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1.
Sigma is a metric that quantifies the performance of a process as a rate of Defects-Per-Million opportunities. In clinical laboratories, sigma metric analysis is used to assess the performance of laboratory process system. Sigma metric is also used as a quality management strategy for a laboratory process to improve the quality by addressing the errors after identification. The aim of this study is to evaluate the errors in quality control of analytical phase of laboratory system by sigma metric. For this purpose sigma metric analysis was done for analytes using the internal and external quality control as quality indicators. Results of sigma metric analysis were used to identify the gaps and need for modification in the strategy of laboratory quality control procedure. Sigma metric was calculated for quality control program of ten clinical chemistry analytes including glucose, chloride, cholesterol, triglyceride, HDL, albumin, direct bilirubin, total bilirubin, protein and creatinine, at two control levels. To calculate the sigma metric imprecision and bias was calculated with internal and external quality control data, respectively. The minimum acceptable performance was considered as 3 sigma. Westgard sigma rules were applied to customize the quality control procedure. Sigma level was found acceptable (≥3) for glucose (L2), cholesterol, triglyceride, HDL, direct bilirubin and creatinine at both levels of control. For rest of the analytes sigma metric was found <3. The lowest value for sigma was found for chloride (1.1) at L2. The highest value of sigma was found for creatinine (10.1) at L3. HDL was found with the highest sigma values at both control levels (8.8 and 8.0 at L2 and L3, respectively). We conclude that analytes with the sigma value <3 are required strict monitoring and modification in quality control procedure. In this study application of sigma rules provided us the practical solution for improved and focused design of QC procedure.  相似文献   

2.
Ensuring quality of laboratory services is the need of the hour in the field of health care. Keeping in mind the revolution ushered by six sigma concept in corporate world, health care sector may reap the benefits of the same. Six sigma provides a general methodology to describe performance on sigma scale. We aimed to gauge our laboratory performance by sigma metrics. Internal quality control (QC) data was analyzed retrospectively over a period of 6 months from July 2009 to December 2009. Laboratory mean, standard deviation and coefficient of variation were calculated for all the parameters. Sigma was calculated for both the levels of internal QC. Satisfactory sigma values (>6) were elicited for creatinine, triglycerides, SGOT, CPK-Total and Amylase. Blood urea performed poorly on the sigma scale with sigma <3. The findings of our exercise emphasize the need for detailed evaluation and adoption of ameliorative measures in order to effectuate six sigma standards for all the analytical processes.  相似文献   

3.
Preanalytical steps are the major sources of error in clinical laboratory. The analytical errors can be corrected by quality control procedures but there is a need for stringent quality checks in preanalytical area as these processes are done outside the laboratory. Sigma value depicts the performance of laboratory and its quality measures. Hence in the present study six sigma and Pareto principle was applied to preanalytical quality indicators to evaluate the clinical biochemistry laboratory performance. This observational study was carried out for a period of 1 year from November 2015–2016. A total of 1,44,208 samples and 54,265 test requisition forms were screened for preanalytical errors like missing patient information, sample collection details in forms and hemolysed, lipemic, inappropriate, insufficient samples and total number of errors were calculated and converted into defects per million and sigma scale. Pareto`s chart was drawn using total number of errors and cumulative percentage. In 75% test requisition forms diagnosis was not mentioned and sigma value of 0.9 was obtained and for other errors like sample receiving time, stat and type of sample sigma values were 2.9, 2.6, and 2.8 respectively. For insufficient sample and improper ratio of blood to anticoagulant sigma value was 4.3. Pareto`s chart depicts out of 80% of errors in requisition forms, 20% is contributed by missing information like diagnosis. The development of quality indicators, application of six sigma and Pareto`s principle are quality measures by which not only preanalytical, the total testing process can be improved.  相似文献   

