Blockchain Papers

Tina Yi Jin Hsieh, Carl Eriksson, Garth Meckler, Matthew Hansen · 12 authors

Introduction and Objective: Traditional adverse safety events (ASE) identification relies on domain experts to manually review and annotate charts, which hinders the scalability of processing high-volume EMS data. This study explores the use of large language model (LLM) with a knowledge base to automate extraction of adverse safety events (ASE) from unstructured emergency medical service (EMS) notes for pediatric out-of-hospital cardiac arrest (OHCA) as proof of concept. Data Sources and Study Design: Pediatric OHCA records from a national EMS provider were obtained from 2017 to 2020. Leveraging the Pediatric Prehospital Adverse Safety Event Detection System (PEDS) as a foundational knowledge base, we used the LinkML framework to develop an ontology to define ASEs across six essential EMS care domains. To convert unstructured EMS narratives into structured prompts, we used the Structured Prompt Interrogation and Recursive Extraction of Semantics (SPIRES) method, which generated schema-driven prompts to guide the GPT-3.5 model in identifying ASEs. By mapping unstructured data into structured concepts consistent with PEDS guidelines, the model produced targeted prompts that supported effective entity extraction. Results: We evaluated framework effectiveness with accuracy, recall, precision, F1 score, and specificity across 42 pediatric OHCA cases covering ASE-related entities. RescueGPT showed high accuracy in detecting common ASEs (Patient Rhythm, Age, Weight, Length) but revealed challenges in rare events (Failure to Establish IV Access, Incorrect Airway Equipment Size, Failure to Ventilate Patient) likely due to more inconsistent and complex documentation. Conclusions: RescueGPT demonstrates potential in scaling automated ASE detection, but performance varies by completeness and clarity of EMS narrative, particularly with rare events. Fragmented clinical documentation limits accuracy and highlights the need for standardized collection protocols in EMS systems. Future directions will focus on implementing rebalancing strategies for rare events, applying explainability methods to improve decision-making transparency, and refining text segmentation techniques to handle mixed outcomes to further improve performance.

Adugna Negussie, Abay Sisay, Agumas Shibabaw, Edosa Kebede · 9 authors

Abstract Background Medical laboratory professionals play vital role in healthcare. The growing demand for quality laboratory services and emerging technologies underscore the crucial need for Continuing Professional Development (CPD). However, there is limited information on CPD programs in Ethiopia. Thus, this study aimed to assess medical laboratory professionals’ perceptions, attitudes, and challenges towards CPD and improve engagement to enhance diagnostic service quality. Methods this cross-sectional study enrolled 228 medical laboratory professionals in Ethiopia from July to October 2023. Using a mixed-methods approach that combined quantitative data from an online survey and qualitative data from interviews. SPSS version 28 was used for data analysis. Results the average age of the study participants was 32.6 ±6.4 (SD) years, the majority were men (88.6%), and 44.3% have worked for more than ten years. Of the participants, 51% never had CPD training. About three-fourth of the participants perceived CPD as essential to their professional career. About 45.2% of the study participants perceived that the purpose of CPD course is to renew their license and gain knowledge and skills that are not covered in basic training. While the majority of participants had good attitudes towards CPD, about 10% of them stated that it is not important in their career growth. The majority of the study participants were not in support of the decentralized CPD system. A notable problem with finance, insufficient manpower, unsupportive employers, a lack of awareness by regulatory bodies, inadequate access to training close to their working area, were identified as significant challenges of the CPD program. Conclusion the study highlights the perception that CPD is crucial for enhanced laboratory practices and career advancement. The study highlights the need for targeted strategies to address the identified problems and increase the engagement of medical laboratory professionals in the CPD program.

Madison Milne‐Ives, Ching Lam, Najib Rehman, Raja Sharif · 5 authors

BACKGROUND: Adverse drug event reporting is critical for ensuring patient safety; however, numbers of reports have been declining. There is a need for a more user-friendly reporting system and for a means of verifying reports that have been filed. OBJECTIVE: This project has 2 main objectives: (1) to identify the perceived benefits and barriers in the current reporting of adverse events by patients and health care providers and (2) to develop a distributed ledger infrastructure and user interface to collect and collate adverse event reports to create a comprehensive and interoperable database. METHODS: A review of the literature will be conducted to identify the strengths and limitations of the current UK adverse event reporting system (the Yellow Card System). If insufficient information is found in this review, a survey will be created to collect data from system users. The results of these investigations will be incorporated into the development of a mobile and web app for adverse event reporting. A digital infrastructure will be built using distributed ledger technology to provide a means of linking reports with existing pharmaceutical tracking systems. RESULTS: The key outputs of this project will be the development of a digital infrastructure, including a backend distributed ledger system and an app-based user interface. CONCLUSIONS: This infrastructure is expected to improve the accuracy and efficiency of adverse event reporting systems by enabling the monitoring of specific medicines or medical devices over their life course while protecting patients' personal health data. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/28616.

