2015 OAP Pathologist Assistant Meeting, September 19 - Niagara Falls, Ontario. EQA and the Grosslab Alan Wolff, PA, MLT. Quality in the Gross Lab

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1 Quality in the Gross Lab Lakeridge Health, Oshawa, Ontario Describe what EQA is Describe the IQMH position and requirement Be aware of the current state of EQA for grossing Have identified good methods to monitor grossing quality Proficiency Testing Competency of our Labs Testing Menu Allows for self evaluation and Bench Marking amongst peer labs Requires Corrective Action to address deficiency Mandatory in Ontario 1

2 Slides of unstained sections are selected and a request to apply a routine, special stain or IHC marker is made Which shall be treated as if it were a patient sample Huge Emphasis on ER/PR/HER2 Which are class II markers (predictive) Because the interpretation of these influences treatment Ongoing surveys about current and changing practice Case study reviews for the Pathologist to review This may incorporate locally stained slides Electronic questionnaire for submission And of course the need for the pathologists to fit this into their already busy day IQMH QMPLS/OLA CAP The College not the Canadian one ciqc There are others.. 2

3 Great infrastructure Proficiency Testing Specialty Panel/Scientific Committee consensus evaluation Online filing, document management - Web portal Patterns of Practice Qview Qtraks Self and Peer Assessments - Accreditation Institute for Quality Management in Healthcare Authentic and simulated human samples of undisclosed content are provided to participants, together with relevant clinical histories. Participants are required to process samples as patient specimens using routine methods. Submitted participant results are compared with the assigned value (reference laboratory results or consensus results of participant laboratories and/or expert laboratories). Participants receive detailed PT reports that demonstrate their testing performance and guidance in the investigation of root causes of the discordant PT results. Discipline-specific scientific committees review PT results after each round and write a report called Committee Comments that summarizes data obtained from the survey, and provide educational comments on results. 3

4 Gross lab Gross Room Cut Up Room All examinations in the scope of accreditation Licensed Test Qtraks L codes Grossing does not have a specific L code 4

5 NOPE 5

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7 When not available or feasible Make your own!!!! Site to Site comparison Radiology Gross pathology correlation Clinical & Laboratory Standards Institute (CLSI) - duplicate testing by two or more personnel - re-examination of a random microscopic slide by all appropriate personnel - analysis of manufacturers' calibration material - blind testing of samples with known results - exchange of samples with other laboratories (split sampling) - interlaboratory comparison of QC results - analysis of patient data - direct observation of technique-dependent tests - clinical correlation 7

8 Quality Systems Essentials ISO The laboratory shall participate in inter laboratory comparisons such as those organized by external quality assessment schemes. Laboratory managementshallmonitor the results of externalquality assessment and participate in the implementation of corrective actions when control criteria are not fulfilled. Interlaboratorycomparison programs shall be in substantial agreement with ISO/IEC Guide External quality assessment programs should, as far as possible, provide clinically relevant challenges that mimic patient samples and have the effect of checking the entire examination process, including pre and post examination procedures. ISO Whenever a formal inter laboratory comparison program is not available, the laboratory shall developa mechanism for determining the acceptability of procedures not otherwise evaluated. Wheneverpossible, this mechanism shall utilize externally derived challenge materials such as exchange of samples with otherlaboratories. Laboratory management shall monitor the results of this mechanism of inter laboratory comparison and participate in the implementation and recording of corrective actions. Comparative Event Acceptance Rate Corrective Action Management or Oversite Review 8

9 Is grossing an examination? Is it covered by existing assessments? Should there be a formal EQA process? At CAP 2014 Toronto: The IQMH (QMPLS) representative seemed to feel Yes, EQA mechanism should be in place and clear. Retrospective: TAT audits CCO Completeness Audits CCO LN sampling audits CCO Pathologist Feedback Prospective: VR accuracy Testing Gross conference and specimen review Thoughts? Questions? Concerns? 9