Modifying Regulatory Practices to Create a Safe and Effective Working Environment Within a Shared Resource Laboratory During a Global Pandemic

The SARS-CoV-2 pandemic has caused profound changes in nearly all routines associated with day-to-day life around the world. Governments and national institutions have put several regulatory guidelines in place to try and limit the spread of the virus in high-footfall, multioccupancy environments such as offices, public transport hubs, hospitals, and care homes. These have included procedures around hand hygiene, cough/sneeze hygiene, maintaining physical distancing, and the use of personal protective equipment (PPE). Shared Resource Laboratories (SRLs) are by nature high-footfall, multioccupancy environments where surfaces are touched and instruments interacted with by many different people and therefore present with the exact same challenges as other public enclosed spaces. Moreover, SRL staff often interact with several different people in normal day-to-day operation, often in close proximity. Therefore, it is highly possible that the actions of one person could have far reaching consequences for the health and well-being of other users and SRL staff. An outbreak of COVID-19 linked to an SRL would inevitably lead to serious reputational damage at both local and institutional levels. Closing down the SRL is simply not an effective solution as much of the technology and expertise housed within the facility will be essential for research into understanding the nature COVID-19 and how we can combat it. Many SRLs have rapidly adapted their operations to incorporate and adhere to regulatory guidelines driven by biosafety concerns, often imposed by governmental and institutional bodies. In this manuscript, we describe how these new regulatory guidelines can be applied to the SRL setting, and how they essentially fall into three broad categories: (1) regulation of access to the SRL space, instruments and services; (2) regulation and control of SRL space; and (3) regulation of SRL staff, user and external visitor (service engineers) behaviors within the SRL space (see Fig. 1). Ultimately, the need to adopt regulatory procedures will be driven by biosafety considerations directly related to the threat and control of SARS-CoV-2, as well as the resulting necessary modification to how the SRL operates. Both of these subjects will be covered in detail elsewhere (please see the biosafety and operations papers in this special edition). The regulatory guidelines outlined herein are based upon common guidelines that have been adopted at the authors' institutions across distinct geographical areas (UK, North America, Central America, Australia). Where possible we have also highlighted specific Government guidelines. It is important to note that determining which measures or how strictly to adopt these measures will depend on your location and the recommendations of your local government/institutional policies. When instituting new COVID-related policies in your SRL, ensure that you comply with any locally enacted guidelines and liaise with relevant safety officers. While most of these guidelines have been described for implementation within the flow cytometry SRL, they are also more broadly applicable to any SRL settings where the predominant operational model is based on multiuser access to space and instrumentation. Finally, in order to gain compliance in following the new regulatory guidelines, it is recommended that the rationale behind the guidelines be explained as new policies are enacted. Probably the most important aspect of regulating access to an SRL and its services/instruments will be ensuring that any staff member, user, or external visitor (e.g., field service engineer) does not attend if they have COVID-19 symptoms or have been exposed to someone who may have COVID-19 symptoms. There will be local institutional guidelines relating to how this situation should be handled. For any SRL that operates under a user access model, it is highly likely that there will be an established protocol for granting an individual access to the space and relevant user-operated instrumentation. This would almost certainly involve some kind of induction and training before access would be granted and also possibly a signed agreement between the trained user and the SRL staff to adhere to the rules and follow the SOPs as shown. As a result of the COVID-19 pandemic and the need to regulate personal proximity for physical distancing, 1-1 or group induction and training of users may have been suspended until further notice (suggested protocols for this will be discussed elsewhere in this special issue, please see the training manuscript). As a result, the SRL may reach a decision to only allow experienced users to enter the facility who have a proven history of competency. These “super users” will also be expected to read, agree, and adhere to any new regulatory requirements deemed necessary by the SRL leadership due to COVID-19 biosafety operational modifications. These may include increased personal hygiene, strict wearing of PPE, and informing the SRL management should they suspect they have or have been exposed to SARS-CoV-2 (see section on regulation of behaviors where we will expand on these areas). Ultimately, however, SRL staff and users must adhere to governmental and institutional policies around coming to work if they suspect they may have SARS-CoV-2 and follow the correct process of notification and self-isolation. In some institutes and workplaces, staff will be asked to undergo testing for the virus and only return to work if and when they test negative. It is not only users that may be subject to access regulations. SRL staff members may also be required to prove that they are able to return to the lab based on competency, skills, or health status. Moreover, based on a detailed appraisal of staff skills across the “business critical” SRL functions, it may be possible to split in teams or shifts in order to minimize the impact of possible staff member infection and still maintain significant operation capacity. When considering splitting into smaller teams, it may be important to regulate annual leave more strictly by setting limits on how many staff members per team can be on planned absence at one time. Within the SRL, effective management of staff safety and activity is critical during a disruption of research activity. For broad purposes, the recommendations for managing staff will be broken into three distinct stages, which will likely be dictated by institutional and local government guidelines. Staff should be alerted to imminent SRL closure as soon as possible, and team activity should focus on notifying users of closure, as well as preparing all necessary