Everything you ever wanted to know about operating room head coverings

In case you might want to challenge your hospital’s policy on the subject, I have gathered all of the recent research I could find on surgical head wear.

In response to a 2013 question from a reader, I blogged about the complete lack of evidence that OR staff hair caused wound infections or any other problem. After a similar question from another reader three years later, I pointed out nothing had changed.

Finally a 2017 paper in the journal Neurosurgery appeared online comparing the incidence of wound infections in clean cases for the 13 months before and the 13 months after the institution of a ban on the wearing of the traditional surgeons’ ca`p. Over 15,000 patients were included in the study which found no statistically significant difference in the rate of wound infections.

The opioid epidemic: What was the Joint Commission's role?

Last year the Joint Commission issued a statement written by its Executive VP for Healthcare Quality Evaluation, Dr. David W. Baker, explaining why it was not to blame for the opioid epidemic. If you haven’t already read it, you should. Here is the first paragraph of that document:

“In the environment of today’s prescription opioid epidemic, everyone is looking for someone to blame. Often, The Joint Commission’s pain standards take that blame. We are encouraging our critics to look at our exact standards, along with the historical context of our standards, to fully understand what our accredited organizations are required to do with regard to pain.”

With the help of an anonymous colleague, I looked at some of the historical context.

In December 2001, the Joint Commission and the National Pharmaceutical Council (founded in 1953 and supported by the nation’s major research-based biopharmaceutical companies) combined to issue a 101-page monograph entitled “Pain: Current understanding of assessment, management, and treatments.”

Here in italics are some excerpts from it. My emphasis is added in bold.

Lean methodology and patient safety

A recent story in U.S. News & World Report described how a Seattle hospital is taking a systems approach in improving healthcare quality and cutting costs. It said, "Virginia Mason Health System...has looked to adopt many of the much-admired and often-emulated business philosophies from Toyota."

The best-known of those philosophies is the so-called "lean methodology" which is based on eliminating waste and focusing on things that add value.

Attempts to incorporate lean into healthcare have met with varying degrees of success. I blogged about this six years ago and pointed out that a literature review done back then found "significant gaps in the [lean and six sigma] health care quality improvement literature and very weak evidence that [lean and six sigma] improve health care quality."

Randomized prospective trials of lean in medicine are lacking. A recent paper from the Journal of the American College of Radiology found only seven studies on the use of lean in radiology and they showed "high rates of systematic bias and imprecision." The authors concluded there was "a pressing need to conduct high quality studies in order to realize the true potential of these quality improvement methodologies [lean and six sigma] in healthcare and radiology."

In addition to the debatable evidence that lean actually works and the cost and time to develop and implement lean measures, the use of Toyota as a model for quality is also highly questionable.

In 2010, Toyota had recalled more than 9 million vehicles for various defects. Nothing has improved. So far this year Toyota has recalled over 11,654,000 vehicles. The problems included exploding airbags, brake failure, fuel tank defects, and minivan doors opening while cars were in motion.

Having adopted lean methodology in 2002, Virginia Mason is not really a new story. How is it doing?

About as well as Toyota.

In May of this year, the Joint Commission paid a surprise visit to Virginia Mason Medical Center and found 29 instances where the hospital was out of compliance with standards. The Seattle Times wrote that among the problems were not having an adequate infection prevention and control plan, failure to store medication safely, and failure to provide a "care, treatment, services and an environment that pose[d] no risk of an immediate threat to health or safety."

On September 17, Virginia Mason regained full Joint Commission accreditation status, and 6 weeks later the hospital announced that it received an "A" grade for patient safety from the Leapfrog Group.

A hospital that failed a Joint Commission site visit because of multiple safety issues gets an "A" for patient safety in the same year? I discussed problems with the Leapfrog patient safety rankings in a previous post.

And if lean works so well in healthcare, can anyone tell me how does a hospital that has been practicing lean methodology for 14 years achieve 29 Joint Commission citations?

It's time to discuss surgeon headgear again

I received this email last week:

My state has recently banned the time-honored surgical cap,

Timed-honored cap

in favor of the “bouffant” cap.

"Bouffant" is French for "doofus"

I have been wearing the disposable surgical caps for my entire career, and have one of the lowest infection rates of any surgeon at my hospital.

Not only are the bouffant caps uncomfortable, I have now developed a severe allergy to them, making them unwearable. Now they say I must wear a full head/beard cover type cap in order to satisfy their requirements...REALLY? 

