Reducing Errors Reducing Errors Preventing InjuryPreventing Injury Saving Lives Saving Lives

Peggy G. Duke, M.D.

Associate Professor Emeritus,

Department of Anesthesiology

Division of Cardiothoracic Anesthesiology

Emory University School of Medicine

September 15, 2015

Developing A Culture of Safety Developing A Culture of Safety Easy to say, hard to doEasy to say, hard to do

At the most fundamental level reducing errors in medicine requires a shift in paradigm

Unwavering commitment and accountability

Organization’s leadership CEO, COO, CFO

Physician leadership

Nursing leadership

Departmental Chiefs

Frontline personnel

Physician role in changing the culturePhysician role in changing the culture

Acquiring new knowledge & skill sets

Assuming leadership roles in quality initiatives

Making practice changes based on new knowledge

Monitoring changes and revising when necessary

Working collaboratively with administrative, quality team departmental, nursing and frontline personnel

Helping develop evidence-based safety-driven protocols

In MedicineIn Medicine

Physicians lack of ownership of quality initiatives

In building and sustaining a culture of safety

Errors Occur Worldwide with Alarming FrequencyErrors Occur Worldwide with Alarming Frequency

Physicians, nurses, patients, all healthcare personnel, and hospital leaders need to

Grasp the scale of the problemAccept that errors are commonUnderstand the need to change to a culture that

views errors not as human failures but as opportunities to improve a faulty system

Institute of Medicine (IOM) 1999Institute of Medicine (IOM) 1999

1. 100,000 patients die in US hospitals annually as a result of medical errors

2. ~1 million excess injuries

3. 70% of the adverse events are likely preventable

4. Problem of accidental injury is serious

5. Cause is not careless people but faulty systems

6. Priority: redesign our systems to reduce errors

7. Patient safety must become a priorityTo Err is Human: Building a Safer Health SystemKohn LT, Corrigan JM, Donaldson MS, eds.

Washington, DC: National Academy Press; 1999.

Major Points

Annualized estimate of drug related errors Annualized estimate of drug related errors resulting in additional care in US resulting in additional care in US

(includes non-hospital care, office visits, etc.) (includes non-hospital care, office visits, etc.)

116 million extra visits to a physician

76 million additional prescriptions

17 million ER visits

8 million admissions to hospital

3 million admissions to long term care

199,000 additional deaths

Total cost $76.6 billion/year

Am J Health Syst Pharm. 1997 Mar 1; 54(5):554-8

2013 2013 Estimated patient harm in US hospitalsEstimated patient harm in US hospitals

Preventable

Deaths > 400,000/year

Serious harm > 4 - 8 million /year

Evidence-based estimate of patient harmIn US hospitalsJames; J Patient Safety 2013; 9: 122-128

Errors are underestimated Errors are underestimated

Many errors do not produce injury

Some errors are caught before reaching patient

Many patients are incredibly resilient

Sometimes we---patient & clinician-- get lucky

X

4-8 X

Medical errors occur Medical errors occur Worldwide Worldwide

With alarming frequencyWith alarming frequency In all settings In all settings

Cause serious harm or deathCause serious harm or death

Estimated that 10-20% of all health care encounters result in harm to patients

Basic Concepts of Human ErrorBasic Concepts of Human ErrorReason, JT Reason, JT

1990 Cambridge, England: 1990 Cambridge, England: Cambridge University Press Cambridge University Press

Errors inevitable part of being human

Errors are made by highly skilled, highly intelligent, conscientious professionals who hold themselves to very high standards

Error primarily results from latent errors caused by flaws in systems processes:

Design

Organization

Training

Management

Common Types of Human Errors Common Types of Human Errors Omission = failure to do

Missed diagnosis

Delayed evaluation

Failure to prescribe needed drug

Inadequate evaluation for respiratory depression

Commission = doing the wrong thing

Giving wrong drug

Operating on wrong side

Ordering wrong drug/wrong dose

Giving opioid to patient with undiagnosed respiratory depression

Communication

Failure to give vitally important information, i.e., allergy, last dose of antibiotic, difficult airway

