Building A culture of safety, high reliability and continuous learning

Building A culture of safety, high reliability and continuous learning
Colorado Healthcare Associated Risk Managers Michael Leonard, MD Safe & Reliable Healthcare Adjunct Professor of Medicine, Duke University

How do you Mitigate Risk?
High risk areas – surgery, OB, ED, ICU, deteriorating patients High risk medications Spontaneous reporting with analysis and feedback Risk surveillance Barriers and hot spots

The Quality of Healthcare in America
30 evidenced based practices: ACE inhibitors for CHF Beta blockers / ASA for post MI The chance of an average patient receiving appropriate care was 55%

Avoidable Patient Harm
30% of hospitalized patients have something happen to them you and I wouldn’t want to happen to us 6% are harmed seriously enough to stay in the hospital longer and go home with a disability >200,000 Medicare patients die every year from medical harm

Type vs. Severity of Hosp. Acquired AE’s
Courtesy Dr. Donald Kennerly, Baylor Healthcare Waste (8,400) +Harm (3,000) +SE (80) +Risk (400) + SE (120) Total (12,000) SE = Sentinel Event

Success going forward under the new healthcare model
Population management is the name of the game Coherence in moving from primary care to acute care Effective med reconciliation in the ED – every time Organized in hospital care Begin planning the discharge upon admission Effective transition back to primary care – care coordinators

Improving Safety Requires a Learning System
Safety is a characteristic of a SocioTechnical system System-level failures occur almost always because of unforeseen combinations of component failures Traditional perspective-software failures are primarily the result of errors in the code causing the software to behave in a manner inconsistent with its performance requirements. All other errors are considered “human error.” Sociotechnical system—consists of many components whose interaction with each other produces or accounts for the system’s behavior. Technology (e.g., software, hardware), People (e.g., clinicians, patients), Processes (e.g., workflow), Organization (e.g., capacity, decisions about how health IT is applied, incentives), and External environment (e.g., regulations, public opinion).

Safety Cultures Evolve
GENERATIVE Organizational Culture “Genetically-wired” to produce safety PROACTIVE “We methodically anticipate”— prevent problems before they occur SYSTEMATIC Systems being put into place to manage most hazards Where are you? Are you on the same page? REACTIVE “Safety is important. We do a lot every time we have an accident” Where is Yours? UNMINDFUL “We show up, don’t we?” Chronically Complacent 11 Attribution: Prof. Patrick Hudson, Univ. Leiden 11 11

SocioTechnical Framework
Unmindful • Reactive • Systematic • Proactive • Generative Patient & Family Centered Care Leadership – Senior and Clinical Effective Teamwork Psychological Safety Organizational Fairness Reliable Processes of Care Learning System - Improvement

The Ideal Unit The organizational clinician begins by examining the department or unit. So walking down the hall the organizational clinician uses the same schema as the clinician. First the organizational clinician looks to get an initial impression Part of that initial impression as you walk onto a unit would be to look at what the Unit is studying, learning about and trying to improve. The information should be readily available and easy to see and understand. Let’s look at what that might be like……. On the ‘wall’ to the left we have the process and outcome boards To the right we have learning boards To understand a department or unit the organizational clinician must study the department and know the signs and symptoms of its disease states

Building the Conditions for Success
How leadership, culture and process come together It is essential to connect the 3 levels of the organization – senior leaders, the middle and caregivers at the bedside

Approaching Common and Serious Problems
With protocols and guidelines, are they suggestions or are they the way we do business? Work as imagined v. Work as done What makes the difference? How do you measure that? How do you drive sustainable improvement? We always have to deal with both process and culture.

Looking at Sepsis Up to 50% of patients are septic at the time of death in American Hospitals Some hospitals treat sepsis very consistently with good outcomes, many do not. Let’s look and see how you think you would do or where the important processes are to become “always events.”

