SAM #26-005795

NIH Procurement of Siemens PFA-100 Platelet Function Analyzer and Accessories

The National Institutes of Health (NIH) Clinical Center, part of the Department of Health and Human Services, is seeking to procure specialized laboratory equipment for platelet function testing. - Government Buyer: - National Institutes of Health (NIH), Clinical Center, Department of Health and Human Services - OEMs and Vendors: - Siemens Healthcare Diagnostics (OEM and sole-source vendor) - Products Requested: - 1 Siemens PFA-100 Platelet Function Analyzer (part number 10459298) - 1 Siemens Barcode Scanner/Cable for PFA-100 (part number 11539138) - Notable Requirements: - Sole-source procurement justified by proprietary technology and compatibility with existing laboratory workflows - Equipment is required to replace an outdated instrument, ensuring continuity in patient care and clinical research - Only Siemens products are compatible with the validated methodologies and reagents currently in use

Description

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:

Quantity/ Part Number/ Description of Equipment

1/10459298/PFA 100

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: Shasheshe Goolsby Team Leader Hospital and Laboratory Support Division Office of Acquisition and Logistics Management (OALM) National Institutes of Health Email: shasheshe.goolsby@nih.gov  

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