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首页> 外文期刊>Fertility and Sterility: Official Journal of the American Fertility Society, Pacific Coast Fertility Society, and the Canadian Fertility and Andrology Society >Economic cost for implementation of the U.S. Food and Drug Administration's Code of Federal Regulations Title 21, Part 1271 in an egg donor program.
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Economic cost for implementation of the U.S. Food and Drug Administration's Code of Federal Regulations Title 21, Part 1271 in an egg donor program.

机译：在鸡蛋捐赠者计划中实施《美国食品药品监督管理局联邦法规第21号标题》第1271部分的经济成本。

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OBJECTIVE: To assess the economic cost of implementing the U.S. Food and Drug Administration's Code of Federal Regulations Title 21, Part 1271 for infectious screening of egg donors in our practice during the first year. DESIGN: Physicians and employees of our practice were surveyed to ascertain the scope of duties and the number of hours spent to implement the regulations. The economic cost to the practice and the cost of additional laboratories were calculated. SETTING: Private practice. PATIENT(S): Egg donors and recipient couples who underwent treatment in our center from May 25, 2005 (the day regulations became effective) to May 25, 2006; and physicians, administrators, and staff who were employed by the practice during this time frame. INTERVENTION(S): Using a questionnaire, structured interviews were conducted for all physicians and employees of our practice. The information regarding number of hours was provided to our chief financial officer, who calculated the cost to the practice. The cost that recipient couples paid for laboratory tests that would not otherwise be required to meet American Society for Reproductive Medicine guidelines and the cost of an external audit were also added to the overall practice costs to determine a total cost associated with the regulations in the first year. MAIN OUTCOME MEASURE(S): List of activities associated with implementation of the regulations, personnel hours involved to implement the regulations, and economic cost to the practice and to recipient couples. RESULT(S): The total number of personnel hours spent by our practice in preparation for implementation of the regulations was 623.3 hours. In the first year, 675.2 additional hours were required to implement the regulations for 40 donors who cycled during this time. The economic cost to the practice for both preparation and implementation of the regulations was Dollars 219, 838, and the cost of additional laboratory work borne by the recipient couples was Dollars 15,880. Thus, the total cost was calculated to be Dollars 235,718 at 1 year after implementation of the regulations. CONCLUSION(S): Implementation of the FDA 21 CFR, Part 1271 was associated with a very high economic cost, even if the costs incurred by the government to develop and implement the regulation are excluded.
机译：目的：评估在第一年的实践中，实施美国食品药品管理局的联邦法规法典第21篇第1271部分对卵子供体进行感染性筛查的经济成本。设计：对我们的执业医师和员工进行了调查，以确定职责范围和执行法规所花费的时间。计算了该实践的经济成本和其他实验室的成本。地点：私人执业。患者：自2005年5月25日（法规生效之日）至2006年5月25日在我们中心接受治疗的卵子捐赠者和接受者夫妇;以及在此时间范围内受雇于该实践的医师，管理人员和员工。干预：使用问卷，对我们业务的所有医生和员工进行结构化访谈。有关工时数的信息已提供给我们的首席财务官，该首席财务官计算了实务成本。接受治疗的夫妇为满足美国生殖医学学会的指导方针而不需要的实验室检查费用和外部审计费用也被添加到了总体执业费用中，以确定与第一条规定相关的总费用。年。主要观察指标：与实施法规相关的活动，实施法规所涉及的人员小时数以及对执业者和新婚夫妇造成的经济损失。结果：我们的实践为准备执行法规所花费的人员总小时数为623.3小时。在第一年，要实施40个在此期间骑自行车的捐赠者的法规，还需要675.2小时。制定和实施法规的做法所造成的经济成本分别为219美元和838美元，而接受者夫妇承担的额外实验室工作成本为15,880美元。因此，在执行该条例后一年，总费用经计算为235,718美元。结论：即使不包括政府制定和实施法规所产生的成本，实施FDA 21 CFR第1271部分也带来了很高的经济成本。

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