免疫学检验结果自动审核程序的建立及其应用

目的探讨基于实验室信息管理系统(LIS)的免疫学检验项目的自动审核程序的应用价值。方法参照美国临床和实验室标准化协会(CLSI)AUTO·10A文件的流程框架,综合运用医嘱溯源性校验、各免疫学检验项目的线性范围、不准确度、检验结果间的逻辑关系以及患者结果的回顾性校验,制定嵌入LIS的自动审核规则和审核程序。结果免疫学检验定性项目设4项规则,平均通过率85%;定量项目设9类规则,平均通过率80%。运用智能审核可有效拦截违反规则的检验报告,节省人力资源和缩短报告时间。结论基于LIS的免疫学检验项目的自动审核程序提高了工作效率,避免人为差错或经验不足而误发报告,是LIS在医学检验的智能化管理的应用方式之一。     

检验报告审核中的问题与技巧

根据ISO/DIS15189医学实验室-质量和能力的具体要求,对分析后的检验报告单要建立完整而有效的审核制度.检验报告的审核属于分析后质量控制中的一个环节,也是非常重要的环节,检验报告单如果没有认真进行审核,一旦有错误的报告发送到临床医生和患者手中,科室工作会相当被动,容易造成医疗纠纷,特别是由此产生临床医生或患者对科室的不信任,很难消除.目前,大家都比较重视分析中的质量控制,在这方面进行了大量的研究,而对分析后检验报告单的审核则相对忽视.检验报告单的审核需要良好的医学综合素质和工作经验,作者在这方面进行了分析和总结,希望能和同行进行探讨.     

分析变异和个体内生物学变异与检验结果的关系

目的利用生物学变异建立差值显著性评价方法,并用于检验结果评价。方法通过室内质量控制数据获得贝克曼AU68全自动生化仪的累计在控变异系数,结合个体内生物学变异计算肝肾功能和电解质等12项生化项目的参考变化值,并评价慢性肾炎患者连续监测的检验结果。结果仪器的分析变异相对固定,总的分析变异与个体内生物学变异相关。差值显著性计算后慢性肾炎患者治疗3个月时的总蛋白、清蛋白、丙氨酸氨基转移酶和肌酐有显著性改变;治疗后8个月肾功能的指标变化没有显著性。结论临床实验室可以使用差值显著性评价方法对患者检验结果和监测指标的系列结果变化进行评价,帮助临床医生科学解读检验报告。     

规范实验审核步骤提高检验质量

目的 通过规范实验报告的核对、审阅程序,保证检验报告质量的真实可靠性.方法 规范分析前、分析后标本核对程序,分析后实验结果的审阅方案,建立临床沟通及信息反馈渠道.结果 有效的杜绝了标本由核对错误所引起报告结果出现质的变化;大大提高了检验结果的检出率,减少误差率;解除临床医生对检验结果的疑问,提高检验科的诚信.结论 规范实验审核步骤是提高检验质量最基本、最重要的质量控制.     

检验报告审核中的问题及应对策略

随着医疗卫生事业的发展和社保、医保的普及,人民群众健康保健意识和就医需求逐渐加强,临床实验室的规范及要求也更为严格。检测结果的准确性对临床诊断治疗起着重要作用,每一个质量控制环节都不可被忽视。分析前和分析中的质控环节在越来越多被重视的时候,检验工作往往会忽略对检验结果的审核。有的检验人员认为有实验室的信息系统和全自动的检测仪器能保证检查结果的准确无误,而忽视了检验报告审核这个质量控制的最后一个环节。报告审核,需要审核人员     

一院三址模式下生化定量项目自动审核系统的建立与优化

目的 建立并优化一套适用于多个院区的生化检验报告自动审核系统,缩短检验报告周转时间,提高检验效能。方法 按照行业指南标准,针对53项临床生化检验项目,在检验信息系统中设计开发6类自动审核规则,并对其临床应用效果进行优化和验证。通过对标本的实验室内报告周转时间、危急值报告时效、自动审核通过率等关键指标进行评估,持续优化审核规则。结果 创建617条规则,以291 765个已审核结果作为模板进行验证,优化规则细节,在3个院区分别设置不同的规则,最终人工审核与自动审核符合率达到100%,其中住院患者标本和非住院患者标本的自动审核通过率分别为67.3%和82.1%,住院患者和非住院患者检验报告的实验室内周转时间分别缩短了30.4%和41.1%。结论 人工审核规则限制是确定自动审核率的最关键步骤,依托检验科信息系统建立的自动审核规则完全适用于一院三址模式,能够降低人工审核比例、缩短标本周转时间,提高检验质量和效率。     

临床化学审核规则的制定及计算机自动确认的应用

目的 制定合理的临床化学检验结果 自动审核规则,运用计算机系统实现检测结果 的自动审核确认.方法 按照美国临床实验室标准化协会(CLSI)AUTO-10A文件的流程框架,依据布林逻辑设计临床生化自动审核的运算法则,结合运用医嘱溯源性校验、各检测项目的 医学决定水平、检验结果 间的逻辑关系以及患者结果 的回顾性校验,制定...     

