Notice of Intent to Sole Source Blood Donor Testing for Naval Hospital Guam

Closed Pre-Solicitation Posted

Solicitation number
HT941025N0017
Agency
Responses due
Set-aside
No set-aside

Opportunity facts

NAICS code
621511 Medical Laboratories
Place of performance
Guam 96910, United States

Notice details come from SAM.gov. Updated .

About this opportunity

The Defense Health Agency Contracting Activity (DHACA) intends to award a sole source firm-fixed-price contract to Bloodworks for comprehensive blood donor testing services at Naval Hospital Guam. The contract requires extensive medical laboratory testing to ensure blood product safety, including 14 different screening tests such as antibody screening, blood typing, and infectious disease testing for HIV, hepatitis, syphilis, and West Nile Virus. Interested vendors may submit technical capability statements in PDF, MS Word, or MS Excel format to April L. Burbage by December 11, 2024, at 0800 PST to potentially challenge the sole source determination. The contract will be evaluated based on the vendor's ability to provide the required testing services and meet FDA, Defense Health Agency, and Association for the Advancement of Blood and Biotherapies (AABB) standards. The government retains sole discretion in determining whether to conduct a competitive procurement based on received capability statements.

The contract is classified under NAICS code 621511 for Medical Laboratories, with a business size standard of $41.5 million, and has no specific set-aside restrictions. The base contract period runs from December 15, 2024, to December 14, 2025, with three optional one-year renewal periods extending through December 14, 2028. The work will be performed at Naval Hospital Guam in Agana Heights, with testing primarily conducted for approximately 1,400 individual blood donations, estimated at 3-5 shipments per week. The Product Service Code (PSC) is Q301 for Medical Laboratory Testing, and the contract requires the contractor to provide all necessary equipment, supplies, facilities, transportation, and personnel to complete the required testing services. Key performance requirements include 100% transfer of results within 48 hours of shipment and 100% completion of all mandated tests.

Notice text

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.

Files

File Type Posted
Notice of Intent to Sole Source.pdf PDF
PWS - Redacted.pdf PDF

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