[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: 42CFR493.803]

[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 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]