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乳腺X线摄影质量保证的立法和监管要求。

Legislative and regulatory mandates for mammography quality assurance.

作者信息

Fintor L, Alciati M H, Fischer R

出版信息

J Public Health Policy. 1995 Spring;16(1):81-107.

PMID:7738160
Abstract

The current practice of screening mammography in the United States has been the focus of numerous legislative and regulatory mandates at the state and federal levels, both in terms of increasing access to age-eligible women and elevating the quality of mammographic imaging. Several parameters have emerged as central to a comprehensive mammography quality assurance program: (1) equipment specifications, (2) equipment performance testing including radiation dose limits, (3) facility quality assurance procedures, and (4) personnel qualifications. In 1992, Congress enacted the Mammography Quality Standards Act (MQSA) (P.L. 102-539) to address the problem of differences in mandated standards across states. By October 1994, all facilities will be required to comply with interim MQSA regulations which were released in December 1993. However, depending upon the specific requirements of applicable state standards, the extent and nature of modifications of existing quality assurance procedures will differ for facilities across states as they attempt to come into compliance with uniform Federal standards. In addition, because some provisions within state standards are likely to be more stringent than Federal standards, some level of variation will persist. This paper reviews the components of mandated standards established by states and the standards established by other organizations, including the Federal Government, prior to the MQSA interim regulations. This review will provide an understanding of the highly technical and complicated requirements surrounding mammography quality assurance.

摘要

在美国,当前乳腺钼靶筛查的实践一直是州和联邦层面众多立法和监管指令的焦点,这体现在增加符合年龄条件的女性接受筛查的机会以及提高乳腺钼靶成像质量两个方面。若干参数已成为全面乳腺钼靶质量保证计划的核心:(1)设备规格,(2)设备性能测试,包括辐射剂量限制,(3)机构质量保证程序,以及(4)人员资质。1992年,国会颁布了《乳腺钼靶质量标准法案》(MQSA)(第102 - 539号公法),以解决各州强制标准存在差异的问题。到1994年10月,所有机构都将被要求遵守1993年12月发布的MQSA临时规定。然而,根据适用的州标准的具体要求,各州机构在试图符合统一的联邦标准时,现有质量保证程序的修改程度和性质会有所不同。此外,由于州标准中的一些规定可能比联邦标准更为严格,某种程度的差异仍将存在。本文回顾了在MQSA临时规定之前,各州制定的强制标准以及包括联邦政府在内的其他组织制定的标准的组成部分。这一回顾将有助于理解围绕乳腺钼靶质量保证的高度技术性和复杂性的要求。

相似文献

1
Legislative and regulatory mandates for mammography quality assurance.乳腺X线摄影质量保证的立法和监管要求。
J Public Health Policy. 1995 Spring;16(1):81-107.
2
MQSA (Mammography Quality Standards Act) update--focusing on quality assurance.《乳房X线摄影质量标准法案》(MQSA)更新——聚焦质量保证
Radiol Manage. 1998 Jul-Aug;20(4):40-50.
3
FDA's mammography facility quality assurance program.美国食品药品监督管理局的乳腺摄影设施质量保证计划。
Adm Radiol. 1994 Feb;13(2):43-4.
4
1998 MQSA (Mammography Quality Standards Act) final rule released. American College of Radiology.1998年发布了《乳房X线摄影质量标准法案》(MQSA)最终规定。美国放射学会。
Radiol Manage. 1998 Jul-Aug;20(4):51-5.
5
Quality standards and certification requirements for mammography facilities--FDA. Interim rule with request for comments.乳腺摄影设施的质量标准和认证要求——美国食品药品监督管理局。征求意见的暂行规定。
Fed Regist. 1993 Dec 21;58(243):67565-72.
6
Quality mammography standards--FDA. Final rule.优质乳腺钼靶摄影标准——美国食品药品监督管理局。最终规则。
Fed Regist. 1997 Oct 28;62(208):55852-994.
7
Quality standards and certification requirements for mammography facilities--FDA. Interim rule; opportunity for public comment.乳腺钼靶检查设施的质量标准和认证要求——美国食品药品监督管理局。暂行规定;公众意见征求机会。
Fed Regist. 1994 Sep 30;59(189):49808-13.
8
Requirements for accrediting bodies of mammography facilities--FDA. Interim rule with request for comments.乳腺摄影设施认证机构的要求——美国食品药品监督管理局。征求意见的暂行规定。
Fed Regist. 1993 Dec 21;58(243):67558-65.
9
The negative impact of MQSA (Mammography Quality Standards Act) on rural mammography programs.《乳腺X线摄影质量标准法案》(MQSA)对农村乳腺X线摄影项目的负面影响。
Radiol Manage. 1998 Jul-Aug;20(4):31-9.
10
MQSA update.乳腺X线摄影质量标准法案更新
Radiol Technol. 2003 Jan-Feb;74(3):202-20; quiz 221-4, 227.

引用本文的文献

1
The impact of mammography quality improvement legislation in Michigan: implications for the National Mammography Quality Standards Act.密歇根州乳腺X线摄影质量改进立法的影响:对《国家乳腺X线摄影质量标准法案》的启示
Am J Public Health. 1998 Apr;88(4):667-71. doi: 10.2105/ajph.88.4.667.
2
Impact of the Mammography Quality Standards Act on access in Minnesota.《乳房X线摄影质量标准法案》对明尼苏达州医疗服务可及性的影响。
Public Health Rep. 1997 Mar-Apr;112(2):142-5.