The Alabama Department of Public Health (ADPH) Bureau of Clinical Laboratories (BCL) is identified as the primary laboratory for conducting microbiological and chemical food analyses on behalf of the ADPH Bureau of Environmental Services? Manufactured Food Regulatory Program (MFRP). According to Standard 10, the primary laboratory must perform testing in conformance with ISO/IEC 17025:2005 standards. Laboratory accreditation for performing food testing is critical for ensuring defensible data and providing prompt and appropriate state and federal response to foodborne illness outbreaks and emergencies. Therefore, the goal of this project is to achieve and maintain ISO/IEC 17025:2005 accreditation for the BCL?s microbiological and chemical food testing programs which will help satisfy MFRP Standard 10. This will require enhancements to the Quality Assurance program to upgrade to the more stringent process requirements for this prestigious accreditation. The schema for accomplishing the objectives for this accreditation includes an initial quality management system assessment and gap analysis; implementation of processes to address gaps identified; development of a timeframe to address identified gaps; scheduling of final assessment; and achieving ISO/IEC 17025:2005 accreditation status. Laboratory quality management personnel will participate in the initial gap analysis and subsequently be primarily responsible for developing practices and procedures for meeting accreditation requirements processes. Testing 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 develop and implement tools to achieve and maintain processes and mechanisms for the timely and accurate sharing of laboratory data with federal agencies for regulatory, surveillance, and emergency response activities.

Public Health Relevance

Becoming an accredited food testing public health laboratory will advance Alabama?s manufactured food regulatory program and thus enhance efforts to protect the state?s food supply and ensure the public?s health. Laboratory accreditation such as ISO/IEC 17025:2005 attests to the laboratory?s ability to maintain rigorous quality standards throughout all phases of laboratory testing, so that test results are highly reliable and traceable. Such analysis aligns the laboratory with the core function of a public health laboratory to collaborate in the detection, monitoring, and response to food safety, as well as the core function of public health to assess, monitor, diagnose, and survey local health problems, hazards, and needs.

Agency
National Institute of Health (NIH)
Institute
Food and Drug Administration (FDA)
Type
Research Demonstration--Cooperative Agreements (U18)
Project #
1U18FD005553-01
Application #
9103568
Study Section
Special Emphasis Panel (ZFD1-SRC (99))
Project Start
2015-09-10
Project End
2020-08-31
Budget Start
2015-09-10
Budget End
2016-08-31
Support Year
1
Fiscal Year
2015
Total Cost
$300,000
Indirect Cost
Name
Alabama State Department of Public Health
Department
Type
DUNS #
613842061
City
Montgomery
State
AL
Country
United States
Zip Code
36104