appendix i vista laboratory blood bank user manual hazard analysis

August 1998 Laboratory V. 5.2 Appendix I-1Blood Bank User Manual

APPENDIX IVISTA LABORATORY BLOOD BANKUSER MANUALHAZARD ANALYSIS

Appendix I-2 Laboratory V. 5.2 August 1998Blood Bank User Manual


Table of Contents

Introduction ----------------------------------------------------------------------------------------------- 5

Section XI: Hazard Analysis -----------------------------------------------------------------------5Procedure---------------------------------------------------------------------------------------------- 5

Definitions of Terms: ----------------------------------------------------------------------------5

Donor Intended Uses Hazards Analysis ----------------------------------------------------------- 7

Inventory Intended Uses Hazard Analysis ----------------------------------------------------- 29

Patient Intended Uses Hazard Analysis -------------------------------------------------------- 53

Table of Contents



Introduction

Section XI: Hazard Analysis

Procedure

A Hazard analysis was performed on the Intended Uses of the VISTA Blood BankSoftware Version 5.2. The method used to perform this analysis was modeled afterthe Software Failure Mode, Effects, and Criticality Analysis (SFMECA) mode asdescribed in the NIST Special Publication 500-234 entitled Reference Informationfor the Software Verification and Validation Process. The report is divided intothree sections Donor, Inventory, and Patient. Each Intended Use (as described inSection V) was reviewed for potential software hazard. Related Intended Uses havebeen combined when the Hazard was similar or related.

Definitions of Terms:

The Intended Use Hazard Analysis is listed using table format.

The First column is the HA#.

The Second column is the actual HAZARD. This is the potential risk involved if theIntended Use does not function as advertised.

The Third column is CAUSES. This is an assessment of possible causes for theIntended Use to not function as advertised or could also be unavoidableconsequences of human intervention.

The Fourth column is LEVEL OF CONCERN. This is a qualitative assessment andwill use the following terms:

HIGH: High probability that patient harm could occur.MOD: Moderate probability that patient harm could occur.LOW: Low probability that patient harm could occur.NONE: No harm to patient possible.

Introduction


The Fifth column is LIKELIHOOD. This is a qualitative assessment and will usethe following terms:

HIGH: Very likely that a situation could occur allowing this hazard.MOD: Somewhat likely that a situation could occur allowing this hazard.LOW: Unlikely that a situation could occur allowing this hazard.NONE: This hazard would never occur in a user's environment.

The Sixth column is METHOD(s) OF CONTROL. This is a description of thecontrols built into the software to prevent the Intended Use Hazard from occurring.

The Seventh column is TRACE. This is a trace to the Software RequirementSpecifications (SRS#--see Appendix H) and Safety Critical Requirements (SCR#-seeAppendix G) of the Intended Use Hazard.


Donor Intended Uses Hazards Analysis

HA# Hazard Causes Level ofConcern

Likelihood

Method (s)of Control

Trace

HD1 Chance ofduplicate Donorrecords existingin the BLOODDONOR file(#65.5).Previous donordeferral historymay not beaccuratelydisplayed.

1) Female patientmarrying andchanging lastname.2) Typographicalerror on donor lastname during dataentry.

LOW LOW Softwarechecks donorlast nameand Date ofBirth forpossiblematchesduring dataentry.Optionexists tomerge data(donationsubrecords)from twodonorrecords inthe eventthat aduplicatedonor recordis created.

SRS# D10SRS# D20SRS# D83

SCR# D1

HD2 Chance ofduplicate orincompletesubrecords for aparticulardonation date.

Data entry for adonation episodenot completed anddonor has repeatdonation.

LOW LOW During dataentry, onlymost recentdonation/deferral datecan beedited.

SRS# D11

SCR# D3

HD3 Unable todeterminecorrectdonation type.Unit testingacceptancecriteria arebased ondonation type.

Data entry error. LOW LOW Autologousrequiresexact matchentry fromthePATIENTfile (#2) intheRestrictedFor field(#1.2).

SRS# D9SRS# D34

SCR# D4

HD4 Recordincompleteafter dataentry.

Computer crashduring data entry.

NONE LOW Data can bere-enteredoncecomputerproblemresolved.

SRS# D11SRS# D12

SCR# D7

Donor Intended Uses Hazard Analysis



Likelihood

Method (s)of Control

Trace

HD5 Unable todeterminepersonperforming aparticular stepin data entryprocess.

NONE NONE NONE Assignmentof respon-sibilityautomaticbased onidentity ofindividualdeterminedupon log-into system.

SRS# D12SRS# D14

SCR# D7

HD6 Unable to usebar-codeidentification ofdonor units.

1) Site not barcodelabeling productsprocessed in-house.2) Barcode Scannermalfunctions.

NONE LOW If bar-codescanner notused, twoseparateindividualsarerequired tocompletetheLabeling/release ofdonor units

SRS# D15

SCR# D4

HD7 Changes inverified datanot tracked.

VA FileMan used toedit fields directlyrather thanspecified menuoptions.

LOW LOW Directaccess toBlood Bankdata filesthrough VAFileManshould berestrictedby sitepolicy.

SRS# D16

SCR# D5

HD8 Sensitive Donordata security iscompromised

Menu optionsdisplaying sensitivedata not restrictedappropriately

LOW LOW Menuoptionscontainingsensitivedata shouldberestrictedby securitykeys.

SRS# D1

SCR# D2

HD11 Erroneous UnitID’s assigned toDonor upondata entry ofhistorical data.

Data entry error. LOW LOW SoftwaresearchesBLOOD IN-VENTORYfile (#65) forpossibleduplicateentries.

SRS# D18

SCR# N/A




Likelihood

Method(s)of Control

Trace

HD12 Donationinterval forallogenic donornot longenough.

1) Duplicate recordcreated due to HA#HD1.2) Previousdonation at adifferent site, suchas a Red CrossCenter.

LOW LOW Acumulativedonationrecord keptfor eachdonor insystem isused tocalculatethedonationinterval andreject donorif criteriafor allogenicdonationnot met.


SCR#D10

HD13 Donor outsideof establishedage limitsallowed todonate withoutproperauthor-ization.

Data entry error. LOW LOW Softwarecalculatesthe age ofthe donorbased onthe DOBentry anddisplays awarningmessage iflimitsexceeded.

SRS# D10SRS# D22

SCR# D11SCR# D12

HD14 Donor historyquestions donot reflectcurrentguidelines.

Responsibleindividual at sitenot current onchanges in donorhistory questionrequirements.

LOW LOW Siteresponsibleformaintainingthe list ofdonorhistoryquestionsvia theoption Editdonorhistoryquestions[LRBLSEH]

SRS# D24SRS# D31

SCR# D13




Likelihood

Method(s)of Control

Trace

HD15 Donor consentform does notreflect currentguidelines.

Responsibleindividual at sitenot current ondonor consent formrequirements.

LOW LOW Siteresponsibleformaintainingthe donorconsentform via theoption Editdonorconsent[LRBLDCX]

SRS# D25SRS# D31

SCR# N/A

HD16 Donordemographicinformation,donor historyquestions andconsent notavailable.

Site not utilizingfunctionality

LOW LOW Donorhistoryphysicaland consentform[LRBLDR]option whenprintedcontains allnecessaryinfo.


SCR# N/A

HD18 A permanentlydeferred donorcould donate ata remote sitewhen thecomputersystem is notaccessibleand/orpreprinteddonor historyforms availablefor all potentialdonors.

1) Donor notflagged aspermanentlydeferred.2) Preprinted donorhistory forms notused.3) Copy of thePermanent donordeferral report[LRBLDPD] notbrought to site.

LOW LOW If donor isappropriate-ly markedas“permanent-lydeferred”furtherprocessingof donationwhenreturn tomain donorsite is notpossible.

SRS# D10SRS# D26SRS# D27SRS# D28SRS# D29

SCR# D14SCR# D15

HD19 Allogenic donormarked as“permanentlydeferred” hasdonationcompletelyprocessed.

NONE NONE NONE Processingof allogenicdonation for“permanent-lydeferred”donor notallowed.

SRS# D9SRS# D10SRS# D26SRS# D27

SCR# D14SCR# D15




Likelihood

Method(s)of Control

Trace

HD20 “Permanentlydeferred” donorincorrectlyprocessed asHomologouswhenAutologous isintended.

NONE NONE NONE OnlyAutologousorTherapeuticdonationtypes areallowed fordonors whoare flaggedas“permanently deferred”.


SCR# D14SCR# D15

HD21 Donors withspecialhandling needsnot identified atdonor sites.

1) Permanentdeferral/specialcomments[LRBLDEF] optionnot used to enterappropriate data.2) Donor history,physical andconsent form[LRBLDR] notprinted prior tocollection.

LOW LOW Informationavailableusing optionto printDonorhistory,physicaland consentform[LRBLDR].


SCR# D16

HD22 Autologousdonations notspecificallylinked tointendeddonor/patient.

Data entry error,not usingAUTOLOGOUS asthe TYPE ofdonation duringdata entry.

LOW LOW Autologoustypedonationcannot beprocessedwithout anexact matchlink to apatient inthePATIENTfile (#2).


SCR# D9

HD23 Cannotdeterminewhich unitshave beencollected usinga specific lot #collection bag.

1) Data entry error.2) BB siteparameter not setup to prompt forthe bag lot #'s.

LOW LOW VA FileMancan be usedto searchthedatabase foralldonationsprocessedusing aspecific lot#.

SRS# D4SRS# D36

SCR# D17SCR# D7




Likelihood

Method(s)of Control

Trace

HD24 Cannotdetermine thecorrect volumeof a specificdonation.

Data entry error LOW LOW User ispromptedfor Grossweight,empty bagweightduringcollectiondata entry.Softwarecalculatesvolumebased onspecificgravity ofwhole blood.

SRS# D11SRS# D40

SCR# D4

HD25 Assignment of anon-uniqueUnit ID for aspecificdonation.

NONE NONE NONE Softwaresearchesexistingentries inthe BLOODDONOR file(#65.5) forpossibleduplicateUnit ID.Cannotassign aUnit IDwhichalreadyexists.

SRS# D11SRS# D21

SCR# D7

HD26 Specialcomments notavailable todonor roompersonnel.

1) The Permanentdeferral/specialcomments[LRBLDEF] optionnot used to enterdata.2) Donor history,physical, andconsent form[LRBLDR] optionnot printed prior tocollection.

LOW LOW Informationavailableusing theprint Donorhistory,physicaland consentform[LRBLDR]option.


SCR# D14SCR# D16




Likelihood

Method(s)of Control

Trace

HD27 Previous donorreactioninformation notavailableduringsubsequentdonationepisode.

1) The Permanentdeferral/specialcomments[LRBLDEF] optionis not used to enterdonor reactioninformation.2) Donor history,physical andconsent form[LRBLDR] option isnot printed prior todonation.

MOD MOD A separateoptionPermanentdeferral/specialcomments[LRBLDEF]requiring ahighersecurityaccess isrequired toenter donorreactioninformationwhich isthenprinted onthe Donorhistory,physicaland consentform[LRBLDR]for thedonor.

SRS# D33

SCR# D16

HD28 Futuredonationepisode dataentered.

NONE NONE NONE Softwarescreens dateentered. Nofuture datesallowed.

SRS# D38

SCR# D4

HD29 Inconsistentdate/times ofcollection startand stops

NONE NONE NONE Cannotinput acompletiondate/timeprior to thecollectionstartdate/time.

SRS# D39

SCR# D4




Likelihood

Method(s)of Control

Trace

HD30 Incomplete orinaccuraterecords ofcollectiondispositions andunit storage.

Data entry errors LOW LOW Softwarechecksparametersdefined inthe BLOODPRODUCTfile (#66)during unitprocessing.


SCR# D4SCR# D7SCR# D18

HD31 No record ofperson enteringcomponentpreparation infoin computer.

NONE NONE NONE Softwareautomatical-ly assignsthis basedon identityof userupon log intocomputer.


SCR# D7SCR# D18

HD32 Previousdonationcollectioninformation canbe edited.

NONE NONE NONE User cannotspecify aunit IDwhich isfrom otherthan themost recentdonation.

SRS# D11SRS# D41

SCR# D3

HD33 Componentpreparationpolicies/procedures notfollowed.

1) Data entryerrors.2) Specificcomponent entriesin the BLOODPRODUCT file(#66) not fullydefined.

LOW LOW Collectiondisposition/componentpreparation[LRBLDCP]optionchecksparametersdefined inthe BLOODPRODUCTfile (#66) forvalidity.

SRS# D47

SCR# D19




Likelihood

Method(s)of Control

Trace

HD34 Inappropriatenumber andtype ofcomponentsprepared from adonation.

