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Interpretive Quality Assurance In Pathology: Where Is The Current State And Future Direction In Canada? Maritime Pathology Conference Gunita Mitera November.

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Presentation on theme: "Interpretive Quality Assurance In Pathology: Where Is The Current State And Future Direction In Canada? Maritime Pathology Conference Gunita Mitera November."— Presentation transcript:

1 Interpretive Quality Assurance In Pathology: Where Is The Current State And Future Direction In Canada? Maritime Pathology Conference Gunita Mitera November 29, 2014

2 Objectives To provide an overview of the rationale for the Quality Initiative in Interpretive Pathology (QIIP) project To describe the current landscape of interpretive pathology quality in Canada To have a discussion on the QIIP framework and plans for local implementation 2

3 Elements of Quality Timeliness Accuracy CompletenessUsability

4 Importance of Quality Assurance in Pathology Robust QA programs for pathology exist across the country These programs are particularly well developed to address the technical aspects of pathology QA While 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 Responsibility for Clinical Practice / Interpretive Quality Guidelines: Where does it lie? CountryPathology organization(s)Responsible for Guidelines USACollege of American PathologistsYes U.K.Royal College of PathologistsYes Australia/ New Zealand/ South East Asia Royal College of Pathologists AustralasiaYes IrelandRoyal College of Physicians of Ireland, Faculty of PathologyYes CanadaRoyal College of Physicians and Surgeons of Canada Canadian Association of Pathologists No Recent & Limited

6 International Examples of Implementation of Quality Assurance in Pathology Ireland  National quality assurance program in histopathology o Only national interpretive pathology QA Program

7 A Re-Conceptualization Of The Pathology Testing Cycle… From The Perspective Of Interpretive Pathology Pre- Analytical Analytical Post- Analytical Interpretive Pre-interpretive Post-Interpretive

8 General Pathology Workflow Process Map Slides from lab & demographic info Pre- Interpretive Activities Interpretive Activities Post- Interpretive Activities Additional Clinical Information Previous and Concurrent Specimens from the Same Case Prospective Peer Review Additional Work- up

9 Quality And Accuracy Across The Country Some provinces have groups in place to address quality and accuracy in pathology No national consistency in terms of guidelines, standards or recommendations – National survey results

10 QIIP Thought Leaders - Membership RepresentativeProvince Robert WolberBritish Columbia/ Yukon Martin TrotterAlberta/ Northwest Territories Fergall MageeSaskatchewan Esther RavinskyManitoba Meg McLachlinOntario/ Nunavut John Srigley (Chair)Ontario/ Nunavut Diponkar BanerjeeOntario/ Nunavut Bernard TêtuQuebec Tarek RahmehNew Brunswick Laurette GeldenhuysNova Scotia Rosemary HendersonPrince Edward Island Stephen RaabNewfoundland and Labrador Gunita MiteraCPAC Representative 10

11 TECHNICAL lab accreditation program in the province 11 Interpretive Quality Across The Country: National Survey Results Professional group(s) that represents pathology in the province

12 Interpretive Quality Across The Country: National Survey Results (continued) Coordinated provincial quality assurance program related to the INTERPRETIVE aspects of pathology?

13 QIIP Project Timeline Draft recommendations developed by QIIP Thought Leaders Apr – June 2014 Pan-Canadian consensus process to refine and validate the recommendations June 2014 – Aug Final draft recommendations Aug – June 2015 Public review period/ Endorsement June 2015 – Nov Finalize the recommendations document Nov – Mar. 2017

14 QIIP Work Plan - Activities Completed Environmental scan conducted – 45 quality documents reviewed (institutional, provincial/ jurisdictional, national, international) Relevant interpretive pathology sections collated Framework headers developed by QIIP Thought Leaders with pan-Canadian expert input Consensus process

