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Accreditation in clinical laboratories

By Tomáš Zima


At the beginning of the 21st century there are defined priorities in laboratory medicine such as laboratory automation, laboratory consolidation, molecular diagnostics, and accreditation of laboratories aiming to improve the quality of patient care. Laboratory medicine is backbone in the medical treatment, diagnosis and prevention. Laboratory diagnostics influences 70-80% of hospital health care decisions and costs between 3-5% of total health care costs. Laboratory attempts to improve quality aim to reduce diagnostic errors and decrease turn around time with traceability of all laboratory procedures. Concerning quality, the strategic plans of IFCC and EFCC include focusing of accreditation of labs based on ISO standards and cooperation with European Accreditation and national accreditation bodies. IFCC recognises that ISO15189:2007 - Medical laboratories - Particular requirements for quality and competence, encompasses all the assessment criteria specified in the policy statement and as such should form the basis for the accreditation of laboratories. There are also different systems in EU countries based on national quality systems which are based on ISO 15189. Accreditation is not about who the best is, but who has a system of standard procedures. Quality system is about people, with people and for people

Topics: accreditation; ISO15189 standard; quality system
Publisher: Medicinska naklada
Year: 2010
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