SPE2D117D0022 36C25024F0049_1.docx

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J065--CANON AQUILION LARGE BORE CT SCANNER PM
Solicitation number
36C25024F0049
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This document is a justification and approval notice for a sole source contract award to Canon Medical Systems USA, Inc. for annual post-warranty service maintenance agreements for radiology and imaging equipment owned by various Department of Veterans Affairs medical facilities. The contract was awarded through the VA-DLA Joint Radiology Imaging Systems Program indefinite-delivery/indefinite-quantity contract SPE2D1-17-D-0022, with an initial award amount of $298,420. Individual service maintenance agreement delivery orders will be issued on an annual basis to individual VA medical centers ranging in value from $50,000 to $1 million, and will cover equipment such as CT scanners, MRI systems, X-ray equipment, and other medical imaging technologies. The justification cites FAR 16.505(b)(2)(i)(B) for the sole source award as Canon Medical Systems is the original equipment manufacturer, making them the only source capable of performing proprietary post-warranty maintenance without risk of damage to the equipment or voiding warranties.

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SUBJECT*

CANON AQUILION LARGE BORE CT SCANNER PM

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE*
45409-1337

SOLICITATION NUMBER*

DELIVERY/TASK ORDER NUMBER
36C25024F0049

BASE NOTICE TYPE

ARCHIVE
60 DAYS AFTER THE RESPONSE DATE
RECOVERY ACT FUNDS
N
PRODUCT SERVICE CODE*
J065
NAICS CODE*
423450

CONTRACTING OFFICE ADDRESS

Department of Veterans Affairs Network Contracting Office (NCO) 10 3140 Governor’s Place Blvd. Suite 210 Kettering OH 45409-1337

POINT OF CONTACT*

Contracting Officer Chad Kemper chad.kemper@va.gov

AWARD INFORMATION

STATUTORY AUTHORITY*
2
AWARD NUMBER*
SPE2D117D0022

MODIFICATION NUMBER

AWARD AMOUNT*
298,420.00

LINE ITEM NUMBER

AWARD DATE (MM-DD-YYYY)*
10-20-2023

AWARDEE NAME*

CONTRACTOR’S UEI

CANON MEDICAL SYSTEMS USA, INC.

F8BEW1DHADP8

AWARDEE ADDRESS LINE 1*

AWARDEE ADDRESS LINE 2*

AWARDEE ADDRESS LINE 3*
2441 MICHELLE DR

AWARDEE ADDRESS LINE 4*

AWARDEE CITY
TUSTIN
AWARDEE STATE
CA
AWARDEE ZIP CODE
92780

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS
chad.kemper@va.gov
EMAIL DESCRIPTION
POC email address

Justification and Approval Notice Justification and Approval Notice

DESCRIPTION

*= Required Field
Justification and Approval Notice

Justification and Approval Notice

DepartmentofVeteransAffairs OfficeofAcquisitionandLogistics National Acquisition Center P.O.Box76 Hines,IL60141

ClassJustificationforanExceptiontoFairOpportunity FAR16.505(b)(2)(i)(B)–Onlyonecapablesource

(1) Identificationoftheagencyandthecontractingactivity.

This class justification for an exemptionto fair opportunity (JEFO) is on behalf of the Equipment Lifecycle Management (ELCM) program within the Veteran’s Healthcare Administration (VHA)and willbe executed bythe DepartmentofVeteran’sAffairs(VA) National Acquisition Center (NAC) located in Hines, IL.

(2) Natureand/ordescriptionoftheactionbeingapproved.

This activity proposes to issue sole sourcedelivery orders against IndefiniteDelivery, Indefinite Quantity (IDIQ) contract SPE2D1-17-D-0022 awarded to Canon Medical Systems for the purchaseof annual service maintenance to existingequipment located at individual VHA medical facilities.Requirements that are executed by VHA local contractingoffices can be processedunder the authority of the class JEFO.A copyof the classJEFO mustgo in the award file forallrequirementsprocessedunderauthority of this classJEFO. ThisclassJEFO will apply to allservicemaintenanceagreementordersplaced under the subject contract commencingwith the date ofapproval ofthis class JEFO through February 7th, 2027 at the end of the contract periodof performance.

