In Italy, lessons learned for lab testing

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June 2020—The key lesson for policymakers and hospital administrators stemming from the pandemic is that continuing to cut human and economic resources will create large organizational issues when the entire system of care, including laboratory diagnostics, is challenged by “an enormously amplified volume of tests to manage emergent situations,” write Giuseppe Lippi, MD, of the University of Verona, and Mario Plebani, MD, of University Hospital of Padova, Italy, in an opinion paper published online March 19 (Clin Chem Lab Med. https://doi.org/10.1515/cclm-2020-0240).

They write that high-throughput instrumentation, too few employees, and reduced levels of health care funding, especially for public facilities, “all contributed to considerably reducing the flexibility to develop emergent responses” to viral outbreaks, the most recent being COVID-19.

With laboratory diagnostics central to future viral outbreak response, they are hoping what has been learned will not be forgotten.

At the University of Verona, Dr. Lippi is a professor of clinical biochemistry and clinical molecular biology; he is also director of the clinical chemistry and hematology laboratory at the university’s hospital. Dr. Plebani, at University Hospital of Padova, is a professor of clinical biochemistry and clinical molecular biology and chief of the laboratory medicine department. They spoke with CAP TODAY writer Meredith Salisbury on April 27.

“What we should learn from this lesson,” says Dr. Giuseppe Lippi (right), here with Dr. Mario Plebani, “is that working at the minimal viable standard is not enough.”

How have automation, high-throughput systems, smaller clinical lab teams, and less funding changed the ability of labs to respond to an emergency like COVID-19?
Dr. Plebani: The consolidation and downsizing experiences of the last few years—starting in the U.S. but moving to Europe—have strongly decreased the power of clinical laboratories to answer some challenges, such as the COVID-19 outbreak. In Italy and in other countries, the limited capacity for molecular tests, serological tests, and other laboratory testing is due to the decrease in the power of the laboratory professional and to the view that laboratory tests are commodities.

This is a great opportunity, first of all to make visible to all citizens and communities the importance and the key role of clinical laboratories in modern health care. Second, clinical laboratories, particularly in the public sector, should have the staff and technological facilities to answer the challenge of an outbreak such as COVID-19. Third, there are many commonly requested tests such as CBC that play a great role in distinguishing severe from mild disease. In addition, some new tests such as the MDW (monocyte distribution width) and presepsin have been found very promising. This is very important in managing COVID-19 patients. This should teach us to make more visible to the public the role of clinical laboratories and laboratory medicine in diagnosis, in prognostication, and even in surveillance of infected patients.

In the paper you suggest that a network of regional labs could help absorb spikes in testing demand, rather than leaving it to each individual lab to scale up. Does this exist anywhere?
Dr. Plebani: In Italy, until some years ago, laboratory professionals did create a network and exchanged experience and data based on voluntary willingness to increase the quality of laboratory medicine and make possible better care for patients. In the last few years there was a trend toward more autonomous organization. This is absolutely wrong. In this outbreak we did realize once again the importance of a network—of cooperation and collaboration.