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10.10.05.00.htm 10.10.05.00. Title 10 DEPARTMENT OF HEALTH AND MENTAL HYGIENE Subtitle 10 LABORATORIES Chapter 05 Medical Laboratories ― Proficiency Testing Authority: Health-General Article, §17-202 and 17-211, Annotated Code of Maryland
10.10.05.01.htm 10.10.05.01. 01 Participation and Evaluation.. A. Participation. A licensee operating under a permit shall ensure that the laboratory:. 1) Enrolls in and participates satisfactorily in a PT program that meets the criteria set forth in this chapter for each of the tests that the laboratory offers to perform or performs;2) Tests PT samples in the same manner and number of times that it routinely tests patient specimens; and
10.10.05.02.htm 10.10.05.02. 02 Discipline, Specialty, and Subspecialty.. A. Primary Standard. A licensee operating under a permit shall ensure that the laboratory participates successfully in PT, when applicable, for each test or analyte in each of the following disciplines, subdisciplines, and specialties:1) Microbiology, including the subdisciplines of:. a) Bacteriology;. b) Mycobacteriology;. c) Mycology;. d) Parasitology; and. e) Virology;. 2) Immunology, including the subdisciplines of:.
10.10.05.03.htm 10.10.05.03. 03 Program Approval.. A. Approval Required. A private, nonprofit, or commercial organization or government agency may not provide a PT program in this State without first obtaining program approval from CMS or the OHCQ.B. Approval Granted Automatically. Except in the discipline of job-related alcohol and controlled dangerous substances, or other disciplines, subdisciplines, or specialties not covered by federal PT requirements, a PT program is approved when it is b
10.10.05.04.htm 10.10.05.04. 04 Cytology ― Departmental Requirements.. A. The Secretary may not issue a license to operate a laboratory that examines gynecologic cytology specimens if the laboratory does not enroll and participate satisfactorily in a cytology PT program operated or approved by the Secretary.B. The OHCQ shall conduct annual PT for each pathologist and cytotechnologist who examines gynecological cytology slides acquired in the State.C. The OHCQ or an agent of the Department shall ha
10.10.05.05.htm 10.10.05.05. 05 Cytology ― Laboratory and Individual Standards.. A. Primary Standard. A pathologist or cytotechnologist who examines gynecological cytology specimens from individuals in this State shall participate satisfactorily in an annual cytology PT program approved by the Secretary.B. Laboratory Standards.. 1) A licensee operating under a permit to examine gynecologic cytology specimens shall ensure that each pathologist and cytotechnologist who examines gynecologic cytology spec
10.10.05.9999.htm 10.10.05.9999. Administrative History Effective date: October 5, 1998 (25:20 Md. R. 1529) ― Chapter, Job-Related Alcohol and Controlled Dangerous Substances Testing, repealed and new chapter, Medical Laboratories―Proficiency Testing, adopted effective December 13, 1999 (26:25 Md. R. 1897)Regulation .01 amended effective June 1, 2009 (36:11 Md. R. 787). Regulation .02B amended effective June 1, 2009 (36:11 Md. R. 787). Regulation .03 amended effective June 1, 2009 (36:11 Md. R. 787).
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