JA FY250116 ASBP FINAL Redacted 10082025.pdf

CUI

Control Number: JAFY25-0116

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

1 NOV 2024

Justification and Approval (J&A) Modified for Federal Acquisition Regulation (FAR) 13.501

1. Identification of the Agency and Contracting Activity:

The requiring activity is the Defense Health Agency (DHA) Armed Services Blood Program (ASBP) Division. The Contracting Activity for this acquisition is Defense Health Agency Contracting Activity (DHACA), Professional Services Contracting Division (PS-CD).

2. Nature and/or Description of Action being Approved: This is a Justification and Approval (J&A) pursuant to Federal Acquisition Regulation (FAR) Part 13.501 Simplified Acquisition Procedures.

The action being approved is for an individual firm fixed-price task order under FAR Part 13.5.

The requirement is for a direct award to the Association for the Advancement of Blood & Biotherapies (AABB) as required by Department of Defense Instruction (DoDi) 6480.04 ASBP Operational Procedures, 3.1.c. General Provisions, which states blood collection and transfusion facilities must be maintained using the AABB accreditation.

This contract is for a renewal membership, expected to begin 30 September 2025 and end 29 September 2030 with a 12-month base period and four 12-month options periods. The contract will include clause 52.217-8, should a need as described in FAR 37.111 be appropriate. To facilitate use of the clause, a fifth option period not to exceed six months will also be included.

The fifth option would potentially extend the contract through 31 March 2031.

3. Description of Supplies/Services:

The services required under this contract support the DHA and the ASBP by maintaining annual site memberships and accreditations of Transfusion Services (TS) and Blood Donor Centers (BDC) to include providing updated electronic-learning (eLearning) subscription services based on current regulatory guidance as well as obtaining accreditation for non-accredited locations.

Key services include:

A. Accreditation:

• Standards that combine the field’s leading quality management system essentials with technical requirements designed to ensure optimal quality and safety for donors, patients and staff.

• Internationally recognized as a symbol of quality, accredited facilities will be known to provide high quality products and services within the blood and biotherapies community.

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Source Selection Information - See FAR 2.101 and 3.104-4

2 NOV 2024

B. Membership:

• The contractor will provide annual membership and accreditation services to maintain the compliance of the ASBP TS and the BDC.

• The contractor will also facilitate the Food and Drug Administration (FDA) registrations for Department of Defense (DoD) blood collection and transfusion facilities to ensure compliance with federal regulatory standards.

C. eLearning Subscription Services:

• This requirement includes the provision of electronic-learning (eLearning) resources, including eCasts for each of the supported sites. These eLearning resources will help maintain the readiness and knowledge base of blood service personnel, ensuring they meet accreditation standards and stay up to date with best practices in blood collection, transfusion, and processing.

D. Quality Assurance (QA) and Regulatory Compliance:

• The contractor is responsible for supporting FDA compliance and ensuring adherence to regulatory standards, including the standards for blood collection and transfusion operations across DoD facilities.

• The contractor is responsible for assisting with QA to maintain high standards of blood product safety and effectiveness, including compliance with Good Manufacturing Practices (GMP).

Period Period of Performance Estimated Value Funding Type Base Period 30 SEP 2025 TO 29 SEP 2026 $546,635.00 O&M

Option Period 1 30 SEP 2026 to 29 SEP 2027 $563,034.05 O&M Option Period 2 30 SEP 2027 to 29 SEP 2028 $579,925.07 O&M Option Period 3 30 SEP 2028 to 29 SEP 2029 $597,322.82 O&M Option Period 4 30 SEP 2029 to 29 SEP 2030 $615,242.51 O&M FAR 52.217-8 30 SEP 2030 to 31 MAR 2031 $307,621.25 O&M

Total $3,209,780.71

4. Statutory Authority Permitting the Sole Source Acquisition: In accordance with 41 United States Code (U.S.C) 1901(e), as implemented under FAR 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items/services.

5. Rationale Justifying Use of Authority Cited:

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Source Selection Information - See FAR 2.101 and 3.104-4

3 NOV 2024

The justification for a sole source award contract is based on DoD Instruction 6480.04 ASBP Activities, 3.1.c. General Provisions, blood collection and transfusion facilities will maintain Association for the Advancement of Blood Biotherapies “AABB” accreditation. As result of this DoD Instruction, DHA is required to use AABB for their AABB accreditation.

Additionally, through market research, it has been determined that is the only company that provides AABB accreditation.

6. Efforts to Obtain Competition:

Market research was conducted on September 25, 2024, to determine if any other vendors could meet the specific requirements for accreditation, blood collection, transfusion services, biotherapies services, and relationship testing services. The government's requirements were researched using internet search engines to identify potential vendors and found there were vendors who could only partially fulfill the necessary requirements. Similarly, the Government also reviewed mandatory sources such as AbilityOne.gov and Federal Prison Industries (FPI) through their websites and conducted a small business search through the Dynamic Small Business Search (DSBS) database. No vendors were identified through those searches.

