REPORT ON IMPROVEMENT REVIEW OF NHS GRAMPIAN CLINICAL GOVERNANCE ARRANGEMENTS IN MATERNITY SERVICES

REPORT ON IMPROVEMENT REVIEW OF NHS GRAMPIAN CLINICAL GOVERNANCE ARRANGEMENTS IN MATERNITY SERVICES July 2010 Produced by: Expert Team Page 1 of 15 Review Date :n/a

ACKNOWLEDGEMENTS NHS QIS acknowledges the professionalism and co-operation shown by all the staff we met and spoke with at NHS Grampian, qualities which helped us immeasurably in undertaking this review. We also commend the proactive approach taken by NHS Grampian in inviting NHS QIS to carry out this work which will be of benefit to all NHS Boards. This review and the associated report could not have been achieved without the support, commitment and valuable contribution of the expert team that carried out the review. They all participated at short notice and over a tight timescale, despite other clinical commitments. It is this level of professional support and willingness to challenge and reflect on practice that makes it possible to continually improve health services in Scotland. Produced by: Expert Team Page 2 of 15 Review Date :n/a

EXECUTIVE SUMMARY Context Over 60,000 babies are born every year in Scotland. In most cases this follows a straightforward pregnancy and birth. In some cases (about 10%) highly specialised care is needed. Maternity services are provided by midwives, obstetricians, gynaecologists, neonatologists and neonatal nurses. They work closely together in multidisciplinary teams and have long been at the forefront of safe, effective and person-centred care. They have shaped and informed the way clinical risk is managed in other clinical services. Uniquely, maternity services have an additional governance structure in Statutory Supervision of Midwives to ensure safe practice and protection of the public. However even the highest performing health services cannot completely eradicate risk or fully control the actions of individuals staff, and/or patients. All NHS Boards in Scotland have clinical governance and risk management (CGRM) systems in place to ensure care is safe, effective and person-centred. These need to be tested regularly either proactively, or in response to concerns. The Review NHS Grampian identified cause for concern within their maternity services and was proactive in addressing and investigating this. The safety of the mothers, babies and staff on the unit was their priority throughout. NHS Grampian and the Maternity Unit were already working to address a number of issues and as part of testing their CGRM systems they requested that NHS Quality Improvement Scotland (NHS QIS) carry out an independent review of their CGRM arrangements to inform their own enquiry and to identify and share as much learning and improvement as possible. In response NHS QIS set up an expert team and structured the review around the following question: Were there CGRM arrangements in place to identify and manage repeated, unexpected or high risk/severe incidents and if so were they robust? The Outcome Healthcare delivery is complex and for an NHS board to provide safe and effective care, formal and informal systems at local and corporate levels need to work effectively together. In NHS Grampian, there were a number of disconnects, some of which stemmed from a failure to recognise warning patterns emerging from local data. Some support arrangements were persondependent; the Unit sickness absence rates were high; while they did use the NHS Grampian Incident Reporting system (Datix) the Unit also had their own risk management system. Information from this does not yet feed directly into Datix to support pattern recognition of issues; it is important that a comprehensive multidisciplinary and managerial overview of events and incidents from the DATIX and their own risk management system takes place and the risk if this does not occur is that systematic failures are not identified and vertical silos are created rather than an effective clinical governance framework. In summary, the expert team concluded that the CGRM arrangements in place in NHS Grampian and in Maternity Services at the time of this review were not robust. Further development is required to enable the service to improve patient safety by detecting and dealing with potentially serious issues at an early stage. Recommendations This review has provided a rich opportunity to learn more about improving and safeguarding clinical services generally. Our summary high-level recommendations are that: 1. NHS Grampian provides NHS QIS with an action plan within one month of this report being published (this should include a plan for addressing short term sickness) 2. NHS QIS undertakes a follow-up review in six months (November 2010) 3. NHS QIS and NHS Grampian shares the learning from this review across NHSScotland 4. Scottish Government Health Directorates (SGHD) consider the current practice of open access to certain drugs in a labour suite 5. SGHD and the Nursing and Midwifery Council to consider providing updated guidelines on the respective roles of the Local Supervisory Authority Midwifery Officer and Human Resources. Also to consider further standardising the annual midwife review process. Produced by: Expert Team Page 3 of 15 Review Date :n/a

