There are flaws in our nation’s diagnostic capabilities

Pandemics are crises in the best-case scenarios, but the inability to quickly and accurately diagnose the presence of the novel coronavirus and begin treatment for COVID-19 put us in a worst-case scenario. The United States has the most patients diagnosed and hospitalized and now accounts for roughly one in four COVID-19 deaths. 

The pandemic provides a stark illustration of how our systems and tools must support accurate, timely, and well-communicated diagnosis, and the devastating results when they do not. 

When a diagnosis is wrong or delayed, the disease can spread, treatments are not started, and outcomes worsen. It’s a challenge as old as Hippocrates. We don’t know whom to treat or what to treat them for if we don’t have the tools and processes to determine what is causing the illness.

Currently, there are multiple tests capable of identifying active COVID-19 infections approved in the United States. We don’t know the performance characteristics of these tests, that is, what is the likelihood of a false positive or false negative test result? False-negative results are a major concern; these patients will think they are not infected, but will unknowingly expose their family, friends, and co-workers to infection. In cases of communicable viruses like COVID-19, not having an accurate and timely test result is particularly threatening because every minute a patient does not know their diagnosis is another opportunity for the virus to spread. 

Ensuring systems are in place to safeguard the diagnostic process for non-communicable diseases is no less important. Every minute a stroke patient, a cancer patient, or a sepsis patient lacks an accurate diagnosis is a lost opportunity to arrest serious harm. 

We should be thankful for the laboratories and testing companies working around the clock to develop the COVID-19 tests needed to diagnosis infected patients quickly and accurately and to ascertain immunity from prior infection. Government, especially at the federal level, must support testing companies’ ability to create and distribute these tests to ensure the proper availability and utilization wherever they are needed while at the same time ensuring there are protections for the public in terms of test quality and reliability.

Even with an accurate test result, the clinical diagnostic process may break down. Malpractice and patient safety databases include too many stories of test results being lost, not communicated in a timely manner, or communicated to the wrong patient. 

The diagnostic errors we are experiencing in relation to the COVID-19 pandemic are a major concern but are not unique. Our health care systems may be the most advanced in the world, but the diagnostic process is complex and error-prone. Five years ago the National Academy of Medicine report, Improving Diagnosis in Health Care, designated diagnostic errors to be an urgent public health concern, one likely to affect each of us in our lifetime. More recently, the ECRI Institute identified diagnostic errors as the nation’s number one patient safety hazard for the third year in a row. 

A quarter-million hospitalized patients will experience harm related to diagnostic errors as inpatients this year, and diagnostic error will affect another 12 million outpatients. Individually, each of these is a tragic story; taken together, they point to broader system-related weaknesses that can and must be identified and addressed. 

Despite the prevalence of diagnostic errors, as a nation, we are not focused on preventing them. 

Federal support for research in this area, compared to other health care quality and safety domains, has lagged substantially and that must be addressed immediately. It should not take a global crisis for us to prioritize improving diagnosis—these errors can be deadly whether or not the patient has a pandemic-level virus.

As medical professionals struggle to address the immediate threat of COVID-19, the pandemic will have ripple effects throughout our health care system for months, and possibly years, to come. There are lessons that must be acted upon now. The federal government must fully fund and maintain pandemic resources, as well as increase its support of diagnostic science, including studies of how, when, and why the process fails in clinical settings. Health systems must increase their attention to the diagnostic process and focus on improving the accuracy, timeliness, and effective communication of each patient’s diagnosis. 

We as a country have largely ignored or fail to appreciate the severe problem of misdiagnosis in America. Congress needs to fund long-term research into improving diagnosis, improving electronic records and assuring diagnostic accuracy in telemedicine. A core group of bipartisan Members in the House and Senate have begun to take action but this effort needs to be accelerated. 

When the full history of COVID-19 is written, the opening chapter will really be about diagnostic errors on a global proportion — our inability to evaluate, test, accurately diagnose, and communicate their diagnosis to patients as quickly as possible. Just as the pandemic will be marked as a turning point in the use of telemedicine, pandemic preparedness, and other cardinal issues, hopefully, it will also mark a global awakening to the critical need to address the quality and safety of diagnosis.

Paul Epner is the CEO and co-founder of the Society to Improve Diagnosis in Medicine, which catalyzes and leads change to improve diagnosis and eliminate harm from diagnostic error.