Cancer/Radiothérapie 19 (2015) 621–623
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Clinical radiotherapy audits in Belgium, 2011−2014 Audits cliniques en radiothérapie en Belgique, 2011−2014 P.G.M. Scalliet ∗ , on behalf of the Federal College of Radiotherapy, Brussels Service de radiothérapie oncologique, cliniques universitaires Saint-Luc, université catholique de Louvain, 10, avenue Hippocrate, 1200 Bruxelles, Belgium
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Keywords: Quality Audit Reporting
a b s t r a c t Systematic clinical radiotherapy audits have been introduced in Belgium in 2011, as part of the Federal Cancer Plan. This is in compliance with article 11 of the 97/43 Council directive of Euratom states, translated into the Belgian legislation by royal decree in 2002. The principle of clinical audits has thus been part of the federal legal requirements for more than 10 years. However, its application had to wait for the development of a practical approach: what authority will audit, who will be the auditors, along which methodology, at what frequency, etc. Since 2002, the Federal College of Radiotherapy has the mission to monitor quality of radiotherapy at large. It was therefore decided after discussions with the relevant administration at the Ministry of Health and the Federal Agency for Nuclear Control that the College would practically organise the audits. Early in the 2000s, the IAEA developed a manual for comprehensive audits, as a tool for quality improvement. Auditors were professionals of the domain and the audit visit took the form of a peer review. Great care was taken to assemble an audit party able to cover all aspects of clinical radiotherapy with a radiation oncologist, a medical physicist, a radiation therapist and, on demand, a quality officer. The IAEA manual contains a series of questionnaires to be prepared by the audited centre in advance (pre-audit and self-assessment), indicating what specific areas the auditors would assess. It is also a template for the auditors, ensuring that no area is left aside or forgotten during the site visit. The report, at the end of the visit, is drafted according to a specific report template, also developed by IAEA. Several members of the Belgian radiotherapy community have developed their auditor’s skills by participating to the IAEA audit program; they are the core of the auditor Belgian team. © 2015 Société française de radiothérapie oncologique (SFRO). Published by Elsevier Masson SAS. All rights reserved.
r é s u m é Mots clés : Qualité Audit Rapport
Des audits cliniques en radiothérapie sont systématiquement organisés en Belgique depuis 2011, dans le cadre du plan Cancer, et en application de la directive 97/43 du conseil de l’Euratom, article 11. Cette directive a été traduite dans la législation belge par arrêté royal en 2002. La nécessité d’organiser des audits cliniques est donc dans la législation depuis plus de 10 ans. Toutefois, dans la pratique, plusieurs questions devaient être réglées : quelle est l’autorité compétente pour auditer, qui seront les auditeurs, quelle méthodologie, à quelle fréquence, etc. ? Depuis 2002, le Collège de radiothérapie a dans ses attributions la surveillance de la qualité en radiothérapie en général. Après discussion avec les administrations compétentes (ministère de la Santé, Agence fédérale de contrôle nucléaire), il a été décidé de charger le collège d’organiser les audits en pratique. Au début des années 2000, l’Agence internationale de l’énergie atomique (AIEA) a développé un manuel pour des audits cliniques, comme instrument d’amélioration de la qualité. Les auditeurs sont des professionnels du domaine, et l’audit est en réalité une visite sur site par des pairs, émanant des trois disciplines : radiothérapie, physique médicale et manipulateur. Au besoin, un qualiticien est associé. Le manuel de l’AIEA contient une série de questionnaires que le centre audité prépare à l’avance (préaudit, autoévaluation). Ces questionnaires permettent au centre audité de savoir
∗ Corresponding author. E-mail address:
[email protected] http://dx.doi.org/10.1016/j.canrad.2015.05.006 1278-3218/© 2015 Société française de radiothérapie oncologique (SFRO). Published by Elsevier Masson SAS. All rights reserved.
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quels sont les domaines qui seront audités et de quelle manière. Il s’agit également d’un guide pour les auditeurs afin d’éviter tout oubli en cours de visite. Le rapport final suit également un canevas de l’AIEA. Plusieurs professionnels belges ont pris part à des audits de l’AIEA ; ils constituent le « cœur » du groupe des auditeurs actuellement actif en Belgique. © 2015 Société française de radiothérapie oncologique (SFRO). Publié par Elsevier Masson SAS. Tous droits réservés.
