BloodWorks JA FAR Part 13.501_Fully Signed_Redacted.pdf

CUI

Control Number:

Controlled by: Defense Health Agency (DHA) Controlled by: Healthcare Contracting Division - West CUI Category: Source Selection Information Limited Dissemination Control: FED Only POC: Merlinda M. Labaco merlinda.m.labaco.civ@health.mil

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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: Defense Health Agency, Contracting Activity (DHACA) � Healthcare Contracting Division � West (HCD-W)

2. Nature and/or Description of Action being Approved: The approval is for a new Firm Fixed Price contract, individual J&A Modified for Federal Acquisition Regulation (FAR) 13.501.

3. Description of Supplies/Services: This acquisition is for non-personal services to perform bloodwork processing and testing of all donor samples in support of the Blood Bank Department at US Naval Hospital Guam. This is a follow-on requirement for contract # HT941025P0025

The Blood Donor Center at US Naval Hospital Guam provides comprehensive testing services for all collected blood donations through reference laboratory testing to ensure a safe and sufficient blood supply for beneficiaries. These services adhere to Department of Defense (DoD), Defense Health Agency (DHA), and Food and Drug Administration (FDA) regulations, with specific adaptations to address regional health concerns. The following is a detailed description, reflecting practices at NHG as of late 2025:

I. Donor Screening & Eligibility:

Medical History Questionnaire: A detailed questionnaire assessing donor health, travel history (particularly relevant given Guam�s location), medications, and potential risk factors for transfusion-transmitted infections. Emphasis is placed on recent travel to areas with endemic diseases.

Physical Examination: Includes vital signs (temperature, pulse, blood pressure) and hemoglobin/hematocrit assessment to ensure donor meets minimum requirements.

Temporary Deferral Review: NHG personnel actively review potential temporary deferrals related to recent vaccinations, medications, or minor illnesses.

II. Mandatory Infectious Disease Testing:

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Source Selection Information - See FAR 2.101 and 3.104-4

2 NOV 2024

NHG�s Blood Donor Center performs the following mandatory testing through reference laboratory testing on each unit of donated blood:

HIV-1/2 Antibody/Antigen Combination Assay: Detects both antibodies and the p24 antigen for earlier HIV detection.

Hepatitis B Surface Antigen (HBsAg): Identifies active Hepatitis B infection.

Hepatitis C Virus (HCV) Antibody: Detects antibodies to HCV. Reactive samples undergo confirmatory Nucleic Acid Testing (NAT).

Human T-Lymphotropic Virus (HTLV) I/II Antibody: Screens for HTLV infection.

Syphilis (RPR/VDRL with confirmatory testing): Screens for syphilis infection.

West Nile Virus (WNV) NAT: Nucleic Acid Testing to detect WNV RNA, given the potential for mosquito-borne illness in the region.

Babesia NAT: Screens for Babesia microti, a parasitic infection transmitted by ticks.

Chagas Disease Antibody: Testing is conducted for donors with a history of travel or residence in Central or South America.

III. Blood Typing & Compatibility Testing:

ABO and RhD Typing: Determines the donor�s ABO blood group and RhD status.

Antibody Screen: Detects unexpected antibodies in donor plasma.

ABO/Rh Compatibility Testing: Performed prior to transfusion to ensure compatibility with recipient blood.

IV. Specialized Testing & Considerations at NHG:

Monitoring for Emerging Threats: NHG actively monitors for emerging infectious disease threats in the Pacific region and adjusts testing protocols as needed, in consultation with DHA and CDC guidance.

V. Laboratory Technology:

NHG utilizes automated blood screening systems and advanced testing technologies through reference laboratory testing, including:

4 NOV 2024

procedures to the maximum extent practicable, even in a sole-source environment exceeding the Simplified Acquisition Threshold (SAT). Due to the high level of quality required by regulatory agencies and the unique, highly specialized nature of the supplies and services, no other laboratory testing can meet this need given the time required to ship specimens (specimens will not be viable). Bloodworks is the sole source provider, as it is the only option for blood donor services that will meet the required turnaround time for testing. Limited resources due to geographical location mean no other company is available to perform the requested services.

Bloodworks has been the sole source provider for this requirement for several years. The core principle of obtaining best value is best achieved by focusing evaluation on the vendor�s unique capabilities and demonstrated performance. Given the sole source justification based on limited qualified vendors, simplified procedures allow for a focused evaluation of technical expertise, regulatory compliance, and past performance, ensuring the best possible outcome for patient safety and blood supply reliability.

