August 29, 2012 | Laboratory tests with single results are one thing. Tests with multiple results may be more complicated. But DNA sequencing goes orders of magnitude beyond: It’s a laboratory test with millions of results. How can laboratory accreditation inspectors grapple with the quality issues DNA sequencing raises—especially as increasing numbers of clinical labs turn to next-generation sequencing?
To answer that question, last year the college of American Pathologists (CAP) appointed a special next-generation sequencing working group to develop a new section of the College’s Laboratory Accreditation Program molecular pathology checklist. The group completed its work last January, the accreditation program quickly won approval from the Centers for Medicare and Medicaid Services for a dedicated NGS section, and the deadline was met to add the new section to the 2012 checklist. As a result, on July 31, the nation’s first standards for accrediting labs that perform next-generation sequencing for clinical purposes were published and took effect. CAP Today