Mobilizing an Institutional Research Enterprise to Support Pandemic Diagnostic Care: Establishing a Clinical Laboratory Volunteer Operation

At Vanderbilt, MIDL is responsible for conducting polymerase chain reaction (PCR) and other nucleic acid–based techniques to diagnose bacterial, viral, fungal, and parasitic infections. As the pandemic emerged in the United States, clinical laboratories initially focused on the implementation of the Centers for Disease Control and Prevention (CDC) nucleic acid testing for SARS-CoV-2. This approach received US Food and Drug Administration Emergency Use Authorization (EUA) and required local validation as prescribed by the CLIA. In practice, though, these options remained mainly limited to the EUA assay initially developed by the CDC.¹⁵  Soon after SARS-CoV-2 testing was launched on March 7, 2020, the preeminent challenges of diagnostics shifted due to basic considerations of demand and supply. There was a massive demand for clinical testing from an alarmed public that was coupled with a now tightly allocated supply of the necessary molecular reagents from manufacturers. Equally challenging to testing capacity, particularly during the next 2 to 3 months, were issues related to laboratory labor. At the time, commercial EUA methodologies for COVID-19 were not yet widespread, especially those involving fully automated platforms that provide scalability. As a result, testing strategies were largely limited to manual or semimanual extraction techniques followed by quantitative reverse-transcription PCR (qRT-PCR), with the CDC-promoted primer/probe sets as the most viable option.

A daunting new reality for VUMC emerged during the course of just a few weeks. There became a daily need to perform 1000+ labor-intensive COVID assays in a subspecialized laboratory section with only 11 full-time technologists at the start of the pandemic. Of note, such volume represents roughly triple the previous aggregate daily testing conducted by this group. Not surprisingly, COVID-19 necessitated a rapid transition to a 24-7 scheduling model for MIDL and created a fundamental need for an expanded labor pool. Addressing this gap required a creative approach, real-time problem solving, and leadership. The rapid increase in COVID-19 specimens processed by the MIDL also highlighted a growing problem in laboratory medicine, the shortage of certified medical technologists. Additional personnel were needed to supplement full-time employees, to ensure expanded testing capabilities in the short term. Nevertheless, the specialized skill sets and credential requirements for laboratory technologists hindered the necessary increase in size of the MIDL labor pool.

Tennessee was 1 of 12 states and US territories at the start of the pandemic (California, Florida, Georgia, Hawaii, Louisiana, Montana, Nevada, New York, North Dakota, Rhode Island, West Virginia, and the territory of Puerto Rico) that required the licensure of medical laboratory technologists. Under the Medical Laboratory Board of Tennessee, licensed technologists must have laboratory work experience in addition to fulfilling specific educational requirements such as a bachelor’s degree in medical technology or in one of the biological, chemical, or physical sciences in order to qualify to work within a clinical laboratory. Due to these requirements, research professionals without a medical laboratory technologist license (ie, postdoctoral fellows or research faculty) at VUMC would have been excluded from participating in various diagnostic laboratory tasks.

On March 19, 2020, Tennessee Governor Bill Lee released Executive Order 15, which granted emergency eligibility for individuals with doctoral degrees in the basic sciences to attain temporary medical laboratory technologist licensure, if testing was performed under the supervision of a medical laboratory director.¹⁶  Through this first-in-kind order, interested and qualified volunteers could apply for this credentialing from March 23 to May 18, 2020, enabling them to assist in the medical response by performing COVID-19 testing. Never in the history of the Tennessee Medical Laboratory Board had such an emergency license been offered. Through this temporary medical technologist licensure, PhD-level basic science researchers were permitted to function as medical technologists after focused training and competency assessment in specific procedures. Even without such emergency credentialing, scientists might also engage in clinical laboratory roles not requiring licensure. Such tasks can vary among states, and in Tennessee include mainly low-complexity preanalytic processes (eg, specimen sorting, centrifuging, and aliquoting). Executive Order 15 significantly expanded potential options in analytic-phase activities. Foremost, these included assistance with nucleic-acid extraction and purification protocols, given the acute shortage of these reagents and the resultant need to implement multiple parallel processes to ensure continuity of testing. Combined, volunteers and MIDL laboratory staff were able to perform 34 790 total tests during the volunteering initiative.

