[Walson_Lei]

From:https://wjla.com/news/local/cdc-shut-down-army-germ-lab-health-concerns
弗雷德里克马里兰州-2019年，德特里克堡的一个研究埃博拉和天花等致命传染病材料的陆军实验室在疾控中心检查后关闭了一段时间，许多项目暂时停止。
实验室本身报告说，停工令是由于正在进行的污水净化基础设施问题造成的，CDC出于国家安全考虑拒绝提供关闭的原因。
案文如下：马里兰州陆军细菌研究实验室。在埃博拉治疗上的工作被cdc关闭了。
ABC 7收到了CDC的文件，概述了他们在那年的一系列检查中发现的违规行为，其中一些被称为“严重的”。
当年早些时候，美国陆军医学研究所已宣布在德特里克堡实验室进行的一项实验将涉及感染活跃的伊波拉病毒的恒河猴，以测试他们正在开发的治疗方法。
疾控中心在2019年注意到的几项实验室违规行为涉及“非人类灵长类动物”感染了一种“特定的病原体”，其身份不明--所有收到的文件都对其进行了修改，因为披露该制剂的身份和位置将危及公众健康或安全，该机构说。除了埃博拉病毒，该实验室还与其他致命药物如炭疽和天花合作。
疾病控制和预防中心将其定义为“已确定有可能对公众健康和安全、动植物健康或动植物产品构成严重威胁的生物制剂和毒素”。
以下是CDC在当年检查德特里克堡时观察到的一些违规行为：
意见1严重程度：严重程度
疾控中心报告说，一个人多次进入一个房间，没有必要的呼吸保护，而房间里的其他人正在对一只非人类灵长类动物在身体桌上做手术。
CDC写道：“这种对实体程序的偏离导致了呼吸道职业暴露于某些制剂气溶胶。”
意见2严重程度：严重程度
疾病控制和预防中心报告说，实验室没有确保员工培训在接触毒素和挑选制剂时得到适当核实。
他们的报告说：“这些失败是通过对实验室在BSL 3和ABSL 3实验室工作的视频回顾来发现的。”“[这些]表明[实验室]的手段用于核实人员明白培训是无效的，从而增加了职业接触的风险。”
疾控中心还指出，一名没有戴上适当呼吸保护的实验室人员多次“部分进入”被感染的非人类灵长类动物“被关押在露天笼子”的房间。他们还观察到一个实验室在没有戴手套的生物危险垃圾箱中处理废物。
意见3严重程度：中度
在这一违反行为的观察中，疾控中心对工人在处理生物危险废物时不戴手套的事件作了更详细的说明，称“生物安全和遏制程序必须足以遏制所选择的制剂或毒素”。
他们建议的纠正行动是确认有关人员受过戴手套以防止接触危险材料的培训。
意见4严重程度：严重程度
在这一观察中，疾病控制和预防中心注意到，美国陆军传染病医学研究所“系统地未能确保执行与与某些制剂和毒素有关的风险相称的生物安全和遏制程序”。
具体观察到的侵权行为涉及“实体人员[.]将“门”打开，同时将“大量生物危险废物”从相邻的房间移走，“[增加][该房间]受污染的空气逃逸和被吸入”的危险，在那里工作的人“通常不戴呼吸保护装置”。
意见5严重程度：中度
疾病控制和预防中心报告说，实验室未能防止未经授权的访问而进行选择。他们写道，在去污过程中所穿的个人防护设备，被某种特定的药剂污染后，被储存在开放式的生物危险袋中，这是疾病预防控制中心出于安全考虑对该设施的一个区域进行了修改。
他们写道：“通过在这一领域存储受监管的废物，该实体并没有限制那些获得许可的人进入。”
意见6严重程度：中度
疾控中心报告说，实验室中有人没有对毒素进行准确或最新的盘点。
意见7严重程度：低
疾控中心报告说，德特里克堡实验室的一栋建筑没有“密封的表面，便于清洁和净化。”这包括管道盒周围的裂缝，天花板上的裂缝，以及生物安全柜上方的裂缝。
Army germ lab shut down by CDC in 2019 had several 'serious' protocol violations that year | WJLAFREDERICK, Md. — In 2019, an Army laboratory at Fort Detrick that studies deadly infectious material like Ebola and smallpox was shut down for a period of time after a CDC inspection, with many projects being temporarily halted.
