Adherence to a Medication Safety

Protocol: Current Practice for

Labeling Medications and
Solutions on the Sterile Field
DIANA BROWN-BRUMFIELD, RN, APRN-BC, MSN, CNS, CNOR; AGRIPINA DeLEON, RN, MSN, CNOR

ABSTRACT
MedicationlabelingomissionsintheORandtheadverseeventsthatresultfromthem
remain a challenge in health care facilities. Standardization of protocols based on
guidance from the Joint Commission, AORN, the Institute for Safe Medication
Practices,andotherorganizationsisimportanttoensurethatpatientsdonotmistakenly
receivethewrongmedication.Aclinicalnursespecialistandaperioperativeeducation
coordinatorattheClevelandClinic,Cleveland,Ohio,undertookadirectobservation
quality improvement project to assess the adherence of 21 nurses and 19 surgical
technologiststoarevised medicationandsolutionlabelingprotocolimplemented in
February 2008. Results showed that overall, 70% of staff members adhered to the
medicationandsolutionlabelingprotocolbutadherencevariedamongspecialtyareas.
Therewasincreasedadherencetotheprotocolbyjuniorstaffmemberscomparedwith
more experienced staff members. AORN J 91 (May 2010) 610617. AORN, Inc,
2010.doi:10.1016/j.aorn.2010.03.002

Keywords:medicationsafetyprotocol,perioperativeerrors,medicationlabeling.
thesurgicalfield.3
Additionalprocess
expectationsinclude
2007,specific
thatnomorethanone
requirementswere
addedtothegoal,
medicationorsolution
edicationerrorsintheperioperativesettingare
recognizedasaseriouspotentialthreatto
patientsafety,1andthe
statingthatalllabels
shouldbelabeledata
practiceofsafemedicationdispensingandlabeling
shouldincludethe
time.If,duringthe
requiresconsistencyacrosstheperioperative
medicationsname,
perioperativeperiod,a
spectrum.TheJointCommissionfocusedattention strength,amount,and
solutionormedication
onthisissuein2006viatheNationalPatientSafety
expirationdate.3Each
thatisremovedfrom
Goals,whichdirecthealthcareprovidersto
medicationshouldbe
itsoriginalcontainer
immediatelylabelallmedications,medication
labeledasitis
willbeusedoverthe
containers(eg,syringes,medicinecups,basins),and
dispensed,evenwhen
courseofaprocedure,
othersolutionsonandoffthesterilefieldin
thereisonlyonemedi
thereceivingcontainer
perioperativeandotherproceduralsettings. 2In
cationorsolutionon

doi:

