normalization of deviance - maryland patient safety center · normalization of deviance

Normalization Of DevianceNormalization Of Deviance

<1% 5% 50% 80% 100% percent of driversPERFORMANCE

Indi

vidu

al A

uton

omy

The posted speed limit is 60 mph- the ‘legal’ space

Driving 64 mph-the illegal-

normal space

Driving75 mph –the ‘illegal-illegal’space (for almost all of us!)

VE

RY

UN

SAFE

SPA

CE Individual

Pressures

PerceivedVulnerability

Belief inSystems-guidelines

Accident

Driving 100 mphDriving 100 mph

illegal for allillegal for all Borderline ToleratedBorderline ToleratedConditions of UseConditions of Use

Defining NormalDefining Normal

How safe is normal?How safe is normal?

When does normal become unsafe?When does normal become unsafe?

How safe is safe?How safe is safe?

Normalization Of Deviance in Normalization Of Deviance in ObstetricsObstetrics--GoalsGoals

Usual obstetric practice frequently deviates from guidelinesUsual obstetric practice frequently deviates from guidelinesUnderstand what drives deviation from guidelinesUnderstand what drives deviation from guidelinesDiscuss that harm occurs with and without deviation from Discuss that harm occurs with and without deviation from the guidelinesthe guidelinesDiscuss that harm may occur during deviation from Discuss that harm may occur during deviation from guidelines and the association with malpracticeguidelines and the association with malpracticeDiscuss how infrastructure can reduce errorDiscuss how infrastructure can reduce error

CompetentStaff

Infrastructure

Leadership

EvidenceBased

Medicine

Reliability

Reliably Delivering Reliably Delivering WhatWhat The Patient Needs Or The Patient Needs Or Wants Wants WhenWhen They Need It They Need It EachEach And And EveryEvery TimeTime

Will

Ideas

Execution

Managing InfrastructureManaging Infrastructure Delivering Reliably What The Delivering Reliably What The Patient Needs Or Wants When They Need It Each And Every Patient Needs Or Wants When They Need It Each And Every

TimeTime

Risk Identification

& Management

Communication

Just Culture

Human FactorsKnown habitsand patterns

Standardization

Team Response

Patient/familyunit

Identify thruvisible failures

MitigateFailures

PreventFailures

Redesign

ViolationViolationof the of the

StandardsStandards

What drives deviation to the What drives deviation to the Borderline Tolerated Conditions of Use?Borderline Tolerated Conditions of Use?

PressuresPressuresMarket Market Individual Individual

Belief in guidelinesBelief in guidelinesExperiencesExperiences

Individual or CollectiveIndividual or CollectivePerceived vulnerabilityPerceived vulnerability

Adverse outcomeAdverse outcomeDetection and punishmentDetection and punishment

Impact that deviation from Impact that deviation from guidelines has on following careguidelines has on following care

Operative deliveryOperative deliveryPitocinPitocinTiming of Elective CesareanTiming of Elective Cesarean

Concept of BorderConcept of Border--line Tolerated Conditions line Tolerated Conditions of Use (BTCU)of Use (BTCU)

Driven by embedded Driven by embedded combination of combination of system system performance improvement performance improvement and individual benefits and individual benefits i.e. i.e. wwe save time, avoid e save time, avoid conflictconflict

Implicitly (sometimes Implicitly (sometimes explicitly) explicitly) tolerated by the tolerated by the proximal hierarchy proximal hierarchy i.e. i.e. those in those in charge working charge working closest to usclosest to us

Rene Amalberti, MD, PhD

Medical MalpracticeMedical Malpractice

DutyDutyStandard of CareStandard of Care-- Breach (deviation)Breach (deviation)CausationCausation--Breach (deviation) caused harmBreach (deviation) caused harm

