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LPCH’s 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 Children’s Hospital
0
Opening Remarks
 Thank you for the invitation!
 Honor to come to Children’s Hospital of Philadelphia!
 Worked with Annette Bollig (and others at CHOP) for years, as
well as knowing Ron Karen since residency
1
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 children’s 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
2
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 ain’t going away
3
Background
(Bare with me just a little…)
4
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.)
5
Harm vs. Error (IHI)
 “Error”: concept of preventability, process-focused
 “Adverse event”: harm, outcome focused
 Relationship between errors and adverse events
Adverse
Events
6
Errors
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” (< 30
days old) had an Adverse Drug Event
7
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…
8
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
(> 1) Unique AEs: 245 (33%)
 Average LOS: 7.1 Days
9
 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)
Average Rate Per Exposure of Catastrophes and
Associated Deaths Per Activity (“Reliability”)
Amalberti, et al. Ann Intern Med.2005;142:756-764
10
Strategies to Address Adverse Events
 Practical-Target top offenders




11
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…
Are we better off 5 years after IOM???
JAMA. 2005 May 18;293:2384-90
“…Although these efforts are affecting safety
at the margin, their overall impact is hard to
see in national statistics”
12
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 mind…To 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
13
What do you call an organization/industry
that is complex and risky…
But very safe?
High Reliability Organization
14
Definition: High Reliability (IHI)
 Failure free operation over time from the perspective of the
patient.
 Reliability Index:







15
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
Average Rate Per Exposure of Catastrophes and
Associated Deaths Per Activity (“Reliability”)
Amalberti, et al. Ann Intern Med.2005;142:756-764
16
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 it’s intended functions reliably. In healthcare:
 Help providers minimize defects in care
 Increase consistency in care
 Improve patient outcomes
17
Highly Reliable Organizations
Characteristics (Attributes)
Karl E. Weick, PhD Organizational Psychologist
University of Michigan
18
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
19
Weick, et al. Research in Organizational Behavior. 1999;21:81-123
Weick, Managing the Unexpected: Assuring High Performance in an Age of
Complexity, Jossey Bass 2001
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
20
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, …
21
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…”
22
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”
23
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”
24
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
25
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.”
26
Rene Amalberti, MD, PhD
Cognitive Science Department, Bretigny-sur-Orge, France
Amelberti et al. Ann Intern Med 2005;142:756-764
…the most important difference among
industries…lies 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…
27
How do you translate all of this theoretic
garbage?
A few ideas from Paul…
28
Paul’s Practical Solutions to Move Toward High Reliability
in Healthcare
 Leadership
 Zero defect philosophy
 Organizational clarity
 Stop the line
 Human factors integration
 Systems thinking
 Culture
 Standardization
 “Patient first” mantra
 Mission statement
 Goals/incentives aligned
 Fatigue, staffing ratios, labels
 “patients first”, collegiality,
communication, reporting
 Simulation
 Prepare in advance for high risk
situations
