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Five Independent Reports into the Obstetric and Gynaecology Service at Royal Cornwall Hospitals NHS Trust

February 2013

Five Independent Reports into the Obstetrics and Gynaecology Services at the Royal Cornwall Hospitals NHS Trust Executive Summary

Contents
Executive Summary Appendix 1 Recommendations from the Organisational Learning Review Appendix 2 Recommendations from the NHS Cornwall and Isles of Scilly (PCT) Organisational Learning Review Appendix 3 Recommendations from the Rapid Response Review Appendix 4 Royal Cornwall Hospitals NHS Trust Organisational Learning Review Appendix 5 NHS Cornwall and Isles of Scilly (PCT) Organisational Learning Review Appendix 6 Patients Association Review of Recent Patient Experiences & Feedback in Gynaecology Services at the Royal Cornwall Hospitals NHS Appendix 7 Rapid Response Review Appendix 8 Independent Case Note Review (ICNR) - Gynaecology Patients Under the Care of Mr K R Jones (former Consultant) - Interim Report 19th February 2013 Royal Cornwall Hospitals NHS Trust

Five Independent Reports into the Obstetrics and Gynaecology Services at the Royal Cornwall Hospitals NHS Trust Executive Summary

1. Introduction Following the removal from practice and subsequent self-erasure from the GMC Register in 2012 of Mr KR Jones, former Obstetric and Gynaecology Consultant at the Royal Cornwall Hospitals NHS Trust (RCHT), it became clear that a number of significant questions needed to be addressed in a systematic and transparent way. While the issues are complex these central questions can be summarised as follows: 1. Were any women harmed as a consequence of Mr Jones practice? 2. What lessons need to be learned by RCHT and others to ensure that concerns raised by staff in the future lead to swifter and more decisive action against clinicians whose practice is below standard? 3. Is the current Obstetrics and Gynaecology service provided by RCHT safe and of good quality? In order to answer these questions a number of reviews were commissioned as follows: Question 1 The Royal Cornwall Hospitals NHS Trust commissioned an Independent Case Notes Review (ICNR) conducted by Royal College of Obstetricians and Gynaecologist (RCOG) approved and external recruited Consultant Gynaecologists, using the RCOG agreed specification for appointees. The appointees had no relationship with the Trust or the individual under review. The ICNR examined all the information in the case notes and all correspondence. To assure the validity of decision making in the case notes review, there was a case note review randomly selected at a rate of 1:10 by a second and independent Consultant Gynaecologist, who was approved by the RCOG. Question 2 On recommendation from NHS South of England a highly experienced NHS Foundation Trust Chief Executive, Julie Acred OBE, was commissioned by The Royal Cornwall Hospitals NHS Trust (RCHT) and NHS Cornwall and Isles of Scilly (NHSC&IOS) respectively to conduct two reviews: Royal Cornwall Hospitals NHS Trust Organisational Learning Review - to identify the learning the Royal Cornwall Hospitals NHS Trust needed to take from the relevant events. The findings of the review covering the period 1992 - 2012 will be used to improve the responsiveness of the organisation and enhance a positive safety culture that protects patients and actively listens to staff. NHS Cornwall and Isles of Scilly Organisational Learning Review - to examine the circumstances surrounding the reporting of concerns regarding the practice of a Consultant Obstetrician and Gynaecologist at the Royal Cornwall Hospitals NHS Trust (RCHT) from 1

1992 - 2012, and to establish how the NHSC&IOS and successor commissioning and performance management systems can learn lessons and mitigate future risks. Question 3 - A Rapid Responsive Review was commissioned by NHS South of England, and in line with nationally agreed practice, to assess the safety and quality of the Obstetrics and Gynaecology services provided to the majority of the women of Cornwall and the Isles of Scilly by the Royal Cornwall Hospitals NHS Trust. 2. Executive Summary of Findings The five independent reports have sought to follow the principles of openness, transparency and candour as described in the Francis report 2013. "Openness - enabling concerns and complaints too be raised freely without fear and questions asked to be answered. Transparency - allowing information about the truth about performance and outcomes to be shared with staff, patients the public and regulators. Candour - any patient harmed by the provision of a healthcare service is informed of the fact and an appropriate remedy offered, regardless of whether a complaint has been made or a question asked about it." (Francis Report 2013) The full set of reports and recommendations for all the Reviews conducted can be found in the Appendices to this Executive Summary. The following is a summary of the key findings to answer the core questions: a) Were any women harmed as a consequence of Mr Jones practice? The case notes of 2396 women who had been seen by or treated under the care of Mr KR Jones, former Consultant between 1st April 2010 and 1st October 2012 have been subject to an Independent Case Note Review (ICNR). The methodology for the ICNR was developed, shared and agreed by the Royal College of Obstetricians & Gynaecologists (RCOG), Public Health Cornwall, and the Medical Leads of NHS Cornwall & the Isles of Scilly (NHSCIOS), NHS South of England and Kernow Clinical Commissioning Group (KCCG). Letters were sent to all women informing them of the review and inviting them to provide feedback about their experiences of the care under Mr Jones or about the gynaecology service in general. 946 women replied. The case notes were reviewed by a panel of external independent Consultant Gynaecologists appointed in line with recommendations from the Royal College of Obstetricians and Gynaecologists. As at 19th February 2013 all case notes have been reviewed subject to the Independent Case Note Review (ICNR). In 2275 of the 2396 cases (94.95%), the independent external Consultant Gynaecologist reviewers found no evidence of harm caused and no indication for recall for further clinical assessment. 52 women (2.17%) were found to have suffered complications of surgery. In all these cases the women had been identified previously and had been managed appropriately with further intervention as necessary. 69 women (2.88%) were felt to be at risk of harm either through failure to manage their case appropriately (1.88%)or because the quality of record keeping did not permit the necessary assurances to be given (1%). A number of women had been seen by other specialties or departments in the intervening time. 57 women have been recalled for outpatient review and clinical assessment by a Consultant Gynaecologist not previously involved in their care. Clinical outcomes from the women are not currently available as clinics and clinical investigations are still on-going. To date 50 women have been seen, some of whom are now awaiting the results of further tests. None of these cases relates to suspected cancer. 2

A total of 55 complaints have been received since November 2012 following media publicity and the Trust sending out letters to women whose case notes were being reviewed as part of the ICNR. The dates of complaints range from 1992 to 2011. The final Independent Case Note Review Report (ICNR) is expected for publication at the end of March 2013, following approval and recommendations from the Clinical Oversight Group (COG) which comprises senior clinicians and Directors across the NHS system. b) What lessons need to be learned by RCHT and others to ensure that concerns raised by staff in the future lead to swifter and more decisive action against clinicians whose practice is below standard? The Royal Cornwall Hospitals NHS Trust Organisational Learning Review Julie Acred OBE, concluded that at various stages RCHTs response to the concerns expressed has been less than adequate. The shortfalls identified fall into a number of categories. The early reviews (1997 to 2001) concluded that there was no evidence of incompetence in Mr Joness practice. The value of these investigations was limited by a lack of meaningful data to compare the practice of individual clinicians. The paperwork available does not confirm that the required action was taken. The Investigation undertaken in 2007/8 did identify serious concerns about practice, but the subsequent action taken did not adequately address the issues identified. Advice was given by the National Clinical Assessment Service, but elements of the advice were not followed. The Medical Director at the time sought further information and reassurance in respect of issues raised in the report, and was persuaded that appropriate action had been taken to address any deficiencies in knowledge and skills. By early 2010 a number of concerns were being raised by the then well established risk systems in Obstetrics and Gynaecology, including a Serious Untoward Incident in January 2010. There was more information available to support concerns about RJs practice than in any previous period, but it took some time for the seriousness of those concerns to be properly assessed. The evident confusion about who should be taking action added to the delay in making a formal assessment of the possible risks to patients. Many of those involved in more recent years were committed to addressing the concerns they had identified, but the lack of clarity on roles and process, and the weaknesses in communication and sharing of meaningful information made this extremely difficult for those involved. Formal action did commence in October 2011, instigated by the new Chief Executive and Medical Director and was broadly managed in accordance with relevant policies. There was a considerable delay before the Trust received the Royal College of Obstetricians and Gynaecologists Report in May 2012, but this was not as a result of any action or lack of action by the Trust. The review has identified a number of weaknesses which need to be addressed by the Trust to ensure that its systems and processes for managing concerns regarding clinical practice are more effective. These include: Board level governance arrangements Specialty based risk and governance arrangements Risk escalation processes 3

Clinical Audit Trust policies and procedures Roles and responsibilities Performance management arrangements Development of the specialty team Appraisal, including arrangements for medical appraisal, and Liaison with other providers The Trust has demonstrated that action is already being taken to address the weaknesses identified. NHS Cornwall and Isles of Scilly Organisational Learning Review Julie Acred OBE concluded that there was no evidence that the NHS C&IOS had any opportunity to intervene earlier in the events covered by this review. The NHS C&IOS took reasonable steps to assess the quality of service, and took account of feedback from various sources in doing this. Where concerns about services were identified appropriate action was taken, and outstanding concerns escalated. There was no evidence of themes or trends which might have alerted NHS C&IOS to concerns in Obstetrics and Gynaecology. As part of this review a number of areas of NHS C&IOS have been identified where arrangements could be strengthened. It is difficult to conclude whether these arrangements would have identified concerns about the Obstetrics and Gynaecology services, but they will assist to improve monitoring and assurance processes, and may be used to enhance the commissioning arrangements that will come into operation in April 2013. c) Is the current Obstetrics and Gynaecology services provided by RCHT safe and of good quality? Overall the Rapid Response Review team found no compelling evidence to find that this was an unsafe service. The Review team was led by the Medical Director of NHS Cornwall and Isles of Scilly, supported by the PCTs Director of Nursing. The Chair of Kernow Clinical Commissioning Group provided a local GP presence. The team also included the Deputy Director of Public Health and the Associate Director of Patient Safety from NHS Southwest, and the Local Supervising Authority Midwife for the region. It also included three clinicians from out of the region, with a senior obstetrician and gynaecologist who is a previous RCOG Honorary Secretary, a gynaecology matron, and an independent consultant, midwife, previously NMC Head of Midwifery. However in Gynaecology, the Review team found areas where the patient experience could be improved. In Obstetrics, where the Trust is not alone in experiencing the national increased pressures on Obstetric units and is often working close to capacity, the Review team identified actions that will accentuate quality and safety and reduce risks further. As part of preparation for the Review, the team scrutinised all available data provided by the Trust on safety and quality indices. The Review team found a high level of engagement by staff in all clinical areas, who demonstrated loyalty and commitment to the Trusts clinical strategy, from Board level down. The Review team found some evidence of communication difficulties between staff and management and observed there to be a disconnect between senior medical staff in the 4

Obstetrics and Gynaecology services which could impact on the Trusts future vision. However we also heard of the Chief Executives high visibility and approachability from staff at all levels. On Tolgus Ward the Review team found privacy and dignity issues and were concerned that male urology patients, although in separate bays, were being nursed on the same ward as gynaecology inpatients. There were also environmental issues, with poor facilities for breaking bad news, and for examination of gynaecology patients out of hours, along with inappropriate signage and confidential patient information on public display. The Review team found no safety issues on Tolgus ward and were impressed with the commitment of the staff and their plans to improve the environment, so far thwarted by the whole health and social care system winter pressure management. The Trusts Development plans for Tolgus ward have been shared with the Review team and will, when implemented, significantly improve the environment on the ward. The team recommends that the timescale of change be expedited. In Gynaecology, the Review team found that efforts are made by Risk Management clinicians to gather complication data and present it meaningfully to medical staff but that the systematic analysis and governance requires investment and IT support in order to provide robust assurance of the safety of the department going forward. In Obstetrics, the outcomes of the Trusts Obstetric unit are e xcellent with low rates of lower segment Caesarean section (LSCS) high levels of patient choice of place of delivery, and high levels of womens satisfaction with care received, all compared to the regional averages. However on the Obstetric unit the Review team found cause for concern. They heard first hand about staffing pressures and recruitment difficulties, and observed midwifery staff managing caseloads with levels of staffing that the Review team felt had the potential to expose staff, women and their babies to risks. These risks are not shown by routine recording and evaluation. They were informed of midwifery staff working at capacity, with long hours and overtime worked to support the close-knit team. They were made aware of the Clinical Site Development Plan and also that the numbers of midwifery staff had been identified as inadequate. Eleven additional midwives have already been recruited, but they are not yet in post due to factors outside of the control of RCHT. They observed some suggestion of a culture of reluctance to escalate concerns by some staff. The Review team also noted that not all Consultants have engaged with the commissioning needs of the local population and RCHTs responsibilities to respond. Coupled with this the Review team noted that the department will need to review medical staff planning in the light of mid-grade staff shortages and longstanding recruiting difficulties and future NHS plans for seven day Consultant cover. The Review team has made its recommendations broadly under the following categories: Privacy and Dignity, Clinical Quality and Service provision, Adequate staffing levels Cultural issues. 3. Next Steps

The Royal Cornwall Hospitals NHS Trust Board has now had the opportunity to consider all the Reviews and makes the following commitments: RCHT will continue to support in any way it can the women directly affected by the practice of Mr Jones, former Consultant in Obstetrics and Gynaecology. The RCHT Board has accepted the findings and recommendations of all the Reviews It has now asked the Chief Executive to present a single Action Plan taking account of all Review recommendations and internally generated initiatives - to the Trust Board meeting in public on March 28th 2013. All Review authors will be asked for their input into the Action Plan. When RCHT becomes licensed as an NHS Foundation Trust its Council of Governors will also be asked to provide oversight of the Boards timely monitoring of the implementation of the Action Plan. RCHT will proactively report to the wider public, and its NHS Foundation Trust membership once licensed, at least quarterly on its progress against the Action Plan.

Appendix 1 Recommendations from the Royal Cornwall Hospitals NHS Trust Organisational Learning Review I. The Governance Committee and sub-groups: The Governance Committee should consider approving annual programmes of work for the sub-groups which report to it, and require that the reports it receives summarise progress against these work plans. The focus of the Committees attention should be directed to areas where delivery is at variance with the work plan and on critical issues arising from this work. The membership of the sub-groups should be reviewed to ensure those attending are able to progress the priorities identified in the annual work plans. Reporting concerns to the Board: The Board should seek to clarify the nature of the reports it and the Governance Committee should receive in respect of concerns about poor practice and the performance of individual clinicians. This could usefully include summary information of cases where serious concerns have been expressed, where staff have restrictions placed on their practice, or where disciplinary action is being taken in respect of conduct. Board assurance from external reviews: The Board may wish to consider expanding the current procedures for recording external reviews, so that it is briefed on the assessments that take place and the number and urgency of recommendations made, and receives regular updates on progress in delivering these requirements. This need only be reported in summary form, and would enable the Board to identify and query any plans where actions are overdue. Specialty based risk and governance processes in the light of comments made regarding attendance at risk meetings, and the resources available to support risk activities in gynaecology in particular, the Trust should review the timing of these meetings and the resources available to support this work. Work needs to be undertaken to properly describe how concerns or risks identified from within individual specialties are escalated beyond the specialty. This will need to address communication arrangements, the information needed to allow proper assessment of the cases identified, and should clearly describe which posts are responsible for what action. The possible development of a Professional Standards Committee should be considered as part of these arrangements. Culture and attitudes: There would be value in further work by the Board to reinforce its commitment to deal with any concerns identified through the local governance processes in a fair and transparent fashion. Staff should be reminded of their responsibility to report concerns about practice, and of the Trusts policy for raising concerns. Clinical Audit Progress has already been made in this area with the establishment of a Clinical Audit and Outcomes Committee. Further work should be undertaken to implement the recommendations of the recent Internal Audit Report, and to encourage the specialty team to develop meaningful indicators of quality and outcomes which should be measured and monitored over time. Trust Policies and procedures: Existing policies should be reviewed with the intention of simplifying, shortening and aligning where possible. If not already in place the Trust may wish to consider creating an ongoing process for doing this. Additional work is needed to clarify the arrangements in place for SUI investigations, particularly in respect of the leadership of these investigations. The Trust should also ensure that

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the requirements set out in the MHPS policy and procedure are properly aligned and cross referenced to other relevant policies. IX. Roles and responsibilities: Existing job descriptions do include requirements for governance activities, but these could be more clearly defined to remove any ambiguity regarding responsibilities. Further work should be done on these once the package of work to improve the escalation process has been completed. As part of this work consideration should be given to maintaining appropriate files of information for subsequent post holders, together with formal handover and training support. Providing additional support for new post holders, through such means as mentors, may also help the development of individuals in their roles. Performance management: The arrangements for performance management of Divisions are balanced and robust. Consideration should be given to how the additional actions and action plans created from specific pieces of work can be assimilated into the overall arrangements. This will ensure there is the same level of discipline applied to these, and absolute clarity regarding their delivery and monitoring. The specialty team: There is an urgent need for a package of development for the O&G team. Historical differences and recent events have strained some relationships and put pressure on many individuals. This package should be discussed and developed with the team. Medical appraisal: Many of the required improvements are already planned or underway. The Board or the Governance Committee on the Boards behalf should review completion of these plans to ensure that the Medical Appraisal process includes a more complete assessment of clinical practice and conduct. This should be cross referenced to other relevant information including complaints and claims. Many doctors already include relevant outcome measures in their appraisal documents, and all clinicians should be encouraged to do this. Trust wide appraisal targets: The Board should consider how it can increase the target completion of appraisals for the organisation as a whole, and address the underperformance on appraisals within the Women, Childrens and Sexual Health Division. Communication with other healthcare providers: There appear to be no formal arrangements for notifying other providers of concerns raised about an individual clinician or service. These arrangements will require liaison beyond the geographical area, and the Trust may wish to refer this issue for consideration by the NHS on a regional or national level

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Appendix 2

Recommendations from the NHS Cornwall and Isles of Scilly (PCT) Organisational Learning Review I. Internal reporting and information sharing: The PCT may wish to consider how it can strengthen internal reporting and information sharing so that all key staff are aware of all relevant issues Sources of external assurance: The PCT should ensure that all feedback received from external sources is routinely fed into the quality and contracting processes Further analysis of provider based quality information: As part of its ongoing work to develop new commissioning arrangements the PCT should work with providers to develop and improve the level of analysis of complaints, PALS contacts and other quality measures so that trends and themes can be identified more easily Analysis of quality indicators for individual clinicians: Consideration should be given to how the PCT should be informed of the frequency of incidents or concerns in relation to an individual clinician Reporting of serious concerns: The PCT should agree with its providers the indicators which should prompt a report to the PCT. The criteria agreed will need to acknowledge the respective roles and responsibilities of providers and commissioners, and add value to the quality assurance processes Clinical input to commissioning: The PCT should ensure that the commissioning and clinical input under the new arrangements is adequate for all services, and that the requirement for consistent clinical attendance at the meetings with providers is made clear in the Terms of Reference Service or specialty deep dives: The PCT may wish to consider how it can create an opportunity for those involved in commissioning acute services to work with RCHT to achieve a better understanding of the services, their challenges and their aspirations. This might be done as part of a rolling programme, or in response to alerts from the performance management processes Administrative systems: The PCT should ensure it has sound systems for briefing and handover within the commissioning team, and that efforts are made to minimise the loss of organisational memory when changes take place within provider teams. Better use of action logs for the liaison meetings should assist in highlighting where there are delays in completing actions Liaison across other NHS and private sector providers: The PCT should ensure that the arrangements for liaison with other NHS providers and with the private sector are clarified and strengthened Organisational learning: The CCG may wish to use the learning from the events covered by this review to test reporting and escalation processes within the new commissioning structure

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Appendix 3 Recommendations from the Rapid Response Review I. Gynaecology

Immediate: Privacy and Dignity issues; 1. Improve privacy and dignity in day room and facilities for breaking bad news on Tolgus. 2. Review privacy and dignity across Tolgus ward including the examination room. 3. Undertake immediate review of mixed sex accommodation compliance on Tolgus ward. 4. Review facilities in EPU for breaking bad news. Within 3 months: Clinical Quality; 5. Review Datix database in Gynaecology and compile reports linking individual consultant clinical activity with clinical outcomes and complication rates to be reported three-monthly to the Divisional Governance Board and further up through the Governance structures of the Trust where appropriate. 6. Evaluate through national linked audit the benign laparoscopic service against the principles as outlined by RCOG, BSUG (British Society for Uro-Gynaecology) and MHRA. Within 6 months: Clinical Quality and service provision; 7. Meet with Commissioners to resolve the future funding stream of the currently unfunded areas of the laparoscopic surgery service. 8. Review the balance of work across the benign gynaecology services to reflect the needs of the District General Hospital and Commissioners. 9. Reduce the bed base to accommodate Gynae and Urology patients only and seek an alternative solution for flexi beds. Review the potential to change the case mix on the ward to achieve single sex accommodation. 10. Review the two-year Capital programme and develop a solution for a single-sex Gynaecology ward of 15-20 beds (which could be part of a female surgical ward). 11. Review and make plans to improve the environment at Penrice. II. Obstetrics

Immediate: adequate staffing levels: 1. Review processes for accessing extra staff when there are peaks in activity ensuring such systems are compliant with the Working Time Directive across the service. 2. Review the current process for authorising recruitment of substantive midwifery posts with the aim of reducing delays. Urgent (within 1 month): Staffing levels: 3. Ensure that the agreed staffing establishment is available to provide patient care over a 24 hour 7 day period. Cultural issues: 4. Commence review of management styles and leadership approaches to ensure that the skills and knowledge of clinical staff are harnessed to improve and develop the service. 10

Clinical quality and service provision: 5. To commence an active engagement programme with all levels of Wom ens Health care staff to harness their expertise and commitment, to meet organisational objectives. Within Three months: Service provision: 6. Review the elective LSCS pathway to improve workflows and patient experience. Within Six months: Clinical quality and service provision: 7. To consider how organisational systems can best support cross-departmental working 8. Undertake a review of transfer rates during labour from the Penrice and Helston units to the main unit at RCHT to ensure that staff are maintaining sufficient levels of expertise and confidence and feel appropriately supported. 9. Conduct an audit of the postnatal pathway in the community to ensure it is safe. III. Obstetrics and Gynaecology:

