Trust Board: Wednesday 18 January 2017 TB Ionising Radiation (Medical Exposures) Regulations

Transcription

1 Trust Board: Wednesday 18 January 2017 TB Title Ionising Radiation (Medical Exposures) Regulations Status History For review / discussion This is a new report Board Lead(s) Tony Berendt, Medical Director Key purpose Strategy Assurance Policy Performance IR(ME)R CQC Response Page 1 of 4

2 Oxford University Hospitals TB Executive Summary 1. An Improvement Notice was issued to the Trust under Section 21 of the Health and Safety at Work Act 1974, by the Care Quality Commission (CQC) in August 2016, following a short notice inspection to assess compliance with the Ionising Radiation (Medical Exposures) Regulations, commonly referred to as IR(ME)R. 2. The Trust produced a comprehensive action plan to address issues identified by the CQC, both within the area inspected, and across the whole organisation 3. The Improvement Notice required improvements to be completed by the end of December The Trust has recently reported to CQC and on the basis of selfassessment and a report from the Trust s Internal Auditors, believes it is now compliant with the IR(ME)R requirements. 4. This reports presents the following: A copy of the original improvement notice (Appendix 1) The letter of response to the CQC outlining the completion of the action plan and remaining areas for completion (Appendix 2) The Internal Audit Report provided to the CQC as part of the letter of response (Appendix 3) The current action plan provided to the CQC as part of the letter of response (Appendix 4). Recommendations 5. The Board is asked to review this report and its appendices; to note the content and response given to CQC; to decide if it is adequately assured; and to note the intention for further work. IR(ME)R CQC Response Page 2 of 4

3 Oxford University Hospitals TB Introduction 1.1. On 18 th August 2016 the CQC undertook a short notice announced inspection of the Radiology Department at the John Radcliffe Hospital to assess compliance with the Ionising Radiation (Medical Exposures) Regulations, commonly referred to as IR(ME)R The inspection had been announced on 15 th August 2016 and had required pre-visit submission to the CQC of a number of documents relevant to compliance with the regulations, followed by interviews of Trust staff and a clinical walk-round by inspectors The inspection may have been triggered by the number of CQC-reportable IR(ME)R incidents (but not their rate against volume of work, for which benchmarking does not exist). CQC-reportable IR(ME)R incidents are notifiable patient safety incidents involving incorrect exposure of patients to radiation, for example by carrying out a CT scan on the wrong patient, or by carrying out the wrong examination, so requiring a repeat scan The Trust is aware that compliance with IR(ME)R is one of the many areas of focus from CQC and that a programme of inspections of this kind is underway The outcome of the inspection was the issue, by CQC under their enforcement powers, of an Improvement Notice. This was due to the identification of a number of breaches of the regulations as set out in a letter from CQC to the Trust (see Appendix 1) received on Friday 19 th August The CQC required improvements to be made to deliver compliance with IR(ME)R by the end of December 2016, following which a repeat inspection would be carried out Following an urgent meeting on Wednesday 24 th August 2016, chaired by the Medical Director, attended by Director of Assurance, Deputy Medical Director, members of the CSS Divisional leadership and management team (including clinical governance), the Radiology Directorate leadership and management team, and the Radiation Protection team, an action plan was devised and submitted to the Trust Executive on 26th August A final quality assurance review of the action plan was performed on 30 th August 2016 by the Director of Assurance with the Divisional and Directorate leadership teams, prior to its submission to CQC It is important to note that while the Improvement Notice pertained solely to the Radiology Department at the John Radcliffe Hospital, the action plan has reviewed all four of the Trust site Radiology Departments and all other areas in the Trust (managed in other clinical Divisions) where clinical activity falls under IR(ME)R. 2. Work undertaken and assurance to date The Trust action plan has comprehensively addressed the issues identified in the Improvement Notice, overseen by a weekly meeting to track and coordinate actions. Trust management has been kept updated on progress In addition, the Trust has recently carried out an internal assurance review of progress 2.3. Furthermore, the Trust s Internal Auditors were commissioned by the Medical Director to conduct an independent review of the completion of the action plan. As part of their review the Internal Auditors conducted visits at the John Radcliffe, Churchill, Nuffield Orthopedic Centre and the Horton, including mobile units. IR(ME)R CQC Response Page 3 of 4

4 Oxford University Hospitals TB On the basis of self-assessment and the report from the Trust s Internal Auditors, the Trust believes it is now compliant with the IR(ME)R requirements The Internal Audit gives assurance on the completion of the action plan; the capabilities of the Trust to self-assess compliance at an appropriate standard; and the capability of the Trust Assurance team, which reached similar conclusions This reports presents the following: A copy of the original improvement notice letter (Appendix 1) The letter of response to the CQC outlining the completion of the action plan and remaining areas for completion (Appendix 2) The Internal Audit Report provided to the CQC as part of the letter of response (Appendix 3) The current action plan provided to the CQC as part of the letter of response (Appendix 4) The Trust will develop additional actions to address the wider areas for improvement identified by the Internal Audit Report, and these will be managed through the Trust s clinical governance processes 3. Recommendation 3.1. The Board is asked to review this report and its appendices; to note the content and response given to CQC; to decide if it is adequately assured; and to note the intention for further work. Dr Anthony Berendt Medical Director and Chair, Radiation Protection Committee Report prepared by: Dr Anthony Berendt Clare Winch, Deputy Director of Assurance IR(ME)R CQC Response Page 4 of 4

5 Care Quality Commission (CQC) 151 Buckingham Palace Road London SW1W 9SZ Telephone: Fax: IMPROVEMENT NOTICE Issued under the Health and Safety at Work etc Act 1974 and the Ionising Radiation (Medical Exposure) Regulations 2000 TO: Chief Executive Officer Oxford University Hospitals NHS Foundation Trust John Radcliffe Hospital Headley Way Headington Oxford OX3 9DU By I Rachael Catherine Rose Ward ( the Inspector ), being an Inspector appointed by the Care Quality Commission by an instrument in writing pursuant to section 19 of the above Act, am of the opinion that you have contravened the Regulations cited below: Ionising Radiation (Medical Exposure) Regulations 2000, Regulations 4(1)(a), 4(2), 4(3)(b), 4(4)(a) and 4(4)(b) Duties of the Employer Regulation 4(1)(a)The employer shall ensure that written procedures for medical exposures including the procedures set out in Schedule 1 are in place and shall take steps to ensure that they are complied with by the practitioner and operator Regulation 4(2) The employer shall ensure that written protocols are in place for every type of standard radiological practice for each equipment. Regulation 4(3)(b) The employer shall establish quality assurance programmes for standard operating procedures. Regulation 4(4)(a) and (b)the employer shall take steps to ensure that every practitioner or operator engaged by the employer to carry out medical exposures or any practical aspect of such exposures complies with the provisions of regulation 11(1) and undertakes continuing education and training after qualification including, Registered office: 151 Buckingham Palace Road London SW1W 9SZ Page 1 of 5

6 in the case of clinical use of new techniques, training related to these techniques and the relevant radiation protection requirements; Ionising Radiation (Medical Exposure) Regulations 2000, Regulation 7(8) Optimisation Regulation 7(8) The employer shall take steps to ensure that a clinical evaluation of the outcome of each medical exposure, is recorded in accordance with the employer s procedures or, where the employer is concurrently practitioner or operator, shall so record a clinical evaluation, including, where appropriate, factors relevant to patient dose. Ionising Radiation (Medical Exposure) Regulations 2000, Regulation 8 Clinical Audit Regulation 8 The employer's procedures shall include provision for the carrying out of clinical audit as appropriate. Ionising Radiation (Medical Exposure) Regulations 2000, Regulations 11(1) and 11(4) Training Regulation 11(1) Subject to the following provisions of this regulation, no practitioner or operator shall carry out a medical exposure or any practical aspect without having been adequately trained. Regulation 11(4) The employer shall keep and have available for inspection by the appropriate authority an up-to-date record of all practitioners and operators engaged by him to carry out medical exposures or any practical aspect of such exposures or, where the employer is concurrently practitioner or operator, of his own training, showing the date or dates on which training qualifying as adequate training was completed and the nature of the training. at: John Radcliffe Hospital The reasons for the Inspector s opinion are as follows: 1. As part of a short notice announced inspection on 18 th August 2016 Trust Employer s Procedures as required under Schedule 1 of IR(ME)R were reviewed. I established that there was no robust review of the employer s procedures required under Schedule 1(b), specifically relating to identification and entitlement of non-medical referrers, and Schedule 1(e) where poor revision and document control demonstrated concerns with the quality assurance of Registered office: 151 Buckingham Palace Road London SW1W 9SZ Page 2 of 5

