Georgetown U. Hospital closes lab after problems with breast cancer tests
Friday, August 6, 2010
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.
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.
Work at the lab, which provides molecular-based tests for cancer, infectious disease and genetics, was suspended two weeks ago and sent to outside labs, Stephen Evans, the hospital's chief medical officer, said this week. He said the suspension was unprecedented. Federal officials are continuing to investigate the employee's allegations, according to an official with the Centers for Medicare and Medicaid Services, the federal agency in charge of overseeing the quality of testing in medical laboratories.
Georgetown officials confirmed problems with the breast cancer testing but said the results nonetheless show a 99 percent accuracy rate.
Last month, accreditors reviewed the tests performed by the lab on other diseases and found the lab deficient in documentation. But Evans said the flaws were not in the way tests were performed and did not result in potentially faulty results. Deficiencies, if not corrected promptly, can lead to a hospital lab's losing its accreditation.
About 15 to 20 percent of breast cancers have extra copies of a gene called HER2, which makes the malignancy more likely to spread and come back. Women who test positive typically respond to treatment with Herceptin, a drug that may slow or stop the tumor's growth. Treatment should start within 12 months of diagnosis, experts said.
The closed Molecular Diagnostics Laboratory is part of Georgetown's pathology department. Evans said the lab is expected to resume testing in four to eight weeks.
In interviews this week, Evans said 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, he said. The lab corrected its procedures, he said.
The quality-control tests are administered by the College of American Pathologists, a Chicago-based committee that accredits medical laboratories.
Evans said he could not comment on the employee's allegation of supervisors' failure to act.
Through a spokeswoman, Evans said the hospital had taken numerous measures to ensure quality and accuracy of testing "because we want our policies and procedures to be impeccable." The lab conducted an internal investigation, passed two subsequent quality-control tests, voluntarily performed retesting that showed a high accuracy rate and is sending other work to outside labs, he said. That demonstrates "both the accuracy of the outcomes of the testing and how seriously we take the quality of our work," he said.