The machine at the centre of the latest Eastern Health testing debacle is a beneficial technology, but labs must keep on top of the pitfalls that can cause errors, says a German scientist who authored the research paper the health authority says it missed when it set up the machine.
"There is a wide variety of mistakes to be made," said Dr. Michael Vogeser, acting head of the Institute of Clinical Medicine at the University of Munich, co-author of a 2005 paper that has been referenced in relation to mistakes in Eastern Health's biochemistry laboratory.
Until The Telegram contacted Vogeser Thursday, he was unaware of the problems with the machine that occurred at Eastern Health.
Testing stopped
The mistakes sparked the halting of cyclosporine testing in St. John's and required the results of 212 patients be retested. One boy who was ill when he received too much cyclo-sporine remains in the Janeway in critical condition and the deaths of three patients are being re-examined.
The machine on which the errors were made, a mass spectrometry analyzer, is used to measure levels of the drug in patients' blood. It is given to people with immune disorders and as an anti-rejection drug for organ transplant patients. The machine was not calibrated to recognize there can be an interfering substance, known as metabolite, which exists naturally in some patients and, in rare instances, can interfere with cyclosporine causing the machine to show artificially low levels of the drug. Too much cyclosporine can be toxic.
Vogeser and a colleague identified that interfering substance in a 2005 paper, which has been newly discovered by Eastern Health since the mistakes came to light several weeks ago. The machine was installed in June 2009.
Eastern Health CEO Vickie Kaminski has been referring to the paper as "obscure" when speaking to the media.
But Vogeser, whose major field of interest is mass spectrometry, told The Telegram Thursday that while the journal it was published in - Clinical Chemistry and Laboratory Medicine - is "almost unknown" outside Europe, a citation of it should have been easily found by lab doctors or officials using a standard medical publication database by merely searching cyclosporine and interference.
Vogeser said he finds it hard to fault colleagues for mistakes.
However, he said keeping on top of research literature is imperative when it comes to mass spectrometry analyzer technology, which has great potential in testing, but has only been around for a decade. And with models changing, pitfalls must be taken into consideration.
"Colleagues are very enthusiastic about this technology. As well, in consideration, we have this seemingly powerful technology ... some people forget or do not want to see there are many mistakes that can be done, and this is a general problem."
Eastern Health has already admitted it did not do a literature search when it set up the device.
Nor was the interfering substance identified in the manufacturer's standard operating procedures, according to Eastern Health, and so the health authority is looking into the responsibilities of Waters Corp. and whether or not it should have known about the issue.
University Health Network of Toronto arrived in St. John's Thurs-day to begin an investigation of the biochemistry lab errors.
It will move on to a review of all labs in Eastern Health and then the province.
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