610

AORNJournalMay2010

Vol91No5

10.1016/j.aorn.2010.03.002

AORN,Inc,
2010

MEDICATION SAFETY PROTOCOL www.aornjournal.org

heleftthespecimen
mustbelabeledimmediatelywhenthatmedication
storagecontaineronthe
orsolutionistransferredfromtheoriginal
sterilefieldandleftthe
packaging.Alllabelsshouldbeverifiedbothver
OR.Thecontainer,
ballyandvisuallybytwoqualifiedindividualswhen
whichwasnotlabeled,
thepersonpreparingthemedicationisnottheperson
contained
administeringthemedication.3
glutaraldehydetopre
Proactivepreventionofmedicationerrorsin
servetheeye.Nearthe
perioperativesettingsisvitaltopositivepatient
endoftheprocedure,
outcomes.Tothisend,AORNhasproduceda
theanesthesiologist
guidancestatementtoaidcliniciansinthedevel
accidentally
opmentandimplementationofpoliciesandproce
administeredanintra
duresrelatedtosafemedicationpracticesinsettings
thecalinjectionofthe
whereinvasiveproceduresareperformed. 4AORN glutaraldehyde,
alsotookaleadershiproleinaddressingthisissueby believingitwasthe
developingaSafeMedicationAdministrationTool
patientsspinalfluid.
Kit5thatprovidesstrategiesthatareconsistentwith Thepatientexperi
evidencebasedpracticetoreducemedicationerrorin encedimmediate
theperioperativearea.
cardiacarrestandlater
Despitetheserecommendationsandpractice
died.
guidelines,therecontinuetobenationwideprob
TheInstitutefor
lemswithmedicationlabelingcompliance.This
SafeMedication
articledescribesaqualityimprovement(QI)project Practices(ISMP)has
weconductedintheORattheClevelandClinic,
alsoreportedincidents
Cleveland,Ohio,forthepurposeofassessingstaff involvingunlabeled
medicationsin
adherencetoarevisedmedicationandsolution
labelingprotocolthatwascreatedbasedon
proceduralsettings.7In
recommendationsfromtheJointCommissionand Seattle,Washington,a
womandiedaftershe
AORN.
wasinjectedwithan
antisepticskin
THE NEED FOR STANDARDIZATION
Unlabeledmedicationsandsolutionsonthesterile preparationsolution
insteadoftheintended
fieldhavecausedmanyerrorsandsometragic
7,8
outcomes.Oneoftheearliestcasereportsappeared contrastmedia. In
anotherincident,a
intheJuly1989MedicationErrorReportsin
physicianmistakenly
HospitalPharmacy.Duringanenucleationofa
cancerouseye,anunlabeledspecimencupcontaining appliedagermicidal
detergentwithapHof
glutaraldehydewasmisidentifiedasspinalfluid. 6The
13toamalepatients
anesthesiologisthadaspiratedspinalfluidtodecrease genitals,believingthat
thepatientsocularpressureandhadplaceditina itwasvinegar.The
smallvialmarkedSFonthesterilefieldfor
patientexperienced
reinjectionattheendofthesurgery.An
severeburns.7,8
ophthalmologyresidententeredtheroomtoretrieve
Thesecasesclearly
theeyeforbiopsy,butbecausethespecimenwasnot
demonstratethat
yetreadytobetaken,
incidentsofunlabeled

medicationintheOR
canresultintragic
errors,andthey
supporttheneedfor
additionaldiligencein
thisareaof
perioperativepractice.
Ineachofthesecases,
arootcauseanalysis
suggestedreviewand
revisionofcurrent
practiceand,when
analyzed,supported
theimplementationof
standardizationin
methodsfor
identifyingsolutions
andmedicationsonthe
sterilefield.
Findingsfromthe
2004ISMPMedication
SafetySelfAssessment,
whichincludeddata
gatheredfrommore
than1,600hospitals,
showedthatlessthan
halfofstaffmembers
(41%)alwayslabeled
containers(eg,syringes,
basins,othermedication
orsolutionstorage
containers)onthe
sterilefield.9Fortytwo
percentappliedlabels
inconsistently,and
18%didnotlabel
medicationsand
solutionsonthesterile
fieldatall.9Although
theseresults
representedan
improvementfromthe
2000ISMPfindings(ie,
25%reportedconsistent
labeling;24%reported
nolabeling),
surprisingly,thisbasic

safetymeasurehasnotbeenwidelyimplementedin surgicalpatients
typicallyaresedated
hospitals.9Thisisespeciallydisturbingbecause
andcannotinterveneon

theirownbehalfand,
therefore,maybemore
vulnerableto

AORNJournal611

BROWN-BRUMFIELDDeLEON
May2010Vol91No5

m
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cal
tea
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ex
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nd
th
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to
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allergies,and
confirmationof
preprocedural
antibiotic
administration.
Cliniciansshould
adheretothe
practiceofrepeat
andverifyduring
handoffsbetween
scrubpersonnel
andsurgeons.
Clinicians must
examine policies
and procedures
for accuracy and
clarity.
Managersmust
examinewhy
policiesarenot
beingfollowed,
whichmayinclude
anassessmentof
thepractitioners
awarenessofthe
policies.
Verbal
communication
betweenthe
circulatingnurse
andscrubperson
mustbeclear,and
bothmustconfirm
themedicationson
thesterilefieldas
wellasthelabeling
ofthemedications
onthefield.
Allmedications
shouldbelabeled
toaccommodate
theneedsofthe

anesthesiacare
provider.
Medicationsshould
belabeledin
accordancewith
generallyaccepted
safetystandards
(eg,productname,
strength,nameof
staffmember
preparing).
Miscommunication,
inadequate
documentation,and
failuretofollow
proceduresand
protocols

