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lactate(mmol/L) Performance Improvement in a
Congenital Heart Surgical Program:Measuring and Improving Outcomes
after Congenital Heart Surgery
Anthony F. Rossi, MD
Director, Cardiac Intensive Care ProgramMiami Childrens Hospital, Miami, FL USA
http://gifarchiv.com/index.php?news1=send.php&image=rootx/Jahreszeiten/Sommer/palmen.gif&lang=enhttp://gifarchiv.com/index.php?news1=send.php&image=rootx/Jahreszeiten/Sommer/palmen.gif&lang=enhttp://gifarchiv.com/index.php?news1=send.php&image=rootx/Jahreszeiten/Sommer/palmen.gif&lang=en8/14/2019 performance improvement in congenital heart surgery
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FLA
One Program
Two Campuses
A Single Vision
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Surgical Center
Congenital Heart Surgical Outcomes: STS DataCongenital Heart Surgical Outcomes: STS Data
Harvest of Outcomes for Congenital Heart SurgeryHarvest of Outcomes for Congenital Heart Surgery
in Large Volume Centers 2001-2004in Large Volume Centers 2001-2004
The performance of individual cardiac surgical programs is blinded to all reviewers. As of today,accurate and timely outcomes data for individual congenital heart surgery programs isunavailable to the consumer, except in states such as New York or California.
3.9% is theaveragemortality forpatientsundergoing
congenital heartsurgeryaccording to theSTS. Over ofthe largevolumeprograms in the
STS exceed thismortality rate.
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Improving Outcomes after CHSImproving Outcomes after CHS
Be blessed with an outstanding CVBe blessed with an outstanding CV
surgeonsurgeon
Hire a second!Hire a second!
Redmond Burke and Robert Hannan, congenital heart surgeons
at Miami Childrens Hospital. You can not have excellence in acongenital heart surgical program without outstanding surgery.
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WHY NOT ZERO PERCENTWHY NOT ZERO PERCENT
MORTALITY?MORTALITY?
Redmond Burke, 2000Redmond Burke, 2000
Mortality is not, and will never be, an acceptableMortality is not, and will never be, an acceptable
outcome for any patient after CHS, at any time.outcome for any patient after CHS, at any time.
This philosophy must be the cornerstone of allThis philosophy must be the cornerstone of allcongenital heart surgery programs.congenital heart surgery programs.
Unfortunately, mortality as an outcome is far tooUnfortunately, mortality as an outcome is far too
often accepted as a necessary evil in someoften accepted as a necessary evil in some
programs.programs.
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Improving Performance in a CongenitalImproving Performance in a Congenital
Heart Surgery ProgramHeart Surgery Program
Performance Assessment/PerformancePerformance Assessment/Performance
Improvement RelationshipImprovement Relationship
Point of Care Testing-Goal DirectedPoint of Care Testing-Goal Directed
Medical TherapyMedical Therapy Electronic Medical Record andElectronic Medical Record and
Information TechnologyInformation Technology
Team ResonanceTeam Resonance
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You want to be an Olympic 1500 meterYou want to be an Olympic 1500 meter
Champ. You should:Champ. You should:
Run hard every day. Measure nothing. ShowRun hard every day. Measure nothing. Show
up for the race. Hope for the best.up for the race. Hope for the best.
Measure your 1500 m time once a year andMeasure your 1500 m time once a year and
race.race. Measure your 1500 m time repeatedly over theMeasure your 1500 m time repeatedly over the
year.year.
Measure your 1500 m time, your split times,Measure your 1500 m time, your split times,
your technique repeatedly. Make adjustmentsyour technique repeatedly. Make adjustmentsin technique accordingly and repeatedly.in technique accordingly and repeatedly.
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You want to have the best outcomesYou want to have the best outcomes
after CHS. You should:after CHS. You should:
Try hard every day. Measure nothing. SubmitTry hard every day. Measure nothing. Submit
your raw data to the STS. Hope for the best.your raw data to the STS. Hope for the best.
Measure your mortality data once a year andMeasure your mortality data once a year and
submit your data to the STS.submit your data to the STS. Measure your mortality data repeatedly overMeasure your mortality data repeatedly over
the year.the year.
Measure your mortality data, your LOS, yourMeasure your mortality data, your LOS, your
technique, and any objective outcome variabletechnique, and any objective outcome variablerepeatedly over the year and in real-time.repeatedly over the year and in real-time.