Khaled Al–Surimi

We are pleased to publish the second issue of the Global Journal on Quality and Safety in Healthcare (JQSH). In this issue, we would like to discuss the similarities and differences between research and quality improvement (QI) projects in health care. Imagine you are working in a hospital or a department within a hospital and you want to improve an aspect of health-care quality and safety by focusing on the issue of medication errors. Given that situation, you decide to implement a “zero harm” rule because of medication errors. The question is will this be a QI or a research project? In another example, you are a resident working in an oncology department and you noticed that most patients receiving certain chemotherapeutic agents had neuropathy complications, so you decided to collaborate with the physical therapist on a project to compare patients who received chemotherapy drugs and exercise with those who did not exercise. Again, the question is will this be a research project or a QI project? Regardless of the answer, it is important to implement the project systematically. If your project is focused on QI, then you should consult the QI specialists in your hospital who can help you to use the appropriate QI methodology, which includes Plan, Do, Study, Act (PDSA) cycles. If your project qualifies as research, then you should consult a research methodologist and biostatistician regarding study design, sample size, and others and work with the institutional review board (IRB) to provide guidance and templates.Many health professionals do not know how a research project differs from a QI project and when they complement each other.[1–3] Our traditional thinking is that quality and safety improvement in health care as well as the effectiveness of an intervention can only be studied in the form of a traditional scientific research project, as it has its own well-established rigorous approach. We may be ignorant or unaware of how to use the QI scientific approach to study the performance of a health-care system.[4,5] The problem lies within our frame of thinking because we are prioritizing the proof of effectiveness over bringing about and sustaining improvement. We use the results of pre-assessment and post-assessment research as the gold standard for evidence-based policy and practice, whereas in reality, sustaining the improvement is continuous and more dynamic.[1,6]Research projects are question-driven and focus on providing proof of effectiveness. The main purpose of research is to generate new generalizable knowledge about a particular subject to a study population, where the study results often end up published in academic journals. In this case, researchers must follow a strict study protocol approved by the IRB, including obtaining the consent from study participants before starting the project and report any deviation from the protocol to the IRB, if needed.[7–9] However, QI projects are data-driven and focus on showing sustained improvement to a specific process and system or outcomes within a health-care organization using, if possible, the research evidence generated as the basis for developing the improvement interventions.[10] A QI project does not aim to generate new knowledge as a research project does, rather, it generates several learning lessons as to what actually works and does not work and why. A QI project produces empirical evidence to benefit other organizations within a similar context and setting, which are interested in replicating the change to improve a process or system using the rapid PDSA cycle approach.[11] Through cycles of testing, we learn what is going to improve and why, without the need to generalize the results to another context, as research projects usually aim to do. Also in QI projects, the measurement framework is not about pre and post. It is about continually measuring the metric of interest that you want to improve and coming up with not just one intervention but multiple interventions based on learning from prior PDSA cycles. At the end, you reach the point of realizing sustained improvement through a series of interventions that were informed by testing in the actual system that you want to improve. The PDSA cycle is repeated, and new changes are made to continue to improve a process and, ultimately, the outcome. The essential measurements included in a QI project are process measures, outcomes measures, and balancing measures, which are used to show that the improvement occurs over time. Data from QI activities are usually aggregated and presented in run/control charts, histograms, and line graphs, whereas data from research are analyzed using statistical tests such as t-test, chi-square test, and regression analysis, and then aggregated and presented in appropriate tables and/or graphs.Typically, QI results are shared within the organization and might be implemented in other departments. The lessons learned from QI activities can be published; however, it must be clear to the readers that the project was for QI, not traditional research. Although a QI project does not require IRB approval, some organizations have QI committees that approve and coordinate QI project activities, and some organizations require articles to be approved before submitting for publication.In summary, the sustained improvement realized in a QI project can be complemented and validated with a thorough research-based assessment of effectiveness.[12] We should not consider the proof of effectiveness the same as the proof of sustained improvement, but they both are very important. I would like to emphasize that both research and QI projects use scientific and systematic approaches, albeit different, but both methods are scientific and rigorous in their own ways. The aims, methods, and outcomes in research and QI projects are quite different. Hence, understanding the differences and similarities between research and QI projects will help to determine the right approach when designing and implementing the right project for the right purpose using the right method. Table 1 is a snapshot comparison between QI and research with more focus on the project's aim and method aspects.In research projects, we can be guided by asking the following: Do we have a clear question to be investigated and answered?What do we hope to accomplish by answering the question?What is currently known about the topic?What are the risks and benefits for patients involved with the study of this topic?What type of study design will be used (observational vs. experimental)?How will the data be analyzed and presented (statistical tests, P-values, etc.)?In QI projects, we can ask the following: What is the magnitude of the quality problem based on available data?What types of quality tools have been used to measure and assess the problem?What is the measurement plan to be used during implementation of the project?What types of changes/interventions will be tested during the PDSA cycles?Has the proposed change/intervention been used in other health-care settings or reported in the literature?Will the results of this project directly improve patient-care outcomes or processes?Is the organization's management supportive of the project and willing to dedicate employee's time and supplies to do the project?What is the sustainability plan for the results?

