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 7.2.5: Sample transportation
What does 7.2.5 require?
Instructions from the laboratory shall address how samples are packed, how the interval from collection to receipt is kept suitable for the examinations requested, how the stated temperature range is held, and any particular integrity needs such as preservatives. If a sample's integrity is lost in a way that endangers health, the organization responsible for transport shall be told straight away and steps taken to lower the risk and stop it happening again. The laboratory shall set up its transport arrangements and assess from time to time whether they remain adequate.
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.
9.08 High acuity settings and critical requests: ensure high acuity settings know who collects and transports specimens, use evidence-based approaches so testing occurs within the clinically optimal timeframe, identify, track and monitor high acuity and critical request samples through the laboratory, give high acuity requesters access to turnaround times and the critical result process, and let requesters flag a suspected or confirmed critical request so testing and reporting are expedited