LPCH

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LPCHs Most Excellent Adventure Transitioning to
High Reliability

• Paul Sharek, MD, MPH
• Assistant Professor of Pediatrics, Stanford
  University
• Medical Director of Quality Management
• Chief Clinical Patient Safety Officer
• Vice President of Quality, Safety, and Outcomes
  Management
• Lucile Packard Childrens Hospital

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Opening Remarks

• Thank you for the invitation!
• Honor to come to Childrens Hospital of
  Philadelphia!
• Worked with Annette Bollig (and others at CHOP)
  for years, as well as knowing Ron Karen since
  residency

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The Basics

• Learning objectives
• Understand the rationale for the patient safety
  imperative
• Review concepts of reliability science
• Translate high reliability constructs into
  practical improvement strategies
• Take home messages
• Harm occurs at high frequency in childrens
  hospitals
• Traditional quality improvement strategies will
  only move us to patient safety mediocrity
• Translating high reliability concepts into health
  care will be challenging, but will move us into
  ultrasafe care

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Why should we care about patient safety?

• Institute of Medicine report (1999)
• Data is flat out disturbing
• 44,000-120,000 deaths/yr in US hosp (est)
• 7,000 deaths/yr from medication errors in US
  (est)
• Compared to 45,000 deaths in car accidents
• Costly (LOS, malpractice)
• Lay press/public (credibility)
• Joint Commission
• Medical systems increasingly complex
• Problem aint going away

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Background(Bare with me just a little)
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Adverse Medical Event (AE)

• Adverse Event (AE) - An injury, large or small,
  caused by the use (including non-use) of a drug,
  test, or medical treatment. This may be as
  harmless as a drug rash or as serious as death.
  (modified from IHI definition of an adverse drug
  event or ADE.)

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Harm vs. Error (IHI)

• Error concept of preventability,
  process-focused
• Adverse event harm, outcome focused
• Relationship between errors and adverse events

Adverse Events
Errors
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Pediatrics ADE Rates with Trigger Tool Takata,
Mason, Taketomo, Logsdon, Sharek. Pediatrics
April 2008
960 Pediatric Inpatients 11.1
ADEs per 100 admissions 22x more ADEs than
incident reports
12 of 95 neonatal patients (lt 30 days old) had
an Adverse Drug Event
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74 Adverse Events per 100 admissions
56 of all Adverse Events Preventable
Adverse Events in the NICU setting are
substantially higher than previously described.
Many events resulted in permanent harm, and the
majority were classified as preventable
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PICU Trigger Tool Trial Preliminary Results

• Total Patient Count 734
• Total Triggers 2,816
• Total AEs identified 1,488
• Total Number of Patients with Adverse Events
  455 (62)
• 91 of patients with an AE Identified with a
  Trigger (416/455)
• Number of patients with multiple (gt 1) Unique
  AEs 245 (33)
• Average LOS 7.1 Days

• Average AEs over all Patients 2.03/patient
• Average AEs in patients with adverse events
  3.27 / patient
• Overall AEs per 100 pt. Days 28.6
• Average AEs per Trigger (Positive Predictive
  Value of any given trigger) 0.444
• Average Triggers per Patient 3.84
• Mean Time for Chart Reviews 24.7 minutes (per
  reviewer)

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Average Rate Per Exposure of Catastrophes and
Associated Deaths Per Activity (Reliability)Ama
lberti, et al. Ann Intern Med.2005142756-764
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Strategies to Address Adverse Events

• Practical-Target top offenders
• Rational and Logical
• I contend that this is like being on call,
  putting out fires
• Will get you to 10-2 or 10-3 level of reliability
• Results not impressive nationally

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Are we better off 5 years after IOM???JAMA. 2005
May 182932384-90
Although these efforts are affecting safety at
the margin, their overall impact is hard to see
in national statistics
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Strategies to Address Adverse Events

• Practical-Target top offenders
• Rational and Logical
• I contend that this is like being on call,
  putting out fires
• Will get you to 10-2 or 10-3 level of reliability
• Stretch your mindTo really address pt safety, to
  make a huge impact on patient safety
• shift in philosophy
• paradigm shift
• Look to other complex high risk industries who
  have done this well

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What do you call an organization/industry that is
complex and riskyBut very safe?

