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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 Errors
Events
6
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 Average AEs over all Patients:
Total Triggers: 2,816 2.03/patient
Total # AEs identified: 1,488 Average AEs in patients with adverse
Total Number of Patients with events: 3.27 / patient
Adverse Events: 455 (62%)
Overall # AEs per 100 pt. Days=
91% of patients with an AE 28.6
Identified with a Trigger (=416/455)
Average AEs per Trigger (Positive
Number of patients with multiple
(> 1) Unique AEs: 245 (33%) Predictive Value of any given trigger):
0.444
Average LOS: 7.1 Days
Average Triggers per Patient: 3.84
Mean Time for Chart Reviews:
24.7 minutes (per reviewer)
9
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
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…
11
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:
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
15
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
Weick, et al. Research in Organizational Behavior. 1999;21:81-123
Weick, Managing the Unexpected: Assuring High Performance in an Age of
19 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
“Patient first” mantra Defects in care not accepted as inevitable
Organizational clarity Stop the line
Mission statement Responsibility to stop dangerous processes
Goals/incentives aligned and fix
Human factors integration Systems thinking
Fatigue, staffing ratios, labels Systems and processes drive outcomes
Culture Standardization
“patients first”, collegiality, Checklists, boarding passes, order sets
communication, reporting
Data driven
Simulation Data driven and evidenced based decision
Prepare in advance for high risk making
situations
Technology: Tools for supporting ideal
processes
29
Transitioning Toward High Reliability: the LPCH Experience
Leadership Zero defect philosophy
“Patient first” mantra Defects in care not accepted as inevitable
Organizational clarity Stop the line
Mission statement Responsibility to stop dangerous processes
Goals/incentives aligned and fix
Human factors integration Systems thinking
Fatigue, staffing ratios, labels Systems and processes drive outcomes
Culture Standardization
“patients first”, collegiality, Checklists, boarding passes, order sets
communication, reporting
Data driven
Simulation Data driven and evidenced based decision
Prepare in advance for high risk making
situations
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
NeoSim,
SimTrans Neonatal
OB Sim,
FetalSim,
Sim DR
PediSim,
Pediatric Office Emergencies
Disclosing Unanticipated Consequences,
Delivering Bad News,
Perinatal Counseling
NALS/PALS
…
33
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 Pt Safety Program Manager
Oversight
Committee
Chief Clinical Pt Safety Officer
“P-SOC” Medical Director of Quality
34
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 care of real patients
Senior leadership, Risk
dedicated time @ CAPE
Quality/Patient safety dept
36
Operationalization: Step 1
