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10.05.03.00.htm 10.05.03.00. Title 10 MARYLAND DEPARTMENT OF HEALTH Subtitle 05 FREESTANDING AMBULATORY CARE FACILITIES Chapter 03 Freestanding Major Medical Equipment Facilities Authority: Health-General Article, §19-3B-01 et seq. Annotated Code of Maryland
10.05.03.01.htm 10.05.03.01. 01 Definitions.. A. In this chapter, the following terms have the meanings indicated.. B. Terms Defined.. 1) Freestanding Facility Operating Major Medical Equipment.. a) "Freestanding facility operating major medical equipment" means a facility using major medical equipment.b) "Freestanding facility operating major medical equipment" does not include any freestanding ambulatory care facilities or service owned or operated by a hospital and regulated under COMAR 10.07.01.
10.05.03.02.htm 10.05.03.02. 02 License Requirements.. A. A facility operating major medical equipment shall meet all general licensing requirements for a facility as provided in COMAR 10.05.01 and all requirements of this chapter.B. An owner of mobile major medical equipment shall obtain a license under this chapter.. C. A facility operating major medical equipment that is engaged exclusively in biomedical research is not required to be licensed under this chapter if:1) Charges for any health
10.05.03.03.htm 10.05.03.03. 03 Licensing Procedure.. A. A person desiring to establish or operate a facility that operates major medical equipment shall submit an application for licensure.B. The following information for each piece of equipment shall accompany the application:. 1) Manufacturer and model of the equipment;. 2) Address where the equipment is to be located; and. 3) Qualifications of the licensed physician who will be supervising the use of the equipment..
10.05.03.04.htm 10.05.03.04. 04 Inspections by the Secretary.. A. The Secretary may verify compliance with licensing requirements through on-site random sample record reviews.B. For the purpose of verifying compliance, the Secretary shall have access to:. 1) The facility or office where the equipment is located;. 2) Patients' medical records, including image or scan records;. 3) Quality assurance records, including peer review documentation;. 4) Records documenting in-service training on use of the equipment;.
10.05.03.05.htm 10.05.03.05. 05 Personnel.. A. Operators of Magnetic Resonance Imager (MRI) Equipment. Operators of MRI equipment shall demonstrate competency to successfully and safely complete magnetic resonance procedures.B. Operators of Radiation-Producing Equipment. The licensee shall ensure that operators of radiation-producing equipment are qualified in accordance with Health Occupations Article, §14-306 and 14-606, Annotated Code of Maryland.C. Students and Graduate Technologists. This regul
10.05.03.06.htm 10.05.03.06. 06 Quality Assurance Program.. A. A facility operating major medical equipment shall develop and implement:. 1) A quality assurance program in compliance with the guidelines outlined in COMAR 10.05.01.08; and. 2) Additional quality assurance requirements of this regulation.. B. Scope. The quality assurance program shall apply to all personnel supervising or operating major medical equipment.C. Appropriate Use.. 1) The administrator shall develop a procedure to
10.05.03.07.htm 10.05.03.07. 07 Operating Standards for Safety.. A. A person may not operate major medical equipment unless the operator uses safety measures to protect the patient and the operator in accordance with the requirements of this chapter.B. The administrator shall ensure that all equipment:. 1) Is manufactured according to the requirements of 21 CFR 800―1299, which is incorporated by reference;2) Is appropriately labeled and includes an operating manual;. 3) Is considered safe and
10.05.03.08.htm 10.05.03.08. 08 Medical Records.. A. A facility operating major medical equipment shall comply with all requirements of COMAR 10.05.01.09 and the requirements of this regulation.B. A facility operating major medical equipment shall maintain a medical record for each patient on whom a test is performed and make the information available to the Secretary on request.C. Each patient's medical record shall include the following information:. 1) Symptoms exhibited by the patient;.
10.05.03.9999.htm 10.05.03.9999. Administrative History Effective date: August 23, 1999 (26:17 Md. R. 1322). Regulation .04A amended effective February 27, 2017 (44:4 Md. R. 252).
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