Iacknowledgethat Andhis/Herhealthcareteamhaveprovided

PatientName: MRN:

AFFIXPATIENTIDENTIFICATIONLABELHERE:

InformedConsentForm

OrganTransplantSurgery

Iacknowledgethat andhis/herhealthcareteamhaveprovided

(nameofphysician)

mewiththeinformationlistedbelowregardingmytransplantsurgery.Ihavehadanopportunitytodiscussthe procedureandanesthesiawiththephysician(s)involved,Ihavebeengivenanopportunitytoaskquestions andmyquestionshavebeenanswered.

Iacknowledgethat istheresponsible

(nameofattendingsurgeon)

practitionerperformingthe surgery.

(nameofprocedure)

IalsounderstandthatbecauseTransplant Centerisateachinginstitution,Fellows,Residents,andotherhealthcare providers,actingunderthesupervisionanddirectionofmyprimarysurgeon/practitionermayperformimportant tasksrelatedtothesurgery.

Ifanyunforeseenconditionarisesinthecourseoftheprocedurecallinginthephysician’sjudgmentfor proceduresinadditiontoordifferentfromthosenowcontemplated,Ifurtherrequestandauthorizethe physiciantodowhateverthephysiciandeemsmedicallyadvisable.

IconsenttotheadministrationofanesthesiatobeappliedunderthedirectionoftheTransplant CenterDepartmentof Anesthesiologyandtotheuseofsuchanestheticsastheymaydeemadvisable.Thenatureandpurposeofthe anesthesia,possiblealternativemethodsofanesthesiaandthepossibilityofcomplicationshavebeenfully explainedtome.

Ireceivedinformationaboutmydiagnosis,prognosis,andtreatmentplan,includinganexplanationoftherisks, complications,benefits,andanyalternativemethodsoftreatment.

Ireceivedinformationanddiscussedwithmyhealthcareteamthetransplantsurgery,thespecificprocedures tobeperformedduringthesurgery,andthepotentialmedicalandpsychosocialrisksinvolvedin transplantation.Iunderstandthatspecificriskstothissurgeryinclude,butarenotlimitedto:Death, transplantedorganpoorfunction,transplantedorgannon-function,needforre-transplantation,and transmissionofdiseasefromthedonor.Additionalrisksinthiscaseinclude:

Ireceivedinformationanddiscussedwithmyhealthcareteamthepossiblealternativemethodsoftreatment, theprobabilitythattheproposedtreatmentwillbesuccessful,andtheprobabilityofrecoveryifnotreatmentis received.Noguaranteeorassurancehasbeenmadetomeastotheresultsthatmaybeexpected.Further, theTransplant Centertransplantoutcomeshavebeendisclosed.

Ireceivedinformationanddiscussedwithmyhealthcareteamtheexpectedpostsurgicalcourseand discomfortsofthetransplantsurgery.

Iunderstandthatexamination,testing,disposal,photographs,orpreservationofanytissue,partsororgans, includingtheuseforresearchorteachingpurposesmayoccurduringthetransplantsurgery,insuchmanner thatmaybedeterminedbyTransplant Center,itsemployeesoragents.

Iauthorizefilms,photographs,videos,orotherrecordingsofthissurgerytobetakenforthepurposeofmedical researchoreducationprovidedthepicturesdonotrevealmyidentityandIamnotidentifiedbyname.

IfIhaveaDNRorder,LivingWill,orAdvanceDirectivethatexpressesmydesiretoavoidheroicmeasures suchascardiopulmonaryresuscitation,Iunderstandandconsenttothesuspensionofsuchordersforthe durationofthesurgicalprocedureandrecoveryperiod,andrequestthatmywishesbereinstatedfollowingthe recoveryperiod.

ConsentforBloodTransfusion:IhavebeentoldthatImayneedatransfusionofbloodorbloodproducts andhavebeentoldwhatthebenefitstomemightbe.Ihavereceivedinformationabouttransfusion alternatives,includingautologousanddirecteddonations.

Ihavebeentoldhowabloodtransfusionisgivenandthepossiblerisksandconsequencesofthetransfusion, includingbruising,anallergicreaction,feverandhives,andbeingexposedthroughtransfusiontoinfectious diseasesuchashepatitisandHIV.TheestimatedriskofgettingHIVfromatransfusionisapproximately1in2 millionperunitofbloodtransfused.Theestimatedriskofgettinghepatitisisapproximately1in1.6millionfor HepatitisC virusand1in150,000forHepatitisB virusperunitofbloodtransfused.

