S02_JnA__Q0135_All_signed_.pdf

Last Updated: 02/01/22

36C770-24-AP-0117

Omnipods Reservoir

36C77024Q0135 – 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:36770-24-AP-0117

Contracting Activity: The Department of Veterans Affairs, NCO 15 – CMOP Division - Contracting Office will be procuring 4500 packages (PG) of Insulet Omnipod Reservoir G6 (Gen5). Contracting office will utilize 2237 #760-24-1-050-0170 for the replenishment of low stock levels at the Leavenworth CMOP, Leavenworth, KS.

Nature and/or Description of the Action Being Processed: This procurement is for one 1 medical surgical supplies (med/surg) (Insulet Reservoir Omnipod 5, G6) 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 the one (1) medical surgical items listed in the below table. 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:

36C770-24-AP-0117

Omnipods Reservoir’s

36C77024Q0135 – 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

(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):

Products have 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 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.

36C77024Q0135 – 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

|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 Brand Name only requirements.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Contracting Officer anticipates the cost of award will be fair and reasonable based on competition.

36C770-24-AP-0117

Omnipods Reservoir’s

36C77024Q0135 – 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

The Item Master File Number (19387) was then used to query VISTA – in order to review past procurement history. RFQ:

36C77024P0104 was reviewed. Product made in the USA.

Manufacturer - INSULET CORPORATION.

b. 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.

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 VARR 810 market research was conducted 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 (IMFN), manufacturer/ Original Equipment Manufacturer (OEM) can be confirmed.

36C77024Q0135 – 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

c. The following databases/websites were queried to identify manufacturers/packagers and domestic availability of the required Medical Surgical items.

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

o OEM confirms they are a large business.

Federal Procurement Data System (FPDS) https://www.fpds.gov/fpdsng_cms/index o Past procurements were reviewed.

o Reviewed past procurements, confirmed that both items are made in the USA.

SBA – DSBS

o https://dsbs.sba.gov/search/dsp_dsbs.cfm o 18 Vendors generated as doing business with NAICS Code:

325413, with Keyword: Manufacturing o Vendor Specific OEM (Insulet Corporation) did not generate on the SBA/DSBS website.

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 o https://www.omnipod.com/what-is-omnipod/omnipod-dash

Product information – what it does and country of origin Company Information

Dun & Bradstreet (D&B) website: https://riskanalytics.dnb.com/en- US/login o OEM Company size information 2600 employees

EDGAR- OEM Search https://www.sec.gov/edgar/searchedgar/companysearch o OEM is listed on EDGAR.

36C77024Q0135 – 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

d. 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.

Discuss consideration to BAA TAA/Exception to BAA (See FAR Part 25) The item is Brand Name only. Per FAR 25. 01(a)(5) .

Therefore, Act (BAA) ies 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.

Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Market research shows previous awardees as being both large and small businesses.

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 orservices required: No action is being taken at this time due to the fact that no (MPNs) Manufacturer Part Numbers, substitutions are permitted based on physician’s specific orders.

36C77024Q0135 – 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

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.

Diane Nolting Logistic Manager Leavenworth CMOP

Jennifer Knight Contract Specialist Network Contracting Office 15 – CMOP Division

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.

Michael McAlhaney Contracting Officer Network Contracting Office 15 – CMOP Division

Jennifer Knight Digitally signed by Jennifer Knight Date: 2024.01.22 14:09:28 -06'00'

DIANE

NOLTING

Digitally signed by

DIANE NOLTING

Date: 2024.01.22 15:04:41 -06'00'

MICHAEL MCALHANEY Digitally signed by MICHAEL MCALHANEY Date: 2024.01.23 10:16:27 -06'00'

36C77024Q0135 – 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

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.

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

Benjamin DuFour Division Chief Network Contracting Office 15 – CMOP Division

JUSTIN SMITH Digitally signed by JUSTIN SMITH Date: 2024.01.23 14:25:15 -06'00'

BENJAMIN

DUFOUR

Digitally signed by BENJAMIN

DUFOUR

Date: 2024.01.29 09:53:15 -06'00'

ANDREW Digitally signed by ANDREW

RAIBER

Date: 2024.01.30 08:58:26 RAIBER_____________________________-06'00'

Andrew J. Raiber Director of Contracting Network Contracting Office 15

Gerald F. Jacobs Head of Contracting Activity

Daryl A. Berg

DARYL BERG Digitally signed by DARYL BERG Date: 2024.02.01 13:45:03 -06'00'