By Kelly A. Briganti, Editorial Director, G2 Intelligence
Proactively responding to the debate about laboratory developed tests (LDTs), the College of American Pathologists (CAP) has added new requirements relevant to LDTs to its accreditation checklists. On July 28, the CAP released enhanced Laboratory Accreditation Program checklists. The Centers for Medicare and Medicaid Services reapproved CAP’s accreditation program earlier this year.
A press release announcing the enhanced checklists explains that changes addressing LDTs include requirements for “a minimum number of samples to ensure analytic accuracy.” “Now—with the evolution of diagnostic practices into new advances like in vivo microscopy and next generation sequencing (NGS)—it is more important than ever that we remain diligent in monitoring and improving the practice of pathology,” Richard R. Gomez, MD, FCAP, chair of CAP’s Council on Accreditation said in a CAP statement.
The CAP has opposed the FDA’s proposed Framework for regulating LDTs as “too burdensome” and argued it could “stifle innovation.” The organization proposed its own alternative structure for oversight of LDTs in 2009 and reiterated that proposal earlier this year in a comment letter to the FDA. The CAP proposal included a tiered risk-based approach that focused on analytic and clinical validity but differed from the FDA on defining LDTs and risk classifications as well as the role of CLIA and CMS.
The changes in the enhanced checklists also address cancer reporting and in vivo microscopy in anatomic pathology and enhanced quality control measures as well as guidelines regarding personnel qualifications, according to CAP’s press release announcing the checklists.