Patient safety in external beam radiotherapy, results of the ACCIRAD project: Recommendations for radiotherapy institutions and national authorities on assessing risks and analysing adverse error-events and near misses.

The ACCIRAD project, commissioned by the European Commission (EC) to develop guidelines for risk analysis of accidental and unintended exposures in external beam radiotherapy (EBRT), was completed in the year 2014. In 2015, the "General guidelines on risk management in external beam radiotherapy" were published as EC report Radiation Protection (RP)-181. The present document is the third and final report of the findings from the ACCIRAD project. The main aim of this paper is to describe the key features of the risk management process and to provide general guidelines for radiotherapy departments and national authorities on risk assessment and analysis of adverse error-events and near misses. The recommendations provided here and in EC report RP-181 are aimed at promoting the harmonisation of risk management systems across Europe, improving patient safety, and enabling more reliable inter-country comparisons.

Patient safety in external beam radiotherapy, results of the ACCIRAD project: Current status of proactive risk assessment, reactive analysis of events, and reporting and learning systems in Europe.

PURPOSE: To describe the current status of implementation of European directives for risk management in radiotherapy and to assess variability in risk management in the following areas: 1) in-country regulatory framework; 2) proactive risk assessment; (3) reactive analysis of events; and (4) reporting and learning systems. MATERIAL AND METHODS: The original data were collected as part of the ACCIRAD project through two online surveys. RESULTS: Risk assessment criteria are closely associated with quality assurance programs. Only 9/32 responding countries (28%) with national regulations reported clear "requirements" for proactive risk assessment and/or reactive risk analysis, with wide variability in assessment methods. Reporting of adverse error events is mandatory in most (70%) but not all surveyed countries. CONCLUSIONS: Most European countries have taken steps to implement European directives designed to reduce the probability and magnitude of accidents in radiotherapy. Variability between countries is substantial in terms of legal frameworks, tools used to conduct proactive risk assessment and reactive analysis of events, and in the reporting and learning systems utilized. These findings underscore the need for greater harmonisation in common terminology, classification and reporting practices across Europe to improve patient safety and to enable more reliable inter-country comparisons.

Patient safety in external beam radiotherapy - guidelines on risk assessment and analysis of adverse error-events and near misses: introducing the ACCIRAD project.

In 2011 the European Commission launched a tender to develop guidelines for risk analysis of accidental and unintended exposures in external beam radiotherapy. This tender was awarded to a consortium of 6 institutions, including the ESTRO, in late 2011. The project, denominated "ACCIRAD", recently finished the data collection phase. Data were collected by surveys administered in 38 European countries. Results indicate non-uniform implementation of event registration and classification, as well as incomplete or zero implementation of risk assessment and events analysis. Based on the survey results and analysis thereof, project leaders are currently drafting proposed guidelines entitled "Guidelines for patient safety in external beam radiotherapy - Guidelines on risk assessment and analysis of adverse-error events and near misses". The present article describes the aims and current status of the project, including results of the surveys.

How can a cost/benefit ratio be optimized for an output measurement program of external photon radiotherapy beams?

We estimated cost/benefit ratios for different quality control programs of radiation output measurements of medical linear accelerators. The cost/benefit ratios of quality control (QC) programs (a combination of output measurement time interval and measurement action levels) were defined as workload divided by achievable dose accuracy. Dose accuracy was assumed to be inversely proportional to the 99% confidence limit of shifts of total treatment doses and workload as inversely proportional to the output measurement time interval. Our previously reported method was used to estimate the distribution of shifts of total treatment doses due to changes in accelerator radiation output (Gy/MU). The confidence limits of dose shifts were estimated for different QC programs and for different levels of output measurement reproducibility. Output shifts used in the estimations had previously been observed for four linear accelerators over 5 years. We observed that the cost/benefit ratio increases remarkably when the output measurement time interval is less than 1 month. The ratio depends strongly on the action levels and reproducibility of the QC measurements. Improvement of these factors optimizes the cost/benefit ratio by a factor of several times. The most cost-effective output measurement time interval to achieve 99% confidence limits of ±2, ±2.5 or ±3% for dose shifts ranged from 0.25 month to as much as 6 months depending on the factors given above and the intended accuracy level. It is several times more cost effective to increase dose accuracy by lowering the action levels of the QC measurements and by attempting to improve their reproducibility than by simply shortening the time interval of the output measurements. Methods improving utilization and interpretation of the results of the QC measurements play a key role in further optimization of cost/benefit ratios in dosimetric QC.

Clinical audits and regulatory inspections--double efforts and expenses for radiation protection?

BACKGROUND: Clinical audit as a systematic examination of medical procedures improves the quality and outcome of patient care. The purpose of a regulatory inspection is to check and verify that the operation and facilities are in full conformance with all legal requirements. PURPOSE: To examine the content of the clinical audits and regulatory inspections of radiological procedures and whether these overlap, and to evaluate the costs to radiological units. MATERIAL AND METHODS: Clinical audits were carried out at each imaging unit of Helsinki University Hospital (HUS) Medical Imaging Center in Finland in 2004 and 2005. The regulatory inspections were carried out after the clinical audits from 2005 to late 2007. The contents of the clinical audit and inspection reports were analyzed statistically and by content analysis. The results of the audits and the inspections were compared to analyze the overlaps, differences, and costs. RESULTS: The validity and conditions of the safety license, lines of authority, and responsibilities for the use of radiation and patient doses caused by different examinations were evaluated in both audits and inspections. The coverage and frequency of quality control procedures were monitored in every audit and inspection, but inspectors, in addition, checked radiation output. The costs of clinical audit and inspection were under 20 cents per radiological procedure. The auditors gave 98 recommendations, while inspectors gave 62 recommendations and 25 requirements. In clinical audits most of the recommendations concerned guidelines for examining a patient. In the inspections most recommendations were in the category of quality assurance activities. CONCLUSION: The clinical audits and regulatory inspections were cheap and had few overlapping topics, but several differences were apparent: in clinical audits, a broader and deeper view of the clinical procedures was taken by comparison with good practices, while regulatory inspections have mainly verified conformance to basic regulatory requirements.

Portable TL dosemeter--ESD phantom combination for chest and lumbar spine radiography.

A thermoluminescence dosemeter (TLD)-entrance surface dose (ESD) phantom combination was calibrated in terms of air-kerma in IEC RQR X-ray radiation qualities between 50 and 150 kV. The ESD phantom was designed and constructed as a part of the work. With the combination, air-kermas were measured for four radiological examinations (two chest and two lumbar spine examinations in two hospitals), and converted to ESDa using Monte-Carlo calculated BSF data tabulated for different tube voltages, filtrations and beam diameters at 1 m distance. The results agreed with the ionisation-chamber measurements within the reported overall uncertainty of the TLD method. In the calibration, the ESD phantom can be replaced by the ISO water slab phantom unaffecting the reported overall uncertainty. Backscatter-related parameters for the ISO water slab phantom and the newly designed ESD phantom were determined for the IEC RQR qualities used in the secondary standard dosimetry laboratory of STUK at 1 m distance, including an approximate Hp(10)/Hp(0.07) ratio.