Laura M. Lee, R.N.Laura M. Lee, R.N.Clinical Center, NIHClinical Center, NIH

The Epidemiology The Epidemiology of Clinical Errors of Clinical Errors

in a Research Hospital:in a Research Hospital: Mining Occurrence Reporting Mining Occurrence Reporting

Data for Data for ““Low Hanging Fruit”Low Hanging Fruit”

Bona BenjaminBona Benjamin Steve BergstromSteve BergstromGinnie DaineGinnie Daine Charles DanielsCharles DanielsClare HastingsClare Hastings David HendersonDavid HendersonMary SparksMary Sparks

• 250 bed hospital at NIH250 bed hospital at NIH• Mission is clinical research; Mission is clinical research;

primary primary product is scienceproduct is science• All patients are volunteers All patients are volunteers • Over 1100 protocols (Phase I or Over 1100 protocols (Phase I or

II clinical trials, natural history)II clinical trials, natural history)• ““High risk; high reward” High risk; high reward”

The Clinical CenterThe Clinical Center

The TeamThe Team

• First implemented in 1980First implemented in 1980• Part of Medical Information SystemPart of Medical Information System• Exceeded regulatory requirementsExceeded regulatory requirements• User feedback – uniformly negativeUser feedback – uniformly negative

Inflexible architectureInflexible architecture Limited data entry optionsLimited data entry options ““Black hole” - no feedback Black hole” - no feedback Limited use as an improvement toolLimited use as an improvement tool

Electronic Occurrence Reporting: Electronic Occurrence Reporting: 1980 - 19971980 - 1997

• In 1998 reengineered entire system based In 1998 reengineered entire system based on stakeholder requirementson stakeholder requirements Non-punitive environmentNon-punitive environment Web-basedWeb-based Logical, user-friendly data entryLogical, user-friendly data entry Automatic notification of “content Automatic notification of “content

experts”experts” Users ability to view occurrence reports Users ability to view occurrence reports

and follow-up informationand follow-up information Flexible architecture that allows for Flexible architecture that allows for

customizable data collection customizable data collection Customization of reports (e.g., unit, Customization of reports (e.g., unit,

Institute, protocol)Institute, protocol)

Occurrence Reporting: PresentOccurrence Reporting: Present

Occurrence Reporting SystemOccurrence Reporting System

0

1000

2000

3000

4000

5000

6000

1986 1987 1999 2000 2001 2002

1st Qtr 2nd Qtr 3rd Qtr 4th Qtr Year Total Ave/Qtr

Nu

mb

er o

f O

ccu

rren

ces

System redesignSystem redesign

Education and Education and increase attention to increase attention to

patient safetypatient safety

Regular feedback Regular feedback provided to usersprovided to users

Occurrence Reporting TrendsOccurrence Reporting Trends

Medication 22%

Treatment 50%

Falls/Injury5%

Support Services

14%

Equipment6%

Environment3%

Treatment RelatedTreatment Related Code Blue Code Blue Protocol/Consent Protocol/Consent Clinical CareClinical Care AllergyAllergy Contact difficultyContact difficulty TransfersTransfers Specimen collectionSpecimen collection RestraintsRestraints Vascular Access DeviceVascular Access Device

