Introduction
At present, radiotherapy is an interdisciplinary field employing an advanced therapeutic and imaging apparatus and computerized therapy planning and simulation systems. This means that both the patient-related aspects (diagnosis, selection, treatment indication, justification, referral, planning, therapy, follow-up) and the control and measurement procedures, forming the technical part of the treatment process, should be subject to regular planning, verification and, most importantly, constant improvement [1].
While as of late, quality assurance in radiotherapy has been believed to play a key role in ensuring safe and effective treatment in the physical and technical context (efficient equipment, in vivo dosimetry, portal imaging), now a more systemic approach to quality is beginning to prevail [2-4]. This, however, calls for designing, implementing, maintaining and improving formalized quality systems or, in other words, implementing versatile quality management systems to cover all areas of activity (administrative, organizational, physical, technical and clinical) of a health care institution applying ionizing radiation for medical purposes. Aim of the study
The aim of this study is to present clinical quality standards for radiotherapy as developed by the author. Material and methods
Based on applicable EU directives [5-7] and Polish legal acts published in the period of 2002-2006 [8-23], Guidelines for Quality Assurance in Radiotherapy published by the World Health Organization in 1988 [24], Recommendations for a quality assurance programme in external radiotherapy published by the European Society for Radiotherapy & Oncology (1995) [25], American Association of Physics in Medicine Report no 13. on physical aspects of quality assurance in radiation therapy (1994) [26], requirements of ISO 9001:2000 and 9001:2008 for quality management systems [27, 28], International Basic Safety Standards for Protection against Ionizing Radiation developed by the International Atomic Energy Agency (1996) [29], Guidelines for comprehensive audit of radiotherapy practice developed by the International Atomic Energy Agency (2005) [30], Clinical Assessment Guide developed by the Organization of European Cancer Institutes (2003) [31], and relevant literature review [32-85], a model of quality management system in radiotherapy was designed, including a detailed list of organizational, physical, technical and clinical standards.
This paper will be confined to clinical quality standards. Results
The analysis of reference material resulted in the development of 352 quality standards which were categorised into the three following groups: a) organisational standards; b) physics and technical standards; c) clinical standards [86].
The clinical standards were divided into the following ca-tegories:
1.1. Referral for treatment/decision to treat/treatment prescription.
1.2. Therapeutic (treatment) protocol.
1.3. Interdisciplinary approach.
1.4. Communication.
1.5. Treatment planning.
1.6. Verification of treatment plan, irradiation time, radiotherapy form.
1.7. Treatment delivery.
1.8. Verification of treatment delivery.
1.9. Termination or withdrawal of treatment.
1.10. Medical accidents and radiological events.
1.11. Treatment quality control.
1.12. Radiation dose reference levels.
1.13. Documentation and records.
1.14. Follow-up.
1.15. Clinical audits.
A detailed description of the clinical standards is provided in Table 1. Conclusion
The proposed clinical quality standards can be used in any institution employing ionizing radiation for medical purposes. However, quality standards are of value only if implemented, regularly reviewed and improved through a quality management system functioning in the institution concerned to enable verification whether the pre-set standards are complied with.
Therefore, it is also very important that a quality management system is developed and implemented to contribute to:
a) improvement of work organization,
b) quality of service provided,
c) reduction of activity costs owing to rational material management,
d) patient-orientation,
e) reduction in the number of non-conformities and failures, and costs of their removal,
f) increased patient and staff safety through on-going control of equipment and work
place; application of uniform procedures and documentation,
g) creation of a clear organisational structure with regard to the responsibility for assigned work,
h) strengthening of teamwork and cooperation between staff members and organisational units,
i) increased commitment of the staff in continuous improvement of the institution and its QMS. References
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Marta Bogusz-Czerniejewska
Wielkopolskie Centrum Onkologii
ul. Garbary 15
61-866 Poznań
e-mail: martabogusz@wco.pl
Submitted: 25.06.2010
Accepted: 18.01.2012