Defects in care not accepted as inevitable
Responsibility to stop dangerous processes
and fix
Systems and processes drive outcomes
Checklists, boarding passes, order sets
 Data driven
Data driven and evidenced based decision
making
 Technology: Tools for supporting ideal
processes
29
Transitioning Toward High Reliability: the LPCH Experience
 Leadership
 Zero defect philosophy
 Organizational clarity
 Stop the line
 Human factors integration
 Systems thinking
 Culture
 Standardization
 “Patient first” mantra
 Mission statement
 Goals/incentives aligned
 Fatigue, staffing ratios, labels
 “patients first”, collegiality,
communication, reporting
 Simulation
 Prepare in advance for high risk
situations
Defects in care not accepted as inevitable
Responsibility to stop dangerous processes
and fix
Systems and processes drive outcomes
Checklists, boarding passes, order sets
 Data driven
Data driven and evidenced based decision
making
 Technology: Tools for supporting ideal
processes
30
Example 1: Transitioning to High Reliability @ LPCH
Operationalizing Simulation
31
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
32
CAPE: program development since 1995












33
NeoSim,
SimTrans Neonatal
OB Sim,
FetalSim,
Sim DR
PediSim,
Pediatric Office Emergencies
Disclosing Unanticipated Consequences,
Delivering Bad News,
Perinatal Counseling
NALS/PALS
…
Patient Safety Oversight Committee
LPCH
LPCH Board of Directors
CEO
Chief Risk Officer
COO
Chief of Surgery
Chief of Staff
VP Patient Care Services
Director of Quality
Patient
Safety
Oversight
Committee
“P-SOC”
34
Pt Safety Program Manager
Chief Clinical Pt Safety Officer
Medical Director of Quality
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”
35
Moving Closer to High Reliability:
The “Circle of Safety” @ LPCH
drills @ LPCH
dedicated time @ CAPE
36
care of real patients
Senior leadership, Risk
Quality/Patient safety dept
Operationalization: Step 1
Feasibility of project
(i.e. ability to move
all necessary people
Severity of
Frequency of
thru sim program)
Adverse Events (1-5) Adverse Events (1-5)
1: extremely difficult
1: no harm
1: rare
2: difficult
2: mild, temporary harm
2: infrequent
3: reasonable
3: permanent harm
3: moderate
4: severe permanent harm 4: easy
4: frequent
5: very easy
5: death
5: very common
1. Multi-disciplinary team training (NICU +
OB) in Delivery Room
Simulation Program opportunities
available at CAPE
1) multidisciplinary team training in the delivery room
(operationalization of CAPE’s NeoSim
+ OB Sim programs)
2. ECMO simulation (initiating/changing
circuits)
2) sentinel event mitigation
3. Interpersonal communication in
stressful situations
4) interpersonal communication in stressful situations
3) disclosure of unanticipated outcomes
5) ECMO team training for CVICU, PICU, NICU
(operationalization of CAPE’s ECMO Sim program)
6) Sedation management throughout LPCH
37
MD Champion
1: none
2: yes but not
influential
3: yes and influential
Paul’s Practical Solutions to Move Toward High Reliability
in Healthcare
 Leadership
 Zero defect philosophy
 Organizational clarity
 Stop the line
 Human factors integration
 Systems thinking
 Culture
 Standardization
 “Patient first” mantra
 Mission statement
 Goals/incentives aligned
 Fatigue, staffing ratios, labels
 “patients first”, collegiality,
communication, reporting
 Simulation
 Prepare in advance for high risk
situations
Defects in care not accepted as inevitable
Responsibility to stop dangerous processes
and fix
Systems and processes drive outcomes
Checklists, boarding passes, order sets
 Data driven
Data driven and evidenced based decision
making
 Technology: Tools for supporting ideal
processes
38
Example 2: Transitioning to High Reliability @ LPCH
Rapid Response Team Implementation
39
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.2002;109:200-209
**Nadkarni et al. JAMA.2006;295:50-57
***Young et al. Annals of Emerg Med. 1999;33:195-205
40
