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Non-conformities in tissue typing laboratory: Croatian experience
N Katalinić1,2, A Starčević1, M Mavrinac3
1Tissue Typing Laboratory, Clinical Institute for Transfusion Medicine, Clinical Hospital Centre Rijeka, Rijeka, Croatia.
Transfusion Medicine (Oxford, England)
|October 19, 2019
Summary
Non-conformities in tissue typing laboratories (TTL) primarily occur during the examination phase, linked to employee competency and experience. Improving laboratory quality requires enhanced training, IT integration, and rigorous error reporting.
Area of Science:
- Medical Laboratory Science
- Immunogenetics
- Quality Management Systems
Background:
- Quality management systems (QMS) are crucial for enhancing accuracy and timeliness in tissue typing laboratories (TTL).
- Effective non-conformity management is an essential component of a robust QMS in diagnostic laboratories.
Purpose of the Study:
- To determine the frequency and types of non-conformities in a Croatian tissue typing laboratory (TTL).
- To evaluate laboratory testing quality and adherence to quality management system (QMS) requirements.
Main Methods:
- Retrospective analysis of non-conformities recorded between 2006 and 2017.
- Classification of non-conformities by examination phase, employee characteristics, work relation, laboratory section, and testing priority.
Main Results:
- The overall non-conformity frequency was 0.43%, with most occurring during the examination phase (54.0%).
- Inadequate competency and less experience correlated with higher non-conformity rates.
- Non-conformities were evenly distributed across organ transplantation and HLA-associated disease diagnostics.
Conclusions:
- Intensifying staff training and education is fundamental for improving laboratory quality.
- Implementing information technology and enhancing error detection/reporting are key to advancing laboratory services.