0

0.0005

0.001

0.0015

0.002

0.0025

0.003

0.0035

0.004

Vac & forceps c/s afterforceps/vacuum

forceps vacuum c/s in labor SVD c/s no labor

Relationship of Intracranial Hemorrhage to Mode of Delivery

Towner NEJ 1999;341:1709-171483,340 singleton, nulliparous

Reliability 10-3 10-4

Concept of BorderConcept of Border--line Tolerated line Tolerated Conditions of Use (BTCU)Conditions of Use (BTCU)

•• Result in a Result in a ‘‘stabilised usual level of performancestabilised usual level of performance’’ that lies that lies outside the expected safe field of use defined in outside the expected safe field of use defined in policy, policy, procedure, and regulationsprocedure, and regulations

•• Are seen first as benefits rather than problems: benefits are Are seen first as benefits rather than problems: benefits are immediate payback, additional risks are knownimmediate payback, additional risks are known and are and are supposedsupposedly underly under control, and de facto scarcely penalised. control, and de facto scarcely penalised.

•• Driven by embedded combination of system performance Driven by embedded combination of system performance improvement and individual benefits .improvement and individual benefits .

•• Implicitly (sometimesImplicitly (sometimes explicitly) tolerated by the explicitly) tolerated by the proximal hierarchy proximal hierarchy


0

0.01

0.02

0.03

0.04

0.05

0.06

0.07

0.08

37wkscs nolabor

38wkscs nolabor

39wkscs nolabor

37wksvag

38wksvag

40wksvag

40wkscs nolaborNS

39wksvagNS

Respiratory Morbidity At Term

Morrison Br J Ob Gyn 1995 Oct;102 (2):101-6 33,289 deliveries between 37-42 weeks

40+0 to +6 = 1

More infant deaths with elective C-sections

Procedure has three times higher mortality rate than babies born vaginally

Most PopularUpdated: 7:13 p.m. CT Sept 14, 2006NEW YORK - A new study has found a higher risk of infant deaths among infants born by Caesarean section to mothers who have no medical need for the procedure.While C-sections have saved the lives of "countless" women and babies, and the risk of infant death is still very low, it is crucial to determine the reasons for the higher infant mortality seen with C-section, because the rates of this surgery are becoming increasingly common, Dr. Marian F. MacDorman of the National Center for Health Statistics at the Centers for Disease Control in Hyattsville, Maryland and colleagues conclude.Rates of Caesarean have risen steadily in the U.S., from 14.6 percent of all first-time births in 1996, to 20.6 percent in 2004, MacDorman's group notes in the September issue of Birth.

http://www.reuters.com/

Concept of BorderConcept of Border--line Tolerated line Tolerated Conditions of Use (BTCU)Conditions of Use (BTCU)

Because we do them regularly with only Because we do them regularly with only rare rare adverse outcomesadverse outcomes, we come to feel safer and safer , we come to feel safer and safer and come to the BTCU as normal and safe. The and come to the BTCU as normal and safe. The BTCU BTCU becomes the becomes the ‘‘stabilized usual level of stabilized usual level of performanceperformance’’ even though it lies outside the even though it lies outside the expected safe field of use defined in policy, expected safe field of use defined in policy, procedure, and regulationsprocedure, and regulationsAre Are seen first as benefits rather than problemsseen first as benefits rather than problems: : benefits have immediate payback like saving time, benefits have immediate payback like saving time, additional risks are knownadditional risks are known and are and are supposedsupposedlylyunderunder control, and control, and de factode facto scarcely penalisedscarcely penalised


The The resultresult of migration of migration isis wellwell knownknown(1)(1)

The result of migrations is a large range of The result of migrations is a large range of illegal practices... which over time became illegal practices... which over time became ““normalnormal”” for everyone, and which are part of for everyone, and which are part of the systemthe system’’s s ““normalnormal”” operation. operation.

