Mistakes can be made, doctor says

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Barb Sweet
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German scientist comments on pitfalls of machine at centre of Eastern Health debacle

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.

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.

bsweet@thetelegram.com

Organizations: Institute of Clinical Medicine, University of Munich, Chemistry and Laboratory Medicine Waters Corp. Health Network

Geographic location: Eastern Health, St. John's, Europe Toronto

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Recent comments

  • g-man
    July 02, 2010 - 13:31

    doctors sometime have too much leaway when it comes to treating patients.i just lost a family member from the hospital,because the idiot doctor we had, never consulted with family members before administrating medications.it caused a drug overdose and killed my family member.it was like witnessing an exacution.watching my family member just slip off into the sunset.the funny thing about all of this,i never got a call from anyone at the hospital to say they were sorry about my loss.its called,NO DIGNITY LEFT FOR THE PASSING.

  • C
    July 02, 2010 - 13:30

    My ?s for Dr. Michael Vogeser are did it just affect the Walters Corp mass spectrometry analyzer or other analyzers? If also other analyzers, did those companies inform their clients & if so how.

    Importantly, in the scientific method, studies are usually replicated was this done? It seems that in an issue which can severely impact a persons health, that I would have expected US & other researchers to have conducted experiments on this & published them & for this to be incorporated quickly & in a loud fashion to those in fields using the equipment & by manufacturers & sellers of the equipment.

    My ?'s are also with Walters Corp - manufacturer of the mass spectrometry analyzer (MSA) (1) Did they know of Dr. Michael Vogeser's 2005 paper and what is their response to it? (2) What efforts did they make to inform the purchasers of this equipment, hospitals & laboratories who do this type testing?

    Did the big hospitals & especially those focusing on the diseases that use significant cyclosporine for treatment do the calibration?

    The Tely article says that it is rare that there are rare instances where the metabolite causes the MSA to show artificially low levels of cyclosporine. How rare? (& the deeper ? is how much of an increase in cyclosporine would be prescribed as a result & what impact might this have on patients health).

    With respect to the differences in levels between the old & new equipment, I would have thought that one fo the 1st things to do would be to compare results using both pieces of equipment to see if they are consistent. (if they could both be run at the same time or definitely to play close attention to results from a fair # of patients to ensure that results appeared normal. Furthermore, with most lab equipment, there are standards run on a specified basis to verify their accuracy of to calibrate them to a standard. If a metabolite in some people could cause a problem, it should have been included in the test material when calibrating the machine. (An earlier Tely article, said both machines were in use for at least some of the time).

    I am not in the medical or health field. However, of the 3 top level individuals who resigned from their positions, I knew one pretty well many years ago he is a brilliant man, who did most all his training at MUN; the other did most of his specialist training at MUN and also did detailed training for months at other hospitals & wanted to have a permanent position in NL. These men are pathologists who are in very short supply in NL and at least one of them has made impassioned pleas for more pathologists & many pathologists & oncologists & other specialists have discussed the huge workload issues and stress associated with it. I have never heard anything negative about their work, in which case, it is good that they are remaining with Eastern Health. I recall that one employee in particular was very impressive during the Cameron Inquiry so I am like any valuable employee,. The problems have been associated with the breast screening lab tests & with the MSA. (I didnt pay enough attention to the line of responsibility for the breast screening problems at Eastern Health and what role pathologists would have but it seems that that would fall upon lab personnel as would the MSA work. (I note that other hospitals have also had problems with breast screening since The NL problems). If it is accurate that Dr. Denic wished to resign from his position as clinical chief of laboratory medicine in Dec (due to workload issues) & was asked to stay on for 3 months while they found a replacement, that is something that Eastern Health needs to pay attention to: workload issues for their specialists & management. One would have thought this would have been done and Eastern Health & those who provide funds for same need to look at these issues. + the impact of their statements on people within Eastern Health & in persons considering recruitment here. Also, is there sufficient lab staff & management & what is being done to verify the accuracy of procedures & work. Since this was a major issue from Cameron, seems to me that sufficient resources should be dedicated to it. I believe that Eastern Health probably runs hundreds of different types of tests on many types of equipment & that literature searches on interference cyclosporine (& every other test) is not something that is routinely done by hospitals especially with an ongoing type of test when the only difference is a new machine.

