Expanding molecular testing

At the time of the Covid-19 onset in February and March of 2020, we were eagerly awaiting the shipment of a new automation system for our microbiology department. Most of the instrumentation was being manufactured in northern Italy. That region of the world was one of the first areas, outside of China, to confront widespread SARS-CoV-2 infection rates. We thought the shipment of our specimen processing and culture incubation system would be delayed, but it arrived on time in July 2020. In addition to automation, we also converted to a new bacterial identification and sensitivity system and added MALDI-TOF mass spectrometry. Had we been able to predict the impact of the novel coronavirus on our microbiology department, we would have chosen another year to transform our bacteriology systems. As it turned out, the staff embraced the new technology, and the transition was very smooth.

What adjustments were made to the lab during the COVID-19 pandemic?

Our first priority was patient and staff safety. Early on, we were unsure how infectious the SARS2 virus would become. We knew several laboratory workers throughout the world had become infected and died during the original SARS1 outbreak of 2003. We made sure to process all respiratory specimens in BSL cabinets and constantly reviewed guidelines. We were especially concerned with aerosol production, even in blood specimens. Fortunately, it was determined early in the pandemic that the SARS2 virus was not transmitted via blood sources. It became evident the greatest risk for SARS2 transmission was human-to-human, and our normal universal precautions for specimen processing were adequate.

With the six new molecular platforms that were purchased for COVID-19, now that the pandemic numbers are not as high as before, will those be put to a new use?

We made a decision to utilize only NAAT methods for our hospital system. We already had partnerships, but testing supplies for SARS-CoV-2 were not available until April. After April 2020, all vendors were limiting shipments due to supply and demand. We ordered a high-throughput analyzer in early May, and waited until late September to receive the instrument, again with limited supplies from the vendor. The challenges we faced with testing instruments and supplies were the same challenges felt in hospitals throughout the United States. There was not enough testing capacity, so we partnered with our public health system, neighboring hospitals, reference laboratories, and vendors to incrementally increase our test capacity over time.

Fortunately, the instruments we purchased have clinical utility in a post-pandemic world. We will continue using the instruments for various PCR tests and plan to offer additional viral load testing on the high-throughput analyzer, which is an expansion of our test menu.

With the new oncology unit, what tests will be done in-house, and will any be sent out?

SMH will be adding a flow cytometry laboratory to the new facility to increase and enhance the range of diagnostics and personalized cancer treatments we provide to our patients. We maintain connections with many large cancer centers in the nation, and based on the type of cancer and tissue in question, will partner with them when more specific testing is needed.

We are working with our pathology team to expand diagnostics and facilitate the profiling and identification of patients who are candidates for personalized medicine and targeted immunotherapy.

What is the most exciting new technology being used in the laboratory?

SMH Laboratory has always relied on automation to allow growth, maintain efficiency, and improve safety through standardization. We are one of the most automated laboratories in the country with our single automation line in the core laboratory and a full specimen processing and culture incubation system in microbiology. While we have added new technologies for NAAT, MALDI-TOF, and FISH, automation and the accompanying information technologies represent a nearly limitless area of advancement for laboratories.

Were there any supply challenges to overcome during the pandemic, and if so, were there any creative solutions worth mentioning?

Like many, we had shortages of swabs and viral media early on. We found ways to split the media and create two for one. Running out of a needed supply or reagent was a daily event for all laboratories.

Our partnerships were an important resource and source of pride. Our local/state health department helped tremendously, and our partners at a reference laboratory were helpful in times of need. A large hospital in Tampa was quite helpful, and we were helpful to others in return. We ultimately overcame the challenges by working together across public and private sectors.

Anything else you would like to add?

The medical laboratory profession is a challenging and rewarding field for those with a sincere interest in the sciences. Approximately 70% of clinical decisions are based on laboratory test results. Laboratory professionals delivering accurate, prompt and reliable results are vital members of the healthcare team. Although most of our work is done outside of public view, laboratory professionals contribute a great deal to the safety and high-quality care of patients, and that has been especially true during this pandemic.