A team of Beth Israel Deaconess Medical Center staff recently implemented an in-house COVID-19 test soon after the US Food and Drug Administration (FDA) granted American healthcare institutions permission to do so. In the process, the team launched the first high throughput COVID-19 test in a New England medical center.
“So many people were involved,” notes Stefan Riedel, MD, PhD, Associate Medical Director of the Microbiology Lab in BIDMC’s Department of Pathology. “When I reflect on it, it just feels like truly remarkable effort and teamwork.”
A Demand for Faster Test Results
Before deploying the in-house test, BIDMC’s Infectious Diseases faculty found themselves fielding constant requests from concerned providers regarding their patients with COVID-19 symptoms. But the Infectious Diseases staff had to follow many steps just to get state approval to submit a test to the state laboratory, only then to await results. Creating an onsite test would simplify the process, produce faster results and make testing available to more people, a key to more accurate insight into how many patients and staff were infected.
Beginning on March 14, BIDMC’s Division of Infectious Diseases, Microbiology Labs, and Pathology Department—a few of the many teams managing the coronavirus crisis—quickly came together to address the challenge. Pathology began testing a polymerase chain reaction (PCR) test, a process used to detect the presence of infectious diseases in lab samples. Meanwhile, Riedel and the microbiology staff performed a validation of a PCR test for other respiratory pathogens to provide the capability to differentiate between the influenza and other respiratory pathogens, and COVID-19.
Molecular Clinical Supervisor Annie Cheng was among those who spent hours upon hours in the lab as the tests were validated.
“This was the first time in my career that such a test completed the validation process and was implemented for clinical testing in less than a week,” Cheng says. “The success was a team effort and we had great support from the team, lab directors, my manager, and colleagues beyond the Pathology department.”
Thinking Outside the Box
Within three days, tests were ready for analysis and approval. The group worked rapidly to not only set up the new test, but to maintain the required standards and processes, all in just days. Under normal circumstances, the process of deciding on a test, purchasing equipment, and then performing the vital quality control measures often take months or even up to a year.
In-house testing began on March 17, earlier than most anticipated. BIDMC’s labs have run multiple batches of COVID-19 tests each day since the launch.
Other key members of the team included Microbiology Laboratory Director James Kirby, MD, Medical Director of the Molecular Laboratories; Jeremy Ryan Peña, MD; Vice Chair of the Division of Laboratory Medicine, Lynne Uhl, MD; Senior Hospital Epidemiologist, Sharon Wright, MD; Infectious Diseases specialist Christopher Rowley, MD; and Molecular Lab Manager Tammy Galloway.
The group credited leadership throughout the hospital and the Beth Israel Lahey Health system for thinking outside the box to remove obstacles. New equipment purchases came together quickly. Other staff helped get clearance for a team from a Watertown, MA, bioscience company, Aldatu Biosciences, to help develop critical diagnostic kits when other vendors faced shortages. Pathology Department Chair Jeffrey Saffitz, MD, cited the company’s nimbleness, along with efforts from BIDMC staff and faculty, as vital to the rapid increase in COVID testing at BIDMC.
“All of this is due to the round the clock efforts that our lab team made,” said Peter Healy, President of BIDMC. “We are very grateful and very proud.”
Staying Ahead of the Curve
Currently, BIDMC runs COVID-19 tests on over 700 samples from across the Beth Israel Lahey Health system on four separate machines. This approach can currently accommodate approximately 1,500 samples daily. Today, more COVID-19 tests can be performed at the medical center in one day than the total number of influenza tests processed over the course of a flu season.
“It changes everything to be able to run these tests onsite at BIDMC, rather than sending samples to an external lab,” Riedel explains.
The team is now looking ahead to the next phase of this pandemic. They’re investigating new solutions to meet regulatory standards and address supply shortages faced across the nation including viral transport media and swabs to collect the nasopharyngeal specimens. As preparations are underway for managing future shortages of materials, they feel confident that they’ll adapt to these new challenges.
“We’re seeing people from all areas of the medical center come together,” notes Christopher Rowley, MD, an infectious disease physician and one of the project leaders. “It’s something that makes me extremely proud.”
“It makes me very proud to be part of this great team,” says Riedel. “I am confident that our teams will continue to find solutions to the continued challenges during this evolving pandemic so that we will continue to provide the best care to our patients here at BIDMC and throughout the BILH network.”