For both routine and crisis-level care, recognizing the value of strong clinical laboratories is critical, and empowering these labs is a valuable investment, whether during COVID-19, other public health threats or routine clinical care.

By Karen Kaul, MD, PhD

While the importance of SARS-CoV-2 RT-PCR results for appropriate patient care is well recognized, the impact of clinical laboratories and clinical laboratory scientists on the operations and finances of hospitals is less appreciated.

Since the start of the COVID-19 pandemic, clinical laboratories were in the spotlight more than ever before. The urgency, anxiety, and focus on laboratory testing for COVID-19 led to surprising discussions with colleagues, administration, and even the public about the ins and outs of testing platforms, regulatory pathways, supply chains, and Ct values. Laboratory staff scrambled to implement new tests, manage supply chain issues, adjust work schedules, and train new or borrowed staff to deal with the massive demands for COVID-19 testing.

While hospital laboratory data is foundational for all patient care, laboratory testing for COVID-19 is the key for diagnosis and triage, as well as tracking, quarantining, limiting disease spread, and resource management. The gold standard remains nucleic acid amplification testing of a nasopharyngeal swab (NP), and a multitude of laboratory-developed tests and commercial options are now available using NP and other samples. Faster and cheaper antigen-based options with lower performance capabilities are primarily used for screening programs.

SARS-CoV2 testing is performed at three general laboratory sites:  public health, hospital and health systems, and commercial reference labs. 

Public health laboratories were first to offer testing and are critical for epidemiologic data, but lacked the capacity and infrastructure to provide clinical testing to all segments of patients in a clinically meaningful timeframe. 

Large referral laboratories were better equipped to handle high volume testing, but their locations required sample transport, adding hours to days to the time to result; testing at commercial labs is best suited to outpatients who are minimally symptomatic or asymptomatic.  Many hospitals experienced sick patients waiting on a SARS-CoV2 RT-PCR result from a commercial lab, necessitating repeat testing at our hospitals. 

The Pandemic Financial Lifeline

It is hospital clinical laboratories that were truly on the front lines of the pandemic. Sick patients arrived in emergency departments and clinics with urgent decisions needed for their care, isolation, and more– there was no time to wait days for a test result. It can’t be said enough: Time to result matters! Strengthening hospital and health system laboratories will be key to our ability to provide proper patient care during COVID-19 or any future pandemic.

There’s something less recognized that can’t be stressed enough as we take stock of the pandemic’s impact on our society and healthcare systems. In-system labs with rapidly available results were instrumental in keeping our institutions functioning and solvent during the pandemic.

As a system laboratory that was able to offer in-house testing early in the pandemic, the clinical laboratory at NorthShore HealthSystem quantified the financial benefit to our healthcare system.

First, COVID-19 testing provided an important revenue stream at a time when elective medical care was suspended. We were able to provide all testing needed by our healthcare system at a cost lower than a send-out test. As our capacity expanded, we were able to provide testing to other area hospitals, state swab collection facilities, nursing homes, and more, further increasing revenue — yet maintaining a time to result of about 24 hours.

Patients admitted at risk for COVID-19 were swabbed and placed in contact isolation with N95 mask use until a negative COVID-19 PCR was reported; with isolation practices costing upwards of $150 daily (materials and time), the reduction in use of PPE and effort resulting from a negative COVID-19 result within a day was enormous. Approximately 35,000 isolation days were avoided as a result of our rapid in-house COVID results, savings the hospital upwards of $5 million on isolation costs compared to a slower send-out test. 

Rapid results became even more important with the state public health requirement of a negative COVID-19 test within 72 hours of entering the hospital. Rapid COVID-19 results permitted our institutions to resume routine care, and, in fact, allowed us to perform 89% of the surgeries projected for fiscal year 2020.  This would have been impossible with a referral test; and, indeed, we performed testing for other local hospitals for this reason. On-site testing was key, allowing our system to reopen and provide necessary care to our patients.

Our lab’s contribution this past year was not unique, but occurred in countless hospitals across the country, improving both patient care and hospital balance sheets. For both routine and crisis-level care, recognizing the value of strong clinical laboratories is critical, and empowering these labs is a valuable investment, whether during COVID-19, other public health threats or routine clinical care.

About the Author

Karen Kaul, MD, PhD, is chair of Pathology and Laboratory Medicine at NorthShore University HealthSystem, Evanston, Illinois, and is a clinical professor of Pathology at the University of Chicago Pritzker School of Medicine. Kaul is board-certified in anatomic and molecular genetic pathology, has been deeply involved in education, quality, and standardization of molecular pathology. She served as president of the Association for Molecular Pathology, and editor-in-Chief of the Journal of Molecular Diagnostics. She is a trustee of the American Board of Pathology.

This article was first published as an Association for Molecular Pathology blog post and is reprinted by permission.