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Medical Testing Site (MTS) Proficiency Testing (PT)
ENROLLMENT REQUIREMENTS
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Except where there is no available PT program or PT is not required,
each MTS shall demonstrate satisfactory participation in a Federal
Health and Human Services Centers for Medicare and Medicaid Services (CMS)
approved PT program, appropriate for the tests performed on-site, excluding
waived tests. (Note: Bacteriology, Mycology, Mycobacteriology: these
subspecialties do not have "regulated analytes" per se. However, the
laboratory must subscribe to a module that covers the testing performed.) The
MTS must enroll each year. If the MTS is currently enrolled in an approved PT
program, the provider will automatically send a renewal form for the next year
in the Fall of the year.
For non-regulated analytes or tests for which there is no PT available, the MTS must
have a system for biannual verification of the accuracy of
its test results. Biannual verification may be accomplished by analyzing specimens from a
PT company or reference laboratory, by comparing split samples with a reference
laboratory, by performing patient correlation, etc. At least 2 specimens should be used
for test verification every six months.
LQA will monitor performance throughout the year for regulated analytes. During the
on-site survey, unregulated/ungraded tests will be reviewed to see if: (1) laboratory is
reviewing PT results for these tests; (2) any problems have been noted by the laboratory;
and, (3) corrective action has been taken when indicated. The laboratory may be cited if
it is not reviewing the unregulated/ungraded tests and/or has not taken appropriate
corrective action when problems are noted.
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