Donor Safety, Discrepancies Between Practice and Theory: Analysis of the Polish Supreme Audit Office’s Report

Rafał Patryn, Anna Zagaja, Mariola Drozd Department of Humanities and Social Medicine, Medical University of Lublin, Lublin, PolandCorrespondence: Mariola Drozd, Department of Humanities and Social Medicine, Medical University of Lublin, 1, Raclawickie str 20-059, Lublin, Poland, Tel +48 448 68 50, Email marioladrozd@umlub.plAbstract: The introduction and development of genetic testing has caused the emergence of numerous dilemmas, which pertain to the performed tests, their results, and the influence they have on an individual person. To minimize potential doubts, it is crucial to ensure compliance with established procedures and to fulfill all test-associated formalities. In 2018, a report of the Polish Supreme Audit’s Office (a governmental control agency) on the quality of genetic tests revealed that there is much to be done in the field of laboratory diagnostics in Poland. The inspection of six selected laboratories performing genetic tests identified shortcomings in terms of formalities accompanying the process of performing laboratory tests, keeping patient documentation and personal data protection. Although the observed shortcomings pertained to legal aspects of genetic tests, and not the quality of the tests themselves, the aforementioned may be detrimental to the individual person and the society (eg, lack of consent undermines the concept of biological material ownership), may cause legal liability to the laboratory personnel and even undermine public trust in genetic testing.Keywords: safety, laboratory tests, genetics, consent, quality