1 SETTING THE SCENE There are over 130,000 staff working in the NHS in Scotland; over 16,000 in NHS Grampian. Concerns that patients could be being harmed systematically whether intentionally or not - are rare and when such incidents do occur they need to be thoroughly investigated. They also attract a lot of attention, locally and nationally. On 17 March 2010 a midwife at NHS Grampian Aberdeen Maternity Hospital (AMH) was suspended following reported concerns about her clinical practice. The context for this decision was to support this healthcare professional and to protect those working in and using AMH services. NHS Grampian set up an Investigation Group and as part of their investigation, they asked NHS Quality Improvement Scotland (NHS QIS) to carry out a review of the clinical governance and risk management arrangements in the Aberdeen Maternity Hospital (AMH) to determine whether these were robust and could identify trends and serious errors and support incident management. Clinical governance is the term used to describe how NHS boards make sure care is safe, effective and patient centred. Risk management is used to identify risks and develop the Board s response to them. NHS Grampian was keen to identify any learning and improvement points that could be implemented locally and also potentially shared across the wider health community. This review was independent and was structured around the following question: Were the clinical governance and risk management systems and arrangements in place to identify and manage repeated, unexpected or high risk/severe incidents and if so were they robust? This was not a critical incident review (CIR). Nor was it a review of clinical competence. This report has no legal standing and will inform the broader investigation that is being carried out by NHS Grampian. Our findings are based on the evidence made available to us, our meeting with NHS Grampian staff and our collective knowledge and expertise of maternity services and of governance and risk management. 1.1 Methodology NHS QIS has developed a process for reviewing situations where data or information raises potential concerns about the quality and safety of care. This process sets out a review framework which provides external support in establishing whether or not there is cause for concern and also promotes learning and sharing of experience. It is continually improved based on evaluation and feedback. In this case, concerns about NHS Grampian maternity services were raised and, in response to this, NHS QIS was asked to focus on the clinical governance and risk management arrangements. In discussion with NHS Grampian it was agreed the review team would: develop a template based around key themes to support review of relevant areas visit NHS Grampian (Aberdeen Maternity Hospital) to explore and discuss these themes and associated evidence report to NHS Grampian and make recommendations which are set in context and include timescales. The expert team template was developed as a checklist of potential prompts/questions that would structure discussion. We also identified associated supportive Produced by: Expert Team Page 4 of 15 Review Date :n/a

documents/intelligence to provide evidence and examples of practice. The template covered five themes: clinical governance and incident management, including triggers, investigation, escalation and action/improvement plans professional standards (maternity services) medicines management (maternity services) human resources, training and staff support organisational culture and leadership. 1.2 The Expert Team The Expert Team members were: Ian Laing Consultant Neonatologist, NHS Lothian (Chair) Hilary MacPherson Consultant Obstetrician. Associate Medical Director, NHS Forth Valley Pamela Milliken Head of Clinical Governance and Risk Management, NHS Lanarkshire Maria Wilson Chief Midwife, NHS Lothian NHS QIS professional support was provided by: Fiona Dagge-Bell Team Leader, Clinical Development and Improvement Midwifery Lead Jan Warner Director of Patient Safety and Performance Assessment Governance Lead Observer Catherine Calderwood Senior Medical Officer, Scottish Government Health Directorate, Women and Children s Health (Did not attend visit to NHS Grampian) Project management support was provided by Leanne Hamilton, NHS QIS Clinical Governance Support Unit. Produced by: Expert Team Page 5 of 15 Review Date :n/a

