Medical Test Oversight Unchanged Since 1988

Connecticut residents likely understand that medical tests are not foolproof and inaccurate results are a possibility, but they may be dismayed to find that many of the tests performed in labs across the country have not been reviewed or approved by the FDA. Congress established the rules for medical test oversight in 1988, but a lot has changed since then.

When Congress laid down the rules regarding medical tests in 1988, there were only a handful of tests that would be performed in only a single lab and therefore not subject to FDA scrutiny, but that number has since grown to more than 3,000. The sophistication of these waived tests has also increased dramatically since the law was passed. In 1988, most waived tests were straightforward and simple for lab staff to perform, but many of the tests currently being performed with no oversight are highly sophisticated and even minor mistakes can lead to a wrong diagnosis. Calls have also been made to increase the number of labs being inspected.

The results of inaccurate medical test results can be catastrophic. Case studies have shown that patients have undergone unnecessary surgery due to test results indicating the presence of a medical condition that did not exist, and the results of a progressive condition like cancer remaining undetected can be even more dangerous.

Individuals may suffer serious consequences when medical tests are performed incorrectly or doctors fail to correctly diagnose serious illnesses. Those who suffer injury, loss or damage due to errors made by physicians or health care facilities may want to pursue civil remedies, and an attorney who has experience in this area can explain the procedures that are required for the filing of a medical malpractice lawsuit.