S02_JandA_Q0368_allsigned.pdf

CMOP: 761

36C770-24-AP-0773 | 761-24-4-014-0316

RESERVOIR, Omnipod 5 G6, MPN: 08508-3000-21 & CATH SET, INTERMIT 14FR, MPN: H96144 36C77024Q0368 – 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

DEPARTMENT OF VETERANS AFFAIRS

BRAND NAME JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR

CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C770-24-AP-0773

1. Contracting Activity: The Department of Veterans Affairs, NCO 15 – CMOP Division - Contracting Office will be procuring this acquisition: 2-line Med/Surg (RESERVOIR, Omnipod 5 G6, MPN: 08508-3000-21) & (CATH SET, INTERMIT 14FR, MPN: H96144) for the Chelmsford CMOP.

2. Nature and/or Description of the Action Being Processed: This procurement is for one

(2) medical surgical supplies (med/surg) (RESERVOIR, Omnipod 5 G6, MPN: 08508-3000-

21) & (CATH SET, INTERMIT 14FR, MPN: H96144) 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.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: This is an individual brand name justification to support the procurement of the two (2) medical surgical items listed in the below table.

Delivery will be10 days after receipt of order.

Line Item: 1 (RESERVOIR, Omnipod 5 G6, MPN: 08508-3000-21) "Omnipod tubeless systems are made of two main components, the Pod and a smartphone-like Controller.

The pod is a small device that you fill with insulin and wear directly on your body. The Pod receives insulin delivery instructions from the Controller. It then delivers insulin into your body through a small, flexible tube called a cannula".

Line Item: 2 (CATH SET, INTERMIT 14FR, MPN: H96144) Per label description/ usages information – Product is a size specific, Pre-Lubricated, Intermittent Catheter with protective tip & Urine bag, Straight. Natural Rubber; not latex.

RESERVOIR, Omnipod 5 G6, MPN: 08508-3000-21 & CATH SET, INTERMIT 14FR, MPN: H96144 36C77024Q0368 – 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

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

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.

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

RESERVOIR, Omnipod 5 G6, MPN: 08508-3000-21 & CATH SET, INTERMIT 14FR, MPN: H96144 36C77024Q0368 – 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: 2 – CATH SET, INTERMIT 14FR, MPN: H96144 |

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 the Gray Market/Brand Name only, OEM 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.

RESERVOIR, Omnipod 5 G6, MPN: 08508-3000-21 & CATH SET, INTERMIT 14FR, MPN: H96144 36C77024Q0368 – 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. The procurement package was received by the Contracting Office on 6/21/2024 Market research is being conducted on 7/19/2024 for the upcoming acquisition: 2-line Med/Surg (RESERVOIR, Omnipod 5 G6, MPN: 08508-3000-

21) & (CATH SET, INTERMIT 14FR, MPN: H96144)

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

National Library of Medicine DailyMeds website.

1. Due to the products being Brand Name only, I retrieved the Original

Equipment Manufacturer (OEM) information from the VA CMOP Image Library.

a. Line Item: 1 – RESERVOIR, Omnipod 5 G6, | MPN: 08508-3000-21| OEM: Insulet Corporation.

b. Line Item: 2 – CATH SET, INTERMIT 14FR, | MPN: H96144 | OEM: Hollister.

2. Past Procurement history was reviewed in VISTA and FPDS for both items.

3. VetCert, https://veterans.certify.sba.gov/#home - generated 89 SD/VOSB businesses using NAICS code: 325413 database was checked for the OEMs (INSULET CORPORATION

& Hollister) and both searches yielded no results. Confirming that the manufacturers, Insulet & Hollister are not registered with VetCert.

The businesses that did generate are distributors of large wholesalers.

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

SAM.gov – o Both OEMs were searched on https://sam.gov/content/home o Both OEMs, Insulet Corporation & Hollister are registered and active on SAM.gov.

Both OEMs are registered within SAM.gov and are self-registered as large businesses.

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

SBA – DSBS

o https://dsbs.sba.gov/search/dsp_dsbs.cfm o 29 Vendors generated as doing business with NACIS Code:

325413, with Keyword: Manufacturing.

o Vendor Specific OEMs (Insulet Corporation & Hollister) did not generate on the SBA/DSBS website. Confirming that the two manufacturers, Insulet & Hollister are not registered with

SBA.

NAC – National Acquisition Center (CCST) o https://www.vendorportal.ecms.va.gov/NAC/Search o Searched both products on the MedSurg Catalog.

This yielded no results.

o Searched the products on the pharmaceutical catalog.

Line Item: 1 – RESERVOIR, Omnipod 5 G6, Search yielded the Omnipod 4 Dash product. The requested Omnipod 5, is not on the NAC.

Line Item: 2 – CATH SET, INTERMIT 14FR did not generate results.

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.hollister.com/en/products/Continence-Care-

Products/Intermittent-Catheters#

The Nonmanufacturer Rule: Applies o 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

RESERVOIR, Omnipod 5 G6, MPN: 08508-3000-21 & CATH SET, INTERMIT 14FR, MPN: H96144 36C77024Q0368 – 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 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) Items are Brand Name only. Per FAR 25.01(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.

Market research and past procurement history indicates that the Line Item: 1 – RESERVOIR, Omnipod 5 G6, MPN: 08508-3000-21, is made in the USA and will not require a BAA waiver.

Market research and past procurement history of Line Item: 2 – CATH SET, INTERMIT 14FR, MPN: H96144, (IMFN:6056) shows the product is made in India by its sole manufacture, Hollister. Line Item: 2 will require a BAA waiver. A Pre-RFQ waiver will be submitted to the MIAO.

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 have been both small and large business.

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.

Signature:

Jennifer Knight Contract Specialist Network Contracting Office 15 – CMOP Division

Joseph Sousa Inventory Management Specialist Chelmsford CMOP

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.

Michael McAlhaney Contracting Officer Network Contracting Office 15 – CMOP Division

Jennifer Knight Digitally signed by Jennifer Knight Date: 2024.07.22 06:53:19 -05'00'

JOSEPH SOUSA

Digitally signed by JOSEPH

SOUSA

Date: 2024.07.22 09:24:48 -04'00'

MICHAEL MCALHANEY Digitally signed by MICHAEL MCALHANEY Date: 2024.07.23 07:10:21 -05'00'