The purpose of this chapter is to: Outline the licensing, site, and staffing requirements for a provider of limited private inpatient facility services; and Provide a flexible model of service delivery and oversight. In this chapter, the following terms have the meanings indicated. Terms Defined. "Administration” means the Behavioral Health Administration. “Department” means the Maryland Department of Health or its designee. “Facility” means a limited private inpatient facility. “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. “Individual treatment plan” means the plan prepared according to the requirements outlined in: Health-General Article, §10-706, Annotated Code of Maryland; and COMAR 10.21.03. “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. “License” means a license issued by the Department to operate a limited private inpatient facility in this State. “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. Limited Private Inpatient Facility. “Limited private inpatient facility” means a private inpatient treatment facility that provides mental health evaluation and treatment to adults 24 hours per day. “Limited private inpatient facility” does not include: 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 A facility that bills for reimbursement under the Medical Assistance Program. “Mental health professional” means an individual who is licensed, certified, or otherwise legally authorized to provide the mental health service: Under Health Occupations Article, Annotated Code of Maryland; or In the state where the service is rendered. “Secretary” means the Secretary of Health. Usable Square Feet. “Usable square feet” means physical space that is available for resident use. “Usable square feet” does not include: Service areas; Administrative offices; Entrance ways including the space where a door swings open; Closets, lockers, and wardrobes; Spaces where ceiling heights are less than acceptable for habitable space, as defined by the applicable local building code; or Corridors. In this chapter, the following is incorporated by reference. Document Incorporated. “Standards for Behavioral Health Care, 2013 Edition, The Joint Commission, One Renaissance Blvd., Oakbrook Terrace, Illinois 60181”. An individual is eligible for limited private inpatient facility services if the individual: Requires 24-hour inpatient mental health evaluation and treatment services but does not require acute or long-term psychiatric hospital services; and Has stated a willingness to comply with program rules. An individual is not eligible for limited private inpatient facility services if the individual: Has a sole diagnosis of substance abuse, intellectual disability, or dementia; Is in need of immediate involuntary inpatient psychiatric admission; Is medically unstable as determined by an individual authorized under Health Occupations Article, Annotated Code of Maryland, to make medical determinations; or Does not meet the eligibility criteria under §A of this regulation. An applicant shall obtain a license from the Department before providing services. Initial and Renewal Licensure. In order to be licensed as a limited private inpatient facility, the facility shall: File an initial application with the Department that: 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 Includes documentation of: Fire, liability, and hazard insurance coverage on the building in which the facility is located; Compliance with relevant federal, State, or local ordinances, laws, regulations, and orders, including zoning and safety; and Accreditation as a limited private inpatient facility or comparable facility by the Joint Commission under its Standards for Behavioral Health Care; Be subject to: 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 The investigation of complaints and incidents by the Department; Submit a facility service plan as required by Regulation .10 of this chapter; and Submit all required fees for licensure as specified in §I of this regulation. An application filed 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 Include the: Names of all Board members; Names of persons holding 2 percent or more of the stock or assets; and Ownership of property, real estate, and equipment, if other than the licensee’s. Display of License. The facility shall visibly post the facility’s license in a public area in the facility. 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. 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. Renewal of License. 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. The Department shall grant a renewal license to an applicant to operate if the applicant submits: A completed application for license renewal with the required fees as specified by the Joint Commission; A copy of the triennial survey report; A copy of the corrective actions taken for standards not met; and A copy of the certificate for accreditation by the Joint Commission. Loss of Accreditation. 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. When performing surveys, whether based on loss of accreditation, complaints received, or incidents reported, the Department shall determine compliance or noncompliance based on: Applicable State and federal law; and The Standards for Behavioral Health Care. License Fees. A facility shall submit a written or electronic application on a form approved by the Department along with the fee established in this regulation. A facility that has filed an application for accreditation that meets the requirements for a provisional license shall: Submit a $500 nonrefundable license fee payable to the Department; and On receiving accreditation, pay an additional $1,500 nonrefundable license fee per accreditation period of 3 years, payable to the Department. A facility shall submit a $1,500 nonrefundable license fee per accreditation period of 3 years, payable to the Department. Provisional License. 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. The provisional license shall be issued for a period of not greater than 1 year from issuance. 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. 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. The Secretary shall issue a license to an accredited facility for the term of the facility's accreditation. 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. A separate license is required for facilities maintained on separate premises, even if both facilities are operated under the same management. A separate license is not required for separate buildings on the same grounds. 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. The facility’s administrative and medical records shall be available for review and for copying by the Department. New Facilities. 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: This chapter; and The Standards for Behavioral Health Care. 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: Cease operations; and 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. 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. To resolve expeditiously a complaint that alleges the existence of any non-life-threatening deficiency: The Department shall refer the complaint directly to the facility; and The facility shall: Conduct an internal investigation into the complaint; and Submit the investigation and supportive evidence to the Department within 30 days of the receipt of the complaint. 