While it was clear that the MIDL and related VUMC clinical teams would benefit from specialized volunteers, the implementation of such an endeavor presented challenges. The first step was to address the reality that volunteers would be working in an environment where the causative agent of an emergent pandemic was being processed. It was crucial to emphasize that all personnel in the VUMC clinical lab followed available CDC biosafety guidance for COVID-19 specimens in diagnostic settings. In retrospect, SARS-CoV-2 has not become a significant threat for laboratory-acquired infection. Nevertheless, the early weeks of the pandemic were characterized by tremendous uncertainty, as knowledge of the virus was rapidly evolving.

With institutional support, recruiting efforts for scientists began with an email to all Vanderbilt Institute for Infection, Immunology and Inflammation members employed by VUMC asking them to complete a survey indicating whether they were willing to be placed on an email list should a clinical need for their bench skills arise. This survey (generated through Google Forms [Google LLC]) collected information such as name, email address, position, highest degree earned, department, level of biosafety training, availability, and molecular biology skills. Due to the nature of COVID-19 diagnostic testing, we specifically inquired about proficiencies in RNA work. To ensure that volunteers were sufficiently trained, and in light of the licensure considerations described above, we initially only accepted volunteers holding a PhD, MD, or MD/PhD. As demand increased, the opportunity was opened to all research professionals with extensive wet-lab experience. Some activities that required specific licensing, as outlined above, were limited to volunteers with the aforementioned terminal degrees. Easier navigation of human resources was allowed due to the use of volunteers. We excluded any scientists working at VUMC not employed by the medical center (such as graduate students who were affiliated with the Vanderbilt, a corporately distinct entity). This left only one set of employment policies for navigation by the volunteer organizers and the leadership team. Of note, institutions implementing a similar initiative should investigate the eligibility of those on visas (non–US citizens) prior to recruitment. Because there are institution-dependent restrictions concerning activities that can be exerted on specific visa types, this will prevent negative immigration-related consequences for international volunteers. At the end of the volunteer recruitment stage, we compiled a list of 149 individuals who were willing to be mobilized into the clinical laboratories (Figure 1, A). Of these, 8 volunteer scientists applied to perform COVID testing and were approved by the laboratory board.

We sent out 23 separate emails during the first wave of the pandemic to announce ongoing task-specific needs in MIDL and other laboratory sections to the interested individuals. A majority of these opportunities revolved around (1) specimen receiving, sorting, and processing (1194 total volunteer hours) or (2) preparation of viral transport media (358 total volunteer hours). Sample sorting included tube triage, quality control, and data entry into the laboratory information system. Volunteers processed samples (aliquoting, centrifugation) before delivering them to the appropriate testing locations within the lab. Within MIDL, several additional opportunities covered high-complexity roles limited to volunteers with emergency licensure, including (3) nucleic acid extraction from respiratory specimens, using methods covered by the CDC-assay EUA, (4) molecular reagent preparation, qRT-PCR assays, and (5) PCR data analyses. A limited number of volunteers contributed to (6) ongoing preimplementation verification studies for the CDC assay. Finally, volunteers assisted in (7) referring COVID-19 specimens to outside clinical laboratories when testing volume still exceeded on-site capacity. In addition to the primary tasks listed above, volunteers were trained to (8) receive inventory at the blood bank in case staff became ill, a scenario that fortunately never arose during the period of our engagement. Flexible assistance among these diverse areas proved critical, given the general stresses on the entire laboratory and the need for reallocation of effort among regular personnel.

