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Accreditation and Quality Assurance: Journal for Quality, Comparability and Reliability in Chemical Measurement (v.9, #3)
The European conference on quality in the spotlight in medical laboratories, 17–18 March 2003, Antwerp, Belgium
by J. C. Libeer; H. M. J. Goldschmidt (pp. 123-124).
How far can the concepts of traceability and GUM/VIM can be applied to measurement results in laboratory medicine
by Henk Goldschmidt; Jean-Claude Libeer; Paul De Bièvre; Heinz Schimmel; Per Hyltoft Petersen (pp. 125-127).
Integration of data derived from biological variation into the quality management system of medical laboratories by Carmen Ricós; Virtudes Alvarez; Fernando Cava; José Vicene García-Lario; Amparo Hernández; Carlos Víctor Jiménez; Joana Minchinela; Carmen Perich; Margarita Simón (pp. 128-131).
A comprehensive overview is given on the current status of quality management in laboratory medicine. Using the three phases: pre-analytical, analytical, and post-analytical, a variety of sub-processes are discussed. Evaluation of this process using innovative statistical tools leads to the conclusion that much can be gained by incorporating the concept of biological variation in quality management system routines, calculations, delta checks, and reference change values.
Keywords: Laboratory medicine; Biological variation; Quality management system
The theory: some generic issues in the revision of VIM by Paul De Bièvre (pp. 132-136).
Unambiguous and consistent concepts and terms such as measurand, metrological traceability, measurement uncertainty, comparability of measurement results, target measurement uncertainty, etc., must govern the description of results of chemical measurements in order to enable a valid comparison of measurement results. This is not yet the case, as numerous workshops worldwide have shown over the last decade , and as chemical literature continuously displays. For international trade in food and feed to be fair, for border-crossing implementation of environmental regulations to be the same for all parties concerned, for interchangeability of results of clinical measurements to become a reality, and for any border-crossing interpretation of measurement results in chemistry to become possible, well-understood and mutually accepted concepts and terms are essential. Similarly, their translation from English into 30–40 other languages must be realized and fixed unequivocally. Countries using English as a common language have not yet realized the considerable advantage they have over countries where translated terms describing concepts may not yet be available, let alone understood and accepted. A number of ambiguities in the definitions and terms are described which illustrate the importance of the ongoing revision of the International Vocabulary of Basic and General Terms in Metrology (VIM).The revision of VIM is of primary importance for good understanding within and between measurement communities worldwide, including laboratory medicine.
Keywords: VIM; Clinical chemical measurement; Traceability; Target Measurement Uncertainty
From a single analyzer to multiple instruments—The GUM approach by Solveig Linko (pp. 137-140).
Assessment and expression of analytical quality have become novel spotlights in medical laboratories since accreditation began in the early 1990s, in Europe. Evaluation of uncertainty of measurement by definition was launched in Finland when the Finnish Accreditation Service (FINAS) accredited the first medical laboratories in the mid 1990s. In spite of all the analytical and statistical knowledge which has been available in medical laboratories for years, evaluation of total uncertainty of measurement has not yet caught on. The concept is still unfamiliar to experts and, indeed, little guidance has been available. National and international activities, with good results, can be shown when the educational aspect is considered. The Guide to the Expression of Uncertainty in Measurement (GUM) remains the main document for uncertainty evaluation. Uncertainty of measurement together with target value of uncertainty can be used as a good measure for analytical quality in large or smaller laboratories over time, because it is a quantitative indication and the evaluation is easy to repeat as running practical tools are available.
Keywords: Measurement quality; Target value of uncertainty; Accuracy; Trueness; Precision
CYBERLAB: today’s technology building the future by Henk M. J. Goldschmidt; Yvonne T. J. Somers-Pijnenburg; Bert L. H. van Berlo; Lieven van Poucke (pp. 141-144).
The availability of a large number of Internet connections creates a new attitude of the users toward society in general and information accessibility and supply in particular. This also includes medical services, especially those that are thriving on measurements such as diagnostic services. Medical laboratories and biometrical departments are suited very well to data/information exchange through web-based technologies. First of all, the location of the actual measurement does not correlate with the location of use of such information (virtual laboratory). Secondly, the time and number of people interested in the data/information obtained are not well defined and vary over time (knowledge factory). So the Internet and web-based technologies are supposed to help out in the order entry, report, and consultation stages of diagnostic services request and provision. Here we describe a pilot study to implement and evaluate such a future-directed tool (i.e, CyberLab from MIPS).