2 CONTEXT It is well recognised that Maternity Services face unique challenges which fall into two main categories planning and capacity: birth rates can change unexpectedly; babies are not born on schedule; expectant mothers often need unscheduled care and the work force is specialised and works largely autonomously. risk management: maternity services are provided for women (and their wider families) who are generally well. If pregnancy and birth do not work out as expected the consequences are often wide reaching and long term. Accordingly risk assessment is a core element of maternity services. Maternity Services have been in the forefront of risk management and this is evident in the findings of a recent NHSScotland cultural survey of maternity services (NHSScotland Maternity Services Cultural Report 2009). Additionally they face the pressure of high financial pay outs for claims against the NHS. At 34.6million this is more than half the total number of claims related payouts in NHSScotland in the period 2006/7 2008/9. There are over 60,000 live births in Scotland every year; 6000 of them in NHS Grampian. Scotland participates in the UK Confidential Enquiries into Maternal and Child Health and also performs national audit into maternal and perinatal mortality and serious morbidity to further drive improvements in care and has carried out ground breaking work on reducing Sudden and Unexpected Deaths in Infancy. Even the highest performing health services cannot completely eradicate risk and cannot fully control the actions of individuals staff, and/or patients. Understanding the way in which a number of factors can combine to heighten risk allows NHS boards and professional groups to further reduce the possibility of the workplace providing the opportunity of harm to patients and staff. Our learning points highlight ways in which multiple risk factors can be monitored and managed to improve the governance arrangements and reduce risk of harm at local and national level. Produced by: Expert Team Page 6 of 15 Review Date :n/a

3 KEY FINDINGS 3.1 Clinical Governance and Incident Management 3.1.1 Clinical Governance The Clinical Governance and Risk Management (CGRM) arrangements in NHS Grampian were recently reviewed at a strategic (board) level and were found to be mature and robust (NHS Grampian Clinical Governance and Risk Management local report November 2009). The challenge for every NHS Board is to ensure that CGRM works from board to ward : well developed protocols and arrangements do not easily translate into everyday clinical care and monitoring the health of an organisation at every level is challenging given the data available and the number of services in any NHS Board. We confirmed that at a strategic level the arrangements are clear and robust. However, connections between AMH and the wider Acute Sector/NHS Grampian do need to be strengthened; and Statutory Supervision of Midwives needs to be embedded into the overarching governance structure. 3.1.2 Safe, effective and person-centred care at every level NHS care strives to be person-centred and this is particularly true of maternity services. Because of this it is difficult to chart one route that suits all. For some women the experience will be straightforward; others will need extensive services from community care to neonatal care for sick babies and intensive care for sick mothers. AMH is well aware of the risks involved in providing these services and over the years has put in place arrangements to manage and protect those working in and using their services. We have described our observations about these recommendations in the table below. Table 1: AMH governance, operational and risk arrangements Arrangements Frequency Comments 1 Quarterly Governance meetings: Obstetrics Good midwifery representation Pharmacy representation Action and escalation unclear Governance meetings: Neonatology Quarterly Good midwifery representation Pharmacy representation Governance meetings: Gynaecology Quarterly No midwifery representation. Pharmacy representation Senior Clinical staff meetings Monthly Specialty specific. No midwifery input. No pharmacy input. Not clear how actions are managed and escalated where necessary Clinical leads meeting Monthly Includes Unit Nurse Manager Senior staff Obstetrics Monthly /Gynaecology meetings Team leaders meetings Monthly To be minuted and copied to the appropriate Clinical Midwifery Manager Ward sisters meetings Monthly To be minuted and copied to the appropriate Clinical Midwifery Manager Team leaders and ward sisters joint meetings Four monthly To progress matters and share information across the Service 1:1 with all team leaders Monthly Template developed for information 1 Representation as described in the evidence provided by NHS Grampian Produced by: Expert Team Page 7 of 15 Review Date :n/a

Healthcare governance meetings Clinical risk committee meetings Clinical practice committee meetings required at these meetings.? To discuss issues. Unsure where complaints are discussed (here or RM Group?) Two monthly To advise on clinical risk throughout the Acute Sector Monthly To inform Acute CG Committee with regard to governance of clinical practice Education and training committee meetings Unit management meeting Wednesday lunchtime meetings Review of unit reported incidents Risk Management Committee Handover meetings Monthly Weekly Weekly Advise on the appropriateness of education and training Medical staff CTG and case note review Weekly Obstetrician and risk coordinator led no link to Board system and no requirement to link to Board system Weekly Review risk and Unit reports of incidents Two in 24 hours 12 o clock Unit meeting Daily Mainly for capacity management and risk review not clear how issues are managed or escalated or where the long-term plan is. Midwife meetings and senior nurse/midwife meetings Monthly This table illustrates the effort in providing a range of platforms to cover managerial, clinical and teaching requirements. However this amounts to over 50 meetings each month within one unit. It was also unclear how the actions agreed at these meetings formally report into board clinical governance structures and vice versa. These meetings all cover important topics but the approach taken can lead to uni-disciplinary, or vertical silos, which are difficult to manage as it precludes taking advantage of broader cross-cutting support systems. The Unit appears to be lacking an overarching, proactive approach to clinical governance although this has been recognised and is being addressed. It also suggests the communications in the unit between medical and midwifery staff and more generally between the acute sector and the unit need to be reviewed (the Unit being one of the Directorates that sits within the Acute Sector). Again this has been recognised and is being addressed. The evidence provided makes it clear that there are many protocols, processes and arrangements in place. Overall support, coordination, implementation and audit of these are less evident. 3.1.3 Reporting and monitoring The NHS Grampian Clinical Governance Committee reports into the Board. Their agenda is vast, spanning the whole organisation. Maternity Services are not routinely scheduled on this agenda although the Acting Head of Midwifery and LSAMO attend annually to present the Maternity Services LSAMO report and findings. Produced by: Expert Team Page 8 of 15 Review Date :n/a