Sepsis: Getting it Right or Wrong
Define Time Zero Diagnosis / high Index Suspicion Sepsis Bundle < 3hours Lactate > 4, unstable gets CVP, MVO2 measurement, pressors PRN Who owns the patient? Warm handoff. No delay

Sepsis – A Phased Approach
Severe sepsis – 4 things every time within hours Septic shock – hemodynamic monitoring, pressure support, etc. Patients who declare themselves in the hospital – surveillance and EWS Patients who return septic after discharge

Patient & Family Centered Care
GENERATIVE Organization wired for safety and improvement Truly patient-centered care, a true partnership, all about them Structured process for patients and family at the table, visible results Care process visible, learning and feedback sporadic Customer service is the primary focus Care process built around the convenience of providers PROACTIVE Playing offense - thinking ahead, anticipating, solving problems SYSTEMATIC Systems in place to manage hazards REACTIVE Playing defense – reacting to events UNMINDFUL No awareness of safety culture

Seeing Through the Patient’s Eyes
How do you assess the patient experience? When does that happen? What is the real story? How do you meet their expectations? How do we fail them? What happens when we do?

Senior Leadership GENERATIVE
Organization wired for safety and improvement Cyclic flow of information with feedback and organizational learning Systematic engagement with dialogue, support and learning Process for interaction between senior leaders and front line staff They’re here – something bad must have happened We don’t know or see them PROACTIVE Playing offense - thinking ahead, anticipating, solving problems SYSTEMATIC Systems in place to manage hazards REACTIVE Playing defense – reacting to events UNMINDFUL No awareness of safety culture

Leadership Characteristics
Non Negotiable Mutual Respect, Every Interaction, Every Day. Paul O’Neill – “Once you get used to taking the high road, putting values over expedience, and treating people like people and not the means, it gets easier and easier.

Chris Argyris Why is it so hard? Single loop learning
Double loop learning Not talking about the stuff we don’t talk about

Clinical Leadership GENERATIVE
Organization wired for safety and improvement Leaders create high degrees of psych safety and accountability. Leaders model the desired behaviors to drive culture of safety Training and support exists for building clinical leadership Episodic, completely dependent on the individual clinician Absent for the most part PROACTIVE Playing offense - thinking ahead, anticipating, solving problems SYSTEMATIC Systems in place to manage hazards REACTIVE Playing defense – reacting to events UNMINDFUL No awareness of safety culture

Adaptive versus Technical Leadership
Known v. unknown problems Differences in style Knowing when to shift your leadership style

Gary Klein – Expert Decision making
Experts pattern match Quick and accurate as long as one tests Mental simulation is common and valuable – high performing teams simulate together What about the newbies?

Culture and Leadership

Effective Leadership Set a positive active tone
Think out loud to share the plan – common mental model Continuously invite people into the conversation for their expertise and concern Use their names

Local Leadership by Unit

Psychological Safety GENERATIVE
Organization wired for safety and improvement Primary responsibility of leaders, continuously modeled everywhere. Leaders model and expect the behaviors that promote psychological safety In some units it feels safe to speak up and voice a concern Personality dependent – it depends who I’m working with Fear based – keep your head down and stay out of trouble PROACTIVE Playing offense - thinking ahead, anticipating, solving problems SYSTEMATIC Systems in place to manage hazards REACTIVE Playing defense – reacting to events UNMINDFUL No awareness of safety culture

Psychological Safety Is Local
© 2012 Pascal Metrics

PSYCHOLOGICAL SAFETY CHANGES THIS PARADIGM
We are our own image consultants and best image protectors To protect one’s image, if you don’t want to look STUPID Don’t ask questions INCOMPETENT Don’t ask for feedback In order for the learning system to generate and institutionalize improvements, we need to make sure there is psychological safety. Amy Edmondson states that we are the owners of our image, our own “image consultants”. In order to protect our image we don’t want to look: Stupid; therefore Don’t ask questions Incompetent; therefore Don’t ask for feedback Negative; therefore Don’t be doubtful or criticize Disruptive; therefore Don’t suggest anything innovative When psychological safety exists in a unit or organization, these things don’t exist, and, in fact, aren’t tolerated. Creating psychological safety is one of the critical roles of leaders at all levels of the organization. NEGATIVE Don’t be doubtful or criticize DISRUPTIVE Don’t suggest anything innovative PSYCHOLOGICAL SAFETY CHANGES THIS PARADIGM Source: Amy Edmondson

