Wireless Laboratory Equipment Temperature Monitoring System

Amendment / Modification

This addendum to the Combined Synopsis/Solicitation 75F40126Q133352 introduces the following:

• Addition of FAR Clause 52.217-6, Option for Increased Quantity (Mar 1989): This clause allows for potential contract extension.

• Clarification of Requirements: Additional details are provided for Scope, Security Requirements, Questions & Answers, and Floor Plans.

• Scope: The requirement is for an environment monitoring system that is FDA OIM Master Approved, ITIM / MAT approved, and uses 900 MHz wireless technology. The vendor must be A2LA accredited and meet SRL's ISO 17025 accreditation requirements for vendor calibration services. The system must comply with accreditation for monitoring analytical critical control points, with ISO 17025 accredited calibration certificates. Immediate notification for out-of-tolerance situations is required.

• Security Requirements: Standard security controls for field VM servers on the regulatory network will apply.

• Questions & Answers: Several vendor questions are addressed, including:

  • Floor plans are provided for coverage verification.
  • Vendor is responsible for repair/replacement of defects during warranty; end-user is responsible for damage caused by misuse.
  • Solutions can be server-based or cloud-based (Microsoft Azure), and will be evaluated against existing CTP/TPL's Viewpoint server and software.
  • Strict security and configuration settings are in place for user/computer management.
  • Monitoring points are approximately 140-156 inputs.
  • Dickson's Services (mapping, installation) may be proposed and will be evaluated.
  • Items to be monitored include fridges, freezers, incubators, and warehouse space.
  • WiFi and/or Ethernet are available in monitored areas.
  • Timeline is within 1-month of Award.
  • Bluetooth 6.0 is not allowed; 900MHz technology is required.
  • Compatibility with the existing monitoring system is a requirement.
  • Walk-throughs are not hosted due to building renovations; floor plans are provided.

• Floor Plans: Provided for Area 1 (First and Second Levels) and Area 3 (Second Level).

• Response Due Date: Extended to April 15, 2026, at 1:00 PM CST.

Solicitation / RFP / RFQ

This is a combined synopsis/solicitation for commercial items to acquire, install, and provide training for a Wireless Laboratory Equipment Temperature Monitoring System for the U.S. Food and Drug Administration (FDA) Atlanta Human and Animal Food Laboratory (ATLHAFL). The system is needed to ensure compliance with accreditation for monitoring analytical critical control points and to ensure timely and accurate tracking of environmental conditions in labs and specific laboratory equipment.

• A standalone, complete wireless temperature monitoring system.

• Compatibility with the existing 24/7/365 environmental monitoring system.

• 900 MHz wireless technology approved by FDA IT.

• FDA OIM approved software package compliant with 21 CFR Part 11.

• Ability to measure, transmit, centrally collect, and analyze temperature data from multiple instruments across a multi-floor facility.

• Local data storage of up to 10,000 logged data points.

• LCD display with user interface, local audible and visual alerts.

• Specific temperature probe requirements for various equipment (refrigerators, freezers, water baths, incubators, ultra-low freezers) with specified accuracy (e.g., ±0.2°C).

• NIST traceable calibrations and ISO 17025 certification.

• User-programmable system with capabilities for setting limits, alerts, and alarms.

• Ability to generate reports (user logins, change history, alert frequency, corrective actions).

• Expandable and upgradeable system.

• Installation, training, consultation, and design services.

• IQ/OQ validation.

• On-site user and system administrator training.

• 24/7 Technical Support and Training.

• Minimum 1-year warranty with 4 option periods for annual calibration/validation services.

• Contract Type: Firm-Fixed Price.

• Period of Performance: Not explicitly stated for the base contract, but includes 4 option periods for post-warranty service/maintenance, each for 1-year.

• Estimated Value: Not stated.

• Proposal/quote submission deadline: April 13, 2026, 1:00 PM Central Time.

• Submission method: Email to howard.nesmith@fda.hhs.gov.

• Evaluation Factors: Lowest price technically acceptable and responsible offeror. Offers will be evaluated on technical acceptability first, then price.

• Technical Acceptability: Determined by review of submitted descriptive material demonstrating capabilities.

• Price: Lowest priced offer will be evaluated first among technically acceptable offers.

• This requirement is set aside for Small Business.

• NAICS Code: 334513 - Instruments and Related Products Manufacturing for Measuring, Displaying, and Controlling Industrial Process Variables.

• Small Business Size Standard: 750 employees.

• Offerors must be registered and active in SAM.gov.

• Any catalog number, manufacturer brand name, or proprietary description is used for descriptive purposes only.

• Offerors must submit an Accessibility Conformance Report (ACR) for items not in compliance with Section 508 standards.

• Electronic documents must not contain macros.

• FOB Destination: U.S. Food and Drug Administration, Atlanta Human and Animal Food Laboratory, 1777 Hardee Ave SW, Atlanta, GA 30310.

• Payment Terms: Net 30 Days After Government Acceptance of Supplies/Services via Invoice Processing Platform (IPP).