Below this sits the Acute Sector Clinical Governance Committee which has three daughter committees clinical risk, clinical practice and education and training. Obstetrics, gynaecology, neonatology and midwifery are only represented on the education and training committee. As obstetrics, gynaecology and neonatology are recognised as high risk services, we were concerned about the apparent lack of visibility of these services, particularly as these committees would provide an ideal forum for the unit to report into and to tap into broader support for delivery of healthcare in NHS Grampian. NHS Grampian acknowledges this view and has now agreed membership on each of the daughter committees. 3.1.4 Incident reporting Along with other NHS Boards in Scotland, NHS Grampian has adopted the Datix Incident Management system and has developed this successfully. Much of their work on Datix has informed and supported other NHS Boards and they have dedicated support for staff across the Board. AMH has also developed their own risk management system (Risk Management Forms) and they continue to use this. At the time of the review they had started migration of information from the risk management system into Datix but at the time of this review two systems were in use without clear guidance as to: how they feed into each other who has overall responsibility for incident management and investigation (at Board and unit level) consistent terms, definitions and follow up arrangements arrangements for audit, learning and follow up. We also felt that more work is needed nationally to introduce reliable and shared triggers. Sentinel events ( must report incidents) required by the two systems differed and there was no formal traffic lights system that identified red or high priority incidents in the AMH system. The escalation, systematic investigation and feedback processes for reported incidents were unclear. Putting such systems in place would support the closing of the loop and contribute to shared learning and service improvement. In essence, the reported tendency to use the AMH risk management system coupled with the lack of a reporting link into Datix means a loss of corporate information that could inform patient safety, learning and effective change. Datix is the system used by the Board to support the clinical governance process and the parallel reporting arrangements and lack of coordination could lead to the service being unaware of the full impact of their high risk areas. There was an awareness of the issues facing the unit, reactive approaches are being taken to address these - for example noon daily capacity meetings. While the approach taken manages the situation on a daily basis, it does not support longer term and sustainable planning which needs to go hand in hand with real-time management and monitoring. Routine monitoring using the maternity dashboard would promote a more proactive approach to monitoring trends and highlighting potential risks or areas of practice which may require more detailed scrutiny and AMH and NHS Grampian are already working on this. Document management arrangements within maternity services and more generally need to be reviewed so that a clear audit trail of activity, decision making and action is available. Based on the documentation presented for this review, the expert team highlighted specific issues to be addressed: the chronological order of information ensuring a clear system of document management (e.g. headers and footers) having ownership and responsibility for documents listing circulation lists. Produced by: Expert Team Page 9 of 15 Review Date :n/a

