eSafety
New CANADIAN GUIDELINES
Enhancing PATIENT SAFETY in eHealth
Don Newsham
BA Health Administration, BSc, CPHIMS-CA
CEO, COACH
eSafety Guidelines Key Messages
1.
• Patient Safety is paramount and eHealth safety is coming to
the forefront
• UK, US and now – CANADA , COACH and it’s partners
• eSafety Guidelines, developed with partners:
2.
3.
• Integral component of patient safety programs
• Methodology for managing safety risks
• Practical, integrated into standard project processes
• Leading practice eSafety Guidelines can be used in eHealth
product developments, projects and implementations.
• Early reviewers enthusiastic / trial use starting
2
COACH’s eSafety Guidelines – Reviewers Feedback
“document is excellent,
very thorough &
streamlined” (Physician)
“messaging around patient
safety is present and
consistent throughout”
(Physician)
“an impressive body of
work” (Product Executive)
“very comprehensive document
that I'm sure will serve the
community very well”
(Large Teaching Hospital HI Executive)
“Wonderful document and
contribution to health
care” (Nursing)
“seems to be quite
comprehensive” (Vendor)
“most thorough report on
eSafety I have read”
(Medical Association)
“quite frankly learned a lot
from the information that
you have brought together
in a very structured
manner”
(Medical Association)
“I am so looking forward to
the deployment of these
guidelines – it is so much
needed”
(CIO)
“The document is very
extensive, I like the
examples they are relevant
to the field” (CIO)
3
e… Becoming More Complex
Traditional
Systems
Today’s
“e” Solutions and
Software
“e” Solutions and
software are inherently
more complex and can
also introduce patient
safety risks
• much more ‘closed’
• supported common health care business functions
within a limited domain
• implemented within a local organization
•
•
•
•
•
sophisticated solutions
integrating data across the continuum of care
sharing across traditional organizational lines
complex, inter-operable solutions
sophisticated decision support that clinicians depend
on in caring for patients
• We, clinicians, vendors and informatics professionals,
need to proactively identify and manage these risks
4
Examples of eSafety Incidents
System failed to produce appropriate alert for patient
Software design, implementation or use leads to patient mis-identification
Software maintenance error causes patient lab results going to wrong physician
Drug mapping errors or errors in displaying data in the correct context
Incorrectly computed ages for pre-natal screening (150 patients notified “not at
risk” when several were at risk)
Radiotherapy rates 10-30% lower than required in patient population due to
computer programming error
Data migration errors in converting data from one system to another
Potential for double-dosing patients when RX system-to-EMR interfaces misfire
Pathology results dropping from EMR results review or original results not being
replaced by secondary reviews
Stat results not being picked up by physicians because their MD inbox function only
displays them passively (rather than via an alert)
5
The
opportunity
and the
challenge…
 An Australian research study on the effects of two commercial electronic prescribing
systems on prescribing error rates in hospital in-patients identified that “there was a high
rate of system-related errors for both hospitals accounting for 35% of prescribing errors in
the intervention wards in the post period”.
 In the UK, there are an average of 35 documented software safety incidents reported every
month; while a large number resulted in no harm, without appropriate attention to root
cause and action to prevent re-occurrences, patient safety could be compromised.
6
eSafety - NHS Clinical Safety Program
for Health IT
Leading practice in training/certification programs
• NHS has been offering education and training to clinicians across the UK in principles, safety and risk
in health IT (since 2005). They have also embedded patient safety into their risk management and
conformance testing processes.
1,000+ accredited clinicians across the UK focused on:
• Safe implementation – Clinical champions at the local level, who are certified and responsible to sign
off systems as ‘ready for clinical use’ in their organization
• Human factors, which are an important element of the risk profile
• Working with IT leaders to ensure clinical risk factors are identified and mitigated
Strong practical use of standards as tools/guidelines
• Prior to go-live, local health delivery organizations must accept responsibility for any adverse events
to patients, so following best practices is important:
• Two specific UK standards (started within ISO) define required best practices for:
• Application of clinical risk management to the manufacture of health software
• Management of clinical risk relating to the deployment and use of health software
7
eSafety- IOM Report on Health IT and Patient Safety
Institute of Medicine. (2011). Health IT and Patient Safety:
Building Safer Systems for Better Care.