No one is ever hesitant to voice a concern about a patient
A Culture of Safety No one is ever hesitant to voice a concern about a patient Skilled caregivers playing by the rules feel safe to discuss and learn from errors Concerns raised by front line caregivers are taken seriously & acted upon Action is taken, feedback reliably provided, changes are visible for staff and patients

Why is Culture Important?
Culture reflects the behaviors and beliefs within an organization. There are behaviors that create value individually, for the patient and the organization. There are behaviors that create unacceptable risk. These attitudes and behaviors are reflected in how people interact with each other both internally and externally with patients and their families Culture is the social glue Work as Imagined v. Work as Done

Culture is related to… The teamwork climate domain of the SAQ survey has proved to be an effective predictor of various adverse events and patient satisfaction at the unit level We have data from >40 hospitals demonstrating this remarkable relationship These diagnostic insights point to specific training opportunities that our TEM program systematically address A very important correlations with HCAHPS which in the age of the ACO, has dramatic impact HCAHPS 50 92 Medication Errors per Month 6.1 2.0 Days between C Diff Infections 40 121 Illustrative Data: Extracted from Blinded Client Data Days between Stage 3 Pressure Ulcers 18 52

… and Unfavorable Employee Outcomes
<60% Score = Danger Zone The teamwork climate domain of the SAQ survey has proved to be an effective predictor of various adverse events and patient satisfaction at the unit level We have data from >40 hospitals demonstrating this remarkable relationship These diagnostic insights point to specific training opportunities that our TEM program systematically address A very important correlations with HCAHPS which in the age of the ACO, has dramatic impact Employee Satisfaction 55 91 Employee Injury per 1000 days 16 0.1 Employee Absenteeism per 1000 days 15 10 Illustrative Data: Extracted from Blinded Client Data RN Vacancy Rate 9 1

Wrong Site Surgery or Retained Foreign Body in 17 Operating Rooms

Culture – What is Your Approach?
What instrument do you use? At what level do you measure – hospital v. work setting? What response rate is the desired minimum? Does it accurately reflect the perceptions of caregivers? What is the process of debriefing and addressing the issues raised? How is the process used to build trust, improve culture and drive visible learning? Follow with qualitative assessment and explicit actions

The Value of an Integrated Survey
The SCORE survey measures important dimensions of organizational culture. It evolved from 20 years of experience with the Safety Attitudes Survey and a dozen years of experience with the AHRQ survey. Survey questions need to be both diagnostic and actionable. The insights are critical for organizational improvement and the ability to drive habitual excellence. Specific actions can be taken to leverage organizational strengths and address areas of fundamental opportunity.

All Domains - Hospital-wide

(c) 2013 SCORE Survey Domains Learning Environment – The ability to learn from defects and drive improvement. Perceptions of Local Leadership - management interactions that enable learning, safe systems, and appropriate behavioral choices related to risk and quality. Resilience/Burnout - the shared ability to cope, and the perceived availability of resources related to health and well being. Teamwork - the quality of teamwork and collaboration within a given unit. Safety Climate - the perceived level of commitment to and focus on patient safety within a given unit. Work/Life Balance - is the consensus of people related to self care and human limitations. Engagement – the demands and resources that influence strain and cynicism

Domain - Learning Environment
(c) 2013 Domain - Learning Environment

Learning Environment by Unit
(c) 2013 Learning Environment by Unit

Local Leadership – SCORE Survey

Debriefing – Linking teamwork and Improvement
What did we do well ? What did we learn so we can do it better the next time ? What got in the way that needs to be fixed ?

