CAJ | 학술논문

目的：通过对上海市18家医院实验室在ISO15189实验室认可现场评审中不符合项的汇总分析，提出不符合项规范纠正方法和路径，为其他医学实验室提供参考和借鉴。方法收集18家医学实验室ISO15189现场评审不符合项，按分布条款进行筛选、整理和分析，并按照不符合描述、原因分析、纠正措施、纠正实施、纠正验证5个方面重新编写，提出对共性问题的纠正方法。结果共收集18家医学实验室297个不符合项，其中管理部分76项，占25．6％，技术部分221项，占74．4％；检验程序的质量保证共61项，占20．5％（61/297），有6类47种表现形式。结论通过对不符合项的汇总分析和重新整理，理清了各种不符合项的原因，对医学实验室质量改进和实验室认可起到了很好的借鉴参考作用。
목적：통과대상해시18가의원실험실재ISO15189실험실인가현장평심중불부합항적회총분석，제출불부합항규범규정방법화로경，위기타의학실험실제공삼고화차감。방법수집18가의학실험실ISO15189현장평심불부합항，안분포조관진행사선、정리화분석，병안조불부합묘술、원인분석、규정조시、규정실시、규정험증5개방면중신편사，제출대공성문제적규정방법。결과공수집18가의학실험실297개불부합항，기중관리부분76항，점25．6％，기술부분221항，점74．4％；검험정서적질량보증공61항，점20．5％（61/297），유6류47충표현형식。결론통과대불부합항적회총분석화중신정리，리청료각충불부합항적원인，대의학실험실질량개진화실험실인가기도료흔호적차감삼고작용。
Objective To perform summary analysis on ISO1 51 89 accreditation on-site review nonconformity items of 1 8 medical laboratories in Shanghai,to give the correct methods and pathways for the nonconformity items,and to provide reference for other medical laboratories.Methods ISO1 51 89 accreditation on-site review nonconformity items of 1 8 medical laboratories in Shanghai were collected, screened and analyzed. According to the nonconformity description,cause analysis,corrective action,correct implementation and correct verification,the correct methods and pathways for common problems are put forward.Results A total of 297 nonconformity items were collected,including 76 items about management (25.6%)and 221 items about technique (74.4%).There were 61 items for the quality insurance of laboratory procedure,accounting for 20.5%(61/297),with 6 classes of 47 forms.Conclusions Through the summary and rearrangement analysis of nonconformity items,the causes of nonconformity items are cleaned up,and the qualities of medical laboratory and laboratory accreditation are improved with reference effects.