Laboratory quality and safety expertise and support to CDC's NCIRD
CDC has three laboratory divisions and several laboratory units within the National Center for Immunization and Respiratory Diseases (NCIRD). These 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).
CDC has an ongoing project to develop and implement a Quality Management System (QMS) across all CDC Infectious Diseases (ID) laboratories regardless of their function or location within the Agency, and Karna's work on this project supports QMS implementation across NCIRD. Laboratories within NCIRD, are currently implementing a QMS based on the Clinical and Laboratory Standards Institute’s 12 Quality System Essentials (QSEs). A QMS provides a framework for managing and monitoring activities to address quality standards and achieve organizational goals. The overall goal of this project is to provide center-wide coordination and support to facilitate QMS implementation and safety compliance. Karna provides subject matter expertise in the form of Lab Quality Managers, BioSafety Specialists, and QMS Specialists.