|
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.
|