Patient safety and quality improvement. Notice of proposed rulemaking

This document proposes regulations to implement certain aspects of the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act). The proposed regulations establish a framework by which hospitals, doctors, and other health care providers may voluntarily report information to Patient Safety Organizations (PSOs), on a privileged and confidential basis, for analysis of patient safety events. The proposed regulations also outline the requirements that entities must meet to become PSOs and the processes for the Secretary to review and accept certifications and to list PSOs. In addition, the proposed regulation establishes the confidentiality protections for the information that is assembled and developed by providers and PSOs, termed "Patient safety work product" by the Patient Safety Act, and the procedures for the imposition of civil money penalties for the knowing or reckless impermissible disclosure of patient safety work product.     

Reliance on internal autopsies in coronial investigations: a review of the issues

Internal autopsies are invasive and result in the mutilation of the deceased person's body. They are expensive and pose occupational health and safety risks. Accordingly, they should only be done for good cause. However, until recently, "full" internal autopsies have usually been undertaken in most coroners' cases. There is a growing trend against this practice but it is meeting resistance from some pathologists who argue that any decision as to the extent of the autopsy should rest with them. This article examines the origins of the coronial system to place in context the current approach to a death investigation and to review the debate about the role of an internal autopsy in the coronial system.     

Psychological autopsies: the current Department of Defense effort to standardize training and quality assurance

Psychological autopsies have been gathered by the US military for a long time, both for lessons learned after a known suicide and to investigate an equivocal death. The term "psychological autopsies" is now being restricted to define an investigation by mental health to help determine, in an equivocal death, if the manner of death is a homicide, suicide, an accident, or from natural causes. The Department of Defense has developed policy, and is now implementing training and peer review. A sample model curriculum, report format and quality assurance standards are included.     

Unusual fentanyl patch administration

Fentanyl is an extremely potent narcotic analgesic that is becoming more popular as a drug of abuse. Because of the unique way in which the drug is packaged and delivered, the potential for unusual methods of abuse exists. We report the first case of true fentanyl patch ingestion in the medical literature. Initially, though unusual, cases of fentanyl ingestion were thought to have been reported, but further investigation of the literature revealed that in other case reports the patches had been held in the mouth and chewed. Because no reports of swallowing the patch had been published, suicide was initially a strong consideration in this case; however, further investigation showed that the decedent and his brother enjoyed swallowing the patches for quick "highs." Cases such as these serve to remind medical examiners and law enforcement officials of the value of performing thorough death investigations by performing complete autopsies with toxicological testing and correlating with investigation information to form an opinion with regard to the cause and manner of death.     

The most severe chronic organ findings in official public health autopsies--a medico-sociologic contribution

At the Vienna Institute, in the year 1986, 79 carcinoma findings were recorded in 1736 cases of natural death. The most common were carcinomas of the respiratory and gastrointestinal tracts. Seventeen unidentified tumors were found to have been the cause of death. Public health autopsies, therefore, contribute to the clarification of tumor disease and thus to cancer statistics. Although diagnosed fatal cancer cases correspond to only 0.33% of all cancer deaths in Vienna, the question arises why a patient with very advanced cancer is not under medical care and why the affliction is revealed only in autopsy, the purpose of which is to elucidate sudden, unexpected deaths. The comparatively few individual cases should nevertheless give cause for reflection and are discussed from a medicosociological view, taking into consideration the statistical and epidemiological data relating to cancer diseases.     

Why hasn't integrated health care developed widely in the United States and not at all in England?

There have been influential advocates for financing and organizing health care in the United States and England based on the model of integrated health care delivery systems (IHCDSs). Despite good evidence that a few IHCDSs provide high-quality health care economically, such organizations are rare and localized in a few market areas in the United States and are absent in the English National Health Service (NHS). The explanation of why this is so includes various contributory factors: the way the development of the medical profession in each country pursued specialization; the division in British medicine between general practitioners and specialists; and the characteristics that we identify of established successful IHCDSs, which created formidable barriers to entry for a new IHCDS. This explains why currently the most promising organizational developments in U.S. health care are hybrids resulting from vertical integration. In England government policies of an "internal market," as adopted in the 1990s and currently, were and are based on a purchaser-provider split with the objectives that providers would compete and be funded by a system in which "money follows the patient." These policies recognize the division in British medicine, which also means that it is difficult to implement a reorganized English NHS based on high-performing IHCDSs.     

