Minimising the Risk of Unintended Exposures from Newer Radiation Therapy Technologies Comments from the Health Protection Agency UK 24 April 2009. Thank you allowing us the opportunity to comment. The scope of this document is broader than ‘newer radiation therapy technologies’. The document could be employed by departments who provide conventional established radiotherapy evaluating their safety processes, changing processes or upgrading kit or software. Therefore the title of this document underplays its value this wider context. It is clear that this document is pitched at the global community. There is nothing new contained for the UK, where risk analysis in radiotherapy has already gone further than this document. This is evidenced by the publication of ‘Towards Safer Radiotherapy (2008)’ (http://www.rcr.ac.uk/publications.aspx?PageID=149&PublicationID=281) and ‘A Guide to Understanding the Implications of Ionising Radiation (Medical Exposure) Regulations in Radiotherapy (2008)’ (http://www.rcr.ac.uk/publications.aspx?PageID=149&PublicationID=289). For example training records are mandatory, workers can only be entitled to undertake tasks relating to the delivery of RT once they have received appropriate training (this includes local training), this responsibility is shared between the individual undertaking the task and the employer. Clinical departments are obliged to undertake clinical audit and have a prescribed list of procedures in place that help reduce incidents – patient identification, list individuals entitled to carry out various roles in the treatment planning and delivery, establishment of QA programmes, assessment of patient dose, evaluation of all medical exposures and agreed methods to reduce the probability and magnitude of accidental or unintended doses to patients. The document was repetitive and unclear in places. It highlighted that ‘human common sense’ would no longer be as effective a mechanism to detect errors in new complex technologies. However it also explores the risks in manual data entry and warns against over reliance on automated systems. Eg end of paragraph 69& 80, last bullet point page 41. Surely the focus should be on appropriate commissioning of new systems and routine independent checking of the system as part of a QA programme. The importance of rigorous commissioning and QA checks are highlighted through out the document. However the importance of appropriate and effective checks should also be laboured. These checks should be audited to identify what value they add to the process and to minimise redundancy. Paragraph 33 makes recommendations on the use of photo ID to ensure correct identification of the patient; this alone might not be sufficient to ensure correct patient ID. A 3 point ID system could be recommended, whereby every patient is identified by 3 unique identifiers prior to each set of medical exposures by the person undertaking the exposure. This could include photo ID, asking the patient their date of birth and home address. The answers could be checked against the source treatment/ planning document (treatment sheet). Procedures should also indicate how the correct electronic record is identified at all stages in the process. It may be useful to recommend that the patient identity is cross checked with the dataset (eg record & verify system) and any ancillary equipment (eg patient specific customised medical devices such as thermoplastic shells or bolus, paper documentation). There should also be a local procedure in place to deal with patients who can not answer for themselves; children, deaf, mute and patients who do not speak the local language, which also states clearly what needs to be done in the event the patient cannot be identified. (A Guide to Understanding the Implications of Ionising Radiation (Medical Exposure) Regulations in Radiotherapy 2008 (http://www.rcr.ac.uk/publications.aspx?PageID=149&PublicationID=289)). Page 62. (140) refers to ‘staffing levels in Scotland were less than 60% of the recommended levels’, where the incident shared took place. This is the only incident included in the publication where the country of origin is named. Also this statement is inaccurate, where was this referenced? This statement should be removed or modified at a minimum. Page 70 (161). This paragraph reports that ‘possible failure modes should include those reported in the literature and on public databases.’ Data available from national incident reporting systems could be included here. International events might not be applicable locally depending on the culture that exists in that country. Therefore, it might be worth noting that the use of literature and public databases is not intended to replace local and national initiatives, which have an invaluable role to play in minimising risk in clinical departments. All departments should report radiotherapy errors and near misses locally (ideally at a national level, so that lessons learned can be shared). Not enough is made of the value of errors and near misses reporting in improving safety in radiotherapy. Analysis of these can help identify process weaknesses. Audit of local processes can also be an effective tool in the identification of parts of the process that are at risk and to indicate what processes provide true benefits. This can be done both internally and externally through peer review. This document could reinforce these proven methodologies of minimising risk in radiation therapy departments. Page 76 (183) This paragraph discusses the potential role of the medial physicist in checking the radiation oncologists target volume. This role may be more appropriate for another clinician, dosimetrist or radiographer; it would really depend on individual training. However this is an opportunity to highlight the need for increased checking in this part of the process and should be discussed further. • Minor typos – o Page 3. Point 7. Last Line ‘such problems may to escape conventional tests’ o Page 12. Vilaragut reference. ‘radiotherapyradiation therapy’ o Page 20 (3.1) Third point. 1st line. ‘A number or reports’ o Page 41. 1st line reference is missing. o Page 41. 1st bullet point reference is missing. o Page 43. (86) 3rd bullet point. ‘images used in for patient’ o Page 68 (155) & (156). The examples of the process flow chart & the process tree are not included in the document. o Page 69 (158) Towards Safer Radiotherapy is called ‘Towards Safer Radiation Therapy’