Research question

The study set out to identify corrective measures aimed at reducing the risk of aerosol-mediated viral infection within an IVF laboratory.

Design

A failure modes and effect analysis (FMEA) was conducted by a multidisciplinary IVF team. A schematic representation of new protocols and procedures adopted during COVID-19 emergency has been defined, including directives about the behaviour to adopt when entering the clinic and the laboratory, in case of face-to-face contact with patients and between staff members. In addition, the risk of cross-contamination between samples belonging to different patients during cell handling and manipulation has been evaluated. Potential failure modes for each phase of the emergency have been analysed, focusing on possible sources of error. Risk priority numbers have been calculated as products of Occurrence × Severity × Detection scores.

Results

Except for cell–cell contamination, which was considered highly unlikely, failure modes during patient–staff, staff–staff and staff–cell interactions were estimated as carrrying a moderate to high risk of infection. The main corrective measures entailed precautionary logistic measures, the implementation of additional personal protective equipment and changes in the IVF laboratory procedures and scheduling of the daily routine. Some procedures were also revised, aiming to increase staff's awareness and caution.

Conclusions

Standard laboratory protocols are insufficient to face a virus whose transmission is aerosol mediated. The measures outlined in this FMEA should thus be considered not only for facing this pandemic, but also for the future to promptly manage any aerosol-mediated virus infection, whose impact on the management of an IVF laboratory might be less severe than COVID-19 although not completely negligible.

中文翻译：

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在IVF实验室中评估和管理SARS-CoV-2感染的风险。

研究问题

该研究旨在确定旨在降低试管婴儿实验室内气溶胶介导的病毒感染风险的纠正措施。

设计

失效模式和影响分析（FMEA）由多学科的IVF团队进行。定义了在COVID-19紧急情况下采用的新协议和程序的示意图，包括有关进入诊所和实验室时在与患者面对面以及在工作人员之间面对面接触时应采取的行为的指令。此外，已经评估了在细胞处理和操作过程中属于不同患者的样品之间发生交叉污染的风险。已经分析了紧急情况每个阶段的潜在故障模式，重点放在可能的错误源上。风险优先级数字已计算为发生率×严重性×检测得分的乘积。

结果

除了被认为极不可能发生的细胞间污染之外，据估计，在员工与员工，员工与员工之间以及员工与员工之间的互动过程中，失效模式会带来中等至高感染风险。主要的纠正措施包括预防性后勤措施，额外的个人防护设备的使用以及IVF实验室程序的更改以及日常工作的安排。还对某些程序进行了修订，旨在提高工作人员的意识和谨慎度。

结论

标准实验室规程不足以应对其传播是通过气溶胶介导的病毒。因此，不仅应考虑该FMEA中概述的措施，而且还应考虑在将来迅速处理任何由气溶胶介导的病毒感染，尽管其对IVF实验室管理的影响可能不如COVID-19严重，不完全可以忽略不计。