Since these practices are illegal, nothing can be Since these practices are illegal, nothing can be written about them, to comment or to accept their written about them, to comment or to accept their existence. existence. The only words written about these are ineffective The only words written about these are ineffective memos reminding the staff about the old, written rule. memos reminding the staff about the old, written rule. These practices are only commented upon verbally. These practices are only commented upon verbally. elective forceps, timing of elective delivery, FHT elective forceps, timing of elective delivery, FHT reassuring, fetal weight for inductionreassuring, fetal weight for induction


The result of migration is well known The result of migration is well known (2)(2)

There is There is great reluctance to monitor these great reluctance to monitor these practices with indicatorspractices with indicators, since no one really , since no one really knows what to do with the results obtained knows what to do with the results obtained

(for example, what should be done with inconsistent (for example, what should be done with inconsistent recording of reassuring/nonrecording of reassuring/non--reassuring FHT, elective reassuring FHT, elective operative delivery, timing of elective delivery). operative delivery, timing of elective delivery).


The The resultresult of migrations of migrations isis wellwell knownknown(3)(3)

It is essential to remember that It is essential to remember that all stakeholders all stakeholders in the system migrate and deviatein the system migrate and deviate from from standards, even if migrations are different, standards, even if migrations are different, depending on whether they occur at Senior depending on whether they occur at Senior Management level, in Departments, or with Management level, in Departments, or with actors on the field. actors on the field.

RRene Amalberti, MD, PhD

The result of migrations is well known The result of migrations is well known (4)(4)

Migrations stabilize over timeMigrations stabilize over timeFirst by the exposure to incidents which First by the exposure to incidents which eventually make up a shared professional eventually make up a shared professional consensus i.e. (elective delivery < 36 weeks) consensus i.e. (elective delivery < 36 weeks) as as ‘‘too unsafetoo unsafe’’


DeviationDeviation

We all deviate all the timeWe all deviate all the timeUsually without harmUsually without harmDeviation based on specific clinical criteria Deviation based on specific clinical criteria improves outcomesimproves outcomes

Managing InfrastructureManaging Infrastructure Delivering Reliably What The Delivering Reliably What The Patient Needs Or Wants When They Need It Each And Every Patient Needs Or Wants When They Need It Each And Every

TimeTime

Risk Identification

& Management

Communication

Just Culture

Human FactorsKnown habitsand patterns

Standardization

Team Response

Patient/familyunit


MitigateFailures

PreventFailures

Redesign

ViolationViolationof the of the

StandardsStandards

Measure

Ascension HealthAscension Health

2004 process to eliminate birth trauma2004 process to eliminate birth traumaFeb 2004 Seton Family of Hospitals in Austin, Feb 2004 Seton Family of Hospitals in Austin, Texas Texas --9005 births in 20049005 births in 2004Feb 2004 St Marys in Evansville, IndianaFeb 2004 St Marys in Evansville, Indiana--2081 births 2081 births in 2004 in 2004 Dec 2004 Our Lady Lourdes Binghampton New Dec 2004 Our Lady Lourdes Binghampton New YorkYork--1021 births in 2004 1021 births in 2004

What did Ascension do?What did Ascension do?

In 2000, the Health System Board committed to In 2000, the Health System Board committed to have zero injurieshave zero injuriesCreated bundlesCreated bundles

Elective induction of laborElective induction of laborAugmentation of laborAugmentation of laborOperative vaginal deliveryOperative vaginal delivery

ExecutedExecuted the process of implementing the the process of implementing the bundlebundle

Birth Trauma Birth Trauma

Category CCategory C--Birth Trauma and required evaluationBirth Trauma and required evaluationFacial nerve injury 767.5Facial nerve injury 767.5Injury to brachial plexus 767.6Injury to brachial plexus 767.6Other injury to other cranial nerves and peripheral nerves 767.7Other injury to other cranial nerves and peripheral nerves 767.7Other specified birth trauma *767.8 Other specified birth trauma *767.8 Unspecified birth trauma *767.9Unspecified birth trauma *767.9

