Newcastle upon Tyne Hospitals NHS Foundation Trust. Directorate of Women s Services. Incident Reporting and Risk Management Procedures

Transcription

1 1. Introduction Newcastle upon Tyne Hospitals NHS Foundation Trust Directorate of Women s Services Incident Reporting and Risk Management Procedures This document sets out the aims of the Women s Services Directorate to manage risk effectively. It also describes the process for managing clinical risk. This document is in line with the Trust Risk Management Policy and details how the Trust Policy is applied to Women s Services. The Women s Services Directorate aims to provide a robust patient safety culture and environment committed to Risk Management control and recognition. All staff are expected to be aware of the principles of risk management and adopt appropriate practice to reduce risk. 2. Scope This procedural document applies to all staff employed in Women s Services. It should be read in conjunction with the Trust s Risk Management Strategy. 3. Aims Version No: 5.0 Effective from: 28 February 2018 Expiry date: 27 October 2018 Date ratified: 25 January 2018 Ratified by: Quality and Safety Committee, Women s Services The organisation recognises risk management as a key element of integrated governance Risk management systems and processes are embedded across the directorate and include business planning, service development, financial planning, project and programme management and education. Risks are identified that have the potential to adversely effect the quality of care, safety and well being of patients, staff, volunteers and visitors. The directorate adopts a co-ordinated and multi-disciplinary approach in managing risk through the systematic process of identification, analysis, learning, control and management of risk. Risk Management is an important component of Clinical Governance. Its purpose is to: o Protect patients from avoidable harm (physical and psychological). Page 1 of 27

2 o Ensure that the patient and family are informed and supported when an adverse event occurs. o Protect staff and the Trust when an adverse outcome occurs. Key elements are: o Safe, evidence-based practice o Risk assessment o High quality record keeping and documentation o Appropriate clinical policies, procedures and guidelines o An emphasis on learning, not blame, from formal case reviews/ serious incidents o Appropriate responses to complaints and discontent. In order to manage risk effectively and to meet our statutory obligations, it is necessary to ensure that a rigorous system is in place to identify and report all incidents and near misses within the directorate. All staff, irrespective of grade and discipline, are encouraged to report incidents and near misses promptly. Women s Services actively supports the promotion of a positive and non-punitive approach to incident reporting. This is pivotal to effective risk management within the Directorate and will provide information, which will enable us to learn from adverse events and facilitate action to prevent recurrence Errors, incidents, accidents and near misses in all areas of clinical and nonclinical activity can result in serious harm to patients, staff and other personnel as well as to Trust property and reputation. All possible steps should be taken to minimise the risk of initial incident occurrence and subsequent recurrence. All staff must adhere to the principles of risk management as an integral part of best clinical practice with the focus upon patient safety and prevention of avoidable harm. 4. Review and distribution The Incident Reporting & Risk Management Procedures policy will be reviewed every three years by the Quality and Safety Group (available on the Intranet in the Policies database). All staff are informed about the Incident Reporting & Risk Management Procedures policy and Trust Risk Management Strategy document as part of their induction programme. 5. Quality Assurance Framework In Women s Services the Quality Assurance Framework provides the Directorate with assurance that the risks to Women s Services are being managed appropriately. This is achieved by close working links between the Directorate Management team and the Governance Leads. Women s Services will ensure that the following arrangements are in place: Page 2 of 27

3 Quality & Safety Group (Q&S) monitors the risk management and clinical governance processes on behalf of the Directorate. The Incident Reporting & Risk Management Procedures document is effectively communicated to all staff working within the Directorate. An accurate register of all risks (the Risk Register ) within Women s Services is kept and monitored both at department level and by the Governance lead, the Directorate Manager and the Clinical Director. Risk Management / Clinical Governance issues are discussed at regular Directorate Performance Management Reviews which are held 3 times a year and chaired by one of the executive directors. The QAF document is updated twice a year as audits are completed and lessons learnt shared. 6. Leadership and Accountability 6.1. Women s Services leadership and accountability This is outlined below. Operational lead responsibilities are as outlined in the overall Trust Risk Management Strategy. The Clinical Director, Directorate Manager and Head of Midwifery have joint responsibility for overseeing clinical risk management throughout Women s Services. The Clinical Director is accountable to the Medical Director. The Governance Lead s responsibilities include: o Chair of the Quality and Safety Group o Chair of monthly audit and morbidity meetings o Ensuring that the Directorate Quality and Safety Group is held on a regular basis (at least ten times a year) o Ensuring appropriate representation at the meeting o Ensuring that the agenda addresses relevant issues, with standing items that facilitate monitoring of the group s work plan. The Heads of Service below report to the Quality & Safety Group: o Head of Obstetrics o Head of Gynaecology o Head of Neonatal Services o Head of Reproductive Medicine Risk Management Midwives The Senior Risk Management Midwife and the Risk Management support Midwife have responsibility for the co-ordination of clinical risk activities within the Maternity Services. They also assist with neonatal and gynaecological risk issues if required. Their responsibilities include: o Co-ordinating risk identification and analysis through the collation and review of all incidents Page 3 of 27