ICUs that did not DEBRIEF
The Impact Of Acting on Safety Culture Data In Rhode Island ICUs ICUs that DEBRIEFED ICUs that did not DEBRIEF Reflected on culture scores and took action >15% culture score increase in 5/7 domains >10% BSI reduction >15% VAP reduction Did not reflect on SAQ scores nor take action 5% culture score drop in 5/7 domains No reduction in BSIs 5% increase in VAPs * * * Pascal was invited by the state of Rhode Island to improve culture in all its 23 ICUs We measured, mapped safety culture and used the insights to focus on specific culture topics Results: significant improvement in 5 of 6 safety culture domains resulting in significant reductions in BSIs and VAPs Of note: systematically debriefing the safety culture data results in these improvements; measuring is not enough * * Change in survey scores Attribution: M. Vigorito-Cornell et al. Improving safety culture results in Rhode Island ICUs: lessons learned from the development of action-oriented plans. Jt Comm J Qual Patient Saf Nov;37(11):509-14

Effective Teamwork GENERATIVE
Organization wired for safety and improvement Teamwork and continuous learning deeply embedded and central to our culture Teamwork methodically taught and modeled across the organization Training and tools available, partial implementation Focus on teamwork awareness / training in response to adverse events If people would just do their jobs we’d have no problems PROACTIVE Playing offense - thinking ahead, anticipating, solving problems SYSTEMATIC Systems in place to manage hazards REACTIVE Playing defense – reacting to events UNMINDFUL No awareness of safety culture

Teams What Teams Do: Plan Forward
The associated behaviors: Plan Forward Brief (huddle, pause, timeout, check-in) Reflect Back Debrief Communicate Clearly Structured Communication SBAR and Repeat-Back Manage Conflict Critical Language In order to do this teams demonstrate certain behaviors: Plan forward: by briefing or huddling Reflect forward: Debrief Communicate clearly: Using structured communication SBAR and Repeat Back

Courtesy Linda Hummel

Domain: Safety Climate

Safety Climate by Position

Organizational Fairness / Just Culture
GENERATIVE Organization wired for safety and improvement Real events are shared by leaders, true culture of accountability and learning Clear ways to differentiate individual v. system error, safe to discuss mistakes Well understood algorithm, learning is the priority Depends who the boss is, blame and punishment are common Nothing good will come from talking about mistakes PROACTIVE Playing offense - thinking ahead, anticipating, solving problems SYSTEMATIC Systems in place to manage hazards REACTIVE Playing defense – reacting to events UNMINDFUL No awareness of safety culture

Inherent Human Limitations
Limited memory capacity – 5-7 pieces of information in short term memory Negative effects of stress – error rates Tunnel vision Negative influence of fatigue and other physiological factors Limited ability to multitask – cell phones and driving

Drift = Risk 100% Agreement Non - acceptable Usual Space Of Action
VERY UNSAFE SPACE Safety Reg’s & good practices, accreditation standards 100% Expected safe space of action as defined by professional ‘Illegal normal’ Real Life standards 60-90% LOW Individual Benefits HIGH ACCIDENT HIGH Production Performance LOW Attribution: Dr. Rene Amalberti 68

Little Things Can Cause Big Problems
Room 20 Look out the window A simple knee scope He’s OK – he’s not too sedated - you go home What it says on the box is not what’s in the box

