36C24124P0762.docx

SUBJECT*

Intent to Sole Source Pathology and Transportation Service

GENERAL INFORMATION

SOLICITATION NUMBER*

VA Boston Healthcare System Contracting Officer (90C) 940 Belmont Street Brockton MA 02301

POINT OF CONTACT*

deborah.reardon@va.gov

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

Special Notice Special Notice

DESCRIPTION

Special Notice

NOTICEOFTHEINTENTTOSOLESOURCE

Notice of Intent to Sole Source to Natural Disease Research Interchange. Response Due Date July 13, 2024, by 10:00am(EST)NoticeoftheIntenttoASoleSourceSynopsisNetworkContractOffice1,ProcurementOffice East on behalf of The Department of Veterans Affairs, Boston VA Medical Center. The proposed procurement is for products/services for which the Government Intends to Solicit and Negotiate with only one source under the Authority of FAR 6.302-1-Only One Responsible Source and no other Supplies or Services will satisfy AgencyRequirements41U.S.C.3304(a)(1).TheNorthAmericanIndustryClassificationSystemcode(NAICS) for this requirement is 541714-Research and Development in the social sciences and Humanities. All responsible sources that feel they should be considered qualified to provide the below mentioned products may submit a response to this notice by the response due date shown above toDeborah.Reardon@va.gov.

The Information provided shall include detailed and relevant documentation to allow the Government to performadequatemarketresearchandmakeaproperdetermination.AdeterminationbytheGovernmentnotto compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government.Informationreceivedwillbeconsideredsolelyforthepurposeofdeterminingwhethertoconduct a competitive requirement. THIS IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. THERE IS NO SOLICITATIONAVAILABLEATTHISTIME.REQUESTFORASOLICITATIONWILLNOT RECEIVE A RESPONSE

121966StatementofWorkforNDRIPathologyandTransportationServiceContractFY24Q4

A. GENERALGUIDANCE

1. TitleofProject:NDRIControlPathologyandTransportationServiceContract Transaction Number: TBD

2. ScopeofWork:TheNationalDiseaseResearchInterchange(NDRI)willcontinuetoprovidecomprehensive projectmanagement,pathologyservices,andtransportationtotheVABiorepositoryBrainBank(VABBB)asit relates to the recovery of brain, spinal cord, and other central nervous system (CNS) tissues for up to 8 control brains total.

3. Background:TheVABBBcollectsCNS(brain,spinalcord,andnototherwisespecified)tissueandrelevant medical history from control participants to provide high quality tissue annotated with relevant clinical data to qualified investigators. VABBB staff conduct regular telephone follow-up calls with all enrolled donors and coordinates brain and spinal cord recoveries upon the enrollees’ death. Donated organs are shipped via courier toourbiorepositorieseitherinBostonortheSouthernArizonaCoreTissueLaboratory(SACTL)attheTucson VA. Due to the precious nature of these organs and the time sensitive nature of our shipping, NDRI needs pathology and body transportation services in all 50 states 24 hours a day, 7 days a week, 365 days a year.

This contract will be a follow-on to contract 36C24123P1228 with NDRI, which expires 9/21/2024. The contractwillalsosupplementtheexistingpathologyandtransportagreementwithNDRIthathasbeenineffect since 2013 for ALS, GW, and PTSD donors. NDRI provides a highly specialized service to the VABBB that would be more expensive and less specific if obtained elsewhere.

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4. PerformancePeriod:TheanticipatedPOPforthiscontractisSeptember22,2024throughSeptember21,2025

5. TypeofContract:Thisis afirmfixedpriceservicecontract.

B. CONTRACTAWARDMEETING

No“kick-off”meetingwillberequiredasthiswillbeacontinuationoftheexistingcontract.

C. GENERALREQUIREMENTS

NDRIwillprovidepathologyandtransportationasdescribed.

D. SPECIFICMANDATORYTASKSANDASSOCIATEDDELIVERABLES

· monitorOPOscreeningactivitiesandprogress

· confirmthedonorcriteriamatchVABBB’sprotocol

· verify the authorization includes the NOK authorization for donation and future contact to obtain additionalinformation via interview

· coordinatetheacquisitionofbrainfromadultdonorsaccordingtostandardoperatingprocedures(SOP)

· coordinatetheshipmentoftherecoveredbrainandsupportingdocumentstoVABBB

· providecompleteddonorauthorizationtoVABBBthatincludescontactinformationforNOKforfuturecontact maintainadatabaseofeachcasethatincludescopiesofthecompletedauthorization,BDSW,anddonor’smedicaldata

· provideadatasetwithde-identifiedmedicalinformationaftereachshipment.ThedatawillbetransferredtoVA by NDRI via secure means on standardized forms

· recoveruptoeightbrains

E. EVALUATEDOPTIONALFEATURES

N/A

F. SCHEDULEFORDELIVERABLES

Pathologyandtransportserviceswillbeperformedondemandinconcurrencewiththeneedspecifiedbydonors to the VABBB.

