; and (j) Receive initial certification and recertification every 2 years for: (i) Basic first aid taught by a first aid instructor certified by a national organization; and (ii) Basic cardiopulmonary resuscitation (CPR), including a hands-on component, taught by a CPR instructor certified by a nationally recognized organization. (3) An assisted living manager who has completed the training and passed the examination set forth in Regulation .16 of this chapter shall be presumed to have met the knowledge requirements of §A(1)(g) and (h) of this regulation. B. The Department may determine that an individual is not sufficiently qualified to serve as an assisted living manager if that individual’s managerial or administrative experience, or education, is not sufficient to perform the responsibilities set forth in §C of this regulation for the residents the assisted living program intends to serve. C. Duties. The assisted living manager shall: (1) Be on-site or available on call; and (2) Have overall responsibility for: (a) The management of the assisted living program, including recruiting, hiring, training, and supervising all staff, and ensuring that either a criminal history records check or a background check is conducted consistent with the requirements of Health-General Article, Title 19, Subtitle 19, Annotated Code of Maryland; (b) The development and implementation of a staffing plan, which includes an orientation and ongoing training program for all staff, with specific training in the management, assessment, and programming for the resident with cognitive impairment as required by Health-General Article, §19-319.1, Annotated Code of Maryland; (c) The development and implementation of all policies, programs, and services as required by this chapter; (d) Requiring all employees to perform hand hygiene with either soap and water or an alcohol-based hand sanitizer before and after each direct resident contact for which hand hygiene is indicated by acceptable practice; (e) Providing or ensuring, through the coordination of community services, that each resident has access to appropriate medical and psychosocial services, as established in the resident service plan developed under Regulation .28 of this chapter; (f) Ensuring that there is appropriate coordination of all components of a resident’s service plan, including necessary transportation and delivery of needed supplies; (g) Ensuring that there is appropriate oversight and monitoring of the implementation of each resident’s service plan; (h) Ensuring that all record keeping conforms to the requirements of this chapter and other applicable laws; (i) Ensuring that all requirements of this chapter and other applicable laws are met; (j) Implementing a nursing or clinical order of the delegating nurse or documenting in the resident’s record why the order should not be implemented; (k) Notifying the Department: (i) When the manager terminates the program’s contract with or employment of a delegating nurse; and (ii) Of the reason why the contract or employment was terminated; (l) Notifying the resident and, if applicable, the resident representative or interested family member of any: (i) Significant change in condition of the resident; (ii) Adverse event that may result in a change in condition; (iii) Outcome of the resident’s care that results in an unanticipated consequence; and (iv) Corrective action, if any; (m) Ensuring that the annual influenza vaccine has been advised in accordance with current CDC recommendations and documented surveillance of non-immune staff when indicators of local influenza activity are elevated; and (n) Ensuring that the COVID-19 vaccine has been advised in accordance with current CDC recommendations and documented surveillance of non-immune staff when indicators of local COVID-19 activity are elevated. #### Regulation .16 80-Hour Assisted Living Manager Training Course. *COMAR 10.07.14.16* A. In addition to the requirements in Regulation .15 of this chapter, by January 1, 2006, an assisted living manager shall complete an 80-hour manager training course that is approved by the Department. B. The completed manager’s training course shall: (1) Consist of 80 hours of course work and include an examination; and (2) Provide the training through in-person courses, virtual training methods, or a combination of both. C. An assisted living manager employed in a program shall complete 20 hours of Department-approved continuing education every 2 years. D. A program that fails to employ an assisted manager who meets the requirements of this regulation may be subject to: (1) Sanctions under Regulation .57 of this chapter; and (2) A civil money penalty not to exceed $10,000. E. The training requirements of §A of this regulation do not apply to an individual who: (1) Is employed by a program and has enrolled in a Department-approved manager training course that the individual completes within 6 months; (2) Is temporarily serving as an assisted living manager under Health Occupations Article, §9-3A-01, Annotated Code of Maryland, due to an assisted living manager leaving employment and before the hiring of a permanent manager; (3) Has been employed as an assisted living manager in the State for 1 year before January 1, 2006; or (4) Is licensed as a nursing home administrator in the State. F. The Department may require an individual who is exempt under the provisions of §E of this regulation to complete a manager training course and examination if: (1) The Department finds that the assisted living manager repeatedly has violated State law or regulations on assisted living; and (2) Those violations have caused or have the potential to cause physical or emotional harm to a resident. #### Regulation .17 80-Hour Assisted Living Manager Basic Training Course. *COMAR 10.07.14.17* A. The 80-hour assisted living manager basic training course shall include the following content: (1) Philosophy of assisted living, 2 hours, including: (a) Philosophy and background of assisted living and aging in place; (b) Objectives and principles of assisted living resident programs; (c) Comparison of assisted living to other residential programs; (d) Basic concepts of choice, independence, privacy, individuality, and dignity; and (e) Normalization of the environment; (2) Aging process and its impact, 4 hours, including: (a) Physical characteristics of the assisted living residents; (b) Psychosocial characteristics of the assisted living residents; (c) Basic needs of the elderly and disabled; and (d) Activities of daily living; (3) Assessment and level of care waiver, 6 hours, including: (a) Purpose and process; (b) Guidelines for conducting assessments; (c) Level of care assessments; and (d) Collaboration with the delegating nurse; (4) Service planning, 6 hours, including: (a) Required services; (b) Enhanced scope of services; (c) Development of individualized service plans; (d) Scheduling of appropriate activities; (e) Structure of activities; (f) Care notes; and (g) Collaboration with the delegating nurse; (5) Clinical management, 20 hours, including: (a) Role of the delegating nurse; (b) Appropriate nurse delegation; (c) Concept of self-administration of medications; (d) Concept of medication management; (e) Assistance with self-administration of medications; (f) Administration of medications; (g) Coordination of services and care providers; (h) Collaboration with the delegating nurse; (i) Preventing medication errors; (j) Patient safety; (k) Medication monitoring; (l) Pharmacy consultation; (m) Medication storage; (n) Infection prevention and control to include: (i) Standard and contact precautions; (ii) Bloodborne pathogens; (iii) Standard hand hygiene practices; (iv) Safe injection practices; (v) Use of personal protective equipment; and (vi) Cleaning and disinfection of equipment and the environment; (o) Appropriate staffing patterns; (p) Pressure sores; (q) Effective pain management; (r) Basic first aid taught by a first aid instructor certified by a national organization; (s) Basic cardiopulmonary resuscitation (CPR), including a hands-on component, taught by a CPR instructor certified by a nationally recognized organization; (t) Substance abuse; (u) Trauma-informed care; and (v) A trauma-informed approach to care delivery; (6) Admission and discharge criteria, 4 hours, including: (a) Overview of criteria for admission and discharge; (b) Resident contracts; (c) Resident rights; (d) Financial management of resident’s funds; and (e) Working with families of residents; (7) Nutrition and food safety, 8 hours, including: (a) Menu and meal planning; (b) Basic nutritional needs; (c) Safe food handling; (d) Preventing food-borne illnesses; (e) Therapeutic diets; and (f) Dehydration; (8) Dementia, mental health, and behavior management, 12 hours, including: (a) An overview consisting of: (i) Description of normal aging and conditions causing cognitive impairment; (ii) Description of normal aging and conditions causing mental illness; (iii) Risk factors for cognitive impairment; (iv) Risk factors for mental illness; (v) Health conditions that affect cognitive impairment; (vi) Health conditions that affect mental illness; (vii) Early identification and intervention for cognitive impairment; (viii) Early identification and intervention for mental illness; and (ix) Procedures for reporting cognitive, behavioral, and mood changes; (b) Effective communication consisting of: (i) Effect of cognitive impairment on expressive and receptive communication; (ii) Effect of mental illness on expressive and receptive communication; (iii) Effective communication techniques, including verbal, nonverbal, tone and volume of voice, and word choice; and (iv) Environmental stimuli and influences on communication, including setting, noise, and visual cues; (c) Behavioral intervention consisting of: (i) Identifying and interpreting behavioral symptoms; (ii) Problem solving for appropriate intervention; (iii) Risk factors and safety precautions to protect other residents and the individual; (iv) De-escalation techniques; and (v) Collaboration with the delegating nurse; (d) Making activities meaningful consisting of: (i) Understanding the therapeutic role of activities; (ii) Creating opportunities for activities, including productive, leisure, and self-care; and (iii) Structuring the day; (e) Staff and family interaction consisting of: (i) Building a partnership for goal-directed care; (ii) Understanding family needs; and (iii) Effective communication between family and staff; and (f) Managing staff stress consisting of: (i) Understanding the impact of stress on job performance, staff relations, and overall facility environment; (ii) Identification of stress triggers; (iii) Self-care skills; (iv) De-escalating techniques; and (v) Devising support systems and action plans; (9) End of life care, 4 hours, including: (a) Advance directives; (b) Hospice care; (c) Maryland Medical Orders for Life-Sustaining Treatment (MOLST) order form; (d) Power of attorney; (e) Appointment of a health care agent; (f) Living will; (g) Pain management; (h) Providing comfort and dignity; and (i) Supporting the family; (10) Management and operation, 4 hours, including: (a) Role of the assisted living manager; (b) Overview of accounting, accounts payable, and accounts receivable; (c) The revenue cycle and budgeting; (d) The basics of financial statements; (e) Hiring and training of staff; (f) Developing personnel policies and procedures; (g) Census development; and (h) Marketing; (11) Emergency planning, 4 hours, including: (a) Fire, disaster, and emergency preparedness; (b) Occupational Safety and Health Administration (OSHA) requirements; (c) Maintaining the building, grounds, and equipment; (d) Elopements; (e) Transfers to the hospital; (f) Evacuations; (g) Power outages; (h) Severe weather; (i) Fire; (j) Emergency response systems; and (k) Security systems; (12) Quality assurance, 4 hours, including: (a) Incident report processes; and (b) Quality improvement processes; and (13) Survey process, 2 hours, including: (a) State statutes and regulations; (b) What to expect during a survey; and (c) Documentation. B. A person seeking to offer the assisted living manager training course shall request and obtain approval by the Department by: (1) Submitting the proposed curriculum and training materials to the Department; and (2) Being available for an in-person or telephone interview by the Department. #### Regulation .18 Alternate Assisted Living Manager. *COMAR 10.07.14.18* An alternate assisted living manager shall: A. Be available to assume the responsibilities described in Regulation .15C(2)(a)—(l) of this chapter when the assisted living manager is not available; B. Be 21 years old or older; C. Have 2 years of experience in a health-related field; and D. Meet the qualifications of Regulation .19B(1)—(7) of this chapter. #### Regulation .19 Other Staff — Qualifications. *COMAR 10.07.14.19* A. Age Requirements of Other Staff. (1) Direct resident care staff shall be: (a) 18 years old or older; (b) 16 or 17 years old who are enrolled in a certified nursing assistant training program and are supervised until certified; or (c) 16 or 17 years old and are certified as a nursing assistant. (2) Other staff not performing direct resident care may be younger than 18 years old. B. Qualifications of Other Staff. The qualifications of other staff include: (1) Evidence that the staff is: (a) Free from tuberculosis in a communicable form in accordance with Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Facilities; (b) Immune to measles, mumps, rubella, and varicella as evidenced by history of disease or vaccination; and (c) Free from any impairment which would hinder the performance of assigned responsibilities; (2) Having no criminal convictions or criminal history that indicates behavior that is potentially harmful to residents, as evidenced through a background check completed within 30 calendar days before employment; (3) Having sufficient skills, education, training, and experience to serve the residents in a manner that is consistent with the philosophy of assisted living; (4) Participating in and completing an orientation program and ongoing training to ensure that the residents receive services that are consistent with their needs and generally accepted standards of care for the specific conditions of those residents to whom staff will provide services; (5) Receiving initial and annual training in: (a) Fire and life safety, including the use of fire extinguishers; (b) Infection control, including standard precautions, contact precautions, and hand hygiene; (c) Basic food safety; and (d) Emergency disaster plans; (6) Completing basic first aid training taught by a first aid instructor certified by a national organization and recertification every 2 years; (a) Licensed practical nurses and registered nurses are exempted from basic first aid training and retraining. (7) Having training or experience in: (a) The health and psychosocial needs of the population being served as appropriate to their job responsibilities; (b) The resident assessment process; (c) The use of service plans; and (d) Resident’s rights; and (8) Holding appropriate licensure or certification as required by law. C. With the exception of certified nursing assistants (CNAs) and geriatric nursing assistants (GNAs), if job duties involve the provision of personal care services as described in Regulation .30E of this chapter, an employee: (1) Shall demonstrate competence to the delegating nurse before performing these services; and (2) May work for 10 calendar days before demonstrating to the delegating nurse that they have the competency to provide these services, if the employee performing the tasks is accompanied by: (a) A certified nursing assistant; (b) A geriatric nursing assistant; or (c) An individual who has been approved by the delegating nurse. D. Basic cardiopulmonary resuscitation (CPR) training, including a hands-on component, taught by a CPR instructor certified by a nationally recognized organization shall be provided on an initial and ongoing basis to a sufficient number of staff to ensure that a trained staff member is available to perform CPR in a timely manner, 24 hours a day. E. Relief personnel shall be available at all times in the event that the regularly scheduled staff members are unavailable. Relief personnel shall meet the requirements of §B of this regulation. F. Proof of training shall include: (1) Date of class; (2) Course content; (3) Documentation of successful completion of the training content; (4) Written, electronic, or video proof of attendee participation; and (5) Signature, qualifications, and contact information of each trainer. G. Training with No Direct Interaction. When the training method does not involve direct interaction between faculty and participant, the assisted living program shall make available to the participant a trained individual to answer questions and respond to issues during the training. H. Training in Cognitive Impairment, Mental Illness, and Behavioral Health. (1) When job duties involve the provision of personal care services as described in Regulation .30E of this chapter, employees shall receive a minimum of 6 hours of initial training on cognitive impairment, mental illness, and behavioral health within the first 120 calendar days of employment. (2) The training shall be designed to meet the specific needs of the assisted living program’s population as determined by the assisted living manager, including the following, as appropriate: (a) An overview of the following: (i) A description of normal aging and conditions causing cognitive impairment; (ii) A description of normal aging and conditions causing mental illness; (iii) Risk factors for cognitive impairment; (iv) Risk factors for mental illness; (v) Health conditions that affect cognitive impairment; (vi) Health conditions that affect mental illness; (vii) Early identification of and intervention for cognitive impairment; (viii) Early identification of and intervention for mental illness; and (ix) Procedures for reporting cognitive, behavioral, and mood changes; (b) Effective communication, including: (i) The effect of cognitive impairment on expressive and receptive communication; (ii) The effect of mental illness on expressive and receptive communication; (iii) Effective verbal, nonverbal, tone and volume of voice, and word choice techniques; and (iv) Environmental stimuli and influences on communication; (c) Behavioral intervention, including: (i) Identifying and interpreting behavioral symptoms; (ii) Problem solving for appropriate intervention; (iii) Risk factors and safety precautions to protect the individual and other residents; and (iv) De-escalation techniques; (d) Making activities meaningful, including: (i) Understanding the therapeutic role of activities; (ii) Creating opportunities for productive, leisure, and self-care activities; and (iii) Structuring the day; (e) Staff and family interaction, including: (i) Building a partnership for goal-directed care; (ii) Understanding the needs of families; and (iii) Effective communication between family and staff; (f) End of life care, including: (i) Pain management; (ii) Providing comfort and dignity; and (iii) Supporting the family; and (g) Managing staff stress, including: (i) Understanding the impact of stress on job performance, staff relations, and overall facility environment; (ii) Identification of stress triggers; (iii) Self-care skills; (iv) De-escalation techniques; and (v) Devising support systems and action plans. (3) When job duties do not involve the provision of personal care services as described in Regulation .30E of this chapter, employees shall receive a minimum of 2 hours of training on cognitive impairment, mental illness, and behavioral health within the first 120 calendar days of employment. The training shall include: (a) An overview of the following: (i) A description of normal aging and conditions causing cognitive impairment; (ii) A description of normal aging and conditions causing mental illness; (iii) Risk factors for cognitive impairment; (iv) Risk factors for mental illness; (v) Health conditions that affect cognitive impairment; (vi) Health conditions that affect mental illness; (vii) Early identification and intervention for cognitive impairment; (viii) Early identification and intervention for mental illness; and (ix) Procedures for reporting cognitive, behavioral, and mood changes; (b) Effective communication, including: (i) The effect of cognitive impairment on expressive and receptive communication; (ii) The effect of mental illness on expressive and receptive communication; (iii) Effective verbal, nonverbal, tone and volume of voice, and word choice techniques; and (iv) Environmental stimuli and influences on communication; and (c) Behavioral intervention including risk factors and safety precautions to protect the individual and other residents. (4) Ongoing training in cognitive impairment and mental illness shall be provided annually consisting of, at a minimum: (a) 2 hours for employees whose job duties involve the provision of personal care services as described in Regulation .30E of this chapter; and (b) 1 hour for employees whose job duties do not involve the provision of personal care services as described in Regulation .30E of this chapter. I. Training may be provided through various means, including: (1) Classroom instruction; (2) In-service training; (3) Internet courses; (4) Correspondence courses; (5) Prerecorded training; or (6) Other training methods approved by the Department. J. When the training method does not involve direct interaction between faculty and participant, the assisted living program shall make available to the participant during the training a trained individual to answer questions and respond to issues raised by the training. #### Regulation .20 Personnel Records. *COMAR 10.07.14.20* The assisted living program shall maintain the following information for each staff member: A. Full name, age, and gender; B. Address and telephone number; C. Educational background; D. Employment history; E. Notes on references; F. Performance evaluations; G. Attendance records; H. Individual to be notified in case of emergency; I. Documentation that a criminal history records check was conducted in accordance with Health-General Article, §19-1901, Annotated Code of Maryland; J. Documentation that the staff is: (1) Free from tuberculosis in a communicable form in accordance with Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Facilities; and (2) Immune to measles, mumps, rubella, and varicella as evidenced by history of disease or vaccination; K. Evidence that the annual influenza vaccine has been advised in accordance with current CDC recommendations and documented surveillance of non-immune staff when indicators of local influenza activity are elevated; L. Evidence that the COVID-19 vaccine has been advised in accordance with current CDC recommendations and documented surveillance of non-immune staff when indicators of local COVID-19 activity are elevated; M. Documentation of appropriate licensure or certification as required by law; N. Documentation of all required training and courses; and O. Documentation that a check of the federal Department of Health and Human Services, Office of the Inspector General’s List of Excluded Individuals/Entities database was conducted prior to hiring. #### Regulation .21 Delegating Nurse. *COMAR 10.07.14.21* A. The assisted living program shall have a current and signed agreement with a registered nurse for services of a delegating nurse and delegation of nursing tasks. If the delegating nurse is an employee of the assisted living program, the employee’s job description may satisfy this requirement. B. The program shall maintain documentation that the delegating nurse has completed the mandatory training course developed by the Board of Nursing. C. Duties. The delegating nurse shall: (1) Be on-site to observe each resident at least every 45 calendar days; (2) Be available on call at all times as required under this chapter or have a qualified alternate delegating nurse available on call; and (3) Have the overall responsibility for: (a) Managing the clinical oversight of resident care in the assisted living program; (b) Issuing nursing or clinical orders, based upon the needs of residents; (c) Reviewing the assisted living manager’s assessment of residents; (d) Appropriate delegation of nursing tasks; and (e) Notifying the Department: (i) If the delegating nurse’s contract or employment with the assisted living program is terminated; and (ii) Of the reason why the contract or employment was terminated. D. If the delegating nurse is not available to perform any duties, there shall be a qualified alternate delegating nurse available to perform those duties. E. When an assisted living manager fails to implement nursing or clinical orders without identifying alternatives to the care or service order, the delegating nurse shall notify the resident’s health care practitioner, the Department, and the resident, or, if applicable, the resident representative. #### Regulation .22 Preadmission Requirements. *COMAR 10.07.14.22* A. Before Move In. (1) Before admission the assisted living manager or designee in collaboration with the delegating nurse shall determine whether: (a) The resident may be admitted under the assisted living program’s licensure category; (b) Requires a level of care that the Department has approved for the assisted living program; and (c) The resident’s needs can be met by the program. (2) Within 30 days before admission, the assisted living manager or designee shall determine admission eligibilities described in §A(1) of this regulation based on completion of a resident assessment using the Resident Assessment Tool as described in §B of this regulation. The Department may modify the level of care determination made by the assisted living program at any time. The Resident Assessment Tool: (a) Determines the resident’s required level of care; (b) Forms the basis for development of the resident’s service plan; and (c) Determines whether the resident needs awake overnight monitoring. B. Resident Assessment Tool. (1) Within 30 days prior to admission, the prospective resident’s health status shall be documented on the Resident Assessment Tool. (2) Information on the Resident Assessment Tool shall be based on an examination conducted by a primary physician, certified nurse practitioner, certified registered nurse midwife, registered nurse, or physician assistant that is based on the resident’s current health status. (3) If the potential resident is admitted on an emergency basis by a local department of social services, the required assessment using the Resident Assessment Tool shall be completed as soon as possible but no later than 14 calendar days after the emergency admission. (4) Information on the assessment shall include at a minimum: (a) Recent medical history, including any acute medical conditions or hospitalizations; (b) Significant medical conditions affecting functioning, including the individual’s ability for self-care, cognition, physical condition, and behavioral and psychosocial status; (c) Other active and significant chronic or acute medical diagnoses; (d) Known allergies to foods and medications; (e) Medical confirmation that the individual is free from communicable tuberculosis, and other active reportable airborne communicable diseases; (f) Current scheduled and as needed (PRN) medications; (g) Current and other needed treatments and services for medical conditions and related problems; (h) Current nutritional status, risk factors for malnutrition and dehydration, and, if available, height and weight; (i) Diets ordered by a health care practitioner; (j) Medically necessary limitations or precautions; and (k) Monitoring or tests that need to be performed or followed up after admission. C. Reassessment Documented on the Resident Assessment Tool. (1) The Resident Assessment Tool shall be reviewed at least every 6 months and the review shall be documented by the delegating nurse and assisted living manager. (2) A new Resident Assessment Tool shall be completed: (a) At least annually; (b) Within 48 hours, but not later than required by the resident’s condition, after a significant change in a resident’s condition; and (c) Within 48 hours of a delegating nurse’s determination that a new Resident Assessment Tool needs to be completed. (3) If the previous Resident Assessment Tool did not indicate the need for awake overnight staff, each reassessment or review of the assessment shall include documentation as to whether awake overnight staff is required due to a change in the resident’s condition. D. Functional Assessment. Within 30 calendar days before admission, the assisted living manager, or designee, shall collect on the Resident Assessment Tool the following information regarding the current condition of each resident: (1) Level of functioning in activities of daily living; (2) Level of support and intervention needed, including any special equipment and supplies required to compensate for the individual’s deficits in activities of daily living; (3) Current physical or psychological symptoms requiring monitoring, support, or other intervention by the assisted living program; (4) Capacity for making personal and health care related decisions; (5) Presence of disruptive behaviors, or behaviors which present a risk to the health and safety of the resident or others; and (6) Social factors, including: (a) Significant problems with family circumstances and personal relationships; (b) Spiritual status and needs; and (c) Ability to participate in structured and group activities, and the resident’s current involvement in these activities. E. Resident Requirements for Awake Overnight Staff. (1) Before admission, the assisted living manager shall ensure that the resident is assessed using the Resident Assessment Tool. (2) When the resident scores in any of the areas identified as “Triggers for Awake Overnight Staff” in the Resident Assessment Tool, the assisted living program shall provide awake overnight staff or document why awake overnight staff is not necessary in accordance with Regulation .14E of this chapter. F. Short-Term Residential Care Requirements. (1) For persons admitted for short-term residential care, the following are required: (a) Current physical condition and medical status as specified in §B(4) of this regulation; (b) Functional assessment as specified in §D of this regulation; and (c) A resident agreement, in accordance with Regulations .26 and .27 of this chapter. (2) If the person is admitted for a subsequent short-term admission, the following are required: (a) Current physical condition and medical status as specified in §B(4) of this regulation; (b) Functional assessment as specified in §D of this regulation; and (c) A new resident agreement or an addendum to the prior resident agreement. G. A resident admitted as an emergency placement by a local department of social services is exempt from all physical examination and assessment requirements of this regulation if the resident is in temporary emergency shelter and services status, not to exceed 14 calendar days, with notification to the Department of the placement within 48 hours. #### Regulation .23 Admission Requirements. *COMAR 10.07.14.23* A. Discrimination Prohibited. An assisted living program licensed under this chapter may not discriminate in admitting or providing care to an individual because of the individual’s: (1) Race; (2) Color; (3) National origin; (4) Sexual orientation; (5) Gender identity; (6) Religion; (7) Physical disability; or (8) Mental disability. B. An assisted living program may not provide services to individuals who at the time of initial admission, as established by the initial assessment, would require: (1) More than intermittent nursing care; (2) Treatment of stage three or stage four skin ulcers; (3) Ventilator services; (4) Skilled monitoring, testing, and frequent adjustment of medications and treatments where there is the presence of a fluctuating acute condition; or (5) Monitoring of a chronic medical condition that is not controllable through readily available medications and treatments. C. An individual may not be admitted to an assisted living program who is: (1) Dangerous to the individual or others when the assisted living program would be unable to eliminate the danger through the use of appropriate treatment modalities; or (2) At high risk for health or safety complications which cannot be adequately managed. D. The provisions of §§B and C of this regulation do not apply to a resident being admitted to an assisted living program when the resident is under the care of a general hospice care program licensed by the Department which ensures delivery of one or more of the services described under §§B and C of this regulation through the hospice program’s plan of care. #### Regulation .24 Resident-Specific Level of Care Waiver. *COMAR 10.07.14.24* A. An assisted living program may request a resident-specific waiver to continue to provide services to a resident if: (1) The resident’s level of care exceeds the level of care for which the assisted living program has authority to provide; or (2) The resident would require care that falls into one of the categories set forth in Regulation .23. B. An assisted living program may not continue providing services to a resident whose needs exceed the level of care for which the licensee has authority to provide, without approval of the Department. C. Temporary Change in Level of Care. (1) A level of care waiver is not required for a resident whose level of care is expected to increase for a period not to exceed 30 calendar days. (2) The assisted living program shall submit a waiver application as soon as program personnel determine that the increased level of care or the condition requiring the waiver is likely to exceed 30 calendar days. D. When requesting a resident-specific waiver, the assisted living program shall demonstrate that: (1) The assisted living program has the capability of meeting the needs of the resident; and (2) The needs of other residents will not be jeopardized. E. Approval of Waiver Request. (1) The Department may grant a resident-specific level of care waiver, with or without conditions, if the Department determines that the: (a) Resident’s needs can be met; (b) Needs of other residents will not be jeopardized; and (c) Provider complies with the requirements of Regulation .47A of this chapter. (2) Terms of a Resident-Specific Waiver. (a) An approved resident-specific waiver applies only to the resident for whom the waiver was granted. (b) The waiver no longer applies if the resident’s level of care, as determined through an assessment, declines or improves to the point that the resident requires a higher or lower level of care than authorized by the waiver. (c) When the Department grants a waiver to continue to provide services to a resident whose needs fall within one of the categories in Regulation .23, the assisted living program shall, at a minimum, comply with certain federal Medicare requirements for home health agencies referenced in 42 CFR §§484.1, 484.2, 484.40—484.80, 484.100—484.115, 484.200—484.265, and 484.300—484.375. F. Denial of a Resident-Specific Waiver Request. (1) The Department shall deny the request for a resident-specific waiver if the Department determines that the: (a) Assisted living program is not capable of meeting the needs of the resident; or (b) Needs of other residents will be jeopardized if the waiver request is granted. (2) The Department may not grant resident-specific waivers: (a) That total more than 50 percent of the assisted living program’s bed capacity for residents whose needs exceed the level of care for which the assisted living program has authority to provide as specified in Regulation .04D of this chapter; or (b) For the continuation of services to a resident whose needs fall within one of the categories set forth in .23B of this regulation, for up to 20 percent of capacity, or 20 beds, whichever is less, unless a waiver is granted by the Department. (3) The decision of the Department may not be appealed. (4) The Department’s denial of a resident-specific level of care waiver request: (a) Does not prohibit the resident from being admitted to another program that is capable of meeting the resident’s needs and is licensed to provide that level of care; and (b) Does not provide any exception to the admission restrictions set forth in .23A of this regulation. (5) If the Department initially denies a resident-specific level of care waiver request and determines that a resident’s health or safety may significantly deteriorate because of the provider’s inability to provide or ensure access to care that will meet the needs of the resident, the: (a) Denial is not subject to informal dispute resolution; and (b) Department may direct the relocation of the resident to a safe environment. G. The Department’s Decision. (1) The Department shall communicate the decision to grant or deny a resident-specific waiver to the assisted living manager in writing, including all appropriate supporting documentation, within 7 calendar days from receipt of the waiver request. (2) Dispute of a Resident-Specific Waiver. (a) If the resident or the resident representative disagrees with the Department’s denial of a waiver request, the resident or, as applicable, the resident representative may dispute the Department’s decision by: (i) Submitting a written request to the Department within 7 calendar days after receipt of the Department’s denial; and (ii) Including in the written request the reasons why the Department’s denial may be incorrect. (b) The Department shall consider the request and notify the resident or the resident representative within 7 calendar days of receipt of the request whether or not the Department’s decision to deny a level of care waiver is sustained. (c) The Department’s decision from the dispute is not: (i) A contested case as defined in State Government Article, §10-202(d), Annotated Code of Maryland; or (ii) Subject to further appeal. (d) In making a decision to sustain or change the decision to deny a waiver request, the Department shall consider, among other factors, whether the: (i) Granting of waivers has resulted in one or more residents having experienced a decline in their physical, functional, or psychosocial well-being; and (ii) Decline in the residents’ condition might have been prevented had the waivers not been granted. (e) If the Department sustains the decision to deny the waiver request, the Department shall notify the assisted living program of what action is required, including, but not limited to: (i) Revocation of some or all of the resident-specific waivers which have been granted; or (ii) A change in licensure category. (f) Decision to Sustain the Denial of Waiver Request. (i) Upon notification of the decision to sustain the denial of waiver, the assisted living program shall submit a response with an appropriate plan of action for approval by the Department. (ii) If the Department does not approve the assisted living program’s plan of action, the Department shall notify the assisted living program that one or more resident-specific waivers are revoked or that a change in licensure status is required. (iii) The determination to sustain the denial of waiver request may not be appealed. (iv) Failure of the assisted living program to comply with the Department’s decision is grounds for the imposition of sanctions. H. The Department shall, during a survey or other inspection, or when a resident-specific level of care waiver request is made, review the number of resident-specific waivers an assisted living program holds to ensure that the assisted living program continues to be able to provide appropriate care to all of its residents and to ensure that the current licensure category is appropriate. The Department shall notify the assisted living program if, at any time, the Department determines that: (1) The assisted living program is not providing appropriate care to its residents because of the number of resident-specific waivers it holds; or (2) The number of resident-specific waivers an assisted living program holds necessitates a change in licensure category. #### Regulation .25 Payment of Funds Before Admission. *COMAR 10.07.14.25* If an assisted living program requires payment of funds before admission, the funds shall be fully refundable unless the assisted living program discloses, in writing, what portion is not refundable. #### Regulation .26 Resident Agreement — General Requirements and Nonfinancial Content. *COMAR 10.07.14.26* A. Except as otherwise provided under §E of this regulation, for a person admitted for other than short-term residential care, the resident or the resident agent and the assisted living manager or their designee shall sign, before or at the time of admission, a resident agreement that: (1) Is a clear and complete reflection of commitments agreed to by the parties, and the actual practices that will occur in the assisted living program; (2) Is accurate, precise, easily understood, legible, readable, and written in plain English; (3) Conforms to all relevant State and local laws and requirements in effect when the agreement is executed; and (4) Recommends review of the agreement by an attorney or other representative chosen by the resident. B. For a person admitted for short-term residential care, the resident or the resident agent and the assisted living manager or their designee shall sign, before or at the time of admission, a resident agreement as set forth in this regulation excluding the provisions of §D(9)(c) and 8(d) and (e) of this regulation. C. The assisted living program shall: (1) Give a copy of the signed resident agreement to the resident and the resident agent; (2) Maintain a copy of the resident agreement on-site; and (3) Make the resident agreement available for review by the Department or its designee. D. The resident agreement shall include, at a minimum, the following provisions: (1) A statement of the level of care for which the assisted living program is licensed; (2) The level of care needed by the resident, as determined by the initial assessment required by Regulation .05 of this chapter; (3) Unless the assisted living program is part of a continuing care retirement community and the agreement is signed by a continuing care subscriber as defined in COMAR 32.02.01.01B, a statement indicating that if a resident’s level of care, after admission, exceeds the level of care for which the assisted living program is permitted to provide and a waiver for the continued stay of the resident has not been granted, the assisted living program shall discharge the resident from the program; (4) If the assisted living program is part of a continuing care retirement community and a separate, concurrent resident agreement is signed by a continuing care subscriber as defined in COMAR 32.02.01.01B, a statement indicating that if the resident’s level of care, after admission to assisted living, exceeds the level of care for which the assisted living program is permitted to provide and a waiver for the continued stay of the resident has not been granted: (a) The assisted living program may not provide any services to the resident beyond that which it is licensed to provide; (b) If the assisted living program offers either comprehensive care services, or priority access to comprehensive care services, and a comprehensive care bed is available for occupancy, the resident shall be given the option to transfer to comprehensive care; and (c) The resident may be discharged from the continuing care retirement community only for just cause as set forth in COMAR 32.02.01.31B; (5) A listing of services provided by the assisted living program and a listing of personal care and health care services the assisted living program does not provide; (6) An explanation of the assisted living program’s complaint or grievance procedure; (7) A policy on resident self-administration of medications; (8) A policy on the administration of medications to a resident by a spouse or domestic partner who is also a resident of the assisted living program; (9) Occupancy provisions, including: (a) Policies regarding bed and room assignment, including the specific room and bed assigned to the resident at the time of admission; (b) Policies for temporary or permanent changes to the resident’s accommodations, including: (i) Relocating the resident within the facility; (ii) Making a change in roommate assignment; or (iii) Increasing or decreasing the number of individuals occupying a room; (c) Procedures for transferring the resident to another facility; (d) The availability of locks for storage; (e) The availability of locks, if any, for the resident’s room; (f) Security procedures which the assisted living program shall implement to protect the resident and the resident’s property; (g) The staff’s right, if any, to enter a resident’s room; (h) The resident’s rights and obligations concerning use of the facility, including common areas; (i) If non-residents live on the premises, the assisted living program shall disclose what parts of the licensed space they are permitted in and during what hours; (j) Provisions for continuous service in the event of an emergency; (k) An acknowledgment that the resident or the resident representative has reviewed all assisted living program rules, requirements, restrictions, or special conditions that the assisted living program will impose on the resident; and (l) The assisted living program’s bed hold policy in case of unavoidable or optional absences such as hospitalizations, recuperative stays in other settings, or vacation, including: (i) The conditions under which the assisted living program will hold a bed; (ii) Relevant time frames; (iii) Payment terms; (iv) The circumstances under which the program will no longer hold the bed; and (v) The period of time during which the resident is permitted to return and resume residence in the facility; (10) Admission and discharge policies and procedures, including: (a) Any additional admission requirement imposed by the assisted living program; (b) Those actions, circumstances, or conditions which may result in the resident’s discharge from the assisted living program; (c) The procedures which the assisted living program shall follow to verify that the receiving program or facility has the required license to operate that type of program or facility; (d) The procedures which the assisted living program shall follow when discharging a resident without the resident’s consent, except in the case of a health emergency or substantial risk to other residents, including: (i) The termination of the resident agreement on discharge; and (ii) At least 30 calendar days written notice to the resident or resident representative before the effective date of the discharge; (e) Procedures that the assisted living program shall follow when discharging, without 30 calendar days notice, a hospitalized resident whose medical needs have advanced beyond the level of care for which the assisted living program is licensed to provide. The procedures shall include at a minimum: (i) A statement that a transfer to the hospital is not grounds for discharge; and (ii) A requirement that the delegating nurse shall perform and document a nursing assessment of the resident’s condition at the hospital to determine if the resident can safely return to the facility; (f) Procedures that the resident shall follow when terminating the resident agreement; (g) A statement that the resident or resident representative shall give at least 30 calendar days notice to the assisted living program before the effective date of termination except in the case of a health emergency; (h) Procedures the assisted living program shall follow when a multiple person unit is vacated by one resident due to discharge or death, including provisions: (i) For termination of the agreement; and (ii) Appropriate refunds; (11) Obligations of the licensee, the resident, or the resident representative as to: (a) Arranging for or overseeing medical care; and (b) The monitoring of the health status of the resident; (12) Adult medical day care policies and availability; and (13) Any arrangements the resident has made, or wishes to make, with regard to burial, including, but not limited to: (a) Financial; (b) Religion preferred funeral director, if any; and (c) The name, address, and relationship of any person who has agreed to claim the body of the resident or who has agreed to assume funeral or burial responsibility. E. If the services provided in an assisted living program that is part of a continuing care retirement community are covered under a continuing care agreement that complies with Human Services Article, Title 10, Subtitle 4, and Health-General Article, §19-1806, Annotated Code of Maryland: (1) The Department may not require a separate resident agreement for the assisted living program; and (2) The requirements set forth in this regulation and Regulation .27 of this chapter do not apply. F. The assisted living program may not include a provision in the agreement which is inconsistent with any of the requirements of this chapter. #### Regulation .27 Resident Agreement — Financial Content. *COMAR 10.07.14.27* A. The resident agreement shall include financial provisions, which include at a minimum: (1) Obligations of the assisted living program and the resident, or the resident agent, as to: (a) Handling the finances of the resident; (b) The purchase or rental of essential or desired equipment and supplies; (c) Arranging and contracting for services not covered by the resident agreement; (d) Ascertaining the cost of and purchasing durable medical equipment; and (e) Disposition of resident property upon discharge or death of the resident; and (2) Rate structure and payment provisions covering: (a) All rates to be charged to the resident, including, but not limited to: (i) Service packages; (ii) Fee for service rates; and (iii) Any other non-service-related charges; (b) Notification of the rate structure applicable for other levels of care provided by the assisted living program and the criteria to be used for imposing additional charges for the provision of additional services, if the resident’s service and care needs change; (c) Payment arrangements and fees, if known, for third-party services not covered by the resident agreement, but arranged for by either the resident, the resident agent, or the assisted living program; (d) Identification of the persons responsible for payment of all fees and charges and a clear indication of whether the person’s responsibility is or is not limited to the extent of the resident’s funds; (e) A provision which provides at least 45 calendar days notice of any rate increase, except if necessitated by a change in the resident’s medical condition; (f) Fair and reasonable billing, payment, and credit policies; (g) The procedures the assisted living program will follow in the event the resident or resident agent can no longer pay for services provided for in the resident agreement or for services or care needed by the resident, including 30 calendar days notice of the resident’s discharge to the: (i) Ombudsman within the Department of Aging or local area agency on aging; and (ii) Local Department of Human Services or Adult Protective Services; and (h) Terms governing the refund of any prepaid fees or charges, in the event of a resident’s discharge from the assisted living program or termination of the resident agreement. B. When the resident’s needs significantly change and the level of service provided needs to be increased or decreased, the resident agreement shall be amended by the parties to reflect the changes in services being provided and any applicable increase or decrease in charges. C. Charges that incur after the death of the resident may not include services provided to the resident after their death, but may include administrative charges. #### Regulation .28 Service Plan. *COMAR 10.07.14.28* A. Service Plan Development. (1) The assisted living manager, or designee, shall ensure that all services are provided in a manner that respects and enhances the dignity, privacy, and independence of each resident. (2) A service plan for each resident shall be developed in a manner that enhances the principles of dignity, privacy, resident choice, resident capabilities, individuality, and independence without compromising the health or reasonable safety of other residents. (3) The resident shall be invited to participate in the development of the initial service plan and any subsequent service plans. (4) At the resident’s request, a resident representative, family member, or other individual shall be invited to participate in all service plan meetings. (5) When the resident lacks the capacity to participate, the resident representative, as applicable to their authority, shall be invited to participate in all service plan meetings. (6) The assisted living program shall accommodate the schedules of participants in a service plan meeting when possible. B. Assessment of Condition. (1) The resident’s service plan shall be based on an assessment of the resident’s health, function, behavioral, and psychosocial status using the Resident Assessment Tool and the nursing assessment. (2) A full assessment of the resident shall be completed: (a) Within 48 hours but not later than required by nursing practice and the patient’s condition after: (i) A significant change of condition; and (ii) Each nonroutine hospitalization; and (b) At least annually. (3) When the delegating nurse determines in the nurse’s clinical judgment that the resident does not require a full assessment within 48 hours, the delegating nurse shall: (a) Document the determination and the reasons for the determination in the resident’s record; and (b) Ensure that a full assessment of the resident is conducted within 7 calendar days. (4) A review of the assessment shall be conducted every 6 months for residents who do not have a change in condition. Further evaluation by a health care practitioner is required and changes shall be made to the resident’s service plan, if there is a score change in any of the following areas: (a) Cognitive and behavioral status; (b) Ability to self-administer medications; and (c) Behaviors and communication. (5) If the resident’s previous assessment did not indicate the need for awake overnight staff, each full assessment or review of the full assessment shall include documentation as to whether awake overnight staff is required due to a change in the resident’s condition. C. Special Care Needs. The service plan shall reflect increased monitoring, intervention, and oversight, as clinically appropriate for special care needs, including: (1) Fall risk or frequent falls; (2) Pressure ulcer risk, prevention, and treatment; (3) Diabetes management; (4) Oxygen therapy; (5) Enteral feedings; (6) Foley catheter care; (7) Ostomy care; (8) Therapeutic medication levels; (9) Mental illness; and (10) Behaviors that are likely to disrupt or harm the resident or others. D. The assisted living manager, or designee, shall ensure that: (1) A written service plan or other documentation sufficiently recorded in the resident’s record is developed by staff, which at a minimum addresses: (a) The services to be provided to the resident, which are based on the assessment of the resident; (b) When and how often the services are to be provided; and (c) How and by whom the services are to be provided; (2) The service plan is developed within 30 calendar days of admission to the assisted living program; and (3) The service plan is reviewed by staff at least every 6 months, and updated, if needed, unless a resident’s condition or preferences significantly change, in which case the assisted living manager or designee shall review and update the service plan sooner to respond to these changes. #### Regulation .29 Resident Record. *COMAR 10.07.14.29* A. The assisted living manager shall ensure that an individual record or log is maintained at the assisted living program for each resident in a manner that ensures security and confidentiality, and which includes at a minimum: (1) Resident Assessment Tools; (2) Nursing assessments; (3) Medical orders; (4) Service plans; (5) Care notes; (6) Emergency data sheet; (7) Applicable advance directive and mental health advance directive; (8) Maryland Medical Orders for Life-Sustaining Treatment (MOLST) form; (9) Monthly weights or, in accordance with the health care practitioner’s orders for weights, more or less frequently; (10) Pharmacy reviews, if appropriate; (11) Rehabilitation plans, if appropriate; and (12) Any other records related to the care and services provided to the resident. B. Readmission of a Resident. (1) A resident shall be reassessed by the delegating nurse within 48 hours of readmission to the program if the following occurs: (a) Hospitalizations or a 15-day or longer stay in any skilled facility; or (b) There is a significant change in the resident’s mental or physical status upon return to the program after an absence from the program. (2) When the delegating nurse determines in the nurse’s clinical judgment that the resident does not require a full assessment within 48 hours, the delegating nurse shall: (a) Document the determination and the reasons for the determination in the resident’s record; and (b) Ensure that a full assessment of the resident is conducted within 7 calendar days. C. The assisted living manager shall develop policies and procedures to ensure that all information relating to a resident’s condition or preferences, including any significant change as defined in Regulation .02B(81) of this chapter, is documented in the resident’s record and communicated in a timely manner to: (1) The resident; (2) The resident representative, as appropriate; and (3) Health care practitioners and staff who are involved in the development and implementation of the resident’s service plan, as appropriate. D. Resident Care Notes. (1) Appropriate staff shall write care notes for each resident: (a) On admission; (b) At least weekly; (c) With any significant changes in the resident’s condition, including when incidents occur and any follow-up action is taken; (d) When the resident is transferred from the facility to another health care facility; (e) On return from medical appointments; (f) When seen in the facility by any health care practitioner or health care provider; (g) On return from nonroutine leaves of absence; and (h) When the resident is discharged permanently from the facility, including the location and manner of discharge. (2) Staff shall write care notes that are individualized, legible, dated, timed, and signed by the writer. E. The assisted living program shall maintain a resident’s record for 5 years after the resident is discharged. F. If an assisted living program ceases operation, the assisted living program shall make arrangements to retain records as required by §E of this regulation. G. If the assisted living program changes ownership, the prior owner shall provide all written and electronic records of current residents to the new owner in a usable format prior to the issuance of the new license. H. An assisted living program shall: (1) Maintain the privacy and confidentiality of a resident’s medical records and medical information; (2) Release medical records or medical information about a resident only with the consent of the resident or resident representative, or as permitted by Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland; and (3) Maintain and dispose of a resident’s medical records in accordance with Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland. #### Regulation .30 Services. *COMAR 10.07.14.30* A. Meals. (1) The assisted living manager shall ensure that: (a) A resident is provided three meals in a common dining area and additional snacks during each 24-hour period, 7 days a week; (b) Meals and snacks are well-balanced, varied, palatable, properly prepared, and of sufficient quality and quantity to meet the daily nutritional needs of each resident with specific attention given to the preferences and needs of each resident; (c) At a minimum, residents have access to snacks or food supplements between breakfast and lunch, between lunch and dinner, and during the evening hours; (d) All food is prepared in accordance with all State and local sanitation and safe food handling requirements; (e) Food preparation areas are maintained in accordance with all State and local sanitation and safe food handling requirements; and (f) Portion sizes are in accordance with orders from a health care practitioner. (2) The assisted living program shall ensure that menus are nutritionally adequate by having a dietitian or nutritionist review the 4-week menu: (a) Prior to initial licensure; (b) If substantive changes beyond accepted food substitutions have been made; and (c) At least every 3 years. (3) Menus. (a) Menus shall be written at least 1 week in advance. (b) The assisted living program shall post a weekly menu in a conspicuous place that is visible to residents and other interested parties. (c) Menus shall be maintained on file, as served, for 6 months. (4) Special Diets. (a) The assisted living program staff shall: (i) Prepare or arrange for the provision of special diets as ordered by the resident’s health care practitioner or as needed by the resident’s condition; and (ii) Document special diets in the resident’s record. (b) If the diet is beyond the capability of the assisted living program, the resident or the resident’s health care practitioner shall make other arrangements for the resident’s care, or the assisted living program shall discharge the resident. B. Monitoring. The assisted living manager shall ensure that each resident is monitored on a daily basis to ensure that the resident’s service plan is being properly implemented. C. Adaptive Equipment and Assistive Devices. (1) The assisted living manager or their designee shall ensure that all adaptive equipment and assistive devices are in proper working order. (2) The assisted living manager or designee shall facilitate the repair or replacement of adaptive equipment and assistive devices, as needed. (3) Assisted living staff shall assist the resident, as needed, to utilize the adaptive equipment and assistive devices. D. Nursing Services. The assisted living manager, in consultation with the delegating nurse, shall ensure that all nursing services are provided consistent with the Nurse Practice Act, Health Occupations Article, Title 8, Annotated Code of Maryland. E. Personal Care Services. The assisted living manager shall provide or ensure the provision of all necessary personal care services, including, but not limited to, the range of assistance needed by a resident to complete the activities of daily living as defined in Regulation .02B(2) of this chapter. F. Housekeeping Services. The assisted living manager shall ensure that: (1) Housekeeping services are provided; and (2) All areas of the facility are maintained in a clean and orderly condition. G. Health Care and Social Services. The assisted living manager is responsible for facilitating access to any appropriate health care and social services for the resident as determined in the resident’s assessment, including, but not limited to: (1) Social work services; (2) Rehabilitative services, including occupational, physical, speech, and audiology therapies; (3) Home health services; (4) Hospice services; (5) Skilled nursing services; (6) Health care practitioner services; (7) Oral health care; (8) Dietary consultation and services; (9) Counseling; (10) Psychiatric services; (11) Psychological services; and (12) Other specialty health services. H. Social and Recreational Activities. (1) In accordance with the resident’s service plan, the assisted living program staff shall encourage resident participation in social and recreational activities, including: (a) Providing or arranging for transportation to these activities in accordance with the resident’s service plan; and (b) Assisting a resident with communication, interpersonal, and social skills, including managing difficult behaviors in accordance with the resident’s service plan. (2) The assisted living manager shall provide or arrange appropriate opportunities for socialization, social interaction, and leisure activities that reflect the resident’s preferences and promote the physical and mental well-being of each resident. I. Spiritual Activities. (1) The assisted living manager or designee shall facilitate access to spiritual and religious activities consistent with the preferences and beliefs of the resident. (2) The assisted living manager or designee shall provide or arrange for transportation to spiritual and religious activities in accordance with the resident’s service plan. #### Regulation .31 Medication Management and Administration. *COMAR 10.07.14.31* A. All unlicensed staff who will administer medications to residents shall have first completed the medication administration course that is taught by a registered nurse who is approved by the Maryland Board of Nursing to teach the certified medication technician course. B. The assisted living manager shall document completion of the medication technician training and certification as a medication technician by the Maryland Board of Nursing per COMAR 10.39.04 in the personnel file or other readily available record of each unlicensed staff member who administers medications. C. All medications shall be administered consistent with applicable requirements of COMAR 10.27.11. D. Self-Administration of Medication. (1) An assisted living manager shall ensure that the resident’s initial assessment process identifies whether a resident: (a) Is capable of self-administration of medication; (b) Is capable of self-administration of medication, but requires a reminder to take medications or physical assistance with opening and removing medications from the container, or both; or (c) Requires that medications be administered by the assisted living program staff or by a spouse or domestic partner of the resident in accordance with §E of this regulation. (2) For a resident who is capable of self-administration or, although capable, requires a reminder or physical assistance, as stated in §D(1)(b) of this regulation, the assisted living manager shall ensure that the resident is reassessed by the delegating nurse quarterly for the ability to safely self-administer medications with or without assistance. E. Administration of Medication by a Spouse or Domestic Partner. While residing in the same assisted living program as their spouse or domestic partner, a resident may administer medications to their spouse or domestic partner providing the following documentation is maintained in the resident’s record: (1) An initial assessment by their health care practitioner documenting the resident’s competency and ability to safely administer medications to their spouse or domestic partner; (2) Quarterly assessments by the delegating nurse documenting the resident’s continued ability to safely administer medications to their spouse or domestic partner; and (3) Current signed medical orders. F. Medication Regimen Review Upon Admission. (1) The assisted living manager shall consult within 14 calendar days of a resident’s admission with the individuals set forth in §F(2) of this regulation to review a new resident’s medication regime. (2) The medication review may be conducted by a: (a) Health care practitioner; (b) Registered nurse, who may be the delegating nurse; or (c) Licensed pharmacist. G. The purpose of the medication regimen review required by §F of this regulation is to review with the assisted living manager or designee: (1) A resident’s current medication profile, including all prescription and nonprescription over-the-counter medications and tube feedings; (2) The potential that current medications have to act as a chemical restraint; (3) The potential for any side effects; (4) The potential for adverse drug interactions; and (5) Any medication errors that have occurred since admission. H. The assisted living manager, or designee, shall ensure that the medication regimen review required by §F of this regulation is documented in the resident’s records, including any recommendations given by the reviewer. I. Pharmacy Review. (1) The assisted living manager shall arrange for a licensed pharmacist to conduct an on-site review of health care practitioner prescriptions, health care practitioner orders, and resident records at least every 6 months for any resident receiving nine or more medications, including over-the-counter and as needed (PRN) medications. (2) The pharmacist’s review shall include, but is not limited to, whether: (a) The assisted living program is in compliance with Board of Pharmacy’s requirements for packaging of medications; (b) Each resident’s medications are properly stored and maintained; (c) Each resident receives the medications that have been specifically prescribed for that resident in the manner that has been ordered; (d) The desired effectiveness of each medication is achieved based on available information, and, if not, that the appropriate authorized prescriber is so informed; (e) Any undesired side effects, potential and actual adverse drug reactions, and medication errors are identified and reported to the appropriate authorized prescriber; (f) The resident has a medical condition as documented in the resident’s records that is not currently being treated by medication; (g) There is medication use without current indication in the resident’s records of a medical condition that warrants the use of the medication; (h) There is medication overuse that is causing side effects as documented in the resident records; (i) Current medication selections result in inappropriate medication dosage; (j) The resident may be experiencing drug interactions; (k) The resident is receiving medication, either prescribed or over-the-counter medications, as well as herbal remedies that could result in drug-drug, drug-food, or drug-laboratory test interactions; (l) Administration times of medication need to be modified to address drug interactions or meal times, or both; (m) Periodic diagnostic monitoring required by certain medications have been performed; and (n) More cost-effective medications are available to treat current medical conditions. (3) The pharmacist shall document the pharmacy review as required under this section in each resident’s chart and this documentation shall be reviewed every 6 months as part of the assisted living program’s quality assurance activities as required in Regulation .13 of this chapter. J. The person conducting the on-site review under §F or G of this regulation shall recommend changes, as appropriate, to the appropriate authorized prescriber and the assisted living manager or designee. K. If a resident requires that staff administer medications as defined in Regulation .02B(3) of this chapter, and the administration of medications has been delegated to an unlicensed staff person pursuant to COMAR 10.27.11, the assisted living manager shall comply with COMAR 10.27.11 by arranging for an on-site review by the delegating registered nurse at least every 45 calendar days. The delegating nurse shall make appropriate recommendations to the appropriate authorized prescriber, and the assisted living manager or designee. L. Safe Storage of Medication. The assisted living manager, or designee, shall ensure that: (1) Medications are stored in the original dispensed container; (2) Medications are stored in a secure location, at the proper temperature; and (3) The following documentation is maintained for all prescription and over-the-counter medications prescribed to residents: (a) Name of the resident; (b) Name of the medication; (c) Reason for the medication; (d) Dose; (e) Frequency; (f) Route; (g) Authorized prescriber’s name; (h) Date of issuance; (i) Expiration date; (j) Refill limits; and (k) Directions for use. M. Medications and treatments shall be administered consistent with current signed medical orders and using professional standards of practice. N. Only sealed, unopened medication packages or individual unit dose blisters may be returned to the inventory of the pharmacy. O. Required Documentation. (1) A staff member shall record the documentation required under §L of this regulation for all residents for whom medications are administered, or who receive assistance in taking their medications, as defined by Regulation .02B(3)(b) of this chapter, at the time that the resident takes or receives medications. (2) A staff member shall record the documentation required under §L of this regulation for residents who self-administer: (a) Upon admission; or (b) When changes in the resident’s medication regimen are ordered by a health care practitioner. P. Accounting for Narcotic and Controlled Substances. (1) A qualified staff member and a witness shall count and record Schedule II through V controlled substances before the close of every shift. (2) The daily record shall account for all controlled substances documented as administered on the medication administration record. (3) All Schedule II through V controlled substances shall be maintained under a double lock system. (4) As required, the assisted living program shall obtain a Controlled Dangerous Substances registration certificate from the Department’s Office of Controlled Substances Administration. (5) The assisted living manager shall develop written policies and procedures to guard against theft and diversion of controlled substances, that include: (a) Proper storage; (b) Accountability; (c) Access; (d) Destruction; and (e) Reporting procedures. (6) Controlled substances may not be returned to the pharmacy. (7) Controlled substances in need of disposal shall be destroyed on-site at the assisted living program and their destruction shall be: (a) Conducted by two members of the staff, one of whom shall be a licensed practitioner, licensed pharmacist, registered nurse, licensed practical nurse, certified medication technician, or licensed assisted living manager; and (b) Recorded on a form supplied by the Division of Drug Control, a copy of which shall be forwarded to the Division within 10 calendar days of destruction. #### Regulation .32 Alzheimer’s Special Care Unit. *COMAR 10.07.14.32* A. Initial Approval of an Alzheimer’s Special Care Unit. An assisted living program requesting the initial approval to operate an Alzheimer’s Special Care Unit shall submit to the Department a written description of the Alzheimer’s Special Care Unit using a disclosure form developed by the Department. The description shall explain how: (1) The form of care and treatment provided by the Alzheimer’s Special Care Unit is specifically designed for the specialized care of individuals diagnosed with Alzheimer’s disease or a related dementias; and (2) The care in the Alzheimer’s Special Care Unit differs from the care and treatment provided in the nonspecial care unit. B. Approval of an Alzheimer’s Special Care Unit. (1) An assisted living program shall have written approval from the Department prior to