Keywords: Internet; Web-based technology; ICT strategy
Is CLIA 2003 the quality alliance envisioned between manufacturers, laboratory professionals, and regulatory agencies? by Sharon S. Ehrmeyer; Ronald H. Laessig (pp. 145-147).
The Clinical Laboratory Improvement Amendments of 1988 (CLIA’88) had a groundbreaking effect on laboratory professionals, instrument and reagent manufacturers, and regulators in the United States, and by association, worldwide. CLIA’88 defined new levels of responsibility for all three of these stakeholders in modern laboratory testing. As a result, we envisioned a CLIA-driven approach to regulations, which in effect, created a three-member “quality alliance.” In 2003, the long awaited CLIA updates to the quality control and quality assurance requirements were published. The revisions in CLIA 2003 will herald an era in which manufactures take responsibility for meeting new standards of quality (improved accuracy and precision or reduced total allowable error) in the clinical laboratory and, especially, at point of care where testing is performed by non-laboratorians. The European (Bureau International des Poids ed Mesures) efforts at traceability, the National Committee of Clinical Laboratory Standards efforts at estimating total allowable error, and the new CLIA 2003 quality systems approach for quality requirements return to the fundamental concepts of accuracy to assess the efficacy of clinical laboratory testing.
Keywords: Quality alliance; Assured quality; CLIA’88; CLIA 2003
Comprehensive quality control programme for serology and nucleic acid testing using an Internet-based application by Wayne Dimech; Sandy Walker; Darren Jardine; Scott Read; Kathy Smeh; Marina Karakaltsas; Bradley Dent; Elizabeth M. Dax (pp. 148-151).
The National Serology Reference Laboratory, Australia (NRL) has quality assured the serology for high risk blood-borne infections since 1985, commencing with anti-Human Immunodeficiency Virus (HIV) enzyme immunoassays and later extending the programmes to other blood-borne virus testing and to nucleic acid testing. A quality control (QC) programme was considered the most appropriate manner in which to achieve real-time monitoring. An Internet-based application, EDCNet, facilitates the entry of results of QC sample testing and returns the analysed results instantaneously. Results can be displayed in a variety of tables and charts, so that QC results from blood service and diagnostic laboratories can be monitored. Comparison of results between laboratories using the same system offers monitoring of accuracy, while within-laboratory comparisons offer monitoring of the assay precision. More than 200,000 data points were submitted to EDCNet in 2002 from blood service laboratories as well as from diagnostic laboratories. Analysis of reagent batch variability was determined, e.g. the coefficient of variation between batches of seven assays used to detect anti-hepatitis C virus (HCV) antibodies ranged from 4.9% to 21.6%. Using EDCNet, laboratories can monitor both precision and accuracy of results by comparison with the results of other laboratories. The system may be a highly cost-effective method for maintaining quality.
Keywords: QC software; National Serology Scheme; Practical QC tools
One-year’s experience of a ‘repeat analysis’ quality programme for blood gas analysers by Paul Tighe (pp. 152-154).
The aim of this study was to determine the value of a quality assurance (QA) programme based on the ‘repeat analysis’ principle, where a sample is analysed at one site, and sent to another site for repeat analysis and the comparison of the two sets of values. Once each day a routine blood gas sample, collected from a patient in the Intensive Therapy Unit (ITU) of the hospital, was analysed by the ITU nurse on the ITU blood gas analyser. The air bubble was expelled and the sample sealed and sent to the biochemistry laboratory immediately. The sample was re-analysed in the biochemistry laboratory. This programme was continued for a year. The biochemistry laboratory results (gold standard) were compared with the ITU results and ‘rule’ breaches were notified to ITU immediately after the repeat analysis. All results were graphed and linear regressions and correlation coefficients calculated. The correlation coefficients ranged from r 2=0.9317 for pH to r 2=0.4381 for pO2. All parameters except pO2 and Na+ gave satisfactory correlations. The Na+ results should be adjusted by inserting a slope and intercept. It is suspected that improvement in the pO2 would be possible if the time between ITU and biochemistry analyses could be reduced from its current levels.
Keywords: Point-of-care testing; Quality assurance; Blood gases
A practical approach to the implementation of autoverify by Lynn M. Johnstone (pp. 155-158).
