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 7.2.4.4: 7.2.4.4 Instructions for collection activities

So that collection and storage before examination are safe, accurate and suited to the clinical need, instructions shall be issued by the laboratory covering: confirming who the patient is; checking and recording that preparation requirements are satisfied (for example fasting, when medication was taken, timed collections); how primary samples are taken, including containers, additives and draw order; labelling so that each sample links to its patient without ambiguity; recording who collected the sample, on what date and, where it matters, at what time; separating or splitting the sample; stabilising and storing it until it is delivered; and disposing safely of collection materials.

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