Flow cytometry, a multi-parameter, high-throughput cell analysis and sorting technology, is now widely used in clinical practice. While many medical institutions and third-party laboratories in China have established testing platforms, the standardization of laboratory construction lags significantly behind the technology's rapid development. The absence of systematic, national-level guidance has resulted inconsistencies and non-standard practices in laboratory layout, equipment and reagent selection, assay configuration, and personnel training, limiting the full potential of this technology. To address the need for systematic standardization in clinical flow cytometry laboratories, the Molecular Diagnostics Group and the Clinical Immunology Group of the Chinese Society of Laboratory Medicine, in collaboration with the Flow Cytometry Clinical Application Promotion Group of the China National Health Association and domestic experts, have developed this consensus based on the integration of ISO 15189, relevant CLSI guidelines, and the practical experience of ISAC, adapted to the specific context of China. This consensus addresses key areas such as general requirements, personnel requirements, laboratory design and construction, configuration of analytical and auxiliary instruments, and management of reagents and consumables. Its aim is to provide comprehensive and practical guidance for medical institutions at all levels and third-party testing laboratories. The widespread adoption of this consensus is expected to enhance the accuracy, comparability, and reliability of flow cytometry testing in China, thereby better serving clinical needs.

The health industry standard WS/T 408-2024 "Guideline for the verification of analytical performance of quantitative examination procedures" was released in May 2024. The development of this standard fully considered national healthcare-related laws and regulations, domestic and international relevant standards, guidelines, consensus documents, literature evidence, practical experience, and expert opinions. The standard provides verification protocols for the 4 fundamental performance characteristics of quantitative examination procedures: Precision, trueness, linearity, and interference(specificity). This article provides an interpretation of the general principles of the guideline, the design of verification protocols for each performance characteristic, sample preparation, data processing, and result interpretation, aiming to assist relevant professionals and managers in better understanding and applying this standard.

To implement the biosafety management requirements for clinical laboratories as stipulated in the Biosafety Law of the People's Republic of China, the National Health Commission revised and released the health industry standard WS/T 442-2024 "Guideline for clinical laboratory biosafety". This guideline outlines the basic requirements for biosafety risk management, facilities and equipment, and experimental activities in clinical laboratories of medical institutions. It serves as the basis for the construction of level 2 clinical biosafety laboratories and as a guideline for biosafety management. This article provides an interpretation and analysis of the background, development process, main content, and key points of the guideline, with the aim of helping various levels of medical institutions better understand and implement the relevant provisions of the standard, so as to promote the standardization of biological safety management in clinical laboratories, reduce occupational exposure risks, improve public health response capabilities, and provide safety assurance for the prevention and control of emerging infectious diseases.

This article systematically interprets the revision background, core concepts and technical highlights of WS/T 227-2024 "Documental Requirements of Standard Operating Procedure for Medical Laboratory Tests", and explores its positioning and implementation strategies within the clinical laboratory quality management system. Through comparative analysis, the technical differences between the 2002 and 2024 editions are delineated, and a multidimensional interpretation is conducted in conjunction with the ISO 15189:2022 and CLSI QMS02 guidelines. The new standard represents a conceptual leap from the concept of "operating procedures" to the "standard operating procedures (SOP)". It contains 21 elements that build a complete documental framework, innovatively introduces mistake - proofing tools such as "step - operating" table and "if - then" decision table, and strengthens the core status of SOP as a necessary part of the testing system. The release of WS/T 227-2024 marks that the establishment of clinical inspection SOP in our country has entered the phase of systematization and standardization. The laboratory shall establish a SOP system that is complete in elements, unified in format, dynamically managed, thereby supporting the continuous improvement of inspection quality.

Laboratory test panels serves as an important auxiliary tool for clinical practice by helping clinicians select test items efficiently. Under the new circumstances, test panels should followed the principle of being "lean and precise", a goal that has become both a focal point and a significant challenge for medical institutions. To address this issue, this article analyzes the limitations of existing test panels in clinical applications, such as being overly broad or failing to meet clinical needs and elaborates on how to optimize these panels in order to achieve precise adaptation to clinical needs.

To explore the practical value of integrating the dynamic indicator limits derived from national clinical laboratory quality specifications with Six Sigma in driving the continuous improvement of quality indicators across the total testing process in medical laboratories.

Data of 15 quality indicators from the clinical laboratory of a tertiary hospital between 2023 and 2025 were analyzed. Using the 2023 national quality specifications as the baseline and the 2025 specifications as the evaluation standard, 8 quality indicators requiring improvement were included. Based on the root causes of errors, they were divided into process-dependent (n=5) and operation-dependent (n=3) indicators. A dynamic benchmarking management strategy was adopted to implement a stepwise PDCA cycle of "benchmarking, reaching the standard, and setting a new standard," and the improvement effects during 2023 to 2025 were evaluated.

