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Culture of Safety: What’s in Your Toolbox?

Kathy Ghomeshi, PharmD, BCPS

Medication Safety Specialist

Victoria Serrano Adams, PharmD, FASHP, FCSHP

Director of Pharmaceutical Services

UCSF Medical Center

Disclosure

The speakers have no conflicts of interest

Learning Objectives

1. List the key elements or tools in a Culture of Safety Model

2. Explain the role of leadership in developing a Culture of Safety

3. List at least two high leverage risk reduction strategies

4. Identify at least one metric for measuring risk and/or error reduction

Institute of Medicine report 2000

44,000 - 98,000 hospitalized patients die each year from patient safety failures1

Preventable deaths

“The status quo is not acceptable and cannot be tolerated any longer” – IOM Report

To Err is Human

Institute of Medicine 2000

Follow up report 15 years later by National Patient Safety Foundation (NPSF)

Errors still exist

Each hospitalized patient is exposed to 1 medication error per day2

1 in 2 surgeries has a Medication Error or Adverse Drug Event3

700,000 outpatients are treated annually in Emergency Department for Adverse Drug Event4

New data suggests that preventable medical error is the 3rd leading cause of death

To Err is STILL Human

Rather than accepting errors, let’s embrace a solution

Adopting and nurturing a culture of safety

System designed to identify errors and mitigate them before they can result in patient harm

To Forgive Divine?

I. Culture of Safety

II. Role of Leadership

III. Safety Tools and Metrics

Outline

I. Culture of Safety

Culture is a pattern of shared basic assumptions about values, beliefs, and behaviors

What is culture?

Culture is a pattern of shared basic assumptions about values, beliefs, and behaviors

Culture of safety entails:◦ Psychological safety

◦ Active leadership

◦ Transparency

◦ Fairness

What is Safety culture?

Safety Culture

The product of individual and group values, attitudes, perceptions, competencies, and patterns of behavior that determine the commitment to organizational health and safety management.5

Culture of Safety - Intro

Free from Harm: Accelerating Patient Safety Improvements Fifteen Years after To Err is Human. NPSF. 2015

Just culture

Informed culture

Reporting culture

Flexible culture

Learning culture

Culture of Safety – Subcultures6

A brief history of safety culture…

Punitive culture

Blame-free culture

Just culture

Culture of Safety: Just Culture

Just Culture Definition: Culture that recognizes that individual practitioners should not be held accountable for system failings over which they have no control.

Recognizes “active” errors represent predictable interactions between human operators and the systems in which they work

Does not tolerate conscious disregard of clear risks to patients or gross misconduct

Culture of Safety: Just Culture

Free from Harm: Accelerating Patient Safety Improvements Fifteen Years after To Err is Human. NPSF. 2015

What is an error?◦ The failure of planned actions to achieve their desired ends-

without the intervention of some foreseeable event – James Reason

◦ Slip, lapse, mistake

Human error◦ Inadvertently doing other than what should have been done◦ Human errors are UNINTENTIONAL acts, not a behavioral choice

Anatomy of an Error7

What causes an error?

◦ Skill-based error

◦ Rule-based error

◦ Knowledge-based error

Human Error Causes

Human Error◦ Slip, lapse, mistake◦ Error in execution vs error in planning

At-Risk Behavior◦ Choosing to break the rules◦ But why?

◦ Risk is not recognized◦ Belief that action is justified

Reckless Behavior◦ Conscious Disregard of Unreasonable Risk

Just Culture Behaviors

Advancement in patient safety requires overarching shift from reactive, piecemeal interventions to total systems approach to safety8

Culture of Safety

Pronovost P, Ravitz A, Stoll R, Kennedy S. 2015. Transforming Patient Safety: A Sector-Wide

Systems Approach. Report of the Wish Patient Safety Forum 2015.

1. Ensure leaders establish and sustain safety culture

2. Create centralized and coordinated oversight of patient safety

3. Create common set of safety metrics that reflect meaningful outcomes

4. Increase funding for research in patient safety and implementation science

5. Address safety across the entire continuum of care

6. Support healthcare workforce

7. Partner with patients and families for safest care

8. Ensure technology is safe and optimized to improve patient safety

Culture of Safety

II. Role of Leadership


Improving safety requires organizational culture that enables and prioritizes safety.