IamtoldthateverypossibleprecautionistakenbytheBloodBankinchoosingdonorsandinmatchingblood fortransfusion.Ihavehadachancetoaskmydoctorand/ornurseotherquestionsaboutthetransfusion processanditsrisksandconsequencesandtheyhaveansweredthem.Iunderstandthisconsentforblood productsisvalidformyentirehospitalizationoruntilIwithdrawmyconsentforbloodtransfusions.

IconsenttotheuseofbloodproductsIDONOTconsenttotheuseofbloodproducts

CheckHereif:ThedonororganshavebeenprocuredfromadonorflaggedasHighRiskbytheOrganProcurementOrganization(OPO).

IunderstandthattheOrganDonorriskfactorsthatcouldaffectthesuccessofmytransplantsurgeryinclude, butarenotlimitedto,donorhistory,conditionorageoforgansused,patient’spotentialriskofhavingcontracted theHIVvirusandotherinfectiousdiseases.Ialsounderstandthatthedonorsandrecipientswillbescreened and/ortestedforinfectiousagentsanddiseasesbytheOrganProcurementOrganizationusing

currentlyavailabletestsandscreeningtools.Iunderstandthatitispossiblethatthescreeningtoolscouldfailto identifyadonor’sriskfactorsand/orthatthesetestscouldbenegativedespitethepresenceofaninfectious virus,includingHIV,hepatitis,orothertransmissibledisease.Iunderstandthatthereisnomethodof

completelyensuringthatinfectiousdiseaseswillnotbetransmittedbyorgantransplantandIacceptthatrisk. I

understandthedonorhasbeenidentifiedasHighRiskbytheOPOandIconsenttotheuseoftheorgan(s)in thetransplantsurgery.

Iaccepttheorgan(s)procuredfromthedonorflaggedasHighRiskbytheOPO.

(PtInitials)

OrganTransplantOutcomesattheTransplantCenter:Thefollowinginformationshows thesuccessratesoforgantransplantatourfacilityoneyearaftertransplantsurgery.Thisismeasuredby patientsurvival(iftherecipientisalive)andgraftsurvival(iftheorganisworkingoneyearlater).“Observed” ratesarethespecificratesatourcenter,and“Expected”ratesarewhatratesourcentershouldhave,basedon thecharacteristicsofourpatients.The“national”ratesaretheaveragesuccessratesofalltransplantcenters

inthecountry.Thisinformationisavailableonlineat

Thisinformationisforpatientstransplantedbetween7/1/2007and12/31/2009.Thisisthemostrecentdata provided,releasedinJanuaryof2011.

Organ / Patient Survival Observed / Patient Survival Expected / National Patient Survival / GraftSurvival
Observed / GraftSurvival
Expected / National Graft Survival
Kidney / 97% / 97% / 97% / 93% / 92% / 94%
Pancreas / 100% / * / 96% / 75% / * / 80%
Combined
Kidney-Pancreas / 100% / 96% / 96% / 100%kidney
83%pancreas / 94%kidney
87%pancreas / 93%kidney
87%pancreas
AdultLiver / 79% / 89% / 89% / 77% / 86% / 85%
PediatricLiver / 100% / 95% / 94% / 92% / 90% / 88%
Lung / 78% / 87% / 84% / 76% / 85% / 82%
Heart / 88% / 87% / 89% / 86% / 86% / 89%

*Expectedratesarenotcalculatedforpancreas-alonetransplant.

Note:InsomecasestheTransplantCenterrateappearslowerthanexpectedorthenational rate.Thisdifferenceis“notstatisticallysignificant”,meaningthedifferenceisonlyduetothecalculationsand doesnotrepresentameasurabledifferenceinsurvival.

IherebyauthorizeTransplant CentertoperformthetransplantsurgerydescribedaboveandIacknowledgethatIhave reviewedandunderstandthisform.

Patient/RepresentativeSignature:

Patient/RepresentativePrintedName:

Date: Time:

PhysicianSignature:

PhysicianPrintedName: Pager#:

DateSigned:

Time:

Iforgandonorisinhigh-riskcategory,providethefollowingpageofhigh- riskbehaviorinformationtothepatient.

