S02_JnA_Q0115_Provox_Allsigned_.pdf

36C77025Q0115 | 762 & 763 CMOPs

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: 36C770-25-AP-0126 | 36C770-25-AP-0177

Contracting Activity: The Department of Veterans Affairs, NCO 15 – CMOP Division - Contracting Office will be procuring this acquisition for seven (7) medical surgical products.

Contracting office will utilize 2237 #s 762-25-1-040-0359 | 763-25-1-021-0238 for the replenishment of low stock levels at the two CMOP locations.

Nature and/or Description of the Action Being Processed: This procurement is for seven line items - medical surgical supplies. See chart below. 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 seven (7) medical surgical items listed in the table. The contract will be a firm fixed contract. This is a two-year contract; base plus three (3) options. Tentative Delivery Schedule will be as followed.

The Tucson CMOP: equires one delivery for line: 1. This will be a base contract with three options. Three (3) Options will follow every 6-months. Final schedule will be finalized in the contract.

The Lancaster CMOP: Requires monthly deliveries for line items 2-7, over a six-month period. This will be a base contract with three options. Three (3) Options will follow every 6-months. Final schedule will be finalized in the contract.

Line Item: 2 - HEAT & MOISTURE EXCHANGER,PROVOX #8311 = 200 boxes/MONTH

Attachment 1: Request for Sole Source Justification Template >SAT $7.5M under FAR13.5

Last Updated: 02/01/22

vi. Line Item: 7 - TRACH BASEPLATE ADHESIVE PROVOX #7461 boxes MONTH

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.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Market Research confirmed that the products were last awarded on 8/07/2024 from an open market, unrestricted purchase. RFQ number 36C77024Q0333, provided seven (7) compliant quotes that were able to supply the various Provox items. Furthermore, the OEM Atos Medical, has provided their authorized distributor listing. Therefore, a competitive solicitation will be posted to the Government point of entry at SAM.gov to provide public knowledge of VA’s requirement.

Attachment 1: Request for Sole Source Justification Template >SAT $7.5M under FAR13.5

Last Updated: 02/01/22

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.

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 confirmed that the products were last awarded on 8/07/2024 from an open market, unrestricted purchase. RFQ number 36C77024Q0333, received seven (7) compliant quotes. Furthermore, the OEM has an authorized distributor listing, that was reconfirmed on 2/3/2025. Consideration was made on setting the procurement aside as a small business set-aside, but the products are made non-domestically in Sweden by large the business, Atos Medical. Therefore, a small businesses would not meet the 4th prong of the non-manufacture rule. It is unlikely that a sources sought notice would produce significantly new information about the market, as the OEM has provided an authorized distributor listing and past procurements were reviewed. Therefore, a competitive solicitation will be posted to the Government point of entry at SAM.gov to provide public knowledge of VA’s requirement.

Medical Surgical items are generally not found on the National Institutes of Health (NIH) U.S. National Library of Medicine DailyMeds website. All seven (7) line items were searched and yielded no results.

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.

b. All Item Master File Number were then used to query VISTA – in order to review past procurement history.

c. Once the OEM was confirmed, searches continue in VetCert database. First using the NAICS Code: 325413 and then more specifically, searching all the manufacturer/ OEMs.

VetCert, https://veterans.certify.sba.gov/#home - generated 90 SD/VOSB businesses using NAICS code: 325413

The database was checked for the OEM, Atos and yielded no results. Confirming that the OEM is not registered with VetCert.

Attachment 1: Request for Sole Source Justification Template >SAT $7.5M under FAR13.5

Last Updated: 02/01/22

The businesses that did generate are distributors of large wholesalers.

d. 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

OEM – Atos is registered and confirmed to be a large businesses.

SBA – DSBS

o https://dsbs.sba.gov/search/dsp_dsbs.cfm o 112 Vendors generated as doing business with NACIS Code:

325413, with Keyword: Manufacturing.

o The OEM, Atos was searched and did not generate on the

SBA/DSBS website. Confirming that the OEMs are not registered with SBA.

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

This yielded no results.

Reviewed all the Original Equipment Manufacturer (OEMs) websites o https://www.atosmedical.us/ o Line Items: 1-7 – https://www.atosmedical.us/

e. The Nonmanufacturer Rule The Contracting Officer reviewed the Non-Manufacturer Rule as defined in 13 CFR 121.406(b). 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 with this product for med/surg under NAICS Code 325413. The OEM is a large business, and all the products are made in Sweden.

Therefore, the solicitation will be issued unrestricted per the Non-Manufacture Rule.

Attachment 1: Request for Sole Source Justification Template >SAT $7.5M under FAR13.5

Last Updated: 02/01/22

9. Discuss consideration to BAATAA/Exception to BAA (See FAR Part 25) These items are Brand Name/ Dispense as written 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. A pre-solicitation, BAA waiver will be submitted for approval.

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: Past procurements were reviewed and a mix of small and larger vendors have provided the products in the past.

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 (NCO 15) – CMOP Division

Signature:

Tronny McCoggle Inventory Technician Lancaster CMOP

Jennifer Knight Digitally signed by Jennifer Knight Date: 2025.02.05 07:03:30 -06'00'

TRONNY MCCOGGLE

Digitally signed by TRONNY

MCCOGGLE

Date: 2025.02.05 07:37:53 -06'00'

Attachment 1: Request for Sole Source Justification Template >SAT $7.5M under FAR13.5

Last Updated: 02/01/22

Signature:

Juan Silva Inventory Management Specialist Tucson 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.

Signature:

Larry Zaritz Contracting Officer/ Branch Chief 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.

Signature:

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

Signature:

Andrew J. Raiber Director of Contracting Network Contracting Office 15

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

JUAN SILVA Digitally signed by JUAN SILVA Date: 2025.02.05 13:34:00 -07'00'

LARRY ZARITZ Digitally signed by LARRY ZARITZ Date: 2025.02.10 19:34:09 -06'00'

On Behalf of

JUSTIN SMITH Digitally signed by JUSTIN SMITH Date: 2025.02.11 14:29:23 -06'00'

BENJAMIN

DUFOUR

Digitally signed by

BENJAMIN DUFOUR

Date: 2025.02.12 08:34:32 -06'00'

Attachment 1: Request for Sole Source Justification Template >SAT $7.5M under FAR13.5

Last Updated: 02/01/22

Signature:

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

DARYL BERG

Digitally signed by DARYL BERG Date: 2025.02.20 13:33:39 -06'00'