w
T

6
1

plain maybenowaytosafely
or determinewhatthey
with are.
additi
ves)
but THE QI PROJECT
have We(ie,aclinicalnurse
much specialist[CNS]anda
differ perioperativeeducation
ent coordinator)conducted
ac afieldobservationof
tions.nursesandsurgical
When technologistswith
they variedamountsofOR
are experienceworkingin
unlab eightdifferentsurgical
eled specialtyareasto
on assessstaffmember
the adherencetoarevised
sterilemedicationand
field, solutionlabeling
there protocol.Therevised
AORNJournal

protocolwas
developedbasedon
recommendations
fromtheJoint
Commissionand
AORN,anditwas
implementedin
February2008.Staff
membersreceived
educationonthenew
protocolatthetimeit
wasimplemented.
Thedesignofthis
projectwassimilarto
thatofaprevious
projectthatassessed
staffmember
adherencetothe
surgicalinstrument
countpolicyusingOR
fieldobservation.12
Theobservational

MEDICATION SAFETY PROTOCOL www.aornjournal.org

ofexperience,andall
ofthesurgical
technologistshadless
than20yearsof
experience.Surgical
specialtiesincluded
vascular,pediatrics,
gynecology,urology,
generalsurgery,
plastics/ENT,neu
rology,andcolorectal
surgery.
Measures/Instrume
nts
TheCNS(ie,the
primaryinvestigator)
andtheperioperative
Figure 1. Project sample size and team role.
nurseeducators(ie,
sevenexperienced
perioperativestaff
questionsframedforthisprojectincludedthe
members)composed
following:
theeightquestiondata
Wouldstaffmembers(ie,nurses,surgical
collectiontoolforthis
technologists)dispensemedicationsandlabel
fieldproject.Thistool
themaccordingtothemedicationandsolution
consistsoffoursurvey
labelingprotocol?
questionsandfour
Wouldadherencetothemedicationandsolution
observationquestions
labelingprotocoldifferbysurgicalspecialty?
designedtoassess
Wouldadherencetothemedicationandsolution
staffmembers
labelingprotocoldifferbyyearsofstaffmember
experienceand
experience?
practicebehavior
Wesubmittedthisprojecttotheinstitutionalreview (Figure2).Content
boardattheClevelandClinicandtheboarddeemedit validitywasbasedon
aQIproject;thus,nosanctionswereassociatedwith
thisproject.
theextensive
surgical
Sample
The project sample consisted of nurses (n 21),
experienceofthe
certified surgical technologists (n 7), and non
nurseeducators
certified surgical technologists (n 12) assigned to
andtheCNSand
surgicalproceduresidentifiedforthisproject.
theirindepth
knowledgeof
Onenursefunctionedasascrubperson(Figure1).
industrystandards
TenoftheRNshadmorethan20yearsof
regarding
experience,11oftheRNshadlessthan20years
medicationand
solutionlabeling

and
item
material
content that is
directly related to
the new Cleveland
Clinic medication
and

solution
protocol.
Data Collection
Theprimary
investigatoridentified
surgicalproceduresthe
daybeforetheywere
scheduledtooccurand
reconfirmedthemon
thesamedaythedata
werecollected,incase
someprocedureswere
cancelledorotherswere
addedon.Sheselected
surgicalproceduresin
whichfrequent
medicationandsolution
usewasroutineand
proceduresthatshe
determinedtobethat
daysoptimalopportu
nitiesormostdesirable
situationsfordata
collection.Theprimary
investigatorvariedthe
surgicalspecialties(eg,
vascular,pediatrics,
general)observed
duringthedata
collectionperiod.
ANurseofthe
Futurestudentserved
astheobserverand
datacollectorforthis
project.TheNurseof
theFutureprogramis
designedtoexpand
highschoolstudents
knowledgeofscience

andmedicinewhileexposingthemtothewiderange communityhospitals,
ofcareerpathsinnursingattheClevelandClinic,its andfamilyhealth
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F
i