A Notice of Intent regarding this sole source contract will be published on System for Award Management at SAM.gov with the same North American Industry Classification System (NAICS), accompanied by a redacted version of the J&A, when approved. All resulting requests and responses will be addressed prior to award on the sole source contract. No exceptions listed in FAR 5.202 apply to this action.

7. Actions to Increase Competition/Remove or Overcome any Barriers to Competition:

Until such time as the accreditation process for blood collection and transfusion facilities changes, full and open competition is not possible. Future efforts will utilize effective market research strategies to identify other potential vendors that could meet this accreditation requirement.

8. Market Research:

For Market Research, the Government sought vendors by using internet search engines to identify potential vendors to fulfill the Government’s requirement. There were three (3) vendors who were able to meet the capabilities of providing blood donor center support, and an eLearning subscription service, but they were unable to fulfill the AABB accreditation service required. Those vendors were:

• AABB

• New York Blood Center Enterprises

• American Red Cross

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Source Selection Information - See FAR 2.101 and 3.104-4

4 NOV 2024

Although these vendors were considered viable candidates, DoDi 6480.04 requires the use of AABB accreditation for all blood collection and transfusion facilities. Below is a table that highlights each vendor’s capability of being able to fulfill the requirement:

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? Yes, the previous award for this contract was justified as sole source.

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

b. Additional Information:

DoD Instruction 6480.04 restricts the program office to only obtaining the services of AABB. The program office has found two vendors that offer similar services, but do not meet the specifications for the intent of this contract.

10. Interested Sources:

To date, no other sources have written to express an interest other than the current vendor, . Additionally, the notices required by FAR 5.201 shall be published with a redacted version of this approved J&A, and any proposals received shall be considered.

Mary.A.Young Highlight

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Source Selection Information - See FAR 2.101 and 3.104-4

5 NOV 2024

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.

LCDR JERRY HUGHES

Branch Chief, Policy Armed Services Blood Program Division

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.

SPOTT.MARY.AN

N.1293573413

Digitally signed by

SPOTT.MARY.ANN.1293573413

Date: 2025.06.17 06:44:42 -05'00'

DR. MARY ANN SPOTT

Acting Chief, Armed Services Blood Program Division Defense Health Agency, J-3/5, ASBP

13. Fair and Reasonable Cost Determination:

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

Basis for Determination: Current contract prices relied on in the expiring contract will be utilized for determination of fair and reasonable pricing. At time of the contract award and at time of all options exercised, the contract prices will be determined fair and reasonable. The Independent Government Cost Estimate and knowledge of the Contracting Officer will further support this decision.

YOUNG.CHERISH.D

YDigOUitNalGly. CsigHEneRIdS bHy. DAWN.1216315487 AWN.1216315487 Date: 2025.06.17 07:54:25 -04'00'

CHERISH D. YOUNG

DHA Contracting Officer

Professional Services Contracting Division

248523367 Date: 2025.06.17 07:42:45 -04'00'

Mary.A.Young Highlight

Mary.A.Young Pencil

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

6 NOV 2024

Brian C. Habib Attorney DHA Office of General Counsel

15. Contracting Officer Certification: I certify this justification is accurate and complete to the best of my knowledge and belief.

YOUNG.CHERISH.D

AWN.1216315487

Digitally signed by

YOUNG.CHERISH.DAWN.1216315

Date: 2025.06.17 07:54:59 -04'00'

CHERISH D. YOUNG

DHA Contracting Officer

Professional Services Contracting Division

Review

I have reviewed this justification and find it adequate to support the sole source acquisition.

Concurrence

ROBERT E. LEBLANC

Chief of the Contracting Office Professional Services Contracting Division

LEBLANC.ROBERT. Digitally signed by

EDWARD.1011576 11576075

LEBLANC.ROBERT.EDWARD.10

075 -04'00'

14. Legal Review:

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

HABIB.BRIAN.CHRI Digitally signed by

STOPHER.147181

HABIB.BRIAN.CHRISTOPHER.14

71814969

-04'00'

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

7 NOV 2024

Approval

Based on the foregoing justification, I hereby approve the procurement of the Association for the Advancement of Blood and Biotherapies (AABB) Accreditation & Education package, with a potential value of $3,209,780.71 on a sole source basis pursuant to the authority of 41 U.S.C.

1901, as implemented in FAR 13.5, subject to the availability of funds, and provided that the supplies and/or services herein described have otherwise been authorized for acquisition.

KATHRYN D. SKOWRONSKI

Competition Advocate Defense Health Agency

SKOWRONSKI.KATHR

Digitally signed by

SKOWRONSKI.KATHRYN.DE

YN.DENISE NISE MCCUNE.1062851046

-04'00'