The Society & College of Radiographers “Preventing Accidental Exposures from New External Beam Radiation Therapy Technologies” – consultation from the International Commission on Radiological Protection (ICRP) The Society and College of Radiographers welcomes the opportunity to respond to the ICRP consultation on “Preventing Accidental Exposures from New External Beam Radiation Therapy Technologies” This response, which is divided into two parts that includes both general and specific comments, has been put together after careful consideration of the draft report, discussion with professional colleagues and takes account of the views of the radiography professional body. I am responding on behalf of the Society and College of Radiographers and I would be happy to provide further support and information if required - my contact details are Name: Maria Murray MPhil, CRadP, MSRP, FHEA. DCR(T) Job Title: Professional Officer (Radiation Protection) Address: The Society & College of Radiographers 207 Providence Square Mill Street London SE1 2EW Email: MariaM@sor.org Telephone: 01236 736839 The Society and College of Radiographers is the professional body and trade union for all members of the radiographic workforce in the UK. Membership of the organisation includes radiography students, radiography assistant practitioners and radiographers as well as members of a number of other professions associated with the provision of diagnostic clinical imaging and radiatiotherapy / oncology services. Radiography services occupy an ever-more central role in the development of health care. The disciplines of diagnostic and therapeutic radiography are required to keep pace with a significant increase in demand driven by the government-led initiatives and international trends. The Society and College of Radiographers exists to promote the science and practice of radiography in the interests of furtherance of the profession and in the public interest, to support and promote education and research in radiography and to represent the interests of members of the radiographic community. General Comments: The Society and College of Radiographers welcomes this draft report from the international radiation protection community – the ICRP. The objectives of this report are both to summarize lessons from experience to date and to provide guidance on proactive approaches to the reduction of risk of accidental exposure in radiotherapy, with emphasis on the use of advanced and complex planning and delivery technologies and techniques. In summarising the lessons learned from previous errors, the draft report’s authors have selected to review errors which have occurred across the radiotherapy pathway and with various types of equipment, which demonstrates that there is risk in all parts of the pathway and no staff group can afford to be complacent. The Society and College of Radiographers believes that the radiation regulations in the UK are fairly stringent with very good reporting and inspectorate arrangements but that there is, quite obviously, still no room for complacency. It is right that the draft report focuses on radiotherapy equipment (including software) due to the highly technical and ever more advancing equipment design and construction whilst stressing the ever continuing need for ongoing training and development (as is a legal requirement under the Ionising Radiation (Medical Exposure) Regulations 2000). Indeed the Ionising Radiation Regulations 1999 legally require equipment manufacturers to design equipment (including accessories and software) with safeguards to ensure equipment failure or defects and to restrict dose to that required for the intended purpose (i.e. with the use of failsafe mechanisms) The Society and College of Radiographers has been involved in the production of several comprehensive guidance publications over the last 2 years within the UK due to the need for the radiotherapy community to share knowledge and practice, to learn from any errors or near misses and to help to ensure that errors are minimised as much as possible. Three examples of these guidance publications are: 1. A Guide to Understanding the Implications of the Ionising Radiation (Medical Exposure) Regulations in Radiotherapy (2008), The Royal College of Radiologists, College of Radiographers, Institute of Physics and Engineering in Medicine and the Health Protection Agency 2. Towards Safer Radiotherapy (2008), The Royal College of Radiologists, College of Radiographers, Institute of Physics and Engineering in Medicine, British Institute of Radiology and the Health Protection Agency 3. Implementing In-vivo dosimetry (2008), The Royal College of Radiologists, College of Radiographers, Institute of Physics and Engineering in Medicine and the British Institute of Radiology The Society and College of Radiographers also continues to be key partners in UK national work with the National Patient Safety Agency for radiotherapy safety. The Society and College of Radiographers contributed to the development of the recently published World Health Organization (WHO) Radiotherapy Risk Profile (2008) - http://www.who.int/patientsafety/activities/technical/radiotherapy/en/index.html) – our organisation was one of the invited members of the working party developing this and our attendance at the event in Geneva 2007 led to the development of the document through email communications. It would be helpful for this draft report to reference this WHO work. The ICRP working group is to be commended for this extremely useful draft report which contains an excellent overview and useful guidance and which should be essential reading for all therapeutic radiographers but especially those with quality assurance as a major part of their clinical role. The title of the draft report suggests that the recommendations will apply to newer technologies. The Society & College of Radiographers believes that the risk based, quality assured approach with well defined procedures the authors advocate, has equal value in the delivery of non-complex radiotherapy and the title under sells the value of the document to all radiotherapy providers. The Society & College of Radiographers believes that the number of human errors is reduced when technology is properly commissioned, quality assured and introduced with a process that acknowledges the interaction between human and machine, rather than trying to make the machine fit the `old` human process. Analysis has shown that this significantly reduces the number of transcription and machine parameter set up errors and allows the staff member to concentrate on the actions a machine cannot perform such as identifying the correct set up reference marks on the patient for example. It would be helpful to emphasize the point within the report that, as training does vary worldwide for the professional group known as “technologists” (“Therapeutic Radiographers” in the UK), the use of automated technology really does demand higher level skills to enable the safe delivery of radiation. The Society & College of Radiographers believes that this level of skill will be required to increase as technologists / Therapeutic Radiographers become more and more responsible for the IGRT process and ultimately have a large part to play in both IGRT decision making and ultimately with Dynamic Adaptive RT which is yet to be introduced but is most definitely on the horizon. Certain new technologies such as “cyberknife” may require their own dedicated team as the treatment process is fairly specialist, but this may not be the case for all new technologies (i.e. “tomotherapy”) – it is obvious that there is a need for carefully designed and implemented local training, supervision and assessment of competence to effectively and safely take on new technologies by those staff that had previously no experience in that technique or equipment. Generally speaking though, Therapeutic Radiographers are an adaptable professional group that tends to welcome new technology and tend to grasp new concepts fairly quickly. The radiotherapy community is so used to the concept of LinAcs but these newer technologies are very different and are not likely to be available in every department. It will be important for shared learning to encouraged, especially in this health environment which is becoming increasingly business like and competitive. Perhaps there is also the need for the report to emphasize the importance of the potential learning that can take place at specific national / international “equipment meetings” specifically focused upon sharing clinical practice, including clinical protocols and where discussion of clinical cases can take place. This would be wider that the standard equipment users groups, but more a meeting where Clinical Oncologists, Physicists and Therapeutic Radiographers come together to share learning, discuss problems thus helping to minimize the risk of errors etc….. Specific Comments: It is very useful and effective to have the “ten main points” summarized at the beginning of the guidance however, within the main text, there seems to be differing styles in the highlighting of “recommendations” (i.e. Chapter 2 clearly identifies particular recommendations but it is not clear in other chapters). The Society & College of Radiographers agrees with the “ten main points” and believes that they are the most important but would like to add the following points: • Number 2 – It is very important to ensure that education and training specific to equipment and software is given high priority and this should be undertaken with and by the relevant manufacturer “application specialists” in a timely fashion and in a conducive learning environment. All training should be recorded in an individuals’ departmental “training record”. All new equipment should be subject to risk assessment according to local procedure (and relevant legislation) prior to clinical use. • Number 3 – the point about “excessive confidence in computers…..” is well made and any education & training programme should include an alert to this fact. All training should involve, where possible, manual as well as computerized calculations/checks to ensure total understanding. • Number 4 – The Society & College of Radiographers are in general agreement with this point – perhaps a different word from “hospital” could be used as not all radiotherapy is given in that environment. The point about “independent checks” is extremely important but it should be stressed that these checks should be undertaken using a different methodology from the original to ensure total “independence”. • Number 7 – The use of a failsafe method of automatic back-up of data offsite should help to avoid loss of data integrity and better data security. • Number 9 – Within the UK, to ensure compliance with the Ionising Radiations (Medical Exposure) Regulations 2000, it is imperative that all radiation doses, including those from imaging in radiotherapy, are assessed and recorded. • Other - the use of routine in-vivo dosimetry on a patients’ first treatment is recommended. • Robust network communications within a radiotherapy department are required to maintain data integrity. Chapter 1 – This is a good introduction to this draft report and the Society & College of Radiographers would like to add the following point: • In addition to the UK regulatory requirements to report accidents and errors, there is the professional responsibility of all healthcare professionals working with radiation to report “near misses” within the radiotherapy community in order that lessons may be learned. Inspection programmes should involve a “proactive” phase (as is the case in the UK) and where links have been made between inspectors and