4 o Ensuring incidents are investigated promptly and action plans are completed o Reviewing incident analysis, reporting trends and /or issues of concern to Q&S o Assisting in the devising of a programme for monitoring performance and implementation of the QAF and report results across the various departments o Co-ordinating the monthly Directorate audit meeting o Monitoring the progress of audits ensuring that they are registered with the Trust o Ensuring that lessons learnt from audits are fed-back to the relevant people so that an action plan can be formulated to ensure completion of the audit cycle o Publication of the Risky Business Newsletter every three months o Completion of the Annual report on Stillbirths and Annual report on Each Baby Counts o Updating staff on risk management issues through regular communication via the newsletter o Identifying areas of risk that need to go onto the Risk Register and distribute the Risk Register accordingly to all Heads of Departments o Co-ordinating review of the Risk Management Procedures document every three years They will also: o Raise awareness of risk management issues among staff throughout the Maternity Service o Work with the Matrons, Consultants, Clinical Director and Head of Midwifery to ensure risk is minimised o Support staff during investigation and analysis of incidents o Ensure there is appropriate feedback to staff within the Maternity Services regarding lessons learned, actions taken from incidents and identification of risks o Meet all new staff to introduce them to risk management during their induction 6.2 Escalation of the Risk Management Issues to the Trust Board Urgent and immediate escalation of risk management issues should be via the Directorate Manager/ Head of Midwifery or Clinical Director to the Director of Nursing and Patient Services and/or the Medical Director or to the Director of Quality and Effectiveness if a Serious Incident is suspected. This is usually via a telephone call in the first instance with a follow-up later to clarify details and further discussion as required. In the absence of the above Management Team a deputy, together with the Risk Management Midwife, will take on this responsibility and contact the Director for Quality and Effectiveness or the Clinical Governance and Risk Department to request advice and/or support. Out of hours, the on call consultant and on-call senior manager will take responsibility for escalation if deemed necessary. Page 4 of 27

5 In an acute event the risk management issue may resolve quickly and need no further investigation. Any outstanding issues will be discussed with the Head of Department, Head of Midwifery, Clinical Director and Directorate Manager as appropriate. 7. The Risk Register (Please also refer to the Trust policy on the Risk Register) The Risk Register is managed by the Directorate Manager, Clinical Director and Head of Midwifery. New risk issues that are identified should be brought to the attention of any senior member of staff. The risk issue of concern should then be discussed at the next appropriate departmental meeting (if it hasn t been discussed already). If it is deemed that the risk should go onto the Risk Register it should be entered by a member of senior staff and final authorisation is given by the Directorate Manager/ Clinical Director / Head of Midwifery prior to going onto the live register. The Risk Register is a standing agenda item for Q&S and all departmental meetings. New risk issues are discussed at each meeting. The matrons in each area have responsibility for reviewing and updating the risk in their area on a regular basis. A more formal review of the risk register is undertaken 3 times a year this will be done by the Directorate Manager, Clinical Director, Head of Midwifery, Governance Lead and the Senior Risk Management Midwife. The Women s Service Risk Register is reviewed at the Directorate Performance Review meetings, which are chaired by an Executive Director of the Trust (the frequency changes as required by the ED). It is also discussed at the annual Clinical Standards and Practice Review meeting. 8. Risk Management Policy and Procedures 8.1 Incident Reporting: Datix Forms and Greatix Forms (Also refer to Trust Policy on Management and Reporting of Accidents and Incidents) Incidents and adverse events that occur within Women s Services should be reported onto the DatixWeb electronic reporting system. There is a Women s Services specific data set for incident reporting (trigger lists See Appendix 1) in each area which prompts reporting. These lists are neither exhaustive nor exclusive. If in doubt whether an incident should be reported, it should be discussed with the line manager and/or consultant as appropriate. Anyone can complete a datix form about an incident; the member of staff does not need to have been directly involved with the incident. When completing the Page 5 of 27

