Forgot your password?
New user?
New Window Opens on the Secret Life of Microbes: Scientists Develop First Microbial Profiles of Ecosystems
CAS announces the release of SciFinder Scholar for Mac OS X
Press Releases
Press Releases
| Check out our New Publishers' Select for Free Articles |
Accreditation and Quality Assurance: Journal for Quality, Comparability and Reliability in Chemical Measurement (v.7, #11)
The European Conference on Quality in the Spotlight in Medical Laboratories, 7–9 October 2001, Antwerp, Belgium
by J. C. Libeer; H. M. J. Goldschmidt (pp. 429-430).
A review of autovalidation software in laboratory medicine by Henk M. J. Goldschmidt (pp. 431-440).
Although autovalidation procedures have been around for many years, through the use of computers and the application of (medical) protocols, they are now becoming part of the production environment of medical laboratories. The introduction of high volume instruments within routine medical laboratory testing certainly speeded up their application as well. After defining autovalidation, autoverification and autoconfirmation, this paper provides a framework for the different ways and places where these tools can be applied within laboratory medicine. Technology as well as organization are essential building blocks to reach well-defined, transparent and assured quality. A laboratory automation system (LAS) brings both areas together in a logical, future-oriented way. Strengthening the information loop, reaching guaranteed quality (analytical, turnaround times and efficiency), leads towards strict management of the laboratory processes. This includes all laboratory processes and here autovalidation and autoreporting become essential. A survey of currently available software routines and their appraisal from a managerial viewpoint are given. It can be concluded that autovalidation software in laboratory medicine is maturing and is rapidly becoming a critical success factor in any medical laboratory. Quality can be automated for sure and autovalidation software will prove to be a valuable aid to do so.
Keywords: Keywords Autoverification; Autovalidation; Automated test result confirmation; Automated plausibility assessment; Electronic patient record
Bioanalytical method validation and its implications for forensic and clinical toxicology – A review by Frank T. Peters; Hans H. Maurer (pp. 441-449).
The reliability of analytical data is very important to forensic and clinical toxicologists for the correct interpretation of toxicological findings. This makes (bio)analytical method validation an integral part of quality management and accreditation in analytical toxicology. Therefore, consensus should be reached in this field on the kind and extent of validation experiments as well as on acceptance criteria for validation parameters. In this review, the most important papers published on this topic since 1991 have been reviewed. Terminology, theoretical and practical aspects as well as implications for forensic and clinical toxicology of the following validation parameters are discussed: selectivity (specificity), calibration model (linearity), accuracy, precision, limits, stability, recovery and ruggedness (robustness).
Keywords: Keywords Method; Validation; Bioanalysis; Toxicology
A quality systems approach for identifying and controlling sources of error with point of care testing devices by S. S. Ehrmeyer; Ronald H. Laessig (pp. 450-454).
Historically, due to the size and nature of the instrumentation, highly skilled laboratory professionals performed clinical testing in centralized laboratories. Today’s clinicians demand realtime test data at the point of care. This has led to a new generation of compact, portable instruments permitting ”laboratory” testing to be performed at or near the patient’s bedside by nonlaboratory workers who are unfamiliar with testing practices. Poorly controlled testing processes leading to poor quality test results are an insidious problem facing point of care testing today. Manufacturers are addressing this issue through instrument design. Providers of clinical test results, regardless of location, working with manufacturers and regulators must create and manage complete test systems that eliminate or minimize sources of error. The National Committee for Clinical Laboratory Standards (NCCLS) in its EP18 guideline, ”Quality management for unit-use testing,” has developed a quality management system approach specifically for test devices used for point of care testing (POCT). Simply stated, EP18 utilizes a ”sources of error” matrix to identify and address potential errors that can impact the test result. The key is the quality systems approach where all stakeholders – professionals, manufacturers and regulators – collaboratively seek ways to manage errors and ensure quality. We illustrate the use of one quality systems approach, EP18, as a means to advance the quality of test results at point of care.
Keywords: Keywords Quality systems; Point-of-care testing; Decentralized testing; Quality assurance; Quality control; Quality practices; Error rate detection
Biological variation data are necessary prerequisites for objective autoverification of clinical laboratory data by C. G. Fraser; Heather P. Stevenson; Ian M.G. Kennedy (pp. 455-460).
