Diagnostic Expert Weighs in on the Dangers of Allowing Research Staff to Perform COVID-19 Clinical Testing

Clinical laboratories should consider the potential negatives of resolving staffing shortages by using research scientists

The strain of ongoing surges in demand for SARS-CoV-2 coronavirus testing has triggered a need for creative ways to optimize existing clinical laboratory staffing and provide support for testing during the pandemic. One strategy considered is that of redeploying research laboratory personnel to perform testing in clinical laboratories.

However, Matthew J. Binnicker, PhD, warns that clinical laboratory leaders should weigh the pros and cons very carefully. Binnicker is the Director of Clinical Virology at Mayo Clinic and is widely regarded as one of the foremost SARS-CoV-2 testing experts in the US. Binnicker’s research focuses on developing methods of detecting viral pathogens from clinical samples and providing accurate and timely results to healthcare teams.

In recently published commentary on the “Challenges and Controversies Related to Testing for COVID-19” in the Journal of Clinical Microbiology (JCM), Binnicker devotes a section to the shortage of trained, certified personnel to perform clinical testing and considerations for using research professionals as a way to solve that problem.

“Personnel from research laboratories should not be utilized for clinical testing unless they have met the required criteria to perform moderate- to high-complexity testing as outlined by CLIA and other regulatory agencies,” Binnicker wrote. “Although research scientists are highly trained with extraordinary expertise, enlisting their service in a clinical laboratory prior to meeting these requirements sets a dangerous precedent for the clinical laboratory profession.”

The COVID-19 STAT Intelligence Briefings Service spoke with Binnicker about his perspective to better understand what he meant and to learn what he believes is important for clinical laboratory leaders to consider.

“I thought about the words pretty carefully,” Binnicker said, referring to his comment that utilizing research scientists for clinical laboratory testing could set a “dangerous precedent”. “I don’t mean that it would be dangerous for research scientists to perform the testing, or that there may be errors or inaccuracies.”

Instead, Binnicker underscores the need for labs to maintain their dedicated clinical laboratory staff because of their specialized training and expertise that is necessary for normalized clinical lab operations. “Our colleagues in research labs are highly skilled and have a lot of expertise,” Binnicker said, “but I think the clinical laboratory profession has worked very hard over the last decade or two to demonstrate its importance.”

May Present Inspection, Compliance Risks

“Substituting research staff for specifically trained clinical laboratory professionals sets what I think is a dangerous precedent for the field of laboratory medicine,” Binnicker explained, “and in some ways could be interpreted as ‘you don’t need an accredited laboratory technologist, supervisor, or laboratory director because we did it during this situation.’ That’s really the precedent we need to keep in mind.”

Binnicker compared it to having untrained responders doing the work of medical professionals. “It would be somewhat similar to pulling in staff who weren’t specifically trained in surgery to perform necessary procedures following a mass injury event,” Binnicker said. “The precedent would be that you’re not necessarily required to have gone through decades of training to perform that function.”

Ultimately, Binnicker considers having trained and accredited laboratorians performing clinical testing to be vital.

“It’s critical that we have staff who have been specifically trained in performing the testing, ensuring that patient confidentiality is maintained, and aware of all the necessary quality requirements,” Binnicker warned. “Really, the research world and the clinical testing world—they’re two very different areas, and the thought process is very different. It really does require people who have worked in, and have been specifically trained to perform clinical testing. It’s important to ensure that we have not just accurate test results, but that we maintain all the standards—rules of patient confidentiality, HIPAA requirements, and all of the quality components that go into a clinical lab testing environment.”

Clinical laboratory leaders who are considering addressing staffing shortages by reallocating research scientists should be aware of the implications that this could have on the field moving forward. While research scientists are playing a vital role in the COVID-19 response, they should not be replacing the role of trained clinical laboratory professionals.