P03 Single Source Justification MPT to SAT_Medtronic PTeye_Final.pdf

Revision: 01 Effective Date: 11/15/2024 Page 1 of 2 Acquisition ID# 36C241-25-AP-3326

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: 36C241-25-AP-3326

1. Contracting Activity: Department of Veterans Affairs, RPOE, NCO 1 on behalf of

Providence VA Medical Center, 830 Chalkstone Avenue, Providence, RI 02908 2237: 650-25-2-7821-0062

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: The Medtronic PTeye Parathyroid detection system is an intraoperative probe-based near-infrared autofluorescence (NIRAF) detection system. Primarily used in the operating room, the Medtronic PTeye Parathyroid detection system works by emitting light at wavelengths suitable for stimulating native fluorescence in biological tissues from a small probe. Parathyroid glands, due to their biochemical composition, emit a distinct autofluorescence when illuminated by this light emitting probe. The system then captures and analyzes the emitted fluorescence in real-time, allowing physicians to detect parathyroid tissue quickly and accurately during surgical procedures.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: The Medtronic PTeye Parathyroid detection system helps physicians differentiate between parathyroid glands and other tissues, reducing surgical errors by confirming the tissues targeted for removal and protecting healthy parathyroid tissues. This aids in preventing the complication of permanent hypoparathyroidism, which leads to hypocalcemia. This problem causes long-term complications related to bone and kidney health and is hard to manage on a day-to-day basis. For this reason, it can lead to life-threatening heart arrhythmias due to fluctuations in calcium levels in the blood. In a sensitive patient population, such as Veterans, preserving parathyroid tissues and their functions is essential to patient health and well-being. This technology and its capabilities are limited to Medtronic, as it is the first and only dye-free parathyroid detection system on the market. The facility’s primary goals are to maintain high quality care, standardize and improve safety, more effective and efficient use of staff and overall improvement in patient care. By procuring the Medtronic PTeye Parathyroid detection system, a device that is proven to decrease surgical error and increase accuracy, clinical care can be improved.

4. Description of market research conducted and results or statement why it was not conducted: An email was sent to the OEM Medtronics asking if there are any authorized PTeye Parathyroid Detection Systems resellers. They provided three SDVOSBs. Due to the non-manufacturer rule, this requirement will be posted on https://www.acquisition.gov/?q=/browse/far/13

Revision: 01 Effective Date: 11/15/2024 Page 2 of 2 Acquisition ID# 36C241-25-AP-3326 sam.gov as a small business set-aside. The PTeye machine is not manufactured by an SDVOSB, VOSB, or SB, nor is there an SBA waiver. Since at least two SBs distribute the item and it is below the SAT, this will be posted as an SB set-aside on sam.gov.

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.

Sheryl Anthony Date Contracting Officer https://acquisition.gov/far/current/html/Subpart%2013_1.html#wp1125466