A coupled external/internal quality control program for clinical laboratories in the netherlands

1980 ◽  
Vol 107 (3) ◽  
pp. 185-201 ◽  
Author(s):  
Rob T.P. Jansen ◽  
Ad P. Jansen
2016 ◽  
Vol 7 (2) ◽  
pp. 48
Author(s):  
Khushbu Suryaprakash Soni ◽  
Riddhiben Rajendrakumar Patel ◽  
Shailesh Manubhai Patel ◽  
Sarita Jagadishbhai Mangukia

1993 ◽  
Vol 70 (04) ◽  
pp. 588-594 ◽  
Author(s):  
Lloyd E Chambless ◽  
Robert McMahon ◽  
Andrea Finch ◽  
Paul Sorlie ◽  
Gerardo Heiss ◽  
...  

SummaryMethods and results from the quality assurance program of the Atherosclerosis Risk in Communities (ARIC) Study regarding hemostasis variables are presented, following up previous reports in this journal on standardized procedures for blood collection and processing (7) and an organized plan for the performance of those procedures (8). Efforts were made to control for and assess all sources of variability, from venipuncture to laboratory analysis, including also local field center processing and sample shipping. The quality control program included (a) a standardized protocol for blood collection and processing; (b) training, certification, and annual recertification of field center personnel for blood collection and processing; (c) monitoring of fasting times, phlebotomy times, processing times, and shipping problems; (d) hemostatic laboratory internal quality control; (e) a replicate blood sample program; (f) an intraindividual variability study; and (g) continual monitoring of quality control and study participants’ data. This paper focused on items (c), (d), and (e). Measures of Variation, generally Standard deviations and coefficients of Variation, are estimated for replicate blood sampling and internal quality control data, for activated partial thromboplastin time, fibrinogen, factor VII and VIII activity, von Willebrand factor, antithrombin-III, and protein C. The results demonstrate that it is possible to reliably measure these hemostatic variables in a large multicenter study.


1977 ◽  
Author(s):  
C.A. van Dijk-Wierda ◽  
J. Hermans ◽  
E.A. Loeliger ◽  
J. Roos

The 50 laboratories of the Netherlands Federation of Thrombosis Services have participated since 1974 in a voluntary external and internal quality control program. The external program comprises a monthly distribution to the member laboratories of a series of artificially prepared control blood samples, two of which are identical. The overall variation of the coagulation times found were 10% (CV) in 1974 and 8% (CV) in 1975 and 1976. Performance improved rather abruptly at the beginning of 1975, after the application of a tight methodological standardization and improvement by the manufacturer of the thromboplastin preparation (Thrombotest) used by the great majority of the laboratories involved. The main source of variation wasfound to be random error in the Thrombotest determination, approximating 6%. interbatch variation of Thrombotest and inter-aliquot variation of control blood samples both do amount to approximately 3%.


Author(s):  
R T P Jansen ◽  
A P Jansen

In a trial of the Netherlands coupled external/internal quality control program a control serum and an enzyme standard were analysed over a period of eight weeks, five times each week. Five enzymes were determined: alkaline phosphatase, creatine kinase, lactate dehydrogenase, alanine aminotransferase, and γ-glutamyltransferase. The measured values in the serum were converted to the standards. Those laboratories using the recommended methods also submitted their non-transformed serum values. The following standardisation techniques have been compared: ( a) no standardisation of methodology but use of enzyme standards; ( b) standardisation of methodology; ( c) standardisation of methodology combined with use of an enzyme standard. Results were submitted to analysis of variance. Standardisation of methodology did not yield smaller interlaboratory variation than the standardisation with enzyme standards. In this trial a combination of both standardisation techniques yielded generally better results. Results for γ-glutamyltransferase indicate that standardisation of substrate may be necessary apart from the use of an enzyme standard. The preparation of stable enzyme standards is stressed.


Author(s):  
Rob T P Jansen

Routine analytical methods for seven serum analytes (calcium, chloride, cholesterol, glucose, inorganic phosphate, urate, and urea) are assessed using data from the Netherlands coupled external/internal quality control program. From the results of a trial each method can be described by four features: measures of bias, between-day precision, tendency to give erroneous results, interlaboratory variance. These four features of each trial determine a vectorpoint in the four-dimensional space for a particular method. From 12 trials a maximum of 12 vectorpoints per analytical method was obtained. Pattern recognition techniques allowed the detection of clusters of vectorpoints. Analytical methods having vectorpoints classified in different clusters perform differently. The mean feature values of the vectorpoints forming a cluster determine the quality of that cluster. A weighting procedure reveals the importance of the respective features for discriminating the clusters. For all of the seven analytes, clusters of vectorpoints were found. Different features appeared to contain discriminatory power for different analytes. For six analytes (calcium, chloride, cholesterol, glucose, inorganic phosphate, and urea) an analytical method was found to classify predominantly in the qualitative best cluster. One analytical method for the determination of chloride and one for glucose, inorganic phosphate, and urea did not cluster at all.