Shweta Chopra, Manasa Kondapalli

The healthcare system in the United States is comparatively superior to healthcare systems of other countries in terms of advanced and modern technology, drugs used, services offered, and required care. However, hospital management has to face the challenges in the managing of care and addressing safety issues for its patients due to the multiple stakeholders involved such as medical doctors, residents, nurses, diagnostic tool providers, as well as patients. Every year many people lose their lives due to medical errors caused by new employees in hospitals, errors that can be prevented by “mistake-proofing.” Similarly, teaching hospitals face an increase in medical errors in the month of July due to cohort turnover, which occurs when trained residents graduate and new ones begin their residency, resulting in increased fatalities and mishaps; this phenomenon is called the “July effect.” This sudden changeover of workforce puts the quality of healthcare in teaching hospitals at stake. In this paper, we discuss various reasons behind the July effect and several tools of quality that can be implemented to improve healthcare and increase patients’ safety.

David M. Gaba

The healthcare industry may be the largest and most expensive endeavor of the developed world, with the United States at the top of the list of per capita expenditure. Clearly, as indicated by the intense (and continuing) debate over the Affordable Care Act, the issues of the healthcare industry are of extreme interest to the public and policy makers.The biggest problems in the healthcare industry are about how to achieve its fundamental goals—how to provide adequate and equitable care to the entire populace; how to guarantee equitable access to all; how to achieve optimal population health; how to ensure efficacy, quality, and safety of patient care; how to provide choice of provider and hospital; and, most importantly, how to pay for all of these goals and how to obtain political agreement of the populace to make it happen.Fortunately, this monograph will address primarily issues of quality and safety, and will largely ignore these other very large and thorny issues. Some of the ideas in this chapter have been addressed in part by the author in prior journal publications.12From a safety standpoint, it is now well recognized that there is a significant incidence of harming patients in the course of trying to diagnose and treat them.3Many such events are known to be preventable. The incidence of minor problems is very high, but even serious events have been found in approximately 1% of all hospitalizations. It is often said that many of these adverse events are irrelevant because the patients they occur in are already very ill, and hence might well have suffered negative outcomes anyway. However, I contend that no patient “signs up for bad care,” so we should still be very concerned about such events even when they do not, in the final analysis, actually affect the final outcome. The next time, maybe they will.In addition, it is likely that many errors that occur, even serious errors, are hidden. Some are not apparent because the patient is very ill, so only detailed investigation or analysis can disclose an error. In other cases, errors can be hidden simply by failing to inform anyone of them and waiting to see what happens. Moreover, healthcare does not have the robust incident or accident investigation processes that are routine in transportation (e.g., National Transportation Safety Board). Most investigations—in the infrequent occasions that they occur—are conducted only at the local level and with varying degrees of sophistication and alacrity.Parts of healthcare (such as anesthesia and surgery) and nuclear power production are but two examples of activities of “high intrinsic hazard” (aviation is a well-known third). The hazard in these activities is inherent—it can be managed and controlled—but the hazard cannot be eliminated. Yet, the management of hazard in nuclear power and aviation has become so good that it is accepted that adverse events are not “normal.”Nuclear reactors should not unexpectedly interrupt power production, and they should never harm workers or the public, melt down, or explode. Airplanes are not supposed to crash—ever. In these arenas when one of these things happens, we know that something went horribly wrong. Yet, human beings are inherently prone to catastrophic internal failures that result in serious disability or death. Thus, adverse outcomes—not necessarily due to errors or poor care—are very common in healthcare. All of us are going to die, and most of us will die in close proximity to healthcare. It is difficult to sort out which events are the ordinary “natural history” of disease and which are due to suboptimal care. This makes efforts at measuring safety outcomes particularly difficult in healthcare.All of the high intrinsic hazard industries share the fact that they are so critical to human welfare that we cannot just shut them all down while we solve all of their problems. Certainly, we can't stop performing healthcare activities just because they are imperfect—the ravages of disease are worse. While a single nuclear reactor can be shut down whenever necessary, and a flight can be cancelled or delayed, it is sometimes impossible (and possibly unethical) to refrain from or abort an emergency medical procedure due to a significant safety risk when the patient's underlying disease processes will otherwise quickly cause serious harm or death.Decisions on a larger scale are more complicated. While it is in principle possible to abandon the use of nuclear power in some countries, this can only be done temporarily or it must be phased out over a very long period of time. Access to abundant electrical power is the lifeblood of modern societies. Similarly, the dislocations caused by even short stoppages of air travel by the 9/11 terrorist event or the Icelandic volcano's ash cloud demonstrated that air travel also cannot be stopped for long. On the other hand, in healthcare, the introduction of new, potentially lifesaving drugs and devices can be delayed pending proof that they are safe and effective.The calculus of such decisions may vary from country to country, although many aspects of healthcare (and nuclear power production) are similar everywhere. In healthcare, the practices of physicians stem originally from the roots of the “autonomous healer” who used individual, often idiosyncratic, knowledge and “skill” to diagnose and