1. Introduction
4. Financing
The council directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionizing radiation in relation to medical exposure establishes the principle of systematic monitoring of quality to be carried out by member states [1]. Article 6.4 specifies that clinical audits shall be carried out in accordance with national procedures. This same directive specifically points at radiotherapy as a particular point of attention for member states. A royal decree has translated the EU directive in the Belgian legislation in 2002. Around the same period, the International Atomic Energy Agency (IAEA) developed a program of comprehensive quality audits as a tool for quality improvement, a program in which several Belgian specialists actively participated (Quality Assurance Team for Radiation Oncology: QUATRO) [2]. Radiotherapy clinical audits have been organised in Belgium by the Federal College of Radiotherapy since 2011.
In 2010, the Belgian government launched the first Cancer Plan. Its program was established through a series of meetings between the administration and the key-stakeholders. The radiotherapy domain was represented by the Belgian Association for Radiotherapy and Oncology (ABRO-BVRO) and by the Federal College of Radiotherapy. As the sector is quite small in Belgium, there were basically the same experts acting in both structures. The Cancer Plan was detailed in a series of actions. Radiotherapy fell under Action 16, entirely oriented towards improving quality in radiotherapy. The allocated budgets permitted to develop a central office for dosimetry (BelDart), responsible for the audit of equipment at a national level, budget the salary cost of one quality officer per radiotherapy department, and deploy a platform for incident reporting and analysis on a federal basis (PRISMA-RT). The budget was allocated directly to the hospitals, on the condition that clinical audits would be effectively developed by the College of Radiotherapy. But there was no specific budget allocated to the audits, and the College was asked to organise the program on its own (feeble) budget.
2. Definition A clinical audit is a systematic examination or review of medical radiological procedures which seeks to improve the quality and the outcome of patient care through structured review whereby radiological practices, procedures and results are examined against agreed standards for good medical radiological procedures, with modification of practices where indicated and the application of new standards if necessary. A clinical audit is not a regulatory inspection, and the auditors have no authority regarding the accreditation of a radiotherapy department to effectively deliver treatments. This aspect is covered by the regular inspections of the Ministry of Health responsible for the compliance of hospitals with infrastructure requirements necessary for the accreditation. In addition, the Federal Agency for Nuclear Control (FANC) verifies the credentials of the various staff members and is responsible for delivering the authorisation to practice radiotherapy. Therefore, a clinical audit is distinct from an accreditation audit, as provided by legal national structures, or by certification companies, as in the ISO certification.
5. Selection of a methodology During the preparatory discussions, it became rapidly clear that a clinical audit needs a structure, both for the auditors (in need of guidance) and for the audited departments who should know in advance what the auditors would be looking for. A clear structure also ensures that all audits would be carried in a similar way, using the same reference documentation. As said before, the College chose the QUATRO methodology of IAEA, mainly because several of its members had already been trained as auditors, and had quite an experience in audits abroad. Also, QUATRO is a very comprehensive method for auditing, with a broad range of applications, including in modern radiotherapy departments of affluent countries like Belgium. At the time the Belgian program started, the IAEA had already experience with over 70 QUATRO audits in various countries (Central Europe, Africa, Asia, South America). There was thus a solid basis for a “copy and paste” QUATRO to the Belgian environment. 6. Timetable
3. Why the College of Radiotherapy? It was a shared opinion that neither the FANC, nor the Ministry of Health had the manpower or resources to organise systematics audits, which explains why the program did start with a delay (2002–2011). Informal and formal meetings between members of the various administration civil and the members of the College concluded that applying the QUATRO program of IAEA to Belgium was the best practical solution, implying that a clear choice was made to select the “peer review” methodology for clinical audits. The College then accepted the mission to organise the audits and went through a short selection procedure to appoint professionals of the three specialties as auditors.
