Standards serve as the cornerstone for establishing a national technical support system for clinical laboratory quality and provide the foundation for guiding quality improvements in clinical laboratory medicine. This article introduces the National Health Commission Clinical Laboratory Standardization Committee (Standards Committee) and its primary responsibilities. It reviews the significant achievements made by the Standards Committee in standards formulation and revision, promotion, implementation, and international cooperation and exchange over the past six years. The current framework of the clinical laboratory standard system is presented, and the major types of currently effective health industry standards are outlined, covering reference intervals, basic technical standards, performance verification, quality control and evaluation, pre-examination processes, and mutual recognition of test results; clarifies the critical role of health industry standards in ensuring the accuracy and comparability of test results, supporting the construction of laboratory management systems, promoting the mutual recognition of test results, facilitating medical laboratory accreditation, and supporting medical insurance supervision. Examples are provided to illustrate how health industry standards drive the high-quality development of clinical laboratory medicine. Finally, the article future priorities for the Standards Committee in standards formulation and revision, standard promotion, and international exchange, aiming to further advancing the high-quality development of clinical laboratory medicine in China.

As a core element of the national quality infrastructure, accreditation plays a vital role in promoting the high-quality development of medical laboratories in China. By establishing and implementing a quality management system that meets international standards, medical laboratories obtain accreditation, which enhances their technical capabilities, ensures the accuracy of test results, and supports scientific clinical decision-making. This paper systematically reviews the major progress in the accreditation of medical laboratories in China, including the number, types and scope of accredited laboratories, the status of assessment against to ISO 15189:2022, and the current acceptance of accreditation outcomes. It also analyzes key challenges facing current accreditation effort, including the in-depth interpretation and implementation of ISO 15189:2022, the accreditation of point-of-care testing (POCT) and emerging technologies or methodologies, and the insufficient endogenous motivation for continuous improvement in some laboratories. Finally, targeted countermeasure suggestions are proposed, aiming to provide a reference for improving the accreditation system of medical laboratories and promoting the high-quality development of the industry in China.

Vaginal microecological evaluation is essential for the diagnosis and treatment of gynecological infectious diseases. However, the processes of specimen collection and pretreatment, quality control, morphological and chemical examination, result reporting and clinical application remain inadequately standardized across medical institutions at various levels. To address these inconsistencies, the Clinical Laboratory Science and Technology Transformation Professional Committee of the China Association for Promotion of Health Science and Technology and Branch of Clinical Laboratory Physicians of the Guangdong Medical Doctor Association convened a panel of experts in laboratory medicine and clinical practice. By integrating domestic and international standards, guidelines, and the latest research, and through a rigorous process of discussion, revision, and review, the panel formulated the "Expert Consensus on the Standardization of Clinical Laboratory Evaluation and Reporting of vaginal Microecology" (hereinafter referred to as the "Consensus"). This initiative aims to promote the standardized and consistent application of vaginal microecological evaluation.

To support medical laboratory practitioners in better comprehending and applying the Guide to the Assessment of Measurement Uncertainty in Medical Laboratories (hereafter the Guidelines), this article provides a systematic overview of its key elements across three dimensions:the background of its publication, interpretation and application of its core concepts, and illustrative examples of practical application. Through comprehensive case studies, the article analyzes important concepts in measurement uncertainty assessment, such as long-term precision, bias, and bias correction, and clearly delineates the step-by-step assessment process. This work aims to enable readers to fully grasp the essence of the Guidelines and to effectively address the common challenges encountered in uncertainty evaluation within medical laboratory settings..

GB/T 44672-2024/ISO 21151:2020 In vitro diagnostic medical devices-Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples, was released on September 29th, 2024 and came into effect on April 1st, 2025. This standard addresses the need for harmonisation protocols organized and implemented by international bodies in cases where reference measurement procedures, suitable certified reference materials, or internationally agreed calibrators are lacking. By defining the highest achievable level of metrological tracerability for a specified measurand, the standard aims to achieve equivalence of results from different in vitro diagnostic medical devices (IVD MD). This article interprets the core content of the standard and elucidates the value of harmonization schemes in enhancing the comparability of measurement results and promoting result interoperability. The interpretation of this standard will assist clinical laboratories and IVD manufacturers in China in establishing and improving traceability paths based on harmonization schemes in practice, thereby establishing a solid foundation for result consistency across different systems and platforms and homogeneity in clinical decision-making.

Thrombosis and hemostasis testing plays a pivotal role in the diagnosis, treatment, and monitoring of bleeding and thrombotic disorders. Due to the specialized characters and clinical demands, clinical laboratories carry out laboratory developed tests (LDT) to varying degrees. LDT must be validated to ensure that the performance meets clinical needs before they are introduced into routine use; however, clear operational specifications for this process have been lacking. In August 2025, the International Committee for Standardization in Haematology (ICSH) published the Guidance on the Validation of Laboratory Developed Tests in Haemostasis，which provided detailed definitions, performance verification requirements, and implementation strategies for LDT in this field. This article interprets the key provisions of the guideline, aiming to assist laboratory managers and technical personnel in understanding and applying these recommendations effectively.

