Recommendations for the application and follow-up of quality controls in medical laboratories

This is a translation of the paper “Recommendations for the application and follow-up of quality controls in medical biology laboratories” published in French in the journal Annales de Biologie Clinique (Recommandations pour la mise en place et le suivi des contrôles de qualité dans les laboratoires de biologie médicale. Ann Biol Clin (Paris). 2019;77:577-97.). The recommendations proposed in this document are the result of work conducted jointly by the Network of Accredited Medical Laboratories (LABAC), the French Society of Medical Biology (SFBC) and the Federation of Associations for External Quality Assessment (FAEEQ). The different steps of the implementation of quality controls, based on a risk analysis, are described. The changes of reagent or internal quality control (IQC) materials batches, the action to be taken in case of non-conform IQC results, the choice of external quality assessment (EQA) scheme and interpretation of their results as well as the new issue of analyses performed on several automatic systems available in the same laboratory are discussed. Finally, the concept of measurement uncertainty, the robustness of the methods as well as the specificities of near-patient testing and rapid tests are described. These recommendations cannot apply for all cases we can find in medical laboratories. The implementation of an objective alternative strategy, supported with documented evidence, might be equally considered.     

Estimation of the measurement uncertainty and practical suggestion for the description of the metrological traceability in clinical laboratories

Clinicians request a large part of measurements of biological quantities that clinical laboratories perform for diagnostic, prognostic or diseases monitoring purposes. Thus, laboratories need to provide patient’s results as reliable as possible. Metrological concepts like measurement uncertainty and metrological traceability allow to know the accuracy of these results and guarantee their comparability over time and space. Such is the importance of these two parameters that the estimation of measurement uncertainty and the knowledge of metrological traceability is required for clinical laboratories accredited by ISO 15189:2012. Despite there are many publications or guidelines to estimate the measurement uncertainty in clinical laboratories, it is not entirely clear what information and which formulae they should use to calculate it. On the other hand, unfortunately, there are a small number of clinical laboratories that know and describe the metrological traceability of their results, even though they are aware of the lack of comparability that currently exists for patient’s results. Thus, to try to facilitate the task of clinical laboratories, this review aims to provide a proposal to estimate the measurement uncertainty. Also, different suggestions are shown to describe the metrological traceability. Measurement uncertainty estimation is partially based on the ISO/TS 20914:2019 guideline, and the metrological traceability described using the ISO 17511:2020. Different biological quantities routinely measured in clinical laboratories are used to exemplify the proposal and suggestions.     

Integrating moving average control procedures into the risk-based quality control plan in small-volume medical laboratories

IntroductionThe modern approach to quality control (QC) in medical laboratories implies the development of a risk-based control plan. This paper aims to develop a risk-based QC plan for a laboratory with a small daily testing volume and to integrate the already optimized moving average (MA) control procedures into this plan.Materials and methodsA multistage bracketed QC plan for ten clinical chemistry analytes was made using a Westgard QC frequency calculator. Previously, MA procedures were optimized by the bias detection simulation method.ResultsAspartate aminotransferase, HDL-cholesterol and potassium had patient-risk sigma metrics greater than 6, albumin and cholesterol greater than 5, creatinine, chlorides, calcium and total proteins between 4 and 5, and sodium less than 4. Based on the calculated run sizes and characteristics of optimized MA procedures, for 6 tests, it was possible to replace the monitoring QC procedure with an MA procedure. For the remaining 4 tests, it was necessary to keep the monitoring QC procedure and introduce MA control for added security.ConclusionThis study showed that even in a laboratory with a small volume of daily testing, it is possible to make a risk-based QC plan and integrate MA control procedures into that plan.     