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: Of the Joint Commission; or Adopted by the Secretary under this subtitle. Issues relating to the practice of medicine or the licensure or conduct of a health professional shall be referred to the: Facility; and Appropriate licensure board for resolution. The limited private inpatient facility shall provide services in accordance with the facility service plan submitted to and approved by the Department. A written facility service plan shall include at a minimum: The rationale for the facility including discussion of the organization’s mission, vision, and philosophy for provision of services; The range of services that the facility will provide; The populations to be served, including age groups and other relevant characteristics, and the number of individuals that the program expects to serve; The composition of the facility's governing body, board of directors, or advisory committee, whichever applies; A description of staff or care providers necessary to provide the planned services and any necessary training requirements; The facility’s goals, objectives, and expected outcomes; and A detailed scope or description of services offered. 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. 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. 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: A facility director that is responsible for the programmatic and administrative services of the facility under the direction of the governing body; A clinical director who: Is a psychiatrist or psychologist who receives medical supervision by a psychiatrist; and Has overall responsibility for clinical services, including, at a minimum: Establishing and maintaining appropriate standards for diagnosis and treatment, including therapeutic modalities and prescribing practices; Medical aspects of quality management; and Ensuring adequate clinical supervision of treatment staff; A multidisciplinary licensed mental health professional staff that: Provides evaluation and treatment services; and Is in addition to the limited private inpatient facility psychiatrist; A licensed nurse to provide for medication management, treatments, and other health care needs; Other direct care employees to provide for the treatment and monitoring of residents as required by the resident’s individual treatment plan; A physician to provide somatic medical services as required by the clients; and Maintenance and housekeeping staff who are trained and qualified to provide a well-maintained, safe, and sanitary environment for residents served by the program. 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: Crisis intervention and de-escalation techniques; Suicide prevention, including but not limited to identification of warning signs and symptoms; The facility’s disaster and fire safety plan; First aid, CPR, and emergency medical procedures; and Individual rights, as set forth in Health-General Article, Title 10, Subtitle 7, Annotated Code of Maryland. A limited private inpatient facility shall have a building that: Meets all relevant federal, State, or local ordinances, laws, regulations, and building codes; and Provides sufficient space for group and individual therapies, dining equipped with tables and chairs for resident meal service, and administrative services. The areas of the facility shall: Be well-lit and adequately ventilated; Be easily accessible; Be maintained in good repair, safe, clean, and free of insects and rodents and hazards; Provide a central heating system that can maintain the facility at a comfortable temperature; Be furnished with sufficient, appropriate, and functional furnishings, equipment, supplies, and utensils for use by the residents; Be equipped with working smoke detectors and fire extinguishers and meets all requirements of the Maryland State Fire Code; 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; Have a telephone in the residence where residents can make calls and speak privately; Provide a space where residents may visit privately with friends and family; and Provide adequate general use space for therapy, activities, and recreation. Bedroom Area. The facility shall ensure that a bedroom has: A minimum of: 80 usable square feet for a single bedroom; and 180 usable square feet for a double-occupancy bedroom; A door; Closet space and two drawers in a chest or dresser per resident; Window coverings for privacy; A bed with a clean mattress and pillow; A locked drawer or other secured storage for resident’s personal belongings; and No more than two residents per bedroom. 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: Are supplied with hand soap, toilet tissue, and hand towels or an electric hand dryer; Provide hot and cold running water with hot water being a minimum of 100°F and a maximum of 120°F; Are equipped with operable mechanical exhaust ventilation; and Provide at least: One hand sink and one toilet for every 8 residents; and One tub or shower for every 12 residents. 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: Two sets of linens; Two towels; and Two washcloths. 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. The program shall develop an emergency plan and procedures that shall be followed in the event of an internal or external emergency. The emergency plan and procedures shall; Be updated annually; and Include: Easily accessible emergency telephone numbers posted at or near a telephone for: Fire; Police; Ambulance; Poison control; and The program’s on-call staff; 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; Provisions for emergency lighting and fire detection and suppression systems operable during loss of power as required by the Maryland State Fire Code; A 3-day emergency food and water supply; and A relocation plan in the event that the facility is partially or entirely vacated, which shall include: A plan for transportation of the residents, at the facility’s expense, to relocate the residents; A process for transfer of the medical records information for the residents in a manner to protect the residents’ privacy; A system to track where and how the resident was transported; How families will be notified, if desired by the resident; and Provisions that provide for any other associated costs at the facility’s expense. The facility shall ensure sufficient numbers of trained and qualified staff to meet the nutritional needs of residents served by the facility. Nutritional Needs. The facility shall ensure that: A resident is provided three meals in a common dining area and additional snacks during each 24-hour period, 7 days a week; 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; All food is prepared in accordance with all State and local sanitation and safe food handling requirements; Food preparation areas are maintained in accordance with all State and local sanitation and safe food handling requirements; Residents have access to snacks during the evening hours; and 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. The facility shall ensure that menus are: Written at least 1 week in advance with portion sizes to meet the resident’s dietary needs; and Maintained on file, as served, for 2 months. Dining Room. A facility shall provide a well-lit, adequately ventilated, and appropriately furnished dining area. Food Service. A facility shall have a