1) For donor unitscontaining redcells, site does nothave field in theBLOOD PRODUCTfile (#66)CONTAINS REDBLOODCELLS=YES.2) User entersincorrect PRIMARYBAG during dataentry.

LOW LOW Collectiondisposition/componentpreparation[LRBLDCP]optionchecks thenumber ofcomponentspreparedagainst thetype of bagused inoriginalcollection.Only allowsone red cellcomponenttype perdonation.


SCR# D18

HD35 Inappropriateexpiration dateassigned to aprepared unit.

Maximum StorageDays field (#135) inthe BLOODPRODUCT file(#66) not definedcorrectly.

LOW LOW Prior toutilizationof thepackage,the BLOODPRODUCTfile (#66)should bereviewedandcustomized.

SRS# D44SRS# D48

SCR# D20

HD36 Cannotdeterminedate/time storedfor a particularcomponent.

NONE NONE NONE This is arequiredfield.

SRS# D11SRS# D42


HD37 Component canbe preparedfrom aninappropriatelystoredcollection.

Collection/PrepHours field (#13) inthe BLOODPRODUCT file(#66) not definedcorrectly.

LOW LOW Prior toutilizationof thepackage,the BLOODPRODUCTfile (#66)should bereviewedandcustomized.

SRS# D43

SCR# D18SCR# D19




Likelihood

Method(s)of Control

Trace

HD38 TDD Markertestinginformation canbe entered forincorrect unitID.

Data entry error. LOW LOW Lab tests(notABO/Rh) ondonor units[LRBLDT]optionautomaticallyincrementsUnit ID butalso checksfor itsexistencebeforedisplay.

SRS# D49

SCR# D4

HD39 BloodComponentlabeled withincorrectABO/Rh.

Data entry error LOW LOW Test review/Componentlabeling/release[LRBLDRR]optionchecksABO/Rh ofdonorhistoricalrecord ifpresent fora match.Softwarerequirestwoseparateindividualsto doABO/Rhrecheckbefore unitis releasedtoinventory.

SRS# D3SRS# D50SRS# D51SRS# D52SRS# D65SRS# D66SRS# D67SRS# D72

SCR# D21SCR# D27

HD40 Donor UnitTDD testing notperformedaccording tocurrentstandards.

Site did notcorrectly set thesite parameters toturn on HIV Agtesting and turn offALT testing whenstandards changed.

LOW LOW Specificinstructionsdistributedto siteswhen TDDtestingstandardschanged.(LR*5.2*97)


SCR# D22




Likelihood

Method(s)of Control

Trace

HD41 Donor unitTDD resultsfalsely enteredas NEGATIVEwhen in factPOSITIVE.

Data entry error LOW LOW No batchentry ofTDD resultsallowed.Resultsdisplayedfor reviewprior torelease toinventory.


SCR# D4

HD42 TDDinadvertentlynot performedfor a particularDonor ID.

1) Worklistsprovided bysoftware not used.

2) User ignoreswarning messagethat testing isincomplete whenreleasing units toinventory. Userthen answers“YES” to override tocomplete therelease.

LOW LOW Worklistprovidedwhichincludes allTDDtesting.Specimenseasily addedback into aworklistwhenindicated.Test review/Componentlabeling/release[LRBLDRR]optionalerts userif TDDtesting isincompletefor Unit ID.


SCR#D23D26

HD43 Appropriatepersonnel notnotified ifpositive TDDmarker testingentered on aunit previouslyreleased toinventory.

Users withLRBLSUPER keydo not readelectronic mail forextended period oftime.

LOW LOW Bulletin isautomaticallygeneratedand deliversa Mailmanmessage toall users ofLRBLSUPER key ifsuch a unitis tested.

SRS# D57D105

SCR# D24




Likelihood

Method(s)of Control

Trace

HD44 Results of TDDtesting on aunit can beedited after aunit is releasedto inventory.

Users withLRBLSUPER keycan edit TDD resulttesting after a unitis released.

LOW LOW Distributionof theLRBLSUPER keyshould berestricted tothe BBsupervisorand/ordesignee.

SRS# D57SRS# D58

SCR# D6SCR# D24

HD45 Donor unit withpositive TDDtesting islabeled.

TDD testing reportnot reviewed priorto labeling ofproduct.

NONE NONE Unitautomatical-lyquarantinedif attempt ismade torelease anon-autologousunit with apositiveTDD result.

SRS# D68SRS# D69

SCR# D27

HD46 Ambiguousantigen testingresults enteredfor donorphenotyping.

Data input error. LOW LOW Softwaredoes notallow thesameantigenboth‘present andabsent’.Entrieslimited tovalidantigenspart of theSNOMEDcodingsystem.

SRS# D60SRS# D61

SCR# D4

HD47 Units releasedto Inventorythat are thesame Unit IDas a unitalready ininventory.

NONE NONE NONE Softwaresearchesthe BLOODIN-VENTORYfile (#65) forpossibleduplicateUnit ID.Does notallow.

SRS# D62

SCR# D7SCR# D29




Likelihood

Method(s)of Control

Trace

HD48 Units released toInventory prior tocompletion ofABO/Rh testing.

NONE NONE Release ofunits toinventoryprohibited ifno currentABO/Rhresultsexist.

SRS# D63

SCR# D25

HD49 Results ofDonor Unittesting doneprior to releaseto Inventorynot available.

System crashduring Donorlabeling/releaseprocess.

LOW LOW Selecteddata istransferredfrom theentry in theBLOODDONOR file(#65.5) tothe specificunit in theBLOOD IN-VENTORYfile (#65)uponLabeling/release. If datanot inBLOOD IN-VENTORYfile (#65)unit is notavailablefor patientuse.

SRS# D64

SCR# D7




Likelihood

Method(s)of Control

Trace

HD50 Donor unitincorrectlylabeled forABO/Rh can bereleased toInventory.

Data entry error bytwo separateindividuals.

LOW LOW 1) Releaseof units toinventoryprohibited ifcheck of thecurrentABO/Rhresults forthe specificdonor unitagainst thedonor’shistoricalrecordindicate adiscrepancy2) Softwarerequires asecondindividualto performABO/Rhrecheckbefore unitcan berelocated.3) Warningmessagegiven whenenteringcrossmatchresults onunits withno ABO/Rhrecheckresults.

SRS# D3SRS# D50SRS# D51SRS# D52SRS# D65SRS# D66SRS# D72SRS# D73





Likelihood

Method(s)of Control

Trace

HD51 Donor unitincorrectlylabeled forABO/Rhappears to bereleased toInventory.

Current ABO/Rhtesting resultsentered do notmatch historicalABO/Rh results fora specific donorAND the site doesnot require ABO/Rh recheck prior toLabeling/Release ofcomponent to theBLOODINVENTORY file(#65) per siteparameter in theLABORATORYSITE file (#69.9).

LOW LOW Automaticgenerationof a bulletindetailingthe testresult sentto allholders oftheLRBLSUPER key if thecurrentABO/Rhresults for aspecificdonor unitagainst thedonor’shistoricalrecordindicate adiscrepancy. thesoftwarealwaysrequires asecond techto performan ABO/Rhrecheckbefore theunit can berelocated.

SRS# D64SRS# D66

SCR# D21SCR# D27




Likelihood

Method(s)of Control

Trace

HD52 Homologous,directed ortherapeuticphlebotomyunit withpositive diseasemarker testingcan be releasedto inventory.

NONE NONE NONE TDD resultsevaluatedat time oflabeling/release. Ifan attemptis made torelease adonor unitwith apositive/reactiveTDD result,the unit isautomatical-lyquarantinedRequires ahigher levelof securityaccess tomakechanges instatus of acomponentpreviouslyplaced inquarantine.

SRS# D9SRS# D68SRS# D69SRS# D70SRS# D71

SCR# D6

HD53 Unit ID createdin the BLOODINVENTORYfile (#65) withincorrect datafrom BLOODDONOR file(#65.5).

NONE NONE NONE Softwaretransfersspecific datafields fromthe BLOODDONOR file(#65.5) tothe BLOODINVENTORY file (#65)uponlabeling/release ofcomponent.

SRS# D74

SCR# D7SCR# D29




Likelihood

Method(s)of Control

Trace

HD54 Donor unitassigned to theincorrectdivision whenreleased toinventory if siteismultidivisional.

User division isdefined during userlog on.1) Invalid choicesassigned by systemadministrator.2) User withmultiple choiceschooses incorrectlywhen logging in.

LOW LOW Unit isautomatically assignedto thedivision ofthe userwhoreleases ittoinventory.Transferunit to newdivision[LRBLJTR]option isavailable totransfer aunit to anewdivision ifnecessary.

SRS# D75

SCR# D7

HD55 Donor unitswith incompleteTDD markertesting aremodified ortransferred toanother facility.

Shipping invoicenot utilized whentransferring unitsto a differentfacility.

LOW LOW 1) Cannotmodify anon-autologousunit withincompleteTDDresults.2) Whenprocessing aunit to SendElsewhere,softwarepromptsuser thattesting isincomplete.Overriderequired.

SRS# D76SRS# D77

SCR# D7




Likelihood

Method(s)of Control

Trace

HD56 Autologous unitwith positiveTDD testingresults assignedto a differentpatient thanoriginallyassigned.

NONE NONE NONE Softwarepreventsrelease ofautologousunit withpositiveTDD testingfromoriginalpatientassigned.Alsopreventsmodificationof unit intonon-autologouscomponents


SCR# D9

HD57 ABO/Rhconfirmatorytesting resultsnot transferredto the BLOODINVENTORYfile (#65) uponrelease of unit.

1) Site parameternot set up forfunctionality.2) System crashduringlabeling/release ofdonor unit.

NONE LOW Warningmessagegiven whenABO/Rhconfirm-atorytesting notdone whenenteringcrossmatchresults.

SRS# D64SRS# D78

SCR# D7

HD58 Donor unit isomitted fromthe InventoryABO/Rhworklist if unitcontains redcells andABO/Rhconfirmatorytesting nottransferred toInventory basedon the siteparameters.

1) BLOODPRODUCT file(#66) setup forcomponent doesn’thave the ContainsRed Cells field (#19)set to “YES”.2) User doesn’tutilize theInventory ABO/Rhworklist.3) Printermalfunctionsduring print ofworklist.

LOW LOW User isalertedwhencrossmatchresults areentered ona unit withno ABO/Rhconfirmatory resultsavailable.UnitCANNOTbe relocatedif ABO/Rhconfirmatory resultsare notavailable.

SRS# D64SRS# D78

SCR# N/A




Likelihood

Method(s)of Control

Trace

HD59 Autologousand/or directedcomponents notsegregatedappropriately.

User ignoresdisplay ofRESTRICTED FORpatient nameduring variousscreens of thesoftware package.

LOW LOW Softwaredisplays thename of thepatientwhich theunit is‘restrictedfor’wheneverthe unit isdisplayedon thescreen andon theInventoryreports.


SCR# D9

HD60 No onlinestorage ofcumulativedonor historyfor look-backpurposes.

Total systemcrash/failure

NONE LOW Individualsitesperformregularbackups ofdata. If atotal systemcrash/failure, apreviousday’sbackup canbe restoredand lostdata can berebuilt frompaperrecords.

SRS# D10SRS# D80

SCR# D7SCR# D8

HD61 No historicalcumulativedonor historyfor donors whohave notdonated since aspecific date.

Output of reportPrint ex-donors isprinted but thendiscarded.

LOW LOW Option isavailable toprint Exdonor dataprior toremovalfrom thesystem.Donor datacannot beremovedunlesspreviouslyprinted.


SCR# D7SCR# D8




Likelihood

Method(s)of Control

Trace

HD62 Cannot providerecruitmentinformation todonor groupchairpersons.

1) Group affiliationinformation notentered at time ofdonation.2) Demographicdata entryincomplete.

NONE LOW User ispromptedforinformationduring dataentry.Variousreports areavailable toassist thedonor groupchair-persons.


SCR# N/A

HD63 Cannot targetcertain groupsfor donorrecruitment.

1) Group affiliationinformation notentered whenprocessing donors.2) Antigen typingon specific donorsnot entered.3) Demographicdata incomplete.

NONE LOW Standardiz-ed letterscan begeneratedbased on:1) Groupaffiliationor 2) Lackof a specificantigen tobe used fordonorrecruiting.

SRS# D84SRS# D85SRS# D86SRS# D87SRS# D90SRS# D91

SCR# N/A

HD64 Cannot targetdonors whohave notdonated since aspecific date forspecialrecruitmentefforts.

1) Donor recordsremoved fromdatabase using theRemove Ex donoroption.2) Demographicdata incomplete.

