South Carolina Department of Health and Environmental Control Laboratory Flexible Funding Model Grant Submission

SC-DHEC PHL-ISO 摘要 南卡罗来纳州健康与环境控制部 (SC-DHEC)，公共卫生 实验室（PHL），作为国家公共卫生实验室，致力于改善 通过保护和促进公众的健康来提高南卡罗来纳州人民的生活质量 环境。 PHL 食品微生物学实验室保持了检测 40 多年来和 2016 年的食源性病原体和食品质量指示生物 获得 ISO/IEC 17025 认证并自那时起一直保持认证状态。在此期间 合作协议，食品微生物实验室将维持ISO/IEC 17025 通过保持符合我们的认证机构规定的要求来获得认证，并且 通过维护一个解决并符合所有要素的质量管理体系 通过执行内部审核、管理评审、熟练程度来满足 ISO/IEC 17025 标准 测试和质量体系改进。通过与国家制造的合作伙伴关系 食品零售计划标准 (MFRPS) 计划和州动物食品零售产品 食品微生物实验室将参与计划标准 (AFRPS) 计划 加强监测，对总共 500 个人类食品和动物样本进行分析 食品。通过收集将加强食品防御反应的准备工作 50 个样品用于分析炭疽杆菌和鼠疫耶尔森氏菌。整体表现 对 400 个分离株进行基因组测序将有助于增进对 微生物生态学和多样性。共享通过日常监测生成的数据 活动将使食品和药物管理局能够访问我们的数据以进行执法 活动。该数据将在 ISO/IEC 17025 认可的实验室中生成 将简化分析审查并允许 FDA 快速响应并执行监管 合规性。这些项目将作为加强和改进 FDA 的基础 努力预防食源性疾病并尽量减少接触，以便在全国范围内建立 综合实验室科学系统，并为合作伙伴实验室提供额外资源 增加州内的样本吞吐能力。

SC-DHEC PHL-ISO Summary The South Carolina Department of Health and Environmental Control (SC-DHEC), Public Health Laboratory (PHL), serves as the state public health laboratory working towards improving the quality of life for South Carolinians by protecting and promoting the health of the public and environment. The PHL Food Microbiology Laboratory has maintained the ability to test for foodborne pathogens and food quality indicator organisms for over 40 years and in 2016 achieved ISO/IEC 17025 accreditation and has remained accredited since that time. During this cooperative agreement, the Food Microbiology Laboratory will maintain ISO/IEC 17025 accreditation by remaining compliant with requirements set forth by our accrediting body and by maintaining a quality management system that addresses and conforms to all elements of ISO/IEC 17025 standards by performing internal audits, management reviews, proficiency testing, and quality system improvements. Through a partnership with the state Manufactured Food Retail Program Standards (MFRPS) programs, and the state Animal Food Retail Product Program Standards (AFRPS) program the Food Microbiology Laboratory will participate in the enhanced surveillance with a total of 500 samples being analyzed for human food and animal food products. Preparedness for food defense response will be enhanced through the collection of 50 samples for analysis for Bacillus anthracis and Yersinia pestis. The performance of whole genome sequencing on 400 isolates will contribute to growing knowledge and understanding of microbial ecology and diversity. The sharing of this data generated through routine surveillance activities will allow the Food and Drug Administration access to our data for enforcement activities. The fact that this data will be generated in an ISO/IEC 17025 accredited laboratory will streamline analytical review and allow the FDA to rapidly respond and enforce regulatory compliance. These projects will serve as a foundation to strengthen and improve the FDA’s efforts to prevent foodborne illness and minimize exposures in order to build upon a nationally integrated laboratory science system and equips partner laboratories with additional resources to increase sample throughput capacity within the state.