Moving average procedures as an additional tool for real-time analytical quality control: challenges and opportunities of implementation in small-volume medical laboratories

IntroductionMoving average (MA) is one possible way to use patient results for analytical quality control in medical laboratories. The aims of this study were to: (1) implement previously optimized MA procedures for 10 clinical chemistry analytes into the laboratory information system (LIS); (2) monitor their performance as a real-time quality control tool, and (3) define an algorithm for MA alarm management in a small-volume laboratory to suit the specific laboratory.Materials and methodsMoving average alarms were monitored and analysed over a period of 6 months on all patient results (total of 73,059) obtained for 10 clinical chemistry parameters. The optimal MA procedures were selected previously using an already described technique called the bias detection simulation method, considering the ability of bias detection the size of total allowable error as the key parameter for optimization.ResultsDuring 6 months, 17 MA alarms were registered, which is 0.023% of the total number of generated MA values. In 65% of cases, their cause was of pre-analytical origin, in 12% of analytical origin, and in 23% the cause was not found. The highest alarm rate was determined on sodium (0.10%), and the lowest on calcium and chloride.ConclusionsThis paper showed that even in a small-volume laboratory, previously optimized MA procedures could be successfully implemented in the LIS and used for continuous quality control. Review of patient results, re-analysis of samples from the stable period, analysis of internal quality control samples and assessment of the analyser malfunctions and maintenance log have been proposed for the algorithm for managing MA alarms.     

Glucometers-need for external quality control

We performed a pilot accuracy study on glucometers from three sources: “Advantage” from Boehringer Mannheim (A), “Glucometer^* 4” from Bayer (B) and “One Touch Basic” from Life Scan (C) and compared these results with the results on autoanalyzers-Dimension RxL (1) and Hitachi 704 (2). Each glucometer was tested with venous blood in duplicate, from three different groups of 20 patients each, at random, on three different days, in our outpatient phlebotomy section. The rest of the sample was collected into heparinized tubes & the plasma separated within 15 minutes of sample collection & analyzed on both the analyzers in duplicates. The data were analyzed for accuracy by tabulating the number and percentage of test values that vary from the analyzer (reference) method by 10% or less, by 10% to 20%, or greater than 20% and the results tabulated on the Accuracy Study Table. This being a pilot study and the numbers being small, it may be suggested from the Accuracy Study Table alone, that the results of glucose in whole blood done with glucometer (A) were comparable with that of plasma values without applying any factor; whereas the results with glucometers (B) & (C) need to be divided by 1.11 to be comparable with plasma results; statistically though, results with glucometer (C) were comparable with or without factor. Patients using glucometers need to be alerted about the variance in their glucose results when compared to laboratory results, more clearly by the respective companies in their product inserts. An external quality control material that is glucometer method specific is needed, so that the Clinical Biochemistry laboratory in any hospital setup can more effectively monitor the performance of the glucometers in the wards periodically.     

关于审计证据质量控制的思考

审计证据是审计工作的核心,是形成审计结论的基础和保证。当今审计证据面临着一系列的问题,严重影响了其在经济监督职能方面的发挥。文章分析了审计证据中普遍存在的问题,提出了审计证据质量控制的思路方法,以达到提高审计证据质量的目的。     

实验室总硬度分析质量控制试验方案设计及结果分析

根据水利部水文局《关于加强水质监测质量管理工作的实施方案》(水文质〔2010〕143号)的要求,在全国水利系统水质监测实验室开展质量控制考核工作,总硬度项目实验室常规质量控制试验是本次考核工作的内容之一,根据实验室常规质量控制的相关技术方法和要求,结合本次考核工作实际,设计了总硬度的精密度偏性分析试验方案,取得了较好的试验效果。     

人文关怀在提升医疗服务质量中的作用

本文阐述了济宁医学院附属医院近年来在医疗过程中倡导人文关怀的若干做法以及收到的良好效果,表明人文关怀影响着医院的医疗服务、医疗安全、医疗质量以及全院职工的工作态度,对提高医疗服务质量和医务工作者的道德水平,融洽医患关系等具有积极的促进作用。     

