Advancing Patient Safety:A Snapshot History

Tort Reform Efforts (1975-96) Willie King/Rolando Sanchez case (1995) Betsy Lehman Case (1995-96) 104th Congress (“Contract with America”) (1995-96)

Anesthesia Patient Safety Foundation (1985) Leape’s Error in Medicine article (JAMA 1991) Ben Kolb case (1995)

First Annenberg conference (1996) VA implementation efforts & NPSF (1997) IOM1 Report (1999) -- a new plateau IOM2 Report (2001) -- milestone or miss (or both)?

What is a Safety Culture? How Do We Build it?

Problem - No Precedents in Health Care

Solution? Look at High Reliability Service Organizations in other fields

HRO’s are engineered to deliver consistently Good Outcomes in Complex & Dynamic Environments

How Did Other Fields Achieve High Reliability?

HRO Key Attributes…

Reporting Cultures Flexibility in Operation Perceived to be Just Engaged in and dedicated to

Learning

Advancing Patient Safety:Three Fronts of Engagement

The Challenges…

Transforming the External Environment Fostering a New Understanding of

Accountability

Transforming the Internal Environment Growing Internal Cultures that Honor Safety &

Deliver High Reliability Service

More Effectively Managing Knowledge Capturing Safety Information & Converting it

to Practical Tools

Growing a Safety Culture:Knowledge Sources

Health Care Research Systems Analysis, Engineering &

Design Cognitive Psychology Human Factors/Ergonomics Sociology & Organizational Behavior Lessons Learned from other Industries Quality Improvement Complexity Theory

Growing a Safety Culture: The Stakeholders

Consumers The Clinician/Patient/Family Team Health Care Administrators Makers & Purchasers of Medical Products Educators Employers, Payors & Managed Care Orgs Legislators/Regulators/Lawyers Media

The Patient Safety Paradox

We have…

New Technological “Miracles” Pushing Health Care Forward

Ability to Treat Ever Sicker Populations

The Patient Safety Paradox

But we also have…

Increased Process Complexity Escalating Change Information Overload Increased Expectations for

Perfect Outcomes New Patient Vulnerabilities

The Accountability Paradigm

The “Old Look”

Clinicians are Supposed to be Infallible

Bad Things Happen Only when People Make Mistakes

People/Organizations that Fail are Bad

Blame & Punishment Sufficiently Motivate Carefulness

The Accountability Paradigm

The “New Look”

Risk of Failure is Inherent in Complex Systems

Risk is always Emerging Latent Risk is not Foreseeable People are Fallible…No Matter How

Hard They Try Not to Be Systems are Fallible Alert, Well-trained Clinicians are

Crucial

To Err is Human (1999)The IOM Call to Action

Create a National Center for Patient Safety Establish Mandatory Reporting via State Agencies

to Ensure Accountability Encourage External Voluntary Reporting Pass Legislation for “Peer Review” Protection of

External Reporting Programs Raise Standards & Expectations for Safety Through

the Actions of Oversight Organizations, Purchasers, Professional Groups, etc.

Implement Proven Medication Practices by Creating Safety Systems Inside Health Care Organizations

Patient Safety Key Concepts

The Buzz Words...

Growing a Safety CultureThe Buzz Words

1. Patient Safety As a “Core Value”

2. “Human Factors” Engineering

3. “Errors” vs. “Recovery” vs. “Adverse Events”

4. “Near Misses” = “Near Hits” = “Close Calls”

Growing Safety CulturesThe Buzz Words

5. “Swiss Cheese” Model of Complex System Performance

6. “Latent Failure”

7. “Hindsight Bias”

8. “Blunt End vs. Sharp End”

Swiss Cheese Model

Modified from Reason, 1991 © 1991, James Reason

Triggers

DEFENSES

Accident

Regulatory Narrowness

Incomplete Procedures

Mixed Messages

Production Pressures

Responsibility Shifting

Inadequate Training

Attention Distractions

Deferred Maintenance

Clumsy Technology LATENT

FAILURES

Goal Conflictsand Double Binds

The World

Modified from Richard I. Cook, MD (1997)

Hindsight Bias

Before the Accident

After the Accident

Sharp and Blunt Ends

Errors and Expertise

Monitored Process

Organizations, Institutions,Policies, Procedures, Regulations

Resources andConstraints

Practitioner

Knowledge

Focus of Attention

Goals

Modified from Woods, et al., 1994

Sharp and Blunt Ends

The Sharp End

Consumers

Media, Legislators, Regulators, Lawyers, Accreditors, Educators

Resources andConstraints

Health Care Organizations

Administrators

Clinicians, Families, Patients

Pr. Buyers

Modified from Woods, et al., 1994

Employers/Payors & Product Makers

Advancing Patient Safety: Legislative Action in 2001?

