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Mitigating Health Risks to Reopen a Clinical Research Laboratory During the COVID-19 Pandemic: A Framework.

ABSTRACT: Background: The COVID-19 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 reopen. This is particularly challenging for clinical research laboratories due to the dual risk of patient samples carrying the virus that causes COVID-19, SARS-CoV-2, 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.

Objective: In this paper, we propose a framework for reopening a clinical research laboratory and resuming operations with the aim to maximize research capacity while minimizing the risk to research participants and staff.

Methods: This framework was developed by consensus among experienced laboratory staff who have prepared to reopen a clinical research laboratory.

Results: Multiple aspects need to be considered to reopen 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 nonlaboratory 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 rewritten and approved by local committees, and staff training was initiated to ensure compliance.

Conclusions: Laboratories can adopt and adapt this framework to expedite reopening a clinical laboratory during the current COVID-19 pandemic while mitigating the risk to research participants and staff.

SUBMITTER: Walker EM

PROVIDER: S-EPMC7721628 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Mitigating Health Risks to Reopen a Clinical Research Laboratory During the COVID-19 Pandemic: A Framework.

Walker Eloise M EM Jasper Alice E AE Davis Lauren L Yip Kay Por KP Faniyi Aduragbemi A AA Hughes Michael J MJ Crisford Helena A HA Spittle Daniella A DA Sapey Elizabeth E Belchamber Kylie B R KBR Scott Aaron A

JMIR research protocols 20201204 12

<h4>Background</h4>The COVID-19 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 reopen. This is particularly challenging for clinical research laboratories due to the dual risk of patient samples carrying the virus that causes COVID-19, SARS-CoV-2, and the risk to patients being exposed to research staff during clinical sampling. To date, no ...[more]

PMID: 33146625

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Project description:Health services researchers within the Veterans Health Administration (VA) seek to improve the delivery of care to the Veteran population, whose medical needs often differ from the general population. The COVID-19 pandemic and restricted access to medical centers and offices forced VA researchers and staff to transition to remote work. This study aimed to characterize the work experience of health service researchers during the COVID-19 pandemic. A REDCap survey developed from the management literature was distributed in July 2020 to 800 HSR&D researchers and staff affiliated with VA Centers of Innovation. We requested recipients to forward the survey to VA colleagues. Descriptive analyses and logistic regression modeling were conducted on multiple choice and Likert scaled items. Manifest content analysis was conducted on open-text responses. Responses were received from 473 researchers and staff from 37 VA Medical Centers. About half (48%; n = 228) of VA HSR&D researchers and staff who responded to the survey experienced some interference with their research due to the COVID-19 pandemic, yet 55% (n = 260) reported their programs of research did not slow or stop. Clinician investigators reported significantly greater odds of interference than non-clinician investigators and support staff. The most common barriers to working remotely were loss of face-to-face interactions with colleagues (56%; n = 263) and absence of daily routines (25%; n = 118). Strategies teams used to address COVID-19 related remote work challenges included videoconferencing (79%; n = 375), virtual get-togethers (48%; n = 225), altered timelines (42%; n = 199), daily email updates (30%; n = 143) and virtual team huddles (16%; n = 74). Pre-pandemic VA information technology structures along with systems created to support multidisciplinary research teams working across a national healthcare system maintained and enhanced staff engagement and well-being. This study identifies how the VA structures and systems put in place prior to the COVID-19 pandemic to support a dispersed workforce enabled the continuation of vital scientific research, staff engagement and well-being during a global pandemic. These findings can inform remote work policies and practices for researchers during the current and future crises.

Dataset Information

Mitigating Health Risks to Reopen a Clinical Research Laboratory During the COVID-19 Pandemic: A Framework.

Publications

Mitigating Health Risks to Reopen a Clinical Research Laboratory During the COVID-19 Pandemic: A Framework.

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