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Thursday, July 23, 2015, 08:45

Medical blunder affected nearly 10,000 patients

By Kahon Chan

An incorrect set of reference values for liver enzyme levels, caused by human error, appeared on nearly 10,000 reports at Tuen Mun Hospital over the past two years, the Hospital Authority revealed on Wednesday.

Tony Ko Pat-sing, chief executive of New Territories West Cluster of the Hospital Authority, revealing the medical blunder, apologized to the public and also to some 9,443 elderly patients affected by it.

Among them, 236 male patients have been told they need follow-up consultations and blood tests. Another 2,144 male patients’ records are now being reviewed.

The history of the 4,809 affected female patients, deemed less vulnerable to potential risk, will be evaluated later.

Ko said the odds ofmisdiagnosiswere low.

The enzyme analyzer has been used at Tuen Mun Hospital since August 2013. But its default settings were not checked for the next two years. It subsequently analyzed over 9,000 elderly patients’ blood samples.

At a workflow review conducted on July 6, the hospital realized that a laboratory technician who set up the device had made a mistake. The technician had erroneously swapped the male and female reference values for alkaline phosphatase (ALP), a liver enzyme, in the age range of 60 or above. Two chemists also failed to spot this mistake.

Que Tak-lun, director of the hospital’s clinical pathology department, admitted the hospital did not regularly review default settings for such devices. The staffmembers responsible for themistake have been identified. But they were not suspended from work or named at the press conference as an investigation is underway.

The reference values, alongside the actual test results, are shown on patients’ test reports to help doctors. As a result of the swapping of reference ranges, certainmale patients’ ALP readings might have appeared on the report as wrongly being in the safe range.

It remains unclear why doctors reading the reports were unable to see that the reference range was incorrect.

But Henry Chan Lik-yuen, director of the Chinese University of Hong Kong’s Centre for Liver Health, explained that doctors do not routinely question reference values supplied by laboratories.

Secretary for Food and Health Ko Wing-man, in a statement, expressed his deep regrets over the incident. He advised all hospital staff to learn more about using this type of equipment.

But Tony Ko said the ALP level is only one of the many factors in analyzing liver functions. He believed it was unlikely these errors had contributed to wrong medical procedures or deaths over the past two years.

Chan agreed, saying that if a patient faced a life-threatening liver problem, this would have been reflected in numerical indicators onmany reports.

Among the 4,634 male patients affected, 1,425 have died for a variety of reasons. Records of 2,144 male patients and 4,809 female patients are still pending a review. This is a process that will take four months to complete. The hospital claimed it saw no signs of misdiagnosis after reviewing over 1,000 records.

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