ISO17025:2005 MDPH HSLI LABORATORY ACCREDITATION

Accreditation of laboratories performing food testing for regulatory purposes is critical for ensuring prompt and appropriate state and federal response to foodborne illness outbreaks and emergencies. The Massachusetts Department of Public Health (MDPH) William A. Hinton State Laboratory Institute (HSLI) is the primary laboratory for conducting microbiological and chemical food analyses on behalf of the Massachusetts Department of Public Health Bureau of Environmental Health Division of Food Safety (the state manufactured food regulatory program, which is enrolled in the MFRPS). The HSLI currently participates in the Food Emergency Response Network (FERN) for both chemical and microbiological testing. The objective of this project is to achieve and maintain ISO 17025:2005 accreditation for the HSLI microbiological and chemical food testing programs. This will require enhancements to our existing Quality Assurance program that currently serves to allow our laboratory to comply with Clinical Laboratory Improvement Act (CLIA) and College of American Pathologists (CAP) requirements. The project will involve an initial quality management system assessment and gap analysis, followed by the formulation of a timeline for addressing identified gaps, and identification of personnel responsible for addressing the various gaps. Laboratory quality management personnel will participate in the initial gap analysis and will subsequently be primarily responsible for developing practices and procedures for meeting accreditation requirements for pre- and post-analytical processes. Personnel familiar with the technical and operational aspects of chemical and microbiological food laboratory practices will participate in the initial gap analysis and will subsequently be primarily involved with developing practices and procedures to meet analytic laboratory accreditation requirements. Informatics personnel will be involved in the development and implementation of informatics tools used to achieve and maintain accreditation long term. Informatics activities will include the development of processes and mechanisms for the timely, accurate, and complete sharing of laboratory data with federal agencies via eLEXNET for regulatory and surveillance activities.