Obtaining replacements: the organizational framework of organ procurement

In the last ten years there has grown up, in the United States, the most extensive organ procurement system in the world. This system, consisting of approximately 120 organ procurement agencies, retrieved 4435 cadaveric kidneys for transplant purposes in 1981. The nation's organ procurement agencies vary greatly in terms of size, organizational structure, and effectiveness. On average, those agencies not formally part of a transplant hospital appear to be the more effective. This can be accounted for by their superior operational flexibility and their pursuit of a "marketing" strategy. Success in organ procurement requires that medical professionals in non-transplant hospitals, and the potential donors' families, be motivated to assist in the organ procurement process.     

Medicare and Medicaid programs; announcement of additional applications from hospitals requesting waivers for organ procurement service area--HCFA

This notice announces two additional applications that HCFA has received from hospitals requesting waivers from entering into agreements with their designated organ procurement organizations (OPOs) in accordance with section 1138(a)(2) of the Social Security Act. It supplements notices published in the Federal Register on January 19, 1996, May 17, 1996, November 8, 1996, April 21, 1997, and September 17, 1997, that announced hospital waiver requests received by us. This notice requests comments from OPOs and the general public for our consideration in determining whether these waivers should be granted.     

Fifty years of organ transplants: the successes and the failures

More than fifty years have now passed since the first successful human organ transplant. During that time, substantial progress has been made in both surgical techniques and immunosuppressive drug therapy. As a result, transplant success rates have improved dramatically, and thousands of recipients of kidneys, hearts, livers, and lungs have been granted both longer and healthier lives. At the same time, however, many more thousands of patients have died while waiting in vain for a cadaveric donor organ to become available due to a severe and persistent shortage of such organs. That shortage, in turn, is directly attributable to the National Organ Transplant Act of 1984, which proscribes payment to potential organ donors, even if that would increase supply. This atavistic policy and the shortage and deaths it has spawned provides a stirring example of the tendency for public policy to lag behind technological advancement, particularly in the medical field. But the tide of medical opinion may be turning on this issue, and some form of donor payments may soon emerge.     

Medicare and Medicaid programs; conditions of coverage for organ procurement organizations--HCFA. Interim final rule with comment

This interim final rule with comment sets forth changes to the conditions of coverage for organ procurement organizations (OPOs). It redefines an OPO service area, revises the qualifications for the Board of Directors, specifies the assistance to be provided by an OPO to hospitals in establishing and implementing protocols governing organ procurement activity, requires an OPO to establish criteria for allocating organs, and requires an OPO to ensure that tests are performed on prospective organ donors to prevent the acquisition of organs that are infected with the etiologic agent for Acquired Immune Deficiency Syndrome. These changes are required by the Health Omnibus Programs Extension Act of 1988 (Public Law 100-607) and the Transplant Amendments Act of 1990 (Public Law 101-616). We also clarify the distinction between certification and designation and amend the criteria with respect to compliance with performance standards, change of ownership, and termination procedures.     

警医联动机制处置医患矛盾的现状及对策

医院的安全稳定是医疗事业发展的前提和保证,安全稳定已成为医疗工作的重要组成部分。通过对警医联动机制处置医患矛盾存在的问题进行分析,从公安机关角度出发,结合医疗机构实际,提出了警医联动机制建设的对策建议,对促进我国当前警医联动机制的进一步完善,维护医疗机构正常工作秩序,确保医院、医务人员和广大患者的合法权益,提升公安机关的公信力具有积极意义。     

National Association of Medical Examiners position paper on the medical examiner release of organs and tissues for transplantation

The medical examiner community plays a key role in the organ and tissue procurement process for transplantation. Since many, if not most, potential organ or tissue donors fall under medicolegal jurisdiction, the medical examiner bears responsibility to authorize or deny the procurement of organs or tissues on a case-by-case basis. This responsibility engenders a basic dichotomy for the medical examiner's decision-making process. In cases falling under his/her jurisdiction, the medical examiner must balance the medicolegal responsibility centered on the decedent with the societal responsibility to respect the wishes of the decedent and/or next of kin to help living patients. Much has been written on this complex issue in both the forensic pathology and the transplantation literature. Several studies and surveys of medical examiner practices, as well as suggested protocols for handling certain types of cases, are available for reference when concerns arise that procurement may potentially hinder medicolegal death investigation. It is the position of the National Association of Medical Examiners (NAME) that the procurement of organs and/or tissues for transplantation can be accomplished in virtually all cases, without detriment to evidence collection, postmortem examination, determination of cause and manner of death, or the conducting of criminal or civil legal proceedings. The purpose of this position paper is to review the available data, the arguments for and against medical examiner release, and to encourage the release of organs and tissues in all but the rarest of circumstances.     