    What is Health Canadas & provincial & national & international medical associations & laboratory technicians roles in bringing precautions / interferences to light (& even more generally how is medical information transferred to physicians & technicians) I think everyone would want to ensure that this information is getting through & being acted on.& that there are sufficient employees and a positive culture of delivering quality health services within the province. I would hope that employees are comfortable red flagging when there are issues that arise & that there are sufficient resources to ascertain if there is a problem, what it is and to correct it immediately. I am concerned about how the media & those in positions of responsibility handle matters at times like this & that employees in all areas know that they are not being scapegoated. I support every health worker & manager in delivering the best quality health care for the residents of the province.

  • Marie
    July 02, 2010 - 13:29

    Mistakes.....you call it a mistake. br Tell that to the families of the deceased, as well as those who have suffered and are still suffering needlessly. How would you feel if it was your daughter, son, husband, wife, mother, father, sibling, or grandchild? Would you still take it calmly as a Mistake? That's quite easy to say when you can't even put a face to the names. They are just statistics. Numerous deaths, and unbearable heartache and sorrow to the families, are the consequences, and you call that a mistake! Yes, obviously, I am upset and angry.

  • Cindy
    July 02, 2010 - 13:24

    I'm sure the lab employees had all the time in the world to research, read, google, go to the library and order all journals from different countries before using this new machine. br br I'm also sure, that before they even unpacked the machine, they should have been trying to find information on possibles errors that machine could make on one particular drug and one type of human illness even though it wasn't supplied in the documentation with the machine. br br Well, I'm sure the next time a new piece of equipment comes into the lab Ms. Kaminski will understand when the lab employees have to spend time looking for documentation that didn't come with the machine, might never exist, and to keep on researching every possible combination/permutation of drug/human disease testing errors that could possible be conceived of in case it does exist. br br Oh yeah, it's all the lab employees fault. You should have fired them all Ms Vicki. Go have another bag of chips you role model of health.

  • Polly
    July 02, 2010 - 13:18

    There is a wide variety of mistakes to be made ---- Dr. Michael Vogeser . In a poisoned atmosphere -- no pun intended-- such as the one Eastern Health finds itself in today . It comes as no surprise that serious mistakes are being made . With the rush to find a quick fix , due diligence maybe overlooked. Credibility is problematic at Eastern Health subsequent to the Cameron Inquiry and this latest debacle ---- malfunctioning laboratory equipment and the impact ensuing for some 212 to 234 lives . Untimely dismissals before root causes come to light maybe based on political expediency rather than operational necessity . Bravo Ms. Sweet --- an excellent article , your hard work and goog old fashioned investigative journalism has paid off by highlighting this , the latest of the self-fulfilling prophecies .

  • g-man
    July 01, 2010 - 20:20

    doctors sometime have too much leaway when it comes to treating patients.i just lost a family member from the hospital,because the idiot doctor we had, never consulted with family members before administrating medications.it caused a drug overdose and killed my family member.it was like witnessing an exacution.watching my family member just slip off into the sunset.the funny thing about all of this,i never got a call from anyone at the hospital to say they were sorry about my loss.its called,NO DIGNITY LEFT FOR THE PASSING.

  • C
    July 01, 2010 - 20:18

    My ?s for Dr. Michael Vogeser are did it just affect the Walters Corp mass spectrometry analyzer or other analyzers? If also other analyzers, did those companies inform their clients & if so how.

    Importantly, in the scientific method, studies are usually replicated was this done? It seems that in an issue which can severely impact a persons health, that I would have expected US & other researchers to have conducted experiments on this & published them & for this to be incorporated quickly & in a loud fashion to those in fields using the equipment & by manufacturers & sellers of the equipment.

    My ?'s are also with Walters Corp - manufacturer of the mass spectrometry analyzer (MSA) (1) Did they know of Dr. Michael Vogeser's 2005 paper and what is their response to it? (2) What efforts did they make to inform the purchasers of this equipment, hospitals & laboratories who do this type testing?

    Did the big hospitals & especially those focusing on the diseases that use significant cyclosporine for treatment do the calibration?

    The Tely article says that it is rare that there are rare instances where the metabolite causes the MSA to show artificially low levels of cyclosporine. How rare? (& the deeper ? is how much of an increase in cyclosporine would be prescribed as a result & what impact might this have on patients health).

    With respect to the differences in levels between the old & new equipment, I would have thought that one fo the 1st things to do would be to compare results using both pieces of equipment to see if they are consistent. (if they could both be run at the same time or definitely to play close attention to results from a fair # of patients to ensure that results appeared normal. Furthermore, with most lab equipment, there are standards run on a specified basis to verify their accuracy of to calibrate them to a standard. If a metabolite in some people could cause a problem, it should have been included in the test material when calibrating the machine. (An earlier Tely article, said both machines were in use for at least some of the time).

