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Notes

§493.565. Selection for validation inspection—laboratory responsibilities.

42 C.F.R. § 493.565

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.
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.