Autoverification is a process in which computer software will automatically evaluate laboratory test results, verify result integrity, and then release the results to the hospital interface without any technologist intervention. Autoverify release criteria are user defined and can be customized. The process of developing, implementing, and monitoring autoverify is achievable for most test results in laboratory medicine. The use of autoverification will improve result quality, increase revenue, and create faster turn-around times. All of this put together will ultimately lead to improved customer satisfaction. Computers and autoverification are survival tools in the competitive market of laboratory diagnostics services.
Keywords: Autoverification; Autovalidation; Automated test result confirmation; Automated plausibility assessment; Electronic patient record
Performance of electrolyte assays in the United Kingdom—reference target values by M. A. Thomas; S. C. Smith; S. Sall; A. J. Newsam; D. H. Ducroq (pp. 159-163).
Wales External Quality Assessment Scheme (WEQAS) is one of the largest external quality assessment (EQA) providers in the United Kingdom, with over 600 participants. Over the last two and a half years, reference target values have been used for the electrolyte panel in the WEQAS General Chemistry scheme. Reference methods have a vital role in that they ensure the transfer of accuracy from definitive methods to routine methods. Validated reference methods, using flame emission/atomic absorption spectrometry were established for sodium, potassium, calcium, magnesium and lithium. These methods were validated by direct comparison with the definitive method via the use of primary reference material. Comparison against the all laboratory trimmed mean (ALTM) showed a small mixed systematic error for sodium and potassium, with a maximum bias from the reference value of 1% and 2%, respectively. Lithium and magnesium data showed predominant systematic constant errors of +0.03 and +0.02 mmol/l, respectively. For calcium, ALTM results showed a mixed systematic error with a cross over in the reference range (5% positive bias and constant error of −0.1 mmol/l). Over 40% of participants used the cresolpthalein complexone method, greatly influencing the ALTM value, (11% bias, constant error −0.26 mmol/l). Other methods such as the ion selective electrode (ISE) method were in closer agreement to the reference method (−4% bias, +0.05 mmol/l constant error). The study highlights the pitfalls of using the overall mean data as an accuracy target in EQA schemes.
Keywords: EQA; Reference target values; Electrolyte assays
The use of split-sample design for performance evaluation of screening kits by Tijen Tanyalçın; François Eyskens; Eddy Philips; Marc Lefevere; Orcan Tanyalçın (pp. 164-167).
Laboratory medicine is an important discipline in health care with its remarkable effect on risk assessment, diagnosis of health, and disease state. This accounts describes a newborn screening approach involving retest, recall, and follow-up procedures. This real life trial emphasizes the need for split-sample design evaluation of newly opened test kits. Quantitative measurements of phenylalanine and neonatal thyroid stimulating hormone (nTSH) were performed in two laboratories. After validation of the calibration in the laboratory that was using the industrially prepared screening kits for the first time, the same real newborn blood spot samples were analyzed for phenylalanine and nTSH measurements in both laboratories and the results obtained were compared non-parametrically, and examined by Deming regression and difference plots. There was no problem with the phenylalanine results: similar results were obtained for the same blood spot cards in both laboratories (P=0.496; bias estimation 0.13). However, the nTSH values were found to be significantly higher in the laboratory that used the nTSH kit for the first time. Although the validation of the calibration of the nTSH kit was valid with the manufacture’s control materials, spilt-sample results showed that there was a significant difference between the two laboratories (P=0.005; bias estimation 28.6). This study implies that acceptable comparability of split-sample design analysis is needed for testing the analytical performance of industrially prepared tests kits, and this can only be achieved with certified reference materials.
Keywords: Analytical performance; Split-sample analysis; Certified reference material
A prelude of the 2004 Antwerp Quality Conference: Targets and target values—integrating quality management and costing by Frits van Merode (pp. 168-171).
Questions about the value of services in the health care sector and the quality of them have been addressed frequently during the last decade, but as separate issues. In this article a method is proposed to combine these two issues. The starting point is the observation that competition will become fiercer among providers in the health care sector . Moreover, the patient’s opinion about quality in terms of convenience, emotional attention, etc., will be important in a competitive environment and will determine which health care service providers will be successful. These developments will have an impact on the engineering of the health care chain. Methods are discussed to integrate the determination of the value of innovations and new products, and the design of quality systems. The system of target costing is focused upon. It takes the outcome of care processes as desired by customers or the users as the starting point both for pricing the services as well as for designing the delivery system. This will not only improve cost control, but also quality improvements in two ways. First, the delivery system will be better adapted (and integrated if more health care providers are involved) to the needs of the patients, and second quality will improve as health care providers analyze, redesign, and monitor their processes more extensively.
Keywords: Target costing; Quality improvement; Process integration