QUATRO IAEA audits typically last one week, during which auditors are expected to stay close to the audited hospital. It is a full time activity, extending late in the evening, as the auditors continue to meet at the end of the afternoon to share their experience of the day, centralise their observations and select specific areas that need extra audit time. During a QUATRO mission, dedicated dosimetry equipment is shipped by IAEA on site for the medical physicist of the team to check equipment calibration. In Belgium, a systematic dosimetry audit is already carried out by an ad hoc structure financed by Action 16 of the Cancer Plan, as said before (called BelDart). There is thus no need to duplicate dosimetry checks, it is sufficient to verify if a particular depart-
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ment under audit has its certification from BelDart. Actually, 100% of Belgian departments have such a certification [3]. During the various preparatory meetings at the College, it was decided to limit the audits to 3 full consecutive days for two reasons: feasibility and efficiency. Feasibility: as auditors are delegated by their own hospital to audit other departments without any form of payment, it was felt that 3 days were a reasonable time period, easier to accommodate in a busy department schedule than a full week. Efficiency: several professionals were already experienced in IAEA audits, and their feeling was that in the absence of major quality issues in the audited department, a 3-day peer-review would be sufficient to get a full picture of the Quality Management System. With an experience now of 20 audits in Belgium, it is confirmed that 3 days is a reasonable schedule. 7. Selection and training of auditors A QUATRO audit party includes a radiation oncologist, a medical physicist and a radiation therapist. Volunteers were asked to join the core auditor group through the professional organisations of medical physics (BSPH), radiation therapists (VVRO) and radiation oncology (ABRO-BVRO). The final group included five radiation oncologists, five medical physicists and five radiation therapists. A two-day seminar took place in March 2011, using teaching material of IAEA (with permission) to train the auditor group and prepare the first audit campaign. The first audits were then carried out by teams where newcomers and experienced auditors were mixed together. The College also decided that these 15 auditors would remain the core group for at least 5 years, in order to gain experience and know-how.
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Then the auditors, after they are back to their own clinical duties are asked to draft their final report in a matter of weeks. The report is a detailed account of the audit; it also follows the IAEA report template to ensure consistency between the various audit reports. 9. Annual reports Once a year, the auditors meet in a seminar were the 5 reports of the previous years are analysed collegially (in May). A summary report of the 5 audits is then prepared for the ministry of Health and the AFCN-FANC. Currently, the average workload calculated on the 20 audited hospitals is compatible with the existing benchmark values (EORTC, IAEA). Belgian departments treat on average 1367 patients/year, but with a wide divergence (range 2690-545). The workload is 239 treatments per radiation oncologist (± 64), 246 treatments per medical physicist (± 72) and 83 treatments per radiation therapist (± 21). Radiation oncologists work full time in radiation oncology in Belgium, with little or negligible parallel activities in medical oncology. 10. Follow-up of audits The audits started in 2011 with the first five departments (volunteers), and continue with five new departments every year. In 2014, there were 20 departments audited, and the last five will be audited in 2015 (October-December). At the end of this 5-year cycle, a new 5-year cycle will start, and it is foreseen that this periodicity will be kept for the future. Currently, the auditor group is in discussion to design this new campaign. Disclosure of interest
8. Structure of the audit The structure of Belgian audits has remained the same as QUATRO. A series of questionnaires is sent 6–8 weeks in advance to the audited departments (based on IAEA QUATRO), with a series of statistics and demographics to prepare in order to estimate the workload of the various staff groups. Workloads, indeed, are considered to be important quality indicators [4]. Then the audit starts on day 1 by an entrance conference with all the senior staff (medical, physics, radiation therapists) during which the auditors present themselves and explain what will happen during the forthcoming days. The visit begins immediately after and goes on until the morning of day 3. In the last afternoon, the auditors present to the entire department the conclusions of the audit and the recommendations, during a meeting with usually long and passionate discussions.
The authors declare that they have no conflicts of interest concerning this article. References [1] Official Journal L180 1997 [0022-27]. [2] Abratt R, Aguirre F, Andreo P, Coffey M, Drew J, El Gueddari B, et al. Comprehensive audits of radiotherapy practices: a tool for quality improvement: Quality Assurance Team for Radiation Oncology (QUATRO). Vienna: International Atomic Energy Agency; 2007 [Available online at: http://www-pub.iaea.org/ MTCD/publications/PDF/Pub1297 web.pdf]. [3] Schaeken B, Cuypers R, Lelie S, Schroeyers W, Schreurs S, Janssens H, et al. Implementation of alanine/EPR as transfer dosimetry system in a radiotherapy audit programme in Belgium. Radiother Oncol 2011;99:94–6. [4] Cionini L, Gardani G, Gabriele P, Magri S, Morosini PL, Rosi A, et al. Quality indicators in radiotherapy. Radiother Oncol 2007;82:191–200.