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

学科 D 特别项目 - 第 2 轨：NFSDX 和 ORAPP 集成

• 批准号: 10173387
• 负责人: Yong Liu
• 金额: $ 2万
• 依托单位: WA STATE DEPARTMENT OF AGRICULTURE
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-01 至 2021-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10173387
• 关键词: Discipline; Special; Project; Track; NFSDX

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

PAR-20-105：学科D -特殊项目-轨道2：NFSDX和ORAPP 项目摘要 WSDA食品安全和消费者服务（FS&CS）实验室寻求资金， 为了加强我们目前的数据系统，使我们能够以电子方式提交样品测试数据， FDA。我们申请一年的资金。我们希望在第一年完成这个项目， 实验室灵活的资助模式，我们有以下成就和属性： WSDA FS&CS实验室于2012年采用了实验室信息系统（LIMS）。This IT 项目是一个合同设计系统，我们已经能够修改，改进和提高 该系统运行8年。它继续很好地为我们服务。 我们在LIMS和eLEXNET之间建立了通信。我们与FDA密切合作， 数据库通信问题的IT顾问。我们通过电话会议和WebEx会面， 成功地提供了我们LIMS和eLEXNET之间的链接，以便我们能够上传所有 我们的实验室数据到eLEXNET。 我们实验室有两名专门的LIMS管理员。他们接受了现场培训 在LIMS供应商的网站上。我们的两个管理员都是经验丰富和熟练的维护 数据库。 如果我们的第2轨提案被接受，我们愿意并能够做到以下几点： 1.与FDA一起评估我们当前的IT能力。 2.通过与NFSDX集成或采用ORA Partners Portal增强实验室IT系统 上传实验室数据文件根据FDA指南，我们将确定相关的 所需的数据字段、文件格式和实验室交换数据的机制 FDA. 3.参加数据交换会议并完成FDA调查问卷。 4.参加与FDA NFSDX和ORAPP团队的合作会议， 由FDA决定。 5.签署谅解备忘录（MOU）和互连安全协议 (ISA)根据参与计划的要求与FDA联系。 华盛顿州农业、食品安全和消费者服务部实验室