MEMORANDUM OFAGREEMENT
(OrganTransplantandHLALaboratoryServices)
ThisMemorandumofAgreement("MOA")ismadeandenteredbyandbetweentheOPOand Transplant Center.
WHEREAS,OPO isthefederally certifiedorgan procurement organization designated forthegeographicareathatincludesthe TransplantCenterandisamemberoftheOrgan ProcurementandTransplantationNetwork(OPTN);and
WHEREAS, Transplant Center is a hospital which is a member of the Organ Procurement and Transplantation Network (OPTN) and is certified by Medicare to furnish directly, for aspecific organ(s), transplant and other medical and surgical specialty services requiredforthecareoftransplantpatients;and
WHEREAS,thepartiesarerequiredto haveanagreementbetweeneachotherandas membersoftheOPTNwillabidebyalltheapplicablepolicies;and
WHEREAS,theTransplantCenterandOPwishtoenterintoanagreement tofacilitate the donationandtransplantationoforgansandtissuesforthepurposespermittedunderthe Missouri Revised Uniform Anatomical Gift Act (R.S.Mo. § 194.210 et seq.);
NOW,THEREFORE,in considerationofthemutualpromises,terms,provisionsand conditionscontainedinthisMOA,theTransplantCenterandOPOherebyagreeasfollows:
1. ApplicableLaw
Thepartiesagreethatthe Missouri Revised Uniform Anatomical Gift Act (R.S.Mo. § 194.210 et seq.)andtheregulationsimplementingtheAct(together,the"Act") aswell as all applicable federal laws and regulations, including Medicare and Medicaid ConditionsofParticipationforhospitalsandorganprocurementorganizations asmaybe amendedform timetotime(the"Regulations") willcontrol themanner inwhichany activitiesundertakenpursuanttothisAgreementareconducted. Thepartiesfurtheragree that,totheextent itdoesnotconflictwiththeActortheRegulations,suchpolicieson organandtissuedonation andtransplantation asmaybeestablished bytheTransplant CenterandOPOwillguidethepartiesinimplementingthisAgreement.
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2. DutiesandObligationsoftheTransplantCenter
TheTransplantCentershall:
a) Commit to work collaboratively with the OPO to maximize donation of organs and tissuesthrough theuseof"best practices"tobedeveloped jointly bytheOPOandthe TransplantCenter.
b) Comply with all applicable OPTN rules and requirements with respect to listing of patientsfortransplantandallocationoforgans.
c) Provide written documentation to the OPO's HLA Laboratory describing the time intervalsforsubmission ofbloodsamplesandlaboratorytestsrequiredforallrenaland extrarenaltransplantcandidates,recipientsandlivingdonors.
d) Reimburse OPO promptly for all authorized laboratory tests performed and properly invoiced.
e) PromptlyreimbursetheOPOfororganacquisitioncharges,asmaybeineffectfromtime totimeduringthetermofthisAgreementandforallorgansaccepted bytheTransplant Centerfortransplantation.
f) Directlyreimburseaircharterand/orgroundtransportation vendorsfortransportationof extrarenalorgansandrecoverypersonnel.
g) Representand warrant that, withrespecttoeach Recovery Surgeon affiliated withthe
TransplantCenter:
•EachRecovery Surgeon hasmedicalstaffprivilegesattheTransplant Centerto performorganrecoveries;
•the Transplant Center has queried the NationalPractitioners Data Bank concerningeachRecoverySurgeon;
•to the bestof itsknowledge, theTransplant Center isnotaware ofanyCMS
sanctionsorpendingsanctionsagainstanyRecoverySurgeon;and
•each Recovery Surgeon maintains malpractice insurance in minimum required amountsconsistentwiththeTransplantCenter's policiesandapplicablelaw.
h) Notify the OPO of any change in a Recovery Surgeon'smedical staff privileges,licensureorinsurancestatus.
i)MakeavailableinatimelymanneraRecoverySurgeontoperformorganrecoveryof:
(1)allextrarenal donor organstobeallocated topatientsoftheTransplantCenter;
and
(2)allkidneysofdonorsattheTransplantCenter;unlessanotherRecoverySurgeon, acceptabletotheOPO,hasagreedtorecoversuchorgans.