6 form, staff should ensure that the patient details are correct and the MRN included. Document in the notes that a Datix form has been completed. If the datix is about a baby then the maternal details also need to be added to the form. It is important to highlight the trigger for the datix and complete the patient details. The contents should be factual and should not be based on a personal opinion of events. The datix form will then be completed once the incident is investigated and completed for final approval. Under reporting on datix is common and is a major risk issue. If in doubt staff are encouraged to complete the datix to avoid missing a potentially serious incident if there are more than one for the same incident then the additional ones will be deleted. Greatix. Any member of staff can submit a Greatix if they feel that management of a case was excellent. In addition if management is deemed exemplary once a datix has been submitted and investigated, then again a Greatix can be submitted to the Trust. The staff will then be contacted and thanked. 8.3 Review of Incidents Once a Datix form has been completed either the Matron/Risk Management Midwife/ Midwifery Manager/ Consultant in charge will: Review the case notes Consider and, if necessary, debrief the individual staff involved Identify whether or not statements are needed, and supervise their production Ensure that the patient or parent, and their family are kept informed. Determine further action which may include: o Minor (i.e. a retrospective entry to the notes) or no further action, (the majority of adverse events). o Review of the case at a relevant meeting (see below) o Debriefing and formal case review including root cause analysis. The frequency of meetings to analyse adverse events and share lessons to be learnt varies between departments and clinical areas Gynaecology Risk management meetings are currently held on a monthly basis at the end of the audit meeting. It is a multidisciplinary meeting and an open meeting for any staff to attend. This meeting is a forum for presentation of cases and dissemination of learning points to trainees, nursing staff and senior medical staff. In addition, the core members of the risk management team meet on a twice monthly basis to: Page 6 of 27

7 Review and complete Datix forms Identify any potential case reviews and initiate arrangements Identify any urgent issues Ensure actions from risk management meetings have been actioned (includes debriefing if required). Ensure learning points have been disseminated, either through monthly audit meeting or the departmental learning points newsletter. A register of attendance and minutes of these meetings are taken by the Gynaecology sister and kept in the sister s office on ward Reproductive Medicine Reproductive Medicine is based at the Newcastle Fertility Centre at the International Centre for Life. The Centre is licensed by the HFEA for many of its activities. In keeping with Trust policy, specific incidents are reported through the Datix system. The Centre is obliged also to report some incidents to the HFEA. Our reporting SOP is maintained in our document management system: NFC/SOP/QA/9. This incorporates relevant triggers and the required level of reporting. All Datix forms are reviewed at our monthly quality management meeting. This is an open multidisciplinary meeting and all staff are encouraged to attend. Learning points are discussed and the Datix forms signed off as appropriate from that meeting by a senior member of staff. Output is disseminated through management and group meetings in the department Neonatal Incidents relating to Neonatal and Transitional care are investigated by the assigned neonatal Sisters. All completed investigations are finally approved by Matron for Neonates Review of incidents occurs once a month in a morning teaching session This is a multidisciplinary session. Departments involved in the incident outside the Neonatal unit will be invited to attend and assist with shared learning. The shared learning from the incident is discussed at the Departmental and Unit meeting and the Directorate Quality and Safety meeting. Where necessary, lessons may also be shared with other areas of the directorate via their own departmental meetings. Page 7 of 27

