Jan 12, 2015 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
A growing number of media stories claim medical lab companies that develop genetic screening assays oversell the accuracy of such tests and fail to educate parents and doctors about the risks of false positives and false negatives
In response to growing concerns by consumers about the accuracy of some proprietary genetic screening assays, several media outlets have begun reporting on this sector of the clinical laboratory industry.
What gives these news stories emotional punch is the fact that patients use these proprietary medical laboratory tests to make decisions that can be life-changing. In its story about these tests, the Boston Sunday Globe used the headline “Oversold prenatal tests spur some to choose abortions.” (more…)
Jul 25, 2012 | Compliance, Legal, and Malpractice, Digital Pathology, Laboratory News, Laboratory Operations, Laboratory Pathology
Some medical laboratories may be exposed to malpractice suits involving prenatal genetic testing associated with “wrongful birth” claims
Genetic testing is creating a new source of medical malpractice liability and early cases have generated substantial settlements for the plaintiffs. Any clinical laboratory organization or pathologist involved in genetic testing should pay serious attention to this emerging field of malpractice law.
In particular, the media is reporting on malpractice lawsuits that involve prenatal genetic testing that was performed on behalf of parents who were attempting to determine the possibility of serious inheritable diseases in their unborn children.
In these cases, parents of a child born with a debilitating—and frequently financially-devastating—disease that could have been detected by accurate genetic testing are suing their healthcare providers, including medical laboratories. These plaintiffs claim that, through inaccurate genetic testing or lack of available testing, they were denied the choice of terminating a pregnancy that tested positive for serious inherited disease. (more…)
