Quality assurance in laboratory haematology

Author(s):  
S. M. Lewis

SynopsisQuality assurance in laboratory haematology includes (a) constant checking of test reliability by internal quality control, (b) external quality assessment by an independent agency to check performance of a number of laboratories at intervals in order to obtain a retrospective indication of their ability and (c) proficiency control by supervision of the pre-test and post-test phases of laboratory work, from specimen collection to delivery of the report to the clinician.The procedures which comprise quality control are described; these include use of control preparations with control charts, CUSUM analysis, constancy of daily means of the blood count indices of ‘absolute values’, duplicate testing, clinical correlation and the important role of the blood film to check the instrument-derived blood count measurements.A description of the functions of an external quality assessment scheme is based on the UK National Scheme (UK NEQAS). The blood count and other tests of general haematology have been used as models to describe the procedures for qualitative and quantitative tests, low results are analysed and performance is assessed. The tribulations and triumphs of NEQAS are described and it is concluded that NEQAS has a vital role in ensuring good laboratory practice in general, and the reliability of the individual laboratories who participate in the scheme. NEQAS, in turn, must ensure its own ability to provide stable materials which are suitable for each test in the programme, and to analyse data correctly. There is also need to take account of the continued expansion of laboratory services as new techniques are introduced and to develop appropriate EQA procedures and materials in order to incorporate these in a comprehensive scheme.

1980 ◽  
Vol 26 (7) ◽  
pp. 903-907
Author(s):  
D G Bullock ◽  
T J Carter ◽  
S V Hughes

Abstract Effective internal quality control and external quality assessment of high-density lipoprotein cholesterol assay is made difficult by analyte instability, and the suitability of quality-control sera for this purpose has not been studied. We have therefore investigated the properties of 25 different control sera from 15 suppliers by estimating within-batch precision for the two precipitation procedures used most widely (phosphotungstate/Mg2+ and heparin/Mn2+ with enzymic measurement of cholesterol. Some sera had properties similar to those of fresh human serum, but others demonstrated poor precision for one or both procedures or contained apparent high-density lipoprotein cholesterol in unphysiological concentrations. A study of six sera indicated that between-batch precision was consistent with the within-batch findings. We found that eight of the 25 batches of quality-control serum we investigated may be used for internal quality control and external quality assessment of high-density lipoprotein cholesterol assay.


2018 ◽  
Vol 54 (3) ◽  
pp. 159-166 ◽  
Author(s):  
Ewa Młodzińska ◽  
Karolina Bosacka ◽  
Anna Mikołajczyk ◽  
Joanna Rybicka ◽  
Elżbieta Stefaniuk ◽  
...  

The Polish National External Quality Assessment Scheme in Microbiological Diagnostics – POLMICRO programme is organized by the Centre of Quality Control in Microbiology (CQCM). The aim of the POLMICRO 2017 Programme was to evaluate proficiency of laboratories in the identification of microorganisms, determination of susceptibility to antibiotics, detection of resistance mechanisms and interpretation of Gram slides. Bacterial isolates distributed within the Programme differed in their susceptibility to antibiotics and presence of various resistance mechanisms. The paper presents the results of the XXIV edition – POLMICRO 2017.


2016 ◽  
Vol 52 (1) ◽  
pp. 29-38
Author(s):  
Elżbieta Stefaniuk ◽  
Karolina Bosacka ◽  
Ewa Młodzińska ◽  
Anna Mikołajczyk ◽  
Waleria Chryniewicz ◽  
...  

In 2015 Centre for Quality Control in Microbiology (CQCM) conducted Polish National External Quality Assessment Scheme in Microbiological Diagnostics according to the requirements of PN-EN ISO/IEC 17043:2011. The CQCM organized two different types of proficiency programmes: one was designed for laboratories providing a broad spectrum of microbiological diagnostics and the second one was prepared for laboratories dealing with enteric infections only. The aim of the POLMICRO 2015 programme was to evaluate proficiency of laboratories in the identification of microorganisms, determination and clinical interpretation of bacterial susceptibility to antibiotics, detection of different resistance mechanisms and interpretation of Gram slides. The paper presents the results of the XXII edition of the Programme POLMICRO 2015.


2016 ◽  
Vol 2 (1) ◽  
pp. 5-10
Author(s):  
Kuenzang Dorji ◽  
Rixin Jamtsho ◽  
Puja D. Samal ◽  
Partab Rai ◽  
Dorji Wangchuk