operating an Alzheimer’s Special Care Unit. (2) An assisted living program shall have written approval from the Department of an Alzheimer's Special Care Unit prior to advertising or marketing the unit. (3) The Department will either approve or not approve the operation of the Alzheimer’s Special Care Unit. C. Substantive Changes to the Alzheimer’s Special Care Unit. (1) The written description of the Alzheimer’s Special Care Unit shall accurately reflect the current operation of the unit. (2) If any substantive changes are made to the Alzheimer’s Special Care Unit, the revised written description shall be submitted to the Department for review and approval. (3) The Department shall inform the provider of the decision of the review within 30 calendar days from the Department’s receipt of the revised written description. D. An assisted living program with an Alzheimer’s Special Care Unit shall disclose the written description of the unit to: (1) Any person on request; (2) The resident, as appropriate; and (3) The family or resident representative before admission of the resident to the Alzheimer’s Special Care Unit. E. The description of the Alzheimer’s Special Care Unit shall include: (1) A statement of philosophy or mission; (2) How the services of the unit are different from services provided in the rest of the assisted living program; (3) Staff training and staff job titles, including: (a) A description of a minimum of 6 hours of advanced cognitive impairment training for any staff who is licensed, certified, or registered under Health Occupations Article, Annotated Code of Maryland, or any staff whose job duties include providing personal care on the Alzheimer’s Special Care Unit, including: (i) 2 hours related to effective communication; (ii) 2 hours related to behavioral interventions; and (iii) 2 hours related to making activities meaningful; and (b) The number of hours of dementia-specific training provided annually for all staff by job classification and a summary of training content; (4) Admission procedures, including screening criteria; (5) Assessment and service planning protocol, including criteria to be used that would trigger a reassessment of the resident’s status before the customary 6-month review; (6) Staffing patterns, including: (a) The ratio of direct care staff to resident for a 24-hour cycle; (b) A description of how the staffing pattern differs from that of the rest of the assisted living program; and (c) Use of awake overnight staff on the unit; (7) A description of the physical environment and any unique design features appropriate to support the functioning of cognitively impaired individuals; (8) A description of activities, including frequency and type, how the activities meet the needs of residents with dementia, and how the activities differ from activities for residents in other parts of the assisted living program; (9) The assisted living program’s fee or fee structure for services provided by the Alzheimer’s Special Care Unit; (10) Discharge criteria and procedures; (11) Any services, training, or other procedures that are over and above those that are provided in the existing assisted living program; and (12) Any other information that the Department may require. F. The Department shall restrict admission or close the operation of an Alzheimer’s Special Care Unit if the Department determines that the assisted living program has not demonstrated compliance with this regulation or the health or safety of residents is at risk. #### Regulation .33 Incident Reports. *COMAR 10.07.14.33* A. Staff of the assisted living program shall complete an incident report within 24 hours of having knowledge that an incident, as defined in Regulation .02B(39) of this chapter, occurred. B. The assisted living program shall make incident reports available on the premises to the Department and any government agency designated by the Department. C. All incident reports shall include: (1) Time, date, and place; (2) Individuals present; (3) Complete description of the incident; (4) Response of the staff at the time; and (5) Notification to the: (a) Resident or, if appropriate, the resident representative; (b) Resident’s health care practitioner, if appropriate; (c) Delegating nurse; (d) Licensing or law enforcement authorities, when appropriate; and (e) Follow-up activities, including investigation of the occurrence and steps to prevent its reoccurrence. D. The assisted living program shall notify the OHCQ within 24 hours of a resident death resulting from: (1) Abuse; (2) Neglect; (3) Wandering; (4) Elopement; (5) A medication error; (6) Burns; or (7) Any injury incurred at the assisted living program. #### Regulation .34 Relocation and Discharge. *COMAR 10.07.14.34* A. Relocation within the Facility. (1) The assisted living program may not relocate a resident within the facility except in accordance with the terms and conditions of the resident agreement. (2) An assisted living program shall notify a resident and the resident representative at least 5 calendar days before a nonemergency relocation within the facility and obtain the consent of the resident or resident representative. (3) An assisted living program shall document in the resident’s record how the requirements of this regulation have been met. B. Discharge. (1) Discharge of a resident or transfer to another facility or address without the consent of the resident or the resident representative shall be in accordance with the resident agreement. (2) An assisted living program shall notify a resident or the resident representative within 30 calendar days before a non-emergency discharge. (3) In the event of an emergency, the program shall notify the resident or the resident representative as quickly as possible and document the reason for the emergency and abbreviated notice. C. The assisted living program shall consider the resident’s specific care needs and preferences in developing a safe and appropriate discharge plan. D. When the resident is discharged to another facility, the assisted living program shall provide to the receiving facility any information related to the resident that is necessary to ensure continuity of care and services, including, at a minimum, the: (1) Emergency data sheet; (2) Current medication and treatment orders; (3) Medication administration records; and (4) Most current Resident Assessment Tool. E. When the resident is discharged to home or to a non-facility setting, the assisted living program shall provide the resident and resident representative any information related to the resident that is necessary to ensure continuity of care and services, including, at a minimum, the: (1) Emergency data sheet; (2) Current medication and treatment orders; (3) Medication administration records; and (4) Most current Resident Assessment Tool. F. In the event of a health emergency requiring the transfer to an acute care facility, a copy of an emergency data sheet shall accompany the resident to an acute care facility. This data sheet shall, at a minimum, include: (1) The resident’s full name, date of birth, Social Security number, if known, and insurance information; (2) The name, telephone number, and address of the resident representative; (3) The name and telephone number of the resident’s health care practitioner; (4) The resident’s current documented diagnoses; (5) Current medications prescribed for the resident; (6) The resident’s known allergies to food or medications, if any; (7) The resident’s dietary restrictions, if any; (8) Any relevant information concerning the event that precipitated the emergency; and (9) Appended copies of: (a) Advance directives; (b) Maryland Medical Orders for Life-Sustaining Treatment (MOLST) form; (c) Powers of attorney, if any; and (d) Guardianship orders, if any. G. Within 30 calendar days of the date of discharge, the assisted living program shall: (1) Give each resident or resident agent: (a) A final statement of account; and (b) Any refunds due; and (2) Return any money, property, or valuables held in trust or custody by the assisted living program. H. If requested by a resident, a resident representative, a governmental agency, or, on its own initiative, the Office of the Attorney General may: (1) Investigate whether an abuse of a resident’s funds contributed to the decision to discharge the resident; and (2) Make appropriate referrals of the matter to other government agencies. #### Regulation .35 Resident Representative. *COMAR 10.07.14.35* A. An assisted living program shall recognize the applicable authority of: (1) A guardian of the person under Estates and Trusts Article, §13-705, Annotated Code of Maryland; (2) A guardian of the property under Estates and Trusts Article, §13-201, Annotated Code of Maryland; (3) An advance directive that meets the requirements of Health-General Article, §5-602, Annotated Code of Maryland; (4) A surrogate decision maker with authority under Health-General Article, §5-605, Annotated Code of Maryland; (5) A power of attorney that meets the requirements under Estates and Trusts Article, Title 17, Annotated Code of Maryland; (6) A representative payee or other similar fiduciary; and (7) Any other person, if that person was designated by a resident who was competent at the time of designation, and the resident or representative has provided the assisted living program with documentation of the designation. B. Representative Payee or Other Similar Fiduciary. (1) An assisted living program staff member who serves as a representative payee for a resident may not be considered the resident representative. (2) An assisted living program shall notify the Department if an assisted living program staff member is designated as the representative payee for a resident. C. An assisted living program shall document in the resident’s record the name of the person, if any, with the authority identified in §A of this regulation or include the documentation in the record. D. An assisted living program may not recognize the authority of a resident representative if the representative attempts to exceed the authority: (1) Stated in the instrument that grants the representative authority; or (2) Established by federal or State law. E. An assisted living program who commits financial exploitation of a resident shall be in violation of this chapter as well as applicable civil and criminal laws. #### Regulation .36 Resident’s Rights. *COMAR 10.07.14.36* A. Resident Bill of Rights. (1) An assisted living program shall develop a Resident Bill of Rights that, at a minimum, includes the following rights: (a) Be treated with consideration, respect, and full recognition of the resident’s human dignity and individuality; (b) Receive treatment, care, and services that are adequate, appropriate, and in compliance with relevant State, local, and federal laws and regulations; (c) Receive services and supports that optimize autonomy, independence, and personal choice; (d) Actively participate in planning and developing the resident’s service plan and medical treatment; (e) Choose a pharmacy provider, if the provider can comply with the assisted living programs’ reasonable policies and procedures for patient safety in medication supply and administration; (f) Make an informed decision to accept or refuse treatment; (g) Privacy, including the right to have a staff member knock on the resident’s door before entering unless the staff member knows that the resident is asleep or there is an emergency situation; (h) Be free from mental, verbal, sexual, and physical abuse, neglect, and financial exploitation; (i) Be free from involuntary seclusion and physical and chemical restraint used in violation of this chapter; (j) Confidentiality; (k) Manage personal financial affairs to the extent permitted by law; (l) Retain and have access to legal counsel in a private setting; (m) Attend or not attend religious services as the resident chooses, and receive visits from members of the clergy; (n) Possess and use personal clothing and other personal effects to a reasonable extent, and to have reasonable security for those effects in accordance with the assisted living program’s security policy; (o) Determine dress, hairstyle, or other personal effects according to individual preference, unless the personal hygiene of a resident is compromised; (p) Meet or visit privately with any individual the resident chooses, subject to reasonable restrictions on visiting hours and places: (i) In accordance with the resident agreement; and (ii) As posted by the assisted living manager; (q) Make suggestions or complaints or present grievances on behalf of the resident, or others, to the assisted living manager, government agencies, or other persons without threat or fear of retaliation; (r) Receive a prompt response, through an established complaint or grievance procedure, to any complaints, suggestions, or grievances the resident may have; (s) Have access to the procedures for making complaints to: (i) The Long-Term Care Ombudsman Program of the Department of Aging as set forth in COMAR 32.03.02; (ii) The Adult Protective Services Program of the local department of human services; (iii) The OHCQ of the Department; and (iv) The designated protection and advocacy agency, if applicable; (t) Have access to writing instruments, stationery, and postage; (u) Receive and send correspondence without delay, and without the correspondence being opened, censored, controlled, or restricted, except on request of the resident, or written request of the resident representative; (v) Receive a prompt, reasonable response from an assisted living manager or staff to a personal request of the resident; (w) Receive notice before the resident’s roommate is changed and, to the extent possible, have input into the choice of roommate; (x) Have reasonable access to the private use of a common use telephone within the facility; (y) Retain personal clothing and possessions as space permits with the understanding that the assisted living program may limit the number of personal possessions retained at the facility for the health and safety of other residents; (z) To participate in decision making regarding transitions in care, including a transfer or discharge from a facility; and (aa) To receive notice, procedural fairness, and humane treatment when being transferred or discharged from an assisted living facility. (2) An assisted living program shall: (a) Provide the Resident Bill of Rights to all residents and resident representatives prior to or upon admission; and (b) Either: (i) Post the Resident Bill of Rights in a conspicuous place that is visible to residents, potential residents, and other interested parties; or (ii) Post a notice stating where in the facility the Resident Bill of Rights is located. B. Confidential Information. (1) Any case discussion, disclosure of health information, consultation, examination, or treatment of a resident is: (a) Confidential; (b) To be done discreetly; and (c) Not open to an individual who is not involved directly in the care of the resident, unless the resident or resident representative permits the individual to be present. (2) Except as necessary for the transfer of a resident from the assisted living program to another facility, or as otherwise required by law, the personal and medical records of a resident are confidential and may not be released without the consent of the resident or resident representative to any individual who is: (a) Not associated with the assisted living program; or (b) Associated with the assisted living program, but does not have a demonstrated need for the information. (3) The assisted living manager shall share resident information with the Department as necessary to administer this chapter. C. Work Duties. (1) A resident may not be assigned to do any work for the assisted living program without the resident’s consent and appropriate compensation, unless the resident declines to be compensated. (2) The resident’s work duties shall be described in the resident’s record. (3) The resident’s declining to be compensated shall be documented in the resident’s record. (4) The resident may, at any time, discontinue the work duties without threat or fear of retaliation. D. Adult Medical Day Care. (1) Adult day care attendance or attendance at any other structured program shall be voluntary. (2) Adult medical day care availability and policies shall be disclosed in the assisted living program’s resident agreement. #### Regulation .37 Abuse, Neglect, and Financial Exploitation. *COMAR 10.07.14.37* A. An assisted living program shall develop and implement policies and procedures prohibiting abuse, neglect, and financial exploitation of residents. B. An assisted living program may not knowingly employ an individual who has any criminal conviction or other criminal history that indicates behavior that is potentially harmful to residents, documented through either a criminal history records check or a background check. C. Reports of Abuse, Neglect, or Financial Exploitation. (1) An assisted living program or employee of an assisted living program who has witnessed, or otherwise has reason to believe, that a resident has been subjected to abuse, neglect, or financial exploitation shall report the alleged abuse, neglect, or financial exploitation within 24 hours to the: (a) Appropriate law enforcement agency; (b) Office of Health Care Quality of the Department; (c) Ombudsman within the Department of Aging or local area agency on aging; (d) Local Department of Human Services or Adult Protective Services; and (e) Assisted living manager unless they are believed to be involved with the abuse, neglect, or financial exploitation. (2) An assisted living program or an employee may be subject to a penalty imposed by the Secretary of up to $1,000 for failing to make a report required by §C(1) of this regulation within 3 days after learning of the alleged abuse, neglect, or financial exploitation. (3) A person aggrieved by the action of the Secretary under §C of this regulation may appeal the Secretary’s action by filing a request for a hearing in accordance with Regulation .65 of this chapter. (4) A licensed or certified individual who has knowledge of, but does not report, suspected abuse, neglect, or financial exploitation may be referred to their respective health occupation board. D. Investigations. An assisted living program shall: (1) Thoroughly investigate all allegations of abuse, neglect, or financial exploitation and maintain on-site written documentation of the investigation; and (2) Take appropriate action to prevent further incidents of abuse, neglect, or financial exploitation while the investigation is in progress. E. Investigation Reports. (1) The assisted living program or any government agency that investigates the abuse, neglect, or financial exploitation shall send a report to the: (a) Appropriate law enforcement agency; (b) Office of Health Care Quality of the Department; (c) Ombudsman within the Department of Aging or local area agency on aging; and (d) Local Department of Human Services or Adult Protective Services. (2) The entities set forth in §E(1) of this regulation may make a referral, if appropriate, to: (a) The State’s attorney’s office; or (b) The Medicaid Fraud Control Unit of the Criminal Division of the Office of the Attorney General. F. Immunity from Civil Liability. An individual who, acting in good faith, makes a report under this regulation has immunity from liability as described in Health-General Article, §19-347(g), Annotated Code of Maryland. G. Notice. The assisted living program shall post signs that set forth the reporting requirements of §C(1) of this regulation, conspicuously in the employee and public areas of the facility. #### Regulation .38 Restraints. *COMAR 10.07.14.38* A. The resident has the right to be free of restraints used in violation of this chapter. B. A protective device as defined in Regulation .02B(66) of this chapter is not considered a restraint. C. Improper Use of Chemicals or Drugs. Chemicals or drugs may not be used for residents in the following ways: (1) In excessive dose, including duplicate drug therapy; (2) For excessive duration, without adequate monitoring; (3) Without adequate indications for its use; or (4) In the presence of adverse consequences which indicate the dose should be reduced or discontinued. D. Improper Use of Physical Restraints. Residents may not be physically restrained: (1) For discipline or convenience; or (2) If a restraint is not ordered by a physician to treat the resident’s symptoms or medical conditions. E. Restraint Orders. (1) Any restraint shall be ordered by a physician and shall specify: (a) The purpose of the restraint; (b) The type of restraint to be used; and (c) The length of time the restraint shall be used. (2) A resident may not have an as-needed restraint order. (3) Orders for the use of a restraint shall be time specific. (4) A resident may not remain in a restraint for more than 2 hours without a change in position and toileting opportunity. (5) If an order for the use of a restraint is to be continued, the order shall be renewed at least every 7 calendar days by a physician. (6) The delegating nurse shall provide training to staff in the appropriate use of the restraint ordered by the physician. F. Bed Rails. Bed rails may be considered a restraint depending upon the reason for the use of bed rails and how the bed rails are used. This determination is based upon the resident and the effect that bed rails would have upon the resident, as documented in the resident’s record. G. The program shall notify the resident’s family or the resident representative each time a restraint is used. H. When the resident is under the care of a general hospice care program licensed by the Department and is physically located in an assisted living program licensed by the Department, the general hospice program and the assisted living program shall comply with the requirements of this chapter, COMAR 10.07.21, and federal regulations. #### Regulation .39 Protection of a Resident’s Personal Funds. *COMAR 10.07.14.39* A. A resident may: (1) Manage the resident’s financial affairs; or (2) Consistent with State law, choose any individual who is willing and able to handle the resident’s financial affairs. B. An assisted living program may refuse to handle a resident’s financial affairs. C. An assisted living program may not manage a resident’s funds without an express written request from the: (1) Resident; or (2) Resident agent. D. Management of Personal Funds. On the written authorization of a resident or resident agent, an assisted living program shall hold, safeguard, manage, and account for the resident’s personal funds as specified in this regulation. E. Safeguards Required. (1) Each assisted living program shall develop adequate safeguards to secure the personal funds of a resident that are entrusted to the assisted living program. (2) An assisted living program to which $300 or more of a resident’s personal funds is entrusted shall deposit the money in an interest-bearing bank account. If an assisted living program is entrusted with a resident’s personal funds that are less than $300, the assisted living program may deposit the funds in a bank account. (3) An assisted living program that manages residents’ personal funds, regardless of the amount managed, shall maintain on behalf of the residents: (a) A bond, with the State as obligee, equal to the average monthly balance of all the funds held or managed by the assisted living program for the residents of the facility; (b) A letter of credit, with the State as obligee, equal to the average monthly balance of all the funds held or managed by the assisted living program for the residents of the facility; or (c) Net assets equal to the average monthly balance of all the funds held or managed by the assisted living program for the residents of the facility. (4) The bond, letter of credit, or list of assets shall be kept at the assisted living program for inspection by the Department or its designee. F. Establishment of Resident Accounts. (1) When an assisted living program manages a resident’s financial affairs, the assisted living program shall: (a) Establish and maintain a system that ensures a full, complete, and separate accounting, in accordance with generally accepted accounting principles, of a resident’s personal funds entrusted to the assisted living program; and (b) Keep the accounts of its residents separate from the accounts of the facility. (2) Bank accounts opened for residents’ personal funds by an assisted living program shall have minimal or no fees. (3) Any interest earned on the bank accounts shall accrue to the resident. (4) Any fees charged by the bank for the maintenance of the account shall be paid by the resident. G. Records of Resident Personal Funds. For all resident funds entrusted to an assisted living program, the assisted living program shall: (1) Maintain an individual record for each resident, which includes the following information for each transaction: (a) The date of the transaction; (b) The type of transaction, that is, whether it is a deposit, withdrawal, or any other transaction; and (c) The balance of funds after the completion of the transaction; (2) Make available for inspection by the resident, or, when applicable, the resident agent or resident representative, a statement of the resident’s account; and (3) Make available at the assisted living program, for audit by the Department or its designee, records pertaining to each resident’s personal funds, including the written authorization required by §D of this regulation. H. Fire and Theft Coverage. For all resident funds entrusted to an assisted living program, the assisted living program shall establish and maintain adequate fire and theft coverage to protect a resident’s funds that are on the premises of the assisted living program. I. Availability of Personal Funds. (1) A resident or, if applicable, the resident’s legally authorized representative, has the right to access funds entrusted to the assisted living program: (a) During normal business hours, if the funds are held within the facility; or (b) Within 3 banking days, if a bank, the State, or a county or municipal treasurer holds the money. (2) If an assisted living program transfers or discharges a resident, the assisted living program shall: (a) Request and follow the resident’s written instructions for transferring the resident’s funds; (b) Return, upon the resident’s or, when applicable, the resident agent’s demand, the resident’s money that the assisted living program has in its possession and have the resident or resident agent sign a receipt for the money; or (c) Make available to the resident or the resident agent, within 3 banking days, the resident’s money which is held in an account with a bank, the State, or a county or municipal treasurer. J. Ownership Change. (1) If the ownership of an assisted living program changes, the previous owner, with the approval of each resident, shall give the new owner a certified written audit of all funds that residents have entrusted to the assisted living program. (2) The new owner shall give to the previous owner a signed receipt acknowledging the receipt of the accounts. (3) The new owner shall comply with the safeguard requirements of §E of this regulation. (4) If the resident wants the new owner to hold, safeguard, manage, or account for the residents personal funds, then a new written authorization in compliance with §D of this regulation shall be executed. K. Resident Liability. A resident is not liable for any act or omission of the assisted living program concerning the finances of the assisted living program or the resident. #### Regulation .40 Misuse of Resident’s Funds. *COMAR 10.07.14.40* A. A person may not misappropriate a resident’s assets or income, including spending the resident’s assets or income against or without the consent of the resident or, if the resident is unable to consent, the resident agent. B. An individual who witnessed, or otherwise has reason to believe, that there has been an abuse of a resident’s funds shall make a complaint within 24 hours to the: (1) Appropriate law enforcement agency; (2) Office of Health Care Quality of the Department; (3) Ombudsman within the Department of Aging or local area agency on aging; and (4) Local Department of Human Services or Adult Protective Services. C. The agency that investigates the abuse of a resident’s funds shall send a report to any other agency listed under §B of this regulation that participates in the licensure or subsidizes the care of the resident. Any agency may make a referral to the State’s Attorney’s Office, or to the Medicaid Fraud Control Unit of the Criminal Division of the Office of the Attorney General, if appropriate. #### Regulation .41 Approval of Burial Arrangements for Unclaimed Deceased Residents. *COMAR 10.07.14.41* A. An assisted living program shall ascertain and document on admission of the resident, or within 14 calendar days of admission, any arrangements the resident has made, or wishes to make, with regard to burial, including, but not limited to: (1) Financial; (2) Religious; (3) Name of preferred funeral director, if any; and (4) The name, address, and relationship of any person who has agreed to claim the body of the resident or who has agreed to assume funeral or burial responsibility. B. Notification on Death. On the death of an individual who appears to be an unclaimed deceased resident, the assisted living manager or designee shall contact any person who, although not having been identified in advance as being responsible for the burial arrangements, might nevertheless at the time of death be willing to claim the body and assume responsibility. #### Regulation .42 General Physical Plant Requirements. *COMAR 10.07.14.42* A. The facility and exterior grounds, shall be kept: (1) In good repair; (2) Clean; (3) Free of any object, material, or condition that may create a health hazard, accident, or fire; (4) Free of any object, material, or condition that may create a public nuisance; and (5) Free of insects and rodents. B. Bathtubs, shower stalls, and lavatories may not be used by the staff for laundering or storing soiled linens. C. The assisted living program shall provide in the resident’s room adequate storage space for excess supplies, some personal possessions of residents, and similar items which is: (1) Protected from the elements; and (2) Secure, fixed, and locked in a manner that the resident can access without assistance or with that level of assistance normally required and readily available upon request. D. Residents may possess their own cleaning supplies and personal hygiene items if the assisted living manager and delegating nurse have determined that the products would not present a threat to the safety of the resident or others and this decision is documented in the records. The cleaning supplies and personal hygiene items shall be kept in the resident’s room and out of view of other residents when the materials are not in use. #### Regulation .43 Water Supply. *COMAR 10.07.14.43* A. Approved Source. A facility shall be served by water from an approved public water supply. If an approved public water supply is not available, a private water supply may be accepted if it is approved by the local jurisdiction in which the program is located or a private certified vendor to be submitted with an initial licensure application. B. Adequacy. The water supply shall be adequate in quantity and delivered under sufficient pressure to satisfactorily serve all fixtures in the facility. C. Hot Water Temperature. Hot water accessible to residents shall be blended externally to the hot water generator, by either individual point-of-use control valves of the anti-scald or thermostatic mixing valve type, to a maximum temperature of 120°F and a minimum temperature of 100°F at the fixture. #### Regulation .44 Sewage Disposal. *COMAR 10.07.14.44* The facility shall be served by an approved public sewage disposal system, if available. If an approved public sewage disposal system is not available, a private sewage disposal system may be accepted if approved by the local jurisdiction in which the program is located. #### Regulation .45 Security. *COMAR 10.07.14.45* A. The facility shall provide: (1) Lockable exterior doors and windows; and (2) An effective automated device or system to alert staff to individuals entering or leaving the building. B. A facility need not use an automated alert for an exit door when the exit is staffed by a receptionist or other staff member who views and maintains a log of individuals entering and leaving the facility. #### Regulation .46 Assist Rails. *COMAR 10.07.14.46* A. An assisted living program shall provide assist rails in stairways used by residents and for all toilets, showers, and bathtubs used by residents unless, through a waiver request, the Department determines that the physical abilities of the residents make these devices unnecessary for resident safety. B. An assisted living program with a licensed capacity of 17 or more beds shall also provide assist rails on both sides of corridors used by residents. #### Regulation .47 Emergency Preparedness. *COMAR 10.07.14.47* A. The facility shall comply with: (1) All applicable local fire and building codes; and (2) The National Fire Protection Association (NFPA) 101 Life Safety Code, including Chapter 24 of NFPA 101 if the facility is a one or two family dwelling as defined by NFPA 101. B. Fire Extinguishers. An assisted living program shall: (1) Ensure that fire extinguishers are: (a) Located on each floor and adjacent to, or in, special hazard areas, such as: (i) Furnace rooms; (ii) Boiler rooms; (iii) Kitchens; or (iv) Laundries; (b) Of standard and approved types; (c) Installed and maintained to be conveniently available for use at all times; and (d) Serviced annually, as evidenced by documentation maintained on-site, by an individual or company licensed by the Maryland State Fire Marshall; and (2) Initially and at least annually instruct staff in the use of fire extinguishers. C. Emergency and Disaster Plan. (1) The assisted living program shall develop an Assisted Living Emergency Preparedness Packet in compliance with the requirements of §C(2)—(11) of this regulation, which shall be readily available to all staff. (2) The assisted living program shall develop an emergency and disaster plan that includes procedures that shall be followed before, during, and after an emergency or disaster, including: (a) Evacuation, transportation, or sheltering in-place of residents; (b) Notification of families and staff regarding the action that will be taken concerning the safety and well-being of the residents; (c) Staff coverage, organization, and assignment of responsibilities for ongoing sheltering in-place or evacuation, including identification of staff members available to report to work or remain for extended periods; and (d) The continuity of services, including: (i) Operations, planning, financial, and logistical arrangements; (ii) Procuring essential goods, equipment, and services to sustain operations for at least 72 hours; (iii) Relocation to alternate facilities or other locations; and (iv) Reasonable efforts to continue care. (3) The assisted living program shall have a tracking system to locate and identify residents in the event of displacement, an emergency, or a disaster that includes at a minimum the: (a) Resident’s name; (b) Date and time that the resident was sent to the initial alternative facility or location; (c) Name of the initial alternative facility or location where the resident was sent; and (d) Contact person and phone number for the facility where the resident was sent. (4) When the assisted living program relocates residents, the assisted living program shall send a brief medical fact sheet with each resident that includes at a minimum the resident’s: (a) Name; (b) Medical condition or diagnosis; (c) Medications; (d) Allergies; (e) Special diets or dietary restrictions; and (f) Family or legal representative contact information. (5) The brief medical fact sheet for each resident described in §C(4) of this regulation shall be: (a) Updated upon the occurrence of change in any of the required information; (b) Reviewed at least monthly; and (c) Maintained in a central location readily accessible and available to accompany residents in case of an emergency evacuation. (6) The assisted living program shall review the emergency and disaster plan at least annually and update the plan as necessary. (7) The assisted living program shall: (a) Identify a facility, facilities, or an alternate location or locations that have agreed to house the licensee’s residents during an emergency evacuation; and (b) Document an agreement with each facility or location. (8) The assisted living program shall: (a) Identify a source or sources of transportation that have agreed to safely transport residents during an emergency evacuation; and (b) Document an agreement with each transportation source. (9) Upon request, an assisted living program shall provide a copy of the facility’s emergency and disaster plan to the local emergency management organization for the purpose of coordinating local emergency planning. The assisted living program shall provide the emergency and disaster plan in a format that is mutually agreeable to the local emergency management organization. (10) The assisted living program shall identify an emergency and disaster planning liaison for the facility and shall provide the liaison’s contact information to the local emergency management organization. (11) The assisted living program shall prepare an