Kim Kelly N, Wyneken Henry L, Ryan Joan M, Costa Sylvia, Harrell Jessie, Yandow Lily, Fleming Adam E J, Lauer Erin, Nubbe Karl, Gunther Noah, De Silva Navin, Evans Nicholas G, Gehlen Dall Bello Aline, Chouikha Anissa, Bohn Sherry Supernavage, Ritterson Ryan, Al-Hmoud Nisreen, Masmoudi Sana, da Veiga Ana Beatriz Gorini, Moritz Rebecca, Casagrande Rocco
Gryphon Scientific, Takoma Park, Maryland, USA.
Colorado State University, Fort Collins, Colorado, USA.
Appl Biosaf. 2025 Mar 7;30(1):4-10. doi: 10.1089/apb.2024.0009. eCollection 2025 Mar.
Quantitative data informing biosafety practices have long been lacking. In this study, we describe the conduct of the first large-scale investigation into human reliability in the life sciences laboratory to estimate an error rate during routine biological experiments.
To generate these critical data, we conducted two sets of experiments: blinded experiments in clinical laboratories in Brazil, Jordan, and Tunisia, and volunteer experiments in training laboratories in two U.S. universities. In these experiments, GloGerm was used to indicate where spills occurred during laboratory manipulations. In the blinded clinical experiments, dummy samples were introduced into the normal workflow and workers processed them as they would a normal clinical sample. Surfaces were examined at the end of the shift for contamination. In the experiments in the United States, volunteers would repetitively pipette a solution of GloGerm into a 96-well plate and the work area was inspected after each plate.
The median volunteer is estimated to have an error rate of about 4 or 8 errors per 1,000 manipulations (for volunteers with significant laboratory experience vs. those with little laboratory experience, respectively). Estimated error rates from both experiments are comparable, suggesting that studies using volunteers who know they are working with nonhazardous materials can be used to replicate real laboratory conditions to provide critical data in biosafety. The volunteers were also asked to declare when they thought they made an error. By comparing true errors to those declared, we found that volunteers identified a maximum of 52% of their total mistakes, indicating that many mistakes go unnoticed.
长期以来，一直缺乏用于指导生物安全实践的定量数据。在本研究中，我们描述了首次对生命科学实验室中的人员可靠性进行大规模调查的过程，以估计常规生物学实验期间的错误率。
为了生成这些关键数据，我们进行了两组实验：在巴西、约旦和突尼斯的临床实验室进行的盲法实验，以及在美国两所大学的培训实验室进行的志愿者实验。在这些实验中，使用GloGerm来指示实验室操作过程中发生泄漏的位置。在盲法临床实验中，将虚拟样本引入正常工作流程，工作人员像处理正常临床样本一样对其进行处理。轮班结束时检查表面是否有污染。在美国进行的实验中，志愿者会将GloGerm溶液反复移液到96孔板中，每完成一盘后检查工作区域。
估计志愿者的中位数错误率约为每1000次操作出现4次或8次错误（分别针对有丰富实验室经验的志愿者和实验室经验较少的志愿者）。两个实验的估计错误率具有可比性，这表明使用知道自己正在处理非危险材料的志愿者进行的研究可用于复制真实的实验室条件，以提供生物安全方面的关键数据。还要求志愿者在认为自己犯错时进行申报。通过将实际错误与申报的错误进行比较，我们发现志愿者最多只能识别出其总错误的52%，这表明许多错误未被注意到。
