Laboratory Quality Management System
The mission of the National Center for Immunization and Respiratory Diseases (NCIRD) is to prevent disease, disability, and death through immunization and by control of respiratory and related diseases. CDC has an ongoing project to develop and implement a Quality Management System (QMS) across all CDC Infectious Diseases (ID) laboratories. Laboratories within NCIRD, are currently implementing a Quality Management System (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. Karna provides QMS and safety compliance support services to NCIRD's Office of the Director (OD). QMS and laboratory management services are provided to the Division of Viral Diseases (DVD) and the Division of Bacterial Diseases (DBD) and their respective Branches. Karna's work includes:
- Overall leadership in QMS development and implementation. This entails expertise in CLSI guidelines, ISO standards, CLIA regulations, FDA regulations and compliance and quality system implementation.
- Oversight and management of scientific and regulatory responsibilities, which may call for a number of inspections or investigative approaches applicable to a variety of regulatory functions or intensive program evaluations.
- Imparting knowledge of CDC and Federal safety regulations and expert knowledge of Department of Health and Human Services (DHHS) and United States Department of Agriculture (USDA) select agent regulations.
- Implementing, communicating, and maintaining all laboratory quality measures.
- Coordinating the implementation, management and continual improvement of the DBD quality management system.
- Supporting the quality planning, assistance with documentation, assistance with resolution of key issues and direct support of DBD staff for system implementation.
- Serving as the liaison with Division ADLS, Branch Chiefs, and Team Leaders to establish processes and procedures for all laboratory work processes and to ensure that all scientific quality control requirements are documented.
- Coordinating internal quality assessments and facilitate the external audit process for DBD Branches.
- Establishing, modifying, and updating a Division-wide documents and records management system.
- Monitoring the implementation of inventory control processes and procedures and establishing procedures for managing equipment within DBD laboratories.
- Accomplishing sensitive, or long-term special studies concerning major laboratory quality management programs.