9. Produce a quarterly audit of clinical complication rates (including denominator data) in Obstetrics and Gynaecology to be reported to the Senior Management Team and the Board of the Trust. This will require analytical support and for Obstetrics, may require the procurement of additional IT systems in the Division. 10. Review levels of medical staffing at all grades, to ensure there will be adequate cover in the service of the future in the expectation of fewer trainees and the need for seven day working by Consultants

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Royal Cornwall Hospitals NHS Trust


Organisational Learning Review
Julie Acred OBE
2nd January 2013

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Table of Contents Executive Summary ................................................................................................... 3 1. ....................................................................................................................................... Introduction ................................................................................................................ 5 2. ....................................................................................................................................... Retrospective review for the period 1992 to 2012 ..................................................... 6 Summary of events 1992 to 2006 .............................................................................. 6 Summary of events 2007 to May 2008 ....................................................................... 8 Summary of events June 2008 to March 2009 ......................................................... 11 Summary of events April 2009 to October 2011 ....................................................... 12 Summary of events October 2011 to September 2012............................................. 16 3. ....................................................................................................................................... Themes Emerging from the review .......................................................................... 18 4. ....................................................................................................................................... Conclusions and Recommendations ........................................................................ 25 Appendix A Terms of Reference .............................................................................. 29 Appendix B List of interviewees ............................................................................... 30 Appendix C Reviews and investigations 1992 to 2012 ............................................. 31 Appendix D Relevant Policies and Procedures ........................................................ 32 Appendix E Abbreviations and terms used in the report ........................................... 33

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Executive Summary

The Royal Cornwall Hospitals NHS Trust commissioned this Independent Organisational Learning Review on 29 October 2012. The purpose of the review is to identify learning from the way in which the Trust and the Obstetrics and Gynaecology specialty had responded to repeated concerns raised by staff and a succession of investigations over a number of years. The conclusion from this review is that at various stages over this period the Trusts response to the concerns expressed has been less than adequate. The shortfalls identified fall into a number of categories. The early reviews (1997 to 2001) concluded that there was no evidence of incompetence. The value of these investigations was limited by a lack of meaningful data to compare the practice of individual clinicians. The paperwork available does not confirm that the required action was taken. The Investigation undertaken in 2007/8 did identify serious concerns about practice, but the subsequent action taken did not adequately address the issues identified. Advice was given by the National Clinical Assessment Service, but elements of the advice were not followed. The Medical Director at the time sought further information and reassurance in respect of issues raised in the report, and was persuaded that appropriate action had been taken to address any deficiencies in knowledge and skills. By early 2010 a number of concerns were being raised by the then well established risk systems in Obstetrics and Gynaecology, including the Serious Untoward Incident in January 2010. There was more information available to support concerns about RJs practice than in any previous period, but it took some time for the seriousness of those concerns to be properly assessed. The evident confusion about who should be taking action added to the delay in making a formal assessment of the possible risks to patients. Many of those involved in more recent years were committed to addressing the concerns they had identified, but the lack of clarity on roles and process, and the failures in communication and sharing of meaningful information made this extremely difficult for those involved. Formal action did commence in October 2011, and was broadly managed in accordance with relevant policies. There was a considerable delay before the Trust received the RCOG report in May 2012, but this was not as a result of any action or lack of action by the Trust. The review has identified a number of weaknesses which need to be addressed by the Trust to ensure that its systems and processes for managing concerns regarding clinical practice are more effective. These include:

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Board level governance arrangements Specialty based risk and governance arrangements Risk escalation processes Clinical Audit Trust policies and procedures Roles and responsibilities Performance management arrangements Development of the specialty team Appraisal, including arrangements for medical appraisal, and Liaison with other providers The Trust has demonstrated that action is already being taken to address the weaknesses identified, and the recommendations made in this report will reinforce and support this work. Many of the staff interviewed have shown a real commitment to providing high quality services to patients. The current situation, though unfortunate from everyones perspective, is an opportunity to rebuild, and to bring about improvements which will make a real difference to patient care.

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1. Introduction 1.1. Reasons for the Review 1.1.1. The Royal Cornwall Hospitals NHS Trust (RCH) has identified that repeated concerns were raised concerning an Obstetrics and Gynaecology (O&G) Consultant (RJ) over a number of years. Several reviews and investigations regarding this consultant and the O&G service more generally were also undertaken over this period. This review had been commissioned by the Trust Board to identify the learning from these events. The findings of the review will be used to improve the responsiveness of the organisation and enhance a positive safety culture that protects patients and listens to staff. A copy of the agreed terms of reference is attached at Appendix A

1.1.2.

1.2. Methodology 1.2.1. The information required for this review has been collected from 34 interviews, correspondence (letters and emails), previous reviews and a number of other Trust documents including policies, Terms of Reference for various Trust Committees, Committee minutes and structure charts. A list of those interviewed is attached at Appendix B.

1.3. Context 1.3.1. This report covers a significant period of time, and it should be recognised that there have been considerable changes in many aspects of healthcare delivery over this period. The availability of data has increased substantially over the years, as has the ability to compare local performance with national standards. Clinical audit, risk management and learning from untoward events have become a more routine part of professional activities. The support for doctors, and expectations regarding their professional standards and ongoing development have developed and improved. The introduction of revalidation, and the framework provided by the Maintaining High Professional Standards policy agreed in 2006 provides clearer expectations and processes than existed in the early years covered by the review. There have been changes in culture across the NHS over the period. The views of patients have become a more important part of the evaluation of services, and NHS organisations have become more open and more accountable. The NHS has taken significant steps to develop a culture which supports greater openness and transparency in respect of service quality. The level of support for Trusts in dealing with concerns about the performance of medical staff has been significantly increased. The creation of the National Clinical Assessment Service (NCAS), as part of the National Patient Safety Agency has created a more structured approach to the action taken by Trusts in these cases. It should also be recognised that these cases are difficult. Senior clinicians in any Trust will have their own unique range of skills and experience; they may have a 5

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different mix of patients from their colleagues. These factors can and do create challenges for any organisation in identifying and dealing with inadequate clinical practice. 2. Retrospective review for the period 1992 to 2012 2.1. Introduction 2.1.1. Based on the information provided there have been a total of eleven reviews which are relevant to the O&G Department, with eight of these being directly concerned with RJs practice. A list of the eleven reviews is attached at Appendix C. This section provides a summary and appraisal of these reviews, and an overview of relevant correspondence which continued between the reviews so that the full picture of activity can be understood. This section is divided into time periods which highlight the key developments over the whole period.

2.1.2.

Summary of events 1992 2006

2.2. September 1997 - File note regarding clinical concerns 2.2.1. RJ was appointed in 1992, and the first reference to concerns about his practice is made in a file note by the then Medical Director. It refers to cases highlighted by an O&G consultant colleague in relation to patients operated on at the Duchy Hospital. In the file note there is reference to a third party who was already undertaking an investigation as a result of comments received. There is no documentation available to evidence that this investigation was undertaken. This is not one of the reviews included in the list provided by RCH, and it is not clear whether any review of cases did in fact take place. The file note indicates that a list of claims settled and outstanding for all O&G consultants was reviewed, and that although RJ had a higher number of claims, the claims related to obstetric cases, and were not related to the specific concerns raised by the cases at the Duchy.

2.2.2.

2.3. 9 June 1998 - File note regarding clinical concerns 2.3.1. A second file note was made by the Medical Director on this date, referring to concerns expressed by the same colleague in respect of the number of urological complications experienced by patients of RJ. The Medical Director notes that he requested a review of all cases with this complication over the last two years. The file note states that the review found that this complication was not confined to one surgeon, and is associated with a number of patient features. The review document itself was not available.

2.4. August 2000 - Concerns regarding urological complications 2.4.1. In August 2000 the same O&G consultant wrote to the Medical Director regarding two patients who had received injuries during elective surgery. In this letter the consultant states that he has been advised that there was an investigation three years previously, and that the findings and recommendations were never presented to the O&G Directorate. 6

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2.4.2.

Further correspondence referring to these two cases was not available.

2.5. Early 2001 - Complaint raised by a nurse 2.5.1. The paperwork relevant to this complaint consists of a file note by the Medical Director dated 21 February 2001, a Summary and Assessment of Complaints relating to 15 cases undertaken (unsigned and undated), and a letter from RJ (dated 7 February 2001) which again refers to 15 cases highlighted by a member of the nursing team. The Summary and Assessment of Complaints examines the treatment of a number of patients between the dates of June 1998 and November 2000.The conclusion of the review is that the author does not believe that RJ has behaved in an appropriate manner, and notes that RJ always had the patients best interest at heart. It goes on to say it is impossible to judge whether RJs complication rate is higher or lower than anyone elses without reviewing all procedures done by his colleagues, and comparing the complication rate for each of them. The report suggests this would be a mammoth task. The report states there is no evidence of incompetence, although there is an interesting comment in an addendum relating to 3 additional patients. This states that none of the patients show any serious errors of judgment individually... However since I started using routine suprapubis catheterisation I have had much less problem with catheterisation problems. This suggests that a change in RJs practice may have a similar positive impact on catheterisation problems, but there is nothing in the paperwork to indicate that this was followed up. The Medical Directors file note on this particular review states that as a result of concerns raised there would be a full documented audit of all gynaecology cases, with particular reference to complication rates, and there would be a full nursing review of the Ward. There is no evidence to suggest these actions were completed.

2.5.2.

2.5.3.

2.5.4.

2.6. 15 August 2005 - Letter from outgoing Medical Director to New MD 2.6.1. This letter was sent some years after the last reported concerns in 2001. There are no documents relating to the cases, although there is reference to cases from 2005 in a later letter. The letter, from the outgoing Medical Director to the new Medical Director refers to three separate cases in gynaecology which raise some concern. The letter states there needs to be a real push to establish some meaningful audit within the directorate.....As a bare minimum they need to record and audit any gynaecological surgical complications. It goes on to suggest that complications should be discussed at regular audit meetings, and that compliance with the protocol introduced five years before should be audited. The letter does suggest there may be a culture developing within the specialty which does not encourage open learning from difficult cases. The Medical Director at the time has clarified that following the concerns raised in 2000 he introduced a protocol which required that where there were issues with the ureter or the bladder, a urologist should be contacted. While he could not remember the details, he felt sure he would have followed up on the required actions.

2.6.2.

2.6.3.

APPEENDIX 4

2.7. Overview of period 1992 to 2006 2.7.1. It is difficult to draw any conclusions from the early incidents and reviews given the limited amount of information and the unavailability of many of the people in post at this time. Concerns about RJs care to patients, and in particular his post operative complications, were raised several times during the early part of this period, as were concerns about the lack of audit. Although not all the relevant correspondence is available, it is clear that there was a response to the concerns raised. Surgical complications in gynaecology and claims were examined, although no specific concerns about RJ were identified from these. Steps were taken to address concerns about urological complications with the introduction of a new protocol, which it was later suggested should be audited. All of these actions are reasonable. It is likely that the early case reviews were limited by the lack of data which would have provided a clearer picture of trends and specific areas of concern. There is no firm evidence of further complaints in this period beyond 2001, but the letter in 2005 indicates that the specialty is not yet in a position to demonstrate it is auditing its outcomes in a meaningful way.

2.7.2.

2.7.3.

Summary of events 2007 to May 2008

2.8. March 2007 - Management of High Grade Cervical Abnormality 2.8.1. Three separate clinical issues were raised in March 2007. The first concerned RJs management of patients with high-grade cervical cytology abnormalities. A fellow consultant wrote to RJ asking for an urgent review of a number of cases who had colposcopic examination under RJs care between xx. In his letter the consultant suggests that their lack of biopsy treatment was not in line with national, regional or local guidelines. This letter was copied to the Clinical Director (CD) of Obstetrics and Gynaecology (O&G). RJ did reply to this letter on the 19 March 2007, offering his interpretation of the relevant guidelines, and advising that he had arranged to see the women again, and would counsel them about his planned treatment. The South and West Regional Cervical Screening Quality Assurance Reference Centre (QARC) became involved from late March, with written advice provided to the Trust in April 2007. This advice stated that All cases, as reviewed, fail to reach the standard of care expected for patients seen within the NHSCSP system. The initial report from QARC is dated 30 April 2007, and outlines the progress made and the further action required. A further seven patients potentially at risk have been identified by this point, and the report documents both the action taken to review these cases, and various other actions required of the Trust. In July 2007 RJ was appointed as colposcopy lead for the department. The CD at the time has explained that RJ was the only candidate for this role.

2.8.2.

2.8.3.

2.8.4.

2.8.5.

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2.9. March 2007 - Two Week Post Menopausal Bleeding (PMB) Clinic 2.9.1. The second issue raised in March 2007 concerned the management of six patients seen in a PMB Clinic on xx 2007 by RJ. A colleague wrote to RJ outlining his concerns regarding the patients management, and RJs failure to investigate according to protocols. The letter gave details of the treatment proposed or given in each case, and commented on the appropriateness of those decisions. This letter was copied to the CD of O&G. The CD replied to this letter, saying that he had discussed the issues with RJ, and that RJ had agreed that the management of the patients was not as it should have been. He also noted that since the member of staff who had first expressed the concerns had filed a Datix (risk) report, the issue would also be reviewed through the gynaecology risk management process. March 2007 - General concerns about Clinical Governance

2.9.2.

2.10.

2.10.1. In March 2007 the consultant who had raised concerns throughout this period wrote to the MD. The letter summarised previous issues and reviews, including cases from 2005/6. The MD responded in early April, requesting evidence that the rate of complications for RJ was greater what would be expected in a comparative service. 2.10.2. The consultant replied in August 2007, outlining the Royal College of Obstetricians and Gynaecologists (RCOG) guidance in relation to injury to the bladder or ureter. In addition he raised new cases which had concerned him or other staff. He wrote again later that month regarding a new case, and in September requesting an update on action being taken. 2.11. January 2008 - Report of Initial Investigation Panel

2.11.1. The MD requested advice from the National Clinical Assessment Service in September 2007. The NCAS summary states There appears to be a long history of problems with the doctor in that a previous investigation confirmed skill deficiencies following which the doctor underwent further training. 2.11.2. It should be noted that there is no reference to further training in any of the documentation received, or in any of the interviews. 2.11.3. The NCAS advice summary indicates that they considered the process the MD had set up to be appropriate, but highlighted the need for the investigator to interview other doctors, theatre staff, nurses and theatre technicians and anaesthetists who may have noted the frequency of problems. NCAS also suggest it would be appropriate to look at complication rates across the doctors practice, return to theatre rates and complaints. The comparison should be within the group of surgeons and against national standards. 2.11.4. The NCAS letter queries whether the Trust consider the allegations are sufficiently serious, taken in the context of previous problems, for the doctors practice to be restricted, at least during the period of the investigation. The MD at the time has confirmed that he felt he had no sound reason to restrict RJs practice at this point. 2.11.5. The subsequent investigation process was carried out in accordance with Trusts policy on Maintaining High Professional Standards (MHPS). RJ was advised of the progress of the investigation and there are further case summary letters from

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NCAS in October and December, noting the progress made with the investigation. 2.11.6. The report of the Investigation Panel is dated January 2008. The Panel of four clinicians undertook their review by examining the notes of 45 identified patients going back to 2007, along with various documents including national guidance, published papers and some local guidelines. There is no reference in the report to interviews with other staff or the other areas of investigation recommended by NCAS. 2.11.7. During interview the MD was unable to remember the precise details, but felt that the omission of these areas of the review may have been because the Terms of Reference had already been signed off by the time NCAS provided their advice. I have been unable to find any paperwork to confirm the date that the Investigation was initiated. 2.11.8. The Investigation required the Panel to look at all areas of concern, including the 2 week PMB clinic, colposcopy and gynaecology surgery complications and a number of specific complaints. The review did not look at the areas already dealt with (the PMB clinic where the CD had already spoken to RJ, and the colposcopy issue where QARC had already reported). 2.11.9. For the remainder of the specific patient complaints, which were reviewed in detail, the panel found a number of areas of concern; a lack of appropriate care, significant surgical incompetence, the patient was not effectively counselled. Overall the Panel concluded that there are significant concerns that require resolution. 2.11.10. The Trust has provided an undated and unsigned document which is believed to be RJs response to the report of the Panel. It goes into some detail, outlining relevant guidance and his interpretation of it, 2.11.11. The MD met with RJ in March 2008 to discuss the Panels report, and wrote to RJ to confirm the conclusions of the meeting. It is clear from the letter that the MD had spent some considerable time familiarising himself with the details of the review and the issues raised by the Panels report. At this meeting the cases were discussed in some detail, and it would appear that the MD was persuaded by many of RJs arguments. 2.11.12. The MD writes in his letter to RJ: I was impressed with your response. You came across as a caring reflective clinician. You presented cogent arguments for the clinical decisions that you had taken. You presented information on the remedial actions you had initiated on your own volition to address the issues you had identified with your own practice. The letter goes on to say I confirm that I am not continuing with a formal procedure, but will require evidence to support some of the information that you have provided in response to the investigation. 2.11.13. The additional evidence required in relation to RJs practice is clearly set out in an Appendix to the letter, a total of six items. Reassurance on one of these items was provided by another individual, with some additional input from RJ on some points. The MD wrote to the O&G CD on 12 March seeking urgent reassurance on the remaining five items, and received a reply on 24 April 2008. 2.11.14. This reply does provide answers to the questions posed, but does not adequately address at least one of the concerns. The MD asked the CD to confirm that the PMB clinic management was appropriate and was advised that The management of the patients who attended the PMB clinichas been completed 10

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and is appropriate. The MD wrote to RJ on 30 May 2008, referring to the evidence provided by RJ, the CD and the third party, and advising that the issue is concluded and closed. 2.11.15. At interview the MD reflected on his decision in this case. He felt at that time he needed to make a judgement between the views of the consultant raising the concerns, the findings in the report and RJs response. He found RJ to be charming and caring, and suggested that he may not have been told what others knew. 2.12. Overview of period 2007 to May 2008

2.12.1. A number of separate areas of concern were highlighted during this period. The MD did act in accordance with the agreed MHPS procedure in place at the time, and took advice from NCAS. It was unfortunate that the recommendations made by NCAS in relation to the scope of the review were not included as this may have identified a clearer picture of RJs practice. 2.12.2. There is no evidence that this issue was reported to the Board, and there appears to have been no specific feedback to those involved or structured learning from the cases. The serious concerns identified in the report were resolved based on discussion and only a limited amount of action. This approach does not seem sufficiently robust, particularly as the MD did not have expert knowledge of the specialty. 2.12.3. Based on several other comments made during the interviews it is clear that RJ could be both charming and disarming when challenged about his practice, giving a clear impression that he understood the criticisms and the need to change. These interpersonal considerations played a large part in the MDs decision not to take further action.

Summary of events June 2008 to March 2009

2.13.

Ongoing correspondence regarding colposcopy issues

2.13.1. Following a QA visit by QARC in December 2008, a member of the Assurance Team wrote to the MD outlining the issues of concern identified at the visit. These included the conclusion of the required action in respect of the patients identified in the investigation in April 2007, and completion of the prospective audit for RJ which had still not been done in accordance with the previous agreement. 2.13.2. The letter also expresses concern at the appointment of RJ as lead colposcopist, which is described as inappropriate, even though there were no other candidates. The letter makes clear that the new lead colposcopist was not provided with the details of the investigation, audit and outcomes prior to the QA visit. The MD wrote to RJ on 10 December 2008, after the visit but before receipt of the letter, outlining the requirements of QARC. 2.13.3. It did take some time for the requested information to be supplied, but more recent correspondence from QARC confirms that all the documentation from the audit was subsequently supplied to them, and that all cases have now been identified and managed appropriately. 11

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2.14.

Overview of period June 2008 to March 2009

2.14.1. There were no new complaints raised formally during this period. The colposcopy issues first identified in March 2007 had not been satisfactorily resolved until QARC raised the outstanding issues after their visit in December 2008. 2.14.2. Based on information provided at interview it would appear that there were concerns at operational level, but these were not escalated.

Summary of events April 2009 to 12 October 2011

2.15.

