Teamwork Scores a Big Win for COVID-19 Testing

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The first cases of COVID-19 occurred in Wuhan, China, and were reported globally by Chinese health authorities on December 31, 2019. The first confirmed cases in the United States were reported three weeks later, on January 21, 2020, and it took only two months from the initial outbreak in China for the first case to be reported in Florida, on March 1, 2020. Ironically, another first diagnosed case was reported that same day in densely populated New York City, where the virus quickly spread, infecting and killing thousands, overwhelming the health care infrastructure, and serving as a warning to other heavily populated areas — such as South Florida — about what might coming their way.

The QIAcube nucleic acid purification station extracts and purifies viral RNA from clinical samples, 12 samples per one-hour run. The lab has five of these stations, with a total processing capacity of 60 samples per hour.

At the University of Miami Miller School of Medicine and UHealth – the University of Miami Health System, the response was swift. Recognizing that UM could be facing an unprecedented challenge, Dipen J. Parekh, M.D., chief clinical officer, chief operating officer and chair of the Department of Urology, quickly formed four leadership committees. Three were to address workforce management, clinical therapeutics, and equipment and resources. The fourth committee was tasked with developing and implementing in-house testing and algorithms for testing patients and employees.

“We had to immediately begin operating in crisis mode,” said Stephen D. Nimer, M.D., director of Sylvester Comprehensive Cancer Center, who was asked to chair the Testing Committee. “There was an imperative to make sure we created a safe environment for our patients and our employees. We were dealing with an unfamiliar disease, there were no established testing programs and protocols, and meeting our goals often required collaborating with colleagues we hadn’t worked with before. In addition, we had to accomplish everything as quickly as possible while still performing our regular functions. That meant a commitment to teamwork and long hours — texts, phone calls, meetings at 5 a.m. and 11 p.m., including weekends.”

The QIAgility pipetting station is used for PCR plate preparation with RNA extracted by the QIA cubes. The lab has two of the stations, and each prepared plate can run 30 clinical samples.

The good news is that the team — an interdisciplinary group of physicians, scientists, technologists and administrators from eight academic departments and centers — came through. They built a multi-platform PCR- and serology-based detection program, established drive-thru facilities, and drafted and implemented guidelines that enabled efficient testing of patients and employees. And they did it in record time.

“We went from zero testing capacity to testing hundreds of health care workers and patients daily within three weeks,” Dr. Nimer said. “We believe our experience can inform the efforts of others who may be faced with a crisis situation. We are now able to process 500 tests each day.”

Documenting the Process for Others

In fact, the members of the Testing Committee have authored a step-by-step article about their experience, “A how-to guide to building a robust SARS-COV-2 testing program at a university-based health system,” that is now available as a preprint online.

The authors describe a process that was extremely complex due to the limited availability of needed testing supplies, including reagents. Nonetheless, outreach to UM research scientists and to multiple diagnostic laboratory companies and government officials enabled the team to implement both FDA-authorized and laboratory-developed testing-based platforms. They analyzed their workforce needs and created sub-teams of appropriately skilled and certified workers to conduct testing, safely process patient samples and perform contact tracing. They also interfaced all testing platforms with UHealth’s electronic medical record system.

The Perkin Elmer Chemagic 360 nucleic acid purification unit can extract and purify viral RNA from up to 96 clinical samples in each one-hour run. This automation helps increase throughput capacity three-fold.

“There were a lot of components, and one of the challenges was that we had to engage the research community in what was really a clinical activity,” Dr. Nimer said. “We also had to deal with supply and demand. If the FDA gave a product temporary approval, within minutes of it being announced in the news, thousands of hospitals would be competing to get it. Everyone had to use all of their connections. We began by cobbling things together, but as time went on and companies ramped up their manufacturing, things got better.”

All of those achievements would have been impossible without commitment and teamwork between UHealth’s clinical operations and laboratories, said Merce Jorda, M.D., Ph.D., M.B.A., professor and chair in the Department of Pathology and Laboratory Medicine.

“In the beginning, when there was a shortage of laboratory instruments in the market, we sent out a call for help to our research faculty and investigators. Amazingly, in less than one week, we had a lab built without spending any money,” she said. “We had molecular scientists join our team, and we were very lucky to have them to help implement and validate different testing platforms. My department was also fortunate to have an array of Ph.D.s, pathologists, laboratory managers and administrators who were able to lead implementation and further growth of our COVID-19 testing capacity with extraordinary turnaround times. This allowed our health system to maintain urgent procedures during the first weeks of the pandemic.

Health Care’s Biggest Secret

BSL2 (Biosafety Level 2) hoods are used for processing clinical samples.

“The lab is the biggest secret in health care, and when it is well integrated with clinical care, there is so much that the health system gains from this relationship. I personally had many wonderful revelations through the collaboration. When you work with people outside of your own field, you learn much more because you see another point of view and you can further help our patients.”

Other team members also spoke of the pressures of working at high speed in completely new territory.

“I’m trained as a nurse, but I had never been a pandemic nurse,” said Lauren Gjolaj, M.B.A., RN, assistant vice president for oncology services at Sylvester. “We learned a lot from colleagues, both at UM and at other institutions, especially in cities that had COVID cases earlier in the pandemic. Despite occasional desperation, there was joy in our accomplishments as the team assembled by Dr. Nimer.

There was no playbook to follow, agrees Lazara Pagan, associate vice president for oncology services at Sylvester.

“We would focus our efforts wherever they were needed in the rapidly evolving situation,” she said. “We had to quickly create a foundation that we could build on in order to save lives. For example, creating processes to facilitate plasma donation ensured better access to convalescent plasma for our UHealth patients. You would think, ‘Even if we are tired, we will get through it together.’ What we achieved has national importance as we continue to see COVID-19 infections increasing in our country.”

Success by the Numbers

The 7500 Fast PCR unit, which analyzes and exports test results, can run a 96-well plate in approximately 90 minutes, providing expedited reporting into UChart.

The overall numbers are impressive, and testing operations continue to evolve: Staff and medical student volunteers have fielded more than 6,600 calls to the COVID-19 hotline. More than 1,200 employees and 3,000 outpatients have been tested. With the start of hurricane season, both drive-thru testing sites have been closed; there are now three indoor locations that can test more patients. And with CDC approval, testing sites are now changing over to more-comfortable mid-nasal swabs that can be used by the patient if observed, reducing employee exposure and the amount of PPE required. More improvements are on the horizon, including high-speed tests developed by Miller School researchers that are under review for FDA approval.

“The strength of the University’s research enterprise enabled us to rapidly build up in-house testing capabilities,” Dr. Nimer said. “What is most evident from the current COVID-19 environment is the importance of planning, effective resourcing, nimble regulatory bodies and clinical scientific rigor. Moreover, the role of accessible diagnostics is front and center in this crisis. We hope our experience can help other health care systems ramp up their ability to effectively respond to COVID-19 or similar challenges.”

Two COVID-19 testing webinars produced by the Department of Pathology and the Testing Committee can be viewed at http://pathology.med.miami.edu/webinars.

 

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