A fatal medication error

A 75-year-old woman died at Vanderbilt University Medical Center after receiving intravenous vecuronium, a drug that causes muscle paralysis, instead of Versed, a sedative.

Here’s what happened.

She had been recovering well from an intraparenchymal brain hematoma after a fall. While awaiting a full body positron emission tomography (PET) scan in the radiology department, the patient said she was anxious about being in the machine because she was claustrophobic.

A doctor ordered Versed 2 mg IV in the electronic medical record at 2:47 PM. Two minutes later, the pharmacy verified the order. The radiology department staff said they could not give the medication because they were very busy and the patient would need to be monitored.

So nurse A, who was functioning as the “help all” nurse was asked by the patient’s nurse, nurse B, to go to radiology and give the medication. At 2:59 PM, nurse A went to the automated dispensing cabinet (ADC) and searched for Versed in the patient’s profile. When she couldn’t find the drug listed, she selected the “override” setting to search for the drug. She entered the first two letters of the drug, VE, and clicked on the first medication that popped up.

Are there really 250,000 preventable deaths per year in US hospitals?

For the last couple of days, the Twitter medical community has been discussing the latest in a long line of papers attempting to estimate the role of medical error as a cause of death.

This week's entry appeared in the BMJ (full text available here) and was by a surgeon at Johns Hopkins, Dr. Martin Makary, who claims that 251,454 patients die from medical error every year.

Makary's review extrapolated that figure from three papers published before 2009 which had a combined 35 supposedly preventable deaths. That's not a typo—35 deaths in all. One of the papers stated that all 9 deaths in three tertiary care hospitals were preventable. In his BMJ paper, Makary says, "some argue that all iatrogenic deaths are preventable."

I disagree. I have analyzed other papers on this subject and pointed out that certain complications and deaths are not 100% preventable. For example, no study of deep venous thrombosis and pulmonary embolism shows total efficacy of any prevention strategy. And some patients will suffer myocardial infarctions and die even when they are properly treated.

In this month's BMJ Quality and Safety, Dr. Helen Hogan of the Department of Health Service Research and Policy at the London School of Hygiene and Tropical Medicine discusses the problems associated with using preventable deaths as a measure of quality.

How does a 16-year-old boy receive 38 times the normal dose of an antibiotic?

If you are a doctor, nurse, patient, or just someone interested in patient safety, you should read a five-part story called "The Overdose: Harm in a Wired Hospital" excerpted from a book "The Digital Doctor" by Dr. Robert Wachter.

Dr. Wachter and the hospital are to be commended for publicizing this incident so others may learn from it. The hospital staff, the patient, and his mother, also deserve credit for allowing their stories to be told.

A synopsis does not do justice to this well-written account of the boy's near-death experience in a top hospital in San Francisco. In short, he somehow received a massive overdose of the antibiotic Septra despite the presence of a sophisticated electronic medical record and multiple systems in place that were supposed to prevent such a thing from happening.

After the patient recovered from receiving 38½ pills when he should have been given only one, a root cause analysis found numerous faulty system issues such as an electronic ordering program that was overly complex, a nurse "floating" to an unfamiliar floor, a satellite pharmacy that was too busy and susceptible to distractions, "alert fatigue" among hospital staff, and a culture, like that of most hospitals, that may have discouraged questioning both authority and the almighty computer.

German airliner crash: A system error with a system solution?

From the Associated Press: Airlines around the world on Thursday began requiring two crew members to always be present in the cockpit, after details emerged that the co-pilot of Germanwings Flight 9525 had apparently locked himself in the cockpit and deliberately crashed the plane into the mountains below.

This represents an organization's typical response to a problem. The crash, which by all accounts was caused by a single deranged individual, has been perceived as the result of a “system error” and will be dealt with as such.

The idea that a flight attendant going into the cockpit whenever one of the pilots has to pee will prevent anything seems a bit absurd to me. How is a 5’2” 120 pound female flight attendant supposed to stop a 6’3” 210 pound pilot who is hell-bent on committing suicide by airplane?

When I tweeted a similar thought yesterday, someone suggested that she could simply sound an alarm and unlock the cockpit door. I suppose that’s true as long as the crazed pilot does not punch her in the face and knock her out or shoot her first.

