New Ontario Kidney Allocation System Resource Guide!

Transcription

1 New Ontario Kidney Allocation System Resource Guide DearColleagues, ThenewOntariodeceaseddonorkidneyalgorithmandalloca9onwillbeopera9onalJanuary Thenewalloca9onsystemistheresultofyearsofhardworkandthecollabora9veefforts ofrepresenta9vesfromeachoftheontariokidneytransplantprograms,trilliumgifoflife Network(TGLN),OntarioRenalNetwork(ORN)andtheMinistryofHealth. Thethreemaingoalsofthenewsystemareto: 1) ImproveaccesstotransplantforallOntariansinneedofakidneytransplant 2) Improvepa=entoutcomes 3) EnsurestrengthandviabilityoftheOntarioRenalTransplantPrograms Thisdocumenthighlightstheimportantchangesthathavebeenincorporatedintothenew kidneyalloca9onsystem,inaddi9ontoaprimerondealingwiththevirtualcrossnmatchsystem andhlarelatedissues: 1) Aprovincialratherthanregionalmodelofkidneyalloca=on: AlthoughpreNexis9ngdonorregionswillremain,forthefirst9meinOntario shistorykidneys willbesharedbetweenregions.thefirstkidneywillremaininthetradi9onaldonorregionand thesecondkidneywillbeallocatedtoeitherthena9onalhighlysensi9zedprogram(hsp), whichisscheduledtogoliveinspring2014,orthenextrecipientinanyoftheontario transplantcentersbasedonalloca9onpriori9es. 2) Alloca=ontobemadebasedonanega=veVirtualCrossmatch(theabsenceofDonor SpecificAn=body): Thisreplacesthecurrentsystemofalloca9onmethodbasedonanega9vecrossmatch(see AppendixAformoredetails).Themethodswillbecongruentwithwhatiscurrentlyusedbythe Na9onalLivingDonorPairedExchangeProgramandtheNa9onalHSPregistry. 3) Alloca=onbasedonapointsystem: Whilewehavekeptthepriori9esunchangedfromthepreviousalloca9onsystem,wehave gonefrombinaryvaluestoacon9nuousmetric.asanexample,pa9entswithintheprevious alloca9onsystemwithapraof81getmuchgreaterprioritythanthosewithapraof79. Movingforward,withinallcategoriesofprioritythepointswillbebasedonthesimpleformula below: ALLOCATIONPOINTS=0.1pointper30dayswai=ng+[(cPRA/100)x4]

2 4) A2andA2BdonorscanbeallocatedtobloodtypeBpa=ents: Approximately22ofpa9entslistedforakidneytransplantinOntarioarebloodgroupBbut only12ofdonorsarebloodgroupb.thishasresultedinlongwait9mesandunequalaccess forbpa9ents. Inthenewsystem,A2andA2BdonorscanbeallocatedtopreNiden9fiedbloodtypeBpa9ents beforeiden9calbloodtypefor: a. Programswithpa9entswishingtocrossbloodgroupA2barrier b. BloodtypeBpa9entswithdocumenta9onofan9NA9tres1:8orless 5) Dataandmonitoring: Thechangeswillrequireclosemonitoringanddatacollec9ontoensurethatthegoalsoutlined aboveareachieved.whilethenewsystemhasbeenextensivelymodeled,therewillbethe needforflexibilityandchangeifrequired.inaddi9on,itisexpectedthatforthefirst9mein thehistoryofkidneytransplantinontario,bothtransplantprogramsandreferringdialysis centerswillbeaccountableforoutcomes.thelistofoutcomesisbeyondthescopeofthis document.however,movingforward,dialysiscenterreferralpaberns,wai9ng9mes,onhold statusandanumberofkidneyallografoutcomeswillbepublicallyreported. Thisresourceguidecontainsthefollowinginforma9on: 1. AppendixA:HLATes9nginNewOntarioKidneyAlloca9on 2. AppendixB:OfferingProcessOverview 3. AppendixC:OntarioDeceasedDonorKidney/KidneyNPancreas(KP)/PancreasaFer kidney(pak)transplanta9onalloca9onalgorithm

