Bonginkosi Duma
National Health Laboratory Service, National Institute for Occupational Health, South Africa
Title: Quality indicators as a measure of good practice at the National Biobank in South Africa
Biography
Biography: Bonginkosi Duma
Abstract
The National Health Laboratory Service (NHLS) Biobank is within the National Institute for Occupational Health (NIOH) which has been accredited for ISO: 15189; 17020; 17025 by the South African National Accreditation System (SANAS). Furthermore, there is adherence to ISBER’s Best Practices for Biorepositories as well as compliance with the National Health Act 61 of 2003 which provides a framework for a structured uniform health system within the Republic of South Africa. Th e model of the NHLS Biobank is designed to manage and secure biomaterial collections and storage as well as the associated data for research purposes both in the short-term as well as long-term. Th e Biobank encompasses multiple components of biospecimen for cancer, cell culture, genetics, molecular biology and for non-communicable diseases. Th e storage capacity is large scale for internal NHLS and external clients, can store over a million specimens with additional infrastructure recently created with an additional capacity of four million samples. All stages of the quality cycle, as part of the Quality System Essentials (QSEs), are continually being assessed, namely; equipment, facilities, and safety, organization and personnel, purchasing and inventory, documents and records, information management, corrective action, occurrence management. Th ese QSEs grouped into 3 categories; resource management, process management as well as improved management form quality indicators and ensure maintenance of QMS. Th e biomaterial data tracking system is through specialized soft ware and Biobank Information Management System (BIMS). To date, a substantial amount of resources and time has been invested in continued personal development in ensuring that quality standards are maintained. Future plans of the NHLS Biobank include implementation of the ISO 9001:2015 standard, ISO/TC 276, enhanced networks and stakeholder involvement as well as continued technical improvements on pre-analytical specimen factors which ultimately impact on specimen quality. Th ese future plans tie- in with maintaining quality within the NHLS Biobank.