凝血试验自动审核方案的建立与临床应用

目的?建立凝血试验自动审核方案,验证并应用于常规凝血检验。方法?采用实验室信息管理系统（LIS）、检测设备和中间软件联合构建自动审核实施方案。采用数据库模拟运行和人工审核的方式对历史检验报告进行自动审核规则验证。评估实施凝血自动审核方案后与人工审核之间实验室内周转时间（TAT）情况。结果?构建的自动审核方案涉及9 项凝血检验项目,在LIS中设计了13条自动审核规则。在2018年12月至2019年11月期间临床实践应用中,98.86%的检验报告执行了自动审核程序,检验报告自动审核通过率为73.66%,26.34%检验报告被系统拦截后人工审核。凝血检验单项平均通过率为89.26%,其中PT通过率（97.75%）最高,D-dimer通过率（69.38%）最低。实施自动审核后的实验室内TAT 中位数和第90 百分位值分别较未自动审核时缩短5 min和15 min。实施自动审核期间,自动审核的凝血检验报告TAT 的中位数和第90 百分位值较人工审核分别缩短22 min和27 min。结论?构建的自动审核方案在临床实施后可缩短实验室内TAT,提高工作效率。     

生化免疫检验报告审核专项训练在实习带教中的应用

临床实习是医学检验专业学生将以往学习的基础理论知识转化为实际应用能力的必经过程。临床生化检验和临床免疫检验作为医院检验科日常工作的最重要组成部分,其检验结果的准确性对患者疾病的临床诊断、疗效观察和预后判断具有重要价值,而报告审核是检验质量控制的最后一道防线。因此,优化实习生带教流程与加强报告审核专项训练对提高学生的临床实践能力,提升学生毕业后独立工作能力具有积极的促进作用。该文主要对徐州医科大学附属医院检验科实习带教中生化免疫检验报告审核专项训练的现状、教学和管理进行分析,以供相关单位参考。     

临床生化检验报告审核工作的体会与探讨

检验质量是一切工作的生命线,高质量的检验带给临床高水平的诊断[1],而生化检验是检验工作的主要组成部分.患者的每一项生化检测结果都将为临床的诊断、治疗及预后提供重要参考价值.所以临床医师对检验结果的准确度要求越来越高,而临床生化检验的运行过程中实际包含了各种可波动的误差因素,我们在做好室内、室间质控的基础上,在平时的工作中要总结经验,发现问题并采取适当的措施加以规避.报告审核是保证检验结果准确的最后一道防线,应引起足够的重视.现将几年来在生化报告审核工作中的经验进行归纳、总结,现报道如下. 1 健全完善的实验室质量控制体系 1.1 坚持开展临床常规生化的室内质量控制它是室间质量控制的基础,是进行样本检测的前提条件,是保证检验质量的关键之一.仪器状态、方法选择、参数设置、试剂稳定性、温度湿度等直接影响结果的准确性.因此,开展常规项目的室内质量控制,绘制出质控图,观察是否在控.对于失控项目分析寻找失控原因,解决问题后重新测定质控品在控,再进行标本的检测,以此来监测检验系统的稳定性与精密度,保证发出结果的可靠性.     

Use of patient data for quality control

This article discusses how specific patient data algorithms can be used and optimized for laboratory quality control. These algorithms include delta checks, patient averages, and multivariate checks. With the increasing emphasis on cost containment, the intelligent use of these algorithms should become widespread.     