Perspectives on Human Error – Sidney Dekker
Old View New View Human error is a cause of trouble You need to find people’s mistakes, bad judgments and inaccurate assessments Complex systems are basically safe Unreliable, erratic humans undermine system safety Make systems safer by restricting the human contribution Human error is a symptom of deeper system trouble Instead, understand how their assessments and actions made sense at the time — context Complex systems are basically unsafe Complex systems are tradeoffs between competing goals — safety v. efficiency People must create safety through practice at all levels Healthcare’s perspective regarding human error and attribution is antiquated, and, frankly, contributes to the current lack of psychological safety and Just Culture in many organizations. The outmoded perspectives include the following: Human error is considered a cause of trouble You need to find people’s mistakes, bad judgments and inaccurate assessments Complex systems are basically safe Unreliable, erratic humans undermine system safety Systems are made safer by restricting human contributions These perspectives ignore some very basic issues inherent to known human limitations, all of which play a role in errors. These include: Humans have a limited memory capacity— our short term memory can only accommodate five-to-seven pieces of information; many times we are trying to remember many more items as we are caring for patients Error rates go up in stressful situations— stress can result in tunnel vision. Humans are prone to: “Errors of commission”, doing something wrong about 3/1000 times. “Errors of omission”, forgetting to check information, look at a patient, turn on a pump –occur at a rate of about 1/100 times – a very powerful argument for checklists. Stressors like fatigue, high workload, or emergencies only increase the error rate. Fatigue and other physiological factors have a negative influence on performance. Twenty-four hours without sleep is equivalent to a blood alcohol of 0.10, which translates to a 30% decrease in cognitive processing. Though skilled clinicians can maintain a significant degree of procedural integrity (placing a central venous line) when fatigued, judgment – the ability to solve complex problems - is seriously impaired. Humans, despite their belief, have a limited ability to multi-task— think of cell phones and driving. The accident rate increases 50% when using a cell phone– worse for texting— a 23-fold increase in traffic accidents! To effectively shift from the old perspectives function to a new way of operation that understands and accounts for human factors, new perspectives and mental models must be learned and ingrained as a context for navigating the complexity of healthcare. The new view, according to Sidney Dekker, includes the following concepts: Human error is a symptom of deeper system trouble Instead of looking for what people “did wrong,” understand how their assessments and actions made sense at the time of the error— context can be critical Complex systems are basically unsafe Complex systems are tradeoffs between competing goals— safety vs. efficiency People must create safety at all levels The Field Guide to Human Error Investigations. Sidney Dekker. © Sidney Dekker Ashgate Publishing Co. Burlington, VT. The following is a summary of the salient features of a strong Just Culture: Caregivers are comfortable speaking up because they know they’ll be treated fairly in the aftermath of an unexpected or bad outcome Caregivers understand they are accountable for their actions They cannot be reckless They must be able to justify the selection of a course of action with likely increased risk Violation of established rules, regulations or policies will be evaluated based on a history of the policy’s effectiveness and a litmus test called The Substitution Test in which an individuals actions are compared to those of other equally trained individuals placed in similar circumstance. Caregivers have confidence that the organization will “go to bat for and with them,” if they are unfairly judged or accused by: The media The Public External regulators Dawson D, Reid K. Fatigue, Alcohol and Performance Impairment. Nature. Vol. 388, July 17, P. 235.

Case One Box of heparin comes to the NICU, says 10 units/ ml on the outside, contains 1000 U/ ml vials Pharmacy tech is great, been there 20 years, “wouldn’t make a mistake” 9 people give 100 times too much heparin to very small children

Organizational Fairness and Professionalism
Initial Step 1 Step 2 Step 3 Step 4 Final Step Allan Frankel Michael Leonard Jo Shapiro Algorithm available on our website

Review events for applicability
Event or Near Event Identify Participants Review Event or Near Event. Reassign participants if evidence of: Malicious Behavior – HR, Legal, Impaired Judgment - CMO, CNO, HR, EAP Unprofessional Behavior – Perform Professional Behavior Evaluation

Step 1: Assign level of intent
Step 1: Assign level of intent: Use best judgment to categorize each action as either Reckless, Risky or Unintentional. The categorization determines the general level of culpability and possible disciplinary actions, however these general categories require further analysis as below prior to making a final decision. RECKLESS ACTION RISKY ACTION UNINTENTIONAL The caregiver knowingly violated a rule and/or made a dangerous or unsafe choice. The decision appears to be self serving and to have been made with little or no concern about risk. The caregiver made a potentially unsafe choice. Their evaluation of relative risk appears to be erroneous. The caregiver made or participated in an error while working appropriately and in the patients' best interests

Step 2: Evaluate system influences
Perform a Substitution Test: Ask or consider whether 3 others with similar skills or in a similar situation would behave or act similarly. Ask whether systems factors were present that would affect all individuals similarly, such as schedules leading inevitably to fatigue, unrealistic expectations regarding memory, inability to effectively follow policies or procedures, an unsafe learning environment, or distractions or interruptions? If "Yes" system influence is likely and warrants evaluation. If "No", continue evaluation of the individual.

Step 3: Assign Behaviors
Step 3: IF RECKLESS: The caregiver is accountable and needs re-training. Discipline may be warranted. If the Substitution Test is positive (others would have performed similarly), then the system supports reckless action and requires fixing. The caregiver is probably less accountable for the action, and system leaders share in the accountability. IF RISKY: The caregiver is accountable and should receive coaching. If the Substitution Test is positive (others would have performed similarly) the system supports risky action and requires fixing. The caregiver is probably less accountable for the action, and system leaders share in the accountability. IF UNINTENTIONAL: Focus for improvement should be on system issues. Coaching and reflection on human factors and personal improvement strategies may be appropriate, especially if the Substitution Test is positive (others would have performed similarly). System leaders are accountable and should apply error-proofing improvements.