For each individual task, the organizers worked with a representative from the clinical laboratory team to match volunteers with appropriate volunteering opportunities. This included inquiries about specific training needs and past laboratory experiences prior to volunteer deployment. Documentation of training and proficiency, in fact, is required for analytic activities outside the context of state licensure in order to adhere to accrediting requirements from the College of American Pathologists (or other CLIA-approved oversight bodies). For any tasks (high complexity or otherwise) requiring an initial competency sign-off of regular clinical lab personnel, commensurate sign-off was required for volunteers. Checklists for volunteers were explicitly designed on the commensurate forms for regular staff, addressing the elements of competency for each activity as described by CFR §493.1413(b)(8).¹⁷  Even following competency sign-off, volunteers only performed tasks with on-shift oversight from a regular technologist.

Detailed sign-up sheets for each activity were integral to maintaining an organized network of volunteers. Volunteer sign-up sheets included the following information: specific task requirements (skills, licenses, etc), available shifts, personal protective equipment (PPE) required, and the contact information of the clinical lab supervisor and volunteer coordinator. These details were organized into a Google Sheet that could be edited and shared among volunteers, laboratory medical directors, and supervisory technologists via hyperlink. The sheet contained the dates and times, and was to be populated with name and emails of willing volunteers. A template for such a document can be found in Supplemental Table 1 (see the supplemental digital content containing a table and a figure at https://meridian.allenpress.com/aplm in the November 2023 table of contents).

Occasionally participants would need to cancel their shifts. To prevent disruption of laboratory personnel in these cases, each sheet included 3 to 5 slots for alternates to sign up. Fully booked sign-up sheets were shared with the clinical team to provide them with contact information and inform their own scheduling. As a courtesy for volunteers, shifts for new tasks were generally scheduled to start several days after the initial call-out. However, some emergent tasks required volunteers to cover shifts the same day due to the laboratory’s dynamic needs. Though challenging, this pace of work ensured that clinical needs were met and laboratory gaps were able to be addressed as they arose.

Our volunteering efforts for the pandemic’s first wave began on March 14, 2020, and were concluded—despite ongoing high volunteer participation—on May 15, 2020, when the halt on non-COVID research operations at VUMC officially ended. During the course of this 2-month period, volunteers covered 233 total shifts for a total of 1815 hours (Figure 1, B). Of the 149 VUMC employees who expressed interest initially, 65 volunteers actively participated in at least one shift. On average, volunteers worked for a total of 28 hours. Some of our most active scientists worked more than 100 hours, with the most active scientist working 146 total hours.

On May 15, 2020, VUMC began to reimplement regular research operations, sending volunteers back to their laboratories on a more consistent basis. Widespread volunteer operations in the clinical lab declined at that point, although all of the above resources were maintained to remobilize our team if necessary. During the subsequent “chronic” phase of the pandemic, volunteer efforts, and the underlying need, were admittedly far more restricted. Nevertheless, this extended period—which included the second US “wave” in midsummer 2020, the third peak in late 2020–early 2021, the summer 2021 “delta wave,” and the latest “omicron wave”—has provided several additional lessons for hosting scientist volunteers in the clinical laboratory. It was emphasized that volunteer operations require support from all relevant stakeholders at an institution. Notably, once regular work operations resumed, these stakeholders became more numerous compared to during the pandemic-forced lockdown. As work conditions changed, time commitments for laboratory volunteering had to be weighed against time commitments for full-time research activities, and it was important to define the expectations of the volunteers’ regular supervisors or principal investigators.