NONE LOW Consideration shouldbe given tothis prior toremovingex-donorsfrom thedatabase.


SCR# N/A

HD65 Cannot sendpost visit thankyou letters fordonors whoattempted todonate.

1) Donor roompersonnel do notenter rejecteddonors intodatabase.2) Demographicdata incomplete.

NONE LOW All donationattemptsshould beentered intothecomputer.


SCR# N/A

HD66 Cannotdeterminedonors willingto be called onemergency orregular basis,or cannot reachthem.

Incomplete dataretrieval and/ordata entry duringdonor processing.

NONE LOW Variousreports areavailablefor tailoringrecruitmentefforts.


SCR# N/A




Likelihood

Method(s)of Control

Trace

HD67 Cannotdeterminedonors whohave qualifiedand been givengallon donorawards.

Acknowledge donoraward by deletion[LRBLDAWARD]option not used toenter donor awarddata.

NONE MOD Acknow-ledge donoraward bydeletion[LRBLDAWARD] optionavailable toacknow-ledge donorawards forvariousdonationtypes.

SRS# D96SRS# D97

SCR# N/A

HD68 Cannotacknowledgefirst timedonorsappropriately

Donor roompersonnel do notcompletely gatherand enter donordemographic data.

NONE LOW First timeblooddonors[LRBLDFD]option isavailable tolist all firsttime donorssoacknowledgement canbe made.

SRS# D98

SCR# N/A

HD69 Cannoteffectivelyevaluaterecruitmentefforts of donorprogram.

Donor roompersonnel do notcompletely gatherand enter all donordemographic data.

NONE LOW Variousreportsavailable todetermineeffectiveness ofrecruitingefforts.

SRS# D10SRS# D84SRS# D85SRS# D99D106D107D108

SCR# N/AHD70 Cannot

systematicallyreview shortdraw collectionsfor QApurposes.

All pertinentinformation notentered intocomputer whenprocessing donors.

NONE LOW Reportavailableforsupervisoryreview tosee if anypatterns inlow volumeunitcollections.

SRS# D14D100

SCR# N/A




Likelihood

Method(s)of Control

Trace

HD71 Cannot reviewhistory oftemporarydeferrals and/orcomponentquarantinesand discards.

Deferred donorinformation notentered intocomputer.

NONE LOW Reportavailableforsupervisoryreview oftemporarydeferrals toidentifyproblemareas.

SRS#D101D104

SCR# N/A

HD72 Cannot reviewQualityAssurance datafrom Donorroom.

Donor roomsupervisor does notprint out andreview variousreports.

NONE LOW Variousreportsavailable tomonitorquality ofbloodproductmanufact-ure.

SRS# D14D102D103

SCR# N/A


Inventory Intended Uses Hazard Analysis


Likelihood

Method(s) ofControl

Trace

HI1 No uniquecumulative unithistoryavailable.

Package not fullyutilized

LOW LOW If all functions relatedto Inventory areutilized, there will bea unique cumulativeunit history for eachblood component.

SRS#I18I57

SCR#I1

HI2 Patient recordconfidentialitycompromised.

Menu optionsdisplayingsensitive datanot restrictedappropriately

LOW LOW Menu optionscontaining sensitivedata should berestricted by securitykeys.

SRS#N/A

SCR#I2

HI3 Softwarerequirements forindividualcomponents doesnot reflectfacility operatingprocedures.

Site did not editentries in theBLOODPRODUCT file(#66) to reflectthe site’sindividualrequirements.

LOW LOW Prior toimplementation, sitesare instructed toreview entries in theBLOOD PRODUCTfile (#66) andcustomize this file toreflect the site’sindividualrequirements.

SRS# I1SRS# I2

SCR#I3

HI4 Inventoryrecords notcurrent.

Total systemfailure/crashduring dataentry.

NONE LOW 1) Edit optionsavailable to edit anyrecords affected bysystem crash.2) Integrity reportavailable to check forincomplete records sosite can remedy.

SRS#I10

SCR#I7

HI5 Inventory datainappropriatelyaccessed,causingcorruptedrecords.

Two separateindividualsentering unitconfirmationdata at the sametime.

NONE LOW Unit confirmationoption comparesABO/Rh data entrywith log ininformation. Warningmessage is displayedif a discrepancy.Records are updatedimmediately upondata entry.

SRS#I11

SCR#I3




Likelihood

Method(s) ofControl

Trace

HI6 Barcode reader/scanner not usedto scan Unit ID.

1) Site notutilizing scannertechnology.2) Tech choose tonot use scanner.3) Scanner is notworking.

NONE MOD Use of the barcodescanner is optional. Itis recommended butthe software functionswith or without thescanner.

SRS#I12

SCR#I3

HI7 Barcode reader/scanner not usedto scan the bloodproduct code.

1) Site notutilizing scanner.2) Tech choosesto not usescanner.3) Scanner is notworking for somereason.4) Code field inthe BLOODPRODUCT file(#66) not filledin.

NONE MOD Use of the barcodescanner is optional. Itis recommended butthe software functionswith or without thescanner.

SRS#I29

SCR#I3

HI8 Barcode reader/scanner not usedto scan theexpiration date.

1) Site notutilizing scanner.2) Tech choose tonot use scanner.3) Scanner is notworking.4) BloodComponent notlabeled with abarcodeexpiration datelabel or label isbar-coded with a4-digit year.

NONE MOD Use of barcodescanner is optional. Itis recommended butthe software functionswith or without thescanner.

SRS#I25

SCR#I3

HI9 Units can beaccessed whichdo not reside inthe currentdivision site ismulti divisionaland is anoperating BloodBank in morethan onedivision.

User division isdefined duringuser log on.1) Invalid choicesassigned bysystemadministrator.2) User withmultiple choiceschoosesincorrectly whenlogging in.

LOW LOW Unit choice isautomaticallyrestricted to thoseunits in the divisionassigned to the userduring log on.

SRS#I14

SCR#I3




Likelihood

Method (s) ofControl

Trace

HI10 Cannotdetermine theidentity ofperson enteringtest results intocomputer.

NONE NONE NONE Assignment ofresponsibilityautomatic based onidentity of individualdetermined upon log-in to system.

SRS#I14

SCR#I7

HI11 Changes inverified data nottracked.

VA FileMan usedto edit variousfields directlyrather thanspecified menuoptions.

LOW LOW Direct access to BloodBank data filesthrough VA FileManshould be restrictedby site policy.

SRS#I15I16

SCR#I4

HI12 Cannotdetermine theexact date andtime inventoryunits arereceived.

Data input error. LOW LOW The Date/TimeReceived field isrequiredFuture date/times arenot allowed.

SRS#I17

SCR#I7

HI13 Identicalcomponents withidentical UnitID's exist.

NONE NONE NONE Software searchesBLOODINVENTORY file(#65) for possibleduplicates during unitlog in process.

SRS#I18

SCR#I1

HI15 Autologous orDirected unitswith pos/incompletescreening testsnot properlyidentified.

During the unitlog in process, anincorrect entry ismade at thepromptPOS/INCOMP.SCREENINGTESTS.

LOW LOW User is promptedduring unit log inprocess to enter if apositive (autologousonly) or incompletescreening test ispresent.

SRS#I21

SCR#I16I26

HI16 Units previouslydiscarded can bere-entered intoInventory.

NONE NONE NONE 1) Software preventsthe existence ofidentical componentswith identical UnitID’s.2) In the event that aunit is shipped toanother facility, theunit can be re-accepted intoInventory,reactivating theprevious record.

SRS#I22

SCR#I1




Likelihood


Trace

HI17 Units re-enteredinto Inventorydo not have acumulative Unithistory.

NONE NONE NONE For units which arere-entered, there istransfer of theoriginal log-in anddisposition datawhich creates acumulative record.

SRS#I23

SCR#I6I7

HI18 Short datedunits do nothave anappropriate dateand time ofexpirationassigned.

During unit login, theappropriate timeis not enteredalong with thedate for specificblood products.

LOW MOD The expiration datefield accommodatesthe entry of time. Ifno time is entered,then midnight isassumed.

SRS#I24

SCR#I10

HI19 Donor units withpositive orincomplete testsare notidentified as apotentialbiohazard whenshipped to anoutside facility.

The shippinginvoice providedwith thesoftware may notbe acceptable tosome bloodsuppliers andmay not be used.

LOW MOD 1) The shippinginvoice provided withthe software clearlyidentifies units whichmay be a potentialbiohazard.2) The text appearingon the shippinginvoice can bemodified to satisfymost blood suppliers.

SRS#I21I26

SCR#I11#I16

HI20 Inappropriate orincompleteinformationappears on thesystemgeneratedshipping invoice.

Site did notreview and editthe informationthat appears onthe shippinginvoice asdefined in theLAB LETTERfile (#65.9).

LOW LOW A menu option existswhich allows users toedit the informationwhich appears on theshipping invoice.

SRS# I4

SCR#I11

HI21 Recording oftemperatureinformation notrecorded on thesystemgeneratedshipping invoice.

1) Site edited theexported LABLETTER file(#65.9) entry forSHIPPINGINVOICEremoving theprompts for thisinformation.2) User ignoresprompts anddoes not recordinformation.

LOW LOW The exportedSHIPPING INVOICEentry contains theseprompts. Access tothe option used to editthe LAB LETTER file(#65.9) should berestricted.

SRS# I4I27

SCR#I12




Likelihood


Trace

HI22 Units assignedan inappropriateproduct typeduring log in.

Site did not editthe BLOODPRODUCT file(#66) to reflectproduct typesand suppliers.

LOW LOW The software preventslogging in ofcomponent typeswhich do not have atleast one supplieridentified.

SRS# I1I28

SCR#I3

HI23 Inappropriateexpiration datescan be assignedto blood producttypes duringinventory log in.

The MaximumStorage Daysfield (#135) for aparticularcomponententered in theBLOODPRODUCT file(#66) isinappropriate

LOW LOW 1) Sites areresponsible forreviewing thecontents of theBLOOD PRODUCTfile (#66) for accuracyand edit according tosite policy.2) During log in, theuser is alwaysprompted to reviewlog in data foraccuracy and can editif necessary.

SRS#I30

SCR#I22

HI24 1) Inappropriateunits can beedited using theoption Editpooled bloodproduct.2) Pooled bloodproducts cannotbe edited usingthe option Editpooled bloodproduct.

The BLOODPRODUCT file(#66) entry for aproduct has thePooled Productfield (#27)inappropriatelyset.

LW LOW Units which can beedited using the Editpooled blood product[LRBLJM] optionmust have the PooledProduct field (#27) intheir BLOODPRODUCT file (#66)entry set to “YES”.

SRS#I31

SCR#I3

HI25 Volume of a unitof blood cannotbe determined.

Site did notdefine theVOLUME (ml)field (#.1)correctly for theblood productinvolved.

NONE LOW Software assumes theaverage volume for aunit, based on theentry in theVOLUME (ml) field(#.1) in the BLOODPRODUCT file (#66)for that specific bloodcomponent.

SRS#I32

SCR#I7




Likelihood


Trace

HI26 1) Cannotdetermine thecost of bloodproductsbetween varioussuppliers.2) Inaccuratecost accountingwhen units areRETURNED TOSUPPLIER.

Site does notmaintain theCOST field (#.02)for specificSUPPLIERS forcomponents inthe BLOODPRODUCT file(#66).

NONE MOD This is a requiredfield but must bemaintained foraccuracy at each sitewhenever suppliercosts change.

SRS#I33I34

SCR#N/A

HI27 Incompleterecords when aunit istransferred to adifferentDIVISION of amultidivisionalfacility.

1) Siteparameters forMultidivisionalsite not definedaccording to VAStandards.2) Transfer unitto new division[LRBLJTR]option is notused to transferunit to adifferentdivision.

LOW LOW Transfer unit to newdivision [LRBLJTR]option available totransfer a unit to avalid division of amultidivisionalinstitution as definedby the site’sINSTITUTION file(#4) entry in theDIVISION field (#.16)All historical datastays with the unit.

SRS#I35

SCR#I6

HI28 Inventory unitshave futuredispositiondates.

NONE NONE NONE Software prohibitsentry of a futuredisposition date.

SRS#I36

SCR#I3

HI29 Cannot recordsite-specificspecialcommentsduring unitdisposition.

Site does notutilize optionEdit blood bankdescriptions file[LRBLSEF] tocreate “cannedcomments” to beused duringdisposition otherthan Modify orTransfuse.

NONE LOW Edit blood bankdescriptions file[LRBLSEF] optionallows creation of“canned comments” tobe used during dataentry of unitdisposition.

