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乳腺钼靶检查审核:乳腺钼靶质量标准法案(MQSA)入门指南

The mammography audit: a primer for the mammography quality standards act (MQSA).

作者信息

Linver M N, Osuch J R, Brenner R J, Smith R A

机构信息

X-Ray Associates of New Mexico, Albuquerque 87102, USA.

出版信息

AJR Am J Roentgenol. 1995 Jul;165(1):19-25. doi: 10.2214/ajr.165.1.7785586.

DOI:10.2214/ajr.165.1.7785586
PMID:7785586
Abstract

The medical audit of a mammography practice is a recognized method for evaluating mammography and the accuracy of mammographic interpretation [1-4]. As such, portions of the audit will become integral to the quality assurance activities of every mammography practice under the Mammography Quality Standards Act (MQSA) of 1992, administered by the Food and Drug Administration (FDA). The FDA Interim Rules, which became effective October 1, 1994, state that "each facility shall establish a system for reviewing outcome data from all mammography performed, including follow-up on the disposition of positive mammograms and correlation of surgical biopsy results with mammogram reports" [5]. It is expected that the proposed final rules, due to be released for public comment in 1995, will require collection of additional data for medical audits (public meeting of the National Mammography Advisory Committee, May 3, 1994). Although most mammography practices are now collecting clinical outcomes data on abnormal mammographic examinations, very few have established an organized and deliberate system of data collection necessary for a more complete mammography audit [6]. A detailed discussion of and recommendations for such an audit were recently published as part of the Quality Determinants of Mammography Guideline by the Agency for Healthcare Policy and Research (AHCPR) [7]. As members and consultants on the multidisciplinary panel that produced the guideline, we offer the following review of the various elements, definitions, and processes of the mammography audit. This is intended as a primer for all radiologists who will be performing some of the same audit activities for the MQSA.

摘要

乳腺钼靶检查实践的医学审计是评估乳腺钼靶检查及钼靶影像解读准确性的一种公认方法[1 - 4]。因此,根据1992年由美国食品药品监督管理局(FDA)管理的《乳腺钼靶质量标准法案》(MQSA),审计的部分内容将成为每个乳腺钼靶检查实践质量保证活动的组成部分。1994年10月1日生效的FDA暂行规则规定,“每个机构应建立一个系统,用于审查所有乳腺钼靶检查的结果数据,包括对阳性钼靶检查结果的后续跟踪以及手术活检结果与钼靶检查报告的相关性”[5]。预计将于1995年发布以供公众评论的最终规则将要求收集更多用于医学审计的数据(1994年5月3日全国乳腺钼靶咨询委员会公开会议)。尽管现在大多数乳腺钼靶检查实践都在收集乳腺钼靶异常检查的临床结果数据,但很少有机构建立起一个有组织、有计划的数据收集系统,而这对于更全面的乳腺钼靶检查审计是必不可少的[6]。医疗保健政策与研究机构(AHCPR)最近发布了《乳腺钼靶检查质量决定因素指南》,其中对这种审计进行了详细讨论并提出了建议[7]。作为制定该指南的多学科小组的成员和顾问,我们对乳腺钼靶检查审计的各个要素、定义和流程进行如下综述。这旨在作为所有将为MQSA开展一些相同审计活动的放射科医生的入门指南。

相似文献

1
The mammography audit: a primer for the mammography quality standards act (MQSA).乳腺钼靶检查审核:乳腺钼靶质量标准法案(MQSA)入门指南
AJR Am J Roentgenol. 1995 Jul;165(1):19-25. doi: 10.2214/ajr.165.1.7785586.
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.
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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.
4
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.
5
Quality assurance audits of community screening mammography practices: availability of active follow-up for data collection and outcome assessment.社区乳腺筛查实践的质量保证审计:用于数据收集和结果评估的主动随访的可用性。
AJR Am J Roentgenol. 1994 Oct;163(4):825-9. doi: 10.2214/ajr.163.4.8092017.
6
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.
7
Compliance Guidance: The Mammography Quality Standards Act Final Regulations Document #1; availability. Food and Drug Administration, HHS. Notice.合规指南:《乳腺X线摄影质量标准法案》最终法规文件#1;可获取性。美国卫生与公众服务部食品药品监督管理局。通知。
Fed Regist. 1999 Mar 19;64(53):13590-1.
8
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.
9
Approval of an alternative requirement of the Mammography Quality Standards Act; availability--FDA. Notice.《乳房X线摄影质量标准法案》替代要求的批准;可用性——美国食品药品监督管理局。通知。
Fed Regist. 1998 Nov 9;63(216 Pt 1):60352.
10
Medical devices; Mammography Quality Standards Act of 1992; inspection fees--FDA. Notice.医疗器械;1992年《乳房X线摄影质量标准法案》;检查费——美国食品药品监督管理局。通知。
Fed Regist. 1998 Jan 14;63(9):2245-8.

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