treat ailments. There were few curative or invasive therapies. While administering potions to, cupping, and bleeding patients didn't usually help them very much, and might have hastened their demise, they were not generally powerful enough to directly cause serious harm or death. Hospitals were originally organized more as “guild workshops” 4 wherein the members of the physician's guild could independently ply their trade.Now, in the early 21st century, some things have changed drastically while others have not. We have many more diagnostic and treatment interventions that can often cure. Many are very powerful and can themselves directly, and quite quickly, cause serious harm or death. I like to say that there is a high potential lethality per square meter in settings like the operating room, intensive care unit, emergency room, or chemotherapy administration unit. Wielding such interventions requires very complex care coordinated across many individuals and many work units.Since the latter half of the 20th century, it has become possible to compare many patient outcomes in response to diagnosis or treatment, a process that is still unfinished. Despite all of this change, the structure of the hospital, for example, has not changed much in hundreds of years, retaining many elements of the guild workshop. Even where an institution is the employer of physicians, the amount of autonomy of practice given to physicians is enormous, despite the grumblings of how medicine is dictated by the rules and regulations of payers and other bodies. The system also is structured around assumptions that the individual skill of the professionals will be uniform, solid, and unvarying over time, which of course is impossible to guarantee.Even the division of labor is old. I conjecture that if healthcare were to be developed now, from scratch, we would not have job types of “doctor,” “nurse,” “pharmacist,” and “respiratory therapist,” to name only a few. We would have many other job types and a vastly different organizational and work structure—hopefully based on a more rational assessment of how best, and how safely, to achieve the goals of the work in the first place.A fundamental difference in healthcare versus other industries is that “we” do not design or construct the units we work on: human beings—nor are we given an instruction manual for them. We do not understand a great deal of how the human body works, how it fails, or why and how it gets sick or recovers from illness. Yes, great strides have been made and more discoveries are happening every day, but we are mostly working empirically by trial and error.In my own field of anesthesia, we do not know many of the fundamental mechanisms by which our drugs can render patients unconscious, unaware, resistant to pain, immobile, and (fortunately) unable to recall what has transpired during surgery. Yet, by trial and error, we have worked out the methods to do these things—which clearly evolution never really intended for human beings—on a regular basis with low, but not low enough, rates of serious problems.In healthcare, the public is very concerned with personal and intimate aspects of the work, and such individual, societal, and ethical issues are commonplace. They also care very deeply about choosing and seeing “their” doctor. This is not the case for other industries where the public doesn't care specifically who exactly is doing the work (pilots and nuclear power plant operators interact with the public minimally, if at all). However, for nuclear power, the public has great concerns over the long-term impact of accidents, and also a hard to grasp “dread” factor of radiation that does not come into play in healthcare.56Organizationally, the nuclear power industry and healthcare are very different. There are just over 100 nuclear power reactors in the United States, owned and operated by 30–40 firms and under significant scrutiny by the federal regulator, the U.S. Nuclear Regulatory Commission (NRC).Healthcare is a vastly more decentralized and massive undertaking. There are 4,000– 6,000 hospitals, owned by 1,000–2,000 firms. There are roughly the same number of stand-alone surgicenters. There are more than 200,000 physician offices. More than 20 million surgical operations with anesthesia are performed, just under one billion doctor visits occur, and about three billion prescriptions are written every year in the United States. Yet, there is no federal regulatory agency of the practice of healthcare. That comes under the jurisdictions of the 50 states and the federal health systems (e.g., Department of Defense, Department of Veterans Affairs, and the Indian Health Service).The federal U.S. Food and Drug Administration regulates the approval and sale of drugs and devices. The federal Centers for Medicare & Medicaid Services (CMS) controls the criteria for federal payment for medical services. CMS may act as an indirect regulator of practice—if you won't get paid for it, you probably won't do it—and there are other indirect regulators by accreditation (e.g., The Joint Commission) or by voluntary participation (e.g., Institute for Healthcare Improvement and the Leapfrog Group). However, indirect regulation is generally not comparable to direct regulation, as in the NRC's direct oversight of nuclear power, or the Federal Aviation Administration's direct oversight of aviation.Of note, in aviation and nuclear power, the firms themselves (individual airlines or individual power utility companies) impose strong safety control over the day-to-day work of personnel, often over and above the requirements of the regulator. This is only partially true for healthcare. The work of nurses, pharmacists, and allied health personnel comes under the direct purview of the employing institution, although the degree to which actual practices at the front line reflect the stated goals or policies of the institution varies greatly.The practices of physicians have less direct oversight by the firm; the majority of physicians are independent (fee-for-service, not salaried) members of the hospital's medical staff. As such, though not under direct line authority of the hospital, they must apply for clinical privileges and their actions can be scrutinized by the institution. Other influences on physician practices come from specialty board certification and professional society practice guidelines.However, when guidelines are well articulated, strongly evidence based, and widely agreed upon by the medical community, it typically takes a decade until