“To fully capitalize on the potential that health IT may have on patient
safety, a more comprehensive understanding of how health IT impacts
potential harms, workflow, and safety is needed” (p. 49)
Recommendation 6: The Secretary of HHS should specify the quality and
risk management process requirements that health IT vendors must
adopt, with a particular focus on human factors, safety culture, and
usability.
Recommendation 7: The Secretary of HHS should establish a mechanism
for both vendors and users to report health IT––related deaths, serious
injuries, or unsafe conditions.
8
eSafety - ONC HIT Patient Safety Action & Surveillance Plan for
Public Comment FY2013-15 (Dec 21, 2012)
Health IT has the potential to greatly improve patient safety; however, its full potential
can only be realized if all interested parties, including the government and private sectors,
recognize that patient safety is a shared responsibility.
The Health IT Patient Safety Action and Surveillance Plan (Health IT Safety Plan) places the
role of health IT within HHS’s overall commitment to patient safety and builds upon the
recommendations made in the 2011 Institute of Medicine Report, Health IT and Patient
Safety: Building Safer Systems for Better Care.
Summary of Plan: The Health IT Safety Plan’s goal is to “Inspire Confidence and Trust in
Health IT and Health Information Exchange,” by taking steps to: (1) Use health IT to make
care safer, and (2). Continuously improve the safety of health IT
9
eSafety Stakeholder Ecosystem
Accountability & Culture
Health Organization Champions
Governments
(Provincial
And Federal)
COACH
CMA
Canadian Patient
Safety Institute
CNA/CNIA
Patients
Canada Health
Canada Health
Infoway
Healthcare Delivery Organizations
CPA
Physicians
Nurses
And NI
ITAC
Vendors &
Consultants
Allied Health
Providers
HI & HIM
Professionals
CIHI
Accreditation
Canada
Academics &
Researchers
10
COACH’s Canadian eSafety Contributors
Task Group
•Elizabeth Keller, COACH Director and
eHealth Safety Task Group CHAIR
•Margie Kennedy, CNIA, President
•Alex Drossos, Clinician
•Chris Hayes, Clinician, CPSI CMO
•Brian Forster, OntarioMD, CEO
•Brendan Seaton, ITAC Health President,
Guidelines Lead
•Andre Krushniruk Professor, U of
Victoria
•Joe Cafazzo / Svetlena Taneva Metzger,
UHN
•Grant Gillis, ED Forums and Practices,
COACH
•Don Newsham, CEO, COACH
•Neil Gardner, President , COACH
Advisory Group
•Neil Gardner, COACH President-Elect
and eSafety Advisory Group CHAIR
•Jennifer Zelmer, Senior Vice President,
Infoway
•Scott Murray, CTO, CIHI
•Hugh Macleod, CPSI CEO
•Bill Pascal, CMA CTO
•Sandra Cascadden, CIO, Nova Scotia
•Lynn Nagle, Asst. Professor, Faculty of
Nursing, U of T , CNIA
•Diane Salois-Sallow, CIO York Central
•Dr Peter Rossos,Clinician, UHN
•Michael Green, Chair, ITAC Health
•Nancy Shadeed, Health Canada
•Bernadette.MacDonald and Wendy
Nicklin, Accreditation Canada
•Elizabeth Keller, Chair, eSafety Forum
and Program Planning Task Group
•Don Newsham, CEO, COACH
Guidelines Expert
Group
•Brendan Seaton
•Elizabeth Keller
•Alan Coley
•Blair White, NLCHI
•Dr. Darren Larsen, Physician
•Olivier St-Cyr, HF Engineer
•Joe Cafazzo / Svetlena Taneva Metzger,
UHN
•Neil Gardnerr, ehealth SK
•Linda Lindsay, GE
•Shelley Irvine-Day, Manitoba eHealth
•Laura Jean MacDermid , NS HIT
•Don Newsham, COACH
• Plus NUMEROUS REVIEWERS
11
eSafety
New CANADIAN GUIDELINES
Enhancing PATIENT SAFETY in eHealth
Elizabeth Keller
BA (Hon), MA, PmP, CPHIMS-CA
Director, COACH
Director, Product Management, OntarioMD
Question
How many of you have experienced or
are aware of an esafety incident in any
project, implementation or
deployment ?
13
eSafety Purpose and Goals
Provide
Awareness
and
Education
Protect patients against
harm throughout
development,
implementation and use
of ehealth solutions and
health software.