The wealth of quantitative data on random biological variation has been used for setting quality specifications, assessing the utility of conventional reference values, and deciding of the significance of changes in serial laboratory results. Most analytes have marked individuality and this makes conventional population-based reference values of low utility. In consequence, reference limits are not ideal for autoverification strategies. Clinical decision limits may be better criteria for holding results for verification by laboratory professionals. Changes in serial results are significant only when the reference change value is exceeded. Such values can be generated by all laboratories and can be implemented, not only to flag reports, but also in delta checking and autoverification since these are objective rather than empirical. We have put these considerations into operation into our laboratory. Apart from special cases, our general approach is that results flagged as having changed 0.05<P<0.01, flagged as just outside the reference limits, or not flagged in any way, are autoverified and reported to the user without intervention. Only results outside pre-set clinical limits and those that have changed highly significantly P<0.01 are held for verification by clinical scientists and medical staff. This strategy allows autoverification of ca. 60% of reports.
Keywords: Keywords Autoverification; Biological variation; Delta check; Reference values; Clinical decision limits
Using a learning curve approach to reduce laboratory errors by Jan Krouwer (pp. 461-467).
Hospital laboratories have error rates that are too high and in some cases may be responsible for adverse patient treatment. This paper introduces reliability growth management (RGM), which is based on learning curve theory, as a method to improve laboratory error rates. RGM is widely used in the defense and automotive industry to solve problems when resources are limited and knowledge about the product and/or process is incomplete. An example of RGM, which was used to improve the reliability of instrument assay systems in the medical diagnostics industry is presented. RGM is a closed-loop process that entails creating a goal and event model, classifying events with failure review and corrective action system (FRACAS), tracking progress and predicting completion with Duane analysis. Results achieved by RGM were far better than those obtained by previously used methods. RGM techniques can be transferred to hospital laboratories to reduce laboratory error rates. The advantages of RGM compared to other quality initiatives such as ISO 9000 and Six Sigma are discussed.
Keywords: Keywords Reliability growth management; Quality; ISO 9000; FRACAS; Six Sigma
The quality of leadership (QL): the EFQM leadership criterion in relation to the 360° feedback evaluation method by H. M. J. Goldschmidt; N. C. V. Péquériaux; J. De Jongh-Leuvenink (pp. 468-472).
The European Foundation for Quality Management (EFQM) integral quality management model covers nine issues: five so-called enabler criteria and four so-called result-oriented criteria. The first enabler criterion concerns leadership and covers all kind of strategic management aspects. However, directly or indirectly, the leadership of the board of directors or its individual members is characterized and scored. An even more explicate technique, originated in a totally different way, is the 360° feedback evaluation method. In this paper both methods are compared and practiced on various individuals. A checklist was developed to facilitate scoring in the EFQM leadership submodel. Both methods, although from a different origin, could be linked easily, covered very similar aspects and gave results that were in excellent agreement with each other. The scoring showed almost identical results, supporting in large the use of the integral EFQM model.
Keywords: Keywords EFQM model; 360° feedback evaluation method; Quality of leadership; Management style
The College of American Pathologists laboratory accreditation program by A. Rabinovitch (pp. 473-476).
The College of American Pathologists (CAP) operates voluntary programs in proficiency testing (PT) and quality monitors, which are briefly described. Additionally, a peer-based laboratory accreditation program covers over 6,100 clinical laboratories. Participation requires successful PT and on-site inspections using a series of 18 checklists structured along traditional subdisciplines of laboratory medicine and anatomic pathology. The laboratory general checklist contains over 250 questions covering broad issues affecting all disciplines. Among these are three items within the computer services section that specifically probe the laboratory’s use of autoverification. Data autoverification is defined as the process by which the computer performs the initial verification of test results; any data that fall outside of set parameters should be reviewed by the human operator. Central to these questions is the role of the laboratory director in approving the rules and validation. CAP does not define the specific technical details, recognizing the uniqueness of each laboratory setting and the patients it serves.
Keywords: Keywords College of American Pathologists; Laboratory accreditation; Proficiency testing; Autoverification
LabRespond: a tool for autoverification by Jan P. Kuijsters (pp. 477-479).
Autoverification is defined as the process by which a computer performs the initial verification of test results. Any data that fall outside set parameters are then reviewed by the technologist [1]. LabRespond is an open system with an integral approach to control which monitors all the phases of the laboratory process. In particular, the statistical-based multi-two-dimensional test ”frequency of occurrence” has a high detection rate for suspicious test results. The content of LabRespond, the validation rules and, in particular, the test ”frequency of occurrence” is mainly the work of members of the Dutch Working Group of Clinical Chemometrics1(1Members of the Dutch Working Group of Clinical Chemometrics are: Marcel Volmer, Martin van der Horst, Remi Wulkan, Kees van Dongen, Wytze Oosterhuis, Herman Ulenkate and Henk Goldschmidt.) and the staff of the laboratory of the Saint Elisabeth Hospital in Tilburg.
Keywords: Keywords Autoverification; Integral quality system approach
How autoverification through the expert system VALAB can make your laboratory more efficient by Laurent Prost; E. Rogari (pp. 480-487).
