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Georgetown University Hospital closes Lab After Employee WhistleBlower Alleges Patients Were Not Timely Notified of Breast Canc

Posted Aug 08 2010 11:52pm

Overall there were 2 patients that were mis-diagnosed and the issue was with an employee stating they did not immediately call to notify patients and doctors of the errors and need for re-testing. 

Inspectors found other deficiencies in other area that the lab needs to correct as well and none reflect any test problems such as this one.  The last will be closed for 4-8 weeks.  BD 

Georgetown University Hospital has shut down a lab that performs genetic analysis for breast cancer patients and has had 249 women's tissue samples independently retested while federal health officials investigate procedures at the lab. image

Hospital officials said the process ultimately identified two women who had been falsely told they did not have a particularly aggressive form of breast cancer, known as HER2 positive.

The allegedly improper testing took place over 11 months starting in May 2009. The lab received failing results from a quality-control assessment of its HER2 testing in January 2010, and in the following weeks an employee asked supervisors to notify patients and recommend retesting. In an April complaint to hospital administrators, she alleged that nothing had happened, according to a federal official and Georgetown staff. The tests were outsourced later that month, and the two women's physicians were notified of the new, positive findings in the past two weeks as federal regulators began their inspection of the lab.

The employee, whose name has not been released, hired a lawyer, who brought her complaint to top hospital officials in April, a federal official and Georgetown staff said. The employee alleged that the lab director, Dan Hartmann, and other supervisors had rejected her suggestion in March that patients be alerted to the problem or their samples retested.

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