Use Guidelines and
Standards
Implement, Monitor
and Report eHealth
Safety
14
eSafety Guidelines
Essential Component of Protecting Patients
1. The eHealth Safety Guidelines
- a practical and pragmatic guide for
healthcare organizations, vendors
and system integrators.
2. Guidelines provide practices to
manage and minimize patient safety
risks associated with eHealth
systems implemented in support of
health care delivery
15
eSafety Guidelines - Table of Contents
Part 1: eHealth and Safety
Part 2: Foundations of eHealth Safety
Part 3: A Practical Approach to Implementing an eSafety Management
Program
Part 4: Buiding the eSafety Case
Case Study’s 1 and 2
Appendices
International Standards
eHealth Adoption Checklist
eSafety Maturity Model
Risk Register Template
16
The Foundation Principles
17
Example - eSafety Culture Principle
Encourage
Appropriate
behaviour
Promote
CULTURE
18
18
The Practical
Approach to
an eHealth
Safety
Program
19
eSafety Case
 Is a method to confirm the development, deployment and use
of an eHealth system will not pose an unacceptable level of
safety risk to patients.
 Is prospective and preventive
 Is complimentary to PIA’s
 Is built from leading practices (ISO 31000 standard on Risk
Management, NHS England, Failure Mode and Effects Analysis
(FMEA)
20
Focus of eSafety Cases Based by Role
Developers
• Development and support of eHealth products and
services
Implementers
• Integration of many products and services into a complex
eHealth ecosystem
Operators
• Real-world operation of integrated eHealth systems in the
technical and clinical environments
End-users
• Direct application of eHealth by health care providers,
patients and others at the point-of-care
21
The eSafety Case Components
* In addition to Health Care Failure Mode
and Effects Analysis, other risk assessment
tools (use case review, observations,
checklists, critical analysis) may serve to
supplement or combine specific steps in
the detailed risk assessment, due to
unavailability of documentation, limited
resources or time constraints. The
identification of potential safety failures
(WHAT COULD GO WRONG) is key,
regardless of methodology used to arrive
at that identification.
22
Enterprise Risk Register
23
Sample Checklist
In place
3
Human Factors Principle
3.1
The application of human factors engineering to eHealth systems and
components
3.1.1
The Organization that develops eHealth systems and components
shall employ human factors engineering techniques.
3.1.2
The Organization that implements, operates and/or uses eHealth
systems shall employ human factors engineering techniques in the
design of clinical and business workflows.
3.1.3
The Organization that develops eHealth systems shall employ
heuristic evaluation techniques.
End-User
Operator
Implement
er
Developer
No
Guideline Statement
Yes
#
Applies to
X
X X X
X
24
Example Case Study of the eSafety Case
• Two “created” eSafety case examples, based on real
telehomecare and EMR implementations
1. The Happy Valley Regional Health Authority
Telehomecare Program
2. The Happy Valley Physician Clinic EMR
Implementation
25
Emerging Practices on Reporting
Aligning with
national patient
safety priorities
• Medication Incident
Reporting
• Leading work by 4
Canadian agencies
• CIHI, ISMP, CPSI, HC
• COACH is working to
support enhanced
standards on eHealth
contributing factors to
medication incidents
26
Canadian Guidelines for eHealth
Safety
Initial roll-out &
field test group
Field test
National
deployment
Fall 2013
Starting
May/June 2013
4-6 months
Cross Canada
Introduction
Sessions
4-6 organizations
• Hospital, Provincial
Telehealth,
Jurisdiction(s),
Vendor(s), …
Available to
members, public
and jurisdictions
27
eSafety Trial Participants
 UHN
 ACD Bariatric Interdisciplinary Assessment Notes Initiative
 NWT / AGFA / HealthTech Consultants
 “Xero” Viewer
 NLCHI
 Drug Information System
 GE Healthcare
 TBD
 Ontario Telemedicine Network
 TBD
28
eSafety
New CANADIAN GUIDELINES
Enhancing PATIENT SAFETY in eHealth
Bill Pascal
Chief Technology Officer
Canadian Medical Association
eSafety
New CANADIAN GUIDELINES
Enhancing PATIENT SAFETY in eHealth
Turner Billingsley
Intersystems
eSafety
New CANADIAN GUIDELINES
Enhancing PATIENT SAFETY in eHealth
THANK YOU