The importance of culture change is brought to forefront.


Human error Console

At-risk behavior Coach

Reckless behavior Punish

Focus on managing at-risk behavior

Managing Behavior in a Just Culture

How do we identify at-risk behavior?◦ Safety information systems (Informed Culture)

◦ Utilize reporting systems to identify hazards, at-risk behavior, and close calls (Reporting Culture)

What do we do with the reports?◦ Leadership support to make actionable changes

Tools: Just culture algorithm

Leadership Role in Just Culture

Leadership Role in Just Culture9

What happened?

What normally happens?

What’s supposed to happen?

Why did it happen?

Leadership Role in Just Culture9

High Reliability Organizations (HROs) manage with a goal of safe, reliable performance in complex industries

High Reliability Organization◦ Preoccupation with system failures

◦ Reluctance to simplify

◦ Sensitivity to operations

◦ Commitment to resilience

◦ Deference to expertise

Culture of Safety – Leadership Support

Designating safety resources

Patient Safety Officer

Medication Safety Officer

Informatics Pharmacist


Support of Continuous Quality Improvement initiatives◦ Support for best practices

◦ Gap analyses and follow up


Just culture, informed culture, safety culture

Leadership support

Incorporate multi-modal strategies to reduce risk

Culture of Safety – Risk Reduction Strategies


High-leverage strategies•Active, continuous, focus on systems•More effective but require more resources

Low-leverage strategies•Passive, intermittent, focus on individuals•Improve awareness but must be combined with a more comprehensive program

Cohen, M. High alert Medications: Safeguarding against errors. Medication Errors. APhA. 2007. P 317-28 ISMP medication safety alert. Selecting the best error-prevention "tools" for the job. Feb 2006


High leverage examples:

Fail-safes Hard stops in order entry or smart pump programming

Constraints Concentrated K+ or insulin only stored in pharmacy

Forcing function Enteral syringe designed to only connect with enteraltubing



Low leverage examples:

Education Bulletin

Information Labels


High-leverage strategies◦ Active, continuous, focus on systems

◦ More effective but require more resources

Low-leverage strategies◦ Passive, intermittent, focus on individuals

◦ Improve awareness but must be combined with a more comprehensive program


III. Safety Tools and Metrics

Introduction to variety of tools to create and maintain safe culture

Some tools will yield data that can be used to capture metrics◦ Qualitative data

◦ Quantitative data

Culture of Safety – Tools & Metrics

Leadership tools

Communication tools

Outcomes data tools

Engagement tools

Error prevention and response tools

Types of Safety Tools

Organizational compacts

Respect training

Strategies for addressing disruptive behavior

Culture surveys

Executive WalkRounds

Leadership Tools

Leadership Tools

Pros:

Provide education on safety culture

Can facilitate culture change

Cons:

Difficult implementation

Not always proven to be effective

SBAR (Situation, Background, Assessment, Recommendation)

Huddles

Brief

Debrief

CUS words (I’m Concerned, I’m Uncomfortable, There is a Safety Issue)

Safety Communication Tools

Organized, succinct communication of important information

Can be used at every shift, or each day, week, etc.

Safety Communication Tools

Safety Attitudes Questionnaire

2 Question survey

Comprehensive Unit-Based Safety Program

Unit-Based Leadership Team

Safety engagement tools

Provides valuable qualitative insight

Proactive collaboration

Interdisciplinary nature

Requires engagement and follow-up

Safety engagement tools

Error Reporting system◦ Error reporting systems are typically voluntary and confidential

Great catch award

RCA (Root Cause Analysis)

FMEA (Failure Modes and Effects Analysis)

Institute for Safe Medication Practices (ISMP) Self-Assessment

ISMP Acute Care Newsletter

Error prevention and response tools

Voluntary Reporting

Incident reporting system captures voluntary reports

Information can be used for qualitative analysis and some quantitative analysis◦ Cannot be used to determine an error rate

Can highlight actual errors, near misses, and unsafe conditions

Medication ErrorsMedication Error

Near Miss Reached Patient

No Harm Caused Harm

Qualitative Analysis

Allows information to flow from sharp end to blunt end

Improves visibility of system weaknesses and vulnerabilities

Visibility can lead to system changes

Quantitative Analysis

Incident report data cannot be used for demonstrating error rates or trends due to voluntary nature◦ Eg, error may occur and not be reported

