Attachment_3_DNA_Sequencing-SOW_Final_3-25-16.pdf

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Attached to
DNA Sequencing Services Federal contract opportunity
Solicitation number
NIEHS2016-0217
Issued by
Department of Health and Human Services National Institutes of Health

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Attachment 3 - SOW

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Attach_4-Add_Bus_Prop_Inst_5-6-2016.pdf PDF
DNA_Sequencing_Services_RFP_NIEHS2016_0217.pdf PDF
Attachment_2_Intent_Form.pdf PDF
Attachment_1_PackandDelivOfProposal.pdf PDF
DNA_Sequencing_Services_RFP_NIEHS2016_0217.pdf PDF
Attachment_5_NIH-RC-2_Invoice_Instr.pdf PDF
Attach4-Add_Bus_Prop_Inst.pdf PDF

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Attachment 1

DNA SEQUENCING SERVICES

StatementofWork
fortheNationalInstitutesof

Environmental Health Sciences (NIEHS)

March 21, 2016

A. Introduction

TheNationalInstituteofEnvironmentalHealthSciences(NIEHS)
(http://www.niehs.nih.gov/index.cfm),locatedinResearchTrianglePark(RTP),
NorthCarolina,isoneof27researchinstitutesandcentersthatcomprisethe
NationalInstitutesofHealth(NIH)(http://www.nih.gov/).Themissionofthe
NIEHSistoreducetheburdenofhumanillnessanddisabilitybyunderstandinghow
theenvironmentinfluencesthedevelopmentandprogressionofhumandisease.
Insupportofthismission,NIEHSseekstoestablishareliable,rapidandcost‐
effectiveSangerMethodcapillary‐basedDNAsequencingservicescontractwhich
supportsinvestigatorswithintheintramuralresearchprogramatNIEHS.This
sequencinginformationwillprovidevitalinformationtoongoinginvestigations
regardingenvironmentaldiseasemechanismsandthegeneticcomponentinvolved
incauses,outcomes,andprogressionofenvironmentaldiseases.
ThiscontractwillprovidehighqualityDNAsequencingofindividualsamplesand
accompanyingbioinformaticssupport.Themajorityofthebiologicalsampleswillbe
plasmidDNAandPolymeraseChainReaction(PCR)generatedsamplesfroma
varietyofspeciesthatinclude,butarenotlimitedto,human,rodentand
recombinantDNAisolatedfromvarioustissuesourcesandcelllines.Thecontractor
shallprovidesamplestorageandpreservationwhicharecriticalforsubsequent
nucleicacidanalysis.Informationneededtoassistthecontractorintheirabilityto
performtheservicecorrectlywillbeprovidedpriortosequencing;dataanalysis
willbeperformedbyNIEHS.

B. Requirements/Specifications

IndependentlyandnotasanagentoftheFederalGovernment,thecontractorshall
supplyservices,qualifiedpersonnel,materials,equipmentandfacilitiesnot
otherwiseprovidedtothecontractorbytheGovernmentundertermsofthis
contract,asrequiredtoperformworksetforthbelow:
1. Thecontractorshallperformhigh‐throughputSangerDNAresequencing
usingroboticautomationandsamplebarcodetracking,sufficientto

Attachment 1

supportavolumeofapproximately67,500sequencingsamplesper
contractperiodwithanestimatedrangeof4,000–9,000permonthandan
averageof7,500permonth.

2. The contractor shall provide sequence data from user‐provided 96 well

platesorPCRstriptubescontainingPCRamplifiablematerial,whichmay
begenomicDNAorplasmidDNA.TherequirementforPCRamplification
priortocyclesequencingwillbespecified,atthetimeofsamplesubmission,
bythesamplesubmitterforeachsamplewithingivenplateortube.The
contractorshallverify(bygelelectrophoresis)successofPCRsrequiredto
producetheDNAtemplateforsuccessfulsequencing.
Note:SamplesrequiringPCRfortheproductionoftheDNAtemplatefor
sequencingwillbeprovidedadditionaltimeforthisprocess.The
contractorwillnotberequiredtoisolategenomicDNAfromcellsortissues.
SuccessfulPCRamplificationsrequireproductionofasingleDNAbandof
theappropriatesize.

3. Contractor shall normalize DNA template(s) for PCR amplification and sequencing when requested by the submitter.

4. Samples which fail to produce data due to capillary failure or other contractor technical problems are repeated immediately.

Note‐Successfulsequencingrunscoverthedesiredregioninlengthfor
PCRproducts,atleast500basesforplasmidDNAwhileachievingaquality
scoreforeachbaseof>20.

