Newswise — The Foundation for the Accreditation of Cellular Therapy (FACT) has approved the College of American Pathologists (CAP) as an accrediting organization for laboratories providing histocompatibility services for cellular therapy transplant patients. The CAP will be accepted in FACT Accreditation applications and included in FACT Standards because of the approval.


“The CAP has made a significant commitment to complying with FACT requirements for such designation and has made all necessary revisions to standards and checklists. FACT appreciates the amount of time and effort that went into these changes recommended by the HLA Typing Accreditation Committee,” said Joseph Schwartz, MD and chair of the FACT HLA Accreditation Committee.


FACT establishes standards for high-quality patient care and laboratory practice in cellular therapies and regenerative medicine. It promotes improvement and progress by establishing minimum standards, providing education, and inspecting and accrediting programs worldwide.


“The CAP’s Laboratory Accreditation Program accredits the entire spectrum of laboratory test disciplines using the most scientifically rigorous customized checklist requirements that are the basis of on-site laboratory inspections,” said Bharati Jhaveri, MD, FCAP, chair of the CAP Council on Accreditation. “We will include FACT during review and revision of our own standards and checklists on an annual basis to ensure continued appropriateness for inclusion in FACT Standards and Accreditation Program.”


The Centers for Medicare & Medicaid Services (CMS) regulates all clinical laboratory testing performed on humans in the US through the Clinical Laboratory Improvement Amendments (CLIA). The CAP, through its Laboratory Accreditation Program, 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. CAP teams use the checklists as a guide to assess the laboratory's overall management and operation.



The CAP accreditation program is internationally recognized and the largest of its kind that utilizes teams of practicing laboratory professionals as inspectors. It incorporates all the required standards from CLIA, US Food and Drug Administration (FDA), and the US Occupational Safety and Health Administration (OSHA). In addition to its deemed status with CMS, the CAP also has deemed status with The Joint Commission (TJC), the United Network for Organ Sharing (UNOS), the National Marrow Donor Program (NMDP), and many US state agencies. In addition to FACT, the CAP partners with the Society for Assisted Reproductive Technology (SART) as related to the CAP’s Reproductive Laboratory Accreditation Program. 



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 2017 CAP Annual Report at CAP.ORG.