these practices are consistently adopted and executed. Regardless of whether physicians are actual employees of the hospital or are independent medical staff members, in practice they have nearly unlimited discretion as to how they manage individual patients. Local standardized operating procedures are occasionally imposed, but even then their authority and compliance may be minimal, especially without specific incentives for compliance or disincentives for noncompliance.In fact, all of the hazardous industries suffer from a phenomenon in which what is articulated for safety on paper does not always correspond to the reality at the front line or even to a plausible reality that could be implemented at the front line. One aspect of this has been described by the sociologist Lee Clarke as “fantasy documents,” such as policies, procedures, or plans that are created to satisfy a regulatory, internal, or public relations need, but are known by most participants to be infeasible. They “sound good” and make people feel better, but it is widely known—at least by frontline staff—that they cannot really work as described.78One factor about the aftermath of accidents that affects other industries in a profound way that doesn't happen in healthcare is that a severe accident in nuclear power, in oil refining, or even in aviation, can seriously harm the “means of production.” That is, not only may the accident hurt workers or the public, it also takes out of service the facilities (power plants, refineries, or airplanes) that are used to do the work. Even ignoring cleanup or repair costs (if relevant), this means that there is a huge financial and operational loss from the lost means of production.As indicated above, for nuclear power, this can expand all of the way to long-term plans to abandon this method of generating electricity. None of these effects is seen in healthcare. If we harm a patient in the operating room, that may be very sad, may generate litigation, and may (rarely) garner bad publicity for the hospital, but we just “send for the next patient.”I cynically suggest that if the aftermath of medical errors or preventably suboptimal care events in an OR, ICU room, or emergency department bay would be to take that room out of service for days or months, that would generate a much more aggressive response for improvement by the healthcare institution than we currently see.It is true that healthcare cannot strive for the same level of standardization within a facility, or especially between facilities having the same basic technology, as is achieved in nuclear power or the aviation industry. Human beings are not reactors or airplanes and diseases are not understood at fundamental levels, hence healthcare personnel need more flexibility to respond to unanticipated situations. However, as for many things in healthcare, the pendulum is currently too far to the side of insufficient standardization.On the equipment and procurement side, the decentralization and huge number of sites of care raise all sorts of issues. Unlike the 106 nuclear power plants of perhaps a few dozen designs, the hundreds of thousands of patient rooms, ORs, ICU bays, etc., in the 8,000 institutions each needs outfitting with various devices such as monitors and infusion pumps.Rather than being purchased as large, integrated, preconfigured units, such devices are often purchased one at a time, or, at best, in periodic bundles of hundreds. The combinatorics of all of the devices makes it impossible for vendors to test them in use all together. And, until fairly recently, there was little demand on vendors—either from regulators or the marketplace—for serious human factors testing of either prototypes or actual devices.The decision to purchase equipment is often made by small committees or single influential individuals based on idiosyncratic assessments of features. Purchase decisions are strongly affected by the purchase cost of the equipment and disposable supplies, and only rarely by total life cycle or systems cost. One area where both nuclear power and healthcare can benefit is to achieve and maintain a high degree of user-centered human factors testing of concepts, prototypes, and actual equipment during the design, premarketing, marketing, and postmarketing phases of product life.Issues of design are compounded in healthcare by the current variability in the preparation and training of personnel on the use of the equipment, even that which is life critical. Nursing and allied health disciplines generally have more structured mechanisms for providing training to personnel before they use advanced equipment via “in-services” and checkoffs of competency.Even so, experience suggests that such checkoffs can be “fantasy activities”—showing that immediately after training, and in a quiet environment, a clinician can demonstrate performance of specific tasks doesn't necessarily correlate with skill with the device during actual use in challenging real-life conditions. Fortunately, most of the time, personnel do rapidly learn to use the essential aspects of equipment in their routine bedside activities.However, problems may arise especially for devices that are used only rarely (e.g., defibrillators), in situations requiring the use of advanced and complex device features, or when it is necessary to deal with unexpected glitches or faults (e.g., when something isn't hooked up quite right or the wrong button is accidentally pressed) in a stressful in physicians have been more resistant to to training, which is rarely made Thus, it is not for a physician to a device a anesthesia in patient having never or seen or used the healthcare, there is like the in aviation, of how much experience has as an they cannot an they have been specifically and as on that of In nuclear power, each plant has a of the control room on so it is that plant operators would be to control the reactor and systems if they are not with the this suggests that perhaps healthcare nuclear power have the optimal structure for In healthcare, it is and with little devices and systems are In nuclear power, there is strong control and little risk of by but at the cost of extreme and to especially in safety critical in so many there may be a in the Clearly, to its and physician autonomy and control by firms or but has to up to its for very high Nuclear power has an safety at least in the United States, but is, to a in its not of and other the two in many there are many of where of and may each industry to a that is more and at cost to the

