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.

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.

Objective To analyze nonconformities between 2012 and 2022 version of ISO 15189,and provide strategies of transitioning to new standard for laboratories.Methods A total of 522 nonconformities from 32 on-site audits in 24 laboratories against ISO 15189:2012 were collected and mapped them to the relevant clauses of ISO 15189:2022.Strategies for transitioning ISO 15189 to new version were explored based on the standard requirements,literature review and current laboratory practices.Results On average,16 noncon-formities(range from 8 to 31)were identified in every on-site audit.Most of them were related to ISO 15189:2022 clauses 7.3 Exami-nation Processes(165 nonconformities).The others were clause 6.5 Equipment Calibration and Metrological Traceability(43)and clause 6.6 Reagents and Consumables(40).Relatively fewer nonconformities involved new/enhanced requirements,such as risk man-agement,patient-related processes and point-of-care testing.Conclusion The main nonconformities in ISO 15189:2022 predominantly involved in the link of examination processes.It should be suggested that the laboratories strengthen the management in this area by a-dopting digital/intelligent technologies in order to smoothly implement the requirements of the new version of ISO 15189:2022 standard.A comprehensive strategy,including incorporating training,gap analysis,document revision,implementation involved in all staff,stringent risk management and continuous improvement should be recommended to ensure successful transition progress for replacement of ISO 15189:2022.

The medical consulting service, disease inquiry and seeking medical advice functions of 10 commonly available APP software in China for seeking medical advice, such asRapid Asking Doctors,Handholding Doc-tor Selection, andChunyu Handholding Doctors, were compared, which showed that although the functions of APP software in China for seeking medical advice could meet the requirement of people for seeking medical advice, importance should be further attached to their accurate and integrative information and establishment of profit-making model in order to promote the sustainable development of medical APP software.