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[德国门诊诊断超声的技术质量保证]

[Technical quality assurance in diagnostic ultrasound in outpatient care in Germany].

作者信息

Pfandzelter R, Sander G, Balhar T, Langer M

机构信息

Kassenärztliche Bundesvereinigung, Berlin, Germany.

出版信息

Ultraschall Med. 2012 Dec;33(6):574-80. doi: 10.1055/s-0032-1313079. Epub 2012 Aug 7.

Abstract

PURPOSE

Technical quality assurance in diagnostic ultrasound is based on nationally standardized protocols which are mandatory for outpatient care in Germany. Quality assurance includes technical requirements for sonographic instruments based on limiting values for technical parameters and requirements for image quality and documentation. Certification by regional Associations of Statutory Health Insurance Physicians (Kassenärztliche Vereinigungen - KV) requires acceptance tests to prove compliance with all required standards.

MATERIALS AND METHODS

Between April 2009 und December 2011a total of 7457 acceptance tests were performed by the KV Westfalen-Lippe, which represents nearly 13 000 physicians in northwestern parts of Germany. Results of these acceptance tests are evaluated with respect to display mode or Doppler technique, anatomic region and year of manufacture of the instruments.

RESULTS

In 2469 acceptance tests (33 %), objections were raised, mainly due to noncompliance with technical parameters. The frequency of objections strongly increases with the age of sonographic instruments and exceeds 90 % for instruments manufactured before 1995. In acceptance tests where compliance with technical parameters has been approved, insufficient documentation was reported in 6 % and inadequate image quality in 8 % of the tests. Frequency and cause of objections depend on display mode and anatomic region.

CONCLUSION

The study shows that sonographic instruments of higher age often do not meet the required standards, and it can be expected that updates in technical equipment will result in improvements in diagnostic performance and clinical outcome.

摘要

目的

诊断超声的技术质量保证基于德国门诊医疗强制要求的国家标准化协议。质量保证包括基于技术参数限值的超声仪器技术要求以及图像质量和文档要求。地区法定医疗保险医师协会(Kassenärztliche Vereinigungen - KV)的认证要求进行验收测试,以证明符合所有要求的标准。

材料与方法

2009年4月至2011年12月期间,代表德国西北部近13000名医生的威斯特法伦 - 利珀地区协会(KV Westfalen-Lippe)共进行了7457次验收测试。这些验收测试的结果根据显示模式或多普勒技术、解剖区域和仪器制造年份进行评估。

结果

在2469次验收测试(33%)中提出了异议,主要原因是不符合技术参数。异议频率随着超声仪器使用年限的增加而大幅上升,对于1995年以前制造的仪器,这一比例超过90%。在技术参数符合要求的验收测试中,6%的测试报告文档不足,8%的测试报告图像质量不佳。异议的频率和原因取决于显示模式和解剖区域。

结论

该研究表明,使用年限较长的超声仪器往往不符合要求的标准,可以预期技术设备的更新将带来诊断性能和临床结果的改善。

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