Inactive

Acquisition Description: This is a Notice of Intent, not a request for proposal. The National Institute of Health, Clinical Center (NIH-CC) intends to negotiate on an other than full and open competit... Acquisition Description: This is a Notice of Intent, not a request for proposal. The National Institute of Health, Clinical Center (NIH-CC) intends to negotiate on an other than full and open competition basis with Waters Technologies Corp. The National Institute of Health Clinical Center (NIH-CC) has a Clinical Pharmacology Lab (CPL) (“Program”) provides clinical pharmacology support for the NIH’s intramural program including clinical trial design, biospecimen collection, bioanalytical assay development, and pharmacokinetic/pharmacogenomic analyses. Through the use of state-of-the-art UPLC-MS/MS instruments, the CPL is able to quantify preclinical and clinical compounds in various matrix such as serum, plasma, sputum etc allowing for determination of pharmacokinetic parameters and dosing recommendations. The CPL currently has many projects and collaborations that are dependent on the use of these instruments for dosing guidance and pharmacokinetic assessment. The purpose of the procurement is for the vendor to provide performance maintenance (PM) and qualification of the Waters instruments in the Clinical Pharmacology Laboratory, which are essential for conducting pharmacology analyses of preclinical and clinical studies at the National Institutes of Health. The list of services to be provided are as follows: -PM to ensure system operates at peak performance -Original Equipment Manufacturer (OEM) - Waters Quality Parts, including documented standardized protocols, will be delivered to the lab by a Waters Certified Field Service Specialist upon a PM visit -Personalized flexible support, maintenance, and service options will be provided to the lab whenever required. Justification: Waters Technologies Corp. is the manufacturer of the equipment that needs to be serviced. They are the only Original Equipment Manufacture (OEM) service provider and can provider OEM parts. The use of OEM parts and qualified service providers is important to ensure the equipment runs as originally intended. Due to the complexity and precision of our instruments, Waters Corporation, the original manufacturer, is uniquely qualified to provide the thorough and prompt service required. Engaging a third-party service provider that may not have access to OEM specifications, knowledge, and parts could jeopardize the integrity of our equipment, potentially leading to irreparable damage that Waters may be unable to rectify, thus compromising our lab's critical work. Additionally, third-party repairs often involve extended wait times, which is untenable given the urgent nature of CPL projects. It is crucial that our instruments be serviced or repaired immediately when issues arise. Moreover, certain specialized parts are only available through Waters, further complicating any attempt to use third-party services. This service is essential to maintaining the operational integrity of our laboratory, particularly given the highly sensitive nature of our UPLC-MS/MS instruments. These instruments are not only integral to our research and testing capabilities but are also significant financial investments for the government. Their expertise and reliability are crucial in safeguarding our assets and ensuring uninterrupted scientific operations. To ensure their optimal performance and longevity, it is imperative that they receive the highest quality maintenance and repair services. Requirements: Maintenance of the following with OEM parts, OEM service providers,etc.: -Xevo G2-XS w/ I-Class -Xevo TQ Absolute/ I-Class – NIH -Xevo TQXS/ I-Class PLUS - NIH -I-Class/ Sciex MS - NIH Place of Performance or Delivery: The Period of Performance is up to one (1) year from 09/27/2024 to 09/26/2025. This is broken down into a base 6 months from 09/27/2024 – 03/26/2025 and an option 6 months from 03/27/2025 – 09/26/2025 Place of Performance: NIH Clinical Center in Bethesda, MD The statutory authority for this sole source requirement is 41 U.S.C. 1901 (a) (1) as implemented by FAR 13.106-1 only one responsible source and no other supply of service will satisfy agency requirements. THIS IS NOT A REQUEST FOR PROPOSAL. All responsible sources that could provide the required may submit a capability statement that will be considered by email (subject line to reference NOI-CC-24-009470) by 10:00 AM eastern standard time on 08/27/2024 to: lu-chang.lu@nih.gov All responses received by the closing date of this synopsis will be considered by the Government. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.