P03_Justification and Approvals_under 250K_770-23-3-801-0459_Redacted.pdf

VHAPM Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Unusual and Compelling Urgency Justification for SAP under the SAT

Last Updated: 02/01/22

Any delay in award would undermine medical care for Veterans, and cause serious damage to the United States.

This waiver and justification is being made and approved after contract award because preparation and approval prior to solicitation would be unwarranted due to the possibility of US made alternate items, and preparation and approval prior to award would unreasonably delay the acquisition.

Requests are sent to the contracting office due to the items not being available from required source such as the Prime Vendor, NAC, etc., or are available by open market procurements only. The National Logistics Office combines as many requirements as possible to reduce the number of single orders for the same items.

When the request is sent to the contracting office, the item is already needed to fill prescriptions. Not getting a timely award will delay in filling the prescription for a Veteran that needs their medication and can make the need into an urgent and compelling order. If CMOP doesn’t get the needed pharmaceuticals, the prescription must be canceled back to the VA Medical Center. Then, they must try to procure the product. All of this causes undue hardship on the VAMCs, is frustrating to everyone, but worst of all, is detrimental and significantly impacts patient care and treatment of our Veterans.

One or more of the items under this acquisition is subject to the Buy American statute.

In accordance with FAR 25.502(c)(2) and 25.103, no quotes of domestic end products were received, and therefore, I am making a non-availability determination and awarding to the best value/lowest offer.

The Determination of Nonavailability was submitted to the MIAO after award per the guidance in OMBs memorandum for Improving the Transparency of Made in America Waivers, dated October 26, 2021.

According to this memo, “in situations of urgency, reporting of the waiver post-award is for informational purposes; MIAO will not provide a determination on such waivers.” The reason this determination is being accomplished post award is to ensure quality care is not impacted.

4. Description of market research conducted and results or statement why it was not conducted:

This pharmaceutical is not available from the Prime Vendor.

No Federal Supply Schedule contracts were found for this product. A search of the GSA eLibrary resulted in no record found.

CO Does not have enough time to post a RFI searching for domestic sources due to quick turn-around time on pharmaceuticals.

Because the Government is not allowed to do business using Wholesale Trade or Retail Trade NAICS codes, searches must be conducted using manufacturer NAICS codes.

Market research was conducted through VetCert under NAICS 325412(Pharmaceutical Preparation Manufacturing).

This search resulted in 2 or more SDVOSB companies doing business using this NAICS code. Despite these results, there are no known SDVOSB, VOSB, HUBZone, 8(a), or small business organizations that manufacture the items required for this procurement.

A SD/VOSB set-aside is not feasible as the Non-Manufacturer Rule (NMR) and the Limitations on Subcontracting (LOS) require the contractor to supply the product of a small business or an offeror must either manufacture the item in accordance with the Limitations on Subcontracting or supply the product of a small business made in the United States.

An SDVOSB concern would need to prove they are a manufacturer or are providing the products of a small

VHAPM Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Unusual and Compelling Urgency Justification for SAP under the SAT

Last Updated: 02/01/22 business manufacturer to be eligible for award of a contract or the CO would have to obtain an approved individual waiver to the NMR through the Small Business Administration (SBA).

As stated above, no small business manufactures these items and SBA has not granted a non-manufacturer class waiver for pharmaceuticals. These requirements apply to all SD/VOSB set asides regardless of dollar value. Due to the urgency and risk to patient safety we do not have time to request and receive approval for an NMR waiver to set-aside for SDVOSB’s.

Based on this research and policy, the VA Rule of Two cannot be met to set the procurement aside for SD/VOSB contractors. Although we cannot set-aside to SDVOSB due to the NMR and LOS, this does not preclude a SD/VOSB from quoting and/or receiving an award as a small business

Based on the exception to the NMR for acquisitions under $250K, a small business set-aside is feasible.

Contracting Officer requesting a(n) SMALL BUSINESS/Small Business procurement, to a(n) Open Market Vendor.

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Prepared by:

McAlhaney, Michael W.

Contracting Officer

MICHAEL MCALHANEY Digitally signed by MICHAEL MCALHANEY Date: 2023.06.01 10:43:46 -05'00'