H965--IV Room Certification & Testing Services (VA-26-00003362) 36C255-26-AP-0020

Closed Pre-Solicitation Posted

This opportunity was awarded. See the award notice from , or the latest solicitation from .

Solicitation number
36C25526Q0054
Agency
Responses due
Set-aside
Service-Disabled Veteran-Owned Small Business

Opportunity facts

NAICS code
621511 Medical Laboratories
Place of performance
Visn 15 Multiple Facilities, United States

Notice details come from SAM.gov. Updated .

About this opportunity

The Department of Veterans Affairs Veterans Integrated Service Network 15 (VISN 15) is seeking testing and certification services for primary engineering controls and clean rooms used in compounded sterile preparation across VA Heartland Health Care Network facilities. The procurement encompasses comprehensive testing of biological safety cabinets, laminar airflow workbenches, compounding aseptic containment isolators, compounding aseptic isolators, and related equipment in accordance with United States Pharmacopeia Chapter 797 and Chapter 800 guidelines. The contract will also include personnel training, evaluation, and requalification services for staff involved in compounding compounded sterile preparations. The contractor must comply with the complete Statement of Work to be published with the formal solicitation. The Request for Proposal is scheduled to be posted on November 13, 2025, with proposals due by December 1, 2025, at 9:00 AM Central Time.

This procurement is designated as a 100 percent set-aside for Service-Disabled Veteran-Owned Small Businesses and is classified under NAICS code 621511 (Medical Laboratories) with a small business size standard of $42 million. No incumbent contractor or award value information is provided in the presolicitation notice. The contract will be managed by the VA Network Contracting Office, with points of contact Lisa A. Buchanan and Erika Kobulnicky available to answer inquiries. All work must be performed in accordance with current USP guidelines and applicable regulations governing compounded sterile preparation facilities. While the specific scope, duration, and number of facilities requiring certification have not been disclosed in this presolicitation notice, these details will be included in the full Request for Proposal.

Notice text

Presolicitation Notice

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DESCRIPTION

THIS IS A PRESOLICIATION NOTICE NOT A SOLICITATION.

A REQUEST FOR PROPOSAL WILL BE POSTED ON OR ABOUT November 13, 2025.

The VISN 15 VAMC Facilities currently has a requirement for testing and certification of all VA Heartland Health Care Network (VISN 15) facilities primary engineering controls (PECs) and clean rooms used for preparation of compounded sterile preparations (CSPs). PECs include biological safety cabinets (BSCs), laminar airflow workbenches (LAFWs), compounding aseptic containment isolators (CACIs), compounding aseptic isolators (CAIs) and Isolators. Testing and certification will be completed in accordance with United States Pharmacopeia (USP) Chapter 797, USP Chapter 800, or current guidelines. This requirement also includes personnel training, evaluation and requalification to compound CSPPs in accordance with 797, 800, or current guidelines.

All work shall be done in accordance with the SOW. The SOW will be posted with the solicitation.

The NAICS code for this procurement is 621511236220 with a small business size standard of $42M.

This project will be 100% set-aside for Service-Disabled Veteran-Owned Small Businesses.

The POC for this project will be Lisa A Buchanan, lisa.buchanan1@va.gov and Erika Kobulnicky at Erika.kobulnicky@va.gov.

Files

File Type Posted
36C25526Q0054_1.docx DOCX document

Notice history

Notice Type Posted
H965--IV Room Certification & Testing Services (VA-26-00003362) 36C255-26-AP-0020 Award Award Notice
36C25526Q0054 VISN 15 IV Room Certification and Personnel Training Latest solicitation Solicitation
This notice Original Pre-Solicitation

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