The purpose of these regulations is: To promote the interests and general well-being of all patients of home health agencies providing service within the State; To protect those interests by a public declaration of support for a patient's bill of rights; and To assure that the treatment of patients is, at all times, fully consistent with the provisions of this Act. All terms used in these regulations shall have the same meaning as those used in the Act. Terms Defined. “Administrator” means an individual who has had: Formal education in health services or administration, as evidenced by being a: Physician, Registered nurse, or College graduate with a bachelor's or higher degree in a health-related field; and At least 1 year of supervisory experience in: Hospital management, Home health management, or Public health program management. “Clinical note” means a dated and signed notation, with service designation by a member of the health team, of a contact with a patient. “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. “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. “Department” means the Maryland Department of Health. “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. “Home health agency” means a health-related institution, organization, or a part of an institution that: Is owned or operated by one or more persons, whether or not for profit and whether as a public or private enterprise; and 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. “Home health aide” means a nonlicensed person who: Has: At least 1 year of practical experience in a hospital, nursing home, home care program; or Satisfactorily completed the Maryland Red Cross Home Care Course or an equivalent program; and Provides personal and health care services to an individual in the place of residence, under supervision of the appropriate health professional. “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. “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. “Parent agency” means the agency that develops and maintains administrative and professional control of the delivery of services either directly or through branch offices. “Physician” means a person who is currently authorized to practice medicine under Health Occupations Article, §1-101, Annotated Code of Maryland. “Professional advisory group” means a committee which includes: One currently licensed physician; One registered nurse; One representative providing input from each allied discipline utilized by the agency; and One consumer representative. “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. “Secretary” means the Secretary of Health. “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. “Skilled nursing services” means services provided by or under the supervision of a registered nurse and in accordance with the plan of treatment. “Utilization review” means a medical record review procedure designed to evaluate: The appropriateness of admissions; The efficiency and adequacy of provided services; and Length of stay and discharge practices. The applicant shall file an application for a license to operate a home health agency on forms provided by the Department. 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. 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. 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. 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. The home health agency shall: 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. Provide liability insurance to cover all employees. The agency shall also ensure that its contractual persons possess appropriate liability protection. Maintain records as determined by the Department and make the records available to the Department upon request. Accept patients for skilled care only on the signed order of a physician, obtained within 28 days after acceptance. 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. Adopt procedures for the administration of drugs and biologicals which shall include: The administration of treatment modalities, including any intravenous procedures, chemotherapy, parenteral feedings, and injections; The assurance of 24-hour-a-day availability of care for the hours during the administration of intravenous medications and nutritional support; The administration of drugs and treatments only by the following licensed agency staff: Physician, Registered nurse, or 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; Minimum training in keeping with applicable law for staff who administer drugs and treatments; Drugs and treatments to be administered only as ordered by the physician; Documentation in the patient's medical record of medications administered and any medication errors, adverse drug reactions, and corrective actions; 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. 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: Establishing a procedure by which any patient may contact a representative of the agency at any time by telephone; 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 Ensuring that the registered nurse: Assesses the patient's needs; and In emergency situations, renders immediate care to the patient, or causes the patient to be treated by an appropriate health care provider. The Department shall: 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. 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. Make inspections and surveys at least annually to determine compliance with the regulations. Conduct its inspections, surveys, and investigations at all reasonable times and at all geographical locations considered necessary for the proper conduct of its business. 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. If a parent agency is located outside the State, the Department shall issue a license if: At least one branch office is located within the State; or The parent agency is located in a state bordering Maryland and either the: Bordering state has a reciprocal agreement for home health licensure, under which the agency may be inspected at the discretion of the Department; or Agency agrees to be inspected by the Department. Investigation of complaints shall be conducted by the Department as necessary. 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: Survey home health agencies at least every 3 years; Verify compliance with licensing regulations; or Investigate complaints. When a home health agency fails to comply with these regulations, the Department may: Deny any application for a license; Suspend or revoke a license; or Issue a provisional license. 