Reference no: EM132258493

Case Discussion

(CBS) Chances are you probably know someone who has died, or nearly died, because of medical mistakes in a hospital. It’s much more common than most people realize, and if it can happen to the children of a movie star, at one of the finest hospitals in the country, it can happen to anyone. Dennis Quaid has starred in more than 50 films, but nothing prepared him for the drama and the near tragedy that unfolded last November at Cedars-Sinai hospital in Los Angeles, when his infant twins were given massive overdoses of a blood thinner that nearly killed them….The nurses had discovered that both twins were in serious danger. They were supposed to have been given a pediatric blood thinner called Hep-lock to flush out their IV lines and prevent blood clots. But instead, they had been given two doses of Heparin, the adult version of the drug, which is 1,000 times stronger.

“We all have this inherent thing that we trust doctors and nurses that they know what they’re doing. But this mistake occurred right under our noses, that the nurse didn’t bother to look at the dosage on the bottle,” Dennis Quaid tells Kroft. “It was ten units that our kids are supposed to get. They got 10,000. And what it did is, it basically turned their blood to the consistency of water, where they had a complete inability to clot. And they were basically bleeding out at that point.”

“There was blood oozing out of little blood draws on their feet, and things like that, you know, through band-aids,” he adds. Quaid says that’s what first alerted the nurse that there was a problem. But the hospital never called the Quaids and they didn’t find out that anything was wrong until the next day when they showed up at the hospital early the next morning and went to the twins’ room. “We were met at the door by our pediatrician, the nurse - head nurse that was on duty,” Dennis Quaid recalls. “Risk management,” his wife adds. “Risk management, which is basically the liability division of a hospital, which is lawyers,” he explains…. “They weren’t just given one massive overdose, they were given two massive overdoses?” Kroft asks. “Two massive overdoses, a thousand times what they should have over an eight-hour period that we know of,” Quaid says.

And to make matters worse the same avoidable mistake had occurred a year earlier at Methodist Hospital in Indianapolis. Six infants were given multiple adult doses of Heparin instead of the pediatric version; three of the infants survived, three did not. Asked when he found out about the Indianapolis incident, Quaid says, “In the morning when I had gone in, a pediatrician told me about it.” “He said, ‘This has happened before’?” Kroft asks.

“Yeah. He had told me about that three babies died. And it sent a chill down my spine,” Quaid remembers.

The Quaids say the crisis went on for 41 hours, as doctors and nurses administered an antidote to Heparin, which helps the blood coagulate. Slowly the twins began to stabilize, and after 12 long days in the hospital, they were allowed to come home.…

But the experiences changed Dennis Quaid. He’s spent much of the past four months trying to dissect what happened and figuring out ways to draw attention to what is one of the leading causes of death in America—preventable human, medical error.

“These mistakes that occurred to us are not unique. And they’re not unique even to Cedars. They happen in every hospital, in every state in this country. And 100,000 people, that I’ve come to find out, there’s 100,000 people a year are killed every year in hospitals by a medical mistakes,” he says.

Because the deaths occur one at a time, all over the country over an extended time period, Quaid says the issue has slipped under the public’s radar. “It’s bigger than AIDS. It’s bigger than breast cancer. It’s bigger than automobile accidents. And, yet, no one seems to be really be aware of the problem,” he says.

The causes range from misdiagnosis to surgical errors to medication mistakes like the accidental Heparin overdose that that nearly killed the Quaid twins, an occurrence that’s not all that unusual, according to Diane Cousins. She’s the vice president of U.S. Pharmacopeia, a non-profit public health group that maintains one of the largest databases on medication errors.

“What we see with Heparin is that it is almost always in the list of top ten drugs that are reported for medication errors, and almost always in the top ten that are harmful,” Cousins tells Kroft.

“What is it about Heparin that there’s so many mistakes?” Kroft asks.

“Well, Heparin is very commonly used in the hospital. And the number of opportunities for error are very high,” she explains.

But Cousins says another contributing factor with Heparin is labeling that can easily lead to mistakes. The 10-unit pediatric dose and the 10,000-unit adult dose come in vials of identical size and shape and in different shades of blue that can easily be confused, if not seen in reference to each other. And they are not the only drugs with that problem.

Asked to give some examples, Cousins, showing two medications, tells Kroft, “In this case, we have a solution of Lidocaine, which is an anesthetic often used to swab a child’s throat or mouth for mouth pain. Here, you have lithium oral solution used for manic depression.”

“Lithium is not something you’d wanna give a child. Absolutely not,” she says.

