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 pas…