Head and beard cover even more uncomfortable than bouffant

I asked the hospital to show me a study that proves that the use of a bouffant cap has ANY advantage at all. Of course they can't, because no such study exists.

Some venous thromboembolic events can’t be prevented even with optimal care

I have written several posts about how I get things right before others see the light, but none better than one from three years ago pointing out that some of the Centers for Medicare and Medicaid Services (CMS) "never events" can't really be completely prevented and therefore should not be considered "never events."

One specific "never event" I questioned was hospital acquired venous thromboembolic (VTE) disease which encompasses deep venous thrombosis (DVT) and/or pulmonary embolism (PE). I wrote "I am unaware of any DVT study in which no patients in the experimental arm developed DVTs or PEs. Patients will develop DVT or PE even with the best evidence-based care."

Along comes a brief research letter published last month in JAMA Surgery by a group from Johns Hopkins led by surgeon Elliott R. Haut.

Of 92 patients in their institution who had VTEs in a single year, 43 (47%) had received defect-free care. That is, each of those patients received all doses of risk-appropriate pharmacological prophylaxis ordered for the entire hospitalization.

To put it another way, VTEs for those 43 patients were not preventable. There would be no way to do a quality improvement project for a group of patients who received the right prophylaxis throughout their hospital stays and still got VTEs.

The Joint Commission/CMS criterion states that a hospital is in compliance with VTE prophylaxis if a patient receives one dose of an appropriate drug within 24 hours of admission. The Hopkins study showed that of the 49 patients (53%) whose care was suboptimal, 36 (73%) missed at least one dose of prophylaxis that was correctly ordered. Other studies have shown that missing even one dose of prophylaxis at any time during a hospitalization increases the risk of VTE.

So about half of VTEs are not preventable even with perfect adherence to the prophylaxis protocol, and the standard for compliance established by the JC/CMS is inadequate to judge the quality of an institution's performance for VTE prevention.

The study shows that 1) a lot of good information can be delivered in a two-page paper, 2) JC/CMS criteria for compliance with VTE prophylaxis need to be revisited, and 3) VTE should be removed from the list of "never events.”

Pain is not the "5th vital sign"

No, contrary to what you may  have heard, pain is not the 5th vital sign. It's not a sign at all.

Vital signs are the following: heart rate; blood pressure; respiratory rate; temperature.

What do those four signs have in common?

They can be measured.

A sign is defined as something that can be measured. On the other hand, pain is subjective. It can be felt by a patient. Despite efforts to quantify it with numbers and scales using smiley and frown faces, it is highly subjective. Pain is a symptom. Pain is not a vital sign, nor is it a disease.

How did pain come to be known as the 5th vital sign?

The concept originated in the VA hospital system in the late 1990s and became a Joint Commission standard in 2001 because pain was allegedly being undertreated. Hospitals were forced to emphasize the assessment of pain for all patients on every shift with the (mistaken) idea that all pain must be closely monitored and treated .

This is based on the (mistaken) idea that pain medication is capable of rendering patients completely pain free. This has now become an expectation of many patients who are incredulous and disappointed when that expectation is not met.

Talk about unintended consequences. The emphasis on pain, pain, pain has resulted in the following.

Diseases have been discovered that have no signs with pain as the only symptom.

Pain management clinics have sprung up all over the place.

People are dying. In 2010, 16,665 people died from opioid-related overdoses, a four-fold increase from 1999 when only 4,030 such deaths occurred. And the number of opioid prescriptions written has doubled from 109 million in 1998 to 219 million in 2011.

Meanwhile in the 10 years from 2000 to 2010, the population of the US increased by less than 10% from 281 million to 308 million.

Doctors are caught in the middle. If we don't alleviate pain, we are criticized. If we believe what patients tell us—that they are having uncontrolled severe pain—and we prescribe opioids, we can be sanctioned by a state medical board or even arrested and tried.

Some states now have websites where a doctor can search to see if a patient has been "doctor shopping." I once saw a patient with abdominal pain in an emergency room. After looking up her history on the prescription drug website, I noted that she had received 240 Vicodin tablets from various doctors in the four weeks preceding her visit.

That's a lot of Vicodin, not to mention a toxic amount of acetaminophen if she had taken them all herself during that month.

What is the solution to this problem?

I don't know, but as long as pain is touted as the fifth vital sign, I do not see it getting any better.