(3) A descriptionofthesuppliesorservicesrequiredtomeettheagency’sneeds, including the estimated value.

The VHA has ongoingrequirements for post-warranty maintenance services forpreviously acquired and installed Canon Medical Systems Radiology and ImagingSystems.Service Maintenance Agreement(SMA)orders are awarded annually, and coverhigh tech medical equipment (HTME) which includes,but is not limited to,Computed Tomography (CT) scanners, Magnetic Resonance Imaging (MRI) systems, radiographic systems (X-Ray), nuclear medicine, ultrasounds,computed radiography, magnetoencephalography, Positron Emission Tomography (PET)-CT, PET-MR scanners, cyclotrons, angiography, cardiac catheterization, and mammography systems, etc.There are approximately 170 medical facilities across the VHA and facilities house high tech medical equipment.Each SMA will be awarded on its own delivery order or in certain instances when needed, such as, multiple agreements on one deliveryorder. Pastpricinghas shown thatSMAs range from $50K-$1M.The exactneed ofthe medicalfacility differs based on itsspecific radiology service and maintenancerequirement purchases but will not exceed 12 months.

(4) An identificationof the exceptionto fair opportunity (see 16.505(b)(2)) andthe supportingrationale, including a demonstration that the proposedcontractor’s uniquequalificationorthenatureoftheacquisitionrequiresuseoftheexception

Page 1 of cited.Ifthecontractingofficerusesthelogicalfollow-onexception,therationale shall describewhytherelationshipbetweentheinitialorderandthefollow-onis logical (e.g. in terms of scope,period of performance, orvalue).

Orderswillbe issued as solesource in accordance withFAR16.505(b)(2)(i)(B).All orders willbe issuedunder IDIQSPE2D1-17-D-0022.

Underthe auspices of theVA-DLAJointRadiologyImagingSystemsProgramIDIQ initialdeliveryordersfornewradiologyandimaging systemrequirements arecompeted amongst the IDIQ holders, and all HTME requirements includea warranty with the requirement purchase.After thewarrantyisexhaustedaservicemaintenance agreementis requiredtocover thelifecycleof theequipment purchase.Becausethe requirementsarealreadypurchased andhavenot exhaustedtheir lifecycle,purchasing theservicemaintenanceinsupportof theequipment after post warrantyensures the equipmentiscompliantwithVHAtechnologystandardsandpolicies.The contractor’sRadiology& ImagingSystemsareproprietary;therefore, any follow-on maintenanceshouldbeperformeddirectlyby theoriginalequipment manufacturer (OEM)and not outsourced to a third-partytomaintainthe integrityof the equipment andtoavoidservicersnotfamiliarwiththeproductscausingdamagetothe equipment.Ifdamageis causedbya third-partiesinthe course of repairs,thenthe Governmentcouldbe heldliableforadditionalcostsassociatedwithrepairs performedby theOEMafter damagehas occurred.As such, theworkcanonlybe completedby onesource,whichistheOEMof theequipment.

(5) AdeterminationbytheContractingOfficerthattheanticipatedcosttothe Government will befair and reasonable.

All itemsarecurrentlyonCanonMedicalSystemsIDIQcontractSPE2D1-17-D-0022and have previouslybeendetermined fairandreasonableattime of award.Likewise,pricingis reviewed duringthe modificationprocess and line items modified to be addedarealso determined to be fair and reasonableduring the modification process.

Market research was conducted byELCMby performingan analysis of historical pricing, whichincludedservices,trainingandincidentalservicesrelatedtotheequipmentpurchases. Additionally, a business caseanalysis (BCA) was conducted supportingthe benefits associated with VHA local contactingstations awardingthe SMA deliveryorders to the OEM, which highlighted the seamless coordinationwith VHA technology standardization after equipment installation and established cybersecurity.

(6) Anyotherfactssupportingthejustification.