"Medical errors kill hundreds of thousands each year in the US"

How about that headline?

It appeared on RT.com, "the first Russian 24/7 English-language news channel which brings the Russian view on global news."

The story, which originally ran in November of 2013, was resurrected again on Twitter yesterday. It's subject was a paper that claimed as many as 440,000 patients die from medical errors in the United States every year.

Back in September, I criticized the study because it assumed that every death was both preventable and caused by a medical error. Neither assumption is correct. It also extrapolated the doomsday figures from only four other papers describing just 38 deaths.

In that post I said, "Inflating the incidence of these problems does nothing but further erode the already shaky confidence of the public in the medical profession. And creating the impression that such events are totally preventable leads to unrealistic expectations and unachievable goals."

So why am I bringing this up again?

Take a look at a few of the comments from the RT.com story [printed verbatim]:

Old news, as many as a million die each year cause of doctor errors. Thats why their malpractice insurance is so high. Legal unintentional homicide.

It's convenient to claim such deaths are errors but a great many are deliberate. They know such incidents will not be investigated as crimes. It's very easy to conceal a murder if no one is looking. The medical system is completely corrupt.

if they'd stop getting high in med school and pay more attention maybe this wouldnt happen. then there is their attitudes. Heaven forbid anyone needs medical care, that's for sure.

According to CDC, medical errors is not even a category of death, but they published research that indicates drunk drivers kill about 10,000 yearly. If that is correct, then doctors kill almost twice that many every hour of every day -. MADD should be mad about DEADLY DOCTORS. You are 40 times more likely to be killed by a deadly doc than you are by a drunk driver. And yet - where is the "funding" for this deadly phenomena?

I know those who comment on the Internet usually do not represent the views of rational individuals, but it infuriates the hell out of me that the 440,000 deaths from medical errors estimate, which is clearly wrong, is repeatedly trumpeted all over the place and so readily believed.

By the way, the paper appeared in the Journal of Patient Safety, which recently underwent an editorial change due to a kickback scandal involving former editor Dr. Charles Denham. That's another story (here).

Do doctors and hospitals make mistakes? Yes. Can we improve? Yes. Does it help to exaggerate the magnitude of the problem? Emphatically, no.

Patient falls off OR table: System error or human error?

An anesthetized patient fell to the floor headfirst from an operating room table during a laparoscopic appendectomy in Scotland. The table had been tilted into an extreme head down position to facilitate the operation. Fortunately, no injury occurred.

The Edinburgh Evening News account says that there were 10 staff members in the room at the time the case started, but no one had placed a safety restraint on the patient.

A follow -up story noted that the hospital has experienced 11 other major surgical errors in the last year including two instances of wrong-site surgery and a case in which five swabs were left inside a single patient.

An investigation by the hospital noted that the level of situational awareness of the operating room staff was inadequate, and teamwork and communication were poor. In addition, the safety culture within the operating room was described as not highly attuned to patient safety.

The staff was also distracted by mobile phone use and idle chatter.

Instead of addressing the obvious human errors such as failure to place the safety strap, which in US hospitals is clearly the duty of the circulating nurse, the hospital's plan of correction focused on the following typical system-type corrections:

• Compulsory training of 1200 staff. Although there were 10 staff for a laparoscopic appendectomy (in the US there would be 4, nurse, scrub tech, surgeon, anesthesiologist), I doubt that there are 1200 people working in the operating room of this 570-bed hospital. What will those not working in the OR have to gain from compulsory training? I wonder if anyone considered that 10 staff for an appendectomy is far too many, and that's why there was a lot of idle chatter. Six of the staff had nothing to do until the patient needed to be picked up off the floor.

• A ban on talking at key times during operations. This one will be hard to enforce. Who decides what the key times are? I also don't see what it had to do with the incident since tilting the table would not be considered a key time in the case.

• Daily meetings to improve patient safety. Good luck with that. What on earth are they going to discuss at daily meetings to improve patient safety? I predict that those meetings won't take place for more than 3 or 4 weeks.

• Sanctions for staff who fail to meet the new standards. Also be hard to enforce. How will this be judged?

