Germs and the pseudoscience of quality improvement

No one wants a hospital-acquired infection—a wound infection, a central line infection, or any other kind.  But today, the level of concern in American hospitals about infection rates has reached a new peak—better termed paranoia than legitimate concern.

The fear of infection is leading to the arbitrary institution of brand new rules. These aren’t based on scientific research involving controlled studies.  As far as I can tell, these new rules are made up by people who are under pressure to create the appearance that action is being taken.

Here’s an example.  An edict just came down in one big-city hospital that all scrub tops must be tucked into scrub pants. The “Association of periOperative Registered Nurses” (AORN) apparently thinks that this is more hygienic because stray skin cells may be less likely to escape, though no data prove that surgical infection rates will decrease as a result.  Surgeons, anesthesiologists, and OR nurses are confused, amused, and annoyed in varying degrees.  Some are paying attention to the new rule, and many others are ignoring it.  One OR supervisor stopped an experienced nurse and told to tuck in her scrub top while she was running to get supplies for an emergency aortic repair, raising (in my mind at least) a question of misplaced priorities.

The Joint Commission, of course, loves nothing more than to make up new rules, based sometimes on real data and other times on data about as substantial as fairy dust.

A year or two ago, another new rule surfaced, mandating that physicians’ personal items such as briefcases must be placed in containers or plastic trash bags if they are brought into the operating room.  Apparently someone thinks trash bags are cleaner.

Now one anesthesiology department chairman has taken this concept a step further, decreeing that no personal items at all are to be brought into the operating room–except for cell phones and iPods.  That’s right, iPods, not iPads.  This policy (of course) probably won’t be applied uniformly to high-ranking surgeons or to people like the pacemaker technicians who routinely bring entire suitcases of equipment into the OR with them.

What’s particularly irrational about this rule is that cell phones likely are more contaminated with bacteria than briefcases or purses, even if they’re wiped off frequently.  And I have to ask how an iPhone 6+ meets eligibility criteria while the barely-larger iPad mini doesn’t.  Again, please show me the data demonstrating that this will reduce infection rates, unless someone is making it a habit to toss briefcases and iPads onto the sterile surgical field.

Show me the money

I wish I could say that the driving force behind hospitals’ fear of infection is simply the wish for patients to get well. Unfortunately, it’s probably driven as much by financial motives as benevolent ones.  Today, Medicare won’t pay for care related to surgical site infections, and it fines hospitals whenever too many patients need to be readmitted within 30 days of discharge.  In 2014, a record 2610 hospitals–including 223 in California–were penalized, and will receive lower Medicare payments for all patients over the next year, not just those who were readmitted.

What does this mean at the grassroots level?

It means that the epidemiology department in your hospital is under a lot of pressure to do something.  The epidemiology doctors and nurses are the people charged with preventing infections.  Their mission is to kill germs in the hospital wherever they may be until the day when hospital-acquired infection rates reach zero.

Some progress has been made.  The CDC reports that between 2008 and 2012, central line-associated bloodstream infections decreased by 44%.  This can be credited chiefly to work headed by Dr. Peter Pronovost, a physician anesthesiologist who championed standard aseptic procedures for central line insertion in ICUs.

But other initiatives aren’t based on this type of solid science, with sound methodology and careful tracking of results over time.

The Centers for Medicare and Medicaid Services recently released results of its “Partnership for Patients” (PPP) program, and boasted large improvements in several outcomes including pneumonia.  In reply, Dr. Pronovost and Dr. Ashish Jha wrote an editorial in the New England Journal of Medicine, arguing that “weak study design and methods, combined with a lack of transparency and rigor in evaluation, make it difficult to determine whether the program improved care.”

“Though the evaluation of many other CMS programs also lacks this basic level of rigor, given the large public investment in the PPP, estimated at $1 billion, and the strong public inferences about its impact, the lack of valid information about its effect is particularly troubling,” they concluded.  “Some patient-safety interventions appear to lead to improvements but are no more effective than controls.”