January 2010 - Serious Untoward incident (SUI)

2.15.1. A SUI was declared in January, relating to RJs treatment of a woman xx. This incident was referred to the MD for consideration as a possible SUI. 2.15.2. The subsequent actions appear to have been established in accordance with the Trusts SUI policy. The notes of the meeting held in January 2010 show that RJ gave some explanation for his decision to send the woman home, and admitted that he is open to criticism for this decision. RJ agreed to voluntarily withdraw from obstetric practice during the period of the investigation. 2.15.3. The SUI Panel was set up, and in line with Trust policy a consultant from another specialty was asked to lead it. 2.15.4. The SUI investigation appears to have acted as a catalyst for other areas of concern to be highlighted. There are several items of correspondence between members of the risk management teams, the Divisional Director (DD) and the MD over the following weeks. Various cases were raised but there is a suggestion that the evidence is scanty, and that there have been no cases involving RJs practice where external opinion has deemed his practice indefensible. 2.15.5. It is clear that no one individual had a complete set of information regarding the recent and historical cases during this period, and that information was being found in various files. One important letter sent to the MD in February 2010 which outlined concerns raised by the risk management teams, was not responded to. 2.15.6. The final SUI report is undated, but was issued sometime before 26 February 2010. The incident description refers to xx.only made after the SUI process had been initiated. 2.15.7. The report outlines a number of care and service delivery problems, including not allowing for the full risk of risk factors at initial booking, but is not clear from the report who these concerns relate to. The report also makes reference to contributory factors including Very busy Day Assessment Unit leading to a consultant review without midwife, may have prevented general concerns being voiced, and Medical-midwife hierarchy may have prevented staff questioning the plan of care. 2.15.8. It has been suggested in several interviews that the midwives would try to accompany RJ on his ward rounds to pick up any issues, and in this case RJ had seen the patient without a midwife present. 12

APPEENDIX 4

2.15.9. The SUI Report identified the root causes of the incident as xx, and suggested that concerns about possible xx had blinkered staff to other causes. This is certainly true in terms of explaining the eventual outcome, but does not address the concerns about RJs initial treatment of the woman, or the issues raised about the relationships and processes within the Obstetrics service. 2.15.10. The SUI action plan was completed, but there appears to be insufficient action identified to address some of the more challenging concerns, particularly those relating to the midwifery/consultant hierarchy. 2.15.11. A SUI Review meeting was held on 26 February 2010. The notes of this meeting record that the MD accepts RJs comment that there may have been an error of judgement, but does not agree that there are concerns over his obstetric practice. It is agreed at this meeting that RJ can return immediately to his obstetric practice. 2.16. June 2010 - External Review of benign gynaecology services

2.16.1. The MD has explained that when he took up his substantive MD post in December 2009 he did have concerns about the gynaecology service. There were issues with capacity as well as some clinical concerns. The Terms of Reference for the review were wide ranging, and covered capacity and workforce issues. The final element of the Terms of Reference, to highlight if there are appropriate governance processes in place for the services, was added as a result of the MDs concerns regarding quality and outcomes. 2.16.2. The report was received in June 2010 and provides a range of recommendations. Those relating to clinical governance include a recommendation to review surgical incidents with the surgical teams to ensure there is no recurring pattern; to provide support to ensure a clearer process for the escalation of risk issues; continuation of the work to log and monitor complication rates; and work to define how risks are escalated so that the Trust Board have reassurance regarding quality and safety of services. 2.16.3. The Trust has advised that follow up action would have been taken through the Specialty Governance meeting, but information has not been provided to demonstrate the changes made in response to these recommendations. 2.17. July 2010 onwards - Continuing concerns in gynaecology and obstetrics

2.17.1. It is clear that there remained a high level of concern regarding the practice of RJ after the SUI report had been dealt with and the Review of Benign Gynaecology Surgery had been received. Various separate clinical issues were raised and members of the risk team and the DD considered and agreed various actions to progress the matter. 2.17.2. The DD met with RJ in October 2010 to discuss three specific cases, and was persuaded by RJs arguments that the treatment given was acceptable. This conclusion was confirmed to those involved in an email which stated that RJ expressed clear evidence of reflective learning and intentions to work to improve the issues raised. 2.18. November 2010 - Concerns regarding on call rota

2.18.1. In November 2010 an opportunity arose for one of the consultants to come off the obstetrics rota, and this was offered to all those on the rota. Correspondence

13

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from this time shows that some colleagues felt that RJ should be removed from the rota. 2.18.2. The subsequent correspondence clearly shows that there was no consistent picture of RJs practice at this time, despite the considerable work carried out to collect the required information. Some members of staff felt that those in more senior positions were aware of the concerns and were dealing with them, while those in more senior positions were seemingly unaware of the seriousness of the concerns. 2.18.3. The correspondence continued through to late November when the Specialty Director (SD) asked the MD for support as he did not have the clinical expertise to judge the validity of the claims. The SD at that time was a consultant from outside the specialty, as there had been no applicants from within it. 2.19. March 2011 - Colposcopy issues

2.19.1. In March 2011 one of the O&G consultants wrote to QARC saying that he had discussed with RJ some concerns he had about RJs practice. The letter advised that the option of RJ continuing colposcopy with ongoing audit of his practice for six months had been discussed, but that RJ had decided to stop doing colposcopy. 2.20. Events of the xx 2011

2.20.1. In late March a statement was prepared by a member of the medical staff describing a sequence of events over the weekend of xx. The report outlines concerns about the care of several patients on Labour Ward, and the lack of support given. It also refers to previous cases where the care given by RJ was significantly different from that of other consultants. 2.20.2. The matter was dealt with through informal discussion with a peer, with no formal documentation created to support this action. 2.21. July 2011 - Investigation following anonymous letter

2.21.1. An anonymous letter was sent to the Prime Minister in June 2011, and the Trust commissioned an external review of the elements highlighted in the letter. The points raised covered general concerns about the way the Trust was managed, and a number of more specific issues including safety and quality reporting, and care on one of the wards. The review team conducted a number of interviews with staff and reviewed a wide range of data supplied to them. 2.21.2. The Report did address issues in O&G in relation to care on the ward referenced in the letter. This ward had been moved as part of a wider plan to achieve single sex requirements. The Report notes that the changes were vigorously opposed by the gynaecologists, and concluded that the set of moves was significantly compromised by an absence of appropriate planning, consultation and buy in. 2.21.3. The Trust Secretary has confirmed that the plan was considered by the Board in September 2011, where it was agreed that the action plan should be monitored by the Governance Committee, with quarterly reports to the Board. These requirements were broadly, if not precisely met. 2.22. August 2011 onwards - Continuing concerns re RJ performance

14

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2.22.1. There were several new concerns raised from August through to early September. Several people were involved in collating the information already available, and these concerns were escalated to the MD. The Divisional Manager became involved at this time, and expressed his concerns about patient safety. 2.22.2. The information collected included a summary of all issues found in the files within the Directorate and cases entered on the Datix system; a total of twenty cases occurring between June 2009 and September 2011. On 10 October one of the risk team contacted the Chief Executive. 2.23. Overview of period April 2009 to 12 October 2011

2.23.1. The activity during this period clearly demonstrates that clinical issues were being highlighted through the specialty risk systems. There is no evidence of a clear plan to deal with these, and no effective mechanism to collect all available information. 2.23.2. Several people were involved in the case over this period, with email correspondence between various individuals from January 2010 to October 2011. There is evidence of involvement of the MD, DD, SD for gynaecology, the risk leads and support staff for gynaecology and obstetrics, the Divisional Manager and at least two other consultants. The MHPS Policy requires that the immediate line manager of the clinician should deal with minor misconduct or performance, and that serious concerns should be registered with the Chief Executive so that a Case Manager can be appointed. There is no evidence that a lead was nominated to deal with this case over this period. 2.23.3. Some of those, particularly the more recently appointed consultants in lead risk roles, were taking meaningful steps to raise these issues, and should have been better supported. 2.23.4. Many of those in key roles were relatively inexperienced. The MD had considerable experience in various aspects of medical management, but did not have a great deal of operational experience which would have prepared him for these events. The Specialty Director for Gynaecology was experienced in operational management, but lacked the detailed clinical knowledge of the specialty. The two consultants appointed to the lead risk roles were relatively new in post, and had only limited experience to prepare them for a challenge of this nature. 2.23.5. There was a considerable amount of information gathered over this period. The various cuts of this data, and the numerous lists produced (some of them with undated cases) did not help provide a clear picture of the nature of the concerns, particularly in the early stages. There was no reference back to the cases which occurred before this period, which would have helped highlight the long standing nature of the concerns. 2.23.6. The staff involved with this case all had job descriptions which outline their roles and responsibilities, and there are several relevant policies which describe what should be done. In spite of this there seems to be no clear process being followed. It would appear that a key piece of correspondence in February 2010 which may have helped prompt a more comprehensive assessment of the concerns raised, was either not seen, or not acted upon. 2.23.7. There is no evidence that the Trust Board were briefed at this stage. The Chief Executive in post up to August 2011 recalls discussing the Benign Gynaecology 15

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Review and the SUI with the MD, but was not aware that more general concerns were expressed in writing in February 2010.

Summary of events 13 October 2011 to September 2012

2.24.

October 2011 - Commencement of action under MHPS

2.24.1. The MD took advice from NCAS, and on 13 October 2011 wrote to RJ advising that he had been asked to investigate a number of incidents relating to professional conduct and capability, and asking RJ to attend a meeting on 18 October. The notes of the meeting and the subsequent letter to RJ confirm that RJ was required to restrict his practice to outpatient activity work only. RJ was also notified that in accordance with the procedures set out in MHPS, a Non Executive Director (NED) would be appointed to oversee the process. 2.24.2. The process of liaison with RJ was managed appropriately. Fortnightly meetings were set up, and the outcome of these was notified to RJ in writing. NCAS were kept up to date, and the discussions confirmed in writing. A NED was appointed by the Chairman in line with the MHPS requirements, and this was notified to RJ. RJ advised that he had met the nominated NED, and an alternative was put forward. RJ met with the nominated NED on 20 December. 2.24.3. The referral to RCOG for a review of the case was made in late October, and the Trust was advised that the review may take 6 to 8 weeks. RCOG also advised that the conduct issues should be addressed locally. 2.25. October/November 2011 - Issues regarding restricted clinical practice

2.25.1. As noted above the decision made at the time was to restrict RJs practice to outpatient work only rather than exclude from clinical work, and this was notified to those involved. Concerns were subsequently expressed about the potential risk to patients because of the unsupervised nature of outpatient work. In his response the MD indicated that he had been strongly advised by NCAS not to exclude from all work. 2.25.2. An incident occurred on 24 October when RJ visited the ward to treat a patient. This issue was addressed at the next review meeting with RJ, and notified to NCAS. RJ described his action as inadvertent, but there were continuing concerns expressed at the difficulty RJ faced in drawing boundaries between his outpatient and ward work. 2.25.3. In November 2011 the MD received a letter which raised concerns about a patient seen by RJ at his clinic in St Austell. This letter raises further questions about RJs fitness to practice in an outpatient setting at that time. 2.26. December 2011 - Cervical Cancer audit

2.26.1. The QARC carried out a QA visit on 8 December 2011, and wrote to the MD about the sudden increase in the number of cases of cervical cancer diagnosed in Truro during the period 1 April to 31 March 2011. The letter indicates that around double the normal number of cases were identified.

16

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2.26.2. Later correspondence from QARC confirms that RCH completed the audits required, and that none of the women in this cohort had previous mismanagement at colposcopy or in gynaecology. The correspondence suggests that the identified spike in incidence probably represents normal statistical variation. 2.27. January 2012 - Investigation into alleged conduct issues

2.27.1. In line with the advice from NCAS, the concerns about professional conduct were dealt with locally in line with Trust policy and policy and procedures. The report produced by the Committee appears to acknowledge that there are verifiable incidents, but states that these relate to disagreements on the most appropriate clinical management of obstetric patients, or the behaviour in question reflects a difference in interpretation of the responsibilities of a consultant 2.27.2. The subsequent letter to RJ from the MD, dated 20 February 2012, notified RJ that the matter would not progress to the RCH Disciplinary Policy and Procedures. 2.28. May 2012 - The RCOG Review Report

2.28.1. The RCOG review, initiated in October 2011 was received on 3 May 2012. The Terms of Reference were to review the clinical practice of RJ, and to make recommendations in relation to RJ. The reviewers considered a range of clinical cases which had been provided to them by the Trust. 2.28.2. The review team considered all of the cases in detail, and concluded that RJ could not return to his current position, and given the breadth of deficiencies and the length of time problems have been present re-training was not a realistic option. 2.28.3. The MD met with RJ on 10 May, and on 24 May RJ wrote to the MD acknowledging that retirement seemed the best option. This was confirmed in writing by RJ on 19 June 2012, with RJ leaving the Trusts employment in September 2012. 2.28.4. There does seem to have been some ongoing correspondence regarding RJs voluntary erasure from the GMC Register, but all outstanding issues were satisfactorily resolved by September 2012. 2.29. Overview of events 13 October 2011 to September 2012

2.29.1. The referral to NCAS and the subsequent review were broadly managed in accordance with the Trusts MHPS procedure. The nomination of a NED who knew RJ personally was unfortunate, although once this was identified another was put forward. The initial referral to NCAS was not made in accordance with the requirements of the MHPS policy which requires that the Chief Executive or MD make the referral. Review meetings were held regularly with RJ, and he was provided with other support as required. The Board was informed of the issues surrounding this case in September 2012. 2.29.2. The local process set up to deal with professional conduct issues was not sufficiently robust to address the concerns it considered. 2.29.3. The review requested from the RCOG took longer than expected to complete, and there is no doubt that this added to the anxiety of all concerned during this period. There is nothing to suggest that any action by the Trust contributed to the 17

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delay, although the RCOG team did comment on the difficulties they experienced in obtaining all the relevant information. 2.29.4. Based on all the relevant correspondence, the decision to allow RJ to continue to undertake clinical work in outpatients is questionable. Concerns about these arrangements were raised by clinical and managerial staff, and there is no reference to any explicit consideration of clinical risks associated with this decision. While NCAS will challenge any decision to exclude a doctor from practice, they will not seek to dissuade Trusts from taking these steps where patient safety concerns are present. 2.29.5. The fact that the calls to NCAS during this period seem to have been made by the Deputy Director of HR on many occasions will not have helped clarify and assess the respective interests of the doctor concerned or his patients. 3. Themes emerging from the Review 3.1. Introduction 3.1.1. The events described in the previous section cover a considerable period of time, and have involved a large number of people. Failures relating to individual reviews and the responses to the issues raised are described in the overview section at the end of each time period. There are a number of important lessons emerging from this chronological review which the Board should consider in some detail. The areas for future work are described in the remainder of this section.

3.1.2.

3.2. Board level governance arrangements 3.2.1. The Trust has made considerable progress in the development of its Governance arrangements over recent years. The Board provides positive leadership on safety and quality, with these items given priority on the Boards agenda, and quality objectives are clearly described in the Trusts strategy and plans. These developments have been extremely useful in engaging the Trust Board in the important aspects of quality and safety, and provide important leadership for the organisation. The Integrated Governance Framework has been in place since January 2011, and demonstrates a coordinated and comprehensive approach to quality and patient safety which will continue to develop over the coming years. The terms of reference for the Governance Committee are appropriate and recent minutes from the Committee which show how this work is managed in practice. There are clear links between the Board Assurance Framework (BAF) and the work of this Committee, with key risks from the BAF being allocated to the Governance Committee. The Board has overseen some impressive projects and initiatives to improve the quality of patient care. The MD is seen as providing effective leadership in this area, and the interim Nurse Executive and the Medical Director feel they work well together across the quality agenda. There are a large number of work streams and sub groups within the Governance Committee structure, which is unavoidable given the range of activities which must be covered under the four main headings (patient safety, clinical effectiveness, patient experience and staff experience). It is inevitable

3.2.2.

3.2.3.

3.2.4.

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that the reporting from these complex structures becomes an equally complex and bureaucratic process. 3.2.5. It is vital that the correct information and alerts are passed up through the reporting channels, and the Governance Committee should consider setting annual programmes of work for each sub group. It should also review membership so that the right people are present to deliver those programmes of work. The Governance Committee should ensure that the reports it receives contain a summary of all the key activities undertaken by the sub groups, and not just a list of highlights. These arrangements are already being developed, and will provide an important element of Board assurance in respect of the quality of care offered to patients. Throughout the period covered by this review there is no evidence to suggest that the Board have been briefed or involved with the concerns expressed. The Board cannot know everything, but it is entirely reasonable for the Board to take a view on which indicators and events should trigger a report to the Board or the Governance Committee. Where things go wrong, the Board will quite rightly be called to account for its actions, and must have the opportunity to challenge and be reassured where there are indications of serious concern. The Trust has advised that serious concerns are now reported so the Board is appropriately sighted on such matters. The RCH document Maintaining High Professional Standards in the Modern NHS makes a number of references to Board or NED involvement. In section 1.5 the policy states that all serious concerns must be registered with the Chief Executive and that the Chairman must designate a NED to oversee the case and ensure that momentum is maintained. There is a similar requirement in section 2.3 which deals with exclusion from work, where a single NED is responsible for monitoring the situation. There is no definition of serious concerns in this context. The Board should consider what prompts or indicators it would wish to see in place to ensure they are properly briefed on safety and quality concerns. The policy does quite rightly highlight the potential conflict between the need for the Board to satisfy itself that the procedures are being following, and the need to ensure that the NEDs are not compromised in terms of their possible role on future disciplinary or appeal panels, and the information provided should take account of this requirement. The Trust Board could receive assurances from external reviews and assessments in a more systematic way than they do at present. There are now many external accreditation and assessments in operation across the NHS. The Trust does record these centrally, but does not routinely monitor the completion of any actions required. Had the Board been advised that there were several items requiring further action arising from the colposcopy review in 2007, they could have ensured that they were completed more quickly.

3.2.6.

3.2.7.

3.2.8.

3.2.9.

3.2.10. It will take some time for the changes being made by the Board to have an impact, particularly on culture and attitudes. It is of concern that other staff groups were aware of possible concerns about RJs practice, and generally did not report it. Changing this culture will require real focus and effort on behalf of the Board.

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3.3. Governance arrangements within the specialty 3.3.1. As is the case for all hospitals and specialties, the clinical governance arrangements within the Division have developed over time. Data collection has improved, resources allocated to risk activities have been increased, national standards and guidelines have been developed, and new lead posts for various areas and aspects of service have been created. In some areas (such as cervical screening) there have been national arrangements put in place which have supported local activity. All of these developments have had a positive impact of the risk and quality activities within the service. As in the case in most hospitals, the work on obstetric risk was developed earlier than for gynaecology. The process in place for obstetrics was used to develop a common approach across the O&G service. The two risk leads have worked closely together which has been helpful to both. The information reviewed shows a structured approach to governance, with trigger lists used to determine which incidents should be reported, and a hierarchy of specialty based committees to address quality and safety issues. Many people have indicated their support for the good work being undertaken within the O&G department currently. There is an improved level of reporting of incidents and a clear process for reviewing individual incidents. Steps have been taken to expand governance activities within the Division, including the creation of a Morbidity and Mortality Committee which has improved the focus on outcomes. What is missing is a clear process for escalating concerns beyond the Directorate, as evidenced in the period April 2009 to mid October 2011. Some comments have been made about the level of resources available for the gynaecology risk function which the Trust may wish to review. In a number of interviews with those who have been involved with these activities it has been made clear that there has been some resistance to change within the specialty. Some have described inertia, a desire to carry on doing things in the same way, an unwillingness to embrace the principle of standardisation. There are also regular references to cases not being entered on the Datix system, of acceptance and work around in respect of some colleagues and of those with lead roles being challenged and undermined. The picture formed from the interviews is not a balanced one; there has not been much opportunity to focus on positive developments and improvements. Nevertheless it is of concern that a number of individuals seeking to deal with incidents or near misses, or take steps to improve the service have felt so unsupported by some members of the specialty team. Further information on the O&G team more generally is provided in section 3.8 below. There are several references to lack of attendance at risk and governance meetings in the specialty, although this may be due to clinical commitments. All clinicians have a duty to support appropriate governance activities, and there may be value in clarifying expectations of the clinicians, and ensuring that the relevant meetings take place at a time when the majority can attend. There have been many positive developments within the O&G service over the years. Many staff are proud of the service they provide and the improvements they have made, and hope that these events will not impact on the enthusiasm of the team, or hinder the continued development of the service.

3.3.2.

3.3.3.

3.3.4. 3.3.5.

3.3.6.

3.3.7.

3.3.8.

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APPEENDIX 4

3.4. Clinical Audit 3.4.1. Clinical Audit forms an important part of the Clinical Governance process, and has been a recurring theme throughout the period of time covered by this review. Many of the earlier reviews, and several items of correspondence, have highlighted the need for a clear understanding of the practice of RJ compared to his peers and with national standards. This issue has been discussed with many of those interviewed, and there is acceptance of the complication rates referenced at various points. Comparisons across individual clinicians is made more difficult when the number of complications is small and where the mix of patients seen by different consultants varies, but generally speaking the more data that is available, the more sense can be made of it. An analysis of surgical complications over time would have provided useful additional information at various stages over the period covered by this review. An audit of gynaecology surgery complications over the period July 2007 to June 2008 was undertaken by a member of the medical team. The audit concludes that the rate of post-operative complications is in line with data from other studies, but that the results are questionable due to sample size. Given this statement and the absence of data from earlier periods, It would appear that either that this was the first such audit to be completed, or that there is no arrangement for ongoing audit of surgery complications within the specialty. The Trusts Governance Committee is responsible for reviewing all aspects of clinical governance on behalf of the Board. In the minutes of the meeting held on 3 August 2012 there is reference to the fact that a number of audits have passed their deadline for completion, and that due to operational pressures within the hospital a number of clinical interest audits had lapsed. There is no record of any discussion or required action on this point. An internal audit report on Clinical Audit was published in September 2012. The report provides a set of sensible and useful recommendations which will improve the value of Clinical Audit within the Trust. Recommendation 4 which suggests a more explicit link with the Assurance Framework as part of the Clinical Audit Strategy, and Recommendation 6, which suggests that the Clinical Audit and Outcome Group should include a means for highlighting potential risks to be included in relevant risk registers are of particular relevance to the findings of this review. The Clinical Audit and Outcomes Group is relatively new, and there has been no such group historically. The Terms of Reference for the Clinical Audit and Outcomes Group indicates that there is no lead for Clinical Audit in the Trust, and the MD has advised that he is seeking to identify a clinical lead for this role. The Board should ensure that this activity is adequately resourced and prioritised.

3.4.2.

3.4.3.

3.4.4.

3.4.5.

3.4.6.

3.5. Trust Policies and Procedures 3.5.1. The policies in place at the time of some of the earlier reviews were not available, but those that are relevant from 2007 have been reviewed. These are listed at Appendix D. There are areas of overlap between the various policies which relate to serious incidents, investigations and raising concerns, although these are reasonably well cross referenced.

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APPEENDIX 4

3.5.2.

The exception to this is the MHPS which has no cross referencing with other policies. This policy is reasonably well laid out, although there are inevitably aspects which may require further analysis and amendment following this case. The MHPS policy has two specific requirements which do not seem to have been complied with. The first relates to training for staff and Board members. The policy states in section 4.10 that these training requirements should be agreed by the Board, and the Trust Secretary has confirmed that this was not done. The policy also states that the initial call to NCAS should be made by the Chief Executive or the Medical Director, and according to the NCAS letters I have seen many of the calls were made by the Deputy Director of Human Resources. The MD believed this to be the usual practice at the time. Many of the policies relevant to this review are very long, and anyone wishing to find out what steps need to be taken in respect of an investigation would be required to read a considerable amount of material. I believe the Trust could usefully review these policies with a view to streamlining and aligning them. The existing SUI Policy requires that the MD will identify who should act as Investigating Officer (IO) for the SUI, and that the IO should not work in the area where the incident occurred. This will ensure there is an independent perspective on the incident, but it does also mean that the IO may not have the necessary expertise to draw meaningful conclusions from the findings. The Trust has advised that this aspect of the policy is already under review.

