External Quality Assessment

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External Quality Assessment. External Quality Assessment. EQA - Module 12. 1. Learning Objectives. At the end of this module, participants will be able to: Discuss the importance of an EQA program in improving the quality of laboratory test results. - PowerPoint PPT Presentation

Text of External Quality Assessment

  • Assessment: EQA - Module 10*EQA - Module 12*External Quality AssessmentExternal Quality Assessment

    Assessment: EQA - Module 10

  • Assessment: EQA - Module 10***Learning ObjectivesAt the end of this module, participants will be able to:Discuss the importance of an EQA program in improving the quality of laboratory test results.Describe at least three EQA methods and the advantages and disadvantages of each.Outline a method to investigate an unacceptable test result from an EQA sample.

    Assessment: EQA - Module 10

  • Assessment: EQA - Module 10***Scenario A newly appointed laboratory supervisor has begun reviewing past EQA results, and observes poor Gram stain performance. How should the laboratory investigate this problem?

    Assessment: EQA - Module 10

  • Assessment: EQA - Module 10**The Quality Management System

    Assessment: EQA - Module 10

  • Assessment: EQA - Module 10*External Quality Assessment A system for objectively checking the laboratorys performance using an external agency or facility

    Assessment: EQA - Module 10

  • Assessment: EQA - Module 10**

    Assessment: EQA - Module 10

  • Assessment: EQA - Module 10**External Quality Assessment (EQA) comparison among different test sites early warning for systemic problems objective evidence of testing quality areas that need improvement training needs

    Assessment: EQA - Module 10

  • Assessment: EQA - Module 10*EQA BenefitsLaboratory oriented objectives Public Health oriented objectives

    Assessment: EQA - Module 10

  • Assessment: EQA - Module 10**

    Assessment: EQA - Module 10

  • Assessment: EQA - Module 10*EQAimportant for improvementa measure of laboratory performance

    Assessment: EQA - Module 10

  • Assessment: EQA - Module 10**ISO/IEC Guide 43-1:1997 Proficiency testing schemes (PTS) are interlaboratory comparisons that are organized regularly to assess the performance of analytical laboratories and the competence of the analytical personnel.

    Definition Proficiency Testing

    Assessment: EQA - Module 10

  • Assessment: EQA - Module 10** CLSI GP27-A2 27:8A program in which multiple samples are periodically sent to members of a group of laboratories for analysis and/or identification; whereby each laboratorys results are compared with those of other laboratories in the group and/or with an assigned value, and reported to the participating laboratories and others.

    Definition Proficiency Testing

    Assessment: EQA - Module 10

  • Assessment: EQA - Module 10*PT organization /providerLaboratoryAnalyzeEvaluationPT performance reportReturn resultsPT ProcessPT samples sent regularlyReceive PT reportCorrective Actions

    Assessment: EQA - Module 10

  • Assessment: EQA - Module 10**Laboratory 1Laboratory 2No discussion between labs PT: Roles of LaboratoryFinal PT report receivedISO 15189Analyze same manner with same personnelImprovement

    PT samplePatient sample

    Assessment: EQA - Module 10

  • Assessment: EQA - Module 10*Information received from PT participation must be directed toward improvement in the laboratory to receive the full value.

    PT Results

    Assessment: EQA - Module 10

  • Assessment: EQA - Module 10*PT results are affected by variables not related to patient samples PT will not detect all problems in the laboratoryPT may not detect problems with pre- and postexamination procedures

    PT Limitations

    Assessment: EQA - Module 10

  • Assessment: EQA - Module 10*Other EQA MethodsRechecking/RetestingReference laboratoryPeripheral laboratoryRechecking

    Assessment: EQA - Module 10

  • Assessment: EQA - Module 10**Retestingtested by reference laboratoryperformed on dried blood spots or serumnot blindedstatistically significantprimarily used to assess HIV rapid testing

    Assessment: EQA - Module 10

  • Assessment: EQA - Module 10**Rechecking samples must be collected randomlyavoid systematic sampling biasstatistically significantresolve discrepancieseffective feedbackprimarily AFB

    Assessment: EQA - Module 10

  • Assessment: EQA - Module 10**Comparison of rechecking non-blinded and random blinded smears for acid-fast bacilliMartinez A, et al. Int J Tuberc Lung Dis 2005;9(3):301-5.

    Performance characteristics measuredNon-blinded sample(1998)Random blinded sample (2002)State A-sensitivity99.7% 86.7%State B-sensitivity98.9% 84.7%State A-specificity99.8% 99.1%State B-specificity99.9% 99.7%

    Assessment: EQA - Module 10

  • Assessment: EQA - Module 10*On-site EvaluationLaboratoryto obtain a realistic picture of laboratory practicesto provide assistance with problem areas External group or OrganizerPeriodic visits

    Assessment: EQA - Module 10

  • Assessment: EQA - Module 10*

    AFB Microscopy Comparison of performance before and after on-site monitoring Aziz, M. and G. Bretzel, Int J Tuberc Lung Dis 2002:6(4):340-349.BEFORE (%)AFTER(%)

    No sand bucket9627No decontamination of sputum cups6023No disinfectant314No biohazard waste bin (covered)488No lab coats4846Technologists do not wash hands174Shortage of lab reagents7527Improper sputum collection6031Improper filling of laboratory register294Improper labeling slides/containers3113

    Assessment: EQA - Module 10

  • Assessment: EQA - Module 10**Proficiency Testing and Rechecking

    CharacteristicsPTRCInterlaboratory comparisonYesYesSimulated samplesYesNoReal samplesYes/NoYesTime and resources neededLessMoreAnalytes evaluatedManyFew

    Assessment: EQA - Module 10

  • Assessment: EQA - Module 10**EQA ParticipationRecommended for all laboratories

    Required by ISOISO 15189

    Assessment: EQA - Module 10

  • Assessment: EQA - Module 10*Management Processhandle and analyze EQA samplestreat EQA samples same as patientmonitor and maintain recordsinvestigate deficienciesmanage corrective action effortscommunicate outcomes

    EQA results Corrective actions

    Assessment: EQA - Module 10

  • Assessment: EQA - Module 10**EQA performance problemsCHALLENGESample ManagementExaminationReport PreexaminationPostexaminationPT PROVIDER

    Assessment: EQA - Module 10

  • Assessment: EQA - Module 10**EQAEQA Should Lead to ActionsIdentifyproblemsTake Corrective Action

    Assessment: EQA - Module 10

  • Assessment: EQA - Module 10**SummaryEQA is a system for objectively checking the laboratorys performance using an external agency or facilityAll laboratories should participate in EQASeveral methods of EQA in useEQA samples must be treated the same as patient samples

    Assessment: EQA - Module 10

  • Assessment: EQA - Module 10**Key MessagesEQA uses valuable resources, make best possible useEQA should not be punitiveEQA should be viewed as educationalEQA can help direct improvement effortsEQA is a critical element of a quality management system

    Assessment: EQA - Module 10

  • Assessment: EQA - Module 10**Comments?

    Questions?

    Assessment: EQA - Module 10

    ***

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