SRS# I8

SCR#I6

HI30 Data enteredand verified inerror during login of inventorycannot becorrected.

Misuse ofbarcode scanner,other data entryerrors.

LOW LOW Edit unit log-in[LRBLSEL] optionavailable to edit log indata which requires ahigher security.

SRS#I16I37

SCR#I5




Likelihood


Trace

HI31 Data enteredand verified inerror duringunit dispositioncannot becorrected.

Data entry error NONE LOW Edit unit dispositionfields [LRBLSED]option is available toedit unit dispositiondata which requires ahigher security.

SRS#I16I38

SCR#I5

HI32 Data entered inerror during thepooling of unitscannot becorrected

Data entry error NONE LOW Edit pooled bloodproduct [LRBLJM]option is available toedit Pooled Unitswhich requires ahigher security.

SRS#I16I39

SCR#I5

HI33 Units whichrequireconfirmatoryABO/Rh testingprior to use donot get tested.

1) BLOODPRODUCT file(#66) setup forspecific productdoes not havethe Contains RedCells field (#.19)and/or RetypeAfterPreparation field(#.18) set to“YES”.2) User does notprint out theInventoryABO/Rh testingworksheet[LRBLIW].

LOW LOW Units received froman outside facility orcreated through amodification of otherunits should appearon the InventoryABO/Rh testingworksheet [LRBLIW]option report if theblood component hasa “YES” in theContains Red Cellsfield (#.19) in theBLOOD PRODUCTfile (#66).

SCR#I40I47

SCR#I9I13

HI34 ConfirmatoryABO/Rh testingon Inventorydoes not agreewith log ininformation.

User input error NONE LOW Software comparesconfirmatory testresults to the unit login information anddisplays a warningmessage if resultsdisagree.

SRS#I41

SCR#I13

HI35 ABO/Rh rechecktesting resultsentered on unitsfrom a differentdivision if thesite is multi-divisional.

NONE NONE NONE Software restrictsaccess to units ininventory to those inthe same division asthe user, asdetermined by theuser log in.

SRS#I42

SCR#I9




Likelihood


Trace

HI36 Datatranscriptionerrors onABO/Rh unitconfirmationworksheets.

Barcode scannernot used duringunit log in anduser creates atranscriptionerror during login.

LOW LOW 1) Report availablewhich lists unitswhich requireABO/Rh retestingbased on initial login.2) Barcode scannersgreatly reduce theincidence oftranscription errors.3) Option available toedit unit log in ifnecessary and reportcan be reprinted.

SRS#I40I43

SCR#I3

HI37 Interpretationsof actual testresults notreadilyavailable.

Site did not enterappropriate datainto the LABLETTER file(#65.9) whichcontrols the textwhich appearson the InventoryABO/Rh testingworksheet.

NONE LOW Edit lab letter file[LRBLSLL] optionexists to edit theInventory ABO/Rhtesting worksheet toreflect site’s policy oftest resultinterpretations.

SRS#I5

SCR#I7I9

HI38 Individualcommentsrelating toABO/Rhconfirmatorytesting notavailable.

Site did notcreate special“cannedcomments” to beused duringentry of ABO/Rhconfirmatorytestinginterpretations.

NONE LOW Software allows for“canned comments” tobe available for entryduring ABO/Rhconfirmation dataentry. Thesecomments stayassociated with theunit at all times.

SRS#I9

SCR#I7I9

HI39 Cannot tracklifecycle of unitsmodified whilein the BloodBank.

Disposition –nottransfused[LRBLIDN]option not usedwhen modifyinginventory units.

LOW LOW Software creates anew entry in theBLOODINVENTORY file(#65) for newcomponents createdand assigns a finaldisposition ofMODIFIED to theoriginal unit beingmodified.

SRS#I44I50I91

SCR#I6




Likelihood


Trace

HI40 Units created asa result ofmodification ofunits ininventory aremissing criticaldata.

Disposition –nottransfused[LRBLIDN]option not usedwhen modifyinginventory units.

LOW LOW When a new unit iscreated as a result ofmodification of anexisting unit, criticaldata is transferred tothe new file entry inthe BLOODINVENTORY file (#65).

SRS#I45

SCR#I14

HI41 ABO/Rh recheckresults on unitscreated bymodification ofexisting units isnot transferredto the newlycreated unitwhenappropriate.

Site did not setthe BLOODPRODUCT file(#66), RetypeAfterPreparation field(#.18) = NO forthe newlycreatedcomponent toreflect the site’spolicy.

LOW LOW ABO/Rh confirmatorytesting resultsautomaticallytransferred to newunits created unlessthe Retype AfterPreparation field(#.18) =YES in theBLOOD PRODUCTfile (#66) for theproduct created.

SRS#I46

SCR#I14

HI42 An ABO type isassigned to apool productwhen theindividualcomponents ofthe pool are notall of the sameABO types.

If a pool iscreated usingindividualproducts ofmixed ABOtypes, an ABOgroup for thepool is assignedusing the ABOgroup of the firstunit assigned tothe pool.

LOW HIGH If site policy allowspooling of units fromdifferent ABO groups,the software assignsthe ABO group of thefirst unit added to thepool.

SRS#I48

SCR#N/A

HI43 A poolcontaining anindividual unitwhich is RhPositive isassigned a PoolRh type ofNegative.

NONE NONE NONE Assignment of the Rhof a pool will bedeemed positive if anyof the units in thepool are Rh positive,regardless of theorder in which theunits were pooled.

SRS#I49

SCR#I15




Likelihood


Trace

HI44 Cannotdetermine thenumber ofaliquots createdwhen dividing aunit.

Disposition-nottransfused[LRBLIDN]options orPediatric UnitPreparations[LRBLPED]option is used tocreate aliquotedunits.

LOW LOW When a product isdivided using theseoptions, the numberof aliquots iscalculated by thesoftware and thenumber is stuffed intothe Pooled/DividedUnits field (#4.4) forthe original unit inthe BLOODINVENTORY file(#65).

SRS#I50

SCR#I6

HI45 An Autologousunit with a YESentry in thePos/Incomp.Screening Testsfield (#8.1) canbe modified intoa non-autologouscomponent.

NONE NONE NONE Software does notallow the modificationof an autologous unitwith a “YES” entry inthe Pos/Incomp.Screening Tests field(#8.1).

SRS#I21I51I52

SCR#I16I26

HI46 Units ininventory can bemodified intoinappropriatecomponenttypes.

Site did not editthe BLOODPRODUCT file(#66), Modify Tofield (#.03) forthe specificcomponentsbeing modified.

NONE LOW When modifying unitsin inventory, choicesof components beingcreated is limited tothose defined in theModify To field (#.03)in the BLOODPRODUCT file (#66)for the specificcomponent beingmodified.

SRS#I1I54

SCR#I3




Likelihood


Trace

HI47 Units ininventory can bemodified intoinappropriatenumbers ofcomponents.

Site did not editthe BLOODPRODUCT file(#66), Not OnlyOne Allowedfield (#.02) forthe specificcomponentsbeing modified.

NONE LOW When modifying unitsin inventory theBLOOD PRODUCTfile (#66), Not OnlyOne Allowed field(#.02) for the specificcomponent beingmodified controlswhether more thanone unit can becreated from theoriginal unit.

SRS# I1I55

SCR#I3

HI48 A unit ininventory can bemodified morethan once.

NONE NONE NONE When a unit ismodified, adisposition isautomaticallyassigned. Thesoftware preventsselection of a unitwith a dispositionassigned formodification.

SRS#I56

SCR#I3

HI49 Units created asa result ofmodification ofan existing unitare not uniquelyidentified.

NONE NONE NONE Software requires theassignment of aunique Unit ID forunits created throughmodification ofexisting units ininventory.

SRS#I57I58

SCR#I1

HI50 A unit can bedivided/split intoothercomponentswhose totalvolumes exceedthe originalunit’s volume.

NONE NONE NONE 1) Software keepstrack of unit volumeas pediatric units areprepared.2) Software calculatesunit volume ofdivided units basedon original volumeand the number ofaliquots prepared.

SRS#I59

SCR#I3




Likelihood


Trace

HI51 Units created bymodifying unitsalready ininventory haveincorrect/invalidexpiration dates.

1) Site did notedit the BLOODPRODUCT file(#66), Days Leftfield (#.11) forthe productbeing created.2) Unitmodification dataentry not done inreal time. Thesuggestedexpiration dateof the new unitsis calculatedbased on amodificationdate/time ofNOW.

MOD MOD Software generates asuggested expirationdate for units createdvia modification basedon the Days Left field(#.11). However, thisexpiration date/timeis not assigned unlessaccepted by the user.The user is promptedfor review and canenter new expirationdate/time during dataentry.

SRS#I24I53I60

SCR#I10I22

HI52 A unit created asa result ofmodifying a unitalready ininventory isinappropriatelyassigned anexpiration datewhich exceedsthe expirationdate of theoriginal unit.

Alert messagegenerated bysoftware whenthis occurs isinappropriatelyignored by theuser.

LOW LOW Software evaluatesthe calculatedexpiration date of thenew unit against theexpiration date of theoriginal unit anddisplays an alertmessage if the newunit expiration dateexceeds the originalexpiration date, or inthe case of a pooledproduct, the originalexpiration date of anyof the units in thepool.

SRS#I61

SCR#I10I22

HI53 A futuredisposition dateis entered.

NONE NONE NONE Software prohibitsentry of a futuredisposition date.

SRS#I62

SCR#I3




Likelihood


Trace

HI54 A pediatriccomponent canbe created froma unit which istoo old.

1) Disposition –not transfused[LRBLIDN]option, notPediatric unitpreparation[LRBLPED]option is used toprepare Pediatriccomponent.2) Site did notedit the BLOODPRODUCT file(#66), Max AgeFor PediatricUse field (#.21)appropriately forthe component ofthe unit beingmodified.

LOW LOW Pediatric unitpreparation[LRBLPED] optionevaluates the age ofthe unit selected forPediatric componentpreparation againstthe entry in theBLOOD PRODUCTfile (#66), Max AgeFor Pediatric Usefield (#.21) for thecomponent beingmodified.

SRS#I63

SCR#I3

HI55 Pediatric unitsareinadvertentlycreated from lowvolume units.

Disposition – nottransfused[LRBLIDN]option is used tocreate pediatricunits instead ofPediatric unitpreparation.

LOW LOW Pediatric unitpreparation[LRBLPED] optionevaluates the volumeof the original unitand displays thosewith a volume<150ml.

SRS#I64

SCR#I3

HI56 The combinedvolume ofpediatric unitspreparedexceeds theoriginal unit’svolume.

NONE NONE NONE The Pediatric Unitpreparation[LRBLPED] optionupdates the volume ofthe original volumebased on the numberand volume ofPediatric unitsprepared. When theoriginal unit has avolume of zero, a finaldisposition ofMODIFIED isassigned to theoriginal unit.

SRS#I65I66

SCR#I3




Likelihood


Trace

HI57 Units created bymodifying unitsalready ininventory cannotbe traced by thebag lot #.

1) Data entryerror.2) BB siteparameter notset up to promptfor the bag lot #’sduring dataentry.

LOW LOW VA FileMan can beused to search thedatabase for alldonations/unitsprocessed using aspecific lot #.

SRS# I3I67

SCR#I17

HI58 Patient and unitinformation onsystemgeneratedcaution tag doesnot matchcurrentinformation incomputer.

Disposition –relocation[LRBLIDR]option not usedto verifyinformation atthe time a unit issigned out toward personneland the unitswere “released”from the patientin the computerbut units werenot untagged.

LOW LOW The system generatedcaution tag cannot beprinted until allnecessarypretransfusion testingis complete andentered intocomputer. If a unit isno longer appropriateto transfuse to apatient for anyreason, it must bemanually untagged aswell as “released”from the patient inthe computer.

SRS#I68

SCR#I24

HI59 Patients withautologousand/or directedunits availableare transfusedwith homologousunits instead ofthe autologous/directed units.

1) Units notlogged intosystem asautologous ordirected.2) User ignoresthe alertmessagedisplayed on thescreen thatautologous ordirected unitsare available onthe patient.

LOW LOW When autologous ordirected units arelogged into thecomputer, the user isrequired to enter avalid PATIENTNAME in theRestricted For field(#8). This causes theautologous or directedunits to be flagged onthe screen wheneverthe Patient is selectedfor options in theBlood Bank software.

SRS#I69

SCR#I8




Likelihood


Trace

HI60 A “doublecrossmatched”unit isinappropriatelytransfused.

1) Warningmessage that theunit selected isdoublecrossmatched isnot evaluatedthoroughly priorto proceedingwith relocation.2) Disposition –relocation[LRBLIDR]option not usedat the time aunit is relocated.

