1. Implementation of a patient-centred clinician-led National Quality Assurance (QA) Programme in Histopathology to enhance patient care and safety November 7 th 2014 Dr. Niall Swan, Faculty of Pathology, Royal College of Physicians (RCPI)

2. WHAT IS HISTOPATHOLOGY? WHAT DO HISTOPATHOLOGISTS DO?

3. PATHOLOGY / LABORATORY MEDICINE MICROBIOLOGY BLOOD SCIENCES -HAEMATOLOGY -BLOOD TRANSFUSION -CHEMISTRY -IMMUNOLOGY HISTOPATHOLOGY

4. Patient Journey

5. Tissue Specimens in Laboratory

6. Sample labelling Cassette labelling Embedding Microtomy

7. Microscopic analysis and interpretation

8. Zarbo et al. Arch Pathol Lab Med 2005;129:1237-45 TEST CYCLE

9. Background to the QA Programme Need for Formal Measures of Quality Assurance In Histopathology  High Profile cancer misdiagnosis cases in 2007 & 2008  No formal measures to reassure the public that Irish Histopathology Laboratories provide a quality service to the highest international standards  No set national standards or benchmarks for key aspects of diagnostic service

10. External Laboratory Accreditation ISO 15189 standards for medical laboratories (NSAI / INAB) Technical competence requirements and management system requirements necessary to consistently deliver technically valid results Faculty of Pathology had concerns clinical aspects of service not fully addressed by the accreditation process

11. Vision of National QA Programme A patient centred Quality Assurance framework within each department, which routinely reviews performance and drives improvement, in key quality areas against intelligent targets.

12. Aim of the National QA Programme in Histopathology  Patient centred, Pathologist / Laboratory-Led programme  Establish a national QA framework that ensures patient safety and enhancement of patient care with timely, accurate and complete diagnoses and reporting  Provide evidenced based assurance to the public of the quality of Irish diagnostic services

13. Process 1. Engagement 2. Definition 3. Governance 4. Working Group 1.Guidelines 2. ICT 3. Schedule 1.Training & support 2.Phased Implementation 3. National Database Programme Model

14. Scope – All Laboratories West –7 Departments Dublin – 14 Departments South/SE – 3 Departments Mid Leinster – 1 Department North East– 2 Departments 8 Private Laboratories

15. Governance Overview Steering Committee Members: HSE Quality & Patient Safety, National Cancer Control Programme, HSE ICT, HSE service management, Independent Hospitals Association of Ireland (IHAI), Dept of Health, Faculty, RCPI Observer: HIQA Faculty of Pathology Programme Management Quality & Clinical Care, RCPI HSE ICT Clinical Working Group Local Hospital Participant Teams ** ** Note Data owner is the local unit & governance of the data is with that unit’s local, regional and national governance structures 15

16. Summary of Guidelines MonitorKey Indicators Inter-institutional review% Agreement Intradepartmental Consultation% Cases Frozen Section Correlation% Concordance, % Deferral, TAT Cytological/histological correlation% Discordant, % False positive, % False negative Retrospective review (Focused real time / report completeness) % Agreement / % Completeness Multi disciplinary Team meetings% Agreement, % of total cases discussed Non-conformance reportingNo. of non-conformances, Clinical impact External Quality AssessmentList of Schemes, results Turn around TimeTAT by case type Addendum ReportsSupplementary, corrected, amended Critical Diagnoses ReportingNo. of cases reported directly to clinician

17. Data Collection & Extraction

18. Atlas - framework 1 big table Analysis Report Query Parameters Analysis Results A4 portrait Many parameters Horizontal display Numbers (Ct, %, median...) Comparison Trend Each parameter – 1 row Intuitive at a glance User – dates, comparator Language: Clinical > business Simple Concise 1.Log into system from your desktop

19. NQAIS (National Quality Assurance Intelligence System) Report Preview

20. Process 1. Engagement 2. Definition 3. Governance 4. Working Group 1.Guidelines 2. ICT 3. Schedule 1.Training & support 2.Phased Implementation 3. National Database 1.National Quality Benchmarks (KQI) 2.Embedding 1.Data Collation & Analysis November 2014 Programme Model

21. Benchmarking Methodology used 1.Review and investigate the National QA Reports from NQAIS-Histopathology 2.Review national and international benchmarks relating to each Quality Activity 3.Define excellent and achievable standards for each Quality Activity, where applicable

22. Objectives Keep it simple Compare to international standards Avoid setting unachievable targets but also ensure targets set are credible Use the national data gathered Tailor each one to clinical practice in Ireland

23. National NQAIS Report 2013

26. National NQAIS Report 2013 Intradepartmental Consultation

27. National Histology Workload 2013 TypeNo. (Cases) Specimens566,912 (357,249) Blocks950,791 Total Stains2,030,484 Routine H&E1,448,313 (319,245) Extra H&E224,022 (47,266) IHC stains248,920 (35,491) Frozen Section stains6,757 (1,482)

28. Key to success

29. Achievements  A completely unique national programme Across public and private laboratories Across 8 different Laboratory Information Systems (LIS) Across small and large hospitals with different levels of resourcing  Development of a central repository NQAIS-Histopathology  Collection of national data for Histopathology Never before collected on this scale  Confidence in the data to understand in real time our workload and extent of quality activities  Ability for us to set national targets based on our data

30. Programme Benefits  Improved patient care and public confidence  Less need for large scale look backs  QA data for local service enhancement  Identification of good practice  Identification of areas requiring development  Improved communication between institutions leading to strategic links/networks  Development of National Targets for QA activities  Model for other National QA Programmes (Radiology, Endoscopy)

31. Next Steps  On-going review of national data quality  Propose and set further National Q marks  Gather and share best practice (Annual Workshops)  Promote use of NQAIS reports at hospital level  Continuous quality improvement through use of NQAIS reports  www.rcpi.ie for National Implementation & Data Reports www.rcpi.ie

32. Acknowledgements Ms. Mairead Guinan, Mr. Philip Ryan, Prof. Conor O’ Keane, Prof. Kieran Sheahan, Dr. Julie McCarthy, Dr. Jennifer Martin, Mr. Seamus Butler, Mr. Brian Dunne, Dr. Howard Johnson, Dr. Mary Hynes, Ms. Louise Casey, Mr. John Magner, Mr. Leo Kearns