§493.567. Refusal to cooperate with validation inspection.
42 C.F.R. § 493.567
Laboratory with a certificate of accreditation.
A laboratory with a certificate of accreditation that refuses to cooperate with a validation inspection by failing to comply with the requirements in § 493.565—
Is subject to full review by CMS or a CMS agent, in accordance with this part; and
May be subject to suspension, revocation, or limitation of its certificate of accreditation under this part.
A laboratory with a certificate of accreditation is again deemed to meet the condition-level requirements by virtue of its accreditation when the following conditions exist:
The laboratory withdraws any prior refusal to authorize its accreditation organization to release a copy of the laboratory's current accreditation inspection, PT results, or notification of any adverse actions resulting from PT failure.
The laboratory withdraws any prior refusal to allow a validation inspection.
CMS finds that the laboratory meets all the condition-level requirements.
CLIA-exempt laboratory. If a CLIA-exempt laboratory fails to comply with the requirements specified in § 493.565, CMS notifies the State of the laboratory's failure to meet the requirements.
Notes, amendments, and revision history
Source
Source: 63 FR 26732, May 14, 1998, unless otherwise noted.
Authority
Authority: 42 U.S.C. 263a, 1302, 1395x(e), 1395x(s)(3) and (s)(17).
Source
Source: 55 FR 9576, Mar. 14, 1990, unless otherwise noted.