Discipline D Special Project - Track 2: NFSDX and ORAPP Integration

part20 -105：学科D -特殊项目-专题2:NFSDX和ORAPP

PAR-20-105: Discipline D – Special Projects - Track 2: NFSDX and ORAPP Project Summary The WSDA Food Safety and Consumer Services (FS&CS) Laboratory seeks funding for this track in order to enhance our current data systems to enable us to electronically submit sample testing data to FDA. We request funding for one year. We prefer to complete this project in Year 1 of the Laboratory Flexible Funding Model, and we have the following accomplishments and attributes:  The WSDA FS&CS Laboratory adopted a Laboratory Information System (LIMS) in 2012. This IT project was a contracted design system and we have been able to revise, improve and enhance the system for 8 years. It has continued to serve us well.  We established communication between our LIMS and eLEXNET. We worked closely with FDA IT consultants on database communication issues. We met via conference call and WebEx to successfully provide linkage between our LIMS and eLEXNET so that we are able to upload all of our laboratory data into eLEXNET.  We have two dedicated LIMS administrators in our laboratory. They have received onsite training at the LIMS vendor’s site. Both of our administrators are experienced and skilled at maintaining databases. If our Track 2 proposal is accepted, we are willing and able to do the following: 1. Assess our current IT capabilities in conjunction with FDA. 2. Enhance the laboratory IT system by integrating with NFSDX or adopting ORA Partners Portal by uploading laboratory data files. Based on FDA guidance, we will determine the relevant and required data fields, file formats and mechanism by which the lab can exchange data with FDA. 3. Participate in data exchange meetings and complete the FDA questionnaire. 4. Attend collaboration meetings with FDA NFSDX and ORAPP teams at the frequency determined by FDA. 5. Enter into a Memorandum of Understanding (MOU) and Interconnection Security Agreement (ISA) with FDA as required for program participation. Washington State Department of Agriculture, Food Safety and Consumer Services Laboratory