Section 144-256-TWO-12 - HEALTH SCREENING LABORATORY (HSL)12.1Health screening laboratory (HSL). PART TWO of these rules govern health screening laboratories (HSLs) as defined in Section 1.11 of these rules. 12.1.1Applicable rules. The purpose, applicable definitions and other provisions in Sections 1 through 11 of these rules apply to HSLs.12.1.2CLIA 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.12.2Responsibility for compliance. The HSL applicant and permit-holder must comply with the provisions of these rules.12.3Permit 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. 12.3.1Term 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.12.3.2Valid permit. A permit is valid only for the HSL identified on the issued permit.12.3.3Nontransferable. An issued HSL permit is not transferable or assignable.12.3.4Permit 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.12.4Exempt from state licensure. HSLs are exempt from state licensure. See 22 M.R.S.A. §2013-A(1)(G).10-144 C.M.R. ch. 256, § TWO-12