P03 - JOFOC - 36C257-26-AP-0034 - Amarillo Lab Blood Services.docx

Attachment 1: Request for Sole Source Justification >SAT

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C257-26-AP-0034 RPOW JOFOC Tracker Number: FY25-NCO17-1638

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office (NCO) 17, located at 5441 Babcock Road, Ste 302, San Antonio, TX 78240, in support of the Amarillo VA Health Care System (AMAVAHCS), Pathology and Laboratory Medicine Services (P&LMS), located at 6010 Amarillo Blvd West, Amarillo TX 79106.

Anticipated Purchase Request Number: REDACTED

2. Nature and/or Description of the Action Being Processed: The Thomas E. Creek VA Health Care System located in Amarillo, Texas has an ongoing need for the supply of blood and blood products from the Oklahoma Blood Institute (OBI). The activity requires a continuous source for various transfusions as well as services related to transfusion screening services on a daily and 24/7 emergency basis. NCO-17 intends to establish an IDIQ with the OBI for the acquisition of these products and services and consumable items. The action will be awarded as a new Firm Fixed Price IDIQ with five (5) ordering periods. The estimated period of performance is 10/1/2025 through 9/30/2030.

The price for the proposed action, based on the quote received from OBI on 06/22/2025, is REDACTED for the first ordering period, and a total of REDACTED for all five periods.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The blood support services contract for the Amarillo VA Health Care System (AVAHCS) requires the Contractor to maintain specific certifications and licenses to ensure compliance with federal and industry standards. All blood products and testing services must adhere to Food and Drug Administration (FDA) regulations under 21 CFR Parts 606, 610, and 630, governing blood collection, processing, and distribution. The Contractor’s facilities must be accredited by the American Association of Blood Banks (AABB) and registered with the FDA, with transfusion-related and compatibility testing conducted in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory. Personnel performing testing or handling blood products must hold valid licenses or certifications from a U.S. state, territory, or the District of Columbia, ensuring competency in medical laboratory or blood bank operations. Additionally, courier services must comply with Occupational Safety and Health Administration (OSHA) bloodborne pathogen standards (29 CFR 1910.1030) for safe transport.

4. Statutory Authority Permitting Other than Full and Open Competition:

(X) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4

( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): The Oklahoma Blood Institute (OBI), through its Coffee Memorial Blood Center in Amarillo, is uniquely positioned, offering validated processes, emergency specimen pickups, and blood product deliveries, compliant with FDA (21 CFR Parts 606, 610, 630), AABB, and CLIA standards. Major competitors, such as the American Red Cross, lack a local presence since, and Vitalant relies on third-party logistics, unable to meet AVAHCS’s stringent response times.

Per the procurement history, Oklahoma Blood Institute (OBI) is a large non-profit organization with over 100 satellite donor facilities in the US. Market Research conducted by the COR shows there are 3 other vendors; Lubbock Red Cross, North Dallas Red Cross, and Albuquerque Red Cross, that can supply blood and blood products, but not within the turnaround time that is required. This would take anywhere from 1-8 hours and enlist the US mail as a courier service, which is known to incur delays, and the precious product may not be viable/stable if not kept at a constant temperature.

Customary commercial practices for blood support services, as required for the Thomas E. Creek VA Health Care System (AVAHCS) blood bank, align with industry standards for nonprofit blood banks providing blood products, transfusion-related and compatibility testing, and courier services. Blood banks, such as those operated by the Oklahoma Blood Institute (OBI), collect, process, store, and distribute blood products (e.g., leukoreduced red blood cells, apheresis platelets, plasma) in compliance with FDA regulations (21 CFR Parts 606, 610, 630) and AABB standards, ensuring product safety and traceability. Compatibility testing, including ABO/Rh typing, antibody screening, and antigen typing, is conducted in CLIA-certified laboratories, adhering to strict quality control and validation protocols. Daily inventory management, with short-dated unit replacements at no cost, is standard to minimize waste and ensure supply reliability. 24/7 courier services, with rapid response times are within industry norms for supporting hospitals and comply with OSHA bloodborne pathogen standards (29 CFR 1910.1030). Contracts typically include technical support consistent with the IDIQ structure and performance metrics.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Market research did not identify an alternative procurement source for this requirement. A search of the mandatory sources of procurement for maintenance, DSBS, AbilityOne, Unicor, GSA, and open market searches did not identify any other vendor that offers blood support products or services.

A search of the DSBS revealed 66 SDVOSBs using NAICS 621991. Of those found, only one provides blood and blood products, but it does not provide the necessary 24-hour services needed by the Amarillo VAHCS.