Medical malpractice as reflected by the forensic evaluation of 4450 autopsies

A multicentre retrospective analysis of 4450 autopsies carried out due to suspicion of medical malpractice in 17 German institutes of forensic medicine from 1990 to 2000 was performed for the German Federal Ministry of Health. During the time period analysed an increase of cases could be mentioned. The main results of the study are: in the cooperating institutes the total number of autopsies due to suspected medical malpractice ranged from 1.4 to 20%. In more than 40% of the cases preliminary proceedings were started because the manner of death was certified as non-natural or not clarified. Hospital doctors were more affected by medical malpractice claims than doctors in private practice. However, the number of confirmed cases of medical malpractice was higher for doctors in private practice than for hospital doctors. Although surgery is still at the top of the disciplines involved in medical malpractice claims the number of confirmed surgical cases was below the average. Mistakes in care were confirmed to be above the average. Medico-legal autopsies are still a very sufficient method to evaluate cases of medical malpractice: 2863 cases could already be clarified by autopsy. Up to now there is no systematic registration of medical malpractice charges in Germany. A systematic registration should be initiated to build up and/or improve error reporting systems and, thus, to improve patient safety. Compared to other sources of medical malpractice claims (arbitration committees of the medical chambers, reference material of health and insurance companies, files of civil courts) the data of the present multicentre study are in so far unique as only lethal cases were evaluated and a complete autopsy report was available as basis of an expert opinion in alleged medical malpractice cases.     

Why public opinion changes: the implications for health and health policy

Research on stasis or change in public opinion toward health, health policy, and medical care tends to focus on short-term dynamics and to emphasize the impact of discrete messages communicated by individual speakers in particular situations. This focus on what we term "situational framing," though valuable in some respects, is poorly equipped to assess changes that may occur over the longer term. We focus, instead, on "structural framing" to understand how institutionalized public health and health care policies impact public opinion and behavior over time. Understanding the dynamics of public opinion over time is especially helpful in tracking the political effects of the Patient Protection and Affordable Care Act of 2010 as it moves from the debate over its passage to its implementation and operation.     

Error Reduction, Patient Safety and Institutional Ethics Committees

Institutional ethics committees remain largely absent from the literature on error reduction and patient safety. In this paper, the author endeavors to fill the gap. As noted in the Hastings Center's recent report, "Promoting Patient Safety," the occurrence of medical error involves complex web of multiple factors. Human misstep is certainly one such factor, but not the only one. This paper builds on the Hastings Center's report in arguing that institutional ethics committees ought to play an integral role in the transformation of a "culture of blame" to a "culture of safety" in healthcare delivery.     

Death resulting from ruptured cerebral artery aneurysm: 219 cases

To characterize the demographics of ruptured cerebral artery aneurysm as a cause of death and to examine the effect of improved diagnostic and therapeutic techniques on the incidence of sudden death associated with the condition, the authors reviewed 219 autopsies performed at the Dallas County Medical Examiner's Office between 1977 and 1997 in which the cause of death was ruptured cerebral artery aneurysm. Ruptured cerebral artery aneurysms accounted for 1.5% of 15,033 natural deaths and 0.4% of all deaths (45,492) followed by autopsy during this period. The majority (56%) of cases occurred in females, with Caucasian females composing the largest group (38%). Seventy-seven percent of cases occurred in individuals between the ages of 31 and 70 years, with the highest concentration in the 41- to 50-year decade (29%). The most common location for ruptured aneurysms was the middle cerebral artery distribution (39%). Multiple aneurysms occurred in 22 (9.1%) cases. Other factors, such as medical history, coexisting disease, symptoms, activity at onset of symptoms, survival time, and toxicology results are also presented. Compared with literature reports before 1980, when ruptured cerebral artery aneurysms were reported as the cause of death in approximately 4% to 5% of sudden natural deaths, the results of this study suggest that despite improved diagnostic and therapeutic techniques during the past two decades, morbidity and mortality from ruptured aneurysms remain a significant health problem.     

Significance of various analytical methods with reference to the causes and manners of death in alcoholics

It was the aim of the present investigation to apply a broad spectrum of analyses to forensic autopsies of alcoholics in order to estimate the significance of the various analytical methods with reference to the cause and manner of death. The analyses were performed on a consecutive series of 73 medico-legal autopsies in alcoholics. Both extensive histology as well as toxicology and microbiology were used. The microbiology did not contribute substantially to the determination of the cause of death, while histology was decisive in six cases. Toxicology analyses were necessary for determining the cause of death in 37 cases. The results of the investigation may help in the selection of analytical priorities.     

500 psychological autopsies

Five hundred psychological autopsies on equivocal (suicide versus accident) deaths were reviewed to ascertain which factors are significant in making the determination between suicidal and accidental deaths. Factors varied in relative importance according to the method used to cause death. Significant factors included life-style, recent stress, suicidal communications, previous self-destructive behaviors, history of depression, and obvious factors from the physical evidence such as large amounts of drugs in the blood. Although the court-provided decision guideline is "a preponderance of the evidence", in practice, the assembled evidence is often used to construct a "most credible" scenario to explain the death.     

Evaluation of sudden death in psychiatric patients with special reference to phenothiazine therapy: forensic pathology

The investigation of sudden unexpected death in psychiatric patients and the ensuing litigation has brought to our attention many unusual features important in the evaluation of such deaths. Certain pathophysiologic mechanisms of death, rarely encountered in routine forensic science practice, may be important in determining the cause of death in psychiatric patients, especially in cases where the autopsy is unrevealing. Of particular concern is a tendency in the current literature to implicate phenothiazines as a cause of death when the death investigation and the autopsies are incomplete. Thus, based on our experience and on a review of the current literature, we have set forth factors that the forensic pathologist should consider when faced with a sudden psychiatric death. A case report illustrates these unique aspects of scene investigation and analysis of terminal events and autopsy findings.     

