implementation of a patient-centred clinician-led national quality assurance (qa) programme in...
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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