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B. The Analytic Phase
1. Quality Control (QC)
Quality control provides assurance that the
test system has performed as expected, and
alerts the user when problems occur which
may affect patient results; these can be
problems due to operator error, reagent or
test kit deterioration, instrument malfunction
or improper environmental conditions.
If quality control testing fails to perform
as expected, patient testing should not be
performed or results should not be reported
until the problem is identified and corrected.
QC test results should be recorded and
monitored. Records of control results should
be periodically reviewed by the person
responsible for testing oversight to detect
shifts or changes in performance over time
which may affect patient results.
2. Test Performance
Follow the steps in the test procedure exactly
as described in the manufacturer’s product
insert and /or the written procedures.
3. Results Interpretation.
Results can be recorded directly in a
patient's chart, in log books, or on a
separate report form. Interpretation of
the results should be in accordance with
instructions in the product insert.
4. Resolving problems
If a test result is not acceptable or requires
repeat testing (e.g., out of range or invalid),
record the initial result, noting it was
unacceptable, take steps necessary to
resolve the problem, then repeat the test
and record the correct result. Good
laboratory practice includes recording what
happens, whether acceptable or not, and
what is done to correct problems
encountered during testing. Results should
not be reported until the problem is
resolved. Follow the steps in the product
insert to resolve problems with the test
results. If repeat testing does not resolve the
problem, contact the manufacturer or
technical representative.
reported in a timely manner to the
appropriate person. All verbal reports of
test results should be documented and
followed by a written report. Critical
values require immediate notification of
the clinician, and procedures should be in
place to ensure documentation of these
values along with the time of notification
of the proper medical personnel.
2. Confirmatory testing
The product insert should explain when
additional testing is needed to confirm a
waived test result or when the test is to be
used as part of a multi-test algorithm (e.g.
throat culture needed to confirm a negative
result for rapid group A strep antigen).
There should be written policies and
procedures to ensure that all confirmatory
and supplemental testing is performed
when needed. When collecting specimens
for referral to another laboratory, the
instructions provided by the...
C. The Post-analytic phase:
1. Reporting Test Results
Patient reports should be legible and
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