Presentation on theme: "Maritime Pathology Conference Gunita Mitera November 29, 2014"— Presentation transcript:
1 Maritime Pathology Conference Gunita Mitera November 29, 2014 Interpretive Quality Assurance In Pathology: Where Is The Current State And Future Direction In Canada?Maritime Pathology ConferenceGunita MiteraNovember 29, 2014
2 ObjectivesTo provide an overview of the rationale for the Quality Initiative in Interpretive Pathology (QIIP) projectTo describe the current landscape of interpretive pathology quality in CanadaTo have a discussion on the QIIP framework and plans for local implementation
3 Elements of QualityTimelinessAccuracyCompletenessUsability
4 Importance of Quality Assurance in Pathology Robust QA programs for pathology exist across the countryThese programs are particularly well developed to address the technical aspects of pathology QAWhile interpretive elements of QA are woven into these programs, a comprehensive QA program that addresses interpretive pathology QA (i.e. determining the accuracy of the diagnosis) is minimal
5 Pathology organization(s) Responsible for Guidelines Responsibility for Clinical Practice / Interpretive Quality Guidelines: Where does it lie?CountryPathology organization(s)Responsible for GuidelinesUSACollege of American PathologistsYesU.K.Royal College of PathologistsAustralia/New Zealand/South East AsiaRoyal College of Pathologists AustralasiaIrelandRoyal College of Physicians of Ireland, Faculty of PathologyCanadaRoyal College of Physicians and Surgeons of CanadaCanadian Association of PathologistsNoRecent & Limited
6 International Examples of Implementation of Quality Assurance in Pathology IrelandNational quality assurance program in histopathologyOnly national interpretive pathology QA Program
7 A Re-Conceptualization Of The Pathology Testing Cycle… From The Perspective Of Interpretive PathologyPre-AnalyticalAnalyticalPost-AnalyticalInterpretivePre-interpretivePost-Interpretive
8 General Pathology Workflow Process Map Slides from lab & demographic infoPre-Interpretive ActivitiesInterpretive ActivitiesPost-Interpretive ActivitiesAdditional Clinical InformationPrevious and Concurrent Specimens from the Same CaseProspective Peer ReviewAdditional Work-up
9 Quality And Accuracy Across The Country Some provinces have groups in place to address quality and accuracy in pathologyNo national consistency in terms of guidelines, standards or recommendationsNational survey results9
11 Interpretive Quality Across The Country: National Survey Results Professional group(s) that represents pathologyin the provinceTECHNICAL lab accreditation program in the province
12 to the INTERPRETIVE aspects of pathology? Interpretive Quality Across The Country: National Survey Results (continued)Coordinated provincial quality assurance program relatedto the INTERPRETIVE aspects of pathology?
13 QIIP Project TimelineDraft recommendations developed by QIIP Thought LeadersApr –June 2014Pan-Canadian consensus process to refine and validate the recommendationsJune 2014 –Aug. 2014Final draft recommendations Aug –June 2015Public review period/ EndorsementJune 2015 –Nov. 2016Finalize the recommendations documentNov –Mar. 2017
14 QIIP Work Plan - Activities Completed Environmental scan conducted45 quality documents reviewed (institutional, provincial/ jurisdictional, national, international)Relevant interpretive pathology sections collatedFramework headers developed by QIIP Thought Leaders with pan-Canadian expert inputConsensus process
16 Sample Recommendations: High Degree Of Consensus Section I: Overarching Foundational ElementsInformatics Systems - Support for QA activitiesRecommendation: The following resources and elements are essential to ensure successful implementation of a quality assurance program:Mechanisms to collect, analyze and share quality indicator dataA suitable laboratory information system (LIS) that can facilitate quality assurance processesSufficient personnel (professional and support staff)Information technology resources to develop and maintain the program Other Foundational Resources - Decision support toolsRecommendation: All practicing pathologists should have access to the latest decision support tools to remain up to date on the most recent evidence and advances in the field to make an informed and accurate diagnosis, including:Up-to-date textbooks and relevant pathology journals to make an informed, evidence-based diagnosisUp to date evidence-based standards and clinical guidelines to improve practiceSection IV: External Quality AssuranceExternal Quality AssuranceRecommendation: All laboratories delivering interpretive pathology services should participate in established quality assurance programs including both External Quality Assessment (proficiency testing) and pathologist peer assessment
17 Sample Recommendations: Debated Section I: Overarching Foundational ElementsGovernance/Oversight - InstitutionalRecommendation: Each institution delivering pathology services should have the following in place:A Laboratory Quality Assurance Committee with authority vested by the board, to provide oversight for technical laboratory services from the health authorityA quality management system that includes policies and procedures for achieving optimal results and ongoing quality improvementA laboratory or specialty-specific professional/interpretive quality committee, reporting to an institutional-level senior quality committee, that is responsible for implementing and monitoring of quality assurance (QA) within the laboratory specialty; laboratory directors and laboratories implement and monitor the practice guidelines and/or standards developed including:Development of quality plan and implementation of QA policiesRegular review of QA metrics and monitoring of complianceReporting on the performance of the quality management system and areas for improvementProvision of a forum for peer discussion and resolution of quality issuesIdentification of acceptable QA targets/metricsA laboratory medical Director, fully supported by the organizational governance and able to fulfill fiduciary duties, who is accountable and responsible for the institutional quality program
18 Sample Recommendations: Debated Institutional-Level Internal Quality Assurance Procedures and Policies (QAPP) Pertaining to the Overall ProcessInternal retrospective reviews and auditsRecommendation:On a regular basis, areas perceived as being prone to diagnostic discordance should be selected for audit. Retrospective audits must be targeted and random reviews are not recommended under any circumstancePathologists should document correlation for all cases reviewed retrospectively for rounds, tumour boards, at the request of a physician/patient, review of previous material when diagnosis of previous surgical specimen and current surgical specimen do not correlate On a regular basis, data from these reviews including the factors that contribute to the error should be documented in a report and previous reviews must be documented in a report
19 Points of DiscussionCan these QIIP recommendations be implemented within your current pathology QA system?Are there any local barriers to focus on prior to implementation?Do you have any concerns with implementation or buy-in from key individuals that would prevent implementation?Are there specific meetings in the next couple of years that you feel we should be attending to help increase the awareness and engagement in the QIIP recommendations development process?Is there anything else we have not considered or you would like to flag?