Choosing action over evidence

The need to do something—anything—to improve healthcare quality often leads to action that isn’t justified by evidence or subjected to controlled follow-up study.  Writing in the New England Journal of Medicine, Dr. Andrew Auerbach and his colleagues analyzed “The Tension between Needing to Improve Care and Knowing How to Do It.”  They elegantly described arguments often used in favor of rapid quality improvement interventions, and then explained why scientific evaluation is critical. Among the key points:

1.  The need to treat disease is just as urgent as quality improvement, but we demand rigorous evidence that a therapy works before recommending it widely.

2.  Emulation and collaboration can incorrectly promote or even overlook interventions that have not worked.

3.  Given the complexity of quality and safety problems, the complexity of their causes, and how little we understand them, we should use rigorous study designs to evaluate them.

Hospitals have little incentive to examine their quality improvement efforts critically, the authors concluded, since “if anecdotal reports or superficial analyses are positive, the organization will understandably focus on advertising these measures of success rather than pursuing more rigorous evaluation.”

While no one is suggesting a randomized study of parachute use, or of sterile vs. non-sterile glove use for surgeons and scrub techs, other issues aren’t as straightforward, Dr. Auerbach noted.  “Many apparently obvious quality-improvement interventions have more in common with calls for world peace than with parachutes–the goal is not in question, but the path for achieving it is.”

“Squames” vs. long sleeves

Some rules seem to mutate over time.  A while back, nurses were told not to wear long-sleeved scrub jackets in the OR because the sleeves could accidentally contaminate sterile surfaces.  Now, the AORN says that everyone should wear long sleeves to reduce the risk that those pesky “squames”—dead skin cells which everyone routinely sheds—will cause contamination of the OR.

Of course, no one knows if squames or sleeves have any relation to surgical infection rates because the research hasn’t been done. This controversy reminds me of the argument in years past over the wearing of shoe covers in the OR.  That rule seems to have faded into oblivion, whether because it had no beneficial effect or because the shoe covers cost too much money, I’m not sure.

Even hand-washing isn’t as obvious a solution as it seems.  A much-quoted study in the American Journal of Infection Control reported that anesthesiologists and nurse anesthetists were poorly compliant with World Health Organization (WHO) guidelines for hand hygiene (HH).  However, full compliance with the guidelines is impossible.  An average of 149 “HH opportunities” were identified by observers during each hour of anesthesia care.

“Complete compliance with HH practice as recommended by WHO guidelines would have consumed more than the 60 minutes available in each hour of anesthesia time,” the authors concluded.  “HH compliance is especially difficult during the complex and rapidly evolving induction and emergence phases of anesthesia, a situation that is not easy to improve.”

The hand-washing study ignored the fact that the anesthesia practitioner who is directly administering anesthesia is caring for only one patient at a time, not going from patient to patient without appropriate hand hygiene. The study involved observation of only 10 surgical cases, and did not report whether or not any of the patients developed a surgical site infection or any other postoperative infectious complication.  Most important, it did not address the fundamental question of whether bacterial counts in the anesthesia work area, which is physically separated by sterile drapes from the surgical field, have any bearing on the real issue of patient wellbeing.

What are we to do?

Certainly sleeves can be contaminated.  Skin, shoes, cell phones—all harbor bacteria.  Yet most patients don’t develop infections after surgery.

Everyone knows that the patient whose thyroid gland is removed is at less risk for surgical site infection than the patient whose large intestine is removed, because the large intestine is contaminated with fecal bacteria.

Everyone knows that patients who are diabetic or immunocompromised are more susceptible to surgical site infections.

So perhaps we’re asking the wrong questions and setting in place new rules that don’t address the roots of the infection problem.

Instead of creating more and more rules governing the care of all patients, perhaps we need to focus on the subsets of patients and case types that we already know are at higher risk, and examine what additional steps we need to take on their behalf.

As an example, we already know that the bacterial count found on surgical scrubs increases as the day wears on, and OR staff members stop by the preoperative and recovery care areas, the cafeteria, and (inevitably) the bathroom.  No one yet, to my knowledge, has done a rigorous, controlled, prospective study to see if there is any correlation between the bacterial counts on surgical scrubs and surgical infection rates when cases are done in the morning compared to later in the day.