kitchen that has adequate: Storage, refrigerator, and freezer space for perishable and nonperishable foods; Food preparation area or areas with cleanable surfaces; Equipment to deliver foods at safe and palatable temperatures; Space and equipment to wash, sanitize, and store utensils; Space to store and clean garbage cans; Ice-making capabilities; Equipment for the preparation of food; and Equipment for serving and distributing food to residents. A facility’s dietary services shall be licensed by the local health department and comply with the requirements of COMAR 10.15.03. A facility shall: 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; Provide, in writing, information regarding an individual’s rights as outlined in §A of this regulation to a resident; and Prominently display, in accessible centralized locations, the individual’s rights as outlined in §A of this regulation. The facility shall, either manually or electronically: Establish a record for a resident; and 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. The facility shall ensure that residents’ records are: Maintained in a manner that is consistent with the medical records confidentiality and disclosure requirements of: Maryland Confidentiality of Medical Records Act, Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland; and 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; Located so that the records are convenient and available to designated staff; Managed by a designated staff member who is responsible for appropriate records control, including storage, security, and indexing of records; and Subject to the requirements of confidentiality laws and regulations, are made available to the Department as necessary to carry out required activities. Upon the death of an individual in the facility, the administrative head of the facility shall: Submit a written report to the Department within 5 working days of the death; and Use the form required by the Administration. The Secretary may deny or revoke the license of a limited private inpatient facility that: Does not comply with: Health-General Article, §§10-501—10-511, Annotated Code of Maryland; Health-General Article, §§10-701—10-713, Annotated Code of Maryland; or The provisions of this chapter; Loses accreditation by the Joint Commission; or Fails to be awarded accreditation within 1 year of the issuance of a provisional license by the Department. 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. A facility that has lost or been denied accreditation by the Joint Commission may operate pending appeal only as permitted by this chapter. 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: Revoke or place restrictions on the license; Impose a civil money penalty of not more than $10,000 per instance or per day; Impose a directed plan of correction; or Impose appropriate operating conditions. When considering whether to impose a civil money penalty and the amount of the penalty, the Secretary shall consider the following factors: The number, nature, and seriousness of the violations; The extent to which the violation or violations are part of an ongoing pattern during the preceding 24 months; The degree of risk, caused by the violation or violations, to the health, life, or safety of the patients of the facility; The efforts made by, and the ability of, the licensee to correct the violation or violations in a timely manner; and Such other factors as justice may require. 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. The Secretary may immediately suspend a license on a finding that the public health, safety, or welfare requires emergency action. The Department shall deliver a written notice to the licensee: Informing the licensee of the emergency suspension; 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 Notifying the licensee of the licensee's right to request a hearing and to be represented by counsel. The filing of a hearing request does not stay the emergency action. When a license is immediately suspended, the licensee shall: Immediately return the license to the Department; and Stop providing services immediately. 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. 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. If the Secretary's final decision does not uphold the emergency suspension, the licensee may resume operation. 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. The Secretary may revoke a license if the licensee: Has been convicted of a felony that relates to Medicaid or Medicare or a crime involving moral turpitude; Does not comply with the requirements of this chapter; or 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. The Secretary shall notify the licensee in writing of the following: The effective date of the revocation; The reason for the revocation; The regulations with which the licensee has failed to comply that form the basis for the revocation; That the licensee is entitled to a hearing if requested, and to be represented by counsel; That the facility shall stop providing services on the effective date of the revocation if the licensee does not request a hearing; 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 That the licensee is required to surrender the license to the Department if the revocation is upheld. 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. 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. 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. The burden of proof is as set forth in COMAR 10.01.03.28. 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. The aggrieved person may file exceptions as set forth in COMAR 10.01.03.35. The Secretary shall issue a final decision in accordance with COMAR 10.01.03.35. 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. Application for Licensure Standards Waiver. A facility shall submit a request for a waiver on a form developed by the Department. The requestor shall provide in writing the: Regulation from which a waiver is sought; Reason the facility is unable to comply with the regulation; Reason that compliance with the regulation will impose a substantial hardship; and Reason that a waiver will not adversely affect residents. Evaluation of Application for Licensure Standards Waiver. In evaluating a waiver request, the Department shall review the statements in the application, and may: Inspect the limited private inpatient facility; Confer with the limited private inpatient facility director; or 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. Grant or Denial of Licensure Standards Waiver. The Department may grant a waiver request if the Department determines that: Compliance with the regulation from which the waiver is sought cannot be accomplished without substantial hardship; and A waiver will not adversely affect residents. 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. Written Decision. 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. If the Department grants the waiver, the written decision shall include: The waiver’s duration; and Any conditions imposed by the Department. 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. Health-General Article, §§10-501—10-511, Annotated Code of Maryland Effective date: December 10, 2015 (42:24 Md. R. 1504) Regulation .05B,G,I amended effective March 13, 2017 (44:5 Md. R. 292) Regulation .23 adopted effective December 19, 2016 (43:25 Md. R. 1384)