c
T

sp
on
se
to
be
in
g
ob
se
rv
ed
),
st
af
f

memberswere
informedthatthe
studentwouldbe
observingteam
dynamics.
Thisinternprogram
hasrigorouscriteriafor
admittance,andthe
studentsareconsidered
tobetemporary
employeeswho
completehospitalori
entationbeforecoming
totheirrespective
clinicalareas.
Compliancewith
HealthInsurance
Portabilityand
AccountabilityAct
regulationsandconfi
dentialityarepartof
theirorientation.
Patientsdidnothaveto
givetheirpermission
forthestudents
presencebecausethis
projectwasan
observationofstaff
membersonly.
We briefed the
observer for each
surgical procedure.
The observer used the
data collection tool to
achieve consistency
andtofacilitatedata

AORNJournal

MEDICATION SAFETY PROTOCOL www.aornjournal.org

Figure 3. Adherence to the medication and solution safety protocol.

collectionintheOR.Thetoolincludedinformation
onspecificservicesandprocedures.Shecompleted
formsatthestartofeachprocedureandduringrelief
ofscruborcirculatingpersonnel.Sheobservedthe
handoffcommunicationforthemedicationsand
solutions.
Weprovidedtheobserverwithascriptofquestions
toaskstaffmembersabouttheservice,status,andlength
oftimeintheORaswellasquestionsaboutthetypeof
procedurebeingperformed.Datawerecollectedforfive
daysintheORforsurgicalproceduresscheduledduring
routinebusinesshours.Wereviewedalldatacollected
eachdaywiththeobserver,andsheplacedallcompleted
dataformsinafileinasecurelocationknownonlyto
us.
Data Analysis
We performed descriptive statistics and analysis
with the collected data. The analysis included a
written narrative, as well as a presentation with
tablesandgraphsforaddedclarityanddetail.
RESULTS
Theobservercollecteddataon24surgicalproce
duresduringafivedayperiod.Thisrepresentsthe
totalnumberofsurgicalproceduresthatwere
availablefordatacollectionduringthedesignated
period.Eightyfivepercentofthetime,thedata
collectorobservedstaffmembersidentifyingmed
icationsandsolutionsaccordingtotherevised

protocol.Sheobserved
teammemberslabeling
medicationand
solutioncontainers
immediatelybeforeor
afterdispensingthem
ontothesurgicalfield
70%ofthetime,
reconfirming
medicationsand
solutionsduringthe
procedure60%ofthe
time,andreviewingall
medicationsand
solutionsduringbreak,
relief,orshiftchange
75%ofthetime
(Figure3).
Additionally,the
projectprovidedthe
insightthatlackof
adherencetothe
protocolwassomewhat
relatedtolengthof
employment.Inmostof
thecategoriesobserved,
nurseswithmorethan
20yearsofexperience
hadahigherrateof
nonadherencetothe

protocol,whereasstaffmemberswithlessthan20
resistanttochange.The
yearsofexperienceweremorecompliant(Table1). lessseniorstaff
ThiswasconsistentwiththeearlierQIprojecton
membersweremore
surgicalcountsinwhichitwasnotedthatmoresenior opentomodifyingtheir
staffmembershadtheirownmethodsandwere
practiceandmore
comfortablethattheirmethodworked.Theyjustified acceptingof
thisbythefactthattheyhadnotexperienced
explanationsaboutwhy
problems.Peoplewhohavedonesomething
thechangewasneeded.
repetitivelyforalongtimewithoutilleffectsareoften

Therateofadherence
withtheprotocolalso
variedbyspecialtyarea,
creatingan
inconsistencyof
practiceamongthe
specialites.
Standardizing

AORNJournal615

BROWN-BRUMFIELDDeLEON
May2010Vol91No5

T
A
B
L
E
1
.
C
o
m
p
li
a
n
c
e
W
i
t
h
E
l
e
m
e
n
t
s
o
f
t
h
e
M
e
d
i
c
a
t

i
o
n
a
n
d
S
o
l
u
t
i
o
n
L
a
b
e
li
n
g
P
r
o
t
o
c
o
l
b
y
S
t
a
f
f
M
e
m
b

ers Years of Experience

Staff members with less than

20 years of experience (n30)