An important consideration stems from the funding mechanisms that support scientist volunteers as part of their regular research activities. Many sources, including federal funding, stipulate the effort breakdown of supported scientists (ie, time devoted to a specific grant or project). Once routine work activities resumed, it had to be clarified on a volunteer-by-volunteer basis whether their particular funding source(s) might interpret it as a conflict of effort for them to volunteer in an alternate laboratory environment at the same institution. Overall, large-scale volunteering becomes much more challenging once routine scientific activities resume, despite continued enthusiasm among potential volunteers for serving the community. In this context, volunteer efforts at VUMC during the aforementioned July 2020 wave were limited to a small number of individual cases (<100 total volunteer-hours), and volunteer efforts were not mobilized at all during the 2020–2021 winter wave. This dynamic was effective, given that the fundamental purpose of such volunteering is to address specific challenges that cannot be addressed in any other way, allowing the institution to adapt their regular operations to the long-term phase of an emergency (via employee restructuring, additional hiring, and technology procurement).

The most recent COVID-19 delta and omicron waves briefly precipitated yet another resurgent need for additional clinical laboratory effort. Nevertheless, in line with the above sentiments, our institution opted not to mobilize volunteers but temporarily onboarded medical center staff with compensated supplemental pay. In general, this scenario highlights an important decision point that institutions may face: whether mobilizing volunteers or recruiting overtime staff is a more effective and appropriate strategy for addressing emergency needs. While there may be no universal criteria for navigating this fine line, key considerations include (1) the ability of either staffing modality to meet critical needs and (2) whether routine work activities of volunteers are suspended at the time (eg, due to pandemic lockdown).

Finally, a recent development in Tennessee highlights another consideration when incorporating emergency staff (volunteer or paid) into a clinical laboratory. It was discussed above how an important factor at VUMC was Tennessee’s licensure requirements for medical technologists and how they impacted the tasks that volunteers could perform, with and without emergency declaration. Of note, however, such requirements are not necessarily static. In fact, in recent months, Tennessee legislatively amended its licensure requirements for clinical laboratory staff, exempting technologists employed by “private” laboratories, and including in that exemption “hospital-based” laboratories.¹⁸  This law changes Tennessee state requirements for technologist credentialing to the level of individual employers, as it already stands in many other locations. Needless to say, such laboratory-quality discussions are complex, and institutional policies must be weighed in light of local circumstances at a given time (at baseline or during an emergency).

After the completion of volunteer-driven activities related to the COVID-19 crisis, we evaluated the entire volunteering process through the perceptions of participating members. To do so, a survey was created to assess the experiences and observations of participating volunteers. The survey was distributed to the volunteers 73 days after completion of their last shift. It contained questions pertaining to the volunteering experience, including (1) communication clarity and timeliness, (2) sign-up process for volunteering shifts, (3) individual preparedness for and performance of laboratory tasks, (4) interactions with professional laboratory personnel, and (5) laboratory safety conditions. We received 37 survey responses from a total of 65 volunteers who were active in these efforts (response rate: 57%). The average survey respondent worked 37 hours, which was slightly above the average of 28 volunteer hours contributed across the entire pool of volunteers.

First, we assessed volunteer preparedness for the various tasks required during their shifts, and whether additional training specific to their work in the clinical laboratory setting would have been beneficial. Of note, all volunteers had extensive prior experience navigating and performing tasks in a laboratory environment, either through advanced degrees related to biomedical sciences or through professional positions that require work in a research laboratory setting. Additionally, 11 of 37 survey respondents (29.7%) reported previous exposure to a clinical laboratory setting (Supplemental Figure 1, A). Although day-to-day routines in biomedical research differ from the practices in a clinical laboratory (eg, quality control and organizational schemes), all volunteers reported that their scientific background at least somewhat prepared them for their respective tasks (Supplemental Figure 1, B). The combination of previous lab experience and guidance from trained diagnostic laboratory personnel was credited for this level of comfort with the tasks. Correspondingly, only 5 of 37 respondents (13.5%) reported that they would have preferred additional training opportunities to be available (Supplemental Figure 1, C). These volunteers suggested improvements to preparation, such as (1) distributing explicit standard operating procedures via email prior to volunteering; (2) offering a more extensive introduction to the clinical laboratory setting and explanation of specific relevant tasks, especially during shifts where fewer clinical laboratory personnel are present (ie, night or weekend shifts); and (3) providing additional relevant biosafety information. In general, active communication with volunteers concerning challenges that might arise during the process should be encouraged, as this allows for quick adjustment and optimization of procedures. These lines of communication are particularly important in an environment where direct communication between volunteers and clinical lab leadership might not always be possible, and the volunteer coordinators serve as liaison between the different parties. Additional feedback could be solicited during the sign-up period or after the first shift to assess whether volunteers would like to receive additional training before continuing their shifts.