For over 10 years now various expert systems have been on the market, but very few have reached the level of performance of Validation Assistée pour les Laboratoires d’Analyses Biologiques (VALAB). Over 25,000 rules are combined through an inference engine to reproduce human reasoning in the complex ”biological validation” process. After a review of the product concept and its development program, we will see how this ”intelligent” tool can bring quality to clinical laboratories, from a production as well as legislation point of view. With more than 140 laboratories using VALAB in Europe in daily routines, our designer and vendor experience in installation, maintenance, upgrading, reliability, efficiency, and liability is excellent.
Keywords: Keywords Autoverification; Expert system; Post analytical phase
Importance of the choice of assumptions and models in the estimation of analytical quality specifications by Per Hyltoft Petersen (pp. 488-493).
The validity of any model depends on its ability to imagine the situation or problem to which it is applied. Further, the assumptions made in relation to the model are determining for the actual outcome. Within the field of clinical biochemistry a lot of models for analytical quality specifications, based on a variety of concepts and ’clinical settings’, have been proposed. A hierarchical structure for application of these approaches and models has been agreed on at several occasions in 1999. In this hierarchy, the highest rank is given to evaluation of analytical quality specifications based on ’clinical settings’/’clinical outcome’ models, followed by specifications based on biological variation and on ’clinicians opinions’. This contribution, deals with the problems of combining random and systematic errors and the implications of application of different models to a variety of clinical settings.
Keywords: Keywords Analytical bias; Bi-modal distributions; Ordinal scale; Point-of-care-testing (POCT); Random error; Ratio scale; Systematic errors; Uni-modal distributions
Getting the most from your laboratory information system in the hematology laboratory by Irina Lutinger (pp. 494-497).
As laboratories continue to downsize, commercialize and become more businesslike in today’s managed care environment, their present and future success will greatly depend on the efficiency and flexibility of their laboratory information system (LIS). Today, LIS is a primary tool for managing business and communication. Laboratories that hope to remain competitive in today’s dynamic health care must continue to implement new and innovative approaches with their LISs.
Keywords: Keywords Laboratory information system; Autoverification; Autovalidation; Review range; Reference range; Reflex testing
A marked difference between two populations under mass screening of neonatal TSH and biotinidase activity by T. Tanyalçın; François Eyskens; Eddy Philips; Marc Lefevere; Benal Büyükgebiz (pp. 498-506).
Health-associated reference values are universally needed in clinical chemistry. The aim of this study was to establish the reference intervals of two populations from data obtained by the mass screening of newborn babies and to demonstrate how to determine 95% confidence intervals around the lower and upper limits of reference values from values that are not normally distributed. Biotinidase activities from Belgian (n=260) and Turkish (n=328) populations were measured by fluorometric assay and expressed as 1 IU (1 nmol/(dl min). Neonatal thyroid-stimulating hormone (nTSH) values from Belgian (n=4186) and Turkish (n=1663) populations were also measured by the solid phase two-site fluoroimmunometric assay, the results were given as µU/ml blood. Transformation of data was performed for each parameter. A parametric method was used for determination of reference values of biotinidase activity and the Belgian population was significantly higher than the Turkish population. nTSH reference values were evaluated by an exact non-parametric method, but approximate calculation based on the central limit theorem was also performed for confidence intervals around the reference limits. nTSH values of the Turkish population were found to be significantly higher than for the Belgian population. Rank numbers were found by an exact non-parametric method based upon the assumption of a binomial distribution. This study shows a procedure to define the rank numbers for n>1000 and to obtain reference values with 95% confidence intervals for lower and upper reference limits.
Keywords: Keywords Mass screening; Confidence limits; Reference values
Quality and quantity within medicine by Patrick Triadou (pp. 507-511).
The concept of quality is placed both within a historical as well as philosophical light. It is argued that nowadays general and laboratory medicine is a logical extension of economical and social concepts which stem from the beginning of the twentieth century. However, it seems that medicine cannot be explained based entirely upon these concepts. The medical field has a variety of definitions of quality: all depending on the person and/or institution posing the questions. The quality concept sometimes concerns an individual and sometimes a group of individuals. The quality definition and indicator scores are then different. This quantified quality can also be looked upon from an eastern (i.e. Japanese, Chinese, ancient Greece) perspective. The ideal world, framed within a cyclic evaluation between well-defined static situations, does not relate easily with the individualized (quantified quality) western medical world. Nevertheless, we are in search of a quality concept that balances the western industrial model of medicine and the eastern, philosophical approach.
Keywords: Keywords Quality management; Health care; Laboratory medicine; Economics; Evidence-based medicine