The two small vials Cousins used as an example both have blue caps and cluttered labels, but one contains a hormone and the other a children’s antibiotic.

“If you’re at arms’ length, it’s hard enough to read these labels because of their type size,” Cousins says.

“And I’d need my reading glasses,” Kroft remarks.

Baxter International, which manufactures the Heparin given to the Quaid twins, was fully aware that there had been fatal mistakes that may have been caused by confusion over its labeling.

When the three infants in Indianapolis died after receiving an adult dose, Baxter issued a nationwide safety alert and last October, began shipping Heparin with a redesigned, peel-off label to end the confusion. What it didn’t do was recall the old stock that was sitting in hospitals all over the country, including Cedars-Sinai in Los Angeles.

“And as a result, our kids were given an old stock which was basically the same packaging and form that the kids in Indiana had gotten. Now, they recall toasters. They recall trucks. They recall dog food that came from China last year. But they don’t recall medicine that kills people if you give it in the wrong dosage,” Dennis Quaid tells Kroft.

The Quaids believe that Baxter was the first link in a series of events that led to the overdosing of their infants and they’re suing the company for negligence on behalf of their children.

Debra Bello, a senior director at Baxter, says there was nothing wrong with their product, and it wasn’t their fault. “One of the most important components of medication administration is to read the label, and not rely on color, shape or size,” she says.

“You sent out this warning which mentions not to rely on the color but to read the label…and you redesigned it,” Kroft remarks. “When you designed this new vial, why didn’t you recall the old ones?”

“The, these vials are given over 100,000 times each day, safely, effectively. But nothing replaces reading that drug before you administer it,” Bello says.

Asked if the company didn’t think it was necessary to recall those drugs, Bello says, “No, because the product was safe and effective and the errors, as the hospital was acknowledged, were preventable and due to failures in their system.”

That’s not in dispute. A California Department of Health Services investigation found that there had been at least three critical systems failures at Cedars-Sinai hospital, in which pharmacy technicians and nurses neglected to check the drugs they were distributing and administering. Thomas Priselac, the president and CEO of Cedars-Sinai, didn’t dispute the findings.

“This was a preventable error. It was the result of human error,” Priselac says.

“You’re talking about a situation here where you had three different people make a mistake,” Kroft points out.

“Yes,” Priselac acknowledges.

“What coulda been a fatal mistake. You got the people who put the wrong drug in the drawer. You got the people who picked it up and brought it to the floor. And you got the nurses that looked at it—or didn’t look at it—and put it in the IV line. Three people,” Kroft says.

Any time an error occurs, almost by definition, the unusual or the unexpected is what’s occurred. And certainly in this particular case, that’s what occurred,” Priselac says. “We have to make sure we have backup systems that pick up things when human error may occur to prevent that error from manifesting itself.”

“But you had backup systems. You had three people,” Kroft remarks.

“Right,” Priselac replies.

“You haven’t sued the hospital even though they’re - all sorts of reports have been done and the hospital has acknowledged serious mistakes,” Kroft asks Dennis Quaid.

“I’d like to see Cedar Sinai take the lead in doing something to change what’s going on in what I consider to, in the end, a broken healthcare system in patient medical care,” the actor says.

Quaid calls it a conspiracy of silence, where doctors protect nurses, nurses protect hospitals, and insurance companies protect drug manufacturers. Almost no one, he says, is aggressively trying to find ways to eliminate medical mistakes. So the Quaids are in the final stages of launching a foundation they hope will help remedy a situation that almost destroyed their lives.

“You’re lucky,” Kroft remarks.

“Yeah. Extremely lucky. And not a day goes by since then that I don’t think a day this one’s changed for me, is that I don’t take a day for granted anymore ‘cause if they hadn’t made it, there never woulda been another happy day, really,” he says.

Since the Quaid incident, Baxter International has voluntarily recalled all supplies of Heparin from the market. It had nothing to do with the Quaids, but with possible contamination at a Chinese manufacturing facility that may have contributed to at least 19 deaths.

1.? Identify the adverse events that took place in this situation.

2.? What preventive measures should have been taken that might have prevented the adverse events in the first place?

3.? Based on what you read, did the Quaid’s have cause to bring legal action against the hospital? What did they do instead, and do you agree with their approach?

4.? As this case unfolded what role do you think the hospital’s risk management and quality improvement departments may have played? Thinking of the tools used to support risk management such as incident reports and health records, would an incident report been completed in this situation and how would the twins’ health records been handled?

5.? What are some ethical implications raised by this case?