7 employer s procedures and other documentation required under IR(ME)R 2. During the inspection, I established that there were incomplete and inadequate reviews of written protocols for medical exposures for plain film and interventional procedures 3. The radiology service manager confirmed that there were no clinical audits as required under IR(ME)R performed and that there was no audit programme in place 4. A review of training records established that, for practitioners and operators, there were incomplete and missing training records as required under Regulation 11 and Schedule 2 and there was inadequate demonstration of theoretical and practical training for these duty holders 5. A discussion with the radiology service manager highlighted the lack of training records and induction for agency staff to ensure that they are adequately trained to use the Trust equipment prior to entitlement to act as an operator And I hereby require the said contraventions to be remedied by 1 st January 2017 This Notice is effective from the date specified below. In order to comply with this Notice you shall carry out the measures in the attached schedule Failure to comply with this Notice is an offence under section 33 of the Health and Safety at Work etc. Act Right of Appeal You are required to comply with the terms of this Notice within the timescales specified. Should you dispute the terms of this Notice you have the right to appeal to the Employment Tribunal. An appeal must be made within 21 days of service on you of this Notice. Bringing an appeal has the effect of suspending this notice, until the appeal is disposed of or withdrawn. This notice is issued under sections 21 and 23 of the Health and Safety at Work etc Act 1974 Signed: Dated: 23 nd August 2016 Rachael Catherine Rose Ward Clinical Specialist Inspector 151 Buckingham Palace Road London SW1W 9SZ Registered office: 151 Buckingham Palace Road London SW1W 9SZ Page 3 of 5

8 SCHEDULE In order to comply with the attached Notice you should take the following steps OR take any other equally effective measures to comply with this Notice a) Ensure that all the operators and practitioners working at the Trust have been adequately trained as required by Schedule 2 and that there are associated records available for inspection b) Ensure that agency staff are adequately trained in the use of the equipment and that associated records are established and made available for inspection c) Ensure that there is a revision of the equipment specific competency and training pack and that a designated trainer or competency assessor carries out that assessment of competence prior to entitlement to act as an operator. Particular attention must be paid to specialised imaging techniques including paediatrics d) Ensure that for each radiological procedure a written protocol in is in place and that these protocols for part of the quality assurance programme for standard operating procedures e) Ensure that there is a clinical audit programme in place with regular audits carried out against Employer s procedures and standard operating procedures f) Ensure that clinical evaluations that are carried out outside of radiology are subject to regular audit g) Ensure that non-medical referrers are cited in the Trust procedure, Entitlement of Operators, Practitioners and Referrers, and that there is clear identification and entitlement for these individuals and that this information is available for operators to refer to Registered office: 151 Buckingham Palace Road London SW1W 9SZ Page 4 of 5

9 Notes 1. The Care Quality Commission ( CQC ) is the independent regulator of health and adult social care in England. We were established by the Health and Social Care Act 2008 and replaced the former Commission for Social Care Inspection, Healthcare Commission and Mental Health Act Commission. 2. CQC is the enforcing authority for the Ionising Radiation Medical Exposure Regulations 2000 ( IR(ME)R ) in England. Its powers of enforcement for IR(ME)R derive from the Health and Safety at Work etc Act 1974 ( HSWA ). 3. This Improvement Notice is issued under section 21 and 23 of the HSWA. 4. Failure to comply with this Improvement Notice is an offence under section 33(1)(g) of the HSWA and section 33(2) and Schedule 3A of this Act renders the offender liable on summary conviction to imprisonment for a term not exceeding 12 months, or a fine not exceeding 20,000, or both, or on conviction on indictment imprisonment for a term not exceeding two years, or a fine, or both. 5. Where an Improvement Notice does not take immediate effect, an inspector has power to withdraw it or to extend the period specified in the notice, before the end of the period specified in it. Should you wish this to be considered you should apply to the Inspector who issued the notice, but you must do so before the end of the period given in the notice. Such an application is not an appeal against this notice. 6. The issue of this notice does not relieve you of legal liability for failing to comply with any statutory provision referred to in this notice or to perform any other statutory or common law duty resting in you. 7. For more information on the Employment Tribunal appeals process contact the Employment Tribunal on or their website at: www. Employmenttribunals.gov.uk The rules for the hearing of an appeal are given in the Employment Tribunals (Constitution and Rules of Procedure) Regulations 2013 (SI 2013/1237).. 8. CQC for its own purposes, records and monitors trends in the enforcement action it takes, and the convictions and penalties imposed by the Courts. It is CQC s policy that this information should be brought to the public s attention. CQC also has a statutory obligation under the Environment and Safety Information Act 1988 to maintain a public register of certain notices. Details from this notice will therefore be stored on an electronic database, which is available on CQC s Website ( Information on a notice will not be entered onto the database until after the right of appeal against the notice has expired. Where a notice is withdrawn or cancelled on appeal no entry will be made. Entries relating to notices served on individuals will be kept on the register for a period no less than 5 years from the date of issue. Information will be withheld where, in CQC s belief, its disclosure would: cause harm or prejudice; or be in breach of the law. Personal information is dealt with in accordance with the Data Protection Act Where disclosure of personal information would be incompatible with the Act it will not be included on the database. If you are not satisfied with the information contained in the entry you have a further right to appeal to the CQC in the first instance. Registered office: 151 Buckingham Palace Road London SW1W 9SZ Page 5 of 5

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12 Ionising Radiation (Medical Exposure) Regulations (IR(ME)R) Review Oxford University Hospitals NHS Foundation Trust Healthcare Advisory Report Final report December 2016

13 Contents The contacts at KPMG in connection with this report are: Andrew Bostock Partner KPMG LLP (UK) Tel: Sue Cordon Director KPMG LLP (UK) Tel: Page Section one: Executive summary 3 Section two: Key findings 6 Section three: Trust s IR(ME)R CQC action plan 10 Appendices 1. Results of clinical visits Areas visited Staff interviewed 30 Pippa Jackson Manager KPMG LLP (UK) Tel: pippa.jackson@kpmg.co.uk This report, together with its attachments, is provided pursuant to the terms of our engagement. The use of the report is solely for internal purposes by the management of Oxford University Hospitals NHS Foundation Trust, pursuant to the terms of the engagement, it should not be copied or disclosed to any third party or otherwise quoted or referred to, in whole or in part, without our written consent. 2

