INTERCEPT® Platelet Processing Set with Dual Storage Containers

INTERCEPT Platelet Processing Set with Dual Storage Containers

• Product Service Code: 6640
• NAICS Code: 334516
• Place of Performance: Bethesda, MD

POTS: 25-005138

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), Office of Purchasing and Contracts, on behalf of the Department of Transfusion Medicine (DTM), intends to award a firm fixed price contract on a sole-source basis to Cerus Corporation, located at 1220 Concord AVE STE 600 Concord, California 94520-4906, for a five (5) month base year of INTERCEPT Platelet Processing Set with Dual Storage Containers (INT2540B). The period of performance will be from 04/01/2025 to 09/30/2025.

The Department of Transfusion Medicine currently utilizes the Cerus INTERCEPT Technology to process platelets in the Transfusion Service Laboratory. This process reduces the potential of virus replication by ensuring that the transfused platelets are safe for patient use. The INTERCEPT Platelet Processing Set with Dual Storage Containers are proprietary products and must be used with the existing equipment. The INTERCEPT Blood System, is a registered trademark of the Cerus Corporation. As outlined in the Standard Operating Procedures of the Department of Transfusion Medicine, any of the following, materials, supplies, equipment, and services that impact the quality of products or services are considered critical. Specific characteristics must be controlled to guarantee the safety and quality of the outcome. The Cerus Corporation meets all the Department of Transfusion Medicine requirements, and compliance with the following:

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 Act of 1988

AABB Standards for Blood Banks and Transfusion Services

AABB Standards for Cellular Therapy Product Services

AABB Standards for Immunohematology Reference Labs

ASHI Standards for Histocompatibility Testing

JC Hospital Accreditation Standards

AAHRPP Standards for Accrediting Human Research Protection Programs

ACGME Common Program Requirements

CAAHEP Standards and Guidelines

To ensure the continuity of patient care without interruption, it is crucial to procure the requested supplies. Cerus Corporation will ship 8 cases of the INTERCEPT Platelet Processing Set with Dual Storage Containers per month from 04/01/2025 to 09/30/2025.

This acquisition is being conducted using policies unique to the Federal Acquisition Regulation (FAR) Part 13 Simplified Acquisition Procedures, Subpart 13.106-1(b)(1), For purchases not exceeding the simplified acquisition threshold (SAT), contracting officers may solicit from one source if the contracting officer determines that the circumstance of the contract action deem only one source reasonably available. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements.

Interested parties may identify their interest by sending their 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 CC, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Tasha Lowe, Contract Specialist, lowet2@mail.nih.gov by the due date March 31, 2025 and time marked in this notice.