Notice of Intent to Award Sole Source Contract Preventative Maintenance Agreements for Temperature-Controlled Equipment

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