As notated in the ELCM BCA, issuingthis class JEFO would reduce the administrative burden the VHA local contractingoffices assume when issuingthe SMAs.The national contracting office, VA NAC, issues approximately 1000 equipment delivery orderseach yearand each piece ofequipmenthas a post-warrantyservice agreementforapproximately five years (yearly maintenanceagreements).The issuance of this class JEFO allows the

Page 1 of local contractingoffices to save time and this will create a seamless process for the contractingspecialist/officerto timely award the SMAwithoutinterruption toon-going patientcare.

(7) A statementoftheactions,ifany,theagency maytaketoremoveorovercomeany barriers that ledto the exceptionto fair opportunity before any subsequent acquisitionfor the supplies or services is made.

At thistime,thereareno actionsthatcanbetakento removeorovercomebarriersthatlead to the exception to fair opportunity.The Government will continueto conduct market research to ascertainif therearechangesin themarketplacethatwould enablefutureaction to becompeted;however,allfuturerequirementswillbehandled onacase-by-casebasisto determine any future acquisition strategy.

(8) The contracting officer’scertificationthatthejustificationisaccurateand complete to the bestof the contracting officer’s knowledge andbelief.

Bysigningthis justification,theContractingOfficerherebycertifiesthatthejustifications are accurate andcomplete to the best of their knowledge.

(9) Evidence thatany supporting data that is the responsibility ofthe technicalor requirementspersonnel (e.g., verifying the Government’s minimumneeds or requirements or other rationalefor anexceptionto fair opportunity) andwhich formabasisforthe justificationhavebeencertifiedascompleteandaccurateby the technical or requirements personnel.

Bysigningthis justification,theNAC/HTMandELCMagree thejustificationis accurateand complete to the best of their knowledge.

(10) Awrittendeterminationbytheapprovingofficialthatoneofthecircumstancesin (b)(2)(i)(A)through (F) of this sectionapplies to the order.

Based on the information containedherein, a determinationhas been made that this requirement meetsthe exception at FAR 16.505(b)(2)(i)(B).Only onesource can providetherequiredsuppliesandservices.Allawardeesweregivenfairopportunitytobe considered for the original order.

Page 1 of

CERTIFICATIONANDAPPROVAL

TECHNICAL/REQUIREMENTSCERTIFICATION:

Pursuant to FAR 16.505(b)(2)(ii)(B)(9), I certifythat any supportingdatathat is my responsibility andwhich formsa basisforthe justificationiscomplete andaccurateto the best of my knowledge and belief.

DANIELCRESPO260355

DigitallysignedbyDANIELCRESPO 260355 Date:2020.12.1713:33:08-06'00'

12/17/2020

DanielC.Crespo Date Deputy ProgramManager–EquipmentLifeCycleManagement

CONTRACTINGOFFICERCERTIFICATION:

Pursuantto FAR16.505(b)(2)(ii)(B)(8), Icertifythatthejustificationiscomplete and accurate to thebest of my knowledge andbelief.

Ann English 217355 Digitally signed by Ann English 217355 Date:

2020.12.17 14:15:51 06'00' AnnEnglish Date ContractingOfficer VANationalAcquisitionCenter–Hines HighTechMedicalEquipmentContractAdministration

DigitallysignedbyMonicaE.Mende MonicaE.Mende17204161720416 Date:2020.12.1811:03:31-06'00'

MonicaE.Mende Date SupervisoryContractingOfficer VANationalAcquisitionCenter–Hines Chief–High-TechMedicalEquipmentContractAdministration

Page 1 of

HEADOFCONTRACTINGACTIVITYAPPROVAL:

CRAIGROBINSON254508

DigitallysignedbyCRAIGROBINSON254508 Date:2021.01.1908:28:34-06'00'

CraigRobinson Date AssociateExecutiveDirector VANationalAcquisitionCenter–Hines Head of ContractingActivity (orders>$13.5Mup to $68M) Pursuant to 16.505(b)(2)(ii)(C)) Page 1 of image1.png

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