5. The contractor shall employ staff trained in bioinformatics to perform successful primer production for new sequencing projects.

6. Contractor will be required to develop assays necessary to determine the

DNAsequenceasrequestedbytheCORorInvestigator.Thisincludes,but
isnotlimitedto,primerdesign,PCRoptimization,andsequencereaction
optimization.DNAreferencesequence(s)oraccessionnumber(s)willbe
provided.Thegovernmentretainsallrightstousedevelopedassaysand
mustbeprovidedalltechnicalinformation,includingbutnotlimitedto,
formulationsofreagentsusedinassay,instrumentationtypeusedandall
settingsandcalibrationsofinstrumentregardingeachassaywithin24
hoursofwrittenrequestfromtheCORorPrincipalInvestigator.

7. The contractor shall provide a reliable method of sample transport both to

andfromNIEHScampusandcontractor’slaboratory/facility.Thismaybe
achievedby:in‐housecourier,localcontractedcourier,orthroughFedExor

UPS.

Attachment 1

8. Thecontractorshallprovideallnecessarysamplecollectionmaterialfor
theshipmentofsamples,includingbutnotlimitedto:samplecollection
plateorvial,refrigeratedsamplestoragemethodofsamplespriorto
sequencinganalysis,appropriatepre‐paidshippingcontainers,anda
samplerecordtrackingsystem/method.

9. When submitting samples, the investigator shall provide plate key or tube

labelinformationcontainingsamplenameswithsampleidentifiersatthe
timeofsubmission.Multiplesequencingrunsmayberequestedper
templateasspecifiedbyuser.

10. Data shall be returned to the investigator via the Internet or by email as

attachmentswithintwo(2)workingdaysofreceiptofplasmidDNA
samplesandwithinfive(5)workingdaysofreceiptofgenomicDNA.This
willrequiregenerationoftheDNAtemplatebyPCR,thenDNAsequencing
ofthatproduct.Datashallbegeneratedusingappropriatesoftware
compatibleinbothPCandAppleformatsfordataanalysisasspecifiedby
theContractingOfficer’sRepresentative(COR).Exceptasexplicitly
authorizedbyNIEHS,thecontractorshallmaintaintheconfidentialityofall
sequencingdatageneratedbythiscontract.TheContractorshallnot
publishorusethedataandresultsforanypurposeotherthanthose
expresslyauthorizedbytheCOR.
NOTE:Turnaroundtimefordataiscalculatedaccordingtoreceiptof
samplesatcontractor’sfacility.ThecontractorshallnotifyNIEHSofreceipt
ofmaterialsonthesamedayasreceipt.

11. The contractor shall promptly identify to the COR any concerns or barriers

toperformancewithin24hoursofidentificationofproblem.The
contractorisresponsibleforproductionandimplementationofsolutions
within24hoursofCORcontact.

12. The contractor shall provide any requested information and respond to the

COR’s comments and suggestions within 24 hours of contact.

13. The contractor shall provide Weekly Status Reports listing the following information:

a) numberofsamplesreceived,includingdatereceived;
b) numberofsamplessuccessfullysequenced,includingdatedatawas
senttoNIEHS;
c) numberofsamplesunsuccessfullysequenced,includingthecauseof

failure and the date that notification was sent to the NIEHS investigator;

d) numberofsamplesrequiringPCRamplification;
e) numberofsamplesrequiringDNAnormalization;

Attachment 1

f) status of Quality Control data, including the week’s success and error rate.

14. The contractor shall provide monthly written reports summarizing

sequencingactivitiestoincludenumberofsamplessequenced,numberof
samplesrequiringPCRamplification,numberofsamplesrequiringDNA
normalization,numberofassaysdeveloped.

15. All reports and other electronic deliverables must be Section 508 compliant.

16. Contractor shall maintain confidentiality of all data and secure back‐up of

allessentialdata,includingbutnotlimitedto,allDNAsequencingdata
generated,sampletrackingandstorageinformation,andQualityControl

information.

17. The contractor shall have no access, and shall not attempt access, to any

typeofpersonalidentifiersorotherformofidentifyinginformationwith
thehumansamplesprovided.

18. The contractor shall return or destroy, as instructed by the COR, all DNA

frominvestigatorsnosoonerthan180daysaftercompletingsequencingor
asagreeduponandapprovedbytheCOR.Remainingunusedprimerswill
bereturnedtotheCORforlongtermstorage.
NOTE:Thisincludesprimersproducedandsynthesizedbythecontractor
foruseintheperformanceofthiscontract.

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