Nottingham Brachytherapy Inspection 2023 Process

The Nottingham Experience of an IR(ME)R Inspection of Brachytherapy Dr. Keith Langmack Head of Radiotherapy Physics

Background IR(ME)R have decided to proactively inspect brachytherapy in 2023 & 2024 Nottingham was in the first wave of 5 centres Brachytherapy service is simple only gynaecological indications with HDR Last radiotherapy inspection possibly in 2004 most senior staff have changed since then

Timetable CQC emailed the Chief Nurse on the morning of 28/6/23 (Wednesday) This was cascaded via two divisional routes and received by the department by mid-afternoon on the same day This informed us that the inspection would take place on 12/7/23 They required a list of documents (next slide) to be supplied by 4 pm on Monday 3/7/23

Documentation requested By 3/7/23 Employer s procedures Organisational structure for management of radiation protection Any documentation outlining how IR(ME)R/radiation protection is managed within the organisation Minutes of the last three radiation protection committees (or any other meetings relating to radiation governance) IR(ME)R equipment inventory Document detailing the provision of clinical audit Overview of employer and practitioner licences or certificates Study of risk of unintended and accidental exposures for radiotherapeutic exposures A list of radiation incidents for the last 12 months (including those not externally notifiable) On the day (12/7/23) Examination/clinical protocols Training records for all duty holders Equipment performance test results Details of clinical audits Authorisation guidelines (where applicable)

Suggested Personnel and timetable Personnel Medical Physics Expert and/or Radiation Protection Advisor Brachytherapy lead Brachytherapy service manager Lead clinician for Brachytherapy Brachytherapy governance lead anyone who plays a key role in IR(ME)R compliance for the brachytherapy service Inspection timetable

Immediate Actions Meeting of Radiotherapy Service Manager and Head of Radiotherapy Physics to compile a list of required evidence and who would collect it Shared folder set up to compile evidence as set out by inspectorate Informed those who would be part of the inspection (clinicians) of the requirements Met with Trust governance to agree actions

Evidence Stage 1 Local Employer s procedures, schedule 2 (from ISO9000) Trust wide Organisational structure for management of radiation protection (IRSP) (noted out of date) IR(ME)R equipment inventory (from ISO9000) Any documentation outlining how IR(ME)R/radiation protection is managed within the organisation (IRSP) Document detailing the provision of clinical audit (from ISO9000) Minutes of the last three radiation protection committees (or any other meetings relating to radiation governance) (IRSC minutes plus local MEC minutes) Overview of employer and practitioner licences or certificates (from ISO9000) Study of risk of unintended and accidental exposures for radiotherapeutic exposures (Datix / see appendix 9 of guidance doc) A list of radiation incidents for the last 12 months (including those not externally notifiable) (from Datix)

Evidence Stage 2 Clinical protocols from ISO9000 Training records for all duty holders ensure we had all the individual training records centrally Equipment performance test results this is electronic system so had people present with access Details of clinical audits collected clinical audits from clinical team Authorisation guidelines (where applicable) not used locally

On the day Ensure full brachytherapy team, radiotherapy service lead, head of RT Physics, RT service manager, Divisional nurse, RPA, chair of IRSC present at first meeting General introductions. Inspectors (2) gave overview of the day. The Trust general IR safety was discussed first of all so those not required for the rest of the day could leave out of date IRSP was noted. Then went through all the evidence point by point just like any other audit Also visited the brachytherapy facility to see that

Findings 1 CQC gave formal feedback on the next day to the governance team. This was generally very positive department is very safe and the work around clinical audits was brilliant . Our CSAUE protocol did not have a formal definition of clinically significant . This was a minor, but material breach of the regulations So an improvement notice was served Needed to be compliant by 18/8/23 The inspectors gave helpful guidance on how to meet the requirements So we re-wrote our CSAUE process

Findings 2 Final report was provided on 28/7/23 and we could fact check it. Were then given 6 weeks to write an action plan Areas for improvement 6(5)b as Trust level document on radiation safety were out of date then this had to be addressed. The Trust is doing this. 7 clinical audit. Although our audit was good the documentation did not adequately define clinical audit. The inspects suggested where to find definitions. So we re-wrote our documentation and now have a formal clinical audit plan

Reflections The inspectors were supportive and actively helped with the evidences gathering when on-site Documentation is key everything must be documented and up to date (even the Trust level documents) If in doubt about how to comply then Guidance on IR(ME)R implications for clinical practice in radiotherapy should be followed. It has lots of helpful examples to use.