2019 accreditation checklists to assist medical labs with CMS regulations

Sept. 18, 2019

The College of American Pathologists (CAP) published the 2019 edition of its accreditation program checklists on September 17, 2019, assisting medical laboratories in meeting and maintaining compliance with the Centers for Medicare and Medicaid Services (CMS) regulations.

The CMS regulates all lab testing, except research, performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). The CAP, through its Laboratory Accreditation Programs, is a CMS-approved accreditation organization with deeming authority to inspect laboratories under CLIA. The CMS requires laboratories to undergo an unannounced on-site inspection once every two years.

“The checklists are the backbone of our accreditation program, developed and updated annually by practicing pathologists and other medical laboratory professionals,” said Bharati Jhaveri, MD, FCAP, chair, CAP Council on Accreditation. “In addition, we collaborate with other medical specialty and regulatory agencies to ensure the checklists reflect the current medical and regulatory landscape, all for the benefit of patients who rely on accurate medical testing for diagnosis and treatment.”

The 2019 checklist edition includes nearly 3,000 requirements organized into 21 checklists which represent the CAP accreditation program’s rigorous accreditation standards. During inspections, CAP teams use the checklists as a guide to assess the laboratory's overall management and operation. The program is internationally recognized and the largest of its kind that utilizes teams of practicing laboratory professionals as inspectors.

The CAP annually reviews and updates the checklists, led by the CAP Checklists Committee, to maintain program stringency and the highest standards of patient care while reflecting advancements in medicine, technology, and laboratory management. The committee, made up of practicing pathologists, relies on the expertise of pathologists and other laboratory professionals to continually review the checklists which culminates in the annual release. Some highlights of 2019 accreditation checklist edition changes include:

  • Revision of multiple checklist requirements in the Histocompatibility (HSC) checklist to be compliant with the Foundation for the Accreditation of Cellular Therapy (FACT) standards.
  • Revision of the Biorepository (BAP) checklist for biorepository laboratories to be consistent with CLIA regulations.
  • Addition of a new checklist requirement in the Chemistry (CHM) checklist on opiate testing.
  • Addition of a new checklist requirement in the Transfusion Medicine (TRM) checklist to align with the Food & Drug Administration (FDA) on the labeling of red blood cells with historical antigen typing.

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