CORE 3: Environmental Health and Biosafety Regulations and Requirements

核心 3：环境健康和生物安全法规和要求

• 批准号: 10663831
• 负责人: Kevin Michael Tuohey
• 金额: $ 192.7万
• 依托单位: BOSTON UNIVERSITY MEDICAL CAMPUS
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-06-01 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10663831
• 关键词: Address; Advisory Committees; Area; Boston; Budgets; Centers for Disease Control and Prevention (U.S.); Certification; Chemicals; Collaborations; Competence; Contract Services; Core Facility; Decontamination; Development; Disease Surveillance; Emergency Situation; Emergency response; Emerging Communicable Diseases; Employment; Ensure; Environmental Health; Equipment; Equipment and supply inventories; Exercise; Health; Human Resources; Hygiene; Individual; Infectious Diseases Research; Institution; Investigation; Laboratories; Leadership; Maintenance; Medical; Medical Surveillance; Monitor; Occupational Health; Occupational Medicine; Principal Investigator; Process; Professional Organizations; Public Health; Radiation; Readiness; Records; Regulation; Regulatory Affairs; Reporting; Research; Resources; Role; Safety; Services; System; Testing; Training; Universities; Work; biosafety level 4 facility; chemical safety; exercise program; follow-up; hazard; institutional biosafety committee; operation; programs; response

Core 3: Environmental Health and Biosafety Regulations and Requirements Abstract The Environmental Health and Biosafety Regulations and Requirements (EHBRR) Core includes three components: Environmental Health and Safety, Emergency Management, and Occupational Medicine. The Core is integrated with campus-wide services under the direction of the Office of Research Compliance (ORC). The role of the EHBRR Core at the NEIDL is to provide for and ensure the health, safety and preparedness of all personnel who work at and support the NEIDL's BSL4 facility, and in this manner all who work within the building. These responsibilities are carried out in a coordinated and collaborative manner starting with the initial application for NEIDL employment or assignment, and continuing throughout the duration of work in the NEIDL. The EHBRR Core includes the Chief Safety Officer, Responsible Official, Occupational Health Officer, and the BSL-4 Biosafety Officer. EHBRR, as part of the BU Office of Research Compliance utilities the expertise of the University Chemical Hygiene Officer, Chemical Safety Officer, Environmental Manager, Radiation Safety Officer, Chief Medical Physicist and others. EHBRR oversees the NEIDL Personnel Suitability and Reliability Program (PSRP) addressing initial and annual clearances and chairs the Personnel Suitability Review Team. Once individuals are cleared for entry into the NEIDL, EHBRR provides or coordinates initial and ongoing competency-based training including NEIDL orientation, lab safety, CPR, select agents, insider threat, agent/lab/equipment specific information and response to emergencies. EHBRR manages emergency response planning, exercises, after-action reports and correction action plans. The BSL-4 Biosafety Officer chairs the BSL-4 NEIDL Training Advisory Committee tasked with ensuring that those entering BSL-4 labs are prepared to do so. EHBRR coordinates, manages and documents inventory audits with the Laboratory Manager and the Principal Investigator and conducts follow up investigations and reporting if necessary. The core is responsible for all aspects of safety within the BSL-4 laboratories including the testing and verification of biocontainment systems in coordination with the Facilities Core, the decontamination of equipment and space and the management of certifications. EHBRR does so using contracted services when unable to do so directly. EHBRR manages compliance with the Centers for Disease Control and Surveillance (CDC) Select Agent Program and the Boston Public Health Commission (BPHC) BSL-4 Laboratory Regulations. These responsibilities include registration/permitting activities, maintenance of records and oversight of administrative actions required to maintain compliance. EHBRR coordinates closely with Principal Investigators on proposed work plans prior to submission to the Institutional Biosafety Committee (IBC).

核心3：环境健康和生物安全法规和要求 摘要 环境健康和生物安全法规和要求（EHBRR）核心包括三个 组成部分：环境健康和安全，应急管理和职业医学。的 核心是研究合规办公室（ORC）的指导下，与校园范围内的服务集成。 NEIDL的EHBRR核心的作用是提供并确保健康，安全和准备 在NEIDL的BSL 4设施工作和支持的所有人员，以及以这种方式在NEIDL的BSL 4设施内工作的所有人员 建设这些责任是以协调和协作的方式履行的， 申请NEIDL就业或分配，并在整个工作期间继续在 尼德尔。EHBRR核心包括首席安全官、负责官员、职业健康官， 和BSL-4生物安全官EHBRR作为BU研究合规办公室的一部分， 大学化学卫生主任，化学安全主任，环境经理， 辐射安全官、首席医学物理学家等。EHBRR监督NEIDL人员的适用性 和可靠性计划（PSRP），解决初始和年度许可，并主持人员适用性 审查小组。一旦个人获准进入NEIDL，EHBRR提供或协调初始 以及持续的基于能力的培训，包括NEIDL方向，实验室安全，心肺复苏术，选择代理人，内部人员 威胁、特工/实验室/设备特定信息以及对紧急情况的响应。EHBRR管理紧急情况 应对计划、演习、行动后报告和纠正行动计划。BSL-4生物安全官 主持BSL-4 NEIDL培训咨询委员会，负责确保进入BSL-4实验室的人员 准备这样做。EHBRR与实验室协调、管理和记录库存审计 经理和主要研究者，并在必要时进行跟进调查和报告。的 核心负责BSL-4实验室内所有方面的安全，包括测试和验证 与设施核心协调的生物防护系统，设备的去污， 空间和认证管理。EHBRR在无法这样做时使用合同服务 直接. EHBRR管理与疾病控制和监测中心（CDC）选择的合规性 代理计划和波士顿公共卫生委员会（BPHC）BSL-4实验室法规。这些 职责包括登记/许可活动、保存记录和监督行政 保持合规性所需的行动。EHBRR与主要研究者密切协调， 在提交给机构生物安全委员会（IBC）之前，