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Nine months after the federal government declared a public health emergency on SARS-CoV-2, clinical labs are still reporting deficits in needed testing supplies and challenges with staffing. Many have sought out innovative approaches and partnerships to keep up with testing demands, profoundly changing the way they do daily business. Laboratory leaders also uniformly express pride in how team members have stepped up their game, going above and beyond to serve patients at this unprecedented time.
“The laboratory has become a much more cohesive group, working as a unit and not just as different sections,” observed Cynthia Bowman, MD, chief of pathology at VA New Jersey Health Care Services in East Orange. “Staff has become more flexible with their schedules or tours . . . [and] have assumed different roles as needed, transporting specimens and supplies and helping clinical units. We have all been able to adjust more quickly to uncertainty and to set priorities.”
Providing proper safety precautions for staff also has loomed large since the pandemic started. “We have implemented more stringent safety measures, [namely personal protective equipment] (PPE) to protect our lab staff,” said Yusheng Zhu, PhD, DABCC, FADLM, medical director of clinical chemistry and the automated testing laboratory at Penn State University Hershey Medical Center in Hershey, Pennsylvania. Zhu’s lab also struggled with PPE and test reagent shortages even as it was increasing testing capacity to offer quick SARS-CoV-2 test results.
PPE shortages and staffing challenges top the list of ongoing hurdles at Ronald Reagan UCLA Medical Center in Los Angeles, according to Lu Song, PhD, DABCC, FACB, interim co-chief of clinical chemistry.
The pandemic completely disrupted standard operating procedures at the University of Rochester Medical Center’s lab in New York. Many challenges have arisen, “such as the availability of reliable tests, obtaining samples for verification or validation of an emergency use authorization or a laboratory-developed test (LDT), and maintaining several methods and platforms at the same time,” said Yan Victoria Zhang, PhD, MBA, director of the chemistry division.
Labs went to extraordinary lengths to ramp up for testing capacity, including at the University of Cincinnati Medical Center. “A laboratory constructed with the intent of precision medicine testing that was due to open this year was commandeered for SARS-CoV-2 testing,” said Chris Crutchfield, PhD, HCLD(ABB), DABCC, technical director for clinical chemistry, toxicology, and point-of-care. “Research was significantly impacted by reducing laboratory personnel capacity to 50% of pre-pandemic levels. The decision-making that went into these initiatives was extraordinarily challenging, but tremendously important in helping keep the community safe.”
A rolling series of AACC surveys on the laboratory response to SARS-CoV-2 reflect the struggles they’ve faced. In the August survey, AACC found that more than 50% of respondents didn’t have the supplies they needed to run viral tests. Among respondents to this survey, 67% are struggling to obtain supplies such as reagents and test kits—the highest this figure has been since the surveys began in May. Twenty-eight percent estimated that supply issues and other challenges prevent them from processing all requested tests, a notable increase from 21% in May. Additionally, 32% said supplies are scarce for non-pandemic tests, compared with just 12% earlier this summer. Another 58% of August respondents reported COVID-19-related staffing challenges.
Individual labs across the country related the challenges they’ve faced. Mary Mayo, PhD, ABB, DABCC, MT (ASCP), FADLM, lab director of Heartland Women’s Healthcare in Mount Vernon, Illinois, worries about scarcity of supplies. “Even though we are capable of COVID-19 testing, we were not a high enough priority to get reagents,” due to the lab’s small size, she said. Diverting resources to COVID-19 testing has led to a tip shortage for other types of tests and suspended testing for human papillomavirus, calculated globulin, and other analytes, diverting these tests to larger reference labs more than once, noted Mayo, who added, “We have ordered tips via eBay!”
At Montefiore Medical Center in the Bronx, “our labs were absolutely transformed,” as New York City emerged as the epicenter of the first wave of the pandemic earlier this year, said Sean Campbell, PhD, assistant director of hematology and coagulation laboratories. “Every area was touched.” Surgical pathology essentially shut down, chemistry went to very low levels, and coagulation increased in volume, “so much so we were running out of reagents,” he elaborated.
Meanwhile, virology went into high gear to create and validate a SARS-CoV-2 LDT. Montefiore “went to nearly 100% COVID-19 during the height of the outbreak, seeing a high of 2,000 concurrent patients across our system. Everything was bent to that purpose,” added Campbell.
Montefiore is not alone in dealing with swings in lab section workloads. “Microbiology had a fairly constant heavy workload, but hematology and blood bank saw surges with demands for coagulation testing, blood smear review, and blood products,” recalled Bowman. “Chemistry overall volumes dropped, but rapid testing—especially for blood gases and metabolites—increased. All sections had to call numerous critical values.”
Houston Methodist, another facility that crafted an LDT for SARS-CoV-2, restructured its molecular lab and began outsourcing all non-COVID-19 testing. Pathology informatics faculty “created multiple online reports and dashboards for hospital and system leadership that were critical to understanding the status of each hospital as well as each patient, as the first wave of COVID-19 hit Houston,” said David W. Bernard, MD, PhD, director of clinical laboratories, and Roger Bertholf, PhD, DABCC, FADLM, director of clinical chemistry.
Launching an LDT was no easy feat, according to Bernard and Bertholf. “Securing instruments for extraction and testing to allow increasing capacity was a large issue. Scouring the marketplace, working with vendors who were working night and day to meet customers’ needs, and learning new aspects of the virus and the pandemic was daily 24/7 activity,” they said. As of early October, Houston Methodist had performed nearly 200,000 SARS-CoV-2 tests.
During this time, the lab also brought in-house testing for interleukin-6, procalcitonin, and SARS-CoV-2 serology.
Crucially, Houston Methodist began preparing for the pandemic from the earliest reports of a novel virus emerging in Wuhan, China. The hospital not only dusted off disaster plans and mobilized business units to identify, procure and store critical supplies but also began extensive and still ongoing collaborations with sister Texas Medical Center institutions. Bowman also credited the deep well of the national VA health system in “sharing situations, guidance, information, experience, etc. We shared a lot of process and scientific information. We also shared our stresses and supported each other.”
Back in Rochester, changing guidance and the unavailability of test reagents, supplies, and reference labs forced Zhang’s lab to act quickly to accommodate rapidly changing test demands. The lab performs testing not only for the University of Rochester Medical Center but also five affiliated hospitals and other associated regional hospitals and physician offices, totaling more than 1,000 locations. “The pressure and the stakes were high to have a timely and reliable solution,” said Zhang.
With all vendors still experiencing supply challenges Zhang’s lab is using at least six SARS-CoV-2 testing platforms to meet testing demands, while continuing “to investigate alternate testing methods,” she said.
While overall volumes have calmed down at Montefiore after New York’s early surge, “we are concerned about testing during the ‘fluvid’ season, as we are calling it,” said Campbell. “Supplies for COVID-19 testing, and especially combined testing, are still tight, and our turnaround time for SARS-CoV-2 tests has gotten much better but still is not as fast as many would want.”
Despite their ongoing trials and tribulations lab directors could only praise their teams’ dedicated hard work. “Crisis can bring out either the worst or the best in people. We are very fortunate to work with people in the latter category,” said Bernard and Bertholf. “The teamwork has been truly extraordinary.”
“We have learned that in times of crisis and chaos, our laboratory teams will stop at nothing to pull together and support each other to ensure there is no delay in patient results,” added Zhang. “Personally, I have never been prouder of our teams and to work in laboratory medicine.”