This blood donor testing service supports all blood collected at the Naval Hospital Guam Blood Donor Center. The service meets the time, temperature, and testing requirements necessary to qualify blood products for human transfusions in a clinical setting. Therefore, to ensure rapid delivery, quality assurance, and adherence to testing requirements � ultimately enhancing the military�s ability to support its growing patient population � a sole source acquisition has been determined to be in the Government�s best interest. This approach will enable the contractor to provide timely, high-quality services that meet the Government�s specifications.

6. Efforts to Obtain Competition:

Extensive market research was conducted to identify potential sources capable of meeting the stringent technical standards and certifications required for blood donor testing services at Naval Hospital Guam. A notice of the proposed contract action was publicized during the previous two contract periods, in accordance with FAR Part 5.2, including posting on the Governmentwide Point of Entry (GPE) to ensure broad dissemination and solicit responses from all responsible sources. However, no other vendors responded demonstrating the capability to meet the requirement.

The remote location of Guam presents logistical challenges for accessing external infectious disease testing facilities. Bloodworks is the sole source reference for these critical services for the USNH Guam Blood Donor Center. Their services ensure patient access to safe blood products through rapid specimen delivery and timely turnaround of infectious disease testing results. This research confirms that Bloodworks is the only provider possessing the necessary capabilities and certifications.

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

Naval Hospital Guam and the DHA Healthcare Contracting Division � West remain committed to fostering competition for this requirement. We will continue to actively survey and engage the market for potential vendors capable of providing these specialized blood donor testing services.

5 NOV 2024

Future requirements will be considered for full and open competition should additional vendors demonstrate the ability to meet the stringent technical, certification, and logistical demands.

Specifically, the following actions will be taken:

Ongoing Market Research: Continuous market research will be conducted utilizing industry databases, professional organizations, and networking events to identify new potential sources.

Capability Statement Review: A thorough review and due diligence process will be implemented for any vendor submitting capability statements, focusing on technical expertise, certifications (e.g., CLIA, CAP), and logistical feasibility for supporting USNH Guam.

Solicitation of Vendor Feedback: We will proactively solicit feedback from vendors � including those who did not respond to previous solicitations � regarding the procurement process. This feedback will be used to identify and address potential barriers to entry and improve future solicitations.

Exploration of Consortiums/Partnerships: We will explore the potential for consortiums or partnerships between smaller vendors to collectively meet the requirement, potentially lowering barriers to entry.

Future Requirement Flexibility: Future statements of work will be reviewed to identify potential opportunities to modularize the requirement, allowing for partial competition and increased vendor participation.

These efforts demonstrate a commitment to maximizing competition to the greatest extent practicable while ensuring the continued provision of safe and reliable blood donor testing services to the patients of Naval Hospital Guam.

8. Market Research:

Market research indicated that similar services are available from multiple companies on the US mainland; however, due to the high level of quality required by regulatory agencies and the unique, highly specialized nature of the supplies and services, no other laboratory testing can meet this need given the time required to ship specimens (specimens will not be viable).

Bloodworks is the sole source provider, as it is the only option for blood donor services that will meet the required turnaround time for testing. Limited resources due to geographical location mean no other company is available to perform the requested services. Bloodworks has been the sole source provider for this requirement for several years.

Additionally, market research conducted by the Contract Specialist through mandatory Government sources (AbilityOne and UNICOR) yielded negative results. A search of the General Services Administration (GSA) Advantage website also yielded no results for blood donor testing services. Similarly, a search of the Dynamic Small Business Search website found

6 NOV 2024

no small business concerns with the NAICS code 541380 using the search terms �Blood Donor Testing Services.� The contract specialist also reviewed similar contracts for Blood Donor Testing Services on the Federal Procurement Data System-Next Generation (FPDS-NG) and found that the same vendors previously contacted had been awarded contracts. Historically, previous solicitations were posted as full and open competition; however, no other sources responded to express an interest or provide quotes, leading the customer to recommend a sole-source acquisition. Despite this, a recent Sources Sought notice (HT941025N0136) posted in SAM.gov from August 14, 2025, through August 29, 2025, received no capability statements, further confirming the lack of available competition. Therefore, based on the documented lack of response to market research and the historical inability to attract competing offers, a sole-source acquisition with the incumbent vendor is the only viable option to ensure continued, uninterrupted service and maintain the quality of blood products for Naval Hospital Guam�s patient population.

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. Sole Source.

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

b. Additional Information: No other source can fulfill the requirements of testing due to geographic location.

10. Interested Sources:

The previous contract was sole-sourced. No other entities have expressed interest.

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: