I’m aware this sounds like a Hollywood tabloid headline but what can I say. Cedars Sinai, an LA hospital which brags on its website at http://www.cedars-sinai.edu/5.html (below) administered radiation overdoses 8 times normal to over 200 patients for an 18 month period before a patient picked up the error.
Magnet Excellence in Nursing
In 2008 Cedars-Sinai was re-awarded the Magnet Excellence in Nursing designation from the American Nurses Credentialing Center (ANCC). Cedars-Sinai is one of only six hospitals to receive this designation three times, which recognizes commitment to nursing development and quality care. …The ANCC found that Cedars-Sinai’s nursing services "represent the highest standards in the nation and internationally."
NRC’s Consumer Choice Award
For more than 20 years, Los Angeles area residents have named Cedars-Sinai the "Most Preferred Hospital for All Health Needs" in National Research Corporation’s (NRC) annual Healthcare Market Guide survey
U.S. News & World Report Ranking
In the 2009 U.S. News & World Report rankings, Cedars-Sinai was named one of America’s best hospitals. Of the 4861 U.S. hospitals, only 174 were ranked in at least one specialty.
This error lasted for 18 months and affected at least 206 patients. The story below quotes Dr. Thomas Dehn, a radiologist and chief medical officer for National Imaging Associates Inc., which manages health plans for private insurers, as saying he believes that overrides are more likely to occur at large, state-of-the-art hospitals. “At a small hospital, you are not going to try and out-think GE. You have to be pretty confident to think you know more than the guys who designed the equipment."
There are two related stories below.
http://www.latimes.com/news/local/la-me-cedars13-2009oct13,0,7725347,print.story
Hospital error leads to radiation overdoses
By Alan Zarembo, October 13, 2009
After Cedars-Sinai reset a CT scan machine in February 2008, more than 200 brain scans on potential stroke patients were performed at eight times the normal dose of radiation, the hospital says.
Scores of radiation overdoses at Cedars-Sinai Medical Center have been traced to a single cause: a mistake the hospital made resetting a CT scanner.
Hospital officials said Monday that the error occurred in February 2008, when the hospital began using a new protocol for a specialized type of scan used to diagnose strokes. Doctors believed it would provide them more useful data to analyze disruptions in the flow of blood to brain tissue.
That meant resetting the machine to override the pre-programmed instructions that came with the scanner when it was installed.
"There was a misunderstanding about an embedded default setting applied by the machine . . . ," officials at the renowned Los Angeles hospital said in a written statement that provided no other details about how the error occurred. "As a result, the use of this protocol resulted in a higher than expected amount of radiation."
The dose of radiation was eight times what it should have been.
Once the scanner was programmed with the new instructions, the higher dose was essentially locked in. Each patient who got the procedure — known as a CT brain perfusion scan — was subjected to the overdose.
The machine was used for other types of scans but the reset error affected only the potential stroke patients, said Richard Elbaum, a hospital spokesman.
The error went unnoticed for the next 18 months, until this August, when a stroke patient informed the hospital that he had begun losing his hair after a scan.
When the hospital reviewed its records, it found — and contacted — 206 people who had received the overdoses to inform them of the mistake. Only then, Elbaum said, did the hospital learn that about 40% of them had suffered patchy hair loss. Many also experienced reddening of the skin.
A CT scan uses a series of X-rays to create a highly detailed image. Possible stroke victims are injected with an iodine solution, which appears in the scans and is used to track blood flow in the brain.
Even under normal circumstances, the procedure requires more radiation than most other types of CT scans, said David Brenner, director of radiological research at Columbia University Medical Center in New York.
Excess radiation would be difficult to detect from simply looking at the scan results, he said. More radiation simply produces a clearer image.
Radiation exposure increases the likelihood of cancer, though the risk is lower in older patients because they are likely to die of other causes first. The median age of the patients who received the overdose is 70, said Elbaum, the Cedars-Sinai spokesman.
The discovery of the overdoses prompted the Food and Drug Administration to issue an alert last week warning hospitals across the country to check their CT protocols.
The hospital has received calls from other "advanced hospitals" that now are reviewing their own safety procedures, according to the statement.
General Electric, the manufacturer of the scanner, released its own statement Monday saying there were "no malfunctions or defects" of the machine.
It said that any new scanning protocol should be carefully evaluated "against the validated protocols that are provided on the scanners during installation."
Experts on medical radiation said it is not uncommon for radiologists to override the pre-programmed instructions — most commonly when the doctors believe they can glean the necessary information using less radiation.
Dr. Thomas Dehn, a radiologist and chief medical officer for National Imaging Associates Inc., which manages health plans for private insurers, said he believes that overrides are more likely to occur at large, state-of-the-art hospitals.
"At a small hospital, you are not going to try and out-think GE," he said.
"You have to be pretty confident to think you know more than the guys who designed the equipment."
alan.zarembo@latimes.com Copyright © 2009, The Los Angeles Times
http://www.latimes.com/news/local/la-me-cedars-sinai14-2009oct14,0,3329856,print.story
Cedars-Sinai radiation overdoses went unseen at several points
The dosage — eight times the programmed amount — appeared on technicians’ screens during CT scans. Doctors also missed the problem. Experts say blind trust of medical machinery is a growing concern.
