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Lecturer(s)
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Žáková Pavla, Mgr. Ph.D.
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Čegan Alexander, prof. Ing. CSc.
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Course content
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Problems of good laboratory practise. International norms. Directive 98/79/EU. ISO 15189:2000 - Quality management. EN 14136:2003 External quality assessment. National norms and laws: ISO 15189:2001, ČSN EN ISO/IEC 17025:2001, 10012-1:2003. Intimation 296/2000 Sb. M. of Health a M. of Agriculture Law 130/2003, Laws 123/2000, 274/2003. National accreditation centre for clinical laboratories NASSKL, establishing, competence and tasks. The rules for accreditation of clinical laboratories. Ensuring of quality system. Creating of national standards and accreditation standards of clinical laboratories ČSKB ČLS JEP and ČIA. Registration of laboratory medicine workers. Audit of quality system of clinical laboratories. Database standards system Ministry of Health, national dial of laboratory items and its structure. Creating of the local dial of laboratory items. Laboratory manual and its structure. Creating of the standard operation programs and their use. Laboratory information systems, operation and comunication with hospital information system. Electronical storage of documents at system of good laboratory practise and their scurity. Computer aplications: DSMZ, NČLP, LIS and NIS - practical using.
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Learning activities and teaching methods
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Monologic (reading, lecture, briefing)
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Learning outcomes
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According the subject, students will be acquainted with european and home norms arranged the system of good laboratory practise at analytical and clinical laboratory. He will be acquainted with procedures of the National accreditation centre for clinical laboratories and Czech Institute for the accreditation of clinical laboratories.
Student will get the knowledge about content of european and home norms arranged the system of good laboratory practise at analytical and clinical laboratory. He will know the content and significance of european norm ISO 15189 and he will be able to lead the laboratory according the rulles of good laboratory practise. He will be acquainted with practical procedures of the National accreditation centre for clinical laboratories and Czech Institute for the accreditation of clinical laboratories.
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Prerequisites
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not specified
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Assessment methods and criteria
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Oral examination, Written examination
Check-up of the study - 2 writen exam at seminary time - 25% of the exam Final writen exam of the class - 50% of the exam Oral examination (1 question) - 25% of the exam
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Recommended literature
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KOLEKTIV. Mezinárodní akreditační standardy pro laboratoře, Joint Commission International, Grada 2005.
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KOLEKTIV. Správná laboratorní praxe - software firmy SEKK s.r.o., Pardubice 2004.
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Pešek J. Tvorba systému jakosti ve zdravotnictví a lékarenství, Grada 2003.
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WEINBERG S. Good laboratory practise regulations. Quality Assurance Unit, Virginia Tech 1995.
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