台灣地區RIA醫學實驗室適用ISO 15189認證標準之調查研究：初期報告

Fitness Investigation on Accreditation of RIA Medical Laboratories by Using ISO 15189 in Taiwan: A Preliminary Report

廖建國(Jian-Guo Liao) ； 王昱豐(Yuh-Feng Wang) ； 邱建勳(Jainn-Shiun Chiu) ； 田惠蘭(Hui-Lan Tien) ； 張錦標(Jin-Biou Chang)

《核子醫學雜誌》 22卷4期 (2009/12) Pp. 205-212

https://doi.org/10.6332/ANMS.2204.001

摘要

背景：ISO 15189爲醫學實驗室認證之國際標率現範，本研究目的爲調查目前RIA實驗室之執行現況及符合情形，以檢討其中符合率較差之部份，並作爲RIA實驗室中請認證或提升檢驗品質之參考。
方法：參考ISO 15189規範，設計163條問卷，於97年11月至98年2月期間，以e-mail方式，針對國內27家醫院之RIA實驗室工作人員，進行不記名問卷調查。
結果：總計發出問卷27份，有效問卷19份，回收率70.37%。RIA實驗室符合ISO 15189之平均比率爲71.40%，且管理要求(67.68%)之符合情形明顯較技術要求(75.13%)爲差，其中人力愈少或不參與認證之RIA實驗室，其符合率愈低，且管理要求和技術要求之符合率差距愈大。認證規範中「不同儀器或方法之間的相關性評估」、「參與臨床巡視」及「急診檢體之接收與處理」等要求，可能對部份核醫科之RIA實驗室較不適用。
結論：RIA實驗室應努力達成ISO 15189之規範要求，並儘量中請認證。但限於各院不同的人力狀況及營運政策，是否申請認證應由各醫院作適當的考量。無論是否中請認證，遵循ISO 15189之統範及要求，必能大幅提升實驗室檢驗品質。

關鍵字

ISO 15189 ； RIA實驗室 ； 醫學實驗室認澄 ； 認證

並列摘要

Background: ISO 15189 is the international accreditation standard. The aim of the study was to investigate the rate at which RIA laboratory practice conform to the ISO 15189 standard to know which item was the worse part and refer to accreditation or quality promotion.
Methods: According to ISO 15189, 163 questionnaire items were designed and administered to RIA laboratories of 27 hospitals from November 2008 to February 2009. The members of the RIA laboratories were inquired through the e-mail and responded anonymously to questionnaires.
Results: The response rate was 70.37% (19 out of 27 laboratories). The mean rate of conformity was 71.40%. With respect to management and technical practices, the former conformed to the ISO1589 standard at an obviously lower rate (67.68%) than the latter (75.13%). The fewer technologists that a laboratory had, or the lower its accreditation, the less it conformed. There were few requirements including ”conducting the clinical visits”, ”receiving and processing for emergency specimen” and ”correction study for different instruments or methods” might not comparatively fit several RIA laboratory in nuclear medicine department.
Conclusion: RIA laboratory should try hard to achieve the requirement of ISO 15189 and apply the accreditation as much as possible. Every laboratory can appropriately select participating in accreditation based on their conditions. In spite of accreditation or not, the quality of laboratory practice would be improved with the requirement of ISO 15189.

並列關鍵字

ISO 15189 ； RIA laboratory ； medical laboratory accreditation ； accreditation