PUBLIC COOPERATION WITH THE POLICE IN GHANA: DOES PROCEDURAL FAIRNESS MATTER?*

Recent criminological emphasis on the salience of normative concerns, such as procedural fairness and legitimacy, in understanding public law‐abiding behavior has been based on evidence from Anglo‐American studies. This article examines these issues in the African context based on general survey data from Accra, Ghana. The results show a lack of empirical validity, in the Ghanaian context, of the Sunshine–Tyler legitimacy scale. The results also show that public cooperation with the police in Ghana is shaped by utilitarian factors such as perceptions of current police effectiveness infighting crime. It is argued that the importance of perceived police effectiveness to public cooperation is a result of police legitimation deficits and the public's alienation from the Ghana police, which in turn are traced to the colonial history of the police and current poor police performance.     

Giving until it hurts: prisoners are not the answer to the national organ shortage

This Note argues that prisoners, whether executed or living, should not become organ donors. The introduction acknowledges the shortage of transplantable organs in the United States and the steps that have been taken to ameliorate the crisis. Part I discusses the procurement of organs from executed prisoners, beginning with a brief examination of China, a country where this type of procurement is routinely practiced. Part I also examines organ procurement legislation pertaining to executed prisoners. Finally, Part I asserts the reasons that prisoners should not become donors, including the dead donor rule, the ban against physicians as executioners, the Oath of Hippocrates, the risk of transmissible diseases, and the negative perception that would result if organ procurement was tied to executions. Part II of this Note discusses prisoners donating their organs in return for mitigated sentences. Part II then argues that this practice should not be adopted because of the lack of informed consent and voluntary choice. Finally, Part III of this Note introduces potential solutions to the possibility of maintaining a voluntary system, moving to a presumed consent system, and using financial inducements to create a larger supply of transplantable organs.     

Ethical criteria for procuring and distributing organs for transplantation

This article provides an ethical analysis and assessment of various actual and proposed policies of organ procurement and distribution in light of moral principles already embedded in U.S. institutions, laws, policies, and practices. Evaluating different methods of acquisition of human body parts--donation (express and presumed), sales, abandonment, and expropriation--the author argues for laws and policies, including required request, to maintain and facilitate express donation of organs by individuals and their families. Such laws and policies need adequate time for a determination of their effectiveness before society moves to other major alternatives, such as a market. In organ allocation and distribution, which have close moral connections with organ procurement, the author defends the judgment of the federal Task Force on Organ Transplantation that the community should have dispositional authority over donated organs, that professionals should be viewed as trustees and stewards of donated organs, and that the public should be heavily involved in the formation of policies of allocation and distribution. Concentrating on policies being developed in the United Network for Organ Sharing, the author examines the point system for cadaveric kidneys, the access of foreign nationals to organs donated in the U.S., and the multiple listings of patients seeking transplants. He concludes by identifying two major problems of equitable access to donated organs that will have to be addressed by social institutions other than UNOS: access to the waiting list for donated organs and the role of ability to pay in extrarenal transplants.     

Medicare and Medicaid programs; announcement of additional application from hospital requesting waiver for organ procurement service area--HCFA. Notice with comment period

This notice announces an additional application that HCFA has received from a hospital requesting waiver from dealing with its designated organ procurement organization (OPO) in accordance with section 1138(a)(2) of the Act. This notice requests comments from OPOs and the general public for our consideration in determining whether such a waiver should be granted.     

