final draft module 3 word - ensuring specimen integrity ...€¦ · module 3 – ensuring specimen...

1 DRAFT

Module3–EnsuringSpecimenIntegrityforViralLoadTesting

Learningobjectives:

Bytheendofthemodule,participantswillbeableto:

• Listthespecimensrejectioncriteriaforviralloadtesting

• Describethecorrectspecimencollectionproceduresforviralloadtesting

• Performcorrectproceduresforseparationofplasmafromwholeblood

• Properlypreparedriedbloodspots(DBS)forviralloadtesting

• Properlystoreandpackagespecimensfortransport

• Trackspecimenreferralstatustoensuretimelyreturnofalltestresults

Targetaudiences:allcadresinvolvedinpre‐testingsamplecollection,processing,storage,andpackaging(Clinicians,Phlebotomists,Counselors,andLaboratorians)

Pre‐requisites:Module1

Participanthandouts:3‐1,3‐2,3‐3,3‐4,3‐5,3‐6,3‐7,3‐8,3‐9,3‐10,3‐11,3‐12

Specialpreparationsbeforefacilitating:None

Icon Meaning

RefertoHandout

Customizetheslideforlocalcontext

2 DRAFT

Module‐at‐a‐glance

Segment Whatyoudo Time Handout

Moduleopening 0:05

Slides1‐2 Statethemoduleobjective.

1. SpecimenTypeusedforViralLoadTesting 0:15

Slides3‐7 Explaintheslidesaccordingtothecontentnotes. Slide8 Gaugeparticipants’knowledgewiththeKnowledgeCheck

question.

2. SpecimenCollectionandProcessing 0:45

Slides9‐11 Explaintheslidesaccordingtothecontentnotes. Slides12‐13 Gaugeparticipants’knowledgewiththeKnowledgeCheck

questions.

Slides14‐18 Explaintheslidesaccordingtothecontentnotes. 3‐1,3‐2,3‐3

Slides19‐26 Conductactivity3A:IsthisDBSValid accordingtocontentnotes.

Slide27‐28 Explaintheslideaccordingtothecontentnotes. 3‐4 Slides29‐33 Gaugeparticipants’knowledgewiththeKnowledgeCheck

questions.

3. SpecimenPackagingandTransport 1:20

Slides34‐39 Explaintheslidesaccordingtothecontentnotes. 3‐5,3‐6,3‐7,3‐8

Slides40 Conductactivity3B:PackagingSpecimensfor ShipmenttoReferralSitesaccordingtocontentnotes.

3‐6,3‐7

Slides41‐42 Explaintheslidesaccordingtothecontentnotes. 3‐9,3‐10 Slides43‐45 Gaugeparticipants’knowledgewiththeKnowledgeCheck

questions.

4. SpecimenTracking 0:15

Slides46‐48 Explaintheslidesaccordingtothecontentnotes. 3‐11

5. SpecimenRejectionCriteria 0:40

Slide49‐51 Conductactivity3C:TrackingReferralSpecimens accordingtocontentnotes.

3‐12

6. MakingandPackagingDBSfromEDTATubes(Apracticallaboratorysession)

2:30

Slide52 SessionA‐MakingofDBSspecimens 3‐2 SessionB(nextday)‐ DBSpackaging 3‐7

Moduleclosing 0:10

Slides53‐54 Inviteparticipantstosupplywordstocompleteeachkeymessage

TOTALMODULEDURATION: 6:00

3 DRAFT

SlideNumber

ContentNotesforPowerPointSlides

1. SpecimenTypeusedforViralLoadTesting

3 Heading‐TheQualityofSpecimensAffectsViralLoadTestResultsSpecimenintegrityisthecornerstoneofaqualityviralloadtestresult.Toprotectspecimenintegrity,theymustbeproperlycollectedinthecorrecttypeoftube,storedatthecorrecttemperature,properlyprocessedandwithinthepropertimeframe,transportedintherighttemperatureandpackaging.Coordinationbetweentheclinic,specimentransportmethodandthelabisimportanttoensuretimelypickupandproperdeliveryofspecimens.Thetestinglaboratorywillrejectanyspecimensthatarrivewithanincorrecttemperatureorimproperpackaging,orwithouttheappropriatepaperwork.Youwilllearnthespecimenrejectioncriterialaterinthismodulesoyouknowhowtopreventyourspecimensfrombeingrejected.

