When Laboratory Medicine Rose to the COVID-19 Challenge

When New York confirmed its first COVID-19 patient, no one could have anticipated the tidal wave that would later crash into low-income neighborhoods like the Bronx. Here, five pathologists from Montefiore-Einstein share their accounts of the pandemic – and how the pathology department was able to rise so quickly to the challenge of bringing service and care to the surrounding communities.

Amy Fox, Vice Chair, Clinical Research; Division Chief, Point of Care Testing & Outreach Laboratories; Advisor, Molecular Infectious Diseases Diagnostics; and Professor, Montefiore Einstein Department of Pathology, Bronx, New York, USA

I was, at the time, director of our Virology Laboratories. By the time we got a call from the New York State Department of Health, announcing that they were allowing our laboratory to perform COVID-19 in-house testing, we already had patients suspected of having COVID-19 in the hospital. However, no one could have anticipated the full scale of what was to come, and it wasn’t until the significant increase in the numbers of possibly infected patients coming through our doors that we began to understand the severity of what was happening.

We quickly realized that we would outgrow our in-house capacity for laboratory testing using the initial platform we had started with (under an Emergency Use Authorization). That’s when I started reaching out for assistance from everyone who I thought might be working on COVID-19 testing. At the same time, we reached out to colleagues and industry partners, asking them to put us on their list for platforms and reagents as they were being developed. Shortly after that, I learned that the prioritization and distribution of supplies was being controlled at the level of the White House – a shocking, distinct difference between this pandemic and any public health emergency we had been through previously. In fact, I can’t recall a time in my 30-year career when we were getting information filtered through industry leaders who had been in communication with the White House. It was surprising – and totally unprecedented.

The Montefiore leadership immediately accepted what we needed to do and we had ongoing, weekly meetings with C-suite leaders – constantly sharing information in a bi-directional fashion. The pandemic is the only time I’ve been given carte blanche – a blank cheque – to get the job done. That empowerment, though initially scary, allowed us to build in redundancy and reach out to all of our industry partners; there was no way we were going to put all our eggs in one industry basket.Our partners reciprocated with nothing but kindness – understanding our need to build in redundancy; within a short time, we were up and running on six different platforms. You can imagine the impact this had on laboratory staff and the need for cross-training, but our team functioned like a master ballet troupe. My own energies were split between oversight on the clinical lab side of testing on multiple platforms and working with the research team on developing COVID-19 antibody testing. Everyone stepped up and brought their A-game, which resulted in a strong partnership among Einstein researchers, infectious disease colleagues, and clinical laboratorians.

A sense of camaraderie
Over time, the intense energy and enthusiasm of the moment has waned, but the camaraderie remains. Though SARS-CoV-2 is no longer the focus of every project, there is still something special about having gone through that unique experience with our scientists, clinicians, and clinical colleagues. We entered into and emerged from the trenches together and, though I would never want to do it again – and we can’t forget that we’re still living through the pandemic – the relationships forged during those days of the acute crisis are the silver lining in this awful cloud. 

At the same time, the pandemic has highlighted some real challenges ahead. For example, medical technologists are in seriously short supply in the US and, in particular, in New York. What’s the solution? The answer is complicated and costly. Laboratory medicine needs a bigger seat at the table. While the role of “the lab” has gained a degree of recognition on the national and global stage as a result of COVID-19, I’m not so sure that we, as laboratory medicine professionals, have done a good job of capitalizing on the increased visibility. 

Looking back, looking ahead
We need to reflect and ask what we could have done differently when COVID-19 first took over the Bronx; however, I believe we should also be asking this same question of our organizations and professional societies. There was a lot of misdirection early on in the US and, by the time laboratory professionals were finally allowed to voice an opinion, the situation was beginning to resolve. But how much time was lost? What if the CDC had sought guidance earlier from laboratory directors at major university hospitals who have been doing this type of work for a long time? Instead, CDC officials waited until the last days of February 2020 to announce that testing was being opened up to our laboratories – a decision that came down without warning. Although we can’t go back and change the past, the input of experienced laboratory professionals would have been valuable early on, and would have avoided significant delays in diagnostic test implementation.

