SAM #NOI-CC-OLAO-26-006540

Sole Source Procurement of TSI Air Samplers and Particle Counters for NIH Clinical Center Pharmacy

This notice announces a sole source procurement by the NIH Clinical Center Pharmacy Department for TSI Air Samplers and Airborne Particle Counters. - Agency: National Institutes of Health (NIH), Clinical Center - Purpose: Environmental monitoring and testing in Aseptic Processing Facilities (APF) - Equipment: TSI Air Samplers and Airborne Particle Counters - Used for monitoring air quality during intravenous medication processing and clinical research - Sole Source Justification: Only TSI Inc. is considered capable of meeting the technical requirements - No specific part numbers or quantities provided - FAR 6.302-1 cited for sole source justification - Opportunity for other vendors: Capability statements may be submitted for consideration - No service or maintenance requirements specified

OEM and Vendor Information - TSI Inc. is the sole source manufacturer and vendor

Commercial Opportunity - Potential for other manufacturers to submit capability statements if they can meet the requirements

Technical Requirements - Equipment must be suitable for environmental monitoring in aseptic pharmaceutical processing - Replacement of existing particle counter units

Procurement Details - No attachments or detailed line items provided - No contract value or period of performance specified

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 the following vendor: TSI Inc. (Trust.Science.Innovation)

Acquisition Description:

Background

1.1  The National Institutes of Health (NIH) Clinical Center (CC) is a clinical research hospital providing all medical services for patients participating in human research protocols of the NIH. The CC provides patient facilities and services for clinical investigations by the NIH Institutes, research in related areas and supervises residency and other training programs.

1.2  The NIH Clinical Center Pharmacy Department provides Drug Distribution Services that include concurrent drug use review, preparation and distribution of sterile and non-sterile products, and investigational drug dispensing to inpatients and ambulatory patients.  The Investigational Drug Management includes protocol support activities, investigational drug information development, and control and accountability of investigational agents. Moreover, Clinical Programs include participation in drug selection and experimental protocol design and implementation; monitoring patient response to drug therapy; patient education; provision of drug information; drug use evaluation; and patient counseling.   

Purpose

2.1  Purchase of the TSI Air Samplers and Airborne Particle Counters for routine Environmental Monitoring testing of all Pharmacy Department APF sections.

Scope of Work

3.1  The TSI Air Samplers and Airborne Particle Counters will replace existing particle counter units which are used for Environmental Monitoring and testing of all Pharmacy Department Aseptic Processing Facilities (APF) which include the I-IVAU, E-IVAU and P-IVAU sections.  The TSI Air Samplers and Particle Counters units are essential medical equipment which provide a critical function in the processing of patient intravenous medications for all ongoing clinical research studies being conducted in collaboration with NIH institutes.  Continuous operation and maintenance of all TSI Air Samplers and Particle Counters is essential in avoiding prolonged interruption of pharmacy services and consequently delaying completion of clinical patient study pharmaceutical drugs, sterile and non-sterile products, and investigational drugs for all ongoing NIH clinical studies.

The statutory authority for this sole source requirement is 41 U.S.C. 253(c) (1) as implemented by FAR 6.302-1 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-OLAO-CC-26-006540) by 12:00 PM eastern standard time on 07/21/2026 to: valerie.gregorio@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.

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