September 23, 2014
We identified inconsistencies in three sophisticated molecular genetic tests performed by our clinical laboratories between March 15, 2013 and March 27, 2014. Oncologists may use these results in a variety of ways, including medication selection, prognosis, and research.
On April 4, 2014, a quality review conducted by a Medical Center pathologist found inconsistencies in the test results of one patient, which triggered a full process review, including the retesting of the patient tumor samples for approximately 120 patients. The retesting was done by outside, accredited laboratories.
How did it happen?
In processing these particular tests, a lab technician used different testing procedures than the Medical Center's validated testing processes. This resulted in the inconsistent test results.
Why are these tests performed?
These tests are performed after a patient has been diagnosed with cancer – sometimes with advanced stage cancer – to help determine potential treatment options.
These tests are not used to diagnose whether or not a patient has cancer. They may be used in combination with other tests to inform potential treatment options for patients whose cancer diagnosis has already been determined.
They also may be used to provide information to physicians conducting cancer research.
What kind of tests were these?
The tests were conducted on patient tumor specimens. The tests are designed to identify mutations in three specific genes (KRAS, BRAF, and EGFR).
Identifying the presence or lack of mutations in these genes in a tumor can influence the treatment options that a doctor might offer to patients with certain types of cancer.
Since discovering the issue, what steps has Penn State Hershey taken to ensure that future results are accurate?
Upon identifying the testing issue, we immediately stopped in-house testing for these three tumor gene variants (KRAS, BRAF, EGFR). We began sending all KRAS, BRAF, and EGFR testing to independent, accredited external laboratories and continue to do so.
How many other patients are affected by this?
124 patients had molecular lab tests that were part of the group of inconsistent tests we identified.
These patients are divided into three categories: 1) Patients whose original test results were confirmed by the external lab; 2) patients whose original test results were found to be different by the external lab but whose physicians determined the change did not affect treatment; and 3) patients whose original test results were found to be different by the external lab and whose physicians determined the change could affect the patients treatment plan. This last group of patients represents approximately 10 percent of the 124 patients.
What are you doing about the patients who were affected?
As we received the results of the tests conducted by the external laboratory, we began communicating them to physicians and patients. We sent letters to patients and their treating physicians providing information about what occurred.
Clinical leaders at Penn State Hershey spoke personally with treating physicians and engaged them in communicating with their patients, so that patients could work with their doctors to make informed decisions about their ongoing treatment.
Does my doctor already know about the inconsistent test results?
Immediately prior to informing the affected patients, we informed their treating physicians. We shared information about results of the original test and the retest, so that physicians would be prepared to discuss this new information with their patients and make informed decisions about ongoing cancer treatment.
What should I do?
If you are not one of the patients we contacted about this matter, there is no need to take any action. If you are one of the patients we contacted, you should discuss the matter with your treating physician.
Were patients or their insurance carrier billed for the repeat testing?
What happened to the employee?
We cannot discuss details about personnel matters, but he is no longer an employee of the Medical Center.