36C25719Q0669-002.pdf

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: 36C257-19-AP

1. Contracting Activity: Department of Veterans Affairs, VISN 17, Network Contracting Office in San

Antonio is purchasing on behalf of Dallas VA Medical Center, under request (2237) number 549-19- 3-014-0641.

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

Request for other than full and open competition for the purchase of Trauma One Kits for the VA North Texas Health Care System (VANTHCS). These items are prosthetic appliances which are required for the fitting, supplying, training, and use by dental surgeons at the VANTHCS to meet the uniquely sensitive and individual to the veteran that needs them.

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

The Partial Trauma One Kit requirement contains plates, screws, and tools that are proprietary in nature and are used in surgery to repair facial trauma on patients that are arriving or transferred to the facility. The required items are needed to replenish the existing inventory which is used by three surgical departments for facial reconstruction after major injuries have occurred to patients as well as for training of new dental and emergency surgeons. The required items of the Partial Trauma One Kit are used to meet the needs of individual veterans.

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

A search on VIP, DSBS, and SAM were used, using NAICS Code 339113 (Surgical Appliance and Supplies Manufacturing). VIP resulted in 322 SDVOSBs; DSBS provided 14 SDVOSBs, 18 VOSBs, 3 WOSBs, 1 8(a) company, and 2 HUBZone companies; and SAM, once filtered for vendors not on the Exclusion List and small businesses that are registered under NACIS Code 339113, displayed 3,922 potential small businesses of various or no set-asides.

A search of GSA Advantage showed that some items were available, but most would be on the open market. Searching GSA e-Library resulted in Schedule 65II A/A-20C (Other Implants, Surgical) 17 SDVOSBs, 5 VOSBs, 5 WOSBs, 16 other than small businesses, and 15 small businesses as potential vendors on the schedule.

The most recent purchase was from NCO 17 for a similar product (36C25719P0438). This contract was initially awarded to Veteran’s Healthcare Supply Solutions, a SDVOSB, for $577,275.70 on February 4, 2019 but was terminated for the Government’s convenience in March 2019. The contract was terminated due to a miscommunication concerning the acceptability of the KLM System that was offered by Veteran’s Healthcare Supply Solutions.

The original requirement received three offers, and one was considered non-responsive as the measurements for the plates and screws were larger by 1mm, which would not have met the needs of the Government. Of the two that passed technical evaluations, the contract was awarded to Veteran’s Healthcare Supply Solutions who provided a similar item, the KLM System.

https://www.acquisition.gov/?q=/browse/far/13

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)

According to the Operating Room surgeons, the KLM System is not standardized when compared to the other implant trays utilized in the facility. They are neither compatible or interchangeable nor act as viable backup in an emergency surgery situation. Purchasing another kit would have a significant impact on surgical procedures where there is a new fracture, or a patient requires additional surgery.

Plates for the other systems do not bend and conform to facial fractures and the benders supplied by other manufacturers do not allow for unbending and re-shaping to achieve fits on sub-orbital and facial fractures. This results in wasting the plate and using another at a cost of hundreds to thousands of dollars per plate, depending on size and shape of plate (T, H, flat, etc.).

The screws from the KLM and the torque wrench or screwdriver to seat them, has historically resulted in an unseated screw that may lead to shifting of the plate, poor alignment and lack of healing to possible implant replacement. This is rare in the Trauma One Kit that was originally requested.

Based on market research conducted for the full Trauma One Kits in January 2019, there are only two (2) vendors that can provide this requirement: ERA Health, LLC (a SDVOSB) and Biomet Microfixation (a large business and OEM).

Therefore, it is recommended that this requirement be solicited unrestricted on the open market per Section 41 U.S.C. 235(c)(5) and 38 U.S.C. 8123, which allows for prosthetic appliances to be procured in any manner that is proper without a set-aside being necessary.

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.

Date

Contracting Officer

04/30/2019 https://www.acquisition.gov/?q=/browse/far/13 https://acquisition.gov/far/current/html/Subpart%2013_1.html#wp1125466