Installation And Calibration Of IntelliSense ZB Hardware

This is a notice of intent to sole source to E-Control Systems for purchase, installation, and calibration of IntelliSense ZB Hardware. CDC’s Mycotic Diseases Branch (MDB) works to determine the burden of fungal infections, respond to outbreaks, and address related public health challenges. To fulfill this mission, MDB relies on state-of-the-art laboratory equipment that must remain fully operational and compliant with Clinical Laboratory Improvement Amendments (CLIA) regulations and International Organization for Standardization (ISO)

requirements. These standards mandate continuous monitoring of temperature and humidity in laboratory areas where quality assurance materials and samples are produced, stored, or tested. Accurate environmental monitoring is critical to ensuring the integrity of laboratory materials and processes. Currently, temperature and humidity are tracked manually, with more than half of the laboratory’s equipment requiring at least daily checks. This approach is inefficient, costly, and increases the risk of undetected environmental fluctuations. The absence of automated alerts when conditions fall outside acceptable ranges further heightens the risk of compromised specimens and noncompliance. To address these challenges, MDB has an urgent need for a robust, automated temperature and humidity monitoring and notification system to maintain quality standards and ensure ongoing regulatory compliance. The purpose of this acquisition is to procure and implement a comprehensive, automated temperature and humidity monitoring and notification system for the CDC’s Mycotic Diseases Branch (MDB) laboratories. This initiative will support MDB’s mission to ensure the quality, integrity, and regulatory compliance of laboratory operations related to fungal disease surveillance, outbreak response, and public health research. This project involves collaboration among MDB laboratory personnel, CDC information technology and facilities teams, and the selected contractor. The contractor will be responsible for providing, installing, integrating, and fully operationalizing a monitoring system capable of continuous environmental surveillance across all designated laboratory areas. The overall

objective is to replace manual monitoring processes with a reliable, automated system that continuously records temperature and humidity levels, provides real-time alerts when conditions fall outside established thresholds, and integrates with existing CDC software to generate reports required for compliance. Performance

objectives include: Continuous, accurate monitoring and recording of temperature and humidity in all required laboratory spaces Automated notifications to laboratory staff when environmental conditions exceed acceptable ranges Integration with existing CDC systems to support automated reporting and audit readiness for CLIA compliance Secure data storage and retrieval capabilities to maintain complete environmental records High system reliability with minimal downtime and an intuitive user interface Operating constraints include compliance with federal IT security

requirements, compatibility with existing CDC infrastructure and software platforms, minimal disruption to laboratory operations during installation and deployment, and adherence to all applicable regulatory and safety standards. The anticipated outcome is a fully compliant, automated monitoring system that improves operational efficiency, reduces the risk of environmental excursions, safeguards laboratory specimens and materials, and ensures sustained compliance with CLIA and ISO

requirements. The required monitoring system must integrate with the existing E-Control Systems environmental monitoring infrastructure currently deployed within CDC’s Mycotic Diseases Branch laboratories. The system currently monitors critical laboratory environments including refrigerators, freezers, incubators, ambient room temperature, and humidity conditions that support CLIA-regulated laboratory operations. E-Control Systems has certified that its IntelliSense™, IntelliGate™, and FusionLive™ systems are proprietary technologies designed and manufactured exclusively by E-Control Systems. The company further states: No third-party manufacturer or distributor is authorized to replicate or provide equivalent systems, all components are specifically designed to operate within the E-Control Systems ecosystem and are not interchangeable with non-ECS products, any modifications, integrations, or expansions must be performed or approved by E-Control Systems, and calibration and maintenance must be performed directly by E-Control Systems employees. The Government requires full compatibility and integration with the currently installed system to maintain uninterrupted environmental monitoring, data integrity, automated alerting, and compliance with CLIA and ISO