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1. For full disclosure, I am the friend who Paul quotes toward the end of his blog. Allow me to offer a, hopefully, balanced and respectful perspective to this discussion as the father of a two-time leukemia survivor and as one who worked in healthcare for over thirty years. For your information, my background is in industrial engineering, operations research and IT and I apologize upfront for any resulting biases that may cloud my thinking. I am humbly reminded by Dr. William Osler comment that “No human being is constituted to know the truth, the whole truth, and nothing but the truth; and even the best of men must be content with fragments, with partial glimpses, never the full fruition”.

   First, thanks to incredibly smart, competent and, above all, kind and compassionate physicians and terrific nurses, our daughter is now a thriving and healthy 21 year old senior at a top university in the US. My family and I will forever be grateful to this wonderful team. Over the years, I also had to privilege of working with physicians who are internationally recognized leaders in their specialty. Through them, I learned a great deal about the wonderful things they do and the challenges they face in caring for patients, teaching medical students and conducting research.

   Second, I recognize that EHRs have failed to deliver on their promise for a variety of reasons and I have met many a physician and nurse rightfully lamenting these cumbersome and user-unfriendly tools.

   Third, I also recognize that the healthcare industry as a whole is changing rapidly and dramatically. It has now reached a state that the military would classify as volatile, uncertain, complex and ambiguous. The impact of this turbulence is without a doubt extremely challenging for healthcare administrators and physicians alike. In addition to the shift from volume to value with all its consequences, the rise of savvy, critical and vocal health service consumers has a major impact on how well healthcare organizations and physicians are being perceived and judged.

   No doubt the role of physicians is especially undergoing dramatic changes in this brave new world. Many may experience a sense of loss of control and authority. Free access to good medical information is readily available on the Internet. In addition, many physicians are now employees in a large group practice or health system, where financial, quality, safety and patient satisfaction greatly influence the way they are expected to care for patients. The result is that many feel constrained and second-guessed while caring for patients. I do get that and empathize with them. Having been on the “cancer coaster” twice, I know from experience that having to undergo rapid and dramatic change in your life, especially a change that requires you to become utterly dependent on others, is anything but easy and pleasant.

   Fourth, we will never reach the ideal of zero errors. I fully agree with Dr. Samuels on this one. After all, not all patients are easy to diagnose or treat as many illness share symptoms with other diseases or abnormalities. Many patients also suffer multiple co-morbidities, further complicating matters. It takes a great deal of skill, knowledge and experience to arrive at the right diagnosis and counter-measures. With so many variables at play, it can be very easy to overlook something. It took top experts two days to determine that our daughter’s leukemia had returned.

   Finally, I think it is fair to agree that we still lack a meaningful and agreed to set of quality and safety measurements that can be used to measure the performance of individual physicians. Ironically, it is currently far easier to measure and judge the performance of healthcare administrators based on the degree to which financial performance, physician and staff morale, quality, safety and patient satisfaction of the organization they lead are satisfactory and/or improving steadily. We are just not there yet.

   Now, on the flip side, I believe the following comments are in order. First, it is counterproductive and unfair to label those who do not actively treat patients as ignorati or greedy, heartless and insensitive bureaucrats. Physicians do not have a monopoly on diagnosing and solving complex problems or making life or death decisions. Healthcare administrators and many others in healthcare have to diagnose and solve complex organizational problems each and every day, while also ensuring that the mission of their organization is secured for the future in a volatile, uncertain, complex and ambiguous environment. Airline pilots, military commanders and many others work in fields where lack of proper leadership, experience and attention to details can quickly harm many people. Furthermore, many other professions and jobs require individuals to diagnose and solve complex problems on a daily basis, including lawyers, accountants, engineers, nurses, etc. There are, of course, differences in scope and magnitude but you don’t have to actively see patients to know how hard this can be.

