[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: 42CFR493.827]



[Page 1013]

 

                         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.  493.827  Standard; Mycology.



    (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.