Implementation of a patient-centred clinician-led National Quality Assurance (QA)

Programme in Histopathology to enhance patient care and safety

November 7th 2014

Dr. Niall Swan,Faculty of Pathology, Royal College of

Physicians (RCPI)

WHAT IS HISTOPATHOLOGY?

WHAT DO HISTOPATHOLOGISTS DO?

PATHOLOGY /LABORATORY MEDICINE

MICROBIOLOGY

BLOOD SCIENCES-HAEMATOLOGY-BLOOD TRANSFUSION-CHEMISTRY-IMMUNOLOGY

HISTOPATHOLOGY

Histopathology Diagnosis Cycle

Patient requires diagnosis

Clinician decides on test

Clinician orders test

Specimen taken from patient by

Surgeon/Clinician Specimen labelled

Specimen transported to Lab

Specimen examined by

Pathologist with naked eye

Specimen embedded into

wax or resin support

Specimen cut into smaller samples

Specimen mounted onto

slides

Specimen stained

Specimen examined by

Pathologist under microscope

Pathologist makes opinion on diagnosis

Pathologist completes report

Report sent to Clinician

Report reviewed as part of full

patient case multi disciplinary review

Patient treatment plan determined

Patient begins treatment

Patient informed of diagnosis & treatment plan

Treating Clinician

Patient

Surgeon/Clinician

Surgical Nurse

Pathologist

Medical Scientist

Multi disciplinary team

Any diagnosis is made under conditions of uncertainty and the opinion of the Pathologist is a judgment of specimen information in the context of all other information available interpreted against his or her knowledge and experience.

Specimen preparation requires a high degree of skill, patience and accuracy. Complex electronic equipment, computers, and instruments are

employed, each with limits of precision

PatientJourney

Tissue Specimens in Laboratory

Sample labelling Cassette labelling

Embedding Microtomy

Microscopic analysis and interpretation

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

TEST CYCLE

Background to the QA Programme

Need for Formal Measures of Quality AssuranceIn 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

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

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.

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

Process

1. Engagement2. Definition3. Governance4. Working Group

1.Guidelines2. ICT3. Schedule

1.Training & support2.Phased Implementation

3. National Database

Programme Model

Scope – All Laboratories

West –7 Departments Dublin – 14 Departments

South/SE – 3 Departments

Mid Leinster – 1 Department

North East– 2 Departments

8 Private Laboratories

Governance OverviewSteering 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 ManagementQuality & 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

Summary of GuidelinesMonitor Key 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 reporting No. of non-conformances, Clinical impact

External Quality Assessment List of Schemes, results

Turn around Time TAT by case type

Addendum Reports Supplementary, corrected, amended

Critical Diagnoses Reporting No. of cases reported directly to clinician

Data Collection & Extraction

Atlas - framework

1 big table

Analysis

Report QueryParameters

AnalysisResults

A4 portraitMany parametersHorizontal displayNumbers (Ct, %, median ...)ComparisonTrendEach parameter – 1 rowIntuitive at a glance

User – dates, comparator

Language: Clinical > businessSimpleConcise

1. Log into system from your desktop

NQAIS (National Quality Assurance Intelligence System) Report Preview

Process

1. Engagement2. Definition3. Governance4. Working Group

1.Guidelines2. ICT3. Schedule

1.Training & support2.Phased Implementation

3. National Database

1.National Quality Benchmarks (KQI)

2.Embedding

1.Data Collation & Analysis

November 2014

Programme Model

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

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

National NQAIS Report 2013

National NQAIS Report 2013

National NQAIS Report 2013

National NQAIS Report 2013 Intradepartmental Consultation

National Histology Workload 2013Type No. (Cases)

Specimens 566,912 (357,249)

Blocks 950,791

Total Stains 2,030,484

Routine H&E 1,448,313 (319,245)

Extra H&E 224,022 (47,266)

IHC stains 248,920 (35,491)

Frozen Section stains 6,757 (1,482)

Key to success

AchievementsA 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

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)

Next Steps

On-going review of national data qualityPropose and set further National Q marksGather and share best practice (Annual Workshops)Promote use of NQAIS reports at hospital levelContinuous quality improvement through use of

NQAIS reportswww.rcpi.ie for National Implementation & Data

Reports

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