P03_Justification and Approvals_Lifescan_770_Redacted.pdf

VHAPM Part 813.5 Simplified Acquisi on Procedures for Certain Commercial Items A achment 1: Request for BRAND NAME Jus fica on Template >SAT-$7.5M under FAR13.5

Effec ve Date: 11/15/24

REVISION: 01

Acquisi on ID#: 36C770-22-AP-0639

DEPARTMENT OF VETERANS AFFAIRS

BRAND NAME JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisi on Plan Ac on ID: 36C770-22-AP-0639 (770)

1. Contrac ng Ac vity:

Network Contrac ng Office 15 (NCO 15) - CMOP Division 3450 S. 4th St. Trafficway Leavenworth, KS 66048-5581 Reques ng Ac vity:

VA CMOP Na onal Office 23501 W 84th Street Shawnee, KS 66227-3296

PR-IFCAP (2237): TBD

2. Nature and/or Descrip on of the Ac on Being Processed:

This procurement is for BRAND NAME supplies as requested by the VA Medical Centers from the VA CMOP NATIONAL OFFICE in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documenta on Requirements, where acquisi ons conducted under Simplified Acquisi on Procedures are exempt from the requirements of FAR Part 6, but s ll require a jus fica on using the format of FAR 6.303-2.

PR-IFCAP: TBD

ACTION REQUESTED: 1 (New Requirement) Ac on will be awarded as a new contract, firm-fixed-price.

CLASSIFICATION CODE: 65 (MEDICAL EQUIPMENT)

CONTRACT TYPE: 1 (Commodi es) Purchase of: MedSurg.

Descrip on: Diabe c Tes ng Supplies, 6 month supply PROCUREMENT METHOD: Compe ve PROCUREMENT VEHICLE: Open Market SOCIOECONOMIC CATEGORY: Service Disabled Veteran Owned SB PURCHASING SCOPE: 3 (Mul -VISN-Wide) Est. Award Date: 03-21-2025

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

Effec ve Date: 11/15/24

REVISION: 01

Acquisi on ID#: 36C770-22-AP-0639

The Contrac ng Officer conducted further searches in VetCert u lizing NAICS code 325413 and yielded a total of 90 SDVOSB/VOSBs.

Further market research was conducted via the SBA Dynamic Small Business Search database using the criteria of NAICS code 325413, business type includes Manufacturing, and firms with no more than 500 employee(s), which resulted in 109 small businesses who iden fied as authorized distributors or manufacturers. Based on procurement history of these items, it is an cipated that at least two or more of the small businesses are authorized distributors capable of fulfilling VA’s requirement at a fair and reasonable price.

The Contrac ng Officer reviewed the Non-Manufacturer Rule (NMR). In accordance with the NMR as defined in 13 CFR § 121.406, the requirement that a Non-Manufacturer supply the product of a small business concern is referred to as the NMR. In order to qualify as a small business concern for a small business set-aside, an offeror must either manufacture the item in accordance with the Limita ons on Subcontrac ng (see FAR sec on 52.219- 14, 52.219-27 and 13 C.F.R. § 125.6) or supply the product of a small business made in the United States. There is an exis ng NMR Class Waiver for NAICS 325413 that covers the diabe c test strips in this requirement. The Class waiver was posted to the Federal Register in 85 Fed. Reg. 43634 on July 17, 2020. The current list of NMR Class Waivers is maintained by the SBA and can be found at Non-manufacturer rule class waiver list | U.S. Small Business Administra on (sba.gov). Based on the market research conducted, the CO determined there is a reasonable expecta on that quotes would be received from two (2) or more SDVOSBs that can comply with the

NMR.

As described in Sec on 6 above, market research, in accordance with FAR Part 10, was conducted by synopsis of the proposed acquisi on, and will advise industry of the pending acquisi on and solici ng inquiries from interested par es.

9. Any Other Facts Suppor ng the Use of Other than Full and Open Compe on:

Previous acquisi on history with this VA contrac ng office has shown a mix of large and small businesses have met and fulfilled this product in the recent past.

10. Lis ng of Sources that Expressed, in Wri ng, an Interest in the Acquisi on:

Market research shows previous awardees listed below have demonstrated an interest in this requirement.

• McKesson Drug Co. (Large Business)

• Core Trading Company (Small Business)

• The Davinci CO LLC (SDVOSB)

• ASE Direct Inc. (SDVOSB)

• Na onwide Pharmaceu cal LLC (SDVOSB)

11. A Statement of the Ac ons, if any, the Agency May Take to Remove or Overcome any Barriers to Compe on before Making subsequent acquisi ons for the supplies or services required:

No ac on is being taken at this me due to the fact that no MPN subs tu ons are permi ed based on physician’s specific orders.

Effec ve Date: 11/15/24

REVISION: 01

Acquisi on ID#: 36C770-22-AP-0639

12. Requirements Cer fica on: I cer fy that the requirement outlined in this jus fica on is a Bona Fide Need of the Department of Veterans Affairs and that the suppor ng data under my cognizance, which are included in the jus fica on, are accurate and complete to the best of my knowledge and belief.

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

a. Contrac ng Officer or Designee’s Cer fica on (required): I cer fy that the foregoing jus fica on is accurate and complete to the best of my knowledge and belief.

Prepared by:

Michael W. McAlhaney Contrac ng Officer

b. One Level Above the Contrac ng Officer (Required over SAT but not exceeding $750K): I cer fy the jus fica on meets requirements for other than full and open compe on.

Larry M. Zaritz Branch Chief Network Contrac ng Office 15 (NCO 15) - CMOP Division

MICHAEL MCALHANEY Digitally signed by MICHAEL MCALHANEY Date: 2025.02.24 13:28:34 -06'00'

LARRY ZARITZ Digitally signed by LARRY ZARITZ Date: 2025.02.25 09:56:31 -06'00'