Fostering rational regulation of patient safety

After decades of inattention to the problem of medical injuries, patient safety is now occupying a prominent place on the health policy agenda and garnering renewed regulatory interest. Health care providers' behavior, with respect to patient safety and health care quality improvement, is now being shaped by top-down regulation through statutes and administrative agency oversight, as well as bottom-up drivers such as tort litigation and the forces of the consumer-driven health care market. Patient safety today exemplifies that eclectic mix of regulation that can occur when a new problem is exposed to the general public; it also demonstrates the difficulties of coordinating regulatory signals from multiple sources and regulating incomplete information. This article reviews the evolution of the regulatory environment for patient safety, examines some of the tensions and challenges that currently define patient safety oversight, and suggests strategies for more rational and responsive regulation.     

Medical Error and Patient Safety: Understanding Cultures in Conflict

Evidence documenting the high rate of medical errors to patients has taken a prominent place on the health care radar screen. The injuries and deaths associated with medical errors represent a major public health problem with significant economic costs and erosion of trust in the health care system. Between 44,000 and 98,000 deaths due to preventable medical errors are estimated to occur each year, making medical errors the eighth leading cause of death in the United States. However, the recent prominence of the issue of safety or error does not reflect a new phenomenon or sudden rift in the quality of health care (although it is a system fraying at the edges). Rather, the prominence of the issue reflects a radical change in the culture of health care, and in how relationships within the health care system are structured and perceived. In this paper, I discuss the multiple factors responsible for the change in the culture of health care. First, the culture has shifted from a clinician cantered system, in which decision making is one–sided, to a shared system of negotiated care between clinician and patient, and, often, between administrator or payer. Second, the nature of quality in health care has changed due to the geometric increase in the availability of technological and pharmaceutical enhancements to patient care. Third, the health care culture continues to rely on outdated models of conflict resolution. Finally, the regulatory structure of health system oversight was set in place when fee–for–service care governed physician–patient relationships and where few external technologies were available. In the current health care culture, that structure seems inadequate and diffuse, with multiple and overlapping federal and state regulatory structures that make implementation of patient safety systems difficult.     

The hospital board at risk and the need to restructure the relationship with the medical staff: bylaws,peer review and related solutions

This article argues that the current structure of the hospital governing board and medical staff relationship does not support and promote quality and patient-centered care. The fundamental flaw in the current structure is the interdependent, yet independent and discordant relationships between hospital governing boards and medical staffs. These relationships are described as cultures and fit into three types of "silos": organizational (the "structural silo"); professional (the "professional silo", including the "culture of blame"); and the fragmented quality information silo (the "informational silo"). While case law, statutory requirements and regulatory expectations clearly state that governing boards are ultimately responsible for quality of patient care, governing boards delegate these functions to medical staff without having sufficient information to measure and monitor quality. As a result, problems manifest because of these failures of oversight and compliance. Dramatic lapses in quality occur due to overuse, underuse, and misuse of healthcare services. Furthermore, the challenges and opportunities from improved quality and patient safety, as a strategic business driver, cannot be seized until the underlying structural flaws are understood and addressed. This article proposes that solutions become apparent when the various health care constituencies are educated about these cultural impacts and when multidisciplinary bodies, with board leadership and direct authority, integrate and consider quality information.     

Hospital utilization review: past experience, future directions

Utilization review (UR) programs seek to determine whether specific services are medically necessary and whether they are delivered at an appropriate level of intensity and cost. Although UR programs have been operating for more than 40 years, they have changed dramatically during the past two decades. Today, many health care providers, analysts, and policymakers view UR as a possible solution to hospital inpatient cost and quality problems. This paper addresses how UR has evolved, how UR is used today by different delivery mechanisms (i.e., Medicare, health maintenance organizations, preferred provider organizations, Blue Cross, and commercial insurers), the cost effects of various UR approaches, and how UR will be used in the future.     