3.5.3.

3.5.4.

3.5.5.

3.6. Roles and Responsibilities 3.6.1. There are several layers of clinical management, general management and governance arrangements, as would be expected in an organisation as large and complex as RCH. Many individuals, and many different systems and processes played a part in identifying and addressing the concerns raised in relation to RJs conduct and capability. Many of those interviewed were asked if they were clear about their roles at various points in the process, and most said they were. The events of the period April 2009 to October 2011 in particular would suggest that these roles were not clearly enough defined, and that the required actions were not clearly allocated to individuals. It is impossible to define precisely who should do what in every instance, but with good communication, appropriate sharing of information and regular review of progress, the right action should be taken on a timely basis. Inadequate communication has been a significant factor in this case. Many individuals believed they had expressed their concerns clearly, and had provided the necessary information to support their concerns. There was a considerable delay before all of the available information was brought together and considered as a whole. There has been a lack of effective handover at many stages of the process. Several people have taken up new posts without any knowledge of previous concerns. Files have been found, many documents within the files were not filed correctly, and other documents, particularly from the earlier years are missing. There needs to be a clear and standard approach to maintaining appropriate records on clinical concerns so that historical information is not lost. Many of the staff involved in this case have experienced considerable pressure as a result of the lack of information, training and practical support. These gaps 22

3.6.2.

3.6.3.

3.6.4.

3.6.5.

APPEENDIX 4

in knowledge and skill have undoubtedly impacted on the Trusts ability to effectively manage this case. 3.6.6. Any member of staff who may be required to participate in action regarding the performance of individual clinicians must receive appropriate support and training. NCAS do offer this service, but the Trust may wish to consider a range of possible solutions for this training need.

3.7. Performance Management 3.7.1. The Trusts performance management system is robust and covers all aspects of quality in the various performance measures. The material reviewed, including recent reports for the Women and Childrens (W&C) Division shows that performance is assessed across a wide range of measures, including risk management, patient feedback, hospital acquired infections and clinical supervision. Where gaps are identified these are highlighted for further action. Overall the process seems robust and balanced. Performance Management of other ad hoc action plans or individual actions is not always as robust. There are examples of actions included in the SUI action plan for example which are not clearly defined, and the same degree of discipline does not always extend to follow through. Where action plans are set up by the Board, there does seem to be a more formal process identified and followed, although reporting has not always been with the frequency originally agreed. It has proved more difficult to track progress made on plans which are delegated to Divisions, or overseen by an individual. Comments have been made about the number of separate action plans which may be in place at any one time, even for the same issue. This can add to the confusion which exists about who is doing what, and the Trust should engage in ongoing streamlining of additional plans and the assimilation of these into the mainstream performance management arrangements wherever possible.

3.7.2.

3.7.3.

3.8. The O&G Specialty Team 3.8.1. The O&G team has undergone a transformation which would be recognised by many specialties in hospitals across the country. At the start of the period covered by the review there were a small number of consultants, each of them undertaking a full range of O&G activities. Over time the team has grown, and there has been an increasing level of specialisation across the various elements of service. As the team has grown, many of the newer consultants have taken on the lead roles for specific areas of service, or for managing risk processes within obstetrics and gynaecology. The O&G specialty has not found this journey an easy one, and several people have described the difficulties they experienced working within the team. The team itself has been described as divided and dysfunctional. It is difficult to identify the cause of this behaviour at department level, but the more senior consultants with the knowledge and experience to support their newer colleagues could have done more to support the transition. It is not clear what the rest of the team felt about RJs clinical practice. Some of the consultants in the team had a clearly identified role in the risk management process, were aware of the concerns and did their best to make progress. RJs practice has been described to me as old fashioned, at the conservative end of the scale, and in need of updating. Several people have suggested that there was deterioration in RJs practice and behaviour in the later years. 23

3.8.2.

3.8.3.

APPEENDIX 4

3.8.4.

There is a range of skill and experience in every team in virtually every profession. Many people will have experience of working round individuals who are poor timekeepers, disorganised, poor communicators and so on. As long as these individuals can fulfil their role at an acceptable standard these compromises and managing strategies are acceptable. What is missing from the correspondence and interviews is any evidence that the concerns about RJs performance, which seem to be widely known, were ever properly assessed within the specialty. This can be difficult; the range of skills evident in any group of clinicians will vary and some will appear at the bottom of the range, just as others will appear at the top. It is not simply a matter of good and bad practice. There are references throughout the period covered by this review to the respective roles and relationships between the medical staff and other professionals. The culture within the specialty as a whole has not supported open discussion at various points, and there has been a element of acceptance of RJs practice. Action may have been taken as a result of the SUI findings in early 2010, but considerably more needs to be done to ensure that all staff groups are able to play their part in the governance arrangements. During the interview stage staff from the department were asked what they would wish to see coming out of the review. One of the most frequent responses was that the O&G team should have the opportunity to rebuild. As one member of the consultant staff said, there are some extremely skilled people in the team, and it would be good to see them working together in the right way, and moving in the right direction.

3.8.5.

3.8.6.

3.8.7.

3.9. Relationships between the O&G team and Trust management 3.9.1. There have been some turbulent times in recent years with frequent changes in the management team and clinical management structures, and financial and performance challenges. Several items of correspondence provide evidence of the tension this has created. The characteristics of the O&G team described in the previous section have been evident in many of the issues raised and addressed between Trust management and the O&G team over the years. A lack of good communication and effective partnership working has hindered the development of a clear vision for the service. The most effective working arrangements can be developed where all parties acknowledge that there is only one job to be done, and that is to deliver the very best service to patients within the resources available. At times this will require compromise, and acceptance of solutions that are less than ideal, but the best solution will only be found where all parties work effectively together to achieve this. The current Board members have a clear desire to play their part in this. With some investment in the further development of the O&G team they will be in a better able to respond in a positive manner. Appraisal

3.9.2.

3.9.3.

3.10.

3.10.1. RJs appraisal took place in March 2011 and was less than adequate. The Trusts use of the new revalidation paperwork may have played a part in this. The Trust lead for medical appraisal acknowledges the shortcomings and is intending to deal with them. The areas for development include improved training for appraisers, and inclusion of outcome measures, complaints and claims. 24

APPEENDIX 4

3.10.2. The Trusts target for appraisal in the current year is set at 80%. Based on the reports presented in October 2012 the actual level is around 70%, and W&C Directorate seems to have the lowest percentage within the Trust at only 62%. Appraisal is a key tool to provide support to staff, an opportunity for them to express their concerns, and to identify training needs. The Board should consider how it can secure an increase in the actual performance so that a larger percentage of staff is appraised each year. This may well have a positive impact on the Trusts currently low scores for staff morale. 3.11. Professional Standards Committee

3.11.1. There is an ongoing discussion about the need for a Professional Standards Committee within the Trust, and there is some evidence that the Medical Director Advisory Group has addressed aspects of this in the past. This may prove to be a useful addition to the overall arrangements, particularly if there is representation from other professional groups. If such a Committee is established its part in the overall process should be clearly defined. 3.12. Implications for other providers

3.12.1. Some of the concerns expressed over the period covered by the review related to patients treated in the private sector. This point was picked up by the MD in the review meeting with RJ on 16 November 2011, a month after RJs practice had been restricted at RCH. RJ confirmed he had contacted the Duchy himself, even though he was not aware that it was his duty to do this. 3.12.2. Given the increasing number of alternative healthcare providers, the Trust should clarify the requirements for reporting serious concerns about practice or conduct to other providers, and may wish to refer this item for wider discussion within the NHS. 4. Conclusion and recommendations 4.1. Conclusion 4.1.1. Any NHS Trusts response to serious concerns about clinical practice or conduct will be determined by a number of interrelated factors: culture and attitudes, systems and processes, the posts which exist within the structure and the training post holders have received to help them carry out those roles. It is difficult to judge the extent to which these factors played a part in the response to the earlier reviews, but in more recent years several aspects of the Trusts response have been inadequate. Many of those involved in this case did not have relevant experience, did not receive the necessary training or briefing, and were not clear of their role. Culture and attitudes within the specialty have contributed to the lack of escalation of issues. The opportunity for the Board to challenge progress was missed because they were not made aware of the concerns raised. If the overall arrangements for dealing with serious concerns are to be effective, all of these requirements need to be carefully aligned so that the process overall is coherent and understood by those required to use it. It is clear that the Trust did respond to many of the issues raised in respect of RJs practice. These responses were not always robust enough to deal with the issues raised, or timely enough to prevent further harm to patients. Many of the

4.1.2.

4.1.3.

4.1.4.

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APPEENDIX 4

staff involved have said that with the benefit of hindsight they would have tried to do more, or they would have acted more quickly. 4.1.5. This remainder of this section provides a set of detailed recommendations which address the weaknesses identified. The Trust Board should consider these issues as a whole, should engage with staff in the development of appropriate solutions, and should use this work as a way of rebuilding the morale of the team and the confidence of the public. There is much to be valued within the O&G team, and many of those I have interviewed have expressed a genuine desire to offer a first class service to the women of Cornwall. It will require a sensitive and well planned approach if the potential of the service is to be realised.

4.1.6.

4.2. Recommendations 4.2.1. The Governance Committee and sub-groups The Governance Committee should consider approving annual programmes of work for the sub-groups which report to it, and require that the reports it receives summarise progress against these work plans. The focus of the Committees attention should be directed to areas where delivery is at variance with the work plan and on critical issues arising from this work. The membership of the sub-groups should be reviewed to ensure those attending are able to progress the priorities identified in the annual work plans. Reporting concerns to the Board The Board should seek to clarify the nature of the reports it and the Governance Committee should receive in respect of concerns about poor practice and the performance of individual clinicians. This could usefully include summary information of cases where serious concerns have been expressed, where staff have restrictions placed on their practice, or where disciplinary action is being taken in respect of conduct. Board assurance from external reviews The Board may wish to consider expanding the current procedures for recording external reviews, so that it is briefed on the assessments that take place and the number and urgency of recommendations made, and receives regular updates on progress in delivering these requirements. This need only be reported in summary form, and would enable the Board to identify and query any plans where actions are overdue. Specialty based risk and governance processes In the light of comments made regarding attendance at risk meetings, and the resources available to support risk activities in gynaecology in particular, the Trust should review the timing of these meetings and the resources available to support this work. Work needs to be undertaken to properly describe how concerns or risks identified from within individual specialties are escalated beyond the specialty. This will need to address communication arrangements, the information needed to allow proper assessment of the cases identified, and should clearly describe which posts are responsible for what action. The possible development of a Professional Standards Committee should be considered as part of these arrangements. Culture and attitudes There would be value in further work by the Board to reinforce its commitment to deal with any concerns identified through the local governance processes in a fair and transparent fashion. Staff should be reminded of their responsibility to report concerns about practice, and of the Trusts policy for raising concerns. 26

4.2.2.

4.2.3.

4.2.4.

4.2.5.

4.2.6.

APPEENDIX 4

4.2.7.

Clinical Audit Progress has already been made in this area with the establishment of a Clinical Audit and Outcomes Committee. Further work should be undertaken to implement the recommendations of the recent Internal Audit Report, and to encourage the specialty team to develop meaningful indicators of quality and outcomes which should be measured and monitored over time. Trust Policies and procedures Existing policies should be reviewed with the intention of simplifying, shortening and aligning where possible. If not already in place the Trust may wish to consider creating an ongoing process for doing this. Additional work is needed to clarify the arrangements in place for SUI investigations, particularly in respect of the leadership of these investigations. The Trust should also ensure that the requirements set out in the MHPS policy and procedure are properly aligned and cross referenced to other relevant policies. Roles and responsibilities Existing job descriptions do include requirements for governance activities, but these could be more clearly defined to remove any ambiguity regarding responsibilities. Further work should be done on these once the package of work to improve the escalation process has been completed. As part of this work consideration should be given to maintaining appropriate files of information for subsequent post holders, together with formal handover and training support. Providing additional support for new post holders, through such means as mentors, may also help the development of individuals in their roles.

4.2.8.

4.2.9.

4.2.10. Performance management The arrangements for performance management of Divisions are balanced and robust. Consideration should be given to how the additional actions and action plans created from specific pieces of work can be assimilated into the overall arrangements. This will ensure there is the same level of discipline applied to these, and absolute clarity regarding their delivery and monitoring. 4.2.11. The specialty team There is an urgent need for a package of development for the O&G team. Historical differences and recent events have strained some relationships and put pressure on many individuals. This package should be discussed and developed with the team. 4.2.12. Medical appraisal Many of the required improvements are already planned or underway. The Board or the Governance Committee on the Boards behalf should review completion of these plans to ensure that the Medical Appraisal process includes a more complete assessment of clinical practice and conduct. This should be cross referenced to other relevant information including complaints and claims. Many doctors already include relevant outcome measures in their appraisal documents, and all clinicians should be encouraged to do this. 4.2.13. Trust wide appraisal targets The Board should consider how it can increase the target completion of appraisals for the organisation as a whole, and address the underperformance on appraisals within the Women, Childrens and Sexual Health Division.

27

APPEENDIX 4

4.2.14. Communication with other healthcare providers There appear to be no formal arrangements for notifying other providers of concerns raised about an individual clinician or service. These arrangements will require liaison beyond the geographical area, and the Trust may wish to refer this issue for consideration by the NHS on a regional or national level.

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Appendix A Terms of Reference To undertake a retrospective review for the period 1992-2012 to identify organisational learning arising from the way in which the Trust and specialty has dealt with concerns raised by individuals, reports commissioned and subsequent actions taken in respect of Mr X, former Consultant Obstetrician and Gynaecologist employed by the Royal Cornwall Hospital NHS Trust. The review will take into account Trust structure and policy relevant at the time, consider the investigations and reports produced; and involve interviews with key individuals. The findings of the review will be reported to the Board of Directors to ensure any lessons learned are fully integrated into the Trust's governance, leadership and management arrangements. Where appropriate, relevant findings will also be reported to other key interested parties including regulators, patients or their relatives and within the wider NHS. The findings will also be used to bring about closure for key individuals and to promote learning in the wider organisation Where in conducting the review, issues falling outside the scope of the review( but which merit attention in the interests of patients) are identified, the reviewers should report these separately to the Chief Executive of the Royal Cornwall Hospitals NHS Trust for a decision as to whether the scope of this review should be widened to include those matters or what other mechanism should be adopted to resolve them.

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Appendix B List of interviewees


xxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxx

30

APPEENDIX 4

xxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxx

Appendix C Reviews and Investigations 1992 to 2012

1. Clinical concerns raised around September 1997 Investigation by a third party unconfirmed Review of claims settled not conclusive in respect of individual practice 2. Clinical concerns raised around June 1998 Review of complications over the previous two years Findings concluded complications not confined to any individual surgeon 3. Clinical concerns raised by a nurse early 2001 Review of specific cases carried out by O&G colleague No evidence of incompetence 4. Initial Investigation of the South West Regional Cervical Screening Quality Assurance Reference Centre Guidance April 2007 Findings confirmed that all cases, as reviewed, fail to reach the standard of care expected for patients seen within the NHSCSP system 5. Initial Investigation Panel re clinical practice January 2008 Findings confirmed there were serious concerns that require resolution 6. External Review of Benign Gynaecological Services 2010* 7. Serious Untoward Incident report January 2010 8. Report following receipt of anonymous letter July 2011* 9. South West Regional Cervical Screening QARC, Cervical Cancer Audit Dec 2011* Initial concerns related to an increase in the number of cases of cervical cancer diagnosed. Subsequent audit confirmed identified spike probably represents normal statistical variation 10. Investigation Report into Conduct Issues January 2012 11. Royal College of Obstetricians and Gynaecologists Report January 2012

*Investigations not relating to the practice of a specific consultant

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APPEENDIX 4

Appendix D Relevant Policies and Procedures

Incident Reporting and Management Policy and Procedure First approved August 2004, updated December 2011 25 pages, including 6 pages of Appendices

Maintaining High Professional Standards in the Modern NHS Issued November 2006 (no standard documentation control section) 40 pages, including 10 pages of Appendices

Policy and Procedure for being open First approved March 2007, last updated November 2010 48 pages, including 35 pages of Appendices

Policy for analysis and improvement: learning from experience First approved June 2011, last updated May 2012 17 pages, including 7 pages of Appendices

Raising concerns in the public interest (Whistleblowing) Policy First approved October 2004, last updated August 2010 15 pages, including 3 pages of Appendices

RCT Investigation Policy First approved December 2007, last updated December 2011 39 pages, including 17 pages of Appendices

Serious Incident Management Policy and Procedure First approved August 2004, last updated December 2011 53 pages, including 34 pages of Appendices

32

APPEENDIX 4

Appendix E Abbreviations and terms used in the report

CD Datix

Clinical Director The Trust's electronic risk management system which includes reporting of incidents, PALS, legal claims and complaints through various modules within the system Deputy Medical Director Divisional Director Investigating Officer Medical Director Maintaining High Professional Standards National Clinical Assessment Service Non Executive Director Obstetrics and Gynaecology Post menopausal bleeding Quality Assurance Reference Centre Royal College of Obstetricians and Gynaecologists Royal Cornwall Hospitals Serious Untoward Incident Women and Children

DMD DD IO MD MHPS NCAS NED O&G PMB QARC RCOG RCH SUI W&C

33

APPENDIX 5

Cornwall and Isles of Scilly PCT Organisational Learning Review

Julie Acred OBE

APPENDIX 5

1. Introduction 1.1. Reasons for the Review 1.1.1. The Cornwall and isles of Scilly PCT has commissioned this review to examine the circumstances surrounding the reporting of concerns regarding the practice of a Consultant Obstetrician and Gynaecologist at the Royal Cornwall Hospitals NHS Trust (RCHT) from 1992 - 2012, and to establish how the PCT and successor commissioning and performance management systems can learn lessons and mitigate future risks. The review will establish why the PCT did not become aware of and take action in relation to serious concerns, identify learning from the case, and offer advice in respect of future commissioning arrangements. A copy of the agreed terms of reference is attached at Appendix A.

1.1.2.

1.2. Methodology 1.2.1. The information required for this review has been collected from nine telephone interviews with current and previous PCT staff, and from a number of documents including correspondence (letters and emails), minutes from internal groups and from liaison meetings with RCHT, terms of reference for those committees and various quality and performance reports.

1.3. Context 1.3.1. The Cornwall and Isles of Scilly PCT came into existence in 2006. No relevant paperwork has been supplied prior to 2007, and this review has focused on the activities and correspondence from 2007 to 2012. The provision of high quality care is inherently complex, and requires strong leadership from Boards, high standards of clinical leadership and practice, and systems and processes which support quality improvement and the management of risk. The arrangements for monitoring the quality of care, whether by healthcare providers or commissioners, are equally complex. The range of information to support performance management activities across the NHS has increased over time, with more comparative data now available. All NHS organisations have responsibility for quality. Commissioners are responsible for commissioning services that meet the needs of their local populations, and they must assure themselves of the quality of care that they have commissioned. At the same time the leadership within provider organisations is ultimately responsible for the quality of care being provided by that organisation. Fulfilment of these respective responsibilities requires a open an collaborative approach on the part of both providers and commissioners. Over the period covered by the review there has been a wide range of guidance and resources made available, specifically a number of documents from the National Quality Board. These have supported the development of robust arrangements for quality as PCTs have prepared for the transition to new commissioning arrangements.

1.3.2.

1.3.3.

1.3.4.

Cornwall and Isles of Scilly PCT - Organisational Learning Review

APPENDIX 5

2. Findings from the review 2.1. The PCTs role in the reporting of concerns 2.1.1. This review has focused specifically on the correspondence between the PCT and RCHT in respect of concerns relating to a specific consultant in O&G. It is known that a number of reviews were undertaken over the period 1997 to 2012, and only limited information on these reviews was shared with the PCT. Information relating to individual serious incidents is provided to the PCT as a matter of course under the national arrangements, and these are discussed as part of the overall liaison arrangements between the PCT and RCHT. The External Review of Benign Gynaegology which was set up in 2010 to examine various aspects of the O&G service was discussed with RCHT on many occasions. While this review did examine the overall arrangements for clinical governance within the O&G service, it was not intended to highlight concerns about individuals, and none were identified in the report. There is no evidence that any specific concerns identified by RCHT were notified to the PCT from 2007 up to the point when the practitioner retired from clinical practice. Various quality monitoring reports were examined as part of this review, and there is no indication that warning signs or evidence of poor care were missed. The PCT received no complaints about the service and no whistle blowing contacts. The quality information provided by RCHT and other relevant measures were examined and evaluated by the PCT as part of the ongoing performance management arrangements, and no trends or themes were identified. Based on the information examined as part of this review, there appears to have been no earlier opportunity for the PCT to act in response to concerns identified. They received formal notification of concerns relating to an individual clinician until September 2012, and there were no specific trends or themes emerging from the performance management system prior to that to suggest that a specific area of service might be an issue. There are a number of areas of commissioning activity that could usefully be reviewed and improved which will help strengthen future commissioning arrangements. These are outlined in sections 2.2 to 2.8 below.

2.1.2.

2.1.3.

2.1.4.

2.1.5.

2.1.6.

2.1.7.

2.2. PCT Governance and reporting 2.2.1. The internal quality reporting has developed over the years, and the Board receives information on a wide range of quality measures. These include serious incidents and never events including timeliness of reporting, health care acquired infections, mixed sex accommodation, CQC visit reports, fractured neck of femur and stroke, and mortality data. Issues of concern within specific areas of service may arise as a result of new targets or standards, regional or national reconfiguration of services, demand and capacity issues, or clinical practice changes. All of these factors have the potential to impact on service delivery, and require the same level as scrutiny as performance and quality failures. Cornwall and Isles of Scilly PCT - Organisational Learning Review 3

2.2.2.