Feasibility of project
(i.e. ability to move
Frequency of Severity of all necessary people
Adverse Events (1-5) Adverse Events (1-5) thru sim program)
1: rare 1: no harm 1: extremely difficult MD Champion
2: infrequent 2: mild, temporary harm 2: difficult 1: none
3: moderate 3: permanent harm 3: reasonable 2: yes but not
available at CAPE 1. Multi-disciplinary team training (NICU +
Simulation Program opportunities 4: frequent
5: very common
4: severe permanent harm 4: easy
5: death 5: very easy
influential
3: yes and influential
OB) in Delivery Room
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) disclosure of unanticipated outcomes 3. Interpersonal communication in
stressful situations
4) interpersonal communication in stressful situations
5) ECMO team training for CVICU, PICU, NICU
(operationalization of CAPE’s ECMO Sim program)
6) Sedation management throughout LPCH
37
Paul’s Practical Solutions to Move Toward High Reliability
in Healthcare
Leadership Zero defect philosophy
“Patient first” mantra Defects in care not accepted as inevitable
Organizational clarity Stop the line
Mission statement Responsibility to stop dangerous processes
Goals/incentives aligned and fix
Human factors integration Systems thinking
Fatigue, staffing ratios, labels Systems and processes drive outcomes
Culture Standardization
“patients first”, collegiality, Checklists, boarding passes, order sets
communication, reporting
Data driven
Simulation Data driven and evidenced based decision
Prepare in advance for high risk making
situations
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
7 CT Surgery service CHCA handoffs
6 collaborative (1/04)
Education
5
Hospitalists 7/03
Number of Codes
4
3
2
1
0
Patient progression
(8/03)
1
3
1
3
1
3
1
3
1
3
1
3
1
Q
Q
Q
Q
Q
Q
Q
Q
Q
Q
Q
Q
Q
01
01
02
02
03
03
04
04
05
05
06
06
07
41
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
Rapid Response
7 Team 9/05
6
5
Number of Codes
4
3
2
1
0
1
3
1
3
1
3
1
3
1
3
1
3
1
Q
Q
Q
Q
Q
Q
Q
Q
Q
Q
Q
Q
Q
01
01
02
02
03
03
04
04
05
05
06
06
07
43
Results: Codes Outside of ICU:
Rate (per 1000 pt days)
Codes Outside of ICU Rate
2.00
Mean Code Rate 0.52 Mean Code Rate 0.15
Code Rate (per 1000 eligible pt days)
1.80 Baseline Pre-RRT period Post- RRT period
1.60
1.40
1.20
1.00
0.80
0.60
0.40
0.20
0.00
P < 0.01
Ap 1
Ap 2
Ap 3
Ap 4
Ap 5
Ap 6
07
O 1
O 2
O 3
O 4
O 5
O 6
1
2
Ju 3
4
5
Ju 6
Ja 1
Ja 2
Ja 3
Ja 4
Ja 5
Ja 6
l-0
l-0
l-0
l-0
l-0
l-0
0
r- 0
0
r- 0
0
r- 0
0
r- 0
0
r- 0
0
r- 0
-0
-0
-0
-0
-0
-0
n-
n-
n-
n-
n-
n-
n-
ct
ct
ct
ct
ct
ct
Ju
Ju
Ju
Ju
Ja
Decrease of 71%
44
45
Mortality Rate (per 100 admissions)
0.0
0.2
0.4
0.6
0.8
1.0
1.2
1.4
1.6
1.8
2.0
Jan-01
Mar-01
May-01
Jul-01
Sep-01
Nov-01
Jan-02
Mar-02
May-02
Jul-02
Sep-02
Nov-02
Jan-03
Mar-03
May-03
Jul-03
Sep-03
Nov-03
Mean Mortality Rate 1.01
18% reduction
Jan-04
Baseline Pre-RRT period
Mar-04
May-04
Jul-04
Sep-04
p < 0.01
Nov-04
Jan-05
Hospital-Wide Mortality Rate
Mar-05
1.01
May-05
Jul-05
Sep-05
Mortality Rate-Housewide
Nov-05
Jan-06
Mar-06
May-06
Jul-06
Sep-06
34 kids lives saved in 19 mo!