14 Section one Executive summary Context Since April 2010, all providers of healthcare services have been obliged to register with the Care Quality Commission (CQC). NHS organisations are now subject to a regime of more frequent monitoring. This is part of the new, more dynamic and responsive system of regulation which places the views and experience of patients and other stakeholders at its core. An improvement notice was issued to Oxford University Hospitals NHS Foundation Trust under Section 21 of the Health and Safety at Work Act 1974, following an IR(ME)R inspection on 18th August 2016 at John Radcliffe Hospital. This inspection identified concerns around identification of non-medical referrers, quality assurance of procedures, the absence of a clinical audit programme and incomplete or absent training records for substantive and agency duty holders as required under Ionising Radiation (Medical Exposure) Regulations (IR(ME)R). IR(ME)R regulations are intended to protect those undergoing medical examination or treatment using ionising radiation from unnecessary and un-optimised radiation used as part of their diagnosis or treatment. The improvement notice has a compliance deadline of January 1 st The Trust has asked us to review their arrangements to assess compliance in the key areas outlined in the notice. Although the CQC visit was at the John Radcliffe hospital site, the Medical Director has asked us as part of the review to undertake visits to the Radiology departments at all four sites John Radcliffe Hospital; Churchill Hospital; Nuffield Orthopaedic Centre; and the Horton Hospital site in Banbury. Conclusion The Trust has implemented an action plan to monitor the progress made in the response to the areas highlighted by the IR(ME)R improvement notice. The action plan is discussed at several meetings; Divisional Governance meeting; Radiology Governance meeting; and the Radiology Business meeting. A weekly CQC action plan meeting also follows the Radiology Business meeting where the status of each action is reviewed. We used the Trust s action plan as the basis for our review. Good progress has been made with the areas for improvement. There are still some areas where further work is required, and some areas where the actions will be ongoing, for example the discussion of training compliance in annual appraisal sessions. The Radiology Directorate has taken an approach of long term sustainability, developing processes for long term use and ones that will assist in their aim for ISAS (Imaging Services Accreditation Scheme) next year (May 2017). During our review we visited the Trust's four hospital sites, John Radcliffe, Churchill, Horton and Nuffield Orthopaedic Centre. We visited 17 locations where radiation is used for imaging, most were housed within the Clinical Support Services Division but some were within Surgery and Oncology Division and Neurosciences, Orthopaedics, Trauma and Specialist Surgery Division. Staff in all areas were professional and welcoming. Staff were aware of the recent CQC visit and the fact that an improvement notice had been issued. Staff had a good understanding on the areas for improvement and were very keen to talk to us regarding the local changes in their areas. We also interviewed a number of managers and senior management teams at Divisional and Directorate level, and staff from Medical Physics. We reviewed information stored on the O drive to evidence the progress documented on the CQC action plan. There are some areas that require further input, however the Trust is broadly on target to meet the requirements as described in the IR(ME)R improvement notice issued by the CQC. In areas where we consider further work is required we have raised the urgent actions with the Radiology Senior Management Team. The Trust will need to demonstrate further progress in these areas to satisfy the CQC that all aspects of the improvement notice have been achieved and will be sustainable. We have RAG rated the key areas for further development. We have made six recommendations for you to progress. 3

15 Section one Executive summary Conclusion (continued) The relationship between Medical Physics and Radiology requires improvement. A service level agreement should be developed by both parties to document the plan of work and to manage expectations and requirements of both parties. Medical Physics currently sits within Surgery and Oncology Division and whilst some cite this as an issue, the independence this offers could be seen as a benefit. The list of procedures for non-medical referrers requires updating. The current documents held on the O drive are out of date, some are dated in 2001, and most of the documents were signed off by staff no longer in the Trust. Whilst we acknowledge these procedures may not have changed it is best practice for documents of this type to be reviewed every 3 years. Currently the Trust is issuing nonmedical referrer entitlements on procedure documents that are considerably out-of-date. During the last Radiology weekly CQC meeting we attended it became apparent that someone had inadvertently deleted the current version of the action plan from the O drive. Some updates had therefore been lost and this was a frustration to the team. We advised the team to work with IT to implement a robust version control / collaboration process to allow multiple editing whist protecting the document integrity. The Radiology Directorate has a number of staffing vacancies across all areas and uses a number of temporary staff. Staff were conscious of the need for continual improvement, however some superintendent radiographers stated they were drawn into clinical practice at times of staff shortages and this had impacted on some of their managerial responsibilities. We are aware that plans are in place to address the recruitment and retention issues, and many schemes are already providing some benefit e.g. Band 6 retention measures, therefore we have not made a recommendation in this area. Considering the size of the Directorate there are limited resources for governance activity. There is currently 0.4 WTE (30 hours) Clinical Governance Lead for Radiology. This post holder was able to demonstrate a clear understanding of the role and works effectively, however the impact of the pursuit of ISAS compliance cannot be underestimated. Although the Division has a clinical lead for audit, a clinician with a dedicated programme activity allowance, there is no local audit support role that could assist the Governance Lead in the monitoring of actions that emerge from the audit programme that is run by Medical Physics. Such a role would be beneficial in facilitating change of practice, working with the Superintendent Radiographers where required, encouraging local ownership of clinical practice and required improvements, and working to maintain compliance with the regulatory environment. Medical Physics has designed a comprehensive programme of audits for the year. This has been well organised and is being distributed and analysed by Medical Physics. Staff within Radiology have found the programme and the findings to date helpful in determining improvement areas. Radiology will need to ensure that recommendations emerging from audit findings are actioned, monitored and progress reported in Governance meetings. Additional support to the Clinical Governance Lead will be required to action this at the pace required to satisfy CQC and the content of its improvement notice. Although there is a Divisional newsletter, staff stated there is no regular newsletter for the Radiology Directorate or for specific modalities and this should be developed by the Modality Leads. This could assist in harmonisation of the sites, develop common working practices and improve communication. Acknowledgements We would like to thank all of the staff that made themselves available during our visits and interviews. 4

16 Section one Executive summary Objectives The objectives of our review were: Objective Objective One Compliance with IR(ME)R Objective Two Site visits to assess compliance Description We interviewed the key staff with managerial responsibility, and reviewed evidence to assess governance arrangements regarding compliance of the following regulation sub-sections. Duties of the employer Regulation 4(1)(a) The employer shall ensure that written procedures for medical exposures including the procedures set out in Schedule 1 are in place and shall take steps to ensure that they are complied with by the practitioner and operator. Regulation 4(2) The employer shall ensure that written protocols are in place for every type of standard radiological practice for each equipment. Regulation 4(3)(b) The employer shall establish quality assurance programmes for standard operating procedures. Regulation 4(4)(a) and (b) The employer shall take steps to ensure that every practitioner or operator engaged by the employer to carry out medical exposures or any practical aspect of such exposures complies with the provisions of regulation 11(1) and undertakes continuing education and training after qualification including, in the case of clinical use of new techniques, training related to these techniques and the relevant radiation protection requirements. Optimisation: Regulation 7(8) The employer shall take steps to ensure that a clinical evaluation of the outcome of each medical exposure, is recorded in accordance with the employer s procedures or, where the employer is concurrently practitioner or operator, shall so record a clinical evaluation, including, where appropriate, factors relevant to patient dose. Clinical Audit Regulation 8 The employer's procedures shall include provision for the carrying out of clinical audit as appropriate. Training Regulation 11(1) Subject to the following provisions of this regulation, no practitioner or operator shall carry out a medical exposure or any practical aspect without having been adequately trained. Regulation 11(4) The employer shall keep and have available for inspection by the appropriate authority an up-to-date record of all practitioners and operators engaged by him to carry out medical exposures or any practical aspect of such exposures or, where the employer is concurrently practitioner or operator, of his own training, showing the date or dates on which training qualifying as adequate training was completed and the nature of the training. We visited the following Radiology Departments: John Radcliffe hospital site; Churchill hospital site; NOC; and Horton hospital site. These sites are all managed in the Radiology Directorate within the Clinical Support Services Division. Following our initial investigations we undertook spot checks in a sample of other Directorates within other Divisions where IR(ME)R activity is undertaken. 5

