Choose one component of the Framework for Safe, Reliable, and Effective Care. Describe the component. What is the nursing leader’s role in implementing the component? A

A Framework for Safe,

Reliable, and Effective Care

How to Cite This Paper: Frankel A, Haraden C, Federico F, Lenoci-Edwards J. A Framework for Safe, Reliable, and Effective Care. White

Paper. Cambridge, MA: Institute for Healthcare Improvement and Safe & Reliable Healthcare; 2017.

WHITE PAPER

AUTHORS:

Allan Frankel, MD: Co-Founder, Safe & Reliable Healthcare

Carol Haraden, PhD: Vice President, IHI

Frank Federico, RPh: Vice President, IHI

Jennifer Lenoci-Edwards, RN, MPH: Director, Patient Safety, IH

Acknowledgements:

The authors would like to thank the IHI Patient Safety Executive Development Program faculty and participants who, over

15 years, have helped to create and refine the framework described in this white paper. Special thanks to Michael Leonard

and Terri C. Frankel for their extraordinary insights that have continuously made the framework stronger and more

cohesive. Thanks also to Jana Dean, Doug Salvador, and Don Goldmann for their excellent and thorough review of our draft

paper. We also thank Jane Roessner and Val Weber of IHI for their support in developing and editing this white paper.

The Institute for Healthcare Improvement (IHI) is a leader in health and health care improvement worldwide. For more than 25 years, we have partnered

with visionaries, leaders, and frontline practitioners around the globe to spark bold, inventive ways to improve the health of individuals and populations.

Recognized as an innovator, convener, trustworthy partner, and driver of results, we are the first place to turn for expertise, help, and encouragement for

anyone, anywhere who wants to change health and health care profoundly for the better.

Safe & Reliable Healthcare (SRH) is at the forefront of measuring and improving culture, and building highly reliable learning systems. Our work across

the healthcare continuum and around the globe has given us unique insights into the specific attributes, skills, and characteristics of effective leaders

who are able to achieve the cultural transformation needed to improve operational excellence. We believe that safe, high-quality, cost-effective care is

based on collaborative relationships, and we partner with organizations to transform their culture and foster nimble learning.

Copyright © 2017 Institute for Healthcare Improvement and Safe & Reliable Healthcare.

All rights reserved. Individuals may photocopy these materials for educational, not-for-profit uses, provided that the contents are not altered in any way and that proper

attribution is given to the Institute for Healthcare Improvement and Safe & Reliable Healthcare as the source of the content. These materials may not be reproduced for

commercial, for-profit use in any form or by any means, or republished under any circumstances, without written permission.

Institute for Healthcare Improvement • ihi.org Safe & Reliable Healthcare • safeandreliablecare.com 3

Contents

Foreword 4

Executive Summary 6

Introduction 6

Background 7

The Overarching Domains: Culture and the Learning System 7

The Components of Culture 9

The Components of the Learning System 16

Engaging Patients and Families 25

Conclusion 27

Appendix: Resource List for Select Patient Safety Methods and Tools 28

References 30

WHITE PAPER: A Framework for Safe, Reliable, and Effective Care

Institute for Healthcare Improvement • ihi.org Safe & Reliable Healthcare • safeandreliablecare.com 4

Foreword

Patient safety has always been at the heart of the movement to improve quality in health care.

More than 30 years ago, the Harvard Medical Practice Study helped kick off the quality movement

by demonstrating that many, if not most, instances of harm in hospitals were caused by system

failures. These system failures are what quality improvement methods and tools are designed to

address, and applying these methods and tools is why IHI was founded.

In 1999, the Institute of Medicine’s To Err Is Human report shocked the US with its estimate that

at least 44,000 —and as many as 98,000 — people were dying in hospitals each year as a result of

preventable medical errors. A few years ago, a new estimate suggested there may be as many as

400,000 preventable deaths per year. And in 2016, a study published in The BMJ estimated the

number at more than 250,000, which, the authors asserted, would make preventable patient harm

the third leading cause of death in the US. Understanding the true impact of preventable harm is

important, but whether the number is 40,000 or 400,000, we can all agree that it’s far too many.

I believe we are at an inflection point in the history of improving patient safety. Changing payment

models, the uncertainty surrounding health reform, and the ever-increasing scrutiny of the modern

digital age demand fresh and creative thinking on how best to ensure harm-free care.

