The College of American Pathologists (CAP) published a revised version of its molecular pathology checklist with a dedicated section on next generation sequencing (NGS) as part of the new edition of the CAP Laboratory Accreditation Program checklists released July 31, 2012.
CAP checklists are used in the accreditation process to help laboratories meet Centers for Medicare and Medicaid Services (CMS) requirements. CMS regulates all human clinical laboratory testing, other than research and clinical trials, in the United States through the Clinical Laboratory Improvement Amendments (CLIA). The CAP accredits more than 7,000 laboratories in the United States and abroad.
The new NGS section has 18 requirements that address the analytical wet bench process including conversion of DNA into a NGS library followed by sequencing, and the subsequent bioinformatics analyses comprised of sequence alignment and mapping, variant calling, and annotation.
