Code of Maine Rules
10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES
144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL
Chapter 256 - MAINE MEDICAL LABORATORY RULES
Part TWO - PERMITS FOR HEALTH SCREENING LABORATORIES
Section 144-256-TWO-12 - HEALTH SCREENING LABORATORY (HSL)

Universal Citation: 10 ME Code Rules ยง 144-256-TWO-12

Current through 2024-38, September 18, 2024

12.1 Health screening laboratory (HSL). PART TWO of these rules govern health screening laboratories (HSLs) as defined in Section 1.11 of these rules.

12.1.1 Applicable rules. The purpose, applicable definitions and other provisions in Sections 1 through 11 of these rules apply to HSLs.

12.1.2 CLIA certification. HSLs must be CLIA certified and must comply with the federal CLIA standards, certification requirements and conditions of participation in accordance with Sections 2.1 and 2.2 of these rules.

12.1.2.1 A violation of any of the federal CLIA standards, certification requirements or conditions of participation constitutes a violation of HSL rules.

12.2 Responsibility for compliance. The HSL applicant and permit-holder must comply with the provisions of these rules.

12.3 Permit required. Except as set out in Section 1.11.1 of these rules, no medical laboratory is authorized to operate as a HSL without a department-issued permit. Prior to securing a department-issued permit, no specimens may be obtained and no testing may be performed.

12.3.1 Term of permit. The issued permit expires 24 months after the date issued. Permits are not renewable. Upon approval of a new HSL application, a new permit is issued.

12.3.2 Valid permit. A permit is valid only for the HSL identified on the issued permit.

12.3.3 Nontransferable. An issued HSL permit is not transferable or assignable.

12.3.4 Permit posted at test site. During the HSL event, the issued permit must be posted at the HSL location where it is visible to the public.

12.4 Exempt from state licensure. HSLs are exempt from state licensure. See 22 M.R.S.A. §2013-A(1)(G).

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