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Laboratory Medicine Takes Its Seat at the Table During the Pandemic

Gary W. Procop, MD, MS
American Board of Pathology
Specialty: Anatomic Pathology & Clinical Pathology
Subspecialty: Medical Microbiology

“When there is a crisis, such as the COVID-19 pandemic, you have to be 100 percent on top of your game—there’s no time to try to play catch-up,” said Gary W. Procop, MD, MS. “My continuing board certification helped me stay up-to-date and prepared me to get through the early days of the pandemic, when we were urgently working to bring up, create, validate, and operationalize accurate and timely COVID-19 testing.”

Team Approach
As the Director of Molecular Microbiology, Virology, Mycology and Parasitology, Dr. Procop is responsible for COVID-19 testing at the Cleveland Clinic in Ohio. As soon as his institution heard reports of the deadly new novel coronavirus occurring in China, it pulled together an Incident Command team and conducted a tabletop exercise to prepare for worst-case scenarios. Unlike most Incident Command teams that are of a short duration around a singular event, such as a fire or accident, this particular team met twice a day throughout the months-long initial surge of COVID-19.

Dr. Procop sees great value in this team approach. “I was the laboratory representative on this interdisciplinary, institution-wide team, and it was amazing to work with a microcosm of engaged and knowledgeable professionals dedicated to delivering optimal patient care. I would like to see us continue to use this cross-discipline approach, complete with its collegial push-and-pull, for our future shared challenges.”

Testing, Testing
By the time the first COVID-19 cases were reported in the United States, the Cleveland Clinic laboratory team was ready. They hit the ground running as soon as they received approval from the Food & Drug Administration to begin testing in non-Public Health Department laboratories. “Within one week—which is remarkably fast—our team was able to bring up the original Centers for Disease Control and Prevention SARS-CoV-2 assay, validate it, turn it into a live test, and demonstrate that our laboratory could perform it correctly. We became the first hospital in Ohio to offer COVID-19 testing.”

To help meet the skyrocketing demand for COVID-19 testing, the laboratory team worked around the clock, operating in three shifts. “Our lab team was so dedicated and focused on turning around test results as quickly as possibly that we often had to remind these heroes to go home at the end of their shifts,” said Procop. As a result, the Cleveland Clinic went from zero COVID-19 tests in February to more than 160,000 by July.

To preserve scarce testing supplies and meet different clinical needs, the laboratory team diversified their diagnostic portfolio by bringing on more tests, including one they submitted for FDA Emergency Use Authorization (EUA) approval. The Cleveland Clinic laboratory offers six different COVID-19 tests from “rapid” tests for severely sick patients to “traditional” tests that take approximately 8–12 hours for less acute cases.

In April, Dr. Procop and his team shared their findings (manuscript submitted for publication) on the sensitivity and diagnostic accuracy of five of the most commonly used tests. Their research concluded that not all tests had equal performance and that one popular test had an alarming false negative rate of 16.7 percent, far below the acceptable level of five percent. Their research was covered by national media, including National Public Radio, CNN and MSNBC and helped spark a closer look at the COVID-19 rapid tests on the market. The high false negative rate for this assay has been confirmed by other researchers publishing in the Journal of Clinical Microbiology: Comparison of Abbott ID Now and Abbott m2000 methods for the detection of SARS-CoV-2 from nasopharyngeal and nasal swabs from symptomatic patients and Performance of Abbott ID NOW COVID-19 rapid nucleic acid amplification test in nasopharyngeal swabs transported in viral media and dry nasal swabs, in a New York City academic institution.

Laboratory Medicine at the Table
This pandemic has highlighted the contributions of many overlooked essential workers, such as grocery store employees, factory workers, and, in the health care arena, laboratory professionals. “While laboratory medicine professionals are often ‘forgotten’ when people discuss health care, this pandemic has placed them squarely at every single table for critical discussions about how to respond to this infection and provide the best patient care. Collaboration is the key to quality patient care,” commented Dr. Procop.

The Future
When asked how he feels about the future, as the infection rates continue to soar across the United States, Dr. Procop expressed frustration and concern. “It is surreal to me that many Americans believe this is some sort of hoax and are unwilling to follow some commonsense actions to save lives, including wearing masks and maintaining safe social distances. I am concerned that if we do not get this under control soon, we will be facing this virus and the flu season at the same time and our laboratories and hospitals will be completely overwhelmed.”

Certified by the American Board of Pathology, Dr. Procop serves as Vice Chair of Pathology Education; Director, Molecular Microbiology, Virology, Mycology, & Parasitology; and Professor of Pathology at the Cleveland Clinic. He chairs the Commission of Science, Technology and Public Policy for the American Society for Clinical Pathology. Dr. Procop is a member of the ABMS Board of Directors and Life Trustee of the American Board of Pathology.

(Published: July 28, 2020)

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