Inaccurate Diagnostic Tests Lead to Misdiagnosis, Death and FDA Scrutiny

There is a certain vulnerability when going to the doctor. When people have the option, they seek recommendations in order to find someone with whom they can build a trusting relationship. Yet, even if you can find a doctor you trust to literally have your life in her hands, there are many individuals involved that impact the quality of medical care for which there is no way to research. Now, the Federal Drug Administration is seeking to increase oversight in one crucial area that has come under increased scrutiny.

Advances in research have led to the development of medical tests that can detect thousands of conditions. Tests that would take days, if not weeks, to get results just a few decades ago can now give health care providers answers in mere hours or even minutes. From glucose testing to HIV tests, doctors and hospitals rely heavily on these tests in order to diagnose patients. Some tests, like pregnancy indicators, can be done in the doctor’s office. Others are sent to labs which have their own rapid tests that can provide information quickly. Yet for several years now these tests, and the laboratories and technicians that administer them, have come under greater scrutiny due to errors that have led to misdiagnosis and even death.

Diagnostic tests are regulated differently depending on how they are manufactured and distributed. Currently, the FDA has to review and approve tests that are manufactured and sold commercially to multiple labs. It is the manufacturers’ responsibility to inform the government if there has been a death or serious injury as a result of the tests, as well as if there is a recall. However, tests that are manufactured by and for use in a single lab do not fall under FDA review. Often these “waived tests” are based off commercially approved ones, though their accuracy may vary.

Over the years, lab developed tests have claimed to be able to detect ovarian cancer, heart disease risk, and even fetal abnormalities. A recent investigation by the FDA has discovered that many of these claims have not been scientifically supported. Doctors and patients have made treatment decisions based on information that was ultimately false. This has resulted in unnecessary treatments, or the wrong treatment for a condition, as well as abortions or drastic surgeries in order to correct a condition that ultimately did not exist.

Whether it’s a commercial testing kit or a waived test, the accuracy is also highly dependent on which laboratory is used and who in the lab performs the test. In an investigative report published in the Milwaukee Journal Sentinel in October, they found that more than half the time, directions on how to perform the test were not followed, expired products were used, chemicals weren’t properly refrigerated or stored, and labs performed tests they were not authorized to do. They also found that there is little to no training and education for lab technicians who perform the tests. Furthermore, of the more than 180,000 labs in the United States, barely one percent of these labs are ever inspected – and most are done by private companies which charge for doing so.

The problem is that current law allows waived tests to be used without oversight. Passed by Congress in 1988 the law allowed labs to administer simple tests that were proven to have little risk of being inaccurate, or, if an incorrect result did occur, a patient would not be harmed. At the time the law passed, there were only eight tests, such as a simple urinalysis, that qualified. Today there are over 3000 waived tests.

In addition, most of these tests are much more complex than a simple testing strip. Even with detailed instructions, often with pictures, technicians and even nurses can perform tests incorrectly. Some are so sensitive that if a sample does not incubate for the exact amount of time, or if more than one drop of blood is used, the results will be inaccurate. Doctors rely on these results, not knowing how the testing was done, and patients have to make decisions based on the information their doctor provides.

Makers of these diagnostic tests are unsurprisingly not supportive of more regulation, highlighting that current law doesn’t allow the FDA to oversee these labs. Nevertheless, the Obama administration is seeking ways to exert authority over this sector, which many doctors and laboratories welcome. Many detractors fear that excess oversight would stunt innovation, but supporters argue that the right regulation can still foster innovation and provide safety by separating the bad tests from the good.