CLIA Genetics Specialty

The Clinical Laboratory Improvement Amendments (CLIA) were enacted in 1988. CLIA certifies laboratories that perform genetic tests. CLIA currently has specialty areas to address quality control, personnel qualifications, and proficiency testing in specific areas. Though genetic tests are high in complexity, requiring specially trained personnel, a specialty for genetics does not currently exist under CLIA.

In 2000, the Centers for Medicare and Medicaid Services (CMS) announced its intent to issue a proposed rule for a genetic testing specialty. Public comments on the proposed rule were taken, but no further action occurred for five additional years. In April 2006, the Department of Health and Human Services placed issuance of the proposed rule on its regulatory agenda for completion by November, and many organizations received assurances that CMS would finally create a genetic specialty under CLIA. However, CMS now says that current regulations are adequate and that no genetic specialty is needed. CMS has set standards for most other complex tests except genetic tests performed by diagnostic laboratories. In the absence of genetic testing standards, laboratory practices are widely divergent and often substandard.

In the 110th Congress, Senator Kennedy (D-MA) and Senator Smith (R-OR) introduced the Laboratory Test Improvement Act (S.736) and Senator Obama (D-IL) and Senator Burr (R-NC) introduced the Genomics and Personalized Medicine Act (S. 976). Both bills require CMS to create a genetics specialty under CLIA.

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