Clinical chemistry and laboratory medicine · 2026
Ethical evaluation of reflex and reflective testing in conformity with ISO 15189:2022 at the value-based laboratory medicine era.
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Yilmaz Gulsen, Budelier Melissa M, Datta Sudip K, Zaninotto Martina, Verona Julian, Amayo Angela, Fink Nilda, Wiencek Joesph R, IFCC Task Force on Ethics
Аннотация
OBJECTIVES: The objective of this study is to evaluate the ethical dimensions of reflex and reflective testing (RRT) within the framework of value-based laboratory medicine and in alignment with ISO 15189:2022. The study aims to highlight the challenges in guiding and standardizing these practices in an era of value-based medicine.
METHODS: The ISO 15189:2022 requirements for quality and competence were examined alongside the IFCC Code of Ethics and relevant literature. The ethical evaluation was structured around the four core principles of bioethics: beneficence, non-maleficence, autonomy, and justice. Specific ethical issues related to RRT were identified through expert discussion and compared with the ISO standard.
RESULTS: The thorough examination reveals that although ISO 15189:2022 does not use the RRT terminology directly, its requirements provide a robust framework for these interventions. Based on beneficence, non-maleficence, autonomy, and justice, RRT interventions align with ISO 15189:2022 and promote value-based laboratory medicine.
CONCLUSIONS: Laboratory specialists/professionals must balance the four ethical principles to ensure that the "total testing process" serves the patient's best interest in conformity with ISO 15189:2022. By adopting a strong ethical culture, the profession can successfully transition from being a producer of test results to a key partner in personalized and value-based medicine.
METHODS: The ISO 15189:2022 requirements for quality and competence were examined alongside the IFCC Code of Ethics and relevant literature. The ethical evaluation was structured around the four core principles of bioethics: beneficence, non-maleficence, autonomy, and justice. Specific ethical issues related to RRT were identified through expert discussion and compared with the ISO standard.
RESULTS: The thorough examination reveals that although ISO 15189:2022 does not use the RRT terminology directly, its requirements provide a robust framework for these interventions. Based on beneficence, non-maleficence, autonomy, and justice, RRT interventions align with ISO 15189:2022 and promote value-based laboratory medicine.
CONCLUSIONS: Laboratory specialists/professionals must balance the four ethical principles to ensure that the "total testing process" serves the patient's best interest in conformity with ISO 15189:2022. By adopting a strong ethical culture, the profession can successfully transition from being a producer of test results to a key partner in personalized and value-based medicine.