Should the American healthcare system pay for fresh disposable scrubs to be worn for cases at high infection risk?  Could the system conserve resources by allowing staff the option to select, purchase, and launder their own scrubs for routine use, just as they select, purchase, and launder the socks that they wear to the OR every day?

No one really knows the answer to this basic question:  Do higher bacterial counts on scrubs, cell phones, or nonsterile surfaces, assuming that these are carefully kept apart from the sterile surgical field, actually correlate with a higher risk of surgical site infection?  Right now, rule-makers simply assume that they do.  We urgently need good science, with prospective, controlled studies, to answer this question.  If the answer is no, then we need to look elsewhere for ways to lower infection rates.

Could dust from computer fans in the OR, for instance, be part of the problem?  Air particle counts in ORs aren’t tracked as meticulously as they are in the manufacture of smart phones.  Or are problems due to lapses in sterile processing, or postoperative dressing changes? Or to individual patient risk factors such as periodontal disease?

Finally, it’s fair to ask if the quest to eliminate all bacteria from the operating room is creating an environment in which the truly dangerous bacteria flourish since they have no competition from the relatively harmless ones. This is the process that takes place when antibiotics and antibacterial cleansers are overused, killing off weak bacteria and allowing the resistant ones to multiply and thrive.

You may have heard of the “hygiene hypothesis“, which argues that lack of exposure to normal bacteria, and overexposure to antibacterial chemicals, makes children more prone to a wide range of food and environmental allergies.   Early childhood exposure to common pathogens appears to be essential in building healthy immune responses.  A child who isn’t exposed to normal bacteria may develop an overactive immune system that misfires against food proteins, pollen, or pet dander.

The three-week-old baby in the photo?  He just celebrated his fourth birthday.  He’s never had an ear infection, has never needed a prescription for antibiotics, and requests peanut butter every day for lunch.

Maybe we should schedule a “take your dog to the OR” day.

9 COMMENTS

Karen, spot on.

One can’t escape the conclusion that devising and implementing this myriad of rules and guidelines has become a prestige-enhancing and ladder-climbing opportunity for some of our nursing colleagues, aside from the questionable good the rules might achieve. Not to mention an attractive cudgel to wield against physicians.

[Reply]

Nice post. I share your concerns and frustration.

A couple of observations.

We may be seeing the sleeve issue crop up again, only this time from the WHO. (Without any clear data I could see) WHO has decided sleeves and clothing provide infection risk, and in addition to asking doctors to launder neckties frequently and keep them clipped/pinned, they are making a recommendation for arms to be bare below the elbow. A bummer if you wear a suit or live in a cold climate…

Also, I actually did a little review of whatever I could find in the literature about infection risk from washable cloth scrub hats. AORN does not like them, despite it being a huge cottage industry, and I wanted to see what the data was when our infection control nurse and OR manager decided to ban them. There isn’t much out there, and studies are small. But there were a few studies, ironically on scrubs and not hats. There was one well done albeit small study for OB nurses, culturing scrubs to compare the hospital ones to those washed at home–no difference was seen (infection rates per se were not studied). But the delivery room and NICU are sensitive areas for infection.

All of this speaks to the adage that where data are weak, opinion is strong.

In this age where we should look to “green” alternatives, and mindfulness of waste of energy and resources, it would be valid to do the studies and settle these questions.

If we purport to practice evidence based medicine, then we should have assurances that hospital and nursing policies as well as our medical staff policies and practices are also evidence based. There is huge variability from one hospital to he next, even in the same town.

Otherwise, these rules seem arbitrary and capricious, which undermine the “buy-in”‘and compliance by staff, not to mention eroding morale.

Let’s keep speaking up, we may yet be heard.

[Reply]

John Snow MBBS

Karen please tell us that you are collecting all these posts into a book that will soon be sold to the general public! PS: Note the irony that all these arbitrary and untested rules that are being thrown at doctors come from the same people that think doctors should be sued anytime we even think of using some treatment or drug that is not “evidence based medicine”.
We live in an Alice in Wonderland environment and you could help awaken the public to its absurd detrimental effect on their health and wealth!
BradJohnSnow

[Reply]

Ha! Just did a post, not as good as this one, on the subject of arbitrary rules. Agree totally. There’s no evidence for any of this.

