[Code of Federal Regulations]
[Title 42, Volume 3]
[Revised as of October 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR493.565]

[Page 993-994]
 
                         TITLE 42--PUBLIC HEALTH
 
  CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF 
                  HEALTH AND HUMAN SERVICES (CONTINUED)
 
PART 493_LABORATORY REQUIREMENTS--Table of Contents
 
     Subpart E_Accreditation by a Private, Nonprofit Accreditation 
  Organization or Exemption Under an Approved State Laboratory Program
 
Sec. 493.565  Selection for validation inspection--laboratory 
responsibilities.

    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.

[[Page 994]]

    (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.