Medical errors should not be prosecuted as crimes: Systemic change is needed

As reported recently in MedPage Today, Kentucky has become the first state to pass a law shielding medical professionals from criminal prosecution for clinical errors. This is important. It is a good thing and had the support of many professional organizations. It is not about protecting nurses and doctors who actually commit crimes, as ‘it does not apply to "gross negligence or wanton, willful, malicious, or intentional misconduct."’ For example, the Pennsylvania nurse convicted of murdering patients with insulin would not be covered by this law. But mistakes happen, and while they can have very bad outcomes in the medical setting – including death – when they are not intentional they should not be prosecuted as criminal acts.

The case cited as motivating this law occurred in the neighboring state of Tennessee, and involved a nurse named RaDonda Vaught at Vanderbilt Medical Center. She mistakenly gave a paralytic rather than a sedative with a similar name to a 75 year old woman, causing her death. She did not try to cover it up but reported it immediately, and yet was charged with and convicted of reckless homicide and impaired adult abuse. The outcome, the woman’s death, was terrible, but the criminal charges were neither justified nor functional. Yes, you can bet that the particular nurse would be extra careful the next time she gives medication – although, of course, with the criminal conviction she has lost her nursing license. Maybe it could be a deterrent to other nurses and doctors making inadvertent mistakes? Think about how well this works in other areas, about, for example, how a pedestrian or bicyclist being killed by a car in your town has suddenly made all the other drivers extra careful. Right.

Doctors, nurses, and other health professionals are already careful (barring the rare truly malicious exception, who is not covered by this law). The issue is how to make it increasingly difficult to make mistakes, to make errors. A whole field of health safety and error prevention exists, originally stimulated by the work of W. Edwards Deming and Avedis Donabedian, and including such luminaries as the Institute for Healthcare Improvement (IHI) and founders Donald Berwick and Paul Batalden, and Harvard professor Gordon Schiff.  One thing that is clear is that the solution is not draconian punishment of those who have made mistakes. It is mostly (almost all) about systems, about making it difficult (and some day, hopefully impossible) to commit errors. Deming said “To find the mistake is not enough. It is necessary to find the cause behind the mistake, and to build a system that minimizes future mistakes”. Every mistake is a gem, because it offers us the opportunity to discover the cause and to develop systems to prevent that, and similar, mistakes in the future.

Many systems have been developed in many places and areas of healthcare to do this. For example, in pharmacy drug lists, similar sounding or spelled drugs are often distinguished by having the letters that are different capitalized, calling attention to it and making it less likely to prescribe the wrong one. Surgery now almost never takes place without a final “timeout” in which a checklist is gone through with all the operating team present, including “which side are we operating on”! There are many more examples. In the field of occupational health, the first choice in preventing injuries is architectural, e.g., don’t put a big window next to a place on the shop floor where slippery substances are spilled. The second choice is engineering: ok, the window is there, so let’s put up bars across it so if people do slip they don’t go through. The last choice is behavioral: tell the people who work there to be careful! If this last sounds unlikely to be completely successful, it is both the most common and the least effective. Imagine your being responsible for changing the behavior, consistently and always, of a person. Now make that everyone! Think back to drivers…

It is true that many, maybe most, healthcare facilities are and have been working to improve quality and limit the number of possible places that workers can make mistakes, but these procedures are processes and must continually be upgraded and enhanced, primarily by identifying mistakes that continue to be made and figuring out how they can be prevented. Quality improvement is not something that can be “put in place”; it is both a state of mind of individuals and most importantly an overarching commitment on the part of the institution, in all places. Yes, it costs money – but so do the lawsuits that come when it is inadequate, and that should not be the motivation.

