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Accreditation and Quality Assurance: Journal for Quality, Comparability and Reliability in Chemical Measurement (v.5, #12)
Uncertainty calculations in the certification of reference materials. 1. Principles of analysis of variance by A.M.H. van der Veen; J. Pauwels (pp. 464-469).
The preparation and certification of reference materials is a rapidly developing area. Many innovative reference materials have limited homogeneity and stability, and, additionally, the uncertainty estimation of the property values must be brought in agreement with the principles of the “Guide to the expression of uncertainty in measurement” (GUM). The results of the homogeneity and stability studies must be included to a certain extent in the uncertainty of the property values of the reference material, in order to comply with these requirements. The basic theory needed to accomplish this is essentially the theory of analysis of variance (ANOVA). As GUM also allows alternative evaluations other than Type A evaluations, a reinterpretation of the theory of ANOVA is necessary to establish a model for the certification of reference materials that is widely applicable. For this, analysis of variance can be used as a statistical technique to derive standard uncertainties from homogeneity, stability and characterisation data.
Keywords: Keywords Reference materials; Measurement uncertainty; Analysis of variance; Homogeneity study; Stability study
Accreditation of small laboratories by M. Holmgren; N. Müller (pp. 470-474).
This paper presents the result of an investigation concerning which areas of EN 45001 are considered as especially problematic by small laboratories (<10 employees). The investigation was performed by distributing questionnaires to European laboratories. To be able to differentiate between areas considered as problematic only by small laboratories and areas considered as problematic by laboratories in general, some questionnaires sent in by larger (>10 employees) laboratories were used. The determination of measurement uncertainties within reasonable efforts and the requirements to take part in round robin and proficiency testing were considered problematic by laboratories of all sizes. Training is an area where small laboratories have specific problems and so are the requirements for the identification of all equipment. Other problematic areas for small laboratories are areas were there are needs for personnel, e.g. appointing supervising personnel and expenditure for internal audits. The last area to be considered as problematic is matters concerning documentation. Finally some advice concerning assessment of small laboratories is given.
Keywords: Keywords EN 45001; Small laboratories; Accreditation
Can the progress in quality management tools for POC tame the fiends from Pandora's box? by M. R. Groves (pp. 475-481).
POCT provides the opportunity to significantly improve the overall quality of blood testing in an organization. The design of the product, the redesign of the testing process and the tools used to manage a completely distributed testing process, are key to the quality implementation of POCT. Both theoretical considerations and practical outcomes are discussed in this paper, using the i-STAT® System as an example of a POCT system.
Keywords: Keywords POCT systems; Quality management; Process redesign
The EC4 European Register for Clinical Chemists in relation to quality aspects by G. T. Sanders (pp. 482-484).
The European Register for Clinical Chemists is founded and guarded by the European Communities Confederation of Clinical Chemistry (EC4). This register fits the current mind set of harmonization and globalization of occupations within the European Community. But in addition it enables and serves the continuing quest for quality assessment and improvement within the field of laboratory medicine. The content and position of clinical chemists in the European Union is described and the European Register outlined.
Keywords: Keywords Certification; European register; Clinical chemistry occupation; EC4; IFCC
Quality [r]evolution in diabetes care by R. N. M. Weijers; J. W. Jager; C. B. Brouwer (pp. 485-487).
To implement the St. Vincent Declaration Action Programme, initiatives have been started in the quality development of diabetes care across Europe. The main elements of the quality development cycle implemented in our hospital were realized by the use of the software package ‘CamitPro’ and participation in ‘the DiabCare Q-net NL’ network. From 1997 to 1999, 955, 1468, and 1624 patients with diabetes mellitus type 2 were integrated in the DiabCare Q-net NL network by using ‘CamitPro’ software, respectively. These patients showed substantial improvement in all of the clinical measures monitored. In addition, there was a drop in HbA1c level. From 1997 to 1999, an HbA1c interval of 5.1%–8.3% (mean up to mean +4SD) was recorded for 66%, 76% and 81% of the patients, respectively. An extension of the use of the software to a pan-European level should markedly improve diabetes care throughout the community.