By 2025, the process-dependent indicators improved significantly: Error rates for specimen type, container, and collection volume decreased substantially, with corresponding σ values increasing to 5.4σ (P＜0.01)、5.3σ (P＜0.001)、5.3σ (P＜0.01), respectively. The σ value for the IQC CV failure rate rose to 6.0σ (P＜0.001), and the σ value for the incorrect laboratory report rate increased to 5.3σ (P＜0.001). Among the operation-dependent indicators, the σ values for the blood culture contamination rate and specimen hemolysis rate improved to 4.6σ (P＜0.001) and 4.7σ (P＜0.05), respectively, while the improvement in the anticoagulated specimen coagulation rate was not statistically significant.

The dynamic benchmarking management strategy combined with Six Sigma metrics, through stepwise goal setting and focusing on indicators requiring improvement, can significantly enhance the quality level of the total testing process, with the intervention effect on process-dependent indicators.

To investigate the association of serum interleukin-1 (IL-1), platelet activating factor (PAF), and poor prognosis in patients with acute massive hemorrhage complicated with transfusion-related acute lung injury (TRALI).

Clinical data of 108 patients with acute massive hemorrhage complicated with TRALI treated at the Tianmen First People's Hospital and Jingmen People's Hospital from June 2021 to August 2024 were retrospectively collected. Based on survival status within 7 days after TRALI, patients were divided into a good prognosis group (88 cases, 81.48%) and a poor prognosis group (20 cases, 18.52%). The levels of serum IL-1 and PAF detected at the time of diagnosis of TRALI were collected. The relationship between the levels of serum IL-1 and PAF and the poor prognosis of patients with acute massive hemorrhage complicated with TRALI were explored through statistical methods such as t-test, receiver operating characteristic curve (ROC curve), logistic regression analysis, and interaction.

The proportion of patients with a history of blood transfusion and smoking in the poor prognosis group was significantly higher than that in the good prognosis group(P＜0.05). The serum levels of IL-1 and PAF in the poor prognosis group were higher than those in the good prognosis group(P＜0.05). Logistic regression analysis showed that after adjusting for confounding factors, serum IL-1 and PAF remained poor prognostic factors in acute massive hemorrhage complicated with TRALI (P＜0.05). The ROC curves were plotted, indicating that the area under the curve (AUC) values of serum IL-1 alone and PAF in combination for predicting poor prognosis in patients with acute massive hemorrhage complicated with TRALI were 0.774, 0.824, and 0.891, respectively. The combined prediction had the highest value, among which the cutoff value of serum IL-1 was 111.900 pg/ml. The cut-off value of PAF was 99.950 μg/L. Serum IL-1 and PAF had a positive interaction effect on poor prognosis in patients with acute massive hemorrhage complicated with TRALI. When both of them were highly expressed, the risk of poor prognosis was 53.200 times and 43.908 times higher than that when both of them were low expressed and other location factors, respectively. The synergistic effect was 6.300 times greater than the sum of the effect of the two alone. Among the co-occurrence risks, 82.53% were caused by their interaction.

There is a close correlation between serum IL-1 and PAF levels and poor prognosis in patients with acute hemorrhage complicated with TRALI. When serum IL-1 levels are greater than 111.900 pg/ml and PAF levels are greater than 99.950 μg/L, the risk of poor prognosis in patients with acute hemorrhage complicated with TRALI is higher.

To explore a risk management framework based on ISO 15189 and biosafety to enhance risk management capabilities in biochemical testing.

According to CLSI QMS03 requirements, a risk management practice framework was constructed, including standardized online theoretical training, nonconformity management practices based on ISO 15189 and WS/T 442, and digital intelligence-based practices following the ISO 22367 risk management process. In 2025, 42 trainees were enrolled to validate the training effectiveness of this framework by assessing their mastery level (5-point scale) and theoretical assessment results (100-point scale), while evaluating risk management practices and risk priority numbers (RPN) in biochemical testing.

Trainees achieved a mastery level of 4.50±0.27 for risk management practices, and theoretical assessment scores significantly increased from 61±15 to 91±11 after training (P＜0.001). Established A general laboratory risk source database containing 122 items was established and 30 potential risk points specific to biochemical testing were identified, including 27 low-risk, 2 medium-risk, and 1 high-risk point. For the three medium- and high- risk points, quality control monitoring throughout the process (RPN 48), handling of infectious specimens (RPN 24), and delayed critical value reporting (RPN 24), corresponding risk control measures were implemented, reducing the risks to acceptable levels, and these were incorporated into the risk monitoring list.