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2.2.3.

There are many examples in the material reviewed to suggest these sorts of issues were identified and properly addressed by the PCT. The PCT Board and the Professional Executive Committee have been kept informed of progress in respect of a number of O&G service related issues over the period. Areas of concern or delays in implementing change have been escalated within the organisation, and appropriate plans have been put in place to deal with major service changes or serious concerns about quality. Efforts are made to triangulate the various elements of quality assurance received by the PCT. Serious incidents are examined in detail, and looked at alongside a wide range of other indicators including complaints and other forms of patient feedback. The development of a dashboard approach has improved the level of scrutiny, and overall the quality assessment processes are balanced and comprehensive. There is a quite reasonable focus on exception reporting through the hierarchy of groups and committees within the PCT. There is some risk that a number of small and seemingly unrelated issues discussed across the organisation are not individually escalated by any of the current structures and processes. Important trends and warning signs may therefore be missed. The full range of information is brought together at the regular meetings with CQC, but not all of this collated information will be fed back to the staff involved in contracting and performance management activities. The PCT may wish to consider how it can strengthen internal reporting and information sharing so that all key staff are aware of all relevant issues. Various reports from the South West Cervical Screening Programme were considered as part of this review. Feedback from the quality assurance visits is routinely copied to the PCT and dealt with within the Public Health team. It is not clear how concerns raised through this route are fed into the quality and performance management processes, and the PCT should examine how it can strengthen the feedback mechanisms. Reviews and assessments carried out by external bodies provide a valuable source of assurance for NHS Boards, and these should be considered alongside other quality monitoring information. The PCT should consider what further information on outcomes or processes is available from external assessment and accreditation processes, and ensure this is integrated into the performance management structures.

2.2.4.

2.2.5.

2.2.6.

2.2.7.

2.2.8.

2.3. The availability and use of information 2.3.1. Considerable information is provided to the PCT by RCHT, and many of those interviewed have suggested that there is a reasonably good level of openness with providers. There is evidence that the PCT have sought to gain a more detailed understanding of what the quality indicators are telling them, and have requested information on themes and trends emerging from complaints for example. Not all of this information has been readily available, although the provision and use of information has improved over time. There is little opportunity for the PCT to identify concerns about specific location (wards or departments), areas of service or individual clinicians as much of the information it receives does not provide all of the required analysis. The PCT Cornwall and Isles of Scilly PCT - Organisational Learning Review 4

2.3.2.

2.3.3.

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recognises the importance of other performance measures including workforce measures and these are included on the agenda of the provider liaison meetings, although much of the information received is at a high level. 2.3.4. Pulling together a full range of hard performance measures and other indicators of quality including workforce measures may help provide an early warning that a particular service is under pressure. As part of its ongoing work to develop new commissioning arrangements the PCT should work with providers to develop and improve the level of analysis of complaints, PALS contacts and other quality measures so that trends and themes can be identified more easily. Consideration should be given to how the PCT should be informed of the frequency of incidents or concerns in relation to an individual clinician. The very proper concerns about confidentially may be addressed if providers are able to share information they already use to monitor the frequency of complaints and incidents for individual clinicians, but in an appropriately anonymous format. Given the failure to notify the PCT of specific concerns relating to an individual practitioner, the PCT should agree with its providers the indicators which should prompt a report to the PCT. NHS Trusts would expect to see a number of referrals to the National Clinical Assessment Service, not all of which will suggest concerns about clinical practice. Similarly not all restrictions to practice will be as a result of serious concerns about practice. The criteria agreed will need to acknowledge the respective roles and responsibilities of providers and commissioners, and add value to the quality assurance processes.

2.3.5.

2.3.6.

2.3.7.

2.4. Commissioning structures 2.4.1. Not all of the services commissioned by the PCT have had a lead commissioner. There is currently an individual who leads on Obstetrics and Childrens services, but no lead for gynaecology. Resources have been made available to support work within a particular service when required (for example in response to the Review of Benign Gynaecology service in 2010). Many of those interviewed have commented on the importance of clinical input to the commissioning process, and the value this adds to the contracting, performance management and provider liaison arrangements. In preparation for the new commissioning arrangements which will come into effect in April 2013 the CCG has identified the need for clinical leads for a range of specialties, and these are in the process of being appointed. The PCT should ensure that the commissioning and clinical input under the new arrangements is adequate for all services, and that the requirement for consistent clinical attendance at the meetings with providers is made clear in the Terms of Reference.

2.4.2.

2.4.3.

2.4.4.

2.5. Liaison arrangements with RCHT 2.5.1. The overall relationships between the PCT and RCHT are considered to be good. Despite recent events the various contract monitoring meetings are considered to be mature and open most of the time. The meeting structure in place works well, with an executive level group to monitor contractual requirements, and sub groups to examine activity and Cornwall and Isles of Scilly PCT - Organisational Learning Review 5

2.5.2.

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quality. Quality measures are reviewed in considerable detail by the quality subgroup, and there is evidence that issues of concern have been appropriately escalated to the executive level group. 2.5.3. A wide range of quality measures are reviewed as part of the monitoring process, and it is clear that the PCT understands the importance of looking at other relevant feedback such as workforce (staffing levels, appraisals and staff survey results). What is less clear is how this information is used to form a overall picture of individual services commissioned by the PCT. It is inevitable that with busy agendas on all sides the focus of the liaison arrangements has been on the pressure points. There is a danger that those involved, and those who receive reports and assurance from these processes are not fully aware of the wide range of challenges and opportunities which lie ahead for the services they commission. Without this understanding of individual services and specialties, commissioning staff may miss the possible connection between capacity pressures, the impact of service changes and reconfiguration, and various quality related indicators. The PCT may wish to consider how it can create an opportunity for those involved in commissioning acute services to work with RCHT to achieve a better understanding of services, and their challenges and aspirations. This might be done as part of a rolling programme, or in response to alerts from the performance management processes. It has been suggested that consideration should be given to the establishment of a new clinical forum, attended by representatives from the provider and the commissioner, where concerns about service standards or practice might be shared. This may add value to the arrangements already in place, but the role of such a group in the quality monitoring process as a whole should be clearly specified and understood by those involved. Several of those interviewed have mentioned the challenges posed by frequent changes in staff, and the inevitable delays as those new in post begin work to understand the priorities of the service. This is difficult to avoid, but risks can be minimised with good quality documentation, briefing and handover. The PCT should ensure it has robust systems for doing this with the commissioning team, and that efforts are made to minimise the loss of organisational memory when changes take place within provider teams. Better use of action logs for the liaison meetings should assist in highlighting where there are delays in completing actions

2.5.4.

2.5.5.

2.5.6.

2.5.7.

2.6. Liaison across providers 2.6.1. Many practitioners will work across different providers, and there need to be mechanisms in place for appropriate communication and liaison across different providers where concerns are identified. The PCT are aware of the need to follow through with other providers where there are serious concerns about practice, although the arrangements for doing largely informal, and it is not clear how the interface with private practice is managed. The PCT should ensure that the arrangements for liaison with other NHS providers and with the private sector are clarified and strengthened.

2.6.2.

2.7. Culture and attitudes Cornwall and Isles of Scilly PCT - Organisational Learning Review 6

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2.7.1.

All staff interviewed have demonstrated a real desire to properly assess the quality of service they commission, and secure real improvements in standards. The commissioners will need to work with providers in an open and collaborative way so that appropriate information is shared, properly analysed and acted upon where this is required.

2.8. Implications for future commissioning arrangements 2.8.1. The PCT have taken reasonable steps to prepare for the forthcoming changes in commissioning responsibilities. Good use has been made of the guidance issued by the National Quality Board, and a number of the How To guides have been applied as part of the PCTs work on O&G. Consideration has been given to how quality will be managed in the new structures, and how intelligence from the quality surveillance teams and other sources will be fed in. Many of the recommendations made in this report are relevant for future commissioners, and the involvement of primary care clinicians and the intelligence they can bring from their practices has the potential to add real value to the commissioning process. The events examined as part of this review offer an opportunity for the CCG to re-examine the proposed commissioning arrangements, and to test how they would respond to similar events in the future. The CCG may wish to use the learning from the events covered by this review to test reporting and escalation processes within the new commissioning structure.

2.8.2.

2.8.3.

3. Conclusion and summary of recommendations 3.1. Conclusion 3.1.1. There is no evidence that the PCT had any opportunity to intervene earlier in the events covered by this review. The PCT took reasonable steps to assess the quality of service, and took account of feedback from various sources in doing this. Where concerns about services were identified appropriate action was taken, and outstanding concerns escalated. There was no evidence of themes or trends which might have alerted the PCT to concerns in O&G. As part of this review a number of areas of PCT have been identified where arrangements could be strengthened. It is difficult to conclude whether these arrangements would have identified concerns about the O&G service, but they will help improve monitoring and assurance processes, and may be used to enhance the commissioning arrangements that will come into operation in April 2013. These recommendations are listed below.

3.1.2.

3.2. Recommendations 3.2.1. Internal reporting and information sharing The PCT may wish to consider how it can strengthen internal reporting and information sharing so that all key staff are aware of all relevant issues (paragraph 2.2.6). Sources of external assurance The PCT should ensure that all feedback received from external sources is routinely fed into the quality and contracting processes (paragraphs 2.2.7 and 2.2.8). Further analysis of provider based quality information As part of its ongoing work to develop new commissioning arrangements the PCT should work with providers to develop and improve the level of analysis of complaints, PALS Cornwall and Isles of Scilly PCT - Organisational Learning Review 7

3.2.2.

3.2.3.

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contacts and other quality measures so that trends and themes can be identified more easily (paragraph 2.3.4). 3.2.4. Analysis of quality indicators for individual clinicians Consideration should be given to how the PCT should be informed of the frequency of incidents or concerns in relation to an individual clinician (paragraph 2.3.5). Reporting of serious concerns The PCT should agree with its providers the indicators which should prompt a report to the PCT. The criteria agreed will need to acknowledge the respective roles and responsibilities of providers and commissioners, and add value to the quality assurance processes (paragraphs 2.3.6 and 2.3.7). Clinical input to commissioning The PCT should ensure that the commissioning and clinical input under the new arrangements is adequate for all services, and that the requirement for consistent clinical attendance at the meetings with providers is made clear in the Terms of Reference (paragraph 2.4.4). Service or specialty deep dives The PCT may wish to consider how it can create an opportunity for those involved in commissioning acute services to work with RCHT to achieve a better understanding of the services, their challenges and their aspirations. This might be done as part of a rolling programme, or in response to alerts from the performance management processes (paragraph 2.5.5). Administrative systems The PCT should ensure it has sound systems for briefing and handover within the commissioning team, and that efforts are made to minimise the loss of organisational memory when changes take place within provider teams. Better use of action logs for the liaison meetings should assist in highlighting where there are delays in completing actions (paragraph 2.5.7). Liaison across other NHS and private sector providers The PCT should ensure that the arrangements for liaison with other NHS providers and with the private sector are clarified and strengthened (paragraph 2.6.2)..

3.2.5.

3.2.6.

3.2.7.

3.2.8.

3.2.9.

3.2.10. Organisational learning The CCG may wish to use the learning from the events covered by this review to test reporting and escallation processes within the new commissioning structure (paragraph 2.8.3).

Julie Acred OBE 4th February 2013

Cornwall and Isles of Scilly PCT - Organisational Learning Review

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Appendix A Terms of Reference for the review

Organisational Review of NHS Cornwall & Isles of Scilly role in the Commissioning and Performance Management of Obstetrics and Gynaecology Services at the Royal Cornwall Hospitals Trust

Purpose To review the circumstances surrounding the reporting of ongoing concerns regarding the practice of a Consultant Obstetrician and Gynaecologist to the Royal Cornwall Hospitals NHS Trust Commissioners between1992 - 2012 and to establish how the Primary Care Trust and successor commissioning and performance management systems can learn lessons, and mitigate future risks

Objectives To review the reasons why NHS Cornwall & Isles of Scilly PCT did not become aware of and take action in relation to serious concerns about the practice of a Consultant Obstetrician and Gynaecologist at the Royal Cornwall Hospitals covering the period 1992 2012. To make recommendations on what commissioners and performance managers in Clinical Commissioning Groups and Local Area Teams can learn from the case to be sure they are advocating effectively on patients behalf. To set out what steps commissioners should reasonably be expected to take in assessing the risks of services they purchase on behalf of their communities.

Cornwall and Isles of Scilly PCT - Organisational Learning Review

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Review of Recent Patient Experiences & Feedback in Gynaecology Services at

Commissioned by Final Report December 2012

Author: Lynn Dunne Contents page South West Regional Manager - The Patients Association Lynn@patients-association.com Mobile: 07527 362 107

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Executive Summary ............................................................................................................. 3 Forward................................................................................................................................. 3 Introduction .......................................................................................................................... 4 National Context .. 5 Local Context . ..5 Methodology .........5 Findings .........7 Conclusions .10 Recommendations ........................................................................................................... ...11 Appendices.............................................................................................................................12 Appendix 1 Terms of Reference..12 Appendix 2 Table of Results......13 Appendix 3 Letters to Staff & Patients.16 Appendix 4 Interview Proforma...18

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Executive Summary
The Patients Association was approached by Kernow Clinical Commissioning Group (KCCG) to conduct a review of current patient experiences of Gynaecology services provided by the Royal Cornwall Hospitals Trust (RCHT). The purpose of the review is to reassure current and future patients and the general public about womens recent experiences of the gynaecology services at RCHT. The timing of the review is pertinent due to recent media interest in RCHT gynaecology services following events concerning to two consultant gynaecologists employed by the Trust. The review is also conducted against a national backdrop of currently high levels of media interest in the NHS concerning the quality of its services and where patients, their carers and the general public are looking for reassurance following recent well documented failures in care. KCCG requested that the review be undertaken by The Patients Association due to our considerable experience in Listening to Patients, and providing high quality feedback to partner organisations. The Patients Association is an independent, trusted third party that is able to offer the participants guaranteed anonymity and alongside an undertaking to provide meaningful feedback to the KCCG and RCHT; two important factors in obtaining feedback from patients. The Patients Association interviewed 16 patients who were currently or had recently used gynaecology services. The results of the review clearly show that patient experiences of gynaecology services provided by RCHT are positive with 13 out of 16 (81%) women saying they were happy with the care they had received. The positive scores ranged from 25% to 100% with a mean of 91% (see results table in appendix). Three patients were dissatisfied with elements of their care (19%). Dissatisfaction was mainly as a result of poor communication with one incident concerning dignity. Anecdotal evidence concerning the various aspects of their outpatient and inpatient care is detailed in the findings. The majority of patients (81%) would be happy for a member of their family to be treated at RCHT based on their own experiences. Overall 25% of patients felt that their care and treatment was better than they had expected, 56% felt it was exactly as they had expected and 19% felt it was worse than expected.

Foreword
The Patients Association is a unique healthcare charity which campaigns for improvements in health and social care. Our willingness to listen to patients and the public and then Speak Up for Change, has always informed our work, research and campaigns. Our Helpline, which answers dozens of calls, letters and emails every day provides us with a valuable insight into what is of current concern to patients. For almost 50 years, the Patients Association has always been there listening to patients, carers and the general public and acting as a champion for their concerns about health and social care. We have spoken up for change through our many campaigns and have acted as a critical friend to the Department of Health, voicing concerns and advising about current and future policy, and providing solutions. The Patients Association believes that patients should be at the heart of the health and social care system, and that all patients should be given the opportunity to be actively involved in decisions about their healthcare. We believe in reducing the bureaucratic burden on the NHS and improving communication between staff and patients, so that care is truly patient centred.

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On 4th May 2011 the Patients Association South West Project was officially launched. Projects across the south west are being set up in partnership with local NHS Trusts to help improve patient experience. In order to maximise impact of the projects it was agreed at an early stage that all projects should fit the following criteria: Sustainability that they should be sustainable in some way beyond the lifetime of the Patients Association South West Project Replicable it should be possible to replicate the projects elsewhere with similar results Improve the patients experience the projects should make a real difference to the experience of patients Leave a legacy projects should result in permanent improvements in the patients experience and increased knowledge about best practice. Supported by the South West Strategic Health Authority, local Trusts, the Care Quality Commission, the Independent Complaints Advisory Services, a range of voluntary sector bodies, patients, carers and the public, the Patients Association have been able to start and complete a number of projects to improve patient and carer experience in the region.

1. Introduction
The Patients Association was approached by Kernow Clinical Commissioning Group (KCCG) to conduct a review of current patient experiences of Gynaecology services provided by the Royal Cornwall Hospitals Trust (RCHT). The review is a snapshot of patient experiences around gynaecology outpatient, day case and inpatient services provided at Royal Cornwall Hospital, Treliske and some of the outpatient clinics provided in the community hospitals. The review was conducted over a 10 day period from 3/12/12 12/12/12. The purpose of the review is to reassure current and future patients and the general public about womens recent experiences of the gynaecology services at RCHT. The timing of the review is also pertinent due to recent media interest in RCHT gynaecology services following the resignation of a consultant gynaecologist from both the Trust and the General Medical Register with a resulting clinical review which has been a cause of local public concern. These concerns were compounded by the restricted clinical practice of a second consultant gynaecologist at RCHT whilst the review was being conducted. KCCG requested that the review be undertaken by The Patients Association due to our considerable experience in Listening to Patients, and providing high quality feedback to partner organisations. Of critical importance was The Patients Association independence as a trusted third party and our ability to offer the women who agreed to participate in the review complete anonymity alongside an undertaking to provide meaningful feedback to the commissioners. The Patients Association were asked to interview 10 15 women about their recent experiences of current gynaecology services provided by RCHT. A total of 17 women agreed to participate with 16 completing the interview process.

2. National Context
There are currently high levels of media interest in the NHS concerning the quality of its services. In particular, patients, their carers and the general public are looking for reassurance following the failures in care such as those at Winterbourne Stoke and Mid Staffordshire that these events will not be repeated. The NHS anxiously awaits the publication of the Francis report in 2013. The Patients Association has just published its latest volume of patient stories for the fourth year running. Since 2009, the themes that concern patients and their carers who contact the PA

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helpline remain unchanged: poor communication; lack of dignity and respect; inadequate nutrition; lack of help with toileting and poor pain relief. The recent publication of Compassion in Practice, The Willis report, and the focus of the National Outcomes Framework on ensuring that people have positive experiences of care and are treated in a safe environment, protected from harm all emphasise the need to be continually monitor and evaluate the quality of care patients receive when they are at their most vulnerable.

3. Local Context
The RCHT serves a population of 535,000 living in Cornwall and the Isles of Scilly. The population is growing rapidly, with the biggest increases being seen in the over 65 years and youngest age groups, reflected by the year on year increase in birth rates. Cornwall is a rural county with a widely dispersed population, that has specific pockets of need arising from deprivation and its concomitant health needs. Further challenges arise in summer when the population can increase by as much as 300,000 with visitors to the area. Access for the residents of Scilly is a dependent air and sea links which are vulnerable to local weather conditions. Gynaecology services are provided at Treliske Hospital in Truro, St Michaels Hospital, Hayle, West Cornwall Hospital, Penzance, with further outpatient clinics being held at the community hospitals based around the county. In the 12 months ending 30/9/12 RCHT gynaecology services saw 7,770 GP referrals; 7,664 new outpatients; 7,108 follow up outpatients; 3,282 surgical day cases; 1,330 elective surgical procedures and 5,168 emergency gynaecology cases.

4. Methodology
4.1 Review steering group

The steering group comprised of Head of Strategic Communications, KCCG and SW regional manager, The Patients Association. We are grateful for the cooperation and support of staff at RCHT and also the Patients Association Ambassadors who generously gave their time to assist with the telephone interviews. 4.2 Gathering feedback

It was agreed to use a modified version of the mystery shopper diary as a proforma for the telephone interviews (see appendix 4). The proforma was specifically amended to include suitable questions for the gynaecology review. In addition two letters were written, staff and patient versions, to explain the purpose of the review, methodology and to assure patients that their confidentiality and anonymity would be respected and maintained (see appendix 3). 4.3 Finding people

During the week commencing 3/12/12, visits were made by The Patients Association to a variety of outpatient clinics at Royal Cornwall Hospital, Treliske and other gynaecology venues throughout the county to find patients willing to be interviewed. The Patients Association also visited the Surgical Admissions Lounge, Theatre Direct and Tolgus Ward at the Royal Cornwall Hospital to recruit suitable participants for the review. Each of the volunteers was given a copy of the patient letter and an explanation of the review including a guarantee of confidentiality and anonymity. When the patient had agreed to be interviewed, contact telephone details were recorded along with convenient contact times. A total of 17 women were recruited for interview. The final number interviewed was 16, with one patient who originally agreed to participate unable to be interviewed due to ill health.

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Of the 16 interviews, 10 concerned outpatients visits, 4 inpatient stays and 2 were day cases. It had been hoped to interview more day cases but this was not possible due to time constraints and the cancellation of 2 day cases for reasons beyond the hospitals control. 4.4 Interviewers

All the interviews were conducted using the agreed telephone proforma and in accordance with the Patients Association telephone interview guidelines by Patient Association members of staff and approved volunteer ambassadors.

