Laboratories performing one or more tests listed in § 493.15 and no others must notify HHS or its designee—
(a)
Before performing and reporting results for any test or examination that is not specified under § 493.15 for which the laboratory does not have the appropriate certificate as required in subpart C or subpart D of this part, as applicable; and
(b)
Within 30 days of any change(s) in—
[57 FR 7142, Feb. 28, 1992, as amended at 60 FR 20045, Apr. 24, 1995]