8 In line with Duty of candour outcomes and lessons learnt are, where appropriate, shared with parents. In incidents where it is felt there are lessons applicable to similar services to ours, these are shared via the Northern Neonatal Network within the region or BAPM or NHSE nationally. Neonatal death All infants who die while under the care of the neonatal service are discussed with the coroner and have a local multidisciplinary case review meeting with involved clinicians and where possible independent external clinician presence. The output and lessons learnt from this process are shared with the infants local Child Death Overview Panel (CDOP) and with the trust executive. Lessons learnt and changes to practice are raised at the local departmental meeting, trust exec level and the Northern Neonatal Network Northern Neonatal Transport Team (NNeTS) Incidents involving clinical care of babies under the care of the Northern Neonatal Transport Team (NNeTS) may be raised by team members, service users or families, and will be investigated by the Specialist Nurse Team Lead, Medical lead or Specialist Transport Nurse with a special interest in governance. Daily review of Transport episodes from the previous day and preceding out-of-hours period is conducted by the NNeTS team on duty. Any investigation findings will be finally approved by the Matron for Neonates or Medical Lead. The results of formal investigations are presented for shared learning to the multidisciplinary bi-monthly NNeTS governance meeting The shared learning may also be taken to the Directorate Quality and Safety meeting or, if appropriate/serious enough, disseminated to other service users across the Northern Neonatal Network, or to the NTG and NHSE nationally. In line with Duty of candour outcomes and lessons learnt are, where appropriate, shared with parents NNeTS will contribute to reviews of incidents carried out by its service users when invited, where the NNeTS team has been involved in any aspect of the care of a baby Maternity (See flowchart on page 12) The majority of datix in the department are reported within maternity. The process of managing and acting on datix is described below and on the flowchart on the next page. Datix will be sorted into categories and RAG rated: Serious Incident (SI) or cases needing formal case review see section 8.5 Page 8 of 27

9 Term babies to NNU o The Term baby to NNU meeting takes place weekly. Cases are reviewed by 1-2 consultant obstetricians, delivery suite matron, consultant neonatologist, neonatal sister and the risk management midwife. A prospective record is kept of cases and presented monthly at Intrapartum Governance Group, quarterly at Obs Group and annually at audit. o Cases where care is considered suboptimal or of educational value are discussed at Risk Management that takes place 2/week on Delivery Suite at In addition, where care is considered suboptimal or a change in management may have made a difference to outcome, the staff involved will be informed so that they have the opportunity to reflect on care given. Perinatal Losses o Perinatal losses are discussed at the Perinatal Group, which consists of a lead midwife, the consultant obstetric lead for perinatal, the delivery suite lead, risk management midwife and matron for delivery suite. Care will be reviewed and management classified into appropriate, sub-optimal or requiring formal case review. o Cases of educational value will be presented and discussed at the monthly Perinatal Mortality/Morbidity Meeting. Delivery Suite / Newcastle Birthing Centre o Datix forms will be RAG rated by the risk management midwives. o Amber and red incidents will be discussed at Risk Management that takes place (twice a week on Delivery Suite at 8.15). o The Consultant Obstetrician rostered that day for ward rounds, antenatal clinic and fetal medicine should be in attendance and will assist to chair the meeting with the Risk Management Midwife. Also in attendance should be one of the Midwifery Managers. This meeting is multidisciplinary and multi-professional all tier levels of doctors, midwives and anaesthetists are encouraged to attend. Cases will be presented by trainees (allocated in advance). Antenatal and Community o Antenatal datix are reviewed by the Antenatal Clinical Lead, Antenatal Matron, antenatal sisters for the ANC, MAU, antenatal ward as appropriate and Risk Management Midwives. o Antenatal incidents relating to community care are discussed at the monthly community meeting with the Community Manager and attending community staff. Page 9 of 27

10 o A summary of numbers, RAG ratings and themes from antenatal services and community are presented at the Antenatal Governance Group o Cases where care is considered suboptimal or of educational value will be discussed at Risk Management (twice a week on Delivery Suite at 8.15). Postnatal o Postnatal datix are reviewed by the Postnatal Clinical Lead, Postnatal Matron, sisters and Risk Management Midwife. o A summary of numbers, RAG ratings and themes from postnatal services and postnatal community issues are presented at the Postnatal Governance Group o Cases where care is considered suboptimal or of educational value will be discussed at Risk Management (twice a week on Delivery Suite at 8.15). Screening Incidents and Fetal Medicine o There is a Quality Assurance framework specific to screening. Incidents from all partners within the Screening Pathway (including CHRD, Laboratories, FMU, ANC, Lead Health Visitor, Community Midwives, SCBU and PICU) are reported via Datix to the Screening Midwives for escalation. o Screening incidents include: mislabelled or lost samples in relation to all antenatal screening bloods i.e. Hepatitis, HIV, Rubella, Combined testing. They also includes NIPE issues (newborn examination), missed fetal anomalies, failure to give baby vaccinations on babies born to Hepatitis mothers, errors with the newborn blood spot such as delayed or missed samples. Any Serious Incidents will be investigated in conjunction with the PHE Area Team for Cumbria and North East. o Fetal Medicine datix are reviewed at the twice-monthly Fetal Medicine Governance Group. o Cases where care is considered of educational value will be discussed at Risk Management that takes place 2/week on Delivery suite at 8.15 or presented at Departmental Audit. Minor clinical incidents and those not patient related. These are reviewed by the risk management midwives and after review of the incident either closed if there is no need for further management or escalated to the Head of Dept/Head of Midwifery if deemed necessary. Page 10 of 27

