Recent Activities - 2019
NRL TRAINING: IVD Evaluations and Proficiency Testing Provider Training for
The accuracy and reliability of in-vitro diagnostic medical devices (IVDs) play a significant role in patient care in terms of diagnosis and treatment for infectious diseases. IVD evaluations involve a specific regulatory assessment of the quality, safety and performance of an IVD for use in clinical settings. External Quality Assessment Schemes (EQAS) or proficiency testing (PT) is an important tool for the laboratory or health care provider to use to verify the accuracy and reliability of its testing. PT providers need to ensure they meet the required standards and regulations; and ISO/IEC 17043 accreditation is a key quality criterion. The importance of having in-country PT providers is economical and critical in maintaining the quality of testing for the local community.
Between 25-29 March 2019, NRL staff member Susie Braniff provided the National Institute of Haematology and Blood Transfusion (NIHBT) in Hanoi, technical support for performing IVD evaluations and preparation in gaining accreditation as a PT provider as per ISO 17043: Conformity assessment -- General requirements for proficiency testing. As part of such ISO preparations, training in the development and maintenance of a Sample Bank was also conducted. NRL would like to acknowledge the training sponsor, Roche Vietnam, for their commitment to enhancing the quality of infectious diseases testing by initiating and facilitating this training. NRL would also like to commend NIHBT staff on their journey towards becoming accredited as a PT provider in Vietnam.