0 lpch’s most excellent adventure transitioning to high reliability paul sharek, md, mph assistant...

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LPCH’s Most Excellent Adventure Transitioning to High Reliability

Paul Sharek, MD, MPHAssistant Professor of Pediatrics, Stanford University

Medical Director of Quality ManagementChief Clinical Patient Safety Officer

Vice President of Quality, Safety, and Outcomes ManagementLucile Packard Children’s Hospital

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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

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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 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

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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 CommissionMedical systems increasingly complexProblem ain’t 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

ErrorsAdverseEvents

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Pediatrics: ADE Rates with Trigger ToolTakata, 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

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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 (> 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”)Amalberti, et al. Ann Intern Med.2005;142:756-764

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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 18;293:2384-90

“…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 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

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What do you call an organization/industry that is

complex and risky…But 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”)Amalberti, et al. Ann Intern Med.2005;142:756-764

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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 it’s 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. 1999;21:81-123Weick, Managing the Unexpected: Assuring High Performance in an Age of Complexity, Jossey Bass 2001

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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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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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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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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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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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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 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…

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How do you translate all of this theoretic garbage?

A few ideas from Paul…

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Paul’s Practical Solutions to Move Toward High Reliability in Healthcare

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

Zero defect philosophyDefects in care not accepted as inevitable

Stop the lineResponsibility to stop dangerous processes and

fix

Systems thinkingSystems and processes drive outcomes

StandardizationChecklists, boarding passes, order sets

Data drivenData driven and evidenced based decision

making

Technology: Tools for supporting ideal processes

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Transitioning Toward High Reliability: the LPCH Experience







situations



fix




making


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Example 1: Transitioning to High Reliability @ LPCH

Operationalizing 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

LPCH Board of Directors

CEO

Chief Risk Officer COO Chief of Surgery Chief of Staff

VP Patient Care Services

Director of Quality

Chief Clinical Pt Safety OfficerMedical Director of Quality

Pt Safety Program ManagerPatient 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” @ LPCH

drills @ LPCHdrills @ LPCH

dedicated time @ CAPEdedicated time @ CAPE

care of real patientscare of real patients

Senior leadership, Risk Senior leadership, Risk Quality/Patient safety deptQuality/Patient safety dept

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Operationalization: Step 1

Simulation Program opportunitiesavailable at CAPE

Frequency of Adverse Events (1-5)1: rare2: infrequent3: moderate4: frequent5: very common

Severity of Adverse Events (1-5)1: no harm2: mild, temporary harm3: permanent harm4: severe permanent harm5: death

Feasibility of project (i.e. ability to move all necessary people thru sim program)1: extremely difficult2: difficult3: reasonable4: easy5: very easy

MD Champion1: none2: yes but not influential3: yes and influential

1) multidisciplinary team training in the delivery room(operationalization of CAPE’s NeoSim+ OB Sim programs)

2) sentinel event mitigation

3) disclosure of unanticipated outcomes

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

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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situations



fix




making


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Example 2: Transitioning to High Reliability @ LPCH

Rapid 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.2002;109:200-209**Nadkarni et al. JAMA.2006;295:50-57***Young et al. Annals of Emerg Med. 1999;33:195-205

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Chapter 4 of our tale…“Panic in Palo Alto: The Hero Gets Desperate”

Codes Outside of ICU LPCH: Jan 2001 thru Sep 2005

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mb

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CT Surgery service

EducationHospitalists 7/03

Patient progression (8/03)

CHCA handoffs collaborative (1/04)

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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 ICU:Absolute Number

Codes Outside of ICU LPCH: Jan 2001 thru March 2007

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1

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01 Q

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Rapid ResponseTeam 9/05

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Results: Codes Outside of ICU:Rate (per 1000 pt days)

Codes Outside of ICU Rate

0.00

0.20

0.40

0.60

0.80

1.00

1.20

1.40

1.60

1.80

2.00

Co

de

Rat

e (p

er 1

000

elig

ible

pt

day

s)