professional bodies has proved to be invaluable in raising awareness within the community. Chapter 2 – A very useful insight into the lessons to be learned from accidental exposures with recommendations being clearly laid out. The Society & College of Radiographers would like to add the following points: • Although it is not a legal requirement within the UK to be subject to a quality management system, all radiotherapy departments within the UK do have a quality management system to International Standard certification status (ISO 9001) which is subject to internal and external audit. • Point 18 – Medical physicists within the UK are subject to registration with the regulatory body, the Health Professions Council – this ensures parity and standardization of education & training. Therapeutic Radiographers are also registered with the UK Health Professions Council and their undergraduate training includes radiotherapy dosimetry – both professional groups are essential in maintaining radiation safety. • Point 21 – this is well made and indeed the Society & College of Radiographers advocate that exercising professional responsibility by constantly challenging safety procedures and expressing professional viewpoints is imperative to an open and transparent safety culture within radiotherapy. • Point 33 – At times, the draft report seems to be contradictory by advocating the increased use of technology but then stating that this cannot be relied upon so manual methods should continue to be used. The leaves the reader unclear of the advice when text such as the following is used (in point 33): “Provision for identifying the patient by a photograph is indispensable as is a provision for identifying fiducial markers and tattoos. Modern digital techniques make this approach simpler, as every radiation therapy department can have digital cameras and the means to incorporate the picture into the treatment chart. Modern techniques can also be useful to further ensure identification in future, such as individual identity card with bar code or fingerprint identification. Some of the positioning errors are automatically excluded by “record and verify” systems, although these systems can bring other type of problems such as relying too much on an automatic system as opposed to a manual system where the user is forced to maintain a higher degree of vigilance”. Not all departments have access to the latest versions of R&V software into which digital images can be imported. The R&V system will only automatically exclude positioning errors if treatment parameter tolerances have been set up in such a way that they have to be overridden if there is a discrepancy. Their effective use also depends on the staff who have the rights to do this being experienced enough to understand the consequences of overriding such parameters. At the very least formal identification of any patient must include the active response by the patient to three unique identifiers, namely name, address and date of birth. Procedures for the identification of patients who are unconscious, deaf, mute, who speak in a foreign language etc must also be in place. There is no discussion within the draft report about the patient who is unable to positively respond to a verbal identification procedure. The draft report highlights the need for correctly identifying the patient but could go further in its recommendations and suggest that mechanisms are also in place for selecting for example, the correct CT dataset to export into the planning system and selecting the correct treatment dataset. There is potential for error where patients have multiple planning scans and multiple phases of treatment. Whilst the use of ID photographs will help in getting the correct patient it does not mean that the correct dataset has been selected. In addition patient photographs can easily become out dated, particularly for those patients undergoing chemo radiation treatment regimes or those who have had chemotherapy prior to radiotherapy. Chapter 3 – An excellent overview of the safety issues concerning new technologies. The Society & College of Radiographers would like to add the following points: • It is unclear what the significance of the bullet pointed boldface text is within each sub-heading. Are these recommendations? • Point 40 – again, it must be stressed that equipment training should be relevant, undertaken in a conducive learning environment and recorded in an individual’s training record. There should also be some mechanism for ensuring competence following training (i.e. assessment of competence). • Point 43 - The Society & College of Radiographers are of the opinion that treatment prescription is not just the responsibility of the Radiation Oncologist but could equally be the responsibility of an appropriately qualified and trained Therapeutic Radiographer (i.e. a Consultant Therapeutic Radiographer). • Point 50 - There seems to be an assumption within this paragraph that the push alarm held by patients is similar to the device used to control breathing (ABC). Hand held push alarms are valuable for patients, and should be considered, but the point shouldn’t be confused with the mechanism for ABC. • Point 51 – Availability of IGRT should not be a substitute for the principles of good immobilisation techniques. The point being made in the draft report is understandable but the wording used may suggest that IGRT could be seen as a replacement for embedding principles of good immobilization – particularly in developing countries. An example can be given from a recent ESTRO presentation where a physicist presented a paper about treatment for the rectum (i.e. patient was prone and IGRT used) but the actual image shown in the presentation was of a “large” patient who was prone with lateral tattoos for set –up – the real concern was that, the ladies “tights” were still