I would have talked with the nursing staff and asked them whose job it was to place the safety strap. If you want to make a system change, why not clearly specify which staff member is responsible for that action? And how about using a checklist?

Five years ago, the Scottish Patient Safety Program recommended using pre-surgery meetings and checklists to protect patients. The investigation showed that in this hospital, checklists were completed about 10% of the time and often not properly. The staff claimed that they didn't have time to do the checklists. Ten people in the room for an appendectomy and no one has time to complete a checklist?

Next I would have asked the anesthesiologist where he was. Usually the job of adjusting the table is his, and the controls are at the head of the bed. He should have noticed the patient was beginning to slide off the table and intervened.

Finally I would have asked the surgeon just how much head down tilt he needed. I have never even come close to having a patient more than about 30 degrees of head down during a laparoscopic appendectomy.

Patient falling from an OR table—human error.

Wrong site surgery—human error.

Leaving foreign objects inside patients—human error.

The OR staff of every hospital counts instruments and swabs. Wrong-site surgery is 100% avoidable. This hospital had a number of appropriate systems in place. The staff simply disregarded them. Creating more meetings and rules that are unlikely to be followed or make a difference will not solve the problem of a staff with a "can't do" attitude.

9-year-old boy flies to Vegas without a ticket. System error or human error?

Last week, a 9-year-old boy managed to fly from Minneapolis to Las Vegas by himself without a ticket on Delta Airlines.

According to a CNN report, Delta is reviewing its "policies and procedures to make sure something like this does not happen again." This is the predictable response by most organizations when a screw-up occurs.

Do you think this was a system error or a human error?

I favor the latter. And the errors weren't confined only to Delta employees.

How many people had to have not followed established procedures for the child to have pulled this off?

At most airports, you can't even enter the security line without showing your boarding pass and ID. Children under 18 are not required to carry identification, but someone from the TSA had to have overlooked the fact that the boy had no boarding pass to scribble on.

Another possible check might have occurred as he passed through the metal detector by himself.

At the gate when boarding starts, an agent either marks each boarding pass or scans its bar code to tally the number of passengers on board. Obviously, the boy didn't have a pass so that did not happen.

Once he got on the plane, he had to have picked a seat at random. He would not have known which seats were unassigned. It is highly likely that he had to change seats at least once or twice. Again no one noticed that he didn't have a boarding pass.

The story says the flight crew became suspicious when the plane was in the air. They eventually noticed that he was an accompanied minor that they had not been made aware of.

What happened to the head count prior to closing the door? Most flights I've been on do not leave the gate until the flight attendants have walked through the cabin and counted the number of seated passengers.

Rather than a review of policies and procedures, the airline and the TSA should "counsel" the personnel involved in this event.

For other examples of human errors being thought of as system errors, type "system errors" in the search field of this blog.

Medical errors and deaths: Is the problem getting worse?

Medical errors are a real problem. I won't deny that.

It was bad enough when the often-quoted Institute of Medicine figure that 98,000 deaths per year in the US are caused by medical errors was in vogue, but now a paper in the Journal of Patient Safety states that adverse medical events result in 210,000 to 440,000 deaths per year and 10 to 20 times those numbers of serious harms.

Since the paper disparages the medical profession, it has received a lot of media attention.

Most articles about it simply regurgitate the dismal estimates without any real attempt to dig into the paper's methods.

Let's take a closer look.

As is true of many papers, the abstract is a bit sketchy when describing how the paper arrived at its conclusion.

The full text of the paper reveals the author found four studies that looked at what are described as preventable adverse events in US hospitals within the last seven years. All four used the Global Trigger Tool which involves the screening of records for adverse events by nurses or pharmacists and a secondary review by physicians.

Based on opinions by "experts," the author made a key, but erroneous, assumption that all adverse events are preventable.

The basis of that assumption was apparently this statement in the methods section of a 2011 paper in Health Affairs about the Global Trigger Tool.

"Because of prior work with Trigger Tools and the belief that ultimately all adverse events may be preventable, we did not attempt to evaluate the preventability or ameliorability (whether harm could have been reduced if a different approach had been taken) of these adverse events."

The "belief that ultimately all adverse events may be preventable" is not supported by any facts, which are not necessary I suppose if one simply has a "belief."