The combination of multiple meetings and documentation that is not easy to follow or clear in terms of the actions required heightens the risk of missing opportunities to identify or manage problems even if systems are in place. 3.1.5 Clinical Effectiveness and Audit We were provided with the NHS Grampian Clinical Effectiveness Strategy. However the associated NHS Grampian Audit Programme did not include any audits of maternity/obstetrics/gynaecology services. We were also given a separate AMH Audit programme which did not obviously link to the NHS Grampian Clinical Effectiveness Strategy, although it is understood that all audits undertaken are shared with clinical governance both at inception and sharing the final results and action points. It was not clear from this information how Directors, Senior Managers and the Board were assured that required changes have been achieved. An example of lack of audit coordination is the auditing of record keeping which is not included in the Programme for NHS Grampian or for AMH. It is reported on in the LSA report but this is not subject to any more general scrutiny or benchmarking. Local learning/action AMH should continue with the progression of migrating their bespoke system into Datix. The support provided by the Clinical Governance and Risk Management team is integral to the success of this and it is also important that the strengthened incident reporting, systematic investigation and escalation arrangements build on the experience and learning already gained. AMH needs to complete their review of the number of meetings scheduled in the Unit, the agendas, attendance lists and the reporting and follow up arrangements. We would anticipate a reduction in the numbers of groups now they have informed us they are all different types. NHS Grampian needs a planned approach to improving document management. National learning/action All NHS Boards need to review their speciality specific CGRM arrangements and the need for effective interface of professional and clinical governance committees with operational and strategic committees. 3.2 Professional standards (Maternity Standards) The NHS Grampian team we met with on our review visit were professional, enthusiastic, motivated individuals and the review did not relate to concerns about their professional or clinical standards. At our visit we confirmed our view that the actions taken in this case were intended as protective and in the interest of women and staff. We commend the team s clear commitment to the delivery of high quality clinical care, despite the often complex and challenging working environment. The review team was not set up to comment on outcomes although they did identify a number of indicators that could affect these and which could usefully be reviewed in all units. The data we reviewed included; Elective and emergency caesarean section rates (and associated factors such as time of day) Attendance levels in particular short term sickness absence levels Incident reports, including those recording concerns about staff coverage, loss of morale, limited breaks and supervision and the number of junior staff. Produced by: Expert Team Page 10 of 15 Review Date :n/a

NHS Grampian is currently working up their Maternity Dashboard and is taking into account these indicators. We also explored the clinical and managerial leadership arrangements in place in AMH. At present there is an acting Head of Midwifery and a Consultant Midwife leading midwifery staff and we did not find their respective leadership roles to be well defined within the organisational and management structures. As important is the interaction between midwifery and medical leadership and it has been acknowledged that this could be strengthened. The Acute Sector General Manager responsible for AMH works closely with the Unit but there was a sense that they were a relatively insular part of the bigger organisation, used to managing their own services. Links with the Clinical Governance and Risk Management team have been in place for some time and over the last few months these links have been enhanced with the NHS Grampian Programme Manager for the Scottish Patient Safety Programme working closely with AMH. All those we spoke with welcomed this closer engagement which is already delivering improvements in service despite the fact that Maternity Services are not formally part of the Scottish Patient Safety Programme. Local learning/action AMH needs to complete implementation of their Maternity Dashboard, which should include workforce issues, management and escalation plans AMH should consider more formal clinical leadership arrangements and test these with staff National learning/action All NHS Boards should have a maternity dashboard in place in line with RCOG recommendations All NHS Boards should regularly review key clinical indicators. A national pro forma could be developed to support this 3.3 Medicines Management (Maternity Services) The evidence provided in relation to NHS Grampian pharmacy policy and protocols confirmed this is thorough and well managed. While we saw evidence that pharmacy has developed flow charts to undertake routine audit, they do not take responsibility for initiating audit of usage. Pharmacy has developed flow charts to undertake audit, which they do routinely (approximately 16 week cycle) to review stockholding and carry out additional audits in relation to specific initiatives and requests. AMH has a designated pharmacist who takes responsibility for filling pharmacy orders and general oversight of pharmacy in the Unit. This highly experienced professional works as part of the Royal Aberdeen Children s Hospital (RACH) team and line management is provided by the RACH Pharmacy Team Leader. To support this there is rotation of junior pharmacists which includes RACH and AMH. Within the Unit it was reported that any issues are addressed informally through discussion and education and this includes escalating issues to the senior medical staff. The AMH pharmacist plays a core role in the AMH team and it is important that this role does not become highly person dependent. Maternity services across NHSScotland differ from most other hospital services in that medicines/supplies are available on trolleys within the labour suite to support the delivery Produced by: Expert Team Page 11 of 15 Review Date :n/a

