An Interview with a Diagnostic Laboratory Director
For every major challenge of the COVID-19 pandemic, many lesser-known difficulties have multiplied the complexities of laboratory diagnostics. Logistical issues, for example, continue to impact the speed and efficiency of COVID-19 testing. Although SARS-CoV-2 assays quickly became available, laboratories have needed to repeatedly adapt to new guidelines and challenges. To better understand the lesser-known impacts of the COVID-19 pandemic on clinical laboratories, we interviewed John (Jack) Wolk, M.D., Laboratory Director at CareMount Medical, to see how his lab has adapted.
Interview with John (Jack) Wolk, M.D
How has COVID-19 impacted your daily work environment?
Dr. Wolk: COVID-19 has presented some major challenges, as you can imagine. We must make sure our employees and patients are safe with ever changing protocols for authorized visitors. We are dealing with logistical issues, but I would say the supply chain issues have been the biggest challenges for an organization like ours (and probably all laboratories). These challenges include anything from the inability to source a key component to the inability to assemble orders at a warehouse. In some cases, our major diagnostics vendors have been unable to fulfil orders because of people who are out on quarantine or out for other reasons related to the pandemic. So the supply chain has probably been the most unpredictable issue with COVID-19.
Of course, the ever-changing landscape of testing has created its own challenges because new tests have continued to become available right up to the present time through FDA processes of Emergency Use Authorization or Emergency Use Notification. Labs must complete due diligence to make sure they select high quality products. A few products lost their EUAs or had to modify their EUAs. Fortunately, this did not happen with any of our major vendors. CareMount hasn’t had a problem develop with a test after it was put into use, although other laboratories have.
That said, the other challenge is that everyone, from the clinicians to our leadership, wants results at WARP speed. As a test came out, we had to accelerate our pace over our usual methodical vetting process. Normally there is a stepwise procedure where you evaluate the test. You make sure it’s preforming according to the manufacturer’s specifications. In fact, it’s a CLIA and New York State requirement that you do your own independent verification of how the assay is performing. Yet this is only the first step or two in the process of bringing in a test. The test needs to be integrated into the laboratory information system, so orders can be sent from the electronic medical record and results submitted to the electronic medical record once testing is complete. The entire process of introducing a new test was accelerated, the same way that COVID vaccine production was accelerated by doing multiple steps simultaneously, instead of sequentially. We were less concerned with the normal questions of financial viability and workflow implications under the assumption that, if the test was performing as expected according to the manufacturer’s instructions for use, we were going to use it anyway. This approach allowed us to work on necessary LIS and interface steps without waiting to see how the assay performed in our own hands.
Did your lab have to bring in instruments or tests from outside your normal preferred manufacturers, just to keep up with all the COVID testing?
Dr. Wolk: No, we were fortunate in that our platforms came online quickly. Only one of our assays changed during the process, and it changed early in the pandemic. For example, we were doing a respiratory multiplex panel even before COVID, which tested for flu, parainfluenza, human metapneumovirus, and even a couple of bacterial targets like pertussis and parapertussis. Rather than wait until that assay manufacturer could introduce COVID-19 PCR into that existing panel, which obviously was going to take some time, they released a standalone COVID-19 test. That was actually one of the first PCR tests we were able to perform, and we had it running by mid- to late-May of 2020. In the grand scheme of things, this was incredibly fast, considering the pandemic was not officially declared until March.
How is your lab preparing for the respiratory season this year? How is your preparation this year different from last year when COVID was still fairly new?
Dr. Wolk: We are going in with a better understanding of the difficulties. We are better prepared for allocation issues, non-reagent shortages in the supply chain, and other logistical challenges. Last year, a vendor had an earthquake near a distribution center that delayed shipments. We are more agile in our responses to the unforeseen.
Do you anticipate performing more multiplex testing or standalone testing this respiratory season?
Dr. Wolk: I think we are going to still see a fair amount of both because standalone testing and multiplex testing serve different purposes. We will continue to perform a lot of standalone testing to clear people for surgeries and to allow people to travel, attend events, and go to work.
What are some lessons that you have learned that you would be willing to share with other laboratories to help them run smoother and more efficient (especially during respiratory season)?
Dr. Wolk: Expect the unexpected, and always know that, as much as you’d like to predict the problems before they occur and manage the allocations, there will be surprises. We’ve experienced supply issues with reagents, media, swabs, and virtually every material used in testing. In one case, we stocked up on materials to avoid shortages, only to find out that some of the materials were outdated. You also must realize that some of the people now involved with testing may not be as attentive as the laboratorians who are trained to manage their testing materials. For example, some of the clinical support staff performing point-of-care tests may not pay as close attention to expiration dates. With the added complexity of COVID testing, you have to stay on the lookout for these unexpected challenges.