S02_JnA_36C77024Q0233.pdf

Last Updated: 02/01/22

ACQ-Plans: 36C770-24-AP-0317 | : 760-24-2-050-0493 Omnipods Reservoir’s

36C77024Q0233 – Knight/McAlhaney

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

DEPARTMENT OF VETERANS AFFAIRS

BRAND NAME JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR

CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID:36 770-24-AP-0317

Contracting Activity: The Department of Veterans Affairs, NCO 15 – CMOP Division - Contracting Office will be procuring 4800 packages (PG) of Insulet Omnipod Reservoir G6 (Gen5). Contracting office will utilize 2237 # 760-24-2-050-0493, for the replenishment of low stock levels at the Leavenworth CMOP, Leavenworth, KS.

Nature and/or Description of the Action Being Processed: The procurement is for one medical surgical supplies (med/surg) (Insulet Reservoir Omnipod 5) in accordance with

FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2. The proposed procurement action will be a new firm-fixed-price contract.

Description of Supplies/Services Required to Meet the Agency’s Needs: This is an individual brand name justification to support the procurement of one (1) medical surgical items listed in the chart below. Contract will be a firm fixed contract. Items are to be delivered 10 days after receipt of order.

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 – Brand Name Only

ACQ-Plans: 36C770-24-AP-0317 | : 760-24-2-050-0493 Omnipods Reservoir’s

36C77024Q0233 – Knight/McAlhaney

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

Last Updated: 02/01/22

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

Product has been prescribed for patients by VA physicians. Pharmacy employees do not have the training and/ or authority to countermand physician’s orders. “Brand Specific” products are the same thing as “dispense as written” on a physician’s prescription. No Manufacture Part Number (MPN) substitutions are permitted. In the VA, Pharmacy Benefits Management (PBM) has determined that CMOP IDs in the Manufacturer Part Number (MPN) will always identify “brand specific products in the “VA PRINT NAME” This is not always inclusive where a particular NDC or MPN has been determined to be “formulation specific” by clinical evaluation performed by the PBM or in the case where only one product in the marketplace has been identified to contain the specific ingredients to match the product code or work in coordination with brand name, medical surgical equipment.

Line-Item: 1 – Reservoir, Omnipod 5 G6 | Local Stock Number/ MPN#: 08508-3000-21|

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A sources sought notice was not posted for this acquisition because Med/Surge buys are routine, and the Contracting Officer is very knowledgeable about the Med/Surg marketplace. It is unlikely that a sources sought notice would produce significantly new information about the market. Therefore, a competitive solicitation will be posted to the Government point of entry at SAM.gov to provide public knowledge of VA’s requirement. Only qualified vendors will be able to submit quotes due to Gray Market/Brand Name only requirements.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Contracting Officer anticipates cost of award will be fair and reasonable based on competition, the Independent Cost Government Estimate (IGCE), and previous acquisition cost history for the same requirements.

36C77024Q0233 – Knight/McAlhaney

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

Last Updated: 02/01/22

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: In accordance with FAR Part 10 and VAAR 810 market research was conducted. Market research is being conducted on 3/19/2024 for the upcoming acquisition of Omnipods (Insulet Reservoir Omnipod 5, G6).

Medical Surgical items are not found on the National Institutes of Health (NIH) U.S.

National Library of Medicine DailyMeds website.

a. In lieu of DailyMeds, search began by utilizing the VA image library – where the requested product manufacturer/ Original Equipment Manufacturer (OEM) can be confirmed.

b. The Item Master File Number (19387) was retrieved from the 2237, and used to query VISTA – to review past procurement history. 760-A40063 |RFQ:

36C77024P0171 was reviewed, procurement listed product as USA made, by the sole manufacturer - INSULET CORPORATION.

c. Once the OEM was confirmed, (OEM: INSULET CORPORATION) searches continue in VetCert and SBA’s DSBS databases. First using the NAICS Code:

325413 and then more specifically, searching for the manufacturer/ OEM

(INSULET CORPORATION).

VetCert, https://veterans.certify.sba.gov/#home - generated 86 SD/VOSB businesses using NAICS code: 325413

SBA’s DSBS, https://dsbs.sba.gov/search/dsp_dsbs.cfm -generated 18 Small businesses using NAICS code: 325413 o Both databases were checked for the manufacture/ OEM (INSULET CORPORATION) and the two searches yielded no results. Confirming that the manufacture, Insulet is not registered with VetCert or the SBA.

o The businesses that did generate are distributors of large wholesalers.

d. The following databases/websites were queried to identify the manufacturer and domestic availability of the required Medical Surgical items.

