Medical Errors: Accountability and Reform

In 2002, the General Assembly of the State of Connecticut, in an attempt to be responsive to increasing concerns regarding the quality of hospital-based health care, mandated that hospitals licensed in Connecticut develop performance improvement plans and report to the Department of Public Health, on a regular basis, all adverse medical events/outcomes that resulted in unexpected mortality or morbidity (P.A. 02-125). This was an attempt to cause focus, concern and moment-to-moment interest on a genuine public health problem: medical errors, a problem that had been minimized or excused for too long. The General Assembly’s initiative did not presume any listing of adverse events or errors would fix the problem. It was, effectively, nothing more than a very serious “call for action” on the part of the medical profession.

All understood the real answer to the problem of medical errors, the malpractice dilemma and the problem of the impaired medical professional is to focus once more on the creation and nurturing of a climate of excellence within the medical profession. Legislatures and regulatory agencies have a role to play in this effort by establishing the baseline, i.e., the minimum educational and performance standards for licensure. They also have the responsibility to establish reporting requirements to track performance and show trends, to create programs for the rehabilitation and monitoring of impaired professionals and to enact immunity provisions that encourage whistle blowing by colleagues when necessary. Ultimately, licensing boards have the responsibility of removing substandard providers from the practice of medicine. But even if scrupulously and attentively undertaken, these actions only ensure the minimum of adequate care.

American society demands much more than minimally adequate medical care. We support, pay for and expect the highest quality medical care. We grant limited monopolies on the practice of medicine to those who can meet minimum standards. We further grant to the medical profession the almost unique, and certainly special, right to police themselves through licensing boards composed of colleagues from their own professions. In return, we expect a rigorous, self-imposed standard of professional excellence.

The current crisis in the availability and cost of medical malpractice insurance in many states is an indicator something is not right in this balance between regulatory and professional standards. In an otherwise equal world, one would expect legislators’ primary concern would be for the continued availability of high-quality medical services to their constituents, and legislators would be responsive to doctors’ pleas for relief from the burden of high insurance costs and the debilitating effects of the constant threat of malpractice litigation. One would not expect to see insurance companies pulling out of the medical malpractice insurance business entirely when they have a guaranteed market in physicians, who must carry insurance in order to be licensed to practice, and, further, when those physicians have a monopoly on the provision of a critical service needed at some time in life by 100 percent of the American public. The current situation makes no sense from accepted political or business perspectives.

But there is a very strong backlash from angry patients and their attorneys that is preempting the political stage. Clearly, a significant (and very vocal) portion of the American public does not believe the medical profession deserves relief, and they are not willing to submit to medical care from these professionals without the safety net of open-ended malpractice coverage in the event something goes wrong. They are not willing to wait for the creeping pace of regulatory investigation and discipline to deal with what they perceive as a real and immediate threat. There is a real disconnect between the medical profession’s view of itself and the view held by the general public. Too many medical care consumers tell stories of oversights and errors, refusals to listen or to take their concerns seriously for the American public to trust that medical professionals can be left to themselves to ensure delivery of the highest quality health care. Submitting to medical care is an act of faith for most Americans, and that faith is being sorely tested by a system that, for too many people, does not seem to be, first and foremost, dedicated to medical excellence. Doctors have their side of the story to tell, but the public is not yet ready to listen to it.

The “system” must look inside itself for ways to reverse this image in the public’s mind. Quality medicine is the goal. This does not mean miracles or freedom from unexpected outcomes, but simply means attentive, educated and competent application of evidence-based, current knowledge and care. As we will discuss further, this is the responsibility of all parts of the system: the legislators who set minimum standards for licensure and who fund the regulatory agencies and tracking systems; the regulatory agencies who are responsible for enforcing standards and investigating complaints; the professional licensing and certifying boards that attest to competency, generically as well as in a specialty, and that may impose sanctions for violating minimal professional standards; and the practitioners and institutions that provide the medical care and educate future practitioners. Hospitals and doctors should be leading this effort, as they have the most to lose if it fails.

Health care is not always as straightforward as many would like to believe. It is a complex business dependent upon many variables, some of which are unknowable until it is too late. It is dependent upon the patient, a variable that sometimes includes the patient’s family, the patient’s age, pre-existing conditions, financial status (insurance and the like), cultural beliefs and ability to understand and/or comply with difficult or complicated instructions (e.g. , stop smoking and/or drinking). Health care outcome depends upon the illness, the timing and presentation of it and whether there is a cure or treatment for it. It relies heavily upon the diagnosis, judgment and treatment plan devised by a physician or health care provider.