Public Good, Private Protections: Competing Values in German Transplantation Law

Organ transplantation has become almost routine practice in many industrialized countries. Policy, ethical, and legal debates tend to center on fairness of allocation rules or alternatives to promote greater numbers of donations. There are also certain beliefs about the use of bodily materials that are often presumed to be homogenous across Euro–American societies. In Germany, however, the idea of using the bodies of some for the good of others, and the right to proclaim some bodies dead for large–scale medical and political purposes is highly charged. This is due to the historical context of medical experimentation, selection, and euthanasia under National Socialism, and the former East German socialist policies which intervened in the private lives and bodies of citizens. This article is based on an ethnography of organ procurement practices during the period when German policymakers struggled with writing a transplant law. Active public resistance revealed deep concern about state intervention in private matters and amplified the growing unrest over definitions of moral community in a changing, post–reunification society. The article shows how public disputes about health policy become a way through which societies deal with other social conflicts.     

Disclosure of information to organ procurement organizations. Interim final rule

This document amends the Department of Veterans Affairs (VA) regulations to implement section 204 of the Veterans Benefits, Health Care, and Information Technology Act of 2006. This regulatory change will provide authority for VA to provide individually-identifiable VA medical records of veterans or dependents of veterans who are deceased or whose death is imminent to representatives of organ procurement organizations (OPOs) as defined in section 371(b) of the Public Health Service Act (PHS Act), eye banks, and tissue banks to determine whether the patients are suitable potential donors.     

Why we need the independent sector: the behavior, law, and ethics of not-for-profit hospitals

Among the major forms of corporate ownership, the not-for-profit ownership form is distinct in its behavior, legal constraints, and moral obligations. A new empirical analysis of the American Hospital industry, using eleven years of data for all urban general hospitals in the country, shows that corporate form accounts for large differences in the provision of specific medical services. Not-for-profit hospitals systematically provide both private and public goods that are in the public interest, and that other forms fail to provide. Two hypotheses are proposed to account for the findings, one legal and one moral. While no causal claims are made, not-for-profit hospital behavior is consistent with the behavior required by law and morality. The moral argument, developed as a preliminary theory of not-for-profit ethics, also provides a potential reason to prefer not-for-profit hospitals. The findings provide a new justification for the not-for-profit tax exemption for hospitals, and also suggest new uses for ownership categories as regulatory tools.     

Financing Services of General Interest in the EU: How do Public Procurement and State Aids Interact to Demarcate between Market Forces and Protection?

Abstract:  The present article reveals the interplay between public procurement and state financing of public services within the regulatory régime of state aids. The symbiotic flexibility embedded in the regime of regulating the award of public contracts which permits the introduction of public policy considerations in dispersing public services is established. This finding removes the often-misunderstood justification of public procurement as an economic exercise, and places its regulation in the centre of an ordo-liberal interpretation of the European integration process. The significance of public procurement for the financing of services of general interest is verified through an asymmetric geometry analysis. The article concludes that the public procurement framework will be relied upon for two main purposes: first to insert competitiveness within the public sector and market forces in the provision of services of general interest and secondly, to be used by the European judiciary and the European Commission as a system to verify conceptual links, create compatibility safeguards and authenticate established principles applicable in state aid regulation.     

Medicare program; changes to the hospital inpatient prospective payment systems and fiscal year 2001 rates. Health Care Financing Administration (HCFA), HHS. Final rule

We are revising the Medicare hospital inpatient prospective payment system for operating costs to: implement applicable statutory requirements, including a number of provisions of the Medicare, Medicaid, and State Children's Health Insurance Program Balanced Budget Refinement Act of 1999 (Pub. L. 106-113); and implement changes arising from our continuing experience with the system. In addition, in the Addendum to this final rule, we describe changes to the amounts and factors used to determine the rates for Medicare hospital inpatient services for operating costs and capital-related costs. These changes apply to discharges occurring on or after October 1, 2000. We also set forth rate-of-increase limits and make changes to our policy for hospitals and hospital units excluded from the prospective payment systems. We are making changes to the policies governing payments to hospitals for the direct costs of graduate medical education, sole community hospitals and critical access hospitals. We are adding a new condition of participation on organ, tissue, and eye procurement for critical access hospitals that parallels the condition of participation that we previously published for all other Medicare-participating hospitals. Lastly, we are finalizing a January 20, 2000 interim final rule with comment period (65 FR 3136) that sets forth the criteria to be used in calculating the Medicare disproportionate share adjustment in reference to Medicaid expansion waiver patient days under section 1115 of the Social Security Act.     