17 Key Findings

18 Section two Key findings and recommendations During the course of the review we undertook many interviews and site visits and met with numerous staff. This contributed to our key findings and evidenced the status of progress with the Trust s required actions to address the CQC s IR(ME)R improvement notice. Our detailed findings against your action plan are contained in the next section of this report. This section details our key findings and area where further work is recommended. Relationship between Medical Physics and Radiology The relationship between Medical Physics and Radiology requires improvement. Medical Physics sits within the Surgery and Oncology Division whilst Radiology sits within Clinical Support Services Division. Whilst some staff we interviewed cite this as an issue, considering the policing role of Medical Physics, the independence this offers could be seen as a benefit. There are a number of effective communication channels and forums already in place that ensure appropriate interaction between Medical Physics and Radiology. However some improvements are required. Medical Radiation Executive Committee (MREC) meets 3-monthly; a multi-disciplinary meeting driving compliance with the IR(ME)R regulations. This Committee is chaired by Medical Physics and attended by modality radiographers, Clinical Leads, and managers from all sites (including community hospitals), and by the Consultant Radiologist IR(ME)R Lead. The Terms of Reference are clear and current. The purpose of the Committee is to define and implement a radiation safety management system in order to safeguard patients who undergo procedures involving ionising radiation, and to ensure all clinical exposures to ionising radiation are as low as reasonably practicable. Reports and recommendations are made to the Trust s Radiation Protection Committee, Clinical Risk Management Committees and Directorate Board as appropriate, with a written report annually. The Radiation Protection Committee meets quarterly, although we note the July 2016 meeting was cancelled. The Terms of Reference are clear and current. Membership includes the attendance of various representatives from Radiology, Oncology and Cardiology. The purpose of the Committee is to define and implement a Radiation Protection Policy and safety management systems for dealing with radiation risks, and to encourage and foster a greater awareness of radiation safety throughout the Trust. Exception reports are made to the Trust Health and Safety or Clinical Risk Management Committees as appropriate, with a written report annually. The Medical Director chairs this Committee and attendees report the content as appropriate. From review of the minutes we note some Department and Modality Lead radiology reports are verbal, whereas written reports should be available for presentation in the Committee. Medical Physics also attend the Radiology Governance meeting. During the course of this review we saw positive interactions between Medical Physics and Radiology and their contribution to the CQC IR(ME)R action plan has been essential to ensure the Trust are compliant with its legal requirements. Whilst some staff cite an apparent failure of Medical Physics to maintain IR(ME)R compliance, Radiology had poor housekeeping in several areas and both parties contributed to CQC s findings and subsequent issuing of its Improvement Notice. Work has now occurred at pace to rectify the situation. Currently there is no Service Level Agreement in place for Medical Physics and Radiology, and this should be developed by both parties to document the plan of work and to manage expectations and requirements of both parties. This will formalise the relationship in a business transaction model, and one that can be, and should be, regularly monitored. The two Divisions triumvirate management teams should meet every three months (in this initial phase) with the Radiology and the Medical Physics Leads to discuss the progress of the SLA. Both Divisions (Divisional Director or Associate Divisional Director) should formally meet with the respective leads (CD for Radiology and Head of Medical Physics). This was already occurring within CSS where regular meetings were held however this was not occurring at Divisional level in Surgery and Oncology Division, and therefore they were insufficiently aware of the IR(ME)R requirements and status of compliance. Recommendation 1 A Service level Agreement should be developed by Medical Physics and Radiology to document the plan of work and to manage expectations and requirements of both parties. This will formalise the relationship in a business transaction model, and should be monitored. The two Divisions triumvirate management teams should meet every three months (in this initial phase) with the Radiology and the Medical Physics Leads to discuss the progress of the SLA. Both Divisions (Divisional Director or Associate Divisional Director) should formally meet with the respective leads (CD for Radiology and Head of Medical Physics). 7

19 Section two Key findings and recommendations Non medical referrers The Trust has undertaken considerable work with regard to non-medical referrers. Training for these staff is undertaken every five years face-to-face with updates in between. There is now a centrally held list of non-medical referrers. On the CRIS radiology system IR(ME)R appears after the referrers name and this indicates their IR(ME)R registration/training and entitlement to request procedures. The list of procedure protocols for non-medical referrers requires updating. The current documents held on the O drive are out of date, some are dated in 2001, and most of the documents were signed off by staff no longer in the Trust. Whilst we acknowledge these procedures may not have changed it is best practice for documents of this type to be reviewed every 3 years. Currently the Trust is issuing non-medical referrer entitlements on procedure documents that are significantly out-of-date. Recommendation 2 The list of procedure protocols for non-medical referrers should be updated with immediate effect. This will ensure that all non-medical referrer entitlements are based on current procedures. Version control of documents held on the O drive During the last Radiology weekly CQC meeting we attended it became apparent that someone had inadvertently deleted the current version of the action plan from the O drive. Some updates had therefore been lost and this was a frustration to the team. We advised the team to work with IT to implement a robust version control / collaboration process to allow multiple editing whist protecting the document integrity. Recommendation 3 The Operational Service Manager for Diagnostics should arrange support from IT to implement a robust version control / collaboration process to allow multiple editing whist protecting the document integrity. Staffing The Radiology Directorate has a number of staffing vacancies across all areas and uses a number of temporary staff. Staff were conscious of the need for continual improvement, however some superintendent radiographers stated they were drawn into clinical practice at times of staff shortages and this had impacted on some of their managerial responsibilities. We are aware that plans are in place to address the recruitment and retention issues, and many schemes are already providing some benefit e.g. Band 6 retention measures, therefore we have not made a recommendation in this area. Clinical Governance Considering the size of the Directorate there are limited resources for governance activity. There is currently 0.4 WTE (30 hours) Clinical Governance Lead for Radiology. This post holder was able to demonstrate a clear understanding of the role and works effectively, however the impact of the pursuit of ISAS cannot be underestimated. IAS accreditation is being pursued for 2017 with a deadline for information and evidence in May 2017 and involves considerable work to meet the standards required. Although the Division has a clinical lead for audit (a clinician with a dedicated programme activity allowance) there is no local audit support role that could assist the Governance Lead in the monitoring of actions that emerge from the audit programme that is run by Medical Physics. Such a role would be beneficial in facilitating change of practice, working with the Superintendent Radiographers where required and encouraging local ownership of clinical practice and required improvements. Other Directorates and Departments such as the Trust s laboratories utilise Quality Manager roles to align and maintain practice to regulatory compliance. This type of role could be beneficial in Radiology, working alongside the Clinical Governance Lead. Recommendation 4 Radiology Directorate should consider ways to support the Clinical Governance Lead to manage the governance workload, continual assessment of regulatory compliance in practice to IR(ME)R and ISAS accreditation. 8

20 Section two Key findings and recommendations Implementation and monitoring of audit recommendations Medical Physics has designed a comprehensive programme of audits for the year. This has been well organised and is being distributed and the results collated and analysed by Medical Physics. Staff within Radiology were aware of the audit programme have found the audits and the findings to date helpful in determining improvement areas. Radiology will need to ensure that recommendations emerging from audit findings are actioned, monitored and progress reported in Governance meetings. Additional support to the Clinical Governance Lead will be required to action this at the pace required to satisfy CQC and the content of its improvement notice. Recommendation 5 Radiology need to consider how best they will ensure implementation and ongoing monitoring of actions that emerge from audit findings. Support will be needed to ensure the Clinical Governance Lead is able to facilitate this additional responsibility as part of the Directorate's current and expanded portfolio. Communications There has been a recent reorganisation of the senior team. Previously site leads were in place, however a decision was made by the Radiology Directorate to move to a Modality Lead model e.g. CT, working across the sites to improve working relationships and maximise capacity. However some of these Modality Leads still maintain site responsibilities, and some staff feel this is confusing, although there is recognition that this structure is relatively new. Staff stated there is no regular newsletter for the Radiology Directorate or for specific modality and this is something that the Modality Leads could develop. This could assist in harmonisation of the sites, develop common working practices and improve communication. We noted during our visits that the sites work very differently. Whilst this issue could be viewed as outside of the scope of this review staff did discuss the issue with communication, especially with regard to shared learning following incidents, and that is why we have reported it. Recommendation 6 Modality Leads should introduce newsletters for their specialty. This will assist in harmonising practices for the modality across all sites, develop common working practices and improve communications. 9