Introduction: Quality Assurance comprising External Quality Assessment Scheme (EQAS) and Internal Quality Control (IQC) is an indispensible part of the laboratory analytical process to ensure reliable results from the laboratories. However, due to various challenges in many developing countries such as limitations in resources and manpower, EQAS samples are often given less importance at laboratories. The objective of this study is to assess performance on hematology EQAS samples received from Pacific Paramedical Training Center- External Quality Assesment Scheme (PPTC-EQAS) and International External Quality Assesment Scheme-United Kingdom (IEQAS-UK)since 2007 and 2008 respectively. The findings from this study will be helpful to establish an effective system to ensure timely follow up and corrective actions to improve the quality of laboratory services. Methods:The feedback of the EQAS results submitted thrice a year to the PPTC-EQAS and six times a year to the IEQAS-UK since 2007 and 2008 respectively were reviewed to assess the laboratory’s performance and to determine the effectiveness of EQAS participation for improving the performance of laboratory hematology in Bhutan. Results:For PPTC-EQAS, the average yearly scores were 69.00%, 75.00%, 87.66%, 87.50%, 70.00%, 80.33%, 80.50%, 85.00% for the years 2007-2014. For IEQAS-UK, the average yearly scores were 76.66%, 75.95%, 77.91%, 85.83%, 92.50%, 63.88% and 98.14% for the years 2008-2014. Our results show inconsistent performances on both EQAS samples despite gradual improvement over the last seven years. Conclusions:We conclude that, strengthening the system for regular follow up and implementing corrective actions for the outlying results in addition to replacement of the equipment could improve the trend and ensure consistency of the performance.


Author(s):  
Fumeng Yang ◽  
Wenjun Wang ◽  
Qian Liu ◽  
Xizhen Wang ◽  
Guangrong Bian ◽  
...  

Background The Six Sigma theory is an important tool for laboratory quality management. It has been widely used in clinical chemistry, haematology and other disciplines. The aim of our study was to evaluate the analytical performance of plasma proteins by application of Sigma metric and to compare the differences among three different allowable total errors in evaluating the analytical performance of plasma proteins. Methods Three different allowable total error values were used as quality goals. Data from an external quality assessment were used as bias, and the cumulative coefficient of variation in internal quality control data was used to represent the amount of imprecision during the same period. Sigma metric of analytes was calculated using the above data. The quality goal index was calculated to provide corrected measures for continuous improvements in analytical quality. Results The Sigma metric was highest using the external quality assessment standards of China: it was sigma ≥6 or higher in 57.1% of plasma proteins. But Sigma metric was lower by using RiliBÄK or biological variation standards. IgG, C3 and C-reactive protein all required quality improvements in imprecision. A single-rule 13s for internal quality control was recommended for IgA, IgM, C4 and rheumatoid factor, whereas multiple rules (13s/22s/R4s) were recommended for IgG, C3 and C-reactive protein, according to the external quality assessment standards of China. Conclusions Different quality goals can lead to different Sigma metric for the same analyte. As the lowest acceptable standard in clinical practice, the external quality assessment standard of China can guide laboratories to formulate reasonable quality improvement programmes.


2020 ◽  
Vol 55 (2) ◽  
pp. 99-106 ◽  
Author(s):  
Ewa Młodzińska ◽  
Karolina Bosacka ◽  
Anna Mikołajczyk ◽  
Joanna Rybicka ◽  
Waleria Hryniewicz

POLMICRO programme – the Polish National External Quality Assessment Scheme in Microbiology is organized by the Centre of Quality Control in Microbiology (CQCM). The aim of the POLMICRO 2018 Programme was to evaluate proficiency of laboratories in the interpretation of Gram slides, identification of microorganisms, determination of susceptibility to antibiotics, detection of resistance mechanisms like ESBL, MBL, KPC, PRP or resistance of staphylococci to methicillin. Bacterial isolates distributed within the Programme differed in their susceptibility to antibiotics and the presence of various resistance mechanisms. The paper presents the results of the XXV edition – POLMICRO 2018.


2006 ◽  
Vol 96 (11) ◽  
pp. 597-601 ◽  
Author(s):  
Anne Goodeve ◽  
Marian Hill ◽  
Ian Jennings ◽  
Steve Kitchen ◽  
Isobel Walker ◽  
...  

SummaryMolecular genetic analysis of families with haemophilia and other inherited bleeding disorders is nowa common laboratory investigation. In contrast to phenotypic testing in which strict quality control is adhered to, in haemophilia molecular genetic testing there has been a lack of any external quality assurance schemes. In 1998 the UK National External Quality Assessment Scheme (UK NEQAS) established a pilot quality assurance scheme for molecular genetic testing in haemophilia. Results from three initial surveys highlighted problems with the quality of samples when used to screen for the intron 22 inversion within the F8 gene. The scheme was re-launched in 2003, and since that time there have been five exercises involving whole blood or immortalised cell line DNA. The results together with an overall summary of the exercise are subsequently returned to participants. Exercises to date have focused exclusively on haemophilia A and QA, material has included screening for the intron 1 and intron 22 inversions as well as sequence analysis. A paper exercise circulated in 2003 highlighted problems with the format of reports and, following feedback to participants, onlya single error has been made in the subsequent four exercises. Participating laboratories now receive QA material every six months. Immortalised cell line material was introduced in 2005 and was shown to perform well. This will allow expansion of the scheme and a reduction in the dependence on blood donation.


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