Joseph Bernstein

The American malpractice system is a mess, and in orthopaedic surgery, it is messier still. One problem is frivolous lawsuits. The Harvard Medical Practice Study [5] reviewed the hospitalization records of more than 30,000 patients and determined for each case whether negligence was committed and a suit was filed. The researchers found most of the events for which claims were made did not involve negligence. It is small consolation that physicians usually prevail at trial. Even when a doctor wins the case, defending a malpractice claim is a losing proposition. At best, the physician is portrayed by the plaintiff’s counsel as a bumbling incompetent. Also, malpractice insurance (which routinely exceeds USD 100,000 per year in some states) indemnifies against only financial damages; the losses of time, reputation, and serenity are for the physician alone to bear. The net drain on happiness probably exceeds what one experiences in contracting appendicitis or breaking an ankle. In response, the orthopaedic surgery community has pressed for change. The hallmark of the orthopaedic approach is limits on noneconomic damages. These so-called “caps” would mandate that while all medical expenses and lost wages caused by malpractice are compensable, no more than a given amount, say USD 250,000, can be awarded for “pain and suffering.” Caps are an appeal to logic and fairness. For one thing, the argument goes, it is impossible to place a precise dollar value on pain and suffering, and if any amount is to be arbitrary, why not keep the dollar values modest? In addition, limits on noneconomic damages mitigate the harm caused by “runaway” juries, making the system less volatile and therefore less expensive for all. But let’s face it: the real appeal of caps is that they limit the number of suits. Most cases are brought forward on a contingency basis; the lawyers get paid only if they win. If the payoff of a case is limited, its attractiveness to an attorney is, likewise, limited. Caps work. In general, malpractice premiums are much lower in those states (such as California) that have caps in place [10]. But the problem with caps is that they solve the wrong problem. While there is plenty amiss with the American medical malpractice system, the largest flaw is not having too many lawsuits. If anything, there are too few. The Harvard Medical Practice Study cited above, for example, reported only eight of the 280 patients (2.9%) who were the victims of medical negligence actually filed malpractice claims. As such, if we can agree a central purpose of a malpractice system is to compensate victims of negligence, we can also agree caps, which discourage litigation across the board, and not just the frivolous cases, undermine that purpose. And, if another central purpose of a malpractice system is to deter errors, then we might also agree any method that discourages litigation in general, benefiting bad physicians as well as good ones, similarly undermines deterrence. Orthopaedic surgeons should favor a system that minimizes physician pain yet allows victims of error unfettered access to fair compensation. Abraham and Weiler [1] have proposed such a system. They call it “enterprise liability.” Under this approach, it is the organization, not the physician, that is named as the defendant in a suit. The rationale is simple: because many medical errors are, in fact, systems failures, it stands to reason that the enterprise should bear primary responsibility for compensation and deterrence. Local enterprises, when held accountable in this way, should likewise do a better job of policing practice and eliminating bad practitioners, as opposed to the current approach to malpractice, which indiscriminately lumps (and punishes) many good surgeons along with the few bad players. There are, of course, impediments to applying enterprise liability. For one thing, even for procedure-oriented specialties like orthopaedic surgery, much health care is not delivered within the confines of a single enterprise. Also, it is not assured that enterprises themselves will avoid hunting for scapegoats. Even so, the advent of Accountable Care Organizations (as promoted by the 2010 Patient Protection and Affordable Care Act) and the heightened political awareness among physicians regarding liability rules will, respectively, mitigate those concerns. Enterprise liability is a practical option moving forward. We orthopaedic surgeons, as advocates for our patients, should favor a system that limits error and compensates victims when errors occur. As human beings, we can’t help but hate attacks on our competence and character. Thus, we are also right to favor a system that minimizes finger pointing. A system of enterprise liability meets all of those standards. Enterprise liability, not caps on noneconomic damages, should be our favored approach. Commentary James Herndon MD, MBA Chairman Emeritus, Department of Orthopaedic Surgery, Harvard Medical School; Partners Healthcare System, Boston, MA, USA Dr. Bernstein has raised an important issue: the use of a method of professional liability reform called enterprise liability. The US medicolegal system has not accepted it in the past, and it will be difficult to implement such a major culture change in the future. However, Dr. Bernstein raised this method of compensating injured patients because he sees a new opportunity for change under the Patient Protection and Affordable Care Act, with the new development of Accountable Care Organizations. I agree with him on this point and would argue it is also a desired method in the new practice model in which physicians are increasingly becoming paid employees of a hospital or hospital system. The best example of enterprise liability in practice that I know of involves the aviation industry. As in medicine, system errors can occur, but also individuals make mistakes. In the case of an airplane crash, the airline company is responsible for all damages. The pilots are not personally liable because their profession has agreed to full transparency and reporting of individual errors. However, the pilot does bear individual responsibility under two circumstances: when he or she is under the influence of drugs or alcohol at the time of the crash or if he or she did not follow the required checklist for flying the aircraft. This model seems perfect for surgeons and hospital systems to adopt. But I am pessimistic that it will happen. In the past, trial lawyers have mounted strong opposition to any professional liability reform; the courts and our legislators (most of whom are lawyers) likewise have not favored such change. There is too much money at stake. Also, I am pessimistic that even our own profession would support enterprise liability. For just as pilots have to admit and disclose their individual errors, so would surgeons under this approach. Physicians fear the loss of reputation, the resultant loss of income, and the difficulty of admitting to colleagues and patients that we erred and caused harm. I believe our profession would accept individual responsibility for errors committed while under the influence of drugs or alcohol, but the challenge for many surgeons will be the acceptance and use of required checklists before, during, and after surgery. Most changes in past attempts at healthcare reform have been at the margins: a small fix or BAND-AID® here, a small change there. It would be wonderful if leaders of the professions of medicine, law, and politics, along with our patients, would come together and implement enterprise liability in health care as it is used in the airline industry. Such are quixotic dreams. Only if state and federal leaders, along with physicians, agreed such reform was necessary because of the continued rise in healthcare costs, the continued threat of adverse events, and the importance of shared decision making, would such reform become a possibility. Even then, though, it would be but a small one. Commentary Christopher D. Stombaugh JD Laufenberg, Stombaugh & Jassak, SC, Milwaukee, WI, USA “It isn’t what we don’t know that gives us trouble, it’s what we know that ain’t so.” Will Rogers It is becoming more and more difficult to engage physicians and lawyers who represent patients in a productive dialogue about fixing what ails the medical liability system. Each group views the other with suspicion and distrust. Nonetheless, to have a productive dialogue, the participants must first agree about the nature of reality. Evidence-based liability reform, like evidence-based medicine, must look at the facts as they are, not as we assume them to be. The arguments in favor of medical liability reform are more faith-based than fact-driven. The author begins by rounding up the usual suspects: “frivolous lawsuits,” caps on “pain and suffering,” discouraging lawyers from bringing cases. These are driven by fears. The fears of plaintiff’s counsel, loss of reputation, rising liability insurance premiums, loss of time, loss of peace and enjoyment of life, runaway juries. Fears, although real, do not make the thing feared a reality. Truth should matter, especially when it comes to changing our laws to deny a person his or her right to full and fair compensation. That