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 7.4.1.1: Reporting of results: general
What does 7.4.1.1 require?
Every result shall be reported in line with the examination procedure, accurately, clearly and without ambiguity, and with everything needed to interpret it. A procedure shall set out how users are told when results are delayed, based on the effect on the patient. All information linked to reports that have been issued shall be kept in accordance with 8.4.
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.
7.03 Communicating results: use a results system that supports interoperability through SPIA-aligned terminology and structures, addresses report structure and content, delivers accurate, clear, concise and verified reports to requesters, patients and other providers within clinically appropriate timeframes, keeps a competent person available to interpret results, identifies and documents provisional reports, completes final reports before release, provides reports directly to patients on request and uploads to the national health record as regulation requires, retains specimens and reports for the defined periods, and keeps report amendments documented and traceable