LOW LOW Disposition relocation[LRBLIDR] optiondisplays a warningmessage if the unitselected has beendouble crossmatchedand is still assigned toanother patient at thetime the unit is beingissued for transfusion.

SRS#I70

SCR#I24

HI61 Presence ofpatient antibodyor other specialBLOOD BANKCOMMENTSnot availablewhen unitsbeing issued.

1) Specialinstructions[LRBLPSI]option not usedto enterimportant data.2) Antibody IDnot entered inthe AntibodiesIdentified field(#.075) duringEnter Test Data[LRBLPET]option.3) Disposition –relocation[LRBLIDR]option not usedat the time aunit is relocated.

LOW LOW 1) Special instructions[LRBLPSI] option canbe used to enterspecific data to bedisplayed for apatient when usingBlood Bank options.2) Antibodies enteredusing the AntibodiesIdentified field (#.075)will always bedisplayed with thepatient, even if thecurrent specimendoes not have adetectable titer.

SRS#I71

SCR#I19




Likelihood

Method(s) ofControl

Trace

HI62 Can issue unitswhich are notassigned to thepatient.

Disposition –relocation[LRBLIDR]option not usedat time of issue.

LOW LOW Disposition –relocation [LRBLIDR]option limits theselection of units forissue, which have acurrent status of‘assigned’ to thepatient specified.

SRS#I72

SCR#I19I24

HI63 Patients withclinicallysignificantantibodies canbe issued unitsnot typed andfound to benegative for thecorrespondingantigen.

1) Site did notuse the EditCorrespondingAntigen/Antibody[LRBLSNO]option to defineclinicallysignificantAntibodies.2) Antibody IDnot entered inthe AntibodiesIdentified field(#.075) whenentering patienttest data.3. Disposition–relocation[LRBLIDR]option not usedat time of issue.

LOW LOW For patients with anentry in theAntibodies Identifiedfield (#.075) theDisposition –relocation [LRBLIDR]option evaluates unitphenotyping ofallogenic unitsagainst clinicallysignificant antibodiesand prevents issue ifunit phenotyping isnot appropriate, i.e.,for each entry in theAntibodies Identifiedfield (#.075), theremust be acorresponding entryin the RBC AntigenAbsent field (#.05) forthe unit.

SRS# I6I73

SCR#I19I25

HI64 Units whichrequirecrossmatch canbe issued priorto completion ofcrossmatch.

Site did not editthePatient/ProductRequirementfield (#.09) forthe specificproduct in theBLOODPRODUCT file(#66).

LOW LOW Products with anentry ofCROSSMATCH in thePATIENT/PRODUCTREQUIREMENT field(#.09) cannot be giventhe status of“assigned” until thereis an entry in theCrossmatch Resultfield (#.04) for theunit.

SRS#I74

SCR#I19




Likelihood

Method(s) ofControl

Trace

HI65 Unit requiringABO/Rh recheckto be done can beissued withoutABO/Rh recheckresults entered.

1) Site did notdefine theBLOODPRODUCT file(#66), ContainsRed Cells =YESfield (#.19) forthe specificcomponent.2) Disposition –relocation[LRBLIDR]option not usedat time of issue.

LOW LOW Disposition –relocation [LRBLIDR]option prevents issueif no recheck resultsare entered for acomponent defined inthe BLOODPRODUCT file (#66),Contains Red BloodCells = YES field(#.19).

SRS#I75

SCR#I19I20

HI66 Units with apreviousinspection of“Unsatisfactory”can be issued.

Disposition –relocation[LRBLIDR]option not usedat time of issue.

LOW LOW Disposition –relocation [LRBLIDR]option prevents issueif the unit has had aprevious inspection of“Unsatisfactory”.

SRS#I76I77

SCR#I21

HI67 Expired unitscan be issued.

1) Disposition –relocation[LRBLIDR]option not usedat time of issue.2) User ignoreswarning messagethat unit isexpired.

LOW LOW Disposition –relocation [LRBLIDR]option evaluates theunit’s expiration dateand displays awarning message ifunit is expired whencompared to thecurrent time.

SRS#I78

SCR#I22

HI68 Units whichshould bemodified beforerelease can beissued.

Site did not editthe BLOODPRODUCT file(#66) and set theModified BeforeRelease field(#.14) to “YES”for specificcomponents.

LOW LOW When the ModifiedBefore Release field(#.14) is set to “YES”,the Disposition –relocation [LRBLIDR]option prevents issue,thereby forcing theuser to ‘modify’ theunit.

SRS#I79

SCR#I23




Likelihood

Method(s) ofControl

Trace

HI69 Inappropriatedate/time ofrelocation/issuecan be entered.

Supervisory editoption, Edit unitpatient fields[LRBLSEC]option is usedrather thanDisposition–relocation[LRBLIDR]option to issueunits.

LOW LOW 1) Disposition –relocation [LRBLIDR]option evaluates thedate/time relocationand prevents entry ofa date time prior tothe date/time the unitwas assigned to thepatient or a futuredate/time.2) Supervisory editoption [LRBLSI]should have restrictedaccess.

SRS#I80I81

SCR#I3I6

HI70 Inappropriatelocations can beused to relocateunits.

Disposition–relocation[LRBLIDR]option userenters aninappropriatehospital locationand overrides thewarningmessage.

LOW LOW Standard locationsare restricted to thoseentries in theHOSPITALLOCATION file (#44)with the samedivision as the user.Non-standardlocations can beentered, however, theuser is given awarning message andchance to override.

SRS#I82

SCR#I3

HI71 Issue/relocationdata entered inerror cannot becorrected.

NONE NONE NONE Edit unit - patientfields [LRBLSEC]option available toedit verifiedinformation relatingto the issue/relocationof a specific unit ID.(Requires a higherlevel of security).

SRS#I83

SCR#I5

HI72 Unable tostandardize theidentification ofRBC and HLAantigens.

NONE NONE NONE Software uses theSNOMEDnomenclature tostandardize RBC andHLA typing.

SRS# I6I84

SCR#I25




Likelihood

Method(s) ofControl

Trace

HI73 Unable to definewhich RBCantigens arevalid choices.

Site did notreview and editthe FUNCTIONFIELD file(#61.3) entriesprior to use ofsoftware.

LOW LOW The FUNCTIONFIELD file (#61.3) isexported populatedwith standardizedIdentifier field (#4)entries for RBCantigens.

SRS# I6I85

SCR#I25

HI74 Clinicallysignificantalloantibodiescannot bedefined for thesite.

Site did not usethe EditCorrespondingAntigen/Antibody optionprior to use ofsoftware to fill intheCorrespondingAntigen/Antibody field(#04) in theFUNCTIONFIELD file(#61.3).

LOW MOD The EditCorrespondingAntigen/Antibody[LRBLSNO] option isavailable for sites touse to define whichall antibodies are tobe consideredclinically significant.Requires a highersecurity.

SRS# I6

SCR#I19I25

HI75 Cannotdetermine unitsin inventorywhich have beenphenotyped.

1) Site does notenterphenotypingresults insystem.2) Site does notprint out reportprovided bysoftware.

LOW LOW Report Phenotypedunits available[LRBLIPH] optionprovides a listing ofall units in inventorywhich have beenphenotyped, includingall entries for RBCantigens present andabsent, for a specifiedcomponent of aspecified ABO/Rh.

SRS#I86

SCR#I18I25

HI76 User can entersame antigen asboth present andabsent on a unit.

Site did not usethe EditCorrespondingAntigen/Antibody[LRBLSNO]option prior touse of softwareto fill in theCorrespondingAntigen/Antibody field(#.04) in theFUNCTIONFIELD file(#61.3).

LOW MOD Software checks theCorrespondingAntigen/Antibodyfield (#.04) in theFUNCTION FIELDfile (#61.3) entry todetermine if theresponse entered bythe user is valid.

SRS# I6I87

SCR#I25




Likelihood

Method(s) ofControl

Trace

HI77 Donor recordsnot updatedwhen a donorunit isphenotyped afterthe unit hasbeen released toInventory.

Unitphenotypingresults notentered intocomputer.

NONE LOW Software checksdonor records whenthe supplier for theunit is SELF andupdates the donorrecord with thephenotyping resultsfor future reference.

SRS#I88

SCR#I18

HI78 Autologous/directed donor unitwith a ‘yes’ inthe Pos/Incomp.Screening Testsfield (#8.1) canbe released forallogenic use.

NONE NONE NONE Software preventsrelease of autologous/directed donor unitswith a ‘yes’ in thePos/Incomp.Screening Tests field(#8.1) for allogenicuse.

SRS#I89

SCR#I26

HI79 Units located outof the BloodBank are madeavailable inInventory.

NONE NONE NONE Units release to stock(cancel) by patient[LRBLIUR] optionevaluates the locationof unit and onlyallows release if thelocation is the BloodBank.

SRS#I90

SCR#I3I6

HI80 Cannot createmeaningful QAreports for BloodUtilizationReview.

Site did notcreate cannedcomments whichcan be usedwhen releasingcrossmatched/assigned units backto inventory.

NONE LOW Edit blood bankdescriptions file[LRBLSEF] optionavailable to createcanned comments foruse when releasingassigned units toinventory.

SRS# I7

SCR#I6

HI81 Cannot traceunit historywhen a new unitis createdthroughmodification.

User does notuse optionDisposition –nottransfused[LRBLIDN]option to modifyunit from onecomponent toanother.

LOW LOW Software tracks theunit modificationinformation for boththe unit beingmodified and theunit(s) created toinclude data on unit’sModified To/Fromfield (#.091).

SRS#I91

SCR#I6I14




Likelihood

Method(s) ofControl

Trace

HI82 The BLOODINVENTORYfile (#65) mayhave missingdata nodes.

User does notuse the Bloodbank inventoryintegrity report[LRBLII] optionto check formissing dataafter systemcrash.

NONE LOW It is recommendedthat the Blood bankinventory integrityreport [LRBLII]option be used on aregular bases andafter unexpectedsystem down time tocheck the BLOODINVENTORY file(#65) for missingdata.

SRS#I92

SCR#I7

HI83 Cannot examineunit history forlook-backpurpose.

Print units withfinal disposition[LRBLRUF]option used priorto Remove unitswith finaldisposition, thenreport isdiscarded.

LOW LOW Inventory data can bekept on lineindefinitely. However,if a site needs topurge the BLOODINVENTORY file(#65), an option existswhich can purge unitswith a finaldisposition, butrequires that they beprinted first.

SRS#I93I96I97

SCR#I6I7

HI84 Cannot viewcumulative unithistory.

BLOODINVENTORY file(#65) purged.

LOW LOW Option exists whichcan print hard copy ordisplay on screen thecomplete unit history.

SRS#I93I94

SCR#I1I6I7

HI85 Cannot viewcurrent status ofa unit ininventory.

Computersystemdowntime.

LOW LOW Single unit (display/print) information[LRBLQSU] optionexists which can printhard copy or displayon screen thecomplete unit historyand current status.

SRS#I95

SCR#I7

HI86 Cannot searchinventory forCMV negativeunits.

Users do notenter CMVtesting resultsinto computer.

NONE LOW CMV Antibody StatusReport [LRBLICV]option searches thedatabase for CMVnegative units.

SRS#I98

SCR#I18




Likelihood

Method(s) ofControl

Trace

HI87 Cannot performutilizationreview forinventory unitsthat have a finaldisposition butwere nottransfused.

Incomplete dataentry by site.

NONE LOW Report for a specifiedrange of dispositiondates for a specifieddisposition isavailable forsupervisory review.

SRS#I99

SCR#I7

HI88 Cannotdetermine unitsin inventory andtheir status.

Systemdowntime

NONE LOW Report availablewhich lists all in-dateunits. Sorted bycomponent, ABO/Rhand expiration date.

SRS#I100

SCR#I7

HI89 Cannotdetermine ifInventoryrecords arecomplete.

Units with nodisposition[LRBLRUN]option notreviewedregularly.

NONE LOW Units with nodisposition[LRBLRUN] option isavailable which listsall units that have nodisposition dataentered (both in dateand outdated). Thisshould be reviewedregularly to check forincomplete dataentry.

SRS#I101

SCR#I7

HI90 Cannot properlymanageinventory byappropriatelyreleasing unitsfrom patients.

NONE NONE NONE Units on Xmatch bydate/time Xmatched[LRBLIX] optionavailable to assist inmanaging inventoryby listing units in“assigned” status inchronological order bydate/time assigned.

SRS#I102

SCR#I6

HI91 Cannotaccuratelydeterminesupplier chargesfor bloodproducts.

Responsibleperson does notmaintain theCOST field (#.02)in the BLOODPRODUCT file(#66) and/or editthe charges foran individualunit whenappropriate.