At Montefiore, we’ve always taken care of those who have no one else to care for them. Here in the Bronx, where we work with one of the poorest patient populations in the US, there was not a single healthcare professional in our Montefiore Einstein community who did not go above and beyond. The pandemic has shown us that when an unanticipated, horrific situation arises, the humanity of every individual has the potential to surface. When you’re in the midst of a crisis, seeing the best of humanity all around you is what keeps you moving forward.

Everyone who enters the trenches emerges differently; the question is, what happens the next day? Many of my colleagues are reevaluating whether they want to stay in healthcare. For others, the pandemic has given a sense of clarity about what’s important. I just hope it’s sustainable, that those of us who have been granted this clarity can hold onto it, and that it guides us through whatever comes next.

Lucia “Lucy” Wolgast, Director, Clinical Pathology Laboratories, and Associate Professor, Montefiore Einstein Department of Pathology, Bronx, New York, USA

We were preparing for COVID-19 even before admitting our first patient; working with New York State to test persons of interest, trying to screen people who were coming into our emergency department, and developing in-house testing. The day we admitted our first patient, I met with the laboratory staff to reassure them that we had the right safety protocols in place while encouraging them to get on board with our important mission. Initially, there were a few people who were nervous – but who wouldn’t be? Nevertheless, throughout the pandemic everyone stepped up, asking what needed to be done, rather than what they had to do. 

The Bronx was one of the worst-hit counties in the US. Usually, it’s a very active place but, on the day we shut down, all was quiet; looking back, that was probably one of the saddest moments – seeing the vibrancy of the city and neighborhood suddenly stripped away. The Bronx was suddenly a ghost town – until you stepped through the doors of the hospital into complete chaos. Our mission was clear: to fight the pandemic and take care of our patients. But I also needed to make sure the staff were okay – and that they could physically and mentally handle what was happening. I not only oversee the lab staff with testing but also the phlebotomy staff – and they really had it rough. They were going to the COVID-19 floors and drawing blood from patients, witnessing firsthand the scale of the illness. I tried to be as supportive as possible and constantly checked up on them. They were risking their lives to take care of patients and do their jobs, and I was just their cheerleader as we all tried to get through our days together.

The COVID-19 Command Center
The week we started testing, it was like a tidal wave of swabs hitting the lab. They were coming in from everywhere – the pneumatic tube systems, people dropping off at the STAT window, and, eventually, deliveries and courier services from our collection tents. I couldn’t believe how quickly the volume increased – we had “the test” and everybody wanted it. We realized that we simply couldn’t do it all in one place – we also had other testing to do – so we decided that all the swabs and processing should be in a dedicated space with a whole new processing team. And that was the start of Montefiore’s COVID-19 Command Center. However, the day we started construction, I suddenly felt so exhausted that I had to go home. I woke up the next morning to many phone calls about the center, but I had a fever so I couldn’t go into work. The next day, I found out I had COVID-19. Wendy Szymczak and Sean Campbell were assigned as the new heads of the center. 

New workflows
When I came back to work two weeks later, other staff were out with COVID-19 and I mobilized the surgical pathologists – who no longer had surgical cases to sign out – to cover crucial laboratory areas that needed oversight. A few covered one of the Emergency Department’s rapid response laboratories that was expanding its COVID-19 PCR testing. A few helped support the phlebotomy team on the morning rounds, which were very busy with patient draws. At that point, all the inpatient floors had COVID-19 patients and the clinical teams were ordering numerous tests. The phlebotomy staffing levels were not keeping up with the volume of orders and patient draws and, many times, the phlebotomists were returning to the same patients several times a day. Concerned about their safety and burnout, I knew we needed to standardize test ordering for the inpatient COVID-19 patients. To help with this, we created order sets in collaboration with the IT and clinical teams that included all the tests we felt were important for COVID-19 monitoring. This led to less-frequent blood draws because all relevant tests could be drawn at a single time by the phlebotomist, on a schedule with limited contact between the phlebotomists and COVID-19-positive patients.