Category DCategory D--severe birth trauma with NICU admissionsevere birth trauma with NICU admissionSubgaleal hemhorrageSubgaleal hemhorrage--epicranial subaponeurotic massive 767.11epicranial subaponeurotic massive 767.11Subdural or cerebral hemorrhage (secondary to trauma or anoxia oSubdural or cerebral hemorrhage (secondary to trauma or anoxia or hypoxia) **767.0r hypoxia) **767.0Intraventricular and intracerebral hemorrhage **772.1Intraventricular and intracerebral hemorrhage **772.1Subarachnoid hemorrhage 772.2Subarachnoid hemorrhage 772.2Other injuries to skeleton (excludes clavicle) ***767.3Other injuries to skeleton (excludes clavicle) ***767.3Injury to spine and spinal cord ***767.4Injury to spine and spinal cord ***767.4Fetal blood loss/hemorrhage requiring transfusionFetal blood loss/hemorrhage requiring transfusion--772.0 & procedure code 99.0 772.0 & procedure code 99.0 *Exclude minor injuries codes as unspecified or other*Exclude minor injuries codes as unspecified or other** Exclude preterm infant < 2500 grams and < 37 weeks or ** Exclude preterm infant < 2500 grams and < 37 weeks or << 34 weeks34 weeks*** Excludes any diagnostic codes of osteogenesis imperfecta 756*** Excludes any diagnostic codes of osteogenesis imperfecta 756.51.51

What did Ascension do?What did Ascension do?

In 2000, the Health System Board committed to In 2000, the Health System Board committed to have zero injurieshave zero injuriesCreated bundlesCreated bundles

Elective induction of laborElective induction of laborAugmentation of laborAugmentation of laborOperative vaginal deliveryOperative vaginal delivery

ExecutedExecuted the process of implementing the the process of implementing the bundlebundle

Ascension's Augmentation BundleAscension's Augmentation Bundle

Estimated fetal weightEstimated fetal weightPelvic assessmentPelvic assessmentMonitoring fetal heart rate for reassuranceMonitoring fetal heart rate for reassuranceMonitoring and management of Monitoring and management of hyperstimulationhyperstimulation

AscensionAscension’’s Elective Induction Bundles Elective Induction Bundle

Assessment of gestational age (ensuring Assessment of gestational age (ensuring gestational age gestational age >> 39 weeks)39 weeks)Monitoring fetal heart rate for reassuranceMonitoring fetal heart rate for reassurancePelvic assessmentPelvic assessmentMonitoring and management of Monitoring and management of hyperstimulationhyperstimulation

Operative Delivery BundleOperative Delivery BundleACOG criteria for timing and indications for ACOG criteria for timing and indications for operative deliveryoperative deliveryLimit vacuum applications to 3. Limit Limit vacuum applications to 3. Limit application time to no more than 20 minutesapplication time to no more than 20 minutesDocumentation of vacuum pressure not to Documentation of vacuum pressure not to exceed 500exceed 500--600 mm Hg600 mm HgLimit vacuum to Limit vacuum to >> 34 weeks34 weeksComplete a progress note on all operative Complete a progress note on all operative deliveriesdeliveries

Managing InfrastructureManaging Infrastructure to rto reliably ensure safe eliably ensure safe administration of pitocin administration of pitocin eacheach and and everyevery timetime


MitigateFailures

PreventFailures

Redesign


MitigateFailures

PreventFailures

Redesign

PowerPassengerPassage

MonitoringFHT PatternFor Reassurance


MitigateFailures

PreventFailures

Redesign

Monitoring and Management ofhyperstimulation

Vacuum BundleVacuum Bundle

A.A.Alternative labor strategies consideredAlternative labor strategies consideredB.B.Prepared patientPrepared patient--

Informed consent discussed and Informed consent discussed and documenteddocumented

C.C.High probability of successHigh probability of successEFW, fetal position and station knownEFW, fetal position and station known

D.D.Maximum application time & number of Maximum application time & number of poppop--offs predeterminedoffs predeterminedE.E.Exit strategy availableExit strategy available

Cesarean & resuscitation team availableCesarean & resuscitation team available

Key Learning PointsKey Learning Points

Hard work and vigilance although Hard work and vigilance although commendable is not a good design principle commendable is not a good design principle

