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Accreditation and Quality Assurance: Journal for Quality, Comparability and Reliability in Chemical Measurement (v.6, #9-10)
The European Conference on Quality in the Spotlight in Medical Laboratories, 19–20 October, 2000, Antwerp, Belgium
by J.C. Libeer; H. M. J. Goldschmidt (pp. 387-387).
The EFQM management model for TQM applied to laboratory medicine by H. M. J. Goldschmidt; I. Brandslund; W. Vogt; J. O. Westgard; L. M. Voipio-Pulkki; N. Péquériaux; P. De Bièvre; S. Ehrmeyer; J. C. Libeer (pp. 388-395).
The EFQM (European Foundation for Quality Management) model offers a structure to describe and characterize one’s organization and allows the user to adapt the model to a great extent to the local working environment. Using five organization oriented enablers and four result oriented focused criteria, any organization, or substantial part of it, can be characterized. This accounts certainly for a medical laboratory in a hospital setting. The model tries to encourage practical usefulness and self-guidance, continuous improvement in a natural, stepwise way, and change management focused on the positive things within the organization. Application leads to consciousness of the quality of the entire operation, diagnoses, and advises for quality improvement and managerial control, i.e., through indicators. As the work of Islin and Thystrup illustrated, the EFQM model can be very elegantly and effectively applied to medical laboratories [1]. This paper is a compilation of nine lectures given in sequence to elaborate on each of the nine EFQM criteria. The following compilation explores the possibilities of using in a dedicated laboratory service this general quality management model by each of the criteria.
Keywords: Keywords Quality management system; EFQM; Laboratory medicine
The German perspective of using the EFQM model in medical laboratories by Wolfgang Vogt (pp. 396-401).
The financial resources of health care services are only nominally growing in Germany. Therefore, the politicians have been forced to act. Up to now, a fixed limit of remuneration should not affect the quality of patient management. However, these primary economic issues have initiated positive and negative reactions from the laboratory medicine community. In hospital laboratories the challenge is to realise continuous improvement of service quality but at the same time reduce costs. This can only be achieved by introducing total quality management (TQM) and measuring the quality obtained by the European Foundation for Quality Management (EFQM) model. Predominantly formal attempts to improve quality at the level of ”enablers” such as certification (ISO 9000) or accreditation (EN 45000, ISO 15189) will not solve these problems. Two groups in Germany work on TQM and EFQM: the Working Group ”Laboratory Management” of the German, Austrian and Swiss Societies for Laboratory Medicine and for Clinical Chemistry, and the Institute for Quality Management in Medical Laboratories (INQUAM). Their work has resulted in several books on the subject, successful propagation of application of the EFQM model and a proposal for a formalized ”certification” procedure according to the model.
Keywords: Keywords EFQM; INQUAM; ISO 9000; EN 45000; ISO 15189; TQM
Post-analytical ’error’ rates in point-of-care testing: use of a quality assurance programme by Paul Tighe (pp. 402-404).
Laboratory tests are subject to error, pre-analytical, analytical and post-analytical. Post-analytical error includes misinterpretation of results. Point-of-care testing (POCT) can be subject to the same errors This study utilized an external quality assurance programme for capillary blood glucose and ’dipstick’ urinalysis to investigate post-analytical errors of result interpretation by various grades of nurse performing POCT. When the results simulated a hypoglycaemic patient, 84.1% of nurses interpreted the results correctly. In the case of diabetes mellitus, 95.7% of nurses interpreted the results correctly. Whereas in the simulation of a case where the capillary blood glucose was falsely raised due to puncture site contamination only 5.4% of nurses interpreted the POCT results correctly. As the seniority of the nurse made little or no difference to the interpretation given, this study demonstrated the need for improved training within the Taunton and Somerset NHS Trust Hospital.
Keywords: Keywords Quality assurance; Point-of-care systems; Blood glucose; Urinalysis; Nursing education
Cyclosporin Measurement – who cares about inaccuracy? by D. W. Holt; Kirsty Denny; Terry Lee; Atholl Johnston (pp. 405-408).
Most medical laboratories measure the immunosuppressive drug cyclosporin using one of a number of commercial immunoassays, or high-performance liquid chromatography (HPLC). The calibration of these assays is based on material supplied by the kit manufacturers or prepared in-house. We have examined inaccuracy for the measurement of cyclosporin in samples spiked to known concentrations and the impact of any inaccuracy on the results for cyclosporin measurement in pooled samples from patients prescribed the drug. The data were from the International Cyclosporin Proficiency Testing Scheme, based on aliquots of cyclosporin-free blood to which known amounts of the drug had been added or aliquots of pooled samples collected from patients receiving cyclosporin. Compared with the results using HPLC, the immunoassays had a median bias which ranged from –4.5% to 8.2% for the spiked samples. When pooled samples from patients were analysed the percentage difference from the measured HPLC value, allowing for assay inaccuracy, was as high as 29.9%. It is concluded that inaccuracy is a factor in between-assay performance for this measurement and that proficiency testing schemes should attempt to put more emphasis on this aspect of assay performance.
