Hospital Lab errors...INR

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LUVMyBirman

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Jun 16, 2001
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Thought you all would find this most interesting. Very distrubing to say the least!


Lawyers Consulted in Lab Error Cases

By BILL BERGSTROM
.c The Associated Press


PHILADELPHIA (AP) - Nearly six weeks after the death of a retired South Philadelphia barber, a letter arrived at his home warning of a possible hospital laboratory error affecting the dosage of his blood-thinning medication.

Louis Vitello's widow, Carmella, said hospital officials from St. Agnes Medical Center, who visited her the same day, told her that her husband probably died as a result of the error.

``I'm shattered,'' Carmella Vitello said Sunday. ``You hear that they made that mistake with your husband, and it wasn't a natural death. I was so shocked, really.''

The city medical examiner's office is investigating five deaths that hospital officials said may have been linked to the laboratory mistake. Philadelphia Department of Public Health spokesman Jeff Moran said it may be weeks before results are released.

The state Department of Health and the U.S. Centers for Medicare and Medicaid Services also are investigating.

Vitello has hired a lawyer, Marvin Lundy, who said he was talking with others who may have been affected by the test error about possible legal action.

Catherine Hines, 75, of South Philadelphia, who was taking the blood-thinning medication following a mitral valve replacement, has already filed a lawsuit. She alleges that she suffered massive internal bleeding as a result of the error, her attorney, Aaron Freiwald, said Friday.

Hospital officials, however, defended their response to the crisis.

After the error was discovered on July 25, ``we spent most if not all of the first 24 hours notifying patients and doctors,'' Richard F. Afable, chief medical officer of Catholic Health East, told The Philadelphia Inquirer for a story Sunday.

Afable didn't respond to messages left at his home seeking comment Sunday.

He said the mistake resulted from a ``system failure'' in the hospital's lab, and was ``not a case where disciplinary action was necessary.''

Officials at the hospital have said 932 patients may have received incorrect doses of the anticoagulant medication Coumadin between June 4 and July 25, because of a laboratory miscalculation that gave incorrect blood-thickness data.

Vitello said her husband had taken Coumadin for the last seven years after undergoing heart valve and bypass surgery. She said they were accustomed to monitoring the dosage carefully with biweekly and sometimes weekly tests.

The blood-thinning drug is given to patients such as those recovering from heart attacks or heart surgery to prevent blood clots that could cause a stroke or another heart attack. The dose must be closely monitored to avoid too great a decrease in clotting ability, which could lead to bruising or internal bleeding.

Vitello said her 89-year-old husband was hospitalized May 29 with what was diagnosed as pneumonia. She said he developed bedsores and bruises in the hospital, and on June 18 she found him in a fetal position. A CAT scan indicated bleeding in his brain and he was transferred to the Medical College of Pennsylvania Hospital. He died the next day and was buried on June 23.

``He was already dead and buried at the time I got the letter,'' Vitello said.

On the Net:

Pennsylvania Health Department: http://www.health.state.pa.us

AP-NY-08-06-01 0522ED
 
Another Horror Story!

Another Horror Story!

Thank you Gina, I didn't pick up this story if it was in our papers.
I will print it and add it to my collection. The lesson here is that you cannot trust many large central labs. The best way to go is to get your own monitor, check it out against a good central lab and then self test. Eventually when you learn your own dose- self regulate! Marty
 
The next time I'm in the hospital, I'll take my Protime monitor with me just in case. How common are "central lab" errors? Aren't there internal controls? I would hope so. I don't understand how such an error could have happened, even if there were an error in "arithmetic". I'll just keep my handy Protime handy.
 
Great idea Stayze!

You know....have had two doctors question the accuracy of my Coaguchek. From what I have seen it is more accurate than most labs. Fully trust it!
 
Hi Gina,

I am wondering if I should get the monitor but I am doing well. I have been on Coumadin for over 18 months and have had no serious problems. I keep thinking that I should check it more often based on what I read here, but I feel foolish if nothing is wrong. My internist does my checks with the coaguchek and I don't think he would sign for me to have a monitor at home, or would they readily give me an RX? How often do you check it by yourself? I was thinking of going to the lab this week to check it, but after reading your post I am wondering??? :confused:
 
What a horror story. And you are the only one in this group who seems to have seen it. Imagine all the errors out there that nobody ever hears about!! Thanks for sharing it. My brother takes coumadin and it's always a concern for us. God bless
 
LAB ERROR

LAB ERROR

Gina, I showed the newspaper article you picked up to our chief lab tech. She said it would be easy to produce a "systemic" error like this that could effect all tests if they changed thromboplastin and did not change the isi or if they did not recheck their control with the new thromboplastin.
She felt someone should answer for this "systemic"
error. Marty
 
Hi Marty,

Thank you for posting your findings!

I understand it is crucial to run controls.....but how much so when using the Coaguchek? I think we had discussed running them upon opening a new box. This is the practice I use as well as a few others. My trainer suggested this as well. Running controls each time is major overkill.

Thoughts or are we really doing ourselves an injustice?
 
Controls with Coaguchek

Controls with Coaguchek

Hi Gina, I'm with you. I only run controls with a new chip and a new bunch of strips. According to David Phillips it was the government that mandated
controls at every test. This is overkill. I will say if you get a reading that is out of whack like your 6.5 you might do controls with your next test.By the way a hematologist friend of mine who
shall go un-named agrees with us. Marty
 
In the initial reports of the hospital INR error in Philadelphia it was reported as a "mathematical" error. This seemed odd to me to characterize it as such. Haven't been able to get any descriptive accounts. Be that as it may, I'll take my handy Protime with me for backup. Aren't they nifty?
 
Here is roughly how the error occurred. Each time the lab gets a new batch of thromboplastin testing material, they have to key in a new number for the sensitivity (ISI). This is what is used to calculate the INR and why you do not want to go by protimes.

The lab technician forgot to do this. As a result the 900+ protimes were low and everyone's warfarin dose was increased.

Interestingly enough it was not a person from the lab or a doctor that noticed the mistake. It was a PATIENT who questioned why their warfarin dose had to suddenly keep being increased.

As you know, on your CoaguChek or ProTime there is a chip or sensor that must agree with the lot number being used. That was the ISI that the machine thinks it has is always the same as the strip.

Now you all have ammunition for when your doctor doubts that your machine is as accurate as the lab.

The PT is an inherrently inaccurate test to being with and there is nothing that can be done about that.
 
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