    I am not in the medical or health field. However, of the 3 top level individuals who resigned from their positions, I knew one pretty well many years ago he is a brilliant man, who did most all his training at MUN; the other did most of his specialist training at MUN and also did detailed training for months at other hospitals & wanted to have a permanent position in NL. These men are pathologists who are in very short supply in NL and at least one of them has made impassioned pleas for more pathologists & many pathologists & oncologists & other specialists have discussed the huge workload issues and stress associated with it. I have never heard anything negative about their work, in which case, it is good that they are remaining with Eastern Health. I recall that one employee in particular was very impressive during the Cameron Inquiry so I am like any valuable employee,. The problems have been associated with the breast screening lab tests & with the MSA. (I didnt pay enough attention to the line of responsibility for the breast screening problems at Eastern Health and what role pathologists would have but it seems that that would fall upon lab personnel as would the MSA work. (I note that other hospitals have also had problems with breast screening since The NL problems). If it is accurate that Dr. Denic wished to resign from his position as clinical chief of laboratory medicine in Dec (due to workload issues) & was asked to stay on for 3 months while they found a replacement, that is something that Eastern Health needs to pay attention to: workload issues for their specialists & management. One would have thought this would have been done and Eastern Health & those who provide funds for same need to look at these issues. + the impact of their statements on people within Eastern Health & in persons considering recruitment here. Also, is there sufficient lab staff & management & what is being done to verify the accuracy of procedures & work. Since this was a major issue from Cameron, seems to me that sufficient resources should be dedicated to it. I believe that Eastern Health probably runs hundreds of different types of tests on many types of equipment & that literature searches on interference cyclosporine (& every other test) is not something that is routinely done by hospitals especially with an ongoing type of test when the only difference is a new machine.

    What is Health Canadas & provincial & national & international medical associations & laboratory technicians roles in bringing precautions / interferences to light (& even more generally how is medical information transferred to physicians & technicians) I think everyone would want to ensure that this information is getting through & being acted on.& that there are sufficient employees and a positive culture of delivering quality health services within the province. I would hope that employees are comfortable red flagging when there are issues that arise & that there are sufficient resources to ascertain if there is a problem, what it is and to correct it immediately. I am concerned about how the media & those in positions of responsibility handle matters at times like this & that employees in all areas know that they are not being scapegoated. I support every health worker & manager in delivering the best quality health care for the residents of the province.

  • Marie
    July 01, 2010 - 20:16

    Mistakes.....you call it a mistake. br Tell that to the families of the deceased, as well as those who have suffered and are still suffering needlessly. How would you feel if it was your daughter, son, husband, wife, mother, father, sibling, or grandchild? Would you still take it calmly as a Mistake? That's quite easy to say when you can't even put a face to the names. They are just statistics. Numerous deaths, and unbearable heartache and sorrow to the families, are the consequences, and you call that a mistake! Yes, obviously, I am upset and angry.

  • Cindy
    July 01, 2010 - 20:09

    I'm sure the lab employees had all the time in the world to research, read, google, go to the library and order all journals from different countries before using this new machine. br br I'm also sure, that before they even unpacked the machine, they should have been trying to find information on possibles errors that machine could make on one particular drug and one type of human illness even though it wasn't supplied in the documentation with the machine. br br Well, I'm sure the next time a new piece of equipment comes into the lab Ms. Kaminski will understand when the lab employees have to spend time looking for documentation that didn't come with the machine, might never exist, and to keep on researching every possible combination/permutation of drug/human disease testing errors that could possible be conceived of in case it does exist. br br Oh yeah, it's all the lab employees fault. You should have fired them all Ms Vicki. Go have another bag of chips you role model of health.

  • Polly
    July 01, 2010 - 19:59

    There is a wide variety of mistakes to be made ---- Dr. Michael Vogeser . In a poisoned atmosphere -- no pun intended-- such as the one Eastern Health finds itself in today . It comes as no surprise that serious mistakes are being made . With the rush to find a quick fix , due diligence maybe overlooked. Credibility is problematic at Eastern Health subsequent to the Cameron Inquiry and this latest debacle ---- malfunctioning laboratory equipment and the impact ensuing for some 212 to 234 lives . Untimely dismissals before root causes come to light maybe based on political expediency rather than operational necessity . Bravo Ms. Sweet --- an excellent article , your hard work and goog old fashioned investigative journalism has paid off by highlighting this , the latest of the self-fulfilling prophecies .