Section 144-256-ONE-2 - CLIA CERTIFICATION2.1CLIA certification required. All medical laboratories that perform testing on human specimens must be certified pursuant to the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA), as amended. Laboratories subject to PART ONE or PART TWO of these rules must comply with CLIA.2.2Federal CLIA standards and certification requirements. All applicants and certificate-holders must comply with the federal CLIA standards and certification requirements set forth in 42 Code of Federal Regulations Part 493, as revised October 1, 2010, which is incorporated herein by reference pursuant to 5 M.R.S.A. §8056 of the Maine Administrative Procedures Act.2.2.1 Copies of the federal CLIA standards and certification requirements ( 42 CFR Part 493), including the Certificate of Waiver and the Provider Performed Microscopy Certificate requirements, may be obtained from the Department of Health and Human Services, Division of Licensing and Regulatory Services, 11 State House Station, 41 Anthony Ave, Augusta, Maine 04333; the Maine Office of the Secretary of State, 101 State House Station, Augusta, Maine 04333, or online at http://www.gpo.gov/fdsys/pkg/CFR-2010-title42-vol5/xml/CFR-2010-title42-vol5-part493.xml.
2.3Violation of these rules. A violation of any of the federal CLIA standards, certification requirements or conditions of participation constitutes a violation of these rules.10-144 C.M.R. ch. 256, § ONE-2