4 Heading‐KeepYourTurnAroundTimeShortTurnaroundtime(TAT)isalwaysachallenge.TherearemanystepsalongthewaythatcanimpactTATandeachstepshouldbetrackedtodeterminewhereandifthereisabreakdown;improvementprojectsshouldbeinitiatedtoeliminatethebreakdownstoreducetheTAT.

5 Heading‐MethodsforBloodCollectionThereareseveralmethodsofbloodcollection–venipuncture,fingerprick,andheelstick(forbabies). ThepreferredmethodforviralloadtestingisvenousbloodinEDTAtube. Fingerprickhasbeenutilizedforviralloadtesting.However,thismethodhaslimited

datasupportingitsvalidityandcurrentlyisnotrecommendedbymanufacturers.CountrieswhowanttousethisspecimencollectionmethodforviralloadtestingshouldevaluatethisformofspecimencollectiontoensureDBScreatedfromfingerprickisaseffectiveasvenipuncture.

HeelstickforcreationofDBSisnotcurrentlywidelyusedforviralloadtestingbutisthecornerstoneforEIDtesting.

6 Heading‐SpecimensUsedforViralLoad:PlasmaandDriedBloodSpots(DBS)Beforetesting,wholebloodcollectedmustbeprocessedintoeitherplasmaordriedbloodspot(DBS)specimensforviralloadtesting.Thegoldstandardspecimenforviralloadtestinghasbeenplasma.DBScreatedfromvenousbloodwasvalidatedonlyrecently.

7 Heading‐Plasmavs.DBSforViralLoadTesting:ProsandConsTradeoffsexistwitheachsampletype,andtheseshouldbebalancedagainstclinicalandoperationalconsiderations.Forexample,driedbloodspotsmayeliminatetheneedforcoldchaintransport,butthismayrestrictthetypeofviralloadplatformtobeusedandtheapplicableclinicalthresholds.Ontheotherhand,EDTA‐derivedplasmarequirescentrifugation.Smallandinexpensivebattery‐operatedcentrifugesmaybeasolution;however,wherelogisticsforadequatesampletransporttoalaboratorydonotexist,thiswillrequirededicatedstaffattheclinicleveltrainedinphlebotomy,sampleprocessing,storageandtransportaswellassafetyprecautionsassociatedwithsamplemanipulationandwastemanagement.AskparticipantswhataretheprosandconsofusingplasmaversusDBSforviraltestingintheirsetting.Listtheircontributionsontheflipchartbeforeshowingtheanswersontheslide.

4 DRAFT

SlideNumber


8 Heading‐KnowledgeCheckGaugeparticipants’knowledgewiththeKnowledgeCheckquestion.

2. SpecimenCollectionandProcessing

10 Heading‐ExampleofValidandInvalidVenousBloodSpecimensWholebloodsamplesreceivedintothelaboratoryshouldbeinspectedtoinsurethatthebloodisavalidspecimen.Invalidwholebloodspecimensincludespecimensthatarehemolyzedorclotted. Hemolysisoccursifthespecimenisshakentoovigorouslycausinglysisofthered

bloodcells.Thiscanhappenwithimpropermixingorduringtransportifthespecimensarepackagedorhandledinappropriately.

ClottingcanoccuriftheEDTAtubeisnotmixedimmediatelyorproperlybyinversionafterbloodcollection.

11 Heading‐ExampleofValidandInvalidPlasmaSamplesValidplasmasamplesareclearandhaveaslightyellowtintwithdefinedbuffycoatandredbloodcelllayers.Hemolyzedplasmaspecimensappearbrightpinktoredincoloraftercentrifugation.Lipemicplasmaoccurswhenthereisanelevatedamountoffatinthebloodandtheplasmaiswhiteandthick.Otherspecimensthatarecontaminatedcanhaveextralayersofunidentifiablecellsordebris.ContaminatedspecimenscouldbecausedbyissueswiththeEDTAcollectiontubeorbutterflyortubingassociatedwithbloodcollection.Besuretoinspectalloftheseitemspriortouse,butdonotopenEDTAtubes.Contaminationcanbeseenwithoutopening.

