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Notice of Intent to Sole Source – Sterility Testing Service LIMS Project

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NOI-CC-26-001899Federal

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The National Institutes of Health Clinical Center (NIH-CC), under the Department of Health and Human Services, has issued a Notice of Intent for a sole-source procurement (solicitation number NOI-CC-26-001899) to acquire additional professional services days from LabVantage for the Sterility Testing Service Laboratory Information Management System (LIMS) project. This procurement supplements the configuration and rollout of a cGMP-compliant Commercial Off-the-Shelf (COTS) LIMS Portal previously purchased and currently undergoing configuration. LabVantage, the original vendor for the system, is uniquely positioned to provide these additional services, as only they possess the necessary knowledge and integration experience for completing the project and addressing compliance gaps identified during the Site Process Analysis. The acquisition will support full functionality deployment of the Portal component and enable operational efficiencies in sterility testing processes. The notice clarifies that this is not a solicitation or request for quotations and that no competitive evaluation process or pricing details are involved; the procurement is conducted under FAR Part 13 Simplified Acquisition Procedures with sole-source justification according to FAR 13.106-1(b)(1). The place of performance is Bethesda, Maryland, with a submission deadline of January 14, 2026, for electronic correspondence directed to the contract specialist, Ryssa Nix. There is no information on contract type, specific performance periods, or payment terms. Requirements include adherence to cGMP standards, and while no formal contract clauses, inspection criteria, or attachments are provided in the notice, the emphasis is on LabVantage’s exclusive ability to fulfill the configuration needs stemming from its prior involvement in the LIMS project. This procurement aims to complete configuration activities critical to achieving regulatory compliance and improved laboratory workflows for the NIH Clinical Center’s sterility testing services.

General Info

NIH sole-sources LabVantage for LIMS configuration to ensure cGMP compliance and operational efficiency.

Agency

Department Of Health And Human Services → National Institutes Of Health - CcView Agency

NAICS

541511 - Custom Computer Programming ServicesView NAICS

Place of Performance

Bethesda, MD, 20892, USA

Set-Aside

NONE

Documents

(1)

NOI-CC-26-001899 Notice of Intent to Sole Source – Sterility Testing Service LIMS Project

DOCXnotice-of-intent

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → National Institutes Of Health - Cc
Contacts1 person available
OfficeBETHESDA, MD, 20892, USA
Organization / Agency
Department Of Health And Human Services → National Institutes Of Health - Cc
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Office AddressBETHESDA, MD, 20892, USA
Contacts
Chris Ryssa Nix

Full Description

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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.


This procurement is for additional professional services days to supplement the cGMP compliant Commercial Off the Shelf (COTS) Laboratory Information Management System (LIMS) that has already been purchased and that is currently under configuration. This request is being made because the need was identified for additional professional services days to support the configuration and rollout of the Portal and to supplement the time already included under the original SOW based on the information gathered during the Site Process Analysis. Procurement and implementation of these items will ensure that all required functionality is available and will allow the STS to realize many process improvements/efficiencies and close the compliance gaps identified in the original procurement.


LabVantage was awarded the contract for the STS LIMS procurement. As the approved vendor for this project, the additional professional service days can only be provided from LabVantage. Through the system build discussions, LV was able to determine that additional professional service days would be required to accomplish all the configuration and rollout work required. This prompted the STS to obtain a new quote to cover the Poral licenses and additional professional services days.

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