executive summary of its evacuation procedures to provide to a resident, family member, or legal representative upon request. The executive summary shall, at a minimum: (a) List means of potential transportation to be used in the event of evacuation; (b) List potential alternative facilities or locations to be used in the event of evacuation; (c) Describe means of communication with family members and legal representatives; (d) Describe the role of the resident, family member, or legal representative in the event of an emergency situation; and (e) Notify families that the information provided may change depending upon the nature or scope of the emergency or disaster. D. Evacuation Plans. The facility shall: (1) Conspicuously post individual floor plans with designated evacuation routes on each floor; and (2) Ensure that all staff have access to the entire emergency preparedness plan. E. Orientation and Drills. (1) The assisted living program shall: (a) Orient staff to the emergency and disaster plan and to their individual responsibilities within 24 hours of the commencement of job duties; and (b) Document completion of the orientation in the staff member’s personnel file through the signature of the employee. (2) Fire Drills. (a) The assisted living program shall conduct fire drills at least quarterly on all shifts. (b) Documentation and Retention. The assisted living program shall document and maintain on file for a minimum of 2 years the: (i) Completion date and time of each drill; (ii) Names and signatures of staff who participated in the drill; (iii) Fire scenario used in the drill; (iv) Steps taken by staff during the drill; (v) Successful and non-successful actions taken by staff during the drill; and (vi) Opportunities for improvement identified as a result of the drill. (3) Semiannual Disaster Drill. (a) The assisted living program shall conduct a semiannual emergency and disaster drill on all shifts during which it practices evacuating residents or sheltering in-place so that each is practiced at least one time a year. (b) The drills may be conducted via a table-top exercise if the program can demonstrate that moving residents will be harmful to the residents. (c) The assisted living program shall document and keep on file for a minimum of 2 years the: (i) Completion date and time of each disaster drill or training session; (ii) Names and signature of staff who participated in the drill or training; (iii) Type of disaster utilized for the drill or training; (iv) Type of drill or training undertaken; (v) Steps taken or discussed by staff during the drill or training; (vi) Successful and non-successful actions taken or discussed by staff during the drill or training; and (vii) Opportunities for improvement as identified as a result of the drill. (4) The assisted living program shall cooperate with the local emergency management agency in emergency planning, training, and drills and in the event of an actual emergency. F. Emergency Electrical Power Generator. (1) Generator Required. By October 1, 2009, an assisted living program with 50 or more residents shall have an emergency electrical power generator on the premises, unless the program meets the requirements of §F(7) of this regulation. (2) Generator Specifications. The power source shall be a generating set and prime mover located on the program’s premises with automatic transfer. The emergency generator shall: (a) Be activated immediately when normal electrical service fails to operate; (b) Come to full speed and load acceptance within 10 seconds; and (c) Have the capability of 48 hours of operation of the systems listed in §F(5) of this regulation from fuel stored on-site. (3) Test of Emergency Power System. (a) The program shall test the emergency power system once each month. (b) During testing of the emergency power system, the generator shall be exercised for a minimum of 30 minutes under normal emergency facility connected load. (c) Results of the test shall be recorded in a permanent log book that is maintained for that purpose. (d) The assisted living program shall monitor the fuel level of the emergency generator after each test. (4) The emergency power system shall provide lighting in the following areas of the facility: (a) Areas of egress and protection as required by the State Fire Prevention Code and Life Safety Code 101 as adopted by the State Fire Prevention Commission; (b) Nurses’ station; (c) Medication distribution station or unit dose storage; (d) An area for emergency telephone use; (e) Boiler or mechanical room; (f) Kitchen; (g) Emergency generator location and switch gear location; (h) Elevator, if operable on emergency power; (i) Areas where life support equipment is used; (j) If applicable, common areas or areas of refuge; and (k) If applicable, toilet rooms of common areas or areas of refuge. (5) Emergency electrical power shall be provided for the following: (a) Nurses’ call system; (b) At least one telephone in order to make and receive calls; (c) Fire pump; (d) Well pump; (e) Sewerage pump and sump pump; (f) If required for evacuation purposes, an elevator; (g) If necessary, heating equipment needed to maintain a minimum temperature of 70°F (24°C) in all common areas or areas of refuge; (h) Life support equipment; and (i) Nonflammable medical gas systems. (6) Common Areas or Areas of Refuge. If the emergency power system does not provide heat to all resident rooms and toilet rooms, the program shall provide common areas or areas of refuge for all residents. The areas shall meet the following requirements: (a) The common area or areas of refuge shall maintain a minimum temperature of 70°F (24°C); (b) Heated toilet rooms shall be provided adjacent to the common areas or areas of refuge; and (c) The program facility shall provide to the Department a written plan that defines the: (i) Specified common areas or areas of refuge; (ii) Paths of egress from the common areas or areas of refuge; and (iii) Provision for light, heat, food service, and washing and toileting of residents. (7) Applicability of Emergency Power Requirements. (a) An assisted living program shall be exempt from the requirements of this section if the program can safely transfer residents through an enclosed corridor to a building that is equipped with an electrical power generator that satisfies the requirements of §E of this regulation. (b) An assisted living program may request a waiver from the requirements of this section in accordance with the procedures outlined in COMAR 10.07.14.09 on a year-to-year basis. The program shall demonstrate in the waiver request financial hardship that would create an undue financial burden on the facility and will require the facility to cease operation of the assisted living program. (c) When the Department grants a waiver to an assisted living program for the requirements of this section, the assisted living program shall: (i) Disclose in writing to current and prospective residents that the program does not have an emergency generator; and (ii) Develop a plan to follow in the event of a loss of electrical power. #### Regulation .48 Smoking. *COMAR 10.07.14.48* A. The assisted living program shall have a written smoking policy that indicates whether or not the program permits smoking. B. When smoking is permitted, the assisted living program shall: (1) Establish smoking policies and procedures which are designed to minimize the risk of fire; (2) Provide in the policies and procedures at least the following: (a) Prohibit smoking in any hazardous location and in any room or compartment where flammable liquids, combustible gases, or oxygen are used or stored; (b) Designate smoking areas; and (c) Provide the smoking areas with ash trays of noncombustible material and safe design; (3) Provide smoking areas that comply with all applicable, local, State, and federal regulations; (4) Assess each resident who smokes to determine if assistance or supervision is needed and document the assessment in the resident’s service plan; and (5) At least annually or after a change of condition that may impact a resident’s ability to smoke, reassess a resident who smokes to determine if assistance or supervision is needed and document the reassessment in the resident’s service plan. #### Regulation .49 Common Use Areas. *COMAR 10.07.14.49* A. Multipurpose Space. (1) The assisted living program shall provide at least 35 square feet of usable multipurpose floor space per licensed bed. Multipurpose space includes: (a) Dining; (b) Living; and (c) Indoor recreational space. (2) Usable floor space in a facility does not include: (a) Service areas; (b) Administrative offices; (c) Entrance ways; (d) Closets; (e) Lockers; (f) Wardrobes; (g) Spaces where ceiling heights are less than acceptable for habitable space, as defined by the applicable local building code; or (h) Corridors. (3) The assisted living program may not restrict residents from any area constituting multipurpose space unless a comparable multipurpose space is available for resident use. B. Living Room. (1) The assisted living program shall make at least one living room available for resident use. (2) The assisted living program shall ensure that the living rooms are: (a) Well lit and ventilated; (b) Easily accessible; and (c) Furnished with a sufficient number of reading lamps, tables, chairs, or sofas based on residents’ needs. C. Outdoor Space. An assisted living program shall: (1) Provide or arrange for outside activity space; (2) Adequately light outside activity space during all times residents have access to the space; and (3) Provide the necessary security and supervision of the outside activity space sufficient to meet the needs of the residents. D. Public Toilets. (1) An assisted living program with a licensed capacity of 17 or more beds shall provide public restrooms that are: (a) Sufficient in number, and appropriately located, to serve both residents and visitors; and (b) Located close enough to activity areas to allow all residents to participate comfortably in activities and social opportunities. (2) The public toilet is not calculated in the ratio required by Regulation .50A of this chapter. E. Dining Room. An assisted living program shall provide a well lit, adequately ventilated, and appropriately furnished dining area. F. Kitchen. (1) An assisted living program shall have a kitchen that has adequate: (a) Storage, refrigerator, and freezer space for perishable and nonperishable foods; (b) Food preparation area or areas with cleanable surfaces; (c) Equipment to deliver foods at safe and palatable temperatures; (d) Space and equipment to wash, sanitize, and store utensils; (e) Space to store and clean garbage cans either within or outside the kitchen; (f) Ice-making capabilities; (g) Equipment for the preparation of food, unless all food service is catered; and (h) Equipment for serving and distributing food to residents. (2) An assisted living program with a licensed capacity of 17 or more beds shall comply with the food service facility regulations in COMAR 10.15.03. (3) An assisted living program with fewer than 17 residents is not required to comply with COMAR 10.15.03 unless required to comply by its local jurisdiction or the Department determines and directs that a program shall comply with particular provisions of COMAR 10.15.03 in order to minimize health risks to its residents. (4) An assisted living program with fewer than 17 residents: (a) Shall obtain food from sources that comply with all laws and regulations relating to food, food processing, food handling, and food labeling; (b) Shall protect food from contamination while being stored, prepared, displayed, served, or transported; (c) Shall promptly discard the following: (i) Spoiled food; (ii) Swelled, rusty, or leaky canned foods; and (iii) Food exposed to fire, smoke, or water damage; (d) May not serve to residents home-canned food or food in a hermetically sealed container as defined in COMAR 10.15.03.02B, which was prepared in a place other than a licensed food processing establishment; (e) Shall maintain potentially hazardous food as defined in COMAR 10.15.03.02B at 45°F or below, or 140°F or above, until served to residents; (f) Shall maintain food equipment, appliances, and utensils in a clean and sanitary manner and in good repair; (g) Shall maintain food contact surfaces smooth and free of breaks, open seams, cracks, chips, and pits; (h) Shall maintain floors, walls, and storage areas in a clean and sanitary manner and in good repair; (i) Shall provide refrigeration operated at or below 45°F and equipped with an indicating thermometer graduated at 2°F intervals; and (j) Shall provide freezer space operated at 0°F or less and equipped with an indicating thermometer graduated at 2°F intervals. #### Regulation .50 Resident’s Room and Furnishings. *COMAR 10.07.14.50* A. Resident Room. (1) More than two residents may not share a resident room. (2) An assisted living program shall provide at least 80 square feet of functional space for single occupancy resident rooms and 120 square feet of functional space for double occupancy resident rooms. (3) Functional space in a resident room does not include the floor area of: (a) Toilet rooms and bathing facilities; (b) Closets, wardrobes, bureaus, or lockers; (c) Entrance vestibules; or (d) The arc of any door, excluding closet doors, that opens into the room. (4) A room may not be used as a resident room if: (a) The only access to the room is through a bathroom or other resident room; or (b) In order to move from the room to a living room or dining room a person must first go outdoors. (5) For a program with a licensed capacity of 17 or more beds, a room may not be used as a resident room if in order to move from the room to a living room or dining room, an individual is required to first pass through a kitchen. (6) Resident rooms shall be for the private use of the assigned resident or residents. A resident’s room shall have a latching door and may have a lock on the resident room side of the door at the licensee’s option. (7) If a resident in a double occupancy room requests dividers, curtains, or screens between the beds to ensure privacy, the assisted living program shall furnish them. (8) A resident shall have access to a mirror either in the resident’s room or in the resident’s private bathroom, unless a health care practitioner documents in the resident’s record that access to a mirror would be detrimental to the health of the resident. (9) A resident’s room shall have window shades or their equivalent. (10) The assisted living program shall provide adequate closet or wardrobe space, conveniently located to allow each resident to keep personal clothing. B. Furnishings. Unless a resident brings personal furnishings, or as otherwise specified in the resident agreement, the assisted living program shall provide the following to each resident: (1) A bed, which may not be a rollaway, cot, or folding bed, but shall: (a) Be at least 36 inches wide; (b) Be in good repair; (c) Meet the resident’s medical needs; and (d) Include: (i) A clean mattress sized to fit the bed frame; and (ii) At least two clean pillows; (2) A bedside stand with a drawer; (3) A chair; (4) At least two dresser drawers in a chest of drawers; (5) A bedside or over-the-bed lamp; and (6) A sufficient supply of bath and bed linens. C. A competent resident may waive the resident’s right to one or all of the furnishings listed in §B of this regulation by signing a waiver and having the waiver placed in the resident’s record. D. The assisted living program shall inform a resident of all of the furnishings that the assisted living program provides. The resident may choose, at their cost, to provide a personal bed or other furnishings if they are not hazardous. #### Regulation .51 Bathrooms for Residents. *COMAR 10.07.14.51* A. Toilets. (1) An assisted living program shall provide toilets in a separate room or compartment with latching hardware for privacy. (2) Buildings with one to eight occupants shall have a minimum ratio of one toilet to four occupants. (3) Buildings with nine or more occupants shall have a minimum ratio of one toilet to four occupants and a minimum of one toilet for each floor on which a resident room is located. B. Hand Sinks. (1) Buildings with one to eight occupants shall have a minimum ratio of one hand sink to four occupants. (2) Buildings with nine or more occupants shall have a minimum ratio of one hand sink to four occupants and a minimum of one hand sink for each floor on which a resident room is located. C. Bathtubs or Showers. An assisted living program shall: (1) Provide residents with bathtubs or showers that are enclosed in a separate room or compartment with latching hardware for privacy; and (2) Have a minimum ratio of one bathtub or shower to eight occupants. #### Regulation .52 Illumination. *COMAR 10.07.14.52* A. Resident’s Room. (1) An assisted living program shall ensure that a resident’s room: (a) Is lighted by an outside window that: (i) Contains a glass surface; and (ii) Has square footage at least equal to 10 percent of the room’s required floor area; (b) Has a minimum of 60 watts or the equivalent of artificial light provided for reading; and (c) Is provided with additional artificial light as required for other uses, such as night lights to enable residents to get to the bathroom at night. (2) An assisted living program shall provide additional lighting or watts upon reasonable request by the resident or the resident’s legal representative. B. Common Use Areas. An assisted living program shall ensure that common use areas, such as entrances, hallways, inclines, ramps, cellars, attics, storerooms, kitchens, and laundries, have sufficient artificial lighting to prevent accidents and promote efficient service. C. The assisted living program shall provide sufficient light to meet the resident’s needs. #### Regulation .53 Heating, Ventilation, and Air Conditioning. *COMAR 10.07.14.53* A. An assisted living program may not use space heaters unless approved by the State or local fire authorities. B. Minimum Temperature. The facility shall have a system that provides in areas used by residents a minimum temperature of 70°F in cold weather and a maximum temperature of 80°F in hot weather. C. Temperature Control. (1) An assisted living program with a licensed capacity of one to eight beds shall provide at least one thermostat per building. (2) An assisted living program with a licensed capacity of nine or more beds shall provide for each resident’s room: (a) A thermostat; or (b) An approved mechanical device for modulating a room’s temperature, such as adjustable vanes in a hot air vent. D. An assisted living program shall: (1) Ensure that all rooms and areas have sufficient ventilation to prevent excessive heat, steam, condensation, smoke, and other noxious odors; and (2) Provide forced mechanical exhaust ventilation or an approved equivalent for: (a) All bathing compartments; (b) Toilet rooms; (c) Any area used for toileting; (d) Soiled utility rooms; (e) Designated smoking rooms; and (f) Other rooms, as determined by the Department. #### Regulation .54 Radiators. *COMAR 10.07.14.54* A. If steam or hot water plumbing reaches a temperature in excess of 130°F or directly powered radiating surfaces are located in areas of the facility that are accessible to residents, the assisted living program shall position or shield the radiating surfaces in a manner to prevent resident contact. B. The assisted living program shall ensure that the radiator shielding device: (1) Allows for efficient heat transfer; (2) Is constructed to minimize vermin harborage; (3) Is constructed of easily cleanable materials; and (4) Complies with all State and local fire codes. #### Regulation .55 Laundry. *COMAR 10.07.14.55* A. An assisted living program shall furnish laundry service, either on-site or off-site. B. An assisted living program shall ensure that the laundry is: (1) Adequate to meet the needs of the residents; (2) Processed and handled in a manner to prevent the spread of infection; and (3) Adequately sanitized by the use of sufficient hot water or appropriate chemical agents, or a combination of both. C. Unless otherwise agreed by the program and the resident, dry cleaning services are not considered part of required laundry services in this chapter. #### Regulation .56 Telephones. *COMAR 10.07.14.56* A. An assisted living program with a licensed capacity of one to eight beds shall provide: (1) At least one common-use telephone for residents; and (2) A posting next to the common-use telephone or in a conspicuous location that contains the telephone numbers for the local police department and fire department. B. An assisted living program with a licensed capacity of nine to 16 beds shall provide at least one common-use telephone. If there are nine or more residents that do not have private telephones in their own rooms, the assisted living program shall provide a second common-use telephone. C. An assisted living program with a licensed capacity of 17 or more beds shall provide: (1) That each resident’s room accommodates the use of the resident’s own private telephone; and (2) An adequate number of common-use telephones to accommodate those residents who do not have private telephones installed in their rooms. #### Regulation .57 Sanctions. *COMAR 10.07.14.57* A. If the Secretary determines that an assisted living program has violated this chapter, the Secretary, in addition to the sanctions set forth in this chapter, may impose one or more of the following: (1) Restrict the number of residents the assisted living program may admit in accordance with Health-General Article, §19-328, Annotated Code of Maryland; (2) Require the assisted living program to reduce the number of residents in care; (3) Restrict the levels of care for which the assisted living program may provide services; (4) Require the assisted living program, and any of its staff, to receive remedial instruction in a specific area; (5) Require the assisted living program to use the services of and cover the costs of a management firm approved by the Department; (6) Require the assisted living program to use the services of and cover the costs of a consultant to provide expertise related to: (a) One or more licensure requirements; (b) Standards of care; or (c) Discharge planning. (7) Mandate staffing patterns which specify number of personnel, personnel qualifications, or both; (8) Require the establishment of an escrow account in accordance with Health-General Article, §19-362, Annotated Code of Maryland; (9) Direct the assisted living program to correct the violations in a specific manner or within a specified time frame, or both; (10) Notify, or require the assisted living program to notify, the representative or family of any resident who is affected by the noncompliance; (11) Increase the frequency of monitoring visits during a specified period of time; or (12) Enter into an agreement with the assisted living program establishing certain conditions for continued operation, including time limits for compliance. B. If the Secretary determines that the assisted living program has violated a condition or requirement of an imposed sanction, the Secretary may suspend or revoke the license. C. Appeals. (1) An assisted living program aggrieved by the imposition of a sanction under §A(1), (2), or (3) or B of this regulation may appeal the Secretary’s action by filing a request for a hearing in accordance with Regulation .65 of this chapter. (2) An assisted living program aggrieved by the imposition of a sanction under §A(8) of this regulation may appeal the Secretary’s action in accordance with Health-General Article, §§19-364 and 19-367, Annotated Code of Maryland. (3) This section does not, however, create an appeal for a decision made under Regulation .23A of this chapter. #### Regulation .58 Civil Money Penalties. *COMAR 10.07.14.58* A. The Secretary may impose a civil money penalty on a person if: (1) The person maintains or operates an unlicensed assisted living program; (2) A deficiency or an ongoing pattern of deficiencies exists in the assisted living program; or (3) The person falsely advertises a program in violation of Regulation .06B(2) of this chapter. B. In determining whether a civil money penalty is to be imposed, the Secretary shall consider the following factors: (1) Nature, number, and seriousness of the deficiencies; (2) The extent to which the deficiency or deficiencies are part of an ongoing pattern during the preceding 24 months; (3) The degree of risk to the health, life, or safety of the residents of the program that is caused by the deficiency or deficiencies; (4) The efforts made by, and the ability of the program to correct, the deficiency or deficiencies; and (5) An assisted living program’s prior history of compliance. C. If the Department determines that a deficiency or an ongoing pattern of deficiencies exists, the Department shall notify the program of the deficiency or deficiencies and may: (1) Impose a per day civil money penalty until sustained compliance has been achieved; (2) Permit the program the opportunity to correct the deficiencies by a specific date; or (3) Impose a per instance civil money penalty for each instance of violation. D. If the Department permits a program the opportunity to correct the deficiencies by a specific date, and the program fails to comply with this requirement, the Department may impose a per day civil money penalty for each day of violation until correction of the deficiency or deficiencies has been verified and sustained compliance has been maintained. E. If the Department proposes to impose a civil money penalty, the Secretary shall issue an order which shall state the: (1) Deficiency or deficiencies on which the order is based; (2) Amount of civil money penalties to be imposed; and (3) Manner in which the amount of civil money penalties imposed was calculated. F. A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary’s action by filing a request for a hearing in accordance with Regulation .65 of this chapter. #### Regulation .59 Amount of Civil Money Penalties. *COMAR 10.07.14.59* A. A civil money penalty imposed on a person under this chapter may not exceed the amounts identified in Health-General §19-1809, Annotated Code of Maryland. B. In setting the amount of the civil money penalty under this chapter, the Secretary shall consider the following factors: (1) Nature, number, and seriousness of the deficiencies; (2) The degree of risk to the health, life, or safety of the residents of the program that is caused by the deficiency or deficiencies; (3) The efforts made by, and the ability of, the program to correct the deficiency or deficiencies; (4) Whether the amount of the civil money penalty will jeopardize the financial ability of the program to continue operation as a program; and (5) Other factors as justice may require. C. A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary’s action by filing a request for a hearing in accordance with Regulation .65 of this chapter. #### Regulation .60 Criminal Money Penalties — Hearings. *COMAR 10.07.14.60* A. A hearing on the appeal shall be held consistent with the State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland. B. The Secretary shall have the burden of proof with respect to the imposition of the civil money penalties under this chapter. #### Regulation .61 Criminal Penalties. *COMAR 10.07.14.61* A. Operating Without a License. (1) A person may not knowingly and willfully operate, maintain, or own an assisted living program without a license. (2) A person who violates §A(1) of this regulation is guilty of a felony and on conviction is subject to: (a) For a first offense, a fine not exceeding $10,000, imprisonment not exceeding 5 years, or both; and (b) For a subsequent offense, a fine not exceeding $20,000, imprisonment not exceeding 5 years, or both. (3) If the Department finds a credible allegation that an assisted living program is operating without a license, the Department, or the Office of Health Care Quality, shall investigate whether residents in the assisted living program have been subjected to neglect, abuse, or financial exploitation. (4) On receipt of a credible allegation, or after an investigation that results in a finding that residents in an unlicensed assisted living program have been subjected to neglect, abuse, or financial exploitation, the person operating the unlicensed program shall be subject to immediate prosecution under §A(2) of this regulation. (5) If the person operating an unlicensed assisted living program fails or refuses to cooperate fully in an investigation by the Department, or the Office of Health Care Quality, conducted under §A(3) of this regulation, the person operating the unlicensed assisted living program shall be subject to immediate prosecution under §A(2) of this regulation. (6) If the Department finds, after an investigation conducted under §A(3) of this regulation, that there is no reason to believe that residents in the assisted living program operating without a license have been subject to financial exploitation, neglect, or abuse: (a) The Department shall provide written notice to the unlicensed assisted living program that the program shall come into compliance with licensure requirements within 30 days after receipt of the written notification; and (b) The person operating the program may not be subject to prosecution under §A(2) of this regulation if the person: (i) Has promptly and in good faith submitted a complete application to the Department for an assisted living program license; (ii) Is awaiting a decision from the Department regarding the application; and (iii) Has not been denied an assisted living program license on a prior occasion. (7) In recommending the amount of the criminal penalty under §A(2) of this regulation, the State shall consider factors including the nature, number, and seriousness of the violations. (8) The Department, the Attorney General, a State’s Attorney, or a local health officer may petition a circuit court for injunctive relief against the operation of an assisted living program operating without a license. (9) A violation of §A(1) of this regulation shall be a violation of the Consumer Protection Act. B. Advertisement and Representation of an Assisted Living Program. (1) A person may not advertise, represent, or imply to the public that an assisted living program is authorized to provide a service that the program is not licensed, certified, or otherwise authorized by the Department to provide when the license, certificate, or authorization is required under this subtitle. (2) A person may not advertise an assisted living program in a misleading or fraudulent manner. (3) A person who violates §B(1) of this regulation is subject to a civil money penalty imposed by the Secretary not exceeding $10,000 for each offense. (4) In setting the amount of a civil money penalty on the program under §B(1) of this regulation, the Secretary shall consider factors including the nature, number, and seriousness of the violations and the ability of the assisted living program to pay the penalty. C. Referral to an Assisted Living Program Operating Without a License. (1) A person may not willfully and knowingly refer another person to an assisted living program that is operating without a license. (2) A person who violates §C(1) of this regulation is subject to the following civil penalties: (a) For a first offense, a civil penalty not exceeding $1,000; (b) For a second offense, a civil penalty not exceeding $2,000; or (c) For a third or subsequent offense, a civil penalty not exceeding $3,000. (3) The Secretary shall remit all civil penalties collected under this regulation to the Office of Health Care Quality for the purposes of carrying out the provisions of Health-General Article, §19–1813, Annotated Code of Maryland. #### Regulation .62 Health Care Quality Account. *COMAR 10.07.14.62* A. The Department shall establish a health care quality account in the Department for assisted living programs. B. The health care quality account shall be funded by civil money penalties paid by assisted living programs. C. The Department shall use funds from the health care quality account to improve the quality of care in assisted living programs. D. Expenditure of funds may include, but is not limited to, the following: (1) Funding for the establishment and operation of a demonstration project; (2) A grant award; (3) Relocation of residents in crisis situations; (4) Provision of educational programs to assisted living programs, the Office of Health Care Quality, other government, professional, or advocacy agencies, and consumers; and (5) Any other purpose that will directly improve quality of care. E. Suggestions for the use of funds may be submitted to the Department from: (1) Members of the public; (2) Advocacy organizations; (3) Government agencies; (4) Professional organizations, including trade associations; (5) Assisted living programs; and (6) Assisted living associations. F. Decision on Expenditure of Funds. (1) The Department, in its sole discretion, shall decide how to spend funds from the health care quality account. (2) The Department’s decision to spend funds or not to spend funds for a specific project or purpose is not a contested case as defined in State Government Article, §10-202(d), Annotated Code of Maryland, and therefore may not be appealed. #### Regulation .63 Emergency Suspension. *COMAR 10.07.14.63* A. The Secretary may immediately suspend a license on finding that the public health, safety, or welfare imperatively requires emergency action. B. The Department shall deliver a written notice to the assisted living program: (1) Informing the program of the emergency suspension; (2) Giving the reasons for the action and the regulation or regulations with which the assisted living program has failed to comply that forms the basis for the emergency suspension; and (3) Notifying the assisted living program of its right to request a hearing and to be represented by counsel. C. The filing of a hearing request does not stay the emergency action. D. When a license is suspended by emergency action: (1) The assisted living program shall immediately cease the use of all previously issued assisted living program licenses and return all paper licenses to the Department; (2) The assisted living program shall stop providing assisted living services immediately; (3) The assisted living manager or their designee shall notify the residents and resident representatives of the suspension and make every reasonable effort to assist them in making safe and appropriate discharge plans, including to other licensed assisted living programs; and (4) The OHCQ shall immediately notify the following entities of the emergency action: (a) Ombudsman within the Department of Aging or local area agency on aging; and (b) Local Department of Human Services or Adult Protective Services. E. In the event of an emergency suspension, the Department may assist in the relocation of residents. F. A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary’s action by filing a request for a hearing consistent with Regulation .65 of this chapter. G. Show Cause Hearing. (1) In addition to the right to request a hearing consistent with Regulation .65 of this chapter, a person aggrieved by the action of the Secretary under this regulation shall be provided with the opportunity for a hearing to show cause why the Department should lift the summary suspension. (2) If requested in writing, the show cause hearing shall be held promptly within a reasonable time after the effective date of the order of summary suspension. The time limit for filing an appeal with the Office of Administrative Hearings to obtain an evidentiary hearing shall be followed by the filing of a request for a show cause hearing. (3) The show cause hearing shall be a nonevidentiary hearing to provide the parties with an opportunity for oral argument on the summary suspension. (4) The show cause hearing shall be conducted before the Secretary or a designee of the Secretary, who: (a) Shall determine procedural issues; (b) May impose reasonable time limits on each party’s oral argument; and (c) Shall make rulings reasonably necessary to facilitate the effective and efficient operation of the show cause hearing. (5) At the conclusion of the show cause hearing, the Secretary or the Secretary’s designee may: (a) Affirm the order of summary suspension; (b) Rescind the order of summary suspension; (c) Enter into a consent order; or (d) Enter into an interim order warranted by the circumstances of the case, including one providing for a stay of the summary suspension subject to certain conditions. (6) After the show cause hearing, if the Secretary or the Secretary’s designee decides to continue the summary suspension, the person aggrieved by the decision may request an evidentiary hearing before the Office of Administrative Hearings consistent with Regulation .65 of this chapter. H. Hearing. (1) The Office of Administrative Hearings shall conduct a hearing as provided in Regulation .65 of this chapter and issue a proposed decision within the time frames set forth in COMAR 28.02.01. (2) An aggrieved person may file exceptions pursuant to COMAR 10.01.03. (3) The Secretary shall make a final decision pursuant to COMAR 10.01.03. (4) If the Secretary’s final decision does not uphold the emergency suspension, the assisted living program may resume operation. #### Regulation .64 Revocation of License. *COMAR 10.07.14.64* A. The Secretary, for cause shown, may notify the assisted living program of the Secretary’s decision to revoke the assisted living program’s