11 Flowchart for Maternity Risk management midwives have overview of all Datix. They will determine where cases should be followed up/discussed and will review cases if deemed necessary. Minor, not patient related datix form completed and followed up if necessary by relevant staff Needing formal case review will be organised by Risk Mx M/W Term babies to NNU: Case will be reviewed the following day by risk Mx midwife and at the weekly Term baby to SCBU meeting Perinatal Loss case will be reviewed at monthly Perinatal Meeting Review by appropriate Matrons / Clinical leads Community Antenatal Postnatal Fetal medicine Screening Anaesthetic Intrapartum and remainder i.e. not fitting other categories: Primary review by Risk Mx M/W If deemed necessary: Secondary review by risk management midwives and 2 consultant obstetricians Management reviewed and followed up if necessary by relevant staff Cases will be selected if deemed of educational value or where care warrants further discussion Management reviewed and followed up if necessary by relevant staff Educational value (either good care or suboptimal care) Consider presenting at one of the following: Risk Management meeting on Delivery suite (twice a week) Page 11 of 27 Audit meeting Perinatal meeting

12 8.4 Formal Case Review and Serious Incidents Serious Incidents (SIs) (This section must be read in conjunction with the Trust Serious Incidents (SI s) Reporting and Management Policy available on the Intranet.) SI cases include: o Maternal death o Intrapartum stillbirth o Cases of serious birth trauma/ injury to a baby for example: skull fracture o HIE (hypoxic ischaemic injury) in a term baby o Baby abduction. o Retained swab Serious Incidents must be discussed with the Head of Midwifery/Directorate Manager and Clinical Director as soon as possible after the event has occurred. The Head of Service should also be informed. If the incident is considered a possible SI the Director for Quality and Effectiveness and Medical Director should be informed. All SI s will be reported to the relevant commissioner for the service by the Trust Patient Safety Advisor. All SIs require a Formal Case Review and must be attended by an appropriate person, who is external to the Directorate and can offer unbiased and impartial input into the investigation. The Trust Patient Safety Advisor must also be kept informed of the progress of a SI investigation and minutes of the meeting must be sent to the Director of Quality and Effectiveness via the CGARD representative. The SI investigation will be organised by the Risk Management Midwives and all staff involved in the case will be invited to attend. Ideally the meeting should take place within four to six weeks of the incident, however it must be recognised that there may be a delay in organising the Case review if key people are unavailable within the desired timescale. Statements should be obtained before the meeting. When a serious incident occurs within Women s Services it is necessary that it be examined in detail in order to learn from it. A debriefing meeting may be required and should be held within 72 hours. It may not be practical to get everybody together that was involved in the incident within 72 hours therefore in some cases staff may need to be spoken to on an individual basis by their Manager / Consultant / Risk Management Midwife. Lessons learnt from SIs will be minuted and an action plan written. The Trust Patient Safety Advisor will communicate on a frequent basis with the Risk Management Midwife to ensure that lessons learnt are implemented and monitored. The SI will not be closed by the commissioners until they are assured that action plans have been completed. Page 12 of 27

