ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
Clause 6: Resource requirements – ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence 6.8.2: Referral laboratories and consultants
What does 6.8.2 require?
Referral laboratories and consultants shall be told what the laboratory requires regarding: the procedures, examinations, reports and advisory work they are to deliver; how critical results are to be handled; and the qualifications and competence their staff must hold. Unless otherwise agreed, it is the laboratory that referred the sample which must make sure referral results get to the person who asked for them. The laboratory shall keep an up-to-date list of every referral laboratory and consultant it uses.
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.
1.06 Referral laboratories: ensure Australian referral laboratories are accredited to the relevant NPAAC standards and ISO 15189, prefer accredited international laboratories, communicate costs and consequences such as data security to clinicians and patients, keep responsibility for packaging, transport and handover of international specimens, manage turnaround risks, receive reports and agree in writing who communicates critical results