OP168 The EUnetHTA Quality Management System: Development And Evaluation

Abstract

IntroductionOne objective of the European Network for Health Technology Assessment (EUnetHTA) Joint Action 3 (JA3) is to set up a quality management system (QMS) for joint work that serves as a standalone infrastructure for a sustainable European HTA-collaboration. Structures of the QMS (quality policy, processes and procedures, and organizational structures) combined with the measures of QM (quality planning, assurance, control and improvement) both ensure achieving the objective of producing high-quality HTAs.MethodsBased on a thorough concept with involvement of a spectrum of EUnetHTA partners, re-evaluation, internal workshops and national expertise, the existing inventory consisting of procedures, templates, methodological guidelines and tools is being refined, complemented and revised. Procedures are gradually being transferred into Standard Operating Procedures (SOPs), seamlessly and chronologically covering all assessment phases. Supplemented by quality-control-checklists and templates these SOPs are linked to relevant guidelines and tools. The so-established QMS is subject to continuous improvement by recurrently applying the Plan-Do-Check-Act (PDCA)-cycle. Members of the assessment teams are surveyed after the publication of each EUnetHTA-report (check-phase). Processed results lead to modification, maintenance and improvement of the inventory (act-phase).ResultsThe majority of content has already been developed or revised and was already made available to the assessment teams to put to practical test. The survey results are systematically collected, processed and compiled. Derived from these results, a comprehensive report and a thorough list of improvement measures have been developed and will serve as a basis for further adaptions.ConclusionsThe establishment of structures of QMS and measures of QM both are supposed to assure high-quality HTA-reports for EUnetHTA and a possible permanent European collaboration on HTA after JA3 as proposed by the EU-commission's regulation proposal 2018/0018 (COD). The installed systematic data collection, processing and compilation mechanisms are a solid basis for the identification of future needs for developments.