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
To Err is Human Institute of Medicine report 2000 44,000-98,000 hospitalized patients die each year from patient safety failures 1 Preventable deaths The status quo is not acceptable and cannot be tolerated any longer IOM Report Institute of Medicine 2000
To Err is STILL Human 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 day 2 1 in 2 surgeries has a Medication Error or Adverse Drug Event 3 700,000 outpatients are treated annually in Emergency Department for Adverse Drug Event 4 New data suggests that preventable medical error is the 3rd leading cause of death
To Forgive Divine? 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
Outline I. Culture of Safety II. Role of Leadership III. Safety Tools and Metrics
I. Culture of Safety
What is culture? Culture is a pattern of shared basic assumptions about values, beliefs, and behaviors
What is Safety culture? Culture is a pattern of shared basic assumptions about values, beliefs, and behaviors Culture of safety entails: Psychological safety Active leadership Transparency Fairness
Culture of Safety - Intro 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 Free from Harm: Accelerating Patient Safety Improvements Fifteen Years after To Err is Human. NPSF. 2015
Culture of Safety Subcultures 6 Just culture Informed culture Reporting culture Flexible culture Learning culture
Culture of Safety: Just Culture 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 Free from Harm: Accelerating Patient Safety Improvements Fifteen Years after To Err is Human. NPSF. 2015
Anatomy of an Error 7 What is an error? The failure of planned actions to achieve their desired endswithout 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
Human Error Causes What causes an error? Skill-based error Rule-based error Knowledge-based error
Just Culture Behaviors 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
Culture of Safety Advancement in patient safety requires overarching shift from reactive, piecemeal interventions to total systems approach to safety 8 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.
Culture of Safety 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 - Intro 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
II. Role of Leadership
Culture of Safety - Intro 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 - Intro 1. Ensure leaders establish and sustain safety culture Improving safety requires organizational culture that enables and prioritizes safety. The importance of culture change is brought to forefront.
Managing Behavior in a Just Culture Human error Console At-risk behavior Coach Reckless behavior Punish Focus on managing at-risk behavior
Leadership Role in 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 Culture9
Leadership Role in Just Culture 9 What happened? What normally happens? What s supposed to happen? Why did it happen?
Culture of Safety Leadership Support 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
Culture of Safety Leadership Support Support of Continuous Quality Improvement initiatives Support for best practices Gap analyses and follow up
Culture of Safety Risk Reduction Strategies 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
Culture of Safety Risk Reduction Strategies 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 enteral tubing 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
Culture of Safety Risk Reduction Strategies Low leverage examples: Education Bulletin Information Labels 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
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
III. Safety Tools and Metrics
Culture of Safety Tools & 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
Types of Safety Tools Leadership tools Communication tools Outcomes data tools Engagement tools Error prevention and response tools
Leadership Tools Organizational compacts Respect training Strategies for addressing disruptive behavior Culture surveys Executive WalkRounds
Leadership Tools Pros: Provide education on safety culture Can facilitate culture change Cons: Difficult implementation Not always proven to be effective
Safety Communication Tools 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 engagement 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
Error prevention and response 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
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 Errors Medication 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)
Qualitative Analysis 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
Qualitative Analysis 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
Safety outcomes data tools Trigger reports Dashboards Intervention data
Safety outcomes data tools Quantitative data Useful for evaluating if actionable change can be implemented
Culture of Safety 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 - Metrics 3. Create common set of safety metrics that reflect meaningful outcomes 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
Culture of Safety Metrics 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
Culture of Safety- Summary 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
Test Question 1 True of False: Leadership support is a key element of the Culture of Safety Model. A. True B. False
Test Question 1 True of False: Leadership support is a key element of the Culture of Safety Model. A. True B. False
Test Question 2 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 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 3 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 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
References 1 Aspden P, Wolcott J, Bootman J, Cronenwett LR. Preventing Medication Errors. Washington, DC: National Academies Press; 2007. 2 Kohn LT, Vorrigan JM, Donaldon MS, eds. To Err is Human: Building a Safer Health System. Washington, DC: Nationl Academies Press; 2000. 3 Nanji KC, Patel A, Shaikgh S, Seger DL, Bates DW. 2015. Eavluation of perioperative medication errors and adverse drug events. Anesthesiology. 2015. 4 Budnitz 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. 5 NPSF Free from Harm. 2015. Executive Summary 6 Smetzer JL. Chapter 23 Managing Medication Risks Through a Culture of Safety. Medication Errors. American Pharmacists Association. 2007. 7 Institute for Safe Medication Practices Self-Assessment. 2011 8 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 9 https://www.outcome-eng.com//wp-content/uploads/2013/01/alg.png
Culture of Safety: What s in Your Toolbox?
Session Code: 1. Write down the course code. Space has been provided in the daily program-at-aglance sections of your program book. 2. To claim credit: Go to www.cshp.org/cpe before December 1, 2016.