JUSTIFICATION BLOOD PRODUCTS_Redacted.pdf

Simplified Acquisition Procedures for Certain Commercial Items Sole Source Justification

Effective Date: 02/01/2022 Page 1 of 6

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR

CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C261-26-AP-0589 RPOW JOFOC Tracker:

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

(NCO) 21 on behalf of Veterans Integrated Service Network (VISN) 21, Reno VA Medical Center (VAMC), 975 Kirman Ave, Reno, NV 89502-0993 2237:

2. Nature and/or Description of the Action Being Processed: This procurement is a new requirement for Blood and Blood Products provided on an as-needed basis by Vitalant, 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. This will be a five-year Indefinite Delivery / Indefinite Quantity, firm fixed price contract.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The estimated value for this five-year IDIQ is for the first ordering period and over five ordering periods. The requirement will include FAR 52.217-8, Option to Extend Services and has an estimated ceiling of

Period of Performance:

Ordering Period 1 – 12/01/2025-09/30/2026 - Ordering Period 2 – 10/01/2026-09/30/2027 - Ordering Period 3 – 10/01/2027-09/30/2028 - Ordering Period 4 – 10/01/2028-09/30/2029 - Ordering Period 5 – 10/01/2029-09/30/2030 -

Supplies and services required as a part of this procurement are as follows with services being the minor element of estimated value:

Item Category Product Red Cells RBC LEUKOREDUCED Red Cells RBC LEUKOREDUCED IRRADIATED Red Cells RBC LEUKOREDUCED WASHED Red Cells RBC LEUKOREDUCED IRRADIATED WASHED Platelets PLATELET STANDARD Platelets PLATELET STANDARD IRRADIATED Platelets PLATELET PATHOGEN REDUCED

Effective Date: 02/01/2022 Page 2 of 6

Plasmas PLASMA FROZEN Plasmas PLASMA LIQUID Cryo CRYO POOLS (5) Cryo CRYO SINGLES Whole Blood WHOLE BLOOD Whole Blood WHOLE BLOOD RECONSTITUTED RLTS Testing ABO/RH RLTS Testing DIRECT ANTIGLOBULIN TEST RLTS Testing ANTIBODY IDENTIFICATION PANEL RLTS Testing ANTIBODY IDENTIFICATION PANEL, RARE RLTS Testing ANTIBODY SCREEN, EACH

RLTS Testing

ANTIGEN TYPING, DONOR - CONFIRMED OR HISTORICAL,

PER ANTIGEN

RLTS Testing ANTIGEN TYPING, PATIENT, PER ANTIGEN

RLTS Testing

ANTIGEN TYPING, DONOR, RARE - CONFIRMED OR

HISTORICAL, PER ANTIGEN

RLTS Testing RED CELL AND PLATELET MOLECULAR TESTING RLTS Testing AUTOLOGOUS FEE RLTS Testing DIRECTED DONOR FEE RLTS Testing GRANULOCYTE FEE RLTS Testing ADDITIONAL BLOOD BAGS FEE RLTS Testing STERILE CONNECTION FEE RLTS Testing ABO GROUPING RLTS Testing ABO DISCREPANCY RLTS Testing RH(D) TYPING RLTS Testing ANTIGEN TYPING, PATIENT, RARE, PER ANTIGEN RLTS Testing 4C ANTIBODY SCREEN RLTS Testing ENZYME PANEL - MANUFACTURED RLTS Testing PREWARM SETUP RLTS Testing SALINE REPLACEMENT SETUP RLTS Testing ADSORPTION PROCEDURE RLTS Testing RED CELL TREATMENT RLTS Testing RED CELL STROMA-ALLOADSORPTION RLTS Testing ENZYME TREATMENT RLTS Testing ELUTION PROCEDURE RLTS Testing TITRATION STUDIES, PER TITRATION RLTS Testing RED CELL SEPARATION METHOD RLTS Testing RED CELL SEPARATION - PERCOLL RLTS Testing SERUM NEUTRALIZATION/INHIBITION PROCEDURE RLTS Testing SERUM TREATMENT WITH CHEMICAL AGENTS RLTS Testing THERMAL AMPLITUDE TEST RLTS Testing POLYAGGLUTINATION SCREEN RLTS Testing DONATH-LANDSTEINER TEST

