Waived laboratories must meet only the following ... - Infolab

Changing the Status of a Laboratory (42 CFR 493)
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):
a. before performing and reporting results for any test or examination that is not waived, and
b. within 30 days of any change(s) in ownership, name, location or director.
Subpart C - Registration Certificate and Certificate
Section 493.51 - Notification requirements for laboratories issued a certificate
Laboratories issued a certificate must:
a. 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.
b. 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
c. 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:
a. Before performing and reporting results for any test or examination that is not waived or PPM.
b. 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.
(http://www.aafp.org/x2249.xml?printxml)
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.
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