NONE LOW 1) Edit unit log-in[LRBLSEL] optionallows editing ofsupplier cost for anindividual unit.2) Special typingcharges (inventory)[LRBLRIS] optionexists to allowrecording of anyspecial typing chargesby the supplier.

SRS#I33I34I103I104

SCR#I6




Likelihood

Method(s) ofControl

Trace

HI92 Cannot verifybilling fromoutsidesuppliers.

Responsibleperson does notmaintain theCost field (#.02)in the BLOODPRODUCT file(#66) and/or editthe charges foran individualunit whenappropriate.

NONE LOW Reports available forunits entered into theBLOODINVENTORY file(#65) for a specifieddate range to reviewsupplier charges, bothstandard and specialtyping.

SRS#I33I34I103I104I105I106I107

SCR#I5

HI93 Cannot reviewAutologousprogram for QApurposes.

Autologous unitsnot identified asAutologousduring dataentry.

NONE LOW Autologousdisposition report[LRBLJB] optionexists for monitoringAutologous units witha disposition ofTRANSFUSE for QAreview.

SRS#I19I108I109

SCR#I8

HI94 Cannot trackunit relocations.

Disposition -relocation[LRBLIDR]option not usedto enter all unitrelocations.

NONE LOW Unit issue bookentries [LRBLIRB]option exists to detailall relocation activitywithin the BloodBank for a specifieddate range.

SRS#I110

SCR#I6

HI95 Cannotdetermine thenumbers ofABO/Rhrechecks done oninventory units.

ABO/Rhconfirmationtesting resultsnot entered intocomputer.

NONE LOW Inventory ABO/Rh re-check counts[LRBLC] option existswhich tallies theABO/Rh rechecksresults entered incomputer.

SRS#I111

SCR#I9

HI96 Cannotaccuratelydetermineworkloadstatistics forlocal andnational reports.

Responsibleperson does notenter workloadcodes in specificBlood Bank andthe EXECUTECODE files(#62.07)according toguidelinesincluded in thePlanning andImplementationGuide v 5.2.

NONE LOW When workload codesare defined forparticular tests,products, andprocedures, workloadis automaticallycollected as abackground activitywhenever data isentered into thecomputer.

SRS#I112

SCR#N/A


Patient Intended Uses Hazard Analysis


Likelihood

Method(s) ofControl

Trace

HP1 Site routinelydoes Direct AHGpretransfusiontesting but can'teasily enterpatient results.

Site parameterwhich controlswhether thesefields areprompted forduring dataentry not setproperly.

LOW LOW Site parameter isavailable to indicatewhether fields forDirect AHG testresults are to beincluded in the edittemplate for enteringABO/Rh results.

SRS#P3

SCR#P11P20

HP2 Site specificcannedcomments notused for Patienttesting resultdata entry.

Site does not usethe Edit bloodbankdescriptions file[LRBLSEF]option to buildmeaningfulcannedcomments to beused during dataentry.

NONE LOW Both previouslydefined cannedcomments and freetext are acceptable forinput for commentfields during dataentry. Cannedcomments are easilydefined and can bescreened to be choicesat specific areas ofdata entry.

SRS#P4

SCR#N/A

HP3 No consultativereports forpatients withantibodies orpositive directAHG testsavailable forplacement onchart.

1) Site did notcustomize theLAB LETTERfile (#65.9) entryfor specificreports.2) Blood bankconsultationreports not used.

LOW LOW Blood bankconsultation reportsavailable which canbe placed on apatient’s chart forfuture reference.

SRS#P5P54

SCR#P11

HP4 Cannotdetermine whichantibodies areclinicallysignificant soantigen checkingcan be done onRBC units.

Site did not usethe EditCorrespondingAntigen/Antibody[LRBLSNO]option to defineclinicallysignificantantibodies.

LOW LOW Edit CorrespondingAntigen/Antibody[LRBLSNO] optionmust be used by thesite to define whichantibodies need tohave unitsphenotyped and foundnegative for thecorrespondingantigens.

SRS#P6

SCR#P7




Likelihood

Method(s) ofControl

Trace

HP5 Cannot doprospectivereview of bloodutilization whenrequestingcomponents on apatient, bothpre-op and notpre-op.

Site did not useoption Tests fordisplay onpatient look-upto define testswhich willdisplay uponpatientcomponentrequest.

LOW LOW Tests for display onpatient look-up[LRBLST] optionexists to define Testsfor display on patientlook-up. Whendefined, the mostrecent lab value of thedefined tests aredisplayed duringcomponent requestfunctions. This allowsBlood Bank personnela chance to doprospective utilizationreview and takeaction if necessary.

SRS#P7P37

SCR#P17

HP6 Cannot definestandardtransfusionreaction types tofacilitatereporting.

Site did not usethe Edit bloodbank utility file[LRBLSEU]option to defineacceptabletransfusionreaction types foruse during dataentry.

LOW LOW During transfusionresult data entry useris prompted if atransfusion reactionassociated with theunit. There is also aseparate option toreport transfusionreactions whichcannot be associatedwith a specific unit.Free text entry is notallowed.

SRS#P8

SCR#P12

HP7 Cannot provide auniquecumulativerecord for eachindividualpatient.

NONE NONE NONE Records updateimmediately upondata entry. Printsingle BB patientreport [LRBLPPRINT SINGLE]option provides acumulative record forBlood Bank testingdata on each patient.

SRS#P9P11P52P86

SCR#P1P12

HP8 Patient recordconfidentiality iscompromised

Menu optionsdisplayingsensitive datanot restrictedappropriately.

LOW LOW Menu optionscontaining sensitivedata should berestricted by securitykeys.

SRS#N/A

SCR#P2




Likelihood

Method(s) ofControl

Trace

HP9 Cannotdetermine pretransfusionrequirements forspecific bloodcomponents.

Responsibleperson did notedit the BLOODPRODUCT file(#66) to reflectsite policies priortoimplementation.

LOW LOW Edit blood product file[LRBLSEB] optionshould be used tocustomize therequirements forblood productscurrently in use atspecific sites.

SRS#P2

SCR#P16P19P25P26

HP10 Corruptedpatient recordsdue to duplicatedata entry.

NONE NONE NONE Record locking isemployed whichprevents Patientblood bank test dataentry by more thanone individual at atime.

SRS#P10

SCR#P1

HP11 Cannot reviewtransfusionhistory on apatient.

Computer down-time

LOW LOW Patient reportavailable whichdisplays the patient’stransfusion record inreverse chronologicalorder for a specifieddate range. Reportincludes history oftransfusion reactions,antibodies identified,and BLOOD BANKCOMMENTS.

SRS#P12

SCR#P1

HP12 Patient can beassigned unitsfrom a differentdivision if site ismultidivisionaland a BloodBank exists atmore than onesite.

User division isdefined duringuser log on.1) Invalid choicesassigned bysystemadministrator.

2) User withmultiple choiceschooseincorrectly whenlogging in.

NONE LOW Access is limited tounits from thedivision of the userthat is determinedduring log on tosystem. Even ifcomputer allowedunits to be assigned,units would notphysically beavailable.

SRS#P13P79

SCR#P3




Likelihood

Method(s) ofControl

Trace

HP13 Barcode scannernot used to readUnit ID.

1) Site does notuse scanner.2) Scanner notworking.3) User choosesto not usescanner

NONE LOW Softwareaccommodates bothscanner and manualinput of Unit IDinterchangeably.

SRS#P14

SCR#P3

HP14 Cannot trackchanges toverified data inthe Blood BankPatient records.

VA Fileman usedto edit fieldsdirectly ratherthan specifiedmenu options.

LOW LOW Direct access to BloodBank data filesthrough VA Filemanshould be restrictedby site policy.

SRS#P15P16

SCR#P4

HP15 Cannotdetermine whoentered data incomputer.

NONE NONE NONE Assignment ofresponsibilityautomatic based onidentity of individualdetermined upon log-in to system.

SRS#P17

SCR#P8

HP16 Unit Inventoryrecord notupdated whenappropriate dataentered throughPatient options.

Total systemcrash/failure.

NONE LOW Edit unit - patientfields [LRBLSEC]option can be used ifnecessary to updateentries in the BLOODINVENTORY file(#65) to reflectcurrent Patient data.(Requires a highersecurity).

SRS#P11P18

SCR#P3P9

HP17 Cannot reviewpatientdemographicdata during dataentry.

NONE NONE NONE All patient optionsdisplay demographicdata, including firstand last names, socialsecurity number, dateof birth, ABO/Rh ofrecord (if one exists)and admittingdiagnosis.

SRS#P19

SCR#P13P15




Likelihood

Method(s) ofControl

Trace

HP18 Cannotdetermine apatient’spreviousantibody history.

User did notenter presence ofantibody in theAntibodiesIdentified field(#.075) duringdata entry.

LOW LOW Antibodies entered inthe AntibodiesIdentified field (#.075)during the Enter testdata option willalways display withthe patient name,regardless of divisionor whether theantibody is stilldetectable on thecurrent specimen.

SRS#P20

SCR#P12P14

HP19 Cannotdetermineprevioustransfusionreactions on apatient.

Previoustransfusionreaction data notentered intocomputer.

LOW LOW 1) Blood transfusionresults [LRBLPT]option prompts forentry of TransfusionReaction associatedwith a specific unit.2) Unknown unittransfusion reaction[LRBLPTXR] optionallows entry oftransfusion reactionnot associated with aspecific unit.Transfusion reactiondata always displayedalong withdemographic datawhen present.

SRS#P21P83P87

SCR#P12

HP20 Cannotdetermine ifautologous ordirected unitsare available fora patient.

Autologous ordirected unitsnot properlyidentified andrestricted topatient whenlogged in tosystem.

LOW LOW When units definedas either autologousor directed are loggedin to the BLOODINVENTORY file(#65), the user isrequired to enter avalid patient name atthe RESTRICTEDFOR: prompt. Theseunits are alwaysdisplayed along withthe patient namewhen blood bankpatient options areexecuted.

SRS#P22

SCR#P18




Likelihood

Method(s) ofControl

Trace

HP21 Can requestinappropriatecomponents for apatient.

Site did not editthe Can BeRequested field(#.15) in theBLOODPRODUCT file(#66).

LOW LOW Component requestsare limited to thosecomponents with theCan Be Requestedfield (#.15) = YES inthe BLOODPRODUCT file (#66).

SRS#P2P23

SCR#P19P25

HP22 Blood BankSupervisorcannot reviewwork as requiredby accreditationagencies.

Reports notregularlyprinted.

LOW LOW A variety of reportsexist to facilitatesupervisory review ofall work done in theBlood Bank asrequired byaccreditationagencies.

SRS#P24

SCR#P8

HP23 Cannotdetermine ifpatient has anyspecialcomponentrequirements.

Specialinstructions[LRBLPSI]option not usedto enter patientspecific specialinstructions.

LOW LOW Data entered via theSpecial instructions[LRBLPSI] option aredisplayed along withdemographic datawhenever Blood Bankpatient options areexecuted.

SRS#P25P27P62

SCR#N/A

HP24 Patienttransfusionhistory prior toimplementationof software notavailable on line.

Site chooses tonot use thePrevious records[LRBLPER]option enterpatienttransfusionhistory availableprior toautomation ofthe Blood Bank.

LOW LOW Use of functionality isvoluntary. Sites maychoose to updatepatient recordscompletely or rely ona combination ofautomated andmanual records. Sinceactual testing resultsstill need to bemaintained, sitesusually havetransfusion historyrecords available.

SRS#P26

SCR#P1




Likelihood

Method(s) ofControl

Trace

HP25 Units currentlyin inventory canbe entered ashaving beenhistoricallytransfused to apatient using theoption Previousrecords[LRBLPER].

NONE NONE NONE Software searches theBLOODINVENTORY file(#65). If a unit ispresent, then itcannot be entered viathe Previous Records[LRBLPER] option.

SRS#P26P28

SCR#P1

HP26 Cannot editinformationentered from oldrecords prior tocomputerization.

NONE NONE NONE Previous records[LRBLPER] optionallows editing ofpatient testinginformation butrestricts editing ofprevious transfusionepisodes entered viathis option.

SRS#P29

SCR#N/A

HP27 Cannot usecomputer toplace orders forpretransfusionor other BloodBank relatedtests.

1) Computersystem is down.2) Appropriatetests not definedin theLABORATORYTEST file (#60).

NONE LOW Sites are required tohave a contingencyplan in the event thatthe computer systemis not working. Dataentry can be thendone at a later time toupdate records.

SRS#P30

SCR#P20

HP28 Ward personnelcannot view testdescriptioninformation.