Types of OccurrencesTypes of Occurrences

Medication EventsMedication Events

0

20

40

60

80

100

120

140

160

Num

ber

of O

ccur

renc

es

Oth

er is

sues

Oth

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sues

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rug

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ate

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issues

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rong f

orm

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atien

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ient

Delay i

n adm

in

Delay i

n adm

in

Allerg

y

Allerg

yW

rong

Wro

ng

quant

quant

Treatment-Related OccurrencesTreatment-Related Occurrences

0

100

200

300

400

500

600

700

800Clin

ical

Clinica

l

Care

Care

Specim

en co

llect

ion

Specim

en co

llect

ion

Oth

er ev

ents

Oth

er ev

ents

Vascu

lar a

cces

s

Vascu

lar a

cces

s

Difficu

lty w

ith tr

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Difficu

lty w

ith tr

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Blood

and b

lood

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ducts

Blood

and b

lood

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ducts

Code B

lue

Code B

lue

Restr

aints

Restr

aints

Delay i

n serv

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Delay i

n serv

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r to I

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Transfe

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Difficu

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D

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rong p

t info

Wro

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nfo

Conse

nt

Conse

nt

Num

ber

of O

ccur

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es

Total reports classified as errorsTotal reports classified as errors 38%38%Did not reach patientDid not reach patient 24%24%Reached patient but no change in patient statusReached patient but no change in patient status 36%36%Resulted in increased monitoringResulted in increased monitoring 37%37%Temporary change in statusTemporary change in status 2%2%Prolonged LOS or harmProlonged LOS or harm <1%<1%Near-death eventNear-death event <1%<1%DeathDeath --------

Errors adversely affecting Errors adversely affecting patient outcomespatient outcomes 3%3%

Errors adversely affecting Errors adversely affecting clinical researchclinical research <1%<1%

Impact on Patient Care and Impact on Patient Care and Clinical ResearchClinical Research

So we know that bad things So we know that bad things happen… happen…

• We now haveWe now have lots lots of data about “untoward of data about “untoward events” that occur in our clinical research events” that occur in our clinical research environmentenvironment

• Needed a process / methodology for:Needed a process / methodology for: Managing the dataManaging the data Identifying clusters of eventsIdentifying clusters of events Driving process improvementDriving process improvement Continuously monitoring the eventsContinuously monitoring the events

Medication ClustersMedication Clusters

Fent/Mida mix-Fent/Mida mix-upsups 99

Look alike Look alike medsmeds 4545 OngoingOngoing

Delay in starting Delay in starting PCAPCA 2020

Cyclosporine Cyclosporine levelslevels 88

Peds dosing Peds dosing errorserrors 77

Rituximab ratesRituximab rates 44 Meds at bedsideMeds at bedside 1212

Omitted resp Omitted resp therapy rxtherapy rx 66

Omissions r/t Omissions r/t roller clampsroller clamps 55 OngoingOngoing

Sterile product Sterile product labelslabels 6565 OngoingOngoing

ORS Data

Staff e

duca

tion

Comm

unica

tion

Patien

t Edu

catio

nIn

form

ation

Sys

tems

Docum

entat

ion

Device

Cha

nge

Policy

Cha

nge

Practi

ce C

hang

e

Proce

ss R

edes

ign

Contin

uous

M

onito

ring

ClusterCluster

Care Delivery and Device ClustersCare Delivery and Device Clusters

Device RelatedDevice Related

Butterfly Butterfly needle failureneedle failure 2828

ORS Data

Staff e

duca

tion

Comm

unica

tion

Patien

t Edu

catio

nIn

form

ation

Sys

tems

Docum

entat

ion

Device

Cha

nge

Policy

Cha

nge

Practi

ce C

hang

e

Proce

ss R

edes

ign

Contin

uous

M

onito

ring

ClusterCluster

Care DeliveryCare Delivery

Management Management

of tracheotomy of tracheotomy patientspatients

OngoingOngoing 1717

• Implementation of a non-punitive, interactive Implementation of a non-punitive, interactive Occurrence Reporting System dramatically Occurrence Reporting System dramatically increased reporting of clinical care events in a increased reporting of clinical care events in a clinical research institution;clinical research institution;

• The ORS database facilitates The ORS database facilitates epidemiological identification of clusters of epidemiological identification of clusters of adverse events;adverse events;

• Data from the ORS can be used to drive Data from the ORS can be used to drive clinical performance improvement activities clinical performance improvement activities and increase patient safety in our and increase patient safety in our environment;environment;

The ORS is a reliable mechanism for The ORS is a reliable mechanism for monitoring the efficacy of improvement monitoring the efficacy of improvement interventions.interventions.

ConclusionsConclusions