ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
Clause 5: Structural and governance requirements – ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence 5.3.3: Advisory activities
What does 5.3.3 require?
Laboratory management shall make sure suitable advice and interpretation are on hand and satisfy what patients and users need. Arrangements shall cover talking with users about which examinations to choose and how to use them (sample type, clinical indications, limitations, how often to request), professional judgement on interpreting results, making effective use of examinations, and scientific and practical matters such as samples that do not meet acceptance criteria.
This control maps to 2 controls across 2 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.
7.01 Supporting requesters: advise on available services, request requirements including the clinical information needed, appropriateness, limitations, prerequisites and preparation, communicate accurate and complete information in a timely manner, keep a competent workforce member available to answer enquiries, and make the designated person or delegated supervisors available for virtual consultation
1419-1457 The clinical consultant is available to advise the laboratory's clients on the appropriateness of tests ordered and the interpretation of results, and ensures reports carry the information needed for patient-specific interpretation and that consultation on result quality and interpretation is communicated to clients