Current Projects

• Developing guidance for applying CLIA to genetic testing laboratories
   
• Participate in Clinical laboratory Standards Institute guideline and standards development
   
• Participate in the International Organization for Standardization (ISO) TC212 / Clinical laboratory testing and in vitro diagnostic test systems
   
• Participate in the Organisation for Economic Co-Operation and Development (OECD) development of the international recommendations covering quality assurance and proficiency testing for molecular genetic testing

Competed Projects – Participated in development of

• Clinical and Laboratory Standards Institute (2005). Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline. CLSI document MM9-A
   
• Clinical and Laboratory Standards Institute (2008). Verification and Validation of Multiplex Nucleic Acid Assays; Approved Guideline- CLSI document MM17-A.
   
• U.S System of Oversight of Genetic Testing: A Response to the Charge of the Secretary of Health and Human Services. Report of the Secretary’s Advisory Committee on Genetics, Health, and Society. Department of Health and Human Services, Washington, DC, April 2008.