GroundRules
42 CFR 493.565: Selection for validation inspection—laboratory responsibilities.
Where this section sits in the code
- Title 42—Public Health
- CHAPTER IV—CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER G—STANDARDS AND CERTIFICATION
- PART 493—LABORATORY REQUIREMENTS
- Subpart E—Accreditation by a Private, Nonprofit Accreditation Organization or Exemption Under an Approved State Laboratory Program
A laboratory selected for a validation inspection must do the following:
(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.
(b) Authorize CMS or a CMS agent to conduct a validation inspection.
(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.
(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.
Collected 2026-08-27T02:26:11Z. Source file · JSON