Although making money is a strong motivation. Insurance companies, for example, are very good at instituting procedures that make them money. ProPublica recently published an article about Dr. Debby Day, who was one of the physician reviewers at CIGNA, tasked with reviewing the decisions about approving or denying coverage for people’s care, after the initial decision was made by a nurse reviewer (mostly working in the Philippines). CIGNA continually monitored the number of minutes taken for each review, and physicians like Dr. Day were sanctioned or even fired if they took too long. They took too long making decisions that could not only affect people’s health, but their life and death. Your life and death. Your family’s. How were they supposed to keep up with the speedup expectations? ‘“Deny, deny, deny. That’s how you hit your numbers,” said Day, “If you take a breath or think about any of these cases, you’re going to fall behind.”’ This makes CIGNA (and, to be fair ALL the big health insurance companies) money. The speedup is part of it, but the denials are where the real money is made. Denying ‘coverage for a cancer patient or a sick baby’. Your cancer. Your baby.

To be sure, insurance companies as such are not the actual providers of health care, like hospitals and doctors. Except, increasingly through vertical integration, they are – UnitedHealth, for example, owns Optum (and OptumRx, a pharmacy benefits manager). The thing is that they are corporations and are very good at putting systems in place to increase their bottom-line profits, even when that harms the health of – or kills – people who are their clients. So, I think, they should and can be equally effective in putting in place systems that protect and benefit those clients/customers/patients/people.

Hopefully, the type of law passed in Kentucky will become more widespread. This will make it more difficult for the prosecutors and politicians who want to make their “tough on crime” reps by such prosecutions, which is good. But also, hopefully, it will be combined with renewed efforts to strengthen the systems of quality control, and greatly limit the possibility of an individual making a mistake.

The health of people should be the goal of healthcare organizations.

Medical errors: to err may be human, but we need systems to decrease them

An op-ed by Sanjay Gupta, MD, the Atlanta neurosurgeon and CNN medical correspondent, appeared in the New York Times on August 1, 2012. “More treatment, more mistakes” makes the case that medical errors are common and that they are largely due to the pressure to “do more”, to do more tests, to do more x-rays, to do more surgery. This is not news in itself; the Institute of Medicine (IOM) of the National Academy of Sciences published its study “To Err is Human” in September 1999, observing that between 44,000 and 98,000 deaths occurred per year as a result of medical errors (full text available at http://www.nap.edu/openbook.php?isbn=0309068371).

To Err is Human itself was not the beginning of the study of medical errors. It uses a taxonomy dividing errors into “Diagnostic”, “Treatment”, “Preventive” and “Other”, published 6 years earlier in a study by Lucian Leape, et al., in the Quality Review Bulletin.[1] To Err is Human detailed the variety of types of medical errors that could occur, the relative frequency with which they occurred, and the reasons why they occurred, and provided suggestions as to how to prevent them from occurring. The Institute for Healthcare Improvement (IHI), founded by Leape and former CMS director Don Berwick (who were among the authors of the IOM report) has been working on this issue for more than 25 years. Its “100,000 lives campaign” sought to save that many lives by having hospitals sign on to implementation of certain strategies that had been shown to reduce errors. These included “timeouts” in surgery to be certain that everything was correct (right patient, right part of the body, etc.) before beginning, particular ways of managing people on breathing machines in intensive care units to prevent “ventilator associated pneumonia”, and the like.

A key point is that very few of these errors are intentional – they are not malpractice in the traditional sense, they are rarely the result of physicians being “bad doctors” – and yet people, avoidably, die from them. A key part of the strategies promulgated by people like Berwick and Leape, IHI, by the IOM report, and others working in the field is to employ the systematic approach to error reduction developed in other industries, such as airlines. (A common trope is that if airlines had errors as frequently as medicine, a jumbo jet full of people would be crashing several times a day.) Continuing follow-ups have looked a “how we are doing”, such as in “Five years after ‘To err is human’: what have we learned?” by Leape and Berwick in JAMA in 2005[2] and the summary of it by the Commonwealth Fund.