Keywords: Keywords Cyclosporin; Proficiency testing; Calibration and reference methods
Credibility of forensic DNA typing is driven by stringent quality standards by A. D. Kloosterman (pp. 409-414).
The quality of a forensic DNA investigation is by its nature limited by the condition and integrity of the sample, which is subjected to analysis. In the forensic laboratory a diverse range of items has to be searched for evidentiary biological stains. After detection, the DNA evidence is collected, labeled, stored, and analyzed in such a manner that the quality and integrity of the sample is preserved at every stage of the process. The enormous evidentiary strength of evidence, which is obtained when a reference DNA sample from a suspect is declared to match with the DNA from the evidentiary stain, has required forensic science laboratories to adopt stringent quality control measures. Sample mix-up and contamination of forensic evidence are the most serious concerns throughout the laboratory process. Various measures can be taken by the individual forensic science laboratory to assure high quality standards. Laboratory accreditation is essential in assessing the quality of the forensic science laboratory. Reanalysis and a second test by an independent laboratory can further prove the integrity and correctness of the DNA-typing results. Forensic DNA typing should be state of the art, however new DNA-typing technologies can only be introduced after its full acceptance in the world of molecular genetics. Subsequently, it is the responsibility of the forensic community to demonstrate the validity of any new application in the forensic context.
Keywords: Keywords Forensic DNA typing; Quality control; Accreditation; Standardization; SGM Plus
Quality planning in the ’in vitro diagnostic’ industry by Fred D. Lasky (pp. 415-420).
In vitro diagnostic (IVD) manufacturers play an important role in helping to provide laboratory results that meet the needs of patient care. Industry, the primary source of new technologies, uses established processes to assure a continuous supply of products that satisfies health care needs. The processes include validation of user needs, with well-controlled procedures that are used to manufacture quality products. Management uses routine audits and customer complaint monitoring to identify improvement opportunities. The processes used in the IVD industry are recognized quality practices that should be, and often are, used in the clinical laboratory.
Keywords: Keywords Quality system; In vitro diagnostics; Manufacturing; Design
Strategy to establish the number of replicates of a medical laboratory test by H. M. J. Goldschmidt; Eva M.L. Smets (pp. 421-423).
The allowable error of a test in medical laboratories can be defined by the customer demands based upon the use of the test, or by the appropriate biological variation. After correction for systematic bias, the actual analytical variation is compared to the stated allowable error. On top of that, proper quality control rules should be implemented regarding the number of control materials and the desired analytical quality assurance as well as assessment. A strategy is outlined that balances all these factors, taking advantage of the possibility to diminish the actual analytical variation through the use of replicate tests.
Keywords: Keywords Random variation; Medically allowable error; Quality control rules
Standardized method comparison for ACS:180 plus and Immulite sensitive PSA (sPSA) measurement methods by Yusuf Kurtulmus; T. Tanyalçın; Giray Bozkaya; Ogˇuzhan Gündüz; Ömür Çerçi; Fatma Z. Kutay; Biltan Ersöz (pp. 424-426).
The aim of this study was to compare two immunoassay measurement methods, the ACS:180 Plus (Chiron Diagnostics) kit and the Immulite sPSA (DPC) kit. Method comparison analysis was performed according to EP9-A; approved guideline of NCCLS 51. Serum samples having a wide range of total prostate-specific antigen (PSA) concentrations were evaluated in split-sample analysis. F-test, t-test analysis and regression statistics were performed. In Deming regression analysis the coefficients were as follows; the slope=0.967; y-intercept=-0.148, r=0.989. An acceptable bias was seen since the systematical error was calculated to have a value less than the total allowable error calculated from biological variations. Non-parametric evaluation of the area under ROC curves for ACS:180 Plus and Immulite sPSA were 0.997 and 0.987, respectively. Diagnostic accuracy was at the level of p= 0.000 and no statistical difference was found between the two assay methods.
Keywords: Keywords Standardized method comparison; PSA; ROC curve analysis
Interference study should be performed for every protein measurement method used by T. Tanyalçın; F. Z. Kutay; D. Aslan (pp. 427-430).
