CHAPTER 7
PROFICIENCY TESTING PROGRAMS FOR TESTS OF MODERATE COMPLEXITY (INCLUDING
THE SUBPARAGRAPH), HIGH COMPLEXITY, OR ANY COMBINATION OF THESE TESTS
7-1. Approval of proficiency testing programs (§493.901)
In order for a proficiency testing program to receive OASD(HA) approval,
the program must be offered by a private nonprofit organization or a Federal
or State agency, and the program must submit to OASD(HA) written evidence
from HCFA that they meet proficiency testing criteria established by HCFA
(paragraph 493.901 of 42 CFR Part 493). DoD will consider all programs that
meet HHS approval as meeting DoD minimum requirements. DoD as an entity
may approve specific non-HCFA approved programs if and when necessary to
meet proficiency testing standards in military unique circumstances, which
will be limited to overseas laboratories. Overseas laboratories, except
in time of war or mobilization, will not be exempt from performance of proficiency
testing.
7-2. Administrative responsibilities (§493.903)
The proficiency testing program must (if there are any DoD users of the
proficiency testing program):
a. Provide TSGs and participating laboratories with an electronic or a hard
copy, or both, of reports of proficiency testing results and all scores
for each laboratory's performance in a format as required by and approved
by OASD(HA) for each certified specialty, subspecialty, and analyte or test
within 60 days after the date by which the laboratory must report proficiency
testing results to the proficiency testing program.
b. Provide TSG with reports of PT results and scores of individual performance
in cytology and provide copies of reports to participating individuals,
and to all laboratories that employ the individuals, within 15 working days
of the testing event;
c. Furnish to TSG cumulative reports on an individual laboratory's performance
and aggregate data on DoD-certified laboratories for the purpose of establishing
a system to make the proficiency testing results available, on a reasonable
basis, upon request of any person, and include such explanatory information
as may be appropriate to assist in the interpretation of the proficiency
testing results;
d. Provide TSG with additional information and data upon request and submit
such information necessary for TSG to conduct an annual evaluation to determine
whether the proficiency testing program continues to meet CLIA requirements
(paragraphs 901-959 of 42 CFR Part 493).
e. Maintain records of laboratories' performance for a period of five years
or such time as may be necessary for any legal proceedings; and
f. Provide TSG, if there are any DoD users of the specific proficiency test
program, with an annual report and,if needed, an interim report which identifies
any previously unrecognized sources of variability in kits, instruments,methods,
or PT samples, which adversely affect the programs' ability to evaluate
laboratory performance.
7-3. Nonapproved proficiency testing programs (§493.905)
A proficiency testing program that fails to meet CLIA requirements will
be notified by HCFA as such. That proficiency testing program must notify
OASD(HA) and all laboratories enrolled of the nonapproval and the reasons
for nonapproval within 30 days of the notification.
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