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Matthew Nace
Matthew Nace
Attorney • (202) 930-0292

Improper Genetic Testing and Delayed Corrections Lead to Shut Down at Georgetown

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In the age of highly sophisticated and technological medical treatment, testing is still only as effective as the competence of those conducting the tests. This weekend Georgetown University Hospital shut down one of its genetic analysis laboratories after a complaint was made by an employee to the Centers for Medicare and Medicaid Services.

According to an article published in the Washington Post,

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.

As described by the Post’s article, the HER2 gene makes the malignancy of a breast cancer patient more likely to spread and come back. If a woman tests positive for the HER2 gene, she should be treated with Herceptin in order to slow or possibly stop the tumor’s growth.

According to the Post,

accreditors reviewed the tests performed by the lab on other diseases and found the lab deficient in documentation…the hospital learned early this year that lab staff members were not using proper temperature, timing and tissue-embedding methods in processing samples. That caused the lab to fail the quality-control test for HER2.

Despite these issues of concern, what might be even more shocking is the manner in which Georgetown allegedly went about correcting the problem. Knowing of its failing results from a quality-control assessment and a recommendation from an employee to her supervisors to notify the patients and recommend retesting, a complaint filed in April alleged that nothing happened.

Early last month, a federal official said, the employee and her lawyer made a formal complaint to the Centers for Medicare and Medicaid Services, expressing concern that Georgetown was taking a long time to do the retesting and was not yet sharing the problem with patients. The complaint was also sent to the College of American Pathologists, which began its own investigation, the federal official said.

Federal regulators and inspectors from the pathology group visited the lab the week of July 19.

Around the same time, Georgetown began alerting the physicians of patients whose tests came back positive for HER2 breast cancer. After two rounds of outside retesting, six patients were found positive, and their physicians were notified. Four of those had separately received other independent negative results. In the end, Georgetown said, only two patients were misdiagnosed.

While Georgetown makes the claim that only two patients were misdiagnosed and neither misdiagnoses affected their treatment, it does not change the fact that these patients were left sitting unaware and ignorant of their testing while Georgetown was well aware of the potential issues. The Post goes onto state that,

Hospital officials said they did not notify the 249 patients who initially tested negative because that would have been premature.

"Premature"? When would this information have been mature? After Georgetown had re-run the tests and pinpointed which individuals were misdiagnosed? After those misdiagnosed individuals suffered a recurrence that could have possibly been avoided by proper treatment?

We can all acknowledge that mistakes happen. But when they do, accountability must set in. Today, we see a total denial and refusal to accept accountability.