Some operational challenges were mitigated when we created the new COVID-19 inpatient order sets, updated our COVID-19 PCR ordering into expedited and routine orders, and expanded our courier services. Over time, we no longer needed the command center; we dismantled it after a couple of months, but we are keeping the new ordering systems in place and even applying them to our day-to-day, non-COVID-19 work. The pandemic was a lesson in the need to be fully prepared; it’s almost irrelevant what the next challenge is, as long as you have the right foundation in place. For me, that meant to have a ready and willing laboratory team, to communicate with them effectively, and to gain their trust – all while listening to their feedback and making adjustments along the way. Collaboration has been at the heart of our pandemic fight – not only within our teams, but across departments with our Albert Einstein College of Medicine colleagues in the development of antibody testing for COVID-19. I can only hope this collaborative spirit endures post-pandemic.

Sean Campbell, Associate Director, Clinical Chemistry and immunology Laboratories, and Assistant Professor, Montefiore Einstein Department of Pathology, Bronx, New York, USA

At the end of February 2020, I was in Spain. As soon as I got back to the Bronx, everything exploded and I was appointed second-in-command of our new, under-development COVID-19 Command Center (Lucia Wolgast had tested positive for COVID-19, as she mentioned above). Everything happened so rapidly that sometimes it felt like we were just trying to keep our heads above water. Within the first week of Montefiore’s first confirmed patient, we had set up the command center as a triage center for specimens, with multiple reference labs that we could send to – we received all the samples for COVID-19 testing, made sure the testing was accurate, checked in on the patient’s condition, and directed samples to the most appropriate lab. At first, we were sending all samples to reference labs, but as testing was increasingly brought in-house, we had decisions to make. Next, rapid testing appeared; it only took 45 minutes but was highly restricted in terms of volume, so we had to decide between rapid testing versus traditional testing.

While we were dealing with everything changing almost minute to minute, there was a very real and understandable fear amongst our clinicians. We came close to running out of reagents for tests; because patients were being tested multiple times per day, it was hard to keep stock. To help staff the command center, medical students joined the fray – and they were absolutely incredible, doing incredible work right in the thick of it. They ensured that everything got to each lab; if something went missing, they tracked it down. They also made protocols and flowcharts, and ensured processes were consistent across shifts. Alongside the shifting requirements of COVID-19 testing, they also dealt with the other volumes of the lab – and because they were willing to take that pressure off the main lab, it meant the command center was able to do an incredible job.

On top of that, Montefiore rapidly expanded its ability to take in patients. We had about 800 beds but, at our peak, we had around 1,200 concurrent COVID-19 patients. Even now, you can see the remnants of our setup; for example, we have an auditorium that has false walls and hookups for oxygen. We rapidly converted every available space – even our children’s hospital essentially shut down and was turned into an adult hospital and ICU.

Even in the early stages of the pandemic, ensuring the technologists had the right supplies was not straightforward – everyone got hit with surprise needs, particularly for tests that we only occasionally needed prior to the pandemic. Sure, we could do the tests – but we weren’t expecting the sheer volume. PCR reagents were running out everywhere… And we even had people with 3D printers explore the potential of making swabs! At the time, I was associate director of our Hematology and Coagulation Laboratories and worked closely with Clinical Chemistry. We were lucky that very few of our technologists got sick, which meant we were able to keep the lab on track; without technologists, the lab comes to a standstill.

As far as current challenges go, we still encounter supply issues and shortages, but they tend to change from week to week. Our biggest challenge now is burnout. We’ve been dealing with the pandemic for over 18 months now and our technologists have been working extremely hard the whole time. There’s no quick fix for this, considering the pandemic is still ongoing, but we try to support everyone the best we can so we don’t have issues with people retiring early or leaving because they can no longer handle the constant stress.

The pandemic has at least had a lasting impact on the visibility of laboratory medicine. Locally, it has been helpful in prompting collaborations and relationships with departments we wouldn’t have usually connected with. Personally, prior to the pandemic I had not had opportunities to forge relationships with the infectious disease or emergency department teams. The pandemic brought us together and I have formed meaningful, professional relationships with my colleagues across the institution that I will take with me as we go forward.

Wendy Szymczak, Director, Clinical Microbiology Laboratory, and Associate Professor, Montefiore Einstein Department of Pathology, Bronx, New York, USA

I actually don’t remember our first confirmed patient, but I remember when we started getting patients who were at least suspected of having COVID-19. We knew something was coming and we started to have regular meetings about what we were going to do and how we couldn’t do testing because, at that time, the health department was the only place that was able to offer testing. We knew we would have to come up with a workflow to coordinate testing with them – but how? How were we going to get the specimens? How were we going to keep track of everything? What safety protocols did we need to change and implement? There were many unknowns.

