Independent committee to evaluate Singapore’s KTPH lab error that led to breast cancer patients getting unnecessary treatment

About 200 breast cancer patients were misdiagnosed with a type of malfunctioning gene because of a lab error at Khoo Teck Puat Hospital. — Picture by Anna Tarazevich/Pexels via TODAY
About 200 breast cancer patients were misdiagnosed with a type of malfunctioning gene because of a lab error at Khoo Teck Puat Hospital. — Picture by Anna Tarazevich/Pexels via TODAY

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SINGAPORE, Jan 4 — The National Healthcare Group (NHG) has set up an independent review committee to carry out a “thorough evaluation” of the incident at Khoo Teck Puat Hospital (KTPH) that led to 200 breast cancer patients being misdiagnosed with a type of malfunctioning gene in the past eight years.

About 90 of them may have received unnecessary treatment, the authorities revealed last month. 

Affected patients will receive full refunds of the portions of their bills arising from unnecessary treatment at the hospital, Senior Minister of State for Health Koh Poh Koon told Parliament today. 

They will also receive financial and clinical support, including for ongoing and follow-up treatment that may be needed as a result of over-treatment from the misdiagnosis.

Dr Koh was responding to questions from five Members of Parliament (MPs) over the incident. 

It resulted from an incorrect process in KTPH’s laboratory in relation to tests for human epidermal growth factor receptor 2 (HER2), a gene determining how a healthy cell grows.

Some patients were classified to be HER2-positive, instead of HER2-negative, because of slip-ups at the lab. A positive test result suggests that the gene is malfunctioning, leading to the uncontrolled growth of cells, and affects how a patient is treated, usually with a drug called Herceptin.

Initial estimates made public on December 11 last year showed that about 180 breast cancer patients may have to be reclassified from HER2-positive to HER2-negative, and about half of them may have received unnecessary treatment.

Dr Koh said today that as of December 23 last year, 200 patients had been reclassified from HER2-positive to HER2 negative.

Among the parliamentary questions tabled, MP Joan Pereira of Tanjong Pagar Group Representation Constituency (GRC) wanted to know what was being done to prevent similar incidents.

Dr Lim Wee Kiak (Sembawang GRC) asked about the cost of medication incurred by patients who were misdiagnosed and how many of them suffered side-effects as a result of being given the wrong treatment.

In his response, Dr Koh said that the committee convened by NHG, the public healthcare cluster overseeing KTPH, comprises external experts from “multiple relevant disciplines” in the healthcare industry.

The objective is to conduct a thorough evaluation of the incident, to understand better the lapses that have occurred and recommend appropriate measures to improve the process. This ensures that any system gaps are identified and addressed swiftly to prevent recurrence of similar incidents.”

He added that the committee’s investigations were in progress and it would provide an update when more information becomes available.

Of the 200 affected patients, 192 were treated at government hospitals and eight at private hospitals. Another eight patients have pending re-tests, said Dr Koh.

He added that KTPH and the patients’ treating doctors were reviewing their care plans and would assess them for potential side-effects due to the unnecessary treatment.

Common side-effects from the Herceptin treatment include diarrhoea, chills and fatigue. About 3 to 4 per cent may also experience heart problems.

On November 19 last year, KTPH was informed by its lab that its tests for HER2 were producing higher-than-expected rates of positive results for breast cancer patients.

Based on preliminary investigations by the lab, the inaccurate results could be due to a suboptimal staining process.

Dr Koh said that the hospital has since stopped in-house testing of HER2 and the Ministry of Health (MOH) has not received any reports of similar risks in testing from other healthcare institutions.

KTPH has sent the samples of all patients who have tested HER2-positive since 2012 — when testing for the gene started at the hospital — to external laboratories for re-testing to determine how many had received inaccurate results. 

The department of laboratory medicine at KTPH is subject to regular inspections by MOH, as part of regulatory processes under the Private Hospitals and Medical Clinics Act, to ensure that lab facilities, systems and processes are in place to meet safety standards for patients and staff. The lab is also accredited by the College of American Pathologists and the last inspections by peers — done every two years — were in 2019, Dr Koh said.

Chew Kwee Tiang, KTPH’s chief executive officer, last month apologised to patients as well as their families and 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,” she said, vowing to take “all the necessary steps to ensure this does not happen again”. — TODAY

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