Sinlge Source Justification Bravo_Redacted.pdf

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

Last Updated: 02/01/22 Page 1 of 2

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: 36C260-23-AP-2367

1. Contracting Activity: Department of Veterans Affairs, Veterans Health Administration, Regional Procurement Office West, Network Contracting Office 20 on behalf of the Roseburg VA Medical Center. 2237: 653-23-2-9961-0085

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

This is a new requirement for 2 Bravo Capsule pH Systems: implanted in the esophagus to monitor pH. Total cost:

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

In accordance with FAR 13.106-1(b) this will be single sourced to the large business and manufacturer, Medtronic. The Bravo Capsule pH System is implanted in the esophagus for up to 96 hours to record pH. It is used in various GERD related diagnoses and is the only recorder that can monitor up to 96 hours. It prietary chip and software wirelessly transmit data to a recorder

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

Last Updated: 02/01/22 Page 2 of 2 while the patient is able to continue with the Activities of Daily Living, including eating , drinking, and showering, at home. This device has been FDA approved for children over 4, and is confirmed to be the only device of its kind by the facility physician. The chips (capsules) that are implanted, as well as the recorder and software, are proprietary to Medtronic. Allowing patients to partake in this testing from home rather than hospitalized for up to 96 hours is more convenient for the patients, saves time and money, and frees up hospital beds for other needs. For these reasons, it is the decision of the Contracting Officer that limiting this procurement to one source is in the best interest of the government.

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

Government-wide databases of contracts were searched. A search of contractdirectory.gov revealed no results. A search of the NAC revealed no results. A search of gsaelibrary.gsa.gov revealed no results. A search of GSA Advantage revealed no results. ECAT contract SPE2D1-20-D- 0002 was found, but has been disabled due to a greater than expected utilization against the agreement and its revenue ceiling. A search for Medtronic on FPDS revealed several contracts for similar items awarded to Medtronic, not competed. Staff at the requiring facility, including a gastroenterologist physician provided insight as to why this particular device is needed, and one of a kind. Per Medtronic, there are authorized distributors for the commodities portion of this requirement, but the service plan can only be purchased directly from Medtronic. FPDS was searched to establish price reasonableness, and Medtronic has extended the ECAT pricing, which has been determined fair and reasonable.

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.

Robert Hamilton Contracting Officer

Michael Allred Branch Chief, Medical Equipment