Posts Tagged ‘Quality’

Today’s noteworthy definitions, not new but often ignored:

1. Unintended consequences: The principle stating that an intervention in a complex system tends to create unanticipated and often undesirable outcomes.

2. Good intentions: The paving stones of the road to hell.

In anesthesiology, these precepts should be kept firmly in mind in our attempts to improve “quality”. Anyone who speaks out against measures that are taken under the banner of improving “quality of care” or “patient safety” risks coming across as reckless, heartless, or both. Yet the pursuit of “quality” in healthcare has a track record of implementing changes and policies that haven’t been subjected to any rigorous scientific study, in effect “prioritizing action over evidence.”

Quantitative neuromuscular monitoring

In anesthesiology, we love our gadgets. We especially like gadgets that generate numerical values we can track. It’s no wonder that quantitative nerve stimulators measuring thumb movement via acceleromyography are gaining in popularity. They give us a ratio of neuromuscular recovery that we can document and trumpet as evidence of high-quality care, blessed by the Anesthesia Patient Safety Foundation (APSF) in its most recent recommendations for patient monitoring.

A recent review article in Anesthesiology concluded that “the use of quantitative monitoring may reduce the risk of hypoxemic events and episodes of airway obstruction in the PACU, decrease the need for postoperative reintubation, and attenuate the incidence of postoperative pulmonary complications.”

Note the use of hedging verbs such as “may” and “attenuate”. The authors, Drs. Murphy and Brull, are not claiming that the use of quantitative nerve stimulators should be considered an absolute standard of care or a guarantee of improved outcomes. That’s because they are scientists and understand the hazards of confusing association with causation.

From the trenches of clinical care, is quantitative monitoring turning out to be an unmixed blessing? Hardly, especially if your clinical practice involves trainees. The problem isn’t the technology. The problem is with failure to understand the limits of the technology, and the consequences that arise from uncritical interpretation of the data that the monitor generates.

The electronic health record now badgers us to document quantitative neuromuscular monitoring, regardless of whether the arms are tucked or tightly secured. If the thumb can’t move, the monitor won’t be reliable. A resident may assume the patient is adequately relaxed even if it isn’t true, failing to appreciate subtle signs of return of neuromuscular function such as an increase in peak inspiratory pressure or a change in the end-tidal CO2 waveform. This works until the patient actively bucks on the tube. Our surgical colleagues may be justifiably irritated if they have already remarked on inadequate relaxation only to be told that the patient has no twitches and therefore must be paralyzed.

Conversely, when the monitor demonstrates barely one twitch, the resident may decide to give more muscle relaxant when it isn’t clinically necessary or even appropriate. This in turn may lead to the patient’s being profoundly paralyzed at the end of the case. If the patient received a drug that can be reversed with sugammadex, there may be no problem. However, on one recent morning I took over from the night call team the care of a patient who required a full gram – 1000 mg – of sugammadex to reach full recovery. What was the need to give 100 mg of rocuronium during a renal transplant?

What we’re seeing here are unintended consequences and a steep slide toward mediocrity in the management of muscle relaxation. In the interest of avoiding a citation from the quality-improvement committee for inadequate reversal, residents are steered away from using cis-atracurium, even in cases of complete renal failure, and are getting little experience in the use of neostigmine.

If a patient moves or attempts to breathe over the ventilator, the solution is more rocuronium – not appropriate deepening of anesthesia, improvement of ventilatory parameters, or correction of acid-base status. As TIVA – total intravenous anesthesia – increases in popularity (for reasons unclear to me), the dependence on profound muscle relaxation increases proportionately.

What will happen one day if we have a shortage of rocuronium or sugammadex? Our PACUs will be full of patients on ventilators. In today’s era of supply-chain misadventures, drug shortages are not a merely theoretical concern.

Adverse event reporting

 It’s a good thing – isn’t it? — that errors are now considered system problems, not individual failings. The idea is that we shouldn’t hesitate to report adverse events as these will be reviewed with an eye to correcting system problems, not accusing people. (I’m not so sure that argument is watertight now that a nurse has been convicted of negligent homicide for a medication error.)

Yet there is no question that behavior alters when it is observed and reported on (often referred to as the “Hawthorne effect,” so named after Western Electric’s Hawthorne manufacturing plant where pioneering productivity studies were done in the 1920’s). If the consequences of behavior must be reported, then the behavior will never be quite the same as it might have been without oversight.

Let’s take the example of esophageal intubation. If unrecognized it may be catastrophic, but when immediately recognized we used to think of it as something that simply happened from time to time, especially when working with trainees. Even in the hands of an experienced anesthesiologist, an occasional esophageal intubation can happen if the view during laryngoscopy isn’t ideal or the tube bumps against the arytenoid cartilages. Pull out the tube and reintubate – no harm, no foul.

If you know that you have an obligation to report for quality surveillance every event of esophageal intubation, are you going to allow the medical student to intubate without a video laryngoscope?  Are you going to be less likely to allow a resident to make a second attempt if the first one wasn’t successful? Are you going to bother to document it if you did it yourself and you corrected it right away? Will data on the incidence of esophageal intubation ever be reliable? Probably not.