The lab itself reported that the shutdown order was due to ongoing infrastructure issues with wastewater decontamination, and the CDC declined to provide the reason for the shutdown due to national security concerns.
READ: Army germ research lab in Md. that was working on Ebola treatment is shut down by CDC
ABC7 has received documents from the CDC outlining violations they discovered during a series of inspections that year, some of which were labeled "serious."
Earlier that year, the US Army Medical Research Institute had announced an experiment at the Fort Detrick laboratory that would involve infecting rhesus macaque monkeys with active Ebola virus to test a cure they were developing.
Several of the laboratory violations the CDC noted in 2019 concerned "non-human primates" infected with a "select agent", the identity of which is unknown — it was redacted in all received documents, because disclosing the identity and location of the agent would endanger public health or safety, the agency says. In addition to Ebola, the lab works with other deadly agents like anthrax and smallpox.
Select agents are defined by the CDC as “biological agents and toxins that have been determined to have the potential to pose a severe threat to public health and safety, to animal and plant health, or to animal or plant products.”
Here are some of the violations the CDC observed during inspections of Fort Detrick that year:
OBSERVATION 1Severity level: Serious
The CDC reported that an individual partially entered a room multiple times without the required respiratory protection while other people in that room were performing procedures with a non-human primate on a necropsy table.
“This deviation from entity procedures resulted in a respiratory occupational exposure to select agent aerosols,” the CDC wrote.
OBSERVATION 2Severity level: Serious
The CDC reported that the lab did not ensure that employee training was properly verified when it came to toxins and select agents.
“These failures were recognized through video review of laboratorians’ working in BSL3 and ABSL3 labs,” their report said. “[These] indicate the [lab]’s means used to verify personnel understood the training had not been effective, leading to increased risk of occupational exposures.”
The CDC went on to specify that a laboratorian who was not wearing appropriate respiratory protection was seen multiple times “partially entering” a room where non-human primates that were infected with [redacted] were “housed in open caging.” They also observed a laboratorian disposing of waste in a biohazardous waste bin without gloves on.
OBSERVATION 3Severity level: Moderate
In this violation observation, the CDC went into more detail on the incident of the worker not wearing gloves while disposing of biohazardous waste, writing that “biosafety and containment procedures must be sufficient to contain the select agent or toxin.”
The corrective action they recommended was to confirm that relevant personnel have been trained to wear gloves to prevent exposure to hazardous materials.
OBSERVATION 4Severity level: Serious
In this observation, the CDC notes that the United States Army Medical Research Institute of Infectious Diseases had “systematically failed to ensure implementation of biosafety and containment procedures commensurate with the risks associated with working with select agents and toxins.”
The violation specifically observed involved “entity personnel [...] propping open” a door while removing “large amounts of biohazardous waste” from an adjacent room, “[increasing] the risk of contaminated air from [the room] escaping and being drawn into the [redacted]” where the people working “typically do not wear respiratory protection.”
OBSERVATION 5Severity level: Moderate
The CDC reported that the laboratory failed to safeguard against unauthorized access to select against. They wrote that personal protective equipment worn while decontaminating something contaminated by a select agent had been stored in open biohazard bags, in an area of the facility that the CDC has redacted for security reasons.
“By storing regulated waste in this area, the entity did not limit access to those with access approval,” they wrote.
OBSERVATION 6Severity level: Moderate
The CDC reports that someone at the lab did not maintain an accurate or current inventory for a toxin.
OBSERVATION 7Severity level: Low
The CDC reports that a building at the Fort Detrick laboratory didn’t have a “sealed surface to facilitate cleaning and decontamination.” This included cracks around a conduit box, cracks in the ceiling, and a crack in the seam above a biological safety cabinet.