P03 SSJ Dexcom CGM G7_Redacted.pdf

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification >SAT-$7.5M under FAR13.5

Effective Date: 02/01/2022 Page 1 of 4

REVISION: 00

Acquisition ID#:

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: VA-24-00017671

1. Contracting Activity: Department of Veterans Affairs, VISN 09, Tennessee Valley Healthcare System (TVHS), Nashville Medical Center, 1310 24th Ave S, Nashville, TN 37212, and Alvin C. York, 3400 Lebanon Pike, Murfreesboro, TN 37129. 2237# 626-24-2-6817-0518 and 626-24-2-6817-0519.

2. Nature and/or Description of the Action Being Processed: TVHs is requesting a contract vehicle for acquisition of Dexcom Inc G6 and G7 Continuos Glucose Monitoring(GCM) systems. This is a name brand Sole Source purchase order to Geo-Med(SDVOSB) the designated distributor of items listed on National Acquisition Center Contract Number 36F79720D0224 is for a one-year firm-fixed price (FFP) effort of Dexcom Continuous Glucose Monitors (CGM) G6 and G7 systems from Dexcom Inc., 5375 Mira Sorrento Place, San Diego, CA 92121.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: TVHS Prosthetics is requesting a contract vehicle for these Dexcom CGMs to relieve purchase card holders of the timely burden of processing multiple purchase card transactions and provide a timelier issuance of items to veterans. Below is a list of items requested and associated cost:

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

(X) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

( ) Unusual and Compelling Urgency

Item Number Description Quantity Unit of Measure TVHS Nashville VAMC

0001 SYSTEM,MONITORING,GLUCOSE,G7 SENSOR/TRANSMITTER,DEXCOM 105 EA

0002 KIT,RECEIVER,GLUCOSE MONITOR,DEXCOM G7 35 EA

0003 SYSTEM,MONITORING,GLUCOSE,G6 SCOUT,RECEIVER,DEXCOM 60 EA

0004 KIT,TRANSMITTER,GLUCOSE MONITOR,G6,DEXCOM 320 BX

0005 SENSOR,GLUCOSE MONITOR,DEXCOM G6 75 BX

Alvin C York Murfreesboro VAMC

0006 SYSTEM,MONITORING,GLUCOSE,G7 SENSOR/TRANSMITTER,DEXCOM 105 EA

0007 KIT,RECEIVER,GLUCOSE MONITOR,DEXCOM G7 35 EA

0008 SYSTEM,MONITORING,GLUCOSE,G6 SCOUT,RECEIVER,DEXCOM 60 EA

0009 KIT,TRANSMITTER,GLUCOSE MONITOR,G6,DEXCOM 320 BX

0010 SENSOR,GLUCOSE MONITOR,DEXCOM G6 75 BX

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification >SAT-$7.5M under FAR13.5

Effective Date: 02/01/2022 Page 2 of 4

REVISION: 00

Acquisition ID#:

( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services

( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Currently, the TVHS is issuing a variety of CGM’s including: Dexcom G6 and G7 sensors, Free-Style Libre 2 (FSL2) and Free-Style Libre 3 (FSL3) systems. The Dexcom and Free-Style systems are not interchangeable, and each require separate education for effective use by Veteran. The FSL2 and FSL3 are ordered using NAC contract vehicle 36F79721D0079. The Dexcom G6 and G7 have required purchase card transaction for each veteran. The station is requesting the Dexcom devices be placed on a local contract vehicle to reduce patient delay in issue, reduce purchase card transaction and allow ease in replacement of parts of the system as they are identified. The vendor has issued a proprietary letter stating they are the sole manufacturer and distributor for the product, no other product will work with the previously purchased consoles.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A Sources Sought notice 36C24924Q0403 was posted on sam.gov on 8/14/2024. The notice indicated a name brand only requirent and the need to provide proof of authorized distributor for Dexcom devices. Two responses were received from BHPE LLC and Gemco Medical with neither providing proof they were authorized distributors of Dexcom CGM devices.

Dexcom INC was contacted and confirmed that the only VA authorized distributor of the propiertay Dexcom G6 and G7 CGM systems is Geo-med.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Best Value was established in the NAC Award process for 36F79720D0224 and pricing in consistent to previously paid purchase card orders. Prior to contract award fair and reasonable pricing will be determined and documented in contract file.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market research was conducted in accordance with FAR Part 10, VAAR Part 810 and PPM 2016-05(Revised AUG 2019). The VA rule of two can not be meet based on sole proprietary equipment being acquired from Large Business. A review of NAC contracts resulted in a contract vehicle that has G6 and G7 CGMs. Additionally, a review of vista purchases from Geo Med provided evidence of multiple purchase card buys annually. Based on this review, a purchase order with monthly deliveries to station will allow for better service to veterans and gain efficiencies within purchase card team. Dexcom has stated the devices are proprietary and only authorized distributor to VA is Geo Med. Based on all these market research efforts, the Government has determined that only Dexcom Inc. brand name CGMs can meet all of VA’s needs.

Dexcom Inc is a California based company and the CGMs G6 and G7 are manufactured in USA and meet all BAA requirements.