ccreditation of laboratories performing food testing for regulatory purposes is criticalfor ensuring prompt and appropriate state and federal response to foodborne illnessoutbreaks and emergencies. The Massachusetts Department of Public Health(MDPH) William A. Hinton State Laboratory Institute (HSLI) is the primary laboratoryfor conducting microbiological and chemical food analyses on behalf of theMassachusetts Department of Public Health Bureau of Environmental HealthDivision of Food Safety (the state manufactured food regulatory program, which isenrolled in the MFRPS). The HSLI currently participates in the Food EmergencyResponse Network (FERN) for both chemical and microbiological testing. Theobjective of this project is to achieve and maintain ISO 17025:2005 accreditation forthe HSLI microbiological and chemical food testing programs. This will requireenhancements to our existing Quality Assurance program that currently serves toallow our laboratory to comply with Clinical Laboratory Improvement Act (CLIA) andCollege of American Pathologists (CAP) requirements. The project will involve aninitial quality management system assessment and gap analysis, followed by theformulation of a timeline for addressing identified gaps, and identification ofpersonnel responsible for addressing the various gaps. Laboratory qualitymanagement personnel will participate in the initial gap analysis and willsubsequently be primarily responsible for developing practices and procedures formeeting accreditation requirements for pre- and post-analytical processes.Personnel familiar with the technical and operational aspects of chemical andmicrobiological food laboratory practices will participate in the initial gap analysis andwill subsequently be primarily involved with developing practices and procedures tomeet analytic laboratory accreditation requirements. Informatics personnel will beinvolved in the development and implementation of informatics tools used to achieveand maintain accreditation long term. Informatics activities will include thedevelopment of processes and mechanisms for the timely, accurate, and completesharing of laboratory data with federal agencies via eLEXNET for regulatory andsurveillance activities.

Public Health Relevance

ISO/IEC 17025:2005 accreditation is important for food laboratories performing testing for regulatory activities that safeguard the food supply and the public health. Accreditation attests to the ability of the laboratory to maintain rigorous quality standards throughout all phases of laboratory testing, such that test results are highly reliable and traceable, and therefore well-suited to serve as the basis for regulatory action. Accreditation of the microbiological and chemical food testing programs at the Massachusetts Department of Public Health William A. Hinton State Laboratory Institute will serve to increase national food analytical capacity and enhance efforts to protect the food supply at the state and federal levels.

Agency
National Institute of Health (NIH)
Institute
Food and Drug Administration (FDA)
Type
Research Demonstration--Cooperative Agreements (U18)
Project #
1U18FD004459-01
Application #
8459795
Study Section
Special Emphasis Panel (ZFD1-SRC (99))
Project Start
2012-09-30
Project End
2017-08-31
Budget Start
2012-09-30
Budget End
2013-08-31
Support Year
1
Fiscal Year
2012
Total Cost
Indirect Cost
Name
Massachusetts State Department of Pub Health
Department
Type
DUNS #
878298900
City
Boston
State
MA
Country
United States
Zip Code
02108