21 Review of Trust s action plan

22 Section three Review of Trust s action plan This section of the report details our findings following the review of evidence, staff interviews and site visits. We have detailed our findings against each action on your plan and have RAG rated accordingly. Training records - Ensure that all the operators and practitioners working at the Trust have been adequately trained and that there are associated records available for inspection OUH actions Trust RAG KPMG comments KPMG RAG Create file for information in O' drive. This is complete. The O drive is a useful portal to ensure all information is kept together and easy for staff to navigate. Get all current training templates for operators and practitioners across the directorate. This was undertaken. Training records were paper based and in multiple formats and locations. Review all current templates and select a format for operators and practitioners training template. This is complete. A common training template is now in use. Ratify Rag rating guide for Operators and Practitioners. Complete. This is how the matrix has been populated. Green = trained; Red = training out of date (e.g. maternity leave); Amber = in training; Black = don t use that equipment. Blank areas awaiting population. Obtain a list of staff employed with Radiology. This has been undertaken. Records were significantly out of date. Managers are confident that the list is now complete. A list of Agency staff is also complete. Validate the list for operators and practitioners. Undertaken. These are terms to ensure people are correctly categorised. A practitioner is responsible for justifying any radiation exposure. An operator is personally responsible for their own contribution to the patient s treatment. Validate current equipment list. The Trust s asset register was not up to date for radiology equipment. There were inventory records within the Trust of equipment that was not available or not in use. There is now a list of all kit in current use. Create an equipment / staff matrix. This is a comprehensive document and has been designed to list all staff and all equipment currently in use. There was some difficulty in ascertaining the completeness of the list, records of actual staff in post were incomplete. However this has been worked upon and is now complete. Circulate matrix for superintendents in each area to map staff in their area to the equipment. This has been circulated to the areas and is also on the O drive. Circulate new format for training template to all superintendents and modality leads for equipment specific modification. This has been undertaken. Superintendents we spoke to were aware of the new format and were using the correct version. Each superintendent to complete the training template for staff identified in the matrix. Superintendents we spoke to stated that this was largely complete except for staff absent from work on career breaks, long term sick or maternity/adoption leave. There were a few records that were still being chased at the time of our visits. JR complete. 11

23 Section three Review of Trust s action plan Training records - Ensure that all the operators and practitioners working at the Trust have been adequately trained and that there are associated records available for inspection OUH actions Trust RAG KPMG comments KPMG RAG Superintendents to identify training gaps for Operators and practitioners and rag rate staff on the matrix. Superintendents are still working through some of the white boxes to ascertain which staff use individual pieces of equipment and checking that their training records are complete, in date and therefore valid. Some staff on long term sick or those on maternity leave will require assessment at the time of return. IRMER e-learning training modules to be developed with L&D following discussion at MREC on 30th November Collate completed training documents on O drive. This is ongoing. There are some Radiologist records that are still required, but these are being followed up. Incorrect templates had been used for some and this is being rectified. Audit of process and documentation. This was undertaken by Rachel Lloyd. Upload onto I passport. This is ongoing. This is a considerable task and administration support will be required to meet the aim of uploading documents to I passport. However the documents are uploaded onto the O drive and this should be sufficient to satisfy the CQC s immediate action. The benefit of I passport will be its ability to manage document review dates and reminders and this will be a definite benefit and will contribute to ISAS standards relating to Facilities, Resources and Workforce domain and the Safety domain. Independent Audit of process by the assurance team. A review has been undertaken and the results reported to the Trust s Medical Director 20/12/

24 Section three Review of Trust s action plan Training records - Ensure that all the operators and practitioners working at the Trust have been adequately trained and that there are associated records available for inspection OUH actions Trust RAG KPMG comments KPMG RAG Training records - other areas within the Trust that use Radiation. List of all other operators and practitioners of non radiology ionising radiation outside of Radiology. Create an equipment / staff matrix by site. All departments have been reviewed against I(RM)ER criteria and issued with an action plan to address non-compliances. Lists of operators and practitioners outside of Radiology are held by the individual departments with responsibility for this as per Trust IR(ME)R policy, along with their training records including competency to use equipment. Medical Physics has investigated the arrangements in areas outside of Radiology. Equipment / staff matrices are not appropriate for these departments who either own one piece of equipment or duplicate similar pieces of equipment for which one equipment competency record has been deemed sufficient. Circulate matrix. Not applicable see above. N/A Complete training records for non Radiology operators / practitioners. Upload onto electronic system such as Qpulse. All Departments have training and competency records and duty-holder registers in place, although there remain gaps in training evidence: notably for OCDEM and Xe-133 administration and Plastics regarding evidence of original schedule 2 training. Five yearly refresher training is being organised when required. Records have not been uploaded to a document control system by these Departments as they do not have the facilities for this, but they are all centrally held in folders and are auditable. Therefore records are available and held electronically and this should be sufficient, although the arrangements differ from the process put in place by Radiology. All employee procedures up to date and on the intranet. Radiotherapy hold documentation and records in Qpulse. This system is up to date. This service has ISO 9000 accreditation. Records will be maintained by each Department and audited as part of the audit programme schedule. 13

25 Section three Review of Trust s action plan Written protocol - Ensure that for each radiological procedure a written protocol in is in place and that these protocols for part of the quality assurance programme for standard operating procedures OUH actions Trust RAG KPMG comments KPMG RAG Obtain all current protocols for each procedure across the directorate. Completed. Will need to be kept up to date. The modality leads will monitor this but this needs to be formalised. Review all current templates and select a format for Protocols. Completed. A standard protocol template is now in use. Superintendents and Modality Leads to validate all current protocols and assign a review date. Protocols are written, validated and review days have been assigned. Place current protocols in each viewing area - with version control. From our spot checks we saw good compliance with this in the areas visited. Place all copies of protocols in the O drive. This has been completed. Upload to I passport. To publish the protocols on I passport they need to be authorised on the system and this is work in progress. Proposal to RPC on process to ensure the compliance review actions are fed back via directorate and division to MREC & RPC. This is too early to evidence. Physics to circulate the quality assurance audit program. This has been circulated. Some audits have already commenced and results fed back to areas. Pregnancy status audit was underway at the time of our visits to clinical areas. Staff were aware of the audit and where appropriate had contributed to the sample. MREC / RPC to monitor process with radiology. Progress with the audit programme and results of completed audits will be agenda items at MREC and RPC. Ongoing. ongoing Audit SOPs as per programme and discuss results in MREC. Ongoing compliance monitoring. ongoing Discuss results in monthly Directorate CGC. This will be reported monthly at each Directorate Clinical Governance Committee. ongoing For review at MREC (compliance reviews and IRMER self audits). Progress with the audit programme and results of completed audits will be agenda items at MREC and RPC. Ongoing. ongoing Independent Audit of process by the assurance team. A review has been undertaken by Clare Winch and her team and the results reported to the Trust s Medical Director on 20/12/2016. Reiterate the escalation process for non compliance. Ongoing compliance monitoring. Too early in the process for this to have occurred but should feature in the discussions at Divisional CGC, MREC and RPC. 14

26 Section three Review of Trust s action plan Equipment specific competencies - Ensure that for each radiological procedure a written protocol in is in place and that these protocols for part of the quality assurance programme for standard operating procedures OUH actions Trust RAG KPMG comments KPMG RAG Review the equipment training guides for radiology equipment. This is completed. We saw evidence of these during our spot checks to clinical areas. Validate the list for operators and practitioners. Undertaken. These are terms to ensure people are correctly categorised. A practitioner is responsible for justifying any radiation exposure. An operator is personally responsible for their own contribution to the patient s treatment. Validate current equipment list. The Trust s asset register was not up to date for radiology equipment. There were inventory records within the Trust of equipment that was not available or had not been in use for several years. There is now a list of all kit in current use. Create an equipment / staff matrix. This is a comprehensive document and has been designed to list all staff and all current equipment. Circulate matrix for superintendents in each area to map staff in their area to the equipment. This has been circulated but is also on the O drive. Circulate new format for training template to all superintendents and modality leads for equipment specific modification. This has been undertaken. Superintendents we spoke to were aware of the new format and were using it. Each superintendent to complete the training competency template for staff identified in the matrix. Superintendents we spoke to stated that this was largely complete except for staff absent from work on career breaks, long term sick or maternity/adoption leave. There were a few records that were still outstanding. Superintendents to identify training gaps for Operators and practitioners and rag rate staff on the matrix. Superintendents are still working through some of the white boxes to ascertain which staff use individual pieces of equipment and checking that their training records are complete, in date and therefore valid. Some staff on long term sick or those on maternity leave will require assessment at the time of return. Collate completed templates digitally. These are now held on the O drive. Download all manufacturers user guides for equipment within Radiology. These were present in the clinical areas and most areas we visited had obtained electronic copies as well as paper based manuals. Place current user guides in each room. These were present in all control rooms we visited. Display a list of trainers & assessors for each piece of equipment in each area and store on O drive. We reviewed this on the O drive. As with all of the information held centrally it will require periodic review. This information will eventually be held on I passport. 15

