Siemens Healthcare Diagnostics – PFA-100 Platelet Function Analyzer

Summary

Title: Siemens Healthcare Diagnostics PFA-100 Platelet Function Analyzer Product Service Code (PSC): 6630 Chemical Analysis Instruments and Apparatus

NAICS Code

334516 Analytical Laboratory Instrument Manufacturing

Place of Performance

National Institutes of Health (NIH)

Clinical Center

Bethesda, MD 20892 Description This notice is issued for informational purposes only and does not constitute a request for quotations. A solicitation will not be issued, and quotations will not be requested. The National Institutes of Health (NIH), Clinical Center, intends to award a sole-source firm-fixed-price purchase order to Siemens Healthcare Diagnostics for the acquisition of one (1) new PFA-100 Platelet Function Analyzer. The following items are needed for this order:

1/11539138/Barcode Scanner/Cable-PFA-100

The Department of Laboratory Medicine requires a replacement PFA-100 Platelet Function Analyzer to ensure uninterrupted platelet function testing in support of patient care and NIH clinical research activities. The existing instrument has exceeded its expected service life and is no longer operating reliably.

Background

The Department of Laboratory Medicine serves as the clinical laboratory for the NIH Clinical Center and provides laboratory support for patient care, clinical research protocols, and training in clinical pathology. The PFA-100 system is utilized for special coagulation testing and supports critical clinical patient testing while reducing labor requirements and minimizing manual testing errors. Rationale The PFA-100 utilizes proprietary manufacturer-specific cartridges, reagents, and validated methodologies that are not compatible with alternative testing platforms. Siemens Healthcare Diagnostics is the only source capable of providing a new instrument that maintains compatibility with existing validated testing methods, laboratory workflows, and clinical result interpretation standards. Substitution of another platform would require extensive validation and verification studies and could adversely impact patient care operations. Authority This acquisition is being conducted in accordance with FAR 13.106-1(b)(1) Soliciting from a Single Source. Under this authority, the Contracting Officer may solicit from a single source when it is determined that only one source is reasonably available to meet the Government's requirements. Acquisitions conducted under FAR Part 13 are exempt from the competition requirements of FAR Part 6. Responses This is not a request for quotations. However, interested parties may submit a capability statement demonstrating their ability to provide an equivalent solution that fully meets the Government's requirements. Responses must include: Company name and address Technical capability Documentation demonstrating compatibility with existing validated testing methods Proof of manufacturer authorization, if applicable Relevant past performance The Government will evaluate capability statements received in response to this notice. The determination not to compete this requirement is solely within the discretion of the Government.

Submission Instructions

Responses must be submitted electronically to by June 24, 2026 at 11:30AMEST:

Hospital and Laboratory Support Division

Office of Acquisition and Logistics Management (OALM)

National Institutes of Health

Email: shasheshe.goolsby@nih.gov