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10.10.07.00.htm 10.10.07.00. Title 10 MARYLAND DEPARTMENT OF HEALTH Subtitle 10 LABORATORIES Chapter 07 Medical Laboratories ― Personnel Authority: Health-General Article, §17-202, 17-203, 17-206, Annotated Code of Maryland
10.10.07.01.htm 10.10.07.01. 01 Permitted POL and POCL ― Director and Associate Director.. A. Primary Standard. The licensee of a permitted POL or POCL shall employ or otherwise engage the services of a qualified director or associate director and a laboratory supervisor or consulting supervisor.B. Standards.. 1) Qualifications.. a) POL. The director of a permitted POL shall be:. i) A physician licensed by the Board of Physicians to practice medicine in the State and a member or employee of the practice
10.10.07.02.htm 10.10.07.02. 02 Permitted POL and POCL ― General Supervisor and Consulting Supervisor.. A. Primary Standard. A licensee operating a POL or POCL under a permit shall employ or otherwise engage a qualified general supervisor or consulting supervisor.B. Standards.. 1) Requirement. A laboratory shall employ or otherwise engage a qualified general supervisor or consulting supervisor who shall act in concert with the laboratory director to ensure that the laboratory complies with the stand
10.10.07.03.htm 10.10.07.03. 03 Permitted POL and POCL ― Consulting Supervisor Services.. A. General.. 1) A licensee operating a permitted POL or POCL who does not employ or otherwise engage technical personnel who qualify as a general supervisor shall arrange with a qualified consulting supervisor to provide technical and general supervisory consultation services in laboratory practice.2) The licensee operating a POL or POCL under a permit shall use a consulting supervisor who:.
10.10.07.04.htm 10.10.07.04. 04 Permitted Laboratory Other than a POL or POCL ― Director.. A. Primary Standard. A licensee operating a permitted laboratory other than a POL or POCL shall employ a director who meets the applicable qualifications, responsibilities, and standards set forth in this chapter.B. Standards.. 1) Qualifications. In addition to applicable personnel standards set forth in this chapter, a director shall meet the applicable standards set forth in 42 CFR §493.1443.2) Responsibilities. A di
10.10.07.05.htm 10.10.07.05. 05 Permitted Laboratories ― Technical Supervisors.. A. Primary Standards.. 1) A laboratory director certified, or eligible for certification, in anatomic and clinical pathology by the American Board of Pathology qualifies as a technical supervisor in all disciplines and subdisciplines set forth in COMAR 10.10.01.03B, except:a) Genetics; and. b) Forensic toxicology.. 2) A licensee who does not employ or otherwise engage a director certified in anatomic and clinical
10.10.07.06.htm 10.10.07.06. 06 Permitted Laboratory Other than a POL or POCL ― Supervisors.. A. Primary Standard. A licensee operating a laboratory other than a POL or POCL shall employ a qualified supervisory technologist or general supervisor, who in the absence of the director or technical supervisor is responsible for the proper performance of laboratory procedures and reporting of laboratory test results.B. Standards: General Supervisor.. 1) Personnel Qualifications. A general supervisor
10.10.07.07.htm 10.10.07.07. 07 Permitted Laboratory Other than POL or POCL ― Testing Personnel.. A. Primary Standard. A permitted laboratory other than a POL or POCL shall employ or engage testing personnel, sufficient in number to perform testing for the volume and complexity of testing performed, who meet the qualifications and carry out the responsibilities set forth in this regulation.B. Standards ― General.. 1) Personnel Qualifications. An individual performing one or more laborator
10.10.07.9999.htm 10.10.07.9999. Administrative History Effective date: December 13, 1999 (26:25 Md. R. 1897). Regulation .01B amended effective July 24, 2000 (27:14 Md. R. 1340) June 1, 2009 (36:11 Md. R. 787). Regulation .03 amended effective June 1, 2009 (36:11 Md. R. 787). Regulation .05 amended effective July 24, 2000 (27:14 Md. R. 1340). Regulation .05B amended effective June 1, 2009 (36:11 Md. R. 787).
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