Changing the Status of a Laboratory

How to Change the Status of a Lab

Subpart B: Certificate of Waiver

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):

1. 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.
2. 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.
3. 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.

Section 493.53

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:

1. Before performing and reporting results for any test or examination that is not waived or PPM.
2. 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.