20 Thank you! Aaaa! Look out everyone! It’s a coverslip Life on a microscope slide
22 A National Call for Action 1999Sunnybrook lab (ON): Canadian entertainer received unnecessary treatment due to a misdiagnosis of breast cancer2003Eastern Health authority (NL): “Cameron Inquiry” investigation of breast hormone receptor testing inaccuracy2007Miramichi Hospital (NB): “Creaghan Inquiry” investigation of 15,000 tests audited, indicated 3% of cases were misdiagnosed2008Grey Bruce Health Services, Owen Sound (ON): Investigation of 600 tests audited; indicated 6% of cases were erroneousDiagnostic Services of Manitoba (MB): Review of 700 cases, at least 10 errors confirmed2009College of Physicians (QC): Issued report stating that over 15% of hormone receptor and HER2 tests indicated discrepancies
23 A National Call for Action (continued) 2010Minister ordered investigation at Windsor Hospitals (ON): 3,000 cases audited, several cases were misdiagnosed2011Diagnostic Services of Manitoba (MB): 3,000 cases were reviewed, several were misdiagnosedEdmonton, Alberta Investigation (AB): 1,700 cases reviewed, several were misdiagnosed2013Queen Elizabeth II Health Sciences Centre (NS): Patient charts switched for two patients and slides for two patients were mislabelled, both cases resulting in one patient undergoing needless treatment and another delayed treatmentPasqua Hospital (SK): Tissue specimens of 107 patients were mishandled, proper pathology reports could not be issued for 53 patients of which had to be re-biopsied2014Eastern Health authority (NL): investigation of misintepreted hormone receptor test results, nine women treated needlessly with a drug
25 Interpretive Phase-Quality Assurance Who?GovernanceIntra-departmental and external consultationExternal reviewWhat?Documentation and Informatics systemsInstitutional-Level Quality Assurance Procedures and Policies for the overall processAdditional testsAccess to literatureRelevant clinical informationWhere?EquipmentSpaceWhen?Turnaround timeHow can I make an informed, consistent, timely and accurate diagnosis?MD
26 Overall Consensus Process Pre-Delphi SurveyIn-Person Delphi MeetingPost-Delphi Survey
27 QIIP Consensus Process Pre-Delphi SurveyElectronic survey was circulated to vote on initial recommendations and inform today’s discussionIn-Person ConsensusPathology leaders to attend to discuss recommendations to be included in pan-Canadian frameworkPost-Delphi SurveyElectronic survey, similar to pre-Delphi survey, will be circulated to validate results of the in-person Delphi meeting
28 Provinces With An Established Provincial INTERPRETIVE Pathology Quality Assurance Program Is there a coordinated provincial plan in place ?Program Details; Organization who Provides OversightABYesLaboratory Services Quality Assurance Plan for Anatomic Pathology; Alberta Health Services*Collecting data for the next 6-12 months to establish benchmarks/targets.PEA very comprehensive QA program; Self administered by all 5 pathologists on the island (2 hospitals) - not regulated.
29 Provinces With Plans To Implement A Provincial INTERPRETIVE Pathology Quality Assurance Program Is there a coordinated provincial plan in place ?Program Details; Organization who Provides OversightSKNo*Ongoing discussion for a stronger provincial program; College of Physician and Surgeons and some Ministry of Health involvement .One of the larger labs is College of American Pathologists (CAP) accredited which includes some professional interpretative modules.ON*Ongoing discussion.Standards2Quality has been proposed, only voluntary at the organizational level with oversight at the hospital level.QC*A partial plan in place.*Since 2010, all pathology laboratories must have an internal and external quality assurance program. The external program is provided by the Laboratoire de Santé Publique and part of the activities are interpretive with elements from the CAP program. NL*Ongoing discussion for the Provincial Working Group of Newfoundland to lead this initiative.N/ANBA combination of various External Quality Assurance (EQA) programs such as: CAP check samples/performance improvement program (PIP) for surgical path, NSH/CAP and cIQC for IHC, Atlantic Peer Review Program through the NB College of Physician and surgeons (2008) implemented in the province; New Brunswick Cancer Network(NBCN) Pathology Advisory Committee.NS*No plan in place.The Capital District Heath Authority (CDHA) Anatomical Pathology Laboratory, the largest and only academic laboratory in the province (70% of the lab work for the province), has a QA policy and many policies related to interpretative pathology; The Service Chief of the Division and a Divisional QA Committee.
30 Provinces With NO Established Provincial INTERPRETIVE Pathology Quality Assurance Program Is there a coordinated provincial plan in place ?Program Details; Organization who Provides OversightBCNo*No plan in place.Diagnostic Accreditation Program (DAP) accreditation standards 2010 document - Quality improvement peer review section; College of Physicians and Surgeons of BC .MB*All public laboratories (x6) are run by Diagnostic Services of Manitoba (DSM) with self-reporting conducted manually.*Commercial laboratories mostly run by Gamma Dynacare.The province has implemented the Lab Accreditation Program offered by the College of American Pathologists (CAP), which includes some professional interpretative modules.