FatigueDistractionsFear tospeak up

Lack of leadershipat CEO & other levelsUnderstaffingInadequate equipmentLack of resourcesLack of physician engagement

…Poorly designed processes…

Inconsistent expectations

InexperiencePoorly trained

Creating fear Gave wrong drugForgot crucial detail at handoffGave wrong bloodForgot to do diabetic foot , eye exam

Inadequate monitoring for respiratory depression

Incorporate proven safety Incorporate proven safety principlesprinciples

Train staff Principles of human error

Quality improvement techniques & approaches

Practice evidence-based or evidence-informed medicine

Harness the use of forcing functionse.g., e-prescribing with alerts and other computer assisted functions

Design team-based, protocol-driven approachesEspecially important in highly complex environments

Incorporate proven safety Incorporate proven safety principlesprinciples Standardize

equipment, supplies, & processes

Establish interdisciplinary teams discuss safety issues & problems in work environmentUnderstand your work environment

where are the breakdowns, bottlenecks, dangers?Remove fear

everyone should feel safe to speak up when concerned Stop “blame the person” mentalitySystematically design safety into processes of care

Incorporate proven safety Incorporate proven safety principlesprinciples

Develop checklists for handoffsRead out loud, in order, check off as acknowledged

Develop surgery & procedural checklistsRead out loud, in order, check off as acknowledged

Identify and communicate critical situations with “Repeat Back to Verify” similar to airline safety instructions

RUNWAY SAFETY: A Best Practices Guideto Operations and Communications “Do not acknowledge the ATC instructions or clearances by using your call sign and saying “Roger” or “Wilco” –

Instead read back the entire instruction or clearance including the runway designator and aircraft call sign.”

Managing Human ErrorsManaging Human Errors Blame the person (Traditional approach) AKA “Naming, blaming & shaming”

Systems Approach Assume faulty system design

Errors seen as caused by individuals

CarelessnessInattentionPoor motivationForgetfulnessPoor training

Errors seen as upstream system process design flawsLook for weak linksAdd barriers to reduce chance of human error

Accepts fact that one cannot change the human condition

Traditional approach has and will continue to fail to reduce human errors

"Insanity: doing the same thing over and over again and expecting different results.” Albert Einstein

Work in collaborative multidisciplinary teamsAnalyze the process Determine weak links Determine bottlenecks Determine high risk areas

Reduces errors & can lead to sustained changeStrong support & hard work can lead to a change in culture Culture of Safety >>>>>Just Culture

Management strategy Write more policiesPoster campaignsDisciplinary actionsRe-trainFire the individual

Support multidisciplinary teamsTeach human error theoryTeach systems approach

Change the conditions under which humans workDesign strategies/defenses to avoid/avert errors or mitigate their impact

Medical care: very complex chain of processes Aim to improve patients’ health and well being

Each link in chain can be associated with No problem Intermittent problems Variation Near misses (recognized or not recognized)

Safe throughput requires Knowing where the weak links, high risk areas and

dangers are Having systems’ barriers that reduce likelihood of errors

Healthcare is more complex than any other industryHealthcare is more complex than any other industry

Overwhelming ongoing increase in knowledge

Technology increasing in complexity

Procedures increasingly more complex

Less continuity of care in hospitals; multiple teams deliver care

More handoffs: each handoff increases likelihood of error

Multi-tasking Interruption-driven environment Increasingly older, high acuity patients with little reserve

Pressure to perform more, faster and with less support

One person providing care for multiple patients

Errors occur more commonlyErrors occur more commonly

When clinicians are inexperienced

New procedures are introduced

Patients at extremes of age—(perhaps not more errors, just less resilient )

Patients requiring complex care

Prolonged hospital stays

Highly technical areas, i.e., OR, ICU, ER

In highly technical surgical procedures, i.e., cardiac

surgery, neurosurgery, robotic surgery

You Don’t Have to Reinvent the WheelYou Don’t Have to Reinvent the Wheel

Much work already done

Start with already identified error prone areasMedication

Surgery

ICUs

Handoffs

Research: lots of data about how to begin

Checklists

Computerized forcing functions

Computerized physician order entry

Team developed protocols

How might we apply error reducing principles to How might we apply error reducing principles to an often overlooked but deadly probleman often overlooked but deadly problem

