Hirvonen-Kari Mirja, Järvinen Hannu, Kivisaari Leena
Medical Imaging Center, Helsinki University Hospital, Helsinki, Finland.
Acta Radiol. 2010 Jul;51(6):619-24. doi: 10.3109/02841851003698214.
Clinical audit as a systematic examination of medical procedures improves the quality and outcome of patient care. The purpose of a regulatory inspection is to check and verify that the operation and facilities are in full conformance with all legal requirements.
To examine the content of the clinical audits and regulatory inspections of radiological procedures and whether these overlap, and to evaluate the costs to radiological units.
Clinical audits were carried out at each imaging unit of Helsinki University Hospital (HUS) Medical Imaging Center in Finland in 2004 and 2005. The regulatory inspections were carried out after the clinical audits from 2005 to late 2007. The contents of the clinical audit and inspection reports were analyzed statistically and by content analysis. The results of the audits and the inspections were compared to analyze the overlaps, differences, and costs.
The validity and conditions of the safety license, lines of authority, and responsibilities for the use of radiation and patient doses caused by different examinations were evaluated in both audits and inspections. The coverage and frequency of quality control procedures were monitored in every audit and inspection, but inspectors, in addition, checked radiation output. The costs of clinical audit and inspection were under 20 cents per radiological procedure. The auditors gave 98 recommendations, while inspectors gave 62 recommendations and 25 requirements. In clinical audits most of the recommendations concerned guidelines for examining a patient. In the inspections most recommendations were in the category of quality assurance activities.
The clinical audits and regulatory inspections were cheap and had few overlapping topics, but several differences were apparent: in clinical audits, a broader and deeper view of the clinical procedures was taken by comparison with good practices, while regulatory inspections have mainly verified conformance to basic regulatory requirements.
临床审计作为对医疗程序的系统检查，可提高患者护理的质量和效果。监管检查的目的是检查并核实操作和设施是否完全符合所有法律要求。
研究放射程序的临床审计和监管检查的内容及其是否存在重叠，并评估放射科室的成本。
2004年和2005年，在芬兰赫尔辛基大学医院（HUS）医学影像中心的每个成像科室开展了临床审计。2005年至2007年末，在临床审计之后进行了监管检查。对临床审计和检查报告的内容进行了统计分析和内容分析。比较审计和检查的结果，以分析重叠之处、差异和成本。
在审计和检查中均评估了安全许可证的有效性和条件、权限范围以及不同检查所致辐射使用和患者剂量的责任。每次审计和检查都监测了质量控制程序的覆盖范围和频率，但检查人员还额外检查了辐射输出。临床审计和检查的成本每项放射程序低于20美分。审计人员提出了98条建议，而检查人员提出了62条建议和25项要求。在临床审计中，大多数建议涉及患者检查指南。在检查中，大多数建议属于质量保证活动类别。
临床审计和监管检查成本低廉，重叠的主题较少，但存在一些明显差异：与良好做法相比，临床审计对临床程序的审查更广泛、更深入，而监管检查主要核实是否符合基本监管要求。
