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.

Some data is better than no data at all

Do you believe that?

I heard it frequently when the infamous Propublica Surgeon Scorecard first appeared three years ago. Back then I blogged about it saying “To me, bad data is worse than no data at all.”

A recent study in BJU International confirmed my thoughts about this type of publicly posted data and identified a previously unreported issue. The paper attempted to determine whether the public was able to accurately interpret statistics used in the Surgeon Scorecard. It turns out they were not very good at it.

Investigators from the Department of Urology at the University of Minnesota surveyed 343 people who attended the Minnesota State Fair in 2016. Those who took the survey had a median age of 48, were 60% female, 80% white, and 60% college educated. Their median annual income was $26,550 with an interquartile range of $22,882-$32,587.

More negative data about the nonoperative management of simple appendicitis

If you think I am the only one urging restraint in the adoption of nonoperative management of patients with uncomplicated appendicitis, you are wrong. A pediatric surgeon and a research fellow from Harvard and Massachusetts General Hospital have recently published their thoughts on the matter online in Annals of Surgery.

They call their opinion piece “Ulysses Syndrome” because they liken the fate of those undergoing nonoperative management to the “10-year ordeal filled with unexpected peril and ample misfortune” that befell Ulysses while attempting to go home.

Here are a few highlights.

Why public reporting of individual surgeon outcomes should not be done

Please take a look at my latest post on Physician's Weekly. It's called "Why public reporting of individual surgeon outcomes should not be done."

Click here for the link.

Fatal internal jugular vein cannulation by a misplaced NG tube

A case report published last month involves a 79-year-old man with multiple comorbidities including depression, alcohol abuse, hypertension, CHF, and COPD who was admitted because of abdominal pain and distention which was found to be a perforation of the right colon. 

He underwent a resection and did well until the seventh postoperative day when he became distended. A nasogastric tube was inserted. Its position was checked by injecting air through the tube and auscultating over the upper abdomen [a notoriously inaccurate method of locating an NG tube’s position].

A few hundred mL of dark blood came out. He was treated for a presumed upper gastrointestinal bleed. A chest x-ray showed the tube in good position but the tip was not seen.

When the patient’s vital signs deteriorated, a new NG tube was put in and drained 2 L of blood. The patient suffered a cardiac arrest and could not be resuscitated. At autopsy, the NG tube was found to have gone through the right pharyngeal wall and into the right internal jugular vein. The tip was in the superior vena cava.

Although I had never heard of this complication before, it has been reported in the literature at least one other time.

Are incentive spirometers useless?

Has this ever happened to you? You walk into a patient's room on postoperative day 1 and find the incentive spirometer still in its plastic wrap. And it's on a windowsill 10 feet from the patient's bed.

Here's another question. Does it matter?

A friend just had a 4-vessel CABG at a major academic center. Despite a lack of evidence that incentive spirometers are effective, he was told to use one in the hospital and to use it hourly at home which he has faithfully done.

That’s right. The effectiveness of incentive spirometry in postoperative cardiac and abdominal surgery patients has never been proven.

Three Cochrane Reviews (2007, 2012, 2014) have been done. In the 2014 review analyzing 12 studies with 1834 subjects who underwent abdominal surgery, the authors noted problems with study methodologies and lack of data on compliance with the use of spirometers. For preventing pulmonary complications, spirometry was not superior to deep breathing exercises or no respiratory intervention at all.

"Malpractice" from the viewpoint of a plaintiffs' attorney

Lawrence Schlachter is a neurosurgeon who after 23 years in practice, was forced to stop operating because of a hand injury. He went to law school, became a plaintiffs’ attorney, and wrote a book called “Malpractice.” Although it is intended for patients, physicians might want to read it to learn something about how a plaintiffs’ lawyer thinks.

I’m not surprised that Schlachter cites the heavily extrapolation-based Journal of Patient Safety study claiming 400,000 medical error-related deaths per year and the thoroughly debunked Makary study claiming 251,000 deaths per year due to medical error. He does a little extrapolating of his own and comes up with 562,000 patients per year.

I agree with Schlachter about many issues. He says the best way to avoid becoming a victim of negligence is to take good care of yourself. If you need to be hospitalized, aggressively be your own advocate or have a relative or friend do it. You cannot assume that mistakes will not happen.