1) Menu Testdescriptioninformation[LREV] optionnot assigned toappropriatepersonnel.2) Keyinformation notdefined for BloodBank tests in theLABORATORYTEST file (#60).

NONE LOW Test descriptioninformation [LREV]option lists keyentries for Laboratorytests as defined in theLABORATORY TESTfile (#60).

SRS#P31

SCR#N/A




Likelihood

Method(s) ofControl

Trace

HP29 Orders for BloodBank testsplaced by wardpersonnel cannotbe accepted intothe Blood Bank,updating thestatus of theorder.

Computersystem is down.

NONE LOW Sites are required tohave a contingencyplan in the event thatthe computer systemis not working. Dataentry can be thendone at a later time toupdate records.

SRS#P32

SCR#N/A

HP30 Cannot reviewprevious BloodBank accessionsfor a specificpatient.

Computersystem is down.

LOW LOW Sites are required tohave a contingencyplan in the event thatthe computer systemis not working.Patients withantibodies identifiedand/or other specialinstructions should bereadily identifiable inthe event of computerdowntime.

SRS#P33

SCR#P12

HP31 Blood Bankpersonnel cannotenter specificcomponentrequests for apatient.

Site did not editthe Can BeRequested field(#.15) in theBLOODPRODUCT file(#66).

LOW LOW Component requestsare limited to thosecomponents with theCan Be Requestedfield (#.15) = “YES” inthe BLOODPRODUCT file (#66).

SRS#P2P34

SCR#P3P25

HP32 Cannotdetermine if avalidpretransfusionspecimen isalready presentin the BloodBank.

1) Site did notdefine testTransfusionRequest in theLABORATORYTEST file (#60),RequiredComment field(#320) =TRANSFUSION.2) Site did notdefine thespecimen usedfor pretrans-fusion testing tohave a site/specimen ofBLOOD.

LOW LOW When the RequiredComment field (#320)= TRANSFUSION thesoftware evaluatesprevious specimensfor Blood Bankaccessions to see ifany meets therequirements basedon the entry in theMaximum SpecimenAge field of theBLOOD PRODUCTfile (#66) for thespecific componentrequested.

SRS#P2P35P36P57

SCR#P16P20P25P26




Likelihood

Method(s) ofControl

Trace

HP33 Cannot doprospectiveutilizationreview of bloodcomponentrequests basedon currentpatient labvalues.

BLOODPRODUCT file(#66) entries forspecific productsdo not have theTests To Checkfield (#.04)and/or Pre-OpTests To Checkfield (#.08)defined forhigh/low valuesof lab tests tocheck.

LOW LOW When components arerequested, thesoftware evaluatesthe most recent labvalues for the patientbased on the entriesin the BLOODPRODUCT file (#66),Tests To Check field(#.04) and Pre-OpTests To Check field(#.08). If results areoutside the set limits,the user is promptedto enter additionaljustification and therequest is included inthe Inappropriatetransfusion requestsreport.

SRS#P2P7P37P95

SCR#P17

HP34 Cannot reviewpreoperativecomponentrequests tocompare againstMSBOS.

1) Site did notdefine the MSBOSparameters forspecific surgeryusing theMaximum surgicalblood order edit[LRBLSMS]option.2) Surgical staffdoes not enterspecific CPTcodes whenscheduling theirsurgery.

LOW HIGH The review of MSBOSusing the Bloodcomponent requestsoption is triggered bythe CPT code of thesurgery the patient isscheduled for. This isnot a required fieldand surgerydepartments often donot enter a CPT codeuntil after surgery iscomplete. The specificMSBOS files are builtby defining surgeryby each possible CPTcode.

SRS# P38P39

SCR#P17

HP35 Cannot revieworderingpractices bytreatingspecialty.

Report assignsrequests based ontreating specialtyon admission.Transfusion maybe ordered byother physician.

NONE MOD Report should bechecked against themanually prepared SF518 forms used by theVA for actual bloodorder and transfusionrecording.

SRS#P40

SCR#P8P17




Likelihood

Method(s) ofControl

Trace

HP36 Accession withverified data isdeleted fromsystem.

NONE NONE NONE Cannot delete anaccession if any datahas been entered.

SRS#P43

SCR#P1

HP37 No record ofABO/Rhinterpretationmaintained onpatients forfuturecomparison.

NONE NONE NONE The first timeABO/Rhinterpretation resultsare entered for apatient, a historicalrecord is createdwhich is used in allfuture testing forcomparison.

SRS#P44

SCR#P14

HP38 HistoricalABO/Rh recordinappropriatelyedited.

Patient ABO/Rhedit[LRBLPEDIT]optioninappropriatelyused to edit apatient historicalrecord.

LOW LOW Patient ABO/Rh edit[LRBLPEDIT] optionshould be restrictedby security keys tothe Blood Banksupervisor ordesignee.

SRS#P45

SCR#P14

HP39 No warning ifcomparison ofcurrent ABO/Rhinterpretationswith historicalrecord do notagree.

NONE NONE NONE Software comparescurrent ABO/Rh typeof specimen to thepatient history anddisplays a warningmessage if adiscrepancy exists.

SRS#P46

SCR#P3P14

HP40 No warning if nohistoricalABO/Rh recordexists forcomparison.

NONE NONE NONE Software displayswarning message ifno historical ABO/Rhrecord exists.

SRS#P47P69

SCR#P3P14

HP41 Cannot evaluatepositive directantiglobulintests to see ifdrug induced.

1) Site not fullyutilizingPharmacypackage.2) Patient takingdrugs prescribedfrom non-VAphysicians.

LOW LOW Upon entry of apositive direct AHGresult, the softwareautomatically reviewspharmacy profiles forthe patient andprovides report of allcurrent medicationsprescribed for patient.

SRS#P48P49

SCR#P11




Likelihood

Method(s) ofControl

Trace

HP42 Cannot trackpatient dataentry errors forABO/Rhinterpretations.

Print datachange audits[LRBLAD]option notreviewedregularly bySupervisor ordesignee.

LOW LOW Data entry errors forABO/Rh areautomaticallycaptured by thesoftware and areincluded in the Printdata change auditsreport [LRBLAD]option, which shouldbe reviewed regularlyand saved accordingto record retentionrequirements.

SRS#P50

SCR#P4P8

HP43 Changes inverified data forpatient testing isnot clearlymarked onpatient reports.

NONE NONE NONE Changes in verifieddata for ABO/Rh,antibody screening ordirect AHG testingare clearly markedand included in theBlood Bank TestReport for thepatient.

SRS#P51

SCR#P4P5

HP44 Cumulativepatient BloodBank test reportnot available.

NONE NONE NONE The Blood Bank Testreport includespatient demographics,historical and currentABO/Rhinterpretations,antibodies identified,and if requested,current componentrequests. This can beprinted by individualpatient or batchprinted. As a patientdata is entered, thereport goes onto aprint queue for batchprinting.

SRS#P11P52P53P86

SCR#P1




Likelihood

Method(s) ofControl

Trace

HP45 Expired unitscan be routinelyselected fortransfusion.

NONE NONE NONE Select units forpatients [LRBLPIC]option only allowsindate units to beselected. In case ofcomputer downtime,the supervisory Editunit - patient fields[LRBLSEC] option isavailable (i.e., whichrequires a higherlevel of security) toenter compatibilityinformation andassign an expired unitto a patient.

SRS#P16P55P56

SCR#P21

HP46 Units can beinappropriatelyassigned to apatient if novalid patientspecimen exists.

1) Site did notedit thePatient/ProductRequirementfield (#09) to beCROSSMATCHfor specificproduct types.2) The Edit unit -patient fields[LRBLSEC]option is usedinappropriatelyto assign units topatients.

LOW LOW Select units forpatients [LRBLPIC]option evaluates thePatient/ProductRequirement: field(#.09) in the BLOODPRODUCT file (#66)for the productselected. If set toCROSSMATCH, thenthe software searchesfor a valid specimen.If no valid specimenexists, user is alertedto obtain a validspecimen and cannotproceed. Edit unit -patient fields[LRBLSEC] option isavailable (requires ahigher level ofsecurity) which canbe used in the eventof prolonged computerdown time to enterrequired data. Thisoption should berestricted.

SRS#P16P35P36P57P58

SCR#P20P25P26




Likelihood

Method(s) ofControl

Trace

HP47 ABO/Rhincompatibleunits can beselected for apatient.

BLOODPRODUCT file(#66), Patient/Product ABOfield (#.07) andPatient/ ProductRh field (#.08)not definedproperly forspecific bloodcomponents.

LOW LOW Software evaluatesspecific requirementsfor components basedon the Patient/Product ABO field(#.07) and Patient/Product Rh field(#.08) and determinescompatibility basedon entries here.

SRS#P59

SCR#P23P24P25P26

HP48 Under specialcircumstancesan ABO/Rhincompatibleunit cannot beassigned to apatient.

NONE NONE NONE Edit unit - patientfields [LRBLSEC]option can be used toassign ABO/Rhincompatible unitswhen indicated. Thisoption requires ahigher level ofsecurity and shouldbe restricted.

SRS#P16P60

SCR#P23P24P25P27

HP49 Cannot “doublecrossmatch”units.

During theSelect units forpatients[LRBLPIC]option, user doesnot answer “NO”to the promptSelect onlyunassigned/uncrossmatchedunits ? YES//

NONE LOW During unit selection,there is a usercontrolled choice as towhether selection ofunits should belimited to those notcurrently assigned toanother patient.

SRS#P61

SCR#N/A

HP50 Blood Bankpersonnel notmade aware of apatient’s specialneeds.

SpecialInstructions[LRBLPSI]option not usedto enter patientspecificcomments whichare displayedwhenever aBlood Bankoption is used forpatient dataentry.

LOW LOW Special Instructions[LRBLPSI] optionshould be used toenter patient specificinformation. Thisinformation is thendisplayed withdemographic datawhenever patientBlood Bank optionsare executed.

SRS#P27P62

SCR#N/A




Likelihood

Method(s) ofControl

Trace

HP51 Cannotdetermine if aunit is a lowvolume unit.

1) BLOODPRODUCT file(#66) entry forspecificcomponent hasan incorrectvalue entered inthe Volume (ml)field (#.1).2) Unit notproperly labeledas a low volumeunit by site.

LOW LOW Units with a volumeless than the averagevolume for thecomponent as definedin the BLOODPRODUCT file (#66),Volume (ml) field (#.1)have the volumedisplayed inparenthesis by theUnit ID when such aunit is selected for apatient.

SRS#P63

SCR#N/A

HP52 Cannotdetermine thenumber of daysbefore expirationof unit.

Data entry errorduring unit login.

LOW LOW During unit selectionfor a patient, thesoftware calculatesand displays thenumber of days leftbefore expiration ofunit.

SRS#P64

SCR#P21

HP53 Crossmatchresultsinterpretationscan be routinelyentered on unitsnot specificallyselected for apatient.

Edit unit -patient fields[LRBLSEC]option usedroutinely toassign units andenter crossmatchresults.

LOW LOW Enter crossmatchresults [LRBLPT]option restricts accessto those units selectedfor the patient. Forspecial circumstances,like after extendeddowntime, the Editunit -patient fields[LRBLSEC] optioncan be used for dataentry. This optionshould be restricted.

SRS#P16P65

SCR#P3

HP54 Units requiringABO/Rhconfirmatorytesting arecrossmatched ona patient.

User ignoreswarning messagedisplayed duringEntercrossmatchresults[LRBLPT] optionif requiredconfirmatorydata not presentfor specific unitID.

LOW LOW Enter crossmatchresults [LRBLPT]option checks ifconfirmatory testingis required for a unit.If no confirmatoryresults are availableon the unit, awarning is displayedto the user.

SRS#P66

SCR#P22P25




Likelihood

Method(s) ofControl

Trace

HP55 Units whoseABO/Rh recheckresults do notmatch the log-ininformation areavailable forcrossmatch.

NONE NONE NONE Enter crossmatchresults [LRBLPT]option prohibits entryof crossmatch resultsfor any units with adiscrepancy betweenthe ABO/Rh duringlog in andconfirmatory testing.

SRS#P67

SCR#P3P22

HP56 HistoricalABO/Rh recordon a patient canbe deleted.

NONE NONE NONE Software prohibitsactual deletion ofhistorical ABO/Rh.

SRS#P68

SCR#P14

HP57 Patient whosecurrent ABO/Rhresults do notmatch historicalrecord or haveno ABO/Rhresults enteredarecrossmatched.

