MMWR Vol. 58 / No. RR-6

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Title: MMWR Vol. 58 / No. RR-6

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	Early Release Volume 58, No. RR-6 June 12, 2009

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Good Laboratory Practices for Molecular Genetic Testing for Heritable Diseases and Conditions
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations, laboratory testing is categorized as waived (from routine regulatory oversight) or nonwaived based on the complexity of the tests; tests of moderate and high complexity are nonwaived tests. Laboratories that perform molecular genetic testing are subject to the general CLIA quality systems requirements for nonwaived testing and the CLIA personnel requirements for tests of high complexity. This report provides recommendations from the Clinical Laboratory Improvement Advisory Committee for good laboratory practices for ensuring the quality of molecular genetic testing for heritable diseases and conditions. Improvements in the quality and use of genetic laboratory services should improve the quality of health care and health outcomes for patients and families of patients.
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Appendix A: Terms and Abbreviations Used In This Report
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Appendix B: Examples of State-Required Components of Informed Consent for Genetic Testing Selected States
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Appendix C: Selected Proficiency Testing Programs and Interlaboratory Sample Exchange Programs for Molecular Genetic Testing for Heritable Diseases and Conditions
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Department of Health and Human Services
Centers for Disease Control and Prevention

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