Personally, I do not share the belief that all adverse events are preventable. Let me give you a few examples of why.

Aspiration of gastric contents is considered a preventable adverse event, yet I can see no way to prevent every single occurrence of aspiration. If you can, please share it with the rest of us.

Leukopenia [a dangerously low white blood cell count], which often leads to sepsis, and is a common side-effect of cancer chemotherapy could be prevented by never using chemotherapy, but is that a realistic solution?

Repeated studies of deep venous thrombosis have found that no measure, be it drug or mechanical device, is 100% effective in preventing DVTs.

Several papers addressing the use of the Surgical Care Improvement Project guidelines for prevention of surgical site infections after colon surgery have found that even when guideline adherence is nearly perfect, at least 8-10% of patients develop SSIs.

Sometimes adverse events are due to patient-related factors. From an editorial in this month's JAMA Surgery commenting on a paper about SSIs:

"[W]e are left with the yet unanswered question about how to remediate the problem [SSI] beyond adherence to SCIP. Short of a large scale public health campaign to address smoking, obesity, and comorbid disease, the findings do not expose a practical way forward."

Pop quiz.

The Journal of Patient Safety paper estimating 210,000 to 440,000 deaths due to preventable adverse events was based on four papers with a total of how many deaths?

a. 38
b. 380
c. 3,800
d. 38,000
e. 380,000

If you said "c. 3,800," you would have only been wrong by a factor of 100. The correct answer is "a. 38."

Adverse events and deaths due to medical errors are serious issues that need to be addressed. But inflating the incidence of these problems does nothing but further erode the already shaky confidence of the public in the medical profession.

And creating the impression that such events are totally preventable leads to unrealistic expectations and unachievable goals.

Note: Upper range of supposed deaths from medical error corrected from 400,000 to 440,000 on 2/24/14.

A prank in the OR backfires

An anesthesiologist at a California hospital pasted stickers simulating a mustache and teardrops on the face of a hospital employee while she was having surgery on a finger.

According to the LA Times, the doctor said, "I thought she would think this is funny and she would appreciate it."

And if that wasn't bad enough, a "nursing attendant" took a photograph.

The patient, who said she had to quit her job because of the humiliation, is suing the hospital and the physician for this confidentiality breach.

The woman who took the photo said she deleted it after showing it to the patient and didn't post it anywhere. One version of the story is that she texted the photo to the plaintiff.

Others have testified that they saw the image on Facebook although the hospital said that there is no proof the photo was ever posted online. Multiple news outlets, including the LA Times, have published the photo which was obtained via court documents. 

One thing is certain. The photo is readily available now.

The plaintiff also claims that general anesthesia was unnecessary and only used so that the picture could be taken.

The anesthesiologist and some hospital employees were disciplined, but the hospital says the patient has fabricated and exaggerated some of her complaints.

At a deposition, a nurse manager at the hospital testified that in 2009, a sales representative took some pictures of a naked patient in the operating room. The hospital maintained that no such photos were ever taken. But then not only barred that sales rep from its OR, it also established a policy that no cell phones or cameras would be permitted in that area. This was an attempt to rectify a human error in judgment and common sense with a system correction. Obviously, it didn't work.

There are lots of issues to discuss.

It seems the OR is not a good place for a prank.

Bad ideas. One, pasting the stickers on the patient. Two, taking a photo (without consent). Three, texting it to the plaintiff. Four, posting it on Facebook (allegedly).

The Internet doesn't forget. Once something is posted it tends to stay there—somewhere—forever.

There is this thing called HIPAA, which contains many strict rules about patient privacy. People have been fired, fined, and even jailed for breaches of patient privacy.

Why didn't the hospital settle this case, which has gone viral? Do they really think they can win? Have they never heard of the "Streisand Effect"?

The hospital had a policy of no cell phones and no photos in the OR, but it was observed about as well as the 55 MPH speed limit. 

If there is nothing else to learn from this case, a hospital should not establish policies it cannot or will not enforce. Lawyers feast on that sort of thing.

Bottom line: The cell phone and its camera are not the culprits here. Smartphones don't take pictures of people; people take pictures of people.