首页 | 本学科首页   官方微博 | 高级检索  
相似文献
 共查询到20条相似文献，搜索用时 31 毫秒
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.

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   

3.
Variability in analytical performance of some analyte indicated the need of evaluation of quality plan of our laboratory. We tried to put the same degree of effort into our quality metrics as we put into the laboratory processes themselves. Application of six sigma methodologies improve the quality by focusing on the root causes of the problems in performance and analyzing by flowcharts, fishbone diagrams and other quality tools. Sigma metric was calculated for laboratory parameters for a period of 8 months during 2018–19. The analytes with poor sigma metric were free Thyroxine (FT3, FT4), Sodium, Calcium and Magnesium. Sigma metric of free Thyroxine (FT3, FT4), Sodium, Calcium and Magnesium were below 3. A road map for process improvement was designed with DMAIC (Define-Measure-Analyze-Improve-Control) model to solve the issue. Possible causes for low analytical performance of the particular analytes were depicted in Fishbone diagram. The Fishbone analysis identified the water quality issues with electrolyte analysis while high ambient temperature was culprit for poor assay performance of free Thyroxine. Sigma metric of the analytical performance was assessed once again after root cause analysis. Sigmametric showed marked improvement in control phase. Identification of problems led to reduction in non value added work leading to adequate resource utilization by addressing the priority issue. Therefore, DMAIC tool with Fish bone model analysis can be recommended as a well suited method for troubleshooting in poor performance of laboratory parameter.  相似文献   

4.
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   

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.
2000 vials of lyophilized QC of two different levels (low and high) were donated by Roche Diagnostics GmbH, through the IFCC and received by CMCH in June 2001. A total of 240 la boratories were enrolled for this 6 month pilot study. In addition to the 12 analytes in the liquid QC programme, six additional analytes, LDH, triglyceride, urate, total bilirubin, phosphate and amylase were included. It was also possible to measure sodium and potassium by ion selective electrode (ISE) methods in the QC for the first time. The performance of the laboratories for the existing 12 analytes using liquid stabilized QC was compared to the performance using lyophilized QC. Using a statistical comparison of the methodwise mean variance index score (MVIS) values, five assays viz glucose, albumin, cholesterol, and SGOT and SGPT performance was the same in liquid QC and lyophilized QC. Three assays viz urea, calcium and creatinine were significantly better, and 4 assays total protein, sodium, potassium and ALP were significantly worse. However the overall VIS (OMVIS) for the laboratories was the same and the ranking pattern of this 6 month OMVIS was also unaltered. The lyophilized QC scheme highlighted a negative bias between flame and ISE methods for sodium and potassium, and a definite standardization problem in reporting LDH and amylase results, but triglyceride, urate and total bilirubin assays were performing well. It was concluded that the introduction of lyophilized QCs will not cause any deterioration of performance to participating laboratories. Stability of the material seems to be good and the laboratories are generally using a good reconstitution technique.  相似文献   

7.
覃双苗 《大众科技》2014,(9):226-228
化验室的质量管理包含质量策划、质量控制、质量保证、质量改进。确定检验方法的适用性是一项很重要的工作;质量控制主要手段有工作区域的现场管理,设备、器具的维护和保养,试剂的选购与保管,标准物质的溯源,质量控制图;实验室认可是向顾客提供达到检测质量要求的信任最重要的途径;内部审核、管理评审和QC小组活动都能改进、提升检验质量。  相似文献   

8.
Laboratory analytical turnaround time is a reliable indicator of laboratory effectiveness. Our study aimed to evaluate laboratory analytical turnaround time in our laboratory and appraise the contribution of the different phases of analysis towards the same. The turn around time (TAT) for all the samples (both routine and emergency) for the outpatient and hospitalized patients were evaluated for one year. TAT was calculated from sample reception to report dispatch. The average TAT for the clinical biochemistry samples was 5.5 h for routine inpatient samples while the TAT for the outpatient samples was 24 h. The turnaround time for stat samples was 1 h. Pre- and Post-analytical phases were found to contribute approximately 75% to the total TAT. The TAT demonstrates the need for improvement in the pre- and post-analytical periods. We need to tread the middle path to perform optimally according to clinician expectations.  相似文献   

9.

Background

Failure to follow-up laboratory test results has been described as one of the major processes contributing to unsafe patient care. Currently, most of the laboratories do not know with certainty not only their rate of missed (or unreviewed) requests but the economical cost and impact that this issue implies. The aim of our study was to measure that rate and calculate the resulting costs.

Material and methods

In January 2015, we checked in our Laboratory Information Management System (LIMS) for every emergency request from 1st July 2011 to 30th June 2014, if they had been reviewed by any allowed user or not. 319,064 requests were ordered during that period of time. Results were expressed as “ordered requests”, “missed requests” and its percentage. Additionally, total cost of missed requests was calculated in euros (€). “Non-productive days” were theorised (as the days producing requests that were not reviewed) based on these results.

Results

7924 requests (2.5%) were never reviewed by clinicians. This represented a total cost of 203,039 € and 27 “non-productive” days in three years. Significant differences between inpatients, outpatients and emergency department as well as different emergencies units were found after application of statistical analysis.