3 AppendixA HLATes=ngintheNewOntarioKidneyAlloca=on (notethevxmrulesdonotapplytopancreasorpakalloca7on). TheNewOntarioKidneyAlloca7onwillbebaseduponprinciplesofanega7vevirtual crossmatchandassignprioritybaseduponcpra. Thefollowinginforma7onisprovidedtoinformyouoftheuseofHLAtes7nginthenew alloca7onandwhenconsulta7onwithyourhlalaboratorymayberequired. YouareencouragedtospeakwithyourHLAlaboratorytoinformyourselfoftheirunique processesandtounderstandtheirworkflowasitrelatestoalloca7on. HLATYPING AlldeceasedDONORSwillbetypedat HLAA,B,C,DRB1,DRB345,DQA1,DQB1,DPA1,DPB1. NotethatRECIPIENTSneednotbefullytyped(asmanyhavebeenonthewai9nglistforsome 9meandfulltypingmaynothavebeenstandardwhentheywerelisted). CompletenessofHLAtypingonrecipientsinnowayimpactskidneyoffer. DECISIONPOINT: EachprogramshouldconfirmwiththeirownHLAlaboratorieshow/iftheywouldliketyping completedonrecipientsbefore/azertransplant. VIRTUALCROSSMATCHING Thealloca9onalgorithmispredicatedona CUMULATIVENEGATIVEVIRTUALCROSSMATCHto: HLAA,B,C,DRB1,DRB345,DQA1,DQB1 ThismeansthatifyourHLAlaboratoryhaseverdetectedHLAan9bodiestoan9gensatanyof theseloci,kidneyrecipientwillnotappearonthealloca9onlist.kidneypancreasandpancreas aferkidneypa9entswills9llappearonthealloca9onlistandwillbeofferedaccordingly regardlessofthevxmresult NotetheVXMresultsforDPA1andDPB1arecalculatedandavailablebutdonotimpactkidney offer. Allpa=entsappearingonthealloca=onlistwillhaveanega=vecurrent(mostrecentserum) andcumula=ve(allseraevertested)vxmwiththefollowingexcep=onsthatmayrequire addi=onalinforma=ontoresolve: AlleleSpecificAn=bodies DPAandDPBan=bodies

4 UntestedAn=bodies NewSerumreceivedandTes=ngNotYetCompleted Allele$Specific$An+bodies(ASAb)$$ Anan9bodyissaidtobeallelespecificifitreactswithonlyanallelicsubsetofanan9gengroup. Forexample,ifyourHLAlaboratoryhasiden9fiedanASAbtoA0203thismeansitreactsonlyto an9genscodedbya*02:03andnottoan9genscodedbyothera*02alleles.(e.g.a*02:01or A*02:10) AlthoughtheVXMAlgorithmcannotautoma9callyevaluateASAbasDSAitwillflagthe POSSIBILITYOFDSAandtheTGLNcoordinatorswillworkwiththerecipientHLAlabto determineifanasabislikelyorunlikelytobedsa,priortomakingakidneyoffer. Communica9onbetweenlabsandinsomecasesextrates9ngmaybeneededtomakethis determina9on. ThePRCwillonlyofferoutkidneystorecipientswithPOSSIBLEASAbDSAWHERETHE RECIPIENTLABHASALREADYDETERMINEDTHESEARE(ORNOTLIKELY)DSA. DPA$and$DPB$an+bodies$ Notethatatthis9me,an9bodiestoan9gensatDPA1andDPB1donotruleoutdonors. RecipientswithDSAtoDPA1andDPB1an9genswills9llappearonthealloca9onlist. AnyDSAtoDPA1orDPB1foranyrecipientappearingonthealloca=onlistwillbe communicatedtotheaccep=ngprogrambytheprccoordinator. Thera9onalefornotincludingDPDSAtoruleoutrecipientsatthis9meis: Thereagentsfordetec9ngDPan9bodiesmayleadtoiden9fica9onoffalseposi9ves TheclinicalimpactofisolatedDPDSAisnotknown Aflowcrossmatchcanbeperformedpriortotransplant Assuchwiththeseconcerns,theKidneyPancreasWorkingGroupagreedthatatthis9me recipientswouldnotbeautomaticallyexcludedbasedupondpdsa. TheKPWGwillcon9nuetomonitortherateofunexpectedposi9veXMthatmaybeabributed todpdsaandthisrulecanberevisitedasneeded. DECISIONPOINT: EachprogramshoulddeterminewiththeirownHLAlaboratorieshowtheywouldliketo proceedifdpa/dpbdsaarepresenttobeconsistentwiththeircentreprac=seorphilosophy. Op+ons$to$discuss$may$include:$ Decline$all$offers$with$DP$DSA$ Accept$all$offers$with$DP$DSA$ Determine$decision$on$a$case$by$case$basis$(if$this$op+on$is$chosen,$the$receiving$ program$will$need$to$be$prepared$to$speak$with$their$hla$lab$before$accep+ng$an$organ$ offer)$$ RECOMMENDATION:

