P03 Sole Source Justification-Signed CO.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#: 672-25-1-078-0109

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: 36C248-25-AP-1800

1. Contracting Activity: Department of Veterans Affairs, VISN 8, Regional Procurement Office- East, NCO-8, San Juan Services and Commodities and Services contracting team and the VA Caribbean Healthcare System in San Juan, Puerto Rico is the organizational activity responsible for the proposed contracting action. The transaction number for this request is 672-25-1-078-0109.

2. Brief description of supplies required, their intended use, and their estimated amount:

This procurement is for the acquisition of an Impella CP Pump Set Catheter to be use in a hemodynamic support technology system that is already installed and in use in the Cardiology Service at the VA Caribbean Healthcare System, VACHS.

The Impella CP Catheter is a hemodynamic support technology that is used in two main clinical scenarios. First, in patients with coronary artery disease and severe cardiac dysfuntion who require a high rick coronary angioplasty. The selective use of an Impella device for hemodynamic support during the procedure is beneficial to improve procedure outcomes and facilitate the safely completion of highly complex procedures. The second clinical scenario in which an Impella device is used is in care of acute heart attack patients who develop cardiogenic shock. In that scenario that carries >50% mortality,the Impella device can be of help to stabilize the patient until the benefial effects of the emergency angioplasty are manifested. Estimated Amount: $25,125.63.

Vendor shall provide the following products:

Part Number Description Quantity 0048-0003 Impella CP Catheter Pump Set 01

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: This is a recurring expendable supply for a BIOMED system that is already installed and in use in Cardiology Service. No other company can provide these supplies. Currently the VACHS doesn’t have any supplies available on shelve to satisfy the demand of the customer in case of an emergency with a cardiac patient. In case of an emergency, patients should be be referred to the Tampa VA or to the Menonita Hospital in Cayey, the only other hospital in Puerto Rico with an Impella System. In some cases, the clinical status of the patient may not allow for save air travel or even ground transport to another hospital, the reason for which it would be beneficial to have the system fully operational in the station.

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#: 672-25-1-078-0109

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

The following sites were visited as part of this market research:

The search in VetCert for NACIS Code 339112 resulted in 668 certified capable VOSB/SDVOSB vendors.

The search in NAC for Impella Catheter didn’t yield any results.

The search in the VA Master Chain Master Catalog for Impella Catheter resulted in yielded one

(1) contract, 36C25622A0016, for the same item on this procurement acquisition with the VA Department of Veterans Affairs, which authorized only for All Warranted NCO16 Contracting officers within RPO Central as the contract dictates on page 5, “Contractor agrees to the following terms of the BPA exclusively with Central Arkansas”. The price in the contract is $25,125.63, the same as the IFCAP for this procurement.

Searching GSA E-library did not have any results.

Searching on FPDS for Impella catheter resulted in 1150 awards.

After concluding the market research, including the SBA’s NMR decision tree and no waiver applicable for the NAICS, this procurement should be solicited as unrestricted Sole Source.

The product been requested had been previously acquired by the VACHS under Contract 36C24824P2338. The Small Business Rule of Two or the VA Rule of Two don’t apply to this procurement because the product been requested is not distributed by any small business, VOSB or

SDVOSB.

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.

Wilfredo Perez Date Contracting Officer

WILFREDO PEREZ Digitally signed by WILFREDO PEREZ Date: 2025.01.23 13:23:07 -04'00'