license. The revocation shall be stayed if a hearing is requested. B. The Department shall notify the assisted living program in writing of the following: (1) The effective date of the revocation; (2) The reason for the revocation; (3) The regulations with which the assisted living program has failed to comply that form the basis for the revocation; (4) That the assisted living program is entitled to a hearing, if requested, and to be represented by counsel; (5) That the assisted living program shall stop providing services on the effective date of the revocation if the assisted living program does not request a hearing; (6) That the revocation shall be stayed if a hearing is requested; and (7) That the assisted living program is required to surrender its license to the Department if the revocation is upheld. C. The assisted living manager or their designee shall: (1) Notify the residents and residents’ representatives of the revocation; (2) Make every reasonable effort to assist residents and resident representatives in making safe and appropriate discharge plans, including to other licensed assisted living programs; and (3) Immediately notify the following entities of the revocation: (a) Ombudsman within the Department of Aging or local area agency on aging; and (b) Local Department of Human Services or Adult Protective Services. D. OHCQ shall notify the following entities of the revocation: (a) Ombudsman within the Department of Aging or local area agency on aging; and (b) Local Department of Human Services or Adult Protective Services. E. The Department may assist in the relocation of residents or require the assisted living program to use the services of and cover the costs of a consultant to arrange safe and appropriate discharges for residents. F. A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary’s action by filing a request for a hearing in accordance with Regulation .65 of this chapter. #### Regulation .65 Hearings. *COMAR 10.07.14.65* A. A request for a hearing shall be filed with the Office of Administrative Hearings, with a copy to the Office of Health Care Quality of the Department, not later than 30 days after receipt of notice of the Secretary’s action. The request shall include a copy of the Secretary’s action. B. A hearing requested under this chapter shall be conducted in accordance with State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, and COMAR 10.01.03 and 28.02.01. C. The burden of proof is as provided in COMAR 10.01.03.28. D. Unless otherwise stated in this chapter, the Office of Administrative Hearings shall issue a proposed decision within the time frames set forth in COMAR 28.02.01. E. The aggrieved person may file exceptions as provided in COMAR 10.01.03.18. F. A final decision by the Secretary shall be issued in accordance with COMAR 10.01.03.18J. ### Chapter 15 — Application for Hospitals and Related Institutions **Authority:** Health-General Article, §§19-320 and 19-323, Annotated Code of Maryland **Administrative History:** Effective date: August 29, 1983 (10:17 Md. R. 1521) **Administrative History:** Regulation .01 amended effective February 12, 2007 (34:3 Md. R. 297) **Administrative History:** Regulation .01B amended effective January 20, 2014 (41:1 Md. R. 13) **Administrative History:** Regulation .02 amended effective February 12, 2007 (34:3 Md. R. 297); August 29, 2016 (43:17 Md. R. 953) **Administrative History:** Regulation .03 repealed effective August 29, 2016 (43:17 Md. R. 953) **Administrative History:** Regulation .03A amended effective December 20, 1993 (20:25 Md. R. 1947); February 12, 2007 (34:3 Md. R. 297); January 20, 2014 (41:1 Md. R. 13) #### Regulation .01 Definitions. *COMAR 10.07.15.01* A. In this chapter, the following terms have the meaning indicated. B. Terms Defined. (1) “Department” means the Maryland Department of Health. (2) “Health care facility within a correctional institution” means a specified area within the correctional institution in which general and clinical health care services are provided to inmates in the custody of the Division of Corrections. (3) “Intermediate care facility for Individuals with Intellectual Disabilities or persons with related conditions (ICF/IID)” means a facility which provides residential care, treatment, or custody for the intellectually disabled. (4) “Person” means an individual, receiver, trustee, guardian, personal representative, fiduciary, or representative of any kind and any partnership, firm, association, corporation, or other entity. (5) Related Institution. (a) “Related institution” means an organized institution, environment, or home that: (i) Maintains conditions or facilities and equipment to provide domiciliary, personal, or nursing care for two or more unrelated individuals who are dependent on the administrator, operator, or proprietor for nursing care or the subsistence of daily living in a safe, sanitary, and healthful environment; and (ii) Admits or retains the individual for overnight care. (b) “Related institution” does not include: (i) An adult residential environment or home that is certified by the Department of Human Services; (ii) A nursing facility or visiting nurse service that is conducted only by or for adherents of a recognized church or religious denomination, in accordance with tenets and practices that include reliance on treatment by spiritual means alone for healing; or (iii) Any sheltered housing for the elderly, as defined in Article 70B, §1, Annotated Code of Maryland, that is certified by the Department of Aging, unless the housing provides for more than 11 individuals in one building that does not have more than one apartment unit, or if there are apartment units in the building, in one apartment unit. (6) “Residential treatment center for emotionally disturbed children and adolescents” means a facility which houses two or more non-related children or adolescents referred for treatment upon the recommendation of a physician. The overall program must be approved by the Maryland Department of Health, the Department of Human Services, and the State Department of Education. (7) “Secretary” means the Secretary of Health. #### Regulation .02 Application Requirements. *COMAR 10.07.15.02* A. Any person desiring to open a related institution or to continue the operation of a related institution shall file an application with the Secretary, on a form provided by the Secretary. B. Applications on behalf of a corporation, association, or governmental unit or agency shall be made by two officers of the corporation, association, or governmental unit or agency and names of their board members shall be submitted. C. Ownership of property, real estate, and equipment shall be disclosed if it is other than the licensee’s. D. The names of persons holding 2 percent or more of the stock or assets shall be disclosed. #### Regulation .03 Fee Assessment — Repealed. *COMAR 10.07.15.03* ### Chapter 16 — Limited Private Inpatient Facilities **Authority:** Health-General Article, §§10-501—10-511, Annotated Code of Maryland **Administrative History:** Effective date: December 10, 2015 (42:24 Md. R. 1504) **Administrative History:** Regulation .05B,G,I amended effective March 13, 2017 (44:5 Md. R. 292) **Administrative History:** Regulation .23 adopted effective December 19, 2016 (43:25 Md. R. 1384) #### Regulation .01 Scope. *COMAR 10.07.16.01* The purpose of this chapter is to: A. Outline the licensing, site, and staffing requirements for a provider of limited private inpatient facility services; and B. Provide a flexible model of service delivery and oversight. #### Regulation .02 Definitions. *COMAR 10.07.16.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) "Administration” means the Behavioral Health Administration. (2) “Department” means the Maryland Department of Health or its designee. (3) “Facility” means a limited private inpatient facility. (4) “Facility service plan” means a statement of the facility’s mission, vision, scope, and purpose, as well as all specific requirements detailed under Regulation .10 of this chapter. (5) “Individual treatment plan” means the plan prepared according to the requirements outlined in: (a) Health-General Article, §10-706, Annotated Code of Maryland; and (b) COMAR 10.21.03. (6) “Joint Commission” means a voluntary national healthcare accreditation service recognized for Medicare certification purposes by Public Law 89-97 and for Maryland State licensure purposes by Health-General Article, §19-2302, Annotated Code of Maryland. (7) “License” means a license issued by the Department to operate a limited private inpatient facility in this State. (8) “Licensed nurse” means a practical nurse or registered nurse licensed by the Board of Nursing under the provisions of Health Occupations Article, Title 8, Annotated Code of Maryland. (9) Limited Private Inpatient Facility. (a) “Limited private inpatient facility” means a private inpatient treatment facility that provides mental health evaluation and treatment to adults 24 hours per day. (b) “Limited private inpatient facility” does not include: (i) A facility licensed to provide mental health services under authority of a statute other than Health-General Article, §§10-501—10-511, Annotated Code of Maryland; or (ii) A facility that bills for reimbursement under the Medical Assistance Program. (10) “Mental health professional” means an individual who is licensed, certified, or otherwise legally authorized to provide the mental health service: (a) Under Health Occupations Article, Annotated Code of Maryland; or (b) In the state where the service is rendered. (11) “Secretary” means the Secretary of Health. (12) Usable Square Feet. (a) “Usable square feet” means physical space that is available for resident use. (b) “Usable square feet” does not include: (i) Service areas; (ii) Administrative offices; (iii) Entrance ways including the space where a door swings open; (iv) Closets, lockers, and wardrobes; (v) Spaces where ceiling heights are less than acceptable for habitable space, as defined by the applicable local building code; or (vi) Corridors. #### Regulation .03 Incorporation by Reference. *COMAR 10.07.16.03* A. In this chapter, the following is incorporated by reference. B. Document Incorporated. “Standards for Behavioral Health Care, 2013 Edition, The Joint Commission, One Renaissance Blvd., Oakbrook Terrace, Illinois 60181”. #### Regulation .04 Eligibility. *COMAR 10.07.16.04* A. An individual is eligible for limited private inpatient facility services if the individual: (1) Requires 24-hour inpatient mental health evaluation and treatment services but does not require acute or long-term psychiatric hospital services; and (2) Has stated a willingness to comply with program rules. B. An individual is not eligible for limited private inpatient facility services if the individual: (1) Has a sole diagnosis of substance abuse, intellectual disability, or dementia; (2) Is in need of immediate involuntary inpatient psychiatric admission; (3) Is medically unstable as determined by an individual authorized under Health Occupations Article, Annotated Code of Maryland, to make medical determinations; or (4) Does not meet the eligibility criteria under §A of this regulation. #### Regulation .05 Licensure Process. *COMAR 10.07.16.05* A. An applicant shall obtain a license from the Department before providing services. B. Initial and Renewal Licensure. In order to be licensed as a limited private inpatient facility, the facility shall: (1) File an initial application with the Department that: (a) Is on the written or electronic form approved by the Department with the requirement that all questions are answered and all required documents are attached; and (b) Includes documentation of: (i) Fire, liability, and hazard insurance coverage on the building in which the facility is located; (ii) Compliance with relevant federal, State, or local ordinances, laws, regulations, and orders, including zoning and safety; and (iii) Accreditation as a limited private inpatient facility or comparable facility by the Joint Commission under its Standards for Behavioral Health Care; (2) Be subject to: (a) An initial survey to determine compliance with all appropriate statutes or regulations related to zoning, construction, fire safety, food service, and any other applicable codes; and (b) The investigation of complaints and incidents by the Department; (3) Submit a facility service plan as required by Regulation .10 of this chapter; and (4) Submit all required fees for licensure as specified in §I of this regulation. C. An application filed on behalf of a corporation, association, or governmental unit or agency shall: (1) Be made by two officers of the corporation, association, or governmental unit or agency; and (2) Include the: (a) Names of all Board members; (b) Names of persons holding 2 percent or more of the stock or assets; and (c) Ownership of property, real estate, and equipment, if other than the licensee’s. D. Display of License. The facility shall visibly post the facility’s license in a public area in the facility. E. The facility shall immediately notify the Department in writing of any change in the information the licensee had submitted with the most recent application, including the program service plan. F. To ensure the completion of any review or inspection by the Department of any major renovations, any construction of resident care areas, or the establishment of a medical service as defined under Health-General Article, §19-120, Annotated Code of Maryland, that has not previously been provided by the facility, the facility shall notify the Department 60 days before the facility begins to accept occupancy or begins operation. G. Renewal of License. (1) An application on the written or electronic form provided by the Department for the renewal of the license shall be made by an accredited facility within 30 calendar days of the exit date of the triennial survey conducted by the Joint Commission. (2) The Department shall grant a renewal license to an applicant to operate if the applicant submits: (a) A completed application for license renewal with the required fees as specified by the Joint Commission; (b) A copy of the triennial survey report; (c) A copy of the corrective actions taken for standards not met; and (d) A copy of the certificate for accreditation by the Joint Commission. H. Loss of Accreditation. (1) In the event of the loss of accreditation and the conclusion of all appeals to the Joint Commission, the facility may continue to be licensed only until the facility promptly arranges for the safe discharge of each resident to another facility or to appropriate outpatient services. The facility shall cease operation upon the discharge of all residents. (2) When performing surveys, whether based on loss of accreditation, complaints received, or incidents reported, the Department shall determine compliance or noncompliance based on: (a) Applicable State and federal law; and (b) The Standards for Behavioral Health Care. I. License Fees. (1) A facility shall submit a written or electronic application on a form approved by the Department along with the fee established in this regulation. (2) A facility that has filed an application for accreditation that meets the requirements for a provisional license shall: (a) Submit a $500 nonrefundable license fee payable to the Department; and (b) On receiving accreditation, pay an additional $1,500 nonrefundable license fee per accreditation period of 3 years, payable to the Department. (3) A facility shall submit a $1,500 nonrefundable license fee per accreditation period of 3 years, payable to the Department. J. Provisional License. (1) A facility that submits documentation showing the facility has applied to the Joint Commission for accreditation but has not yet been accredited at the time of application but otherwise meets the requirements for licensure shall be issued a provisional license. (2) The provisional license shall be issued for a period of not greater than 1 year from issuance. (3) A facility issued a provisional license shall be subject to subsequent surveys by the Department to determine compliance with this chapter and applicable standards of the Joint Commission until accreditation is awarded. (4) If the Joint Commission denies accreditation to a facility before the expiration of the provisional license, the facility shall cease operations upon the prompt and safe discharge of all residents. #### Regulation .06 Duration of License. *COMAR 10.07.16.06* A. The Secretary shall issue a license to an accredited facility for the term of the facility's accreditation. B. The Secretary shall issue a provisional license to a non-accredited facility that otherwise meets the requirements for licensure for a term not to exceed 1 year with the requirement that the facility shall become accredited within that 1-year period or cease operations. #### Regulation .07 Separate License Required. *COMAR 10.07.16.07* A. A separate license is required for facilities maintained on separate premises, even if both facilities are operated under the same management. B. A separate license is not required for separate buildings on the same grounds. #### Regulation .08 Inspections. *COMAR 10.07.16.08* A. A facility shall be open to inspection by the Department at all times for the purpose of quality oversight and investigation of complaints or incidents. B. The facility’s administrative and medical records shall be available for review and for copying by the Department. C. New Facilities. (1) A facility that is issued a provisional license shall be subject to inspections by the Department every 6 months and at any other time to determine compliance with: (a) This chapter; and (b) The Standards for Behavioral Health Care. (2) If the facility has not attained accreditation by the Joint Commission within 1 year after beginning operations or has had its application for accreditation rejected, the facility shall: (a) Cease operations; and (b) Be subject to inspection to insure that all residents are receiving care and treatment in accordance with their needs as a safe discharge is arranged. D. A facility shall be open to inspection by the Department to follow up on the findings identified in the accreditation report of the Joint Commission. #### Regulation .09 Complaint Investigations. *COMAR 10.07.16.09* A. To resolve expeditiously a complaint that alleges the existence of any non-life-threatening deficiency: (1) The Department shall refer the complaint directly to the facility; and (2) The facility shall: (a) Conduct an internal investigation into the complaint; and (b) Submit the investigation and supportive evidence to the Department within 30 days of the receipt of the complaint. B. If the Department determines that the facility has not satisfactorily addressed the referred complaint or if the complaint alleges the existence of a serious or life-threatening deficiency, the Department shall conduct an independent investigation using the standards: (1) Of the Joint Commission; or (2) Adopted by the Secretary under this subtitle. C. Issues relating to the practice of medicine or the licensure or conduct of a health professional shall be referred to the: (1) Facility; and (2) Appropriate licensure board for resolution. #### Regulation .10 Facility Service Plan. *COMAR 10.07.16.10* A. The limited private inpatient facility shall provide services in accordance with the facility service plan submitted to and approved by the Department. B. A written facility service plan shall include at a minimum: (1) The rationale for the facility including discussion of the organization’s mission, vision, and philosophy for provision of services; (2) The range of services that the facility will provide; (3) The populations to be served, including age groups and other relevant characteristics, and the number of individuals that the program expects to serve; (4) The composition of the facility's governing body, board of directors, or advisory committee, whichever applies; (5) A description of staff or care providers necessary to provide the planned services and any necessary training requirements; (6) The facility’s goals, objectives, and expected outcomes; and (7) A detailed scope or description of services offered. C. The administrative head of the licensee shall assure that the facility service plan is reviewed by its governing body and updated at least every 3 years. D. If the licensee makes any changes to its facility service plan, the licensee shall submit its revised facility service plan for the Department’s approval before implementation of the changes. #### Regulation .11 Staffing. *COMAR 10.07.16.11* A. Required Staff. The facility director shall ensure that the facility’s staff is sufficient in numbers and qualifications to provide clinically appropriate services to the individuals served and includes, at a minimum: (1) A facility director that is responsible for the programmatic and administrative services of the facility under the direction of the governing body; (2) A clinical director who: (a) Is a psychiatrist or psychologist who receives medical supervision by a psychiatrist; and (b) Has overall responsibility for clinical services, including, at a minimum: (i) Establishing and maintaining appropriate standards for diagnosis and treatment, including therapeutic modalities and prescribing practices; (ii) Medical aspects of quality management; and (iii) Ensuring adequate clinical supervision of treatment staff; (3) A multidisciplinary licensed mental health professional staff that: (a) Provides evaluation and treatment services; and (b) Is in addition to the limited private inpatient facility psychiatrist; (4) A licensed nurse to provide for medication management, treatments, and other health care needs; (5) Other direct care employees to provide for the treatment and monitoring of residents as required by the resident’s individual treatment plan; (6) A physician to provide somatic medical services as required by the clients; and (7) Maintenance and housekeeping staff who are trained and qualified to provide a well-maintained, safe, and sanitary environment for residents served by the program. B. Staff Training. Before providing services to residents, staff shall receive orientation and annual training as designated by the facility service plan including, at a minimum, training in: (1) Crisis intervention and de-escalation techniques; (2) Suicide prevention, including but not limited to identification of warning signs and symptoms; (3) The facility’s disaster and fire safety plan; (4) First aid, CPR, and emergency medical procedures; and (5) Individual rights, as set forth in Health-General Article, Title 10, Subtitle 7, Annotated Code of Maryland. #### Regulation .12 Physical Environment Requirements. *COMAR 10.07.16.12* A. A limited private inpatient facility shall have a building that: (1) Meets all relevant federal, State, or local ordinances, laws, regulations, and building codes; and (2) Provides sufficient space for group and individual therapies, dining equipped with tables and chairs for resident meal service, and administrative services. B. The areas of the facility shall: (1) Be well-lit and adequately ventilated; (2) Be easily accessible; (3) Be maintained in good repair, safe, clean, and free of insects and rodents and hazards; (4) Provide a central heating system that can maintain the facility at a comfortable temperature; (5) Be furnished with sufficient, appropriate, and functional furnishings, equipment, supplies, and utensils for use by the residents; (6) Be equipped with working smoke detectors and fire extinguishers and meets all requirements of the Maryland State Fire Code; (7) Provide a secure storage area for medications if a resident has been determined capable of self-administration of medication and for residents’ funds and valuables; (8) Have a telephone in the residence where residents can make calls and speak privately; (9) Provide a space where residents may visit privately with friends and family; and (10) Provide adequate general use space for therapy, activities, and recreation. C. Bedroom Area. The facility shall ensure that a bedroom has: (1) A minimum of: (a) 80 usable square feet for a single bedroom; and (b) 180 usable square feet for a double-occupancy bedroom; (2) A door; (3) Closet space and two drawers in a chest or dresser per resident; (4) Window coverings for privacy; (5) A bed with a clean mattress and pillow; (6) A locked drawer or other secured storage for resident’s personal belongings; and (7) No more than two residents per bedroom. D. Toilet and Bathing Facilities. The facility shall ensure that the facility provides easily accessible and conveniently located toilet and bathing areas that allow for individual privacy and that: (1) Are supplied with hand soap, toilet tissue, and hand towels or an electric hand dryer; (2) Provide hot and cold running water with hot water being a minimum of 100°F and a maximum of 120°F; (3) Are equipped with operable mechanical exhaust ventilation; and (4) Provide at least: (a) One hand sink and one toilet for every 8 residents; and (b) One tub or shower for every 12 residents. E. The facility shall ensure that a resident is provided per week, or more frequently if necessary or if requested by the resident, with at least: (1) Two sets of linens; (2) Two towels; and (3) Two washcloths. F. The facility shall provide for personal privacy in all bathrooms and in multiple occupancy bedrooms unless otherwise determined in the resident’s individual treatment plan. #### Regulation .13 Emergency Procedures. *COMAR 10.07.16.13* A. The program shall develop an emergency plan and procedures that shall be followed in the event of an internal or external emergency. B. The emergency plan and procedures shall; (1) Be updated annually; and (2) Include: (a) Easily accessible emergency telephone numbers posted at or near a telephone for: (i) Fire; (ii) Police; (iii) Ambulance; (iv) Poison control; and (v) The program’s on-call staff; (b) An emergency evacuation procedure that is explained to the residents and practiced by residents and staff on all shifts at a minimum of once every 3 months; (c) Provisions for emergency lighting and fire detection and suppression systems operable during loss of power as required by the Maryland State Fire Code; (d) A 3-day emergency food and water supply; and (e) A relocation plan in the event that the facility is partially or entirely vacated, which shall include: (i) A plan for transportation of the residents, at the facility’s expense, to relocate the residents; (ii) A process for transfer of the medical records information for the residents in a manner to protect the residents’ privacy; (iii) A system to track where and how the resident was transported; (iv) How families will be notified, if desired by the resident; and (v) Provisions that provide for any other associated costs at the facility’s expense. #### Regulation .14 Dietary Services. *COMAR 10.07.16.14* A. The facility shall ensure sufficient numbers of trained and qualified staff to meet the nutritional needs of residents served by the facility. B. Nutritional Needs. The facility shall ensure that: (1) A resident is provided three meals in a common dining area and additional snacks during each 24-hour period, 7 days a week; (2) Meals and snacks are well-balanced, varied, palatable, properly prepared, and of sufficient quality and quantity to meet the daily nutritional needs of each resident with specific attention given to the preferences and needs of each resident; (3) All food is prepared in accordance with all State and local sanitation and safe food handling requirements; (4) Food preparation areas are maintained in accordance with all State and local sanitation and safe food handling requirements; (5) Residents have access to snacks during the evening hours; and (6) Staff prepares or arranges for the provision of therapeutic or special diets as ordered by the resident's physician or as needed by the resident's condition. C. The facility shall ensure that menus are: (1) Written at least 1 week in advance with portion sizes to meet the resident’s dietary needs; and (2) Maintained on file, as served, for 2 months. D. Dining Room. A facility shall provide a well-lit, adequately ventilated, and appropriately furnished dining area. E. Food Service. (1) A facility shall have a kitchen that has adequate: (a) Storage, refrigerator, and freezer space for perishable and nonperishable foods; (b) Food preparation area or areas with cleanable surfaces; (c) Equipment to deliver foods at safe and palatable temperatures; (d) Space and equipment to wash, sanitize, and store utensils; (e) Space to store and clean garbage cans; (f) Ice-making capabilities; (g) Equipment for the preparation of food; and (h) Equipment for serving and distributing food to residents. (2) A facility’s dietary services shall be licensed by the local health department and comply with the requirements of COMAR 10.15.03. #### Regulation .15 Resident’s Rights. *COMAR 10.07.16.15* A facility shall: A. Explain to a resident their rights as set forth in Health-General Article, Title 10, Subtitle 7, and Title 4, Subtitle 3, Annotated Code of Maryland; B. Provide, in writing, information regarding an individual’s rights as outlined in §A of this regulation to a resident; and C. Prominently display, in accessible centralized locations, the individual’s rights as outlined in §A of this regulation. #### Regulation .16 Records. *COMAR 10.07.16.16* A. The facility shall, either manually or electronically: (1) Establish a record for a resident; and (2) Ensure that entries in the record are dated, signed, and include the signer's degree or license, or if the signer has no degree or license, the signer's staff position. B. The facility shall ensure that residents’ records are: (1) Maintained in a manner that is consistent with the medical records confidentiality and disclosure requirements of: (a) Maryland Confidentiality of Medical Records Act, Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland; and (b) Relevant federal statutes and regulations, including the Health Insurance Portability Act, 42 U.S.C. §1320D et seq., and implementing regulations at 45 CFR Parts 160 and 164; (2) Located so that the records are convenient and available to designated staff; (3) Managed by a designated staff member who is responsible for appropriate records control, including storage, security, and indexing of records; and (4) Subject to the requirements of confidentiality laws and regulations, are made available to the Department as necessary to carry out required activities. #### Regulation .17 Reporting of Deaths. *COMAR 10.07.16.17* Upon the death of an individual in the facility, the administrative head of the facility shall: A. Submit a written report to the Department within 5 working days of the death; and B. Use the form required by the Administration. #### Regulation .18 Denial or Revocation of Approval. *COMAR 10.07.16.18* A. The Secretary may deny or revoke the license of a limited private inpatient facility that: (1) Does not comply with: (a) Health-General Article, §§10-501—10-511, Annotated Code of Maryland; (b) Health-General Article, §§10-701—10-713, Annotated Code of Maryland; or (c) The provisions of this chapter; (2) Loses accreditation by the Joint Commission; or (3) Fails to be awarded accreditation within 1 year of the issuance of a provisional license by the Department. B. A person aggrieved by a decision of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .22 of this chapter. C. A facility that has lost or been denied accreditation by the Joint Commission may operate pending appeal only as permitted by this chapter. #### Regulation .19 Sanctions. *COMAR 10.07.16.19* A. If the Secretary determines serious or life-threatening resident care deficiencies exist at the limited private inpatient facility or that the facility fails to take the necessary corrective action, the Secretary may: (1) Revoke or place restrictions on the license; (2) Impose a civil money penalty of not more than $10,000 per instance or per day; (3) Impose a directed plan of correction; or (4) Impose appropriate operating conditions. B. When considering whether to impose a civil money penalty and the amount of the penalty, the Secretary shall consider the following factors: (1) The number, nature, and seriousness of the violations; (2) The extent to which the violation or violations are part of an ongoing pattern during the preceding 24 months; (3) The degree of risk, caused by the violation or violations, to the health, life, or safety of the patients of the facility; (4) The efforts made by, and the ability of, the licensee to correct the violation or violations in a timely manner; and (5) Such other factors as justice may require. C. A person aggrieved by the action of the Secretary under §A of this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .22 of this chapter. #### Regulation .20 Emergency Suspension. *COMAR 10.07.16.20* A. The Secretary may immediately suspend a license on a finding that the public health, safety, or welfare requires emergency action. B. The Department shall deliver a written notice to the licensee: (1) Informing the licensee of the emergency suspension; (2) Giving the reasons for the action and the regulation or regulations with which the licensee has failed to comply that form the basis for the emergency suspension; and (3) Notifying the licensee of the licensee's right to request a hearing and to be represented by counsel. C. The filing of a hearing request does not stay the emergency action. D. When a license is immediately suspended, the licensee shall: (1) Immediately return the license to the Department; and (2) Stop providing services immediately. E. A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .22 of this chapter. F. The Office on Administrative Hearings shall conduct a hearing as set forth in Regulation .22 of this chapter and issue a proposed decision. Exceptions may be filed by an aggrieved person pursuant to COMAR 10.01.03. The Secretary shall make a final decision pursuant to COMAR 10.01.03. G. If the Secretary's final decision does not uphold the emergency suspension, the licensee may resume operation. #### Regulation .21 Revocation of License. *COMAR 10.07.16.21* A. The Secretary, for cause shown, shall notify the licensee of the Secretary's decision to revoke the facility's license. The revocation shall be stayed if a hearing is requested. B. The Secretary may revoke a license if the licensee: (1) Has been convicted of a felony that relates to Medicaid or Medicare or a crime involving moral turpitude; (2) Does not comply with the requirements of this chapter; or (3) Fails to comply with the standards for the operation of a limited private inpatient facility or comparable facility as set forth in the Standards for Behavioral Health Care. C. The Secretary shall notify the licensee in writing of the following: (1) The effective date of the revocation; (2) The reason for the revocation; (3) The regulations with which the licensee has failed to comply that form the basis for the revocation; (4) That the licensee is entitled to a hearing if requested, and to be represented by counsel; (5) That the facility shall stop providing services on the effective date of the revocation if the licensee does not request a hearing; (6) That the revocation shall be stayed if a hearing is requested unless the license has been immediately suspended or the revocation is based upon the loss or denial of accreditation from the Joint Commission; and (7) That the licensee is required to surrender the license to the Department if the revocation is upheld. D. A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .22 of this chapter. #### Regulation .22 Hearings. *COMAR 10.07.16.22* A. A request for a hearing shall be filed with the Office of Administrative Hearings, with a copy to the Office of Health Care Quality of the Department, not later than 30 days after receipt of notice of the Secretary's action. The request shall include a copy of the Secretary's action. B. A hearing requested under this chapter shall be conducted in accordance with State Government Article, §10-201 et seq., Annotated Code of Maryland, and COMAR 28.02.01 and 10.01.03. C. The burden of proof is as set forth in COMAR 10.01.03.28. D. Unless otherwise stated in this chapter, the Office of Administrative Hearings shall issue a proposed decision within the time frames set forth in COMAR 28.02.01. E. The aggrieved person may file exceptions as set forth in COMAR 10.01.03.35. F. The Secretary shall issue a final decision in accordance with COMAR 10.01.03.35. #### Regulation .23 Licensure Standards Waiver. *COMAR 10.07.16.23* A. The Department may grant a limited private inpatient facility a waiver from the licensure requirements under Regulation .12 of this chapter with, or without, conditions. B. Application for Licensure Standards Waiver. (1) A facility shall submit a request for a waiver on a form developed by the Department. (2) The requestor shall provide in writing the: (a) Regulation from which a waiver is sought; (b) Reason the facility is unable to comply with the regulation; (c) Reason that compliance with the regulation will impose a substantial hardship; and (d) Reason that a waiver will not adversely affect residents. C. Evaluation of Application for Licensure Standards Waiver. In evaluating a waiver request, the Department shall review the statements in the application, and may: (1) Inspect the limited private inpatient facility; (2) Confer with the limited private inpatient facility director; or (3) Discuss the request with the residents or their representatives to determine whether the residents or their representatives believe a waiver is in the residents’ best interest. D. Grant or Denial of Licensure Standards Waiver. (1) The Department may grant a waiver request if the Department determines that: (a) Compliance with the regulation from which the waiver is sought cannot be accomplished without substantial hardship; and (b) A waiver will not adversely affect residents. (2) If the Department determines that the conditions of §D(1) of this regulation are not met, the Department shall deny the request for a waiver. The denial of a waiver may not be appealed. E. Written Decision. (1) The Department shall issue and mail to the applicant a written decision on a waiver request submitted under §B of this regulation within 45 days from receipt of the request and all appropriate supporting information. (2) If the Department grants the waiver, the written decision shall include: (a) The waiver’s duration; and (b) Any conditions imposed by the Department. F. If the limited private inpatient facility violates any condition of the waiver, or if it appears to the Secretary that the health or safety of residents residing in the limited private inpatient facility will be adversely affected by the continuation of the waiver, a waiver may be revoked. The revocation of a waiver may not be appealed. ### Chapter 17 — Limited Service Hospital **Authority:** Health-General Article, §§19-301, 19-307, 19-307.1, 19-308, 19-319, 19-320, and 19-323, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.06 adopted as an emergency provision effective August 23, 1985 (12:19 Md. R. 1842); emergency status expired November 21, 1985; adopted permanently effective December 2, 1985 (12:24 Md. R. 2348) **Administrative History:** Chapter, Freestanding Emergency Facilities, repealed as an emergency provision effective July 1, 2000 (27:16 Md. R. 1519); repealed permanently effective October 30, 2000 (27:21 Md. R. 1975) **Administrative History:** Chapter, Limited Service Hospital, Regulations .01—.10 adopted as an emergency provision effective July 1, 2000 (27:16 Md. R. 1519); adopted permanently effective October 30, 2000 (27:21 Md. R. 1975) **Administrative History:** Regulation .03A amended effective March 13, 2017 (44:5 Md. R. 292) **Administrative History:** Regulation .04A amended effective March 13, 2017 (44:5 Md. R. 292) #### Regulation .01 Definitions. *COMAR 10.07.17.