instrumentation for long-term storage. Staff should also prepare to work remotely for an unspecified period of time. Appropriate preparations may include compiling physical documents, copying computer files, and setting up remote desktop access to work computers. Once critical activities are accomplished, staff should leave the SRL immediately. Because flow cytometry is deemed essential to many projects, some parts of the SRL may continue to operate, particularly to support COVID-19-approved projects. This should be accomplished using the fewest numbers of essential personnel, who can be on-site as necessary to ensure instruments are fully functional and quality controlled. The remainder of the SRL staff should continue to work remotely. Examples of at-home work include data analysis, virtual consultation, updating standard operating procedures (SOPs), devising new SOPs, and addressing remote issues. In some cases, SRL directors may not be able to ensure the well-being of personnel (either due to COVID-19 infection or mental health distress); directors should familiarize themselves with institutional offerings aimed at promoting physical and mental health wellness, should the need arise. There are several critical activities that must be completed by staff prior to safely resuming SRL operations, examples of which are outlined as follows: Although specific guidelines for initial resumption of research may vary between institutions, recommended population densities are typically within 20–50%, including both staff and users. Note that at any time, should it become necessary, institutions may mandate a ramp-down or return to cessation of research activity. Many SRL may benefit from the fact that they have satellite facilities or instruments, which allows for necessary distancing of staff and users. This can be advantageous in increasing the amount of service that can realistically and safely be provided. When designing staff schedules, there are several shift models that can be considered; the appropriate model will vary between SRL and should consider staff preferences and space configurations. In some cases, extending hours into nights/weekends may be necessary. Some commonly adopted shift schedules are listed as follows: Regardless of the model chosen by an SRL, the following should be considered: (1) staff that ordinarily cooperate to provide services are scheduled during similar shifts or days, should they need to responsibly interact; (2) arrival and departure times for shifts do not overlap; (3) arrival and departure times are not scheduled during peak usage times of the facility, thus promoting physical distancing; (4) ongoing projects prior to discontinuation of service and requiring timely completion; (5) foreseeable unmet needs and new projects that have not yet started; and (6) child care and elder care. Note that during initial stages of resumption, it may not be possible for all instruments to be on-line and operational, as this may affect the ability of the SRL to provide service safely. SRLs contain high end, complex analytical instrumentation that require expert maintenance by external parties. Many SRLs will already have procedures and regulations in place for facilitating service engineer visits for preventative maintenance and system faults. These may include documents such as “permits to work” where the health and wellbeing of the engineer while on site will be the responsibility of the host organization/SRL. In the age of COVID-19, such documentation to regulate service engineer visits is even more essential and will include building inductions to explain access and possible one-way systems in the laboratories space. It will also provide assurances that the engineer will be working in a safe, clean environment and what PPE (if any) will be provided by the SRL and what will be required by the engineer. It is now also the case that many instrument manufacturers and servicing companies will also have their own “field service risk assessment method statement” that should be provided to all customers prior to any site visit, with the reciprocal SRL document being provided upfront also. In this way, both parties know what to expect and how each will conduct themselves to minimize and eliminate all risks for SARS-CoV2. An example of a COVID-19 “service engineer visit policy” is given in the Supporting Information S1. Current Center for Disease Control and Prevention (CDC) guidelines recommend a minimum of 6 ft (1.8 m) of distance in each direction be maintained between people at all time (1), though this may vary in other regions/institutional settings (i.e., the United Kingdom and Europe state anywhere from 1 to 2 m of distance should be maintained; Australia and New Zealand state 1.5 m; Canada and Mexico states 2 m). When setting up your SRL to maintain physical distancing, it is recommended that: When multiple instruments are present within a room, are not separated enough to allow proper distancing and no further room can be obtained, engineering controls such as Plexiglas or Perspex dividers be considered (see Fig. 2). If this is not possible, linked calendars between closely located instruments are a good mechanism to prevent simultaneous usage. Based on the current research, the transmission of SARS-CoV-2 occurs predominantly through respiratory droplets and direct contact (2). Due to this, general behaviors such as hand hygiene, surface disinfection, and maintaining physical distance are of particular importance to reduce disease transmission. Within SRLs, there are many strategies that can be easily implemented to follow these guidelines. To reduce the transmission of SARS-CoV-2, it is recommended that hands be washed with soap and water for at least 20 s; use of an alcohol-based hand sanitizer containing at least 60% alcohol is possible when hands are not visibly dirty or hand washing is not possible (3). Hands should be cleaned any time a person enters or exits the SRL, as well as after coughing or sneezing. In rooms where there is no sink and hand washing is not possible, it is recommended that hand sanitizer be made available at each workstation. It is currently recommended that users enter the SRL, wash/sanitize hands, and put on new gloves. At the end of a session, the user would then remove and dispose of the gloves, wash/sanitize hands, and leave the facility. In addition to this, it is recommended that users: It is recommended that a waste bin for used gloves and soiled tissues be placed either near the wash station or at the exit to the SRL. Current evidence shows that SARS-CoV-2 can survive on surfaces such as plastic or stainless steel for several days (4). This would encompass many high-touch surfaces in a SRL, including but not limited to desktops, keyboards, computer