Safety in Radiation Oncology: The Role of International Initiatives by the International Atomic Energy Agency

The International Atomic Energy Agency (IAEA) has a wide range of initiatives that address the issue of safety. Quality assurance initiatives and comprehensive audits of radiotherapy services, such as the Quality Assurance Team for Radiation Oncology, are available through the IAEA. Furthermore, the experience of the IAEA in thermoluminescence dosimetric audits has been transferred to the national level in various countries and has contributed to improvements in the quality and safety of radiotherapy. The IAEA is also involved in the development of a safety reporting and analysis system (Safety in Radiation Oncology). In addition, IAEA publications describe and analyze factors contributing to safety-related incidents around the world. The lack of sufficient trained, qualified staff members is addressed through IAEA programs. Initiatives include national, regional, and interregional technical cooperation projects, educational workshops, and fellowship training for radiation oncology professionals, as well as technical assistance in developing and initiating local radiation therapy, safety education, and training programs. The agency is also active in developing staffing guidelines and encourages advanced planning at a national level, aided by information collection systems such as the Directory of Radiotherapy Centers and technical cooperation project personnel planning, to prevent shortages of staff. The IAEA also promotes the safe procurement of equipment for radiation therapy centers within a comprehensive technical cooperation program that includes clinical, medical physics, and radiation safety aspects and review of local infrastructure (room layout, shielding, utilities, and radiation safety), the availability of qualified staff members (radiation oncologists, medical physicists, and radiation technologists and therapists), as well as relevant imaging, treatment planning, dosimetry, and quality control items. The IAEA has taken the lead in developing a comprehensive program that addresses all of these areas of concern and is actively contributing to the national and international efforts to make radiation therapy safer in all settings, including resource-limited settings.     

Erfahrungen mit einem klinischen Krebsregister für die Strahlentherapie

BACKGROUND: A clinical cancer registry is required to assure result quality in radiation oncology. A simpler system could help small radiotherapy departments to survey their therapy results, as long as there is no connection to a central institution established. METHODS: Our clinical cancer registry RADOC was designed for easy handling on a single working place with standard Windows PC. RESULTS: Without additional costs, we store about 550 treatment courses each year and follow-up data. Several times a year the program provides basic analysis of these data for our internal quality assurance. As an example, the results on breast cancer are shown. CONCLUSIONS: Our department's internal therapy registry enables us to survey continuously important therapy results without additional costs, and thereby adds to our quality assurance process. On the other hand, only a centralized registry can provide complete data.     

Radiotherapeutic quality assurance in the Hodgkin's disease study HD4 supported by the BMFT (Bundesministerium für Forschung und Technologie)

In the German Hodgkin Study Group a radiotherapy assurance program is being carried out at the radiotherapeutic reference centre in G?ttingen since April 1988: 74 patients were entered from 27 radiotherapeutic institutions. 18 of them participated in a quality assurance program and submitted the data of 29 patients: In 21 of the 29 patients the protocol was followed correctly. Physical aspects of quality control showed two major deviations from the protocol: one center used photon energies of more than 15 MVX without mould; another had a anterior-posterior loading of 3:1. The radiation oncology assessment detected six inadequate treatments: The safety margin was inappropriate in three of 26 mantle fields. Another center used a multiple field technique, and in two patients the paraaortic region was not irradiated.     

Dose verification for patients undergoing IMRT.

At Emory Clinic intensity-modulated radiation therapy (IMRT) was started by using dynamic multileaf collimators (dMLC) as electronic tissue compensators in August 1998. Our IMRT program evolved with the inclusion of a commercially available inverse treatment planning system in September 1999. While the introduction of electronic tissue compensators into clinical use did not affect the customary radiation oncology practice, inverse treatment planning does alter our basic routines. Basic concepts of radiation therapy port designs for inverse treatment planning are different from conventional or 3D conformal treatments. With inverse treatment planning, clinicians are required to outline a gross tumor volume (GTV), a clinical target volume (CTV), critical normal structures, and to design a planning target volume (PTV). Clinicians do not designate the volume to be shielded. Because each IMRT radiation portal is composed of many beamlets with varying intensities, methods and practice used to verify delivered dose from IMRT portals are also different from conventional treatment portals. Often, the validity of measured data is in doubt. Therefore, checking treatment planning computer output with measurements are confusing and fruitless, at times. Commissioning an IMRT program and routine patient dose verification of IMRT require films and ionization chamber measurements in phantom. Additional specialized physics instrumentation is not required other than those available in a typical radiation oncology facility. At this time, we consider that routine quality assurance prior to patient treatments is necessary.     