Conclusions

In terms of resources, never reviewed or missed requests appear to be a not negligible problem for the clinical laboratory management. Electronic result delivery, with electronic endorsement to indicate follow-up of requests along with better systems of electronic requesting should be investigated as a way of improving patient outcomes and save unnecessary expenses.Key words: quality indicators, health care, extra-analytical phase, total quality management, clinical laboratory information systems  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.
Quality indicators (QIs) measure the extent to which set targets are attained and provide a quantitative basis for achieving improvement in care and, in particular, laboratory services. A body of evidence collected in recent years has demonstrated that most errors fall outside the analytical phase, while the pre- and post-analytical steps have been found to be more vulnerable to the risk of error. However, the current lack of attention to extra-laboratory factors and related QIs prevent clinical laboratories from effectively improving total quality and reducing errors. Errors in the pre-analytical phase, which account for 50% to 75% of all laboratory errors, have long been included in the ‘identification and sample problems’ category. However, according to the International Standard for medical laboratory accreditation and a patient-centered view, some additional QIs are needed. In particular, there is a need to measure the appropriateness of all test request and request forms, as well as the quality of sample transportation. The QIs model developed by a working group of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) is a valuable starting point for promoting the harmonization of available QIs, but further efforts should be made to achieve a consensus on the road map for harmonization.  相似文献   

12.
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   

13.
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   

14.
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   

15.
Molecular diagnostic tools for tuberculosis (TB) have evolved quickly with new innovations which can provide unprecedented opportunities for the rapid, sensitive and specific diagnosis of M. tuberculosis in clinical specimens and the status of its drug sensitivity. Microscopy and culture methods can not be replaced but the molecular assays can be applied in parallel with any new molecular tests for the diagnosis of TB. For extra pulmonary specimens, the use of the amplification methods is advocated, since rapid and accurate laboratory diagnosis is critical. Customization of the diagnostic usefulness of a molecular assay, according to the ease, reliability and need for health care sector is of immense value in a modern clinical mycobacteriology laboratory.  相似文献   

16.

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.  相似文献   

17.

Introduction

To study the pre-design and success of a strategy based on the addition of hemoglobin A1c (HbA1c) in the blood samples of certain primary care patients to detect new cases of type 2 diabetes.

Materials and methods

In a first step, we retrospectively calculated the number of HbA1c that would have been measured in one year if HbA1c would have been processed, according to the guidelines of the American Diabetes Association (ADA). Based on those results we decided to prospectively measure HbA1c in every primary care patient above 45 years, with no HbA1c in the previous 3 years, and glucose concentration between 5.6-6.9 mmol/L, during an 18 months period. We calculated the number of HbA1c that were automatically added by the LIS based on our strategy, we evaluated the medical record of such subjects to confirm whether type 2 diabetes was finally confirmed, and we calculated the cost of our intervention.

Results

In a first stage, according to the guidelines, Hb1Ac should have been added to the blood samples of 13,085 patients, resulting in a cost of 14,973€. In the prospective study, the laboratory added Hb1Ac to 2092 patients, leading to an expense of 2393€. 314 patients had an HbA1c value ≥ 6.5% (48 mmol/mol). 82 were finally diagnosed as type 2 diabetes; 28 thanks to our strategy, with an individual cost of 85.4€; and 54 due to the request of HbA1c by the general practitioners (GPs), with a cost of 47.5€.

Conclusion

The automatic laboratory-based strategy detected patients with type 2 diabetes in primary care, at a cost of 85.4€ per new case.Key words: type 2 diabetes, HbA1c, diagnosis, preanalytical phase, test request appropriateness, costs, cost analysis  相似文献   

18.
李健  黄一帆 《大众科技》2012,(7):117-118
我国淡水资源短缺,仅为世界人均占有量的28%;水资源浪费严重,农业用水量占90%以上;水质污染严重,我国江河湖库淡水普遍受到了污染,甚至严重污染。因此建设水质实验室,有效、快速、准确地检测水质状况,保护广大人民群众的身体健康和生态环境是非常重要的。  相似文献   

19.
Advances in instrument technology and automation have simplified tasks in laboratory diagnostics reducing errors during analysis thereby improving the quality of test results. However studies show that most laboratory errors occur in the pre-analytical phase. In view of the paucity of studies examining pre-analytical errors, we examined a total of 1513 request forms received at our laboratory during a 3 month period. The forms were scrutinized for the presence of specific parameters to assess the pre-analytical errors affecting the laboratory results. No diagnosis was provided on 61.20% of forms. Type of specimen was not mentioned in 61.60% of the forms and 89.25% of all forms were illegible. Critical results were encountered in 17.30% of patients, and of these 76.60% were not communicated due to incomplete forms. Thus, by following standard operating procedures vigorously from patient preparation to sample processing the laboratory results can be significantly improved without any extra cost.  相似文献   

20.
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.  相似文献   

设为首页 | 免责声明 | 关于勤云 | 加入收藏

Copyright©北京勤云科技发展有限公司  京ICP备09084417号