P03 OTHER THAN FULL AND OPEN COMPETITION SSJ v2- Final_Redacted.pdf

VHAPG Part 806.3 OFOC Page 1 of 4 Revision: 03 Effective Date: 04/15/24 Acquisition ID#: 36C241-25-AP-2482

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C241-25-AP-2482 2237: 689-25-2-7077-0026

1. Contracting Activity: Department of Veterans Affairs, West Haven, CT Medical Center 950

Campbell Ave, West Haven, CT 06516

2. Nature and/or Description of the Action Being Processed: West Haven Veteran Affairs Medical Center (VAMC) requires the purchase of two (2) Heart-Lung Bypass machines to replace the existing Sorin S5 LivaNova heart-lung machines (HLM) that have surpassed life expectancy and deemed end of support by LivaNova. The heart-lung bypass equipment must be fully compatible with the Spectrum Medical Quantum workstations currently in place. These systems are used to support complex perfusion procedures during cardiac surgery.

Per Bypass unit: $296,245.61 Estimated Amount: $592,491.22

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The Quantum Perfusion Technologies, developed by Spectrum Medical, refers to a suite of advanced extracorporeal perfusion technologies designed to support a wide range of clinical therapies involving patient life support during procedures like cardiac surgery and Extracorporeal Membrane Oxygenation (ECMO).

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;

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Acquisition ID#: 36C241-25-AP-2482

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Currently, the Sorin S5 devices that are in place are over 10 years old, and according to LivaNova, they are eligible to continue receiving ongoing Preventive Maintenance, as required by regulatory standards; however, if the devices require corrective maintenance or replacement parts, the parts would be subject to availability, which could result in extended or permanent downtime for the existing devices. This limited ability for support has resulted in an increased urgency for the proactive replacement of these devices, allowing for a safe and planned deployment to a new device.

VACT currently utilizes the Spectrum Medical Quantum workstations and their VISION server, as well as the informatics reporting system, for the two existing heart-lung bypass units on site. These workstations and the reporting system are not being replaced, so the heart-lung bypass equipment that is procured must be fully compatible and able to integrate with them. If the new system is not compatible, an alternative system that is compatible must be procured, integrated, and implemented before initial use of the new heart-lung bypass equipment to maintain the current level of care. Upon reviewing the Liva-Nova product, it has been identified as incompatible with the existing informatics system. It would not be a supported use of that system by the manufacturer, Spectrum Medical, if connected. This will require a new system to be implemented, which LivaNova offers. It is currently estimated that it will take six months to integrate the devices into the patient record, based on similar projects that have required a comparable number of servers to be created, as well as the incorporation of a new system into the patient record.

The additional funds necessary to implement the new system would incur a substantial cost for the government. The Quantum Perfusion System is directly compatible with the existing informatics system. It does not require additional time for integration before implementation. No additional funds are needed to replace the existing system, and savings are estimated to be 28% compared to similar products.

Due to the increased urgency for the proactive replacement of current devices, a shorter timeline to implement new devices reduces the risk that the government will unexpectedly be unable to perform the surgeries associated with the use of the devices being replaced.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: RFI 36C24125Q0288 was posted from 2/26/25 – 3/10/25.

AlphaCare Group and BHPE responded to the RFI.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Pricing will be compared against competitive published price lists, market prices, industry standards, independent government cost estimates or prices obtained through market research.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: AlphaCare Group (SDVOSB) and BHPE (SDVOSB) responded to RFI 36C24125Q0288 that was posted on 2/26/25 – 3/10/25.

Alphacare group provided an authorized distributor letter provided by the OEM that states

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Acquisition ID#: 36C241-25-AP-2482 the letter is valid on a case-by-case basis. These are critical medical machines, an OEM rep confirmed these products should be procured through the OEM. The OEM has completed a free Demonstration of this item prior to the RFI posting. Further market research found AlphaCare has a total of one contract award in FPDS, and it is unrelated to Spectrum Medical Quantum Perfusion Technologies. BHPE did not provide an authorized distributor letter and was not confirmed by the OEM. There is not a reasonable expectation that AlphaCare Group or BHPE can meet the minimum requirement. No other IDV’s or distributors were found during market research. A search in FPDS and ADDS UP using keywords Quantum Perfusion resulted in Spectrum Medical as the sole provider for this product.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: Due to the sensitivity of this acquisition, it is recommended that the bypass units be acquired directly from the OEM, Spectrum Medical. Spectrum Medical has worked with the West Haven VA in the past and is familiar with site.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Market research found AlphaCare has a total of one contract award in FPDS, and it is unrelated to Spectrum Medical Quantum Perfusion Technologies. BHPE did not provide an authorized distributor letter and was not confirmed by the OEM.

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: At this time, there are no actions that can be taken to remove or overcome barriers that lead to the Other Than Full and Open Competition. The Government will continue to conduct market research to ascertain if there are changes in the marketplace that would enable future action to be competed; however, all future requirements will be handled on a case-by-case basis to determine any future acquisition strategy.

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.

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.

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Acquisition ID#: 36C241-25-AP-2482

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