The occasional surgeon

On the Forbes website, Dr. Robert Pearl writes

"When I was selected to become CEO of The Permanente Medical Group, the Permanente half of Kaiser Permanente, the time required for my responsibilities forced me to give up doing surgery on a regular basis. But every year since then, during the week between Christmas and New Year’s Day, I have returned to the operating room. The timing works, as the leadership demands become minimal and it’s unlikely I’ll suddenly be needed to fly to another part of the country. It’s a magical time for me, contrasting dramatically with my world as CEO. For several hours each day, my focus is not on millions of Kaiser Permanente members—or, for that matter, on all the complexities of healthcare policy, politics and strategy—but, rather, on a single patient at a time."

Dr. Pearl is a Yale medical school graduate who trained at Stanford and has been board-certified in plastic surgery since 1979. The American Board of Plastic Surgery did not start requiring maintenance of certification every 10 years until 1995.

We do not know what specific surgical procedures he does during his magical time. Is he removing moles, performing reconstructive surgery, or doing facelifts and nose jobs? Do his patients know that he only operates a few days per year? What happens if a wound complication requiring revision surgery arises? Who follows up his patients?

Good patient safety news you didn’t hear about

In the last five years, there’s been a 21% reduction in hospital acquired conditions (HACs) says a report by the Agency for Healthcare Research and Quality. This means that patients suffered 3.1 million fewer HACs than if the HAC rate had stayed at the 2010 level.

Since 2011, the decrease in HACs has reduced healthcare costs by an estimated $28.2 billion and has saved almost 125,000 lives.

This graphic summarizes the AHRQ findings.

Central line-associated bloodstream infections have fallen by 91%, and postoperative venous thromboembolism by 76%. Here’s a chart that shows the percent decreases in HACs.

The report said the reasons for these improvements “are not fully understood,” but might be due to the following:

• Financial incentives created by the Centers for Medicare & Medicaid Services (CMS) and other payers’ payment policies,
• Public reporting of hospital-level results,
• Technical assistance offered to hospitals by the Quality Improvement Organization (QIO) program, and
• Technical assistance and catalytic efforts of the HHS PfP [[Pay for Performance] initiative led by CMS.

An thorough Google search found a few articles about this important and positive AHRQ report. Were they in the New York Times, Washington Post, Newsweek, US News, or The Daily Mail?

No. the news could only be found on HealthcareIT Analytics, Fierce Healthcare, the website of the Healthcare Association of New York State, Pharmacy Practice News, and HealthcareIT News where I obtained the multicolored graphic above.

Why do you suppose no major media outlet reported the story?

Good news doesn’t get clicks.

No improvement in complication rates after instituting an operating room checklist

A before and after study at the University of Vermont Medical Center found that a 24-item operating room checklist did not significantly reduce the incidence of any of nine postoperative adverse outcomes.

More than 12,000 cases were studied, and outcomes included mortality, death among surgical in patients with serious treatable complications, sepsis, respiratory failure, wound dehiscence, postoperative venous thromboembolic events (VTE), postoperative hemorrhage or hematoma, transfusion reaction, and retained foreign body (FB).

After the checklist was established, respiratory failure rates decreased significantly on the initial analysis, but the difference disappeared when the Bonferroni correction* was applied to the data set.

Why didn’t the checklist work? I have discussed this in previous blog posts here and here. As was true in previous papers of this nature, many of the complications studied—respiratory failure, wound dehiscence, transfusion reaction, postoperative hemorrhage or hematoma—could not have been prevented by a checklist.

How frequently do surgeons and anesthesiologists lie to each other?

More often than you might think.

Results of a survey published in the journal Patient Safety in Surgery found that 27% of anesthesiologists and 7% of surgeons admitted that they “misreported” information to each other at least once a month in the perioperative setting.

Surveys were mailed to 2260 anesthesiologists and surgeons. The response rate was only 11%, which the authors ascribed to the sensitive nature of the questions asked.

The demographics of the respondents in each group were similar regarding age, sex, years of practice, hospital type, and self-described involvement with religion.

The most commonly misreported events by anesthesiologists were actions that affected vital signs, and the misrepresentation of vital signs and amounts of fluid administered. Surgeons most commonly admitted to incorrectly estimating the expected length of a case and misstating the nature of intraoperative adverse events, degree of surgical risk, and how urgent a case was.

Does wearing jackets over scrub suits prevent infections?

