eSafetyNew CANADIAN GUIDELINES

Enhancing PATIENT SAFETY in eHealth

Don NewshamBA Health Administration, BSc, CPHIMS-CACEO, COACH

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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

2.

• eSafety Guidelines, developed with partners:• Integral component of patient safety programs• Methodology for managing safety risks• Practical, integrated into standard project processes

3.

• Leading practice eSafety Guidelines can be used in eHealth product developments, projects and implementations.• Early reviewers enthusiastic / trial use starting

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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)

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e… Becoming More Complex• much more ‘closed’• supported common health care business functions

within a limited domain• implemented within a local organization

Traditional Systems

• 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

Today’s“e” Solutions and

Software

• We, clinicians, vendors and informatics professionals, need to proactively identify and manage these risks

“e” Solutions and software are inherently more complex and can also introduce patient

safety risks

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Examples of eSafety IncidentsSystem 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)

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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.

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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

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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.

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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

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Canada Health

eSafety Stakeholder Ecosystem Accountability & Culture

Healthcare Delivery Organizations

Patients

NursesAnd NI

Allied Health Providers

Canada HealthInfoway

Physicians

Canadian PatientSafety Institute

HI & HIMProfessionals

Health Organization Champions

Accreditation Canada

COACH

CIHIITAC

CMA

CNA/CNIA

Vendors &Consultants

Governments (Provincial

And Federal)

CPA

Academics & Researchers

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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

eSafetyNew CANADIAN GUIDELINES

Enhancing PATIENT SAFETY in eHealth

Elizabeth KellerBA (Hon), MA, PmP, CPHIMS-CADirector, COACHDirector, Product Management, OntarioMD

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Question

How many of you have experienced or are aware of an esafety incident in any

project, implementation or deployment ?

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eSafety Purpose and Goals

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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

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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 StandardseHealth

Adoption ChecklisteSafety Maturity Model

Risk Register Template

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The Foundation Principles

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Example - eSafety Culture Principle

CULTURE

PromoteEncourageAppropriate

behaviour

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The Practical Approach to an eHealth

Safety Program

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eSafety CaseIs 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)

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Focus of eSafety Cases Based by Role

Developers• D

evelopment and support of eHealth products and services

Implementers• I

ntegration of many products and services into a complex eHealth ecosystem

Operators• R

eal-world operation of integrated eHealth systems in the technical and clinical environments

End-users• D

irect application of eHealth by health care providers, patients and others at the point-of-care

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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.

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Enterprise Risk Register

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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. X 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. X X X

3.1.3 The Organization that develops eHealth systems shall employ heuristic evaluation techniques. X

Sample Checklist

# Guideline Statement

In place Applies to

Yes No

Developer

Implementer

Operator

End-User

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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

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Emerging Practices on ReportingAligning 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

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Canadian Guidelines for eHealth Safety

Initial roll-out & field test group

Starting May/June 2013

4-6 organizations• Hospital, Provincial Telehealth, Jurisdiction(s), Vendor(s), …

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eSafety Trial ParticipantsUHN

ACD Bariatric Interdisciplinary Assessment Notes Initiative

NWT / AGFA / HealthTech Consultants“Xero” Viewer

NLCHIDrug Information System

GE HealthcareTBD

Ontario Telemedicine NetworkTBD

eSafetyNew CANADIAN GUIDELINES

Enhancing PATIENT SAFETY in eHealth

Bill PascalChief Technology OfficerCanadian Medical Association

eSafetyNew CANADIAN GUIDELINES

Enhancing PATIENT SAFETY in eHealth

Turner Billingsley

Intersystems

eSafetyNew CANADIAN GUIDELINES

Enhancing PATIENT SAFETY in eHealth

THANK YOU