Description
T itle: Automated Equipment Monitoring – Division of High Consequence Pathogens & Pathology BACKGROUND The Centers for Disease Control and Prevention (CDC) works 24/7 to protect America from health, safety and security threats, both foreign and in the U.S. Whether diseases start at home or abroad, are chronic or acute, curable or preventable, human error or deliberate attack, CDC fights diseases and supports communities and citizens to do the same. CDC’s Division of High Consequence Pathogens & Pathology (DHCPP) aims to prevent disease, disability, and death caused by a wide range of high-consequence pathogens. In order for DHCPP to achieve their mission, state-of-the-art laboratory equipment must be in working order and compliant with either the Clinical Laboratory Improvement Amendments (CLIA) regulations or with the International Standards Organization (ISO) requirements. These regulations and standards require monitoring of temperature and humidity in all laboratory areas where quality assurance materials and other samples are manufactured, stored, and/or tested. Accurate recordings are essential to ensure the quality of the materials being used and stored in the laboratory. Typically, monitoring and recording temperature, humidity, and CO2, and asset management was done manually with over half of our equipment inventory requiring at least daily monitoring. This process is inaccurate, impractical and cost prohibitive. The lack of automated notifications when levels are out of range could lead to severe damage to our collection full of invaluable, well-characterized specimens from around the world. DHCPP laboratories have an urgent need for a robust automated temperature, humidity, and CO2 monitoring and notification system across all five branches. SUBSECTION A – DEFINITIONS CLIA: Clinical Laboratory Improvement Amendments ISO: International Standards Organization PURPOSE This requirement is to obtain an automated monitoring and notification system that will electronically record and transmit environmental data (ie: temperature, humidity, and CO2 levels) obtained from probes installed in equipment and rooms in DHCPP laboratories and automatically notify laboratory staff when measurements are out of established range. SCOPE OF WORK Temperature mapping the areas where laboratories store products ensures the products are kept at the correct condition which is essential for safety and compliance. This requirement includes purchase of equipment, warrantied for one (1) year, installation, software set up and monitoring. Additional options are included for continued annual maintenance and expansion of up to 20 additional probes. The vendor must be ISO 17025 compliant to perform required calibration/recalibration; perform installation qualification (IQ) and operational qualification (OQ) following laboratory protocol; and provide documentation on all installation and calibration activities. Equipment must meet the following Specifications NIST traceable sensors (Temperature range -200 to 300C) Minimum of 0.1C resolution out of specification reporting with the ability to electronically review and/or approve reports Door status sensor and 2 analog sensor inputs on each transmitter LCD temp/humidity/CO2 display on transmitter modules Ability to monitor liquid nitrogen levels Text/email alerts Audible and visual alarms Single-server 21 CFR part 11/CLIA/ISO compliant system Server and SQL instance that supports virtualization using VMWare ESC Hypervisor Active Directory or LDAP Domain Authentication 900Mhz Zigbee IEEE 802.15.4 Wireless Transmitters Transmitter battery-life of at least 12 months, based on minimum two readings per hour Minimum 14 days data buffering when power or connection to server fails Replacing batteries does not erase logged data 900Mhz Zigbee IEEE 802.15.4 Wireless Receivers with Gigabit Ethernet network ports Self-healing, redundant MESH network topology that auto-recovers from receiver failures User-friendly web-based client GUI (no client application required) Ability to create user groups and at least 3 permission levels including admin Ability to track assets by user group and log maintenance and relevant notes Graphs of monitored readings Secure and auditable logs of all system activity, recording user and action with date/time Ability to document corrections/corrective action with electronic signature Table, List and Map views of monitored resources with ability to export to .csv or .xlsx Travel may be required for installation of temperature monitoring system and training of laboratory staff. Contractor will be responsible for all associated travel costs. NOTE: THE DUE DATE FOR QUOTES IS EXTENDED TO MAY 17, 2021 AT 2PM EDT. THE DUE DATE FOR QUESTIONS OR INQUIRIES IS EXTENDED TO MAY 11, 2021 AT 2PM EDT.