Australian and New Zealand three-dimensional conformal radiation therapy consensus guidelines for prostate cancer

Three-dimensional conformal radiation therapy (3DCRT) has been shown to reduce normal tissue toxicity and allow dose escalation in the curative treatment of prostate cancer. The Faculty of Radiation Oncology Genito-Urinary Group initiated a consensus process to generate evidence-based guidelines for the safe and effective implementation of 3DCRT. All radiation oncology departments in Australia and New Zealand were invited to complete a survey of their prostate practice and to send representatives to a consensus workshop. After a review of the evidence, key issues were identified and debated. If agreement was not reached, working parties were formed to make recommendations. Draft guidelines were circulated to workshop participants for approval prior to publication. Where possible, evidence-based recommendations have been made with regard to patient selection, risk stratification, simulation, planning, treatment delivery and toxicity reporting. This is the first time a group of radiation therapists, physicists and oncologists representing professional radiotherapy practice across Australia and New Zealand have worked together to develop best-practice guidelines. These guidelines should serve as a baseline for prospective clinical trials, outcome research and quality assurance.     

Erfassung m?glicher Verbesserungen im Ablauf der Strahlentherapie �� eine Patientenbefragung

Introduction and Background

In the context of quality assurance, increasing demands are placed on the whole radiotherapy treatment process. The patients directly concerned generally do not realize most aspects of the quality assurance program (e.g., additional safety checks) during their daily therapy. It was the aim of this study to systematically ask patients about potential improvements during the course of radiotherapy treatment from their own perspective.

Patients and Methods

In the defined time span (1 month), 624 radiotherapy patients (600 questionnaires were returned, 96.2%) were interviewed using a questionnaire newly developed to inquire about several aspects of their treatment. Furthermore, they were asked for their specific needs and suggestions for improvements that could be made during the course of radiotherapy treatment.

Results

Overall, the patients were satisfied with the course of their radiotherapy treatment and with patient care. As an example, about 90% agreed with the statement: ??My first contact with the radiation oncology unit proceeded with kindness and competence so that I was given the impression that I will be well cared for in this clinic.?? Considering the organization of the course of radiotherapy, a large majority of patients attached great value to set appointments for the therapy fractions. A main point of criticism was waiting times or delays caused by servicing or machine failures. Small, low cost improvements as music in the therapy room were considered as important as expensive measures (e.g., daylight in the therapy room). The patients emphasized the importance of staff friendliness.

Conclusion

The situation of radiotherapy patients was, in general, satisfactory. Future improvements can be mainly expected from smooth organisation of both planning and treatment which can be achieved by electronic scheduling systems. Many results of the survey could be easily implemented in daily practice. In matters of organization radiation oncology with its complex procedures can be used as a model for other clinical departments.     

National intercomparisons of I radioactivity measurements in nuclear medicine centres in India

National intercomparisons of activity measurements of ¹³¹I, a radioisotope widely used for diagnosis and therapy of thyroid related ailments, were initiated in 1979 as a quality assurance program, towards improving radiation safety procedures and related dosimetry in Nuclear Medicine Centres (NMCs) in India. Oral administration of a known quantity of radioiodine to patients requires accurate radioactivity measurements to be performed on a well-calibrated isotope calibrators. Under or over estimation of the activity due to a faulty or uncalibrated isotope calibrator could provide misleading results. Calibration of isotope calibrators and the traceablity of subsequent measurements to the national standards laboratory is one of the essential basic radiation safety requirement of the IAEA. In view of the stringent quality assurance requirements for activity measurements imposed by Atomic Energy Regulatory Board, a National Intercomparison Program was initiated and to date ten such intercomparison programs have been conducted by the Radiation Safety Systems Division, of the Bhabha Atomic Research Centre. This program has benefited the participants by making their measurements traceable to the National Primary Standards. Over the years there has been a marked increase in the number of NMCs participating in the intercomparison programs. As a result, the number of institution showing large deviation from the correct value has decreased considerably over the years. This program thus, has enabled participating NMCs to check their isotope calibrators so as to ensure proper delivery of radiation dose to the patients and hence to optimise patient exposure.     

