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 7.2.4.3: 7.2.4.3 Patient consent

Every procedure performed on a patient requires the patient's informed consent, which the laboratory shall obtain; for routine collection, consent may be taken as given when the patient presents willingly. Special or invasive procedures can call for a fuller explanation and for consent to be recorded. In an emergency where consent cannot be obtained, the laboratory may perform the procedures needed where they serve the patient's best interest.

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