Many patients envision health care in the industrial complex model, where all elements of manufacturing are completely controlled, resources are matched to need, workers are trained and available for a task and all systems work in harmony to produce a finished product. For many repetitive medical procedures, it often works that way — but only if the patients respond in the expected physiologic manner to their treatment. In reality, patients have allergies to medications, respond somewhat unpredictably to anesthetics, bleed and develop such complications as myocardial infarctions during the course of their care. In cases where a diagnosis is not clear, treatment is even more difficult and outcomes less predictable. Is this anyone’s fault? Adverse events will occur, and they will not always be someone’s fault. Our job as medical professionals is to limit the occurrence of adverse events to those that cannot be avoided.

The delivery of health care within hospitals is clearly a key issue in any system-based approach to correction of this problem. What is the legitimate role of the hospital in these circumstances? There is increasing recognition of what are termed “human factors” and “latent errors” in the delivery of care. Human factors recognize the fact that people will make mistakes. Latent errors, a term introduced by James Reason, are errors that are the result of poor planning or design (e.g., staffing, staff training and competence, equipment, policies and environmental factors).¹ They are system flaws that sooner or later will lead to an adverse event that could have been avoided. Human factors and latent errors speak to the need to have a framework designed around high risk areas to prevent poor outcomes. The Institute of Medicine (IOM) report, Crossing the Quality Chasm: A New Health System for the 21st Century, outlines a series of ideal hospital characteristics that are critical to developing this framework (Table 1).^2,3

These recommendations recognize it is the total care delivery system that must work, and that the patient, as well as providers, is a part of that system. Flaws in any one part of the system will have a dramatic impact upon patient outcomes. (For example, simple cleaning not done well can lead to an outbreak of methicillin-resistant staphylococci infection and, in turn, excess mortality).⁴

Such powerful groups as the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and Leapfrog are, step by step, forcing administrators to pay more attention to patient safety and medical outcomes. The JCAHO is achieving this through its seven national patient safety goals (Table 2) and the requirement to study high-risk areas through failure modes and effects analysis. Leapfrog is demanding minimum standards by demanding ICU staffing with intensivists, the presence of computerized physician order entry (CPOE) and performance of minimum numbers of procedures for high-risk, high-morbidity procedures. These are efforts to accelerate change and focus on patient safety and outcomes in a hospital environment that is bombarded by such other challenges as rising pharmaceutical costs, staffing shortages and declining reimbursements. Safety and outcomes must be equal priorities for hospital administrators and board members.

The reality is hospital systems across the United States are in different phases of evolution on the issue of patient safety. In some hospitals, systems like CPOE are already in place, while for other hospitals the expense of these systems seems exorbitant despite the fact that CPOE (which will integrate physician orders with a patient’s historical medical data, current laboratory values and drug use, and, thereby, can detect and prevent inappropriate medication orders) has the estimated potential to eliminate more than 50 percent of serious medical errors and decrease adverse events by almost 20 percent. Hospital reimbursement has been under attack for the past decade. Reductions in reimbursement have forced administrators to balance the need for new equipment, new technologies, sometimes-expensive new medications, staffing and the like. The problem, in part, is to ensure hospital administrators focus on what is really important and to prioritize investments first in patient safety and medical outcomes. Federal investment in information technology for hospitals to augment quality is absolutely critical.

Hospitals have a responsibility to ensure that the environment is as supportive as possible for patient care, staff are well trained and available during all shifts, that systems that enable care are available (CPOE, smart IV pumps, beds with alarms and fall protections, automated systems to draw up medications, etc.), policies are developed collaboratively and make sense for patients and providers and there are systems in place to monitor and measure the effectiveness of care. Hospitals also have a responsibility to ensure that health care providers are competent to treat and care for patients during their hospitalization.

What exactly is competency? For the most part, hospitals rely on proxies for competency. For example, the JCAHO requires age specific competencies for nursing. Loosely translated, this addresses the question of whether a nurse is capable of treating a specific age group — for instance, performing cardiopulmonary resuscitation or administering medications to a pediatric as compared to a geriatric patient. Increasingly, these competencies are assessed by hands-on training, simulators or computerized testing (which is what we do at the University of Connecticut Health Center’s hospital, the John Dempsey Hospital). We also rely on licensure. To be a part of our nursing or advanced practice staff, our therapy staff (radiology technicians, physical and respiratory therapists, medical technicians, dieticians, etc.), our social service or psychology staff, you must be licensed and maintain that license. The question is whether maintaining a license is enough. In some cases, there is a requirement for a minimum number of continuing education credits, but often no practical competency testing is required. The latter is typically judged variably by on-the-job reviews. Some supervisors provide excellent monitoring, feedback and instruction for continuous competency/improvement, while others do not. At John Dempsey Hospital, we mandate annual in-services (e.g., safety, infection control, cardiopulmonary resuscitation) and annual performance assessments requiring an evaluation of knowledge, skills and abilities. Even so, it is sometimes difficult to know if everyone is as competent as we might like. If anyone in the chain of providing care is slightly off, there may be no negative impact on care, but then again, there might be. Hence, redundant systems with multiple checkpoints are necessary to ensure safe care.

