UAMS DEPARTMENT OF PATHOLOGY AND LABORATORY SERVICES
HANDLING OF PROFICIENCY TESTING SURVEYS
To establish a written process for the proper handling of Proficiency Testing
Handling of an alternative performance assessment system for determining the reliability of
analytic results for which no external proficiency testing program is offered are addressed in
section specific policies or procedures.
Proficiency testing is one part of a quality laboratory’s performance
Proficiency testing reflects the accuracy and reliability of a quality laboratory’s performance
in comparison with its peers.
The Clinical Laboratory Director is responsible for oversight of the
proficiency program and
the review of all participant summary evaluations and corrective actions.
Documentation of review is required.
The Clinical Manager, Section Supervisor or Designee is responsible for:
Managing the external proficiency testing program for the department
Purchasing PT material
surveys in their section for timely receipt using the provided
Notifying the PT
provider if expected survey material has not been received
within 7-10 days of the ship date
Notifying the PT provider if material is incomplete or damaged
Completion of PT survey
Rotating survey material among staff responsible for corresponding patient testing
Signing the completed result form and attestation statement
Insuring surveys are
complete and mailed/faxed/entered into the computer within the
time limit set by the PT program (Note: faxed forms will require a print-back function)
Retaining one copy of
the completed result form along with any instrument printouts
or other test result records
Completing corrective action form if required
Documenting review of original participant summary evaluation
Retaining/filing test result forms and participant summaries
to the lab departments regarding survey modifications or changes as
notifications are received by PT providers
completeness of survey activities and follow-up of deficiency activities
Testing personnel is responsible for:
Performing the appropriate test
Recording the test
results as well as the method codes, instrument codes and proper
unit of measure when appropriate on the survey result form
Reviewing the completed form for clerical errors
Signing the attestation statement as the testing personnel
completed result form along with the instrument printout and other material
pertinent to achieving the test result to the Clinical Manager or designee within the set
IV. PROFICIENCY TESTING PROCEDURE
1. All proficiency testing
materials delivered to the facility are distributed
directly to the
individual laboratory departments by laboratory mailroom personnel. Information
regarding the materials received, distribution to departments, additional comments,
and signature of the department personnel receiving the materials is recorded on a
receipt log form. Clinical Managers may design section specific guidelines as
necessary for tracking of survey material.
2. The Clinical Manager or
designee will notify/assign the personnel responsible for testing.
NOTE: Recognizing that some special handling may be required due to the nature of PT
materials, all surveys will be performed as closely as is practical to patient specimen analysis.
Surveys will be rotated through all shifts and staff responsible for similar patient testing.
3. The testing personnel will
perform the appropriate tests. He/she will read and follow
the enclosed instructions. The Clinical Manager or designee should be consulted for
assistance or questions. Testing personnel are prohibited from referring PT specimens
to an outside laboratory for analysis.
4. The testing personnel will
record the test results as well as the method codes, instrument
codes and/or reporting units when appropriate on the survey result form. Testing personnel
are prohibited from communicating with other laboratories regarding PT sample results.
5. The testing personnel will
review the completed form(s) for clerical errors and sign the
attestation statement. The completed result form along with the instrument printouts and
other material pertinent to achieving the test result will be returned to the Clinical Manager
or designee within the set time limit.
6. The Clinical Manager or
designee will sign the completed result form and attestation
7. The Clinical Manager or
designee will mail, fax, or enter
into the computer the completed
results by the set deadline. If forms are faxed, a fax verification receipt will be obtained
and filed with the original result forms.
If offered by the PT provider, the Clinical Educator will receive
receipt of results forms. If the mail/email notification indicates a problem with the receipt
of result forms, the Clinical Manager or their designee will assure that the appropriate action
Linearity/Calibration Verification materials may be obtained in certain
sections for the purpose of assessing method accuracy and precision. Responsibility for
tracking, assignment of testing, reporting and assessment of results will follow the pattern
as described above for PT samples.
V. EVALUATIONS AND PARTICIPANT SUMMARY REPORTS
1. Any results coded as
unacceptable, or an ungraded analyte with a SDI that exceeds 3.0%
will trigger the corrective action process. The corrective action process involves review
of the survey analysis, identifying the problem, taking the appropriate corrective action, and
supplying proof of corrective action. The responsible Clinical Manager or designee will
complete the Proficiency Testing Review Form. This must be done within one month after
the laboratory receives its proficiency testing evaluation. Exceptions may include those
sections where repeat testing of samples requires longer time intervals (e.g. mycobacterial
2. Results with a
positive/negative bias, SDI >2.0% and <3.0%, reflecting a shift or trend,
but are within the acceptable limits may trigger an internal review process. Clinical Managers
may establish section specific guidelines for such reviews, if desired.
3. In the event a Proficiency
test challenge was not graded due to lack of consensus, or our lab
failed to submit results or method code, the section supervisor will investigate the cause,
document corrective action and assess the performance of the results (if available) to
determine if our results were within the majority of the users with the PT final results. The
PT provider may also be contacted to determine if extra PT kits are available to use to perform,
evaluate and document results to assess performance if failed to receive the PT kit.
4. Evaluations, participant
summaries, completed corrective action forms, and any internal
reviews if required, are then forwarded to the Clinical Laboratory Director or Medical
Director for review. The Laboratory Administrative Director will review exception reports
5. The original reports are returned to the responsible Clinical Manager.
6. The Clinical Managers will
coordinate any Proficiency Testing Exception Summary
responses as indicated by repeated failures.
7. The Clinical Manager or designee will retain/file all final responses and PT paperwork.
Linearity/Calibration Verification results will be assessed for any possible
errors in system
linearity and accuracy. Methods demonstrating failure in linearity or calibration verification
will be thoroughly investigated. Documentation of investigation will be retained for long
term monitoring of system or reagent reliability. Review of investigation will follow the
pattern described above for PT samples.
**Policy review date and signatures are available and on file in the Laboratory.
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