person would surely be awarded compensation if only he or she had been injured in a road wreck caused by driver error, rather than violation of the standard of medical care by a physician who commits medical errors. Review of the relevant literature shows the arguments made in support of so-called reform proposals are simply untrue [3]. An ambitious project of the nonprofit Center for Justice & Democracy at New York Law School [3] is an updated survey of the data every orthopaedic surgeon should read. This freely downloadable, heavily footnoted book leads to the conclusion that whatever the infirmities of the current system, they cannot be laid at the feet of the injured patients and their advocates. Rather, we learn the inconvenient truth: We are not inundated with frivolous medical lawsuits. “[P]ortraits of a malpractice system that is stricken with frivolous litigation are overblown” [7]. Capping pain and suffering damages does not reduce malpractice insurance premiums [9] and does not affect physician supply, but it does prevent legitimate cases from being filed [3]. Legitimate cases actually improve the cause of patient safety [3]. Dr. Bernstein’s contention that too few malpractice cases are being filed is also borne out by the literature [2]. Medical errors occur at an alarming number and are, largely, system failures [4]. Recently, there have been small steps in increasing acceptance for physicians to admit medical mistakes as part of the healing process. Most notable was the recent Technology, Entertainment, Design (TED) talk of Canadian emergency physician Brian Goldman MD [8]. This is also good for the overall cause of improving patient safety. In place of the current system, Dr. Bernstein advances the idea of enterprise liability. Enterprise liability has several advantages as a method of bearing the costs of medical errors, obtaining coverage in a pool, holding the system responsible for system failures, and making system wide improvements in the interest of patient safety. Additionally, the enterprise is in a better position to police the few bad, serial malpracticing physicians who create most of the medical negligence payouts and who receive shockingly little discipline from state medical boards [6]. An enterprise liability system would also have the benefit of depersonalizing the effects of litigation. Unfortunately, as of now, this is not the law anywhere in America. A reasonable, workable alternative is the Wisconsin system, The Injured Patients and Families Compensation Fund. Doctors in Wisconsin have unlimited coverage since every healthcare provider has that type of coverage. The fund has nearly USD 1 billion in assets and pays out only a small portion of that every year and is financed through assessments on healthcare providers. Commentary David Seligson MD Chief of Orthopedics, Department of Orthopedic Surgery, University of Louisville Hospital, Louisville, KY, USA Our current tort system resolves disputes through litigation. Dr. Bernstein notes researchers found most events for which claims were made did not involve negligence. This suggests the current system works, since most malpractice suits find for the defendants. Error is not the same thing as malpractice. Although malpractice litigation is demeaning, can be tedious, and certainly is expensive, the alternative—compensating those who allegedly suffer from medical misadventures—would be far worse. Prioritizing the business of medicine first and putting the patient with a bad result in charge are mistakes. Here’s why: Among the patients whose treatment could have been better are other people who think they have been mistreated, and worse, individuals who believe they deserve compensation for actual or imagined dysfunction. Our society, our hospitals, and our prisons are loaded with folks who feel they are entitled. Compensation for situations that are judged by some flawed process to have been caused by medical care will provide a whole new apparatus for undeserved rewards. In real life, few patients tell the whole truth about what happened to them, what they have taken, or what they have done. Review of the discovery process of any lawsuit makes this clear enough. Enterprise liability is a concept borrowed from manufacturing. If a part fails, the company issues a recall and fixes the problem. The underlying assumption is that there has been a flaw in the creation of the product somewhere from design to production and the process is at fault. This concept fits less well when applied to an unemployed motorcycle driver on alcohol and drugs who loses his leg in a high-speed injury that he or she caused. My wise accountant opined any audit will disclose discrepancies; similarly any chart review will find courses of action that might have led to better results. Where will the funds come from to compensate patients for damages they allege? Government? Healthcare insurers? Doctors? Surely a torrent of preferred pathways, algorithms for treatment, and computer-driven systems to control losses will follow; these will, almost necessarily, stifle innovation. We can develop a new system wherein a well-intentioned (though perhaps not well informed) someone will assert an adverse outcome could have been averted, and we even can compensate patients under such a system. But we will probably find ourselves with much more paperwork and in a much-less favorable atmosphere to treat patients as individuals and with dignity and kindness. Commentary Mark A. Geistfeld JD Sheila Lubetsky Birnbaum Professor of Civil Litigation, New York University School of Law, New York, NY, USA The claim that more tort liability could be a cure for our ailing system of medical malpractice liability will undoubtedly strike many physicians as preposterous. The logic of this proposed tort reform, however, is compellingly as laid out by Joseph Bernstein in this column on medical malpractice. Indeed, the case for enterprise liability—a system that shifts liability from physicians to the enterprises that supply health care—is even stronger than Dr. Bernstein shows. In sharp contrast to the current system, enterprise liability is triggered by the occurrence of medically caused injuries, regardless of fault. No-fault liability would result in more tort liability across the run of cases, but this expansion of tort liability could solve the malpractice problem by removing blame from the liability equation. No one likes to be sued, especially when the allegation is one of professional malpractice. Rather than having one’s competence impugned, many physicians understandably engage in defensive medicine or otherwise cover up their mistakes. These allegations can also be upsetting to patients who place faith in their physicians and feel grateful for the care that they have received, even when the physician ultimately is unable to provide a cure. These patients are often loath to sue their physicians, regardless of whether further investigation would support a malpractice claim, whereas others who feel their physicians have not been adequately sensitive can end up blaming the physician for the failure to provide a cure, even if malpractice is not involved. The resultant mismatch between the incidence of medical error and the incidence of malpractice claims is well described by Bernstein and more extensively documented by others [2]. To be sure, fault-based liability has a number of appealing attributes. It requires proof that the defendant was legally at fault for the plaintiff’s injury, enabling risky actors to avoid tort liability by exercising reasonable care. The failure to exercise reasonable care constitutes legal fault, a conclusion that can be quite different from the colloquial attribution of fault. No one can be blamed for not being perfect. We all make mistakes, but any misstep, whether the result of professional incompetence or a simple lapse of attention, can be sufficient to establish negligence liability. The frequency of these mistakes can be reduced by procedures or the design of systems for delivering health care, but fault-based liability largely ignores these issues by instead placing blame on the provider whose inadvertent mistake directly caused the patient’s harm. Requiring the patient to prove instead that the “fault” lies with the enterprise is no panacea because the optimal design of systems and procedures involves complexities that render such proof practically inaccessible to plaintiffs. Is the injured patient, or more precisely, the contingency-fee lawyer, really the party best able to identify the practices that ought to be utilized by the enterprise of health care? By placing responsibility for all medically caused injuries on the enterprise itself, tort liability would create financial incentives for these institutions to adopt procedures and systems that would both reduce the incidence of inadvertent error and provide internal mechanisms for addressing instances of professional incompetence. Eliminating blame from the liability inquiry could be the best way to address the problem of medical error, but doing so requires an expansion and redirection of tort liability, a reform quite different from the reduction of tort liability often championed by medical professionals.

