Medical Need for Quality Specifications - a Nordkem Project for Selecting the Appropriate Quality in Clinical Laboratories

1993 ◽  
Vol 53 (sup215) ◽  
pp. 29-37 ◽  
Author(s):  
Carl-Henric De Verdier ◽  
Torgny Grotfp ◽  
Per Hyltoft Petersen
Keyword(s):  
Clinical Laboratories ◽  
Medical Need ◽  
Quality Specifications

scholarly journals Spanish society of laboratory medicine external quality assurance programmes: evolution of the analytical performance of clinical laboratories over 30 years and comparison with other programmes

2020 ◽  
Vol 1 (2) ◽  
Author(s):  
Carmen Perich ◽  
Carmen Ricós ◽  
Fernando Marqués ◽  
Joana Minchinela ◽  
Angel Salas ◽  
...  
Keyword(s):  
Quality Assurance ◽  
State Of The Art ◽  
Laboratory Medicine ◽  
Analytical Performance ◽  
External Quality Assurance ◽  
Biological Variability ◽  
External Quality ◽  
Spanish Society ◽  
Clinical Laboratories ◽  
Quality Specifications

AbstractThe purpose of this study is to understand the evolution of the analytical performance of the laboratories participating in the Spanish society of laboratory medicine (SEQCML) external quality assurance (EQA) programmes during its 30 years of operation and to compare it with the performance of other EQA programmes to establish whether the results are similar. The results obtained during this period are evaluated by applying the biological variability (BV) and state of the art-derived quality specifications. In addition, the results are compared with those obtained by other EQA programme organisations. It is noted that the laboratories participating in the EQA–SEQCML programmes have improved their performance over 30 years of experience and that the specifications derived from biological variation are achievable. It is difficult to compare EQA programmes, due to lack of accessibility and the differences in the design of these programmes (control materials, calculations used and analytical specifications established). The data from this study show that for some biological magnitudes the results obtained by the programmes are not yet harmonised, although efforts are being made to achieve this. Organisers of EQA programmes should also join the harmonisation effort by providing information on their results to enable comparison.

Analysis and evaluation of the external quality assessment results of quality indicators in laboratory medicine all over China from 2015 to 2018

2019 ◽  
Vol 57 (6) ◽  
pp. 812-821 ◽  
Author(s):  
Min Duan ◽  
Fengfeng Kang ◽  
Haijian Zhao ◽  
Wei Wang ◽  
Yuxuan Du ◽  
...  
Keyword(s):  
Quality Assessment ◽  
Quality Indicators ◽  
External Quality Assessment ◽  
External Quality ◽  
Factors Affecting ◽  
Laboratory Errors ◽  
Continuous Quality ◽  
Clinical Laboratories ◽  
Information Construction ◽  
Quality Specifications

Abstract Background This study aimed to comprehensively evaluate laboratory quality in China and explore factors affecting laboratory errors through analyzing the external quality assessment (EQA) results of quality indicators (QIs). Methods According to model 3 (interpretive) of the proficiency testing scheme, the National Center for Clinical Laboratories of China (CNCCL) developed a questionnaire for 15 QIs. Clinical laboratories from different provinces of China participated in the EQA program of QIs annually and submitted data via an online reporting system named Clinet-EQA. The results of QIs were expressed in percentage and sigma value or minute. Three levels of quality specifications (QSs) were defined based on percentile values. Furthermore, the QIs were analyzed by disciplines, hospital scales and information construction levels of participant laboratories. Results A total of 3450 laboratories nationwide continuously attended the EQA program and submitted complete data from 2015 to 2018. The performance of most QIs has improved year by year. QIs in post-analytical gained the best performance with sigma values that varied from 5.3σ to 6.0σ. The comparison of results among different disciplines showed significant differences for five QIs. More than half of QIs had statistical differences among different hospital scales measured by hospital grades and number of hospital beds. The performance of nine QIs were influenced by information construction levels of participant laboratories. Conclusions The overall laboratory quality in China has improved since the initiation of EQA program for QIs, but the performance of some QIs was still unsatisfactory. Therefore, laboratories should make efforts for continuous quality improvement based on information provided by QSs.

Preliminary probe of quality indicators and quality specification in total testing process in 5753 laboratories in China

2016 ◽  
Vol 54 (8) ◽  
Author(s):  
Yang Fei ◽  
Fengfeng Kang ◽  
Wei Wang ◽  
Haijian Zhao ◽  
Falin He ◽  
...  
Keyword(s):  
Blood Culture ◽  
Quality Indicators ◽  
Critical Values ◽  
Sample Container ◽  
Clinical Laboratories ◽  
Quality Specifications ◽  
Catch Up ◽  
Total Testing Process ◽  
State Of Art ◽  
Minimum Quality