G. CHANGESTOTHESTATEMENTOFWORK

ChangestotheSOWmustbeapprovedbyDr.Huber(PI),OliviaDeJoie(COR),andtheContractingOfficer.

H. REPORTINGREQUIREMENTS

N/A

I. TRAVEL

N/A

J. GOVERNMENTRESPONSIBILITIES

Page 1 of VABBBpersonnelwillcoordinaterecoverieswithNDRIstaff.

K. CONTRACTOREXPERIENCEREQUIREMENTS

QualificationsofKeyPersonnelDr.BertrandHuberandDr.IanRobeywillberesponsibleforreceiptof postmortem brain tissue.

L. CONFIDENTIALITYANDNONDISCLOSURE

NDRIshallcomplywithallrulesandregulationsregardingthedeliveryofthisorder.

CONTRACTORPERSONNELSECURITYREQUIREMENTS

The name of the VA donor who has consented into the VABBB study must be given to NDRI personnel to verifyidentity before performing brain recovery.This information exchange is included in the VABBB consent and explained to donors prior to death. Connection from contractor-owned IT devices to a VA internal network willnotberequired.TheA&Arequirementsdonotapply,andaSecurityAccreditationPackageisnotrequired. VA sensitive information will be exchanged and the security clause must be incorporated.

RECORDSMANAGEMENTOBLIGATIONS

A. Applicability ThisclauseappliestoallContractorswhoseemployeescreate,workwith,orotherwisehandleFederalrecords, as defined in Section B, regardless of the medium in which the record exists.

B. Definitions “Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics,madeorreceivedbyaFederalagencyunderFederallaworinconnectionwiththetransactionof public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

ThetermFederalrecord:

1. includesVHArecords.

2. doesnotincludepersonalmaterials.

3. appliestorecordscreated,received,ormaintainedbyContractorspursuanttotheirVHAcontract.

4. mayincludedeliverablesanddocumentationassociatedwithdeliverables.

C. Requirements

1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII SubchapterB,andthosepoliciesassociatedwiththesafeguardingofrecordscoveredbythePrivacyAct

Page 1 of of1974(5U.S.C.552a).Thesepoliciesincludethepreservationofallrecords,regardlessofformor characteristics, mode of transmission, or state of completion.

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters21,29,31,and33,theFreedomofInformationAct(FOIA)(5U.S.C.552),asamended,and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3. In accordance with 36 CFR 1222.32, the Contractor shall maintain all records created for Government useorcreatedinthecourseofperformingthecontractand/ordeliveredto,orunderthelegalcontrolof the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4. VHA and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of VHA or destroyed except in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage, or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, the ContractormustreporttoVHA.TheagencymustreportpromptlytoNARAinaccordancewith36CFR1230.

5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records, or equipment.Disclosureofnon-publicinformationislimitedtoauthorizedpersonnelwithaneed-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records, and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records, and/or equipment is no longer required, it shall be returned to VHA control or the Contractor must hold it until otherwisedirected.ItemsreturnedtotheGovernmentshallbehand-carried,mailed,emailed,orsecurely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

6. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information,documentarymaterial,and/orrecordsgeneratedunder,orrelatingto,contracts.The Contractor (and any sub-contractor) is required to abide by Government and VHA guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

7. TheContractorshallonlyuseGovernmentITequipmentforpurposesspecificallytiedtoorauthorized by the contract and in accordance with VHA policy.

8. TheContractorshallnotcreateormaintainanyrecordscontaininganynon-publicVHAinformationthat is not specifically tied to or authorized by the contract.

9. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains informationcoveredbythePrivacyActof1974orthatwhichisgenerallyprotectedfrompublic disclosure by an exemption to the Freedom of Information Act.

10. TheVHAownstherightstoalldataandrecordsproducedaspartofthiscontract.Alldeliverablesunder the contract are the property of the U.S. Government for which VHA shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

11. Training.AllContractoremployeesassignedtothiscontractwhocreate,workwithorotherwisehandle records are required to take VHA-provided records management training. The Contractor is responsible

Page 1 of forconfirmingtraininghasbeencompletedaccordingtoagencypolicies,includinginitialtrainingand any annual or refresher training.

**VHAtrainingforcontractorsisavailableinTalentManagementSystem(TMS):

5. RecordsManagementforRecordsOfficersandLiaisons,Item#3873736

D. Flowdownof requirementstosubcontractors

1. TheContractorshallincorporatethesubstanceofthisclause,itsterms,andrequirementsincludingthis paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same.

2. ViolationbyasubcontractorofanyprovisionsetforthinthisclausewillbeattributedtotheContractor.

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