Notice of Intent to Award Sole Source Contract Preventative Maintenance Agreements for Temperature-Controlled Equipment
Closed Pre-Solicitation Posted
- Solicitation number
- 25-007943
- Agency
-
NIH Clinical Center
National Institutes of Health, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 811210 Electronic and Precision Equipment Repair and Maintenance
- 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 (NIH) Clinical Center intends to award a sole source contract to Genesis Engineers Inc. for preventative maintenance services on temperature-controlled equipment used by the Sterility Testing Department, Department of Laboratory Medicine. The contract will provide comprehensive service agreements for critical environmental chambers including refrigerators, incubators, and freezers to maintain compliance with current Good Manufacturing Practices (cGMP). Genesis Engineers Inc. must develop and execute Installation, Operational, and Performance Qualification (IOPQ) protocols, provide temperature mapping equipment and data loggers, compile data packs, and deliver post-execution summary reports. The contractor's ISO 9001 and ISO 17025 certifications demonstrate their ability to meet rigorous cGMP-compliant standards required for the work. Interested parties may submit capability statements by June 23, 2025, at 6:30 AM EST to Lead Contract Specialist Shasheshe Goolsby at shasheshe.goolsby@nih.gov.
This procurement does not utilize any set-aside designations and is being processed under FAR Part 13 Simplified Acquisition Procedures as a sole source award to Genesis Engineers Inc., located in Blue Bell, Pennsylvania. The contract covers five pieces of equipment: one upright 2-8°C refrigerator, one upright -70°C freezer, one upright 20-25°C incubator, and two upright 30-35°C incubators. The base year performance period runs from July 1, 2025, through December 31, 2025, representing a six-month initial contract term. Temperature mapping studies will require a minimum of 10 sensors in predefined locations for both empty and loaded chamber conditions, with each study lasting 24 hours. The work location is specified as Bethesda, MD 20892, and the contract will be awarded on a firm-fixed-price basis.
Notice text
Notice of Intent to Award Sole Source Contract
Preventative Maintenance Agreements for Temperature-Controlled Equipment
- Product Service Code: J066
- NAICS Code: 811210
- Place of Performance:
Bethesda, MD 20892
USA - POTS Number: 25-007943
This is a Notice of Intent, not a request for quotation. No solicitation document will be issued, and no quotations will be requested.
The National Institutes of Health (NIH) intends to award a firm-fixed-price contract on a sole source basis to Genesis Engineers Inc., located at 1 Sentry Parkway E, Suite 100, Blue Bell, Pennsylvania 19422-2310.
The contract will provide a preventative maintenance service agreement for various temperature-controlled equipment used by the Sterility Testing Department, Department of Laboratory Medicine at the NIH Clinical Center.
Covered Equipment:
- Upright 2–8°C Refrigerator
- Upright -70°C Freezer
- Upright 20–25°C Incubator
- Upright 30–35°C Incubator (x2)
Period of Performance:
- Base Year: July 1, 2025 – December 31, 2025
To maintain compliance with current Good Manufacturing Practices (cGMP), all critical environmental chambers—including refrigerators, incubators, and freezers—must undergo routine qualification for their intended use. A comprehensive service agreement ensures system reliability and minimal downtime, both of which are critical to timely patient diagnostics and care.
- Develop CTU IOPQ (Installation, Operational, and Performance Qualification) protocols.
- Execute IOPQ protocol for:
- (1) upright -60 to -80°C freezer
- (3) upright incubators (setpoints: 32.5°C and 22.5°C)
- (1) upright 2–8°C refrigerator
- Provide temperature mapping equipment (data loggers).
- Compile and deliver Data Packs.
- Provide post-execution IOPQ summary reports.
IOPQ Documentation & Verification Includes:
- Standard Operating Procedures (SOPs)
- Equipment and utility installation verification
- Documentation/drawings verification (URS, GxP, PM, O&M Manual)
- Calibration status of critical instruments
- Calibration data for test instruments
- Operational controls and setpoint verification
- Alarm system verification (High, Low, Power Loss, Open Door, etc.)
Temperature Mapping Studies:
Empty Chamber Mapping
- Minimum of 10 sensors in predefined locations
- Loaded Chamber Mapping
- Simulated routine usage under challenged conditions
- Minimum of 10 sensors in predefined locations
- Duration: 24 hours per study
Additional Qualification Testing:
- Open Door and Power Failure simulation tests
Genesis Engineers Inc. is ISO 9001 and ISO 17025 certified. Their quality and process systems meet the rigorous standards required for cGMP-compliant work. After technical evaluation, they have been qualified by the Sterility Testing Service to perform the necessary services.
This acquisition is being processed under FAR Part 13 – Simplified Acquisition Procedures, specifically Subpart 13.106-1(b)(1), which permits sole source awards when only one source is reasonably available. Therefore, this procurement is exempt from FAR Part 6 – Competition Requirements.
Interested parties may submit capability statements detailing their qualifications and ability to fulfill this requirement. Submissions must reference the posting number and be sent electronically to:
Shasheshe Goolsby
Lead Contract Specialist
Email: shasheshe.goolsby@nih.gov
Deadline: June 23, 2025, at 6:30 AM EST
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