• Khoo Teck Puat Hospital will offer compensation to 180 breast cancer patients 
• They had been misdiagnosed with a type of malfunctioning gene; half received unnecessary treatment
• The hospital will work out how much compensation each patient should receive
• An investigation found inadequate quality control at the laboratory handling the tests
• Five staff members, including management, have been disciplined 

SINGAPORE — Khoo Teck Puat Hospital (KTPH) will be compensating its breast cancer patients who, over a span of eight years, were misdiagnosed with a type of malfunctioning gene because of lapses at the healthcare institution. 

The hospital has also taken disciplinary action against five staff members who were found by an independent review committee to have performed their duties and responsibilities inadequately, leading to those lapses.

The five include members of management and staff, and the penalties meted out against them included cessation of employment, financial penalty and stern warning. 

The National Healthcare Group (NHG), which had set up the independent review committee to carry out a thorough evaluation of the misdiagnoses, announced these in a statement on Monday (May 3), saying that the committee has completed its investigation.

WHAT HAPPENED

In December last year, KTPH said about 180 of its breast cancer patients over the past eight years may have been incorrectly diagnosed with a type of malfunctioning gene, and half of them may have received unnecessary treatment.

The hospital’s preliminary investigations indicated this had resulted from an incorrect process in its laboratory in relation to tests for human epidermal growth factor receptor 2 (HER2), which is a gene determining how a healthy cell grows.

Upon full investigation, the independent review committee, which comprised experts in various disciplines from the healthcare industry, found that the inaccurate HER2 positive rates were caused by a suboptimal HER2 staining protocol at the KPTH department handling these laboratory tests. 

NHG said in its statement that the suboptimal HER2 staining protocol was caused by human error when establishing the protocol. 

This led to over-staining of slides, which affected the interpretation of the slides, resulting in a higher-than-usual HER2 positive rate. 

The calibration error was not discovered as the hospital failed to conduct rigorous checks at the point when the protocol was established.

NHG said the investigations by the review committee revealed inadequacies in the quality control at KTPH’s HER2 immunohistochemistry section. 

“The deviation of HER2 positive rates from international benchmarks was noted earlier on during the laboratory’s regular monitoring,” NHG said. 

“The section checked the accuracy of reading of the slides and attributed the deviation to differences in patient population, and did not recheck the accuracy of the staining protocol.”

Staff from the section also failed to perform quality control checks properly, including monitoring and properly analysing the HER2 positive trend closely over time, which affected the interpretation of the over-stained slides and a delay in detection of the error, NHG added.

It was only last year when the clinicians reviewing breast cancer cases noticed the higher than usual positive rate, and an internal review was conducted to follow up on the deviation.

DISCIPLINARY ACTIONS

A Board of Inquiry (BOI) was set up after the review committee’s investigations to examine the roles, responsibilities and actions of specific staff involved.

After the BOI’s deliberations, a disciplinary committee was then convened by the NHG Board in March. 

Five individuals, comprising KTPH’s management and staff, were identified for not adequately performing their duties and responsibilities, leading to the serious lapses, NHG said. 

NHG did not name the staff members who were disciplined, nor did it say how many were fired or penalised financially. 

“Appropriate counselling, retraining and re-education are currently being conducted,” NHG added.

APOLOGY AND COMPENSATION

In the NHG statement, associate professor Pek Wee Yang, the chairman of KTPH’s medical board, said the hospital has reached out to all affected patients and “will look into the appropriate compensation for each individual patient”. 

But he added that this process will “take some time” to complete.

KTPH will also provide psychological counselling to these patients, where needed, during this period, he said.