The College of American Pathologists (CAP) is composed of pathologists certified by the Board of American Pathologists. The college is a leader in laboratory quality assurance and promotes excellence in healthcare. The purpose of CAP laboratory accreditation is to ensure laboratories provide precise test results for accurate patient diagnoses, meet CLIA requirements, and demonstrate compliance with professionally and scientifically sound and approved laboratory operating standards. The CAP laboratory program was provided decision-making authority by the Centers for Medicare and Medicaid Services (CMS), which, in addition to being recognized by the Joint Commission, permits CAP inspection on the behalf of CMS.
Achieving CAP accreditation is a two-year process that encompasses inspection by a CAP-assigned inspection team that determines compliance to specific laboratory standards and identifies any deficiencies for correction prior to accreditation. CAP-accredited laboratories must have a quality management program that validates the quality and safety of laboratory medical services. External quality assurance (also called proficiency testing) establishes laboratory quality and is monitored on a continual basis. Laboratories performing next-generation sequencing have validated sample preparation, library creation, and amplification protocols. Policies exist for the reporting of sequence variants and the re-validation of instrument and other upgrades. Quality assurance of bioinformatics systems must be documented, and accredited laboratories must meet requirements for the methods of storing and confidentiality of data.
Macrogen was awarded CAP certification in 2017.
CAP ID: 8742212