ARTICOLO: Controllo di qualità interno: divergenze tra raccomandazioni IFCC, standard ISO e raccomandazioni SIPMeL

 

La Rivista Italiana della Medicina di Laboratorio 2025 Dicembre;21(4):271-87

DOI: 10.23736/S1825-859X.25.00292-0

Copyright © 2025 EDIZIONI MINERVA MEDICA

lingua: Italiano

Controllo di qualità interno: divergenze tra raccomandazioni IFCC, standard ISO e raccomandazioni SIPMeL

IFCC produced a Recommendation that claims to be inspired by ISO 15189:2022 but diverges from it in many places: in the glossary, in the general principles, where it introduces commutability and known values of control materials, on the objectives of IQC, not compatible with statistical rules, on control materials with commutability, in the case of control lot change or reagent change. IFCC introduces the case of multiple instruments, absent in ISO 15189:2022. IFCC proposes control repetition, absent in ISO and disapproved by subject matter experts, does not follow CLSI C24 guidance for estimation of imprecision and expected value with which to construct control rules and charts. IFCC, in addition to statistical rules and Sigma metrics, adds the additional criterion of clinically acceptable limits, without providing the scientific basis. IFCC diverges from bibliographic sources and ISO 15189:2022 on the moving average of patient and repeat patient samples, as on the mixture (pool) of patient samples, as well as on “sentinel” examinations. IFCC never considers CLSI C24 guidance. IFCC supports the comparison between instruments despite multiple critical points, contained in the references cited by IFCC too. IFCC does not correctly describe the difference between measurement uncertainty and total allowable error.

KEY WORDS: Accreditation; Medical laboratory science; Quality control