Neutrophil antibody testing and various blood products for the Department of Transfusion Medicine

Active

Contract Opportunity

Title

Neutrophil antibody testing and various blood products for the Department of Transfusion Medicine

• Product Service Code: 6506


• NAICS Code: 621991


• Place of Performance:

Bethesda, MD 20892 USA

POTS: 25-005571

Description

This is a notice of intent, NOT a request for a quotation. A solicitation document will NOT be issued, and quotations will NOT be requested.

The National Institutes of Health (NIH) intends to award an indefinite delivery/indefinite quantity (IDIQ) task order on a sole source basis to The American National Red Cross, located in Washington, DC 20006-5310. The scope of the award includes the provision of neutrophil antibody testing and various blood products. The anticipated period of performance is from May 1, 2025, through April 30, 2026.

The National Institutes of Health (NIH) Department of Transfusion Medicine provides specialized care for numerous patients with sickle cell disease. One of the significant challenges in managing these patients is ensuring access to appropriately matched blood for transfusion. Individuals with sickle cell disease often have unique red cell phenotypes and require multiple red cell transfusions that are phenotype-matched to avoid alloimmunization and other complications.

During red cell exchange procedures—which typically require more than five units of blood—close coordination between the donor recruitment team and the blood donor center is essential. When suitable donors are not available within our facility, we often rely on external blood center distributors. Frequently, multiple blood centers must be engaged to source the required number of rare phenotype-matched red cell units, as no single facility may have an adequate supply.

This same challenge applies to patients with Severe Aplastic Anemia or those undergoing post-transplant treatment, where platelet support is critical. These patients often require HLA-matched platelet products, which are not routinely collected and are available only from a limited pool of donors.

Additionally, neutrophil antibody testing—used in the investigation of transfusion reactions and neutropenia—is not currently available in-house at NIH and must be conducted through contract laboratory services.

The American National Red Cross is the only known organization capable of providing both the specialized blood products and neutrophil antibody testing required by the NIH Department of Transfusion Medicine (DTM) within the necessary timeframe. Due to the critical nature of these services—particularly for patients with sickle cell disease, Severe Aplastic Anemia, and post-transplant conditions—timely access to matched blood components and diagnostic testing is essential to ensure patient safety and clinical efficacy.

The American National Red Cross possesses the unique infrastructure, donor base, and laboratory capabilities to supply phenotype-matched blood products and HLA-matched platelet units, as well as to perform neutrophil antibody testing not available in-house at NIH.

As outlined in internal procedures (DTM SOP 0028), any materials, supplies, equipment, or services that impact the quality of products or services are deemed "critical." This standard operating procedure governs elements essential to patient care, blood product manufacturing, and clinical laboratory diagnostics. For critical elements, specific characteristics must be strictly controlled to maintain the safety, integrity, and quality of the final product or service.

Documentation on file confirms that The American National Red Cross meets all applicable regulatory and quality standards, including but not limited to:

• FDA 21 CFR 211: Current Good Manufacturing Practice for Finished Pharmaceuticals


• FDA 21 CFR 606: Current Good Manufacturing Practice for Blood and Blood Components


• FDA 21 CFR 820: Quality System Regulation


• FDA 21 CFR 1271: Current Good Tissue Practices


• FDA Guideline for Quality Assurance in Blood Establishments (July 1995)


• HCFA 42 CFR 493: Clinical Laboratory Improvement Amendments (CLIA) of 1988


• AABB Standards for Blood Banks and Transfusion Services


• AABB Standards for Cellular Therapy Product Services


• AABB Standards for Immunohematology Reference Laboratories


• ASHI Standards for Histocompatibility Testing


• Joint Commission (JC) Hospital Accreditation Standards


• AAHRPP Standards for Accrediting Human Research Protection Programs


• ACGME Common Program Requirements and CAAHEP Standards and Guidelines

There are no other known sources capable of meeting both the specialized blood product and neutrophil antibody testing requirements associated with this action.

This acquisition is being conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13 – Simplified Acquisition Procedures, specifically Subpart 13.106-1(b)(1). Under this provision, for purchases not exceeding the Simplified Acquisition Threshold (SAT), contracting officers may solicit from a single source if it is determined that only one source is reasonably available due to the circumstances of the acquisition.

Contracts awarded using FAR Part 13 are exempt from the requirements of FAR Part 6 – Competition Requirements. The total estimated value of this acquisition will not exceed the Simplified Acquisition Threshold of $250,000.

Interested parties may identify their interest and submit capability statements in response to this posting. The determination by the Government not to compete the proposed requirement based upon responses to this notice is solely within the discretion of the Government.

Comments to this announcement, referencing this posting number, may be submitted to the Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Shasheshe Goolsby, Lead Contract Specialist, shasheshe.goolsby@nih.gov by April 21, 2025 6:30AM EST.

*** Please send your capability statements ONLY. This IS NOT a request for quotation. ***

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