Make adjustments in technique accordingly andMake adjustments in technique accordingly and
repeatedly.repeatedly.
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Real-Time Performance AssessmentReal-Time Performance Assessment
Continued quality improvement requiresContinued quality improvement requires
continued outcome assessmentcontinued outcome assessment
You cant know where youre going untilYou cant know where youre going until
you know where youve come fromyou know where youve come from Outcome assessment must be timelyOutcome assessment must be timely
(real-time)(real-time)
Accurate and unbiasedAccurate and unbiased
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Measuring Performance in a CardiacMeasuring Performance in a Cardiac
Surgical ProgramSurgical Program
Performance Improvement can onlyPerformance Improvement can only
come as the result of the accurate,come as the result of the accurate,
objective and timely measurement ofobjective and timely measurement of
data.data. Performance Assessment can be of anPerformance Assessment can be of an
individualindividual procedure orprocedure or programmaticprogrammatic
performance assessment.performance assessment.
Performance Outcomes must bePerformance Outcomes must be
transparenttransparent and easily accessible toand easily accessible to allallteam members and the public.team members and the public.
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May 7, 2004 -- ALBANY - A groundbreaking state study of pediatricheart surgery in New York shows University Hospital of Brooklyn had the
worst mortality rate in the state - in a program that has since been halted.
The state Health Department's report covering the years 1997-1999
summarizes risk factors and outcomes for pediatric patients undergoing
surgery to correct congenital heart defects.According to the report, 11 out of 92 children who underwent congenital
heart surgery at University Hospital of Brooklyn during the study period
died.
The hospital's mortality rate when adjusted for risk was 17.08 percent, the
highest in the state and significantly higher than the 5.35 percent
statewide rate.
This report was released in 2004. It reports the outcomes of patientsThis report was released in 2004. It reports the outcomes of patients
operated on years earlier. Dont we owe it to our patients to make theseoperated on years earlier. Dont we owe it to our patients to make these
decisions and review that data in a more timely fashion?decisions and review that data in a more timely fashion?
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Mortality as outcome measure is reported in real-timefrom web-based medical record. The data must betransparent to ALL!
Every American should have access to a fullEvery American should have access to a fullrange of information about the quality ofrange of information about the quality of
their health care options. HHS Secretarytheir health care options. HHS Secretary
James Leavitt 2006James Leavitt 2006
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Miami ChildrensHospital has taken aLeading role inoutcomes reporting.
Data from our webbased medical recordis reported in real-timewhen the outcomesreporting page isopened.
Access to our real-time
outcomes reporting pageis available with a singlemouse click.
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Risk adjusted outcomes may be reported in real-timefrom medical record, for programmatic performanceassessment
Miami ChildrensMiami Childrens
Hospital real-timeHospital real-time
outcomes report.outcomes report.
FromFrom
pediatricheartsurgery.compediatricheartsurgery.com
liMCH CUSUM M li
1995 2004
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MCH CUSUM Mortality 1995-2004MCH CUSUM Mortality 1995-2004::The CUSUM mortality graph allows youThe CUSUM mortality graph allows youto track the performance of your congenital heart program. Aberrations into track the performance of your congenital heart program. Aberrations in
performance are readily apparent in this graphic representation, much moreperformance are readily apparent in this graphic representation, much more
readily than might be apparent to the casual observer. Our database calculates areadily than might be apparent to the casual observer. Our database calculates a
CUSUM graph of our performance in real-time.CUSUM graph of our performance in real-time.
CUSUM MORTALITY 1995-2004
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case number
mortalitynumber
4% Mortality
2% Mortality1/1/01
The value of this technique for evaluating congenital heart outcomes was first described by professor Marc DeThe value of this technique for evaluating congenital heart outcomes was first described by professor Marc De
Leval in 1994.De Leval MR, et al. Analysis of a cluster of surgical failures. Application to a series of neonatalLeval in 1994.De Leval MR, et al. Analysis of a cluster of surgical failures. Application to a series of neonatal
arterial switch operations.arterial switch operations.J Thorac Cardiovasc SurgJ Thorac Cardiovasc Surg 1994;107: 914-23.1994;107: 914-23.