Development of a clinical chart audit programme

Radiation oncology charts containing medical information and treatment details are the major methods of communication between the various personnel involved in delivering radiation therapy to the patient. It is paramount to good patient care for this communication to be clear, precise and accurate in detail. A regular chart audit should be a part of the quality assurance programme of every radiation oncology department. The primary aim of this study was to develop and assess an objective and quantitative programme for reviewing radiation oncology charts, thereby improving the quality of communication and hence patient management. A secondary aim was to compare the charts of radically treated patients with those treated palliatively. A pilot study using a new chart review tool, developed at the Perth Radiation Oncology Centre, was carried out over an 8-month period. A sample of charts, representing 25% of our treatment group, were assessed using the tool on a monthly basis. A total of 156 charts were reviewed during this time period. Fifty-six per cent were radical treatments and 44% were palliative. The overall mean chart scores significantly improved over the time of this study (P < 0.001). The individual radiation oncologists' scores were also seen to improve during the study period. The alpha coefficients for intra-rater and inter-rater reliability were 0.99 and 0.88, respectively. The chart review programme was found to be an easy-to-use and a reliable tool by both medical and non-medical reviewers. It appeared to have a positive influence on the standard of radiation oncology charts in our department.     

Impact of Neuroradiology-Based Peer Review on Head and Neck Radiotherapy Target Delineation

BACKGROUND AND PURPOSE:While standard guidelines assist in target delineation for head and neck radiation therapy planning, the complex anatomy, varying patterns of spread, unusual or advanced presentations, and high risk of treatment-related toxicities produce continuous interpretive challenges. In 2007, we instituted weekly treatment planning quality assurance rounds as a joint enterprise of head and neck radiation oncology and neuroradiology. Here we describe its impact on head and neck radiation therapy target delineation.MATERIALS AND METHODS:For 7 months, treatment planning quality assurance included 80 cases of definitive (48%) or postoperative (52%) head and neck radiation therapy. The planning CT and associated target volumes were reviewed in comparison with diagnostic imaging studies. Alterations were catalogued.RESULTS:Of the 80 cases, 44 (55%) were altered, and of these, 61% had clinically significant changes resulting in exclusion or inclusion of a distinct area or structure. Reasons for alteration included the following: gross or extant tumor, 26/44 (59%); elective or postoperative coverage, 25/44 (57%); lymph nodes, 13/44 (30%); bone, 7/44 (16%); skull base, 7/44 (16%); normal organs, 5/44 (11%); perineural, 3/44 (7%); distant metastasis, 2/44 (5%); and eye, 1/44 (2%). Gross tumor changes ranged from 0.5% to 133.64%, with a median change in volume of 5.95 mm³ (7.86%). Volumes were more likely to be increased (73%) than decreased (27%).CONCLUSIONS:A collaborative approach to head and neck treatment planning quality assurance has an impact. Cases likely to have challenging patterns of infiltrative, intracranial, nodal, orbital, or perineural spread warrant intensive imaging-based review in collaboration with a diagnostic neuroradiologist.