4.
基于六西格玛的高校教学质量改进研究   总被引:1,自引:0,他引:1  
文章以高校的教学质量改进为研究对象,以提高高校教学质量,提升顾客满意度为目的,分析了高校的教学服务过程,在此基础上,构建了高校"以过程为基础的,以顾客为中心"的六西格玛管理模型;并运用六西格玛零缺陷的管理理念,以教学质量改进为例,重点分析了其DMAIC步骤的应用,为高校引入六西格玛管理,改善教学服务质量提供了重要思路。  相似文献   

5.
IntroductionFollowing a pandemic, laboratory medicine is vulnerable to laboratory errors due to the stressful and high workloads. We aimed to examine how laboratory errors may arise from factors, e.g., flexible working order, staff displacement, changes in the number of tests, and samples will reflect on the total test process (TTP) during the pandemic period.Materials and methodsIn 12 months, 6 months before and during the pandemic, laboratory errors were assessed via quality indicators (QIs) related to TTP phases. QIs were grouped as pre-, intra- and postanalytical. The results of QIs were expressed in defect percentages and sigma, evaluated with 3 levels of performance quality: 25th, 50th and 75th percentile values.ResultsWhen the pre- and during pandemic periods were compared, the sigma value of the samples not received was significantly lower in pre-pandemic group than during pandemic group (4.7σ vs. 5.4σ, P = 0.003). The sigma values of samples transported inappropriately and haemolysed samples were significantly higher in pre-pandemic period than during pandemic (5.0σ vs. 4.9σ, 4.3σ vs. 4.1σ; P = 0.046 and P = 0.044, respectively). Sigma value of tests with inappropriate IQC performances was lower during pandemic compared to the pre-pandemic period (3.3σ vs. 3.2σ, P = 0.081). Sigma value of the reports delivered outside the specified time was higher during pandemic than pre-pandemic period (3.0σ vs. 3.1σ, P = 0.030).ConclusionIn all TTP phases, some quality indicators improved while others regressed during the pandemic period. It was observed that preanalytical phase was affected more by the pandemic.  相似文献   

6.
Quality can be defined as the ability of a product or service to satisfy the needs and expectations of the customer. Laboratories are more focusing on technical and analytical quality for reliability and accuracy of test results. Patients and clinicians however are interested in rapid, reliable and efficient service from laboratory. Turn around time (TAT), the timeliness with which laboratory personnel deliver test results, is one of the most noticeable signs of laboratory service and is often used as a key performance indicator of laboratory performance. This study is aims to provide clue for laboratory TAT monitoring and root cause analysis. In a 2 year period a total of 75,499 specimens of outdoor patient department were monitor, of this a total of 4,142 specimens exceeded TAT. With consistent efforts to monitor, root cause analysis and corrective measures, we are able to decreased the specimens exceeding TAT from 7–8 to 3.7 %. Though it is difficult task to monitor TAT with the help of laboratory information system, real time documentation and authentic data retrievable, along with identification of causes for delays and its remedial measures, improve laboratory TAT and thus patient satisfaction.  相似文献   

7.
六西格玛质量一直是企业追求的完美境界,然而企业在实施六西格玛质量管理的过程中总是会遇到"五西格玛墙"等问题,导致不能实现六西格玛的质量目标。在这篇文章中组合了六西格玛和TRIZ相关原理设计了一个企业创新模型。这个新的模型在分析了六西格玛改进和六西格玛设计的基础上,针对现在实施六西格玛管理企业的创新模型创新力度不够的情况,将TRIZ理论应用于企业的创新模型。新提出的集成六西格玛理论和TRIZ理论的创新模型能够引导企业在TRIZ理论的帮助下更好地实现六西格玛质量目标,尤其是随着TRIZ理论的发展,它将大大提升企业的创新能力,从而最终实现"质量"与"创新"的双赢。  相似文献   

8.
铝合金外壳以其的轻薄、坚固和优良的导热性逐渐成为电子消费市场的新宠,但对铝合金外壳制造过程来说,化学抛光制程问题一直困扰着阳极处理制造商。本文采用六西格玛的DMAIC流程,通过优化组合磷酸硫酸比、Al3+含量、化抛时间、温度对提高良率最有影响的这4点参数进行设计,从而得到较好的效果。  相似文献   