An effective risk management framework has been established, integrating theoretical learning, contextualized practice, and risk assessment tools, thereby enhancing risk management capabilities and practical proficiency.

This article provides a systematic interpretation of two pivotal studies on the standardization of serum C-peptide measurement published in China in 2023. Addressing the significant variability in C-peptide test results across domestic laboratories, the research established an isotope-dilution liquid chromatography-tandem mass spectrometry (ID-LC-MS/MS) reference method. This method demonstrated excellent performance, with precision ≤2.2% and accuracy (recovery rate) of 99.6%~101.0%, enabling traceability to SI units. Method comparison revealed substantial biases (32.2%~81.7%) in routine immunoassays, which were significantly reduced (to -6.0%~1.2%) after recalibration using frozen human serum pools (FHSP) assigned by the reference method. Furthermore, the studies identified FHSPs as candidate reference materials with satisfactory commutability and stability, offering a solution for the commutability issues prevalent in external quality assessment (EQA) programs. Together, these two studies construct a complete "reference method - reference material - standardization application" system, providing crucial technical support for improving the consistency of C-peptide measurement in China and holding significant importance for advancing precise diagnosis and treatment of diabetes.

The long-term management of chronic hepatitis B (CHB) involves multiple steps, including screening, diagnosis, disease staging, monitoring of antiviral therapy, assessment of treatment discontinuation and risk of relapse, and surveillance for cirrhosis and hepatocellular carcinoma. Laboratory biomarkers are central to clinical evaluation and decision-making in CHB. With advances in hepatitis B virus (HBV) research and diagnostic technologies, laboratory biomarkers for CHB have evolved from conventional serologic and virologic markers to newer markers that reflect viral transcriptional activity, antigen expression characteristics, and the status of the viral reservoir. While improving diagnosis and treatment rates remains a fundamental goal in CHB care, the recognition of functional cure as an important therapeutic endpoint has further increased the need for biomarkers that can assess residual viral activity, stratify relapse risk after treatment withdrawal, and guide long-term follow-up strategies. In this review, we summarize the evidence base and clinical application characteristics of conventional and novel laboratory biomarkers in CHB, and further discuss the roles of reflex testing and laboratory test utilization management in optimizing clinical pathways for CHB. Overall, the optimization of laboratory testing in CHB should not depend on simply increasing the number of assays, but rather on the rational integration of biomarkers according to specific clinical questions, so as to improve diagnostic and management efficiency, reduce unnecessary testing, and better support stratified management, long-term follow-up, and the assessment of functional cure.

In the diagnosis, disease monitoring, and prognosis evaluation of autoimmune diseases, laboratory markers such as autoantibodies hold significant value. However, traditional testing practices face challenges including suboptimal strategies, low positive predictive value, and wastage of medical resources. Evidence-based medicine emphasizes guiding clinical decisions based on the best available research evidence, while machine learning, with its powerful data mining and analytical capabilities, provides robust support for the management and selection of clinical laboratory tests. This article explores the value of a novel strategy for autoimmune disease testing project selection, grounded in evidence-based medicine and machine learning, in disease diagnosis, stratified management, and prognosis evaluation. Using systemic lupus erythematosus as an example, a novel test pannel strategy for autoimmune disease testing panels is constructed. This novel strategy demonstrates significant potential in enhancing diagnostic efficacy, strengthening dynamic management, and optimizing the allocation of medical resources. However, its clinical implementation still faces multiple challenges, including standardization of testing platforms, quality of training data, and integration with healthcare information systems. In the future, through the accumulation of multi-center data and deep integration with clinical decision support systems, it is expected to establish a novel strategy for autoimmune disease testing panel selection that optimizes quality, efficiency, and cost.

Residual risk is the risk that remains and cannot be completely eliminated after risk control and management measures have been implemented. This review summarizes the current status and progress of residual risk management in medical laboratories. It outlines the current application of commonly used risk management tools in clinical and transfusion laboratories for residual risk identification, reassessment, continuous monitoring, and improvement, and further reviews recent advances in disease-related residual risk in clinical laboratory testing and transfusion-related residual risk in transfusion safety. Available evidence suggests that residual risk management facilitates the ongoing identification of weaknesses in existing technologies and workflows, and promotes an expansion of risk management from internal laboratory control to patient safety and clinical decision support, thereby contributing to improved laboratory quality and transfusion safety.