Georgetown Hospital Shuts Lab After Problems With Genetic Testing For Breast Cancer

Georgetown University Hospital has closed a genetics analysis laboratory that performs testing for breast cancer patients after two women were falsely told they do not have an aggressive form of breast cancer known as HER2-positive, the Washington Post reports. CMS officials are investigating allegations by an employee of the lab that hospital administrators did not respond to a request to notify patients of a failed quality-control inspection and recommend that they undergo retesting.

After the failed inspection, an independent lab retested tissue samples for 249 women and found that the two women were falsely told they did not have HER2-positive breast cancer, which occurs in about 15% to 20% of patients and increases the risk that tumors will spread or recur. According to hospital officials, neither of the women's treatment was adversely affected by the delayed diagnoses.

The alleged improper testing began in May 2009 and lasted for roughly 11 months, according to the Post. Georgetown officials confirmed problems with the tests but said the lab has maintained a 99% accuracy rate overall. Stephen Evans, the hospital's chief medical officer, said this week that the hospital learned earlier this year that staff members did not use proper temperature, timing and tissue embedding methods when processing patient samples. As a result, the lab failed quality-control tests administered by the College of American Pathologists, which accredits medical labs. The hospital is adding more quality-control workers and reviewing the "roles, responsibilities and decision-making" of lab personnel, Evans said, adding that the lab should resume testing in four to eight weeks.

Meanwhile, CMS and CAP are investigating procedures at the lab. Unaddressed deficiencies can lead to a lab's loss of accreditation (Leonnig/Sun, Washington Post, 8/6).


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