5 Itisstronglyrecommendedthataprospec=veFCXMbeperformedoncurrentserumforany recipientwithdpdsaiden=fiedatalloca=on. Untested$an+bodies VERYRARELY,adonormayhavean9genstypedforwhichwedonothavean9bodyreagents.In thiscasethean9bodywillbelistedasuntestedandthevxmresultwillbeunknown.for examplewedonothavereagentstodetectabtoa80,howevera80an9genispresentin<<1 ofdonorsinthepopula9on. DECISIONPOINT: EachprogramconfirmshoulddiscusswiththeirownHLALaboratorieswhattheir recommenda=onisforproceedingwithuntestedan=bodyandunknownvxmresultstobe consistentwiththeircentreprac=seorphilosophy. Op+ons$to$discuss$may$include:$$ Accept$all$offers$where$donors$have$an+gens$where$Ab$are$untested$ Decline$all$offers$where$donors$have$an+gens$where$Ab$are$untested.$(not$recommended$ as$risk$can$be$assessed$with$a$prospec+ve$crossmatch$if$concerned)$ Determine$decision$on$a$case$by$case$basis$(if$this$op+on$is$chosen,$the$receiving$ program$will$need$to$be$prepared$to$speak$with$their$hla$lab$before$accep+ng$an$organ$ offer)$$ RECOMMENDATION: Itisstronglyrecommendedthataprospec=veFCXMbeperformedoncurrentserumforany SENSITIZEDrecipientwithUNTESTEDANTIBODIESiden=fiedatalloca=on. New$Serum$received$and$Tes+ng$Not$Yet$Completed$ WhenaserumisreceivedintheHLAlaboratory,itisloggedinTGLN.Duetothebatchnatureof waitlisttes9ng,resultsoftes9ngmaynotbeavailableimmediately.underthesecircumstances, thecurrentserumresultswillbealluntested,andthecumula9veresultswillbenega9ve.all pa9entswithnega9vecumula9vevxmwillnonethelessappearonthealloca9onlist. DECISIONPOINT:

6 EachprogramconfirmwiththeirownHLAlaboratorieswhattherecommenda=onisfor transplantdecisionswhenthemostcurrentserumhasyettohavecompletetes=ngresults. ACTUALCROSSMATCHING Underthenewalgorithm,theFLOWCYTOMETRYCROSSMATCH(FCXM)isrecommendedto confirmdsafreestatus.thefcxmisofcomparablesensi9vitytothesingleagbeadassay ResultsusedintheVXMandwillhavethebestcorrela9onwiththeVXM.TheAHGNCDCXMis muchlesssensi9veforlower9teran9bodiesandwillnotcorrelatewellwiththevxm. TandBcellFCXMwillbedoneeitherSTAT(resultstobereportedpriortotransplant proceeding)orroutine/nonnstat(tes9ngandresultrepor9ngmaybedoneafertransplant hasoccurred). Ingeneral,highlysensi9zedpa9ents,thosewithuntestedAbandthosewithDPAorDPBDSA shouldhaveaprospec9vefcxmperformedpriortotransplant. DECISIONPOINT: EachprogramshalldeterminetheirowncriteriaforSTATandnondSTATXMorderingpriorto proceedingwithtransplant. Anautocrossmatchisnotrequired,howevermaybeofuseinassis9ngwithinterpreta9onof theallo(donor)crossmatch. DECISIONPOINT: Eachprogramshalldeterminetheirowncriteriaforperformingtheautocrossmatch.

7 CrossmatchResultsandRecommendedAc=ons TCellFCXM BCellFCXM Ac9on Nega9ve Nega9ve Proceedwithtransplant Nega9ve Posi9ve Proceedwithtransplantonlywithapprovalfrom HLAlaboratorydirectorordesignate. Ra+onale:$B$cell$XM$may$be$false$posi+ve$ Posi9ve Posi9ve Donotproceedwithtransplantunlessapproved byhlalaboratorydirectorordesignate. Ra+onale:$HLA$laboratory$may$be$able$to$determine$a$false$ posi+ve$crossmatch$due$to$autoan+bodies$under$certain$ circumstances$but$must$be$reviewed$by$the$lab. DECISIONPOINT: EachprogramshalldeterminetransplantdecisionaZercrossmatchinconjunc=onwiththeir ownhlalaboratory,inthecontextofthe Nega=veDSA principleofthealloca=on algorithm.