[Reply]

Dr. Harley Schmidlap

You have many interesting posts. I have an EMR comment:

EMR’s foment inaccuracies in patient records.

All to many physicians obtain the PMH from an EMR, accepting the EMR record without questioning or investigating details-My 2 favorite examples are the Diagnoses of COPD and CHF:

COPD requires a patient have: A) Airway Obstruction which has been present B) Over two years C) When not an inpatients D) Documented by Spirometry.
CHF has multiple versions: A) Systolic, B) Diastolic, C) Left Ventricular, D) Right Ventricular. Each type has different ICD-9-CM codes and different documentations.

Both of these diagnoses are CLINICAL, NOT based on Radiology ONLY. Too many Radiologists ‘leap’ to a clinical diagnosis from one chest x-ray, rather than simply describing the CXR itself, then listing possible differential diagnoses. Too frequently, even in academic affiliated or academis based hospitals, the CXR report consists of
COPD or CHF-as if they could ‘see’ spirometry reports and clinical histories or forget ‘Pulmonary Vascular Congestion’ has more than one differential diagnosis.

These inaccuracies are perpetuated by either Copy/Paste, lack of curiosity, or sloth.
Patients consequently become labeled with diagnoses they don’t have, leading to useless or potentially dangerous treatments…at the time of their hospital admission and subsequently. They may have difficulty, much higher costs, etc. obtaining Life Insurance, Automobile Insurance, or loans.

EMR’s should have an audit trail for Copy/Paste: ‘The above copied from a note written on (date), written by (name of author) and pasted here by (name of copy/paster) on (date copied note pasted) at (time of copy/paste).

At the bottom of each note, prior to e-signing, should be this statement-I’ve done this taking resposibility (medical, legal, and financial) for the above contents.

Too rigid? Don’t all ethics, oaths, and state medical practice acts require each physician to do so?

[Reply]

Zach Barnes

Excellent post. I’ve participated on one of these “quality improvement” projects as they were required for residency completion (a whole other topic entirely, along the appears to be getting stuff done line).

Being someone who values reason and rationality, it was very difficult to sit through and hear some of the just off the wall absurdities you endure in these meetings.

We as a group and unfortunately the face of these policies (either in exclaim or blame) have to stand up or all day we will just be washing our hands, clicking boxes, or re-identifying ourselves incessantly instead of working.

Whats the end goal in these issues? Zero infections, pneumonia, etc…? We all know that while there is a vast amount of possible improvement, zero is impossible. If that kind of nonsense thinking was real we’d just skip the part where they come to the hospital and bless them as cured due to home HH practices and surface disinfection logs. Its ridiculous. At the rate doctors are being piled on with mindless an ineffective beaurocracy in hospitals and from our own groups, high opportunity cost, with decreasing enjoyment and pay, doctors are going to either go down in quality rapidly or fizzle out.

[Reply]

I hate to repeat myself (not really); but once you understand that much of this is about breaking physicians to someone’s saddle, it all makes sense. It’s a lot more about power and control than it is about patient-care improvement.

Ever notice how deeply the nursing profession is imbedded in this sort of busy-bodying? It’s a great chance for groups of non-physician colleagues who’ve traditionally felt “oppressed” by doctors to get a little payback by nipping at our heels like snarly terriers. What they can’t achieve through education, training, and experience they’re happy to acquire via the Long March, like water eroding the stone. How much more fun if they can act in agency with the government to achieve their desired self-aggrandizement.

If you think I’m paranoid, well….Look for licensure in certain jurisdictions increasingly to be tied to compliance with whatever nonsense they come up with, and to participation in government-payer schemes. It’s already been tried in Massachusetts, and narrowly failed. There will be no qualm about seizing the private property of physicians for any pretext or none at all.

[Reply]

Kyle Bunker

“Surgeons, anesthesiologists, and OR nurses are confused, amused, and annoyed in varying degrees.”

I literally laughed out loud, great article! I always enjoy reading your posts.

[Reply]

Marlene

Great article

[Reply]

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