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STS CHS 2006 data harvest: 3.9% mortality
Zone of Acceptable Performance
Zone of Enhanced Performance
4.9% mortality
2.9% mortality
MCH CUSUM 2/02-12/06
CUSUM data may be used to access performance of an individualor program over time. Deviation from accepted norms arereadily apparent.
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Effect of Various Changes in ProgrammaticEffect of Various Changes in Programmatic
Philosophy on CHS OutcomesPhilosophy on CHS Outcomes
CUSUM MCH CHS
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mortalitynu
ERA 1
ERA 2
ERA 3
ERA 4
ERA 1: 6/95-12/2000
ERA 2: new ICU Leadership
ERA 3: point of care testing introduced
ERA 4: i-rounds EMR introduced
STS 2006 data harvest avg mortality NA (3.9%)
2% mortality line
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Tracking Outcomes in a VisiblyTracking Outcomes in a Visibly
Intuitive FashionIntuitive Fashion
Interval b/w Death after CHS
R2 = 0.1377
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50
100
150
200
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1 7 13 19 25 31 37 43 49 55 61 67 73 79 85 91 97 103 109
Mortality Number
casesb/w
mortality
MCH CHS deaths: 1995-2007MCH CHS deaths: 1995-2007
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Improving OutcomesImproving Outcomes
Performance Assessment/performancePerformance Assessment/performance
Improvement relationshipImprovement relationship
Point of care testing-goal directedPoint of care testing-goal directed
therapytherapy EMR/ITEMR/IT
Team ResonanceTeam Resonance
bombarded with clinical data often confusingbombarded with clinical data often confusing
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bombarded with clinical data, often confusingbombarded with clinical data, often confusing
an already complicated problem.an already complicated problem. This canThis can
often lead to the dreaded :often lead to the dreaded : Paralysis ofParalysis of
AnalysisAnalysis
Ultimately, two questions are paramount:Ultimately, two questions are paramount: Are we good?Are we good? Are we headed in the right direction?Are we headed in the right direction?
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Traditional MCH ICU Lab Services: What aTraditional MCH ICU Lab Services: What a
mess!mess!
Blood Drawn
From Pt.
Placed in TubeNurse
Tube Packaged
WardClerk
Transported to Lab
Transporter
Lab Performs Test
LabTech
DoctorReviews Lab Results
Lab EntersTest Result
LabClerk
Pt carePt carealtered as neededaltered as needed
-7 STEPS-7 STEPS-5 CAREGIVERS-5 CAREGIVERS
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i-Stat POC: Introduced to all MCH ICUs ini-Stat POC: Introduced to all MCH ICUs in
20012001
-Blood DrawnFrom Pt.
-Test Run at
-Bedside
-2 STEPS-2 STEPS-2 Caregivers-2 Caregivers
Nurse
ResultsTo
Doctor
Doctor
Pt carePt carealtered asaltered as
neededneeded
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Common Cardiac Surgical Procedures
Arterial switch operation
Repair of tetralogy of Fallot
VSD closure
ASD closure
AVC repair
Rastelli operation
Norwood operation
Bi-Glenn
Fontan
Repair IAA
BTS
Central shunt
Ross
MV replacement
AV replacement
Aortic Valvotomy
Konno Ross-Konno
Repair TAPVC
Repair coarctation
Repair DORV
Senning
Mustard
Double switch
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Maintain optimal tissue oxygen delivery
Single Goal of PO CareSingle Goal of PO Care
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The constant tug of warThe constant tug of war
between DO2 and VO2between DO2 and VO2
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DO2/VO2: Relationship of oxygen delivery to oxygenDO2/VO2: Relationship of oxygen delivery to oxygen
onsumptiononsumption
O2 O2 O2
O2 O2
O2
We normally deliver 5 times as much oxygen to our tissues than we useWe normally deliver 5 times as much oxygen to our tissues than we use
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Relation of DO2 to VO2
DO2
VO2
critical point of DO2critical point of DO2
(VO2 , lactate )(VO2 , lactate )
5/12/1**
**Decreasing CV Reserve
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DO2=CI x Hb x SaO2DO2=CI x Hb x SaO2
CI usually impossible to measureCI usually impossible to measure
because of intracardiac shuntingbecause of intracardiac shunting small patient size makes CIsmall patient size makes CI
measurements impracticalmeasurements impracticalUse indirect measures of DO2
Can You Measure DO2 Following CHS?