• High Reliability Organization

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Definition High Reliability (IHI)

• Failure free operation over time from the
  perspective of the patient.
• Reliability Index
• Unstable process Failure in greater than 20 of
  opportunities
• 10-1 1 or 2 failures out of 10 opportunities
• 10-2 1 failure or less out of 100 opportunities
• 10-3 1 failure or less out of 1,000
  opportunities
• 10-4 1 failure or less out of 10,000
  opportunities
• 10-5 1 failures or less out of 100,000
  opportunities
• 10-6 1 failures or less out of 1,000,000
  opportunities

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Average Rate Per Exposure of Catastrophes and
Associated Deaths Per Activity (Reliability)Ama
lberti, et al. Ann Intern Med.2005142756-764
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Reliability Science

• Principles used to
• Examine complex systems and processes
• Calculate overall reliability
• Develop mechanisms to compensate for limits of
  human ability
• Adopting these principles-increase likelihood
  that the system will perform its intended
  functions reliably. In healthcare
• Help providers minimize defects in care
• Increase consistency in care
• Improve patient outcomes

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Highly Reliable OrganizationsCharacteristics
(Attributes)

• Karl E. Weick, PhD Organizational Psychologist
  University of Michigan

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Attributes of High Reliability Organizations
Weick

• 1. Preoccupation with failure
• 2. Reluctance to simplify interpretations
• 3. Sensitivity to operations
• 4. Commitment to resilience
• 5. Deference to expertise

Weick, et al. Research in Organizational
Behavior. 19992181-123Weick, Managing the
Unexpected Assuring High Performance in an Age
of Complexity, Jossey Bass 2001
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Attributes of High Reliability Organizations
Weick

• 1. Preoccupation with failure
• Small failures are as important as large failures
• Avoid complacency
• Success breeds confidence in a single way of
  doing things and generates complacency
• Ex. My patient has never had a Potassium
  overdose, so why should I change?
• Success narrows perceptions
• Worry about normalization of unexpected events

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Attributes of High Reliability Organizations
Weick

• 2. Reluctance to simplify interpretations
• Closer attention to context leads to more
  differentiation of worldviews and mindsets
• Look for the root cause, not the obvious cause
• Ex. Dumb resident wrote a 10-fold overdose
• Root Cause dumb resident was up all night, in
  ED with seizing kid, called for verbal order,

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Attributes of High Reliability Organizations
Weick

• 2. Reluctance to simplify interpretations
• Differentiation (diverse viewpoints) brings a
  varied picture of potential consequences ? better
  precautions and responses to early warning signs.
• Over dependency on insiders leads to
  simplification
• Ex. Inbreeding at LPCH/Stanford leads to The
  Packard Way

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Attributes of High Reliability Organizations
Weick

• 3. Sensitivity to operations
• Attentive to the front line where the real work
  gets done
• Authority moves toward expertise
• Role of RNs
• Role of Clinical MDs, PNPs
• Role of Parents
• Make continuous adjustments that prevent errors
  from accumulating and enlarging based upon
  reporting from operations, not the master plan

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Attributes of High Reliability Organizations
Weick

• 4. Commitment to resilience
• Develop capabilities to detect, contain, and
  bounce back from those inevitable errors that are
  part of an indeterminate world
• Ex. Trigger tools (and automation)
• A focus on intelligent reaction, improvisation
• Correct errors before they worsen and cause more
  serious harm
• Ex. stop the line

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Attributes of High Reliability Organizations
Weick

• 5. Deference to expertise
• Decisions are made on the front line, and
  authority migrates to the people with the most
  expertise, regardless of their rank
• Avoidance of the structure of deference to the
  powerful, coercive, or senior

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Mindfulness Weick
Together these five processes produce a
collective state of mindfulness. To be mindful
is to have an enhanced ability to discover and
correct errors that could escalate into a crisis.
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Rene Amalberti, MD, PhDCognitive Science
Department, Bretigny-sur-Orge, FranceAmelberti
et al. Ann Intern Med 2005142756-764
the most important difference among
industrieslies in their willingness to abandon
historical and cultural precedent and beliefs
that are linked to performance and autonomy, in a
constant drive toward a culture of safety
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How do you translate all of this theoretic
garbage?