Administering Entitlement: Governance,Public Health Care,and the Early American State

This article explores the federal marine hospitals of the early republic, the first public health care system in US history. Beginning in 1798, the federal government collected twenty cents per month from mariners' wages and used this revenue to subsidize medical care for sick and disabled merchant mariners. Previous studies have traced links between marine hospitals and modern public policy. By studying governance from the bottom up, this article takes a different approach. I argue that jurists, physicians, and officials' regulation of sailors' entitlement to public health care facilitated and reflected a transformation of national authority. Between 1798 and 1816, sailors' entitlement was a local matter, based on the traditional paternalist understandings of maritime laborers as social dependents. By 1836, though, the federal Treasury redefined entitlement around a newly calculus of productivity: only the productive were entitled to care at the marine hospitals. This story about governance, federal law, and political economy in the early United States suggests that the early American state was a more vibrant participant in the market and society than has been previously understood.     

Bioethical and legal considerations in increasing the supply of transplantable organs: from UAGA to "Baby Fae"

In the last 35 years, organ transplant technology has advanced greatly. The major problem associated with organ transplantation is organ availability, and not surgery-related mortality. This article examines current organ procurement procedures and technologies, legislative responses to the scarcity of transplantable organs, as well as the psychological barriers to organ donation. Issues of fairness in the allocation of scarce economic and social resources, the role of religion and ethics in organ donation and transplantation decision, and the impact of the media are also considered.     

Ethical considerations underpinning the donation of live,non-regenerative organs

The recent donation of a kidney to one of Australia's most prominent citizens by a long-time friend and employee has brought to attention the problems of access facing patients who require renal transplantation as a life-saving measure. The lack of availability of cadaver organs, the improved techniques available to minimise tissue rejection and the potential to genetically engineer tissue-compatible individuals for future organ donation have generated an interest in the ethical and legal considerations that underlie live organ donation.     

The politics of organ transplantation: a parable of our time

This paper reviews the historical development of federal government policy for kidney, heart, and liver transplantation. It examines several political dimensions of whole organ transplantation: the role of the print and broadcast media; the management of organ procurement; the certification of transplant centers; the evaluation of new surgical procedures; and the issues of financing, distributive justice, and rationing of scarce medical resources. The author finds that the media, though powerful in affecting transplant policy, have not been subjected to critical analysis. Organ procurement modifications, driven by a need orientation toward closing the gap between actual and desired levels of performance, may have adversely affected performance. The case of liver transplantation suggests the need for improved institutions and mechanisms for evaluating new surgical procedures. Finally, states that confront the need to meet a binding budget-balancing requirement may allocate funds away from expensive medical procedures that benefit the few toward basic services that benefit the many; the Oregon and Virginia Medicaid programs exemplify this point.     

Public procurement as a means to achieving social gains – progress and challenges in European legislation and standards for accessible information and communication technology

This article explores the European Commission goal of improving the quality and level of accessibility in mainstream information and communication technology (ICT) goods and services available in Member States through the use of public procurement legislation and performance standards. Over the past two decades, the Commission has encouraged Member States to adopt common requirements for accessibility and to strengthen efforts to use these requirements in public procurement. In the absence of significant improvements in the level of accessibility over this time, the Commission has more recently committed to bringing forward legislative proposals to harmonize the accessibility requirements used by Member States. A new procurement directive package contains stronger obligations on public bodies to include accessibility as mandatory requirements in Technical Specifications. In parallel to this, a standardization mandate by the Commission to the European Standards Organizations (ESOs) concluded in March 2014 with the publication of the first European standard on ICT accessibility. In light of these developments, this article analyses the trajectory of European policy in the field of accessibility over the last two decades, and the interplay between European public procurement, standardization and law. It examines how far these developments have succeeded in bringing into being a public procurement eco-system that will nudge the market in Europe to producing affordable and accessible ICT products and services for persons with disabilities.