Clinical Laboratory Improvement Act (CLIA)
CLIA AUTHORITY
CLIA is the Clinical Laboratory Improvement Amendments of 1988. The responsibility for carrying out CLIA is vested in the Secretary of Health and Human Services (HHS) under Section 353 of the Public Health Service Act, as amended. The new section 353 required the Department of HHS to establish certification requirements for any laboratory that performs tests on human specimens, and certify through issuance of a certificate that those laboratories meet the certificate requirements established by HHS. Refer to CLIA Law, Document 2-1.doc.
The Secretary of HHS delegated to CMS the responsibility for the implementation of CLIA, including laboratory registration, fee collection, surveys, surveyor guidelines and training, enforcement, approval of Proficiency Testing (PT) providers, accrediting organizations and exempt states. The Centers for Disease Control and Prevention (CDC) has been responsible for test categorization, development of technical standards and CLIA studies. Within CMS, the Division of Outcomes and Improvements, within the Family and Children’s Health Program Group, under the Center for Medicaid and State Operations (within CMS) has the responsibility for implementing the CLIA program.
