Automated Temperature Monitoring Equipment

Title: Automated Equipment Monitoring – Division of High Consequence Pathogens & Pathology BACKGROUNDThe 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 – DEFINITIONSCLIA: Clinical Laboratory Improvement AmendmentsISO: International Standards Organization PURPOSEThis 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 WORKTemperature 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 SpecificationsNIST 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 reportsDoor status sensor and 2 analog sensor inputs on each transmitterLCD temp/humidity/CO2 display on transmitter modulesAbility to monitor liquid nitrogen levelsText/email alertsAudible and visual alarmsSingle-server 21 CFR part 11/CLIA/ISO compliant systemServer and SQL instance that supports virtualization using VMWare ESC HypervisorActive Directory or LDAP Domain Authentication900Mhz Zigbee IEEE 802.15.4 Wireless TransmittersTransmitter battery-life of at least 12 months, based on minimum two readings per hourMinimum 14 days data buffering when power or connection to server failsReplacing batteries does not erase logged data900Mhz Zigbee IEEE 802.15.4 Wireless Receivers with Gigabit Ethernet network portsSelf-healing, redundant MESH network topology that auto-recovers from receiver failuresUser-friendly web-based client GUI (no client application required)Ability to create user groups and at least 3 permission levels including adminAbility to track assets by user group and log maintenance and relevant notesGraphs of monitored readingsSecure and auditable logs of all system activity, recording user and action with date/timeAbility to document corrections/corrective action with electronic signatureTable, List and Map views of monitored resources with ability to export to .csv or .xlsxTravel 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 25, 2021 AT 2PM EDT.This notice ID 75D-301-21-Q-73106, and  75D_301_21_Q_73106 is being merged into Notice ID 75D30121Q73106 which opens 5/21/2021 and closes 5/25/2021. You may also search for keyword Automated Temperature Monitoring.