27 Section three Review of Trust s action plan Equipment specific competencies - Ensure that for each radiological procedure a written protocol in is in place and that these protocols for part of the quality assurance programme for standard operating procedures OUH actions Trust RAG KPMG comments KPMG RAG Competency matrix to be reviewed annually in appraisal. This is the intention and also will be used following any incidents / reflective statements etc. Ongoing Operator and practitioner self assessment sheet on confidence levels to be completed after induction is complete and prior to appraisal. Form completed but not been used as too early. Staff we spoke to in some areas who are responsible for assessing staff were aware of the process. This is intended to become part of the appraisal process. Ongoing Independent Audit of process by the assurance team. A review has been undertaken by Clare Winch and her team and the results reported to the Trust s Medical Director on 20/12/2016. Other areas within the Trust that use radiation List of all other operators and practitioners of non radiology ionising radiation outside of Radiology. Create an equipment / staff matrix by site. Lists of operators and practitioners outside of Radiology are held by the individual departments with responsibility for this as per Trust IR(ME)R policy, along with their training records including competency to use equipment. Medical Physics has investigated the arrangements in areas outside of Radiology. Equipment / staff matrices are not appropriate for these departments who either own one piece of equipment or duplicate similar pieces of equipment for which one equipment competency record has been deemed sufficient. Circulate matrix. Not applicable - see above. N/A Complete training records for non Radiology operators / practitioners. Upload onto electronic system such as Qpulse. Records have not been uploaded to a document control system by these departments as they do not have the facilities for this, but they are all centrally held in folders and are auditable. Therefore records are available and held electronically and this should be sufficient, although the arrangements differ from the process put in place by Radiology. There were some areas e.g. plastics where staff were unsure who would hold training records for staff using radiology equipment such as C Arm Units. Radiotherapy hold records in Qpulse. This system is up to date. This service has ISO 9000 accreditation. Records will be maintained by each Department and audited as part of the audit programme schedule. 16

28 Section three Review of Trust s action plan Non medical referrers - Ensure that non-medical referrers are cited in the Trust procedure, Entitlement of Operators, Practitioners and Referrers, and that there is clear identification and entitlement for these individuals and that this information is available for operators to refer to OUH actions Trust RAG KPMG comments KPMG RAG Review Trust employers procedures; new document is ready for circulation imminently for approval 14th Sept. Employer s Procedures as required under the Regulations and the provision of these is the responsibility of the Employer. IR(ME)R includes a list of procedures required as a minimum in any radiological installation. It is imperative that roles and responsibilities are clearly set out in procedures and that everyone understands their individual role. At the time of the CQC visit the Trust s Employers Procedures were out of date. IR(ME)R Procedures and documents Employers Procedures were ratified at MREC on the 15th September All Trust staff will need to comply with the IR(ME)R Policy and Employers Procedures in order to ensure compliance with IR(ME)R. Radiotherapy run their own Employers Procedures, and this is reflected in Trust Policy. A mapping exercise is underway to ensure all aspects of Trust EPs are covered. EPs have been updated and are on the Trust s intranet and Radiology O drive. Review and validate current Entitlement of Operators, Practitioners and referrers template documentation; as above. We reviewed the procedure protocols on which entitlements are made for non medical referrers. We found several of the procedure documents to be out of date. Some were dated 2001, from the former Trust and signed off by clinicians no longer in post at the Trust. These documents require review every 3 years. Review and validate current Entitlement of Operators, Practitioners and referrers documentation to areas outside of Radiology. Medical Physics seminars have been repeated however staff need to engage in a certain amount of self-learning. This is ongoing. Amalgamate the training lists of non medical referrers which will include scope of practice. Training lists were sent to Radiology by Medical Physics Complete gap analysis of non medical referrer protocols (DT already has a lot of this developed). The gap analysis has ben completed, however the procedure protocols require updating into a common format and assigned 3 yearly review dates. Circulate the training list to all sites. Completed. Store the training lists digitally in a central drive with supporting documentation. This is stored on the O drive. The plan is to migrate this information to I passport. 17

29 Section three Review of Trust s action plan Non medical referrers - Ensure that non-medical referrers are cited in the Trust procedure, Entitlement of Operators, Practitioners and Referrers, and that there is clear identification and entitlement for these individuals and that this information is available for operators to refer to OUH actions Trust RAG KPMG comments KPMG RAG EPR / Radiology information system to be investigated re: best solution to allow entitled referrers only to request imaging. A lot of work has been undertaken in this area. We were shown some electronic referrals from non-medical referrers. The staff name has (IR(ME)R following it and this denotes they are IR(ME)R registered. Most superintendents in the clinical areas were also aware that they could access the list on the O drive. Implement best solution in EPR / CRIS. CRIS referrers being amended to show IR(ME)R training this is being addressed by the PACS team. This work is ongoing and not all staff we spoke to were aware of this and further communication is required. Independent Audit of agency staff training documentation process by the assurance team. A review has been undertaken by Clare Winch and her team and the results reported to the Trust s Medical Director on 20/12/

30 Section three Review of Trust s action plan Clinical Audit - Ensure that there is a clinical audit programme in place with regular audits carried out against Employer s procedures and standard operating procedures OUH actions Circulate a complete clinical Audit programme to MREC. (a. self audit, EP audit, SOPs). Circulate Audit programme to RPC Audit as per programme and discuss results in MREC. Discuss results in monthly Directorate CGC. Review of programme at MREC. Physics to review programme compliance. Independent Audit of process by the assurance team. Trust RAG KPMG comments KPMG RAG Medical Physics have designed a comprehensive programme of audits for the year. This has been well organised and is being distributed and analysed by Medical Physics. To improve compliance and increase the visibility of areas of noncompliance, a more prescriptive internal audit regime has been introduced, applicable to all Directorates who expose patients to radiation. This aims to improve engagement and assist Directorates to evidence their compliance with the internal systems and processes in place for IR(ME)R. This new audit schedule (one audit per month) will also make non-engagement more visible to the Medical Radiations Exposures Committee (MREC), a subcommittee of PS&CR. This in turn will improve the standard of assurance upwards to PS&CR. Some audits have already commenced and results fed back to areas (training records audit). Pregnancy status audit was underway at the time of our visits to clinical areas. Staff were aware of the audit and where appropriate had contributed to it. Staff within Radiology have found the programme and the findings to date helpful in determining improvement areas. This was an agenda item at September 2016 RPC where the audit programme was displayed and discussed. Some audits have already commenced and results fed back to areas (Training Records Audit). Pregnancy status audit was underway at the time of our visits to clinical areas. Staff were aware of the audit and where appropriate had contributed to the sample. Staff within Radiology have found the programme and the findings to date helpful in determining improvement areas. Radiology will need to ensure that recommendations emerging from audit findings are actioned, monitored and progress reported in Governance meetings. Results will be discussed at MREC, compliance noted and actions monitored. Audit programme recently begun. Radiology will need to ensure that recommendations emerging from audit findings are actioned, monitored and progress reported in Governance meetings. Additional support to the Clinical Governance Lead will be required to action this at the pace required to satisfy CQC and the content of its improvement notice. Audit programme recently begun. Radiology will need to ensure that recommendations emerging from audit findings are actioned, monitored and progress reported in Governance meetings. Audit programme recently begun. Compliance will be continually monitored via Medical Physics. Non compliance should be reported at MREC and RPC. Ongoing action. A review has been undertaken by Clare Winch and her team and the results reported to the Trust s Medical Director on 20/12/

