[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: 42CFR493.569]

[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. 493.569  Consequences of a finding of noncompliance as a result of 
a validation inspection.

    (a) Laboratory with a certificate of accreditation. If a validation 
inspection results in a finding that the accredited laboratory is out of 
compliance with one or more condition-level requirements, the laboratory 
is subject to--
    (1) The same requirements and survey and enforcement processes 
applied to laboratories that are not accredited and that are found out 
of compliance following an inspection under this part; and
    (2) Full review by CMS, in accordance with this part; that is, the 
laboratory is subject to the principal and alternative sanctions in 
Sec. 493.1806.
    (b) CLIA-exempt laboratory. If a validation inspection results in a 
finding that a CLIA-exempt laboratory is out of compliance with one or 
more condition-level requirements, CMS directs the State to take 
appropriate enforcement action.