• A few ideas from Paul

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Pauls Practical Solutions to Move Toward High
Reliability in Healthcare

• Zero defect philosophy
• Defects in care not accepted as inevitable
• Stop the line
• Responsibility to stop dangerous processes and
  fix
• Systems thinking
• Systems and processes drive outcomes
• Standardization
• Checklists, boarding passes, order sets
• Data driven
• Data driven and evidenced based decision making
• Technology Tools for supporting ideal processes

• Leadership
• Patient first mantra
• Organizational clarity
• Mission statement
• Goals/incentives aligned
• Human factors integration
• Fatigue, staffing ratios, labels
• Culture
• patients first, collegiality, communication,
  reporting
• Simulation
• Prepare in advance for high risk situations

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Transitioning Toward High Reliability the LPCH
Experience

• Zero defect philosophy
• Defects in care not accepted as inevitable
• Stop the line
• Responsibility to stop dangerous processes and
  fix
• Systems thinking
• Systems and processes drive outcomes
• Standardization
• Checklists, boarding passes, order sets
• Data driven
• Data driven and evidenced based decision making
• Technology Tools for supporting ideal processes

• Leadership
• Patient first mantra
• Organizational clarity
• Mission statement
• Goals/incentives aligned
• Human factors integration
• Fatigue, staffing ratios, labels
• Culture
• patients first, collegiality, communication,
  reporting
• Simulation
• Prepare in advance for high risk situations

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Example 1 Transitioning to High Reliability _at_
LPCHOperationalizing Simulation
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How do we do it at LPCH?What is CAPE (Center
for Advanced Pediatric Education)?

• a physical space at LPCH equipped to simulate
  any pediatric or obstetric healthcare
  environment
• real working medical equipment
• realistic human patient simulators
• AV gear to record and play back all events
  occurring during scenarios

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CAPE program development since 1995

• NeoSim,
• SimTrans Neonatal
• OB Sim,
• FetalSim,
• Sim DR
• PediSim,
• Pediatric Office Emergencies
• Disclosing Unanticipated Consequences,
• Delivering Bad News,
• Perinatal Counseling
• NALS/PALS

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Patient Safety Oversight CommitteeLPCH
Patient Safety Oversight Committee P-SOC
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Taking the plunge

• Membership of P-SOC recommend operationalizing
  simulation at LPCH
• Partnership with Risk Management
• Self insured
• Invest in simulation
• Recommendation construct a 3-5 year strategic
  plan to transition from traditional didactic
  educational model to an active, simulation based
  model

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Moving Closer to High Reliability The Circle
of Safety _at_ LPCH
drills _at_ LPCH
care of real patients
Senior leadership, Risk Quality/Patient safety
dept
dedicated time _at_ CAPE
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Operationalization Step 1
1. Multi-disciplinary team training (NICU OB)
in Delivery Room
2. ECMO simulation (initiating/changing circuits)
3. Interpersonal communication in stressful
situations
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Pauls Practical Solutions to Move Toward High
Reliability in Healthcare

• Zero defect philosophy
• Defects in care not accepted as inevitable
• Stop the line
• Responsibility to stop dangerous processes and
  fix
• Systems thinking
• Systems and processes drive outcomes
• Standardization
• Checklists, boarding passes, order sets
• Data driven
• Data driven and evidenced based decision making
• Technology Tools for supporting ideal processes

• Leadership
• Patient first mantra
• Organizational clarity
• Mission statement
• Goals/incentives aligned
• Human factors integration
• Fatigue, staffing ratios, labels
• Culture
• patients first, collegiality, communication,
  reporting
• Simulation
• Prepare in advance for high risk situations

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Example 2 Transitioning to High Reliability _at_
LPCHRapid Response Team Implementation
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Prelude Literature at the Time of Addressing
Codes Outside of ICU

• 6 to 8 hour period of escalating instability that
  precedes nearly every cardiopulmonary arrest
• Many causative physiological processes prior to
  an arrest are treatable
• Post-cardiac arrest survival
• 24 hour survival 33-36
• Survival to discharge 24-27
• 1 year survival 15,