9.
Quality in laboratory has huge impact on diagnosis and patient management as 80–90% of all diagnosis is made on the basis of laboratory tests. Monitoring of quality indicators covering the critical areas of pre-analytical, analytical and post-analytical phases like sample misidentification, sample rejection, random and systemic errors, critical value reporting and TATs have a significant impact on performance of laboratory. This study was conducted in diagnostic laboratories receiving approximately 42,562 samples for clinical chemistry, hematology and serology. The list of quality indicators was developed for the steps of total testing process for which errors are frequent and improvements are possible. The trend was observed for all the QI before and after sensitisation of the staff over the period of 12 months. Incomplete test requisition form received in the lab was the most poor quality indicator observed (7.89%), followed by sample rejection rate (4.91%). Most significant improvement was found in pre- and post-analytical phase after sensitisation of staff but did not have much impact on analytical phase. Use of quality indicators to assess and monitor the quality system of the clinical laboratory services is extremely valuable tool in keeping the total testing process under control in a systematic and transparent way.  相似文献   

10.
External Quality Assessment Scheme (EQAS) involves evaluation of a number of laboratories by an outside agency on the performance of a number of laboratories based on their analytical performance of tests on samples supplied by the external agency. In developing countries, establishment of national EQAS by preparing homemade quality control material is a useful scheme in terms of resources and time to monitor the laboratory performance. The objective of this study is to implement an EQAS to monitor the analytical performance of the district laboratories in Bhutan. Baseline information was collected through questionnaires. Lyophilized human serum including normal and abnormal levels were prepared and distributed to 19 participating laboratories. Nine routine analytes were included for the study. Their results were evaluated using Variance index scores (VIS) and Coefficient of variations (CV) was compared with Clinical Laboratory Improvement Act (CLIA) Proficiency Testing Criteria (PT) for each analyte. There was significant decrease in CV at the end of the study. The percentages of results in acceptable VIS as ‘A’ were 63, 60, 66, 69, 73 and 74, 75, 76 and 79 % in November 2009–July 2010 respectively. From our results, we concluded that, establishment of EQAS through distribution of home-made quality control material could be the useful scheme to monitor the laboratory performance in clinical chemistry in Bhutan.  相似文献   

11.
Proficiency of laboratory services is the mainstay in clinical medicine in providing error free diagnostic results. The efficiency of the laboratory needs to be evaluated as per standard international criterion. The quality indicators of the different phases of total testing process are considered the fundamental measurable tool for evaluation of laboratory performance. In order to optimize the laboratory’s proficiency and accreditate it as per international standard in our newly established lab, the study was conducted to evaluate the frequency of errors incurred by laboratory and nonlaboratory professionals during the whole testing process. Retrospective analysis was done for data received from April 2016 to Dec 2016 in our lab. Total number of samples received was 61,674, out of which 43200 samples could be analyzed for quality indicators. Total numbers of tests processed in these samples were 172,800. In the study samples, 26.5% errors were due to pre-analytical factors whereas 9.4% of errors were contributed by analytical phase and 18% by post-analytical phase. Inappropriateness of test requisition was observed to be the major attributing determinant for pre-analytical errors. Instrumentation efficiency in form of frequent breakdown (~7%), greatly affected the proficiency of analytical phase in our lab. 12% of post-analytical errors were ascribed by excessive turn-around-time. However, timeliness of critical value call out and reporting for STAT samples revealed high proficiency up to 97%. High error rates were observed in pre–pre- and pre-analytical phases that also accorded for high error frequency in post analytical phase. This emphasizes urgent need to formulate guidelines for processing all steps of total testing process and initiate strategic measures for reducing risk of errors and increasing patient safety.  相似文献   

