TOPICS IN PATIENT SAFETY®VOL. 8, ISSUE 5SEPT/OCT2008

ContentsImproving the Safety of Anticoagulation Therapy in the VAPages 1 and 4

Case Study: Biomedical EngineeringPage 2

News From the Patient Safety Reporting SystemPage 3

VA National Center forPatient SafetyP.O. Box 486Ann Arbor, MI 48106-0486

Phone: ................(734) 930-5890Fax: ....................(734) 930-5877E-mail: ................ NCPS@va.gov

Web sites:Internet ....www.patientsafety.govIntranet...vaww.ncps.med.va.gov

VHA Chief Patient Safety OfficerJames P. Bagian, MD, PE

Editor Joe Murphy, APRGraphics Deb Royal Copy Editing Amy Carmack Deb Royal

TIPS is published bimonthly by the VA National Center for Patient Safety. As the official patient safety newsletter of the Department of Veterans Affairs, it is meant to be a source of patient safety information for all VA employees. Opinions of contributors are not necessarily those of the VA. Suggestions and articles are always welcome.

Thanks to all contributors and those NCPS program managers and analysts who offered their time and effort to review and comment on these TIPS articles prior to publication.

Improving the Safety of Anticoagulation TherapyBy Keith W. Trettin R.Ph., NCPS program managerBackground TheInstituteforHealthcareImprovement(IHI)inDecember2006announcedanexpansionof their“100,000LivesCampaign.”Thenewcampaign,“Protecting5MillionLivesfromharm,”expandedthelistof safetyinterventionsfromtheoriginalsixtotwelve,andincludes“PreventharmfromHigh-AlertMedications...startingwithafocusonanticoagulation,sedatives,narcoticsandinsulin.”1 In2007,theJointCommission(JC)expandedNationalPatientSafetyGoal3(NPSG3),“ImprovetheSafetyof UsingMedications,”toincludeNPSG3E,“Reducethelikelihoodof patientharmassociatedwiththeuseof anticoagulationtherapy.”2

NPSG3EistobephasedinthisyearandfullyimplementedbyJan.1,2009. Therationaleforboththeseactionsincludes:• Anticoagulationisahigh-risktreatment,

whichcommonlyleadstoadversedrugevents.

• Dosingof thesemedicationsiscomplex.• Monitoringisrequired.• Patientcompliancedirectlyaffects

outcomes.• Theuseof standardizedpractices

(thatincludepatientinvolvement)canreducetheriskof adversedrugeventsassociatedwiththeuseof heparin,low-molecularheparin,warfarin,andotheranticoagulants.

Theseactionsweresupportedbynationalanticoagulationtherapyadverseeventdata.Forinstance:• U.S.Pharmacopeiareportedin2006

that4.7percentof allincidentsreportedthroughitsMEDMARXsysteminvolvedanticoagulationtherapy;that7.8percentof incidentscausingpatientharmwere

relatedtoanticoagulation.• Batesreportedthatanticoagulants

accountedfor4percentof preventableadversedrugevents(ADEs)and10percentof potentialADEs.3

• Butnitz also identified in 2007 that one-in-sevenADEstreatedinemergencyroomsandmorethan25percentof allhospitalizationswerecausedbyanticoagulants.4

The VA Response TheVAestablishedamultidisciplinaryanticoagulationworkgrouptoaddresssafetyissues identified by the IHI and JC, as well as thosefoundwithintheVA.Theworkgroupfirst met in January 2007. Themultidisciplinarybackgroundof thegroup’smembersandconsultantshasprovided a firm foundation to analyze VA anticoagulationsafetyissuesanddeveloprecommendationsforimprovement. InadditiontosafetyconcernsnotedbytheIHIandJC,weatVANCPSalsoreviewedrootcauseanalysesof medicationincidents,availableinourNationalPatientSafetyInformationSystem,toidentifyanticoagulationvulnerabilities.5 Theworkgrouphascompleteditsrecommendationsandpreparedapaper,“ConsensusGuidanceontheElementsRequiredtoInsuretheSafeUseof Anticoagulants,”toaddressthem.6 Majorworkgrouprecommendationsincludethefollowing:• AllVAsitesshouldestablishoutpatient

programswhereanticoagulationforallpatientsismanagedbyproviderswhoarespeciallytrainedandskilledinmanaginganticoagulanttherapy.Please Note:InarecentVAstudy,itwasfoundthat70.6percentof patientsseeninhigh-volumeanticoagulation

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Case Study: Biomedical EngineeringBy Joe Murphy, NCPS public affairs officer