   Second, the use of Lean and standards are misunderstood by many and quickly derided as cookbook medicine imposed by “bureaucrats”. There is also the popular misconception that standards stifle innovation and the art part of medicine. Nothing could be further from the truth. For starters, standards should first and foremost be developed by the very people who use them, e.g., physicians and other members of the clinical team. They should never be developed and imposed by management or any other “outsider”. Otherwise, they would be meaningless and quickly ignored by all.

   In addition, standards should reflect evidence-based clinical best practices as established through the scientific method and should regularly be reviewed to determine whether they are still relevant or whether better alternatives should be considered. If pursued well, Lean actually encourages constant innovation and improving evidence-based standards!
   Last but not least, standards are not only supposed to reflect evidence-based best practices but should also be used to make problems visible, such as deviations from the standard. If it turns out that physicians have to deviate from the standard for certain patients on a regular basis, then may be that standard is not effective and new ones may need to be developed for those cases. Standards should not be used rigidly because every patient is different and a current standard may not apply to some. By knowing what an agreed upon standard is, physicians and other members of the clinical team can identify problems and deviations and subsequently improve outcomes, quality and safety.

   Coming back to our discussion about errors, the fact is that some errors simply cannot be avoided due to the complexity of individual patients. But many errors are not caused by the poor judgment of a single physician but rather by lack of respect toward fellow clinical team members, poor teamwork and poor guidelines. There are is now ample evidence that a culture of mutual respect, teamwork and continuous improvement can lead to better patient experiences, outcomes, quality, safety and morale of physicians and staff.

   Physicians might find greater peace of mind about their day-to-day interactions with patients and more joy in their work if they know that they are part of and supported by a team, in addition to well-defined processes, in the care of patients. After all, preventing, reducing or eliminating the suffering of fellow human beings is what healthcare and medicine should be all about. I know because I watched my daughter and many others fight for their lives and endure their grueling treatment with grace and the grit and determination of a Navy SEAL.

2. I do agree with this statement in the post: “We all try to avoid errors but none of us will succeed.” That is all too true. Patients need to understand that fact too. We all need to work together to minimize errors that hurt, maim and kill.
   __

   David Marx — “Just Culture”

   http://regionalextensioncenter.blogspot.com/2014/06/continuing-on-three-legged-stool-riff.html

3. Being a physician is an awesome responsibility and great gift. The relentless focus of that professional should be on the health and well-being of her patients—first, last and always. It is shocking to read the recent post by Samuels, a physician leader who apparently doesn’t get that basic point.

   I only wish that “[t]he current medical culture is obsessed with perfect replication and avoidance of error.”

   If only.

   I do agree with this statement in the post: “We all try to avoid errors but none of us will succeed.” That is all too true. Patients need to understand that fact too. We all need to work together to minimize errors that hurt, maim and kill.

   It’s the rest of that passage that is troubling: “This is fortunate as errors are the only road to progress. Focusing on the evil of errors takes our attention away from the real enemy, which is illness.”

   The problem of course is that these “fortunate errors” almost always have devastating impact on real people—patients who are relying on health professionals including physicians to provide the best possible care. Physician and care system errors happen every single day, and while we do want health professionals and patients to see the mistakes and learn from them—those errors are never “fortunate”.

   The reality is that the healing focus should always be on patients and their families. Their health and well-being is the goal. Illness is something that we address together with patients—it is not and should not be the focus—helping people return to a state of health is the focus. We need to do that great work with them humbly and safely.

   While we’re talking meme’s, here’s one:

   Doctors are human not gods, and humans make mistakes.

   We should be using every venue possible, including medical education, to create a culture of safety in which health professionals from the very beginning of their careers onward work relentlessly and transparently with patients and their families to keep patients as safe as possible from the human errors that will be happening around them while they’re receiving care.

4. Dr. Hadler, I am not talking about “nuts and bolts.” I am talking about preventable harm that is caused to patients. I am not talking about judgment calls where MDs used the best of their knowledge and experience and nonetheless had bad outcomes. I am talking about the manner in which work is organized in many hospitals that permits errors to occur in the normal course of care–medication errors, unwarranted infections, high rates of ventilator associated pneumonia–to mention a few. Several places in the world have been able to apply the scientific method in designing experiments and developing approaches to reduce the incidence of such harm. The most successful places have done so not because the government or some administrator or some insurance company wanted them to. They’ve done so led by practicing clinicians who saw the problem and then acted on it in a sensible and sustainable fashion.