12‐13 Heading‐KnowledgeCheckGaugeparticipants’knowledgewiththeKnowledgeCheckquestions.

5 DRAFT

SlideNumber


14

Handout3‐1

Heading–PlasmausingVenousBloodAlthoughitisoutsidethescopeofthismodule,managementmustmakesurephlebotomistsarecompetentandfollowtheproperprocedureswhencollectingvenousblood.ReferthefollowingthreetoolsfromtheSLMTAcurriculum(https://www.slmta.org/tool‐kit/english)toensurephlebotomistcompetency: 701‐PhlebotomyChecklist 702‐PhlebotomyKeyCompetencies 703‐PhlebotomyPatientSurvey

PlasmaPreparation(http://www.thermofisher.com/us/en/home/references/protocols/cell‐and‐tissue‐analysis/elisa‐protocol/elisa‐sample‐preparation‐protocols/plasma‐and‐serum‐preparation.html) Collectwholebloodintocommerciallyavailableanticoagulant‐treatedtubese.g.,

EDTA‐treated(lavendertops)orcitrate‐treated(lightbluetops).HeparinizedtubescannotbeusedasitinhibitsPCRreactions.Cellsareremovedfromplasmabycentrifugationfor10minutesat1,000‐2,000xg(ideally1500)usingarefrigeratedcentrifuge.

Theresultingsupernatantisdesignatedplasma.Followingcentrifugation,itisimportanttoimmediatelytransfertheliquidcomponent(plasma)intoacleanpolypropylenetubeusingaPasteurpipette.Thesamplesshouldbemaintainedat2‐8°Cwhilehandling.Iftheplasmaisnotanalyzedimmediately,theplasmashouldbeapportionedinto0.5mlaliquots,stored,andtransportedat–20°Cforshorttermstorageof‐70Cforlonger(amonthormore)storage..Itisimportanttoavoidfreeze‐thawcyclesanddonotfreezethawmorethan3times.Sampleswhicharehemolyzed,icteric,orlipemiccaninvalidatecertaintests.

15 Heading‐CentrifugationofWholeBloodintoPlasmaCentrifugationofwholebloodatthecorrectspeedandtimeiscriticaltoproperplasmaseparation.CentrifugationcanbemeasuredusingRPMorxg(RCF).RMP(rotationsperminute)varybasedonrotorinuseandthereforisdifferentforeachtypeofrotorevenwhenutilizingthesamecentrifuge.XgorRCF(relativecentrifugalforce)isaconstantmeasurementanddoesnotvarybymanufacturerorrotor.ThereforRCFshouldbeutilizedtostandardizethespeedatwhichthetubesarespun.Astandardspeedandtimeforseparationofplasmafrombloodis1500xgfor10minutes.Thecentrifugeshouldbecleanedonaregularbasisandmustbecalibratedyearly.Inthelab,utilizetheavailableequipmenttoshowhowtotogglebetweenRPMandRCFandhowthenumbervaries.IfpossibleshowanddiscusstheuseofanomagraphtodetermineRCFwhenallyouhaveisinformationonRPM.

6 DRAFT

SlideNumber


16

Handout

3‐2

Heading–SpottingandDrying theDBSCardfromVenipunctureEDTATubesReferparticipantstothejobaide(3‐2)andwalkthemthroughthesteps.Therewillbealaboratorysessionforhands‐onpracticeofmakingtheDBSspecimens.Provideadditionaltips: TheareawhereDBSarepreparedneedstobeinside,awayfromwindanddust,not

exposedtodirectsunlightandmustbeinacleanandnon‐clutteredspace. AlwaysuseUniversalSafetyPrecautions.Thisincludes:

o Treatallbloodsamplesasthoughtheyareinfectious.o Washhands.o Weargloves,apron/labcoatandifnohoodisavailableuseafaceshieldo Disposeofwasteappropriately.

