Various Roche Cobas® 5800 Rental Reagent Package with Reagents, Controls, Consumables and Maintenance

Various Roche Cobas 5800 Rental Reagent Package with Reagents, Controls, Consumables and Maintenance

Product Service Code: 6640 Laboratory Equipment and Supplies

NAICS Code: 334516 Analytical Laboratory Instrument Manufacturing

Place of Performance:

National Institutes of Health

Clinical Center

10 Center Drive

Building 10, Room TBD

Bethesda, MD 20892

POTS: 25-004242

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 (OPC), on behalf of the Department of Transfusion Medicine (DTM), Clinical Center (CC), intends to award a firm-fixed-price, sole-source contract for a base year and four option years to Roche Diagnostics Corporation, located in Indianapolis, IN 46256-1025. This contract will cover various Roche Cobas 5800/6800 reagents, controls, consumables, and a rental reagent package. The period of performance will be from May 1, 2025, to September 30, 2029.

The Transfusion Transmitted Virus Laboratory currently uses the Roche Cobas 6800 system. This contract aims to transition to two Roche Cobas 5800 systems for performing Hepatitis C, Hepatitis B, and HIV PCR testing for Clinical Center patients. Roche is the original equipment manufacturer, distributor, and service provider for the Roche Cobas 5800 System, along with its proprietary reagents and consumables. The Roche Cobas 5800 System is technically comparable to the 6800 system and will undergo validation, as will the associated test kits, reagents, and consumables used for infectious disease testing. Reagents from other manufacturers are incompatible with the Roche Cobas 5800 proprietary system and can damage the instrument or produce erroneous results, potentially leading to incorrect diagnoses and putting patient safety at risk.

If an alternative automated system were used, the government would incur significant additional costs and time to procure, validate, and transition to new equipment, reagents, and consumables. This would cause delays and disrupt work, ultimately affecting patient testing and, consequently, patient care. Furthermore, both current and retrospective patient samples would need to be tested and re-evaluated to ensure effective treatment and continuity of care. This process would take several months, require additional reagents, and incur extra costs to validate before implementing a new test platform from another manufacturer

****See attached equipment list****

Roche is the original equipment manufacturer, distributor, and service provider for the Roche Cobas 5800 System, as well as its proprietary reagents and consumables. The Roche Cobas 5800 System is comparable to the Cobas 6800 system and will be validated, along with the test kits, reagents, and consumables used for infectious disease testing. Reagents from other manufacturers are not compatible with the Roche Cobas System and could damage the instrument or lead to erroneous results, putting patients at risk for incorrect diagnoses

This acquisition is being conducted using policies unique to the Federal Acquisition Regulation 13.501 Special documentation requirements for sole source acquisitions exceeding the Simplified Acquisition Threshold. 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 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 regarding this announcement, referencing the posting number, may be submitted to the Office of Purchasing and Contracts, Clinical Center (CC), prior to the closing date specified in this notice. Submissions should be made electronically to the attention of Shasheshe Goolsby, Lead Contract Specialist, at shasheshe.goolsby@nih.gov by March 07, 2025, at 12:30 PM EST.