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.

Bezos, Buffett, Dimon and Gawande: Better quality in health maybe; a solution, no

A big item of health news in recent weeks is the planned establishment of some sort of health delivery operation by three major corporations personified by their CEOs: Warren Buffett of Berkshire-Hathaway, Jeff Bezos of Amazon, and Jamie Dimon of JP Morgan. We have no details about what it will actually look like, but we are assured that it will be high-quality, efficient, and cost-effective, utilizing the most modern methods of achieving those goals, which our creaky, antiquated, and resistant-to-change health system does not. It will also be non-profit, important given that none of these companies are, but this is the most common model for health care in the US and in itself says very little. As the first concrete step toward its creation, and clue to what it may be, they have appointed Dr. Atul Gawande as its CEO. Presumably he will be instrumental in creating this new venture, and his views on quality and efficiency may provide guidance on what might characterize it.

Dr. Gawande, a Harvard surgeon and senior writer for the New Yorker, has provided us a prolific body of writing in that magazine and in several books, (including the best-seller about issues occurring at the end of life, “Being Mortal”), to help inform us of his views. He has a wide scope of interest in health care and a demonstrated willingness to learn from other industries. Perhaps his most famous article is “The Cost Conundrum”, which appeared in June 2009 and highlighted the wide variation on expenditures by Medicare for similar populations, focusing on the highest cost region, McAllen, TX, and comparing it to a similar population in El Paso, TX, where costs were much lower. Later, in January 2011 “The Hot Spotters” highlighted the work of Dr. Jeff Brenner in Camden, NJ, and others, to use modern geo-mapping techniques to identify the areas with the highest levels of emergency (911) utilization (unshockingly, in Camden, the two highest were a low-income senior citizens housing unit and a long-term care facility) and try to develop methods for addressing their health needs before they became emergencies. In “Big Med”, August 2012, he discusses application of some of the principles that work in restaurants such as the Cheesecake Factory to health care. The principles include enough variety to meet everyone’s needs without expensive unnecessary redundancy; he shows how this applies in orthopedic surgery and how quality is improved and costs saved when every surgeon in a hospital doesn’t use his (or, more rarely among orthopedists, her) favorite implant device and there is some standardization (commented on in this blog on August 24, 2012, Quality and price for everyone: Bigger may be better in some ways, but not all). A very good review of Gawande’s work and probable priorities has been done by the outstanding Dr. Don McCanne in his “Quote of the Day” on June 22, 2018 “Don’t wait for Atul Gawande”, and I will not repeat it here.

Of course, the employees of Berkshire-Hathaway, JP Morgan, and Amazon already have health insurance, so that this new scheme will not reduce the rate of uninsurance. It is possible that it – whatever “it” turns out to be – will allow enrollment from other employers, or possibly even individuals who are currently insured by another mechanism, whether through Medicare, the ACA-sponsored exchanges, or even Medicaid. This will depend in part on what “it” is – mostly an insurance plan, mostly a care delivery system, or a combination of both like many HMOs.

It is possible that this new operation may indeed succeed in achieving, or at least significantly moving toward, the “Triple Aim” of higher quality, greater patient satisfaction, and lower cost. Certainly the third of these is a major focus of businesses that provide health insurance to their workers, and we will grant these people the benefit of the doubt that they also wish to achieve the first two. Some HMOs have had significant success in doing so already, most notably Kaiser Permanente. Other HMOs that were once “consumer cooperatives” (eliminate the middleman and pay less for the same care or the same for more and better care) have almost all been bought by insurance companies, and it is obvious that the “save money” (or really “make more money”) leg of the #TripleAim is of far greater importance to their business model than patient satisfaction or quality. The bar, as has been demonstrated ad infinitum, including in the work of Dr. Gawande as well as other policy analysts from

academia, the foundation world, and journalism, is so low that large improvements in quality can come from things that it is we already know how to do. The major obstacle to this has always been how providers are paid, and this is where the behemoth strength of this new triumvirate may have significant impact.

Unfortunately, though, there is no suggestion that this new operation would do anything to help those currently either frozen out of the system (including poor people in states that have not expanded Medicaid, undocumented people, and those who cannot afford insurance premiums even with ACA support). The average salaries at JP Morgan and Berkshire-Hathaway are high since so many of the employees are high-level finance types, raising the mean and median. However, Amazon is a different story. Jeff Bezos may be the richest person in the world, he did not get there by paying his employees a living wage; the median income for an Amazon employee is $28,446. While they may have health insurance, it would not be surprising if many of Mr. Bezos’ employees qualify for food stamps, and have difficulty making their copays; that median salary is about the poverty level for a family of four, and if it is the median, many workers make less.

It could be argued that is unfair of me to criticize a program – especially one still in the planning stage -- for not achieving what it does not set out to achieve. However, there is nothing wrong – and indeed it is quite correct – to note that it is far from being a health care panacea. By not setting out to ensure access for everyone, it will not solve the basic problem in achieving the Triple Aim. I mean, it’s good to be focusing on quality, cost and patient satisfaction but without a plan to assure that everyone has access to care it can ring a little hollow.

As was observed by Schiff, Bindman, and Brennan more than 20 years ago, and quoted by me before (Medical errors: to err may be human, but we need systems to decrease them, August 10. 2012), denial of care – or lack of access to care for financial, geographic or other reasons -- is the “gravest of all quality defects”.