Iftherearenopipettesavailableatransferpipetteoracapillarycanbeused.Justensurethatthespotiscompletelyfilled.

Youmustchangetipsbetweeneachpatientandonlyonetubeshouldbeopenedatanygiventime.

17

Handout3‐3

Heading–SpottingandDryingtheDBSCardfromFingerPrickUsingaCapillaryTubeReferparticipantstothejobaide(3‐3)andwalkthemthroughthesteps

18 Heading‐AValidDBSSpecimenAvalidDBSspecimenshouldbelabeledwithapatientIDoruniqueidentifier,adateandthespotsshouldbecompletelyfilled.Ifthereisnotenoughbloodfor5completespots,aminimumof3completelyfilledspotsshouldbecreated.Itisokayifthebloodgoesoutsideofthecircle.

19‐26 Heading‐Activity3A:IsthisDBSValid?Readtheactivityslide(#19)beforeshowingslide#20.Allowparticipants3minutestowritedowntheirresponsesbeforeunveilingtherightanswersusingSlides#21‐#26.

27

Handout

3‐4

Heading‐HowtoPreventUnacceptableDBSSamples?Referparticipantstothejobaide(3‐4).HighlightthecriteriaforacceptableDBSandunacceptableDBSsamples.EmphasizethatunacceptableDBSsampleswillberejectedbythetestinglaboratory.DiscussthingstheycandotopreventunacceptableDBSsamples.Stressthepointsbelow:

Ensurethatallpatientinformation(nameand/oruniqueidentifier)ispresentandlegible

Ensurethedateisincluded Ensurethecirclesarecompletelyfilledin Ensurethereareatleast3godspotspercard Ensurethespotsarenotlayeredorclottedorcontaminatedwithwateroralcohol Ensurethespotsarecompletelydrypriortopackaging

7 DRAFT

SlideNumber


28 Heading‐Recommendedvs.MinimumSpecimenVolumeforViralLoadTestingTheminimumspecimenvolumeissetbecausebelowthatleveltestingcannotbedone.Whenspecimencollecteddoesnotmeetthatminimumrequirement,itwillberejected.Ontheotherhand,wewouldliketocollectmorethanjustminimumspecimenvolumeincaseretestingisrequiredduetoinstrumentfailureoroperatorerrors.


3. SpecimenPackagingandTransport

35

Handout

3‐5

Heading–GuidelinesforSpecimenHandlingConditionsAftercorrectlabelingandpackaging,specimensshouldbeplacedatthecorrectstoragetemperature.Specimensshouldbestoredindedicatedrefrigeratorsandfreezersandshouldnotbestoredwithreagents.Eachspecimentypehasveryspecificrequirementstoensuretheirintegrityfortestinganddifferentmanufacturesoftenhavedifferentsuggestedstorageconditions.Alwaysrefertothemanufacturerforidealspecimenstorage.Ingeneral, Wholebloodshouldbeseparatedintoplasmawithin6hoursofcollection.Ifthisis

notpossible,wholebloodcanbestoredupto24hrsat2‐8Candshouldbetransportedatthissametempwithfrozenicepacks.Wholebloodcanneverbefrozenforlateruseinviralloadtesting.

Plasmacanbestoredat2‐8Cforupto5days.Andpriortofreezing,plasmacanbetransportedatthistemperaturewithfrozenicepacks.Forstoragefrom5‐60daysplasmacanbeheldat‐20Cbutideallyplasmashouldbeplacedat‐70Cforanylongtermstorage.Onceplasmaisfrozen,itmustbetransportedfrozentoavoidfreezethawcycles.

DBSifpackagedproperlycanbestoredatambienttemperatureforupto2weeksandcanbetransportedatthissametemperature.Forstorageafter2weeks,DBSshouldbekeptat‐70C.

36 Heading–PackagingViralLoadSamplesforTransportationAllspecimentypesshouldbetransportedasdescribedutilizingthetriplepackagingsystem.Localandinternationallawsshouldbeutilizedtoavoidanytransportissues.

