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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
er is
sues
Wro
ng dos
e
Wro
ng dos
eO
miss
ion
Om
issio
nNot
doc
umen
ted
Not d
ocum
ente
d
Wro
ng tim
e
Wro
ng tim
eW
rong d
rug
Wro
ng dru
gW
rong r
ate
Wro
ng rat
ePyx
is iss
ues
Pyxis
issues
Expire
d dru
g
Expire
d dru
gW
rong f
orm
Wro
ng for
mW
rong p
atien
t
Wro
ng pat
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
ansfe
r
Difficu
lty w
ith tr
ansfe
r
Blood
and b
lood
pro
ducts
Blood
and b
lood
pro
ducts
Code B
lue
Code B
lue
Restr
aints
Restr
aints
Delay i
n serv
ice
Delay i
n serv
ice
Transfe
r to I
CU
Transfe
r to I
CU
Difficu
lt co
ntact
ing M
D
Difficu
lt co
ntact
ing M
D
Allerg
y
Allerg
yW
rong p
t info
Wro
ng pt i
nfo
Conse
nt
Conse
nt
Num
ber
of O
ccur
renc
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