of care. This has become custom and practice but we agreed this does not mean it is safe or acceptable; tolerating such practice creates risk and provides the opportunity for abuse. National learning/action NHS Boards should consider how clinical pharmacy interacts with services and feeds in information on issues of concern and errors into broader clinical governance structures Scottish Government Health Directorate needs to consider the current practice of open access to certain drugs in the labour room 3.4 Human Resources (HR), Training and Staff Support We confirmed that NHS Grampian has the necessary HR structures, processes and policies in place and AMH are aware of these and make use of them. AMH may wish to consider involving HR directly in monthly management meetings in future as part of implementation of the Maternity Dashboard. The use of a Decision Tree model in incident review is good practice and NHS Grampian used this approach. However we suggest they review their use of Decision Trees to ensure there is comprehensive, timeframed and accurate recording of all actions against the set down HR processes. This is particularly important if HR issues require formal action and highlights the more complex environment in maternity services where supervision of midwives has a professional dimension (which can result in suspension from clinical practice anywhere in the country) as well as an HR dimension linked to staff governance processes. It was unclear how these two approaches interfaced; they have to work alongside each other as well as independently and this can be challenging. We found that there was no formally designated stand-in for the Acting Head of Midwifery when she is absent. It is important that formal arrangements are in place in these circumstances (including reference to the Director of Nursing as required) and that all staff are aware of these arrangements. As senior staff may have more than one role (manager and supervisor) it is important that there is clarity in relation to roles for all staff involved. We understand the challenges faced when clinical supervision arrangements and operational management arrangements run in parallel but patients and staff will not. It is essential that there is close working between the management team using the HR policies and procedures and the LSAMO when concerns such as suspension are being considered and that there are clear escalation processes to board level when this happens. Short term sickness absence rates are high in this unit (reference section 4.2). NHS Grampian has an attendance management policy and an action plan is being developed to address the sickness absence issue. Furthermore the incidents recorded on Datix and scored as red risks did not appear to have any actions or follow up. These record concerns around staffing levels, staff support and the working environment. Most incidents we reviewed were recorded on night shift. Local learning/action There needs to be clearer, more formal arrangements in place to support effective working between the Statutory Supervision of Midwives and HR procedures. Clarity of roles is particularly important Produced by: Expert Team Page 12 of 15 Review Date :n/a

AMH needs to finalise and implement an action plan to tackle short-term sickness rates National learning/action Scottish Government Health Directorate and the Nursing and Midwifery Council to consider providing updated guidelines on the respective roles of the Local Supervisory Authority Midwifery Officer and Human Resources. Also to consider further standardising the annual midwife review process. A maternity dashboard should be in place; this can be adapted locally from the dashboard recommended by the RCOG but the spread of information needs to be recorded, reviewed and acted on. 3.5 Culture and Leadership From our visit we had a strong sense of an organisation committed to a learning culture. Strong leadership at every level is essential to achieve this. Within AMH there are two midwifery leadership roles: the Acting Head of Midwifery and the Consultant Midwife. There is also a midwifery team manager. There is a clearly defined medical lead but it was acknowledged that more formal links are needed to the midwifery lead. The maternity hospital is part of the Acute Service Directorate and has clear links with general management. Quite appropriately they retain local separate clinical governance arrangements and they also have a separate risk management/reporting system. However it is important that triggers are in place to ensure key issues are flagged up in corporate systems and that the wider learning from NHS Grampian clinical governance systems is taken into account. We gained the impression of a strong team who has developed close working relationships and who are very solutions-focussed: for example, in response to pressure on beds they have developed a daily huddle to provide real-time management of these. However it is important that this is underpinned by strategic planning and close working within the wider management structure. Pressure on beds in AMH has broader implications for NHS Grampian and for patient and staff safety generally and this example highlights the importance of avoiding silo working as referenced in 3.1.2. We were of the view that the senior team are already tackling some of these issues and continued support for the AMH team in developing their general management skills and experience is welcomed. Local learning/action NHS Grampian needs to ensure that bottom up and top down intelligence is linked and informs operational management as well as supporting strategic planning NHS Grampian should consider whether the current AMH management structure, responsibility and reporting lines reflect the organisational charts National learning/action All NHS Boards should review their arrangements for linking local and corporate intelligence to support operational management as well as strategic planning Produced by: Expert Team Page 13 of 15 Review Date :n/a

