[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: 42CFR493.807]



[Page 1011-1012]

 

                         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 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]



[[Page 1012]]



   Proficiency Testing by Specialty and Subspecialty for Laboratories 

  Performing Tests of Moderate Complexity (Including the Subcategory), 

           High Complexity, or Any Combination of These Tests