35PROFICIENCY TESTING
Cholestech LDX System Procedure Manual
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Recommended Optional Information
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3. The specimen of choice for the Cholestech LDX System is a specimen of human serum
with no stabilizers.
The type of specimen provided presents a potential problem for some instruments
and methodologies. Lyophilized serum has been the most frequently used sample for
clinical chemistry proficiency surveys. But with some test systems, including the
Cholestech LDX, lyophilized serum may not provide an adequate accuracy check due
to matrix interference. If you are unfamiliar with the concept of matrix effect, please
call Cholestech Technical Service for clarification.
In Section 7.2 of this manual, a list of agencies offering CMS-approved proficiency
surveys is provided. The agencies set in bold are the ones Cholestech has evaluated
and found to demonstrate acceptable performance on the Cholestech LDX. For testing
other instruments in your laboratory, it is important to contact the manufacturer and
request the names of agencies that run compatible surveys with no matrix
interferences on these instruments or system.
4. The survey samples are mailed to the participating laboratories according to a
schedule set by the proficiency testing agency. Within the time limit set by the agency,
the laboratory personnel perform the required tests on the survey specimens.
Only
tests performed in the laboratory should be analyzed. Survey specimens are handled
and analyzed using the same procedure as that for patient specimens.
When you
perform proficiency tests (on the Cholestech LDX) using serum or plasma samples, the
Serum switch must be
on.
Refer to the Cholestech LDX System User Manual for
instructions to reconfigure the menu from Whole Blood to Serum.
5. Results on the survey specimens are entered on a preprinted form, coded according to
reagent-instrument method and returned to the proficiency testing agency.
• After evaluation statistics have been calculated, a summary report of results is sent
to all participating laboratories.
• Laboratories may also request that a proficiency testing agency send a copy of its
results to state or federal regulatory agencies.
• In general, regulatory agencies require documented evidence of corrective action
taken when survey results fall outside acceptable limits. The director of a point-of-
care laboratory will review all proficiency testing results and document the review
and responses to unacceptable results.
• Cholestech Technical Service can provide assistance in troubleshooting proficiency
testing failures.
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