Chapter 4 of our tale…
“Panic in Palo Alto: The Hero Gets Desperate”
Codes Outside of ICU LPCH:
Jan 2001 thru Sep 2005
CT Surgery service
7
Number of Codes
6
Education
5
CHCA handoffs
collaborative (1/04)
Hospitalists 7/03
4
3
2
41
Q
1
07
Q
3
06
Q
1
06
Q
3
05
05
Q
3
04
Q
1
04
Q
3
03
Q
1
Patient progression
(8/03)
03
Q
3
02
Q
1
02
Q
3
01
01
Q
1
0
Q
1
1
New Literature Emerging
…Medical Emergency Team coincident with a
reduction of cardiac arrest and mortality…
42
Results: Codes Outside of the ICU:
Absolute Number
Codes Outside of ICU LPCH:
Jan 2001 thru March 2007
7
Rapid Response
Team 9/05
Number of Codes
6
5
4
3
2
1
43
Q
1
07
Q
3
06
Q
1
06
Q
3
05
Q
1
05
Q
3
04
Q
1
04
Q
3
03
Q
1
03
Q
3
02
Q
1
02
Q
3
01
01
Q
1
0
Results: Codes Outside of ICU:
Rate (per 1000 pt days)
Codes Outside of ICU Rate
Code Rate (per 1000 eligible pt days)
2.00
1.80
Mean Code Rate 0.52
Baseline Pre-RRT period
Mean Code Rate 0.15
Post- RRT period
1.60
1.40
1.20
1.00
0.80
0.60
0.40
0.20
0.00
Ja
n0
Ap 1
r- 0
1
Ju
l-0
O 1
ct
-0
Ja 1
n0
Ap 2
r- 0
2
Ju
l-0
O 2
ct
-0
Ja 2
n0
Ap 3
r- 0
Ju 3
l-0
O 3
ct
-0
Ja 3
n0
Ap 4
r- 0
4
Ju
l-0
O 4
ct
-0
Ja 4
n0
Ap 5
r- 0
5
Ju
l-0
O 5
ct
-0
Ja 5
n0
Ap 6
r- 0
Ju 6
l-0
O 6
ct
-0
Ja 6
n07
P < 0.01
Decrease of 71%
44
Mortality Rate (per 100 admissions)
45
2.0
1.8
1.6
1.4
1.2
1.0
0.8
0.6
0.4
0.2
0.0
18% reduction
p < 0.01
Mar-07
Jan-07
Nov-06
Sep-06
Jul-06
May-06
Mar-06
Jan-06
Baseline Pre-RRT period
Nov-05
Mean Mortality Rate 1.01
Sep-05
Jul-05
May-05
Mar-05
Jan-05
Nov-04
Sep-04
Jul-04
May-04
Mar-04
Jan-04
Nov-03
Sep-03
Jul-03
May-03
Mar-03
Jan-03
Nov-02
Sep-02
Jul-02
May-02
Mar-02
Jan-02
Nov-01
Sep-01
Jul-01
May-01
Mar-01
Jan-01
Mortality Rate-Housewide
Hospital-Wide Mortality Rate
Mean Mortality Rate 0.83
34 kids lives saved in 19 mo!
1.01
Post-RRT period
Our Contribution to the Literature
46
Paul’s Practical Solutions to Move Toward High Reliability
in Healthcare
 Leadership
 Zero defect philosophy
 Organizational clarity
 Stop the line
 Human factors integration
 Systems thinking
 Culture
 Standardization
 “Patient first” mantra
 Mission statement
 Goals/incentives aligned
 Fatigue, staffing ratios, labels
 “patients first”, collegiality,
communication, reporting
 Simulation
 Prepare in advance for high risk
situations
Defects in care not accepted as inevitable
Responsibility to stop dangerous processes
and fix
Systems and processes drive outcomes
Checklists, boarding passes, order sets
 Data driven
Data driven and evidenced based decision
making
 Technology: Tools for supporting ideal
processes
47
Example 3: Transitioning to High Reliability at LPCH
Transparency
48
Transparency of outcomes: Internal
Performance Information Flow
Governing Board
Medical Board
Quality Service and
Safety Committee
Environment of Care
Committee
OR Committee
Critical Care
Committee
Patient Safety
Committee
Code Committee
Quality
Improvement
Committee
Patient Safety Oversight
Committee
Care Improvement
Committee
Faculty Practice Org
Quality Committee
Pharmacy and
Therapeutics Committee
Patient Progression
Committee
Sanctioned Projects
Patient Care QI Committee
49
LPCH Infection
Control Committee
Transparency of outcomes-Internal: Indicator Sheets
3. Medication Incidents with Harm (“Adverse Drug Event Rate” or “ADEs”) (10/2006; last reviewed by QIC 7/2006)
Description of
Indicator
medication adverse
nt which causes at
t temporary harm to
ent.
n be in prescribing,
pensing,
ministration,
cessing, or
nitoring
merator
dverse drug events
 Well baby and
OB excluded
nominator
0 pt days
Relevance:
Dimensions of
Performance:
(from Institute of
Medicine)
■ Safe
■ Effective
■ Patient-centered
■ Timely
■ Efficient
■ Equitable
 Medication delivery
high volume, high risk,
problem prone
 Pt safety increased
regulation
 Ethical mandate to
minimize harm
 Medico-legal
implications
Score:
4.8 adverse drug events
per 1000 pt days (Nov.
