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10.10.03.00.htm 10.10.03.00. Title 10 DEPARTMENT OF HEALTH AND MENTAL HYGIENE Subtitle 10 LABORATORIES Chapter 03 Medical Laboratories ― Licenses Authority: Environment Article, §6-303; Health-General Article, §2-104(b) 17-202, 17-205―17-210, 17-212, 17-502, 17-503, 17-505, 17-508, and 17-510; Annotated Code of Maryland
10.10.03.01.htm 10.10.03.01. 01 General.. A. Requirement.. 1) General. A person shall possess a license before:. a) Offering to perform or performing a medical laboratory test or examination in this State;. b) Offering to perform or performing a medical laboratory test or examination on a specimen acquired from a health care provider in this State at a laboratory located outside this State; orc) Representing or servicing in this State a laboratory regardless of the laboratory's location..
10.10.03.02.htm 10.10.03.02. 02 Letters of Exception.. A. Eligibility.. 1) An individual directing a POL or POCL who offers to perform or performs tests limited to one or more excepted tests may obtain a letter of exception instead of a permit to offer to perform or perform those tests.2) An individual eligible for a letter of exception shall:. a) Be qualified as a laboratory director as set forth in 42 CFR §493.1405, including:. i) Being a doctor of medicine or doctor of osteopathy licensed in the State
10.10.03.03.htm 10.10.03.03. 03 Permits.. A. Requirement. A person operating a medical laboratory that performs one or more tests other than excepted tests shall obtain and renew a laboratory permit as required in this chapter.B. Tests Other than Excepted Tests.. 1) A test other than an excepted test is one not listed in Regulation .02B of this chapter.. 2) A person holding a permit may perform both excepted tests and tests other than excepted tests..
10.10.03.04.htm 10.10.03.04. 04 Letter of Exception and Permit ― Administrative Procedures.. A. Application ― Filing.. 1) Except for a laboratory eligible for a multi-site license as set forth in Regulation .01D(3)b) of this chapter, a person shall apply for a license for each laboratory location.2) A person holding a license to operate a laboratory in the discipline of chemistry or health awareness testing is not required to obtain a separate cholesterol testing permit to conduct cholesterol
10.10.03.05.htm 10.10.03.05. 05 Letter of Exception ― Limited Testing for Rare Diseases.. A. The Secretary may waive the permit requirements under this subtitle for a laboratory that offers to perform or performs a rare disease test if the laboratory:1) Meets the requirements of Regulations .05 and .06 of this chapter; and. 2) Obtains and maintains a letter of exception ― limited testing for rare diseases.. B. Eligibility. A person operating a medical laboratory may be eligible for a letter of exception ―
10.10.03.06.htm 10.10.03.06. 06 Letter of Exception ― Limited Testing for Rare Diseases; Standards and Requirements.. A. Application Requirements and Testing Approval. A person required to obtain a license to operate a laboratory that chooses to operate under a letter of exception ― limited testing for rare diseases shall:1) Submit:. a) A completed:. i) Application as prescribed in Regulation .04 of this chapter; and. ii) Report or questionnaire as required by the Secretary to determine regulatory compliance;.
10.10.03.9999.htm 10.10.03.9999. Administrative History Effective date: December 13, 1999 (26:25 Md. R. 1897). Regulation .01 amended effective July 24, 2000 (27:14 Md. R. 1340) July 23, 2001 (28:14 Md. R. 1321). Regulation .01A amended effective June 1, 2009 (36:11 Md. R. 787). Regulation .01E adopted effective June 1, 2009 (36:11 Md. R. 787). Regulation .02 amended effective July 24, 2000 (27:14 Md. R. 1340) June 1, 2009 (36:11 Md. R. 787) April 13, 2015 (42:7 Md. R. 568)
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