To standardize the collection of capillary blood specimens, the National Health Commission of China issued the health industry standard WS/T 848-2025 "Guidelines for collection of capillary blood specimen " in July 2025. This standard was developed based on an investigation of the current status of capillary blood specimen collection in hospitals across various levels in China, informed by relevant domestic laws, regulations, and health industry standards, as well as international guidelines for capillary blood specimen collection, combined with clinical practice and expert consensus opinions in China. This standard provides detailed technical requirements for the collection, storage, transportation, and processing of capillary blood samples, which helps to improve the quality and safety of capillary blood collection in medical institutions. To facilitate the dissemination and implementation of this standard, this article interprets the key technical aspects and related precautions of capillary blood specimen collection, in order to help specimen collection personnel and relevant managers in better understanding and applying the standard.

With the significant increase in the prevalence of diabetes in China, glycated hemoglobin (HbA_1c), as a core indicator for the screening and diagnosis of diabetes, its detection accuracy and standardization are crucial for clinical diagnosis and treatment. In 2024, the National Health Commission issued WS/T 461-2024 "Guidelines for Glycated Hemoglobin Detection". As a revised version of the 2015 standard, this updated standard closely aligns with international advances and combines with China's clinical practice, further refining the quality control requirements throughout the entire process of HbA_1c detection. Starting from the background, process and basic situation of the standard revision, this paper focuses on interpreting the core revised key points such as terminology and definitions, biological characteristics and clinical significance, technical requirements for the entire inspection process (pre-inspection, in-inspection, post-inspection), and quality control and assurance. The revision and implementation of this standard mark the deepening of the quality control requirements for HbA1c detection in China, which will promote the improvement of the quality and standardization level of HbA_1c detection in China and provide a solid technical guarantee for the precise prevention and treatment of diabetes.

The standard WS/T 229-2024 "Physical, chemical, and morphological examination of urine" was officially promulgated in May 2024. This revision aims to align with the rapid advancements in urinalysis technology in recent years, addressing prevalent issues in clinical laboratories such as inconsistent standards, non-standardized operations, and challenges in achieving result harmonization across practical procedures, performance verification, quality control, and reporting. Its objective is to further elevate the standardization and result comparability of routine urinalysis in China. The core updates of the new standard are manifested in 3 key areas: Expansion of terminology definitions, enhancement of total process quality management, and standardization of result reporting. Notably, it introduces, for the first time, a systematic integration of requirements for "personnel, facilities, and environment" and incorporates critical quality control components such as "performance verification" and "reflex testing rules". This article provides a detailed interpretation of the standard's main content, with particular focus on the revisions. Furthermore, it offers practical application guidance and recommendations for clinical laboratories, drawing upon relevant international and domestic standards, literature, and real-world scenarios. The ultimate goal is to facilitate effective implementation of the standard in support of accurate and efficient clinical diagnosis and treatment.

To address the challenges posed by large number of the point of care testing (POCT) equipment for blood glucose in large-scale hospitals, homogeneous quality management and concealed risks, this paper verified the practical value of 'isk-oriented sampling combined with technical evaluation' strategy for detecting systematic risks and guiding management decisions.

Four-party collaboration mechanism was established, risk-oriented sampling was conducted and public health "risk early warning" theory was introduced. From over 850 POCT glucose meters throughout the hospital, 115 devices (around 13.5%) exhibiting characteristic of "saturation operation" or "minor performance degradation" were selected as risk-oriented devices. Using the fully automatic biochemical analyzer as the reference method, fresh venous blood samples at five different concentration gradients were tested for on-site comparison. Bias was assessed using Bland-Altman analysis, followed by risk tracing and intervention.

The results showed that correlation coefficients (r) of the three brands of glucose meters and the biochemical analyzer were all above 0.99. However, at a biochemical analyzer measurement value of 13.1 mmol/L, Bland-Altman analysis results showed systematic negative bias in Brand Q and H (bias of -0.403 mmol/L and -0.688 mmol/L respectively) and the relative bias ranges were -16.79% to -7.63% for Brand Q and -17.56% to -9.16% for Brand H, with a few points exceeding the conventional ±15% error limit. Although an overall pass rate of 100% was achieved for all the three brands based on conventional standard, this strategy successfully identified the concealed concentration-dependent bias. The data analysis revealed that under the same experimental conditions, detection systems of different brands showed significant response inconsistency at high concentration ranges.

The strategy validated that with limited healthcare resource, risk-oriented sampling was able to effectively identify the systematic negative bias at high concentration ranges for devices with specific brands, which is concealed by conventional pass rate evaluation. These findings provide an evidence-based foundation for management strategy on implementing dynamic calibration of blood glucose POCT devices (to correct systematic drift), establishing of scientific retirement criteria, and implementing of targeted clinical supervision (to mitigate potential error accumulation).