AbstractThe aim of the study was to promote the establishment and implementation of quality indicators (QIs) in clinical laboratories, catch up with the state of art, and provide preliminary quality specifications for established QIs.Clinical laboratories from different provinces in China were included in this QIs survey in 2015. All participants were asked to collect data related to QIs and complete QIs questionnaires. Defect percentages and sigma values were calculated for each QI. The 25th percentile, median, and the 75th percentile of defect percentages and TATs were calculated as optimum, desirable and minimum quality specifications. While 25th, median, and 75th of sigma values were calculated as minimum, desirable and optimum quality specifications, respectively.Five thousand seven hundred and fifty-three clinical laboratories from 28 provinces in China participated in this survey. Median defect percentages of pre-examination QIs varied largely from 0.01% (incorrect sample container) to 0.57% (blood culture contamination) with sigma values varied from 4.0σ to 5.1σ. Median defect percentages of examination phase QIs were all really high. The most common problem in examination phase was test uncovered by inter-laboratory comparison (86.67%). Defect percentages of critical values notification and timely critical values notification were all 0.00% (6.0σ). While the median of defect percentages of incorrect laboratory reports was only 0.01% (5.4σ).Improvements are needed in all phases of total testing process (TTP) in laboratories in China, especially in examination phase. More attention should be paid when microbiology specimens are collected and results are reported. Quality specifications can provide directions for laboratories to make effort for.

Utilizing Dark Field Electron Microscopy to Produce Lantern Slides

1974 ◽  
Vol 32 ◽  
pp. 116-117
Author(s):  
J. N. Meador ◽  
C. N. Sun ◽  
H. J. White
Keyword(s):  
Electron Microscope ◽  
Electron Micrographs ◽  
Dark Field ◽  
Limiting Factor ◽  
Clinical Laboratories ◽  
Field Electron ◽  
Time Element ◽  
Field Electron Microscopy ◽  
Dark Field Electron ◽  
Dark Field Micrographs

The electron microscope is being utilized more and more in clinical laboratories for pathologic diagnosis. One of the major problems in the utilization of the electron microscope for diagnostic purposes is the time element involved. Recent experimentation with rapid embedding has shown that this long phase of the process can be greatly shortened. In rush cases the making of projection slides can be eliminated by taking dark field electron micrographs which show up as a positive ready for use. The major limiting factor for use of dark field micrographs is resolution. However, for conference purposes electron micrographs are usually taken at 2.500X to 8.000X. At these low magnifications the resolution obtained is quite acceptable.

Imprecision of Laboratory Determinations and Diagnostic Accuracy: Theoretical Considerations

1974 ◽  
Vol 13 (03) ◽  
pp. 151-158 ◽  
Author(s):  
D. A. B. Lindbebo ◽  
Fr. R. Watson
Keyword(s):  
Mathematical Model ◽  
Diagnostic Accuracy ◽  
Diagnostic Process ◽  
Clinical Laboratories ◽  
Non Linear ◽  
Theoretical Considerations ◽  
Made In

Recent studies suggest the determinations of clinical laboratories must be made more precise than at present. This paper presents a means of examining benefits of improvement in precision. To do this we use a mathematical model of the effect upon the diagnostic process of imprecision in measurements and the influence upon these two of Importance of Diagnosis and Prevalence of Disease. The interaction of these effects is grossly non-linear. There is therefore no proper intuitive answer to questions involving these matters. The effects can always, however, be calculated.Including a great many assumptions the modeling suggests that improvements in precision of any determination ought probably to be made in hospital rather than screening laboratories, unless Importance of Diagnosis is extremely high.

Factor VII Clotting Assay: Influence of Different Thromboplastins and Factor VII-Deficient Plasmas

1991 ◽  
Vol 65 (02) ◽  
pp. 160-164 ◽  
Author(s):  
Marina Poggio ◽  
Armando Tripodi ◽  
Guglielmo Mariani ◽  
Pier Mannuccio Mannucci ◽  
Keyword(s):  
Heart Disease ◽  
Ischemic Heart Disease ◽  
Dose Response ◽  
Response Curve ◽  
Ischemic Heart ◽  
Factor Vii ◽  
Response Curves ◽  
Assay Sensitivity ◽  
Clinical Laboratories ◽  
Coagulant Activity

SummaryBeing a putative predictor of ischemic heart disease, the measurement of factor VII (FVTI) coagulant activity will be presumably requested to clinical laboratories with increasing frequency. To assess the influence on FVII assays of different thromboplastins and FVII-deficient plasmas we compared performances of all possible combinations of 5 thromboplastins and 6 deficient plasmas. The reproducibility of the clotting times of the dose-response curves for human and rabbit thromboplastins were acceptable (CV lower than 7%), whereas bovine thromboplastin had a higher CV. Reproducibility was very similar for all deficient plasmas when they were used in combination with a given thromboplastin. Responsiveness of the dose-response curve did not depend on the deficient plasma but rather on the thromboplastin: one rabbit thromboplastin was the least responsive, the bovine thromboplastin the most responsive, the human and the remaining two rabbit thromboplastins had intermediate responsiveness. Assay sensitivity to cold-activated FVII varied according to the thromboplastin: the bovine thromboplastin was the most sensitive, the human thromboplastin the least sensitive, of the three rabbit thromboplastins two were relatively sensitive, one was almost insensitive. In conclusion, our results indicate that thromboplastin rather than deficient plasma is the crucial factor in the standardization of FVII assay.

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