SINGAPORE – A test for breast cancer patients that guides their treatment options has produced inaccurate positive results at Khoo Teck Puat Hospital (KTPH), resulting in about 90 patients receiving unnecessary treatment since 2012.
Side effects from the treatment the affected patients may experience include heart problems, diarrhoea, chills and fever.
KTPH said on Friday (Dec 11) it estimates that 180 patients may have got the wrong test results. Preliminary investigations suggest an incorrect staining process for the human epidermal growth factor receptor 2 (HER2) test was the cause.
The HER2 test is used to determine how aggressive the breast cancer is likely to be so that medical practitioners can prescribe the right treatment for patients.
In the test, the tissue sample from the patient is “stained” with antibodies that have a coloured dye, which attaches itself to HER2 proteins.
Since the issue with the test was discovered, the hospital said it has identified all affected patients and their samples dating back to 2012 have been sent to external laboratories to expedite retesting.
As some of the retest results return, the hospital has begun contacting the patients and their treating oncologists to offer support. This process of contacting patients is still ongoing.
To ensure patient safety, the hospital has stopped in-house HER2 testing in its laboratory.
KTPH said it reported the incident to National Healthcare Group (NHG) on Nov 22 and to the Ministry of Health (MOH) on Nov 24.
NHG has convened an independent review committee, which includes external experts, to do a thorough review of how the incident occurred to improve the process and prevent a recurrence of similar incidents.
Said Mrs Chew Kwee Tiang, chief executive of KTPH: “I would like to convey my deepest apologies to all the affected patients, their families and their treating oncologists. I am very sorry that they have to go through this. We will provide all the necessary support and assistance, and will do our best to take care of them.”
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