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5. Findings
The results of the review clearly show that patient experiences of gynaecology services provided by RCHT are overwhelmingly positive with 13 out of 16 (81%) women saying they were happy with the care they had received. The positive scores ranged from 25% to 100% with a mean of 91% (see results table in appendix). Three patients were dissatisfied with their care (19%) and their accounts concerning outpatient and inpatient care are detailed in the findings and comments below. Were the review to be repeated it would be beneficial to redesign the interview proforma to cover outpatient experiences on a dedicated form. 1. BEFORE ADMISSION OR OUTPATIENT ATTENDANCE This section was very well rated with questions relating to pre-appointment admission and directions for the ward/department receiving 100% positive ratings. There was one patient who experienced parking difficulties and 3 respondents referred to previous parking difficulties at RCH, Treliske and several mentioning the high cost of parking at RCH, Treliske. 2. YOUR ADMISSION OR OUTPATIENT ATTENDANCE Again the section received high positive ratings overall with questions relating to whether the ward/dept. appeared clean, tidy and had a good atmosphere receiving 100% positive scores as did a question asking whether patients felt safe. One patient found Tolgus ward unwelcoming when she arrived there post-operatively, which contrasted with her high rating of the Surgical Admission Lounge (SAL), and theatre recovery area. One outpatient had felt pressurised to accept a particular form of treatment by a doctor in the outpatient clinic. She had declined based on the information and options that her GP had discussed with her prior to attending the clinic. Whilst the patient herself was not unduly concerned by the incident because of her GPs advice she felt that other patients faced with a similar situation and not having the benefit of similar GP advice might need an advocate. During one visit to an outpatient clinic, there was anxiety and confusion amongst staff and patients present as a result of media coverage the previous evening concerning the restricted clinical practice of a second, unnamed consultant gynaecologist at RCHT. Staff and patients had incomplete/misinformation and as a result were concerned that the unnamed consultant may still be seeing patients. The Patients Association reported the concern to the RCHT communications team who rectified the situation. 3. YOUR STAY OR OUTPATIENT ATTENDANCE Questions in this section mainly involved day and inpatients and this is reflected in the results table. Patients felt 100% involved in their care and that their confidentiality was respected. Help with eating and drinking and effective pain relief also received 100% positive scorings. One patient was not aware she had a call bell system during her stay on Tolgus ward. One patient commented that unhelpful staff attitudes on Tolgus ward had caused her to feel less confident about her care. For this patient her experience began with a feeling of

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being unwelcome when she was brought to the ward from recovery which continued throughout her stay on the ward. With the exception of one nurse, she found the staff rude and brusque. Her experience was compounded when staff asked her partner to leave the ward at a mealtime in what she felt was an unnecessarily abrupt manner with no explanation as to why i.e. protected mealtimes. An outpatient experience that left a patient stranded in a corridor on the way to her outpatient consultation whilst the nurse discussed an emergency practice routine with another member of staff and another where a patient was not able to see the consultant despite a specific request at the time of booking the appointment caused both women to feel less confident about their experience/care. These experiences also made all 3 patients feel that the nurses concerned did not care or have time for them. One patient had concerns for her safety as the doctor couldnt f ind her notes and she became worried that she might receive the wrong treatment. The majority of women felt that their privacy and dignity was respected at all times, often in deeply intimate circumstances where they felt vulnerable. The exception was the patient left in the corridor on her way to see the doctor, who also commented that the clinic nurse appeared harassed. Several women mentioned how much they appreciated the availability of a separate room to discuss highly sensitive aspects of their care and treatment and felt it was an important feature in maintaining privacy and dignity. Feedback suggests that patients were not generally bothered if a ward was busy, it was only if staff were not calm or appeared harassed as a result that it concerned them. All patients admitted and cared for in SAL, Theatre Recovery and Theatre Direct spoke extremely highly of the staff there that cared for them. Patients felt that the staff really cared for them and went the extra mile to ensure they felt comfortable and reassured. Although there was one patient who had an unsatisfactory experience on Tolgus ward, she did mention one nurse by name who was kind and helpful and went out of her way to explain things and really listened to her. Another patient mentioned a senior nurse on Tolgus ward who was very supportive of staff and patients and was very motivating. Several patients mentioned the kind and caring attitude of one consultant gynaecologist in particular. One patient was deeply touched by a consultant who stood up, introduced himself and shook her hand in the outpatient clinic. Not one patient noticed the information displayed in the wards or outpatients. There was some confusion around identifying different staff with comments ranging from not being able to read name badges because the print was too small, to thinking everyone was a qualified nurse, to knowing who different staff were from previous admissions/visits. 4. GOING HOME The majority of patients questioned felt that they were given clear information about going home (86%) and for follow up appointments (83%). One patient stated that she could not get staff on Tolgus ward to give her clear information about going home and had resorted to phoning her daughter and getting her to call the ward and find out. One outpatient felt

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that she did not have clear information about follow up appointments because she left the outpatients when it became clear she could not see the consultant who was off sick that day, despite a prior request at the time of booking the appointment. What irritated her most was waiting for over an hour (the clinic was running 45 minutes late) to discover that the consultant was not there when she could have been told by the receptionist on arrival. The majority of patients would be happy for a member of their family to be treated at RCHT based on their own experiences. The exceptions to this were the patients who had unsatisfactory experiences on Tolgus ward (1) and outpatients (2). Overall 25% of patients felt that their care and treatment was better than they had expected, 56% felt it was exactly as they had expected and 19% felt it was worse than expected.

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6.

Conclusions

The overall experience of care currently received by gynaecology patients is positive (81%) with feedback ranging from satisfactory to highly satisfactory. Of the 16 patients interviewed, 3 had unsatisfactory experiences 1 as an inpatient on Tolgus ward and 2 as outpatients. Based on the information given by the three women their unsatisfactory experiences could have been avoided if staff attitudes and communication skills had been better. For example if the lady attending outpatients had been told upon her arrival that the consultant was not available she could have rebooked and left immediately, avoiding a wait of over an hour. Likewise improved staff empathy and communication could have avoided the unsatisfactory experience of the patient left stranded in the corridor. The experience of gynaecology patients and their carers/families could be further improved with further staff customer/carer awareness training regarding communication using the feedback from this review. The excellent care provided by staff in SAL, Theatre Recovery and Theatre Direct should be exported to the relevant clinical areas and departments in a similar fashion and the exemplary nurse(s) on Tolgus ward could become patient experience champions and role models for the other staff on the ward. The use of patient stories is a particularly effective way of conveying the patient experience as are exercises that encourage staff to walk in the patients shoes or undertake service safaris. RCHT would find it beneficial to be more proactive in its communication with staff in times of bad or difficult news to ensure that staff are appropriately briefed and able to reassure patients. It would be timely to review information displays and the use of noticeboards to discover if there are more effective ways of conveying important information. RCHT should explore ways of informing patients and visitors to their hospitals who wears which uniform, particularly the different uniforms worn by nursing staff as there is an incorrect assumption amongst some patients that all nurses are qualified registered nurses. Our experience as an organisation that specialises in Listening to Patients reinforces time and time again that guaranteed anonymity and feedback of patient experiences via a trusted independent third party and wherever possible away from the hospital or care setting, is a vital part of getting honest, reliable and complete disclosure from patients.

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7.

Recommendations

The following recommendations have been formulated from the findings of the survey: 1. That the general public and women using the RCHT Gynaecology services are made aware of the results of this review and reassured about the positive patient experiences the majority of patients have. 2. That the staff working in gynaecology services are made aware of the review results and shown appreciation for the excellent work that they do the majority of the time. 3. That KCCG and RCHT continue to gather independent feedback from gynaecology patients concerning their experiences of care and treatment at appropriate intervals using a trusted third party that can guarantee anonymity for participants and high quality feedback to the commissioners and Trust. 4. That the results of this review are used for staff development particularly around developing and improving communication skills. 5. The use of patient stories, getting staff to undertake exercises such as walking in a patients shoes or service safaris should also be considered to further develop staff awareness of the patient experience. 6. RCHT is more proactive in its communication with staff in times of bad or difficult news to ensure that staff are appropriately briefed and able to reassure patients. 7. RCHT gynaecology services conduct a review of information displays and the current use of noticeboards to discover if there are more effective ways of conveying important information to patients. 8. RCHT gynaecology services explore ways of informing patients and visitors to their wards and departments who wears which uniform, particularly nursing uniforms e.g. posters. 9. A redesign of the interview proforma to cover outpatient experiences on a dedicated form is advised.

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8. Appendices
Appendix 1 Terms of Reference RCHT GYNAECOLOGY SERVICE: PCT-SPONSORED CURRENT PATIENT EXPERIENCE REVIEW CONDUCTED BY THE PATIENTS ASSOCIATION TERMS OF REFERENCE Parties Patients Association (PA) Cornwall and Isles of Scilly Primary Care Trust (PCT) and Kernow Clinical Commissioning Group (KCCG) Purpose of the review The aim of the exercise is to reassure the public about the quality of the care in this department. We will also seek to learn from any negative experiences. Ownership of the review This review is being carried out by the Patients Association as an independent body, on behalf of the Primary Care Trust. The PCT owns the findings of the review and the resulting report and reserves the right to publish it at a time appropriate, in conjunction with other reviews of the service. The Patients Association commits not to use the findings, interviews or report for its own purposes without consulting the PCT (or its successor body, Kernow Clinical Commissioning Group). Process The PA will go into gynae wards/clinics at RCHT on two occasions and seek out women who would like to share their experience of the treatment. The PA will then conduct telephone interviews after the women have left hospital using a proforma (attached). The PA will write an anonymous report sharing the experiences and views of the patients who were interviewed. They expect to interview between 10 and 15 women. They will report in draft to the PCT by 14 December. Terms - The PA has agreed to allow two days of consultancy time free of charge as part of our ongoing relationship. Any time spent over that will be charged to the PCT at a rate to be agreed but not exceeding 500 per day.

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Appendix 2 Table 1. Interview results QUESTION NOT APPLICABLE SECTION 1: BEFORE ADMISSION OR OUTPATIENT ATTENDANCE Were you able to park easily? 13 1 (7%) 2 (93%) Were you able to find the 16 ward/department you were (100%) going to easily? Did you receive information before your visit regarding your outpatient appointment/admission to hospital? 15 (100%) 1 YES NO OTHER

SECTION 2: YOUR ADMISSION OR OUTPATIENT ATTENDANCE On arrival to the ward/OP dept. 15 1 (6%) were you welcomed by staff in (94%) the way you would have expected. For example did staff smile and make eye contact with you? How did the ward feel and what was the atmosphere like? Did the ward look clean and tidy? Did you feel safe on the ward? SECTION 3: YOUR STAY Did you find the information displayed on the ward/OP dept. helpful and reassuring? If yes, please tell us what information you saw? Was there anything about the ward or department that made you feel less confident? Did you see or experience anything on the ward that made you worry about safety? If yes, please tell us what this was. 3 (19%) 1 (6%) 13 (81%) 15 (94%) 10 16 (100%) 16 (100%) 16 (100%) Did not notice 5 good (31%) 2 poor (13%) 9 acceptable/ok (56%)

10

Were you able to easily identify 7 (44%) staff and the roles they perform?

4 (25%)

5 unsure (31%)

13

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If you needed to use the call bell, could you reach it? If you needed help with eating and drinking was there a member of staff who could help you? Was your food and drink left within easy reach? If you experienced pain whilst you were in hospital was it well controlled at all times? Did staff return and check that pain relief was effective? Did you feel that you (and your carers) were involved in your care? Did you feel your privacy and dignity was respected at all times? For example, were curtains always fully drawn around your bed when required? Did you feel that other patients around you were treated with dignity and respect? Did you feel that your confidentiality was respected and if so how? Did the ward feel calm or busy? Did you feel that the nurses cared and had time for you? Was there a member of staff who made a particular impression on you? Please tell us what it was that made them memorable for you? SECTION 4: GOING HOME Were you given clear information and involved in the arrangements for leaving hospital and going home? If you were told a time that you could go home? Were you able

5 (83%) 1 (100%)

1 (17%)

10 15

6 (100%)

10

16 (100%) 15 (94%) 1 (6%)

13 (81%) 16 (100%)

3 Did not see (19%)

9 Busy (56%) 4 Calm (25%) 3 Both (19%) 13 (81%) 10 (62.5%) 3 (19%) 6 (37.5%)

6 (86%)

1 (14%)

5 (83%)

1 (17%)

10

14

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to leave home on time or did you have to wait? If you did have to wait, please tell us why. Were you given clear information about any follow up appointments or what to do if you had questions or concerns after leaving hospital? Based on your recent experience, would you be happy for a friend or member of your family to be treated at RCHT? Was your overall care and treatment at RCHT better or worse than you expected? Please say why. 12 (92%) 1 (8%) 3

13 (81%)

3 (19%)

Better 4 (25%) Worse 3 (19%) As expected 9 (56%)

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Appendix 3 Staff and Patient Letters For Patients RCHT Gynaecology Services 23 November 2012 Cornwall and Isles of Scilly Primary Care Trust Zoe Howard Head of Communications NHS Cornwall and Isles of Scilly Sedgemoor Centre Priory Road St Austell Cornwall PL25 5AS zoe.howard@ciospct.cornwall.nhs.uk 01726 627892

Dear Patient NHS Cornwall and Isles of Scilly (the Primary Care Trust) in conjunction with the Patients Association is conducting an independent assessment of patient experience in the Gynaecology Service at Royal Cornwall Hospitals NHS Trust (RCHT). Lynn Dunne, South West Regional Manager for the Patients Association, is visiting the gynaecology wards and outpatients department to speak to patients and would like your permission to contact you at a later date after you have left hospital. All conversations will be confidential and feedback to the Primary Care Trust and RCHT will be completely anonymous. Your anonymous comments and feedback will also form part of a report back to the NHS South of England. A summary of the findings will be available on the Primary Care Trust website www.cornwallandislesofscilly.nhs.uk If you have any questions or concerns, please contact: 1. Lynn Dunne, South West Regional Manager, The Patients Association Mobile: 07527 362 107 Email: Lynn@patients-association.com Thank you in anticipation for your contribution to this important work. Yours faithfully

Zo Howard Head of Communications

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For Staff RCHT Gynaecology Services 23 November 2012

Cornwall and Isles of Scilly Primary Care Trust Zoe Howard Head of Communications NHS Cornwall and Isles of Scilly Sedgemoor Centre Priory Road St Austell Cornwall PL25 5AS zoe.howard@ciospct.cornwall.nhs.uk 01726 627892

Dear Colleagues NHS Cornwall and Isles of Scilly (the Primary Care Trust) in conjunction with the Patients Association is conducting an independent assessment of patient experience in the Gynaecology Service at Royal Cornwall Hospitals NHS Trust (RCHT). Lynn Dunne, South West Regional Manager for the Patients Association, will visit the gynaecology wards and outpatients department to speak to patients and will gain their permission to contact them at a later date after they have left hospital. All conversations will be confidential and feedback to the Primary Care Trust and RCHT will be completely anonymous. The anonymous comments and feedback will also form part of a report back to the NHS South of England. A summary of the findings will be available on the Primary Care Trust website www.cornwallandislesofscilly.nhs.uk If you have any questions or concerns, please contact either: 1. Zo Howard, Head of Communications, NHS Cornwall and Isles of Scilly, Sedgemoor Centre, St Austell. Phone: 01726 627892 Mobile: 07919 995189 Email: zoe.howard@ciospct.cornwall.nhs.uk 2. Lynn Dunne, SW regional manager, The Patients Association Mobile: 07527 362 107 Email: Lynn@patients-association.com Thank you in anticipation for your help and cooperation in this important work. Yours faithfully

Zo Howard Communications

Head of

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Appendix 4 Interview Proforma Introduction Thank you for agreeing to take part in this patient feedback survey for the gynaecology services at RCHT. Please use the diary to make notes about your care. Lynn Dunne, SW regional manager, The Patients Association, (07527 382 107) will contact you as agreed to talk to you about your experiences. Please be assured that the Patients Association are a completely independent charitable organisation with 50 years of experience in Listening to Patients and Speaking Up for Change. Your personal details will not be shared with anyone and your anonymity is guaranteed. Thank you very much for participating in this programme. If your hospital admission was planned please complete your diary starting with section 1. If your admission was unplanned please start your diary from section 2. Please give us your comments on the following: Section 1: Before your admission Were you able to park easily?

Were you able to find the ward/department you were going to easily?

Did you receive information before your visit regarding your outpatient appointment/admission to hospital?

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Section 2: Your admission or outpatient attendance On arrival to the ward were you welcomed by staff in the way you would have expected. For example did staff smile and make eye contact with you?

How did the ward feel and what was the atmosphere like?

Did the ward look clean and tidy?

Did you feel safe on the ward?

Section 3: Your stay or outpatient attendance Did you find the information displayed on the ward helpful and reassuring? If yes, please tell us what information you saw?

Was there anything about the ward or department that made you feel less confident?

Did you see or experience anything on the ward that made you worry about safety? If yes, please tell us what this was.

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Were you able to easily identify staff and the roles they perform?

If you needed to use the call bell, could you reach it?

If you needed help with eating and drinking was there a member of staff who could help you? Was your food and drink left within easy reach?

If you experienced pain whilst you were in hospital was it well controlled at all times? Did staff return and check that pain relief was effective?

Did you feel that you (and your carers) were involved in your care?

Did you feel your privacy and dignity was respected at all times? For example, were curtains always fully drawn around your bed when required?

Did you feel that other patients around you were treated with dignity and respect?

20

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Did you feel that your confidentiality was respected and if so how?

Did the ward feel calm or busy?

Did you feel that the nurses cared and had time for you?

Was there a member of staff who made a particular impression on you? Please tell us what it was that made them memorable for you?

Section 4: Going home Were you given clear information and involved in the arrangements for leaving hospital and going home?

If you were told a time that you could go home? Were you able to leave home on time or did you have to wait? If you did have to wait, please tell us why.

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Were you given clear information about any follow up appointments or what to do if you had questions or concerns after leaving hospital?

Based on your recent experience, would you be happy for a friend or member of your family to be treated at RCHT?

Was your overall care and treatment at RCHT better or worse than you expected? Please say why.

Thank you for taking the time and trouble to participate in this review.

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The Royal Cornwall Hospital Trust Obstetrics and Gynaecology Service

Rapid Responsive Review 10th January 2013

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1. Foreword The purpose of a Rapid Responsive Review is to seek immediate assurance, where concerns have been raised about a service that potentially could have an adverse impact on patient safety. This Rapid Responsive Review provides an opportunity to review the patient pathway in Obstetrics and Gynaecology, and assess safety and quality. Based on the Review teams findings, it will make recommendations that aim to benefit the women of Cornwall and the Isles of Scilly and provide support to the Royal Cornwall Hospitals Trust (the Trust), in championing safety and quality. The methodology provides a clear framework for the commissioners of the review, utilising a structured and systematic process which allows the use of hard data provided by the Trust as well as the Royal College of Obstetricians and Gynaecologists, triangulated with patient feedback and experience and staff vision and opinion. It is important to state that the scope of the Review did not include assessment of the performance of individual clinicians. The leadership of clinicians from within the area which the Trust serves, as well as the Strategic Health Authority, provides a patient-centred focus on quality and safety with additional expertise and insight provided by specialists external to the region. The onus on Trust management to maintain and improve productivity must be complemented by the duty to achieve the best outcome for each and every patient. The report, whilst jointly carried out by representatives of several organisations, is the property of NHS Cornwall and Isles of Scilly, the Primary Care Trust, as the commissioner of the Rapid Responsive Review.

Dr Shelagh McCormick Medical Director and PEC Chair NHS Cornwall and Isles of Scilly

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2. Executive Summary This Rapid Responsive Review sought to assess the safety and quality of the Obstetrics and Gynaecology service provided to the majority of the women of Cornwall and the Isles of Scilly by the Royal Cornwall Hospitals Trust (the Trust). The Review team visited the Gynaecology ward (Tolgus), Antenatal (Wheal Rose) and Postnatal (Wheal Fortune) wards, Delivery Suite, Gynaecology outpatients, and Neonatal Intensive Care Unit at the main RCH site, plus the Penrice birthing suite and outpatient clinic at St Austell Hospital. As well as visits on the day of the Rapid Responsive Review, unannounced visits were made to the maternity wards, Tolgus, and Delivery suite on four other occasions within a week of the planned visit. Overall the review team found no compelling evidence to find that this was an unsafe service. However in Gynaecology, we found areas where the patient experience could be improved. In Obstetrics, where the Trust is not alone in experiencing the national increased pressures on Obstetric units and is often working close to capacity, the Review team identified actions that will accentuate quality and safety and reduce risks further. As part of preparation for the Review, the team scrutinised all available data provided by the Trust on safety and quality indices. The Review team found a high level of engagement by staff in all clinical areas, who demonstrated loyalty and commitment to the Trusts clinical strategy, from Board level down. We found some evidence of communication difficulties between staff and management and we observed there to be a disconnect between senior medical staff in the Obstetrics and Gynaecology department which could derail the Trusts future vision. However we also heard of the Chief Executives high visibility and approachability from staff at all levels. On Tolgus Ward we found privacy and dignity issues and were concerned that male urology patients, although in separate bays, were being nursed on the same ward as gynaecology inpatients. There were also environmental issues, with poor facilities for breaking bad news, and for examination of gynaecology patients out of hours, along with inappropriate signage and confidential patient information on public display. We found no safety issues on Tolgus ward and were impressed with the commitment of the staff and their plans to improve the environment, so far thwarted by winter pressure management. The Trusts Development plans for Tolgus ward have been shared with the Review team and will, when implemented, significantly improve the environment on the ward. The team recommends that the timescale of change be expedited. In Obstetrics, the outcomes of the Trusts Obstetric unit are excellent with low rates of LSCS, high levels of patient choice of place of delivery, and high levels of womens satisfaction with care received, all compared to the regional averages. However on the Obstetric unit we found cause for concern. We heard first hand about staffing pressures and recruitment difficulties, and observed midwifery staff managing caseloads with levels of staffing that the Review team felt had the potential to expose staff, women and their babies to risks. These risks are not shown by routine recording and evaluation. We were informed of midwifery staff working at

APPENDIX 7

capacity, with long hours and overtime worked to support the close-knit team. We were made aware of the Clinic Site Development Plan and also that the numbers of midwifery staff had been identified as inadequate. Eleven additional midwives have already been recruited, but they are not yet in post due to factors outside of the control of RCHT. We observed some suggestion of a culture of reluctance to escalate concerns by some staff. We found that efforts are made by Risk Management clinicians to gather complication data and present it meaningfully to medical staff but that the systematic analysis and governance requires investment and IT support in order to provide robust assurance of the safety of the department going forward. We also noted that not all consultants have engaged with the commissioning needs of the local population and RCHTs responsibilities to respond. Coupled with this we noted that the department will need to review medical staff planning in the light of mid-grade staff shortages and longstanding recruiting difficulties and future NHS plans for seven day consultant cover The Review team has made its recommendations broadly under the following categories: Privacy and Dignity, Clinical Quality and Service provision, Adequate staffing levels Cultural issues. We hope that the Trust will urgently review its development plans in the light of this report, and that it will continue its efforts to harness the expertise and enthusiasm of its clinical staff, as well as the patient voice, in order to achieve the best possible service for the population it serves.

