CAP genetic testing oversight efforts
FDA puts ASR rule back on the table
The College continues to chart a proactive course to address quality concerns
for genetic testing. The conceptual framework for this effort consists
of three primary components:
- Review of laboratory-developed test validation.
- Inspection by inspectors with genetic testing experience.
- Availability of proficiency testing programs for genetictests.
“The CAP’s first goal was to provide a mechanism within the inspection
process for the review of genetic tests developed by the laboratory
without the use of FDA-approved test kits,” said Debra Leonard,
MD, PhD, in testimony at the Sept. 18 meeting of the Clinical Laboratory
Improvement Advisory Committee. Dr. Leonard is chair of the College’s
Molecular Test Validation Project Work Group and director of the
molecular pathology laboratory and associate professor of pathology
at the University of Pennsylvania Health System, Philadelphia.
A new section of the molecular pathology laboratory inspection checklist has been
drafted to address genetic test validation. The draft includes 10
new checklist questions and commentaries, which address analytical
and clinical validity and appropriate reporting. “Specifically,
the clinical validity of the test can be documented through either
literature citations or internal studies,” Dr. Leonard told CLIAC members.
The new questions will apply to all laboratory-developed molecular tests introduced
since the last inspection. The new checklist questions are under
consideration by the CAP Commission on Laboratory Accreditation,
and they are expected to be approved and incorporated into the molecular
pathology checklist by the end of 2003.
The CAPhas a growing list of qualified inspectors for specialty areas, including
cytogenetics, biochemical and molecular genetics, and molecular
pathology. The Collegeis requesting information about experience
in these areas and cosponsoring inspector-training sessions with
the American College of Medical Genetics and the Association for
Molecular Pathology. And, in the area of proficiency testing, it
is working to enhance its existing programs for genetic tests.
Karen Lusky is a writer in Brentwood, Tenn.