Reis, et al. Pediatrics.2002109200-209 Nadkar
ni et al. JAMA.200629550-57 Young et al.
Annals of Emerg Med. 199933195-205
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Chapter 4 of our talePanic in Palo Alto The
Hero Gets Desperate
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New Literature Emerging
Medical Emergency Team coincident with a
reduction of cardiac arrest and mortality
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Results Codes Outside of the ICUAbsolute Number
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Results Codes Outside of ICURate (per 1000 pt
days)
P lt 0.01
Decrease of 71
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Mortality Rate-Housewide
34 kids lives saved in 19 mo!
18 reduction
p lt 0.01
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Our Contribution to the Literature
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Pauls Practical Solutions to Move Toward High
Reliability in Healthcare

• Zero defect philosophy
• Defects in care not accepted as inevitable
• Stop the line
• Responsibility to stop dangerous processes and
  fix
• Systems thinking
• Systems and processes drive outcomes
• Standardization
• Checklists, boarding passes, order sets
• Data driven
• Data driven and evidenced based decision making
• Technology Tools for supporting ideal processes

• Leadership
• Patient first mantra
• Organizational clarity
• Mission statement
• Goals/incentives aligned
• Human factors integration
• Fatigue, staffing ratios, labels
• Culture
• patients first, collegiality, communication,
  reporting
• Simulation
• Prepare in advance for high risk situations

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Example 3 Transitioning to High Reliability at
LPCHTransparency
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Transparency of outcomes Internal Performance
Information Flow
Medical Board
Governing Board
Environment of Care Committee
Quality Service and
Safety Committee
OR Committee
Critical Care
Committee
Patient Safety
Committee
LPCH Infection
Quality
Control Committee
Improvement
Code Committee
Committee
Patient Safety Oversight Committee
Care Improvement
Committee
Faculty Practice Org
Pharmacy and
Quality Committee
Therapeutics Committee
Patient Progression Committee
Sanctioned Projects
Patient Care QI Committee
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Transparency of outcomes-Internal Indicator
Sheets
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Transparency of outcomes-Internal Dashboard
Central Catheter Associated Infections in NICU ?

• Rating
• Compared to benchmark or historical mean
• Range poor ? to excellent ?
• Change
• Internal comparison
• Review status of past 12 months compared to
  previous 12 mos
• Range worse, unchanged, better

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Just why do we want to be transparent again???

• Provide our patients and community with good
  information to make informed decisions about a
  childs or expectant mother's health care
• Offer honest and accurate data about the quality
  of services we provide
• Be leaders and proactive in the data transparency
  movement
• Hold ourselves accountable for providing high
  quality and safe care

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Findings from Dartmouth-Hitchcock(10/2005)
Healthcare systems have the opportunity to 1)
be proactive and accountable for the healthcare
that they provide 2) help patients learn more
about their conditions 3) use public reporting
to foster quality improvement
Journal on Quality and Patient Safety. October
2005, pages 573-584.
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NEJM February, 1 2007
As compared to the control group (n406), P4P
hospitals (n207) showed greater improvement in
all measures of quality After adjustments were
made for differences in baseline performance and
hospital characteristics, P4P was associated with
sig improvements over the 2 year period
Hospitals engaged in both public reporting, and
P4P achieved modestly greater improvements in
quality than did hospitals engaged only in public
reporting
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Characteristics of AMCs with High
QualityUniversity Healthcare Consortium study

• Shared Sense of Purpose
• Patient Care is first among the 3 missions
• Quality, Service, and Safety central to
  competitive advantage
• Leadership Style
• CEO passionate about Quality, Service, and Safety
• Leadership (admin and medical) authentic hands on
  style
• Accountability System for Service, Quality,
  Safety
• Responsibility for S/Q/S at every level
• Central measures, local implementation efforts
• A Focus on Results
• Measure and benchmark ALWAYS
• Data transparency (drives accountability)
• Action oriented, all problems fixable
• Collaboration
• MD, RN, and administration all work together
• Staff input, regardless of rank, always considered

Source Building a Culture of Quality and Safety
Organizational Characteristics Associated with
Superior Performance in Quality and Safety, 9/05
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Conclusions

• Adverse Events in hospitals occur frequently
• Targeted interventions for high frequency events
  valuable, but wont move organizations past
  mediocrity
• To make quantum leaps in quality and patient
  safety
• Use tenets of reliability science
• Integrate attributes of highly reliable
  organization
• Understand and overcome the barriers to high
  reliability in health care
• And remember