Custom IV Starter Kit

Request for SDVOSB/VOSB Sole Source Justification Format IAW VAAR 819.7008/9 VHAPG Part 819.7008/7009 Sole Source Awards to SDVOSB/VOSB Page 1 of 6 Revision:

03 Effective Date: 06/15/2024 DEPARTMENT OF VETERANS AFFAIRS Justification and Approval (J&A) For Other Than Full and Open Competition Acquisition Plan Action ID:

36C262-24-AP-6181 Contracting Activity: Department of Veterans Affairs, VISN 22, Phoenix VA Health Care System, 650 E Indian School Road, Phoenix AZ 85012. PR: 691-24-3-056-7492 Nature and/or Description of the Action Being Approved: VA GLA, custom IV starter kits. This will be a new, firm fixed price contract with a period of performance 8/23/24 12/31/24.

Description of Supplies/Services Required to Meet the Agency s Needs: Acquisition Management and Maintenance at VA GLA is requesting 420 cases (100 kits/case) of custom IV Starter Kits. Each kit will contain the items listed below. With a total estimated value of $619,096.80 Statutory Authority Permitting Other than Full and Open Competition: 41 USC §3304(a)(5), 38 U.S. Code § 8127(c), as implemented by FAR 6.302-5 (Authorized or Required by Statute).

COs may use the non-competitive (sole source) procedures authorized in VAAR 819.7008 (DEVIATION) or VAAR 819.7009 (DEVIATION) up to $5,000,000. Check the specific VAAR clause used below:

(X) 819.7008 Sole source awards to a certified service-disabled veteran-owned small business; or ( ) 819.7009 Sole source awards to a certified veteran-owned small business Demonstration that the Contractor s Unique Qualifications and/or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): The IV Starter Kits that are being requested are highly specialized because they are customized to meet the stations direct needs.

These kits are customized and then assembled, packaged, sterilized, and stocked by Medline, who has only one authorized SDVOSB partner, Geo-Med. As the current supplier of these kits, Geo-Med is already set up to meet FDA production schedule requirements to accommodate both the current requirements and potential pandemic surge requirements.

While there are other manufacturers/distributors that can become postured to provide comparable equivalents, competing this requirement will cause unacceptable delays in fulfilling the agency s needs. The authority allows sole source awards to SDVOSB based on 38 U.S.C. 8127(c) and the SDVOSB concern has been determined to be a responsible source with respect to performance.

Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable, including whether a notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies: An intent to sole source was posted 8/13/24 - 8/19/24 got one response from an Ability One, SDVOSB vendor, Alpha Vets, Inc. This vendor confirmed they would not be able to meet the immediate need, requiring a 4 6 week lead time for initial production and sterilization.

No other responses were received. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The anticipated cost is considered fair and reasonable based on comparison with similar items on the market. I found two standard IV Starter Kits on GSA eBuy, one priced at $90.79/each and the other priced at $108.86/each. Based on that the proposed $147.40/each for a customized kit is considered fair and reasonable. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

NAICS Code: 339112 - Surgical and Medical Instrument Manufacturing Product Service Code: 6515 - Medical and Surgical Instruments, Equipment, and Supplies Size Standard for NAICS: 1,000 employees A search for NAICS code 339112 on VetCert returned six-hundred and sixty-five (665) SDVOSB/VOSB that could fulfill this requirement.

The only known source with both existing stock of the currently approved custom GLA IV Starter Kit and the manufacturing plant tooled to rapidly generate additional kits to fulfill all delivery needs within the next eight weeks with no delay between award and first delivery shipment is Medline.

Multiple medical supply manufacturers were questioned to determine the average time required between notification of award and first run production of medical/surgical packs: all agreed that dependent upon current production capability and desired pack configuration, it may take anywhere from one to three months contingent upon supply chain issues for pack components and in-house production set-up.

Medline already has the supplies and production capability to provide us with enough product to last us the next six months; based on market research there is not another manufacturer/distributor other than their SDVOSB partner Geo-Medical that has been identified as capable to fulfill the requirement as needed. The non-manufacturer rule does not apply as Medline is the manufacturer and Geo-Med, and SDVOSB, is the supplier of the items being requested. The Buy American Act applies as this is a domestic end product.

Accordingly, Medline through their authorized distributor, Geo-Med, is the only firm capable of providing the supplies and services described in Section III above without the Veteran s Health Administration experiencing unacceptable delays in fulfilling its requirements. Any Other Facts Supporting the Use of Other than Full and Open Competition: None. The authority allows sole source awards to SDVOSB based on 38 U.S.C.

8127(c) and the SDVOSB concern has been determined to be a responsible source with respect to performance. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Medline via SDVOSB authorized vendor GeoMed incumbent. Alpha Vets, Inc cannot meet immediate need.

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: The major barrier to competition for this action, is time. With this award in place there will be time to compete and award a 12-month contract. The anticipated award date of the 12-month contract 10/30/24 with an estimated delivery start date of 12/6/2024.