Determining the utility of creatinine delta checks: A large retrospective analysis

IntroductionDelta checks are a long-standing practice for identifying errors in the laboratory. However, with the decrease in errors due to laboratory automation, their utility is unclear. The objective of this retrospective analysis was to determine whether establishment of a creatinine delta check would be an effective means for capturing true laboratory error.MethodsAll patients with a minimum of two creatinine results during March of 2015 were selected for review (n = 23,410 creatinine results). The lowest % change for a previously confirmed creatinine error in our laboratory was approximately 60%; therefore only results that changed by at least ±60% (n = 254) were reviewed. The etiology of creatinine value change was categorized as laboratory error, pathologic change, or non-pathologic change, based upon chart review.Results: 1.2% (3/254) of reviewed delta checks were determined to reflect 2 instances of true laboratory error that went unrecognized by laboratory staff. 91.3% (232/254) of the delta checks were determined to reflect a pathologic or dialysis-related change in creatinine levels. The remaining 7.5% of delta checks (19/234) were deemed to be non-pathologic changes in creatinine.DiscussionThis study identified two instances of laboratory error reflected by 3 delta checks (1.2%); the vast majority (91.3%) of creatinine results that changed by ±60% were pathologic or dialysis-related. Thus, establishment of a ±60% delta check for creatinine would overwhelmingly flag true biological change and would not be an efficient means for identifying rare laboratory errors. Clinical laboratories should perform similar retrospective analyses prior to enacting delta checks to determine whether they will effectively capture laboratory error.     

Autoverification of test results in the core clinical laboratory

Verification of laboratory test results represents the last opportunity to identify errors before they become part of the electronic medical record. Manual verification of test results places significant reliance on the experience and attentiveness of individual observers to identify errors and is vulnerable to errors through omission and neglect. Peer-reviewed publications have documented gains in process efficiency and quality improvement by use of middleware or laboratory information systems to autoverify test results based on pre-defined acceptability criteria. This review evaluates the acceptability of autoverification (AV) as a safe and reliable alternative to total manual review of laboratory test results. AV schemes developed in accordance with international guidelines and standards are applied throughout the laboratory. Careful design of AV systems involves using multidisciplinary teams to develop test-specific decision algorithms, to assist with programming, to verify programming, and validate programmed algorithms prior to use in evaluation of patient test result profiles. Development of test specific decision algorithms makes use of criteria based on instrument messages and flags, quality control status, result limit checks, delta checks, critical values, consistency checks, and patient-related clinical information. Monitoring of the performance of AV parameters, and regular audits of the AV system integrity is recommended in both the literature and guidelines. The potential for gains to process efficiency, error detection and patient safety, through adoption of AV as part of a laboratories quality assurance tool-case, is well supported in published literature.     

Integration of data derived from biological variation into the quality management system

BACKROUND: Data on within- and between-subject biological variation are available for around 250 analytes commonly used in medical laboratories. METHODS: Integration of this data into the quality system occurs at all three levels of laboratory activity: (a) Preanalytic process: biological variation provides the basis for selecting the most appropriate specimen for analysis, for defining sample stability and for deciding suitable timing between samplings; (b) analytic process: biological variation-derived goals are fundamental for designing internal quality control procedures, and for evaluating laboratory performance; and (c) postanalytic process: delta checks based on within-subject biological variation values are used for validating results and for interpreting serial results from a patient. CONCLUSION: The biological variation is a pillar for managing quality in laboratory medicine.     

Rate and delta checks compared for selected chemistry tests

We compared delta and "rate" check methods for 12 selected chemistry tests. Rate checks were determined by dividing delta checks by inter-specimen interval time. The delta and rate check methods were based on differences and percent change of untransformed and absolute value-transformed values. The distribution of delta differences was not symmetrical for calcium, alkaline phosphatase, aspartate aminotransferase, or phosphorus, which led to different check limits between untransformed and absolute value-transformed methods. The dispersion of rate checks was large. The interval time between two consecutive tests was multimodal, which probably reflected adherence to fixed testing protocols.     

Relationship between delta checks for selected chemistry tests

The correlation between delta differences for 20 serum chemistry tests was calculated for 2400 samples from 288 patients. There were 12 pairs of chemistry tests for which correlation coefficients of the delta checks exceeded 0.25; aspartate aminotransferase and alanine aminotransferase had the highest Pearson correlation coefficient, 0.915. The highest negative, indirect, correlation was between the delta checks of bicarbonate and chloride (-0.219). The relationship between delta differences may be used as a quality-control technique to detect analytical errors.     