Effective Date: 02/01/2022 Page 3 of 6

RLTS Testing DRUG DEPENDENT ANTIBODY STUDIES RLTS Testing PATHOLOGICAL COLD AGGLUTININ SCREEN RLTS Testing COLD AGGLUTININ TITER RLTS Testing HEMOGLOBIN S RLTS Testing KLEIHAUER-BETKE, QUANTITATIVE RLTS Testing ROSETTE TEST, QUALITATIVE RLTS Testing MONOCYTE MONOLAYER ASSAY (MMA) RLTS Testing DAT NEG AIHA EVALUATION RLTS Testing PLATELET CROSSMATCH RLTS Testing PLATELET ANTIBODY SCREEN TEST RLTS Testing COMPATIBILITY SCREEN RLTS Testing PLASMA THAWING RLTS Testing BLOOD TYPE RECHECK RLTS Testing MOLECULAR EXTENDED RED CELL GENOTYPE/PHENOTYPE RLTS Testing MOLECULAR GENOTYPE-PLATELET (HPA) RLTS Testing RHD GENOTYPE TEST RLTS Testing RHCE GENOTYPE TEST RLTS Testing MOLECULAR SEQUENCING TEST RLTS Testing DONOR/PRODUCT SEARCH FEE, PER SEARCH RLTS Testing UNCONFIRMED ANTIGEN REQUEST, PER COMPONENT RLTS Testing RARE SEARCH FEE RLTS Testing ARDP FEE RLTS Testing IMPORT FEE RLTS Testing TRANSFUSION REACTION INVESTIGATION - CLERICAL RLTS Testing TRANSFUSION REACTION EVALUATION - PHYSICIAN RLTS Testing HLA MATCHED PLATELET FEE, PER COMPONENT RLTS Testing CROSSMATCHED PLATELET TAGGING, PER COMPONENT RLTS Testing DONOR ANTIGEN SCREENING, 1-10 UNITS SCREENED RLTS Testing RARE UNIT FEE RLTS Testing CMV NEGATIVE, PER COMPONENT RLTS Testing IRRADIATION RLTS Testing LESS THAN 5 DAYS FRESH, PER RBC RLTS Testing LESS THAN 10 DAYS FRESH, PER RBC RLTS Testing ADDITIONAL WASH, EACH RLTS Testing ALIQUOT PREPARATION, EACH RLTS Testing ALIQUOT PREPARATION AND SYRINGE, EACH RLTS Testing ON-CALL FEE RLTS Testing STAT REQUEST RLTS Testing ASAP REQUEST RLTS Testing SAMPLE/MATERIAL HANDLING FEE RLTS Testing BLOOD BANK ARM BANDS, PER BOX RLTS Testing SPECIMEN HOLD, EACH

Effective Date: 02/01/2022 Page 4 of 6

Item Category Services Red Cells RBC RESTOCKING FEE

ORDER-DELIVERY ASAP ORDER-DELIVERY

ORDER-DELIVERY STAT ORDER-DELIVERY

RLTS Testing LOCAL ADD ON DELIVERY FEE

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

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

Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Vitalant is the only vendor established with the United States Food and Drug Administration (FDA) in the Reno, Nevada area to provide blood and blood products required to meet this requirement. Based on the timelines required for delivery, this requirement will necessitate a vendor with a local branch, capable of providing same day turnarounds, and shorter in the case of urgent orders (two to four hours). Vitalant has previously provided the same supplies and services as needed by the Reno VAMC since 2020 with satisfactory performance.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Market research was conducted and a sources sought notice was posted to identify additional sources, but none could be located.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Quoted prices will be reviewed against prices previously paid by the government.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Searches

Effective Date: 02/01/2022 Page 5 of 6 were conducted across Federal Procurement Data System (FPDS) for blood product vendors and to determine the appropriate North American Industry Classification System (NAICs) and Product/Service Code (PSC) for this requirement. NAICs of 621991 for Blood and Organ Banks and PSC of 6506 Blood and Blood Products appear most commonly for similar requirements. FPDS showed numerous vendors including the American Red Cross and Vitalant. A review of the FDA Blood Establishment Registry showed only three active vendors in the Reno area, the Reno VAMC being one of the three. In addition to Vitalant, Biomat USA, Inc. is established with the FDA. Market research inquiries were made via phone and email to Grifols USA LLC (doing business as Biomat USA, LLC) on 8/25/2025 but received no responses on the ability to provide the necessary products. A deeper search within the FDA Blood Establishment Registry showed that the Reno location for Grifols provides only Source Plasma and is not registered to provide the numerous blood products Vitalant offers and that are necessary to meet this requirement. A sources sought notice (36C26126Q0042) was posted to the System of Award Management (SAM.gov) from 09/16/2025 through 09/23/2025. In addition to Vitalant, only one other response was received from Khairat Al Khaleej Company, located in Baghdad, Iraq, who offered no FDA Establishment ID or other details that would suggest the company is local or capable of providing the necessary items in compliance with FDA standards. Additionally, Khairat Al Khaleej Company vendor does not include NAICS 621991 in their representations on SAM.gov and the vendor does not appear in a search of the FDA Blood Establishments. No Service Disabled Veteran Owned Small Businesses (SDVOSBs) or Veteran Owned Small Businesses (VOSBs) were identified as able to meet the requirement.

This shall be a sole source procurement via the open market to the large business, Vitalant, the only source capable of providing an acceptable solution. The Rule of Two cannot be met. The Non-Manufacturer Rule will not apply.

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:

Vitalant, Large Business, GKT4L2JZJ622 Khairat Al Khaleej Company, Large Business, YUP1YZA5XNK5

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: The agency will continue to conduct market research to identify opportunities for competitive procurement in the future.

Effective Date: 02/01/2022 Page 6 of 6

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.

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.

c. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve ($750K to $7.5 million (or $15.0 million for acquisitions described in FAR 13.500(c)) for other than full and open competition.