Published on March 26, 2007
Contact: Gretchen Schaefer
Phone: 202-354-7131 or 202-236-4410
CAP Accreditation Program Can Serve as a Model for Oversight of Genetic Testing
Washington, D.C.—A representative from the College of American Pathologists (CAP) today told a government advisory committee that the CAP’s current laboratory accreditation standards can serve as a model to ensure the quality of laboratory-developed or genetic tests.
“The demonstration of the analytic and clinical validity of genetic laboratory tests is part of the CAP’s Laboratory Accreditation Program,” said Gail Vance, MD, FCAP, and member of the CAP’s Board of Governors. “Our standards go well beyond the existing regulatory requirements for the accreditation of genetic testing laboratories. We have raised the bar to hold our laboratories accountable to these higher standards in order to advance patient care, protect public health and improve genetic testing.”
Dr. Vance spoke on behalf of the CAP today before the U.S. Health and Human Services Secretary’s Advisory Committee on Genetics, Health and Society, in College Park, MD.
In addition to meeting the overall regulatory requirements, the CAP’s standards also include 1,700 additional checklist questions. The CAP initiated through its accreditation program the first cytogenetics checklist in 1976 and molecular pathology checklists in 1993. The cytogenetics checklist covers chromosome analyses including amniotic fluid and chorionic villi, non-neoplastic blood and fibroblasts, and neoplastic blood and bone marrow. The molecular checklist covers most aspects of clinical molecular testing or testing that involves DNA/RNA probe hybridization or amplification and confirms the analytical performance characteristics and the clinical validity of the assay.
The CAP program also requires proficiency testing for genetic tests so the performance of laboratories is regularly evaluated and accuracy is improved.
“If all genetic testing laboratories were held to the high standards set forth through the CAP program, greater quality of care could be delivered to all patients,” Vance concluded.
The College of American Pathologists (CAP) is a medical society serving about 16,000 physician members and the laboratory community throughout the world. It is the world’s largest association composed exclusively of pathologists and is widely considered the leader in laboratory quality assurance. The CAP is an advocate for high quality and cost-effective patient care.