Proficiency Testing and Method Validation
Manager, Proficiency Testing and Method Validation, Center for Specialty Programs
Lacey Guillen, PhD
The proficiency testing and method validation program at the Institute for Food Safety and Health produces proficiency testing (PT) samples for both FDA and USDA food safety programs. The center also manages the food chemistry and microbiology proficiency testing programs for the Food Emergency Response Network (FERN). Laboratory performance is tested by challenging analysts with simulated samples to test within their normal operating conditions in order to produce an interlaboratory comparison.
The Food Emergency Response Network was formed to successfully unite federal, state and local laboratories in the detection, response and recovery from national food emergencies, including bioterrorism. This work benefits our nation by testing the analytical and response capabilities of the FERN laboratories so that they are prepared to respond effectively in the case of an actual food emergency.
Capabilities
- Inoculate virtually any food product including powders, water and fresh produce samples.
- Target any level of inoculation, including extremely low levels, in order to test the limits of detection for specific methods.
- Tailor PT samples to meet the different parameters of testing procedures, including cultural, immunoassay and molecular methods.
IFSH expects to make proficiency testing services available to food industry members in the future. As the PT program expands, the laboratory will enter the process of ISO 17043 certification and expects to offer additional analytical capabilities, such as freeze dried proficiency testing samples.
Proficiency Testing Laboratories
Two proficiency testing labs occupy nearly 1,200 sq. ft. of BSL-2 space and support the PT program at the Institute for Food Safety and Health, which produces PT samples for both FDA and USDA food safety programs, manages the food chemistry and microbiology proficiency testing programs for the Food Emergency Response Network (FERN), and can be used for collaborative work with IFSH industry members. Equipment and features include:
- Well-equipped molecular biology laboratory, for all-purpose DNA and protein experiments
- Newly reconfigured food microbiology/proficiency testing laboratory, for preparing and handling microbiology PT samples
- Able to inoculate virtually any food product, including powders, water and fresh produce samples, and target any level of inoculation, such as extremely low levels in order to test the limits of detection for specific methods
- Dangerous goods shipment capabilities and certifications
- Program expansion plans include additional capabilities in preparing freeze dried proficiency testing samples and preparing the PT program for ISO 17043 accreditation
- Specialized equipment includes a number of cultural, immunoassay and molecular method microbial detection and identification instruments (conventional and automated real-time systems), biosafety hoods, autoclave, ultralow freezers for storing cultures and lysates, gel electrophoresis systems, robotic station, gel imaging and documentation system, hybridization ovens, and more