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Alternative Assessment Procedural Specifics

General AAP requirements
  1. Policy and procedure for alternative assessment is required. The procedure must document the plan and acceptability limits prior to initial incorporation of the AAP into the PT plan.
  2. Laboratory director must establish criteria for acceptability limits for each alterative assessment procedure. These limits may be + 2 or 3 standard deviation or variation documented in literature.
  3. Acceptable criteria must be documented and incorporated into the evaluation process. The evaluation process must be more detailed and robust if incorporating ungraded PT into the plan. Required performance standards must be defined. Evaluation of ungraded proficiency should be inclusive of the standard deviation index (SDI) to compare to peer groups and percentage from the target or the mean.
Specific assessment procedural methods
  • External split sample analysis -- utilizing a reference or other accredited laboratory
    • Employ an alternate laboratory that is CLIA accredited and the same level of complexity or higher.
    • Send samples (two or more) to another laboratory for comparison of results.
    • The number of samples is established by procedure/laboratory director.
    • Try to establish 95% confidence limits. If three samples are tested and all are correct, this is acceptable according to acceptability limits. If only 2/3 are acceptable, test three additional samples and evaluate. In this case, 5/6 must be acceptable.
    • Most useful when both laboratories use the same test method, but is comparable as long as the expected biases are determined.
  • Internal split sample analysis with an established in-house method
    • Use assayed material, standard reference material, or regional pools.
    • Divide a single sample into multiple aliquots and compare results.
  • Ungraded or educational challenge PT samples-- AAP is required for regulated analytes.
    • PT grade of 100% is an artificial score and not reflective of performance due to lack of consensus among all laboratories performing the PT sample(s).
    • The results are scored as “Ungraded” or "Lack of Consensus."
    • Perform a self-assessment using the Participant Summary or manufacturer provided information.
    • Document results of self- assessment.
    • If required, perform and document corrective action, as necessary.
  • Direct observation of technique-dependent tests
    • Experienced senior staff or supervisors may observe a technique-dependent test for correct performance (eg, bleeding time or sweat test).
    • Employ a checklist in the evaluation process to provide an objective evaluation of personnel competency, but not the acceptability of results.
  • Reevaluation of analysis of manufacturer’s product calibrator or trueness control material
    • Use calibration or other reference material provided by the method manufacturer traceable to a reference material or procedure.
    • Use a lot other than the lot currently in use for method calibration and not specific to a lot of reagent.
    • Use only when there is no other alternative material or process.
  • Analysis of patient data -- for quantitative, high volume analytes only
    • Divide a single patient specimen into multiple aliquots.
    • Test by the same method and compare results over time.
    • Use each aliquot one time and discard.
    • Average results of a group of specimens over time for either means, or medians, or continuous QC.
    • Relatively constant results reflect that the procedure is stable.
    • Exclude values outside of the reference population.