A search within AbilityOne using keywords of, “blood compatibility” and “blood transfusion,” and “transfusion-related testing” found zero (0) results capable of meeting the VAHCS needs.

A search within GSA Global Supply using keyword of, “Blood Products” and “NAICS 621991” found zero (0) results.

An entity search within SAM.gov using the business name of, “Oklahoma Blood Institute” found one (1) entity with that name.

A search within the Interagency Contract Directory using the NAICS 621991, PSC 6505, and the keyword of “Veterans Affairs” found thirty-seven (37) contract actions.

A Notice of Intent to Sole Source, 36C25725Q0597, was posted to SAM.gov on 05/22/2025 with a closing date and time of 05/29/2025 at 1:00pm EDT with no responses.

There are no known Service-Disabled Veteran-Owned Small Businesses (SDVOSBs) or Veteran-Owned Small Businesses (VOSBs) with the capability to provide integrated blood product supply, transfusion-related and compatibility testing, and 24/7 courier services in the Texas Panhandle.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The Contracting Officer has determined that establishing an IDIQ with Oklahoma Blood Institute or the requested services and supplies is the best value consistent with FAR 8.404(d). The Contracting Officer will compare the proposed prices with the vendor pricelist and may compare the prices of past contracts or delivery orders to verify the proposed prices are the best value.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market research did not identify an alternative procurement source for this requirement. A search of the mandatory sources of procurement for maintenance, DSBS, AbilityOne, Unicor, GSA, and open market searches did not identify any other vendor that offers blood support products or services.

A search of the DSBS revealed 66 SDVOSBs using NAICS 621991. Of those found, only one provides blood and blood products, but it does not provide the necessary 24-hour services needed by the Amarillo VAHCS.

A search within AbilityOne using keywords of, “blood compatibility” and “blood transfusion,” and “transfusion-related testing” found zero (0) results capable of meeting the VAHCS needs.

A search within GSA Global Supply using keyword of, “Blood Products” and “NAICS 621991” found zero (0) results.

An entity search within SAM.gov using the business name of, “Oklahoma Blood Institute” found one (1) entity with that name.

A search within the Interagency Contract Directory using the NAICS 621991, PSC 6505, and the keyword of “Veterans Affairs” found thirty-seven (37) contract actions.

A Notice of Intent to Sole Source, 36C25725Q0597, was posted to SAM.gov on 05/22/2025 with a closing date and time of 05/29/2025 at 1:00pm EDT with no responses.

There are no known Service-Disabled Veteran-Owned Small Businesses (SDVOSBs) or Veteran-Owned Small Businesses (VOSBs) with the capability to provide integrated blood product supply, transfusion-related and compatibility testing, and 24/7 courier services in the Texas Panhandle.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: The blood support services contract for the Amarillo VA Health Care System (AVAHCS) requires the Contractor to maintain specific certifications and licenses to ensure compliance with federal and industry standards. All blood products and testing services must adhere to Food and Drug Administration (FDA) regulations under 21 CFR Parts 606, 610, and 630, governing blood collection, processing, and distribution. The Contractor’s facilities must be accredited by the American Association of Blood Banks (AABB) and registered with the FDA, with transfusion-related and compatibility testing conducted in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory. Personnel performing testing or handling blood products must hold valid licenses or certifications from a U.S. state, territory, or the District of Columbia, ensuring competency in medical laboratory or blood bank operations. Additionally, courier services must comply with Occupational Safety and Health Administration (OSHA) bloodborne pathogen standards (29 CFR 1910.1030) for safe transport.

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

Oklahoma Blood Institute Clinical Services Division 1001 N. Lincoln Blvd Oklahoma City, OK 73104 Becky Heister - Senior Contracts Manager Phone: (405) 297-5560 Email: becky.heister@obi.org

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: Based on the customary practices for blood support services as required by the AMAVHCS, at this time OBI is the only company capable of fulling the needs of the customer. NCO 17 and Pathology and Laboratory Medicine Service will conduct market research prior to future procurements to consider any advances in the marketplace.

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.

Laboratory Manager Thomas E. Creek VA Medical Center

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Contracting Officer Laboratory Support Services (LSS) Network Contracting Office (NCO) 17

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.

Branch Chief Laboratory Support Services (LSS) Network Contracting Office (NCO) 17

VHAPG Part 806.3 OFOC Page 1 of 4 Revision: 03 Effective Date: 04/15/24 Acquisition ID#: 36C257-26-AP-0034