S02.JnA.pdf

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

Last Updated: 02/01/22 Page 1 of 4

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C770-24-AP-0442

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office 15, CMOP Division. 2237 # 763-24-2-021-0718, Dallas CMOP, Lancaster, TX.

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 item listed below in the following table. Items are to be delivered over a 5 month period.

Item Number

IMF Description MPN Quantity Unit of Measure

Packaging Multiple

SET,INFUSION EXTENDED WEAR #MMT-441 (XL362) MMT-441 350 BX 10

2 SET,INFUSION EXTENDED WEAR #MMT-431 (XL364) MMT-431 700 BX 10

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 ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

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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.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: this requirement will be solicited as full and open utilizing the competitive procedures outlined in FAR 13.

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. 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 18 small businesses using NAICS code 325413. The SBA’s Veteran Small Business Certification (VetCert) database search concluded there are 87 SDVOSB or VOSB companies doing business using NAICS code 325413; however, due to Non-Manufacturer 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. Based on the above market research there is one or more authorized distributors that could support the requirement in its entirety therefore it is anticipated that this requirement will be solicited as full and open utilizing the competitive procedures outlined in FAR 13-Simplified Acquisition Procedures. The basic clauses and provisions prescribed in FAR Part 12 are sufficient for use with the subject requirement and the use of FAR 13-Simplifed Acquisition Procedures is appropriate. The agency anticipates awarding a single award purchase orders to the contractor who meets the qualification requirements outlined herein and included in the forthcoming solicitation.

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The Contracting Officer has determined there is enough competition available to establish price reasonableness.

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

Prepared by:

Kayla Powers Contract Specialist Network Contracting Office 15 – CMOP Division

Approved by:

Michael McAlhaney Contracting Officer Network Contracting Office 15 – CMOP Division

KAYLA

POWERS

Digitally signed by KAYLA

POWERS

Date: 2024.03.29 11:42:22 -05'00'

MICHAEL

MCALHANEY

Digitally signed by

MICHAEL MCALHANEY

Date: 2024.04.03 08:21:18 -05'00'

Last Updated: 02/01/22 Page 4 of 4

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 Network Contracting Office 15 – CMOP Division

JUSTIN

SMITH

Digitally signed by JUSTIN

SMITH

Date: 2024.04.11 14:18:46 -05'00'