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 7.4.1.6: Requirements for reports
What does 7.4.1.6 require?
Each report shall include, unless reasons for omission are documented: unique patient identification, collection date and issue date on each page; the issuing laboratory; the user's identifier; the sample type and describing information; unambiguous identification of the examinations; the method where relevant, with harmonised electronic identification of the measurand where possible; results with units in SI or traceable units; reference intervals, decision limits, likelihood ratios or nomograms as necessary; identification of research or development examinations; the identity of the reviewer and authorizer (or readily available); results to be considered preliminary; indications of critical results; and identification of the report as complete with a clear end.
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.
1291 Report results through a system that transmits them accurately and timely from data entry to final destination; include patient identification, performing laboratory name and address, report date, test, specimen source, result with units or interpretation and specimen condition; make reference intervals, methods and interferences available to clients and update them on change; release results only to authorised persons (and to patients on request); immediately alert the requester to life-threatening or panic values; notify of delayed results; handle referred results without alteration and disclose the performing laboratory; keep reports retrievable; and on error notify promptly, issue corrected reports and keep both versions