Laboratory Safety and Occupational Health Support to CDC’s National Center for Emerging Zoonotic Infectious Diseases (NCEZID), Division of Foodborne, Waterborne, and Environmental Diseases (DFWED)
CDC’s NCEZID works to protect people at home and around the world from emerging and zoonotic infections ranging from A to Z—Anthrax to Zika. To accomplish its mission, the NCEZID laboratories perform a wide range of functions including reference diagnostic testing, outbreak detection and surveillance, production of reagents and kits, and basic research. These laboratories need to comply in varying degrees with a myriad of external standards and requirements such as the Occupational Safety and Health Administration (OSHA) regulations, Clinical Laboratory Improvement Amendment (CLIA) regulations, International Standards Organization (ISO) standards, and FDA requirements for Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP), and Quality Systems Regulation (QSR), and compliance with federal regulations concerning Biological Select Agents and Toxins and CDC policy related to Biosafety Level 3 (BSL-3) facilities, processes, and practices.
SIS supprts the CDC in the following initiatives:
- Develop and implement a Quality Management System (QMS) across all CDC Infectious Diseases (ID) laboratories
- Implement a QMS based on the Clinical and Laboratory Standards Institute’s 12 Quality System Essentials (QSEs)
- Develop SOP based on QMS framework for managing and monitoring activities to address quality standards and achieve organizational goals
- Accomplish the CDC overall goal of Center-wide coordination and support to facilitate QMS implementation and safety compliance
SIS team of subject matter expertise includes Laboratory Quality Managers, BioSafety Specialists, and QMS Specialists.