12.
基于TQM的中小企业六西格玛管理研究   总被引:2,自引:0,他引:2  
六西格玛管理作为目前企业界广泛关注的一种先进的管理方法,在国内外很多大型企业已经得到了成功的应用。而中小企业作为国民经济的重要组成部分也需要通过六西格玛管理来提升企业自身的产品质量,提高企业效益,增强中小企业市场竞争力。在分析六西格玛管理内涵的基础上,针对中小企业自身的特点,分析其实施六西格玛管理的优势和劣势,揭示了中小企业要推行实施六西格玛管理的必要条件,并在此基础上建立全面质量管理基础上的六西格玛管理体系模型。最后提出在实施过程中应注意的几点内容。  相似文献   

13.
六西格玛实施有两个层面,即项目和组织层面。在文献回顾和专家访谈的基础上,从组织层面提出并分析了影响国内企业六西格玛实施成功的十个关键因素,这对国内企业实施六西格玛管理将具有一定的参考价值。  相似文献   

14.
Laboratories have a major impact on patient safety as 80–90 % of all the diagnosis are made on the basis of laboratory tests. Laboratory errors have a reported frequency of 0.012–0.6 % of all test results. Patient safety is a managerial issue which can be enhanced by implementing active system to identify and monitor quality failures. This can be facilitated by reactive method which includes incident reporting followed by root cause analysis. This leads to identification and correction of weaknesses in policies and procedures in the system. Another way is proactive method like Failure Mode and Effect Analysis. In this focus is on entire examination process, anticipating major adverse events and pre-emptively prevent them from occurring. It is used for prospective risk analysis of high-risk processes to reduce the chance of errors in the laboratory and other patient care areas.  相似文献   

15.
服务质量是图书馆赖以生存和发展的根本,以高校图书馆服务质量作为研究对象,以提高图书馆服务质量为目的,运用定性分析与定量分析相结合的方法,提出了图书馆服务质量评价的指标体系.并以M高校图书馆为例,通过问卷调查收集数据,运用该指标体系对其服务质量进行评价,在此基础上,结合6σ管理法,提出了有针对性的6σ改进的步骤及措施,为图书馆实施6σ改进提供了借鉴.  相似文献   

16.

Introduction

Glycosylated hemoglobin (HbA1c) concentrations measured in clinical chemistry laboratories show large differences between their interlaboratory reported values. Laboratory measurements of quality performance should be based on quantitative data. The sigma metrics model provides an objective method for the assessment of current HbA1c assays and is useful in quality management planning. The aim of our study was to evaluate the analytical performance of the MQ-2000 PT HbA1c analyzer test results in the context of our operating conditions on the sigma scale.

Materials and methods

The coefficient of variation was determined from the calculated mean and standard deviation evaluated from internal quality control (QC) (N = 168 days) (Shanghai Huachen Biological Reagent Co. Ltd, China) data, and records of external quality data (KBUDEK, İstanbul, Turkey) measured in the period from May to November 2013 were used to determine the bias. The resulting data and total allowable error rate (TEA = 10%) from the Clinical Laboratory Improvement Amendments of 1988 (CLIA’88) were used to calculate the sigma level.

Results

The calculated coefficient of variations (CVs) at the two levels, normal (QC1 = 36.6 ± 2.38 mmol/mol) and pathological (QC2 = 84.7 ± 2.68 mmol/mol), were 6.5% and 3.1%, respectively. The average bias between the external QC and MQ-2000 PT during the study period was 4.3%. The calculated average sigma value was 1.19.