CDCGuidelinesforHighRiskBehavior

TheinformationbelowoutlinestheCentersforDiseaseControlandPrevention’sdefinitionofhighriskfororgan donors.Forcompleteinformation,see“DonorExclusionCriteria”onpage12ofGuidelinesfor PreventingTransmissionofHumanImmunodeficiencyVirusThroughTransplantationof HumanTissueandOrgans.MMWR43(RR-8);1-17Publicationdate:05/20/1994

DonorExclusionCriteria

RegardlessoftheirHIVantibodytestresults,personswhomeetanyofthecriterialistedbelowshouldbe excludedfromdonationoforgansortissuesunlesstherisktotherecipientofnotperformingthetransplantis deemedtobegreaterthantheriskofHIVtransmissionanddisease(e.g.,emergent,life-threateningillness requiringtransplantationwhennootherorgans/tissuesareavailableandnootherlifesavingtherapiesexist).In suchacase,informedconsentregardingthepossibilityofHIVtransmissionshouldbeobtainedfrom therecipient.

Behavior/HistoryExclusionaryCriteria

1.Menwhohavehadsexwithanothermaninthepreceding5years.

2.Personswhoreportnonmedicalintravenous,intramuscular,orsubcutaneousinjectionofdrugsinthe preceding5years.

3.Personswithhemophiliaorrelatedclottingdisorderswhohavereceivedhumanderivedclottingfactor concentrates.

4.Menandwomenwhohaveengagedinsexinexchangeformoneyordrugsinthepreceding5years.

5.Personswhohavehadsexinthepreceding12monthswithanypersondescribedin items1–4above orwithapersonknownorsuspectedtohaveHIVinfection.

6.Personswhohavebeenexposedinthepreceding12monthstoknownorsuspectedHIV-infected bloodthroughpercutaneousinoculationorthroughcontactwithanopenwound,non-intactskin,or mucousmembrane.

7.Inmatesofcorrectionalsystems.(Thisexclusionistoaddressissuessuchasdifficultieswithinformed consentandincreasedprevalenceofHIVinthispopulation.)

SpecificExclusionaryCriteriaforPediatricDonors

1.Childrenmeetinganyoftheexclusionarycriterialistedaboveforadultsshouldnotbeacceptedas donors.

2.ChildrenborntomotherswithHIVinfectionormotherswhomeetthebehavioralorlaboratory exclusionarycriteriaforadultdonors(regardlessoftheirHIVstatus)shouldnotbeacceptedasdonors unlessHIVinfectioncanbedefinitelyexcludedinthechildasfollows:

Children>18monthsofagewhoareborntomotherswithoratriskforHIVinfection,whohavenot beenbreastfedwithinthelast12months,andwhoseHIVantibodytests,physicalexamination,and reviewofmedicalrecordsdonotindicateevidenceofHIVinfectioncanbeacceptedasdonors.

3.Children<18monthsofagewhoareborntomotherswithoratriskforHIVinfectionorwhohavebeen breastfedwithinthepast12monthsshouldnotbeacceptedasdonorsregardlessoftheirHIVtest results.

LaboratoryandOtherMedicalExclusionaryCriteria

1.PersonswhocannotbetestedforHIVinfectionbecauseofrefusal,inadequatebloodsamples(e.g., hemodilutionthatcouldresultinfalse-negativetests),oranyotherreasons.

2.PersonswitharepeatedlyreactivescreeningassayforHIV-1orHIV-2antibodyregardlessofthe resultsofsupplementalassays.

3.Personswhosehistory,physicalexamination,medicalrecords,orautopsyreportsrevealother evidence ofHIVinfectionorhigh-riskbehavior,suchasadiagnosisofAIDS,unexplainedweightloss, nightsweats,blueorpurplespotsontheskinormucousmembranestypicalofKaposi’ssarcoma, unexplainedlymphadenopathylasting>1month, unexplainedtemperature>100.5F(38.6C)for>10 days,unexplainedpersistentcoughandshortnessofbreath,opportunisticinfections,unexplained persistentdiarrhea,male-to-malesexualcontact, sexuallytransmitteddiseases,orneedletracksor othersignsofparenteraldrugabuse.