Retrospective and prospective studies demonstrate increased efficacy from multidisciplinary physician interaction,^1,2 and team-based approaches to patient care are routine within radiation oncology. However, the process of radiation therapy target delineation remains an essentially solitary activity, and the impact of collaborative peer review is a contested issue. One survey suggested that major alterations from this type of process were rare, occurring in <6% of head and neck (HN) plans, though the extent of alterations was noted to be dependent on the reviewing peer''s subsite experience level.³The weakness of these studies as applied to HN cancer stems from a tendency to underestimate the specialized nature of anatomically defined HN radiation therapy and its unique interdependence with neuroradiology. Head and neck malignancies comprise a heterogeneous group of neoplasms characterized by complex local and regional anatomy, varying patterns of spread, and frequent occurrence of unusual and/or advanced presentations. Acquiring proficiency in the interpretation of HN imaging is difficult due to the subtlety of the characteristics that may suggest benign or malignant disease and distinguishing them from normal or inflamed tissue. Because management frequently consists of staged, multimodal combinations of surgery, systemic therapy, and/or radiation therapy, the interpretation of sequential image sets is exceptionally challenging, particularly the discrimination of posttreatment changes from residual disease.⁴ Previous studies have found that after re-interpretation by a specialist head and neck neuroradiologist, changes in staging or management occur in 38%–56% of cases.^5,6Beginning in 2007, diagnostic neuroradiology participation was included as part of weekly HN treatment planning quality assurance (TPQA) rounds at our institution. The format includes diagnostic imaging review for new and follow-up patients, as well as the highly prioritized review of proposed radiation therapy target volumes and normal organ delineations, which are peer-reviewed by HN radiation oncology and neuroradiology physicians. As of June 2010, electronic documentation was prepared pre- and post-TPQA. This study characterizes the impact of diagnostic neuroradiology involvement on the radiation therapy planning process.     

Quality assurance procedures for the Peacock system.

The Peacock system is the product of technological innovations that are changing the practice of radiotherapy. It uses dynamic beam modulation technique and inverse planning algorithm, both of which are new methodologies, to perform intensity-modulation radiation therapy (IMRT). The quality assurance (QA) procedure established by Task Group No. 40 did not adequately consider these emerging modalities. A review of literature indicates that published articles on QA procedures concentrate primarily on the verification of dose delivered to phantom during commissioning of the system and dose delivered to phantom before treating patients. Absolute dose measurements using ion chambers and relative dose measurements using film dosimetry have been used to verify delivered doses. QA on equipment performance and equipment safety is limited. This paper will discuss QA on equipment performance, equipment safety, and patient setup reproducibility.     

A model QA program in radiation oncology

This article presents a detailed and comprehensive technically oriented quality assurance (QA) program for radiation oncology. The primary aspects of care that relate to all departments are included and may serve as a guide for development of criteria and indicators for specialty areas, such as hyperthermia and interoperative radiation. The Joint Commission on Accreditation of Healthcare Organization's (JCAHO) step-by-step process for QA program development is also summarized to clarify the process.     

Breast radiotherapy: an Australasian survey of current treatment techniques

Prior to the dissemination of evidence-based quality assurance guidelines, the Australian National Breast Cancer Centre Radiation Oncology Group conducted a process survey of breast radiotherapy treatment delivery throughout Australia. A process survey was conducted in August/September 1998. This survey comprised questions enquiring about treatment positioning, immobilization devices used, planning strategies, simulation and dose computation methods, treatment prescribing and quality assurance. The survey was sent to 123 Australian fellows of the Royal Australian and New Zealand College of Radiologists (RANZCR) and to the six directors of New Zealand radiation oncology departments. Fifty-eight questionnaires were returned of which 38 were received from individuals and 20 represented a reply from a department with a routine breast radiotherapy protocol (representing an average of 4.5 radiation oncologists per reply). The study identified great consistency between departments with respect to dose and fractionation for breast tangents. The study also identified some areas of treatment planning and delivery that varied between individuals or departments. These mainly reflected a lack of evidence in some areas of radiotherapy treatment delivery. The circulation of quality assurance guidelines will perhaps improve consistency of radiotherapy techniques in which studies have identified that technique changes improve outcome. This study identified that these areas include the taking of simulation and port films and the use of off-axis dosimetry. Further studies are required for areas of radiotherapy treatment delivery that have little evidence for or against their implementation.     

Misadministration of prescribed radiation dose

During a course of radiation therapy treatments, an incident involving machine malfunction or human error can result in delivering a dose other than the prescribed daily dose of radiation. The process of correcting and documenting the misadministration of prescribed radiation dose led to the creation of a department policy that has proved to be a useful quality assurance tool. Explanation of the policy and the information form is given. Incidents involving misadministration of prescribed dose during 1988 and 1989 have been reviewed and the results are presented. This paper describes the specific categories used to classify misadministrations, the frequency of occurrence for certain types of errors, and constructive quality control measures implemented to avoid recurrence of such incidents.     

