In a recent post, the renowned neurologist, Martin Samuels, paid homage to the degree to which uncertainties create more than just anxious clinicians, they can lead to clinical errors. That post was followed by another by Paul Levy, a former CEO of a Boston hospital, arguing that the errors can be diminished and the anxieties assuaged if institutions adhered to an efficient, salutary systems approach. Both Dr. Samuels and Mr. Levy anchor their perspective in the 1999 report of Institute of Medicine Report, “To Err is Human”, which purported to expose an alarming frequency of fatal iatrogenic errors. However, Dr. Samuels reads the Report as a documentation of the price we pay for imperfect knowledge; Mr. Levy as the price we pay for an imperfect organization of health care delivery. These two posts engendered numerous comments and several subsequent posts unfurling one banner or the other.
I crossed paths with Dr Samuels a long time ago when we were both speakers at a CME course held by the American Geriatrics Society and the American College of Physicians. I still remember his talk for its content and for its clinical perspective. His post on THCB is similarly worthy for championing the role of the physician in confronting the challenge of doing well by one patient at a time. Mr. Levy and his fellow travelers are convinced they can create settings and algorithms that compensate for the idiosyncrasies of clinical care. I will argue that there is nobility in Dr. Samuels’ quest for clinical excellence. I will further argue that Mr Levy is misled by systems theories that are more appropriate for rendering manufacturing industries profitable than for rendering patient care effective.
Errors in process, obvious errors such as giving the wrong dose or leaving a sponge in the abdomen, all of which are incontrovertibly errors, are not the preponderance of preventable medical errors in general and preventable fatal medical errors in particular. Most of the fatal errors that led to the horrifying statistics that elicits national outrage were judgment calls, defined as errors either by peers reviewing medical records or by virtue of the voluntary reporting of errors by doctors and hospitals. Not long after the National Academies published “To Err is Human. Building a safer health system”, a study from the US Veteran’s Administration demonstrated that the preventability of hospital deaths due to medical errors was very much “in the eye of the reviewer.”[1] A panel of 14 board-certified, trained internists undertook multiple structured reviews of the records of 111 hospital deaths, accumulating 383 reviews. They were measuring whether the deaths were “preventable by better care.” About a quarter of the deaths were rated as possibly preventable by optimal care. However, a tiny minority would have left the hospital alive had optimal care been provided. The reviewing clinicians estimated that only 0.5% of patients who died would have lived 3 months or more in good cognitive health if care had been optimal representing 1 patient in 10,000 admissions to the study hospitals. In-hospital deaths are largely the fate of very ill patients suffering from diseases in terminal phases, or suffering from multiple confounding conditions simultaneously, or the frail elderly. Many of these patients die in intensive care units where much is happening to them quickly, often under the pall of desperation, and where errors are usually apparent in retrospect rather than in the heat of the moment.
The American way in dying in hospital demands a national discourse. This is the setting where most “errors” occur, errors of commission in the desperate attempt to “save” the lives of the elderly, the frail, and the terminally ill. The message that merits wide debate is whether this is an appropriate way to die in America. My colleagues estimate that at least 40% of the patients in our many intensive care unit beds at any given time have terminal illnesses. The best we can do with “optimal care” is to prolong their dying. The other 60% may benefit from all the hustle, bustle and hassle of intensivist medicine, perhaps in part because their biology is more forgiving of occasional “suboptimal” care that eludes the checklists and other systems safeguards.
America has made a tremendous investment in intensive care units. We have many times the ICU beds per capita as any other resource advantaged country, 25 per 100,000 people as compared to 5 per 100,000 in the United Kingdom. Not surprisingly, when we build them we also build the demand, so-called demand elasticity.[2] The indications for admission in America result in a very different case-mix than anywhere else. We need ICU beds for patients with acute or potentially reversible conditions, but do we need them for the frail elderly or the terminally ill? Maybe the error is not so much in their medical treatments as in the lack of appreciation of their humanity.
The specter of avoidable complications, including avoidable deaths, has permeated notions of health care reform for 25 years. Blame has been spread thickly and widely under the rubric “human error”. Solutions have come in a torrent of regulations aimed at improving human performance. Some have proved ineffective if not counterproductive, such as restricting trainee hours which has fragmented care and toned down intellectual rigor. In the torrent of regulations are attempts to supplant human performance with computerized algorithms – with consequences that were intended and unintended. The emphasis on the “error” in human error is readily defensible even though the notion that “error” is an epidemic is indefensible. Even more indefensible is the fashion in which emphasizing “error” has come to deemphasize the “human” of human error.
