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  • Title: Preanalytical Nonconformity Management Regarding Primary Tube Mixing in Brazil.
    Author: Lima-Oliveira G, Cesare Guidi G, Guimaraes AVP, Abol Correa J, Lippi G.
    Journal: J Med Biochem; 2017 Jan; 36(1):39-43. PubMed ID: 28680348.
    Abstract:
    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 ma jority 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. UVOD: Složeni klinički laboratorijski proces po deljen je na tri osnovne faze: preanalitičku, analitičku i postanalitičku. Problemi koji potiču iz preanalitičke faze odgovorni su za preko 60% laboratorijskih grešaka. Cilj ovog rada bio je da se istaknu i razmotre nesaobraznosti (tj. nestandardne procedure) u mešanju uzoraka krvi u primarnim epruvetama neposredno posle uzimanja krvi venepunkcijom pomoću sistema evakuiranih epruveta. METODE: Između januara 2015. i decembra 2015. godine, kon taktirano je sa pedeset različitih menadžera za laboratorijski kvalitet u Brazilu i zatraženi su njihovi izveštaji sa internih provera nesaobraznosti u pogledu mešanja primarnih epruveta neposredno po uzimanju uzoraka krvi venepunkcijom obavljenom pomoću sistema evakuiranih epruveta. REZULTATI I ZAKLJUČCI: U manjem broju internih provera (tj. 4%) zaključeno je da mešanje evakuiranih epruveta nije pra vilno obav ljeno posle sakupljanja uzoraka, dok je više od polovine prijavilo da su evakuirane epruvete snažno mešane neposredno posle uzimanja uzoraka, što povećava rizik od nastanka hemolize. Uprkos tome što je većina centara prijavila da su evakuirane epruvete za uzorke krvi mešane nežno i pažljivo, utvrđeni ukupni broj inverzija razlikovao se od onog koji su preporućili proizvođači. Kako se čini da je turbulencija koja nastaje usled standardnog pritiska vakuuma unutar primarne evakuirane epruvete dovoljna da obezbedi solubilizaciju, mešanje i stabilizaciju između aditiva i krvi tokom venepunkcije, izbegavanje mešanja primarnih epruveta verovatno ne unosi značajna odstupanja u rezultate testova i ne mora se smatrati primerom nesaobraznosti tokom provera za akreditaciju.
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