Sole Source JA- VitalFlow.pdf

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

Revision: 01 Effective Date: 11/15/2024 Page 1 of 2 Acquisition ID# 36C242-26-AP-1028

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C242-26-AP-1028

1. Contracting Activity: Department of Veterans Affairs, VISN 02, Buffalo VA

Medical Center, 3495 Bailey Ave, Buffalo NY 14215

2237: 528-26-1-4085-0008

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

The Buffalo VA Medical Center is working to replace the current Cardiohelp Heart-Lung Bypass unit. The FDA has issued a notice recommending the replacement of these units. There have been multiple recalls on these devices that the vendor has failed to remediate which has led to this decision by the FDA. Currently, our OR has no Heart- Lung Bypass unit to use. Therfore, the Buffalo VAMC is seeking to purchase one (1) Heart-Lung Bypass unit to conform with FDA replacement recommendation. Procuring this equipment will ensure device uptime in our OR so that Veterans are receiving the best care possible.

Vitalflow Capital – Heart Lung Bypass unit. $92,795.00.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

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

Multiple recalls have been issued on our current Cardiohelp Heart-Lung Bypass unit.

The vendor was slow to remediate these issues which led to the FDA recommending replacement of these devices and prohibiting purchase of recalled consumables. This has rendered our current unit inoperable.

Since we have run out of consumables, the OR has been operating without a Heart- Lung bypass unit. This has limited the treatment that can be provided to patients.

We considered alternative courses of action including continuing without the device, waiting for the vendor to remediate the recalls, or renting a device. Continuing without a

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

Revision: 01 Effective Date: 11/15/2024 Page 2 of 2 Acquisition ID# 36C242-26-AP-1028 device limits the treatments available to patients. Waiting for the vendor to remediate the recalls would go against FDA guidance. Renting a device is not cost effective.

The current device (Cardiohelp by Getinge) used for Heart/Lung Bypass is on an FDA recall and therefore contracting is not allowed to buy the disposables. The device cannot be used without disposables, so they are unable to provide this treatment to patients until we get the new device.

4. Description of market research conducted and results or statement why it was not conducted:

Because of the multiple recalls issued on our current CardioHelp Heart-Lung Bypass unit, the OR has been operating without a Heart-Lung bypass unit. It is crucial that we get this procured as soon as possible due to the limited treatment that can be provided to veterans. So, it is imperative that we sole source to Medtronic, INC for the reason of getting the OR a functioning Heart-Lung Bypass unit. This is a Emergency Procurement IAW FAR 6.302-2 – Use of other than full and open competition for “unsual and compelling urgency”.

SAM was searched for the vendor Medtronic. The vendor has an active registration and no exclusions. Medtronic is a Large Business.

5. Contracting Officer's Certification: Purchase is approved in accordance with

FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

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