Molecular Testing: Regulatory Issues

  • Frank S. Ong
  • Wayne W. Grody
  • Kingshuk Das
Reference work entry


Molecular diagnostic laboratories receive human samples and perform testing in order to determine the health or disease status of patients. In order to ensure patients safety, all laboratories must meet minimum standards for testing quality, safety, and oversight, for which these laboratories must be appropriately certified and/or accredited. The federal government regulates clinical laboratories through several mechanisms, including the Clinical Laboratory Improvement Amendments of 1988. Various state and local governmental agencies provide governance as well, as do many nongovernmental agencies. In order to ensure patient safety and quality laboratory operation, it is crucial to adhere to the requirements and practice recommendations of these various agencies.


Proficiency Testing Equal Employment Opportunity Commission Accreditation Program Nuclear Regulatory Commission Molecular Diagnostic Testing 
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Further Reading

  1. Centers for Medicare and Medicaid Services (
  2. Chronology of CLIA regulations (
  3. College of American Pathologists (CAP,
  4. Environmental Protection Agency (
  5. Good Laboratory Practices for molecular genetic testing for heritable diseases and conditions (
  6. Health Insurance Portability and Accountability Act (HIPAA,
  7. Joint Commission on Accreditation of Healthcare Organizations (JCAHO,
  8. Listing of provider-performed microscopy procedures (
  9. New York State Department of Health (
  10. Occupational Safety and Health Administration (
  11. Office of Inspector General, United States Department of Health and Human Services (
  12. State of Washington Department of Health (
  13. United States Department of Transportation (
  14. United States Equal Employment Opportunity Commission (
  15. United States Food and Drug Administration (
  16. United States Nuclear Regulatory Commission (

Copyright information

© Springer Science+Business Media New York 2013

Authors and Affiliations

  • Frank S. Ong
    • 1
  • Wayne W. Grody
    • 2
  • Kingshuk Das
    • 3
  1. 1.Department of Pathology and Laboratory MedicineCedars-Sinai Medical CenterLos AngelesUSA
  2. 2.Divisions of Medical Genetics and Molecular Pathology, Departments of Pathology and Laboratory Medicine, Pediatrics, and Human GeneticsUCLA School of MedicineLos AngelesUSA
  3. 3.Department of Pathology and Laboratory MedicineUCLA David Geffen School of MedicineLos AngelesUSA

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