At John Dempsey Hospital, we are attacking four high-risk areas: medication errors, patient falls, nosocomial infections and pain management. By tackling these four areas, we anticipate a significant reduction in adverse events and better patient care quality. Our approach is to develop a focused, highly visible initiative embodied in a new center, the Collaborative Center for Clinical Care Improvement (CCCCI). CCCCI will marshal the talents of physicians, nurses, information management staff, management engineers, facilitators, researchers and an external advisory panel to focus on improving patient safety and medical outcomes.

To minimize medication errors, we are midway through the installation of an electronic medical record with physician order entry and rules-based algorithms. These rules, we expect, will prevent the majority of medication errors (i.e., dosing errors, drug-drug, drug-food allergy interactions), eliminate legibility errors, time date stamp all activities, enable tracking of compliance with evidence-based protocols and facilitate immediate system-wide communications. As importantly, performance improvement data will be gathered about providers to better train, coordinate and improve safety and care. These data will be incorporated into staff competency assessments.

We recognize that it is impossible to completely eliminate patient falls, particularly as we use fewer and fewer patient restraints. Our falls strategy is to minimize patient injury (high-risk screening tool for at risk patients, beds lower to the floor, floor pads, nightlights, bed alarms, hip pads, etc.). The solution to nosocomial infections is well known: attention to detail. This includes frequent 15-second hand washes, appropriate timing of perioperative antibiotics, use of appropriate antibiotics and appropriate cleaning agents, etc.⁶ We, with others, are developing Web-based tools to teach about the neurobiology of pain, the pharmacology of opioids and management of chronic pain in specialized populations of patients.

We support the JCAHO and IOM strategies and believe that over time they will lead to improved outcomes.^2,3 Hospitals need to embrace these concepts. IOM’s six aims are well thought out and should be universally adopted. They include the delivery of safe, effective, patient-centered, timely, efficient and equitable care.²

But hospitals are not exclusively responsible for the care and outcomes of patients treated within their walls. They are part of a system with many degrees of freedom and patient variables. Hospitals are responsible for assuring that the system and its providers have collaborated to create an environment to maximize patient outcomes. The nature of health care will evolve and so, too, will hospitals. Blame, however satisfying, will not solve America’s problems. A relentless pursuit of performance improvement and systems thinking is the solution.

Ultimately, quality medicine is the goal, but, as we have seen, statutory and regulatory systems have inherent limits. Uniformity of standards does well for most cases, but cannot predict or take into account outlying cases or differences in individual patient response to standard therapies. Databases are only as good as the questions asked, the responses received and the ability of those who manage them to draw reasonable conclusions from the data. Regulatory authorities, whether state agencies or licensing boards, are dependent upon adequate financing and staffing to be able to do their jobs. Hospitals can only do so much and are not, in our opinion, the core issue in the problem of medical errors/adverse events.

Physician education and the systematic routine monitoring and accountability associated with education through medical school, graduate medical education and, perhaps most important, the subsequent 35–40 years of each physician’s active career, also lies at the heart of the issue and certainly cannot be minimized or overlooked for significant performance improvement to occur and be maintained.⁵ Medical school curriculums deliver a rather standard and traditional educational product that is carefully monitored for educational consistency and adherence to agreed competencies by the Liaison Committee on Medical Education (LCME). Further, competency of potential graduates is tested by the National Board of Medical Examiners (NBME) and the Federation of Sate Medical Boards (FSMB) that now includes USMLE Step 2 CS, a test of clinical skills in addition to standard tests of cognitive biomedical knowledge.

Medical schools, for the most part, offer dedicated, bright men and women a comprehensive, dynamic and exciting body of biomedical knowledge and basic diagnostic skills; the combination of the two prepare most students well for more specialized and sophisticated training in graduate medical education (GME). Medical schools, certified by the LCME, are not the cause of medical errors or the erosion of public trust.

On the other hand, variability in GME could be a significant contributor. To be sure, the fund of knowledge required in any specialty can be assessed in standardized examinations. A small snapshot in time regarding problem-solving skills can also be determined via written or oral exams. Moreover, in the short-run, weaknesses in these areas can and will be corrected, presuming physician compliance, by electronic medical records, integrated mobile devices and electronic clinical decision support — all of which will facilitate speedy, accurate communication, allow standardization of care, increase efficiency, enhance patient safety and improve outcomes. They will allow evidence-based medicine (best practices) to literally be at one’s fingertips.

