P03 Sole Source Justification CO SIGNED.pdf

Page 1 of 5 VHAPG Part 806.3 OFOC Revision: 03 Effective Date: 04/15/24 Acquisition ID#: 36C263-25-AP-0792

Attachment 1: Request for Sole Source Justification Format >SAT

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID:_ 36C263-25-AP-0792

1. Contracting Activity: Department of Veterans Affairs, VISN 23 Biomedical Engineering, -25-2-6765-0031

2. Nature and/or Description of the Action Being Processed: This will be a fixed price contract.

3.

This is a new PO for annual maintenance and support renewal of the Cepheid laboratory instruments in VISN 23. This is required to ensure proper instrument functionality, accuracy, and uptime of the included lab equipment. The current 2237 number is 499-25-2-6765-0031.

: Service contract for the Cepheid Laboratory instruments in VISN 23. The following equipment should be included:

Serial Number Model VAMC Location

110020218 GX 16-12 Black Hills Fort Meade 839276 GX 16-16 Black Hills Fort Meade

110020163 GX 4-4 Black Hills Hot Springs 839228 GX 4-4 Black Hills Hot Springs

110020205 GX 16-16

Central Iowa Main Facility

840426 GX 16-18

Central Iowa Main Facility

110020206 GX 16-16 Fargo Main Facility 810071 GX 16-16 Iowa City Main Facility 839290 GX 16-16 Iowa City Main Facility

110020853 Infinity 48-40 Minneapolis Main Facility 110003290 GX 16-16 Minneapolis Main Facility 120000054 GX 16-16 NWI Main Facility 110003276 GX 16-16 Sioux Fall Main Facility

839300 GX 16-16 St. Cloud Main Facility

839353 Xpress 4X4 Central Iowa Fort Dodge

839455 Xpress 4X4 Central Iowa Mason City

Attachment 1: Request for Sole Source Justification Format >SAT

Page 2 of 5 VHAPG Part 806.3 OFOC Revision: 03 Effective Date: 04/15/24 Acquisition ID#: 36C263-25-AP-0792

839449 Xpress 4X4 Central Iowa Marshall Town

839503 Xpress 4X4 Central Iowa South Side

839506 Xpress 4X4 Central Iowa Knoxville

110011412 Xpress 4X4 Central Iowa Carroll

840117 Xpress 4X4 NWI Main Facility 840171 Xpress 4X4 NWI Main Facility 838461 Xpress 4X4 Minneapolis Albert Lea 839548 Xpress 4X4 Minneapolis Chippewa Valley 840962 Xpress 4X4 Minneapolis Hayward 840963 Xpress 4X4 Minneapolis Hibbing 838367 Xpress 4X4 Minneapolis Lyle C 839545 Xpress 4X4 Minneapolis Maplewood

839546 Xpress 4X4 Minneapolis Northwest Metro

838404 Xpress 4X4 Minneapolis Rice Lake 838338 Xpress 4X4 Minneapolis Rochester 839547 Xpress 4X4 Minneapolis Shakopee 838463 Xpress 4X4 Minneapolis Twin Ports 845144 Xpress 4x2 Minneapolis St. James 841247 Xpress 4X4 Iowa City CR 840967 Xpress 4X4 Iowa City DEC 840923 Xpress 4X4 Iowa City DUB 841734 Xpress 4X4 Iowa City GAL 840966 Xpress 4X4 Iowa City IC 841732 Xpress 4X4 Iowa City OTT 840964 Xpress 4X4 Iowa City QC 841738 Xpress 4X4 Iowa City QNC 841733 Xpress 4X4 Iowa City STER 841736 Xpress 4x4 Iowa City WLOO

Services to be provided:

1) The contractor will provide unlimited 24/7 technical phone support

2) The contractor will provide 2 day on-site response

3) The contractor will provide next day system swap

4) The contractor will provide all labor, parts, and travel expenses to fully support and maintain the following inventory of Cepheid laboratory analyzers in VISN 23 defined in the manufacturer user and service manuals of each laboratory analyzer. This includes 98%

Page 3 of 5 VHAPG Part 806.3 OFOC Revision: 03 Effective Date: 04/15/24 Acquisition ID#: 36C263-25-AP-0792 uptime guarantee for the Xpert devices and all software upgrades. This also includes 1 annual preventative maintenance check for all devices.

Estimated Cost: $439,785.00 for 1 year. This is a request for a 1 year contract.

4. Statutory Authority Permitting Other than Full and Open Competition:

( X ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4 ( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR

6.302-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

5.

Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

Cepheid is the manufacturer of the Cepheid laboratory instruments and has stated that they are the only authorized provider of service for these instruments in the US. Only authorized and trained parties should service this medical laboratory equipment or risk comprising the devices safety and accuracy.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Market research was conducted. No other vendor was identified meeting the specific requirements. An intent to sole source was published to SAM Contract Opportunities from 12/20/24-12/27/24. There were no responses received.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

The Contracting Officer will make a fair and reasonable determination by using one of the following methods:

1. Comparison of previously proposed prices and previous Government and commercial contract prices with current proposed prices for like items. The procurement history for this service is extensive and comparing the proposed pricing to previous pricing will provide the best value to the

VA.

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8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

Market research was conducted. No other vendor was identified meeting the specific requirements. An intent to sole source was published to SAM Contract Opportunities from 12/20/24-12/27/24. There were no responses received.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

This is medical laboratory equipment utilized in VISN 23 that must be serviced by parties authorized by the orginal equipment manufacturer only.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Cepheid 904 Caribbean DR Sunnyvale, California 94089-1189, United States

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: None, there are no other vendors that can have the training, expertise, or authorization to service this equipment.

12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Kayla Shute Biomedical Engineer VISN 23 Midwest Healthcare Network

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Date

Joshua Imdacha Contracting Officer Network Contracting Office (NCO) 23

Page 5 of 5 VHAPG Part 806.3 OFOC Revision: 03 Effective Date: 04/15/24 Acquisition ID#: 36C263-25-AP-0792

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Date

Chara Collins Branch Chief Network Contracting Office (NCO) 23