Point-of-care testing (POCT) - Requirements for quality and competence
|Publication Date:||1 November 2016|
|ICS Code (Quality management and quality assurance):||03.120.10|
|ICS Code (Laboratory medicine in general):||11.100.01|
This document gives specific requirements applicable to point-of-care testing and is intended to be used in conjunction with ISO 15189. The requirements of this document apply when POCT is carried out in a hospital, clinic and by a healthcare organization providing ambulatory care. This document can be applied to transcutaneous measurements, the analysis of expired air, and in vivo monitoring of physiological parameters.
Patient self-testing in a home or community setting is excluded, but elements of this document can be applicable.
NOTE Local, regional and national regulations are to be taken into consideration.