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10.07.08.00.htm 10.07.08.00. Title 10 MARYLAND DEPARTMENT OF HEALTH Subtitle 07 HOSPITALS Chapter 08 Freestanding Medical Facilities Authority: Health-General Article, §2-104 and Title 19, Subtitle 3A, Annotated Code of Maryland
10.07.08.01.htm 10.07.08.01. 01 Definitions.. 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" mean
10.07.08.02.htm 10.07.08.02. 02 Incorporation by Reference.. 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
10.07.08.03.htm 10.07.08.03. 03 Restrictions.. A freestanding medical facility may not use the name "emergency room" "emergency department" or "hospital" in its title or advertisements or on any signage.
10.07.08.04.htm 10.07.08.04. 04 Licensure Application Procedure.. 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..
10.07.08.05.htm 10.07.08.05. 05 Renewal of License.. 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.
10.07.08.06.htm 10.07.08.06. 06 Inspections.. 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.
10.07.08.07.htm 10.07.08.07. 07 Waiver.. 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.
10.07.08.08.htm 10.07.08.08. 08 Affiliated Hospitals.. 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, inclu
10.07.08.09.htm 10.07.08.09. 09 Treatment of Patients.. 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.
10.07.08.10.htm 10.07.08.10. 10 Personnel.. 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 qua
10.07.08.11.htm 10.07.08.11. 11 Quality Assurance.. 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;
10.07.08.12.htm 10.07.08.12. 12 Laboratory Services.. 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 "Suggeste
10.07.08.13.htm 10.07.08.13. 13 Radiology Services.. 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
10.07.08.14.htm 10.07.08.14. 14 Pharmacy Services.. 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 consiste
10.07.08.15.htm 10.07.08.15. 15 Access to Emergency Medical Services.. 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.
10.07.08.16.htm 10.07.08.16. 16 Transfer of Patients.. 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.
10.07.08.17.htm 10.07.08.17. 17 Medical Records.. 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
10.07.08.18.htm 10.07.08.18. 18 Nourishing Snacks.. 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.
10.07.08.19.htm 10.07.08.19. 19 Infection Control.. 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.
10.07.08.20.htm 10.07.08.20. 20 Equipment and Supplies.. 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.
10.07.08.21.htm 10.07.08.21. 21 Physical Environment.. 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 Sta
10.07.08.22.htm 10.07.08.22. 22 Emergency Preparedness.. 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.
10.07.08.23.htm 10.07.08.23. 23 Emergency Suspension.. 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 emerg
10.07.08.24.htm 10.07.08.24. 24 Sanctions.. 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.
10.07.08.25.htm 10.07.08.25. 25 Hearings.. 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
10.07.08.9999.htm 10.07.08.9999. Administrative History Effective date: February 12, 2007 (34:3 Md. R. 297). Regulation .04B amended effective March 13, 2017 (44:5 Md. R. 292). Regulation .05A amended effective March 13, 2017 (44:5 Md. R. 292). Regulation .05C amended effective August 29, 2016 (43:17 Md. R. 953).
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