In my own practice, I’ve noticed that I’ve become less likely to put in central lines than I was even ten years ago. It has become such a time-consuming production. The potential need to report even a minor or insignificant complication seems like more aggravation than it’s worth. Is this a change that’s in patients’ best interest? Maybe, in the sense that I can get some comparable information, maybe even better information, from a minimally invasive monitoring system like the FloTrac®. But it isn’t a change that was made intentionally, after thoughtful study. It’s a behavioral change due to external forces, not an improvement to point to with pride.

Our fault or not?

Anyone who has worked with me or has read articles I’ve written on deep extubation knows that I’m a proponent of extubating deep whenever it’s appropriate, which in my hands is often. If I didn’t intubate the patient awake or use a rapid-sequence induction due to aspiration risk, there must be a compelling reason for me not to do a deep extubation. Residents are eager to learn how to use this technique safely, and they have often asked me why it isn’t used more frequently, at least by Americans.

Though I can’t speak for other anesthesiologists, I suspect that the rationale for awake extubation may come down to fear of criticism and blame more than any scientific evidence of improved quality or safety.

Potential sequelae of deep extubation are clearly anesthesia-related events that would be ours to own and to manage:

Inspiratory stridor and/or laryngospasm

Upper airway obstruction

Aspiration

Potential sequelae of tumultuous awake extubation, on the other hand, aren’t viewed as direct anesthesia complications though they may be precipitated by anesthesia (mis)management:

Dehiscence of an abdominal wound due to coughing

Neck hematoma after carotid or thyroid surgery

Distressing recall of emergence and extubation

Disruption of free-flap anastomosis

Injury or threat of injury to nursing staff who are attempting to restrain a patient during emergence.

All of these have happened to my personal knowledge and weren’t considered anesthesia-related adverse events. It is only human nature to avoid blame and take the path of least resistance, which too often is poorly controlled awake extubation.

The quest for quality

The quest to improve quality is a worthy one. Anesthesiology has an enviable record of safety and of continuous improvement due to the efforts of so many anesthesiologists over many years. But we should never lose sight of the potential for unintended consequences, as explained in the classic NEJM article by Auerbach and colleagues, “The Tension between Needing to Improve Care and Knowing How to Do It.”

Another excellent read is Greenhalgh’s analysis in the British Journal of Medicine, “Evidence based medicine:  a movement in crisis?” She and her colleagues point out that inflexible rules and technology-driven prompts may produce care that is management-driven rather than in the best interests of the patient, and that evidence-based guidelines often map poorly to complex multimorbidity. Jureidini and McHenry go even further in their very recent 2022 BMJ editorial, “The illusion of evidence based medicine,” stating that “evidence based medicine has been corrupted by corporate interests, failed regulation, and commercialisation of academia.”

Too often, the reporting of one or two complications, even if minor, is considered “evidence” that warrants a new policy or protocol as a recipe to prevent reoccurrence. But every misjudgment should not be treated as a critical error requiring systemic intervention.

Especially in large academic institutions, we should beware of the mindset that “the way we do it” is “the standard of care”. This leads only to mindless conformity, and to tolerance of mediocrity if it is consistent with compliance. Isn’t it obvious that this attitude is contributing to physicians’ feelings of futility and burnout in their clinical work?

The patient in front of us deserves to have our best judgment and experience brought to bear in making clinical decisions, regardless of any pathway, protocol, or local custom. Isn’t that the care we would want for ourselves? 

(Author’s note:  This article first appeared in the July 2022 issue of the ASA Monitor)

The real surprise – to me, at least – came more than halfway through Dr. Atul Gawande’s keynote address at the opening session of the American Society of Anesthesiologists’ annual meeting in Boston.

Much of his talk on October 21 celebrated the virtues of checklists and teamwork, topics that have turned into best-selling books for the well-known surgeon and professor of public health. “We are trained, hired, and rewarded to be cowboys, but it’s pit crews we need,” he said.

Then Dr. Gawande posed this question to the packed room: “What are the outcomes that matter?”

He answered his own question somberly. “The most unsafe operation is the operation that shouldn’t be done,” Dr. Gawande said. “Does the operation serve the patient’s goals or not?”

“We’ve all been there,” he continued. “Taking people to the operating room and wondering what we’re doing.”

Those are comments I’ve heard from anesthesiologists many times before, but I never thought I’d hear them from a surgeon.

Flogging the dead

For any of us who practice anesthesiology in a major hospital – doing cardiac, thoracic, or liver cases, for instance – there are days when all our efforts are spent on behalf of a patient whose health is unsalvageable. “Flogging the dead” is a phrase sometimes used to describe prolonged and futile care in the operating room or ICU.

Sometimes aggressive interventions are driven by a family that wants “everything” done, because in their innocence the family members have no idea how terrible and dehumanizing the process of postponing death can be.

In other circumstances, however, the decision of whether to do surgery is driven by the mission and the financial motivation of the health system to provide care. If care doesn’t occur, if the surgery isn’t done, no one gets paid.