Keywords: Keywords Diabetes care quality; CamitPro; DiabCare Q-net NL; Diabetes mellitus automatic quality assessment
Urine dry reagent strip “error” rates using different reading methods by P. Tighe (pp. 488-490).
The need for “quality” in near patient testing (NPT) has been acknowledged since the mid 1980s. The commonest biochemical NPT device is the dry reagent strip or “dipstick” for urinalysis. Dipsticks may be read in three ways, against the color chart printed along the side of the bottle, using a benchreader (the color chart printed on a flat card) or using an electronic reader. This report uses the results of a urinalysis quality assurance (QA) program, over 1998, to evaluate the “error” rates which occur using the three different reading methods. The QA samples are buffered aqueous solutions which are “spiked” to give concentrations midway between two color blocks for each analyte. Results are scored as ±1 if a color block adjacent to the target value, ±2 for results two color blocks (defined as “error”) and ±3 for results three color blocks (defined as “gross error”) from the target value. Analysis of the results show that the error rates are similar reading visually by either method, but greatly reduced when read electronically. Some persisting errors when using the electronic reader are explained by observation studies. The study highlights the value of a urinalysis QA program for NPT urinalysis in understanding the error rates of this simple but ubiquitous test.
Keywords: Keywords Urinalysis; Quality control; Near patient testing; Quality in point of care testing
Quality improvement through verbal and written interviews of laboratory employees by N. C. V. Péquériaux; J. Puts; H. M.J. Goldschmidt (pp. 491-494).
There is a growing awareness of the importance of the human factors involved in total quality management. Tools to monitor and improve the knowledge and skills of all those involved in production processes in medical laboratories are recognized and applied. The effect of providing written information and verbal presentations concerning specific items (such as documentation, standard operating procedures, etc.) was monitored through an external questionnaire. Not only the level of information but also the employees' perception of their own work gained in depth and positivity.
Keywords: Keywords Human resource management; Quality inquiries; Empowerment; Quality improvement; Quality performance indicator
Statistical evaluation of uncertainty for rapid tests with discrete readings – examination of wastes and soils by H. Malissa; W. Riepe (pp. 495-498).
In the course of the colorimetric determination of analytes using a procedure with discrete readings the measurement uncertainly cannot be calculated in the normally practiced manner. The basic principle of the analytical method used is a stepwise and non-equidistant reading. Based on the fact that half a step can be estimated, a calculation of the measurement uncertainty for the 95% confidence level is possible; this is needed to allow a reliable decision of whether a critical value is exceeded or not.
Keywords: Keywords Colorimetric; Rapid tests; Discrete reading; Statistical evaluation
Cofactors in Biota: results of a German interlaboratory exercise on the determination of total lipids in fish tissue by P. Woitke; M. Haarich; U. Harms (pp. 499-503).
The content of total lipids is a common cofactor necessary for a normalisation of organic contaminant concentrations in biological materials. Lipids are routinely determined gravimetrically after extraction of the material with chlorinated solvents. A new method substituting chlorinated solvents for a cyclohexane/isopropanol mixture was to be evaluated by an intercomparison exercise. The participating laboratories were requested to determine total lipid content in three different samples of fish tissue following their own procedures as well as the new method described in a standard protocol. No significant differences in the overall means of total lipid content were found for the investigated samples regardless of the determination method. Using the harmonised protocol of the new method, between laboratory reproducibilities below 10% were obtained in the exercise. The results indicate the applicability of the harmonised method for the determination of total lipids as a cofactor in the analyses of contaminant concentrations in marine biota samples.
Keywords: Keywords Total lipids; Biota samples; Marine monitoring; Quality assurance; Intercomparison exercise
How do accreditors deal with providers of proficiency tests and with producers of reference materials?
by M. Wloka (pp. 504-505).