The influence of legislative changes on quality and costs in radiotherapy

Abstract

Summary Background On 24 December 2002, in compliance with Euratom Directive 97/43, the Minister of Health issued an ordinance on rules and regulations of safe application of ionising radiation for medical purposes and methods of internal control over observance of the rules and regulations. The ordinance obliges managers of institutions which apply ionising radiation for medical purposes (radiotherapy, X-ray diagnostics, nuclear medicine) to implement, maintain and develop the Quality Management System (QMS). On 25 August 2005, the Minister of Health issued an ordinance on rules and regulations of safe application of ionising radiation with reference to all types of medical exposure which overruled the ordinance of 24.12.2002. Aim The purpose of this paper was (i) the comparative analysis of the aforementioned ordinances in the context of three selected aspects: internal audits, external audits and the system of quality management, and (ii) the analysis of the rise in labour costs, services, depreciation and materials in 2002–2005, as a result of the implementation of the aforementioned legal rules and regulations. Materials and Methods A comparative analysis of the two a fore mentioned ordinances of the Minister of Health was performed: concerning (i) external clinical audits, (ii) internal clinical audits and (iii) requirements of the quality management system. The total cost of implementation of such rules and regulations (in particular the cost of the Quality Management System) has been calculated based on an analysis of labour costs, depreciation, materials and services in 2002–2005. Results Legislative changes in the scope of safe application of ionising radiation for medical purposes enhance not only the organisation of health care institutions applying radiotherapy, but also the rise in costs of the organisations as a result of implementation of the changes, e.g. through (i) the costs of salaries for work groups or consulting companies implementing QMS, (ii) costs of external services, dosimetric audits by independent calibration laboratories, (iii) costs of QMS certification, (iv) awards and bonuses for internal auditors, (v) costs of service contracts, etc. Conclusions The implementation of the quality management system, modernisation of technical infrastructure, systematic controls and measurements of apparatuses and procedures, more effective work organisation, repeatability, regularity and homogeneity not only enhance the quality of medical service, but also the costs in radiotherapy.