Course: Management of Quality in Clinical Laboratories

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Course title Management of Quality in Clinical Laboratories
Course code KBBV/C376
Organizational form of instruction Lecture
Level of course Bachelor
Year of study not specified
Semester Summer
Number of ECTS credits 1
Language of instruction Czech
Status of course Compulsory
Form of instruction Face-to-face
Work placements This is not an internship
Recommended optional programme components None
Lecturer(s)
  • Čegan Alexander, prof. Ing. CSc.
Course content
Problems of management of quality at clinical laboratory. International norms. Directive 98/79/EU. ISO 15189:2000 - Quality management. EN 14136:2003 External quality assessment. National norms and laws: ISO 15189:2004, 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.

Learning activities and teaching methods
Monologic (reading, lecture, briefing)
  • unspecified - 10 hours per semester
  • unspecified - 20 hours per semester
  • unspecified - 5 hours per semester
Learning outcomes
According the subject, students will be acquainted with european and home norms arranged the system of management of quality at clinical laboratory. He will be acquainted with procedures of the National accreditation centre for clinical laboratories and with the binding rulles of accreditation standards for clinical laboratories published from ČSKB ČLS JEP.
Student will get the knowledge about content of european and home norms arranged the system of management of quality at clinical laboratory. He will know the content and significance of european norm ISO 15189 and he will be able to introduce system of management of quality according the rulles of good laboratory practise. He will be acquainted with procedures of the National accreditation centre for clinical laboratories and with the binding rulles of accreditation standards for clinical laboratories published from ČSKB ČLS JEP.
Prerequisites
not specified

Assessment methods and criteria
Oral examination, Written examination

Final writen exam of the class - 75% of the exam Oral examination (1 question) - 25% of the exam
Recommended literature
  • KOLEKTIV. Mezinárodní akreditační standardy pro laboratoře. Joint Commision Int. Grada, 2005.
  • KOLEKTIV. Správná laboratorní praxe-software firmy SEKK s.r.o.. Pardubice, 2004.
  • Pešek J. Tvorba systému jakosti ve zdravotnictví a lékárenství. Grada, 2003.
  • Šprongl L. Příručka k vnitřní kontrole kvality. ČSKB Praha, 2007. ISBN 978-80-254-1130-8.
  • WEINBERG S. Good laboratory practise regulations. Quality Assurance Unit. Virginia Tech., 1995.


Study plans that include the course
Faculty Study plan (Version) Branch of study Category Recommended year of study Recommended semester
Faculty of Chemical Technology Laboratory Assistant (2015) Health service 3 Summer
Faculty of Chemical Technology Laboratory Assistant (2013) Health service 3 Summer
Faculty of Chemical Technology Laboratory Assistant (2016) Health service 3 Summer
Faculty of Chemical Technology Laboratory Assistant (2014) Health service 3 Summer