During this effort, communications were carried out via email. It was important that communications with volunteers through email were (1) limited (eg, by combining calls for volunteers for multiple tasks) and (2) spaced out to avoid information overload.¹⁹  This resulted in approximately 2 to 5 weekly emails sent to the entire volunteering list to relay information regarding new volunteering opportunities or updates on current tasks. Accordingly, 33 of 37 respondents (89.2%) reported that this was an appropriate amount of email correspondence, while the remaining 4 respondents would have preferred slightly more communication (Supplemental Figure 1, D). Every email sent to solicit volunteers contained a link to an online Google spreadsheet that was used to sign up for shifts and share contact information. In our survey, all volunteers acknowledged the efficiency of the Google sign-up sheets (Supplemental Figure 1, E). To assess any privacy concerns (ie, related to the public nature of the Google documents and the display of volunteer contact information), we also asked volunteers for specific feedback on this topic. Although 36 of our 37 respondents (97.3%) did not report any privacy concerns, a balance between effective communication among volunteers and organizers and the protection of privacy should be determined at the beginning of the volunteering period, preferably in close exchange with volunteers (Supplemental Figure 1, F).

Significant effort was made to include a period of several days between the original request to volunteers and the first shift. Correspondingly, 33 of 37 respondents (89.2%) reported that the time between a request for sign-ups and the related shift was sufficient, while 4 volunteers (10.8%) would have preferred slightly more time (Supplemental Figure 1, G). To better estimate the optimal timing for volunteer requests, we asked volunteers for their preferred time frame between sign-up and the first available shift: 9 volunteers (24.3%) preferred 1 to 3 days, 18 (48.6%) chose 4 to 6 days, 8 (21.6%) preferred 7 to 9 days, and 2 respondents (5.4%) preferred 10 to 12 days (Supplemental Figure 1, H). These findings show that a planning period of 6 days or slightly less was ideal to ensure appropriate planning for tasks without resulting in excessively long waiting periods.

Depending on the laboratory needs and availability of clinical lab personnel to ensure training and supervision, volunteer shifts were scheduled at varying times during the day. We anticipated night shifts to be potentially challenging, as these work hours contrast with regular research laboratory and academic setting schedules. Combined with many volunteers opting to work several shifts per week and the stress of working in a new environment, we considered the possibility that volunteers may feel their participation was too taxing at times. Therefore, volunteers were asked if they had ever felt overwhelmed or overworked during the period of their participation. Notably, 36 of 37 respondents (97.3%) reported no such feelings (Supplemental Figure 1, I). Since it is essential to avoid volunteer burnout to ensure the effectiveness of ongoing volunteering efforts, we suggest assessing the preferred work hours of the specific volunteer group. Shifts can then be scheduled according to the availability and preference of the volunteers. Consequently, we asked volunteers which of the available shifts they preferred. Multiple answers were allowed to capture if volunteers were available and willing to work different shifts. In our group, the majority of the 37 volunteers that participated in the survey elected the morning (20 respondents [54.1%]) or afternoon (24 respondents [64.9%]) shifts, while fewer favored late afternoon–early night or overnight shifts (13 [35.1%] and 6 [16.2%] respondents, respectively) (times of individual shifts indicated in Supplemental Figure 1, J).

