NOI to Sole Source to VaLogic, LLC

Project ID: NOI-OD-26-000344 FederalOpportunitiesPresolicitation

Overview

Agency	NIH Office of Logistics and Acquisition Operations
Deadline	05/13/26
Posted	05/08/26
Estimated Value	$25,000 - $90,000 (AI estimate)
Set Aside	None
NAICS	541380 - Testing Laboratories and Services
PSC	J066 - Maint/Repair/Rebuild Of Equipment- Instruments And Laboratory Equipment
Location	Bethesda, MD 20892 United States

Description

Primary Latest Change

The purpose is to purchase of the VaLogic, LLC IQ/OQ/PQ Qualification Services of Cold Temperature Units (CTU) for the Pharmacy Department. Justification: The selected source is based on current service coverage by Valogic Bio, Inc. via the Office of Research Services and Compliance (ORSC) contract with VaLogic (Contract #75N90021D00025, Task Order #75N90021F00001). VaLogic Bio, Inc. will perform IOQ/PQ/RQ testing, calibration, and validation of pharmacy cold temperature units that will require qualification testing. The sole source is also based on the availability to provide GMP/GLP qualifications to all new and existing Pharmacy Department Cold Temperature Unit (CTU) with the capacity to service various manufacturer cold temperature units from Follet, Panasonic, ThermoFisher, and Stirling. Because of the existing VaLogic contract with ORSC as well as the specific IOQ/PQ/RQ validation training and expertise, only one (1) source will be solicited. All other sources have been exhausted due to the service technician specific training, certification, database access, and knowledgebase of manufacturer refrigerator, freezer, and sub-zero equipment as well as the software/firmware that are directly applicable to the operation and management of each CTU. The certified training of VaLogic Bio, Inc. technicians on Follet, Panasonic, Helmer, ThermoFisher, K2 Scientific, and Stirling model cold temperature units which includes specific cold temperature unit manufacturer training, service certification and access to the latest technical developments, repair procedures knowledge base access, updated instrument schematics database access, software & firmware updates, and planned maintenance procedures of multiple manufacturer refrigerator, freezer, and sub-zero units compels the solicitation of only one (1) source. Additionally, since VaLogic has provided qualification, validation, and certification services for various Pharmacy department biomedical equipment and aseptic facilities for the past eight (2) years and currently holds the existing service contract through ORSC, no other solicitations will be made. These specific requirements will not permit competition to the maximum extent possible. Competition will be sought by oral solicitation procedures and no resultant synopsis in FBO will be published. (FAR 5.202 (a) (2))

Summary (Newest Update)

Background The National Institutes of Health (NIH) Clinical Center (CC) is a clinical research hospital that provides medical services for patients participating in NIH human research protocols. The Pharmacy Department at the NIH Clinical Center offers Drug Distribution Services, including the preparation and distribution of sterile and non-sterile products, investigational drug dispensing, and protocol support activities. The purpose of this contract is to purchase IQ/OQ/PQ Qualification Services for Cold Temperature Units (CTU) from VaLogic, LLC, which is justified based on their existing service coverage and specialized expertise in GMP/GLP qualifications for various manufacturer cold temperature units. Work Details The contract includes the following tasks: 1. Initial and follow-up installation, operational, and performance qualifications of new CTUs. 2. Follow-up operational and performance qualifications of existing CTUs that have undergone critical repairs. 3. Comprehensive installation, operation, and performance qualification (IQ/OQ/PQ) service for all CTUs. 4. NIST-traceable 3-point calibration of CTU chamber temperature probes for refrigerated and freezer units. 5. Documentation of all qualifications performed on Pharmacy CTUs in both electronic and paper formats. 6. All services, labor, and travel must be included in the service contract. 7. Qualification services must be initiated within 72 hours of the initial service call. 8. Customer technical support must be available during normal business hours via phone and 24 hours via internet. Period of Performance The qualifications, testing, calibration, and certification services are expected to be performed between November 5, 2025, and December 31, 2025. Place of Performance The services will be performed at the NIH Clinical Center Pharmacy Department located in Bethesda, MD.

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