Luckily, some of our faculty members and lab directors had been through previous, smaller pandemics like swine flu in 2009 or the first SARS pandemic, so there was at least some collective knowledge that we could draw upon. From that, we developed a preliminary plan for simple things, like how to deliver specimens, so when our infectious disease colleagues sent an email letting everyone know we had our first suspected patient and that they met the health department’s testing criteria, we were prepared to send the specimens out for testing. That day we had one specimen, the next day we had three or four; the day after 20, and then 100 – there was an exponential growth and we had to rapidly come up with new processes to handle the large influx. I admit, I did make some slightly naive assumptions that the health department would be able to do a lot of the testing, that there wouldn’t be such a need for us to bring it in-house, and that we wouldn’t receive such a large volume of specimens so quickly. Fortunately, there were others in our department who knew we needed to start thinking about having the capabilities to do testing on site and guided us to start developing it early on.

There was a lot of adrenaline – I think I was on autopilot a lot of the time, but it felt good to have a job where I could come to work and feel like I was doing something to contribute. Not knowing what was going on or what was going to happen was a really out-of-control feeling. And it was hard coming to work in the Bronx; I live in the city and take the train to work every day, and at the start of the pandemic I had to walk past a truck with bodies on it to get to Montefiore – the truck was from a neighboring hospital, but I knew we had them too. It was an awful thing to walk by and see every day. But once I got into work, it was a unique experience – I had never known everyone working together so efficiently. Nothing was siloed; we were working within our department and also collaborating with our colleagues in such a well-organized and efficient manner. Everyone was so involved and wanted to do whatever they could to help.

Time to centralize
We realized early on that we had to change our workflows because we didn’t have the infrastructure in place for the large volume of SARS-CoV-2 specimens we were receiving. The command center was set up as a centralized location in which we could have dedicated staff to triage specimens for SARS-CoV-2 testing, while clinical teams could communicate with us and we could provide guidance and answer any questions they had.

Within a few days of conceptualizing the center, we came up with how many staff we would need for 24/7 coverage, identified physical locations for the room, and secured computers, phones, and a network for it. Unfortunately, two days later, the lab director came down with COVID-19, so Sean Campbell and I were put in charge and we worked together to direct the command center, teach the medical students and dental associates (who we used to staff the center) to come up with protocols, and oversee the overall operation. Eventually, our pathology residents and some of our colleagues from anatomic pathology also helped out. It was a real collaborative effort to keep the center functioning.

Once we brought in our first SARS-CoV-2 PCR-based test, we only had a certain number of reagents per day, so we had to decide the amount of specimens that were going to either go to the health department or to reference labs once they started offering tests. We decided to test the high-acuity patients that needed faster turnaround times in our in-house platform, but we still had to make the decision of who gets what – we needed staff who could actually make a clinical decision based on how the patient was doing. And that’s why it was helpful to have medical students in the command center – they had basic knowledge to be able to handle those tasks and helped us develop protocols as we brought in more and more testing platforms and then transitioned to all in-house testing.

Collaborative effort
The pandemic was one of the first times that our clinical labs worked with basic science researchers at the medical school to rapidly develop a clinical assay. Some of the concepts for our antibody testing were actually developed by our colleagues before manufacturers were releasing similar. The command center staff retrieved remnant serum specimens from patients with and without COVID-19 so that these specimens could be used to develop and validate serology tests. My colleagues within clinical pathology worked alongside the basic research teams to compare test performance for several serologic assays and to ask new research questions. The project really built a bridge between us and our basic research scientist colleagues. 

In the future, what I’ve learned from this experience is that you have to start building testing capabilities much earlier than you initially think. And I think there needs to be more pandemic preparedness across the board. In short, I hope that COVID-19 – and the realization that the lab is here behind the scenes to help – will be used to prepare for future outbreaks.

D. Yitzchak “Yitz” Goldstein, Director, Virology Laboratories, and Assistant Professor, Montefiore Einstein Department of Pathology, Bronx, New York, USA

On March 1, 2020, New York City had its first confirmed case of COVID-19. By then, our pathology department was working with the various city and state health departments on testing of suspected cases and had also begun validation of our own SARS-CoV-2 assay to rapidly test our most seriously ill patients (though it was still tentatively called 2019-nCoV at the time). Although FDA guidance was often found to be lacking in those early days, we quickly completed and submitted our Emergency Use Authorization paperwork to the FDA for clinical testing and performed our first clinical test on March 9. The days and timing are clear in my mind because, within a few short days, our hospital was hit – and hard. 