NONE NONE NONE 1) During patient testdata entry, thecurrent ABO/Rhresults are checkedagainst the historicalrecord and a warningmessage is displayedrequiring override toaccept discrepantresults.2) Select units forpatients [LRBLPIC]option comparescurrent specimenABO/Rh results tohistorical record. Ifdiscrepancy exists orno ABO/Rh testingresults available useris given an alertmessage and is exitedfrom the option.

SRS#P69P70

SCR#P3P14

HP58 Transcriptionerror occurs oncreation ofrequired label tobe attached tocrossmatchedunit.

User does notgeneratesoftwareprovided labeland attach tocrossmatchedunit.

LOW LOW Software provides forgeneration of a labelcontaining patientand unit informationto be used to attach tothe tie tag as requiredby accreditationagencies.

SRS#P72

SCR#P3




Likelihood

Method(s) ofControl

Trace

HP59 Unitsphenotyped aspositive for anantigen whichcorresponds to aclinicallysignificantantibody in apatient can beselected forcrossmatch tothat patient.

1) Site did notuse the EditCorrespondingAntigen/Antibody[LRBLSNO]option to defineclinicallysignificantantibodies.2) User does notenter unitphenotypingresults intocomputer.

LOW LOW Select units forpatients [LRBLPIC]option evaluates unitphenotyping if thepatient crossmatchedhas an entry in theAntibodies Identifiedfield (#.075) and ifthat antibody has acorrespondingantigen defined.Select units forpatients [LRBLPIC]option preventsselection of a unittyped positive for thatantigen.

SRS#P6P73

SCR#P7

HP60 User not warnedwhen a patienthas a clinicallysignificantantibody andunits selected forcrossmatch arenot phenotypedand foundnegative for thecorrespondingantigen.

1) Site did notuse the EditCorrespondingAntigen/Antibody[LRBLSNO]option to defineclinicallysignificantantibodies.2.) User does notenter unitphenotypingresults intocomputer.

LOW LOW Enter crossmatchresults [LRBLPX]option evaluates unitphenotyping if thepatient crossmatchedhas an entry in theAntibodies Identifiedfield (#.075) and ifthat antibody has acorrespondingantigen defined. If thecorrespondingantigen is not enteredin the RBC AntigenAbsent field for theunit beingcrossmatched, awarning message isgiven.

SRS#P6P74

SCR#P7

HP61 Units can beissued ifcrossmatch isrequired andcrossmatch isnot completed.

Site did not setthe BLOODPRODUCT file(#66),Patient/ProductRequirementfield (#.09) =CROSSMATCHwhenappropriate.

LOW LOW Units are not giventhe status of‘assigned’ untilacceptable crossmatchresults are entered forthe unit if the productPATIENT/PRODUCTREQUIREMENT =CROSSMATCH. Onlyunits ‘assigned’ can besigned out using theDisposition -relocation [LRBLIDR]option.

SRS#P75

SCR#P16P26




Likelihood

Method(s) ofControl

Trace

HP62 Units withincompatiblecrossmatchresults can beissued.

NONE NONE NONE Software preventsunits with crossmatchresults other than ‘C’or ‘IG’ from beinggiven a status of‘assigned’.

SRS#P76

SCR#P28

HP63 Units withpreviousincompatiblecrossmatchresults can beinappropriatelyissued.

NONE NONE NONE Status of a unit whichwas not compatiblefor a patient can onlybe changed by a userwith a higher level ofsecurity access.

SRS#P77

SCR#P6P28

HP64 Units which areincompatible fora particularpatient are notavailable forother patients.

NONE NONE NONE Units withcrossmatch resultsentered that are not‘C’ or ‘IG’ areautomaticallyreleased back toinventory.

SRS#P78

SCR#P28

HP65 An autologousunit can beselected for apatient otherthan the onedesignated.

1) Site did notset theAutologous/DirectedComponent field(#25)appropriately forautologouscomponent in theBLOODPRODUCT file(#66).2) Autologousunit not loggedinto system asautologous.

LOW LOW When autologousunits are logged in tothe system, the useris prompted to enter avalid patient name atthe RESTRICTEDFOR: prompt. This isa required field. Thatunit can then only beselected for thatpatient when usingthe Select units forpatients [LRBLPIC]option.

SRS#P80

SCR#P3

HP66 Current patientcomponentrequest andunits assigned/availableinformation notavailable whenrequesting andselecting unitsfor a patient.

NONE NONE NONE Softwareautomaticallydisplays currentpatient informationon componentrequests and unitsassigned/available forissue whenrequesting andselecting componentsfor a patient.

SRS#P81

SCR#N/A




Likelihood

Method(s) ofControl

Trace

HP67 Cannotdetermine thenumber ofindividual unitscontained withina pool that istransfused.

1) Disposition -not transfused[LRBLIDN]option not usedto process apooled productfrom productsalready ininventory.2) Bloodtransfusionresults[LRBLPT] optionnot used for dataentry.

LOW LOW When a pooled unit iscreated from units ininventory using theDisposition -nottransfused[LRBLIDN] optionand transfusionresults are entered forthe pool the numberof units within thepool is calculated andthis number is stuffedinto the Pooled/Divided Units field(#.4) for the pooledproduct.

SRS#P82

SCR#P9

HP68 Transfusion datafor a futuredate/time isentered.

NONE NONE NONE Future transfusiondate/time data isprohibited.

SRS#P84

SCR#P3

HP69 Cannot evaluatetransfusionpractices bytreatingspecialty.

1) Patient isdischarged priorto transfusionresults enteredinto computer.Blood Bank techmay not knowthe treatingspecialty of thepatient at thetime oftransfusion.2) Transfusionordered from adifferent treatingspecialty thanadmission.

NONE MOD Treating Specialtyfield (#.02) is arequired field whenentering transfusionresults. Reportsautomatically assigntreating specialty onadmission totransfusion episodesfor inpatients.Treating specialtymust be entered bythe Blood BankTechnologist at timeof Blood transfusionresult entry whenpatients have beendischarged or weretransfused asoutpatient.

SRS#P40P41P42P85P91

SCR#P17




Likelihood

Method(s) ofControl

Trace

HP70 Cannotdetermine ifpatient has hadprevioustransfusionreaction notassociated with aspecific unit.

Unknown unittransfusionreaction[LRBLPTXR]option not usedto enter delayedtransfusionresults notassociated with aspecific unit.

LOW LOW Unknown unittransfusion reaction[LRBLPTXR] optioncan be used to entertransfusion reactiondata of this type.These are thendisplayed withdemographic datawhenever blood bankpatient options areexecuted.

SRS#P87

SCR#P12

HP71 Cannotinvestigatetransfusionreaction patternsat a facility.

Appropriateoptions not usedto entertransfusionreaction data onpatients.

LOW LOW Report available forall transfusionreaction data, sortedby patient. Includesboth reactionsassociated withspecific units andthose not associatedwith specific units.

SRS#P83P87P88

SCR#P17

HP72 Cannot identifypotential cases oftransfusiontransmitteddisease.

1) Tests fortransfusionfollow-up[LRBLTX] optionnot used todefine tests andlimits whichcould beindicative oftransfusiontransmitteddisease.2) ReportTransfusionfollow-up tests[LRBLTXA]option notreviewed.3) Some testresults may notbe entered incomputer.

LOW LOW Report Transfusionfollow-up tests usesparameters defined inthe Tests fortransfusion follow-up[LRBLTX] option andsearches patients whohave been transfusedwithin a specifiedtime period for testvalues which may beindicative of possibletransfusiontransmitted disease.

SRS#P89

SCR#P17




Likelihood

Method(s) ofControl

Trace

HP73 Cannot reviewcrossmatch:transfusion ratios bytreatingspecialty.

Treatingspecialtiesassigned topatient treatingspecialty uponadmission.Transfusion mayhave beenordered bysomeone else.

NONE MOD Crossmatch/Transfusions by Specialty/Physician [LRBLAA]option is available forreview but reportshould be checkedagainst paper recordsfor accuracy.

SRS#P42P85P90

SCR#P17

HP74 Cannot reviewdata on patientscrossmatched fora specified daterange to revieworderingpatterns.

NONE NONE NONE Crossmatch:Transfusion report[LRBLRCT] optionprovides data onpatients crossmatchedby date/timecrossmatched whichis used to reviewordering patterns.

SRS#P40P41P42P91

SCR#P17

HP75 Cannot evaluateutilizationpatterns ofautologous units

1) Autologousproducts notdefined in theBLOODPRODUCT file(#66) as such.2) Autologousunits not loggedin to inventoryproperly.

LOW LOW Autologousdisposition report[LRBLJB] option canbe used to reviewautologous programutilization patterns.

SRS#P92

SCR#P17




Likelihood

Method(s) ofControl

Trace

HP76 Cannot identifyunits withprolongedinfusion time,based on localparameters, foruse inTransfusioncommitteereview.

1) MaximumInfusionTime(Min) field(#.24) in theBLOODPRODUCT file(#66) not definedfor specificproducts.2) Accurate sign-out date/time notentered usingDisposition –relocation option.3) Accuratedate/time notentered whenentering Bloodtransfusionresults for aspecific unit.

LOW LOW Report Prolongedtransfusion times isavailable which listsinstances of prolongedtransfusion timesbased on the entry inthe MaximumInfusion Time (Min)field (#.24) for specificblood products in theBLOOD PRODUCTfile (#66).

SRS#P93

SCR#P17

HP77 Cannot readilyobtainadministrativedata requestedon the annualAABBquestionnaire.

Not alladministrativedata entered intocomputer.

NONE LOW Report Blood BankAdministrative Data[LRBLA] is designedto capture datarequested on theannual AABBquestionnaire. It isrequested by daterange.

SRS#P94

SCR#P17

HP78 Cannot monitorinappropriatetransfusionrequests for QApurposes.

The Tests ToCheck field (#.04)and Pre-Op TestsTo Check field(#.08) are notdefined withhigh/low valuesof lab tests forspecific bloodproducts to bemonitored.

LOW LOW Inappropriatetransfusion requestsreport can be printedto review orderingpatterns. Requestswhich are outsidetolerances defined forthe specific bloodproduct are includedin the report.

SRS#P40P41P95

SCR#P17




Likelihood

Method(s) ofControl

Trace

HP79 Cannot performoutcome analysison bloodcomponenttherapy based onpost-transfusionlab results.

Tests forinclusion intransfusionreport[LRBLSET]option not usedto define tests tobe used tomonitor outcomeanalysis.

LOW LOW Patient transfusionsand hematologyresults [LRBLPCH]option report can berequested by patientfor a selected daterange. Report listscomponentstransfused by datealong with laboratorytest results based ontests defined throughoption Tests forinclusion intransfusion report[LRBLSET] option.

SRS#P96

SCR#P17

HP80 Cannot reviewall transfusionswithin a specificdate range.

NONE NONE NONE Transfusion datareport provides ahard copy of all unitstransfused within aspecified date rangeand includes a varietyof information usefulto the Blood Banksupervisor for QAreviews.

SRS#P97P98P99

SCR#P17

HP81 Patient bloodbank data isarchived and isno longeravailable forlookup.

NONE NONE NONE Patient Blood Bankdata is not included inthe algorithm whichis used for archivingother Laboratoryresults.

SRS#P100

SCR#P10

HP82 Cannot provide ahard copy listingof patients whohave clinicallysignificantantibodies.

1) Users do notenter patientantibody data inthe AntibodiesIdentified field(#.075) whenentering testdata.2) Site did notuse option EditCorrespondingAntigen/Antibody todefine clinicallysignificantantibodies.

LOW LOW Antibodies by patient[LRBLPAB] optionprovides a listing ofpatients who haveclinically significantantibodies.

SRS#P101

SCR#P10




Likelihood

Method(s) ofControl

Trace

HP83 Cannot provide ahard copy listingof patients whohave Blood Bankdata forreference duringcomputerdowntimes.

1) Users do notenter patientantibody data inthe AntibodiesIdentified field(#.075) whenentering testdata.2) Site did notuse option EditCorrespondingAntigen/Antibody[LRBLSNO] todefine clinicallysignificantantibodies.

LOW LOW Patient antibodyreport (long-list)[LRBLPRA] option isavailable to providesa hard copy listing ofpatients with BloodBank data that can beused during computerdowntimes.

SRS#P102

SCR#P10

HP84 Cannotaccuratelydetermineworkloadstatistics forlocal andnational reports.

Site did notaccurately enterworkload codesin specific BloodBank filesaccording to theguidelinesincluded in theLaboratoryPlanning andImplementationGuide V 5.2.

NONE LOW When workload codesare defined forparticular tests,products, andprocedures, workloadis automaticallycollected as abackground activitywhenever data isentered into thecomputer.

SRS#P103

SCR#N/A

appendix i vista laboratory blood bank user manual hazard analysis

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