At IHI’s National Forum in December 2016, I proposed six patient safety “resolutions” for the new

year — to ensure the great strides already made are sustained and to expand our thinking about

safety:

1. Focus on what goes right as well as learning from what goes wrong;

2. Move to greater proactivity;

3. Create systems for learning from learning;

4. Be humble — build trust and transparency;

5. Co-produce safety with patients and families; and

6. Recognize that safety is more than the absence of physical harm; it is also the pursuit of

dignity and equity.

The first five aren’t wholly new, and they align with IHI’s approach to quality improvement in

general. The sixth is one I’ve been thinking a lot about over the past few years. Now that we know

how to reduce and even eliminate harms that some once thought inevitable — ventilator

pneumonias, central line infections — we need to devote our efforts to eliminating harms we’ve yet

to focus on explicitly. Harms caused by indignities and inequities in health care are just as

preventable, and just as unacceptable, as wrong-site surgeries and medication errors. We’re only

beginning to understand how physical health is affected by psychological trauma. Ensuring patient

safety is about ensuring the right all patients have to a free-from-harm care experience, which

includes being treated equitably and with dignity.

This white paper doesn’t address all six “resolutions” directly. It is focused, rightly, on creating

systems of safety. The paper clearly and compellingly lays out a practical framework for how any

health care organization or system can continuously and reliably improve patient safety. The core

domains of creating a culture of safety and a learning system to ensure reliability, improvement,

and sustainability are foundational, not only for solving the kinds of safety issues we have

experience with, but also for those we haven’t yet imagined. The individual components of the

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framework — leadership, transparency, accountability, etc. — are the necessary ingredients to

create a culture of safety and a system for continuous learning. Health care organizations of any

type or size can build on this foundation to create systems and processes that ensure our first

promise to patients — do no harm — is fulfilled.

Derek Feeley

President and CEO

Institute for Healthcare Improvement

WHITE PAPER: A Framework for Safe, Reliable, and Effective Care

Institute for Healthcare Improvement • ihi.org Safe & Reliable Healthcare • safeandreliablecare.com 6

Executive Summary

Efforts to improve the safety, reliability, and effectiveness of health care are not new; organizations

have been diligently working toward these goals for years. However, they often pursue various

strategies in a vacuum, not fully appreciating how different approaches and initiatives impact one

another. When attempting to achieve more ambitious goals, these health care organizations

sometimes need guidance about how to integrate and sequence their improvement efforts.

In this context, a group of subject-matter experts at the Institute for Healthcare Improvement

(IHI) and Safe & Reliable Healthcare (SRH) have collaborated over 15 years to develop the

Framework for Safe, Reliable, and Effective Care highlighted in this white paper. Made up of two

foundational domains — culture and the learning system — along with nine interrelated

components, with patients and families at the core, the framework brings together succinctly and

in one place all the strategic, clinical, and operational concepts that are critical to achieving safe,

reliable, and effective care.

This white paper describes the domains of culture and the learning system, outlining what is

involved with each and how they interact; provides definitions and implementation strategies for

the nine components (leadership, psychological safety, accountability, teamwork and

communication, negotiation, transparency, reliability, improvement and measurement, and

continuous learning); and discusses patient and family engagement. Throughout the paper, we

provide real-world examples so readers can get a more complete understanding of the various

components and their impact on the framework as a whole.

This paper provides organizations with a clearer understanding of how to achieve safe, reliable,

and effective care. Organizations can use the framework as a roadmap to guide them in applying

the principles contained therein, or as a diagnostic tool to determine how well (or even if) they are

pursuing the different components of the framework. A commitment to using the framework will

enable health care organizations of all shapes and sizes to take the next step toward achieving safe

and reliable operational excellence.

Introduction

Health care organizations have an absolute responsibility to deliver safe, reliable, and effective care

to patients. Yet consistently meeting this obligation can be daunting, and organizations are often

challenged to design a balanced portfolio of improvement projects that will enable them to meet

system-level quality and safety goals. They may have stand-alone safety improvement projects

underway, or regularly conduct staff surveys to better understand the organization’s current safety

culture, but it remains unclear how these various efforts interweave and interact to provide safer,

more reliable care. Diverse data streams are difficult to combine, making it challenging to develop

sustainable, system-wide programs focused on all-cause harms and errors.

