CAP Secures CMS Reapproval as Accreditation Organization

NORTHFIELD, Ill. –The College of American Pathologists (CAP) earned reapproval from the Centers for Medicare & Medicaid Services (CMS) as an accreditation organization for clinical laboratories. As reported in the Federal Register, the CMS determined the CAP, in its application for reapproval, met or exceeded the applicable Clinical Laboratory Improvement Amendments of 1988 (CLIA) requirements.

The CMS regulates all laboratory testing, except research, performed on humans in the U.S. through CLIA. It began granting deeming authority to accrediting organizations in 1994, with the CAP always winning renewals for six years, the maximum allowable period under federal regulation.

The CAP currently accredits nearly 8,000 laboratories worldwide and the program continues to grow despite the shrinking certificate of accreditation market of laboratories permitted to conduct moderate and/or high-complexity testing.

“Our accreditation program, grounded in peer-to-peer review, provides laboratories a practical and relevant inspection,” said CAP President Patrick Godbey, MD, FCAP, laboratory director, Southeastern Pathology Associates and Southeast Georgia Health System, Brunswick, Georgia. “We have the premier accreditation program because of the thousands of dedicated laboratory professionals, including CAP members, who volunteer to perform inspections. Our program offers an educational inspection process designed to continuously improve laboratories, safeguard patient testing, and provide the best patient care possible.”

As part of CAP accreditation, the CAP deploys teams to inspect on-site every two years, with self-inspection required between on-site visits. The teams assess compliance using extensive requirements detailed in CAP Accreditation Checklists.

“CAP accreditation checklist requirements are more complete and educational than other accreditors’ requirements,” said Richard M. Scanlan, MD, FCAP, medical director of the Oregon Health and Sciences University Hospital laboratory, Portland, Oregon. “With peer-based inspections, laboratories have a unique opportunity to learn from their peers and greater confidence in the thoroughness of their inspection to improve the quality of laboratory services.”

Laboratories participating in CAP accreditation are based in variety including large university medical centers, physician offices, and COVID-19 testing sites, to name a few. The accreditation program is designed to help laboratories:

• Meet CLIA regulatory requirements (specific to laboratories subject to US regulations);
• Ensure compliance through the guidance of the most comprehensive scientifically endorsed laboratory standards; and
• Maintain accuracy of test results and ensure accurate patient diagnosis.

About the College of American Pathologists

As the world’s largest organization of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programs, the College of American Pathologists (CAP) serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. For more information, read the CAP annual report at cap.org.