StacksVerified U.S. regulatory reference

42 CFR §493.565

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov
A laboratory selected for a validation inspection must do the following:
  1. (a)Authorize its accreditation organization or State licensure program, as applicable, to release to CMS or a CMS agent, on a confidential basis, a copy of the laboratory's most recent full, and any subsequent partial inspection.
  2. (b)Authorize CMS or a CMS agent to conduct a validation inspection.
  3. (c)Provide CMS or a CMS agent with access to all facilities, equipment, materials, records, and information that CMS or a CMS agent determines have a bearing on whether the laboratory is being operated in accordance with the requirements of this part, and permit CMS or a CMS agent to copy material or require the laboratory to submit material.
  4. (d)If the laboratory possesses a valid certificate of accreditation, authorize CMS or a CMS agent to monitor the correction of any deficiencies found through the validation inspection.