| Course title | Basics of quality management |
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| Course code | KBC/ZRJ |
| Organizational form of instruction | Seminar |
| Level of course | Master |
| Year of study | 1 |
| Frequency of the course | Always in LS |
| Semester | Summer |
| Number of ECTS credits | 1 |
| Language of instruction | Czech |
| Status of course | Compulsory, Optional |
| Form of instruction | Face-to-face |
| Work placements | This is not an internship |
| Recommended optional programme components | None |
| Lecturer(s) |
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| Course content |
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Students will learn about the basics of quality management, risk management, ensuring personnel requirements for the operation of the laboratory, the current legislation in the field of laboratory staff training, compliance with the non-negotiable minimums of individual expertise, the rules for the protection of personal data and GDPR, the principles of documentation. They will also be introduced to the basics of quality assurance of test results, both in the form of internal and external quality control. The rules and principles for the selection of control materials, organization and frequency of performance according to the current recommendations of professional societies will be presented. The course will include practical training in the evaluation of internal control results and basic corrective measures taken. At the same time, the current offer and organisation of international and national programmes External Quality Control and practical training on the evaluation of the results sent will be presented. 1. ISO 15189 standard - individual chapters 4.1.-4.15 2. ISO 15189 - individual chapters 5.1 - 5.10 3. Laboratory quality management and risk management - working with the scoring systems for calculating risk numbers (FMEA) and practical demonstration of the calculation and corrective actions taken 4. Non-negotiable minima for individual specialties, basic legislative requirements for laboratory staffing, human resource management and organisation of lifelong learning 5. Internal quality control - selection of materials, frequency of inspections, methods of evaluation, current IT solutions for small and large laboratories, IKK planning strategy 6. External quality control - organisation, selection of organiser, method of evaluation, basic errors and their correction, current available ECE programmes
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| Learning activities and teaching methods |
Lecture, Dialogic Lecture (Discussion, Dialog, Brainstorming)
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| Learning outcomes |
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The course is intended to explain to students the basic principles of Good Laboratory Practice in clinical laboratories. It provides an explanation of the basic concepts, an introduction to ISO 15189 and the application of each chapter of the standard to clinical practice.
Students will understand the basic principles of Good Laboratory Practice in clinical laboratories. |
| Prerequisites |
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Students have a basic knowledge of clinical biochemistry.
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| Assessment methods and criteria |
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Student performance
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| Recommended literature |
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| Study plans that include the course |
| Faculty | Study plan (Version) | Category of Branch/Specialization | Recommended semester | |
|---|---|---|---|---|
| Faculty: Faculty of Science | Study plan (Version): Biochemistry (2022) | Category: Chemistry courses | - | Recommended year of study:-, Recommended semester: Summer |
| Faculty: Faculty of Science | Study plan (Version): Analytical Biochemist (2024) | Category: Chemistry courses | 1 | Recommended year of study:1, Recommended semester: Summer |