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 7.4.1.3: 7.4.1.3 Critical result reports

If a result falls inside an established critical decision limit, the user or another authorized person shall be told as soon as is clinically relevant. The action taken shall be documented, recording the date and time, who was responsible, who was told, what results were passed on, confirmation that they were communicated correctly, and any problems encountered. There shall be an escalation procedure for cases where the responsible person cannot be reached.

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