By Alan Zarembo October 14, 2009
Every time a patient receives a CT scan, a mundane array of numbers appears on a computer screen before a technician.
The numbers include the radiation dose.
"It’s in your face on the screen," said Dr. Donald Rucker, chief medical officer for Siemens, a manufacturer of CT scanners.
Beginning in February 2008, each time a patient at Cedars-Sinai Medical Center received a CT brain perfusion scan — a state-of-the-art procedure used to diagnose strokes — the dose displayed would have been eight times higher than normal. No standard medical imaging procedure would use so much radiation, which one expert said is on par with the levels used to blast tumors.
Somebody should have noticed. But nobody did — everybody trusted the machines.
Late last week, the U.S. Food and Drug Administration and Cedars-Sinai revealed that 206 stroke patients who received scans at the prestigious Los Angeles hospital were overdosed with radiation. Now doctors and safety experts around the country face a troubling question: In an era of supposedly fail-safe medical technology, how did the problem go undetected for 18 months?
"It’s pretty mystifying to me," said David Brenner, director of the Center for Radiological Research at Columbia University Medical Center.
The FDA and the state Department of Public Health are still investigating the overdoses. Cedars-Sinai has released only basic information, saying the overdoses stemmed from an error made when the hospital reconfigured a scanner to improve doctors’ ability to see blood flow in the brain.
The CT machine in question performed several types of scans, each with its own set of computerized instructions, or protocols. To change the instructions for brain perfusion scans, the hospital had to bypass the protocol that came installed on the machine. Other types of scans were not affected.
In a statement issued Monday, hospital officials said they have "added double-checks to our process whenever a protocol is changed" — raising questions about why such checks were not already in place.
Experts said it was just as worrisome that the hospital apparently missed opportunities to catch the mistake as possible stroke victims continued to be overdosed.
Asked how CT technicians could have missed the dosage levels on their screens, spokesman Richard Elbaum said that will be part of the hospital’s investigation.
CT technicians are trained to monitor dose levels, and some hospitals conduct checks before every scan.
"There are other places where the techs might be operating more as button-pushers," said Dr. Geoffrey Rubin, a professor of radiology at Stanford University. "The user becomes a little blind to these numbers."
Najmedin Meshkati, a professor of industrial and systems engineering at USC, said the airline industry experienced a similar problem with the advent of automated cockpits. The operator must trust the machine, and "sometimes this trust may be misplaced," he said.
Meshkati said the overdoses point to a problem well-documented in medicine over the last decade — the need for multiple backup systems to catch mistakes.
The overdoses are particularly troubling in the wake of another high-profile incident at Cedars-Sinai, he said. In November 2007, the newborn twins of actor Dennis Quaid, as well as another child, were given 1,000 times the intended dosage of a blood thinner.
The mistake, while unrelated to machines, resulted from multiple safety-check failures.
"Where are the lessons learned as a result of the Dennis Quaid incident?" asked Meshkati, who uses the case as an example in one of his classes on how systemic problems lead to mistakes.
As a result of the radiation overdoses, the FDA issued an alert warning of the possibility that CT scanners at other hospitals could be set wrong.
"If patient doses are higher than the expected level, but not high enough to produce obvious signs of radiation injury, the problem may go undetected and unreported, putting patients at increased risk for long-term radiation effects," the alert said.
Dr. Thomas Dehn, a radiologist and chief medical officer for National Imaging Associates Inc., which manages health plans for private insurers, suggested that imaging equipment should have a "radiation threshold" that cannot be exceeded without a person acknowledging that the dosage is intentional. Built-in alarms are another possibility.
The overdoses at Cedars-Sinai may be more significant for exposing a hole in safety procedures than for the risks they pose to the victims.
Brenner, the radiation scientist at Columbia, calculated that each overdose carried a 1-in-600 risk of causing a brain tumor. The risk is more significant in younger patients, since tumors take years to develop.
The median age of patients receiving the overdose was 70, according to the hospital, and it’s more likely they will die of other causes.
Still, the issue of radiation exposure has been gaining attention. The number of CT scans has climbed to more than 70 million annually in the United States, and even a tiny risk translates to thousands of extra cancer cases.
CT technicians are not the only medical personnel who might have caught the problem at Cedars-Sinai. Radiologists might have seen the numbers — but only if the hospital had elected to save the dosage data with the images. Rubin said that is standard procedure at his hospital, but not everywhere.
Even then, radiologists are unlikely to pay close attention to the dosage level once a scan is done, said Rucker, the Siemens doctor.
That is especially true for scan patients whose lives are in imminent danger and for whom the risk of radiation is negligible by comparison, he said. The vast majority of CT brain perfusion scans are for patients who arrive in the emergency room in poor shape.
The overdoses could also have been caught during periodic calibrations of the machines, when radiation levels are tested directly.
Ultimately, it was a patient who alerted Cedars-Sinai to the problem. In August, a stroke victim informed the hospital that he had suffered patchy hair loss after a scan.
When the hospital contacted the 206 patients who had received the overdose, it discovered that about 80 of them had also experienced hair loss.
Many of them told their personal doctors, but hair loss is such a rare side effect of scanning that apparently none of those doctors made the connection, said Elbaum, the hospital spokesman.
alan.zarembo@latimes.com Copyright © 2009, The Los Angeles Times
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