Hershey Medical Center

 

A lab technician at Penn State Hershey Medical Center failed to follow proper procedures when conducting a genetic test used to help physicians decide on cancer treatments, affecting the test results of 124 patients, the organization said this week in response to an Intelligencer Journal/Lancaster New Era inquiry. 

Penn State Hershey determined the flawed procedure was used from March 2013 to March 2014.

The problem came to light in early April, when one of Penn State Hershey’s pathologists noticed an inconsistency in a patient’s test results, the medical center said. That triggered a thorough review.

Penn State Hershey has notified all of the patients as well as their physicians, spokesman Sean Young said. Everyone who was potentially affected knows it, he said.

The organization declined to say if any of them are from Lancaster County, citing patient privacy regulations. Federal law bars the release even of anonymous information if the number of patients involved is small.

Penn State Hershey said it had an independent lab redo all the tests. In many cases, either the results came back the same, or the new result did not change the patient’s recommended treatment.

In about 10 percent of the cases — a dozen patients, give or take — the new result had the potential to affect patients’ treatment, the medical center said.

By comparison, Penn State Hershey saw about 37,000 cancer patients in the 12-month period ending June 30.

The organization stressed that the test was one of many, and that cancer treatment involves many different therapies, including medicine, chemotherapy, radiation and so on. Each patient’s regimen is unique.

For that reason, it’s essentially impossible to say if the flawed testing affected any medical outcomes, the medical center said.

“Given the severity of illness for some of these patients and the individual nature of their treatment plans, there is no general answer,” Young said via email.

Penn State Hershey is continuing to review its procedures. Until that’s complete and appropriate changes are implemented, the tests will continue to be done by an outside lab.

The technician in question is no longer working there, Penn State Hershey said.

The organization voluntarily reported the issue to the state Department of Health and the College of American Pathologists, or CAP. The latter is an accrediting body for clinical laboratories.

The laboratory has been CAP-accredited since 2008, and was most recently inspected Aug. 24 of this year, spokeswoman Julie Monzo said.

CAP sent Penn State Hershey a letter dated June 26 regarding the flawed testing. According to an excerpt provided by Young, CAP said “the issue has been appropriately addressed and is considered resolved.”

The Department of Health issued no new requirements, but asked that Penn State Hershey keep it informed, Young said.

The department did not immediately respond to an Intelligencer Journal/Lancaster New Era request for comment.

The test in question reveals mutations in three genes found in tumors. The mutations predict how well patients will respond to certain kinds of cancer treatment.

According to a February/March 2012 article in the journal Lab Medicine, error rates at hospital laboratories are declining and “are far lower than those seen in overall clinical health care.” One 2007 study found an error rate of one-third of 1 percent.

Most lab errors occur either before or after the actual test and involve issues such as data entry mistakes in the test order or reporting of results. Errors during the test itself, including failures to follow procedure, account for 7 percent to 13 percent of total lab errors, the article said.

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Tim Stuhldreher is a Lancaster Newspapers staff writer who covers business and finance. He can be reached at tstuhldreher@lnpnews.com or (717) 481-6137. You can also follow@timstuhldreher on Twitter.