37

Handout

3‐6

Heading–ExampleofTriplePackagingSystemAlltriplepackagingincludes3layers. Thefirstlaterconsistsoftheprimaryspecimencontainer.Forviralloadthisisatube

orfilterpaper. Thesecondpackagingcontainercontainsabsorbentmaterialandisleakproofto

preventspillage.Thiscanbeaspeciallydesignedscrewtopcontainerorsomethinglikeaziptopbag.Oftenthesecondlayerofpackaginghasarackorsimilaritemtokeepspecimensfrommovingaroundtoomuch.

Theoutercontainershouldhavebiohazardouslabelingwhennecessary(DBSdoesnotrequirethis)andshouldcontainallrelevantformsandpaperworktoaccompanythespecimens.Theoutercontainercanconsistofaboxorcooler.Theoutsideofthe3rdcontainershouldremaincleansoastoeasilybehandledwithoutPPE.

Referparticipantstoandwalkthemthroughjobaide3‐6.

8 DRAFT

SlideNumber


38

Handout

3‐7

Heading‐PackagingWholeBloodandPlasmaforTransportReferparticipantstoandwalkthemthroughjobaide3‐7.

39

Handout

3‐8

Heading‐PackagingDBSforTransportReferparticipantstoandwalkthemthroughjobaide3‐8.TherewillbeapracticalsessionlaterwithspottingtheDBScards.

9 DRAFT

SlideNumber


40

Handout3‐6,3‐7

Heading‐Activity3B:PackagingSpecimensforShipmenttoReferralSitesReferraltestingrequiresproperpackagingandshippingofpatientspecimenstopreservetheirintegrityandsuitabilityandtoprotectallpersonsinvolvedintheirtransportation.Inthisactivity,participantslearntheimportanceofsafeandeffectivespecimenpackingandpracticeappropriatelypackingsampleswithavailablematerialsofvaryinglevelsofsophistication.

Preparationsbeforetheactivity: Setupthreeworkstations(tables),eachequippedwithonesetofmaterialsbelow

andnecessaryPPE Donotuseactualspecimens,butobtainthespecimencollectioncontainersor

materials(i.e.,glassslide)tosimulatethespecimenstobepackaged. LabelallspecimensandtheiraccompanyingtestrequisitionswithpatientID

information,date/timeofcollection,collector’sinitials,andIDnumber.Tosimplifythepatientnameselectionyoumayuse“PatientA,PatientB,etc.”

Set1(Standard–commerciallyavailable)

Testrequisitionforms

6Specimens

3bloodspecimens

3DBScards

Specimentrackingform(s)

Absorbentsheathsand/orsheeting

Clearplasticbags

PathoshieldCarton

Cellotape/ShippingTape

Scissors

Biohazardshieldemblems

Coolerboxw/icepacks

Set2(RudimentaryPackaging)


6Specimens

3bloodspecimens

3DBScards


Severalpapertowels

Secondarycontainer(s)

1ziptopbaglarge

1specimenrack

Severalsheetsofnewspaper

Labtapeorwhateverisavailable

Scissors

Coolerboxw/icepacks

Set3(adhocpackaging)


6Specimens

• 3bloodspecimens

• 3DBScards


Severalnapkinsorteatowels

Secondarycontainer(s)

Clearplasticwrap

1teaboxorsmallboxsuppliescamein(likebloodcollectionsuppliesbox)

Rubberbands,tapeorrope/stringforclosure

SomesortofIcepacks

Conducttheactivity: Divideparticipantsevenlyinto3groupsandassigneachgrouptooneworkstation UseSlide#40toprovideinstructionsfortheactivity After15minutes,debriefbyunpackingeachboxandprovideyourfeedbackmaking

sureallparticipantscanseewhatyouaredoing. Stressthat,regardlessofthesophisticationofthepackagingmaterials,itshouldstill

bepossibletoproperlypackageandshipspecimensforreferral.Fancymaterialsarenotnecessary

Totalactivitytakesabout30minutes(introducing,conducting,anddebriefing)

Formoredetail,refertoModule7,PackagingSpecimensforShipmentactivityintheSLMTAcurriculum(https://www.slmta.org/tool‐kit/english).

