Inactive

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 ... 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 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. 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.