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Testing ceases following July 19 inspection by officials from CMS and CAP

Last Friday, The Washington Post broke the news that Georgetown University Hospital (GUH) had closed the pathology laboratory that performed certain breast cancer tests. The action—described as an “unprecedented” suspension by GUH Chief Medical Officer Stephen Evans, M.D.—was taken in response to an investigation of the pathology laboratory by federal officials.

The closure of the laboratory followed an inspection on July 19, 2010 by officials from the Centers for Medicare and Medicaid Services (CMS) and inspectors from the College of American Pathologists (CAP). Hospital officials say the molecular testing laboratory in question will be closed as long as four to eight weeks. During this time, specimens are being referred to outside laboratory testing sources.

The events described by the Post indicate that allegedly improper testing of breast cancer patients for HER2 took place during an 11-month period, beginning in May 2009. Georgetown University Hospital has confirmed issues with breast cancer testing and it is known that the tissues of 249 women have been retested by independent labs.

Post reporters Lena H. Sun and Carol D. Leonnig wrote that “the [GUH] 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.”

According the timeline of events presented by The Washington Post, an employee of the pathology laboratory, upon learning about the failing results of the quality control testing done in January 2010, had asked supervisors to notify patients possibly affected by the findings and recommend retesting.

The matter didn’t end there. Reporters Sun and Leonnig described the situation, writing that “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.”

Dan Hartmann, Ph.D., is identified on the Georgetown University web site as Professor in the Department of Pathology and Scientific Director of the Molecular Diagnostic Laboratory.

Apparently, unsatisfied with the response by hospital administration to the April complaint, Debra Katz, the attorney for the laboratory staff member, filed a formal complaint to CMS early in July. A copy of the complaint was also sent to the College of American Pathologists. Both organizations then began investigations into the matter. The Washington Post reported that a federal official had said that the complaint “expressed concern that Georgetown was taking a long time to do the retesting and was not sharing the problem with patients.”

The Post wrote that, “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.”

For its part, Georgetown University Hospital has vigorously asserted that it wants its “policies and procedures to impeccable,” and that the laboratory “passed two subsequent quality control tests, voluntarily performed retesting that showed a high accuracy rate and is sending other work to outside labs.” For corrective action, “the hospital is increasing the number of quality control workers at the lab,” among other steps.

As to the patients possibly affected by these issues, Georgetown provided some information. The Post said that, around the time of the July 19 visit by CMS officials and CAP inspectors, Georgetown University Hospital “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.”

For pathologists and clinical laboratory managers, the events unfolding at the pathology laboratory department at Georgetown University Hospital are both a reminder and a warning. Setting aside the issues relating to laboratory testing quality and integrity, this situation has many hallmarks of the classic whistleblower case.

Was this laboratory staff member correctly requesting a necessary response to valid concerns about lab test accuracy and quality that might affect the diagnoses and treatment decisions of those patients affected by the breast cancer tests in question? It seems the action to suspend testing at the Georgetown molecular diagnostics laboratory in July would indicate that the basic issues triggered by this employee’s request to her supervisor earlier this year had some merit.

Thus, it would be timely for pathologists and clinical laboratory managers to review the policies and procedures in place at their respective laboratories to ensure that employees who call attention to situations of lab testing accuracy or quality are handled responsibly, ethically, and to the best interests of the patients whose specimens were tested.

Related Information:

Georgetown U. Hospital closes lab after problems with breast cancer tests

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

Dark Daily recent news coverage on HER2

Dan Hartmann, Ph.D.

Debra Katz

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