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Final Rule (final + rule)
Selected AbstractsThe AJT Report: News and issues that affect organ and tissue transplantationAMERICAN JOURNAL OF TRANSPLANTATION, Issue 9 2010SUE PONDROM The FDA proposes granting vascularized composite allografts the definition of "organs," giving them regulation under the Final Rule. This month, "The AJT Report" explores the implications of this potential change, takes a look at a way to track transplant program profitability, and highlights some hot topics from the American Transplant Congress. [source] The Evolution and Direction of OPTN Oversight of Live Organ Donation and Transplantation in the United StatesAMERICAN JOURNAL OF TRANSPLANTATION, Issue 1 2009R. S. Brown For more than 20 years, the Organ Procurement and Transplantation Network (OPTN) has developed policies and bylaws relating to equitable allocation of deceased donor organs for transplantation. United Network for Organ Sharing (UNOS) operates the OPTN under contract with the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS). Until recent years, the OPTN had little defined authority regarding living donor organ for transplantation except for the collection of data relating to living donor transplants. Beginning with the implementation of the OPTN Final Rule in 2000, and continuing with more recent announcements, the OPTN's role in living donation has grown. Its responsibilities now include monitoring of living donor outcomes, promoting equity in nondirected living donor transplantation and ensuring that transplant programs have expertise and established protocols to promote the safety of living donors and recipients. The purpose of this article is to describe the evolving mandates for the OPTN in living donation, as well as the network's recent activities and ongoing efforts. [source] Development of the New Lung Allocation System in the United StatesAMERICAN JOURNAL OF TRANSPLANTATION, Issue 5p2 2006T. M. Egan This article reviews the development of the new U.S. lung allocation system that took effect in spring 2005. In 1998, the Health Resources and Services Administration of the U.S. Department of Health and Human Services published the Organ Procurement and Transplantation Network (OPTN) Final Rule. Under the rule, which became effective in 2000, the OPTN had to demonstrate that existing allocation policies met certain conditions or change the policies to meet a range of criteria, including broader geographic sharing of organs, reducing the use of waiting time as an allocation criterion and creating equitable organ allocation systems using objective medical criteria and medical urgency to allocate donor organs for transplant. This mandate resulted in reviews of all organ allocation policies, and led to the creation of the Lung Allocation Subcommittee of the OPTN Thoracic Organ Transplantation Committee. This paper reviews the deliberations of the Subcommittee in identifying priorities for a new lung allocation system, the analyses undertaken by the OPTN and the Scientific Registry for Transplant Recipients and the evolution of a new lung allocation system that ranks candidates for lungs based on a Lung Allocation Score, incorporating waiting list and posttransplant survival probabilities. [source] U.S. Federal Regulations for Emergency Research: A Practical Guide and CommentaryACADEMIC EMERGENCY MEDICINE, Issue 1 2008Andrew McRae MD Abstract Emergency medicine research requires the enrollment of subjects with varying decision-making capacities, including capable adults, adults incapacitated by illness or injury, and children. These different categories of subjects are protected by multiple federal regulations. These include the federal Common Rule, the Department of Health and Human Services (DHHS) regulations for pediatric research, and the Food and Drug Administration's (FDA) Final Rule for the Exception from the Requirements of Informed Consent in Emergency Situations. Investigators should be familiar with the relevant federal research regulations to optimally protect vulnerable research subjects, and to facilitate the institutional review board (IRB) review process. IRB members face particular challenges in reviewing emergency research. No regulations exist for research enrolling incapacitated subjects using proxy consent. The wording of the Final Rule may not optimally protect vulnerable subjects. It is also difficult to apply conflicting regulations to a single study that enrolls subjects with differing decision-making capacities. This article is intended as a guide for emergency researchers and IRB members who review emergency research. It reviews the elements of Federal Regulations that apply to consent, subject selection, privacy protection, and the analysis of risks and benefits in all emergency research. It explores the challenges for IRB review listed above, and offers potential solutions to these problems. [source] The Role of Procedural Controls in OSHA's Ergonomics RulemakingPUBLIC ADMINISTRATION REVIEW, Issue 4 2007Stuart Shapiro Few, if any, regulations over the past decade have received as much publicity or engendered such controversy as the ergonomics regulation of the Occupational Health and Safety Administration (OSHA). Some may see the ergonomics rule as the paradigmatic instance of procedural hurdles holding up and eventually destroying a regulation. This article examines the role that procedure played in the ergonomics rulemaking. Lessons are drawn from an analysis of the four publicly available versions of the regulation and interviews with seven high-ranking officials at OSHA and the Small Business Administration. Of the procedural hurdles faced by OSHA, the notice-and-comment requirement had the largest impact on the final rule. OMB review and requirements to conduct a cost-benefit analysis served largely as a fire alarm to political overseers, and the required small business panel had largely symbolic effects. The more traditional control of congressional budgetary oversight had the greatest effect by delaying the rule for three years, and thus eventually doomed OSHA's attempts to regulate. [source] On-call Specialists and Higher Level of Care Transfers in California Emergency DepartmentsACADEMIC EMERGENCY MEDICINE, Issue 4 2008Michael D. Menchine MD Abstract Objectives:, To survey California emergency department (ED) medical directors' impressions of on-call specialist availability and higher level of care (HLOC) transfer needs and difficulties and changes since the passage of the Emergency Medicine Treatment and Active Labor Act (EMTALA) final rule in 2003. Methods:, The authors conducted a survey of all California ED medical directors from February to June 2006 with regard to the composition of the ED on-call panel and need for HLOC transfer. ED demographic data were obtained from the California Office of Statewide Health Planning and Development. Results:, Overall response rate was 243 of 347 (70%). More than 80% of respondent EDs reported having internal medicine, obstetrics/gynecology (OB/GYN), and pediatrics on call. However, fewer than 60% of EDs reported cardiac surgery, otolaryngology, neurosurgery, plastic surgery, or vascular surgery on call. Specialists were less likely to be on call in rural EDs. On-call coverage was rated worse than 3 years ago for 10 of 16 specialties. Rural EDs were more likely, and trauma centers and teaching hospitals were less likely to transfer at least one patient daily for HLOC. ED medical directors reported that the ability to transfer for HLOC has worsened over the past 3 years for all specialties. Respondents indicated that more than 40% of ear, nose, and throat (ENT), orthopedics, plastic surgery, and mental health HLOC transfers take more than 3 hours. Conclusions:, This survey of California ED medical directors suggests ED on-call specialist availability and the ability to transfer for HLOC have worsened since the passage of the EMTALA final rule in 2003. [source] | ||||||||||