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Introduction. Phlebotomy, being one of the most common invasive procedures, is a critical component of the pre-analytical phase, which accounts for up to 60–70% of all errors in laboratory diagnostics. Aim. The aim of this theoretical review is to conduct a systematic analysis of the causes, types, and consequences of errors occurring during phlebotomy, as well as to assess the potential of the regulatory framework for their minimization. Materials and methods. An analytical review of current national (GOST R 59778-2021, GOST R ISO 20658-2025) and international (ISO 20658:2023) standards, scientific literature, and guidelines dedicated to the problems of the pre-analytical stage was conducted. Results. It was established that errors are systemic in nature, with root causes being a lack of specialized staff training, non-compliance with regulations, and organizational stress. Technical factors directly affecting specimen quality were detailed: choice of needle and collection system, tourniquet application time, skin preparation technique. It is shown that the consequences of errors form a cascade from direct harm to the patient (complications) through the risk of diagnostic errors to significant economic losses for the healthcare system. Conclusions. Despite the development of a detailed regulatory framework, the key challenge remains its implementation in practice. To minimize risks, coordinated actions are required: integration of standard requirements into the quality management system of healthcare organizations, implementation of mandatory specialized training modules for nurses within the framework of continuing medical education, and creation of conditions for safe work and regular auditing of the procedure quality.