Adherence to Process Measures Does Not Equal Better Care

Another paper recently published in Annals of Surgery confirms my previous blog on the subject of one of the more popular process measures, the Surgical Care Improvement Project (SCIP). The main components of SCIP are selection of the proper antibiotic(s) and proper timing of and discontinuation of the the antibiotic(s). Even a year ago it was apparent that although it seemed like a good idea, SCIP didn't lower the surgical wound infection rate.

The new paper reports that there is no correlation between a hospital's level of adherence to the SCIP protocol and the incidence of wound infection in surgical patients.

This also calls into question the Joint Commission's selection of "top performing hospitals" based on their rates of compliance with processes such as SCIP. To read more about the absurdity of the Joint Commission's list, see the blog I posted yesterday.

Joint Commission Proves It's as Irrelevant As HealthGrades

The New York Times reports that the Joint Commission has just published a list of its 405 "Top Performing Hospitals." As is typical of these types of evaluations, most of the large, well-known teaching hospitals where knowledgeable folks [like doctors] go for care when they are really sick didn't make the list.

Similar to the HealthGrades list of "top" hospitals [which I have commented about in the past], the JC's list is dominated by small community hospitals without teaching programs. These institutions know how to play the game and have figured out that compliance with process measures results in high marks from the likes of HealthGrades and the JC. For a related post on why process measures don't mean better care, click here.

At least the Times article pointed out that no hospital in New York City made the JC list. What about Chicago? Sorry, just a children's hospital and a VA hospital. Philadelphia? No university hospital but one community hospital. Surely University of Pittsburgh Medical Center? No, not the main hospital but several of its suburban affiliates made the list. St. Louis? Nope, no good hospitals there. Pick any major city. See the list for yourself.

Guess which state had the most top performing hospitals by far? It's a state that immediately comes to mind when one thinks of quality medical care. Of course, Florida with 51, not one of which was a university hospital unless you want to count the University Hospital & Medical Center of Tamarac. A visit to its website fails to reveal the name of the university it is affiliated with. However, Don Shula, former Miami Dolphins coach, endorses the emergency department in a short video.

A survey I would like to see is what hospitals would the executives of HealthGrades and the JC choose if they or a family member had a serious illness? I'm guessing that list would be a lot shorter and would not include more than 400 of the 405 on the JC list of top performers.

Alarms! Sounding the Alarm on Alarms, Finally

“Patient alarms often unheard, unheeded” states a recent headline in the Boston Globe. Now the Joint Commission and the FDA are going to target “alarm fatigue” as a patient safety priority. Apparently it is not a very high priority as the article describing the effort states that the two organizations will be meeting “over the next few months” to “pinpoint a strategy.”

My question is, where has everyone been? This issue has been apparent for years to anyone who has ever worked in an intensive care unit. Walk into any ICU and within 30 seconds, you will hear an alarm sound its annoying bleat and see the staff going about their business without a second thought.

As far back as the early 1990s, studies documented the issues. There are too many alarms. In 1994, researchers from Ohio published a study in which they played some 33 different common alarm tones for 100 ICU staff members. Only 50% of them were able to identify the source of each alarm. The authors concluded that there were too many alarms for even experienced staff to identify and proposed that alarms should be used for only critical problems.

Another 1994 study from a pediatric ICU observed alarm activity over a week’s time. They noted that of 2,176 alarm soundings, 68% were false, 26.5% were induced by staff dealing with patients and only 5.5% were actually significant.

An interesting study performed on college students in 1995 showed that people respond to alarms on the basis of their expectations. In other words, if an alarm is known to usually be false, the individual is less likely to respond to it. Obviously, if 95% of alarms in an ICU are false, the staff will be conditioned to ignore them.

There have been many other papers on the subject documenting the above as well as the stress on the staff that the constant level of noise produces.

In 2011, the problem is even worse as more and more devices have related alarms. For example, the push to prevent patient falls has prompted the invention of the bed alarm. Some of these alarms are so sensitive that the mere touching of the bed by staff triggers the alarm.

The solution to the problem of alarm fatigue is not simple. Every new device seems to come with its own random noise and sound level. A concerted effort by device manufacturers, regulatory agencies and hospitals is needed. My suggestion is to 1) scrap all current alarms and develop standardized tones for a select few important events and 2) improve the sensitivity of triggers to reduce the false alarm rate. Good luck.