学术期刊闭环质量控制与提升

【目的】针对目前我国学术期刊存在重视出版质量、轻视学术质量、忽视传播质量等问题,介绍了学术期刊全方位质量控制途径。【方法】以《煤炭科学技术》、《煤炭学报》为例,提出了提高期刊学术质量控制要点以及吸引高质量稿源的途径和方法,重点介绍了提高期刊显性传播和隐性传播质量方案及方法,即显性传播包括数字化和网络化传播、期刊全覆盖式发行与传播、期刊画册传播、展会宣传、文献精准推送宣传、学术会议宣传;隐性传播包括组建期刊编辑委员会、协办单位、通讯员队伍,出版通讯副刊,主办、承办、协办学术会议,公益活动等。同时也简要介绍了期刊纸本和数字出版质量控制方案。【结果】通过对学术期刊学术质量、传播质量、出版质量的全面协同控制,可大幅提升期刊品牌质量,促进学术期刊影响力和传播力。【结论】实践表明,闭环质量控制方法可行、实用,效果明显。     

The most common nonconformities encountered during the assessments of medical laboratories in Hong Kong using ISO 15189 as accreditation criteria

Introduction:

ISO 15189 was a new standard published in 2003 for accrediting medical laboratories. We believe that some requirements of the ISO 15189 standard are especially difficult to meet for majority of laboratories. The aim of this article was to present the frequency of nonconformities to requirements of the ISO 15189 accreditation standard, encountered during the assessments of medical laboratories in Hong Kong, during 2004 to 2009.

Materials and methods:

Nonconformities reported in assessments based on ISO 15189 were analyzed in two periods – from 2004 to 2006 and in 2009. They are categorized according to the ISO 15189 clause numbers. The performance of 27 laboratories initially assessed between 2004 and 2006 was compared to their performance in the second reassessment in 2009.

Results:

For management requirements, nonconformities were most frequently reported against quality management system, quality and technical records and document control; whereas for technical requirements, they were reported against examination procedures, equipment, and assuring quality of examination procedures. There was no major difference in types of common nonconformities reported in the two study periods. The total number of nonconformities reported in the second reassessment of 27 laboratories in 2009 was almost halved compared to their initial assessments. The number of significant nonconformities per laboratory significantly decreased (P = 0.023).

Conclusion:

Similar nonconformities were reported in the two study periods though the frequency encountered decreased. The significant decrease in number of significant nonconformities encountered in the same group of laboratories in the two periods substantiated that ISO15189 contributed to quality improvement of accredited laboratories.     

加工过程对茶叶卫生质量的影响与控制对策

影响茶叶卫生质量的因素有很多,加工人员只有掌握了这些影响因素,才可以不断地更新、改进工艺。文章探析加工过程对茶叶卫生质量的影响与控制对策。     

自然资源要素综合观测质量管理体系构建

自然资源要素综合观测体系具有观测对象多、观测指标多、观测技术手段多等特点。为保证观测数据质量,必须构建覆盖从采集到发布数据全周期全过程的数据质量管理体系。本文针对自然资源要素综合观测对数据质量管理体系提出的新要求,基于国内外观测领域数据质量管理体系现状分析,依据ISO9000族国际标准,建立由目标层、组织层、制度层、控制层及评估层五部分组成的综合观测数据质量管理体系框架;基于模块化集成思维,构建纵横多级质量控制体系：纵向上,建立综合研究中心—一级站—二级站—三级站4级外部检查,横向上,建立观测—校对—审核3级内部检查制度;质控技术上,重点研究了不同观测过程的质控模块,建立了QC0（样品实验测试质量控制模块）、QC1（观测数据内部质量控制模块）、QC2（观测数据外部质量控制模块）、QC3（数据质量的考核和评估模块）4种质控模块,提高了质控针对性和有效性。本文旨在通过构建全面的数据质量管理体系和科学的质控方法,保证观测数据准确可靠。     

Preparation of lyophilised lipid rich quality control serum by isolating lipids using large scale chromatography technology

The plasma fractionation is a technology to separate therapeutic plasma proteins. The fractionation is carried out either by solvent precipitation (ethanol) or recently by chromatography. During the process of chromatography lipids were found in waste fraction. A new lipid rich lyophilised quality control (Q.C.) sera was prepared inexpensively using this waste plasma fraction. This is probably the first attempt to prepare the Q.C. sera by large scale chromatographic method in India.     