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Nothing brings out the mama lioness in me more than seeing one of my cubs not being treated as well as I think it should be.

Recently I had the unusual experience of accompanying my oldest daughter into an unfamiliar hospital for a minor surgical procedure. Now this daughter isn’t exactly a cub — she’s a full-fledged adult, with a master’s degree in health care administration, a husband, and two small boys of her own.

But as I watched the OR team prepare her for surgery, I started to feel like an odd combination of a mama lioness and a secret shopper. To the staff members who came in and out of the hospital’s preoperative area, it was clear that I was simply the family member in the corner, and they probably figured I had little clue about what was transpiring. Meanwhile, I was taking in every detail. Some tasks were performed excellently — others, not so much.

The hospital where her surgery took place is a small community hospital on Long Island. It enjoys a location where Jerry Seinfeld, Christie Brinkley, and other wealthy New Yorkers maintain lavish homes for weekend and summer holidays.

My daughter was instructed to arrive at 6:30 a.m. Her procedure involved an initial stop in radiology, to be followed by the actual surgery. As a veteran of hospital life, I questioned whether radiology even opened that early, but we had no way of checking. So we left her house at 5:25, driving carefully on dark, icy roads with fresh snow, and lining up for a 5:40 a.m. ferry ride from her home town so that we could arrive at the hospital by 6:30.

The good news — a valet met us at the hospital door and whisked away the car, so we had only a moment to savor the 20-degree weather and the harsh wind that made it feel colder. My daughter was promptly escorted to a private room to change clothes.

Hurry up and wait

A nurse gave her an insulated paper gown with two openings to connect it to a wall-mounted forced air warming unit. This, I thought, was a wonderful thing. Where I’ve worked, we had forced air warming blankets in the ORs but the hospital wouldn’t spend the money to put them in the preoperative areas. I thought of Tina Fey, playing an immigrant from Albania in a Saturday Night Live spoof of the HBO series “Girls”, and imagined her saying, “In my country, we do not have such things.” Within minutes, my daughter’s gown was hooked up to the warmer and she was feeling much cozier.

Then we waited.

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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?

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The Dark Side of Quality

Nobody stands up to argue against quality and value in healthcare. You might as well argue against motherhood, or puppies. Yet many physicians are inherently skeptical of definitions of “quality” that are imposed from above, whether by outside evaluators like The Joint Commission, or (worse) by the government.

There’s good reason for skepticism. Some of the “evidence” behind “evidence-based medicine” has turned out to be flawed, tainted by financial conflict of interest, or outright fraudulent. Any experienced physician knows that there are fads in healthcare just as there are in fashion, and today’s evidence-based medicine may be tomorrow’s malpractice. Let’s take a closer look at what’s really going on in the world of quality metrics, and why it matters if payments to you and your hospital are increasingly linked to how you score.

Surgical Site Infections

The financial toll of surgical site infections (SSIs) is huge, estimated in the U.S. at more than $10 billion a year.(1)  A recent retrospective review from the Veterans Affairs Surgical Quality Improvement Program showed that the majority of SSIs are diagnosed only after hospital discharge, and that 57% will require hospital readmission within 30 days.(2)  The Centers for Medicare and Medicaid Services (CMS) stopped paying for care related to SSIs in 2008 by designating them as “never events”, or non-reimbursable serious hospital-acquired conditions. Now SSIs are part of a long list of hospital-acquired conditions that can result in reduced CMS payments to hospitals, and will bring further reduction in payments over the next several years with the implementation of “value-based purchasing”. More than 1400 hospitals will see their Medicare payments cut by as much as 1.25% this year–a margin that could spell financial disaster for hospitals already struggling.(3)

You may already be among the more than 50% of anesthesiologists who have been reporting performance metrics to the Physician Quality Reporting System (PQRS), which is administered by CMS. When the system started in 2007, CMS offered a bonus payment of 1.5% for successful participation, but that soon shrank to 0.5% and will be discontinued after 2014. Starting in 2015, CMS will impose a 1.5% payment reduction for physicians who do not participate in PQRS, and will push the pay cut to 2% in 2016.

If you participate in PQRS reporting, you know that two of the measures that anesthesiologists report are directly aimed at SSI prevention: perioperative temperature management, and antibiotic timing. PQRS measure #193 specifies that the patient must receive “active warming” or have a temperature above 36C recorded within 30 minutes before or 15 minutes after anesthesia end time. Measure #30 specifies that prophylactic parenteral antibiotics must be administered within one hour before skin incision. Compliance with these two measures isn’t hard to achieve, though no one seems to question the cost to the American healthcare system of all those forced-air warming blankets and machines, or ask why giving antibiotics 61 minutes instead of 59 minutes before skin incision is an automatic “fail”.

But have CMS threats and PQRS compliance done any good? A just-published editorial in Anesthesiology concluded: “Despite early efficacy literature establishing the value of specific antibiotic timing and active warming, repeated large database analyses have not observed robust effectiveness across hundreds of hospitals.”(4)   Simply put, as many of us have noticed in our own hospitals, SSI rates have remained about the same.

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