In this chapter, the following terms have the meanings indicated. Terms Defined. “Advanced life support” means initial resuscitation or emergency care provided to a patient with a serious illness or injury. “Department” means the Maryland Department of Health. “Facility” means a limited service hospital. “License” means a license issued by the Secretary to operate a limited service hospital in this State. “Limited service hospital” means a health care facility that: Is licensed as a hospital on or after January 1, 1999; 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 Retains an emergency or urgent care center for the purpose of providing advanced life support. 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. 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. 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. Along with the application, the applicant shall provide: A statement signed by the applicant that the facility will be open 24 hours a day, 7 days a week; A plan describing the services to be provided by the facility, including but not limited to the following: Types and scope of services, A description of staff, including the number and types of health care professionals who will be on duty at all times, and Qualifications, duties, and responsibilities of personnel; A written description of the facility's quality assurance program which includes, at a minimum: A description of how the facility will comply with Regulation .06A of this chapter, and The manner in which information will be collected; Policies and procedures, including but not limited to the following: The transfer or referral of patients who require services that are not provided by the facility, The administration of medicines unique to the needs of the patients, Infection control procedures, Development and implementation of a quality assurance program, Pertinent safety practices, including the control of fire and mechanical hazards, and Preventive maintenance for equipment in the facility; Protocols for obtaining specialized services; Protocols for emergency situations, including: Procedures for transporting individuals to hospitals or other health care facilities, and Plans to ensure that there will be sufficient nurses and other health professionals with appropriate training on duty to provide advanced life support; 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 A statement that the facility's emergency services are available to all persons regardless of ability to pay. Fee. An application shall be accompanied by the nonrefundable license fee of $1,000. Issuance of a License. The Department shall issue a license to a facility that meets the requirements of this chapter. 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. The licensee shall include with the application for license renewal: Updated documents listed in Regulation .03C(2) — (8) of this chapter if any of the information has changed during the current licensure period; and The nonrefundable license fee of $1,000. A facility shall comply with applicable federal, State, and local laws and regulations. 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. Hours of Operation. The facility shall be open 24 hours a day, 7 days a week. Staff. At least one physician who is credentialed in emergency medicine shall be at the facility at all times. The facility shall have a sufficient number of registered nurses and other health professionals with appropriate training to provide advanced life support. Laboratory and Radiologic Services. The facility shall have basic x-ray and laboratory services available at all times and be staffed by at least: One radiology technician; and One laboratory technician. Pharmaceutical Services. Pharmaceutical services shall be supervised by a pharmacist licensed to practice in this State. The facility shall provide pharmaceutical services in accordance with accepted professional principles and appropriate federal, State, and local laws and regulations. Clinical Records. The facility shall maintain clinical records for all patients in accordance with accepted professional standards and practices. Clinical records shall contain: Identification and summary, including, at least, the patient's name, Social Security number, marital status, age, sex, and home address; Name, address, and telephone number of the personal physician, dentist, parent or next of kin, or authorized representative; 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; Consent forms when required; Diagnostic and therapeutic orders; Reports of medication administration, treatments, and clinical findings; and Discharge summary including final diagnosis and prognosis. 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. 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. Equipment. A facility shall have the equipment necessary to provide at least the following care: Cardiac monitoring, defibrillation, and external pacing; Medication administration; Oxygen therapy; Airway management including endotracheal intubation; Respiratory ventilation; and Intravenous and intraosseous access and fluid therapy. All equipment at the facility shall be in good operating condition at all times. Infection Control. A facility shall: Develop and implement policies and procedures on the use of standard precautions for infection control; and 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. The facility shall plan and implement a quality assurance program which includes: Monitoring and evaluation of the quality of patient care; Identification, evaluation, and resolution of care problems; and A peer review process. The facility shall conduct ongoing quality assurance activities and document the activities on a continuous basis, but not less than quarterly. Peer Review. The facility shall establish a peer review process that includes: A mechanism to evaluate the clinical performance of each health care practitioner on a continuous basis, but not less than annually; Procedures, approved by a supervising physician, to identify and minimize risks to the patient; and Documentation of each health care practitioner's annual evaluation. Equipment Quality Control. The facility shall develop and implement a quality control procedure to monitor the safety and performance of all biomedical equipment. In developing its procedures, the facility shall consider: FDA recommendations; and The equipment manufacturer's recommendations. Quality Assurance Records. The facility shall document the following information for all quality assurance activities: A description of identified problems; Findings; Conclusions; Recommendations; Actions taken; Results; and Follow-up. A facility shall comply with the requirements of COMAR 10.07.01.25. A facility shall comply with the requirements of COMAR 10.07.01.13—.19. A facility shall comply with the requirements of COMAR 10.07.01.24. 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. The Secretary shall revoke the license of any licensee convicted of a felony that relates to Medicaid or to a nursing home. The Secretary may deny or revoke a license if the facility does not meet the requirements of: Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland; and Any regulation adopted under Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland. 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. Health-General Article, §§19-301, 19-307, 19-307.1, 19-308, 19-319, 19-320, and 19-323, Annotated Code of Maryland Effective date: 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) 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) 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) Regulation .03A amended effective March 13, 2017 (44:5 Md. R. 292) Regulation .04A amended effective March 13, 2017 (44:5 Md. R. 292)