Background Apathologistnotedabnormallyhightestresultswhenworkingwithcertainspecializedtesttubes. Heparin,andathixotropicsub-stanceusedtoseparatecellsfromplasmainapatient’sbloodsample,areplacedinthesespecializedtesttubesduringthemanufacturingprocess. Thixotropicsubstancesarethick– like a solid – but can flow like a liquidwhendisturbed. Arecallof contaminatedheparinproducedinChinawasconcurrentwiththeabnormalresults. NCPSBiomedicalEngineerBry-annePatailnotesinthestorybelowthatthoughthe“China”connectioncouldn’tbediscounted,ithadnoth-ingtodowiththeactualproblem. Patailsaidthatmanyissuesencounteredbybiomedicalengineersrequire a significant amount of detec-tive work. It’s often about finding “thedifferencebetweenwhatpeopletellusandwhatactuallyhappened.”Abnormal Results WhenapathologistataVAfacil-ity began finding abnormally high testresults,hesuspectedaproblemwiththetesttubesinvolved. Thetubescontainedathixotrop-icsubstancelayerthat,whenspunonacentrifuge,preventsredbloodcellsfrombeingaspiratedbytheautomatedchemistryanalyzer–onlytheplasmaisaspirated.Alongwiththissubstance,thetubescontainedalithium-heparincompoundtokeepthebloodfromcoagulating. “Hewasgettingabnormalresultsandithappenedatthesametimeasabigheparinrecall,”saidPatail.“WeweregettingcontaminatedheparinfromChina.Andthesetesttubescontainedalithium-heparincom-pound,alongwiththethixotropicsubstance.” Patail’s first call was to the FDA. “WehaveaMemorandumof Under-standingtodocertainworktogether,

likesharinginformationonrecallsorpossiblerecalls,”hesaid. Hewasgiventhenameof thecompanythathadsuppliedthetainted heparin. The firm claimed not tohavesoldheparintoanytesttubecompanyforthepastsevenyears. “Ialsocalledthelabanalyzercompany,becauseoneof theirservicepersonshadbeenattheVAfacilityforaweek,trouble-shootingandrunningcontrolsandstandardsontheequipment,”saidPatail.“Theservicepersonfoundnoirregularitieswiththeequipment.” Pataillearnedfromthetesttubemanufacturerthatthethixotropicsubstancewasverysensitivetovaria-tions in specific gravity: “You have to spinitonaparticularkindof centri-fugeataparticularg-force.” The thixotropic substance floats aboveapatient’sredbloodcells.“The specific gravity is a little bit be-low that of red cells’ specific gravity, butnotaslowasplasma,”saidPatail.“Soitseparatesthetwo.” Hestartedcomparingalltheinformationhehadgottenfromthevarioussources,alongwithconduct-inghisownresearch.“IwentthroughmanydifferentiterationsbeforeIlearnedwhatwaswrong,”Patailsaid.What Went Wrong Itturnedoutthatthemixturewasbeingspunfortooshortatimeandattoolittleag-force. TheVAlaboratoryinquestionhadbeenspinningthismixtureonitscentrifuge“forages,”asthepatholo-gistputit,withnoerroneousresults. “Whenyouspintesttubes,mostdon’t require such specific rpms and g-forces,”saidPatail.“Of the17dif-ferenttypesof testtubessoldbythiscompany, eight have different specifi-cationsforuseonacentrifuge.” Hebelievesthatthelaboratory,throughsheerluck,hadn’texperi-encedproblemswithtestsinthepast.“Ithinkhehadbeenrightonthecuspof beingwithintolerancefora

longtime,”Patailsaid.“Hehadbeendoingthisforsolongthathedidn’tsuspectthatspinningwascausingtheproblem.” Thecomplexinstructions,placedwithinthepackagingof thetesttubes,hadn’tbeennoticedbystaff. Partof theinstructionsindicatedthetimeandg-forcerequired,aswellasthatthetesttubeswouldremainstablefornolongerthan48hours.(Thepathologisthadalsobeencom-paringresultswithtesttubesthathad been in storage for five days.)A Human Factors Problem Patail had first thought the problemwasduetotaintedheparin.“IthoughtIhadstumbledacrosssomethingthatwaswidespreadandbasedontheChinese-suppliedhepa-rin,”hesaid.“Butit’simportantnottojumptoconclusions.” Patailwenttothecompany’sweb site, downloaded the specifica-tions,andrealizedthattheproblemwasassociatedwithhumanfactorsengineering.“Thesystemjustdidn’tsupporttheindividual,”henoted. “Itseemstomethatif thereareonlyafewtesttubesmanufacturedlikethis,theinformationaboutuseshouldbeinbigblockletters:‘Im-portant!Dothisdifferently!’”Patailsaid. “Humanfactorsengineeringproblemsareofteninvolvedinsystemfailures,”hecontinued,“likeprovidinginformationthatiseasytooverlook,aswellasbeingprintedinaverysmallfont.It’simportanttoimproveweakorfaultysystems,notblametheindividualswhohavehadtoworkwithinthem.” Eventhoughonlythreehospi-talsintheVHAusethesekindsof testtubes,itisstillimportantthatallusershaveaclearunderstandingof whatisrequiredof them.