Christopher Bond, Cynthia L. Raehl, Todd Franke

This study evaluated hospital demographics, staffing, pharmacy variables, health care outcomes measures (severity of illness-adjusted mortality rates, drug costs, total cost of care, and length of stay) and medication errors. A database was constructed from the 1992 American Hospital Association's Abridged Guide to the Health Care Field, the 1992 National Clinical Pharmacy Services database, and 1992 mortality data from the Health Care Financing Administration. Simple statistical tests and a severity of illness-adjusted multiple regression analysis were employed. The study population consisted of 1116 hospitals that reported information on medication errors and 913 hospitals that reported information on medication errors that adversely affected patient care outcomes. We evaluated factors associated with the 430,586 medication errors and 17,338 medication errors that adversely affected patient care outcomes. Medication errors occurred in 5.07% of the patients admitted each year to these hospitals. Each hospital experienced a medication error every 22.7 hours (every 19.73 admissions). Medication errors that adversely affected patient care outcomes occurred in 0.25% of all patients admitted to these hospitals/year. Each hospital experienced a medication error that adversely affected patient care outcomes every 19.23 days (or every 401 admissions). The following factors were associated with increased medication errors/occupied bed/year: lack of pharmacy teaching affiliation (slope = 0.8875, p=0.0416), centralized pharmacists (slope = 1.0942, p=0.0001), number of registered nurses/occupied bed (slope = 1.624, p=0.032), number of registered pharmacists/occupied bed (slope = 25.0573, p=0.0001), hospital mortality rate (slope = 2.8017, p=0.0192), and total cost of care/occupied bed/year (slope = 0.01432, p=0.0091). Factors associated with decreased medication errors were location in the Mid-Atlantic census region (slope = -1.5182, p=0.03), affiliation with a pharmacy teaching program (slope = -1.0252, p=0.0349), decentralized pharmacists (slope = -0.9843, p=0.0037), and number of medical residents/occupied bed (slope = -1.478, p=0.0014). There was a 45% decrease in medication errors (1.81-fold decrease) in hospitals that had decentralized pharmacists, compared with hospitals that had centralized pharmacists. In addition, there was a 94% decrease in medication errors that adversely affected patient care outcomes (16.88-fold decrease) in hospitals that had decentralized pharmacists compared with hospitals that had only centralized pharmacists. Based on previous field studies and our findings in 1116 hospitals, it appears that one of the most effective ways to prevent or reduce medication errors is to decentralize pharmacists to patient care areas. The results of this study should help hospitals reduce the number of medication errors that occur each year.