only half pulled down away from the treatment field and thus immediately affected the position of the tattoos! This example highlights that items of clothing such as “tights” should be totally removed when treating the pelvis as they definitely affect the set-up. • Points 57 – 58 - A potential area for error lies with the clinician defining the treatment volume and suggests that the only time for this to be checked is by a planning physicist. It is debatable whether this should actually be the responsibility of a non-clinically trained individual. With a desire to reduce treatment margins and dose escalate there is a move away from the internationally referenced PTV, CTV and GTV definitions. Whilst a number of studies exist setting out the treatment margins used by those exploring these techniques, there is no international consensus on what is a safe reduction in these margins. The authors could make recommendation about such a piece of work being carried out for the various treatment sites where dose escalation techniques are being used. Likewise there is some variability about the acceptable dose constraints used in IMRT planning. • Point 82 – there are a couple of named references missing. The Society & College of Radiographers disagrees with the viewpoint that “…technologists who know that there is an automatic safety system working in the background … tend to relax their attention…” – all Therapeutic Radiographers take their legal and professional responsibility for radiation exposure of the patient in radiotherapy very seriously and do comply with local procedures which require them to constantly check the computer prescription with an appropriate source document (i.e. the paper treatment prescription) before initiating exposure. There has been quite a lot of discussion about ‘involuntary automaticity’ (first described by Professor Brian Toft) within the UK radiotherapy community, with an acknowledgment that this is a phenomenon that really does exist - it is not about blame of the individual, it is about the danger of carrying out very repetitive tasks in computerized controlled work environments. It is extremely important to acknowledge this phenomenon within the final report, and to highlight that, in any error, it is not automatically the technologists / Therapeutic Radiographers’ fault, but that other pressures may arise that increase the risk of error. Therapeutic Radiographers do take their professional responsibilities seriously and in an environment that is as complicated as radiotherapy, the message that technologists / Therapeutic Radiographers are not just “button pushers” should be stressed – they are very much in control and responsible on a computerized LinAc just as they were years ago, prior to the introduction of R&V systems. Chapter 4 – The discussion and lessons to be learned from the various case studies are extremely useful but it is unclear where and from whom the discussions stem. The Society & College of Radiographers would like to add the following point: • Point 94 – “ … requires revisiting staff qualifications..” - the qualifications status of an individual does not, in itself prove competence. It is much better to assess competence through the acquisition of skills and knowledge. • Point 140 - There are two points of factual accuracy which need to be corrected or expanded upon. The draft report states that: “It should be noted that radiation therapy physics staffing levels in Scotland were less than 60% of the recommended levels at the time of the accident, and that staffing levels in treatment planning in the clinic also were well below the level recommended by the professional body in that country” The report should reference the professional guidance on staffing levels which it refers to when making this statement. Whilst the radiation therapy physics staffing levels across the whole of Scotland may have been 60% below recommended levels, those in Glasgow; where the incident occurred, were not 60% below any recommended levels. It should also be noted that there were trained planning staff working in the department but they had been deployed to other duties. The current statements are misleading. Chapter 5 – Proactive approaches to avoiding errors in radiotherapy is always advisable and the Society & College of Radiographers are actively involved in this endeavour through the various guidance publications produced in partnership with other professional bodies within the UK and through the work of the National Patient Safety Alliance in Radiotherapy. The Society & College of Radiographers would recommend that countries where possible work at least regionally if not nationally to address patient safety and to share learning, just as within the UK? The Society & College of Radiographers would like to add the following points: • Point 165 – there is no illustrative diagram. Only patient over-doses with certain criteria are reportable to the authorities in the UK but there is general agreement that under-doses are just as important in patient management and are also considered within the community. • Points 166 and 167 – again, there seems to be no “Figure 3” or “diagram” Chapter 6 – Useful chapter but it is unclear if the bullet pointed boldface text represents the recommendations. The authors could take this opportunity to go further with their recommendations and seek to promote the work being done in areas such as IMRT QA, in-vivo dosimetry, IGRT dose evaluation and combining total patient dose from multiple modalities. Without tools from manufacturers to improve how many of these functions are carried out, their widespread adoption and the potential benefit to many patients will not be realised. The Society & College of Radiographers hopes that the ICRP working group finds this response useful. Maria Murray Professional Officer (Radiation Protection) April 2009