S02_JnA_Q0061_allsigned.pdf

36C77025Q0061 | 761/763/765 CMOPs 9-line Med/Surg | Supplemental Market Research

Acquisition Plans: 36C770-24-AP-1059 | 36C770-25-AP-0054 | 36C770-25-AP-0056 2237’s: 761-25-1-014-0001 | 763-25-1-021-0061 | 765-25-1-021-0069

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-1059 | 36C770-25-AP-0054 | 36C770-25-AP-0056

Contracting Activity: The Department of Veterans Affairs, NCO 15 – CMOP Division - Contracting Office will be procuring this acquisition for nine (9) medical surgical products.

Contracting office will utilize 2237 #s 761-25-1-014-0001 | 763-25-1-021-0061 | 765-25-1-

0069 for the replenishment of low stock levels at the three CMOP locations.

Nature and/or Description of the Action Being Processed: This procurement is for nine 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 nine (9) medical surgical items listed in the below table. Delivery Schedule will be as followed.

The Chelmsford CMOP requires one delivery for line items: 1-5; to be delivered 10 days ARO.

The Lancaster CMOP requires monthly deliveries of 150 cases, over six months; totaling 900 cases - for line item: 6.

The Hines CMOP requires one delivery for line items: 7-9; to be delivered 10 days ARO.

ITEM

NUMBER

ITEM

MASTER

FILE

NUMBER CMOP DESCRIPTION

MANUFACTURER

PART NUMBER

(MPN)

Local Stock

Number QTY

UNIT OF

MEASURE

PACKAGING

MULTIPLE

OEM

NAME Useage Country of

Origin

0001 18828 VA CMOP Chelmsford 761

HEAT & MOISTURE EXCHANGER,

PROVOX #8262 PROVOX #8262 99222 0082 63 400 EA 30

Provox Life/ ATOS Medical

After laryngectomy breathing care Sweden

0002 19927 VA CMOP Chelmsford 761

RESERVOIR,T:SLIM X2 W/T:LOCK,

3ML 10CT 8915 22541 05 8915 22541 05 2000 BX 10

TANDEM

DIABETES CARE Insulin Pump Mexico

0003 761 VA CMOP Chelmsford 761

BAG,LEG LATEX REUSABLE

UROCARE #9532 IDNUC 9532 99999 9532 00 2400 EA 1 UROCARE

Urinary incontinence management USA

0004 12866 VA CMOP Chelmsford 761 LANCET,ACCU CHEK FASTCLIX DRUM 6570 20288 10 6570 20288 10 1800 EA 102 Roche Lancet Drum for diabete care Germany 0005 6056 VA CMOP Chelmsford 761 CATH SET, INTERMIT 14FR H#96144 Hollister 96144 01234 0961 44 400 CS 4 HOLLISTER Catheter system India

0006 18784 VA CMOP Lancaster 763

CATH SET,INTERMIT 14FR APOGEE

H#B14FB HOLLISTER 100/CASE Hollister H#B14FB 08380 0013 05 900 CS 0 HOLLISTER Catheter system India

0007 15988 VA CMOP Hines 765

SET,INFUSION AUTOSOFT XC

TANDEM #1001680 Tandem #1001680 89152 1680 05 4200 BX 10

TANDEM

DIABETES CARE

Infusion Set for Insulin pump Unknown

0008 15987 VA CMOP Hines 765

SET,INFUSION AUTOSOFT XC

TANDEM #1001681 TANDEM #1001681 89152 1681 05 3200 BX 10

TANDEM

DIABETES CARE

Infusion Set for Insulin pump Unknown

0009 19927 VA CMOP Hines 765

RESERVOIR,T:SLIM X2 W/T:LOCK,

3ML 10CT 8915 22541 05 8915 22541 05 3200 BX 10

TANDEM

DIABETES CARE Insulin Pump Mexico

Acquisition Plans: 36C770-24-AP-1059 | 36C770-25-AP-0054 | 36C770-25-AP-0056 2237’s: 761-25-1-014-0001 | 763-25-1-021-0061 | 765-25-1-021-0069

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

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:

Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

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.

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.

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.

Acquisition Plans: 36C770-24-AP-1059 | 36C770-25-AP-0054 | 36C770-25-AP-0056 2237’s: 761-25-1-014-0001 | 763-25-1-021-0061 | 765-25-1-021-0069

Last Updated: 02/01/22

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

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 11/18/2024 for the upcoming acquisition of four med/surg items.

