NOI to Sole Source to VaLogic, LLC
Closed Pre-Solicitation Posted
- Solicitation number
- NOI-OD-26-000344
- Agency
-
Office of Logisitics and Acquisition Operations
National Institutes of Health, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 541380 Testing Laboratories and Services
- Place of performance
- Bethesda, Maryland 20892, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The National Institutes of Health Office of Logistics and Acquisition Operations intends to solicit a sole-source contract with VaLogic Bio, Inc. for Installation, Operational, and Performance Qualification (IQ/OQ/PQ) services on cold temperature units (CTU) for the NIH Clinical Center Pharmacy Department, with a notice-of-intent response deadline of May 13, 2026.
The procurement is justified as sole source under FAR 13.106-1(b)(1). VaLogic Bio, Inc. is the only available source due to its certified technician training across multiple manufacturer platforms—Follet, Panasonic, Helmer, ThermoFisher, K2 Scientific, and Stirling—combined with existing service certification, manufacturer database access, firmware and software update capability, and specialized knowledge of biomedical equipment maintenance for aseptic processing. The vendor has provided qualification and validation services to the Pharmacy Department for eight years and currently holds an Office of Research Services and Compliance contract (Contract #75N90021D00025, Task Order #75N90021F00001) that anchors the sole-source justification.
Work encompasses initial and follow-up IQ/OQ/PQ services for new and existing refrigerators, freezers, and sub-zero units; NIST-traceable 3-point temperature calibration; and comprehensive technical support during normal business hours via phone and 24 hours via internet. Service engineers must initiate and address qualification calls within 72 hours. The period of performance is November 5, 2025 through December 31, 2025. All services, labor, and travel are all-inclusive.
Notice text
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))
Files
| File | Type | Posted |
|---|---|---|
| Statement of Work for VaLogic IQOQ Testing (3).docx | DOCX document | |
| Sole Source Memo VaLogic.docx | DOCX document |
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