血清肌酐苦味酸法自主研发生化诊断试剂的临床研究

目的 评价自主研发的血清肌酐(Cr)生化诊断试剂苦味酸法自身的性能评价及研发试剂与进口优质Cr生化诊断试剂对血清Cr实验检测的可比性及偏倚评估,确认研发试剂是否符合临床要求,能否应用于临床.方法 依据美国临床实验室标准化协会EP9-A文件标准,科学设计试验方案.在设置好各种参数的前提下,首先作自主研发血清Cr生化诊断试剂苦味酸法做自身的性能评价:空白吸光度、重复性和线性检测;然后取样本,在奥林巴斯5421型全自动生化仪上进行两种试剂的比对和偏倚评估.结果 自主研发血清Cr生化诊断试剂空白吸光度、重复性和线性检测符合要求,X组试剂和Y组试剂对临床标本Cr的检测结果经统计学处理显示:方法内重复性检查DX′i≤4DX′i、DY′i≤4DY′i,离群点检查Eij≤4E,Eij′≤4E′,线性回归r=0.999 8、系统误差的估计值及其置信区间|Clow,Chigh|＜允许误差,系统误差符合国际标准要求.结论 自主研发的Cr生化诊断试剂与公认的优质进口ROCHE生化诊断试剂间具有良好的相关性,自主研发Cr生化诊断试剂自身性能良好,安全性和有效性符合临床应用要求.     

Simulations of delta check rule performance to detect specimen mislabeling using historical laboratory data

BackgroundDespite their widespread use, the performance of delta check rules is rarely evaluated because errors are rare and lack a gold standard for detection. In this study we used a simulation-based approach to compare strategies for empirically defining criteria for univariate delta checks, and assessed the performance of these rules for detecting mislabeled specimens in 2 inpatient populations.MethodsWe performed simulations using historical laboratory test results by randomly sampling pairs of specimens successively drawn from the same patient or two different patients. We evaluated the performance of delta check rules using a variety of thresholds, including those currently in use in our laboratory.ResultMean corpuscular volume had the highest positive predictive value for specimen mislabeling, and produced the fewest false positives. Conversely, rules using other laboratory tests had considerably poorer performance. Several of the “best guess” thresholds historically used in our laboratory, notably those for potassium and anion gap, were predicted to have extremely low yields. In addition, rule performance was not consistent between the two patient populations.ConclusionsThe low yield of delta checks based on any single analyte should prompt careful evaluation of their practical utility. Furthermore, our results indicate that it may not be possible to generalize delta rules across institutions.     

血清胆固醇自主研发生化诊断试剂的临床研究

目的进行自主研发的血清胆固醇(CHO)生化诊断试剂自身的性能评价及与进口优质CHO生化诊断试剂对血清CHO实验检测的可比性及偏倚评估,确认研发试剂是否符合临床要求,能否应用于临床。方法自主研发的血清CHO COD-PAP法生化诊断试剂自身的性能评价做空白吸光度、重复性和线性功能评价。两种试剂的比对和偏倚评估依据美国临床实验室标准化协会EP9-A文件标准,科学设计试验方案,以进口日本Olympus诊断试剂为对照组(X),国内中生北控生物科技公司(中生)诊断试剂为实验组(Y),在奥林巴斯(Olympus)AU5421自动生化分析仪上测定血清CHO含量。标本选择高、中、低值血清CHO含量的临床患者血清共计100份,每天10份,每份标本正序、倒序各测定1次,记录测定结果,做统计学分析。结果自主研发血清CHO生化诊断试剂空白吸光度、重复性和线性检测符合要求,X组试剂和Y组试剂对临床标本血清CHO的检测结果经统计学处理显示:方法内重复性检查DXi′≤4DX′,DYi′≤4DY′、离群点检查Eij≤4E,Eij′≤4E′、线性回归r2=0.995、系统误差的估计值及其置信区间|BClow,BChigh|小于允许误差,系统误差符合国际标准要求。结论自主研发的CHO生化诊断试剂与公认的优质进口Olympus生化诊断试剂两者间具有良好的相关性;自主研发的CHO生化诊断试剂自身性能良好,安全性和有效性符合临床应用要求。     

Quality control in computed tomography

In comparison to the constancy checks in conventional roentgenography, quality control in computed tomography (CT) should be limited to a few simple but essential checks for image quality and radiation burden. These requirements, however, can only be fulfilled in part, because of the complexity of CT systems. Possible parameters are: water and air values, pixel noise/contrast resolution, spatial resolution, artifacts, homogeneity, contrast scale/tube voltage, slice thickness, positioning accuracy, image quality of the topogram, radiation dose and film imaging. With a simple test program, comprising 4 CT-scans and a camera test image that is presently being tested, most of the mentioned quantities can be checked.