[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: 42CFR493.569]



[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.  493.569  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.