The Government of Health Care and the Politics of Patient Empowerment: New Labour and the NHS Reform Agenda in England

This article considers the issue of patient empowerment in the context of New Labour's proposed reforms to the National Health Service (NHS) in England. Through an exploration of some of the key measures in the government's white paper High Quality Care for All, the article argues for a conceptualization of patient empowerment as a political technique of governing. Patient empowerment, it is contended, can no longer be understood solely as a quantitative phenomenon to be balanced within the doctor‐patient relationship. Rather, its deployment by the government as a way of governing health and health care more broadly demands that we consider what political functions—including, importantly, it is argued here, managing the problem of the increasing cost of illness and health care—patient empowerment may be involved in performing. In order to assist in this enquiry, the article draws on some of Michel Foucault's work on the art of governing. It is suggested that his understanding of the neoliberal mode of governing best captures the proposed changes to the NHS and the role patient empowerment plays in their implementation.     

A Ten‐year Study of Suicides from a Rural/Suburban County

This study will discuss trends in suicide data compiled over 10 years in Dutchess County, NY, from 2004 to 2013. These data were based on reporting and examination standards recommended by the National Association of Medical Examiners and Department of Justice death investigation standards. Almost 300 cases were analyzed in terms of the deceased's gender, age, race, method of suicide, and weapon used. Results from this study agree with other reports showing significant differences for method of death both in terms of age and gender, with men more likely to choose firearms and women more likely to choose overdose. Furthermore, older persons were more likely to commit suicide by firearms, and the younger persons were more likely to commit suicide by overdose. However, other areas, such as method of suicide, differ from national statistics.     

Reasons, circumstances and results of repeat forensic medicine autopsy

There are only scant literature data on reasons and circumstances of medico-legal second autopsies. The present study includes 12 second autopsies from the period 1992-1997; the first post-mortem examination took place either in the home country (institutes of pathology) or abroad. 7 of the 12 cases of death investigated happened in Germany (exclusively in hospitals) and 5 of them abroad (Netherlands, Romania, Portugal, Libya). Repeat autopsies were ordered by criminal courts (n = 9), private persons (n = 2) and social insurances (n = 1). The main indication was possible medical malpractice (n = 6); acts of violence (n = 3), insurance questions (n = 2) and accidents (n = 1) followed. The time lapse between death and second autopsy was 2-35 days. It was striking, that German institutes of pathology had partially performed autopsies despite the certification of a non-natural death. Clinical autopsies were stopped twice, when evidence of a possible non-natural death occurred. It could be fundamentally stated, that first autopsies in German institutes of pathology had been carefully performed and sufficiently documented. In these cases the second autopsy presented no or only little additional information, as far as the broader taking of (toxicological) samples is not considered. The final medico-legal expertise was then mainly based on the findings of the clinical first autopsy. However, the concurrence of the forensic expert (instead of the clinical pathologist) is undoubtedly essential for the evaluation of these issues involving frequently questions of malpractice. By contrast, the quality of postmortems performed abroad varies widely. 4 of the 5 first autopsies done abroad were regarded as completely or partly insufficient with superficial or almost absent preparation of organs or contradictions in the medical reports, respectively. A repeat autopsy is absolutely necessary in such cases. On the whole, the initial question could be answered in all second autopsies at least in part. This emphasizes the high value of second autopsies and expertises, especially in non-natural cases of death (10 of 12 deaths were finally judged as non-natural).     

病人安全:法律不应缺位——病人安全立法初探

频发的医疗不良事件和医疗错误呼唤健全的病人安全体系。法律能引导和规范人们的行为,其在病人安全体系中应扮演积极的角色。借鉴国外的经验,中国的病人安全立法的重点应当放在建立和完善医疗伤害的预防机制上,病人安全法的原则有:以病人为中心原则,预防为主、重在治本原则,社会系统工程原则,多元风险保障原则。     

Postmortem dismemberment/mutilation--medicolegal and criminalistic evaluation of the autopsies performed by the Institute of Legal Medicine at the Hanover Medical School

Among all the autopsies performed by the Institute of Legal Medicine at the Hanover Medical School between 1978 and 1998. 16 cases of postmortem dismemberment/mutilation were evaluable under criminalistic and medicolegal aspects. In the present study, particular attention was paid to the psychosocial circumstances of the perpetrator's and victim's lives and also to the classification of the different types of postmortem dismemberment/mutilation illustrated by case reports. Apart from an unfavourable personal life situation at the time of the offence, essential predisposing factors were: poor integration in society and family, occupational problems, drug abuse and mental diseases. As the interactions between these factors differ in every single case and may be combined with other factors, the analysis of such homicides should always be based on the assessment of the individual case.