One of the most important components of a safe and ultimately productive workplace is the implementation of sufficient safety measures, such as the available PPE and adherence to occupational and biosafety guidelines. In our survey, 33 of 37 of respondents (89.2%) reported that work in the clinical laboratories felt safe and that sufficient PPE was available to them (Supplemental Figure 1, K). In contrast, the remaining 4 respondents (10.8%) reported some safety concerns, several of which were readily addressed during the volunteering period. Specifically, some volunteers criticized the lack of face masks at the beginning of the pandemic, which was resolved once national guidelines suggested the use of face coverings. Another point of concern was centered around challenges for social distancing within the laboratory. To this end, it is essential that institutional occupation guidelines are followed and appropriate distancing is ensured. Lastly, several volunteers emphasized their preference to work in designated biosafety cabinets, which were made available to volunteers.

Another aspect of a positive work environment is interaction and communication between the volunteers and the personnel of the clinical laboratory. This is particularly important during phases of high work volume and uncertainty, as has been experienced during the COVID-19 crisis. Thus, we asked volunteers to rate their interactions with the clinical lab employees. Very friendly or friendly interactions were reported by 18 (48.6%) and 15 (40.5%) of 37 respondents, respectively (Supplemental Figure 1, L). Of note, volunteer organizers and other Vanderbilt groups (ie, graduate student and postdoctoral associations) actively tried to foster a positive atmosphere by delivering food and notes of encouragement to the clinical lab members and volunteers.

Finally, we assessed the main motives behind participants’ decisions to volunteer and their willingness to volunteer again if a need arises in the near future (Supplemental Figure 1, M). Our survey showed that the individual reasons why volunteers participated were diverse, but often driven by the desire to help their community and colleagues during the pandemic. Volunteers were also motivated by an interest in continuing hands-on scientific activities and advancement of clinical laboratory experience. Altogether, these motivations demonstrate that volunteering operations can be beneficial to all parties involved: (1) clinical laboratories receive much-needed support, (2) volunteers are provided opportunities to acquire clinical lab experience, and (3) most importantly, communities have adequate access to health services during a healthcare crisis. In accordance with the positive experience reported, 35 of the 37 volunteers who participated in the survey (94.6%) suggested that their additional future participation was likely or somewhat likely (Supplemental Figure 1, N). These results indicate that the volunteering efforts not only had a measurable positive impact on the operations of the clinical laboratories, but also were perceived as positive and rewarding experiences by the volunteers.

The COVID-19 pandemic has presented many unique challenges. Fortunately, there are also countless examples of members of society stepping up to meet those challenges within the healthcare setting, whether that involve making masks, providing meals, or taking temperatures. Within the VUMC community, biomedical researchers represent a group of uniquely trained individuals. These highly skilled bench scientists possess specialized proficiencies such that they can support the clinical laboratories at VUMC, such as MIDL and other clinical laboratories, during an increase in the demand for clinical laboratory work. Through the use of surveys, spreadsheets, and email communication, we were able to organize a group of scientists spanning more than 15 academic departments to safely step into the diagnostic laboratories and help to meet the needs of the Nashville community. This effort potentiated a substantial amount of work to support the clinical team during the start of what would become a historic pandemic. The efforts of the volunteers provided the MIDL and others the power needed to transition to a program that could manage the increased demand for clinical microbiology presented by COVID-19. We believe that similar volunteering could be implemented at other institutions and medical centers should the need arise. To aid such institutions in the organization of similar volunteering initiatives, we have summarized our experiences in a roadmap outlining our approach (Figure 2). Of note, some of these steps involve questions that an institution could define even before any particular need for volunteers arises. By defining these regulatory and logistical questions in advance, a clinical laboratory could anticipate their potential options and reduce the time needed to operationalize volunteer activities.

We would be remiss to not end with a message of immense gratitude to each and every one of our volunteers; this would not have been possible without your courage and resilience.