It is in the context of this history that Gupta’s article appears. Its main significance is that it brings to public (New York Times) attention the fact that these problems still exist, and that despite progress (and there has been much) there is much that still needs to be addressed. It is a balanced presentation, but does emphasize the point in the title – that more treatment leads to more errors, or, to put it another way, that more is certainly not always better. He cites “Rule #13” from the novel “House of God”, written by Stephen Bergman, MD (under the pseudonym Samuel Shem) in 1979: “The delivery of medical care is to do as much nothing as possible,” a restatement of the dictum primum non nocere, first do no harm.

An interesting series of letters responding Gupta’s paper appeared under the heading “Taking steps to reduce medical errors” in the Times on August 4. One of them is from Bergman, who echoes Gupta’s concept that fear of malpractice suits (the “whining motor behind doctors’ ordering unnecessary, pricey tests,”) is the cause of many errors, and applauds interventions such as surgical time outs. However, another letter, from Niall O’Dowd, the uncle of Rory Staunton, the 12-year old boy who died after being treated for a “minor” scrape in the NYU Hospital emergency department (see Jim Dwyer, “An infection, unnoticed, turns unstoppable”, NY Times July 10, 2012 and many follow-up articles including a column by Maureen Dowd “The boy who wanted to fly”, 3 days later), points out that there are also dangers, as in his nephew’s case, from doing too little.

Mr. O’Dowd focuses, naturally, on the emergency department, which is where his nephew was treated, inadequately as it turns out. Emergency departments are seeing more and more patients, and are responsible for a very large and increasing number of admissions to hospitals, as detailed in a recent New England Journal of Medicine article by Schuur and Venkatesh, “The growing role of emergency departments in hospital admissions”.[3]  They identify a number of trends that tend to increase the use of the emergency room as a source of care, particularly for acute conditions. These include the lack of availability of acute-care appointments in primary care practices, and the lack of the high-tech instruments such as CT scanners that permit EDs to rapidly diagnose and admit – or rule out and then discharge – conditions such as heart attack and stroke.  They also include public education campaigns that urge people to go to the ED when they have symptoms that could be heart attack or stroke, and, of course, the fact that lack of insurance prevents people from accessing health care in most other settings (federal law requires EDs to assess anyone who presents there). While the fact that the increase in admissions from the ED may have something to do with their “lower threshold” (“…emergency physicians are trained to assume the worst and are more likely to admit patients with uncertain diagnoses and with whom they don't have an ongoing relationship, and that they are unwilling to discharge patients when they cannot guarantee outpatient follow-up,”) it is also possible that in their pressure to diagnose and admit the most sick, they could possibly undertreat some, like Rory Staunton, who do not appear to be so ill.

Mr. Staunton may have benefited from antibiotics he did not get. Other letter writers speak of both the dangers of underusing antibiotics and overusing them; however, the settings they describe (critical care units in the first case, treating viral syndromes in the second) are very different. Doing a lot is not necessarily wrong, or right. Doing little is not necessarily wrong, or right. Both can cause errors, and both can save lives. Yet a fifth letter writer suggests “our mission is clear: if it’s right for the patient, it’s the right thing to do.”

This is true as far as it goes; the difficulty is in ensuring what is right for the patient. But systems, checklists, timeouts, and consistent rules can go a long way to making this be the case. And if people with non-acute, non-emergent conditions can get in to see their doctors, and as important, have doctors and can have the health insurance that allows them to be seen, it would help even more.

This is something that we must not lose sight of; as Schiff, Bindman, Brennan et al note in a 1994 JAMA article, denial of care is the “gravest of all quality defects.”[4]

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[1] Leape L; Lawthers A, Brennan, T, et al. ,“Preventing Medical Injury”. Qual Rev Bull. 19(5):144–149, 1993.

[2] Leape L, Berwick D, “Five years after to err is human: what have we learned?” JAMA. 2005;293(19):2384-2390

[3] Schuur JD, Venkatesh AK, “The growing role of emergency departments in hospital admission”, NEJM 2Aug2012;367(5):391-3.

[4] Schiff G, Bindman A, Brennan T, et al., “A Better-Quality Alternative: A Single-Payer National Health System Reform”, JAMA. 1994;272(10):803-808.