Medical errors: causes, cures, and capitalism.

• Author: Myers, Keith

He that will not apply new remedies must expect new evils.

--Benjamin Franklin

1. INTRODUCTION

   Expenditures for healthcare consumed over thirteen percent of the United States gross domestic product in 1998, totaling over $1.1 trillion dollars. (2) A recent Institute of Medicine (IOM) report estimated that the number of deaths attributable to medical errors in the U.S. was as high as 98,000. (3) This number represented hospital deaths only. (4) Undoubtedly, additional deaths and injuries occurred in the outpatient setting. (5) Whether the IOM estimate was exaggerated or not, the larger issue is whether the overall healthcare industry is operating at an acceptable error rate. (6) If the error rate is unacceptably high, then what should it be? (7) Are there legal impediments to detecting, reporting, analyzing, and improving error rates? (8)

   This article explores the causes of medical error, the medical profession's responses to errors, and how the legal system responds to medical error through litigation and legislation. Part II discusses the definition of "medical error," the frequency and pervasiveness of the problem, and the causes at the individual and system level. Part III considers how the culture of medicine has largely failed to address medical errors as a systems-based problem, and how the legal culture discourages admitting errors due to the threat of litigation. Focusing on systems, data must be collected and analyzed, and legal guidelines developed to encourage error reporting and develop standards, preferably at the state level. Part IV examines how both the legal and medical cultures might be reformed in order to reduce the rate of medical error, which would promote the ultimate goal of better quality healthcare. Legal barriers against error reporting need to be removed and liability theories re-evaluated, with appropriate legislation to foster these changes. Part V discusses the role of economic incentives which promoted the current state of affairs, and how these forces might effectively be employed to shape medical, legal, and legislative responses to medical error. It is clear that if medical error rates are unacceptably high, new approaches by doctors, lawyers, patients, and legislators are needed.

2. ERROR CLASSIFICATION

   1. What is Medical Error?

      A Jehovah's witness is given a blood products infusion to reduce her risk of bleeding. (9) A seven-year-old-boy dies after receiving the wrong medication from an unlabelled cup on an operating room tray. (10) In the first case, the patient is unharmed and unaware that her caregivers have violated her religion-based treatment refusal. (11) In the second case, a child is dead, and a family is devastated. (12) Are these medical errors? It seems intuitively clear that the second case is, but what about the first?

      The term "error" suggests an unintentional act or omission (13) By logical extension, the term "medical error" suggests an unintentional act that is related to the practice of medicine. (14) Patient death or injury is thus not required to meet this definition. Rather, it is sufficient that patient safety is inadvertently threatened, whether actual or potential, or that a patient's refusal for service is not obeyed. (15) Note that patient errors might also be included in this definition if, for example, a patient commits a mistake with medication that proper education could have prevented. (16)

      Excluded from this definition of medical error are willful, reckless, and intentional acts or omissions, because these are outside the scope of "inadvertent." (17) Even though a reckless act or omission may be unintentional, it falls so far outside of the realm of a reasonable standard of due care that it is not mere negligence. (18) Rather, recklessness implies an indifference equivalent to willful behavior. (19) Examples of such recklessness might include a surgeon who operates while intoxicated, or a doctor who treats a condition for which he is not trained despite the availability of referral for more appropriate care. (20) Res ipsa loquitor, however, is a policy-based legal doctrine which creates an inference of negligence (in many jurisdictions), and is reasonably viewed as within the definition of medical error. (21)

   2. The Scope of the Problem

      A recent report by the Institute of Medicine (IOM) estimated that between 44,000 and 98,000 patients die each year in the U.S. from medical errors. (22) The IOM arrived at this number by extrapolation from previous studies in New York, Utah and Colorado. (23) Other prior studies also showed a substantial risk of death from medical error. (24)

