Section 493.39 - Notification requirements for laboratories issued a certificate of waiver.
Laboratories performing one or more waived tests and no others must notify HHS or its designee (state agency, COLA, etc):
Changing the Status of a Laboratory
(42 CFR 493)
Subpart B - Certificate of Waiver
- Notify HHS or its desginee (state agency) within 30 days of any change in ownership, name, location, and/or director. High complexity laboratories must report changes in supervisors.
- Notify HHS no later than 6 months after performing any test or examination within a specialty or subspecialty area that is not included on the laboratory's certificate
- Notify HHS no later than 6 months after any deletions or changes in test methodologies for any test or examination included in a specialty or subspecialty, or both, for which the laboratory has been issued a certificate.
Section 493.53 - Notification requirements for laboratories issued a certificate for provider-performed microscopy (Federal Register, January 19, 1993)
Laboratories issued a PPM certificate must notify HHS or its designee:
- Before performing and reporting results for any test or examination that is not waived or PPM.
- Within 30 days of any change in - ownership, name, location, and/or director.
Subpart D - Certificate of Accreditation
Section 493.63
Same as in Subpart C, Section 493.51.
Same as in Subpart C, Section 493.51.
Contact the AAFP-PT Department (1-800-274-7911) for additional information.
COLA has two CLIA Fact sheets (#7 and # 8) on this topic; COLA's phone number is 800-298-8044.
CLIA and Other Regulatory Information
Good Laboratory Practices for Waived Testing Sites
CLIA Waived and PPM Tests Defined
CLIA Laboratory Classifications
Changing the Status of a Laboratory
CMS Statistics (*PDF file)
(*PDF file. About PDFs)