控制机制对创业能力与突变创新关系影响研究

通过建立一个概念模型论证了企业家创业能力、控制机制与突变创新之间的关系,并采用多行业的大样本数据验证了我们的模型。分析结果表明在需求不确定阻碍企业创新的转型时期,企业家创业能力促进突变创新开展,这一关系进一步受到不同控制机制的调节影响。具体地,行为控制增强创业能力与突变创新间的正相关关系,而结果控制削弱两者间关系。这反映出控制机制在企业突变创新过程中担当的重要角色。     

品管圈在改善护理品质中的应用现状

对品管圈活动在护理工作中如何开展以及进行品质管理的应用现状进行综述,包括护理安全管理、护理质量管理、健康教育,优质护理服务、消毒隔离这些方面。     

Implications of managerial control on performance of Dutch academic (bio)medical and health research groups

Our paper examines the relationship between managerial control and research performance of academic groups. An understanding of the determinants of research performance is a prerequisite for designing effective micro- and macro-research policies. The paper focuses on Dutch medical and health research groups. Our paper addresses the following question: do (certain) research management activities enhance the performance of academic groups? A quantitative approach was used to gather data from research leaders in 160 groups. Correlation analysis and multivariate linear regression analysis show that several aspects of research management have a positive relationship with research performance. Furthermore, this study reveals that managerial choices of Dutch (bio)medical and health research leaders give rise to differences in performances measures. Additionally the disciplinary setting is found to have an impact on relationships between managerial control and performance. The paper concludes by giving suggestions for further research as well as considering possible implications for research policy.     

当前高校素质教育的基本任务及重要性

新时期高校本科生素质教育贴近时代,形式内容并重,而且取得大量成绩,但是依然存在大量问题,在重视度保障措施氛围培养等方面都有很大偏差,其中理念、教师、领导、社会体制管理方面都导致这些问题的产生,要切实重视存在问题,同时切实找出原因,从而更好的把问题解决好。注重三个面向、注重培养学生创新能力,弥补能力素质残缺,为现代化、知识经济培养一专多能复合型人才,为素质教育营造一个良好氛围,同时把素质教育落实好贯彻好。     

中国高研发投入企业运营效率评价研究——基于2017-2020年欧盟产业研发投入记分牌数据

以2017-2020连续4年入选欧盟产业研发投入记分牌的中国247家高研发投入企业为研究对象,通过构建高研发投入企业评价指标体系、构建DEA-BCC模型对其运营效率进行测度和评价,并分别从区域和行业双重视角进行分析,据此提出相关启示建议.     

Impact of combining data from multiple instruments on performance of patient-based real-time quality control

IntroductionIt is unclear what is the best strategy for applying patient-based real-time quality control (PBRTQC) algorithm in the presence of multiple instruments. This simulation study compared the error detection capability of applying PBRTQC algorithms for instruments individually and in combination using serum sodium as an example.Materials and methodsFour sets of random serum sodium measurements were generated with differing means and standard deviations to represent four simulated instruments. Moving median with winsorization was selected as the PBRTQC algorithm. The PBRTQC parameters (block size and control limits) were optimized and applied to the four simulated laboratory data sets individually and in combination.ResultsWhen the PBRTQC algorithm were individually optimized and applied to the data of the individual simulated instruments, it was able to detect bias several folds faster than when they were combined. Similarly, the individually applied algorithms had perfect error detection rates across different magnitudes of bias, whereas the error detection rates of the algorithm applied on the combined data missed smaller biases. The performance of the individually applied PBRTQC algorithm performed more consistently among the simulated instruments compared to when the data were combined.DiscussionWhile combining data from different instruments can increase the data stream and hence, increase the speed of error detection, it may widen the control limits and compromising the probability of error detection. The presence of multiple instruments in the data stream may dilute the effect of the error when it only affects a selected instrument.     

硫酸法钛白生产中磷元素的影响及工艺调控手段

论述硫酸法钛白生产中磷元素的影响以及对钛矿含磷量不同时在生产工艺方面的调节手段,达到稳定和提高产品质量的目的。