Lab Matters Spring 2022 - Page 22


Maryland Undertakes Food Safety Data Exchange Journey

By Rachel Shepherd , specialist , Informatics
The US Food and Drug Administration ( FDA ) Office of Regulatory Affairs ( ORA ) Data Exchange ( DX ) is a unified platform that allows FDA and state partners to securely share sample collection , receipt and analysis data on selected microbiological , chemical and radiological analytes . By using ORA DX System-to- System services , such as the National Food Safety Data Exchange ( NFSDX ), laboratories can seamlessly collect and report data to FDA in near real-time , enabling the rapid review of analytical data to improve food safety efforts , assist in risk assessment analysis , increase efficiencies and aid in timely and accurate regulatory decision making .
The Maryland Department of Health ( MDH ) Laboratories Administration recently implemented system-to-system services , moving from a previously paperbased process to a fully automated one .
A Better Way
“ We knew we wanted to go fully electronic ” says Sinisa Urban , PhD , chief of the Division of Environmental Sciences who is leading MDH Laboratories Administration ’ s electronic data modernization . “ We were manually generating and uploading spreadsheets from paper forms , and , with a quadrupling in testing volume afforded by our Laboratory Flexible Funding Model ( LFFM ) cooperative agreement from FDA , we not only had more data to enter , but more lab science to do . We needed to free time for the science , not the data entry .”
Maryland saw an opportunity to integrate all of its food testing into a single stream and modernize its data reporting 18 months ago through the LFFM funding . For the integration project , Maryland leveraged a long-standing partnership with iConnectConsulting , the vendor that was concurrently working on their laboratory information management system ( LIMS ) upgrade .
Starting the process early had several advantages .
“ The first thing we did was to take all of the different forms we used with our various partners , added the NFSDX requirements and developed one standard form ,” explains Urban . It took several months to harmonize , but when Maryland was ready to integrate its LIMS , all fields had already been standardized .
“ A lot of the complexity in these types of integration projects comes from having a system that has to be reconfigured multiple times during the mapping phase . We were able to avoid that .”
How It Works
When a food sample is collected and a test ordered through the laboratory ’ s online LIMS portal , a message is sent via NFSDX to FDA letting them know that the sample is on the way and what to expect . There are approximately 20 data elements affiliated with a collected sample , including product information , collection date and time , product codes and firm establishment numbers , as well as testspecific data ( e . g ., Salmonella ). Fields are mandatory and the LIMS was configured such that tests cannot be ordered until all data elements are complete . The required information is there from the start and eliminates the need for follow-up data collecting that can be very timeconsuming and labor-intensive .
When the laboratory receives the sample and confirms it is in good order , a second ‘ sample receipt ’ message is sent from the LIMS to NFSDX . Once the test is completed , FDA is automatically notified of the test results by the laboratory ’ s LIMS through a third NFSDX message .
Once configured , NFSDX communications were so seamless — requiring no
Maryland Department of Health Laboratories Administration staff conduct LIMS / NFSDX training for state food collectors . Photo : MD PHL
intervention from the laboratory — that Maryland opted to also include components for monitoring communications and correcting errors . They built a transaction log that tracks what was sent when , and lists replies , including system errors , in a form that scientists could understand . They also added a top-level error alert . Most importantly , they configured a manual control capability to correct and resend transactions to NFSDX so if an error message is returned and something needs correction , all of the required actions for system-to-system communication are available to laboratory scientists at their fingertips .
Paving The Way
Maryland is the first state laboratory to go live with system-to-system services , but they are helping to lay the groundwork for other laboratories . MDH is conducting national demonstrations to show their system in action by providing trainings , as well as sharing lessons learned and challenges faced along the way .
For additional information about how your laboratory can get involved contact AppsDesk @ fda . hhs . gov
20 LAB MATTERS Spring 2022
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