• Facilitating the development of regulatory and voluntary laboratory standards in collaboration with other government agencies, professional organizations, and other private-sector groups
   
• Promote integration of validated genetic tests into clinical and public health practice

Developing regulatory requirements for genetic testing Under CLIA

Currently, laboratories performing genetic testing are subject to the general provisions of CLIA. To provide greater assurance of quality genetic testing, the CDC and Center for Medicare and Medicaid Services (CMS), in consideration of the advice of the Clinical Laboratory Improvement Advisory Committee (CLIAC), are developing specific requirements for a genetic testing specialty under CLIA. A Notice of Proposed Rule Making for a genetic testing specialty under CLIA is currently under development, and is expected to be published in the Federal Register in 2002. 

• The Role of CLIA in the Oversight of Genetic Testing: Slides (PowerPoint) from the 11/05/2001 presentation to the National Society of Genetic Counselors in Washington DC.  PDF version
   
• Recommendations of the CLIAC on modifying the current CLIA regulations to establish specific requirements for genetic testing during 1997 – 1999. 
   
• Publication of a Notice of Intent (NOI) - HTML, PDF in the Federal Register on May 4, 2000, to solicit public comments on the CLIAC recommendations regarding revisions to the current CLIA regulations to specifically address genetic testing. 
    
• Analysis of public comments from professional organizations, government agencies, manufacturers, and individual commenters.
   
• CLIAC recommendations were revised after considering the public comments and additional suggestions from the fifth Genetics Workgroup.
   
• Notice of Proposed rule Making: A genetics Specialty under CLIA – In preparation.  

• State Regulations
   
• Voluntary Laboratory Standards for Genetic Testing
   
• Recommendations for Genetic Testing in US