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News From the Patient Safety Reporting System (PSRS)By Linda Connell, NASA PSRS director

Background ThePatientSafetyReportingSystem(PSRS)isanexternal,con-fidential, voluntary, non-punitive reportingsystemthathasbeeninusesince2001. ItprovidesVAemployeeswitha“safety valve” to confidentially report adverseeventsandclosecallsthat,forwhateverreason,wouldnotbereportedelsewhere. PSRSisoperatedandmanagedbyNASA’sAmesResearchCenter,MoffettField,Calif.,throughaninteragencyagreementwithNCPS. TheprogramismodeledontheNASAAviationSafetyReportingSystem (ASRS), a confidential report-ingsystemthatservestheFAA. ASRShasbeenacollectionpointforimportantsafetyinformationusedtosupportaviationsystemimprovementssince1976.

What’s New ThePSRSteamhasvisited117VAfacilitiesduringthepastfewyearstoprovideinformationaboutthePSRSprogramtoVAstaff. Wehaveanewwebsite:http://psrs.arc.nasa.gov. Thesiteincludesissuesof our“FEEDBACK” publication.Thisshort,two-pagenewsletterisavailablein.htmland.pdf formatsforelec-tronicdistributioninyourfacility. WehaveissuedPatientSafetyBulletinsontopicssuchas:

Communicationof abnormaltestresults.Partialtabletdosing.Theuseof benzocaine.

WehavereceivedfeedbackfromVAPatientSafetyManagersthattherehavebeenimportantchangesto

policiesandproceduresowinginparttoreportsmadebyVAstaff viathePSRSprogram! Someof thechangeshaveincluded:

VA formulary modifications.Removalof disinfectantproductsusedfordentalservices.Changestofacilitypoliciesrelatedtooxygenuseintheoperatingroom.

We’re Here to Help TolearnmoreaboutPSRS,youcanvisitourwebsiteorsendanemailtoaPSRSmedicalsafetyanalyst,usingtheemailaddressesprovidedbelow. Wealwaysappreciatelearninghowwecanimproveandhowtheprogramhashelpedinyourfacility–aswellasreceivingyoursafetyreports. WewanttothankallVAstaff membersthathavecontributedreportstoPSRS.Points of ContactLindaConnell,PSRSDirector:Linda.J.Connell@nasa.gov

VISN2,4,11,16SueAndrew,R.N.suzanne.b.andrew@nasa.gov

VISN5,7,9,22PaulBoehm,M.S.,R.Ph.:paul.e.boehm@nasa.gov

VISN1,6,15,17,20E.CharliFreeman,R.N.:eileen.c.freeman@nasa.gov

VISN10,12,18,21ShoKahatsu,M.D.:shoichi.kohatsu-1@nasa.gov

VISN3,8,19,23StevePakula,M.D.:stephen.b.pakula@nasa.gov

PSRS Products & Publications

New PSRS Posters Will Arrive at Your Facility Fall 2008!

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Improving the Safety of Anticoagulation Therapy Continued from page 1

clinicshadanInternationalNormalizationRatio(INR)calculated;of these,58percentwerewithinthetherapeuticrange.Of veteransnotseeninaclinic,42percenthadanINRcalculated;52percentof thesewereinthetherapeuticrange.Itwas also identified that the most effectiveclinicswerethosethatwereadequatelystaffed–andhadlaboratorystaff includedassupportpersonnel.

• RequirepertinentlabtestsbedrawnandthatlabvaluesfromtestsconductedoutsidetheVAbeenteredintotheComputerizedPatientRecordSystem(CPRS)Please Note:Theworkgroupidentified a wide variation in hownon-VAlabresultsarereportedtoVAproviders,and/orenteredintotheelectronicmedicalrecord.Inmostcases,theresultshadbeenenteredintoaprogressnoteonly.Unfortunately,thisapproachmakestrackingdifficult, and does not link to prescriptiondispensing.Somesiteshavedevelopedwaystoenternon-VAlabresultsintotheVISTAlabpackage.

