I.          PURPOSE

            To establish a written process for the proper handling of Proficiency Testing (PT) Surveys. 
            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 improvement plan. 
            Proficiency testing reflects the accuracy and reliability of a quality laboratory’s performance
            in comparison with its peers. 

III.       RESPONSIBILITY           

            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:

            Testing personnel is responsible for:


            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. 

  8.         If offered by the PT provider, the Clinical Educator will receive mail/email notification of
             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

  9.         Linearity/Calibration Verification materials may be obtained in certain Clinical Laboratory
             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. 


            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. 

  8.         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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