15 Framework headers

16 Sample Recommendations: High Degree Of Consensus Section I: Overarching Foundational Elements – Informatics Systems - Support for QA activities Recommendation: The following resources and elements are essential to ensure successful implementation of a quality assurance program: – Mechanisms to collect, analyze and share quality indicator data – A suitable laboratory information system (LIS) that can facilitate quality assurance processes – Sufficient personnel (professional and support staff) – Information technology resources to develop and maintain the program – Other Foundational Resources - Decision support tools Recommendation: 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 diagnosis – Up to date evidence-based standards and clinical guidelines to improve practice Section IV: External Quality Assurance – External Quality Assurance Recommendation: 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 Elements – Governance/Oversight - Institutional Recommendation: 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 authority – A quality management system that includes policies and procedures for achieving optimal results and ongoing quality improvement – A 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 policies » Regular review of QA metrics and monitoring of compliance » Reporting on the performance of the quality management system and areas for improvement » Provision of a forum for peer discussion and resolution of quality issues » Identification of acceptable QA targets/metrics – A 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 Process – Internal retrospective reviews and audits Recommendation: – 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 circumstance – Pathologists 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 Discussion Can 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! Life on a microscope slide Aaaa! Look out everyone! It’s a coverslip

21 Additional slides

22 A National Call for Action 1999 Sunnybrook lab (ON): Canadian entertainer received unnecessary treatment due to a misdiagnosis of breast cancer 2003 Eastern Health authority (NL): “Cameron Inquiry” investigation of breast hormone receptor testing inaccuracy 2007 Miramichi Hospital (NB): “Creaghan Inquiry” investigation of 15,000 tests audited, indicated 3% of cases were misdiagnosed 2008 Grey Bruce Health Services, Owen Sound (ON): Investigation of 600 tests audited; indicated 6% of cases were erroneous Diagnostic Services of Manitoba (MB): Review of 700 cases, at least 10 errors confirmed 2009 College of Physicians (QC): Issued report stating that over 15% of hormone receptor and HER2 tests indicated discrepancies

23 A National Call for Action (continued) 2010 Minister ordered investigation at Windsor Hospitals (ON): 3,000 cases audited, several cases were misdiagnosed 2011 Diagnostic Services of Manitoba (MB): 3,000 cases were reviewed, several were misdiagnosed Edmonton, Alberta Investigation (AB): 1,700 cases reviewed, several were misdiagnosed 2013 Queen 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 treatment Pasqua 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-biopsied 2014 Eastern Health authority (NL): investigation of misintepreted hormone receptor test results, nine women treated needlessly with a drug

24 Pathologists across Canada Canada # Pathologists = 1091  1263 # CAP-ACP Members = 530 (48.6%) 158  (44.9%) 139  (54.7%) 30  (63.3%) 41  (34.1%) 438  (57.3%) 202  (22.8%) 17  21 7 (41.2%) 23  (56.5%) 36  (77.8%) 7  6 5 (71.4%)

25 Interpretive Phase-Quality Assurance Governance Intra-departmental and external consultation External review Who? Documentation and Informatics systems Institutional-Level Quality Assurance Procedures and Policies for the overall process Additional tests Access to literature Relevant clinical information What? Equipment Space Where? Turnaround time When? How can I make an informed, consistent, timely and accurate diagnosis? MD

26 Overall Consensus Process 26 Pre-Delphi Survey In-Person Delphi Meeting Post-Delphi Survey

27 QIIP Consensus Process Electronic survey was circulated to vote on initial recommendations and inform today’s discussion Pre-Delphi Survey Pathology leaders to attend to discuss recommendations to be included in pan- Canadian framework In-Person Consensus Electronic survey, similar to pre-Delphi survey, will be circulated to validate results of the in-person Delphi meeting Post-Delphi Survey

28 28 Provinces With An Established Provincial INTERPRETIVE Pathology Quality Assurance Program Prov. Is there a coordinated provincial plan in place ? Program Details; Organization who Provides Oversight ABYes Laboratory Services Quality Assurance Plan for Anatomic Pathology; Alberta Health Services *Collecting data for the next 6-12 months to establish benchmarks/targets. PEYes A very comprehensive QA program; Self administered by all 5 pathologists on the island (2 hospitals) - not regulated.

29 29 Provinces With Plans To Implement A Provincial INTERPRETIVE Pathology Quality Assurance Program Prov. Is there a coordinated provincial plan in place ? Program Details; Organization who Provides Oversight SK No *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 No *Ongoing discussion. Standards2Quality has been proposed, only voluntary at the organizational level with oversight at the hospital level. QC No *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 No *Ongoing discussion for the Provincial Working Group of Newfoundland to lead this initiative. N/A NB No *A partial plan in place. A 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 *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 30 Provinces With NO Established Provincial INTERPRETIVE Pathology Quality Assurance Program Prov. Is there a coordinated provincial plan in place ? Program Details; Organization who Provides Oversight BC No *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 No *No plan in place. *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.


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