THE ERRORS INHERENT IN SYSTEMS AND PROTOCOL SOLUTIONS
Most hospital administrators, thanks largely to the minions they hire and pay as consultants, burden and brandish Lean, six sigma, and similar rallying cries in facing the regulatory avalanche in the wake of “To Err is Human.” In a report a year later[1], the same Committee detailed the changes in the system of health care that were necessary to effect a 50% reduction in these errors within 5 years. The report called for Congress to establish a Health Care Quality Innovation Fund of some $1billion to “produce a public-domain portfolio of programs, tools, and technologies…and to help communicate the need for rapid and significant change throughout the health system.” This funding had to wait for the “stimulus” legislation of the early days of the Obama administration. But lesser projects were funded by many. Despite a decade of these efforts, the Office of Inspector General for the Department of Health and Human Services said in 2010 that adverse events contributed to the deaths of 180,000 Medicare insured patients the previous year and 10-times as many suffered from a non-fatal adverse event.[2] By 2013, we were learning that preventable medical errors had climbed to the #3 cause of preventable deaths in America.[3] Something is very rotten in…our hospitals or in our calculations or both. But the press, the public, some policy wonks and some researchers were convinced only of the former. This is a dialectic that precludes alternative explanations, including explanations that could promote patient safety.
Hence, the “quality” zealots hold sway to this day. But maybe they continue to miss the forest for the blighted trees. First off, let’s examine their definitions of avoidable errors more carefully. Some errors are clearly a reflection of the system of care gone awry: operating on the wrong patient or the wrong knee, forgetting to remove surgical instruments from the abdomen, switching blood samples, administering medicines to the wrong patient, faulty equipment, and many more errors of this nature should be avoidable by improving the delivery system. In fact, thanks to the efforts of many in health policy and patient advocacy, great progress has been made. There are checklists in the operating room, redundant labeling systems, and much more that should have greatly reduced the possibility of human errors of this nature with technological solutions. But progress has been slow. Between 2005 and 2011, the adverse-event rates in American hospitals did not decline for surgical patients or patients with pneumonia, only for patients with cardiac conditions.[1] More specifically, the implementation of surgical safety checklists into the hospitals of Ontario, Canada was not associated with a reduction in operative mortality or complications.[2] Lucian Leape is one of the most influential of those advocating for improving the quality of care and a principal voice in the National Academy’s “To Err is Human” polemic for a “systems” approach. He is inclined to dismiss these disappointing observations on the basis that they did not exclude the possibility of various forms of non-compliance.[3] Perhaps he’s correct. However, adjusting for the magnitude of the procedures and for the severity of the illnesses of the patients, operative mortality and 30-day post-operative mortality in acute care hospitals was less than 1% with or without a checklist. Furthermore, all surgical complications, fatal or non-fatal, afflicted less than 4%. These numbers are not trivial, nor are they alarming as they are likely to reflect the degree of desperation that drove the decision to operate in the first place. Routine procedures in well patients, such as hernia repairs or breast biopsies, do not carry anywhere near this risk.
IN PRAISE OF THE VARIABILITY OF HUMANITY
So, I suggest all embroiled in this debate return to Dr. Samuel’s essay. All of us who strive to be trustworthy at the bedside share Dr. Samuel’s uncertainties, anxieties, and drive to provide the best care we can. For the sake of our patients, we need the collegiality that promotes peer review and that is the essence of continuing medical education (https://www.youtube.com/watch?v=iknU6XpYG5Q#t=363 ). I only wish the ever growing corps of hospital administrators realized as much. It’s what W. Edwards Deming called “profound knowledge”, which is as important to his legacy [1] as his pioneering insights regarding the relationship of quality to productivity in industrial systems.
[1] http://asqhdandl.org/uploads/3/3/3/8/3338526/leadership_and_profound_knowledge_final_b_opt.pdf
[1] Hayward RA, Hofer TP. Estimating hospital deaths due to medical errors. Journal of the American Medical Association 2001; 286:415-20.
[2] Gooch RA, Kahn JM. ICU bed supply, utilization, and health care spending. An example of demand elasticity. Journal of the American Medical Association 2014; 311:567-8.
[3] National Research Council. Crossing the Quality Chasm: A new health system for the 21st Century. National Academies Press, 2001.
[4] https://oig.hhs.gov/oei/reports/oei-06-09-00090.pdf
[5] James, JT A New, Evidence-based Estimate of Patient Harms Associated with Hospital Care. Journal of Patient Safety 2013; 9: 122–8 doi: 10.1097/PTS.0b013e3182948a69
[6] Wang Y, Eldridge N, Metersky ML, et al. National trends in patient safety for four common conditions, 2005-2011. New England Journal of Medicine. 2014; 370:341-51.
[7] Urbach DR. Govindarajan A, Saskin R, Wilton AS, Baxter NN. Introduction of surgical safety checklists in Ontario, Canada. New England Journal of Medicine 2014; 370:1029-38.
[8] Leape L. The checklist conundrum. New England Journal of Medicine 2014; 370:1063-4.
[9] http://asqhdandl.org/uploads/3/3/3/8/3338526/leadership_and_profound_knowledge_final_b_opt.pdf
Nortin M. Hadler, MD is a graduate of Yale College and Harvard Medical School. He joined the faculty of the University of North Carolina in 1973 and has been a professor of medicine and microbioogy/immunology since 1985. His assaults on medicalization and overtreatment appear in many editorials and commentaries and 5 recent monographs: The Last Well Person (MQUP 2004) and UNC Press’ Worried Sick (2008), Stabbed in the Back(2009), Rethinking Aging (2011) and Citizen Patient (2013).
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