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10.10.02.00.htm 10.10.02.00. Title 10 DEPARTMENT OF HEALTH AND MENTAL HYGIENE Subtitle 10 LABORATORIES Chapter 02 Medical Laboratories ― General Authority: Health-General Article, Annotated Code of Maryland Regulations Sections .01 17-202, 17-207, 17-208, 17-217, 17-504, 17-507 .02 17-202, 17-504 .03 17-202, 17-504
10.10.02.01.htm 10.10.02.01. 01 Responsibilities of the Department.. A. The OHCQ. The OHCQ shall conduct surveys, as set forth in this subtitle, of laboratories that obtain or retain a license.B. Surveys. The OHCQ shall:. 1) Conduct or oversee an announced or unannounced survey of a laboratory at any time during its hours of operation to assess compliance with applicable sections of Health-General Article, Title 17, Subtitles 2 and 5, Annotated Code of Maryland, and this chapter; and2) Examine, as part of a
10.10.02.02.htm 10.10.02.02. 02 Accredited Laboratory and Accrediting Organization.. A. Accredited Laboratory ― Determination. The Secretary shall accept as meeting the survey requirements of this chapter a laboratory accredited by an organization approved by the Secretary, as set forth in §C of this regulation, if the OHCQ determines that the standards of the laboratory's accrediting organization are equivalent to those under this subtitle.B. Accredited Laboratory ― Requirements. In additi
10.10.02.03.htm 10.10.02.03. 03 Surveys.. A. General.. 1) A licensee shall allow an on-site survey by the OHCQ or, when applicable, by the laboratory's approved accrediting organization, at any time during the laboratory's normal hours of operation, to evaluate the laboratory's compliance with the applicable requirements, conditions, and standards of this subtitle.2) A survey may include but is not limited to:. a) Observation and examination of laboratory facilities;. b) Equipment;.
10.10.02.9999.htm 10.10.02.9999. Administrative History Effective date: December 13, 1999 (26:25 Md. R. 1897). Regulation .01 amended effective June 1, 2009 (36:11 Md. R. 787). Regulation .01E adopted effective January 21, 2002 (29:1 Md. R. 23). Regulation .01E amended effective April 16, 2012 (39:7 Md. R. 492). Regulation .01F adopted effective August 29, 2005 (32:17 Md. R. 1438). Regulation .01F amended effective April 16, 2012 (39:7 Md. R. 492).
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