[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: 42CFR493.823]

[Page 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. 493.823  Standard; Bacteriology.

    (a) Failure to attain an overall testing event score of at least 80 
percent is unsatisfactory performance.
    (b) Failure to participate in a testing event is unsatisfactory 
performance and results in a score of 0 for the testing event. 
Consideration may be given to those laboratories failing to participate 
in a testing event only if--
    (1) Patient testing was suspended during the time frame allotted for 
testing and reporting proficiency testing results;
    (2) The laboratory notifies the inspecting agency and the 
proficiency testing program within the time frame for submitting 
proficiency testing results of the suspension of patient testing and the 
circumstances associated with failure to perform tests on proficiency 
testing samples; and
    (3) The laboratory participated in the previous two proficiency 
testing events.
    (c) Failure to return proficiency testing results to the proficiency 
testing program within the time frame specified by the program is 
unsatisfactory performance and results in a score of 0 for the testing 
event.
    (d)(1) For any unsatisfactory testing event for reasons other than a 
failure to participate, the laboratory must undertake appropriate 
training and employ the technical assistance necessary to correct 
problems associated with a proficiency testing failure.
    (2) Remedial action must be taken and documented, and the 
documentation must be maintained by the laboratory for two years from 
the date of participation in the proficiency testing event.
    (e) Failure to achieve an overall testing event score of 
satisfactory performance for two consecutive testing events or two out 
of three consecutive testing events is unsuccessful performance.