P03 BRAND NAME JA OVER SAT AP0126 -CO Signedpr Redacted.pdf

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

PM Part 813.5 SAP for Certain Commercial Items Page 1 of 3 Original Date: 08/30/17 Revision 03 Date: 02/11/2021

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C770-22-AP-0216

1. Contracting Activity: Department of Veterans Affairs, NCO 15 Contracting, CMOP Division - Tucson CMOP, 2237: 762-22-1-040-0480

2. Nature and/or Description of the Action Being Processed: This is an individual brand-name justification to support he procurement of the following item:

Guardian Glucose Sensor (3) #MMT-7020A

Stock #: XJ430 Size: 5 per Box Quantity: 1,500 Boxes

The Tucson CMOP facility requires the above item to be procured with the support of the instant justification and approval for other than full and open competition. The proposed procurement action will be a firm fixed-price contract award for the supplies.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

The item above supports Veteran patient prescriptions.

This order is to be delivered in 5 day ARO.

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 ( ) 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):

The Guardian Glucose Sensor (GGS) is only manufactured by Medtronic Inc. The GGS is the only sensor on the market that is licensed to power the MiniMed 670G self-adjusting insulin pump and

PM Part 813.5 SAP for Certain Commercial Items Page 2 of 3 Original Date: 08/30/17 Revision 03 Date: 02/11/2021 the Guardian Connect standalone CGM System. The GGS is designed to work with approved transmitters only. It is not interchangeable with transmitters and recorders that are not compatible with the sensor. Connecting the sensor to a transmitter or recorder that is not approved for use with the sensor may cause damage to the components or inaccurate sensor glucose values.

Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

The anticipated cost will be fair and reasonable based off competition and/or the IGCE.

Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

Since the procurement is over SAT then the Non-manufacture rule (NMR) applies. Due to the SBA NMR, as defined in FAR Part 19 and 13 Code of Federal Regulations (CFR) 121.406, an SDVOSB/VOSB/SB set aside of any kind is not feasible as there is no waiver of the Non-Manufacturer Rule from the SBA over the SAT for NAICS code 325413. Based on this research and policy, the rule of two cannot be met to set the procurement aside for a socioeconomic subcategory of small business.

This will be posted unrestricted.

Any Other Facts Supporting the Use of Other than Full and Open Competition: N/A

Listing of Sources that Expressed, in Writing, an Interest in the Acquisition

A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required:

N/A

Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and

Date Michael Sutherland, Director, SW CMOP, or Matthew Lawrence, Inventory Management Specialist

Michael Sutherland, Director, SW CMOP, or

01/11/2022

PM Part 813.5 SAP for Certain Commercial Items Page 3 of 3 Original Date: 08/30/17 Revision 03 Date: 02/11/2021

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Larry Zaritz Date Contracting Officer NCO15 – CMOP Division, Team 1

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Christy Pendlay Date Supervisory Contract Specialist NCO15 – CMOP Division, Team 1

c. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve ($750K to $7.5 million (or $15.0 million for acquisitions described in FAR 13.500(c)) for other than full and open competition.

Name Date VHA Head of Contracting Activity (HCA)

Larry M. Zaritz 184054

Digitally signed by Larry M.

Zaritz 184054 Date: 2022.01.11 14:15:06 -06'00'

CHRISTY PENDLAY Digitally signed by CHRISTY PENDLAY Date: 2022.01.11 16:18:28 -06'00'