The importance of education and training in reducing patient doses

Education and training in radiological protection of patients is an important part of a quality assurance program and it is recognised that the knowledge in radiation protection helps prescriber to a correct indication to procedures and practitioner to design and conduct an optimised examination. In the European Union, the international recommendations have been translated in the European Directive 97/43/Euratom asking proper education and training for professionals involved in medical exposures, both for diagnosis and therapy. International and European guidelines, together with guidelines proposed by international and national bodies and associations, are helping institutions to set up education and training programs. Several experiences and research projects have demonstrated the impact on reduction of patient doses when a quality assurance and training program in radiation protection has been conducted.     

Development,implementation, and associated challenges of a new HDR brachytherapy program

Developing any new radiation oncology program requires planning and analysis of the current state of the facility and its capacity to take on another program. Staff must consider a large number of factors to establish a feasible, safe, and sustainable program. We present a simple and generic outline that lays out the process for developing and implementing a new HDR brachytherapy program in any setting, but with particular emphasis on challenges associated with starting the program in a limited resource setting. The sections include feasibility of a program, starting cases, machine and equipment selection, and quality and safety.     

Radiation safety and quality assurance in US dental hygiene programmes, 1990.

A 1990 survey of US dental hygiene programmes indicated substantial advances in radiation safety and quality assurance techniques since 1985. None the less, further improvements are possible to minimize operator and patient exposure to ionizing radiation from dental radiography. Conversion to faster receptor speed, the use of rectangular collimation and more frequent performance of quality assurance tests represent possible improvements for some establishments.     

Expanding the scope of practice for radiology managers: radiation safety duties

In addition to financial responsibilities and patient care duties, many medical facilities also expect radiology department managers to wear "safety" hats and complete fundamental quality control/quality assurance, conduct routine safety surveillance in the department, and to meet regulatory demands in the workplace. All managers influence continuous quality improvement initiatives, from effective utilization of resource and staffing allocations, to efficacy of patient scheduling tactics. It is critically important to understand continuous quality improvement (CQI) and its relationship with the radiology manager, specifically quality assurance/quality control in routine work, as these are the fundamentals of institutional safety, including radiation safety. When an institution applies for a registration for radiation-producing devices or a license for the use of radioactive materials, the permit granting body has specific requirements, policies and procedures that must be satisfied in order to be granted a permit and to maintain it continuously. In the 32 U.S. Agreement states, which are states that have radiation safety programs equivalent to the Nuclear Regulatory Commission programs, individual facilities apply for permits through the local governing body of radiation protection. Other states are directly licensed by the Nuclear Regulatory Commission and associated regulatory entities. These regulatory agencies grant permits, set conditions for use in accordance with state and federal laws, monitor and enforce radiation safety activities, and audit facilities for compliance with their regulations. Every radiology department and associated areas of radiation use are subject to inspection and enforcement policies in order to ensure safety of equipment and personnel. In today's business practice, department managers or chief technologists may actively participate in the duties associated with institutional radiation safety, especially in smaller institutions, while other facilities may assign the duties and title of "radiation safety officer" to a radiologist or other management, per the requirements of regulatory agencies in that state. Radiation safety in a medical setting can be delineated into two main categories--equipment and personnel requirements--each having very specific guidelines. The literature fails to adequately address the blatant link between radiology department managers and radiation safety duties. The breadth and depth of this relationship is of utmost concern and warrants deeper insight as the demands of the regulatory agencies increase with the new advances in technology, procedures and treatments associated with radiation-producing devices and radioactive materials.     

Quality assurance in x-ray diagnosis as specified in DIN 6868

Regular quality control and safety assurance in diagnostic radiological systems are included in the new radiation protection regulations. The monitoring program for both the equipment and the film processor can enable the user to recognize loss of quality early. Variables in the film processing unit can be differentiated from faults in the X-ray equipment more easily, including its use. The cost and time spent in setting up a safety assurance program are justified by the increase in quality.