CLIA Certificates - Specialties and Subspecialties

One of the specialties reviewed during our most recent laboratory survey is not listed on the new CLIA Certificate of Accreditation. How should we have this corrected?

Any examples are for illustrative purposes only.

Leaders should verify that all specialties and sub-specialties for non-waived testing performed by the laboratory service are listed on both the award letter from The Joint Commission and their new CLIA Certificate of Accreditation. Both documents should accurately reflect the specialties and sub-specialties included in the laboratory services' application for accreditation, and reviewed during the laboratory's most recent survey. If either the award letter or the CLIA Certificate of Accreditation does not list all specialties or sub-specialties for which the laboratory reports patient results  then the laboratory should immediately contact their laboratory Account Executive at The Joint Commission to verify that the specialty or sub-specialty was included on the most recent survey. This will enable The Joint Commission to correct the information sent to the Centers for Medicare and Medicaid Services (CMS).   CLIA certificates are not routinely re-issued between biennial surveys therefore the laboratory should retain a copy of the revised award letter from The Joint Commission as evidence of accreditation for all specialties and sub-specialties.

Note: This FAQ does not apply to CLIA Certificates of Waiver or Provider Performed Microscopy Procedures (PPMP). The laboratory is not required to declare specialties or sub-specialties on these types of certificates. Specialties and sub-specialties are also not listed on the certificate issued to a new laboratory before it is inspected, which is identified as a CLIA Certificate of Registration.
Last updated on April 29, 2020
Manual: Laboratory
Chapter: Leadership LD

If no, please comment on how we could improve this response.

If you have additional standards-related questions regarding this topic, please use the Standards Online Submission Form