BS EN ISO 20166-1:2016 pdf free

BS EN ISO 20166-1:2016 pdf free.Molecular in vitro diagnostic examinations
For general statements on medical laboratory quality management systems and in particular on specimen collection and handling (including avoidance of cross contaminations) see ISO 15189:2012,4.2, 5.4.4. The requirements on laboratory equipment, reagents, and consumables according to ISO 15189:2012, 5.3 shall be followed; ISO 15189:2012, 5.5.1.2 and 5.5.1.3 can also apply.
All steps of a diagnostic workflow can influence the final analytical test performance. Thus, the entire workflow including biomolecule stability and sample storage conditions shall be verified and validated.Workflow steps which cannot always be controlled (e.g. warm ischemia) shall be documented and their impact on the analytical test performance shall be investigated and mitigation measures shall be established to enable the required analytical test performance. In these cases, risk assessment is recommended.
The stability of the specific quantitative RNA profile(s) of interest should be investigated throughout the entire pre-examination process prior to the development and implementation of an examination test. Before tissues are fixed in standard buffered formalin solution, RNA profiles can change significantly depending on the warm and cold ischemia duration and the temperature before formalin fixation (e.g. gene induction, gene down regulation, RNA degradation). In addition, those changes can vary in different donors’ / patients’ tissues.
Generally, the longer the durations of warm and cold ischemia and the higher the ambient temperature before fixation of the tissue specimen, the higher is the risk that changes in the RNA profile can occur.
NOTE Intraoperative warm ischemia can result in more pronounced changes of RNA profiles than in postoperative cold ischemia. RNA profiles can also vary, depending on the origin and type of tssue, the underlying disease, the surgical procedure, drugs administered for anaesthesia or treatment of concomitant disease, and on the different environment conditions after the tissue removal from the body.
As warm ischemia cannot be easily standardized, its duration should be documented. When it is not possible to avoid cold ischemia (e.g.. transport to the laboratory before formalin fixation), duration shall be documented and the temperatures of the specimen transport container’s surroundings should be documented. Where the specimen is transported to another facility for formalin fixation, the transport duration shall be documented and the ambient conditions should also be documented.BS EN ISO 20166-1 pdf download.