JMIR Publications

ABSTRACT

Introduction The SARS-Cov-2 pandemic has led to many countries implementing lockdown procedures, resulting in the suspension of laboratory research. With lockdown measures now easing in some areas, many laboratories are preparing to re-open. This is particularly challenging for clinical research laboratories due to the dual risk of patient samples carrying the SARS-CoV-2 virus and the risk to patients being exposed to research staff during clinical sampling. To date, no confirmed transmission of the virus has been confirmed within a laboratory setting, however operating processes and procedures should be adapted to ensure safe working of samples of positive, negative, or unknown COVID-19 status. Objectives In this paper we describe a framework for re-opening a clinical research laboratory and resuming operations with the aim to maximise research capacity whilst minimising the risk to research participants and staff. Methods This framework was developed by consensus among experienced laboratory staff who have prepared to re-open a clinical research laboratory. Results Multiple aspects needed to be considered to re-open a clinical laboratory. We describe our process to stratify projects by risk, including assessment of donor risk and COVID-19 clinical status, the COVID-19 status of the specific sample type, and how to safely process each sample type. We describe methods to prepare the laboratory for safe working including maintaining social distancing through signage, one-way systems and access arrangements for staff and patients, limiting staff numbers on site and encouraging home working for all non-laboratory tasks including data analysis and writing. Shared equipment usage was made safe by adapting booking systems to allow for the deployment of cleaning protocols. All risk assessments and standard operating procedures were re-written and approved by local committees, and staff training was initiated to ensure compliance. Conclusion Laboratories can adopt and adapt this framework to expedite re-opening a clinical laboratory during the current COVID-19 pandemic while mitigating the risk to research participants and staff.