      The IOM report has been criticized for its methodological flaws, and for possibly overestimating the actual number of deaths caused by medical error. (25) Alternatively, the IOM report has been criticized for study design flaws that may have resulted in an underestimate of deaths. (26) Of note is that the IOM report's number of deaths estimate was derived solely from data on hospitalized patients. (27) Certainly, outpatients also die from medical error, though the number of deaths is uncertain. (28)

      Adverse events and outcomes occur in the absence of medical error, and it may be important to make methodological or semantic distinctions between adverse events and medical errors. (29) Regardless of these technical concerns and of the criticism of the IOM report, medical errors do occur at some rate. The major premise of this discussion is that this rate is too high. (30) Further, there is a subgroup of errors causing patient harm which is preventable. (31) For example, in the Utah and Colorado study the cost of preventable adverse events was nearly half of the total costs attributable to adverse events. (32) The physician's credo primum non nocerum ("first do no harm"), thus suggests that it is incumbent upon medical doctors to lead the effort to reduce medical errors. (33)

   3. Errors Occur at the Level of the Individual

      If medical error creates potential harm to a patient, when does it occur during the delivery of healthcare? The answer is that it can occur at any stage of medical care. (34) Despite the complexity of healthcare as a "system," actual delivery of care operates at the individual level. (35) Thus, the common denominator for all healthcare is a one-on-one interaction between a provider and a patient. (36) It is this interpersonal dynamic which exposes or creates error potential at various stages, such as examination, testing, diagnostic theorizing, or treatment, to name a few. (37) Since healthcare is delivered at the human level, medical errors are ultimately attributable to a person and not to an institution or system. (38) This fact does not mean that legal liability for errors rests solely at the individual level, for clearly organizations and hospitals may be found liable for medical errors. (39)

      If the endpoint or baseline source for all medical error is at the provider-patient level, then what can be done about it? Both sides of the care delivery equation, patients and providers, want to reduce medical error rates to the lowest feasible level. (40) A reduction in medical error rates would be cost-effective through more efficient resource allocation, and the quality of care would improve. (41) However, there are undoubtedly members of the plaintiff bar who fear economic harm if medical error rates are substantially reduced. (42) This latter group has an incentive to maintain the status quo, or to allow error rates to increase, in order to flourish. (43) Therefore, it is not so straightforward to claim that reducing errors is a universal goal.

   4. System Errors

      Although errors are committed by individuals and affect only one patient at a time, the provider-patient interaction does not occur in a vacuum. (44) This interaction is influenced by the environment, an external force which increases or decreases the chance for inevitable human error. (45) This outside force, in the context of a medical errors discussion, is labeled a system. (46) A system may be defined as, "a complex unity formed of many often diverse parts subject to a common plan or serving a common purpose." (47) Alternatively, a system is defined as "an organized or established procedure or method or the set of materials or appliances used to carry it out." (48)

      A healthcare system may thus be viewed as an environmental force which is complex, establishes procedures and methods, and serves a common purpose. Because this force exerts an influence on the patient-provider encounter, it is necessary to examine whether the healthcare system promotes or can prevent medical errors. (49) One caveat is required: Systems exist in many forms and sizes. (50) In the medical context, for example, a system may be a single doctor's office, an operating room, or a large network of hospitals. (51)

      Regardless of the size or complexity of a system, research has consistently shown human error can be accounted for, measured, and reduced through proper organization and methodology. (52) Medical systems are often compared with other industries, particularly aviation and nuclear energy. (53) Research shows systems in these other industries, through proper design and monitoring, share the potential to reduce the likelihood of mishap caused by human error. (54) For example, aircraft manufacturers assume human error will occur, so the planes are designed with automatic and redundant features that effectively buffer or absorb pilot error. (55)

      Individual and system errors may be distinguished by labeling them as "active" and "latent," respectively. (56) Active errors occur at the individual operator level, and usually have more immediate effects. (57) Latent errors are system-based potential errors: Potential meaning that they trigger or promote error. (58) Latent errors are removed from individual control, and because they are unrecognized in a complex system, pose a greater threat to safety. (59) A latent...