Werfen USA, LLC Consumables and Reagents for two (2) ACLTOP 750 instruments

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) intends to award a fixed-price purchase order on a sole-source basis to WERFEN USA LLC, Bedford, Massachusetts 01730-244 for the procurement of consumables and reagents for two (2) ACLTOP 750 instruments that are government owned and already existing within the Clinical Centers, Department of Laboratory Medicine, Hematology Service. The ACLTOP 750 analyzer automates highly specialized assays and enhances assay performance in special coagulation testing for patient care within Hematology Service. WERFEN USA LLC is the only vendor able to provide the consumables and reagents that meet the critical requirements for patient care testing and uses proprietary reagents validated for the current testing method. These reagents are specific for the existing instruments and are the only ones that can meet the needs of this patient care testing. Since only one supplier will fit the instrumentation validation and requirements, any other supply or service could cause delays in completion of the protocol. If the Hematology Service were to adopt a different stainer using non-proprietary reagents, it would require extensive validation work, creating delays in efficient patient care testing and incurring significant additional costs for validation processes and reagent procurement for future testing. The estimated product list and quantity is attached to this notice and titled - List of Supplies - 25-008777. The exact quantity of products cannot be estimated at the time of award. The government reserves the right to increase quantities pursuant to FAR 52.217-6. 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. The North American Industry Classification System (NAICS) code for this acquisition is 324513 with a large business standard size of 1250 mployees. This notice of intent to award is not a request for competitive quotations. Interested concerns capable of providing the same products or services as described in this notice may submit a capability statement outlining their capabilities. No solicitation is available. Information received will be evaluated for the purpose of determining whether to conduct a competitive procurement. Capability Statements must be received within the time set forth in this synopsis to be considered by the Government. A determination to compete this proposed contract based on responses to this notice is solely within the discretion of the Government. Each response should include the following Business Information: a. SAM UEI. b. Company Name, address, POC, Phone and Email address c. Current GSA Schedules or NAICS codes appropriate to this Award. d. Capability Statement Comments to this announcement may be submitted to the Clinical Center, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Kimala Winfield, kimala.winfield@nih.gov or Malinda Dehner, dehnerm@cc.nih.gov by the due date and time marked in this notice.