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10.05.01.00.htm 10.05.01.00. Title 10 DEPARTMENT OF HEALTH AND MENTAL HYGIENE Subtitle 05 FREESTANDING AMBULATORY CARE FACILITIES Chapter 01 General Requirements Authority: Health-General Article, §19-3B-01 et seq. Annotated Code of Maryland
10.05.01.01.htm 10.05.01.01. 01 Scope.. A. This chapter applies to all freestanding ambulatory care facilities.. B. An applicant or licensee shall also comply with the regulations of one of the following chapters as appropriate:1) COMAR 10.05.02;. 2) COMAR 10.05.03;. 3) COMAR 10.05.04; or. 4) COMAR 10.05.05..
10.05.01.02.htm 10.05.01.02. 02 Definitions.. A. In this subtitle, the following terms have the meanings indicated.. B. Terms Defined.. 1) "Department" means the Department of Health and Mental Hygiene.. 2) "Facility" means a freestanding ambulatory care facility as defined in §B(4) of this regulation.. 3) "FDA" means the Food and Drug Administration of the U.S. Department of Health and Human Services.. 4) "Freestanding ambulatory care facility" means a:. a) Freestanding surgical facility;.
10.05.01.03.htm 10.05.01.03. 03 License Required.. A. A person may not establish or operate a freestanding ambulatory care facility without obtaining a license from the Secretary.B. License Period. A license is valid for 3 years from the date of issuance, unless suspended or revoked by the Secretary.C. A license issued under this chapter is not transferable..
10.05.01.04.htm 10.05.01.04. 04 Licensing Procedure.. A. A person desiring to operate a facility shall:. 1) Be in compliance with all applicable federal, State, and local laws and regulations;. 2) File an application on a written or electronic form provided by the Department;. 3) Submit documentation that the Maryland Health Resources Planning Commission has determined that the facility either received a certificate of need or is exempt from certificate of need requirements; and4) Submit a written descr
10.05.01.05.htm 10.05.01.05. 05 Inspections by Secretary of Health and Mental Hygiene.. A. Open for Inspection. A licensed facility 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 patients, for inspection by the Department and by any other agency designated by the Department to:1) Survey freestanding ambulatory care facilities as directed by the Centers for Medicare and Medicaid Services;
10.05.01.06.htm 10.05.01.06. 06 Administration.. A. The licensee is responsible for the overall conduct of the facility and for compliance with applicable laws and regulations.B. Governing Body. The governing body shall identify the administrator who has been given the authority and responsibility for overall policy and fiscal management of the facility. The governing body shall develop a written organizational plan.C. Administrator. The administrator is responsible for the daily operation
10.05.01.07.htm 10.05.01.07. 07 Personnel.. A. The administrator shall ensure that all personnel:. 1) Receive orientation and have experience sufficient to demonstrate competency to perform assigned patient care duties;2) Are licensed or certified by an appropriate occupational licensing board to practice in this State, if required by law; and3) Perform or delegate duties and responsibilities in accordance with standards of practice as defined by the Health Occupations Article, Annotated Code of Maryland.
10.05.01.08.htm 10.05.01.08. 08 Quality Assurance Program.. A. The administrator shall ensure that the facility develops and maintains 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 admin
10.05.01.09.htm 10.05.01.09. 09 Medical Records.. A. The facility shall maintain a complete, comprehensive, and accurate medical record for each patient.B. Each patient's medical record shall include at least the following:. 1) Patient identifier;. 2) Significant medical history and results of a physical examination;. 3) Documentation of care or services provided;. 4) Evidence of consent; and. 5) Discharge diagnosis.. C. The facility shall:. 1) Send a copy of the medical record with the pati
10.05.01.10.htm 10.05.01.10. 10 Patients' Rights and Responsibilities.. A. The administrator shall ensure that the facility develops and implements written policies and procedures concerning patients' rights and responsibilities.B. The facility shall make the policies and procedures available to patients, guardians, or other health care decision makers, as defined by Health-General Article, Title 5, Subtitle 6, Annotated Code of Maryland, and the public.C. The policies and procedures shall ensure that:.
10.05.01.11.htm 10.05.01.11. 11 Physical Environment.. A. The facility shall meet all federal, State, and local laws, ordinances, and regulations for construction.B. The facility shall meet all safety requirements of the National Fire Protection Association, NFPA 101 "Life Safety Code" which is incorporated by reference at COMAR 29.06.01.06.C. The facility shall meet the requirements for handling, treatment, and disposal of special medical wastes as provided in COMAR 10.06.06.
10.05.01.12.htm 10.05.01.12. 12 Complaint Investigations.. A. The Secretary may inspect a facility to investigate and resolve any complaint concerning patient care and safety.B. If the complaint concerns the performance of a health care practitioner or standards of practice, the Department shall refer the complaint to the board that licenses, certifies, or otherwise authorizes the health care practitioner to provide services under the Health Occupations Article, Annotated Code of Maryland.
10.05.01.13.htm 10.05.01.13. 13 Emergency Suspension.. 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 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 forms the basis for the emergency suspension, and notifying the licensee of the licensee's
10.05.01.14.htm 10.05.01.14. 14 Revocation of License.. A. Revocation of License. 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) A felony that relates to Medicaid or Medicare, or. b) A crime involving moral turpitude; or. 2) Does not comply with the requirements of this chapter..
10.05.01.15.htm 10.05.01.15. 15 Penalties.. A. Criminal Penalty. A person who violates any provision of this chapter is guilty of a misdemeanor and on conviction is subject to a penalty not exceeding $1,000, or imprisonment not exceeding 1 year, or both.B. Each day that a violation is continued after the first conviction is a separate offense.. C. Administrative Penalty. The Secretary may impose an administrative penalty of up to $1,000 for a violation of any provision of this chapter.D. When considering wheth
10.05.01.16.htm 10.05.01.16. 16 Hearings.. 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, §10-201 et seq. Annotated Code of Maryland,
10.05.01.9999.htm 10.05.01.9999. Administrative History Effective date: August 23, 1999 (26:17 Md.R. 1322). Regulation .02B amended effective April 16, 2012 (39:7 Md. R. 491). Regulation .04A, I amended effective March 13, 2017 (44:5 Md. R. 292). Regulation .05A amended effective March 14, 2016 (43:5 Md. R. 385). Regulation .08 amended effective April 16, 2012 (39:7 Md. R. 491). Regulation .08C amended effective February 27, 2017 (44:4 Md. R. 252).
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