2018 ◽  
Vol 56 (11) ◽  
pp. 1886-1896
Author(s):  
Min Duan ◽  
Wei Wang ◽  
Haijian Zhao ◽  
Chuanbao Zhang ◽  
Falin He ◽  
...  

Abstract Background: Internal quality control (IQC) is essential for precision evaluation and continuous quality improvement. This study aims to investigate the IQC status of blood gas analysis (BGA) in clinical laboratories of China from 2014 to 2017. Methods: IQC information on BGA (including pH, pCO2, pO2, Na+, K+, Ca2+, Cl−) was submitted by external quality assessment (EQA) participant laboratories and collected through Clinet-EQA reporting system in March from 2014 to 2017. First, current CVs were compared among different years and measurement systems. Then, percentages of laboratories meeting five allowable imprecision specifications for each analyte were calculated, respectively. Finally, laboratories were divided into different groups based on control rules and frequency to compare their variation trend. Results: The current CVs of BGA were significantly decreasing from 2014 to 2017. pH and pCO2 got the highest pass rates when compared with the minimum imprecision specification, whereas pO2, Na+, K+, Ca2+, Cl− got the highest pass rates when 1/3 TEa imprecision specification applied. The pass rates of pH, pO2, Na+, K+, Ca2+, Cl− were significantly increasing during the 4 years. The comparisons of current CVs among different measurement systems showed that the precision performance of different analytes among different measurement systems had no regular distribution from 2014 to 2017. The analysis of IQC practice indicated great progress and improvement among different years. Conclusions: The imprecision performance of BGA has improved from 2014 to 2017, but the status of imprecision performance in China remains unsatisfying. Therefore, further investigation and continuous improvement measures should be taken.


1977 ◽  
Vol 37 (03) ◽  
pp. 509-522 ◽  
Author(s):  
C. A van Dijk-Wierda ◽  
J Hermans ◽  
E. A Loeliger ◽  
J Roos

SummaryThe 50 laboratories of the Netherlands Federation of Thrombosis Services, covering a population of 9 million and responsible for the laboratory control of approximately 150,000 patients under oral anticoagulation, have participated since 1974 in a voluntary external and internal quality control program. The external program comprises a monthly distribution to the member laboratories of a series of artificially prepared control blood samples, two of which are identical. The overall variation of the coagulation times found were 10% (CV) in 1974 and 8% (CV) in 1975. Performance improved rather abruptly at the beginning of 1975, after the application of a tight methodological standardization and improvement by the manufacturer of the thromboplastin preparation (Thrombotest) used by the great majority of the laboratories involved. The main source of variation was found to be random error in the Thrombotest determination, approximating 6%. Interbatch variation of Thrombotest and inter-aliquot variation of control blood samples both do amount to approximately 3% (CV). In terms of rabbit tissue thromboplastins, which have a lower sensitivity than Thrombotest (i. e., a flatter slope of the correlation between the PT and the anticoagulant effect), the total variation in the performance of the Dutch laboratories is 2.2-5.6% (CV), which is unusually low. The main reason for this is the fact that the laboratories can rely not only on the services of the manufacturer but also on a central information office and a reference laboratory responsible for the preparation of the control blood as well as the standardization (calibration) of thromboplastin.


2016 ◽  
Vol 33 (1) ◽  
pp. 3-6
Author(s):  
Nasreen Chowdhury ◽  
Md Ibrahim ◽  
Md Aminul Haque Khan

Introduction: In our country, very few of clinical laboratories are running proper quality control program and to the best of our knowledge the preanalytical, analytical, and postanalytical rates of laboratory errors have not been studied extensively. In this study we evaluated the preanalytical, analytical, and postanalytical components of laboratory errors in 3,200 consecutive specimens of a clinical chemistry laboratory in a tertiary hospital for measurement of different analyte concentrations in plasma or serum. Materials and methods: This study was conducted during the period from June 2009 to July 2010 on 3,200 specimens. Analytical errors were detected by repeat analysis of primary sample and by checking quality control. Results: The numbers of preanalytical, analytical and postanalytical errors were 23, 14 and 76 respectively among 32000 tests that we have done on 3,200 specimens (average 10 tests per specimen). Moreover, the causes of errors were analyzed and it was found that preanalytical errors were mostly due to specimen drawn distal to IV infusion, specimen for potassium first drawn into GREY tube (containing sodium fluoride and K EDTA) and then transferred into GREEN tube, long tourniquet time and underfilling of blood collection tube. The analytical errors were due to random and systemic errors and postanalytical errors were due to transcription errors. Conclusion: Results of our study suggest that errors mostly occur in the postanalytical part of testing and they are due to transcription errors. To reduce the laboratory errors we suggest introduction of Laboratory Information System (LIS) of the clinical laboratories connected with Hospital Management System along with stringent quality control program in preanalytical, analytical and postanalytical stages.J Bangladesh Coll Phys Surg 2015; 33(1): 3-6


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