The Framework for Safe, Reliable, and Effective Care provides clarity and direction to health care

organizations on the key strategic, clinical, and operational components involved in achieving safe and

reliable operational excellence. It comprises two foundational domains — culture and the learning

system — along with nine interrelated components: leadership, psychological safety, accountability,

teamwork and communication, negotiation, transparency, reliability, improvement and measurement,

and continuous learning. Engagement of patients and their families is at the core of the framework —

the engine that drives the focus of the work to create safe, reliable, and effective care.

WHITE PAPER: A Framework for Safe, Reliable, and Effective Care

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The framework serves several purposes. First and foremost, organizations can use it as a roadmap to

guide them in applying the principles contained therein. Second, they can use it as a diagnostic tool to

determine how well (or even if) they are pursuing the different components of the framework.

By employing this framework, organizations can, over time, improve the safety, reliability, and

effectiveness of the care they provide. Redesigning a system of care is complicated, however, and

cannot be rushed. Although the framework can help a health system organize its efforts to build

systems of safe, reliable care, and ensure it pursues the key components necessary to achieve

ongoing success, it is essential for organizations to allocate the time and resources to do the work.

In addition, they must assess their current performance with respect to the different domains and

components: Are they currently working toward implementing any aspects of the framework? How

far have they progressed? What is working? What isn’t working? By establishing this benchmark, it

becomes clearer where the organization needs to focus its attention and efforts.

Background

Throughout its evolution, the Framework for Safe, Reliable, and Effective Care has been a

collaborative effort between subject-matter experts at the Institute for Healthcare Improvement

(IHI) and Safe & Reliable Healthcare (SRH). The components of the framework emerged as part of

collective work to develop the curriculum for the IHI Patient Safety Executive Development

Program, which teaches the concepts and strategies with which a patient safety officer must be

familiar.1,2

Based on in-depth analyses of numerous high-performing, proactive, and generative work settings,

IHI and SRH continuously refined the ideas contained within the framework and, over time,

observed that it yields positive results. Every safe and reliable health care organization the team

has encountered is in the process of applying most — if not all — of the framework’s components.

Although initially focused on the acute care setting, the framework has evolved to be more broadly

applicable in any setting — in acute care, ambulatory care, home care, long-term care, and out in

the community. Like any good model, the framework continues to evolve as organizations weigh in

with their own experiences.

The purpose of this white paper is to explain the framework, describe each domain and its

components in more detail, and offer definitions, strategies, and real-world examples to help

organizations fully understand each facet and get started on the work. There are various tools and

methods organizations need to have in place to support safe, reliable, and effective care, many of

which are noted throughout the paper. It is not the purpose of this paper, however, to cover all of

these; see the Appendix for additional information on select methods and tools.

The Overarching Domains: Culture and the

Learning System

Underpinning the framework are two essential and interrelated domains: culture and the learning

system. In this context, culture is the product of individual and group values, attitudes,

competencies, and behaviors that form a strong foundation on which to build a learning system.

A learning system is characterized by its ability to self-reflect and identify strengths and defects,

both in real time and in periodic review intervals. In health care, this entails leaders highlighting

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the importance of continuous reflection to assess performance. It entails consistently performing

agreed-upon team behaviors like briefings and debriefings where the self-reflection occurs.

Learning systems identify defects and act on them; they reward proactivity rather than reactivity.

Learning and a healthy culture reinforce one another by identifying and resolving clinical, cultural,

and operational defects. By effectively applying improvement science, organizations can learn their

way into many of the cultural components of the framework.

Figures 1 and 2 make it easier to understand the framework holistically. The figures depict the

framework as a circular model where each component locks together with the others. This

reinforces the idea that all parts are interconnected and interdependent, and success in one area is

predicated on success in another. The framework helps make sense of an organization’s prior work

on safety, highlighting areas of strength as well as gaps.

At the core of the framework is the engagement of patients and their families — that is, all the

effort involved in executing the framework should be in the service of realizing the best outcomes

for patients and families across the continuum of care.

Figure 1. Framework for Safe, Reliable, and Effective Care

WHITE PAPER: A Framework for Safe, Reliable, and Effective Care

Institute for Healthcare Improvement • ihi.org Safe & Reliable Healthcare • safeandreliablecare.com 9

Figure 2. Framework for Safe, Reliable, and Effective Care — with Descriptive Detail for the Components

Because the culture and learning system domains are both foundational to the framework, it can be

difficult to know where to begin work. It is somewhat of a chicken-and-egg problem: organizations

need to have the culture to be able to do the learning, and need to do the learning to change the

culture. In the end, there is no perfect place to start; there is justification to pursue either domain first.

