[Code of Federal Regulations]
[Title 12, Volume 1]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR493.807]

[Page 1002-1003]
 
                         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 H--Participation in Proficiency Testing for Laboratories 
                      Performing Nonwaived Testing
 
Sec. 493.807  Condition: Reinstatement of laboratories performing nonwaived testing.

    (a) If a laboratory's certificate is suspended or limited or its 
Medicare or Medicaid approval is cancelled or its Medicare or Medicaid 
payments are suspended because it fails to participate successfully in 
proficiency testing for one or more specialties, subspecialties, analyte 
or test, or voluntarily withdraws its certification under CLIA for the 
failed specialty, subspecialty, or analyte, the laboratory must then 
demonstrate sustained satisfactory performance on two consecutive 
proficiency testing events, one of which

[[Page 1003]]

may be on site, before CMS will consider it for reinstatement for 
certification and Medicare or Medicaid approval in that specialty, 
subspecialty, analyte or test.
    (b) The cancellation period for Medicare and Medicaid approval or 
period for suspension of Medicare or Medicaid payments or suspension or 
limitation of certification under CLIA for the failed specialty, 
subspecialty, or analyte or test is for a period of not less than six 
months from the date of cancellation, limitation or suspension of the 
CLIA certificate.

[58 FR 5228, Jan. 19, 1993, as amended at 60 FR 20048, Apr. 24, 1995]

   Proficiency Testing by Specialty and Subspecialty for Laboratories 
  Performing Tests of Moderate Complexity (Including the Subcategory), 
           High Complexity, or Any Combination of These Tests