A sources sought notice will not be posted for this acquisition because pharmaceutical/Medical Surgical buys are routine, and the Contracting Officer is very knowledgeable about the pharmaceutical/ Medical Surgical 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.

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

National Library of Medicine DailyMeds website. All nine (9) line items were searched and yielded no results.

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.

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

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

Acquisition Plans: 36C770-24-AP-1059 | 36C770-25-AP-0054 | 36C770-25-AP-0056 2237’s: 761-25-1-014-0001 | 763-25-1-021-0061 | 765-25-1-021-0069

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

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

The database was checked for all the OEMs and yielded no results.

Confirming that the OEMs not registered with VetCert.

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 All OEMs was searched on https://sam.gov/content/home o OEMs - Atos, Roche and Hollister were registered and all confirmed to be a large businesses.

o OEMs – Urocare and Tandem were not registered with

SAM.gov/

Federal Procurement Data System (FPDS) https://www.fpds.gov/fpdsng_cms/index o Past procurements were reviewed – Looked for last listed country of origin information as reported.

SBA – DSBS

o https://dsbs.sba.gov/search/dsp_dsbs.cfm o 9 Vendors generated as doing business with NACIS Code:

325413, with Keyword: Manufacturing.

o All Vendor Specific OEMs were 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 Line Item: 1 – https://www.atosmedical.us/ o Line Items: 2 & 9 – https://www.tandemdiabetes.com/ o Line Item: 3 – https://www.urocare.com/EN/ProductsEN.php

Acquisition Plans: 36C770-24-AP-1059 | 36C770-25-AP-0054 | 36C770-25-AP-0056 2237’s: 761-25-1-014-0001 | 763-25-1-021-0061 | 765-25-1-021-0069

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 Line Item: 4 – https://www.roche.com/ & https://www.accu-chek.com/ o Line Item: 5 – https://www.hollister.com/en o Line Item: 6 – https://www.hollister.com/en o Line Item: 7 – https://www.tandemdiabetes.com/ o Line Item: 8 – https://www.tandemdiabetes.com/

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.

• 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. However, market research and past procurement history indicates Line item: 3 is made in the USA. Line items: 7 & 8 are unknown and will not be known until quotes are received. Furthermore, the remaining items all appear to be made non-domestically as shown in the above chart. A pre-solicitation BAA waiver will be submitted.

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: 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.

Acquisition Plans: 36C770-24-AP-1059 | 36C770-25-AP-0054 | 36C770-25-AP-0056 2237’s: 761-25-1-014-0001 | 763-25-1-021-0061 | 765-25-1-021-0069

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

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.

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:

Joseph Sousa Inventory Management Specialist Chelmsford CMOP

Signature:

Signature:

Justin Simon

Inventory Management Specialist Supervisor Hines CMOP

Jennifer Knight Digitally signed by Jennifer Knight Date: 2024.11.22 12:23:39 -06'00'

JUSTIN SIMON Digitally signed by JUSTIN SIMON Date: 2024.11.25 11:00:38 -06'00'

JOSEPH MOREIRA

Digitally signed by JOSEPH

MOREIRA

Date: 2024.11.25 11:28:31 -06'00'

JOSEPH SOUSA

Digitally signed by JOSEPH

SOUSA

Date: 2024.11.25 13:10:10 -05'00'

Acquisition Plans: 36C770-24-AP-1059 | 36C770-25-AP-0054 | 36C770-25-AP-0056 2237’s: 761-25-1-014-0001 | 763-25-1-021-0061 | 765-25-1-021-0069

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

Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

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:

Kelley Cunningham 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.

Signature:

J. Braden Smith Branch/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.

KELLEY

CUNNINGHAM

Digitally signed by

KELLEY CUNNINGHAM

Date: 2024.11.25 13:36:34 -06'00'

JUSTIN SMITH Digitally signed by JUSTIN SMITH Date: 2024.11.27 07:24:08 -06'00'

ANDREW RAIBER

Digitally signed by ANDREW

RAIBER

Date: 2024.11.27 08:41:52 -06'00'

Acquisition Plans: 36C770-24-AP-1059 | 36C770-25-AP-0054 | 36C770-25-AP-0056 2237’s: 761-25-1-014-0001 | 763-25-1-021-0061 | 765-25-1-021-0069

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

Signature:

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

DARYL BERG

Digitally signed by DARYL BERG Date: 2024.12.04 08:50:27 -06'00'