P03 OTHER THAN FULL AND OPEN COMPETITION_BC signed.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 S5 LivaNova heart‐lung machines (HLM) that have surpassed life expectancy and deemed end of support by Spectrum Medical. 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.

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

3. Description of Supplies/Services Required to Meet the Agency’s Needs: West Haven VAMC currently uses the Spectrum Medical Quantum workstations, the VISION server and a informatics reporting system for the two existing heart‐lung bypass units on site. The Spectrum Medical Quantum workstations and the reporting system are not being replaced, therefore the heart‐lung bypass equipment must be fully compatible with the Spectrum Medical Quantum workstations. Spectrum Medical is no longer supporting the LivaNova Essenz Perfussion System. This decision is a result of competitive considerations within the field of cardiopulmonary bypass surgery. LivaNova utilizes its proprietary charting system, Connect, which is incompatible with Spectrum Medical's Quantum workstations. LivaNova was the only heart‐lung bypass unit supported by Spectrum Medical. Procuring an alternative heart‐lung bypass solution that does not integrate with the Spectrum Quantum workstations would require procurement of new workstations and informatics reporting systems, servers, installation and training. This would lead to additional costs, greater service requirements, and an increased timeline to get the two new bypass units up and running, ultimately impacting patient care.

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;

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Acquisition ID#: 36C241‐25‐AP‐2482

( ) (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. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): The Quantum Perfusion Technologies heart‐lung bypass unit is propritray to Spectrum Medical (SB). There are other machines on the market but the Quantum Perfusion Technologies is only compatable with the Quantum Workstations. If we were to look outside of the Spectrum Medical Quantum Perfusion Technologies Heart Lung System, additional workstations would have to be purchased as well resulting in substantial duplication of cost that would not be recovered.

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. An intent to sole source was posted and no responses were received.

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 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

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Acquisition ID#: 36C241‐25‐AP‐2482 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.

Michael Heusser Date Chief Healthcare Technology Management VA Connecticut

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.

Ashley Kenyon Date Contracting Officer

RPOE, NCO 1

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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.

Sheryl Anthony Date Brannch Chief, Commercial Team 3

RPOE, NCO 1