RACCOMANDAZIONI E LINEE GUIDA   

La Rivista Italiana della Medicina di Laboratorio 2019 Settembre;15(3):225-32

DOI: 10.23736/S1825-859X.19.00037-9

Copyright © 2019 EDIZIONI MINERVA MEDICA

language: Italian

POCT accreditation with the new ISO 15189 and ISO 22583: the SIPMeL recommendations

Marco PRADELLA ✉

SIPMeL, Castelfranco Veneto, Treviso, Italia

The new ISO 15189 for medical laboratories should incorporate the requirements of ISO 22870 for POCTs. The SIPMeL Quality and Accreditation Commission has identified ISO 22870 standard points which should be absorbed by the corresponding ISO 15189 points, other ISO 15189 points which should be modified in light of the specific requests of ISO 22870, others that should be included in ISO 15189 to understand special needs of POCTs. On the other hand, the new ISO 22583 for POCTs introduces the concept of “supervisor,” the manufacturer’s instructions for quality control, the execution of the examination in the presence of the patient, the presentation of results in a simplified manner, health and operator safety, laboratory consultancy and clinical intervention. The incorporation of POCT requirements into the ISO standard for medical laboratories can be beneficial for the requirements of traditional medical laboratories, even resolving some ambiguity.

KEY WORDS: Accreditation; ISO 15189; ISO 22870; Point-of-care testing; POCT, Near-patient-testing