S02.JnA.pdf

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

Effective Date: 02/01/2022 Page 1 of 5

DEPARTMENT OF VETERANS AFFAIRS

NAME BRAND JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C770-24-AP-0686 & 36C770-24-AP-0589

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office 15, CMOP Division. 2237# 763-24-3-021-1099& 761-24-3-014-0239, Dallas CMOP, Lancaster, TX and Chelmsford CMOP.

2. Nature and/or Description of the Action Being Processed: This procurement is for medical surgical supplies (med/surg) 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 medical surgical items listed below in the following table. Items are to be delivered over a 6 month period to the Dallas CMOP in Lancaster, TX as well as a single shipment to Chelmsford CMOP.

Line (IMF) CMOP Description MPN Quantity Unit of Measure

Packaging Multiple

1 18632 Lancaster

HEAT & MOISTURE

EXCHANGER,PROVOX #8311 (XK657)

8311 1080 BX 30

2 18636 Lancaster

HEAT & MOISTURE

EXCHANGER,PROVOX #8310 (XK656)

8310 840 BX 30

3 18633 Lancaster

HEAT & MOISTURE

EXCHANGER,PROVOX #8312 (XK658)

8312 240 BX 30

4 18631 Lancaster

TRACH BASEPLATE ADHESIVE PROVOX

#8263 (XK649)

8263 900 BX 15

5 18637 Lancaster

TRACH BASEPLATE ADHESIVE PROVOX

#7460 (XK767)

7460 480 BX 30

6 18638 Lancaster

TRACH BASEPLATE ADHESIVE PROVOX

#7461 (XK768)

7461 360 BX 30

7 18828 Chelmsford

HEAT & MOISTURE

EXCHANGER,PROVOX #8262

8262 240 EA 30

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:

Effective Date: 02/01/2022 Page 2 of 5

(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 orders. “Brand Specific” products are the same thing as “dispense as written” on a physician’s prescription. No National Drug Code (NDC) substitutions are permitted. In the VA, Pharmacy Benefits Management (PBM) has determined that CMOP IDs in the National Drug File (NDF) will most 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.

Effective Date: 02/01/2022 Page 3 of 5

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: : A synopsis of this requirement will be posted to SAM.gov and the RFQ will be posted as unrestricted competition due to the estimated value over SAT. Only qualified vendors will be able to submit quotes due to Gray Market/Name Brand only requirements.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The anticipated cost will be fair and reasonable based on the IGCE.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market research, in accordance with FAR Part 10, was conducted. The National Acquisition Center (NAC) database was checked for existing contracts. No prime vendor (PV) contracts were found. The FSS database was checked for existing contracts and no FSS contracts were found for these specific products. Reviewed results from similar requirements. Checked VetCert and SBA search results. The SBA search showed 22 small businesses using NAICS code 325413. The SBA’s Veteran Small Business Certification (VetCert) database search concluded there are 90 SDVOSB or VOSB companies doing business using NAICS 325413; however, due to Non-Manufactureer Rule (NMR) requirements, unable to set-aside for SDVOSB/VOSB suppliers without a waiver. VA Rule of Two requirements cannot be met based on this market research and the SBA’s NMR as defined in FAR Part 19 and 13 CFR § 121.406. Also, due to the time constraints of this acquisition, there is not sufficient time to request an individual waiver to the NMR. Additionally, one (1) small business was identified as the sole manufacturer of the requested product; therefore, this procurement will be a sole source award based on FAR 6.302-1, only one responsible source and no other supplies or services will satisfy agency requirements. Furthermore, based on FAR 25.401(a)(5) there is an exception to the Trade Agreement Act (TAA) for acquisitions not using full and open competition; therefore, the Buy American Act (BAA) applies to this procurement. Provox XtraFlow Heat and Moisture Exchangers are manufactured in Sweden and therefore this procurement requires a waiver for domestic non-availability from the Made in America Office (MIAO).

Effective Date: 02/01/2022 Page 4 of 5

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: This will solicited as full and open utilizing the competitive procedures outlined in FAR 13- Simplified Acquistition Procedures.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Qualified business vendors tend to vary from procurement to procurement.

11. 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 NDC substitutions are permitted based on physician’s specific orders.

12. 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.

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.

KAYLA POWERS

CONTRACT SPECIALIST

NCO 15, CMOP

Approved by:

MICHAEL W. MCALHANEY

CONTRACTING OFFICER

NCO 15, CMOP

KAYLA

POWERS

Digitally signed by KAYLA

POWERS

Date: 2024.06.24 11:26:12 -05'00'

MICHAEL

MCALHANEY

Digitally signed by

MICHAEL MCALHANEY

Date: 2024.06.25 09:27:31 -05'00'

Effective Date: 02/01/2022 Page 5 of 5

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.

J. BRADEN SMITH

BRANCH CHIEF

NCO 15, CMOP

JUSTIN

SMITH

Digitally signed by

JUSTIN SMITH

Date: 2024.06.25 11:08:14 -05'00'