Identified medications/solutions
Labeled medications/solutions
Reconfirmed medications/
solutions during the
procedure
Reviewed medications/
solutions during relief or
break

p
a
i
D
M
T

Staff members with more than

20 years of experience (n10)

Compliant with
protocol

Not compliant
with protocol

25 (83%)
22 (73%)
20 (67%)

5 (17%)
8 (27%)
10 (33%)

8 (80%)
6 (60%)
5 (50%)

2 (20%)
4 (40%)
5 (50%)

22 (73%)

8 (27%)

8 (80%)

2 (20%)

communicatingthesefindingsand
providingadditionaleducationon
theprotocol,specificallyby
improving communication
hand offs during breaks,
relief,andshiftchange;
developing a quarterly
competency review; and
updatingorientationmodules.
We have identified this as a
highprioritycompetencyandplan
to incoporate it into our annual
competency requirements for all
staffmembers.
ThisQIprojectwillserveasa
pilotprojecttouncover
indicationsforfurther
investigationandprovide
guidanceforothereducational
activitiesthatsupportandfoster
patientsafetyintheperioperative
environment.

Compliant with
protocol

Not compliant
with protocol

MEDICATION SAFETY PROTOCOL www.aornjournal.org

7.

Loudwakeupcall:
unlabeledcontainerslead
topatientsdeath.ISMP
MedicationSafetyAlert!
December2,2004.
InstituteforSafe
MedicationPractices.
http://
www.ismp.org/Newslette
rs/acutecare/articles/2004
1202.asp.Accessed
February2,2010.

CONCLUSION
Thesurgicalteamisresponsibleforusingallrea
sonablemeasurestoprotectthepatient.Medication
errorsintheperioperativesettingposeapotentially
significantthreattopatientsafety.Teammembers
mustacknowledgethatseriousmedicationerrorscan
anddooccureveniftheythemselveshaveneverbeen
involvedinamedicationmishap.Established
guidelines,bestpracticerecommendations,and
8. Unravelingthe
unlabeledcontainers
protocolsareavailableandshouldbediligently
issue.ISMPMedi
followedtodecreasethelikelihoodofmedication
cationSafetyAlert!
labelingerrorsandinjurytothepatientswhorelyon
June18,1997.
InstituteforSafe
ourcare.
Acknowledgement:TheauthorsthankPatricia
Adler,PhD,RN,CNS,seniornurseresearcheratthe
ClevelandClinicFoundation,Cleveland,OH,and
DiamondHaynes,studentpeermentor,the
ClevelandClinic,fortheirassistancewiththe
projectdescribedinthisarticle.

MedicalPractices.
http://www.ismp.org/
Newsletters/
acutecare/articles/1997
0618.asp.Accessed
February2,2010.

9.

References

Erroralert:
unlabeledbasinsin
sterilefield[news
release].Horsham,
PA:Institutefor
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Practices;December
2,2004.
http://www.ismp.org
/
pressroom/PR20041
202.pdf.Accessed
February2,2010.

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ThompsonCA.Surgicalunitshavehighpotentialfor
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4.

5.

6.

11.

DawsonA,Orsini
MJ,CooperMR,
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2005;82(3):399
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12.

BrownBrumfieldD.
Adherencetonew
CCFsurgical
instrumentcount
policy.Poster
presentedat:54thAn
nualAORN
Congress;March11
15,2007;Orlando,
FL.

DianaBrown
Brumfield,RN,
APRNBC,MSN,
CNS,CNOR,isthe
clinicalnursespe
cialistandmanager
forperioperative
educationatthe
ClevelandClinic,
Cleveland,OH.Ms
BrownBrumfield
hasnodeclared
affiliationthat
couldbeperceived
asposinga
potentialconflictof
interestinthe
publicationofthis
article.
AgripinaDeLeon,
RN,MSN,CNOR,is
theeducation
coordinatorfor
perioperative
servicesatthe
ClevelandClinic,
Cleveland,OH.Ms
DeLeonhasno
declaredaffiliation
thatcouldbe
perceivedasposing
apotentialconflict
ofinterestinthe
publicationofthis
article.

AORN
Journal
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