10 DRAFT

SlideNumber


41

Handout3‐9

Heading–GuidelinesforSampleTransportSampletransportbeginsattheclinicwherepackagingtakesplaceandendsatthetestinglaboratorywherespecimensarereceived.Thespecimensmustbeproperlypackagedaccordingtoallsafetyguidelinesandicepacksusedmustbefrozen.Transportdocumentsmustbefilledout,checkedandsignedpriortothehandofftothetransportdriver.Thetransportdrivermustthenacknowledgereceiptofthespecimens.Thedriversmustbetrainedinsafepracticesforbloodbornepathogensandhavecontactinformationifaspilloccursorbetrainedandhavethenecessarymartialstodealwithaspill.Uponarrivalatthetestingfacility,specimensshouldbecheckedforanyissuespriortothedriverleavingthefacility.Referparticipantstojobaide3‐9.Walkthemthroughthehandoutandansweranyquestionstheymayhave.

42

Handout3‐10

Heading‐ChainofCustodyforSampleTransportTransportdocumentsmustbefilledtomaintainandprovechainofcustody.Eachstepintheprocessmustprovideasignaturetoacknowledgeandacceptresponsibilityforthischainofcustody.Dateandtimeshouldberecodedateveryhandoff.Thepackageshouldinspectedateveryexchangetoensuretherearenoissueswithleakageorspills.Referparticipantstojobaide3‐9.Walkthemthroughthehandoutandansweranyquestionstheymayhave.


4. SpecimenTracking

47

Handout3‐11

Heading‐KeepingTrackofAllReferralSamplesatClinicsThereshouldbeadesignatedindividualateachclinicresponsibleforcheckingtodetermineifsampleswerereceivedatthelaboratoryinatimelyfashionandingoodcondition.Thisindividualoranothershouldalsobethepointofcontactforthelabforissueswithspecimensandreturnofresults.Asinglepointofcontactmakesitmucheasierforlabstoknowwhotocommunicatewithwhenneeded.Forthesamereason,asinglepointofcontactatthelaboratoriesfortheclinicshouldalsobeestablished.Referparticipantstojobaide3‐11.Walkthemthroughthehandoutandansweranyquestionstheymayhave.

48 Heading‐ClinicsShouldRoutinelyTrackTheseIndicatorsTrackingtheseindicatorswillhelpensurethatallspecimenscollectedareaccountedforandresultswillbereturnedforpatientmanagement.

5. SpecimenRejectionCriteria

11 DRAFT

SlideNumber


50 Heading‐Activity3C:SampleRejectionCriteriaAssuringthatspecimensareacceptableiscriticaltothequalityofviralloadtesting.Inthisactivityparticipantswillbedividedinto3groups,eachassignedtodevelopalistofsamplerejectioncriteriaforwholeblood,plasma,orDBS.After20minutes,debriefbyconductingalargegroupdiscussionofeachgroup’slist.Provideyourfeedbackandpulloutallitemspertainingtoallthreespecimentypesandwritethemonaseparateflipchartpaperunder“General.”

51

Handout3‐12

Heading–SampleRejectionCriteriaReviewhandout3‐12toconcludeactivity3C.

LaboratoryPracticalSession

52

Handout3‐2,3‐8

Heading‐MakingandPackagingDBS fromEDTATubes‐ APracticalSession

SuppliesneededformakingDBS Suppliesneededforpackaging

Remnantwholebloodsamples 200uLpipettesandtips,ortransfer

pipettes* DBScards(twoforeachperson) Pensforlabeling Serologicalpipettesorsomethingto

utilizetokeepDBSoffthebenchtopwhenspotting

Dryingracks AllassociatedPPE Preferablyhoodtoworkin*Iftherearenopipettesavailable,atransferpipetteoracapillarycanbeused.Justensurethatthespotiscompletelyfilled.

Ziptopairtightbags Siliciapackets‐1perdbs Humiditycards Glassinepaper PPE

Emphasizethattipsmustbechangedbetweeneachpatientandonlyonetubeshouldbeopenedatanygiventime.