I always enjoy papers that reinforce my biases. Here’s one called “The Impact of Perioperative Warm-up Jackets on Surgical Site Infection: Cost without Benefit?”

If you’re a regular reader of my blog, you undoubtedly know the answer. Wearing jackets over scrub suits doesn’t prevent infections and adds costs.

Investigators from the University of Minnesota looked at infection rates one year before the institution of a mandatory warm-up jacket over scrub suit policy and one year after.

The rate of surgical site infection for the 13,302 cases done in the year before jackets had to be worn was 2.42% compared to 2.67% for the 12,998 cases done during the year after. The difference was not statistically significant with a p value of 0.1998.

Operative risk and surgeon decision-making

Should it surprise you that surgeons might have differences of opinion about whether or not a patient should have an operation?

It doesn't surprise me, but apparently a lot of people were taken aback by an Annals of Surgery paper published online last week stating just that.

The authors gave 767 surgeons four brief complex clinical scenarios and asked whether they would operate on each patient. The vignettes were purposely designed to not have "correct" answers.

In response to the question would you recommend an operation, the surgeons could choose one of the following responses: very likely, unlikely, neutral, likely, or very likely.

If you were in the emergency department with mesenteric ischemia, would you want a surgeon who responded "neutral"?

Why the authors selected five possible choices is puzzling. In real life when you are faced with a difficult decision in the middle of the night, you don't have five options. You have only two—operation or no operation.

Deciding whether adverse events are preventable or not

Adverse events and poor outcomes are not always preventable. Deciding whether an adverse event is preventable or not can be difficult.

"To Err is Human: Building a Safer Health System," the original Institute of Medicine report in 1999, stated that  between 44,000 and 98,000 deaths each year were caused by preventable medical errors.

That report was widely cited and spawned a number of studies and reviews claiming that anywhere from 250,000 to 440,000 preventable deaths occur in the United States every year.

I was critical of the 440,000 deaths paper as well as the most recent of these estimates—the one claiming 250,000 deaths due to medical errors per year.

It's not widely known or perhaps simply forgotten, but the 1999 Institute of Medicine report also came under fire. In 2000, two researchers from Dartmouth, Drs. Harold C. Sox Jr, and Steven Woloshin, published a critique called "How many deaths are due to medical error? Getting the number right."

Can patients shower immediately after surgery?

Here’s what a recent paper published ahead of print in Annals of Surgery says:

Between May 2013 and March 2014, 222 patients were randomized to the group allowed remove their dressings and shower at 48 hours and 222 to the group permitted to shower only after the original dressing and the sutures were removed in clinic. There were 4 (1.8%) superficial surgical site infections in the early shower group and 6 (2.7%) in the late shower group, an insignificant difference with p = 0.751.

The authors concluded that clean and clean-contaminated wounds can be safely showered 48 hours after surgery, and early postoperative showering may increase patient satisfaction.

I have always been an advocate of early showering after surgery. Wounds properly closed will be bridged by epithelium within 48 hours. Tap water is relatively sterile or we couldn't drink it. Many studies have shown that even irrigating open wounds with tap water instead of sterile saline does not lead to more infections. [Links here and here.]

Much as I would like to believe the Annals study, I can’t because it is probably underpowered to show a difference between the two groups.

Here is a nice definition of statistical power from a website called effectsizeFAQ.com:

“In plain English, statistical power is the likelihood that a study will detect an effect when there is an effect there to be detected. If statistical power is high, the probability of making a Type II error, or concluding there is no effect when, in fact, there is one, goes down.”

To their credit, the authors did try to estimate the sample sizes they would need by doing a power calculation. They knew that the wound infection rate for the cases they intended to enroll was about 1%. The problem is they estimated that showering at 48 hours would result in a wound infection rate of 5%. That seems very high to me for the types of cases included in their investigation—thyroid, lung, inguinal hernia and skin tumors.

If they had hypothesized that early showering would merely triple the rate of wound infections from 1% to 3%, they would have needed at least 1536 patients in each arm of the study. Then if there was no difference, one could conclude that early showering truly does not cause more wound infections.

Even if the known incidence of wound infection was much larger, say 5%, and the rate of infection with showering was presumed to be doubled (10%), to have enough power a study would need 434 patients in each arm.

Many websites provide calculators for determining the appropriate sample sizes to detect with a reasonable degree of certainty whether one intervention is better than another. Anyone thinking about doing a prospective randomized trial should realistically estimate the expected difference and calculate the power.