Quickly realizing the demands were outstripping the laboratory capacity, we began plans to implement many different testing platforms to meet the needs of our patients. In such a densely populated area like the Bronx, it was hard to know where COVID-19 was and where it wasn’t. In the beginning, patients were told to stay at home if they were stable; we couldn’t do any better without ensuring increased testing availability. It was a frightening time. Running through the reports of patients each week, one single word became far too prevalent: Deceased. It was shocking to see the number of patients being lost to an overwhelmed system.

Three-phase collaboration
Everything we could possibly do, we tried and, eventually, we built three components to the lab that coincided with the three phases of testing: the pre-analytic phase, analytic phase, and post-analytic phase. In the pre-analytic phase, we needed to triage COVID-19 patients – the Command Center was the solution for that and it was the central part of this phase of testing.

The analytic phase of testing was next. At each stage of the pandemic, we incorporated new technologies to ensure sufficient throughput, ultimately operating seven or eight different testing platforms. This was necessary to overcome the massive international supply chain disruptions that we began to experience. Having this much redundancy ensures that if one manufacturer was short on supplies we could pivot seamlessly to another who could provide them.

In the post-analytic phase, the information flow had to get back to the clinicians in a reasonable amount of time. It was pandemonium in the beginning and, because we didn’t have efficient IT solutions in place for something as simple as a clinician order, we still needed ways to get specimens to the laboratory. Clearly, the flow of information is essential to the three phases of clinical laboratory testing, and it needs to be near instantaneous, so we worked with our IT partners and very quickly became a well-oiled machine to achieve the ideal workflow.

The work was happening from the bottom up, and the fact that we were constantly communicating throughout the hospital – with managers and directors at the bench – was a powerful approach. However, the work could not have been possible without our technologists. These men and women are the gasoline on which our internal-combustion engine continues to run, and they are owed more thanks and appreciation than can be showered on them in a lifetime. They worked harder than I had ever seen, voluntarily changing their schedules to expand laboratory operations and simply ensure that as many samples as possible could be completed by our lab. From all directions, we joined forces in the middle to effectuate change at a rapid pace – something that may have been unique to Montefiore because of the mutual respect and trust we have for each other. The technologists who performed the hundreds of 1000s of tests at Montefiore really deserve the highest commendation for their efforts – without question.

There is an entire world of medical laboratory technology that is completely hidden – not only from patients, but often from our clinician colleagues, as well. While a sample may be dropped off at the lab and clinicians magically get a result in the lab system, there is too little taught about what we actually do in the lab. COVID-19 has exposed the value of the laboratory sciences to a broader population that have taken an interest in it and will continue to ask questions. The fact that more people than ever now understand what a PCR test is versus an antibody test is a remarkable feat for the lab. However, we need to capitalize on this and ensure that every doctor and patient realizes that the services we provide are essential to patient care. It’s truly a testament to our performance that, prior to the pandemic, many didn’t even know we existed, let alone our diverse, value-added functions to the hospital and its patients.

Proud of the people
As much as we are proud of the systems we put in place – the command center, testing, and IT systems – none of it would have been possible without the people. Throughout the pandemic, everyone was running at 250 percent by choice. By being upfront with our teams about what was coming and maintaining a constant, immediate flow of information with our technologists, our staff understood the gravity of what we were doing and knew what needed to be done to get through it. No one ever questioned it – they were here, ready and willing to serve, and they were going to do it at the highest levels because the communities in the Bronx needed them.

Perhaps the silver lining of the pandemic is the realization that we can achieve more together than we can individually. We are more than the sum of our parts – the hospital and the medical school. We have been coming closer and closer together and we hope that the relationships fostered throughout the pandemic will continue and further mature. There really is a tremendous opportunity to take what we’ve learned through this trial by fire and produce something great – but we may still have to break down some walls to get there.

The pandemic has shown us that, where there’s a will, there is absolutely a way – and likely a willing partner to help when you need it.