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3. Background The Royal Cornwall Hospital Trust is the sole acute secondary care provider for 80% of the population of Cornwall and the Isles of Scilly, some 400,000, with the remaining population accessing services from Derriford Hospital in Plymouth and a small number from North Devon District Hospital in Barnstaple. The Board of RCHT has been in some flux over recent years, with its Chief Executive being in post for 12 months, with an interim period prior to that. The Director of Nursing is interim and has been in post for six months and the Medical Director has been in post for three years. Prior to that there had been a number of Chief Executives, with resultant instability. The Obstetrics and Gynaecology department is predominantly based at the main site at the Royal Cornwall Hospital in Truro, with outpatient facilities and a small midwifeled birth unit (Penrice) at St Austell and a further small unit in Helston. The majority of gynaecological surgery is undertaken at the RCH site, with some services at the West Cornwall Hospital. The birth rate is rising, with just under 5,700 births in Cornwall in 2011/12, of which 82.6% (~4700) were the responsibility of the RCHT. The Royal College of Midwives is actively campaigning for the NHS to recruit many more midwives into the service, in the light of the rising birth rate nationally and increasingly complex caseload. In November 2012, the commissioner, NHS Cornwall and the Isles of Scilly, its successor organisation Kernow Clinical Commissioning Group, and NHS South of England (previously the Strategic Health authority) were informed by the Royal Cornwall Hospital Trust that it was about to undertake a Clinical Notes Review looking back over two-and-a-half years, reviewing the work of a particular gynaecologist whose work had been giving cause for concern. This gynaecologist has now left the Trust and had taken retirement, including voluntary erasure from the GMC. The Trust also advised that there had been a number of reviews over the past decade including two external reviews, the most recent being a Royal College of Obstetrics and Gynaecology review in January 2012, which had directly led to the need for the Clinical Notes review. The RCOG report raised concerns about the handling of the previous reviews by the Trust. Investigation into the governance of the Trust is outside the scope of this review, but is the subject of a separate external organisational report. Consideration was given to the current service provided by the Trust in Obstetrics and Gynaecology, and the commissioner, in partnership with NHS South, initiated a Rapid Responsive Review in order to satisfy itself of the safety and quality of the service.

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4. Scope of the Enquiry and structure of the visit. The Rapid Responsive Review team was led by the Medical Director of NHS Cornwall and Isles of Scilly, supported by the PCTs Director of Nursing. The Chair of Kernow Clinical Commissioning Group provided a local GP presence. The team also included the Deputy Director of Public Health and the Associate Director of Patient Safety from NHS Southwest, and the Local Supervising Authority Midwife for the region. We also included three clinicians from out of the region, with a senior obstetrician and gynaecologist who is a previous RCOG Honorary Secretary, a gynaecology matron, and an independent consultant ,midwife, previously NMC Head of Midwifery. 4.1 Interviews and discussions. The team undertook a series of formal interviews with senior members of staff and also spoke with a cross-section of other staff. We met with: The Chief Executive The Medical Director The Director of Nursing (Interim) The Divisional Director for Womens and Childrens Services The Specialty Director for Gynaecology who is also the District College Tutor for Obstetrics and Gynaecology The Clinical Lead for Obstetrics The Risk Management Lead Clinician for Gynaecology The Divisional Nurse and Head of Midwifery The Midwifery Matron The Responsible Officer The Theatre Matron and Manager of Tower Block theatres jointly A Consultant Gynaecological Oncologist The Senior Obstetric Anaesthetist The Senior Gynaecology Anaesthetist Two training grade junior doctors in a joint interview. The Contact Supervisor of Midwives These interviews focussed on key lines of enquiry about the Clinical Strategy of the Trust and how widely it is understood and embraced at Board level and below, and also sought to understand the following: How concerns about clinical performance are raised and escalated and to whom How are concerns triangulated with appraisal outputs to facilitate the process of Medical Revalidation How the recommendations in the previous external review have been taken forward What benchmarking of clinical behaviour against others has been undertaken What assessments of skill mix have been undertaken and how has it been acted upon. Where does the responsibility for clinical safety lie and how is this assured? How do the Obstetrics and Gynaecology services work with other departments within the hospital in order to streamline patient flow?

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How do workforce plans meet current and projected need? The team also met with numerous staff informally including the Gynaecology Matron and nursing and midwifery staff from Tolgus ward, Wheal Rose, Wheal Fortune, the Delivery Suite, the Neonatal Intensive Care Unit, and Gynae outpatients. We also spoke opportunistically to patients and their relatives on these wards. These dialogues were mainly concerned with ascertaining information about; Reporting of significant incidents in clinical areas Escalating concerns about safe levels of staffing to management and the responses. The Rapid Responsive Review team is grateful to all the people whom we interviewed, both formally and informally, for their cooperation and willingness to share information with us. 4.2 Briefing Packs for the review team In anticipation of the visit the Review team requested information from and about the Trust in order to inform the key line of enquiry. This information included: The latest Dr Foster hospital guide and a Public Health analysis of the information relevant to gynaecology The South West Regional Quality assurance Reference Centre Cervical Screening Quality assurance Visit report from 6&7 Dec 2011 and subsequent audit reports The National NHS Staff Survey for RCHT for 2011 The Acute Trust Quality Dashboard provided by NHS midlands and East Quality Observatory for Autumn 2012 Data from United Kingdom Gynaecological Oncology Surgical Outcomes and Complications audit as reported in preliminary analysis in November 2011. The CQC Quality and Risk Profile for RCHT November 2012 The Divisional Quality Quarterly report for Womens and Childrens Division, RCHT, Quarter 4 Jan-March 2012 The Clinical scorecard for Maternity services Summary report on Dr Foster Perinatal Mortality Review prepared for RCHTs Governance Committee Data for Maternity Provision prepared by the commissioner for the Overview and Scrutiny Committee Report from NHS South West Local Supervising Authority for CNST Data from NHS South Maternity survey of user experience 2012 RCHTs patient surveys for Maternity services Examples of and list of clinical audits taken part in by the Obstetrics and Gynaecology Department PCT-commissioned review of patient experience and feedback in gynaecology services undertaken in December 2012 in response to the initial concerns which were raised as part of this Review. Report of the External review undertaken in 2010 of the Benign gynaecology Service. Nursing Metrics Summary of workforce Minutes of Gynae Risk management meetings since 2010

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Datix reports relevant to Obstetrics and Gynaecology Job Plans for Consultants List of Outpatients clinics provided. RCOG Standards documents for Obstetrics and gynaecology Obstetric Anaesthetic guidelines Responsible Officer regulations 4.3 Unannounced clinical visits The Review team visited the Royal Cornwall Hospital main site on the day of the Rapid Responsive Review and visited all the Obstetric and Gynaecology wards, Delivery Suite, and Neonatal Intensive Care Unit in small groups. We also made four separate unannounced visits to the main site, two of which were out of normal working hours, and one unannounced visit to the Penrice Birthing Unit and outpatient clinic at St Austell Hospital. The Trust was aware that the Review team would be making unannounced visits but not where or when these would take place. On contacting the Trust, we were welcomed each time and offered a senior member of staff to accompany us should we require it. 4.4 Limitations Whilst the Review team visited as many areas and spoke to as many members of staff as possible, we are aware of the limitations that may creep into drafting such a report as this is based on a relatively short snapshot visit to the Royal Cornwall Hospital. We have therefore chosen to offer observations and reflections in many areas, rather than directives and statements of fact. We have offered some recommendations based on strong evidence when it has been obtained from several sources or when we have ascertained facts ourselves. Where we have made observations which may be outside of the scope of the visit, but which we believe would add value to the report and help inform the Trust, we have included them as headline recommendations.

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5. Summary of findings The following provides feedback from the review team based on information assimilated from the review of data received, the planned visit, and associated unannounced visits. 5.1. Review of data The Review team received and reviewed a large amount of data from the Trust in preparation for the visit. Where possible, we sought to benchmark this data against national standards. This proved difficult due to the absence of such standards in many areas, particularly complications of gynaecological surgery. Having sought advice from the Royal College of Obstetricians and Gynaecologists we looked at the data with reference to the RCOG documents Standards in Gynaecology and Standards for Maternity Care and the joint Association of Anaesthetists of Great Britain and Ireland and Obstetric Anaesthetists Association Guidelines for Obstetric Anaesthetic Services. We also referred to the Child and Maternal Health Observatory tools. We were able to note the following from our scrutiny of the data. Firstly it is evident that the Obstetrics and Gynaecology department takes part in a large number of audits, mostly internal (NICE or RCOG), but some regional and national, and we noted the involvement of the Gynaecological Oncologists in contributing to the UKGOSOC audit of complication rates in Gynaecological Oncology surgery which aims to set benchmarking standards. The Trust also contributed to the National Heavy Menstrual Bleeding audit of July 2012 although we noted the very low recruitment rate comparatively. On reviewing the Acute Trust Quality Dashboard (Autumn 2012) with respect to the Obstetric and Gynaecology service, we noted that the readmission rate of babies within 30 days of delivery is worse than expected by chance (2SD from mean). Generally, most indicators (relating to the Trust as a whole) were within the expected range, however we noted that the rate of patient safety incidents reported and the rate of serious harm incidents reported are below the national mean. We include this as it is relevant to some of our feedback received during the visit. Organisationally, we noted that the sickness rate of nursing staff was high, whereas the sickness rate of midwifery staff was very low on comparison. We reviewed the Cervical Screening Quality Assurance Reference Centre report from their visit in December 2011 and some correspondence related to queries. The initial report suggested some recommendations, all of which apart from four were implemented fully and the remainder of which are in progress. The service has flagged up no concerns and is considered to be safe. Following a Dr Foster HSMR and relative risk alert, the Trust had reviewed its relatively high number of Perinatal Deaths of unspecified cause. The conclusions confirmed that coding is consistent with other Trusts in the South West which are also recording red-rated numbers, and overall raised no cause for concern. The cause is unclear but may be that RCHT codes more cases in this way rather than give a presumed but not conclusive diagnostic code. We reviewed the November 2012 Quality and Risk Profile and noted the following themes across the Trust: Staff reported generally low morale, with low levels of job satisfaction, low levels of staff feeling satisfied with the quality of patient care offered, low rate of staff reporting effective team working, and low levels of staff feeling that

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the Trust provided opportunities for career progression or promotion. There were many red-ratings in Outcome 14 which is concerned with supporting staff. Outcome 16 , which assesses and monitors quality of service provision, red-rated the fairness and effectiveness of procedures for reporting errors, near misses and incidents, and also the proportion of staff who felt able to contribute towards improvements at work was low. The National NHS Staff survey 2011 repeated these findings with the Trust being in the lowest 20% of similar Trusts for staff engagement, and also for the friends and family questions. The bottom ranking scores overall reflected pressure of work felt by staff, percentage of staff suffering work-related stress in the past 12 months, and the percentage of staff who were satisfied with the care they were able to give and with opportunities to develop their potential at work. We are aware that the Chief Executive has already taken active steps to improve these findings with her Listening to Action programme and our visit reflected this clearly. We were told that the latest survey, as yet unpublished, demonstrates improvement in this area. We reviewed two patient surveys, the Trusts in-house survey from December 2009 to March 2012, and the National Maternity Survey of 2010. The overall themes were levels of pain control, communication with clinical staff and waiting times generally for inpatients, with comments on staffing levels also being a theme, especially on Tolgus ward. The number of returns was variable and very low in some months. We asked for further breakdown about patient responses about staffing by ward but were unable to identify any specific concerns about Tolgus. We also commissioned an independent Patient Experience Survey in Gynaecology Services which was undertaken in December 2012 by the Patients Association. This survey was small, with only 16 patients interviewed. However the overall outcome was that overall patient experience was positive (13), with those who were dissatisfied (3) reporting issues with poor communication, and one incident concerning dignity. Three patients felt their care was worse than expected, but 13 said that they would be happy for a member of their family to be treated at RCHT based on their experience. The Review team felt that the results should be treated with caution in view that it was not a representative sample. The Dr Foster data has not yet been validated and although it was analysed by a Public Health consultant for the PCT, it gave limited insight into the safety of the current service as the data covered the period when the now-retired gynaecologist was still in practice. In view of our awareness of the lack of attributable complication rates to individual consultants it is therefore not contributory. The Clinical Negligence Scheme for Trusts was last assessed in 2010 and the Trust achieved level 2, and is due for reassessment this year when it is hoping to achieve Level 3 for Maternity. The NHS South of England Survey of Womens Experience of Maternity Services 2012 was reviewed. The RCHT has lower than average rates of planned and emergency Caesarean section and assisted births. The womens positive responses to questions about involvement with birth decisions and choice were always above the average. On reviewing the paper on Maternity Services in Cornwall and the Isles of Scilly, presented to the Overview and Scrutiny Committee in December 2012, we were able to glean a picture of the service albeit some of the data goes back to 2010/11.

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We noted that the Royal College of Midwives recommends a ratio of one midwife for every 28 hospital births and one to 35 for community births and birth centres. The ratio for RCHT for Quarter 1 of 2012 is 1:32. National policy identifies that maternity services should develop the capacity for every woman who is in established labour to have a designated midwife provide supportive care for her during labour.. For Q1 of 2012, RCHT achieved this 1:1 care 98% of the time. The RCOG publication the Future Role of the Consultant suggests that there should be 40 consultant hours a week present on Delivery suite in a unit delivering fewer than 5000 births per year, and Q1 data 2012 indicates that RCHT had 45 consultant hours per week. During the visit we looked at the Trusts own Clinical Scorecard for Maternity, which is a live document updated month by month. When we visited we were given the most recent version with November 2012 completed. The trend over the year since April 2012 was examined. The numbers of women not receiving 1:1 care in labour has only been recorded since October and November and were 11.5% and 9.4% respectively which is of concern, although still high compared to other units across the South West. We also looked at the shift escalation pattern and noted that there were regularly shifts where the escalation policy was triggered but that the numbers were steadily coming down, with 28 in April 2012 but only 1 recorded in Nov 2012. However, the number of shifts where the labour ward co-ordinator was not supernumerary have only been accurately recorded since October 2012, We also noted that there is a steady birth rate on the antenatal ward of 4-6 nonprecipitate births per month, which was consistent with our feedback on the wards. 5.2 Interviews with staff Formal interviews were held with a broad range of staff from Board level down through the Womens and Childrens Directorate, focussing on the Obstetrics and Gynaecology department. 5.2.1 Chief Executive, Medical Director, Director of Nursing (interim) All Executive Directors were interviewed about the Trusts Clinical Strategy, particularly with reference to the plans to develop the Obstetrics and Gynaecology Department. Chief Executive The Chief Executive spoke knowledgeably about the history leading up to the suspension of the gynaecologist and subsequent need for the Independent Clinical Notes Review, and acknowledged the anxieties around the safety of the service. She spoke in detail about the plans to rebuild the department, with a midwife-led unit alongside the Delivery Suite. There was also a recent bid for monies to build a new additional midwife-led unit at West Cornwall Hospital which, if implemented, will support the main site in meeting the rising birth rate in Cornwall. She stated that the current facilities for both Obstetrics and Gynaecology need upgrading, and that in the maternity wards the bathroom facilities are very small, and that this is planned, as part of major development plan. The gynaecology ward, Tolgus, is currently shared with male urology patients and medical outliers and the environment on the ward is not as it should be. She stated that ideally there would be a dedicated gynaecology ward in the development plan. The Chief Executive advised that a shortfall in midwifery staffing had been identified due to the increasing birth rate and that the Trust had successfully recruited 11 additional midwives.

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The Chief Executive explained that clinical leadership had not been very visible previously in the Trust and that she required her clinical leaders to demonstrate visibility. She expects her Divisional Directors to have regular appraisals and be able to demonstrate that they are keeping up to date and that they interact with other executives and directors. She also expects them to keep her informed and advised of issues and escalate where appropriate to the Board. She now has a management structure in place through which leadership can be cascaded, but she acknowledged that this has been lacking, with instability at both Board level and within the Obstetrics and Gynaecology department. The Chief Executive stated that she has identified that the obstetricians and gynaecologists need to be united by strong leadership both within their ranks and external, to build a strong united team. She felt that these issues were not replicated within other directorates and felt confident that her relationship with these other clinicians is strong. She appoints the Divisional Directors herself. The Chief Executive outlined the poor Staff Survey results and what she has done to date to address these. By emphasising communication and listening she felt that there was beginning to be a sea-change in staff morale for the better. She spoke about the practice of nurses working twelve hour shifts and stated that she had some concerns about staff becoming tired towards the end of the shift but that the shift pattern is popular with some staff nonetheless. The Chief Executive described in detail the data on safety and quality which is available to the Board and stated that this is a high priority. She stated that there is a five year plan which identifies cost efficiency savings and that this is subject to quality assurance which includes clinical input via the Clinical Cabinet. The Chief Executive stated that the findings of the 2010 Benign Gynaecology Report which had led to an action plan overseen by the Medical Director, and requiring feedback to the commissioner, had not been presented to the Board. The Chief Executive stated that she would in future require that all external reviews were presented to the Board. She also stated that there had been a delay in the Trust deciding to instigate the Independent Clinical Notes Review as the RCOG report in 2012 had made no recommendations about how to proceed and it had been necessary to pursue this with the RCOG. The Chief Executive confirmed that the process of dealing with a second gynaecologist whose practice was currently restricted was independent of the Independent Clinical Notes Review. Medical Director The Medical Director stated that there is a high level Clinical Strategy for the Trust, giving a very detailed plan. He stated that there is no plan to provide tertiary level benign gynaecology services. The five year plans had identified that the rising birth rate required increased capacity for maternity services, hence the need to enhance the service offered on site and at Penrice. The Medical Director outlined the changes that had occurred so far and stated that the restrictions of the physical space were difficult to overcome.

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When questioned about safety, the Medical Director stated that he feeds back regular reviews and updates on maternity and gynaecology to the Board but that metrics would not go to the Board but to the Finance and Performance Committee meeting, along with reviews of the assurance framework, operations finance and quality reports. The Medical Director stated that it was difficult to establish standards to benchmark against in gynaecology because they have not yet been standardised. However he had asked for data about complication rates for each consultant in gynaecology after the 2010 review, and had received data related to urological complications from gynaecological surgery. The Medical Director stated that when gynaecology inpatients were relocated from Wheal Agar to Tolgus ward the trained nursing staff transferred also and had not been moved elsewhere by the Trust. He was aware broadly of the concerns of the Review team about privacy and dignity on Tolgus ward. The Medical Director stated that he felt Obstetrics was a safe service about which he had no concerns, but that Gynaecology continued to have relational difficulties which required a strong leader to address within the department. He considered that that leader is now in post. The Medical Director stated that a monthly report on individual doctor performance concerns goes to the Strategic Health Authority, but that he did not report these until they had been investigated and substantiated. In respect of the 2010 review around Benign Gynaecology services, the Medical Director stated that he had not been given any handover from the previous Medical Director who had resigned without notice, and was therefore unaware of the previous investigations until new concerns had been raised. The Medical Director stated that he considered that the commissioners Professional Executive Committee (at which the Benign Gynae Action Plan, written as a response to the 2010 investigation, had been presented and signed off as closed in July 2012) was not an appropriate forum to raise any other concerns about the service, particularly if the performance investigation had not yet been completed and had therefore not come to any conclusion. Director of Nursing The Director of Nursing spoke about the environment on Tolgus ward and advised that many of the trained gynaecology nursing staff who had worked on Wheal Agar had left after the move to Tolgus ward. He acknowledged that the mixing of gynaecology patients with male urology patients, vascular and medical outliers is undesirable. He spoke about the skill mix assessment and the recruitment of additional midwifery staff and that he had not had difficulty in engaging with the Clinical Governance Committee. He stated that his two main areas of concern are the environment, privacy issues on Tolgus ward, and the need to use it for medical outliers. He stated that complaints from patients were low on the ward, but he considered that the ward although compliant with the mixed sex guidelines is unsatisfactory given the nature of the medical conditions of the women being nursed on the ward. 5.2.2 Consultants, Divisional Director, Specialty Leads and Junior Medical staff

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Divisional Director, Specialty Leads and consultants felt that the Obstetrics and Gynaecology services are safe, but all felt that the environment on Tolgus ward was not acceptable, however stated that they understood that there was no alternative at the moment to a mixed sex ward. They stated that the standard of nursing care given to patients was excellent but that organisationally there was not always enough specialist gynae-trained nursing expertise available, although the rota tried to have one nurse available for every shift. Nonetheless all stated that whilst not considered to be unsafe, organisational standards on the ward had dropped since move to Tolgus. The Divisional director and Specialty Leads spoke about the relationship difficulties within the consultant body, but stated that this did not affect the service to patients. When asked about complication rates, the Consultants all advised that these were collected. The Gynaecology Risk Management Lead stated that these were collected on a spreadsheet but that without the supporting information needed - such as numbers and types of operations broken down by individual - there was limited scope for interpretation of this information. She stated that she had not been asked to produce this information until this review. She stated that she would need IT support and more time to work on the spreadsheet but would be willing to do so. She stated that she had not become aware of any outliers by collating the complication rates. Whilst complications and significant incidents were being reported on the Datix system, this is not being accurately entered by clinician, and complications that may occur after the initial few days including readmissions, are not necessarily brought to the relevant doctors attention. The Obstetric Lead stated that she had become aware of a potential outlier (the nowretired gynaecologist), about whom she had raised concerns, through her own risk management processes, and through monitoring the monthly maternity dashboard. She felt confident that she would be listened to if she had any concerns and would approach the Chief Executive directly, and this was echoed by the other Consultants with whom we spoke. There were doubts expressed by several individuals as to whether all the consultants would be willing to cooperate with collection of and analysis of complication data but it was considered that with Medical Revalidation now started, this would add impact. There was a general view that not all medical staff behaviour supported a clear clinical strategy for the department both now and retrospectively. In particular, some individuals expressed concern that the laparoscopic surgery done at the RCH, whilst progressive, may not allow the Trust to provide the correct balance of gynaecological services required to meet the needs of the population. The Review team is also aware that this surgery is not commissioned by the PCT. All acknowledged the midwifery staffing issues and that with the rising birth rate and the increasing complexity of womens health needs, the facilities were no longer adequate. All welcomed the Development plans for Obstetrics and Midwifery, and Tolgus ward, but felt that they were not happening soon enough. The Gynaecology Oncology consultants already had their own data collected and stated that they review this regularly, internally, and contribute to a nascent national database trial so were confident that they would identify any adverse trends at an early stage. The junior doctors stated that whilst they felt well supported by the consultants, they are hard-pressed due to difficulties in recruiting and retaining staff, and high use of locums. They felt stretched most of the time, but that patient care had not suffered.