Ball Memorial Hospital: Section 2 Sherman Act analysis in the alternative health care delivery market

In 1986, the Seventh Circuit Court of Appeals in Ball Memorial Hospital v. Mutual Hospital Insurance denied an injunction sought under the antitrust laws by the plaintiffs, eighty acute care hospitals, which would have precluded Blue Cross and Blue Shield of Indiana from implementing a Preferred Provider Organization. The Ball court used a conservative economic analysis to deny the injunction and failed to consider many industry-specific factors. This Note examines these factors and challenges the Ball court's position by arguing that antitrust scrutiny of alternative health care delivery markets must go beyond the court's narrow approach.     

论政府采购合同的法律性质

《政府采购法》将政府采购合同定位为民商事合同,似乎是对政府采购合同在宏观上具有民商事合同的某些性质作了准确定位。然而,微观分析这一定位,可以发现它既未反映合同类型化的法制演进逻辑,更与政府采购合同国际发展趋势不一致。政府采购合同的本质属性明显有别于民商事合同,属行政合同。     

Two faces of patient safety and care quality: a Franco-American comparison

Patient safety, and more broadly the quality of care, is typically discussed with reference to the reduction of preventable adverse events within hospitals and adherence to practice guidelines on care processes. We call it the 'care-centered approach' and recognize that the United States is a leader in the field. Another face of patient safety and care quality may be defined as the 'system-centered approach'. It focuses on access to a timely and effective continuum of health-care services--clinical prevention, primary care and appropriate referral to and receipt of specialty care. Although France's efforts to pursue a care-centered approach to patient safety are limited, its system-centered approach yields some benefits. Based on the evidence we have reviewed for access to primary care (hospital discharges for avoidable hospital conditions), mortality amenable to medical intervention and consumer satisfaction, in the United States and France, there appear to be good grounds for bolstering the system-centered approach in the United States.     

弱势群体保护的社会契约分析

社会契约的“订立”旨在使人类摆脱“自然状态”进入“社会状态”;作为国家“存在原理”,社会契约主旨是解决个人、社会和国家之间的权利与义务问题,其终极关怀是人民的福祉——保障安全、自由、财富和尊严等。但这些可欲的价值的实现须符合一种正义的原则和道德要求:平等对待和惠及包括弱势群体在内的社会合作体系中的每一个立约者。平等、互惠构成弱势群体保护的社会契约基础和道德义务,也是社会契约和社会秩序的实现条件。在这一意义上,不保护弱势群体,社会契约目的就不能达到,政府合法性就被质疑。弱势群体保护需要对社会契约进行动态完善——创新保护模式、着力后续调整、突出经济权利、建立诉讼制衡机制、高扬人本立约观。     

Interest-based mediation of medical malpractice lawsuits: a route to improved patient safety?

Mediation of medical malpractice lawsuits provides savings for the parties by shortening the litigation process. In theory, information that aids emotional healing and improves patient care can also surface through mediation. The study discussed in this article used structured interviews of participants and mediators in thirty-one mediated malpractice lawsuits involving eleven nonprofit hospitals. The study measured perceptions of the process and mediation's effects on settlement, expenses, apology, satisfaction, and information exchange. Defense lawyers were less likely than plaintiff attorneys to mediate. Both plaintiff and defense attorneys were satisfied with the process, as were plaintiffs, hospital representatives, and insurers. Changes in hospitals' practices or policies to improve patient safety were identified. This study demonstrates that major challenges stand in the way of achieving mediation's full benefits. Absence of physician participation minimizes the chances that mediated discussion of adverse events and medical errors can lead to improved quality of care. Change will require medical leaders, hospital administrators, and malpractice insurers to temper their suspicion of the tort system sufficiently to approach medical errors and adverse events as learning opportunities, and to retain lawyers who embrace mediation as an opportunity to solve problems, show compassion, and improve care.     