Mean Code Rate 0.52Baseline Pre-RRT period

Mean Code Rate 0.15Post- RRT period

P < 0.01Decrease of 71%

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Hospital-Wide Mortality Rate

1.01

0.00.20.40.60.81.01.21.41.61.82.0

Jan-

01

Mar

-01

May

-01

Jul-0

1

Sep

-01

Nov

-01

Jan-

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Mar

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May

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Jul-0

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Jul-0

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Sep

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Jul-0

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Sep

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Sep

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Jan-

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Jul-0

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Sep

-06

Nov

-06

Jan-

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Mar

-07

Mo

rtal

ity

Rat

e (p

er 1

00 a

dm

issi

on

s)

Baseline Pre-RRT period Post-RRT period

Mean Mortality Rate 1.01 Mean Mortality Rate 0.83

Mortality Rate-Housewide

p < 0.01

34 kids lives saved in 19 mo!

18% reduction

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Our Contribution to the Literature

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situations



fix




making


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Example 3: Transitioning to High Reliability at LPCH

Transparency

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Transparency of outcomes: Internal Performance Information Flow

Environment of Care Committee

Patient ProgressionCommittee

Quality Service andSafety Committee

Pharmacy andTherapeutics Committee

Quality

Improvement

Committee

Governing Board Medical Board

LPCH InfectionControl Committee

Patient Care QI Committee

Faculty Practice OrgQuality Committee

Care ImprovementCommittee

Patient SafetyCommittee

Critical CareCommittee

OR Committee

Sanctioned Projects

Code Committee

Patient Safety OversightCommittee

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3. Medication Incidents with Harm (“Adverse Drug Event Rate” or “ADEs”) (10/2006; last reviewed by QIC 7/2006) Description of

Indicator Relevance: Dimensions of

Performance: Outcomes: Collection

Methodology Participating

Disciplines JCAHO Functional

Areas ■ Clinical □ Functional ■ Financial ■ Satisfaction

Medication delivery high volume, high risk, problem prone

Pt safety increased regulation

Ethical mandate to minimize harm

Medico-legal implications

Population

■ Physicians ■ Pt Care Services ■ Pharmacy ■ Quality Management ■ Risk

(from Institute of Medicine) ■ Safe ■ Effective ■ Patient-centered ■ Timely ■ Efficient ■ Equitable

Reporting Frequency

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

Hospital Strategic Goals

A medication adverse event which causes at least temporary harm to patient. Can be in prescribing, Dispensing, Administration, Processing, or Monitoring Numerator # Adverse drug events

Well baby and OB excluded

Denominator 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

Decreasing adverse drug event rates is one of the stated strategic goals for FY 2003

●= 8 per 1000 pt days

Sampling of all LPCH inpatients, excluding well baby and OB

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.

■ Quarterly □ Biannually □ Annual

■ 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

Conclusions: ADE rate for the last 6 months is 4.8/1000 patient days. This is lower than stretch goal of 6/1000 patient days and goal of 8/1000 patient days. These data represent that we are continuing to maintain 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..

Adverse Drug Event Rate

3.3

9.9 8.2

12.88.7

0 0

9.2

0

6.64.2 3.5

16.5

3.8

7.185.45.1

10.610.2

18

7

0

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July

-

Nov

Mar-

Jun

Sep-

04

Nov-

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Mar-

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May-

05 Jul-

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Nov-

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Jan-

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Mar-

06per

1000 p

ati

en

t d

ays 12 hospitals

LPCH

Linear (LPCH)

Goal (8)Stretch goal (6)

*

* start monthly 20 pt review

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 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

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“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.

Findings from Dartmouth-Hitchcock(10/2005)

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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 associated with sig improvements… over the 2 year periodHospitals 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

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

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…

0 lpch’s most excellent adventure transitioning to high reliability paul sharek, md, mph assistant...

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