1. WalktheparticipantsthroughJobAide3‐2andthenhaveeachparticipantcreatetheirownbloodspotwithproperPPEandtechnique.Splitintopairsorgroupsof3andhavethemcritiqueeachother.

2. Comebacktogetherasagroupanddiscusstheissues/difficultiesifany.Thispracticalsessionshouldtakeapproximately30minutestocomplete.

3. AfterallowingDBStodryovernight,breakupintothesamegroupsfromthepreviousdayandfollowingJobAide3‐8topackagetheDBScards.Allowtimeforparticipantstocritiqueeachother.Comebacktogetherasagroupanddiscusstheissues/difficultiesifany.Thispracticalsessionshouldtakeapproximately30minutestocomplete

53‐54 Heading–Module6:KeymessagesInviteparticipantstosupplywordstocompleteeachkeymessage.

12 DRAFT

Handout3‐1

13 DRAFT

Handout3‐2

14 DRAFT

Handout3‐3

15 DRAFT

Handout3‐4

16 DRAFT

Handout3‐5

17 DRAFT

Handout3‐6

Triple Packaging System

PrimaryReceptacles

Containsthespecimen

Mustbewatertightandleakproof

Mustbeappropriatelylabeledastocontent.

Wrappedinenoughabsorbentmaterialtoabsorballfluidincaseofbreakageorleakage.SecondaryPackaging

Enclosesandprotectstheprimaryreceptacle

Mustbewatertightandleakproof

Severalwrappedprimaryreceptaclesmaybeplacedinasinglesecondarypackaging.

ContainsicepacksifneededOuterPackaging

Protectssecondarypackagingfromphysicaldamagewhileintransit Containsspecimendataforms,letters,andothertypesofinformationthatidentifyordescribethe

specimenandidentifytheshipperandreceiver,andanyotherdocumentationrequired.

Mustbeasturdycontainerwithalatchorabletobetapedshut

18 DRAFT

Handout3‐6

Specimen Packaging and Transport

Utilize PPE when packaging specimens. Ensure specimens are in the appropriate transport media (primary containers) for the specimen

collected and the test requested (primary containers). Ensure that primary containers will not leak

Determine the requirements temperature (ambient temperature vs refrigerated) and the

referral timeframe (i.e., 6 hours) for the specimen collect and the test requested. Consult the driver/courier schedule to ensure that the sample will reach the testing center

within the necessary referral timeframe. Place cold packs on the bottom (ideally) or sides of a secure leak-proof secondary container to

properly preserve the specimens during shipping (specimens shipped at ambient temperature may not require cool packs, although it is often still advisable in warm climates.)

Place the primary container(s) in the secondary container with sufficient absorbent material—

paper towels, cotton balls, commercial products—to absorb the entire contents of the primary containers.

– Ambient temperature specimens can be transported in the same secondary packaging as refrigerated specimens, but should be packed as far away from the cool pack as possible and be insulated by at least one layer of absorbent material.

Ensure secondary container(s) is labeled properly with a biohazard sticker or stamp. Place secondary container(s) in an outer shipping container that can be secured with a screw

top, latch mechanism or sealed with tape. Place test requisition forms in a plastic sheath (if possible) or zip top bag inside the outer

shipping container with specimen tracking form. Confirm that the contact information for the laboratory is clearly marked on the outer shipping

packaging and/or in paperwork inside the outer packaging Note the date and time of pick-up on the specimen tracking form/transport log and/or the

driver/courier logbook. Ensure that the drivers/couriers have received safety training in the transportation of

specimens. Disinfect the bench where the specimens were packaged.

19 DRAFT

Handout3‐6

Cross Section of Refrigerated Specimen Packaging

Outer Container

Secondary Container

Cool Pack

Ambient or room temperature specimens

Refrigerated specimens

Paper towels /

absorbent material

20 DRAFT

Handout3‐7

21 DRAFT

Handout3‐8

22 DRAFT

Handout3‐9

23 DRAFT

Handout3‐10

24 DRAFT

Handout3‐11

25 DRAFT

Handout3‐12

final draft module 3 word - ensuring specimen integrity ...€¦ · module 3 – ensuring specimen...

Documents