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. The Department may issue a provisional license for a period of less than 1 year in instances where: 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; 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. The Department shall designate the conditions and the time period under which a provisional license is being issued. 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. 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. 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. 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. 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. Adoption of By-laws. The governing body shall adopt written by-laws, in accordance with applicable legal requirements, for the conduct of business by the home health agency. These by-laws shall include, at least the following: A statement of objectives; and An organizational structure by which agency policies and procedures are implemented. These by-laws shall be reviewed annually and revised as necessary. The governing body shall appoint a home health agency administrator who shall be responsible for the overall management and fiscal operations of the agency. The governing body shall designate a “professional advisory group” whose functions shall include, at least: To regularly review and advise on agency policies covering professional issues, including: Scope of services offered; Criteria for acceptance, discharge and/or rejection of patients; Appropriateness of medical supervision; Emergency care services to patients; Adequacy of system for maintaining clinical records; Adequacy of agency's review and evaluation program; and Mechanism for referrals and continuity of care with allied health care providers; To participate in the annual evaluation of the agency's programs. The Professional Advisory Group shall meet at least three times each calendar year and shall keep documented minutes. 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. The governing body shall assure that all services offered by the home health agency, whether directly or indirectly, are: Monitored and supervised by the parent agency; and When stipulated by a physician's order, provided to an individual within 24 hours after the physician refers the individual to the agency. 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: 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); Describe how the contracted personnel are to be administratively or professionally supervised, or both; Describe how services will be controlled, coordinated, and evaluated by the parent agency; Describe the procedure for submitting clinical and progress notes, scheduling of visits, and periodic patient evaluations; Specify the charges for specific services provided under contract; Specify that only the parent agency shall bill for service and collect the applicable deductible or co-insurance payments; 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; 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; 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. 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. The home health agency shall have written policies on qualifications, responsibilities, and requirements for employment for each classification of personnel, including licensure where required. The policies of the home health agency shall, at a minimum, provide for: Wage and salary schedules; Eligibility for vacation, sick leave, and other fringe benefits; In-service training and orientation of all personnel in the objectives, policies, and functions of the agency, including grievance procedures; and Job descriptions for each classification of personnel. The policies of the home health agency shall be reviewed annually and revised as necessary. The home health agency shall maintain a complete and current personnel record for each employee and volunteer, which, at a minimum, shall include: 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: Will be involved in the direct care of tuberculosis patients, or Is an immigrant from Africa, Asia, or Latin America; Evidence of current licensure, certification, or registration, as appropriate; Evidence of the individual's qualifications for the position; and Periodic performance evaluations. 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. 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. There shall be periodic, on-site supervision of services provided by home health aides, with complete and accurate documentation maintained. Training Requirements for Home Health Aides. Aides shall receive a periodic, structured program of training and orientation which includes, at a minimum: The role of the home health aide as a member of the professional health services team; 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; Instruction in how to assist patients to achieve maximum self-reliance through re-learning and modifying activities of daily living; Principles of good nutrition; Meal planning, food purchasing, and preparation of meals, including special diets; General information on the processes of growth, development, and aging; Information on the emotional and physical problems accompanying illness; Principles and practices in maintaining a clean, health, and safe environment as well as a pleasant one that encourages morale building and self-help; Items requiring referral to the nurse supervisor in the home health agency, including changes in the patient's condition or family situation; Record-keeping, when applicable; Policies and objectives of the agency; Information concerning the duties and responsibilities of a home health aide; and Ethical behavior and confidentiality of information. 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. A clinical record shall be maintained for each patient in accordance with accepted professional standards, including, at a minimum: All pertinent diagnoses; Name, address, and telephone number of physicians; Physician's orders, including specific instructions for services to be rendered, activities and limitations, and medically-necessary supplies and equipment; Drug information, including type, dosage, route of administration, frequency, and history of sensitivities or allergic reactions; Nutritional requirements, including specific dietary plans; Prognosis, including rehabilitation potential; Patient care plans, which should include: Long and short-range goals; Physical needs, including safety measures to protect against injury; Psycho-social needs; Actions taken by individual disciplines; and Evidence of periodic reappraisal of the needs of the patient; Progress notes and modifications to the treatment plan; and Discharge summary. The home health agency should maintain a unit record for all patients receiving multi-disciplinary care. 