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Advanced life support” means initial resuscitation or emergency care provided to a patient with a serious illness or injury. (2) “Department” means the Maryland Department of Health. (3) “Facility” means a limited service hospital. (4) “License” means a license issued by the Secretary to operate a limited service hospital in this State. (5) “Limited service hospital” means a health care facility that: (a) Is licensed as a hospital on or after January 1, 1999; (b) Changes the type or scope of health care services offered by eliminating the facility's capability to admit or retain patients for overnight hospitalization; and (c) Retains an emergency or urgent care center for the purpose of providing advanced life support. #### Regulation .02 License Required. *COMAR 10.07.17.02* A person may not convert to, operate, or continue the operation of an existing limited service hospital without first obtaining a license from the Secretary. A license is valid for 1 year from the date of issuance, unless revoked by the Secretary. #### Regulation .03 Application Procedure. *COMAR 10.07.17.03* A. A person desiring to convert an existing facility, or to change the classification of an existing hospital to a limited service hospital, shall file an application with the Secretary, on a written or electronic form provided by the Secretary. B. An application on behalf of a corporation, association, or governmental unit or agency shall be made by two officers of the corporation, association, or governmental unit or agency. The names of their board members shall be submitted. Ownership of property, real estate, and equipment shall be disclosed if owned by other than the applicant. The names of persons holding 2 percent or more of the stock or assets of the limited service hospital shall be disclosed. C. Along with the application, the applicant shall provide: (1) A statement signed by the applicant that the facility will be open 24 hours a day, 7 days a week; (2) A plan describing the services to be provided by the facility, including but not limited to the following: (a) Types and scope of services, (b) A description of staff, including the number and types of health care professionals who will be on duty at all times, and (c) Qualifications, duties, and responsibilities of personnel; (3) A written description of the facility's quality assurance program which includes, at a minimum: (a) A description of how the facility will comply with Regulation .06A of this chapter, and (b) The manner in which information will be collected; (4) Policies and procedures, including but not limited to the following: (a) The transfer or referral of patients who require services that are not provided by the facility, (b) The administration of medicines unique to the needs of the patients, (c) Infection control procedures, (d) Development and implementation of a quality assurance program, (e) Pertinent safety practices, including the control of fire and mechanical hazards, and (f) Preventive maintenance for equipment in the facility; (5) Protocols for obtaining specialized services; (6) Protocols for emergency situations, including: (a) Procedures for transporting individuals to hospitals or other health care facilities, and (b) Plans to ensure that there will be sufficient nurses and other health professionals with appropriate training on duty to provide advanced life support; (7) A statement of the facility's role in the Emergency Medical Services System as approved by the Maryland Institute for Emergency Medical Services Systems; and (8) A statement that the facility's emergency services are available to all persons regardless of ability to pay. D. Fee. An application shall be accompanied by the nonrefundable license fee of $1,000. E. Issuance of a License. The Department shall issue a license to a facility that meets the requirements of this chapter. #### Regulation .04 License Renewal. *COMAR 10.07.17.04* A. The licensee shall file an application for license renewal on a written or electronic form provided by the Secretary at least 60 days before the current license expires. B. The licensee shall include with the application for license renewal: (1) Updated documents listed in Regulation .03C(2) — (8) of this chapter if any of the information has changed during the current licensure period; and (2) The nonrefundable license fee of $1,000. #### Regulation .05 Standards for Service. *COMAR 10.07.17.05* A. A facility shall comply with applicable federal, State, and local laws and regulations. B. Restriction of License—Nomenclature. A limited service hospital may not use in its title the words “emergency department”, “emergency center”, “emergency room”, or any other terminology in referring to the limited service hospital or any part of the facility that may convey to the public that the facility is prepared to provide the full range of emergency services that are normally provided by a hospital. C. Hours of Operation. The facility shall be open 24 hours a day, 7 days a week. D. Staff. (1) At least one physician who is credentialed in emergency medicine shall be at the facility at all times. (2) The facility shall have a sufficient number of registered nurses and other health professionals with appropriate training to provide advanced life support. E. Laboratory and Radiologic Services. The facility shall have basic x-ray and laboratory services available at all times and be staffed by at least: (1) One radiology technician; and (2) One laboratory technician. F. Pharmaceutical Services. (1) Pharmaceutical services shall be supervised by a pharmacist licensed to practice in this State. (2) The facility shall provide pharmaceutical services in accordance with accepted professional principles and appropriate federal, State, and local laws and regulations. G. Clinical Records. (1) The facility shall maintain clinical records for all patients in accordance with accepted professional standards and practices. (2) Clinical records shall contain: (a) Identification and summary, including, at least, the patient's name, Social Security number, marital status, age, sex, and home address; (b) Name, address, and telephone number of the personal physician, dentist, parent or next of kin, or authorized representative; (c) Evidence of assessment of the patient's needs, of establishment of an appropriate plan of initial and ongoing treatment, and of the care or services provided; (d) Consent forms when required; (e) Diagnostic and therapeutic orders; (f) Reports of medication administration, treatments, and clinical findings; and (g) Discharge summary including final diagnosis and prognosis. (3) Current clinical records and those of discharged patients shall be completed promptly. All clinical information pertaining to a patient shall be centralized in the patient's clinical record. (4) Clinical records shall be retained for a period of not less than 5 years from the date of discharge or, in the case of a minor, 3 years after the patient becomes of age or 5 years, whichever is longer. H. Equipment. (1) A facility shall have the equipment necessary to provide at least the following care: (a) Cardiac monitoring, defibrillation, and external pacing; (b) Medication administration; (c) Oxygen therapy; (d) Airway management including endotracheal intubation; (e) Respiratory ventilation; and (f) Intravenous and intraosseous access and fluid therapy. (2) All equipment at the facility shall be in good operating condition at all times. I. Infection Control. A facility shall: (1) Develop and implement policies and procedures on the use of standard precautions for infection control; and (2) Comply with the requirements of COMAR 10.06.01.07, except in an emergency life-threatening situation when it is not feasible or practical to comply with the infection control measures. #### Regulation .06 Quality Assurance. *COMAR 10.07.17.06* A. The facility shall plan and implement a quality assurance program which includes: (1) Monitoring and evaluation of the quality of patient care; (2) Identification, evaluation, and resolution of care problems; and (3) A peer review process. B. The facility shall conduct ongoing quality assurance activities and document the activities on a continuous basis, but not less than quarterly. C. Peer Review. The facility shall establish a peer review process that includes: (1) A mechanism to evaluate the clinical performance of each health care practitioner on a continuous basis, but not less than annually; (2) Procedures, approved by a supervising physician, to identify and minimize risks to the patient; and (3) Documentation of each health care practitioner's annual evaluation. D. Equipment Quality Control. (1) The facility shall develop and implement a quality control procedure to monitor the safety and performance of all biomedical equipment. (2) In developing its procedures, the facility shall consider: (a) FDA recommendations; and (b) The equipment manufacturer's recommendations. E. Quality Assurance Records. The facility shall document the following information for all quality assurance activities: (1) A description of identified problems; (2) Findings; (3) Conclusions; (4) Recommendations; (5) Actions taken; (6) Results; and (7) Follow-up. #### Regulation .07 Risk Management Program. *COMAR 10.07.17.07* A. A facility shall comply with the requirements of COMAR 10.07.01.25. #### Regulation .08 Utilization Review. *COMAR 10.07.17.08* A facility shall comply with the requirements of COMAR 10.07.01.13—.19. #### Regulation .09 Physician Credentialing. *COMAR 10.07.17.09* A facility shall comply with the requirements of COMAR 10.07.01.24. #### Regulation .10 Penalties. *COMAR 10.07.17.10* A. The Secretary shall deny a license to a person who has been convicted of a felony that relates to Medicaid or to a nursing home. B. The Secretary shall revoke the license of any licensee convicted of a felony that relates to Medicaid or to a nursing home. C. The Secretary may deny or revoke a license if the facility does not meet the requirements of: (1) Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland; and (2) Any regulation adopted under Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland. D. A person aggrieved by an action of the Secretary may request a hearing in accordance with State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, and COMAR 10.01.03. ### Chapter 18 — Comprehensive Rehabilitation Facilities **Authority:** Health-General Article, §19-1201 et seq., Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.07 adopted as an emergency provision effective July 1, 1986 (13:15 Md. R. 1727); adopted permanently December 1, 1986 (13:24 Md. R. 2558) **Administrative History:** Regulation .04B, E amended effective March 13, 2017 (44:5 Md. R. 292) **Administrative History:** Regulation .05A amended effective June 24, 1991 (18:12 Md. R. 1339); September 16, 2002 (29:18 Md. R. 1443) #### Regulation .01 Definitions. *COMAR 10.07.18.01* A. In this chapter, the following words have the meanings indicated. B. Terms Defined. (1) “Commission on Accreditation of Rehabilitation Facilities” means the private, nonprofit organization formed in 1966 which has established standards of quality for rehabilitation services, and which accredits those who provide the services. (2) “Comprehensive physical rehabilitation services” has the meaning stated in Health-General Article, §19-1201(b), Annotated Code of Maryland. (3) “Comprehensive rehabilitation facility” means any person who provides or holds itself out as providing comprehensive physical rehabilitation services on an out-patient basis. (4) “Specialized rehabilitation program” has the meaning stated in Health-General Article, §19-1201(e), Annotated Code of Maryland. #### Regulation .02 Scope. *COMAR 10.07.18.02* This chapter does not apply to a home health agency or special rehabilitation hospital. #### Regulation .03 Compliance Required. *COMAR 10.07.18.03* A comprehensive rehabilitation facility shall comply with the requirements of this chapter before the facility may provide: A. Comprehensive rehabilitation services; or B. A specialized rehabilitation program. #### Regulation .04 License Provisions. *COMAR 10.07.18.04* A. A comprehensive rehabilitation facility license is required before a person may provide or hold itself out as providing comprehensive physical rehabilitation services in the State. B. To obtain a comprehensive rehabilitation facility license, a person shall: (1) Submit an application on the written or electronic form provided by the Secretary; (2) Pay to the Secretary an application fee of $10; and (3) Meet any requirement imposed under Health-General Article, Title 19, Subtitle 1, Annotated Code of Maryland. C. Applications on behalf of a corporation, association, or governmental unit or agency shall be made by two officers of the corporation, or governmental unit or agency, and names of their Board members shall be submitted. Ownership of property, real estate, and equipment shall be disclosed if it is other than the licensee's. The names of persons holding 2 percent or more of the stock or assets shall be disclosed. D. A comprehensive rehabilitation license expires on the first anniversary of its effective date, unless it is renewed for a 1-year term. E. An application for the renewal of the license shall be made on the written or electronic form provided by the Secretary at least 60 days before expiration of the issued license. F. Separate licenses are required for institutions maintained on separate premises, even though both institutions are operated under the same management. #### Regulation .05 Standards of Operation. *COMAR 10.07.18.05* A. A comprehensive rehabilitation facility: (1) Shall be accredited by the Commission on Accreditation of Rehabilitation Facilities; (2) May provide only those specialized rehabilitation programs that the facility has been accredited to provide by the Commission on Accreditation of Rehabilitation Facilities; (3) Shall meet the standards provided by the Commission on Accreditation of Rehabilitation Facilities as set forth in the 2002 Medical Rehabilitation Standards Manual (Commission on Accreditation of Rehabilitation Facilities, 4891 East Grant Road, Tucson, AZ 85712) which is incorporated by reference; (4) Shall meet any other requirements that may be imposed by law. B. Waiver of Accreditation. (1) To allow a comprehensive rehabilitation facility to achieve accreditation by the Commission on Accreditation of Rehabilitation Facilities as required under this regulation, the accreditation requirement shall be waived for any comprehensive rehabilitation facility that has submitted an appropriate application for accreditation. (2) The waiver under this section shall be effective for not more than 2 years from the later of: (a) July 1, 1986; or (b) The date on which the facility begins operations. C. The Secretary may inspect a comprehensive rehabilitation facility to assure that the facility meets the requirements of this chapter. #### Regulation .06 Records and Reports — Inspection. *COMAR 10.07.18.06* Licensees shall keep such records and make reports in the manner and form as the Secretary shall prescribe, and all these records shall be open to inspection by the Secretary. #### Regulation .07 Enforcement. *COMAR 10.07.18.07* The Secretary may enforce the provisions of this chapter by any method available at law, including any civil action or criminal prosecution. Civil actions include, but are not limited to, license revocations. ### Chapter 19 — Private Review Agents *Transferred to COMAR 31.10.21* **Administrative History:** Effective date: June 6, 1994 (21:11 Md. R. 951) **Administrative History:** Regulations .01—.06, .08—.10, and .12 amended, Regulation .07 repealed, Regulations .08—.12 recodified to .07—.11, and entire chapter recodified to new chapter COMAR 31.10.21 as an emergency provision effective January 1, 1999 (26:2 Md. R. 104); amended and recodified permanently effective March 22, 1999 (26:6 Md. R. 491) ### Chapter 20 — Intermediate Care Facilities for Individuals with Intellectual Disabilities or Persons with Related Conditions (ICF/IID) **Authority:** Health-General Article, §§19-318, 19-320, and 19-323, Annotated Code of Maryland **Administrative History:** Effective date: December 28, 1987 (14:26 Md. R. 2747) **Administrative History:** (COMAR 10.07.20 amended and transferred from COMAR 10.22.04 Public and Private Residential Care Facilities Serving the Mentally Retarded (ICF-MR)) **Administrative History:** Regulation .01B amended effective January 20, 2014 (41:1 Md. R. 13) **Administrative History:** Regulation .02 amended effective January 20, 2014 (41:1 Md. R. 13) **Administrative History:** Regulation .03B amended effective January 20, 2014 (41:1 Md. R. 13) **Administrative History:** Regulation .04B, E amended effective March 13, 2017 (44:5 Md. R. 292) **Administrative History:** Regulation .05A amended effective February 20, 1989 (16:3 Md. R. 342) **Administrative History:** Regulation .05E adopted effective December 17, 2007 (34:25 Md. R. 2210) #### Regulation .01 Scope. *COMAR 10.07.20.01* This chapter applies to any person, whether public or private, operating a facility that: A. Provides health-related services on a regular basis to individuals: (1) Who do not require hospital care; and (2) Whose mental or physical condition requires services that: (a) Are above the level of room and board; and (b) Can be made available only through institutional facilities; and B. Has as its primary purpose the provision of health rehabilitative services for individuals with an intellectual disability or related conditions. #### Regulation .02 Applicability of Health-General Article, Annotated Code of Maryland. *COMAR 10.07.20.02* An intermediate care facility for individuals with intellectual disabilities or persons with related conditions (ICF/IID) shall be considered: A. A “related institution” under Health-General Article, §19-301, Annotated Code of Maryland, and shall be governed by the provisions of Title 19, Subtitle 3 of that article; and B. A provider of “services” under Health-General Article, §7-101, Annotated Code of Maryland, and shall be governed by the applicable provisions of Title 7 of that article including: (1) Subtitle 4: Provisions of Services; (2) Subtitle 5: State Residential Centers for Individuals With Mental Retardation if the facility is operated by the State; (3) Subtitle 8: Transfers; and (4) Subtitle 10: Rights of Individuals. #### Regulation .03 Definitions. *COMAR 10.07.20.03* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Department” means the Maryland Department of Health. (2) “Facility” means an intermediate care facility for individuals with intellectual disabilities or persons with related conditions (ICF/IID) within the scope of this chapter. (3) “License” means a license issued by the Secretary to operate a facility. (4) “Secretary” means the Secretary of Health. #### Regulation .04 Licensing Procedure. *COMAR 10.07.20.04* A. A person shall be licensed by the Secretary before the person may operate a facility in the State. B. An applicant for a license shall: (1) Submit to the Secretary an application: (a) In the form and manner prescribed by the Secretary on the written or electronic form provided by the Secretary; and (b) Signed and verified by the applicant; and (2) Pay to the Secretary an application fee in the amount provided in COMAR 10.07.15. C. The Secretary shall issue a license to an applicant who meets the requirements of these regulations. D. A license authorizes the licensee to operate a facility while it is effective and is not transferable. E. Term and Renewal of License. (1) A license expires on the first anniversary of its effective date unless it is renewed for a 1-year term as provided in this section. (2) Before the license expires, the licensee may renew it for another 1-year term, if the licensee submits to the Secretary: (a) A renewal application in the form and manner prescribed by the Secretary on the written or electronic form provided by the Secretary; (b) Satisfactory evidence of compliance with any requirement of the regulations for license renewal; and (c) The license renewal fee provided in COMAR 10.07.15. F. The Secretary may: (1) Deny a license to any applicant; (2) Deny the renewal of a license to a licensee; or (3) Revoke a license of a licensee if the applicant or licensee does not meet the requirements of this chapter. #### Regulation .05 Standards of Operation. *COMAR 10.07.20.05* A. General. Whether or not a facility participates in Medicare or Medicaid, the facility shall meet the requirements set forth in 42 CFR § 483.400 et seq., which is incorporated by reference. B. Safety and Sanitation. The facility, its grounds, fixtures and equipment shall be: (1) Maintained in good repair, clean, and attractive; (2) Free of unnecessary accumulations of personal property or debris; and (3) Free of hazards, insects, and rodents. C. Infection Control. The administrator shall: (1) Establish policies and procedures to investigate, control, and prevent infections in the facility; and (2) Ensure that facility staff follow these policies and procedures. D. Personnel. (1) The administrator shall provide orientation and training for all staff and volunteers. (2) If the center provides care for individuals with Alzheimer's disease or related disorders: (a) The administrator shall provide annual in-service education on the care of individuals with dementia; and (b) Each employee shall complete an instructional unit on dementia as described in COMAR 10.07.02.40H before the later of: (i) 180 days from beginning of employment, or (ii) One year from the effective date of these regulations. (3) Employee Health Screening. A facility shall obtain certification that an employee or volunteer is free from tuberculosis in a communicable form as provided in Regulation .06 only if the employee or volunteer: (a) Will be involved in the direct care of tuberculosis patients; or (b) Is an immigrant from Africa, Asia, or Latin America. E. Emergency Management Plans. State residential centers shall develop an emergency plan for all types of emergencies and disasters that shall include: (1) Procedures that will be followed before, during, and after an emergency to address the following: (a) The evacuation, transportation, or 72-hour shelter-in-place of individuals and staff served; (b) Holding an annual practice drill coordinated with local emergency planners for sheltering-in-place or evacuating; (c) Preparing an after action report and improvement plan after drills that evaluates the plan and takes corrective actions; (d) Ensuring that individuals served and staff have identification with current health, contact, and other important information that is immediately accessible in the event of evacuation; (e) The role of the resident, family member, or legal representative in the event of evacuation; (f) Arranging for medical needs and other accommodations for individuals served and staff at alternative facilities or shelters; and (g) Establishing a communication protocol among all appropriate parties that includes redundant communication means; (2) The notification to families, staff, and respective DDA regional office regarding the action that will be taken concerning the safety and well-being of the individuals served; (3) The staff coverage, organization, and assignment of responsibilities that includes: (a) Planning staff coverage needs for ongoing shelter-in-place or evacuations; (b) Identifying staff members available to report for work or remain during extended periods; and (c) Establishing staff notification and recall contingency plans and procedures; (4) The continuity of operations, including, but not limited to, redundant communications systems, preservation of records and electronic data, the procurement of essential goods, equipment, and services, plans to secure vacated facilities, and the relocation to alternate facilities; (5) Procedures to: (a) Backup and electronically store off-site, appropriate records and data of consumers and staff and facility documents, for access under emergency conditions; and (b) Ensure access to an electronic copy of the emergency plans when requested by local, State, or federal emergency management organizations; (6) Provisions to ensure that the facility's emergency and disaster plans are shared with local emergency management organizations for the purpose of coordinating local emergency planning; (7) An executive summary of the evacuation procedures that shall be provided to the family member of a resident on request; and (8) A summary statement of the facility's community surge capacity abilities. #### Regulation .06 Tuberculosis Screening. *COMAR 10.07.20.06* A. An employee or volunteer may be certified as required in Regulation .05D(3) in one of the following four ways: (1) If the individual has documentation of a negative tuberculin test by the Mantoux method within the past 24 months and has, by history, no contact with a person with tuberculosis in a communicable form subsequent to this documentation or no symptoms consistent with tuberculosis, the individual shall be considered to be a negative tuberculin reactor and to be free from tuberculosis in a communicable form. Further skin testing may not be necessary except for epidemiologic diagnostic purposes which may be required by the local health officer or the Department. (2) If the individual does not have documentation of a negative tuberculin test by the Mantoux method within the past 24 months and does not have a history of having had a positive tuberculin test by the Mantoux method, the following procedure shall be done: (a) Five Tuberculin Units (TU) of Purified Protein Derivative (PPD) shall be administered intradermally and the results read 48—72 hours subsequent to the administration of the test; (b) An individual with induration of 5—9 mm and no history of contact with a person with tuberculosis in a communicable form or an individual with induration of 0—4 mm shall be considered to be a negative tuberculin reactor and to be free from tuberculosis in a communicable form; (c) An individual with induration of 5—9 mm and a history of contact with a person with tuberculosis in a communicable form or an individual with induration of 10 mm or more shall be considered to be a positive tuberculin reactor and shall be handled as described in §A(3)(a),(b), and (c), of this regulation. (3) If the individual is a positive tuberculin reactor as defined in §A(2)(c), of this regulation, or if the individual has a history of a positive tuberculin test by the Mantoux method without documentation of having received an adequate course of therapy, as defined by the local health officer, for tuberculosis disease or received adequate prophylaxis, as defined by the local health officer, for tuberculosis infection, the following procedure shall be done: (a) If the individual does not have documentation of a negative chest X-ray within the past 12 months, the individual shall be evaluated by a chest X-ray. If the chest X-ray is negative, the individual shall be considered to be free from tuberculosis in a communicable form and shall have a repeat chest X-ray in 12 months, unless isoniazid therapy is instituted, in which case the second chest X-ray is unnecessary. (b) If the individual has documentation of a negative chest X-ray within the past 12 months, the individual shall be considered to be free from tuberculosis in a communicable form and shall have a repeat chest X-ray 12 months after the most recent documented chest X-ray unless isoniazid therapy has been instituted, in which case the second chest X-ray is unnecessary. (c) If the individual has had two successive negative chest X-rays 12 months apart, no further chest X-rays are necessary and the individual shall be considered to be free from tuberculosis in a communicable form unless the individual has symptoms consistent with tuberculosis. (4) If the individual has documentation of an adequate course of therapy, approved by the local health officer, for tuberculosis disease or adequate prophylaxis, approved by the local health officer, for tuberculosis infection, no further chest X-rays are necessary and the individual shall be considered to be free from tuberculosis in a communicable form unless the individual has symptoms consistent with tuberculosis. B. The facility shall instruct each employee and volunteer in the signs and symptoms of active tuberculosis and advise the individual to seek immediate medical care should the individual detect these signs or symptoms. C. If the individual meets any of the following criteria, the facility shall have written policies and procedures, acceptable to the Department, for the evaluation, management, and surveillance of this individual: (1) A history of tuberculosis or tuberculosis infection without documentation of adequate treatment as defined and determined by the local health officer; (2) Is currently being treated for tuberculosis disease or tuberculosis infection; (3) Has chest X-rays consistent with tuberculosis without documentation of adequate treatment as defined and determined by the local health officer; or (4) Symptoms consistent with tuberculosis or a history of contact with a person with tuberculosis in a communicable form within the past 12 months. D. The facility shall maintain the following records: (1) Results of Mantoux tests, recorded in millimeters of induration with dates of administration, dates of reading and results of tests; (2) Results of X-rays required in §A(3)(a),(b), and (c), of this regulation; and (3) Documentation of any Mantoux test, chest X-ray, chemotherapy, and chemoprophylaxis which is the basis for the certification that the individual is free from tuberculosis in a communicable form. #### Regulation .07 Inspections. *COMAR 10.07.20.07* A. The Department shall inspect each facility at least annually to determine compliance with these regulations. B. A licensed facility and any facility applying for a license shall be open to inspection by the Department at all times. ### Chapter 21 — Hospice Care Programs **Authority:** Health-General Article, §§19-903 and 19-907, Annotated Code of Maryland **Administrative History:** Effective date: October 2, 1989 (16:19 Md. R. 2104) **Administrative History:** Regulations .01—.16 repealed and new Regulations .01—.28 adopted effective August 10, 1998 (25:16 Md. R. 1274) **Administrative History:** Regulation .04B amended effective August 29, 2016 (43:17 Md. R. 953); March 13, 2017 (44:5 Md. R. 292) #### Regulation .01 Scope and Purpose. *COMAR 10.07.21.01* This chapter applies to any general or limited hospice care program as defined in Health-General Article, §19-901, Annotated Code of Maryland. #### Regulation .02 Definitions. *COMAR 10.07.21.