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j) EnsurethatallRecoverySurgeonssentbytheTransplantCenterfororganrecoveryare trainedandcompetenttocarryouttherecovery. Notwithstandingthis,theOPOreserves therighttorestrictorrevokeapprovalforaRecoverySurgeontoperformrecoveriesof donororgansiftheOPOdetermines,inaccordancewithOPOpolicyandapplicablelaws andregulations,thatsuchRecoverySurgeonisnotsuitable.
k) Togetherwiththeirsurgeons,andinaccordancewithUNOSPolicy3.1.2,beresponsible forensuringmedicalstabilityofdonororgansthathavebeenallocatedfortransplantation intoapotentialrecipientattheTransplantCenter.
l)RequireeachRecoverySurgeontobecertifiedbytheOPO.
m)Provide the OPO with contact information of current personnel and give prompt notificationofchangesinkeypersonnel.
n) ReportinactivationandreactivationoftransplantservicestotheOPO.
o)ParticipateinDonorNet/Unetdata systemstoprovideupdatedpatientstatus/listing informationandtoreceive/respondtoallorganoffersinatimelymanner.
p)To the best of its knowledge, notifytheOPOofadverseeventsthatmightindicatethata donormayhavehada transmissiblediseasethatcouldbetransmittedtootherorganandtissuerecipientsfrom thesamedonor.
q) Utilizethehospital's QAPISystemtoidentify,investigateandresolveissues,complaints andconcernsrelatedtoOPOservicesandinteractions.
r) Provide timely follow-up information and data about the utilization and outcome of allocatedorgans.
s) Facilitate communications between recipients and donor family in accordance with applicablepolicies.
3. DutiesandObligationsoftheOPOTheOPOshall:
a) AllocateorganstopatientsoftheTransplantCenterinaccordancewithapprovedOPTN
rulesandregulationsasmaybeineffectfromtimetotime.
b) Workcollaboratively withtheTransplant Centertomaximize donation oforgansand tissuesthroughtheuseof"best practices"tobedeveloped jointlybytheOPOandthe TransplantCenter.
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c) MeetregularlywithkeyTransplantCenterstafftoprovideinformationonorgandonor potentialandconversionattheTransplantCenter.
d) ProvidetheTransplant CenterwithacurrentlistofOPOapproved RecoverySurgeons withintheOPO'sservicearea,asupdatedfromtimetotime.
e) Coordinateallaspectsoftheorganrecoveries.
f) In consultationwiththeTransplantCenterrecoveryteam,arrangeforappropriate transportation of external donor organs and recovery personnel between the donor hospitalandtheTransplantCenter.
g) ProvideforthetransportationanddeliveryofrenalorganstotheTransplantCenter.
h) CompletetheOPOcertification processforqualifiedRecoverySurgeonsaffiliatedwith theTransplantCenter.
i) Compensate theRecovery Surgeon for any recovery services provided inaccordance withastandardsurgicalfeeschedule.
j) To the best of its knowledge, notifytheTransplantCenterofadverseeventsthatmightindicatethatadonormayhave hadatransmissiblediseasethatcouldbetransmittedtootherorganandtissuerecipients fromthe samedonor.
k) ProvidetimelynotificationtotheTransplantCenterofanychangesinOPOpoliciesthat mayaffectorganrecovery,placement,packaging,labeling,perfusionandtransport.
I) UtilizetheOPO's QAPISystemtoidentify,investigate andresolveissues,complaints andconcernsrelatedto servicesandinteractionsbetweentheOPOandthe Transplant Center.
m)Facilitate communication between recipients and donor family in accordance with applicablepolicies.
4. AdvisoryBoardMemberNomination
Atransplantsurgeon for theTransplant Center shall berecommended bytheTransplant CenteradministrationtoserveontheOPOAdvisoryBoard.Allsuchnomineesaresubjectto OPOapprovalandelectioninaccordancewithOPObylawsandpolicies.