◦ Eg, error may occur and be reported by multiple individuals

◦ Eg, near miss may be reported

◦ Eg, unsafe condition may be reported

◦ Eg, report may have been filed in error (misunderstanding of situation)


Can look at reporting rate◦ High rate means good reporting, not necessarily more errors

◦ Low rate means less reporting, not necessarily safer

Should look at serious events (actual or potential) to prevent future harm


Factors that can impact reporting rate:◦ Culture, culture, culture

◦ Fear of punitive action

◦ Lack of perceived value

◦ Nothing will change

◦ I’m busy

Mandatory reporting

◦ Mandatory reporting is still voluntary

Trigger reports

Dashboards

Intervention data

Safety outcomes data tools

Quantitative data

Useful for evaluating if actionable change can be implemented

Safety outcomes data tools









Culture of Safety


Measurement is foundational to advancing improvement.

Need to establish metrics across the care continuum and create ways to identify and measure risks and hazards proactively.

Culture of Safety - Metrics

Adverse event reporting ◦ Harm/severity score – number of events that resulted in significant patient

harm

◦ National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP)

◦ Agency for Healthcare Research and Quality (AHRQ)

Error reporting ◦ Near miss vs actual harm

◦ Preventable vs non-preventable

◦ Role of reporter (RN, PharmD, MD, other)

◦ Phase of med use process (Prescribing, Compounding, Administration, etc)

◦ High risk medication

◦ Harm score

Culture of Safety – Metrics

Prescribing◦ Medication order alert override

◦ Pharmacist intervention data (RedCap, i-Vent, etc)

Compounding◦ Near miss error tracker

◦ Medication errors returned to pharmacy

Dispensing◦ Automated dispensing cabinet override rates


Administration

◦ Patient armband barcode scanning rate

◦ Medication barcode scanning rate

◦ Smart pump library compliance rate

Monitoring/Use◦ Trigger tools

◦ Drug trigger- naloxone, D50, kayexelate, Vitamin K, Digibind

◦ Lab result- BG, aPTT, INR, serum drug level


Medication errors are still a prevalent source of preventable patient harm

Developing a culture of safety requires leadership support

Applying safety tools and evaluating metrics will enable safer patient care

Culture of Safety- Summary

True of False: Leadership support is a key element of the Culture of Safety Model.

A. True

B. False

Test Question 1

Which of the following actions are considered high leverage risk reduction strategies?

A. Staff education

B. Checklists

C. Two RN independent double check

D. Min/max dose hard stop

E. All of the above

Test Question 2

Which of the following items is NOT a reliable safety metric?

A. Barcode medication administration patient armband scanning rate

B. Automated dispensing cabinet override rate

C. Naloxone use

D. National benchmark

E. All of the above

Test Question 3

References1Aspden P, Wolcott J, Bootman J, Cronenwett LR. Preventing Medication Errors. Washington, DC: National Academies Press; 2007.2Kohn LT, Vorrigan JM, Donaldon MS, eds. To Err is Human: Building a Safer Health System. Washington, DC: Nationl Academies Press; 2000.3Nanji KC, Patel A, Shaikgh S, Seger DL, Bates DW. 2015. Eavluation of perioperative medication errors and adverse drug events. Anesthesiology. 2015.4Budnitz DS, Pollock DA, Weidenbach KN, Mendelson AB, Schroeder TJ, Annest JL, 2006. National surveillance of emergency department visits for outpatinet adverse drug events. JAMA 296:1858-1866.5NPSF Free from Harm. 2015. Executive Summary6Smetzer JL. Chapter 23 Managing Medication Risks Through a Culture of Safety. Medication Errors. American Pharmacists Association. 2007.7Institute for Safe Medication Practices Self-Assessment. 20118Pronovost P, Ravitz A, Stoll R, Kennedy S. 2015. Transforming Patient Safety: A Sector-Wide Systems Approach. Report of the Wish Patient Safety Forum 20159https://www.outcome-eng.com//wp-content/uploads/2013/01/alg.png

Culture of Safety: What’s in Your Toolbox?

1. Write down the course code. Space has been provided in the daily program-at-a-glance sections of your program book.

2. To claim credit: Go to www.cshp.org/cpe before December 1, 2016.

Session Code:

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