State Operations Manual (Pub. 100-07), Ch. 6 § 6018
Replacement and Revised Certificates
6018 - Replacement and Revised Certificates
(Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25)
Replacement certificate means an active CLIA certificate that is reissued with no changes
made.
Revised certificate means an active CLIA certificate that is reissued with changes to one
or more fields displayed on the certificate, such as the laboratory’s name, address,
laboratory director, or approved specialties/subspecialties. For purposes of 42 CFR
493, revised certificates do not include the issuance, renewal, change in certificate type,
or reinstatement of a terminated certificate with a gap in service.
If a laboratory requests a replacement or a revised certificate, the SA will process the
request and the replacement or revised certificate will be issued once the appropriate
fees are paid.