SAM.gov – OEM was searched on https://sam.gov/content/home o OEM, Insulet Corporation is registered and active.

o OEM confirms they’re a large business.

Federal Procurement Data System (FPDS) https://www.fpds.gov/fpdsng_cms/index o Last two procurements were reviewed. (36C77024P0171 & 36C77024 134)

36C77024Q0233 – Knight/McAlhaney

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

Last Updated: 02/01/22 o Past procurements confirmed the item as being made in the

USA.

Original Equipment Manufacturer (OEM) website (Insulet Corporation) o https://www.insulet.com/ o https://www.omnipod.com/ o https://www.omnipod.com/current-podders/resources/omnipod-5 Product information – what it does Company Information

Dun & Bradstreet (D&B) website: https://riskanalytics.dnb.com/en- US/login o Company size information 3000 employees

e. The Nonmanufacturer Rule The Contracting Officer reviewed the Non-Manufacturer Rule.

In accordance with the Non-Manufacturer Rule as defined in 13 CFR 121.406(b), there are two or more small business concerns who identify themselves as authorized distributors.

These small businesses have 500 or less employees, engage in the retail wholesale trade and normally sell pharmaceuticals, take ownership or possession of the pharmaceutical via its facilities or via its personnel. However, market research concludes that there are presently no small business manufacturers that exist in the commercial marketplace. The CO has confirmed there is no class waiver associated for Medical Surgical Supplies under NAICS Code 325413. The Contracting Officer considered the use of an individual waiver, however, is not feasible due to the expedient nature of this acquisition. A small business set-aside is not feasible as a small business would not be able to comply with the NMR since there are presently no small business manufacturers.

9. Discuss consideration to BAATAA/Exception to BAA (See FAR Part 25) The item is Brand Name only. Per FAR 25.401(a)(5) the use of the sole source justification for brand name only - is an exception to the use of trade agreements. Therefore, BAA applies. However, market research and past procurement history indicates that item is made in the USA and will not require a BAA waiver.

36C77024Q0233 – Knight/McAlhaney

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

Last Updated: 02/01/22

10. Any Other Facts Supporting the Use of Other than Full and Open Competition:

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

11. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Market research shows previous awardees listed below have demonstrated an interest in this requirement.

• Amerisource. (Large Business)

• Pharmacy Buying Association (PBA) Health (Small Business)

• 3T Federal (SDVOSB)

• ASE Direct Inc. (SDVOSB)

• Disabled Veterans Hawaii. (SDVOSB)

12. 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: No action is being taken at this time due to the fact that no MPN substitutions are permitted based on physician’s specific orders.

13. 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 belief.

Rodney Yates Inventory Management Specialist Leavenworth CMOP

Jennifer Knight Contract Specialist Network Contracting Office 15 – CMOP Division

14. 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.

Jennifer Knight Digitally signed by Jennifer Knight Date: 2024.03.19 14:51:56 -05'00'

RODNEY

YATES

Digitally signed by

RODNEY YATES

Date: 2024.03.20 07:09:33 -05'00'

36C77024Q0233 – Knight/McAlhaney

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

Last Updated: 02/01/22

Michael McAlhaney Contracting Officer Network Contracting Office 15 – CMOP Division

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.

MICHAEL

MCALHANEY

Digitally signed by MICHAEL

MCALHANEY

Date: 2024.03.20 10:38:29 -05'00'

JUSTIN SMITH

Digitally signed by JUSTIN SMITH

Date: 2024.03.21 07:13:54 -05'00'

Name: J. Braden Smith Branch Chief Network Contracting Office 15 – CMOP Division

Benjamin DuFour

Network Contracting Office 15

Andrew J. Raiber Director of Contracting Network Contracting Office 15

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 $7.5million (or $15.0 million for acquisitions described in FAR 13.500(c)) for other than full and open competition.

Daryl A. Berg Executive Director, RPO Central Head of Contracting Activity

BENJAMIN

DUFOUR

Digitally signed by

BENJAMIN DUFOUR

Date: 2024.03.22 10:05:58 -05'00'

ANDREW

RAIBER

Digitally signed by

ANDREW RAIBER

Date: 2024.03.22 10:47:40 -05'00'

DARYL BERG

Digitally signed by DARYL

BERG

Date: 2024.03.25 12:45:10 -05'00'