Whenever you read a negative study, the first question to ask is, “Was the study adequately powered to avoid a type II error?”

Appendicitis and shared decision-making

Staying with the current theme of appendicitis on my blog, here is a summary of recent developments. A JAMA Surgery Viewpoint suggested that because of the findings of a Finnish randomized trial, surgeons now should give patients with appendicitis a choice between an appendectomy or treatment with antibiotics.

The paper acknowledged my criticisms of the Finnish study which found that simple appendicitis could be treated successfully with antibiotics in almost 75% of patients.

I respect the authors of the JAMA Surgery article and am happy they referenced the blog post noting my concerns about that Finnish trial: the trial compared antibiotics to open appendectomy—an operation with more complications than the more commonly performed laparoscopic appendectomy; the antibiotic used in the Finnish trial is not a first line choice in the United States; patients were followed for only one year.

The JAMA surgery paper answered three questions I posed in a previous post. One, the Viewpoint authors consider antibiotic therapy for appendicitis mainstream. Two, surgeons must assume that patients might opt for antibiotics despite at least a 25-30% chance of suffering a recurrence of appendicitis. Three, an informed consent discussion now should include a mention of antibiotics as an option.

I disagree with the Viewpoint authors’ assertion that antibiotics are as safe and effective as surgery for treating appendicitis. Based on one flawed study, antibiotic therapy cannot yet compare to the many years of excellent results of laparoscopic appendectomy.

Here are some other problems.

Is the surgeon still "captain of the ship"?

A Kentucky appeals court ruled that a surgeon was not responsible for a burn caused by an instrument that had been removed from an autoclave and placed on an anesthetized patient's abdomen.

According to an article in Outpatient Surgery, the surgeon was not in the room when the injury occurred and only discovered it when he was about to begin the procedure.

An insufflator valve had been sterilized and was apparently still hot when an unknown hospital staff member put it down on the patient's exposed skin. [An insufflator is a machine that is used to pump CO2 through tubing into the abdomen for laparoscopic surgery.] When the doctor saw the mild second-degree burn, he asked what happened, but "but no one in the OR claimed any knowledge or responsibility."

The hospital had settled the suit on behalf of its staff, but the surgeon, who as a private practitioner had his own malpractice insurance, held out. The original lower court ruling dismissing the suit against him had been based on the plaintiff's lawyer's failure to prove that the surgeon was responsible for the actions of the hospital staff.

In December 2012, I wrote a post stating my opinion that activities such as counting the sponges during an operation were not the responsibility of the surgeon. Many who commented on the post were highly indignant that I could suggest such a thing.

I wrote another post last year on the subject in response to another surgeon's blog entitled "Everything's my fault: How a surgeon says I'm sorry." I felt that many things that happened to patients were beyond the control of the surgeon. Most of the comments agreed with me.

I keep hearing that medical care has become a team sport. If that's true, then the surgeon, like everyone else, is simply a member of the team. People on teams have different roles and must execute properly for the team to succeed.

One of the most interesting things about the case in question was that none of the OR team members had any idea how that hot insufflator valve found its way to the patient's abdomen.

One thing we know for sure, at least in Kentucky, is that a surgeon is not legally responsible for everything that happens to a patient in the operating room, particularly when he is not even present.

Is this decision the first nail in the coffin of the "captain of the ship" doctrine?

Hospitals Mess Up Medications in Surgery—a Lot

Yes, that was the inflammatory headline on Bloomberg Business News last week. It is great click-bait, but factually off base because the research it refers to was done at only one hospital.

Here's what the study found. During 277 operations with 3,671 medication administrations observed at the Massachusetts General Hospital, 193 (5.3%) involved a medication error or an adverse drug event. One or more errors or adverse drug events occurred in 124 (44.8%) of the procedures.

In all, 40 (20.7%) adverse drug events were not preventable—for instance, an allergic reaction to a drug that was not known about before. Of the remainder, “32 (20.9%) of the errors had little potential for harm, 51 (33.3%) led to an observed adverse drug event and an additional 70 (45.8%) had the potential [emphasis added] for patient harm."

Sounds bad, but the Bloomberg article goes on to say "While all the errors observed in the study had the potential to cause harm, only three were considered [potentially] life-threatening, and no patients died because of the mistakes. In some cases, the harm lay in a change in vital signs or an elevated risk of infection."