31 Section three Review of Trust s action plan Audit of work outside of Radiology - Ensure that clinical evaluations that are carried out outside of Radiology are subject to regular audit OUH actions Trust RAG KPMG comments KPMG RAG Review the current trust wide audit plan for IR(ME)R. For Surgery and Oncology, who are considered the biggest radiation users outside of Radiology, Medical Physics attend the Divisional Governance Committee. However no audits are presented, discussed or monitored at this Committee. The audits are currently presented at MREC and RPC. Surgery and Oncology Divisional Management Team members are not represented at MREC and RPC, however this may be beneficial considering Medical Physics role in working towards IR(ME)R compliance, and work undertaken to satisfy the requirements of the CQC improvement notice. Circulate a complete Clinical Audit programme for IR(ME)R. (a. self audit, EP audit, SOPs). Medical Physics have designed a comprehensive programme of audits for the year. This has been well organised and is being distributed and analysed by Medical Physics. Some audits have already commenced and results fed back to areas. Pregnancy status audit was underway at the time of our visits to clinical areas. Staff were aware of the audit and where appropriate had contributed to the sample. Staff within Radiology have found the programme and the findings to date helpful in determining improvement areas. Audit as per programme and discuss results in MREC. Some audits have already commenced and results fed back to areas. Pregnancy status audit was underway at the time of our visits to clinical areas. Staff were aware of the audit and where appropriate had contributed to the sample. Staff have found the programme and the findings to date helpful in determining improvement areas. Directorates will need to ensure that recommendations emerging from audit findings are actioned, monitored and progress reported in their respective Governance meetings. Results will be discussed at MREC, compliance noted and actions monitored. Ongoing action. Discuss results in monthly Directorate CGC. Programme recently begun. Directorates will need to ensure that recommendations emerging from audit findings are actioned, monitored and progress reported in their respective Governance meetings. Ongoing action. Review of programme at MREC. Programme recently begun. Directorates will need to ensure that recommendations emerging from audit findings are actioned, monitored and progress reported in Governance meetings. Ongoing action. Independent Audit of process by the assurance team. A review has been undertaken and the results reported to the Trust s Medical Director 20/12/

32 Section three Review of Trust s action plan Agency staff - Ensure that agency staff are adequately trained in the use of the equipment and that associated records are established and made available for inspection OUH actions Trust RAG KPMG comments KPMG RAG Ensure local SOPs feed into Trust Induction Policy for all temporary workers and are part of the overall audit programme. The Trust aims to maintain Agency staff records to the same standard, using the same paperwork as its substantive staff. Surgery and Oncology have not used agency staff in radiotherapy since August However records are maintained as a substantive member of staff. Gather all training documents for agency staff across the directorate. This is complete. Maintained on O drive. Create a matrix for agency staff and equipment. Included in same staff matrix for Radiology staff. Other departments outside of Radiology maintain their own electronic records. Ensure training documents are completed in line with the matrix. Completed. Rectify any gaps in training documentation. Completed. All agency staff documentation to be kept electronically. All documentation is stored on the O drive. This will migrate to I passport as soon as possible. Ensure EPs reflect process for agency/locum staff. The Employee Procedures documents have been updated and reflect process for temporary staff. Independent Audit of process by the assurance team. A review has been undertaken and the results reported to the Trust s Medical Director 20/12/

33 Appendices

34 Appendix one Results of findings in clinical areas - JR Area visited: John Radcliffe Trauma Unit; Level 2 X-ray; Dentals; Fluoroscopy; Level 1 X-ray; ED X-ray; and Mobile units Awareness of CQC action plan Training records KPMG comments The Trauma Unit regularly use agency cover and they had limited awareness of the CQC action plan. Regular Agency staff told us they are not copied into s and staff updates, so are reliant on communication from permanent colleagues. We saw evidence of standardised paper based documentation of staff competencies which are scanned on to the O drive once staff have completed the competencies. Incomplete competencies are stored in individual paper staff files. Each competency document we reviewed had recently been reviewed and was in date. There are identified staff who can sign off competencies and authorised staff are listed on each competency sheet. The majority of staff we spoke to had access to the O Drive to review their training although this was not consistent. Managers are aware of this and staff with ongoing difficulties accessing the O Drive are expected to speak to IT services to seek a resolution. Local procedures / SOPs Although we observed some mobile X-ray units with Local Rules attached to them, this was not found to be consistent across the John Radcliffe site. On level 1 X-ray the Local Rules were displayed on the notice board, but not attached to the mobile X-ray machines. Local Rules should be available to operators at all times and not just available at their base. Guidance manuals The Guidance Manuals for individual equipment were generally stored behind the screens in the individual x-ray rooms, although in the Trauma Unit the manuals were stored centrally between the two x-ray rooms. Non medical referrers Staff we spoke to in the Trauma Unit were not aware of the non-medical referral list and were not able to locate it. Audit Support Learning from incidents Staff were aware of the audit programme. Some staff were currently involved in the pregnancy status audit. There is an induction program for new staff and agency staff who join the team. Newly qualified staff have period of supernumerary status and are allocated a mentor who will monitor their progress and support them to achieve their competencies. Staff were positive regarding the support and communication from their managers who were reported to be accessible. All staff can access Datix to raise concerns and told us they are encouraged to report incidents. There was good awareness of local incidents and learning from these events. Some staff told us they have written reflective statements to assist in the understanding of the incident and how to prevent recurrence. Staff awareness of incidents across the wider Trust was not as good and therefore opportunities for learning from these incidents would be limited. 23

35 Appendix one Results of findings in clinical areas JR west wing Area visited: John Radcliffe West Wing; Paediatrics; CT; Plastics Theatres Awareness of CQC action plan Training records KPMG comments Staff in CT and paediatrics were very aware of the Trust s CQC action plan following the IR(ME)R review. Staff in plastics theatres (nursing) were not aware of the CQC IR(ME)R visits and that is probably understandable. Staff were keen to tell us that all training records had been updated and held on the I drive. Staff we spoke to in plastics theatres were unable to tell us if the surgeons had been trained to use the 2 C Arm Units that were available. Local procedures / SOPs We saw local rules on all equipment in paediatric and CT. In paediatrics they also had a detector alert sign on the console to remind staff to ensure the detector has been put in place this has resulted from a recent incident. In Plastic s theatres local rules were in place on just one of the C Arm Units, and these were out of date and required review. The new Unit did not have local rules attached. Guidance manuals Non medical referrers Audit Support Learning from incidents Guidance manuals were in each area. In paediatrics electronic versions of the manuals had also been uploaded onto the O drive. In Plastic s theatres both C Arm Units had guidance manuals. Staff in paediatrics showed us how non-medical refers had (IR(ME)R) stated after their name. This determined that the referrer had current entitlements. Radiology staff were aware of the audit programme and CT and Paediatrics had participated in retrospective pregnancy status audits. Staff felt supported in their areas. CT aim to have weekly staff meetings to discuss learning, breaches, incidents etc. Paediatrics stated they had very good relationships with Medical Physics as they frequently liaise over dosage. Some modalities meet regularly e.g. CT. Staff thought learning from incidents was good in their specific areas. CT were able to describe the process that any incident / breach follows, through reporting, investigation to shared learning. Some staff were not aware of incidents that had occurred in other areas of the Trust even though these would be pertinent to other Radiology areas. Learning opportunities may therefore be lost. 24

36 Appendix one Results of findings in clinical areas - NOC Area visited: NOC General X-ray Awareness of CQC action plan Training records Local procedures / SOPs Guidance manuals Non medical referrers Audit Support Learning from incidents KPMG comments All the staff we spoke to were aware of the CQC action plan, although staff reported that many of the actions that have been recently implemented across the Trust were already routine practice at the NOC. An IR(ME)R folder is kept in each room. We saw evidence of standardised paper based documentation of staff competencies that are currently being scanned on the O drive. Staff told us that they anticipate this will be completed by January. Each competency document had been reviewed and was in date and there are authorised competency assessments that have been signed off. All the staff we spoke to had access to the O drive to review their training although the Superintendent is aware not all staff within the Department are currently able to access the O drive but this is being addressed. The competency documents are described as dynamic documents that will be frequently reviewed and amended. There is a version control process in place where old versions are scanned on with a line drawn through the out-of-date version, and the up to date version available to review. We reviewed the electronic training matrix that is updated monthly. This provides at a glance training gaps. If staff don t use a piece of equipment for an extended period of time there is no process for refresher training recorded. This presumably will be addressed with the introduction of I passport. There are IR(ME)R folders created by the Superintendents in each X-ray room which all include the radiation protection policy, X-ray local rules and supplementary local rules. Radiation exposure times are also displayed. There are standardised notice boards in each area displaying information and the Stop and Pause poster reminding staff of the need to confirm patient identification. There were hard copies of the equipment manuals in each of the X-ray rooms we visited. We reviewed the non medical referrer list and the process staff are required to undertake before being entitled to request X-rays. Staff were aware that Medical Physics provide training to non-medical referrers to ensure appropriate referral procedures are followed and entitlements are documented. There is an audit programme in place and staff stated they have recently completed the pregnancy status audit. There is an established audit programme in place and monthly image quality audit where ten images from each area are reviewed. A report is then completed and displayed, and outcomes reported to the Governance Committee. Each X-ray room displayed a white board that is updated daily to display the designated Duty Radiographer and the individual staffing for each room. All new staff have a three month induction and are allocated a Mentor. There are authorised trainers allocated to each room to support less experienced staff. All staff can access DATIX to raise concerns and told us they are encouraged to report incidents. All significant incidents are discussed at the Governance meeting. There was good awareness of local incidents and learning from these events. However awareness of incidents across the wider Trust was not as established and therefore potential learning opportunities may be lost. 25