Conclusions

The MQ-2000 PT HbA1c is a new analyser in the market; there is need for improvement and the method should be controlled with greater attention to ensure quality.Key words: diabetes mellitus, hemoglobin A1c protein, human, chromatography, high pressure liquid chromatography  相似文献   

17.
IntroductionIt is common for patients to switch between several healthcare providers. In this context, the long-term follow-up of medical conditions based on laboratory test results obtained from different laboratories is a challenge. The measurement uncertainty in an inter-laboratory context should also be considered in data mining research based on routine results from randomly selected laboratories. As a proof-of-concept study, we aimed at estimating the inter-laboratory reference change value (IL-RCV) for exemplary analytes from publicly available data on external quality assessment (EQA) and biological variation.Materials and methodsExternal quality assessment data of the Reference Institute for Bioanalytics (RfB, Bonn, Germany) for serum creatinine, calcium, aldosterone, PSA, and of whole blood HbA1c from campaigns sent out in 2019 were analysed. The median CVs of all EQA participants were calculated based on 8 samples from 4 EQA campaigns per analyte. Using intra-individual biological variation data from the EFLM database, positive and negative IL-RCV were estimated with a formula based on log transformation under the assumption that the analytes under examination have a skewed distribution.ResultsWe estimated IL-RCVs for all exemplary analytes, ranging from 13.3% to 203% for the positive IL-RCV and - 11.8% to - 67.0% for the negative IL-RCV (serum calcium - serum aldosterone), respectively.ConclusionExternal quality assessment data together with data on the biological variation – both freely available – allow the estimation of inter-laboratory RCVs. These differ substantially between different analytes and can help to assess the boundaries of interoperability in laboratory medicine.  相似文献   

18.
An audit of 2509 patient specimens analyzed for both total thyroxine (TT4) and free thyroxine (FT4) by the ACS-180 automated chemiluminescence immunoassay analyzer revealed that there were 219 discrepancies (8.7% of the total). A discrepancy was defined as one analyte within its reference range and the other outside. The discrepant results were divided into 4 groups: group A: normal TT4, but decreased FT4, 101 patients (4.0%); group B: increased TT4, normal FT4, 78 patients (3.1%); group C: decreased TT4, normal FT4, 34 patients (1.4%); and group D: normal TT4, increased FT4, 6 patients (0.2%). TSH measurements were available, by a 3rd generation chemiluminescent assay, in 142 of these patients, and were consistent with the FT4 result in 72 patients, with TT4 in 61 cases and with neither in 9 patients. The clinical diagnosis was investigated in a subgroup of 43 endocrine patients. Thirteen of the 20 endocrine patients in group A were diagnosed as hypothyroid, with a measured serum TSH, in 11 of them, of median 14.6, range 1.2 to 46.2 μlU/ml. Eleven of the 19 endocrine patients in group B were on thyroid replacement, with a measured serum TSH, in 7 of them of <0.01 μlU/ml. The audit of current laboratory practice led to a suggestion to replace the current thyroid function screening strategy of measuring both TT4 and FT4 by the combination of FT4 and TSH. The reasons for the discrepancies and the alternative strategies for screening of thyroid function are discussed.  相似文献   

19.
六西格玛管理是一套客户驱动的追求卓越绩效和持续改进的业务流程改进方法体系,世界500强的大部分企业都已经实施了六西格玛管理.本文通过对GE、福特、东芝、三星、摩托罗拉、戴尔和南昌江铃股份有限公司等国内外著名企业实施六西格玛管理进行了研究,找到它们成功实施六西格玛管理的经验,以期对我国企业实施六西格玛管理有所借鉴.  相似文献   

20.
六西格玛理论在图书馆中的应用   总被引:3,自引:0,他引:3  
焦秋阳  柴雅凌  袁宁 《情报科学》2008,26(3):427-430
图书馆质量评估明确了用户对图书馆各方面的满意程度,然而针对满意度较低的环节,图书馆却缺少一种有效的改进方法。六西格玛是代表高质量水平的管理方法,可有效的改善业务流程、提高服务质量,把其作为图书馆评价体系之后的业务流程改进的方法十分有益。针对图书馆的特点分析引进六西格玛理论的原因,设计出六西格玛在图书馆实行的步骤图并总结出该理论在图书馆应用时的注意事项。六西格玛值得图书馆继续深入研究和发展。  相似文献   

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