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It has been really busy, you find yourself pulled around a bit. They stated that RCH could be a good place to learn, because of the range of services provided, but that because of inadequate staffing levels sometimes trainees did not get the opportunity to go to clinics as they were needed in theatre to assist. They stated that they had observed some delays in medications being given out on the wards and when patients are discharged, which they had noticed since the move to Tolgus ward. They stated that they were not aware of any difficulties between Consultant staff. The Obstetric Anaesthetist reported similar frustrations around staffing levels, with elective LSCSs being postponed if necessary due to pressure on Delivery Suite. She echoed the view of the junior doctors that the workload was often putting them under stress, but stated that they knew when and how to escalate, as do the Midwifery supervisors. She noted that the juniors sometimes missed training opportunities due to pressure to be somewhere else. We sought information based on the Guidelines for Obstetric Anaesthetic services document, of which she provided assurance and knowledge. We were told that there were in excess of the minimum standard of 10 PAs of anaesthetic consultant time per week. Despite this, the unit sometimes breached the recommendation of no more than 30 minutes elapsing from being called to provide an epidural, but felt confident that they could respond in an emergency. She confirmed that complaints are recorded and collated. She stated that there was a sense that the pressure had increased in the past 3 months, and that escalation is happening more often. She said I feel reassured that the coordinators would call to escalate if they felt unsafe The Gynaecology Anaesthetist reported that no conduct or competency issues with the Gynaecology service have been observed. There were some views expressed that communication difficulties exist between managers and clinicians and that some clinicians feel disempowered, and pressurised to follow Trust directives. This must be countered, however by other clinicians reporting that they felt supported and involved, and by the widespread acknowledgement of the Chief Executives visibility and commitment to improve staff morale. Concerns were expressed by several that medical staffing levels may not be adequate in the future with the predicted reduction in trainee numbers, combined with the difficulties in recruiting permanent non-consultant staff. 5.2.3 The Responsible Officer The Responsible Officer for the Trust is an associate Medical Director. He spoke knowledgeably about the current processes at the Trust, and has been instrumental in setting up appraiser training, and the creation of a dashboard which will allow reporting to the SHA. He stated that he has made recommendations to the Board that the integration of performance data needs strengthening, and that there is not currently in place a pro-active intelligence system to deal with serious complaints. The current appraisal policy is due for review in April 2013. This will need to outline the role of the RO, and to whom concerns which arise from the appraisal process are escalated.

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The RO stated that there was still work to be done on securing engagement and acceptance of appraisal within the culture of the Trust, especially with the senior Consultants. However he is confident that progress is being made. The RO advised that there is a whistle-blowing policy in place and that the Trust follows the Maintaining High Professional Standards protocol when concerns are raised. Decisions are passed to and made by the divisional directors whether to escalate further. The RO stated that he had attended a meeting with the gynaecologists and whilst there is an understandable degree of anxiety and distress, that they were being well supported especially by the Chief Executive and other managers. With regard to the raising of concerns, the RO stated that with the onset of Medical Revalidation, softer concerns would be acted on sooner, and that this would provide vigour to any Trusts processes. RCHT is no different from any acute Trust in this respect. The RO felt that the Trusts processes are more robust than previously with strengthened governance. The RO stated that if the Trust had concerns about a doctor who was leaving the Trust, it would pass those concerns on to the new RO. He stated that it would be more difficult if the doctor was transient, or worked predominately within the private sector. The RO advised that there should be a process to ensure that locum doctors have had a recent appraisal if they work in the Trust, and that new staff would have appraisals but that there is not a standard pro-forma for medical staff checks. He advised that a remediation policy exists in draft form only. The RO identified the need for him to be aware of and involved in ongoing concerns and to have access to all available information, and that where mentoring and remediation are required, this should be signed off when completed by the RO. It was noted that in most Acute Trusts, the Medical Director is the Responsible Officer, who then nominates a deputy. The RO stated that he would be willing for this change to be implemented, if it was thought necessary but had no concerns regarding the current arrangements.

5.2.4 Matrons, Senior Midwifery Management and Nursing Staff Senior Midwifery managers reported that there was a high level of commitment amongst the midwifery staff but that they are working to capacity. One said: There is a positive culture and out of several, this is the best unit I have ever worked in. Another commented however that there are challenging staffing issues. It was stated that there is an escalation policy on the Delivery Suite and that the information about how often this happens is monitored. It appears from the Maternity dashboard that escalation has reduced in frequency in the past three months, and one possible reason for this could be a new requirement for coordinators to justify the decision to escalate to the Head of Midwifery. There was some variation between the views of staff on the Delivery Suite and antenatal ward and the managers regarding how often escalation occurred and whether this was discouraged. One manager stated that the maternity Unit can be safe one hour

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and then not the next. With regard to escalating, one comment was: Staff might not always find it easy to explain why they think it is necessary. The Review team found the standard of midwifery to be excellent, however, were concerned that there were frequent occasions when the level of risk is higher than is acceptable, particularly with regard to ratio of midwives to labouring women. All staff who were questioned expressed the view that the service is safe, but that the recruitment of additional midwives and implementation of the development plan to build the midwife-led unit would be welcomed. Births are regularly occurring on the antenatal ward and during the Review births occurred on both the antenatal and postnatal wards. Clearly, women are not in the optimum environment on wards and would not be experiencing 1:1 care. Staff appeared to be frustrated about this situation and concerned about the quality and safety of the experience for women. One midwife, when asked what she would she like to change about the service, replied without hesitation increase the size of the labour ward. The senior Midwifery management were confident that staff would bring any concerns to them, and that they had no concerns about working relationships between consultants and midwives, nor any performance concerns. It was noticeable that the Maternity unit tends to manage itself, and not involve the hospital manager in any bed crises. It was explained that this is because there is nowhere else for the patients to go. One of the bed managers told us that the maternity service solves its own problems. With regard to Tolgus ward, we were advised that all new staff working on the ward are given an induction, with a list of competencies to work through, and that all staff working on the ward presently are thus trained. We were assured that there is always one nurse on duty on every shift with gynaecology nursing expertise. The managers accepted and had already identified that there are privacy and dignity issues on Tolgus ward, and we were told of the plans to move Gynae inpatients to Poldark ward with a refurbishment. 5.2.5 Theatre Matron and Manager These staff members impressed with their knowledge of their theatres and doctors, the assurance system and knowledge of and willingness to escalate concerns. One said my staff work to exceptionally high standards. They explained that they have little or no input to Delivery Suite theatre, and are rarely asked to help but would be willing to do so. They were unaware of a complex case that was taking place on Delivery Suite that day however. 5.3 Unannounced visits The Review team undertook unannounced visits to Tolgus ward, Wheal Rose, Wheal Fortune, Delivery Suite and the Emergency Department on the evening of the 9th January 2013 at 2130. Further visits to all these clinical areas plus the Neonatal Intensive Care Unit, and Gynaecology outpatients as well as the Penrice birthing unit and outpatient clinic were undertaken during the day of the 10th January. This included an unannounced visit to Delivery Suite at 0800 and again at 1830 on the 10th. The team visited Tolgus ward, Gynaecology outpatients, Wheal Fortune and Delivery suite again on the morning of the 11th , and a final unannounced visit took

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place on Wednesday 16th January, to Delivery Suite, Tolgus ward and Gynaecology Outpatients. We had no concerns about the Infertility service which therefore we did not visit. During the ward, clinic and Delivery Suite visits, the Review team spoke to a wide cross-section of staff and some patients also. A separate survey had been commissioned as part of the preparation for the Rapid Responsive Review and was carried out in December 2012. There was universal praise for the staff from patients on all wards. The Review team walked the pathway through ED up to Tolgus ward and subsequently visited the Emergency Gynae Unit in Gynae Outpatients. Although there seemed to be several possible pathways for patients to flow through, all staff from ED onwards knew exactly which patients should be seen in what location and when. The gynaecology inpatient ward is Tolgus, in the tower block. The ward used to be on Wheal Agar which is adjacent to the Princess Alexandra Wing, where the obstetric wards are located, but was moved in anticipation of major redevelopment plans for the hospital. The Clinical Site Development Plan will, when implemented, see the ward moved to Poldark ward on the 3rd floor, where it will be co-located with theatres. However the plans as they currently exist in draft form still have the gynaecology beds co-located with male urology beds, although the re-design attempts to keep the two sub-wards separate, but with no separate entrance to each sub-ward. The Review team found that Tolgus ward staff worked very hard to keep standards high under difficult circumstances, due to the ward having to flexibly increase the number of beds to accept medical outliers during winter pressure on admissions. We were informed that this had also meant that plans to rearrange one of the bays into a more suitable day room had had to be reversed, and that the current day room was the only possible place for it to be, as the other possible room was needed as an examination room for emergency Gynaecology patients out of hours. Unfortunately, the Review team found that the existing day room is unsuitable for breaking bad news, being located immediately behind the nursing station and being the only area available for patients and families to sit away from the beds. It is also used as a waiting area for emergency gynaecology patients out of hours, and we were told that the wait is often lengthy, and the room itself is sparsely furnished, unwelcoming and with inappropriate signage about the wait time. The curtains were hanging off and the room was generally cheerless. In the main corridor, there was some equipment being stored which the team were told was unusual and was due to the usual location being in use (the bay that had been brought into use). There was a large electronic screen in the corridor opposite the nursing station which clearly displayed patient names and details. This was freely accessible by any member of the public and thus breaches privacy and confidentiality guidelines. We were told that this is replicated across other wards in the hospital but did not verify this. We asked whether consideration had been given to providing some additional safeguards, since this is apparently the only location where it could fit, and suggested that the IT department be consulted, for example reducing lateral view , or use of a screensaver.

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There is an examination room on the ward, opposite one of the male bays. This is a small room, with its doors opening directly onto the corridor. The examination couch faces the door and the Review team asked if this could be turned around to face the window to improve privacy, although on a subsequent visit we were told that clinical staff had tried this, and felt that this did not give adequate space for clinical examination to take place. There was another inappropriate sign suggesting that women ask for a chaperone if they required one, but we were subsequently advised that all women are chaperoned and the sign has now been removed. On a positive note, the ward was very clean, although cleaning records were not up to date. The staff were very committed to providing a high quality of care and confirmed that they knew how and when to escalate concerns. Staff reported that the Chief Executive was very visible in the hospital and most knew her by sight, with many also reporting that the Director of Nursing was seen on the ward often. Staff reported receiving feedback from reports of significant incidences to variable degrees. Whilst staff levels were appropriate at the times of our visits to Tolgus ward, we heard from medical staff that there were not always appropriately skilled staff on Tolgus and that this was exacerbated by the use of bank staff when extra beds were opened on the ward. We also heard that the Matron is actively working to ensure staff have the required competencies and specialist knowledge. . When we visited the Gynaecology Outpatient department, we found dedicated, highly skilled staff working in cramped conditions but nonetheless, had few concerns. The early Pregnancy Unit staff demonstrated a high level of care and concern for women, and tried to reduce distress, for example by escorting patients out of a back door rather than have to walk back through the waiting area. There is a small counselling room available off the main corridor. The Review team visited Wheal Rose (antenatal ward), and Wheal Fortune (postnatal ward) and found committed, knowledgeable staff who worked harmoniously within the Midwifery team. Although the surroundings were sometimes shabby, and the rooms small and outdated, we were impressed with the cleanliness, but noted that cleaning records were not up to date again. Our most pressing concern was highlighted on Delivery Suite, but impacts right through the service. On the evening of the 9th, we were told that there were only six staff on duty due to sickness. There were two women who were waiting induction, which could not be initiated due to inadequate staffing levels. There was also one woman at higher risk whose labour necessitated augmentation but this could not be carried out and was delayed many hours. The Review team felt that the staff were managing the situation well, but that they were managing a level of risk that may leave staff and patients vulnerable should an urgent LSCS be required. A patient had delivered in the Recovery room as the other rooms were full and the second theatre was being prepared as a labour room for a new admission.. We were told (and the ward communication board verified)that there were several women who were not receiving 1:1 care on that shift. The Review team were told of the escalation policy which can result in midwives being moved from the wards or from the Community, and sometimes the co-ordinator is called upon to care for women on Delivery Suite. The Review team debated whether we had found the Delivery Suite to be safe that night, and considered contacting the Chief Executive and Director on call, however decided that on balance, the expertise and professionalism of the staff on duty that night could be respected and trusted.

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We returned to Delivery Suite early the following morning to find that the women awaiting induction were still waiting. The situation from the evening before had not been escalated. No adverse events had occurred, but the Delivery Suite was still busy. The Review team spoke at length to midwifery staff and were told of delays incurred in recruiting new staff to substantive posts due to onerous levels of paperwork, which staff were often too busy to prioritise. We heard that the Shift Coordinator could call in extra staff directly out of hours, reducing delays, but will contact the Matron for agreement to do so during working hours. This is to enable her to retain oversight of where demand lies, and reduce the impact on the community. Sometimes, there are no staff available to call in and so staff are working longer hours to help out. The Review team was told of one individual who had worked a 22 hour shift. Some staff members told us that they felt subtle pressure not to escalate, and there were some individuals who reported feeling that they were not listened to by more senior and executive staff. We were also told that there is robust sickness management and some staff reported feeling anxious about going off sick. The Review team was informed that, as part of the response to the recent skill mix review, 11 new Midwives had been appointed but that these were not yet in post, although they are available but awaiting CRB checks and Trust induction dates. It had not been possible to recruit as many Band 6 post holders as desired so the Trust had had to re-advertise at Band 5 with training offered. The maternity unit staff reported that they were familiar with the Chief Executive and Director of Nursing from their walkabouts but there was less recognition of other senior staff. On the Antenatal and Postnatal wards, we found a friendly ambience with excellent focus on patient care and clearly articulated patient pathways. The staffing issues, whilst less acute, were mentioned by staff, and during the Rapid Responsive Review visit, women were delivered on both the antenatal and the postnatal ward, reflecting the difficulties the Trust is experiencing in managing the workload with the current staffing level issues and accommodation pressures. The Review team noted that all elective LSCSs take place on Delivery Suite requiring two midwives to be taken away from other duties. The Team proposed that some of the pressure could be alleviated on Delivery Suite if the elective sections took place in main theatre using a scrub nurse and one midwife. There may be some dignity issues to resolve related to the distance and pathway between the postnatal ward and the main theatre block. The Review team also noted that there was little or no dialogue between main theatres and Delivery Suite, when a complex, high-risk case was delivered during the visit. The expert reviewers on the Review team noted that it would have been appropriate to have informed the main Theatre Manager in case urgent support was needed. The Review team also visited the Penrice Birthing Unit at St Austell Hospital. It was noted to be a rather dated and unwelcoming environment in need of refurbishment. There had been a early bid for monies to improve the environment but it had been unsuccessful, in favour of the West Cornwall bid.

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The midwives expressed concern about the rate of transfer of women in labour to the main unit, although the Trust confirmed that their figures are 45% compared to 50% nationally. We also noted that a change made three years ago to level of care had not been audited to support its use and assure its safety, although there is a protocol which dictates that all primiparous and high-risk mothers are visited. Multiparous women receive a telephone call on day one postnatally and either receive a visit on the same day, or no later than day 5 . There was a level of anxiety amongst midwifery staff about the safety of this approach, and concern that GPs had not been informed about this change in protocol either.

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6 Recommendations The Rapid Responsive Review team makes the following recommendations. 6.1 Gynaecology Immediate: Privacy and Dignity issues; 1. Improve privacy and dignity in day room and facilities for breaking bad news on Tolgus. 2. Review privacy and dignity across Tolgus ward including the examination room. 3. Undertake immediate review of mixed sex accommodation compliance on Tolgus ward. 4. Aim to eliminate sharing of gynae ward with male urology patients within six months using contractual mechanisms. 5. Review facilities in EPU for breaking bad news. Within 3 months: Clinical Quality; 6. Review Datix database in Gynaecology and compile reports linking individual consultant clinical activity with clinical outcomes and complication rates to be reported three-monthly to the Divisional Governance Board and further up through the Governance structures of the Trust where appropriate. 7. Evaluate through national linked audit the benign laparoscopic service against the principles as outlined by RCOG, BSUG(British Society for Uro-Gynaecology) and MHRA. Within 6 months: Clinical Quality and service provision; 8. Meet with Commissioners to resolve the future funding stream of the currently unfunded areas of the laparoscopic surgery service. 9. Review the balance of work across the benign gynaecology services to reflect the needs of the District General Hospital and Commissioners. 10. Review the two-year Capital programme and develop a solution for a single-sex Gynaecology ward (which could be part of a female surgical ward). 6.2 Obstetrics Immediate: -adequate staffing levels:

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1. Review processes for accessing extra staff when there are peaks in activity ensuring such systems are compliant with the Working Time Directive across the service. 2. Review the current process for authorising recruitment of substantive midwifery posts with the aim of reducing delays. Urgent (within 1 month): - staffing levels: 3. Ensure that the agreed staffing establishment is available to provide patient care over a 24 hour 7 day period. - Cultural issues: 4. Commence review of management styles and leadership approaches to ensure that the skills and knowledge of clinical staff are harnessed to improve and develop the service. -Clinical quality and service provision: 5. To commence an active engagement programme with all levels of Womens Health care staff to harness their expertise and commitment, to meet organisational objectives. Within Three months: -Service provision: 6. Review the elective LSCS pathway to improve workflows and patient experience. Within Six months: -Clinical quality and service provision: 7. To consider how organisational systems can best support cross-departmental working. 8. Undertake a review of transfer rates during labour from the Penrice and Helston units to the main unit at RCHT to ensure that staff are maintaining sufficient levels of expertise and confidence and feel appropriately supported. 9. Review and make plans to improve the environment at Penrice. 10. Conduct an audit of the postnatal pathway in the community to ensure it is safe. 6.3 Obstetrics and Gynaecology: 1. Produce a quarterly audit of clinical complication rates(including denominator data) in Obstetrics and Gynaecology to be reported to the Senior Management Team and the Board of the Trust. This will require analytical support and for Obstetrics, may require the procurement of additional IT systems in the Division.

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2. Review levels of medical staffing at all grades, to ensure there will be adequate cover in the service of the future in the expectation of fewer trainees and the need for seven day working by Consultants. Finally, the Rapid Responsive Review team would like to thank the Chief Executive and her staff for their welcome, support and co-operation during the visit.

Dr Shelagh McCormick Medical Director and PEC Chair NHS Cornwall and the Isles of Scilly

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APPENDIX 8

Independent Case Note Review (ICNR) Gynaecology Patients Under the Care of Mr K R Jones (former Consultant) Interim Report 19th February 2013 The case notes of 2396 women who had been seen by or treated under the care of Mr KR Jones, former Consultant between 1st April 2010 and 1st October 2012 have been subject to an Independent Case Note Review (ICNR). The methodology for the ICNR was developed, shared and agreed by the Royal College of Obstetricians & Gynaecologists (RCOG), Public Health Cornwall, and the Medical Leads of NHS Cornwall & the Isles of Scilly (NHSCIOS), NHS South of England and Kernow Clinical Commissioning Group (KCCG). Letters were sent to all women informing them of the review and inviting them to provide feedback about their experiences of the care under Mr Jones or about the gynaecology service in general. 946 women replied. The case notes were reviewed by a panel of external independent Consultant Gynaecologists appointed in line with recommendations from the Royal College of Obstetricians and Gynaecologists. As at 19th February 2013 all case notes have been reviewed. In 2275 of the 2396 cases (94.95%), the independent external Consultant Gynaecologist reviewers found no evidence of harm caused and no indication for recall for further clinical assessment. 52 women (2.17%) were found to have suffered complications of surgery. In all these cases the women had been identified previously and had been managed appropriately with further intervention as necessary. 69 women (2.88%) were felt to be at risk of harm either through failure to manage their case appropriately (1.88%) or because the quality of record keeping did not permit the necessary assurances to be given (1%). A number of the women had been seen by other specialties or departments in the intervening time. 58 women have been recalled for outpatient review and clinical assessment by a Consultant Gynaecologist not previously involved in their care. Clinical outcomes from the women are not currently available as clinics and clinical investigations are still on-going. To date 54 women have been seen, some of whom are now awaiting the results of further tests. None of these cases relates to suspected cancer. A total of 55 complaints have been received since November 2012 following media publicity and the Trust sending out letters to women whose case notes were being reviewed as part of the ICNR. The dates of complaints range from 1992 to 2011. The final Independent Case Note Review Report (ICNR) is expected for publication at the end of March 2013, following approval and recommendations from the Clinical Oversight Group (COG) which comprises senior clinicians and Directors across the NHS system..

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