Notice of Intent to Sole Source.pdf

Notice of Intent to Sole Source

HT941025N0017

THIS IS A NOTICE OF INTENT TO AWARD A SOLE SOURCE SERVICE CONTRACT AND IS

NOT A REQUEST FOR COMPETITIVE QUOTES. The Defense Health Agency Contracting Activity (DHACA), Healthcare Contracting Division – West (HCD-W), San Diego, intends to negotiate and award a firm fixed price contract for Blood Donor Testing in accordance with Federal Acquisition Regulation (FAR) 13.501(a) Sole Source acquisitions and FAR 13.106-1(b)(1)(i), only one source being available to meet the Government’s needs, to:

Bloodworks 921 Terry AVE Seattle, Washington 98104-1239

The North American Industry Classification System (NAICS) code for this requirement is 621511 - Medical Laboratories; the business size standard is $41.5M. The Product Service Code (PSC) is Q301 – Medical - Laboratory Testing.

The Blood Donor Center at Naval Hospital Guam (NHG) requires testing services to ensure the safety of blood products for transfusions. Blood Donor Testing is a requirement of the Food and Drug Administration, the Defense Health Agency, and the Association for the Advancement of Blood and Biotherapies (AABB). The following tests are required to qualify blood products for human transfusions in a clinical setting:

1. Antibody Screen

2. ABO Rh (Blood Type)

3. Syphilis

4. Hepatitis B Surface Antigen

5. Anti-Human Immunodeficiency Virus 1/2

6. Anti-Hepatitis B Core

7. Anti-Hepatitis C Virus

8. Anti-Cytomegalovirus

9. Nucleic Acid Test testing for Human Immunodeficiency Virus -1 Ribonucleic Acid, Hepatitis C

Virus Ribonucleic Acid and Hepatitis B Virus, Deoxynucleic Acid. (Pooled testing is Acceptable with single testing follow up for positive pool)

10. Nucleic Acid Test for West Nile Virus (single testing)

11. Anti-Trypanosoma Cruzi (Chagas)

12. Anti-Human T-Lymphotrophic Virus I/II

13. Babesia NAT by IDT

14. Confirmatory

STANDARD TEST PANEL

Red Cell Allo-Antibody Screen ABO/Rh (including weak-D testing) Standard Test for Syphilis (STS) HBsAg Anti-HBc Anti-HCV Anti-HIV-1/HIV-2 Anti-HTLV-1/11

HIV-NAT

HCV-NAT

HBV-NAT

Anti-Cytomegalovirus* SELECT DONATIONS Chagas Disease Testing* WNV-NAT by IDT* Babesia NAT by IDT* *Included in Standard Panel for an additional charge:

AS REQUESTED

HLA Ab (TRALI) Anti-A/Anti-B Titers.

Licensed Phenotype Screening - E,e,C,c, and Kell antigens Hemoglobin S Antibody Identification ABO/Rh Typing discrepancy resolution Anti-SARS-CoV-2

CONFIRMATORY TESTING

HBsAg Neutralization Anti-HCV Confirmatory-second EIA methodology Bio-Rad Geenius™ HIV-1/-2 Supplemental Testing Abbott ESA Chagas HTLV -I/II Blot Confirmatory Testing STS Confirmatory by Captia Syph G or FTA-ABS WNV Supplemental Testing Zika Supplemental Testing

Period of Performance Base: 15 December 2024 – 14 December 2025 OPT1: 15 December 2025 – 14 December 2026 OPT 2: 15 December 2026 – 14 December 2027 OPT 3: 15 December 2027 – 14 December 2028

The work shall be performed at:

Naval Hospital Guam Bldg #50, Farenholt Ave Agana Heights, Guam 96910

There are not set-aside restrictions for this requirement. The intended procurement will be classified under North America Industry Classification System (NAICS) 621511. This notice of intent is not a request for competitive proposals and no solicitation document exists for this requirement. However, parties interested in responding to this notice will need to submit technical data sufficient to determine capability in providing the same product. All capability statements received by the closing date of this synopsis will be considered by the Government. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement.

If a vendor challenges the basis of this requirement, please email product capability statements (formats for submission: PDF, MS Word, or MS Excel) to April L. Burbage at april.l.burbage.civ@health.mil Closing date for challenges is no later than 0800 PST on 11 December 2024. No phone calls will be accepted.