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Attending physician” means the physician having the most significant role in the determination and delivery of the hospice patient's medical care. (2) Bereavement Services. (a) “Bereavement services” means counseling services provided to the patient's family after the patient's death. (b) “Bereavement services” includes: (i) Personal contacts with the family by hospice employees or volunteers; (ii) Support groups; and (iii) Referrals to other service providers. (3) “Department” means the Maryland Department of Health. (4) “Family” means a group of two or more individuals related by legal status or affection who consider themselves a family. (5) “General hospice care program” means a coordinated, interdisciplinary program of hospice care services designed to meet the special physical, psychological, spiritual, and social needs of dying individuals and their families, by providing palliative and supportive medical, nursing, and other health-related services during illness and bereavement through home or inpatient care. (6) “Home-based hospice services” means hospice care services provided to a patient in the patient's permanent or temporary residence. (7) Hospice Care Program. (a) “Hospice care program” means a coordinated, interdisciplinary program of hospice care services. (b) “Hospice care program” includes a general or limited hospice care program. (8) “Inpatient care services” means services provided by a general hospice care program for the purpose of pain control, symptom management, or respite. (9) “License” means a license issued by the Secretary to operate a general or limited hospice care program. (10) “Limited hospice care program” means a coordinated, interdisciplinary program of hospice care services designed to meet the special physical, psychological, spiritual, and social needs of dying individuals and their families, by providing palliative and supportive nonskilled services during illness and bereavement through a home-based hospice care program. (11) “Physician” means an individual who is licensed to practice medicine in this State under Health Occupations Article, Title 14, Annotated Code of Maryland. (12) “Representative” means an individual with legal authority to make health care decisions on behalf of the patient as set forth in Regulation .20 of this chapter. (13) “Secretary” means the Secretary of Health. (14) “Skilled services” means services that may be provided by an individual licensed under the Health Occupations Article, Annotated Code of Maryland. (15) “Social worker” means an individual licensed to practice in this State under Health Occupations Article, Title 19, Annotated Code of Maryland. #### Regulation .03 License Required. *COMAR 10.07.21.03* A. A person may not operate or represent itself as operating a hospice care program in this State, without first obtaining a license from the Secretary. B. Section A of this regulation applies to a home health agency, hospital, related institution, or other licensed facility that operates a hospice care program that is distinct from the other services that it is authorized to provide. C. Types of Licenses. The Secretary shall require a hospice care program to be licensed as a: (1) General hospice care program if the hospice care program provides, directly or by contract, home-based or inpatient care involving medical, nursing, or other skilled health services; or (2) Limited hospice care program if the program provides, directly or by contract, nonskilled hospice services in a home-based setting. D. A limited hospice care program shall refer patients in need of skilled services to a general hospice care program, or arrange for this care to be provided by an authorized health care provider. E. Duration of License. A license expires on the third anniversary of its effective date unless it is: (1) Renewed as provided in Regulation .04 of this chapter; or (2) Revoked as provided in Regulation .27 of this chapter. F. A license to operate a hospice care program is not transferable. #### Regulation .04 Application Procedure. *COMAR 10.07.21.04* A. Before a person may apply for a license to operate a general hospice care program, the person shall obtain a certificate of need from the Maryland Health Resources Planning Commission under Health-General Article, Title 19, Annotated Code of Maryland. B. The applicant shall submit an application for an initial license or renewal of a license on a written or electronic form provided by the Secretary. C. The applicant shall provide the following information with the application as applicable: (1) If the applicant is an individual and is sole owner of the hospice care program, the name and address of the applicant; (2) If the applicant proposes to operate a facility providing inpatient hospice care services and someone other than the applicant owns the building or real property, or both, the name and address of the owner or owners; (3) If the applicant is a partnership or limited partnership: (a) The legal name of the partnership or limited partnership; (b) Any trade name used by the partnership or limited partnership; and (c) The name and address of each partner; (4) If the applicant is a corporation: (a) The name of the corporation; (b) The date of incorporation; (c) The state of incorporation; (d) The name and address of each director; (e) If the corporation is incorporated outside of the State, the name and address of the resident agent of the corporation; (f) The name and address of each officer; and (g) The name and address of any stockholder owning more than 5 percent of the stock of a corporate applicant; (5) A statement that the applicant meets the requirements of Health-General Article, Title 19, Annotated Code of Maryland, and this chapter; (6) The name of the individual who is to be the medical director of the hospice care program; (7) The location and postal address of: (a) The principal office of the proposed hospice care program; (b) Any other office of the proposed hospice care program; (c) Any facility providing inpatient hospice services to be operated by the hospice care program; and (d) Any location where home-based hospice services are being provided in a residence owned or operated by the hospice; and (8) A copy of the certificate of need determination from the Maryland Health Resources Planning Commission as required under §A of this regulation. D. The Secretary: (1) Shall deny or revoke a license if the applicant or licensee has been convicted of a felony involving Medicaid fraud or other activity involving a nursing home, or its residents; or (2) May deny or revoke a license of the applicant or licensee who does not otherwise meet the requirements of this chapter. E. A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .28 of this chapter. #### Regulation .05 Inspection by the Department. *COMAR 10.07.21.05* A. A licensee, or a program seeking licensure under this chapter, shall be open at all times to inspection by the Department, and any agency designated by the Secretary, to conduct an inspection. B. The Department may: (1) Periodically inspect a hospice care program for compliance with this chapter; and (2) Conduct complaint investigations involving alleged licensure violations. C. Noncompliance. (1) If the Secretary determines that a hospice care program fails to meet any provision of this chapter, the Secretary shall: (a) Advise the hospice care program of the exact nature of the violation; and (b) Require that the hospice care program specify what corrective action it is taking and monitor the hospice care program to ensure that it takes corrective action. (2) This section does not preclude the Secretary from imposing any of the sanctions set forth in Regulation .27 of this chapter. #### Regulation .06 Administration. *COMAR 10.07.21.06* A. Responsibility of Licensee. A licensee shall ensure that the operation of the hospice care program complies with Health-General Article, Title 19, Subtitle 9, Annotated Code of Maryland, and this chapter. B. Governing Body. (1) A licensee shall have a governing body for the hospice care program. The governing body shall: (a) Determine the hospice care program's mission and purpose; (b) Conduct a periodic community needs assessment; (c) Provide outreach programs appropriate to the needs of the communities it serves, including making information about hospice care services readily available and providing appropriate educational activities to the communities it serves; (d) Make efforts to secure access to hospice care services for the underserved; (e) Adopt administrative and clinical policies and procedures, and review them annually; (f) Monitor the hospice's program and establish a process to evaluate the quality of services it is providing; (g) Have fiscal and fiduciary responsibility for the hospice care program including the review and approval of its budget; (h) Ensure compliance with all legal requirements; (i) Adopt bylaws which: (i) Specify the role and responsibility of the governing body; and (ii) Define the hospice care program's relationship to any other governing body; and (j) Develop and implement a written conflict of interest policy which includes guidelines for the resolution of any existing or apparent conflict of interest. (2) All members of the governing body shall participate in an orientation program and continuing education to enable the members to fulfill their responsibilities to the hospice care program. C. Administrator. (1) The governing body or the licensee shall: (a) Identify an administrator who has full responsibility for the day-to-day operations of the hospice care program; and (b) Evaluate the administrator's performance on at least an annual basis. (2) In the absence of the administrator, the program shall remain under the continuous supervision of a designated individual with appropriate experience and training. #### Regulation .07 Policies and Procedures. *COMAR 10.07.21.07* The hospice care program shall adopt and implement written policies and procedures for: A. The use of advance directives; B. Identifying, reviewing, and discussing ethical dilemmas which arise in the care of patients and family; C. The use of specific treatment modalities in different hospice care settings, that is, palliative chemotherapy or radiation; D. The administration of medications, including who is qualified to administer medications; E. The management of treatment-related complications; F. The use of investigational drugs and implementation of research protocols; G. The initiation of resuscitation; H. Attending to remains at the time of death; I. The disposal of controlled drugs after death; J. The provision of inpatient hospice care including: (1) Privacy needs, including space for families to gather; (2) 24-hour visitation and overnight stays; and (3) Religious and spiritual worship; K. Admission, transfer, and discharge, including criteria to be used for each; and L. Obtaining informed consent. #### Regulation .08 Personnel. *COMAR 10.07.21.08* A. The hospice care program shall maintain sufficient health care professionals and volunteers to meet patient care needs. B. The hospice care program shall identify an interdisciplinary care team with responsibility for ensuring continuous assessment of the patient's and family's needs and implementation of an integrated plan of care. The hospice care program shall ensure that: (1) A qualified health care professional coordinates the activities of the interdisciplinary care team; (2) The number of individuals who perform interdisciplinary team services is consistent with the needs of patients and their families and the type of services provided by the hospice care program; and (3) Each interdisciplinary care team consists of at least: (a) The patient's attending physician; (b) A physician with training in palliative care; (c) A registered nurse with demonstrated experience in pain and symptom management and the performance of physical assessments; (d) A master's degree-prepared social worker with clinical experience in counseling and casework for the terminally ill; (e) A volunteer, or volunteers, supervised by an individual with management experience in a hospice care program; and (f) A spiritual care counselor or counselors with education and experience in pastoral counseling. C. An interdisciplinary care team may include additional specialized team members needed to meet specific needs of patients as outlined in the patient's plan of care. Specialized team members may include allied therapists, art and music therapists, registered dietitians or licensed nutritionists, pharmacists, or nursing assistants. D. Specialized team members may be employees, volunteers, or contractual staff. E. Personnel Records. For all employees, volunteers, and contractual staff, the administrator shall ensure that there is: (1) An accurate, complete, and current personnel record that includes: (a) Verification of required licenses or certification; (b) A signed conflict of interest statement; (c) Written performance reviews; (d) Documentation of all required training; and (2) A job description for each position. F. Outside Agreements. If a hospice care program utilizes the services of an outside entity to provide certain hospice services, the hospice care program shall enter into a written agreement with that entity which includes at a minimum: (1) The service or services to be provided; (2) The roles, rights, and responsibilities of the contracting entity; (3) The roles, rights, and responsibilities of the hospice care program; and (4) A plan to ensure that any individual providing services under this section shall have at least comparable training to that required by this regulation. G. Orientation and Training. (1) The hospice care program shall ensure that all licensed staff receive orientation and training, which includes at a minimum: (a) The purpose and philosophy of hospice care; (b) The skills necessary to provide for the physical care of the patient; (c) The skills necessary to provide for the psychosocial and spiritual needs of the patient and family; and (d) The need and importance of maintaining professional boundaries with the patient and the patient's family. (2) The hospice care program shall have written criteria and a clear process for recruiting, selecting, and supervising volunteers, ensuring that: (a) Any volunteer who provides direct patient care receives appropriate orientation and at least 16 hours of training which includes, at a minimum: (i) The purpose and philosophy of hospice care; (ii) The role of the volunteer in hospice; (iii) Concepts of death and dying; (iv) Communication skills; (v) Care and comfort measures; (vi) The physical, psychosocial, and spiritual issues related to death and dying; (vii) The concept of the hospice family; (viii) Patient rights; (ix) Confidentiality; (x) Bereavement; (xi) Infection control; (xii) Safety; and (xiii) Stress management; and (b) A volunteer, other than those specified in §G(2)(a) of this regulation, receives appropriate orientation regarding the volunteer's role in the hospice care program. (3) Training shall be specifically tailored to ensure that staff is capable of providing care to meet the individual needs of patients. (4) The hospice care program shall provide continuing inservice education for all employees and volunteers providing direct patient services at least: (a) Once a year for volunteers; and (b) Four times a year for employees. #### Regulation .09 Quality Assurance. *COMAR 10.07.21.09* A. The governing body shall ensure that the hospice care program conducts ongoing quality assurance and utilization review. B. Quality Assurance Program. The governing body shall assure that the hospice care program develops and implements a quality assurance and improvement program to assess and improve the quality of services being provided by the program. C. The quality assurance and improvement program shall: (1) Focus on: (a) The needs, expectations, and satisfaction of patients and their families; and (b) All services provided by the hospice care program; (2) Have outcomes and results that are measurable and which may be incorporated into systemic changes in the program's operation; (3) Require the systematic collection, review, and evaluation of information and data and the analysis of trends identified through the quality assurance process; (4) Require that regular reports are prepared and reviewed by the governing body and appropriate personnel; (5) Provide for prompt and appropriate response to incidents when the patient's health and safety is at risk; and (6) Include proactive strategies to improve the quality of services. D. The hospice care program shall: (1) Establish goals and standards to measure the quality of the services being delivered and define how these standards are measured; (2) Maintain records to demonstrate the effectiveness of its quality assurance activities; (3) Implement changes based upon results of the evaluated data; for example, when problems are identified in the provision of services, the hospice care program shall document corrective actions taken, including ongoing monitoring, revisions of policies and procedures, and educational interventions; (4) Identify the individual responsible for performing the quality assurance functions as set forth in this regulation; and (5) Review the quality assurance and improvement program at least annually and make revisions as necessary. E. The hospice care program shall be held accountable by the governing body for accomplishing the goals and standards that are established as part of the quality assurance and improvement system. F. Utilization Review. (1) The hospice care program shall have a written plan for monitoring the allocation and utilization of patient and family services in order to identify and resolve concerns relating to the allocation and utilization of these services. The plan shall include: (a) Goals and objectives for utilization review; (b) Use of objective written criteria or treatment protocols to guide decisions about utilization of services; (c) The analysis of the need for services; (d) Time frames for review; (e) Methods for identifying utilization review concerns and mechanisms for resolving problems; and (f) A confidentiality policy consistent with legal and regulatory requirements. (2) The hospice care program shall review the utilization review plan at least annually and make revisions as necessary. (3) The plan shall include a monitoring protocol to address the following utilization concerns: (a) The appropriateness of the services being provided, including the level of intensity; (b) Patient admissions, including delays in the admission process; and (c) Delays in the provision of services and specific treatment modalities. (4) When the hospice care program identifies utilization problems, the hospice care program shall document corrective actions taken, including ongoing monitoring and educational interventions, as well as revisions to policies and procedures, and changes in the provision of services. (5) Reports to the Secretary. (a) Within 90 days after the close of a hospice care program's fiscal year, the hospice care program shall submit to the Department a report of the services it provided during the last fiscal year. (b) The report shall include the: (i) Types of services the hospice care program provided; (ii) Number of patients provided each type of service; (iii) Number of family members provided each type of service; and (iv) Changes in the number of patients or family members provided services from the previous year. #### Regulation .10 The Interdisciplinary Plan of Care. *COMAR 10.07.21.10* A. The interdisciplinary team shall develop a written plan of care for each patient and family. The plan of care shall reflect current standards of practice. The hospice care program shall document the attending physician's participation in the development, revision, and overall approval of the plan of care. B. The interdisciplinary plan of care shall reflect continuing communication between the attending physician and other members of the interdisciplinary care team. The interdisciplinary plan of care shall be reviewed, and revised if necessary, at least: (1) Every 14 days after admission for home-based hospice services; and (2) Every 7 days after admission for inpatient hospice services. C. The interdisciplinary plan of care shall recognize the patient's and family's psychological, social, religious, and cultural values. D. The interdisciplinary plan of care shall reflect efforts that the hospice care program staff and volunteers have made to: (1) Maximize patient independence; (2) Deliver services at the convenience of the patient, family, and caregiver; (3) Arrange respite services for caregivers; (4) Bridge gaps in the patient's care giving network; and (5) Adapt the home environment to meet the patient's physical needs. E. The interdisciplinary plan of care shall be based on the initial assessments conducted by interdisciplinary care team members. F. The hospice care program shall encourage the patient and family to participate in developing and implementing the interdisciplinary plan of care. G. Contents. The interdisciplinary plan of care shall include, at a minimum: (1) Identification of patient and family problems and needs; (2) Identification of realistic and achievable goals, objectives, and outcomes; (3) The frequency and mix of services, including bereavement needs; (4) The level of care to be provided; (5) Prescribed medication and treatments; and (6) Required medical equipment. H. Bereavement Plan. (1) The hospice care program shall initiate a written plan of bereavement intervention at the time of admission to the hospice which shall be incorporated into the patient's plan of care. (2) The bereavement plan shall be based on an assessment of the needs of the family and shall recognize the family's social, religious, and cultural values. (3) At a minimum, the bereavement plan shall include the: (a) Scope and frequency of bereavement services; and (b) Family's acceptance of bereavement services. #### Regulation .11 Continuity of Care. *COMAR 10.07.21.11* A. The hospice care program shall coordinate care to ensure continuity of care for the patient and family. B. Any changes in service delivery are to be based on an assessment of the patient's and family's needs and desires for hospice services and a hospice care program's transfer and discharge criteria. C. The hospice care program shall: (1) Provide case management for the patient and family; (2) Maintain an accurate, complete, and documented record of services and activities provided to the patient and family; (3) Collaborate with other organizations and individuals providing care to the patient and family to ensure coordination of services; (4) Provide on-call medical and nursing services in response to patient and family needs; (5) Ensure the safety of staff and inform the patient and family of any personnel, service, or access limitations; and (6) Have reporting mechanisms to keep all staff informed and updated about patient care changes to ensure continuity and coordination of care among interdisciplinary team members. #### Regulation .12 Transfer or Discharge. *COMAR 10.07.21.12* A. If the hospice care program does not provide inpatient hospice services directly, the hospice care program shall have a written transfer agreement with a hospice care program which provides those services. B. The hospice care program shall provide adequate and appropriate information about the patient and family at the time of transfer or discharge. C. When a patient and family transfers from one hospice care program to another or from home-based service to inpatient service, or vice versa, the current care provider shall provide a written summary of: (1) The services being provided; (2) The specific medical, psychosocial, spiritual, or other problems that require intervention or follow-up; and (3) Any scheduled follow-up by a current interdisciplinary care team member. D. The hospice care program shall document the specific reasons for transferring or discharging a patient from its program. These reasons may include: (1) The patient moves from the service area; (2) There is a change in terminal status; (3) The patient and family are unwilling to comply with the interdisciplinary plan of care or consistently act in a way which compromises the standards of care; (4) Issues of patient safety cannot be resolved; (5) Issues of staff safety cannot be resolved; or (6) Patient and family desire for discharge. E. The hospice care program shall prepare a written discharge summary which shall be provided to the patient or the patient's family before the patient's discharge. F. Before discharge, the hospice care program shall assess the patient's and family's continuing care needs and make referrals to appropriate services. #### Regulation .13 Physician Services. *COMAR 10.07.21.13* A. Medical Director. The hospice care program shall have a medical director who shall be: (1) A physician licensed to practice medicine in this State; and (2) Knowledgeable about the psychosocial and medical aspects of hospice care. B. Medical Director Duties. The medical director is responsible for: (1) Reviewing, coordinating, and managing the clinical and medical care for all patients in the hospice care program; (2) Consulting with attending physicians regarding pain and symptom control; (3) Reviewing patient eligibility for hospice services; (4) Acting as the medical resource for the interdisciplinary team; (5) Acting as the liaison to physicians in the community; and (6) Designating a physician to contact in case the medical director is unavailable. C. Attending Physician. An attending physician shall provide initial and ongoing medical services to the patient and participate in the development of the interdisciplinary plan of care. D. Attending Physician Duties. At a minimum, the attending physician shall provide the following information before the patient is admitted to the hospice care program: (1) Admitting diagnosis and prognosis; (2) Current medical findings; (3) Dietary restrictions; (4) Medication and treatment orders, including instructions for symptom management; and (5) Information concerning the medical management of patient conditions unrelated to the terminal illness. E. The hospice care program shall ensure that the attending physician designates another physician to contact in case the attending physician is unavailable. #### Regulation .14 Nursing Services. *COMAR 10.07.21.14* A. Nursing services shall be provided by licensed or certified personnel, trained or experienced in hospice care and supervised by a registered nurse with training or experience in hospice nursing. All nursing services shall be provided in accordance with the requirements of Health Occupations Article, Title 8, Annotated Code of Maryland. B. The hospice care program shall provide nurse staffing levels based on: (1) An assessment of patient and family care needs; (2) The experience level of the nursing staff available to provide services; and (3) Available assistance from support service staff. C. The hospice care program shall provide nursing services in accordance with each patient's interdisciplinary plan of care. D. Registered Nurse. A registered nurse shall: (1) Conduct the initial assessment of the patient; (2) Regularly reevaluate the patient's nursing needs; (3) Initiate the plan of care and necessary revisions; (4) Prepare clinical and progress notes, coordinate services, and inform the physician and other personnel of changes in the patient's condition and needs; (5) Inform the patient and family in regard to the patient's nursing needs; and (6) Supervise other nursing personnel. E. The initial assessment or any reevaluation of the patient's care needs may not be conducted by a licensed practical nurse or nursing assistant. Licensed practical nurses and nursing assistants shall provide all services in accordance with the patient's interdisciplinary plan of care. #### Regulation .15 Ancillary Services. *COMAR 10.07.21.15* A. The hospice care program shall have a written plan for the provision of pharmacy, laboratory, radiology, chemotherapy, and other ancillary services. When the service is provided by an organization other than the hospice care program, the hospice care program shall enter into a written agreement with the provider of ancillary services which specifies the services being provided and the procedures for accessing those services. B. The hospice care program shall ensure that ancillary services are provided in accordance with federal and State laws and regulations. C. Pharmacy Services. (1) The hospice care program shall employ or contract with a licensed pharmacist to: (a) Supervise all pharmacy services; (b) Serve as a consultant to the interdisciplinary care team; and (c) Ensure that all drugs and biologicals are prescribed, dispensed, administered, stored, and disposed of in accordance with applicable laws and regulations. (2) The hospice care program shall have a system to obtain and provide drugs on an emergency basis, 24 hours per day, 7 days a week. (3) The hospice care program shall maintain a drug profile for each patient and conduct periodic drug reviews and monitoring of each patient. (4) The hospice care program shall ensure that the interdisciplinary care team and the patient and the patient's family are made aware of each medication prescribed for the patient and are given any instructions concerning the administration of prescribed medications. #### Regulation .16 Counseling Services. *COMAR 10.07.21.16* A. Counseling Services. The hospice care program shall provide counseling services which address the needs of patients and families. The hospice care program shall provide counseling services as set forth in §§B—E of this regulation. B. Social Work Services. Social work services are to be based on an initial and continuing assessment of patient and family psychosocial needs. Each assessment shall be conducted by a social worker. Services shall be provided in accordance with each patient's interdisciplinary plan of care with the goal of assisting the patient and family in adjusting to the psychosocial aspects of terminal illness. C. Spiritual Services. The hospice care program shall provide spiritual services that are based on an initial, ongoing assessment of the spiritual needs of the patient and family. Spiritual services are to be consistent with patient and family beliefs and desires. These services shall be provided by a member of the interdisciplinary care team or by local clergy or spiritual counselors. D. Nutritional Counseling. The hospice care program shall provide nutritional counseling to the patient and family. This counseling shall be provided by either a registered nurse, registered dietitian, or licensed nutritionist as specified in the interdisciplinary plan of care. E. Bereavement services shall be provided as set forth in Regulation .10H of this chapter. #### Regulation .17 Emergency Services. *COMAR 10.07.21.17* A. The hospice care program shall ensure that emergency services are available 24 hours per day, 7 days a week. B. Emergency services are to include, at a minimum: (1) Registered nurse and physician services; (2) Palliative medications; and (3) Other services, equipment, and supplies necessary to meet the patient's immediate needs as directed by the patient's plan of care. #### Regulation .18 Volunteer Services. *COMAR 10.07.21.18* A. The hospice care program's volunteer services shall play a vital role in enhancing the quality of care delivered to the patient and family by encouraging community participation in the overall hospice care program. B. Volunteers may assist with patient care and administrative services consistent with the hospice care program's policies and in accordance with the requirements of this regulation. C. Volunteers shall document their activities in the clinical record. D. Volunteers shall comply with personnel policies and procedures. #### Regulation .19 Medical Records. *COMAR 10.07.21.19* A. The hospice care program shall establish and maintain a clinical record for each patient in accordance with accepted principles of practice for maintaining medical records. The record is to be complete, accurately documented, readily accessible, and systematically organized to facilitate retrieval of information. B. The hospice care program shall: (1) Document clinical and progress notes in a patient's medical record within 14 days of a visit or provision of services; (2) Obtain the attending physician's signature on an order within 30 days of receiving a verbal order; and (3) Close a medical record within 30 days of a patient's discharge. C. Access to or release of a patient's medical record by the hospice care program is permitted only with the consent of the patient or the patient's representative, or as required by law. D. If services are not provided directly by the hospice care program, the hospice care program shall obtain a copy of the applicable medical record or written summary of services provided and maintain it in the hospice care program's medical record. #### Regulation .20 Patient's Representative. *COMAR 10.07.21.20* A. A hospice care program shall recognize the authority of: (1) A guardian of the person under Estates and Trusts Article, §13-705, Annotated Code of Maryland; (2) A guardian of the property under Estates and Trusts Article, §13-201, Annotated Code of Maryland; (3) An advance directive established in compliance with Health-General Article, §5-602, Annotated Code of Maryland; (4) A surrogate decision maker with authority under Health-General Article, §5-605, Annotated Code of Maryland; (5) A power of attorney that meets the requirements of Estates and Trusts Article, §13-601, Annotated Code of Maryland; (6) A representative payee or other similar fiduciary; or (7) Any other person, if that person was designated by a patient who was competent at the time of designation, and the patient or representative has provided the hospice care program with documentation of the designation. B. The hospice care program may not recognize the authority of the patient's representative if the representative attempts to exceed the authority: (1) Stated in the instrument that grants the representative authority; or (2) Established by State law. C. The hospice care program shall document in the patient's record the name of the representative, including a copy, when applicable, of the designation. #### Regulation .21 Patient's Rights. *COMAR 10.07.21.21* A. The hospice care program shall provide the patient or representative with a written notice of the patient's rights in advance of furnishing care. Documentation verifying receipt of and understanding of this information shall be included as part of the patient's record. B. The patient has the right to: (1) Be treated with consideration and respect for individual dignity; (2) Confidentiality in all aspects of service or treatment; (3) Privacy; (4) Be free from physical or mental abuse; (5) Participate in the planning of the patient's hospice care; (6) Formulate advance directives as provided under State law; (7) Have all personal property treated with respect; (8) Refuse care and services, including continued participation in the hospice care program; (9) Be informed of short-term inpatient care options available for pain control, management, and respite; (10) Be informed of the hospice care program's discharge policy; (11) Make complaints or grievances to the hospice care program, government agencies, or other persons without threat or fear of retaliation; and (12) Be informed orally and in writing, before care is initiated, of the extent to which payment may be expected from the patient, third-party payers, and any other source of funding known to the hospice care program. C. The hospice care program shall ensure that all employees and volunteers respect the rights of a patient. #### Regulation .22 Complaint Procedure. *COMAR 10.07.21.22* A. A hospice care program shall establish a procedure under which a patient or family member may make a complaint to a representative of the hospice care program. B. The hospice care program shall investigate and seek to resolve the complaint. C. The hospice care program shall maintain documentation which reflects findings of the investigation and efforts to resolve the complaint. D. The hospice care program shall inform each patient and family of: (1) Its complaint procedure; and (2) The address and telephone number of the Department's Licensing and Certification Administration. E. The Department may conduct investigations of complaints involving alleged violations of this chapter. #### Regulation .23 Infection Control. *COMAR 10.07.21.23* A. The hospice care program shall have an infection control program in all care settings. B. There is to be a written plan for identifying, preventing, and controlling the spread of infection, which includes: (1) Identifying an individual responsible for implementing and monitoring the infection control program; (2) Establishing a system for periodic review and update of infection control policies and procedures governing at a minimum: (a) Personal hygiene; (b) Aseptic and isolation techniques; (c) Supplies, medication, and food storage; and (d) Waste disposal; (3) Reviewing patient and family caregiver practices to identify potential exposure to infection; and (4) Ensuring that the infection control program is monitored, reviewed, and evaluated regularly at specified intervals. #### Regulation .24 Safety and Emergency Preparedness. *COMAR 10.07.21.24* A. The hospice care program shall have a safety and emergency preparedness program that includes, at a minimum: (1) A plan for reporting, monitoring, and following up on all accidents, injuries, and safety hazards; (2) Education for patient and family caregivers, employees, and volunteers in the safe use of medical equipment; (3) Evidence that equipment maintenance and safety requirements have been met; and (4) A safe and sanitary system for identifying, handling, and disposing of special medical wastes that meets the requirements of COMAR 10.06.06. B. The hospice care program shall ensure that the emergency preparedness program provides appropriate continuous support and care to patients and families and other caregivers during natural or man-made disasters. C. The hospice care program shall monitor, review, and evaluate the safety and emergency preparedness program at regularly specified intervals. #### Regulation .25 Home-Based Hospice Care Provided in a Licensed Health Care Facility. *COMAR 10.07.21.25* A. Professional Management. (1) When a hospice care program delivers hospice care to a resident of a licensed health care facility, the hospice care program shall assume full responsibility for professional management of the patient's hospice care in accordance with the requirements of this chapter. (2) When a hospice care program delivers hospice care to a resident of a licensed health care facility, the hospice and the facility shall have a written agreement which defines their respective roles and responsibilities in regard to the care of the patient. (3) The hospice care program shall designate a qualified health care professional from the hospice care program who shall coordinate the activities of the interdisciplinary care team and the health care facility staff to assure continuous assessments of the patient's and family's needs, and to ensure implementation of an integrated plan of care. (4) All core hospice services, specifically, physician, nursing, social work, and counseling services identified in the plan of care, shall be provided directly by hospice care program employees or volunteers and may not be delegated to the health care facility. B. Plan of Care. (1) The interdisciplinary plan of care shall be jointly developed by the patient, the patient's family, the hospice care program, and the licensed health care facility, and shall identify the services to be provided by each entity. (2) Both providers shall review the interdisciplinary plan of care at intervals specified in the plan, and shall jointly update the plan as necessary to reflect the patient's current status. (3) Both the hospice care program and the health care provider shall maintain the interdisciplinary plan of care in their respective medical records. #### Regulation .26 Inpatient Hospice Care. *COMAR 10.07.21.26* A. In addition to the other requirements of this chapter, when a hospice care program delivers inpatient care, the hospice care program shall provide nursing services 24 hours a day in a manner sufficient to meet the total nursing needs identified in the patient's plan of care. A registered nurse shall be on duty during each shift. B. The hospice care program shall design and equip all areas for the comfort and privacy of patients and family members. Specifically, the hospice care program shall: (1) Provide accommodation for family members to remain with the patient throughout the night; (2) Provide an adequate supply of hot water at all times for patient use; (3) Have available at all times a quantity of linen sufficient for proper care and comfort of patients; (4) Make provisions for isolating patients with infectious diseases; and (5) Provide privacy for patient/family visitation and accommodations for the family's privacy immediately after a patient's death. C. The hospice care program shall provide food services designed to meet the nutritional needs of the patients, in accordance with physician orders and the following guidelines: (1) At least three meals shall be served each day with not more than 14 hours between the evening meal and breakfast, unless otherwise prescribed by the patient's physician; (2) All foods shall be stored, prepared, and served as required by COMAR 10.15.03; and (3) Medically prescribed special diets shall be planned by a registered dietitian or licensed nutritionist. D. In addition to all other State and federal requirements, all medications shall be labeled, stored, and administered in accordance with the following: (1) All medications shall be ordered by a physician; (2) All medications shall be administered by a licensed nurse or physician; (3) All medications shall be labeled in accordance with Health-General Article, §21-221(a), Annotated Code of Maryland, 21 U.S.C. §§301 et seq. and 801 et seq.; (4) All medications shall be stored in locked compartments under proper temperature control and all schedule II drugs shall be maintained separately from other medications and secured by use of two different locks; and (5) All medications no longer needed by the patient shall be destroyed in the presence of two witnesses authorized by the hospice care program. #### Regulation .27 Penalties. *COMAR 10.07.21.27* A. Administrative Penalty. (1) The Secretary may, for noncompliance with any regulation under this chapter, impose an administrative penalty of up to: (a) $500 for a first violation; and (b) $1,000 for a subsequent repeated violation. (2) When considering whether to impose an administrative penalty and the amount of the penalty, the Secretary shall consider the following factors: (a) The number, nature, and seriousness of the violations; (b) The extent to which the violation or violations are part of an ongoing pattern during the preceding 24 months; (c) The degree of risk, caused by the violation or violations, to the health, life, or safety of the patients; (d) The efforts made by, and the ability of, the licensee to correct the violation or violations in a timely manner; and (e) Other factors as justice may require. B. Emergency Suspension. (1) The Secretary may immediately suspend a license on finding that the public health, safety, or welfare imperatively requires emergency action. (2) The Department shall deliver a written notice to the hospice care program: (a) Informing it of the emergency suspension; (b) Giving the reasons for the action, and the regulation or regulations with which the licensee has failed to comply that forms the basis for the emergency suspension; and (c) Notifying the hospice care program of its right to request a hearing and to be represented by counsel. (3) The filing of a hearing request does not stay the emergency action. (4) When a license is suspended by emergency action: (a) The hospice care program shall immediately return the license to the Department; (b) The hospice care program shall stop providing hospice services immediately; and (c) The licensee shall notify the patients or their representatives of the suspension and make every reasonable effort to assist them in making other hospice service arrangements. (5) In the event of an emergency suspension, the Department may assist in the relocation of patients. (6) A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .28 of this chapter. (7) The Office on Administrative Hearings shall conduct a hearing as set forth in Regulation .28 of this chapter and issue a proposed decision within 10 business days of the close of the hearing record. Exceptions may be filed by an aggrieved person pursuant to COMAR 10.01.03. The Secretary shall make a final decision pursuant to COMAR 10.01.03. (8) If the Secretary's final decision does not uphold the emergency suspension, the hospice care program may resume operation. C. Suspension or Revocation of License. (1) The Secretary, for cause shown, may suspend or revoke the hospice care program's license. (2) The Department shall notify the hospice care program in writing of the following: (a) The effective date of the suspension or revocation; (b) The reason for the suspension or revocation; (c) The regulations with which the licensee has failed to comply that form the basis for the suspension or revocation; (d) That the hospice care program is entitled to a hearing if requested, and to be represented by counsel; (e) That the hospice care program shall stop providing services on the effective date of the suspension or revocation if the hospice care program does not request a hearing; (f) That the suspension or revocation shall be stayed if a hearing is requested; and (g) That the hospice care program is required to surrender its license to the Department if the suspension or revocation is upheld. (3) The licensee shall notify the patients or their representatives of any final suspension or revocation and make every reasonable effort to assist them in making other hospice care arrangements. The Department may assist in the relocation of residents. (4) A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .28 of this chapter. #### Regulation .28 Hearings. *COMAR 10.07.21.28* A. A request for a hearing shall be filed with the Office of Administrative Hearings, with a copy to the Licensing and Certification Administration of the Department, not later than 30 days after receipt of notice of the Secretary's action. The request shall include a copy of the Secretary's action. B. A hearing requested under this chapter shall be conducted in accordance with State Government Article, §10-210 et seq., Annotated Code of Maryland, and COMAR 28.02.01 and 10.01.03. C. The burden of proof is as set forth in COMAR 10.01.03.28. D. Unless otherwise stated in this chapter, the Office of Administrative Hearings shall issue a proposed decision within the time frames set forth in COMAR 28.02.01. E. The aggrieved person may file exceptions as set forth in COMAR 10.01.03.35. F. A final decision by the Secretary shall be issued in accordance with COMAR 10.01.03.35. ### Chapter 22 — Hospice Care Programs: Hospice House Requirements **Authority:** Health-General Article, §19-903, Annotated Code of Maryland **Administrative History:** Effective date: June 10, 2013 (40:11 Md. R. 975) #### Regulation .01 Scope and Purpose. *COMAR 10.07.22.01* A. This chapter is effective January 1, 2014. B. This chapter applies to all general hospice care programs that operate a hospice house. C. An operator of a hospice house shall also comply with all the requirements contained in COMAR 10.07.21 that are applicable to general hospice care programs. #### Regulation .02 Definitions. *COMAR 10.07.22.02* A. In addition to the definition contained in §B of this regulation, definitions set forth in COMAR 10.07.21.02 are applicable to this chapter. B. Terms Defined. (1) “Hospice house” means a residence operated by a Maryland licensed general hospice care program that provides home-based hospice services to hospice patients in a home-like environment and the care is not billed as general inpatient care. (2) “Primary hospice nurse” means the registered nurse who is assigned to oversee the nursing care of an individual hospice patient from the time of admission until the time of discharge. #### Regulation .03 Incorporation by Reference. *COMAR 10.07.22.03* In this chapter, the following document is incorporated by reference: NFPA 101, The Life Safety Code, as adopted by the State Fire Prevention Commission in COMAR 29.06.01. #### Regulation .04 License Required. *COMAR 10.07.22.04* A person may not operate a hospice house without first obtaining a license to operate a general hospice care program. #### Regulation .05 Staffing Plan. *COMAR 10.07.22.05* A. Following an analysis of the number of beds the hospice house intends to serve and the individual needs of each resident, the general hospice care program shall develop a staffing plan that identifies the type and number of staff needed to provide the services required by this chapter. B. The staffing plan shall include on-site staff sufficient in number and qualifications to meet the 24-hour scheduled and unscheduled needs of the residents. C. Relief personnel shall be available at all times in the event that the regularly scheduled staff members are unavailable. D. The staffing plan shall be reviewed annually and as needed. #### Regulation .06 Management of the Hospice House. *COMAR 10.07.22.06* A. The administrator of the general hospice care program shall identify a manager of the hospice house who has full responsibility for the day-to-day operations of the hospice house. B. The administrator shall evaluate the manager’s performance on an annual basis. C. In the absence of the hospice house manager, the hospice house shall remain under the continuous supervision of a designated individual with appropriate experience and training. #### Regulation .07 Staff Qualifications. *COMAR 10.07.22.07* A. The hospice house shall be staffed by sufficient numbers of personnel to ensure that the hospice house is capable of meeting the requirements of this chapter, and all applicable federal, State, and local laws and regulations. B. In addition to meeting all of the other qualifications and requirements for hospice employees, all hospice house staff shall participate in an orientation program and annual training to ensure competency in maintaining the hospice house and meeting the needs of residents in accordance with the plan of care. C. Staff who administer medications to residents shall meet all requirements of the Maryland Board of Nursing or Maryland Board of Physicians. D. Documentation of all required training shall be included in the employee’s personnel record. #### Regulation .08 Admission Requirements. *COMAR 10.07.22.08* A hospice patient appropriate for care in their own home who does not require general inpatient services may be eligible for care in a hospice house, in accordance with the hospice house admission policy. #### Regulation .09 Residential Agreement. *COMAR 10.07.22.09* A. Patients admitted to the hospice house or their representatives shall sign, before or at the time of admission, a patient agreement that: (1) Is a clear and complete statement of commitments agreed to by the parties and the services provided in the hospice house; (2) Is accurate, legible, and communicated in a language understandable to patient and family; and (3) Conforms to all applicable federal, State, and local laws and requirements. B. The residential agreement shall include, at a minimum: (1) The services to be provided by the hospice house; (2) An explanation of the hospice house’s complaint or grievance procedure; (3) Procedures to be followed in transferring the patient to another facility; (4) The availability of secure storage of patient’s belongings; (5) The patient’s and family’s rights and obligations concerning use of the hospice house, including common areas; (6) Written plan and provisions for continued emergency preparedness services; (7) An acknowledgement that the patient or the patient’s representative has reviewed all hospice house rules, requirements, restrictions, or special conditions that the general hospice program will impose on the patient; and (8) Admission and discharge policies and procedures including: (a) Those actions, circumstances or conditions which may result in the patient’s discharge from the hospice house; (b) The procedures which the hospice house shall follow if it intends to discharge a patient without the patient’s agreement, thereby terminating the residential agreement; and (c) The procedures which the patient shall follow if the patient wishes to terminate the residential agreement. C. The residential agreement shall include financial provisions, which include at a minimum: (1) Rate structure and payment provisions covering: (a) All rates to be charged to the patient, including but not limited to any non-service related charges; and (b) Payment arrangements and fees, if known, for third-party services not covered by the residential agreement, but arranged for by either the patient, patient’s representative, or the hospice house; and (2) Obligations of the hospice house and the patient, or the patient’s representative, as to: (a) Handling the finances of the patient; (b) Arranging and contracting for services not covered by the patient agreement; (c) Disposition of the patient’s property upon discharge or death of the patient; (d) Identification of the persons responsible for payment of all fees and charges and a clear indication of whether the person’s responsibility is or is not limited to the extent of the patient’s funds; (e) Fair and reasonable billing, payment, and credit policies; (f) The procedures the hospice house will follow in the event the patient or representative can no longer pay for services provided for in the patient agreement or for services or care needed by the patient; and (g) Terms governing the refund of any prepaid fees or charges in the event of a patient’s discharge from the hospice house or termination of the patient agreement. D. The hospice house shall maintain the patient agreement in the patient’s record. #### Regulation .10 Patient Record. *COMAR 10.07.22.10* The hospice house shall: A. Maintain the privacy and confidentiality of a patient’s medical records; B. Release medical records or medical information about a patient only with the consent of the patient or patient’s representative, or as permitted by Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland; and C. Maintain and dispose of a resident’s medical records in accordance with Health-General Article, Title 4, Subtitle 4, Annotated Code of Maryland. #### Regulation .11 Food. *COMAR 10.07.22.11* A. A patient’s food preferences shall be assessed at the time of admission. The assessment shall be maintained in the patient record. B. Patients shall be provided meals and snacks as requested. C. Patients shall be offered 3 meals and additional snacks during each 24-hour period, 7 days a week in accordance with their individual daily nutritional needs and preferences and consistent with their plan of care. D. Food that is prepared at the hospice house shall be prepared in accordance with all State and local sanitation and safe food handling requirements. E. Food preparation areas are to be maintained in accordance with all State and local sanitation and safe food handling requirements. F. Hospice house staff shall prepare or arrange for the provision of special diets consistent with the plan of care. G. Hospice house staff shall obtain food from sources that comply with all local laws and regulations relating to food, food processing, food handling, and food labeling. H. Hospice house staff shall protect food from contamination while being stored, prepared, displayed, served, or transported. I. Hospice house staff shall promptly discard the following: (1) Spoiled food; (2) Swelled, rusty, or leaky canned food; and (3) Foods exposed to fire, smoke, or water damage. J. The hospice house staff shall maintain kitchen surfaces, floors, walls, storage areas, equipment, appliances, and utensils in a clean and sanitary manner and in good repair. K. The hospice house staff shall provide refrigerator and freezer units operated in compliance with the manufacturer’s specifications. #### Regulation .12 Personal Care Services. *COMAR 10.07.22.12* The hospice house staff shall provide all necessary personal care services to the patient in accordance with the plan of care and as desired by the patient. #### Regulation .13 Medication Management and Administration. *COMAR 10.07.22.13* A. All medications shall be administered consistent with applicable requirements of COMAR 10.27.11. B. Medications and treatments shall be administered consistent with current medical orders and using acceptable professional standards of practice. C. All medications shall be stored in a secure location, at proper temperature. D. Each patient’s medications shall be stored in the original dispensed container; E. Each patient shall receive the medications that have been specifically prescribed for that patient in the manner that has been ordered. F. The hospice house staff shall document and report to the patient’s primary hospice nurse or the hospice nurse on call any symptoms or pain that are not relieved by the current medications and other interventions. G. The hospice house staff shall document and report to the patient’s primary hospice nurse or the hospice nurse on call any undesired side effects, adverse drug reactions, or medication errors. H. The medication administration documentation required under this regulation shall be recorded by a staff member at the time that the patient takes or receives medications on a medication administration report. This documentation shall be maintained in the patient record and include at minimum: (1) Name of the patient; (2) Date of birth; (3) Diagnosis; (4) Allergies; (5) Significant adverse drug reactions; (6) Name of the medication; (7) Reason for the medication; (8) Dose; (9) Authorized prescriber’s name; (10) Date of issuance, and (11) Directions for use. I. Accounting for Narcotic and Controlled Drugs. (1) The hospice house staff shall count and record controlled drugs at shift changes. (2) All controlled substances and all medications with a high abuse potential in the hospice house’s location shall be maintained under a double lock system. #### Regulation .14 Incident Reports. *COMAR 10.07.22.14* A. The staff of the hospice house shall complete an incident report in accordance with hospice policy within 24 hours of having knowledge that an incident has occurred. B. All incident reports shall include: (1) Time, date, place, and individuals present; (2) Complete description of the incident; (3) Response of the staff at the time; and (4) Follow up action, including notification to the: (a) Patient’s primary hospice nurse or hospice nurse on call; (b) Patient’s representative or family; (c) Patient’s attending physician or nurse practitioner; (d) Hospice medical director; and (e) Licensing or law enforcement authorities, when appropriate. #### Regulation .15 Relocation and Discharges. *COMAR 10.07.22.15* A. Relocation within the Facility. The hospice house may not relocate a patient within the facility except in accordance with the terms and conditions of the residential agreement. B. Discharge. (1) Discharge of a patient without the consent of the patient or the patient’s representative shall be in accordance with the residential agreement. (2) When the patient is discharged or transferred to another facility, the hospice house shall provide to the receiving facility all information that is required to ensure that continuity of care and services is maintained. (3) Within 30 days of the date of discharge, the hospice house shall: (a) Give the patient or patient’s representative a final statement of account and refunds due; and (b) Return any money, property, or valuables held in trust or custody by the hospice house. #### Regulation .16 Patient’s Rights. *COMAR 10.07.22.16* A. In addition to all other rights as a hospice patient, the patient residing in a hospice house has the right to: (1) Privacy, including the right to have a staff member knock on the patient’s door before entering; (2) Be free from mental abuse, verbal abuse, sexual abuse, physical abuse, neglect, involuntary seclusion, and exploitation; (3) Be free from physical and chemical restraints; (4) Manage personal financial affairs; (5) Maintain legal counsel; (6) Attend or not attend religious services as the patient chooses, and receive visits from members of the clergy; (7) Possess and use personal clothing and other personal effects to a reasonable extent, and to have reasonable security for those effects in accordance with the hospice house’s security policy; (8) Retain personal clothing and possessions as space permits with the understanding that the hospice house may limit the number of personal possessions retained at the facility for the health and safety of other patients; (9) Meet or visit privately with any individual the patient chooses in accordance with patient and facility safety; and (10) Have reasonable access to the private use of a telephone within the facility. B. Notice of Patient’s Rights. The hospice house shall: (1) Place a copy of the patient’s rights as set forth in this regulation, in a conspicuous location, plainly visible and easily read by patients, staff, and visitors; and (2) Provide a copy to the patient and patient’s representative on admission. #### Regulation .17 Abuse, Neglect, and Exploitation. *COMAR 10.07.22.17* A. The hospice house shall develop and implement policies and procedures prohibiting abuse, neglect, and exploitation of hospice house patients. B. Reports of Abuse, Neglect, or Exploitation. An employee of the hospice house who believes that a patient has been subjected to abuse, neglect, or exploitation shall report the alleged abuse, neglect, or exploitation within 24 hours to: (1) The appropriate local Department of Social Services, Adult Protective Services office, or Child Protective Services; and (2) One of the following: (a) A local law enforcement agency; or (b) The Office of Health Care Quality. C. Investigations. The hospice house shall: (1) Thoroughly investigate all allegations of abuse, neglect, or exploitation and maintain on-site written documentation of the investigation; and (2) Take appropriate action to prevent further incidents of abuse, neglect, or exploitation while the investigation is in progress. D. Immunity from Civil Liability; An individual who, acting in good faith, makes a report under this regulation has immunity from liability as described in Health-General Article, §19-347(g), Annotated Code of Maryland. E. Notice. The hospice house shall post signs that set forth the reporting requirements stated in §B of this regulation, conspicuously in the employee and public areas of the facility. #### Regulation .18 Restraint or Seclusion. *COMAR 10.07.22.18* A. A hospice house shall develop a policy and procedure related to restraint and seclusion. B. Relevant staff shall be trained in accordance with the facility’s policy and procedure related to restraint and seclusion. C. Patients have the right to be free from restraint or seclusion of any form which are imposed as a means of coercion, discipline, convenience, or retaliation by staff. D. Restraint or seclusion may only be imposed to ensure the immediate physical safety of the patient, a staff member, or others and shall be discontinued at the earliest possible time. E. The type or technique of restraint or seclusion used shall be the least restrictive intervention that will be effective to protect the patient, a staff member, or others from harm. F. The use of restraint or seclusion shall be: (1) In accordance with a written modification to the patient’s plan of care; and (2) Implemented in accordance with safe and appropriate restraint and seclusion techniques as determined by hospice policy in accordance with applicable laws. G. All restraints shall be ordered by a physician and shall specify: (1) The purpose of the restraint; (2) The type of restraint to be used; and (3) The length of time the restraint shall be used. H. Restraint and seclusion orders may not be on an as-needed basis. I. A patient may not remain in a restraint for more than 2 hours without a change in position and toileting opportunity. J. The patient’s primary hospice nurse or hospice nurse on call and hospice medical director or physician designee shall be consulted as soon as possible after the implementation of any restraint or seclusion to, as applicable: (1) Review and modify the plan of care; and (2) Determine if the hospice house is an appropriate setting for the patient at this time. K. The program shall notify the patient’s family or the patient’s representative each time a restraint is used. #### Regulation .19 General Physical Plant Requirements. *COMAR 10.07.22.19* A. The facility, which includes buildings, common areas, and exterior grounds, shall be kept: (1) In good repair; (2) Clean; (3) Free of any object, material, or condition that may create a: (a) Health hazard, accident, or fire; or (b) Public nuisance; and (4) Free of insect infestations and rodents. B. The hospice house shall provide adequate storage space, which is protected from the elements, for: (1) Excess supplies; (2) Some personal possessions of patients; and (3) Any other items in the patient’s room. #### Regulation .20 Water Supply. *COMAR 10.07.22.20* A. Approved Source. A facility shall be served by water from an approved public water supply. If an approved public water supply is not available, a private water supply may be accepted if it is approved by the local jurisdiction in which the hospice house is located or a private certified vendor. B. Adequacy. The water supply shall be adequate in quantity and delivered under sufficient pressure to satisfactorily serve all fixtures in the facility. C. Hot Water Temperature. Hot water accessible to patients shall be blended externally to the hot water generator, by either individual point-of-use control valves of the anti-scald or thermostatic mixing valve type, to a maximum temperature of 120ºF and a minimum temperature of 110ºF at the fixture. #### Regulation .21 Sewage Disposal. *COMAR 10.07.22.21* The facility shall be served by an approved public sewage disposal system, if available. If an approved public sewage disposal system is not available, a private sewage disposal system may be accepted if approved by the local jurisdiction in which the program is located. #### Regulation .22 Security. *COMAR 10.07.22.22* The facility shall have policies and procedures in place to provide a secure environment for the patient, family, and staff. #### Regulation .23 Assist Rails. *COMAR 10.07.22.23* A. The hospice house shall provide assist rails in stairways used by patients and for all toilets, showers, and bathtubs used by patients. B. The hospice house with a licensed capacity of 17 or more beds shall also provide assist rails on both sides of corridors used by patients. #### Regulation .24 Emergency Preparedness. *COMAR 10.07.22.24* A. The facility shall be constructed consistent with: (1) All applicable local fire and building codes; and (2) The Life Safety Code, NFPA 101, including Chapter 24 of NFPA 101. B. Hand Extinguishers. Fire extinguishers shall be located on each floor and adjacent to, or in, special hazard areas, such as furnace rooms, boiler rooms, kitchens, or laundries. Fire extinguishers shall be of standard and approved types, and installed and maintained to be conveniently available for use at all times. The hospice house shall properly instruct staff in the use of fire extinguishers. C. Emergency Plan. (1) The hospice house shall develop an emergency plan that includes procedures that will be followed before, during, and after an emergency. The emergency plan shall address: (a) The evacuation, transportation, or shelter in-place of patients; (b) Notification to families, staff, and the Office of Health Care Quality regarding the action that will be taken concerning the safety and well-being of the patients; (c) Staff coverage, organization, and assignment of responsibilities; and (d) The continuity of operation, including: (i) Procuring essential goods, equipment, and services; and (ii) Relocation to alternate facilities. (2) The Hospice House shall have a signed agreement with the facility that will house the program’s patients during an emergency evacuation. (3) Upon request, the hospice house shall provide access to its emergency plan to local organizations for emergency management and for purposes of coordinating local emergency planning. (4) The hospice house shall prepare a summary of its evacuation procedures to provide to the patient, family member, or legal representative upon request. The summary shall, at a minimum: (a) List means of transportation to be used in the event of evacuation; (b) List alternative facilities to be used in the event of evacuation; (c) Describe means of communication with family members and legal representatives; and (d) Describe the role of the patient, family member, or legal representative in the event of evacuation. D. Evacuation Plans. The facility shall conspicuously post individual floor plans with designated evacuation routes on each floor. E. Emergency Electrical Power Generator. (1) Generator Required. A hospice house with 6 or more beds shall have an emergency electrical power generator on the premises. (2) Generator Specifications. The power source shall be a generating set and prime mover located on the program’s premises with automatic transfer. The emergency generator shall: (a) Be activated immediately when normal electrical service fails to operate; (b) Come to full speed and load acceptance within 10 seconds; and (c) Have the capability of 48 hours of operation from fuel stored on-site. F. Test of Emergency Power System. (1) The program shall test the emergency power system once each month. (2) During testing of the emergency power system, the generator shall be exercised for a minimum of 30 minutes under normal emergency facility connected load. (3) Results of the test shall be recorded in a permanent log book that is maintained for that purpose. G. The emergency power system shall provide lighting in the following areas of the facility: (1) Areas of egress and protection as required by COMAR 29.06.01 State Fire Prevention Code and Life Safety Code 101 as adopted by the State Fire Prevention Commission in COMAR 29.06.01; (2) Nurses’ station; (3) Medication area; (4) An area for emergency telephone use; (5) Boiler or mechanical room; (6) Kitchen; (7) Emergency generator location and switch gear location; (8) If applicable, elevator, if operable on emergency power; (9) If applicable, areas where life-support equipment is used; (10) If applicable, common areas or areas of refuge; and (11) If applicable, toilet rooms of common areas or areas of refuge. H. Emergency electrical power shall be provided for the following, if applicable: (1) Nurses’ call system; (2) At least one telephone in order to make and receive calls; (3) Fire pump; (4) Sewerage pump and sump pump; (5) If applicable, an elevator, if required, for evacuation purposes; (6) If necessary, heating equipment needed to maintain a minimum temperature of 70ºF (24ºC); (7) If applicable, life support equipment; and (8) Nonflammable medical gas systems. I. Common Areas or Areas of Refuge. If the emergency power system does not provide heat to all patient rooms and toilet rooms, the program shall provide common areas or areas of refuge for all patients. The areas shall meet the following requirements: (1) The common area or areas of refuge shall maintain a minimum temperature of 70ºF (24ºC); and (2) Heated toilet rooms shall be provided adjacent to the common areas or areas of refuge. J. Orientation. The hospice house shall: (1) Orient staff to the emergency plan and to their individual responsibilities within 24 hours of the commencement of job duties; and (2) Document completion of the orientation in the staff member’s personnel file through the signature of the employee. K. Drills. (1) Fire Drills. The hospice house shall: (a) Conduct fire drills at least quarterly on all shifts; and (b) Document completion of each drill. (2) Documentation. The hospice house shall: (a) Have the documentation referenced in §K(1)(b) of this regulation signed by all staff who participated in the drill; and (b) Maintain the documentation on file for a minimum of 2 years. L. Disaster Drill or Training Session. (1) The hospice house shall: (a) Conduct an annual disaster drill or training session, other than a fire drill, on all shifts; and (b) Document completion of each disaster drill or training session. (2) Documentation. The hospice house shall: (a) Have the documentation referenced in §L(1)(b) of this regulation signed by all staff who participated in the drill or training; and (b) Keep the documentation on file for a minimum of 2 years. #### Regulation .25 Smoking. *COMAR 10.07.22.25* The hospice house shall prohibit indoor smoking in accordance with COMAR 10.19.04 and COMAR 10.12.27. #### Regulation .26 Common Use Areas. *COMAR 10.07.22.26* A. Common Areas. The hospice house shall provide common areas for the use of patients and families. The common areas shall be of a size and furnished to accommodate the number of family members reasonably expected to attend the number of patients provided for by the hospice house capacity. B. Public Toilets. The hospice house shall provide public restrooms that are sufficient in number, and appropriately located, to serve family members and visitors. C. Dining Area. The hospice house shall provide a well-lit, adequately ventilated, and appropriately furnished dining area for the use of patients, families, and visitors. D. Kitchen. The hospice house shall have a kitchen that has adequate: (1) Storage, refrigerator, and freezer space for perishable and nonperishable foods; (2) Food preparation area or areas with cleanable surfaces; (3) Space and equipment to wash, sanitize, and store utensils; (4) Space to store and clean garbage cans within or outside the kitchen; (5) Ice making capabilities; and (6) Equipment for the preparation of food. #### Regulation .27 Patients’ Rooms and Furnishings. *COMAR 10.07.22.27* A. Patient rooms shall be of a size and with furnishings adequate for the hospice residence staff to provide care of the patient as required by the plan of care. B. Patient rooms shall provide accommodation for one family member to remain with the patient through the night. C. Patient rooms shall be for the private use of the assigned patient or patients. D. If a patient in a double occupancy room requests dividers, curtains, or screens between the beds to ensure privacy, the hospice house shall furnish them. E. The hospice house shall provide adequate closet or wardrobe space, conveniently located to allow each patient to keep personal items. #### Regulation .28 Bathrooms for Patients. *COMAR 10.07.22.28* A. Toilets. The hospice house shall provide toilets in a separate room or compartment with latching hardware for privacy. B. Lavatories. Buildings with one to eight occupants shall have a minimum ratio of one lavatory to four occupants. Buildings with nine or more occupants shall have a minimum ratio of one lavatory to four occupants and a minimum of one lavatory for each floor on which a patient room is located. C. Bathtubs or Showers. The hospice house shall provide patients with bathtubs or showers that are enclosed in a separate room or compartment that ensures privacy. #### Regulation .29 Illumination. *COMAR 10.07.22.29* A. The hospice house shall provide sufficient light to meet the patient’s needs. B. Common use areas, such as entrances, hallways, inclines, ramps, cellars, attics, storerooms, kitchens, and laundries, shall have sufficient artificial lighting to prevent accidents and promote efficient service. #### Regulation .30 Heating, Ventilation, and Air Conditioning. *COMAR 10.07.22.30* A. The hospice house may not use space heaters unless approved by the State or local fire authorities. B. Minimum Temperature. The facility shall have a system that provides in areas used by patients a minimum temperature of 70ºF in cold weather and a maximum temperature of 80ºF in hot weather. C. Temperature Control. The hospice house shall provide for each resident's room: (1) A thermostat; or (2) An approved mechanical device for modulating a room’s temperature, such as adjustable vanes in a hot air vent. D. The hospice house shall ensure that all rooms and areas have sufficient ventilation to prevent excessive heat, steam, condensation, smoke, and other noxious odors. The hospice house shall provide forced mechanical exhaust ventilation or an approved equivalent for: (1) All bathing compartments; (2) Toilet rooms; (3) Any area used for toileting; and (4) Soiled utility rooms. #### Regulation .31 Laundry. *COMAR 10.07.22.31* A. The hospice house shall furnish laundry service, either on-site or off-site. B. The hospice house shall ensure that the laundry is: (1) Adequate to meet the needs of the patients; (2) Processed and handled in a manner to prevent the spread of infection; and (3) Adequately sanitized by the use of sufficient hot water or appropriate chemical representatives, or a combination of both. C. The hospice house shall ensure that patient and facility laundry is washed and dried separately. D. Unless otherwise agreed by the program and the patient, dry cleaning services are not considered part of laundry services in this regulation. #### Regulation .32 Infection Control. *COMAR 10.07.22.32* A. The hospice house shall maintain an infection control program that protects patients, staff, and others by preventing and controlling infections and communicable diseases. B. The hospice house shall follow accepted standards of practice to prevent the transmission of infections and communicable diseases, including the use of standard precautions. C. The infection control program shall include the following: (1) Education of employees, contracted providers, patients, and family members about infection control, including their role in preventing the spread of infection and communicable diseases through daily activities; (2) Techniques for hand washing, respiratory protections, asepsis, as well as other means for limiting the spread of contagion; (3) Measures for the: (a) Screening and evaluation of health care workers, including all hospice staff, volunteers, and contract workers, including agency nurses and housekeeping staff for communicable diseases; and (b) Evaluation of staff and volunteers exposed to patients with non-treated communicable diseases; and (4) Monitoring staff for compliance with hospice policies and procedures related to infection control. #### Regulation .33 Pet Visitation. *COMAR 10.07.22.33* A. A hospice house shall have a policy and procedure related to pet visitations. B. Visiting dogs and cats shall have proof of a current rabies vaccination on file. C. If another patient has an allergy or a respiratory condition that is aggravated by an animal, the animal shall remain outside of areas where that resident may be. D. The hospice house has the right to restrict any pet from the hospice house.