Justification and Approval Low Titer Whole Blood_Redacted.pdf

CUI

Control Number: FY26-0814

Controlled by: Defense Health Agency (DHA) Controlled by: HCD Southeast CUI Category(ies): Source Selection Limited Dissemination Control: FEDCON POC: Felicia W. Smith

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

1 OCT 2024

Justification and Approval (J&A) for Other than Full and Open Competition Revolutionary Federal Acquisition Regulation (FAR) Overhaul (RFO) Parts 6 and 12

Implemented by Class Deviation 2026-O0017, Revision 1

1. Identification of the Agency and Contracting Activity: Defense Health Agency (DHA), DHA Contracting Activity (DHACA), Healthcare Contracting Division (HCD) Southeast.

2. Nature and/or Description of Action being Approved: The purpose of this requirement is to award a new sole source supply, Firm Fixed Price, as an individual award that requires Low Titer Whole Blood for treatment of trauma and emergent conditions.

This requirement will be conducted in accordance with FAR Part 12 procedures for commercial supplies.

3. Description of Supplies/Services and Estimated Value: Naval Medical Center Camp Lejeune requires a constant supply of Low Titer Whole Blood to be utilized for the care and emergency treatment of patients within the Level II Trauma Center. Due to the emergent need for the product in certain situations, there is a requirement for the supplies to be available and delivered within 3.5 hours of the receipt of a STAT order. The award will be for a base period and four option periods.

The proposed source is Blood Connection, Inc. (Cage Code: 6ZYS6), 1099 Bracken Rd., Piedmont, SC 29673-9644.

Period Period of Performance or Required Delivery Date

Estimated Value Type of Funding

Base Period 01 October 2026 – 30 September 2027

O&M

Option Period 1 01 October 2027 – 30 September 2028

O&M

Option Period 2 01 October 2028 – 30 September 2029

O&M

Option Period 3 01 October 2029 – 30 September 2030

O&M

Option Period 4 01 October 2030 – 30 September 2031

O&M

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

OCT 2024

Period Period of Performance or Required Delivery Date

Estimated Value Type of Funding

Total $521,250.00

4. Statutory Authority Permitting Other Than Full and Open Competition: Authority 41 USC 3304(a)(1) and FAR 6.103-1(b) the supplies required by agency are available from a limited number of responsible sources but only one can satisfy the agency requirements.

5. Rationale Justifying Use of Authority Cited: While there are other sources that provide the supplies required those sources are either not in the geographical area, they either cannot provide the supplies within the required timeline, cannot guarantee the quantity required, or require an existing drop shipment contract to support the emergent stat order requirement. Blood Connections can provide the quantities required with regular shipments delivered when requested and are within the geographical area to provide STAT delivery within the 3.5-hour timeline for emergent life-saving requirements.

6. Efforts to Obtain Competition: Market research was conducted to establish various sources capable of providing the supplies as required. A sources sought was posted on SAM.gov on 17 June 2026 and closed 22 June 2026. Only one offeror responded to the notice, however, they did not provide a capability statement that demonstrates their ability to provide the required supplies.

When researching their website and capabilities on SDBS, this company did not demonstrate the availability of the required supplies. In addition, an intent to sole source notice will be placed on SAM.gov for three days providing the opportunity for potential vendors to submit capability statements to be accessed for competition. Market research was conducted by querying other vendors known to provide the required supplies, but they were unable to provide the quantities or were not within the geographic area to support the emergency delivery timelines.

7. Actions to Increase Competition/Remove or Overcome any Barriers to Competition: Future instances for this requirement will continue to have extensive market research provided to ascertain any new vendors in the geographic area and if current vendors terms and conditions have changed to allow for greater competition. The need for geographical location will remain a stipulation of the requirement due to the emergent nature of the supply being procured.

8. Market Research: Based on information gathered through market research, several vendors provide Low Titer Whole Blood. However, there were only two vendors that could provide the quantities required and that support the timeframe for expedited delivery in emergent situations.

While both Blood Connections and American Red Cross can provide the supplies, American Red Cross required a standing drop shipment delivery order to be established, which is not conducive to the needs of the facility and would cause increase costs due to potential waste. Blood Connections was the only vendor that could provide the quantity required, with standard

CUI

Source Selection Information - See FAR 2.101 and 3.104-4 deliveries when needed and were within the geographical area to provide the supplies with the timeframes annotated for emergent services.

9. Other Facts:

a. Procurement History:

(1) Is this a new requirement? No

(2) If 9.a.(1) is No, was the action just prior to this one competed? No

(3) If 9.a.(2) is Yes, what has changed where this action cannot be competed? Not applicable

b. Additional Information: N/A

10. Interested Sources: BHPE, LLC, providing an email expressing interest, but did not provide corresponding documentation nor could their ability to provide the required supplies be verified and validated.

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

11. Technical Certification:

I certify the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

12. Requirements Certification:

I certify 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. Legal Review:

I have reviewed this justification and have found it to be legally sufficient.

14. Contracting Officer Determination of Fair and Reasonable Pricing and Certification of Accuracy and Completion.

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

Fair and Reasonable Cost Determination:

I hereby determine that the anticipated cost to the Government for this contracting action will be fair and reasonable.

Basis for Determination: Comparative pricing from several vendors was reviewed and based on the average of those vendors for the same quantities and listed in the Independent Government Cost Estimate it was determined that the pricing was fair and reasonable.

Contracting Officer Certification:

I certify this justification is accurate and complete to the best of my knowledge and belief.

Felicia W. Smith Contracting Officer Office