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. The home health agency shall establish and implement policies concerning clinical records which assure: That records of discharged patients are completed no later than 30 days after the date of discharge; The proper operation of a system for identifying, filing, and retrieving clinical records; Proper mechanisms for the timely transfer of clinical record information upon request from duly-authorized persons and organizations; Proper safeguards for clinical record information against loss, destruction, or illegal or unauthorized use; That clinical records are preserved for at least 5 years from the date of discharge; That, with the approval of the Department, provisions are made for retention of clinical records when it ceases operation; and That progress notes are recorded within 5 working days after service is delivered. The treatment plan shall be modified accordingly. 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. The home health agency shall establish policies and procedures for self-evaluation of its programs. These should include, at a minimum: Evaluations of staffing patterns to assure adequacy and appropriateness of service delivered; An annual review of programs to determine: Trends in service needs and activities; Problems and unmet needs of patients; Anticipated changes in delivery of service; Linkages with related community services. 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. Utilization Review. 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. 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. 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: Number of patients by age, sex, and race receiving each service; Number of patient visits conducted by each discipline; Diagnostic categories; Source of referrals; Reason for discharge; and Sources of reimbursement for all services. The home health agency shall: Prepare a report annually of its documented statistics within 90 days after the close of its fiscal year; and 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. 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: Upon request, a written statement of services offered, including frequency and unit charge; Fully itemized, billing statements, including date of service and unit charge, to be made available on request of the patient; Written disclosure of its policy on uncompensated care; 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; 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; 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; 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; The home health agency shall provide a mechanism for the receipt and timely investigation of written complaints in which: Disruption in service may not result from the filing of a complaint; Complete files are maintained on the source, category, and disposition of the complaint; A summary report is presented to the professional advisory group at its regular meetings; A summary report is made available to the Department at least annually; and A summary report is made available for public inspection, upon request. 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: 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. 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: 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; 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; 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. 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: 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. 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. 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. 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. 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. 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: A history of tuberculosis or tuberculosis infection without documentation of adequate treatment as defined and determined by the local health officer; Current treatment for tuberculosis disease or tuberculosis infection; Chest X-rays consistent with tuberculosis without documentation of adequate treatment as defined and determined by the local health officer; or Symptoms consistent with tuberculosis or a history of contact with a person with tuberculosis in a communicable form within the past 12 months. The following records shall be maintained by the agency: Results of Mantoux tests, recorded in millimeters of induration with dates of administration, dates of reading, and results of tests; Results of X-rays required in §A(3)(a)—(c), of this regulation; and 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. A home health agency that holds itself out to the public as providing a complete array of physical rehabilitation services shall: Provide a program of coordinated interdisciplinary rehabilitative care that shall include: Physical and occupational therapy, Speech and language therapy, Audiology therapy, Psychotherapy, and Social work services; Hold interdisciplinary meetings with the involvement of a physician to plan and monitor patient care; and Meet any other applicable standard required by law. Health-General Article, §19-404, Annotated Code of Maryland Effective date: June 2, 1978 (5:11 Md. R. 884) 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) Regulation .09E amended effective May 24, 1982 (9:10 Md. R. 1022) Chapter revised effective December 14, 1987 (14:25 Md. R. 2660) Regulation .02B amended effective April 11, 1994 (21:7 Md. R. 530) Regulation .04 amended effective April 11, 1994 (21:7 Md. R. 530) Regulation .04B amended effective May 1, 1989 (16:8 Md. R. 909); August 19, 1991 (18:16 Md. R. 1811) Chapter revised effective June 6, 2016 (43:11 Md. R. 634) Regulation .04B, C amended effective August 29, 2016 (43:17 Md. R. 953); March 13, 2017 (44:5 Md. R. 292)