Using law to fight a silent epidemic: the role of health literacy in health care access, quality, & cost

The dominant rhetoric in the health care policy debate about cost has assumed an inherent tension between access and quality on the one hand, and cost effectiveness on the other; but an emerging discourse has challenged this narrative by presenting a more nuanced relationship between access, quality, and cost. This is reflected in the discourse surrounding health literacy, which is viewed as an important tool for achieving all three goals. Health literacy refers to one's ability to obtain, understand and use health information to make appropriate health decisions. Research shows that improving patients' health literacy can help overcome access barriers and empower patients to be better health care partners, which should lead to better health outcomes. Promoting health literacy can also reduce expenditures for unnecessary or inappropriate treatment. This explains why, as a policy matter, improving health literacy is an objective that has been embraced by almost every sector of the health care system. As a legal matter, however, the role of health literacy in ensuring quality and access is not as prominent. Although the health literacy movement is relatively young, it has roots in longstanding bioethical principles of patient autonomy, beneficence, and justice as well as the corresponding legal principles of informed consent, the right to quality care, and antidiscrimination. Assumptions and concerns about health literacy seem to do important, yet subtle work in these legal doctrines--influencing conclusions about patient understanding in informed consent cases, animating decisions about patient responsibility in malpractice cases, and underlying regulatory guidance concerning the quality of language assistance services that are necessary for meaningful access to care. Nonetheless, health literacy is not explicitly treated as a legally relevant factor in these doctrines. Moreover, there is no coherent legal framework for incorporating health literacy research that challenges traditional assumptions about patient comprehension and decision-making, and that emphasizes the need for providers to improve communication and take affirmative steps to assess patient understanding. The absence of a clear and robust consideration of health literacy in these doctrines undermines core access and quality aims, and it means that such laws are of limited efficacy in promoting health literacy. Returning to the theme that the health literacy problem reflects a complementary view of access, quality and cost, it is likely that the cost implications of this problem (and not concerns about quality and access) will motivate the kind of health literacy reform that may ultimately strengthen existing quality and access standards. One recent example of this can be seen in reforms linked to government, insurer and provider attempts to reduce costly medication errors.     

论美国医疗过失案件中注意标准的确定——从历史的视角纵向分析

医疗注意义务是整个医疗过失理论的核心，而注意标准概念则是重中之重。本文从不同时期的判例着手，重点展示美国的注意义务标准的历史发展过程和总体趋势：合同还是侵权，单一程式标准还是多因素可变标准，提高病人安全还是控制医疗费用。通过分析不同时段内法理与司法实践的主要特点，本文将美国医疗注意标准的各种影响因素逐步列出，突出行业惯例和地域因素在整个体系内的辉煌与落败。如今美国的医疗注意义务标准也面临挑战，即医疗保健体系与医疗保险改革背后对医疗费用控制的政策对它产生了冲击。     

Intelligent agents and intentionality: Should we begin to think outside the box?

The emergence of intelligent software agents that operate autonomously with little or no human intervention has generated many doctrinal questions at a conceptual level and has challenged the traditional rules of contract especially those relating to the intention as an essential requirement of any contract conclusion. This paper will explore some of these challenges, and shine a spotlight on the conflict between the traditional contract theory and the transactional practice in the case of using intelligent software agents. Further, it will examine how intelligent software agents differ from other software applications and then consider how such differences are legally relevant. This paper, however, is not intended to provide the final answer to all questions and challenges in this regard, but to identify the main components and provide perspectives on how to deal with such issues.     

论建设工程合同规范定位的嬗变及完善

建设工程合同的规范调整,经历了从统一到分离的长期演变过程,其最终从承揽合同中分离乃因其规范的法律关系的特殊性。然而此种特殊性已非民事合同规范所能容纳或解决,未来建设工程合同制度的规范定位,有待注重商事合同规则和社会公共利益的要求。     

以实质公平理念规制契约自由——以格式合同为例证

吉尔莫所谓的契约之死,无非是契约自由的丧失,也即和契约正义"合体"的契约自由的丧失。契约自由与契约正义由"合体"走向背离,是因着"主体平等"和"完全自由市场"在垄断的语境下不复存在。格式合同的出现成了契约自由背离契约正义的典型例证。在格式合同中,合意和选择失去了意义,契约自由背离了契约正义从而走向了形式正义的泥沼。将实质公平理念引入契约自由原则,或许能带来契约的再生。以实质公平理念规制格式合同,通过国家干预性质的立法、司法和行政手段实现格式合同中自由与正义的"合体"。本文以格式合同的典型司法案例为例证,研究了如何将经济法关于实质公平的价值理念引入格式合同的民商事审判,以探索一条如何达致契约自由与契约正义新的"合体"以及契约自由再生的司法实践路径。     

