JUSTIFICATION_Redacted.pdf

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DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR

CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH REVOLUTIONARY FAR

OVERHAUL (RFO) 12.201-1

Acquisition Plan Action ID:

RPOW JOFOC Tracker:

1. Contracting Activity: Department of Veterans Affairs, Network Contract Office

(NCO) 21 on behalf of Veterans Integrated Service Network (VISN) 21, VA Central California Health Care System (VACCHCS), Fresno VA Medical Center (VAMC), 2615 E. Clinton Avenue, Fresno, CA 93703-2223 2237:

2. Nature and/or Description of the Action Being Processed: This procurement is a new firm-fixed price, estimated quantity purchase order. The estimated total value for the purchase order is The requirement is in accordance with RFO FAR 12.201-1 Simplified Procedures for Certain Commercial Items and specifically RFO FAR 12.102(b), where acquisitions conducted under Simplified Acquisition Procedures require a justification using the format of RFO FAR 6.104.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: This contract will be a one (1) year purchase order. The period of performance will be 06/01/2026-05/31/2027. Items required include an extensive list of blood and blood products as well as on-call delivery to the Fresno VA Medical Center.

4. Statutory Authority Permitting Restricted Competition:

RFO FAR 12.201-1 Simplified Procedures. The statutory authority for applying the Simplified Procedures is 41 U.S.C. § 1901 and is implemented by FAR 12.102(b) 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

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the

Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Only the Central California Blood Center is FDA registered to store and

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distribute blood and blood products to the Fresno VA within short delivery timeframes as is needed for this procurement.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Federal law prohibits consideration of vendors who are not registered for storage and distribution of blood products

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The anticipated unit rates can be found fair and reasonable based on comparison to previous contracts awarded for blood and blood products.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: The Fresno VA Medical Center (VAMC) has a requirement to continue blood and blood product deliveries by an establishment that is registered with the Food and Drug Administration (FDA). All owners or operators of establishments that manufacture blood products are required to register with the FDA, pursuant to section 510 of the Federal Food, Drug, and Cosmetic Act, unless they are exempt under 21 CFR

607.65. Previous contract was issued to Central California Blood Center on 12/01/2020 per the System for Award Management (SAM.gov). The Central California Blood Center and provided satisfactory performance to date on the current award.

Due to the requirement for STAT delivery within two (2) hours of order placement, only Blood Banks located within the Fresno area can be considered. Searches were conducted at the FDA Blood Establishment Registration Database. While Fresno resulted in 10 results, a review determined the VA represents one (1) result, and three (3) vendors are inactive. The Central California Blood Center represents three

(3) active listings. BioLife Plasma Services L.P., Biomat USA, Inc. and Octapharma Plasma, Inc. results were reviewed, determining that all three vendors collect plasma but none are authorized to store and distribute to others as would be required for this procurement. Only the Central California Blood Center is FDA registered to store and distribute to the VA as needed for this procurement. While the Small Business Administration Small Business Search tool resulted in 72 SDVOSBs and VOSBs potentially capable, the FDA requirement for establishment and short turn around time for delivery limit this requirement to one capable vendor.

The Non-Manufacturer Rule will not apply as no the rule of two cannot be met and no set aside can be held. With only one vendor known capable of providing the necessary blood and blood products, this shall be a sole source to Large Business, Central California Blood Center.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

There are no other facts.

10.Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Central California Blood Center, NHLLKL94DAJ7, Large Business

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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 other vendor is able to service the Fresno VAMC with FDA registration and proximity as required to meet this need.

The VA will continue to conduct market research to determine if future requirements can be competed..

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.

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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.

b. One Level Above the Contracting Officer I certify the justification meets requirements for other than full and open competition.