[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: 42CFR493.803]



[Page 1011]

 

                         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.  493.803  Condition: Successful participation.



    (a) Each laboratory performing nonwaived testing must successfully 

participate in a proficiency testing program approved by CMS, if 

applicable, as described in subpart I of this part for each specialty, 

subspecialty, and analyte or test in which the laboratory is certified 

under CLIA.

    (b) Except as specified in paragraph (c) of this section, if a 

laboratory fails to participate successfully in proficiency testing for 

a given specialty, subspecialty, analyte or test, as defined in this 

section, or fails to take remedial action when an individual fails 

gynecologic cytology, CMS imposes sanctions, as specified in subpart R 

of this part.

    (c) If a laboratory fails to perform successfully in a CMS-approved 

proficiency testing program, for the initial unsuccessful performance, 

CMS may direct the laboratory to undertake training of its personnel or 

to obtain technical assistance, or both, rather than imposing 

alternative or principle sanctions except when one or more of the 

following conditions exists:

    (1) There is immediate jeopardy to patient health and safety.

    (2) The laboratory fails to provide CMS or a CMS agent with 

satisfactory evidence that it has taken steps to correct the problem 

identified by the unsuccessful proficiency testing performance.

    (3) The laboratory has a poor compliance history.



[57 FR 7146, Feb. 28, 1992, as amended at 60 FR 20048, Apr. 24, 1995; 63 

FR 26737, May 14, 1998; 68 FR 3702, Jan. 24, 2003]