Post-RRT period
Nov-06
Jan-07
Mean Mortality Rate 0.83
Mar-07
Our Contribution to the Literature
46
Paul’s Practical Solutions to Move Toward High Reliability
in Healthcare
Leadership Zero defect philosophy
“Patient first” mantra Defects in care not accepted as inevitable
Organizational clarity Stop the line
Mission statement Responsibility to stop dangerous processes
Goals/incentives aligned and fix
Human factors integration Systems thinking
Fatigue, staffing ratios, labels Systems and processes drive outcomes
Culture Standardization
“patients first”, collegiality, Checklists, boarding passes, order sets
communication, reporting
Data driven
Simulation Data driven and evidenced based decision
Prepare in advance for high risk making
situations
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 Environment of Care
Safety Committee Committee
OR Committee
Critical Care
Committee
Patient Safety
Committee
LPCH Infection
Quality Control Committee
Code Committee Improvement
Committee
Patient Safety Oversight
Care Improvement Committee
Committee
Faculty Practice Org Pharmacy and
Quality Committee Therapeutics Committee
Patient Progression
Sanctioned Projects Committee
Patient Care QI Committee
49
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 Relevance: Dimensions of Outcomes: Collection Participating JCAHO Functional
Indicator Performance: Methodology Disciplines Areas
medication adverse Medication delivery (from Institute of ■ Clinical 20 charts (excluding ■ Physicians ■ Pt Rights & Ethics
nt which causes at high volume, high risk, Medicine) □ Functional OB and Well baby) ■ Pt Care Services ■ Pt Assessment
t temporary harm to problem prone ■ Safe ■ Financial randomly selected ■ Pharmacy ■ Care of Pt
ent. Pt safety increased ■ Effective ■ Satisfaction over 2 weeks, ■ Quality □ Education
n be in prescribing, regulation ■ Patient-centered repeated monthly. Management □ Continuum of Care
pensing, Ethical mandate to ■ Timely Charts reviewed by ■ Risk ■ Envir of Care
ministration, ■ Efficient Population same quality manager □ Mgmt of Info
minimize harm
cessing, or Medico-legal ■ Equitable using a “trigger tool” □ Infection Control
nitoring implications to identify adverse ■ Pt Safety
Score: Sampling of all LPCH drug events. ■ Human Resources
merator 4.8 adverse drug events inpatients, excluding Reporting ■ Perf Improvement
dverse drug events per 1000 pt days (Nov. Hospital Strategic well baby and OB Frequency ■ Leadership
Well baby and 05-Apr. 06) Goals ■ Quarterly
OB excluded Previous 6 mos: □ Biannually
7.7adverse drug events □ Annual
per 1000 pt days
nominator Standard: 15.7 per 1000 Decreasing adverse
0 pt days pt days (12 children’s drug event rates is one
hospitals mean value) of the stated strategic
Hosp goal: 8 per 1000 goals for FY 2003
Stretch Goal: 6 per 1000 ●= 8 per 1000 pt days
nclusions: ADE rate for the last 6 months is Actions: New allergy process implemented. TPN CPOE software Follow-up: Many medication safety activities
1000 patient days. This is lower than stretch goal implemented in NICU. Physicians Rounds Report developed for Cerner including revising MAR policy, increased safety
6/1000 patient days and goal of 8/1000 patient that improves physician communication. Continue with Medication education, PCA pump selection. Pre-printed
s. These data represent that we are continuing to Reconciliation rollout to include PACU and ED. order sets being built at a rate of 5 new ones per
ntain our excellent ADE rate. month, and edits/enhancements 10-20 per
month..
Adverse Drug Event Rate 12 hospitals
* start monthly 20 pt review
per 1000 patient days
LPCH
18
20
18
16.5 Linear (LPCH)
16
* 12.8
14
10.2 10.6 8 9.9 7.1 9.2
12
7
8.2 7.4 8.7 6.6
10
5.1 5.4 Goal (8)
8
6 3.3 3.8 4.2 3.5
4
0 0 0 0 Stretch goal (6)
2
0
July-
Mar-
Jul-
Nov-
Jan-
Mar-
Nov-
Jan-
Mar-
May-
Sep-
Sep-
Jun
Nov
05
05
06
04
04
05
05
05
06
05
50
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 engaged in both public the 2 year period
associated with sig improvements… over reporting, and P4P
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
– Patient Care is first among the 3 missions
– Quality, Service, and Safety central to competitive advantage
2. Leadership Style
– CEO passionate about Quality, Service, and Safety
– Leadership (admin and medical) authentic hands on style
3. Accountability System for Service, Quality, Safety
– Responsibility for S/Q/S at every level
– Central measures, local implementation efforts
4. A Focus on Results
– Measure and benchmark ALWAYS
– Data transparency – (drives accountability)
– Action oriented, all problems fixable
5. Collaboration
– MD, RN, and administration all work together
– Staff input, regardless of rank, always considered
55
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
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