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Lactate is Predictive of OutcomeLactate is Predictive of Outcome
after CHSafter CHS
Children after cardiac surgery Initial lactate > 4.2 mmol/l - mortality 100%
(Siegel et al.1996) Initial lactate > 4.5 mmol/l - mortality 79%
(Hatherhill et al.1997)
Infants after cardiac surgery
Initial lactate > 7mmol/l - mortality 55% Maximum lactate > 9mmol/l - mortality 86%
(Chefitz et al. 1997)
In 2001 we asked ourselves
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In 2001, we asked ourselvesthe following questions:
If lactate is useful in predictingIf lactate is useful in predicting
outcomes in pts after CHS couldoutcomes in pts after CHS could
lactate be used as a target goal forlactate be used as a target goal for
medical management in this ptmedical management in this pt
population?population?
Can GDT be applied to pts afterCan GDT be applied to pts after
CHS?CHS?
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January 2001: The PremiseJanuary 2001: The Premise
Establish near patient testing of routineEstablish near patient testing of routinecritical care lab values with rapid turn-critical care lab values with rapid turn-around-timearound-time Clinician can react quickly to changing physiologicClinician can react quickly to changing physiologic
conditionsconditions Establish blood lactate measurement asEstablish blood lactate measurement as
objective indicator of oxygen debtobjective indicator of oxygen debt Establish clinical guidelines which areEstablish clinical guidelines which are
directed at normalizing blood lactate levelsdirected at normalizing blood lactate levels
(thereby minimizing oxygen debt)(thereby minimizing oxygen debt) The combination of the above would increaseThe combination of the above would increase
survival after congenital heart surgerysurvival after congenital heart surgery
L t t M tL t t M t
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Initial Lactate > 2.2Initial Lactate > 2.2
No ChangeNo Change Increase in LactateIncrease in Lactate Decrease in LactateDecrease in Lactate
< 5< 5 > 5> 5
Repeat in 4 hrsRepeat in 4 hrs Escalate Medical RxEscalate Medical Rx
Escalate Medical RxEscalate Medical Rx
Repeat in 4 hrsRepeat in 4 hrs
Repeat in 4 hrsRepeat in 4 hrs
Repeat Q 4 HrsRepeat Q 4 Hrs
LactateLactate >> 1010
CPSCPSLactate < 5Lactate < 5 Lactate 5-10Lactate 5-10
Escalate Medical RxEscalate Medical RxRepeat in 4 hrsRepeat in 4 hrs
Repeat q4hrs x 4
CPS = Cardiopulmonary SupportCPS = Cardiopulmonary Support
Consider
Lactate ManagementLactate Management
ProtocolProtocol
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Lactate ManagementLactate Management
Lactate Normalor
DiminishingNo Changes
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PatientsPatients
ERA AgeRangeMedian
WeightRangeMedian
TotalPts
< 1mth
> 1 mth
6/95-6/01 0-72 yrs
311 d
0.5-127kg7.9 kg
1656 321 1335
7/01-10/03
0-72 yrs166 d
P
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Effect of GDT and POC on 30d MortalityEffect of GDT and POC on 30d Mortality
0
2
4
6
8
10
12
14
all pts >1 mth < 1 mth
% Mortality Pre/Post i-Stat
6/95-6/01
7/01-703
all pts > 1 mth < 1 mth
% mortality 6/95-6/01 4.7 2.6 13
(% reduction) 7/01-10/03 2.1 1.5 4.2(55%)(55%) (68%)(68%)(42%)(42%)
P
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Improving OutcomesImproving Outcomes
Performance Assessment/performancePerformance Assessment/performance
Improvement relationshipImprovement relationship
POCT/GDTPOCT/GDT
EMR/ITEMR/ITTeam ResonanceTeam Resonance
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AdvancesAdvancesin IT in the CICUin IT in the CICU
1997 Emtek System1997 Cardioaccess Database
2000 Palm Pilot 2001 CICU Component
Cardioaccess
2002 I-rounds
2001 POC I-stat
2003 Tablet PC
1995 CHS Excel Database
Real-time database
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For decades, tracking the performance of an individual patient through their hospital courseFor decades, tracking the performance of an individual patient through their hospital course
was done on a series of hand written index cards. All of the patients most valuablewas done on a series of hand written index cards. All of the patients most valuable
information, potentially life saving information was kept on these. Is this how we shouldinformation, potentially life saving information was kept on these. Is this how we should
track human performance today, with stakes as high as life and death? We wouldnt do it fortrack human performance today, with stakes as high as life and death? We wouldnt do it for
our bank accounts, we shouldnt do it with patients lives. Sadly, many hospitals continue toour bank accounts, we shouldnt do it with patients lives. Sadly, many hospitals continue to
track data like this today.track data like this today.