This white paper begins by first deconstructing the components of culture and then those of the

learning system. However, readers should keep in mind that the two domains are synergistic, and

in many cases organizations will simultaneously work on multiple components, spanning the two

domains. The eventual goal is to have all the components in place and working together to form a

reliable system that consistently delivers safe, reliable, and effective care to patients.

The Components of Culture

As shown in Figure 1, the framework includes four cultural components (psychological safety,

accountability, teamwork and communication, and negotiation) in addition to one shared

component (leadership) that falls within both domains (culture and the learning system). Below we

closely examine each of these cultural components, providing a definition and steps to

implementing the ideas in daily practice.

Leadership

The primary function of leaders in health care is to influence their “followers” to develop behaviors,

habits, processes, and technologies that result in outstanding and ever-improving performance. In

WHITE PAPER: A Framework for Safe, Reliable, and Effective Care

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the framework, leaders are not identified by position or rank; they exist at all levels and in all

groups, including patients and their families. In fact, the framework is indifferent to the leadership

title: it tacitly acknowledges that senior leaders develop strategy or create alignment; middle-level

leaders predominantly manage; and clinical leaders focus on the clinical acumen of their staff.

These different attributes are key to each specific leadership role; however, the framework

indicates that there are some similar expectations of every leadership position, regardless of role.

The framework requires that all formal and informal leaders are committed to achieving safe,

reliable, and effective operational excellence. Essentially, leaders have four main responsibilities:

 Guarding the learning system: Fully engaging in the work of self-reflection that leads to

transparency; understanding and applying improvement science, reliability science, and

continuous learning; and inspiring that work throughout the organization.

 Creating psychological safety: Making sure that anyone in the organization, including

patients and families, can comfortably voice concerns, suggestions, and ideas for change.

 Fostering trust: Creating an environment of non-negotiable respect, ensuring that people

feel their opinions are valued, and any negative or abusive behavior is swiftly addressed.

 Ensuring value alignment: Applying organizational values to every decision made, whether

in service of safety, effectiveness, patient-centeredness, timeliness, efficiency, or equity.

When leaders consistently deliver on these responsibilities, they set the stage for a culture and

learning system centered on safety and reliability.

Moving from Concept to Reality

Strong leadership involves a series of behaviors that manifest themselves in actions. Consequently,

organizations can assess and cultivate leadership by checking for, monitoring, and encouraging

certain actions.

The following questions can assist organizations in evaluating the current leadership landscape

and identifying opportunities for improvement:

 In what ways does the organization train people for leadership positions?

 How effectively does the organization pursue succession planning?

 How much time and energy do senior leaders and the board spend on quality and safety

topics at board meetings? (The recommended amount of time is about 25 percent.3) Are

safety and reliability issues prioritized in the meeting agenda?

 Do leaders have at least a tacit understanding of the framework and its components, as well

as their roles as leaders?

 Are leaders committed to reviewing learning boards that document the problems people are

having and what is being done to resolve them? (For more information about learning boards

or white boards, see the Transparency section below.)

 Do leaders at every level set clear aims that are actionable? Does everyone know how they can

contribute to the organization’s overarching aim?

Culture surveys are especially valuable in that they can provide insight about leadership and the

perceptions of staff. Some things to look for in culture surveys include whether staff feel that they

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are coached by leaders, whether there is the perception that senior leaders’ values align with stated

organizational values, and whether these values are manifest in leaders’ actions.

Leaders should also be accessible, listen more than they talk, and respond to concerns. Internal

communications must exist in organizations that link leaders’ responses to frontline provider

concerns, in essence ensuring that staff feel their voices are heard. This feedback is critical because

studies have shown that when leaders talk with people and respond with feedback and action,

people feel their voices are heard, and engagement scores go up by 20 to 50 percent, including the

scores that measure leadership effectiveness. However, when leaders listen but don’t respond, or

responses are not known to the frontline staff, engagement scores and perceptions of leadership

effectiveness drop by 10 to 20 percent, according to 2016 SCORE results.4

Psychological Safety

This concept originated with James Reason’s book, Managing the Risks of Organizational

Accidents,5 and was popularized by Amy Edmondson in her early writings and in her book,

Teaming.6 Although thought of colloquially as “I can speak up about concerns,” the specific

elements of psychological safety are much more nuanced and entail the following four attributes:6

 Anyone can ask questions without looking stupid.

 Anyone can ask for feedback without looking incompetent.

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