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 ONE - CLIA CERTIFICATION AND STATE-ISSUED LICENSE
- Section 144-256-ONE-1 - DEFINITIONS
- Section 144-256-ONE-2 - CLIA CERTIFICATION
- Section 144-256-ONE-3 - MAINE REQUIREMENTS AND LABORATORY LICENSE EXEMPTIONS
- Section 144-256-ONE-4 - LICENSE APPLICATION AND RENEWAL PROCESS
- Section 144-256-ONE-5 - FEES
- Section 144-256-ONE-6 - LABORATORY OPERATION
- Section 144-256-ONE-7 - PERSONNEL
- Section 144-256-ONE-8 - PROFICIENCY TESTING
- Section 144-256-ONE-9 - BUILDING AND SAFETY STANDARDS
- Section 144-256-ONE-10 - INSPECTIONS
- Section 144-256-ONE-11 - ENFORCEMENT AND APPEALS
Current through 2024-38, September 18, 2024
PURPOSE
The purpose of these rules is (1) to develop, establish and enforce minimum standards for the licensing of nonexempt medical laboratories pursuant to the Maine Medical Laboratory Act; (2) to incorporate by reference the federal regulations governing the Clinical Laboratory Improvement Amendments of 1988, as amended (CLIA); (3) to align state and federal requirements; and (4) to establish procedures for the issuance of permits for health screening laboratories (HSLs). Medical laboratories provide essential health services by aiding medical practitioners in the diagnosis and treatment of disease. See 22 M.R.S.A. §2012.
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