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Tracking the performance of an individual patient at MCH today: A visual representation of a patients
postoperative progression. I-stat (Abbott) allows the blood lactate level to be obtained and measured in the
operating room and at the bedside. The data is downloaded into our LIS and displayed graphically and in real-
time (i-Rounds, Teges).
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Tracking the performance of an individual patient. I-stat (Abbott) allows
the blood lactate level to be obtained and measured at the bedside. The
data is downloaded into our LIS and displayed graphically and in real-
time (i-rounds, Teges).
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Tracking the performance of an individual patient. A graphic representation
of a patients postoperative progression. Data is available in real-time,
anywhere in the world internet access is available.
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This is how data is often shared between clinicians in a busy hospital. Can the risk for a serioumedical error be more apparent?
Cli k th h t iti l i f ti Thi i h d t iCli k th h t iti l i f ti Thi i h d t i
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Click through to critical information: This is how data isClick through to critical information: This is how data is
shared at Miami Childrens Hospital utilizing the i-Roundsshared at Miami Childrens Hospital utilizing the i-Rounds
web-based medical record.web-based medical record.
Data captured automatically or enteredData captured automatically or entered
at the point of care.at the point of care.
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The Visual Representation of DataThe Visual Representation of Data
Our methods for sharing and displaying dataOur methods for sharing and displaying data
have been based on the inspired work ofhave been based on the inspired work of
Edward TufteEdward Tufte
Certain methods for displaying and analyzingCertain methods for displaying and analyzing
data are better than othersdata are better than others
Superior methods are more likely to produceSuperior methods are more likely to produce
truthful, credible and precise findingstruthful, credible and precise findings
Inspired design can actually cause theInspired design can actually cause themeaningful right numbers to flash out frommeaningful right numbers to flash out from
statistical murkstatistical murk Edward TufteEdward Tufte
Visual Representation of Performance: First 500 vsVisual Representation of Performance: First 500 vs
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Visual Representation of Performance: First 500 vs.Visual Representation of Performance: First 500 vs.
Last 500 Cases: It is readily apparent that ourLast 500 Cases: It is readily apparent that our
performance has improved dramaticallyperformance has improved dramatically
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Sparklines in CHSSparklines in CHS
Data Intense, Simple, Word-SizedData Intense, Simple, Word-Sized
GraphicsGraphics
High resolution graphics embedded in aHigh resolution graphics embedded in a
context of words, numbers and imagescontext of words, numbers and images Sparklines give us some chance to learnSparklines give us some chance to learn
from the flood of data generated byfrom the flood of data generated by
modern scientific monitoring andmodern scientific monitoring andsurveillance technologiessurveillance technologiesEdward Tufte, 2004Edward Tufte, 2004
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Sparkline data analysis is used to graphically display data over time
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p y g p y p y
Sparklines: Data-intense, small, high resolution graphics (Tufte 2006)
Sparkline of vitalSparkline of vital
signs data,signs data,
available toavailable to
clinician in real-clinician in real-time viatime via
an i-phonean i-phone
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Current
1996
SparklineSparkline
representing currentrepresenting current
and pastand pastperformance of aperformance of a
congenital heartcongenital heart
surgical program.surgical program.
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Improving OutcomesImproving Outcomes
Performance Assessment/performancePerformance Assessment/performance
Improvement relationshipImprovement relationship
POCT/GDTPOCT/GDT
EMREMR Team ResonanceTeam Resonance
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There is no I in TEAMThere is no I in TEAM
We share equally in the success and failure ofWe share equally in the success and failure ofevery patient as an individualevery patient as an individual
and the Program as a wholeand the Program as a whole
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Team ResonanceTeam Resonance
Team ResonanceTeam Resonance
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pharmacistpharmacist
PAPA
CICUCICU
ANPANP
CVSCVS
ANPANP
nursenurse
fellowfellow
Team ResonanceTeam Resonance
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Team ResonanceTeam Resonance
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