But, what does this say about skills ranging from a comprehensive, exact, patient-centered history and physical examination to such more threatening interventions as advanced cardiac life support (ACLS), advanced trauma life support (ATLS), central line placement, airway management and intubation, ventilator management, thoracentesis — let alone routine and advanced surgical procedures, interventional cardiology, interventional radiology and shock management? Is it enough to merely count the number of times an individual has performed an intervention to ensure skill and competency? Moreover, is the word or signature of the program director of any residency training program enough to ensure skill, as well as knowledge, in their graduates? That hospital staff credentialing offices accept such well intended but often not fully critical attestations from program directors or others when physicians apply for medical staff privileges, and specialty boards also accept them rather blindly without challenge or seeming concern, falls short of expectations given the increasing complexity of the diseases treated and the technologies used. Likewise, what determines such core attributes of medical professionalism as altruism, sense of duty, compassion, honesty and equanimity have not been replaced by cynicism, self-centeredness and even greed during three to 10 years of grueling training in GME?

While graduate medical education is a significant area of educational concern and accountability, the ongoing education, or lack thereof, throughout 35–40 plus years of most practicing physicians’ careers may be the major contributor to medical error and adverse events. Certainly the physician education during this time frame is highly variable. How is competence measured during that interval? Again, by written multiple choice, recertification examinations that most everyone passes and by renewal of licenses to practice that are, at best, associated with a yearly listing of CME participation where competency is often not assured. Competence is also measured by delineation of privileges in hospital departments that, for the most part, attest to past competence that is rarely challenged — and all this when the pathobiologic and bioethical complexity of the diseases we treat and the medical and surgical diagnostic and therapeutic tools we use are becoming increasingly complex. Moreover, medicine has protected itself and its members. Even today, when electronic tools allow end results reporting and individualized morbidity and mortality reporting with easy, case-adjusted quality analysis and comparison, the profession has shied away from such information, even when it could be used so well, departmentally and individually, as an educational tool. More tragically, established character disorders, mental illness and even dependency on alcohol and drugs are too often ignored, rather than confronted for the practitioner’s and the patient’s well being.

One possible answer: United States medical and osteopathic schools, working closely with the Association of American Medical Colleges (AAMC), the American Board of Medical Specialties (ABMS), American Medical Association (AMA), the Federation of State Medical Boards (FSMB), the American Hospital Association (AHA), the American Osteopathic Association (AOA) and the National Board of Medical Examiners (NBME) must take ownership of the entire educational continuum and be accountable for it. An educational system across the continuum that is focused on “continuous competency” must be developed. The multiple self-protective and self-perpetuating silos that currently exist are a serious impediment. One group must be responsible for integration of the parts into a cohesive whole.

Medical and osteopathic schools working collaboratively with specialty boards might develop and deliver the didactic knowledge content tests and the practicum, by which we mean the practical test of the skills required in a particular specialty. Tests would be rigorous and continually updated. They should be required every five years at a minimum and should be prepared for continuously, not episodically, through Web-based electronic educational offerings regarding the latest knowledge, the most current technical skills and case-based learning. Specifically, such preparation, therefore, would occur not only when necessary at the time of the examination, but on an ongoing basis. Failure to be re-licensed as a result of failure to master fair, evenhanded tests of clinical competence, including knowledge and skills, would ensure the public understands that the health care community took their concerns about medical errors and adverse events seriously. But, even more so, the threat of loss of license would cause all physicians to take their continuing medical education seriously. They might also take their mentoring and teaching responsibilities of students and residents, as well as hospital staff at all levels, who are their direct agents in the care of their patients, more seriously.

In short, rigorous competency-based re-licensure must become an imperative. This process must be specific for what a physician does and not only must one pass tailor-made examinations but personal practice performance data must be regularly examined. CME alone is not enough. Recertification in a specialty would then have some teeth and, more importantly, some credibility.

In conclusion, we must promote systems of conduct and operation in medical education and evaluation, and in health care delivery, that will self-correct as much as possible, thus minimizing the points at which outside intervention is necessary. Although many specific approaches are being developed, we must also change the personal climate as well as the physical climate. Hospitals should make it as comfortable for a nurse or other staff member to report questionable physician behavior as they do to report sexual harassment. All members of a treatment team should be regularly included in discussions of patients’ treatment programs; all opinions should be valued equally; and all should be held accountable for the behavior of every member of the team. Medical schools must emphasize and teach students the importance of patient safety, as well as patient autonomy, and include cases on reporting impaired colleagues in their medical ethics courses. Regulatory systems, specialty certifying and licensure boards should require real and substantive continuing medical education. They must further require a demonstration of skill and experience before allowing the unsupervised practice of complicated, high-risk procedures. Demonstration of continuous competency throughout the life of the physician’s practice must be the norm — and the profession must aggressively and swiftly deal with practitioners and institutions that fail to meet minimum professional standards. Certainly when all this is in place, and is working, malpractice reform would seem to follow quite naturally and easily.