It is particularly important, when analyzing biological material, for the measurement procedure to be specific to the analyte and not to suffer interference by the matrix effect. Tissue fraction studies also require rapid and accurate methods to estimate the concentration of protein in solutions as well as many measurement methods used in medical laboratories. The design of this study is based on a comparison of the Lowry and the bicinchoninic acid (BCA) methods for the measurement of the total protein concentrations of rat liver subcellular fractions. In our experiment, subcellular fractions enriched in peroxisomes (POs) obtained by differential centrifugation were then further separated by means of density gradient centrifugation. We performed the protein measurement assays on all fractions obtained during the purification steps. The protein contents of the fractions obtained were determined by the two methods. The method comparison statistics were performed by linear Deming regression analysis and Altman and Bland bias plot. The regression equation was unacceptable, indicating that the last three fractions separated by means of Nycodenz discontinuous density gradient centrifugation gave remarkably divergent results. For the Lowry method, the Nycodenz effect could not be eliminated with the use of interference blank. In addition to Nycodenz, the potentially interfering compound used in the isolation procedure as isolation medium was 3-(morpholino)propane sulfonic acid (MOPS). In decreased concentrations of MOPS (10 mM), interference blank should be used for correct measurement with Lowry, but in practical use 10 mM does not provide buffering potency. In the BCA method, interference blank correction seemed to eliminate the measurement error in all concentrations of Nycodenz. There was no MOPS effect on the BCA measurement assay. Referring to deviations as sample-inherent matrix effects, we concluded that not only one, but more measurement methods should be used in order to make a correct protein measurement.
Keywords: Keywords Protein analysis; Lowry; Bicinchoninic acid
Application of the NIAZ frame of reference; impact on a departmental level by H. M. J. Goldschmidt; W. E. van der Weide; E.M.S.J. van Gennip (pp. 431-434).
The Netherlands Institute for Accreditation of Hospitals generated a general ”quality standard” applicable to the total quality management of a hospital. In addition departmental standards (NIAZ) are used as a frame of reference within their particular section of the hospitals. So two levels of standards (on an institutional and departmental level) are present and mutually tuned. Both levels can either lead towards a departmental accreditation certificate or a total hospital accreditation certificate. This approach represents a potential that will become extremely important in the future. These various levels should assure and assess their independent as well as joined quality to lead to an overall total quality management system. Various systems applied in Dutch health care, such as NIAZ, EFQM (INK), are discussed. Their use in the hospital setting, the application of indicators and the implications at departmental level are evaluated.
Keywords: Keywords Departmental accreditation; Hospital accreditation; Departmental quality; Health care indicators; NIAZ
How generic is the EFQM model? Art and quality: the EFQM model applied to the field of art by H. M. J. Goldschmidt; H. O. Goldschmidt (pp. 435-439).
Art appraisal is widely regarded as a totally subjective matter. Nevertheless, discussions with art connoisseurs indicate that certain general applicable items are present. A call for comparability is definitely present. An art auction is, in a way, through the standardization of the amount of money paid, a standardization of all art involved. This paper tries to find a general applicable quality model for art appraisal. By the use of the widely accepted EFQM model all aspects are supposed to be covered in any field. The field of art is now subject to this model. It was found that the model was suitable for art; it copes with the various quality types in art as well as the time dependent nature of art appraisal. The EFQM model seemed to be a unique way to compare different works of art in a formalized fashion.
Keywords: Keywords Quality of art; Emotional quality; EFQM model; Art quality scoring system
Chemical measurement laboratories caught in a battle between different forces: Accreditation requirements versus economic pressure – Is there a way out? by Helene Felber (pp. 439-441).
In order to meet the requirements of ISO/IEC 17025 and other regulations, accredited laboratories are forced to put more and more effort into quality assurance activities, which result in an increase in their costs. On the other hand, laboratories face increasing pressure due to international competition and, in order to succeed on the market, they must produce results in a short time at low cost. This is certainly a dilemma. Moreover, most young people who apply for a job as an analytical chemist are not well prepared to solve these problems efficiently. Therefore this dilemma also poses a challenge for universities and colleges to get closer to the practical needs of chemical measurement laboratories.
Keywords: Keywords Analytical chemistry; Validation; Measurement result; Accreditation; Education
Reference values versus consensus values: a reaction to the article of Baldan et al. by Robert George Visser (pp. 442-443).
In a recent article Baldan et al. concluded that reference values can be used in a proficiency test as assigned values and that this does not increase the cost of the proficiency test. They feel that the values found during an homogeneity test could be used as reference values. In this article, it is argued that the conclusions of Baldan et al. have only a very limited validity. Due to the difference in goals, homogeneity data cannot be used for the determination of reference values without a drastic change in set-up. And in practice, in many fields of application, the situation is quite different than Baldan et al. suggest. Thus in many proficiency testing studies it is not technically possible to use reference values and in cases where it is possible, the costs will increase significantly if reference values are used instead of consensus values.
Keywords: Keywords Proficiency test; Assigned value; Consensus value; Reference value; Costs; Feasibility; Homogeneity study
Summary from the workshop ”Improving the Scientific Base for Metrology in Chemistry (MiC) in EU Accession Countries”
by Jørgen V. Nørgaard; Ioannis Papadakis; Philip D. P. Taylor (pp. 443-444).