Management practice of internal audit for homogeneous assay in multi-campus hospitals
10.13602/j.cnki.jcls.2025.08.14
- VernacularTitle:多院区同质化检验内部审核的管理实践
- Author:
Meiyun CHEN
1
;
Changai HU
;
Dagan YANG
Author Information
1. 三门县人民医院检验科,浙江台州 317100;浙江大学医学院附属第一医院检验科,杭州 310003
- Publication Type:Journal Article
- Keywords:
quality management;
internal audit;
nonconformity;
intelligent management
- From:
Chinese Journal of Clinical Laboratory Science
2025;43(8):619-623
- CountryChina
- Language:Chinese
-
Abstract:
Objective To explore the internal audit for homogeneous assay in a multi-campus hospital and provide references for the homogeneous quality management of clinical laboratory.Methods We adopted the unified process of internal audit and the inspection criteria(CNAS-CL02:Guidelines for the Accreditation of Quality and Competence of Medical Laboratories),and collected the non-con-forming items of 3 internal audits in a public hospital with 4 campuses from 2022 to 2024.The non-conforming items and the distribu-tion were statistically analyzed and then the corrective actions were discussed.Results A total of 294 non-conforming items were col-lected in 3 internal audits,and the median of professional group(25th percentile,75th percentile)was 39(34,49).The non-confor-ming items were mainly concentrated in"7.3 testing process"(98),"6.2 personnel"(36),and"6.6 reagents and consumables"(28).Among them,28 non-conforming items related to 2 or 3 different professional areas,and 14 items related to 4 or more areas.The 14 non-conforming items occurred repeatedly in 3 internal audits and crossed multiple areas and multiple campuses simultaneously and involved 6 clauses.Conclusion The homogeneous internal audit for multi-campus hospital could find the shared problems,formulate effective rectification measures,and promote quality management of homogenized assays in clinical laboratories.