Characteristics of processes with 80Characteristics of processes with 80--90% 90% compliancecompliance

Standard order sheetsStandard order sheets

Written policies/procedures Written policies/procedures

Personal check listsPersonal check lists

Feedback of information on complianceFeedback of information on compliance

Suggestions of working harder next timeSuggestions of working harder next time

Awareness and trainingAwareness and training

Provider/patient autonomyProvider/patient autonomy



If 95If 95--99.5% change concepts do not make 99.5% change concepts do not make up at least 25% of the improvement effort up at least 25% of the improvement effort on a given project require the team to on a given project require the team to rethink the designrethink the design

Characteristics of processes with 95Characteristics of processes with 95--99.5% 99.5% compliancecompliance

Decision aids and reminders built into the Decision aids and reminders built into the systemsystem

Desired action the default (based on Desired action the default (based on scientific evidence)scientific evidence)

Redundant processes utilized Redundant processes utilized

Scheduling used in design developmentScheduling used in design development

Habits and patterns known and taken Habits and patterns known and taken advantage of in the designadvantage of in the design

Standardization of process based on clear Standardization of process based on clear specification and articulation is the normspecification and articulation is the norm


Hard work and vigilance although Hard work and vigilance although commendable is not a good design commendable is not a good design principle principle

If 10If 10--22 change concepts do not make change concepts do not make up at least 25% of the improvement up at least 25% of the improvement effort on a given project require the effort on a given project require the team to rethink the designteam to rethink the design

Benchmark outcomes against the Benchmark outcomes against the

industry bestindustry best



If 10If 10--22 change concepts do not change concepts do not make up at least 25% of the make up at least 25% of the improvement effort on a given improvement effort on a given project require the team to rethink project require the team to rethink the designthe design

Benchmark outcomes against the Benchmark outcomes against the industry best industry best

Measure processes against a Measure processes against a specific reliability goal (>95%)specific reliability goal (>95%)



If 10If 10--22 change concepts do not make change concepts do not make up at least 25% of the improvement up at least 25% of the improvement effort on a given project require the effort on a given project require the team to rethink the designteam to rethink the design

Benchmark outcomes against the Benchmark outcomes against the industry best industry best

Measure processes against a specific Measure processes against a specific reliability goal (10reliability goal (10--22))

Biology Protects UsBiology Protects Us

Shoulder Shoulder dystociadystociaincidence 0.6%incidence 0.6%--1.4%1.4%Permanent Brachial Permanent Brachial Plexus Injury (10% Plexus Injury (10% shoulder shoulder dystociasdystocias (0.06(0.06--0.14%)0.14%)



If 10If 10--22 change concepts do not make up at change concepts do not make up at least 25% of the improvement effort on a least 25% of the improvement effort on a given project require the team to rethink the given project require the team to rethink the designdesign

Benchmark outcomes against the industry Benchmark outcomes against the industry best best

Measure processes against a specific Measure processes against a specific reliability goal (10reliability goal (10--22))

Biology Protects UsBiology Protects Us

Monitor more than the sentinel eventMonitor more than the sentinel event--the the near missnear miss

Consider less than 100% ComplianceConsider less than 100% Compliance

With The Bundles A Near MissWith The Bundles A Near Miss

Why do our processes fail?Why do our processes fail?

Intentional Violation of the StandardsIntentional Violation of the StandardsUnintentional Violation of the StandardsUnintentional Violation of the Standards

Current processes in healthcare are highly dependent on Current processes in healthcare are highly dependent on vigilance and hard workvigilance and hard workThere is an inordinate focus on outcomes rather than processThere is an inordinate focus on outcomes rather than processPoor understanding of how to design reliable processes Poor understanding of how to design reliable processes Failure to design standard work which can be used in testing Failure to design standard work which can be used in testing and trainingand trainingInfrastructure isnInfrastructure isn’’t optimalt optimal

normalization of deviance - maryland patient safety center · normalization of deviance

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