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Background: Globally, all medical laboratories seeking accreditation should meet international quality standards to perform certain specific tests. Quality management program provides disciplines targeted to ensure that quality standards have been implemented by a laboratory in order to generate correct results. The hallmark of the accreditation process is method verification and quality assurance. Before introducing a new method in your laboratory, it is important to assess certain performance characteristics that reflect the concept of method verification. Methods: In this review, we illustrated how to verify the performance characteristics of a new method according to the recent guidelines. It includes an assessment of precision, trueness, analytical sensitivity, detection limits, analytical specificity, interference, measuring range, linearity, and measurement uncertainty. Conclusions: Although the presence of several updated guidelines used to determine the performance characteristics of new methods in clinical chemistry laboratories, the real practice raised several concerns with the application of these guidelines which in need for further consideration in the upcoming updates of these guidelines. [ABSTRACT FROM AUTHOR]

One and key of the priorities in laboratory medicine is improvement of quality management system for patient safety. Quality in the health care is tightly connected to the level of excellence of the health care provided in relation to the current level of knowledge and technical development. Accreditation is an effective way to demonstrate competence of the laboratory, a tool to recognize laboratories world-wide, is linked to periodical audits, to stimulate the maintenance and improvement of the quality, which leads to high standard of services for clients (patients, health care providers, etc.). The strategic plans of IFCC and EFLM include focusing on accreditation of labs based on ISO standards and cooperation with European Accreditation and national accreditation bodies. IFCC and EFLM recognised that ISO 15189:2012 Medical laboratories - Requirements for quality and competence, encompasses all the assessment criteria specified in the policy of quality. The last version is oriented to process approach with detailed division and clearly defined requirements. The accreditation of labs improves facilitation of accurate and rapid diagnostics, efficiency of treatment and reduction of errors in the laboratory process. Accreditation is not about who the best is, but who has a system of standard procedures with aim to improve the quality and patient safety. Quality system is about people, with people and for people. [ABSTRACT FROM AUTHOR]

Background: The multifaceted clinical laboratory process is divided in three essential phases: the preanalytical, analytical and postanalytical phase. Problems emerging from the preanalytical phase are responsible for more than 60% of laboratory errors. This report is aimed at highlighting and discussing nonconformity (e.g., nonstandardized procedures) in primary blood tube mixing immediately after blood collection by venipuncture with evacuated tube systems. Methods: From January 2015 to December 2015, fifty different laboratory quality managers from Brazil were contacted to request their internal audit reports on nonconformity regarding primary blood tube mixing immediately after blood collection by venipuncture performed using evacuated tube systems. Results and Conclusions: A minority of internal audits (i.e., 4%) concluded that evacuated blood tubes were not accurately mixed after collection, whereas more than half of them reported that evacuated blood tubes were vigorously mixed immediately after collection, thus magnifying the risk of producing spurious hemolysis. Despite the vast majority of centers declaring that evacuated blood tubes were mixed gently and carefully, the overall number of inversions was found to be different from that recommended by the manufacturer. Since the turbulence generated by the standard vacuum pressure inside the primary evacuated tubes seems to be sufficient for providing solubilization, mixing and stabilization between additives and blood during venipuncture, avoidance of primary tube mixing probably does not introduce a major bias in tests results and may not be considered a nonconformity during audits for accreditation. [ABSTRACT FROM AUTHOR]