ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
Clause 7: Process requirements – ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence 7.3.7.4: Comparability of examination results
What does 7.3.7.4 require?
If an examination is carried out with more than one method or piece of equipment, or at more than one site, a procedure shall be defined for showing that patient results agree across the intervals that matter clinically. The results of comparison and whether they are acceptable shall be recorded, and agreement reviewed periodically. Any differences found shall be assessed for their effect on reference intervals and decision limits and acted upon, and users shall be told of differences that are clinically significant.
This control maps to 1 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.
1281 Twice a year evaluate and define the relationship between results for the same test performed by different methods, instruments or sites, and maintain a system that flags patient results inconsistent with age, sex, diagnosis, result distribution or related parameters, documenting all comparison activity