Changing the Status of a Laboratory
How to Change the Status of a Lab
Subpart B: Certificate of Waiver
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):
- 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 six 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 six 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.
Notification requirements for laboratories issued a certificate for provider-performed microscopy per the Federal Register, January 19th, 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
Same as in Subpart C, Section 493.51.