In-Hospital Cardiopulmonary Arrests (IHCA)

Specifically addressing a huge subset of IHCA

Postoperative Opioid Induced Respiratory Depression

In-Hospital Cardiopulmonary ArrestsIn-Hospital Cardiopulmonary Arrests(IHCA)(IHCA)

Up to 750,000 cardiopulmonary arrests annually in US hospitals

~ 80% of arrest victims do not survive to discharge

Studies show ~ 50% of those patients had been given opioids

Opioid induced respiratory depression

insidious

hard to diagnose using current technology

can lead to death or anoxic brain injury

occurs in very healthy patients

Overdyk, Guerra

American Nurse Today

6(1):November 2011, 26-31

Consider: The SubsetConsider: The SubsetPost-operative Opioid-Induced Respiratory Depression (POIRD) Post-operative Opioid-Induced Respiratory Depression (POIRD)

3rd most common in-patient safety related error

>50 % postoperative respiratory events thought to be caused by opioids

Each institution’s incidence may seem low--- BUT--- that is misleading

~48 million in-patient procedures in US

Absolute number of POIRD events is significant

Unexpected death or brain injury can occur in even healthiest patients

Worse outcomes for respiratory events that occur on general nursing floor

Likely related to intermittent monitoring

Undetected respiratory compromise

Additional IV opioids +/- sedatives

No significant change in patient outcome in past 40 years

POIRDPOIRD

2011 Our goal: “No Patient Shall Be Harmed By

Opioid-Induced Respiratory Depression” Dr. Stoelting, President

Anesthesia Patient Safety Foundation (APSF)

2015 Anesthesiology, Closed Claims Analysis: POIRD

Conclusion:

Multifactorial

88% occur within first 24 hours of surgery

Most events are preventable with improvements in

Assessment of sedation/consciousness level

Monitoring of oxygenation

Monitoring of ventilation

Early response & intervention

Closed Claims AnalysisClosed Claims Analysis March 2015 Anesthesiology Lee, CaplanMarch 2015 Anesthesiology Lee, Caplan

Medication factors

% Claims

Peripheral nerve blocks

0

Opioid given via > 1 modality

50%

Continuous opioid infusion

50%

Opioids + concurrent non-opioid sedating drug

33%

Multiple physicians ordering opioids +/- sedating drugs

33%

Excessive doses rarely the cause

%Claims Timing of event

88% Within 24 hours of surgery

13% Within 2 hours of D/C from PACU

% Claims Monitoring at time of event

50% No respiratory monitors

33% Non-telemetric SPO2

Example:Example:Tragic Error from 2015 Tragic Error from 2015 Closed Claims AnalysisClosed Claims Analysis

1st postop day: Obese, otherwise healthy 46 year old male Described as sleepy, slow to arouse, snoring loudly

SPO2 read 49% on room air

oxygen cannula replaced, SPO2 soon 93%

Described as being without complaints

24 minutes later found apneic

Full code called

Died few days later with anoxic brain injury

We Cannot Continue As UsualWe Cannot Continue As Usual

Large numbers of patients are still being harmed by postoperative opioids

POIRD often leads to death or anoxic brain injury

No change in patients’ outcomes for past 40 years

Monitoring SPO2 on general nursing floors is intermittent, if done at all

Monitoring respiratory rate alone is not adequate

Clinicians should be made awareClinicians should be made aware

SPO2 is a monitor of oxygenation not ventilation

SPO2 can be misleading when a patient is on supplemental oxygen

SPO2 monitors are known to have significant number of false alarms

ETCO2 is misleading and inadequate in non-intubated patients

Respiratory rate does not detect inadequate ventilation

Monitoring ventilation

Tidal volume, minute ventilation and respiratory rate would be ideal

What Safety Lessons Can Be Learned from the What Safety Lessons Can Be Learned from the Closed Claims Analysis DataClosed Claims Analysis Data

