[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: 42CFR493.567]



[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.  493.567  Refusal to cooperate with validation inspection.



    (a) Laboratory with a certificate of accreditation. (1) A laboratory 

with a certificate of accreditation that refuses to cooperate with a 

validation inspection by failing to comply with the requirements in 

Sec.  493.565--

    (i) Is subject to full review by CMS or a CMS agent, in accordance 

with this part; and

    (ii) May be subject to suspension, revocation, or limitation of its 

certificate of accreditation under this part.

    (2) A laboratory with a certificate of accreditation is again deemed 

to meet the condition-level requirements by virtue of its accreditation 

when the following conditions exist:

    (i) The laboratory withdraws any prior refusal to authorize its 

accreditation organization to release a copy of the laboratory's current 

accreditation inspection, PT results, or notification of any adverse 

actions resulting from PT failure.

    (ii) The laboratory withdraws any prior refusal to allow a 

validation inspection.

    (iii) CMS finds that the laboratory meets all the condition-level 

requirements.

    (b) CLIA-exempt laboratory. If a CLIA-exempt laboratory fails to 

comply with the requirements specified in Sec.  493.565, CMS notifies 

the State of the laboratory's failure to meet the requirements.