Special report on liability and insurance. An update on assignment of patient benefits under ERISA

While the holdings in Davidowitz and Arkansas Blue Cross & Blue Shield arose in different contexts, they both reflect the courts' increasing willingness to consider the importance of cost containment in the health insurance arena, even though patient accessibility to health care may be restricted as a result. If the holding in Davidowitz is not successfully appealed, providers may need legislative relief in order to retain their ability to take valid assignments of patient claims for payment from ERISA plans. It is uncertain whether such legislation can be sought at the state level or must instead come from Congress due to ERISA preemption of state legislation. Clearly, the district court decision on remand in Arkansas Blue Cross & Blue Shield will be closely watched for any light it may shed on this question. On a pragmatic note, providers who have not entered into "participation" agreements with insurers or other private payors may now have a greater incentive to do so, and "nonparticipating" providers who continue to obtain assignments from patients in order to collect directly from insurers or other private payors should determine on a case-by-case basis whether the source of the patient's benefits is a group health plan--which is likely to fall under ERISA and may contain nonassignment provisions--or some other form of coverage. For an additional perspective on insurers' responses to copayment waivers, see Newsletter, Vol. 6, No. 10, October 1991, at 7.     

Quality assurance and hospital structure: how the physician-hospital relationship affects quality measures

Mr. Spaeth writes about the relationship between hospital administration and the physician, and how that relationship affects the quality of medical care delivered to the patient. The article focuses on the differences between the employment structure in an academic teaching hospital, and the open, independent contractor medical staff typical of a traditionally smaller community hospitals. The individual traits and nuances of these structures and how they can be distinguished from one another create dynamic differences in the approach for quality care. Peer review, credentialing, and management of adverse outcomes are just a few of the ways in which hospitals continue to strive to provide higher quality care, but the way these methods are implemented and performed in different hospital structures are dramatically different, yielding distinct results. Mr. Spaeth argues that the challenges faced by community hospitals in their effort to provide higher quality care and eliminate medical error are exacerbated because of their unique structure and the particular relationship physicians share with the hospital and its administration.     

Advocate Safety Planning Training,Feedback, and Personal Challenges

Of all the advocacy services provided to partner violence and sexual assault victims, safety planning may be most central. However, unlike many community behavioral health or case management services, there is virtually no literature on standards of care in safety planning, ways to measure its effectiveness, or discussion of the challenges advocates face in their day-to-day practice of planning for victim safety. The purpose of this paper is to describe advocate perceptions of training and supervision, how they obtain feedback about their work with victims, and their personal challenges in safety planning with victims. Study results highlight the need for more guidance, training, and support as well as more coping strategies for the numerous personal challenges advocates face in their day-to-day safety planning work. Implications for research and practice are discussed.     

国际商事仲裁协议法律适用若干问题探析——从仲裁条款的独立性角度出发

国际商事仲裁协议的法律适用,即以何种法律为标准来认定仲裁协议的成立和效力,是一个极为复杂的理论和实践问题。本文从仲裁条款的独立性问题出发,对于国际商事仲裁协议法律适用的特性、主合同的法律适用原则能否及于合同中的仲裁条款等问题进行了初步的探讨。     

Connecting consumer choice to the healthcare system

American healthcare needs to be reformed into competing, efficient, comprehensive care systems. To get there from here, we need a health insurance market in which each person or household has a wide, responsible, informed, individual multiple choice of health care financing and delivery plans. The point of this is competing delivery systems, not just competing carriers. To compete, some carriers will create or contract with selective delivery systems or doctors selected for their quality and cost-effectiveness. Others will already be teamed up with large multispecialty group practices. On the other hand, high deductible plans will not help us get to a reformed delivery system.