Patients on opioids post operatively are high risk for POIRDContinuously monitor oxygenation and ventilation

via telemetry or direct nurse call system

Use non-opioids analgesia when possible

peripheral nerve blocks

acetaminophen

ketorolacDevelop protocols that

Provide oversight by one physician-led team With same goals & knowledge of patient For ordering opioids For ordering sedating drugs

Do not allow opioids by more than one route i.e., if using PCA, do not give additional opioid IV push

Reducing Errors in MedicineReducing Errors in MedicineRequires Engaged PhysiciansRequires Engaged Physicians

Leaders, Champions, and Supporters Leaders, Champions, and Supporters

“Shake Up” the status quo

Look at the data

Understand human error theory

Understand your system processes

Work in collaborative, multidisciplinary teams

administration, nursing, physician, quality, etc.

Help develop & support processes, protocols that drive safety

“Walk the Talk”, i.e., do what you ask others to do

Physicians have the power to lead, change, and sustain a Culture of Safety

Culture of Safety Implies aCulture of Safety Implies a Just Culture Just Culture

Just Culture-------Trust is essential componentCollective understanding of where the line should be drawn between blameless and blameworthy actions.

Accepts that< 10% of errors are culpable> 90% of errors are systems’ flaws

Can be reported without concern for reprisal or sanctions

Reduces fear in reportingAllows learning from errors, near missesProvides data to improve processes

Data and Data AnalysisData and Data Analysis

Gather data about incidents and near-misses

Gather data about all cardiopulmonary arrests

Categorize & manage harm with severity assessment systems

Conduct Root Cause Analysis (RCA) to find sources of errors

Create opportunities for learning from errors and near misses

Establish Clinical Pathways, (evidence-based, standardized patient management)

Establish protocols for high risk situations

Building a Safe EnvironmentBuilding a Safe Environment

Accept as a given:One cannot change the human predisposition to make errors

Know the possibilities:One can change the conditions under which humans work and reduce errors in the delivery of healthcare

It is Also About You, Me, and It is Also About You, Me, and Those We LoveThose We Love

The urgency to decrease errors in healthcare should be readily recognized by anyone who:

is likely to require care sometime in the future

is aging

or both

That anyone is each one of us & our loved ones

Reducing Medical Errors A Marathon, Not a Sprint

24 hrs./day X 7 days/week X 52 weeks/year

ReferencesReferences1) Kohn, Corrigan, etal, eds, To Err is Human: Building a Safer Health System, Washington, DC: National Academy Press; 1999.

2) Am J Health Syst Pharm. 1997 Mar 1; 54(5):554-8

3) James; Evidence-based estimate of patient harm, In US hospitals, J Patient Safety 2013; 9: 122-128

4) Reason, JT , 1990 Cambridge, England:, Cambridge University Press

5) Anesthesiology 2010 POIRD-

6) Lee, Caplan, 2015 Anesthesiology, Postoperative Opioid-Induced Respiratory Depression, Closed Claims Analysis

7) Fecho K, Jackson F, Smith F, Overdyk FJ. In-hospital resuscitation: opioids and other factors influencing survival.

Ther Clin Risk Manag. 2009;5:961-968.

8) Brady WJ, Gurka KK, Mehring B, Peberdy MA, O’Connor RE; American Heart Associations’ Get with the Guidelines (formerly, NRCPR) Investigators. In-hospital cardiac arrest: impact of monitoring and witnessed event on patient survival and neurologic status at hospital discharge. Resuscitation. 2011;82(7):845-852.

9) HealthGrades. The Sixth Annual HealthGrades Patient Safety in American Hospitals Study. http://www.healthgrades.com/business/img/PatientSafetyInAmericanHospitalsStudy 2009.pdf. Accessed August 22, 2012.

10) Overdyk FJ. Postoperative opioids remain a serious patient safety threat. Anesthesiology. 2010;113(1):259-260.

11) Peberdy MA, Ornato JP, Larkin GL, et al. Survival from in-hospital cardiac arrest during nights and weekends. JAMA. 2008; 299(7):785-792.

12) HodgettsTJ,KenwardG,Vlackonikolis,I , etal .Incidence,location and reasons for avoidable in-hospital arrest in a district general hospital. Resuscitation. 2002;54(2):115-123.