Interpretive Quality Assurance
In Pathology: Where Is The
Current State And Future
Direction In Canada?
Maritime Pathology Conference
Gunita Mitera
November 29, 2014
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
Elements of Quality
Timeliness
Accuracy
Completeness
Usability
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
Responsibility for Clinical Practice / Interpretive
Quality Guidelines: Where does it lie?
Country
Pathology organization(s)
Responsible for
Guidelines
USA
College of American Pathologists
Yes
U.K.
Royal College of Pathologists
Yes
Australia/
New Zealand/
South East Asia
Royal College of Pathologists Australasia
Yes
Ireland
Royal College of Physicians of Ireland, Faculty of Pathology
Yes
Canada
Royal College of Physicians and Surgeons of Canada
Canadian Association of Pathologists
No
Recent & Limited
International Examples of Implementation of
Quality Assurance in Pathology
• Ireland
 National quality assurance program
in histopathology
o Only national interpretive
pathology QA Program
A Re-Conceptualization Of The Pathology Testing Cycle… From
The Perspective Of Interpretive Pathology
PostAnalytical
Post-Interpretive
PreAnalytical
Pre-interpretive
Analytical
Interpretive
General Pathology Workflow Process Map
Slides from
lab &
demographic
info
Additional Clinical
Information
PreInterpretive
Activities
Previous and
Concurrent
Specimens from
the Same Case
Interpretive
Activities
Prospective Peer
Review
PostInterpretive
Activities
Additional Workup
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
QIIP Thought Leaders - Membership
Representative
Province
Robert Wolber
Martin Trotter
Fergall Magee
Esther Ravinsky
British Columbia/ Yukon
Alberta/ Northwest Territories
Saskatchewan
Manitoba
Meg McLachlin
Ontario/ Nunavut
John Srigley (Chair)
Ontario/ Nunavut
Diponkar Banerjee
Ontario/ Nunavut
Bernard Têtu
Quebec
Tarek Rahmeh
New Brunswick
Laurette Geldenhuys
Nova Scotia
Rosemary Henderson
Prince Edward Island
Stephen Raab
Newfoundland and Labrador
Gunita Mitera
CPAC Representative
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Interpretive Quality Across The Country:
National Survey Results
Professional group(s) that represents pathology
in the province
TECHNICAL lab accreditation program in the province
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Interpretive Quality Across The Country:
National Survey Results (continued)
Coordinated provincial quality assurance program related
to the INTERPRETIVE aspects of pathology?
Newfoundland
and Labrador
Nova Scotia
New Brunswick
Quebec
Prince Edward
Island
Alberta
Existing Program
Ontario
Saskatchewan
No Program, but plan to
implement one
Manitoba
British
Columbia
No Program, no current
discussion to implement
one
QIIP Project Timeline
Draft
recommendations
developed by QIIP
Thought Leaders
Apr. 2014 –
June 2014
Pan-Canadian
consensus
process to refine
and validate the
recommendations
June 2014 –
Aug. 2014
Final draft
recommendations
Aug. 2014 –
June 2015
Public review
period/
Endorsement
June 2015 –
Nov. 2016
Finalize the
recommendations
document
Nov. 2016 –
Mar. 2017
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
Framework headers
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
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
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
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?
Thank you!
Aaaa! Look out
everyone!
It’s a coverslip
Life on a microscope slide
Additional slides
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
A National Call for Action (continued)
2010
2011
2013
2014
• Minister ordered investigation at Windsor Hospitals (ON): 3,000 cases audited, several cases were
misdiagnosed
• Diagnostic Services of Manitoba (MB): 3,000 cases were reviewed, several were misdiagnosed
• Edmonton, Alberta Investigation (AB): 1,700 cases reviewed, several were misdiagnosed
• 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 10-15 had to be re-biopsied
• Eastern Health authority (NL): investigation of misintepreted hormone receptor test results, nine women
treated needlessly with a drug
Pathologists across Canada
Canada
# Pathologists = 1091  1263
# CAP-ACP Members = 530 (48.6%)
17 
21
7
(41.2%)
158 
221
71
(44.9%)
139 
149
76
(54.7%)
30 
32
19
(63.3%)
41 
48
14
(34.1%)
438 
496
251
202 
211
46
76
5
(22.8%)
(71.4%)
(57.3%)
23 
32
13
(56.5%)
36 
47
28
(77.8%)
Interpretive Phase-Quality Assurance
How can I make an
informed, consistent,
timely and accurate
diagnosis?
Who?
What?
Where?
When?
MD
• Governance
• Intra-departmental and external consultation
• External review
• Documentation and Informatics systems
• Institutional-Level Quality Assurance Procedures and
Policies for the overall process
• Additional tests
• Access to literature
• Relevant clinical information
• Equipment
• Space
• Turnaround time
Overall Consensus Process
Pre-Delphi
Survey
Post-Delphi
Survey
In-Person
Delphi
Meeting
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QIIP Consensus Process
• Electronic survey was
circulated to vote on
initial recommendations
and inform today’s
discussion
Pre-Delphi
Survey
In-Person
Consensus
• Pathology leaders to
attend to discuss
recommendations to be
included in panCanadian framework
• Electronic survey, similar
to pre-Delphi survey,
will be circulated to
validate results of the
in-person Delphi
meeting
Post-Delphi
Survey
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
AB
Yes
Laboratory Services Quality Assurance Plan for Anatomic Pathology;
Alberta Health Services
*Collecting data for the next 6-12 months to establish
benchmarks/targets.
PE
Yes
A very comprehensive QA program; Self administered by all 5
pathologists on the island (2 hospitals) - not regulated.
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Provinces With Plans To Implement A Provincial
INTERPRETIVE Pathology Quality Assurance Program
Prov.
Is there a coordinated provincial plan
in place ?
SK
No
*Ongoing discussion for a stronger provincial
program; College of Physician and Surgeons and
some Ministry of Health involvement .
ON
No
*Ongoing discussion.
QC
No
*A partial plan in place.
NL
No
*Ongoing discussion for the Provincial Working
Group of Newfoundland to lead this initiative.
NB
NS
Program Details; Organization who Provides Oversight
One of the larger labs is College of American Pathologists (CAP) accredited which includes some
professional interpretative modules.
Standards2Quality has been proposed, only voluntary at the organizational level with oversight at the
hospital level.
*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.
N/A
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.
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
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Committee.
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 .
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.
MB
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