42 CFR §493.567

1. (a)Laboratory with a certificate of accreditation.
   1. (1)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—
      1. (i)Is subject to full review by CMS or a CMS agent, in accordance with this part; and
      2. (ii)May be subject to suspension, revocation, or limitation of its certificate of accreditation under this part.
   2. (2)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:
      1. (i)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.
      2. (ii)The laboratory withdraws any prior refusal to allow a validation inspection.
      3. (iii)CMS finds that the laboratory meets all the condition-level requirements.
2. (b)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.