56 research outputs found

    Quality assurance in Belgium137

    No full text
    Clinical laboratories in Belgium working within the social security system require to be licensed. Internal quality control and participation in external quality assessment (EQA) belong to the licensing conditions. The evolution of the Belgian EQAs is outlined, including a performance evolution over the last ten years. Halving of interlaboratory CVs is observed for most clinical chemistry and immunoassay analytes. Improvement is less spectacular for haematological analytes and is missing for coagulation analytes. Using the results of EQAs 1989-1991 the mean overall method interlaboratory CVs could be estimated. Using data from a commercial internal quality control program for clinical chemistry and a request in 145 laboratories, current intralaboratory CVs are estimated</p

    Reply to Wood WG. Questionable results--who directs the EQAS organisers?

    No full text
    No abstract available.</p

    Role of external quality assurance schemes in assessing and improving quality in medical laboratories125

    No full text
    Medical laboratories have a long tradition of external quality assessment. Starting from pure quality control of laboratory performances, most external quality schemes in Europe evolved into a powerful tool for improving quality of clinical outcome of results. External quality assurance in medical laboratories not only includes laboratory performance evaluation, but also evaluation of method performance, post-market vigilance, training and help. In the future, the quality of programmes will further be improved by accreditation of schemes international collaboration and by using IT applications</p

    Effect of accreditation schemes on the setting of quality specifications by laboratories126

    No full text
    In the future, there will be a universal standard for quality management in medical laboratories: ISO 15189. This standard follows the basic principles of ISO 17025, the general standard for test laboratories, but also adds several specific aspects. A comparison between these standards is given. The language of ISO 15189 is designed to be understood by medical laboratory professionals. As this standard is applicable to all medical laboratory fields, requirements are given in general terms requiring the laboratory to implement them correctly. Because it is essential that information provided by laboratory results is useful for healthcare, the requirements covered by ISO 15189 are compared with those needed for providing good medical laboratory services. The capabilities of the personnel at the laboratory clinic interface are the most difficult to assess and evaluate in an adequate quality management system</p

    Solid phase chemistry in clinical laboratory tests: a literature review147

    No full text
    The present review attempts to summarize and discuss the systems based on solid phase chemistry reagent carriers. The development and the principles of the different systems are first discussed, followed by a survey of the literature on different analytes, and a discussion of possible sources of interference in each of the most important commercial systems</p

    Effect of accreditation schemes on the setting of quality specifications by laboratories

    No full text
    In the future, there will be a universal standard for quality management in medical laboratories: ISO 15189. This standard follows the basic principles of ISO 17025, the general standard for test laboratories, but also adds several specific aspects. A comparison between these standards is given. The language of ISO 15189 is designed to be understood by medical laboratory professionals. As this standard is applicable to all medical laboratory fields, requirements are given in general terms requiring the laboratory to implement them correctly. Because it is essential that information provided by laboratory results is useful for healthcare, the requirements covered by ISO 15189 are compared with those needed for providing good medical laboratory services. The capabilities of the personnel at the laboratory clinic interface are the most difficult to assess and evaluate in an adequate quality management system</p

    Total quality management for clinical laboratories: a need or a new fashion?130

    No full text
    In most European countries, concepts of quality management in medical laboratories have been proposed. These concepts are based on general standards for test laboratories (EN 45001, ISO 25) or specific adapted standards. Improvement of quality lays on the foundation of the implementation of quality systems in medical laboratories. This new approach will have consequences on management style and on working conditions. Efficacy on the implementation can only be tested by external audits. During this audit, not only the quality system and analytical competence must be examined, but also if there is a real contact between pathologists and clinicians and if laboratory results are clinically validated (clinical audit). This new vision on quality in medical laboratories will ask a reconsideration of the tasks, duties and knowledge of clinical pathologists</p
    corecore