• HaveeachVAmedicalcenteradoptandplaceintoCPRSaweight-basedheparinprotocol.Astandardizedprotocol7reducesvariationinpractice.Itisalsoarequirementof NPSG3implementationstandardsanda“FiveMillionLives”recommendation.

• Offereducationalopportunitiestomedicalproviders,nurses,pharmacists,laboratorystaff,andothersassociatedwithanticoagulationtherapy.Medicalstaff mustremainup-to-dateonprescribing,dispensing,andmonitoringanticoagulants–arequirementof theNPSG3

implementationstandard.• Reduceturnaroundtimefor

INRresultsatcommunity-basedoutpatientclinicsorotherremotesites.Unlikepatientswhoareseenatamainfacility,thoseseenatremotesitesoftendonothaveaccesstoimmediateINRresults.If theprovidersuspectsapatient’sINRmaybeelevated,adelayinresultscanhavesignificant consequences.

Guidanceonimplementingtheserecommendationsisbeingdeveloped by a VHA Central Office workgroupandwillappearinaVAdirectiveoutdueearlyfall2008.Thegroupincludesrepresentativesfrompharmacy,primarycare,surgery,operations,laboratoryservice,cardiology,nursing,carecoordination,NCPS,andnutritionandfoodservices.What Can Be Done Now? Interestedprofessionalscancompleteasafety“high-riskassessment”fortheirorganizations,suchasareavailableontheInstituteforSafeMedicationPractices(ISMP)8orECRIwebsites.9 VAemployeescancompleteaVAmedicalcenteranticoagulationHealthcareFailureModeEffectAnalysis and/or a specific anticoagulationriskassessment.SamplesareavailableontheNCPSwebsite.10RelatedinformationisavailableontheISMPwebsite.11 VAMCpharmacyandtherapeuticscommitteesshouldevaluatetheconcentrationsof heparinavailableintheirinstitutions:Thegoalbeingtominimizeuseof highconcentrations(suchas10,000units/ml)–thathavebeenassociatedwithlook-alike/sound-alikeissues–throughtheuseof lessconcentratedversions(suchas10units/ml).Suchlook-alike/sound-alikeproblemshavebeenwelldocumentednationally.

VISN15recentlyreviewedheparinconcentrations:Asof July31,2008,heparinwithaconcentrationof 10,000units/mlwasnolongertobestockedwithintheirmedicalcenters.Thisisanexcellentexampleof takingtheappropriateaction.Notes1. Clickto:www.ihi.org

2. Clickto:http://www.jointcommission.org/PatientSafety/NationalPatientSafetyGoals

3. BatesDW,“Incidenceof adversedrugeventsandpotentialadversedrugevents:Implicationsforprevention,”ADEPreventionStudyGroup.JAMA1995:27422-34.

4. BudnitzDS,“Medicationuseleadingtoemergencydepartmentvisitsforadversedrugeventsinolderadults,”AnnInternalMed2007:147(11):755-765.

5. VAemployeescanreadasummaryof thesevulnerabilitiesat: http://vaww.ncps.med.va.gov/Initiatives/Hazards/anticoag.html.ArecentanticoagulationRCAtopicsummaryisalsoavailable:http://vaww.ncps.med.va.gov/Initiatives/RCATopics/index.asp

6. ThepaperisavailabletoVAemployeesontheVA-IHIHighRiskMedicationSharePoint:http://vaww.national.cmop.va.gov/PBM/Clinical%20Guidance/Forms/AllItems.aspx?RootFolder=%2fPBM%2fClinical%20Guidance%2fClinical%20Recommendations&View=%7b786029AE%2d74D9%2d40BC%2dBCC7%2dBECF18B1B7FD%7d

7. VA employees can find links to sample protocolsandpoliciesontheNCPSwebsite:http://vaww.ncps.med.va.gov/Guidelines/NPSG/index.html

8. TheISMPsite:http://www.ismp.org selfassessments/Hospital/2004Hospsm.pdf

9. TheECRIsite:http://www.ecri.org/Documents/Sample_CCRM_Medication_Safety_SAQ.pdf

10.TheVANCPSsite:http://vaww.ncps.med.va.gov/Initiatives/HFMEATopics/list.asp

11.TheISMPsite:http://www.ismp.org/Tools/anticoagulantTherapy.asp