05-Apr. 06)
Previous 6 mos:
7.7adverse drug events
per 1000 pt days
Standard: 15.7 per 1000
pt days (12 children’s
hospitals mean value)
Hosp goal: 8 per 1000
Stretch Goal: 6 per 1000
Outcomes:
Collection
Methodology
20 charts (excluding
OB and Well baby)
randomly selected
over 2 weeks,
repeated monthly.
Charts reviewed by
same quality manager
using a “trigger tool”
to identify adverse
drug events.
■ Clinical
□ Functional
■ Financial
■ Satisfaction
Population
Sampling of all LPCH
inpatients, excluding
well baby and OB
Hospital Strategic
Goals
Participating
Disciplines
■ Physicians
■ Pt Care Services
■ Pharmacy
■ Quality
Management
■ Risk
Reporting
Frequency
■ Quarterly
□ Biannually
□ Annual
Decreasing adverse
drug event rates is one
of the stated strategic
goals for FY 2003
●= 8 per 1000 pt days
nclusions: ADE rate for the last 6 months is
1000 patient days. This is lower than stretch goal
6/1000 patient days and goal of 8/1000 patient
s. These data represent that we are continuing to
ntain our excellent ADE rate.
Actions: New allergy process implemented. TPN CPOE software
implemented in NICU. Physicians Rounds Report developed for Cerner
that improves physician communication. Continue with Medication
Reconciliation rollout to include PACU and ED.
Follow-up: Many medication safety activities
including revising MAR policy, increased safety
education, PCA pump selection. Pre-printed
order sets being built at a rate of 5 new ones per
month, and edits/enhancements 10-20 per
month..
12 hospitals
50
16.5
20
18
10.2
14
12
10
8
7
6
3.3
10.6
*
5.1 5.4
8
LPCH
18
Linear (LPCH)
12.8
9.9 7.1
9.2
7.4 8.7
8.2
6.6
4.2
3.8
0
4
2
0
0
3.5
0
Mar06
Jan06
Nov05
Sep05
Jul05
May05
Mar05
Jan05
Nov04
Sep04
MarJun
0
JulyNov
per 1000 patient days
Adverse Drug Event Rate
* start monthly 20 pt review
16
JCAHO Functional
Areas
■ Pt Rights & Ethics
■ Pt Assessment
■ Care of Pt
□ Education
□ Continuum of Care
■ Envir of Care
□ Mgmt of Info
□ Infection Control
■ Pt Safety
■ Human Resources
■ Perf Improvement
■ Leadership
Goal (8)
Stretch goal (6)
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
51
Just why do we want to be transparent again???

Provide our patients and community with good
information to make informed decisions about a child’s
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
52
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.
53
NEJM February, 1 2007
As compared to the control group (n=406), P4P hospitals
(n=207) showed greater improvement in all measures of
quality… After adjustments were made for differences in
baseline performance and hospital characteristics, P4P was
Hospitals
in both public
P4P
associated
with sigengaged
improvements…
over reporting,
the 2 year and
period
achieved modestly greater improvements in quality
than did hospitals engaged only in public reporting
54
Characteristics of AMCs with High Quality
University Healthcare Consortium study
1.
Shared Sense of Purpose
–
–
2.
Leadership Style
–
–
3.
Measure and benchmark ALWAYS
Data transparency – (drives accountability)
Action oriented, all problems fixable
Collaboration
–
–
55
Responsibility for S/Q/S at every level
Central measures, local implementation efforts
A Focus on Results
–
–
–
5.
CEO passionate about Quality, Service, and Safety
Leadership (admin and medical) authentic hands on style
Accountability System for Service, Quality, Safety
–
–
4.
Patient Care is first among the 3 missions
Quality, Service, and Safety central to competitive advantage
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
56
57
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…
58