Urinalysis is a commonly used clinical test with both screening and diagnostic value. In 2024, the National Health Commission issued two updated standards, WS/T 348—2024"Collection and processing of urine specimens"and WS/T 229—2024"Physical, chemical and morphological urine examination"which integrate the latest domestic and international developments, and provide standardized requirements on specimens, personnels, facilities, environment, equipments, testing procedures, and quality control, et al. throughout the urinalysis workflow. This article focuses on interpreting hot topics including guidance on specimen collection, equipment performance verification, review rules, internal comparison, result reporting. Practical implementation suggestions are provided. To promote the harmonization and standardization of urinalysis, laboratories need to deeply understand the requirements of the new industry standards, to work out standard operating procedures that comply with the standards, to operate according to the standards, and to implement risk management for urinalysis.

With the development of artificial intelligence and big data,indirect methods for establishing ref-erence intervals(RIs)are commonly used for special populations and special forms of RIs,including continu-ous RIs,personalized RIs,and universal RIs.This paper introduces the differences and application progress of indirect RIs algorithms based on TMC,refineR,Hoffmann,Bhattacharya,Kosmic,and provides references for indirect RIs and related clinical decisions.

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 investigate the blood lipid levels in the population undergoing physical check-up population in Hangzhou dis-trict using the laboratory Big Data for providing references in disease prevention.Methods The test results of blood lipid levels of the individuals undergoing health check-up at a certain hospital from January 2022 to October 2023 were collected,excluding the abnormal positive resultss.SPSS 25.0 software was used to calculate the median(M),25th percentile(P25)and 75 Percentile(P75)grouped by gender and age in 10-year intervals.TMC was used to calculate 2.5th percentile(P25)and 97.5th percentile(P97 5),and GAMLSS was used to draw the age-continuous percentile charts.Results Gender differences in blood lipid levels were observed.The levels of total cholesterol(TC),triglycerides(TG),and low-density lipoprotein cholesterol(LDL-C)in males were higher than those of fe-males in the age of 19 to 49 groups.However,the levels of TC and LDL-C in females were higher than those of males in the age of 50 to 90 groups.TG levels in females were higher than those of males in the age of 60 to 90 groups.High-density lipoprotein cholesterol(HDL-C)levels in females were higher than those in males.TG level in males at ages of 40 to 49 reached peak,while females reached the peak of TG level at ages of 70 to 79.The LDL-C level in males at ages 40 to 49 reached the peak,while females reached the peak of LDL-C level at ages 60 to 69.Blood lipid levels were associated with age.The levels of TG,TC in female and LDL-C in female showed particularly significant changes,first increasing and then decreasing with age.Conclusion Blood lipid levels are closely relat-ed to gender and age.Personalized lipid management should be conducted,considering the factors of gender and age.

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 investigate the blood lipid levels in the population undergoing physical check-up population in Hangzhou dis-trict using the laboratory Big Data for providing references in disease prevention.Methods The test results of blood lipid levels of the individuals undergoing health check-up at a certain hospital from January 2022 to October 2023 were collected,excluding the abnormal positive resultss.SPSS 25.0 software was used to calculate the median(M),25th percentile(P25)and 75 Percentile(P75)grouped by gender and age in 10-year intervals.TMC was used to calculate 2.5th percentile(P25)and 97.5th percentile(P97 5),and GAMLSS was used to draw the age-continuous percentile charts.Results Gender differences in blood lipid levels were observed.The levels of total cholesterol(TC),triglycerides(TG),and low-density lipoprotein cholesterol(LDL-C)in males were higher than those of fe-males in the age of 19 to 49 groups.However,the levels of TC and LDL-C in females were higher than those of males in the age of 50 to 90 groups.TG levels in females were higher than those of males in the age of 60 to 90 groups.High-density lipoprotein cholesterol(HDL-C)levels in females were higher than those in males.TG level in males at ages of 40 to 49 reached peak,while females reached the peak of TG level at ages of 70 to 79.The LDL-C level in males at ages 40 to 49 reached the peak,while females reached the peak of LDL-C level at ages 60 to 69.Blood lipid levels were associated with age.The levels of TG,TC in female and LDL-C in female showed particularly significant changes,first increasing and then decreasing with age.Conclusion Blood lipid levels are closely relat-ed to gender and age.Personalized lipid management should be conducted,considering the factors of gender and age.

Urinalysis is a commonly used clinical test with both screening and diagnostic value. In 2024, the National Health Commission issued two updated standards, WS/T 348—2024"Collection and processing of urine specimens"and WS/T 229—2024"Physical, chemical and morphological urine examination"which integrate the latest domestic and international developments, and provide standardized requirements on specimens, personnels, facilities, environment, equipments, testing procedures, and quality control, et al. throughout the urinalysis workflow. This article focuses on interpreting hot topics including guidance on specimen collection, equipment performance verification, review rules, internal comparison, result reporting. Practical implementation suggestions are provided. To promote the harmonization and standardization of urinalysis, laboratories need to deeply understand the requirements of the new industry standards, to work out standard operating procedures that comply with the standards, to operate according to the standards, and to implement risk management for urinalysis.

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.

Objective:To reduce associated risks in the field of laboratory information through risk management software.Method:A risk control team was established to conduct an application research on risk management. Based on ISO 15189 Clause 7.6 control of data and information management, the risk control team used the software to conduct risk assessments on the First Affiliated Hospital, Zhejiang University School of Medicine in 2024 through methods such as brainstorming, Failure Mode and Effects Analysis (FMEA). Risk control, risk monitoring, and risk management review were implemented.Result:42 risk points were identified in the fields of data control and information management. After evaluation by the risk control team,it was determined that one item is high-risk with a risk number of 51.56 and three items are medium risk with risk numbers of 35.45, 31.27, and 30.75 The risk priority numbers of the 4 risk points were reduced to acceptable levels below 25 after taking appropriate risk control measures, then the 4 risk points were monitored.Conclusion:The application of risk management software is helpful for the implementation of risk management in the laboratory information field.

Objective:To reduce associated risks in the field of laboratory information through risk management software.Method:A risk control team was established to conduct an application research on risk management. Based on ISO 15189 Clause 7.6 control of data and information management, the risk control team used the software to conduct risk assessments on the First Affiliated Hospital, Zhejiang University School of Medicine in 2024 through methods such as brainstorming, Failure Mode and Effects Analysis (FMEA). Risk control, risk monitoring, and risk management review were implemented.Result:42 risk points were identified in the fields of data control and information management. After evaluation by the risk control team,it was determined that one item is high-risk with a risk number of 51.56 and three items are medium risk with risk numbers of 35.45, 31.27, and 30.75 The risk priority numbers of the 4 risk points were reduced to acceptable levels below 25 after taking appropriate risk control measures, then the 4 risk points were monitored.Conclusion:The application of risk management software is helpful for the implementation of risk management in the laboratory information field.