   It is so “gracious” of you to say: “But I do not fault Mr. Levy.” But you don’t know me, and you don’t know what was accomplished by the clinical staff (not me) during my years at BIDMC. Instead, you say, “As is the case for most hospital administrators, and the minions they hire and pay as consultants, they burden the “six sigma” rallying cry in facing the regulatory avalanche in the wake of “To Err is Human.” No, that’s not what happened at our hospital and many others. Our improvement in patient outcomes (yes, reduction of harm) originated in our chief of medicine, Mark Zeidel, and other clinical leaders because they decided on their own that doing better was possible–even for world class doctors–by being more systematic in which the way work was organized on our floors and ICUs. My job as CEO was to support them in ways they felt to be most helpful–not to impose bureaucratic strictures on them. It was a good partnership.

   Martin, you are your own worst enemy when you say things like this: “I find it extraordinary that bureaucrats, administrators and doctors who no longer see any patients can feel so strongly about what it is like to actually be on the front lines. These pundits are all so worried about patients, but virtually none of them ACTUALLY SEE patients. Extraordinary chutzpah!” You obviously have chosen your words with care, but they are careless. You imply that people who do not see patients day to day have no right to be interested, to have suggestions, and to advise on process improvement. Further, in so doing, you suggest that they have no expertise that might be brought to bear on the issues. All of that is pure tripe, and you bring no credit to your points by relying on such generalizations.

   And, I don’t ski. I play soccer.

5. 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. Mr. Levy doesn’t get the point. Mr. Levy is talking about nuts-and-bolts; Dr Samuels is talking about the challenges of doing well by our patients.

   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.” 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.

   But I do not fault Mr. Levy. As is the case for most hospital administrators, and the minions they hire and pay as consultants, they burden the “six sigma” rallying cry in facing the regulatory avalanche in the wake of “To Err is Human.” In a report a year later 3, 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 $1 billion 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 many 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.4 By 2013, we were learning that preventable medical errors had climbed to the #3 cause of preventable deaths in America.5 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 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.6 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. 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. 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.

   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.

   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 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
   5 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.
   6 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.
   7 Leape L. The checklist conundrum. New England Journal of Medicine 2014; 370:1063-4.

6. As an Internist/hospitalist/intensivist I know well the errors, uncertainties and self doubts that come with patient care. I also know ways to reduce those doubts. One example is by complying with best practices. Two weeks ago I followed up on one of my patients who’d been transfered post-arrest to our MICU. I watched my senior colleague insert a RIJ CVC without ultrasound and without a sterile gown on himself or a sterile sheet on the patient! (Yes, I’ve since dealt with that problem.) But here we are, 15 years or so after the landmark IOM publication and many years after the CVC bundle was published and entrenched in ICU practise and still my colleague thought that those rules, those evidence-based best-practice standards, didn’t apply to him. I believe that this is an example of the avoidable harm that Paul is refering to and my colleagues’ attitude is the one that Paul is alluding to. Anyone can do that from anywhere so far as I’m concerned.

7. Seriously, I have been seeing patients all morning, while Paul apparently was skiing somewhere, as judged from his picture. I am not sure that I was able to get any of the diagnoses correct today and I live in constant doubt about my abilities and whether I can actually help people. I find it extraordinary that bureaucrats, administrators and doctors who no longer see any patients can feel so strongly about what it is like to actually be on the front lines. I really do try to do the best I can but I make multiple errors every day and those are only the ones I recognize. I fear that this is only the tip of the iceberg as there are all those others of which I am completely unaware. These pundits are all so worried about patients, but virtually none of them ACTUALLY SEE patients. Extraordinary chutzpah!

8. In the realm of diagnosis, that is my realm, an error has often implied a 100 % sensitivity and a 100 % specificity. This is aspirational.