Federal Health Legislation Priorities pre-IOM2

“Safe Harbor” Reporting Protection

Nursing Shortage Interventions Patient Bill of Rights Increased Funding for AHRQ Remedies for the Uninsured?

Advancing Patient Safety: What Have the States Done?

Post-IOM1 Legislation Introduced..

Fifteen states (eleven referencing IOM Report)

Forty-five bills Eight enacted -- FL, MA(2), MO, NY,

SD, WA(2) Ten pending Three tabled for later consideration

Advancing Patient Safety: What Have the States Done?

State Legislation Themes...

Whistle-blower protection Adequate nurse staffing Increasing info to consumers Establishing government

supported patient safety centers Expanded error reporting

Advancing Patient Safety: New Regulations and

Standards

Florida ruling on Medicare access to adverse event info

Expanded PRO activity New JCAHO standards Increased oversight/training in

ambulatory care Multifaceted AHRQ activities

Advancing Patient Safety: Employer/Purchaser

Initiatives

Leapfrog Group Initiatives Computerized medication/order

entry Intensivists in the ICU High volume centers

WBGH focus on medication management

VA initiatives on bar coding, etc.

IOM2: Crossing the Quality Chasm A New Health System for

the 21st Century

So, Does IOM2 mark a change in direction?

Reinforcement of the course set by IOM1?

A different call to action?

And, who’s listening?

Who’s opposing?

IOM2: Crossing the Quality Chasm A New Health System for

the 21st Century

Six Aims -- Health Care should be: Safe - No unintended injuries Effective - Based on evidence Patient-Centered Timely - No harmful delays Efficient - Waste avoided Equitable - No variance in quality

IOM2: Crossing the Quality Chasm A New Health System for

the 21st Century

13 Recommendations/4 Themes: Vision Redesign of the delivery

system Building organizational

supports for change Environmental changes

IOM2: Crossing the Quality Chasm A New Health System for

the 21st Century

Vision: Adopt Explicit Goal to

Improve Quality Every HCO Pursues the 6

Aims Congress to provide funds for

establishing and evaluating progress in achieving 6 Aims

IOM2: Crossing the Quality Chasm A New Health System for

the 21st Century

Delivery System Redesign: Every stakeholder follows same

basic rules & works together AHRQ identifies 15 conditions

and makes progress in 5 years Congress establishes $1 billion

HC Quality Innovation Fund

IOM2: Crossing the Quality Chasm A New Health System for

the 21st Century

Building Organizational Support for change: AHRQ convenes workshops to

promote state-of-art change DHHS supports effort to make

knowledge more accessible National commitment to

infrastructure improvement

IOM2: Crossing the Quality Chasm A New Health System for

the 21st Century

Environmental Changes: Purchasers remove barriers that

impede quality improvement AHRQ and HCFA explore options for

better alignment Clinician education re-examined Legal & regulatory reform studied

Advancing Patient Safety: Is the Media Helping or

Hurting?

Philadelphia Enquirer Series (Spring 2000) Chicago Tribune Series on Nurses (Summer

2000) Florida Ambulatory Care Stories (Summer/Fall

2000) Minneapolis Children’s Hospitals Challenges “Public Relations” Apologies

Growing a Safety Culture in Medicine -- The Road Map

Progress through alignment…

Based on Core Values (First Do No Harm) Focused on Delivery Process Redesign Supported by state-of-art knowledge management

infrastructure Encouraged by payment incentives Not discouraged by legal or regulatory threats Advanced by cooperation among all stakeholders

Advancing Patient Safety:A Lesson from Aviation

“One reason that an incident reporting system worked in aviation...was that the entire aviation community -- essentially all of the stakeholders, including air passengers -- were involved in the process from the beginning and became advocates for the reporting system (as well as severe, but constructive, critics).”

Charles E. Billings, MD, Editorial Arch Pathol Lab Med 1998,

121:214-215