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?
HISTOPATHOLOGY
MICROBIOLOGY
PATHOLOGY /
LABORATORY MEDICINE
BLOOD SCIENCES
-HAEMATOLOGY
-BLOOD TRANSFUSION
-CHEMISTRY
-IMMUNOLOGY
Histopathology Diagnosis Cycle
Patient
Journey
Patient requires
diagnosis
Clinician decides
on test
Specimen taken
from patient by
Surgeon/Clinician
Clinician orders
test
Specimen labelled
Specimen
transported to Lab
Specimen
examined by
Pathologist with
naked eye
Patient
Treating Clinician
Surgeon/Clinician
Surgical Nurse
Patient begins
treatment
Pathologist
Specimen preparation requires a high degree of
skill, patience and accuracy. Complex electronic
equipment, computers, and instruments are
Medical Scientist
employed, each with limits of precision
Specimen
embedded into
wax or resin
support
Multi disciplinary team
Patient informed
of diagnosis &
treatment plan
Specimen cut into
smaller samples
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.
Patient treatment
plan determined
Report reviewed
as part of full
patient case multi
disciplinary review
Report sent to
Clinician
Pathologist
completes report
Specimen
examined by
Pathologist under
microscope
Pathologist makes
opinion on
diagnosis
Specimen
mounted onto
slides
Specimen stained
Tissue Specimens in Laboratory
Sample labelling
Embedding
Cassette labelling
Microtomy
Microscopic analysis and interpretation
TEST CYCLE
Zarbo et al. Arch Pathol Lab
Med 2005;129:1237-45
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
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
Programme Model
1.Guidelines
2. ICT
3. Schedule
Process
Initiation
Design
Rollout
Measure
(2008)
(2009-2010)
(2011-2012)
(2013)
1. Engagement
2. Definition
3. Governance
4. Working Group
1.Training & support
2.Phased
Implementation
3. National Database
Control
Scope – All Laboratories
8 Private Laboratories
North East– 2 Departments
West –7 Departments
Dublin – 14 Departments
Mid Leinster – 1 Department
South/SE – 3 Departments
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
Clinical Working Group
Programme Management
Quality & Clinical Care,
RCPI
HSE ICT
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 Guidelines
Monitor
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
Data extracted
• QA activity data
coded into LIS
• Extract progam
developed by LIS
Vendors
Data collected
Data transferred
• MRN Encrypted
before data leaves
hospital
Data encrypted
• Data transferred
to central
repository: NQAIS
Atlas - framework
1 big table
Analysis
A4 portrait
Many parameters
Horizontal display
Numbers (Ct, %, median ...)
Comparison
Trend
Each parameter – 1 row
Intuitive at a glance
User – dates, comparator
Report 1.
Query
Log
into system from
Parameters
your
desktop
Analysis
Results
Language:
Clinical > business
Simple
Concise
NQAIS (National Quality Assurance Intelligence
System) Report Preview
Programme Model
November
2014
1.Guidelines
2. ICT
3. Schedule
Process
1.Data Collation &
Analysis
Initiation
Design
Rollout
Measure
(2008)
(2009-2010)
(2011-2012)
(2013)
1. Engagement
2. Definition
3. Governance
4. Working Group
1.Training & support
2.Phased
Implementation
3. National Database
Control
1.National Quality
Benchmarks
(KQI)
2.Embedding
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
Percentage of Intradepartmental Consultation Completed per month
- All Hospitals
8.0%
7.0%
6.0%
5.0%
4.0%
3.0%
2.0%
1.0%
0.0%
Percentage IntraD Completed
Achievable target
Minimum target
National Histology Workload 2013
Type
Specimens
Blocks
No. (Cases)
566,912 (357,249)
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
Established
governance
structure
Communication
& Consultation
Clinical
Leadership and
Engagement
Collaboration –
HSE, NCCP,
HSE ICT, IHAI
Successful
implementation
Real Time Data
and ICT support
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
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 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
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