4. Conclusions and summary recommendations The review team posed a key question: Were the clinical governance and risk management systems and arrangements in place to identify and manage repeated, unexpected or high risk/severe incidents and if so were they robust? To answer this question we met with staff, reviewed data and evidence and drew on the experience and knowledge of the highly professional review team members. They concluded that clinical governance and risk management systems were in place that had the potential to identify and manage risks and incidents. However these systems were not being used effectively and there were limited arrangements in place to check the use and effectiveness of the systems. There is no doubt that the combination of a number of factors, organisational and cultural, led to an operational management approach that did not support easy coordination of the necessary governance systems. Co-ordinated, systematic attention is needed to identify trends, manage the service operationally and strategically, and provide assurance on safety and quality. It is not possible for an organisation to design and implement systems and processes that totally eradicate risks. It is possible however to use the systems that are in place to manage and reduce these in support of safe, effective and person-centred care. The pace of change has already picked up in NHS Grampian and they are now actively embedding the corporate, strategic approach to clinical governance, risk management and patient safety into maternity services. This is set in the context of learning and improvement, enabling a dedicated, competent staff group to develop a systematic and risk based approach to ensuring patient safety. In summary, the expert team concluded that the CGRM arrangements in place in NHS Grampian and in Maternity Services at the time of this review were not robust. Further development is required to enable the service to improve patient safety by detecting and dealing with potentially serious issues at an early stage. The local and national actions/learning points within this report are intended to improve the safeguarding of women and staff and improve the quality of services. Most are directly relevant to Units across the country. Recommendations This review has provided a rich opportunity to learn more about improving and safeguarding clinical services generally. We recommend that: 1. NHS Grampian provides NHS QIS with an action plan within one month of this report being published (this should include a plan for addressing short term sickness) 2. NHS QIS undertakes a follow-up review in six months (November 2010) 3. NHS QIS shares the learning from this review across NHSScotland 4. Scottish Government Health Directorates consider the current practice of open access to certain drugs in a labour suite 5. Scottish Government Health Directorate and the Nursing and Midwifery Council to consider providing updated guidelines on the respective roles of the Local Supervisory Authority Midwifery Officer and Human Resources. Also to consider further standardising the annual midwife review process. Produced by: Expert Team Page 14 of 15 Review Date :n/a

Glossary Caesarian section Confidential Enquiries into Maternal and Child Health Confidential Enquiry into Maternal Health (CEMH) Datix Gynaecologist Maternity Dashboard Local Supervisory Authority Midwifery Officer Midwife Neonatal nurse Neonatologist Obstetrician Scottish Patient Safety Programme a surgical procedure in which one or more incisions are made through a mother's abdomen (laparotomy) and uterus (hysterotomy) to deliver one or more babies, or, rarely, to remove a dead fetus aimed to improve the health of mothers, babies and children by carrying out confidential enquiries and related work on a nationwide basis and by widely disseminating their findings and recommendations Programme of work coordinating the assessment of maternal deaths in Scotland and also oversees the Scottish contribution to the UK enquiry the leading supplier of software for patient safety, risk management, incident and adverse event reporting A practitioner of Gynaecology - the medical practice dealing with the health of the female reproductive system a tool that can be employed to monitor the implementation of principles of clinical governance on the ground. It can be used to benchmark activity and monitor performance against the standards agreed locally for the maternity unit on a monthly basis Each Local Supervising Authority (LSA) has an appointed LSAMO to carry out the LSA function. They are all practising midwives with experience in statutory supervision and provide a focus for issues relating to midwifery practice within each area. A practitioner of midwifery - a health care profession in which providers offer care to childbearing women during their pregnancy, labour and birth, and during the postpartum period Nurse practicing in the field of neonatology - a subspecialty of paediatrics that consists of the medical care of newborn infants, especially the ill or premature newborn infant A practitioner of neonatology - a subspecialty of paediatrics that consists of the medical care of newborn infants, especially the ill or premature newborn infant A practitioner of obstetrics - the surgical specialty dealing with the care of women and their children during pregnancy (prenatal period), childbirth and the postnatal period The Scottish Patient Safety Programme is being implemented in every acute hospital in the country. The initial goals are to drive improvements in leadership, critical care, general ward, medicines management and perioperative care. File Name: DG NHS Grampian report Version :1.6 Date: 20-07-2010 Produced by: Review Team Page 15 of 15 Review Date :n/a