5. Term
This Agreement shall remain in effect until terminated by either party. Termination may be made only upon the occurrence of one or more of the following circumstances:
a.Decertification of OPO by the Centers for Medicare and Medicaid Services (“CMS”) as the designated Organ Procurement Organization for the Hospital;
b.Upon designation of another Organ Procurement Organization by CMS to be the Hospital’s designated Organ Procurement Organization;
c.Upon the granting of a waiver to the Hospital by CMS to work with another Organ Procurement Organization; or
d.Upon a showing by the Hospital that it is no longer subject to compliance with any federal or state regulation requiring that it refer potential organ and tissue donors to any Organ Procurement Organization.
Either party desiring to terminate this Agreement as a result of any of the aforesaid circumstances shall provide as much notice as possible, but in no case less than ninety (90) days written notice to the other party. Such notice shall specifically state the reason for the termination of the Agreement, and such party desiring to terminate the Agreement shall provide such documentation to the other party supporting the reason so stated.
6. Insurance
Eachpartyshallprocureandatalltimesmaintain and/or self-insure,atitsowncostandexpense,suchpolicies ofgeneral,productsand/orprofessionalliability,asshallbenecessarytoinsureitselfandits agentsandemployeesagainstanyclaimorclaimsfordamagesarisingbyreasonofpersonal injuries,propertydamage,deathorotherwiseoccasioneddirectlyorindirectlyinconnection withthisAgreementwhichshallataminimumhavelimitsequalto$1millionperoccurrence and$3millionintheaggregate.TheOPOandtheTransplantCentershallprovideeachother with documentary evidence of the above-described insurance coverage. The Transplant CentershallalsoprovideevidenceofinsurancecoverageforeachRecoverySurgeon. The OPOandtheTransplant Centerthereafter shall informeachotherofanyandallmaterial changes,cancellations orterminationsmadeinregardtosuchinsurancecoveragewithinten (10)daysofsaidchange,cancellation ortermination. TheprovisionofthisSection6shall surviveterminationofthisAgreement.
7. Indemnification
Eachpartyagreestoindemnifyandholdharmlesstheotherpartyfromanyclaim,liability,or lossresultingfrom thewillful, wrongful ornegligentactoromission oftheindemnifying party,itsagentsoremployees. Eachpartyshallnotifytheotherimmediately inwritingof anyclaimorinjuryordamage related toactivities performed pursuanttothisAgreement, whethertheclaimisverbalorwritten,orwhetherinformalorbysummons andcomplaint. TheprovisionsofthisSection7shallsurviveterminationofthisAgreement.
8. Confidentiality
In order to carry out its organ and tissue donation and transplantation obligations as a federallyapprovedOrganProcurementOrganization,theOPOanditsemployees,agentsand representativeswillhaveaccesstoindividuallyidentifiablehealthinformationmaintainedby theTransplantCenter,includingpatientnamesandothermedicalinformation,thatmaybein electronic,oral,orwritten form. Incarrying outtheseobligations, theOPO mayneedto discloseindividuallyidentifiablehealthinformationtotheTransplantCenterforthepurposes offacilitatingthedonationoforgansand/ortissuespursuanttothisAgreement. Theparties agreethatanysuchinformationsharedbetweenthepartiesshallbekeptconfidentialandwill not bedisclosed except asnecessary tocarry out theirduties under thisagreement oras permitted or required by law, regulation, or the policies and bylaws of the Organ Procurement Transplantation Network and the regulations promulgated under HIPAA pertainingtoprivacystandards.
9. Notices
Allnoticesandothercommunications underthisAgreementshallbedeliveredinpersonor sentbypre-paidfirstclassmail,asfollows:
TransplantCenter:With copy to:
President/ChiefExecutiveOfficer
OPO:
President/ChiefExecutiveOfficer
10.Amendment
ThisAgreementmaybeamendedormodifiedonlybywrittenagreementofbothparties.
11.Assignment
Neitherpartymayassignitsrightsordelegateperformanceofitsobligationshereunder withoutthepriorwrittenconsentoftheotherpartyhereto.
Signatures continue on the following page.
INWITNESSWHEREOF,theAgreementhasbeenexecutedonthis_____dayof ______2013bythedulyauthorizedrepresentativesoftheTransplantCenterandtheOPO.
OPOTransplant Center
Signature: Signature:
Printed Name:Printed Name:
Title: Title:
Date Signed: ______Date Signed: ______
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