S02_Attachment 1 FAR 13.5 Sole Source Justification - Over SAT Q0036 (002).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 4

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-0001

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office 15, CMOP Division. 2237# 761-24-1-014-0004, NE CMOP, Chelmsford, MA

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:

Item Number IMF Description MPN Quantity

Unit of Measure

Packaging Multiple

LOCAL STOCK

NUMBER

0001 13355

ONE TOUCH VERIO

(GLUCOSE) TEST STRIP

(O0346) 53885027210 2400 EA 100 53885027210

0002 15823

SET, INFUSION

AUTOSOFT 90 TANDEM

#1002820, XJ689 1002820 400 BX 10 89152282005

0003 761

BAG,LEG LATEX

REUSABLE UROCARE

#9532 9532 900 EA 1 99999-9532-00

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

( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert

Services ( ) International Agreement

Effective Date: 02/01/2022 Page 2 of 4

( ) 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 4

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A synopsis of this requirement was posted to SAM.gov and the RFQ will be posted as a SDVOSB set-aside. Only qualified vendors will be able to submit quotes due to Gray Market/Name Brand only requirements and the Non-Manufacturer Rule (NMR) waiver granted by the SBA for diabetic testing strips.

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: As described in Section 6 above, market research, in accordance with FAR Part 10, was conducted by synopsis of the proposed acquisition, advising industry of the pending acquisition and soliciting inquiries from interested parties. The SBA has granted a NMR waiver for diabetic testing strips and the VIP database search concluded there are SDVOSB suppliers for the above referenced MedSurg items for NAICS code 325413. Therefore, the “Rule of Two” can be met and a SDVOSB set-aside is feasible. Furthermore, in accordance with FAR Part 25, the Buy American Act (BAA), applies to the price factors of this solicitation.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: This will be a SDVOSB set-aside due to the SBA’s NMR waiver for diabetic testing strips.

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, Effective Date: 02/01/2022 Page 4 of 4 which are included in the justification, are accurate and complete to the best of my knowledge and belief.

JOSEPH SOUSA

INVENTORY MANAGEMENT SPECIALIST

NE CMOP

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

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

JOSEPH

SOUSA

Digitally signed by

JOSEPH SOUSA

Date: 2023.10.19 11:51:08 -04'00'

KAYLA POWERS

Digitally signed by

KAYLA POWERS

Date: 2023.10.19 15:19:05 -05'00'

MICHAEL

MCALHANEY

Digitally signed by

MICHAEL MCALHANEY

Date: 2023.10.20 11:59:18 -05'00'

JUSTIN

SMITH

Digitally signed by

JUSTIN SMITH

Date: 2023.10.20 12:22:49 -05'00'