[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: 42CFR493.567]

[Page 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. 493.567  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.