Step 4: Promote Learning & Improvement
The caregiver should participate in teaching others the lessons learned. The caregiver should participate in investigating why the error occurred and teach others about the results of the investigation.

Step 5: Evaluate history of unsafe acts
Step 5: Evaluate the individual for a history of unsafe acts Evaluate whether the individual has a history of unsafe or problematic acts. If they do, this may influence decisions about the appropriate responsibilities for the individual i.e. they may be in the wrong job. Organizations should have a reasonable and agreed upon statute of limitations for taking these actions into account.

Case Two A 23 y/o woman is admitted for bowel surgery related to IBD.
Admitted to the hospital bed by the door, her roommate leaves, and she wants to move to the bed by the window. Nurses say yes, but forget to change it in the computer. They anticipate transfusing her during surgery, as she is chronically anemic. Someone comes at 5:00 AM the morning of surgery, doesn’t want to disturb the other patient, doesn’t turn on the light in the room and draws the type and cross on the wrong patient. She is transfused in the OR, wrong blood.

Reliable Processes of Care
GENERATIVE Organization wired for safety and improvement Safety is built at all levels of the organization, continuous risk assessment and learning Active situational awareness leads to early problem detection and resolution Healthcare systems are complex, risk must be actively managed Adverse events stem from human error – who did it? If smart people try hard and know what they’re doing, they won’t make mistakes PROACTIVE Playing offense - thinking ahead, anticipating, solving problems SYSTEMATIC Systems in place to manage hazards REACTIVE Playing defense – reacting to events UNMINDFUL No awareness of safety culture

Process Improvement GENERATIVE
Organization wired for safety and improvement Unit level learning systems, continuous learning aligned with organizational goals Robust unit level learning and improvement is the norm Knowledge of testing, process improvement, collaborative work We try harder after process failures or adverse events Lots of first order problem solving, simple things don’t get fixed PROACTIVE Playing offense - thinking ahead, anticipating, solving problems SYSTEMATIC Systems in place to manage hazards REACTIVE Playing defense – reacting to events UNMINDFUL No awareness of safety culture

Acute Medicines Unit, Ninewells Hospital, Dundee, Scotland Arun Chaudhur, Medical Director
DVT Prescribing Compliance Compliance with Med. Reconciliation O2 Prescribing Early Warning Scores Bundle Hand Hygiene Pressure Ulcer Prevention Bundle Blood Culture Contamination ABX Prescribing Compliance SNAP-CAP

ICU Percent of Patients Receiving all Four Aspects Of Ventilator Bundle
Annotations 1: Marked beds at 30 degree angle 2: Fact Sheet for staff education 3: Poster with weekly data feedback 4: Vent bundle posted in all vent patient rooms 5: Began initial trials of Daily goal sheet and pre-extubation sheet 6: Initiated Powerpoint education for RT/RN 7: Initiated Clinical Pharm rounds 8: 1st test of multidisciplinary rounds 9: Expanded use of Pre-extubation sheet 10: Staff education on Goal sheet; mini inservices on unit on SBT and Pre-extubation sheet 11: Incorporated Goal Sheet into Multidisciplinary Rounds 12: Impact Extravaganza (staff/MD education) 13: Expanded multidisciplinary rounds to include additional disciplines 14: Check compliance on night shift past 2 weeks 15: New sign at HOB, 16: One on one follow up by Nursing & RT managers on collaboratiion in weaning process

Summary The importance of having a framework or roadmap to guide our safety and improvement work. People often don’t know how to move from where they are to where they want to be. Look broadly, act narrowly Remember Edgar Schein: If you want to change behavior, two conditions must be met – be respectful and give people explicit advice. Culture is behavior over time – embed the behaviors that create value in teamwork ( briefing / debriefing) - link the defects and opportunities to the Learning System so the process of learning and improvement is visible and builds trust – then it becomes sustainable.

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