Variation is not causation

I made a rookie mistake in statistics of the “correlation is causation” genre by confusing variation for causation in the recent JAMA Surgery paper referred to in my last post. I contacted Dr. Timothy M. Pawlik, the lead author of the Johns Hopkins study, who said the following:

"The model is explaining and attributing variation in readmission and not attributing readmission itself to the different domains. The model suggested that only 2.8% of the variation in readmissions was attributable to surgeons. This is different than saying that only 2.8% were the 'fault' of surgeons. A more accurate interpretation would be that only 2.8% of the variation seen in readmissions was attributable to provider level factors. The majority of the variation in readmission was due to patient factors."

He added that some of the 82.8% variation in readmissions attributable (note: attributable doesn’t mean it’s the patient’s fault) to the patient could be modified by better medically managing patients' comorbidities or not operating on some of these patients.

That readmissions can be explained by a single domain or a single person is simplistic. Dr. Pawlik's clarification confirms my original concern that attributing differences in patient outcomes solely to differences in technical quality of surgeons is probably inaccurate, statistically speaking.

Variation is not causation but variation is still a call to action. Regardless of who is to blame for unfavorable outcomes, surgery is a team sport. The incision is just as important as the community care. In this regard, I am certain that ProPublica and I are on the same side. Let’s work together so that we see the whole story behind the numbers.

Are surgeons the cause of high postoperative readmission rates?

No, according to a recent paper published online in JAMA Surgery.

The authors concluded, "The majority of the variation in readmission was attributable to patient-related factors (82.8%) while surgical subspecialty accounted for 14.5% of the variability, and individual surgeon-level factors accounted for 2.8%."

The investigators looked at data for over 22,000 surgical patients treated at Johns Hopkins and found the overall rate of readmission within 30 days was 13.2%. After the exclusion of those who performed fewer than 21 operations per year, 56 surgeons made up the study cohort.

Multivariable analysis showed significant non-modifiable patient-related factors associated with readmission were African-American race/ethnicity, more comorbidities, occurrence of postoperative complications, and an extended length of stay.

Variation in readmission by subspecialty ranged from 2.1% after breast, melanoma, or endocrine surgery to 37% following cardiac surgery.

The authors pointed out that this study "echoes growing concerns regarding the use of readmission as a quality metric based on its current methods."

Let's compare it to the controversial ProPublica Surgeon Scorecard.

Both the Surgeon Scorecard and the JAMA Surgery paper used data from the years 2009 through 2013. The scorecard involved only eight high-volume low-risk in-patient procedures while the paper looked at in-patient surgery of all types.

From an article written by the authors of the Surgeon Scorecard: "If a patient was readmitted to any hospital (not just the hospital where the surgery was performed) within 30 days of a surgery for one of the conditions we identified, we counted the case as a complication for the surgeon who performed the initial procedure."

What we learned from the JAMA Surgery paper raises some questions about the the Surgeon Scorecard. On Twitter, I asked for comment from Marshall Allen, the lead author of a white paper [not peer-reviewed] describing the methodology of the Surgeon Scorecard.

Between attacks on my credibility because I choose to use a pseudonym, he said that they did not count most readmissions as complications. It is unclear from the article, the white paper, or its appendices exactly which complications were included. For clarification, we could ask the "surgeon experts" who advised ProPublica, but their names have not been disclosed. They are anonymous, just like me.

According to the white paper, surgeons were blamed for 64,367 (46%) of all complications incorporated into the Surgeon Scorecard. Table 3 of the white paper lists the 20 most frequent complications. The top three, comprising 26,795 complications, were postoperative infection, iatrogenic pulmonary embolism, and infection/inflammatory reaction due to internal joint prosthesis.

Other studies have shown that not all occurrences of those three complications are attributable to a surgeon's misdeed. Among the rest of the top 20 causes of readmission were postoperative pain, fever, and dysphagia (difficulty swallowing)—again possibly not the fault of a surgeon.

So the JAMA Surgery paper says surgeons are responsible for 2.8% of readmissions within 30 days, but ProPublica's self-published white paper says 46% of all readmissions are due to something a surgeon did or did not do.

Who to believe?

Note added at 7:27 a.m. on 9/2/15: See my next post for a clarification about causation and variation. 

The full text of the peer-reviewed JAMA Surgery paper is available here.