mice, cytometers and other SRL instrumentation, light switches, door knobs, and faucets. As such, it is recommended that these surfaces be disinfected regularly with 70% ethanol/30% water (3). The disinfection should be done with a disinfectant-soaked tissue that is used to thoroughly rub all surfaces, considering (1) that an exposure time of 30–60 s is required to properly disinfect the surface, and (2) an excessive amount of liquid should be avoided to prevent damage to electrical components. Spray bottles are not recommended for disinfection purposes. All materials used for disinfection should then be disposed of in appropriate waste bins. Instruments should be wiped down between each user either by the user themselves or by SRL staff wearing appropriate PPE for the task. Guidance from your Institutional Health and Safety office should be followed when creating SOPs for disinfection within the SRL. The chosen method must be validated or at least published as being able to deactivate SARS-CoV-2 (agent, concentration, and time). Currently, many SRLs are having users disinfect instruments and attached work areas before and after each use; other high touch areas are then disinfected by SRL staff throughout the day. If possible, it is highly recommended that water-proof keyboards be purchased or that keyboards be covered in plastic wrap that is replaced regularly (5). Within the SRL, it is recommended to avoid sharing laboratory coats, pens, or other materials that are for personal use. Each staff member and facility user should have their own personal laboratory coat, pen, and so on that is labeled and stored in a manner that prevents cross-contamination (6). The appropriate use of PPE has always been critical in reducing the exposure of personnel to laboratory biohazards and possible pathologies. Correct use of the various forms of PPE is important as it represents the last line of defense against exposure in most situations. However, with SARS-CoV-2 causing a global pandemic, the use of PPE in SRLs has had to adapt. As such, SRL directors/managers and staff have had to think beyond minimal PPE requirements for working in the SRL. Lab coats and body suits: Lab coats should be changed immediately if contaminated and should never be taken home for cleaning. Coats should be closed (buttoned) and purchased in liquid resistant material in order to minimize liquid entrapment. As an alternative, long sleeve water-resistant disposable gown could be considered as an option. A disposable protective body suit (Tyvek), gloves, and shrouds with HEPA filtered Powered Air Purifying Respirator (PAPR) are recommended for situations of sorting SARS-CoV-2 in a BSL-3 facility and in situations where processing hazardous samples for flow is needed (7, 8). This section will provide a very brief overview of guidelines for instruments. For more details, please reference the articles dedicated to flow cytometry analyzers and sorters in this special issue. Prior to the escalation of the SARS-CoV-2 pandemic, work in most of the global SRLs required the presence of personnel to carry out the tasks such as sample acquisition, cell sorting, and user training, among others. This section will discuss modification in communication techniques so SRL staff can efficiently follow regulatory guidelines and continue training, troubleshooting, and providing base services remotely (see Table 1). At the peak of the pandemic, SRL personnel largely moved to working from home, making virtual training strategies and support essential. The use of virtual meeting platforms and remote desktops has become extremely important in maintaining contact with coworkers and users. Applications such as and so on implemented in most For the use of office and such as and so on can be implemented among teams to in communication and SRL guidelines and SOPs throughout the pandemic, communication of new policies and procedures is essential. for these changes include virtual or other may have on computer by the that is not under the control of the It would be for SRLs to work these procedures out in SRLs in various day-to-day activities due to the COVID-19 pandemic, need to be or to minimize the risk of infection and spread of the As SRLs in different and some risks may not to all but Table 2 a good overview of the risks in most SRLs distancing schedules for SRL staff of equipment with and time between users. and Perspex to access disinfection of high of appropriate PPE for such an a contact using instrument of appropriate PPE distancing training using such as not of appropriate PPE to allow physical distancing of training and other material distancing sorting using such as for of appropriate PPE and up the sorting during and to be out in management system attached to use a that does not distancing surface for transmission the door during normal hours to minimize risk distancing out instruments within the room instruments to different rooms if not possible, of instruments to comply with room physical distancing distancing surface transmission hours for of of appropriate PPE to if possible, if not good hand out new to all users and teams and through document to all rooms distancing, room risk of transmission method all samples be with an method before on instruments. If not possible due to functional or time an instrument into a In with Table it is to to your safety and any as well as provide as much as possible to the implementation of appropriate regulatory guidelines. SRLs have adapted and operational procedures on multiple in light of the global pandemic of distancing has changed how SRLs interact with their both in of service and management of each in the operation of SRLs needs to be both SRL staff and users must and the of these new guidelines. to and the SRL team to minimize must and from all staff. While some tasks of the SRL are to such as and data can be done remotely. For of with and tasks not for remote access can be by on site where among SRL staff can be can and be must be discussed on a to the staff while to risk It is that the recommendations outlined within can be used to SRLs in the current situation as well as situations. Some institutes require SRLs to have an of procedures to be followed during However, these regulations is not it is also important to note that the COVID-19 situation can resulting in the need to regulatory guidelines with As such, the regulations outlined herein will need to be adapted to to the nature of the Due to the nature of SRL operations, we will need to be to and are all current SRL is also a current member of the is a member is a SRL and is a current and and and and and and Supporting Information The is not for the or of any by the should be to the for the

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