37 Appendix one Results of findings in clinical areas - Churchill Area visited: Churchill General X-ray; CT; MRI; PET scan Awareness of CQC action plan Training records Local procedures / SOPs Guidance manuals KPMG comments All the staff we spoke to at the Churchill in General X-ray, CT, and PET Scan were aware of the CQC action plan. We also visited MRI whilst realising that radiation was not used we wanted to assess staff awareness of the IR(ME)R visit and also discuss their training records etc. There are standardised paper based documentation for all staff competencies, and these were being used in all the areas we visited. Training records are stored on the O drive which is accessible by most staff we spoke to in General X-ray, CT and PET scanning. The Trust are currently signing off a paper competency record for each member of staff. Once a competence is completed it is scanned and stored onto the O Drive. However the Superintendent in MRI is aware not all staff within the department are able to access the O Drive individually but can view it on the desk top. These access difficulties are know to the Modality Lead and are being addressed. Each competency document had been reviewed and was in date and there are identified staff who are authorised to sign-off competencies. Training is not currently reviewed as part of the appraisal process but senior staff we spoke to were aware this was to be routinely introduced for future appraisals. This is intended to be incorporated into I passport. Agency staff are used usually on long term block bookings. Their training records and competency assessments are the same level as substantive staff. If staff don t use a piece of equipment for an extended period there is no process or refresher training recorded. X-ray local rules and supplementary local rules and radiation exposure times are displayed in each individual room we visited and were frequently duplicated in the staff area between the X-ray rooms. The Stop and Pause poster reminding staff of the need to confirm patient identification was routinely seen to be displayed in the X-ray rooms we visited. The Guidance Manuals were available for staff access in all the areas we visited and some of the equipment had electronic instructions within the equipment's software that staff were able to access for additional information. Non medical referrers MRI staff were aware there was a list of non-medical referrers however they were unable to locate the list. They were aware that the word IR(ME)R occurs after the referrers name on the system if they are entitled to refer. Audit Support Each Department visited told us they were aware of the Trust s audit programme and had recently completed the pregnancy status audit in November. Agency and new starters to the Departments have an induction program and an allocated Mentor. Learning from incidents There was good awareness of local incidents and learning from these events. However awareness of incidents across the wider Trust was not as established and therefore potential learning opportunities may be lost. 26

38 Appendix one Results of findings in clinical areas - Churchill Area visited: Churchill Radiotherapy Department Awareness of CQC action plan Training records Local procedures / SOPs Guidance manuals Non medical referrers Audit Support Learning from incidents KPMG comments Radiotherapy services sit within the Surgery and Oncology Division and not Clinical Support Services. However, the staff we spoke to in Radiotherapy were aware of the IR(ME)R review and subsequent CQC action plan. The training records are centrally held on Q-Pulse which allows both management overview and access to view by individuals. Q-Pulse is accessible through all computers within the Department. There is both a training and competency framework that is continually updated by a Quality Assurance Officer. There are local rule and supplementary rules displayed within the Department and the master copy of these rules is stored on Q-Pulse. The Guidance operating manuals are stored on Q-Pulse and are accessible to all staff. There is strict governance around the referral for radiotherapy and Q-Pulse has a list of each authorised referrer. There is an embedded audit program which is a requirement of the ISO 9001, 2015 certification provided by external auditors, this is now aligned to the Trust s audit programme. There are two designated training Radiographers who monitor training audits. The staff within this service work within teams, there are induction packs for new staff with a six month probation period. Staff feel well supported. Staff told us there was good learning from national incidents and a process in place to evidence that staff have updated themselves with new research and learning. Awareness of other radiology incidents across the wider Trust was not as established and therefore potential learning opportunities may be lost. 27

39 Appendix one Results of findings in clinical areas - Horton Area visited: Horton General X-ray; Mobile units Awareness of CQC action plan Training records Local procedures / SOPs Guidance manuals KPMG comments All the staff we spoke to had an awareness of the CQC action plan and were able to explain how the Trust were implementing the actions. We saw evidence of standardised paper based documentation of staff competencies which are currently being scanned on the O drive and staff told us that they anticipate this will be completed by December. Each competency document had been reviewed and was in date and there are identified clinicians authorised to sign off the competency for each area. We saw the electronic training matrix that is updated monthly providing at a glance training gaps. This document can only be amended by section leads. There are currently no agency staff being used, however the process for agency staff to achieve competency sign-off was the same as substantive staff. Training is not currently reviewed as part of the appraisal process and we were told by the Radiology Site Manager it would not need to be reviewed annually unless new equipment was introduced to the department or new staff joined the team, in which case they would be assessed and records maintained. Not all staff currently have access to the O drive but this is being addressed. The Local Rules are printed out and displayed in each area. There are also supplementary rules available for each individual area with specific instructions for the area in which they are displayed. The master copy of the protocols for each area is stored on the O drive and all the protocols have been reviewed and are up to date. Two portable X-ray units were observed to have the Local Rules stuck on the side of the individual machines. The guidance manuals for the Department equipment are stored centrally in the Superintendents office and there are electronic versions uploaded on the O drive. Non medical referrers Staff were aware of the existence of the non-medical referral list and the limitations of authorisation it identified. However they were not able to locate the list on the O drive. Audit Support Learning from incidents The Department is currently completing the pregnancy status audit for November and are aware of the audit programme. Although there have been difficulties in recruitment there are currently no vacancies in the Radiography team at the Horton. New staff to the Department have a six month probation period with an initial induction during which time they are orientated and supernumerary. Datix incident reporting is available to all staff within the Department. If there is found to be an incidence of referrer or operator error from within the Trust there is an expectation a reflective piece of work will be completed which is kept with the Datix form. Incidents are reported and a record of each incident is kept by the Radiation Protection Officer who will undertake an investigation, produce a report that highlights clinical risk. Although there is the facility to feedback on each Datix once it is completed this does not consistently happen. We were told there was limited shared learning of incidents across the wider Trust although incidents that occurred within the Department would be shared. 28

40 Appendix two Areas visited Areas visited John Radcliffe Hospital site Level 1 X-ray ED majors Level 2 X-ray CT West Wing X-ray Trauma Unit Paediatric X-ray Mobile X-ray units West Wing Theatres - Plastics Churchill Hospital site General X-ray CT MRI PET scan Radiotherapy Nuffield Orthopaedic Centre General X-ray Horton Hospital site General X-ray Mobile X-ray units 29

41 Appendix three Staff interviewed Staff interviewed Tony Berendt Professor Fergus Gleeson Amanda Middleton Michelle Taylor-Siddons Ali Cornall Suzie Anthony Toni Mackay Therese Crawley Toni Hall Debbie Tolley Carol Pook Jayne Lynch Medical Director and Chair of Radiation Protection Committee Divisional Director Clinical Support Services Division General Manager Clinical Support Services Division Divisional Governance and Professional Governance Lead Clinical Support Services Division Associate Divisional Director and Divisional Nurse Surgery and Oncology Clinical Director of Radiology Operational Service Manager for Diagnostics Head of Medical Physics Clinical Unit Operations Manager Clinical Unit Operations Manager Clinical Governance Lead for Radiology Chair of MREC. We also spoke to numerous clinical staff in the areas we visited. 30

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