[Code of Federal Regulations]

[Title 42, Volume 4]

[Revised as of October 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR493.565]



[Page 1002]

 

                         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.

    (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.