Interviews

In the center of the COVID-19 storm in New York, Northwell health hospitals and laboratories worked swiftly to bring up testing. Dr. Sam Reichberg explains how it happened.

In the center of the storm: Dr. Sam Reichberg describes COVID-19 testing at Northwell.

Interview conducted in May 2020

[This interview is part video, part text. The perils of the Zoom age are that sometimes, the recording fails. About halfway through the interview with Dr. Sam Reichberg, the Zoom crashed and wouldn't revive. We finished the rest of the interview using the classical technique of phone, pen, and paper. As the interview notes, in this pandemic era you have to plan defense in depth, multiple redundancies, so that when one thing goes down, you can still continue doing your work.]

Dr. Sam Reichberg, MD, MPhil, PhD, has worked for decades in the laboratories around New York City. His current position as Associate Director of the Northwell Health Laboratory meant he was near the ground zero for COVID-19 testing as the first wave hit and peaked in the New York area. We asked him, a few weeks later, to tell the story of that experience:

Northwell, like so many laboratories around the world, struggled with shortages of swabs, media, and reagents. Indeed, those supply chain issues, while abated somewhat in early June, are growing again, now that growing demand in other States stretches the vendors.

See even more stories about COVID-19 Laboratory Challenges...

In March and early April, as the crisis deepened, Dr. Reichberg watched the positivity rate of PCR-based diagnostic testing go up and up and up. Every morning, he awoke to crunch the latest PCR testing data and get the positivity. By the third week of March, it rose to 63%, so high he started to fear that there might be an error. But it wasn’t. After reaching that peak, it began to slowly abate. About a week to ten days after the peak PCR test positivity, the hospitals had their peak volume of COVID-19 patients. Thus, the testing positivity rate, Dr. Reichberg notes, is a leading indicator of the pandemic’s most tangible manifestation.

Laboratory professionals spend their lifetime focusing on the stability and reproducibility of their testing. That culture nurtures the standards and values for quality that are critical during an emergency. The Quality Management System at Northwell enabled the laboratory to overcome the laboratory testing challenges. Intimate knowledge of testing and processes, which are the substance of lab quality, were truly critical to scaling up virus testing.

Validation was an important step in the testing process. For example, in setting up the serology testing, Northwell settled on a protocol of 40 positive and 40 negative samples, with the positives contrived at first; there was a goal of 95% sensitivity and 95% specificity for SARS-CoV-2 antibodies. Northwell took three weeks to evaluate multiple methods. They chose many of the automated ELISA methods, such as those available on Roche, Abbott, Ortho, and other ELISA methods, such as the Euroimmun. A strategic decision was made to validate and install multiple instruments and methods, so that supply shortages could be mitigated by having flexibility in platform availability.

The pandemic crisis ultimately has brought the laboratory industry closer to the new paradigm, called Lab 2.0, where laboratories are no longer considered factories of test results as commodities, but instead they leverage their expertise and data to provide direct participation in healthcare activities and informatics leadership. The pandemic has now made highly visible the laboratory’s central role in the clinical effort, working directly with clinicians to develop data-driven patient management interventions.

COVID-19 has brought the laboratory to full public awareness. This has also meant a greater awareness of how poor quality testing can negatively impact both patient care and public policy decision-making.

Dr. Reichberg has key advice to laboratories just entering their pandemic testing crisis: increase the scrutiny of quality. With the public so much more aware of the consequence of a lack of test availability and quality, the tolerance for laboratory errors is much lower. Repeated questionable tests on the path to get the right result is not acceptable in the midst of the pandemic.

Another crucial preparation that laboratories should make: develop a clinically-agreed upon protocol for prioritizing testing: for patients in need of immediate test results, test turnaround needs to be within 24h, and where longer turnaround time is OK, the lab can resort to sending the sample to a reference lab. It’s unrealistic to expect that your laboratory will be able to meet every testing demand. Make clear to clinicians they can’t expect that all the specimens and test requests that they ask for can be handled with the same speed. An emphasis by clinicians on repeated, redundant testing is a difficult resource challenge. The common practice - having patients be tested repeatedly until the PCR result is negative for consecutive days - is a strain on the laboratory and causes delays in the testing of patients with more pressing needs.

Beyond the laboratory, Dr. Reichberg cautions everyone to take the pandemic seriously, to wear face masks in public, to be aware of the people around you.

“Every morning, Death is waiting for you at your doorstep.”

We sincerely thank Dr. Reichberg for his time, his recounting of the pandemic first wave in Northwell, and for the exemplary service he provided to his patients.