As New Mexico residents may know, receiving proper treatment for a medical condition may depend on correct diagnostic testing and interpretation of the results. Currently, the Food and Drug Administration does a review of and approves or disapproves tests sold to various labs. However, FDA approval is not required if the test is manufactured by and for use in a single laboratory. These are referred to as “waived tests”.
According to the FDA, at the time the law was passed to provide waivers for certain tests that were considered low risk in 1988, only eight qualified. The number of waived tests has grown to around 3,000 and many of them are complex.
A Food and Drug Administration investigation showed that some claims of disease detection in multiple areas including heart disease, cancer and detection of fetal abnormalities are not supported scientifically. Because physicians treat based on lab results, this false information may have resulted in unneeded treatments, abortions, surgeries or wrong treatments for conditions that were unproven or were non-existent.
In another investigation into laboratory testing, it was found that some labs were not authorized to perform certain tests although the tests were done. In some cases, instructions were left unfollowed, testing materials were improperly stored or expired products were used, The report concluded that accuracy in testing results depended not only on the lab technician performing the test but on the laboratory itself. According to the report, some lab technicians were improperly trained or educated.
A misdiagnosis due to poor testing may lead to a worsened condition and thus adversely impact a patient’s prognosis. An attorney may examine the patient’s medical records and other evidence in order to determine if negligence on the part of a health care practitioner or facility can be established.