13 8.4.2 Other Cases or Incidents Requiring Formal Case Review For other cases/incidents, the Risk Management Midwife, Lead Consultant Matron for the area and Head of Service will determine the necessity of a Formal Case Review. A formal case review will be considered in the following circumstances. o Unexpected transfer to ITU o Eclampsia o Uterine rupture with poor outcome for the infant o Massive Obstetric Haemorrhage o Requiring maternal resuscitation o Hysterectomy o Admission of a postpartum woman to the Mental Health Unit Where there is clear evidence of sub-standard care in any of the above a formal case review must be held Any member of staff wishing to discuss other serious adverse events not included in this list can also suggest a case review meeting. The Head of Service will make the final decision as to whether a case review is necessary Formal Case Review Aims and Process A Formal Case Review should be organised to take place within four to six weeks. The aims of a Formal Case Review are to: o Have the opportunity to analyse and discuss the incident o Review organisational processes that may have contributed to the events. RCA (root cause analysis) will be undertaken if relevant to the case) o Suggest ways in which practice or training may be improved o Encourage reflection and learning through experience o Manage effectively incidents that may lead to a claim. Case review meetings must be multi-disciplinary to be useful to participants, be effective in improving practice and be capable of creating organisational change. They must therefore include all medical, midwifery, nursing and support staff who where involved in the incident. External input from another Trust should be encouraged where possible. The Head of Midwifery, Head of Department, Directorate Manager and Clinical Director should be notified when a formal case review is to take place (notified by the Risk Management Midwife or Matron) and they should receive the minutes of the review meeting. Attendance Those persons requested to attend will include all the members of staff involved in the incident, the Risk Management Midwife/ Lead, the Matron and the Head of Page 13 of 27

14 Department for the area concerned. A representative from the Clinical Governance and Risk department will also usually attend. The review will not be open to other parties except by special arrangement. Chair The facilitator (chair) will usually be the Risk Management Midwife/ Lead. Structure of the meeting o The case will be presented briefly, usually involving a time line displayed for everyone to see and a summary given for all staff to read. o Each individual participant in the meeting will then have the opportunity to highlight the issues from their perspective. o An analysis of these issues will then be conducted using Root Cause Analysis if appropriate. o Action points for reducing the risk of a recurrence of the incident will be agreed. Following the meeting the Risk Management Midwife/ Lead will compile a written summary of the review for distribution to the participants of the meeting. The minutes will include any recommendations with timescales and state who the responsible person for the action plan will be. The report is private and confidential to the participants. Sub-standard Care When there is evidence of sub-standard care, the Risk Management Midwife/ Lead person in charge of the review will inform the Clinical Director, Directorate Manager and Head of Midwifery. Statements should be collected from the persons involved and individual meetings will be organised with their educational supervisor/ Manager/ Matron. The Trust Generic Incident Investigation Tool for Incidents should be used as part of the RCA assessment. All documentation arising from any element of the risk management process may be disclosed to the Trust Solicitors in the event of litigation. Once the case review has been held and minutes verified the Consultant should then arrange to meet with the woman and her family and discuss the findings. A formal letter is then sent to the family after the meeting to clarify events. Depending upon the seriousness of the issue, it may be necessary to discuss the incident with the Clinical Director/ Head of Midwifery/ Directorate Manager or the Director of Quality and Effectiveness. It may be appropriate to contact a trainee s educational supervisor or a Matron if there are issues identified concerning medical / midwifery/ nursing competence. Page 14 of 27

15 8.5 Local and Organisational Learning from incidents/sharing Information Women s Services proactively uses the lessons learnt from audits of practice, incidents, complaints, claims and other information sources to improve clinical care and that staff are trained appropriately in response to these lessons. To achieve this, the following systems are in operation within the Directorate and will be monitored by Q&S. Q&S has a responsibility to ensure that lessons learnt from all formal case reviews, incidents and SIs are implemented and monitored as appropriate. Incidents Issues where lessons can be learnt will be shared via monthly Key messages and the Risky Business Newsletter every three months. The Datix form requires completion of a section on lessons learnt, which can be included in reports as required. Serious Incidents and Formal Case Review On occasions it may be appropriate to all midwives and medical staff and inform them of the outcome of serious incidents. SI report will be written by the Clinical Director or other nominated senior clinician and sent to the Medical Director to provide board assurance that lessons learnt are implemented and monitored. A summary of a formal case review will be presented to the relevant Clinical Group meeting and if required to Q&S. In some circumstances the reviews will also be discussed at the Professional Midwifery Advocates monthly meeting, Obstetric Group, Gynaecology Group, Neonatal Group and Heads of Department meeting if relevant. If there are learning issues for all staff the outcome of the case review will be summarised briefly highlighting the lessons learnt/ change to practice and this will be cascaded through the relevant clinical group. A master copy of the report (once finalised) will be held electronically on the shared drive under Midwifery Secretaries/ Case Reviews. Page 15 of 27

16 9 Duty of Candour (please also refer to Trust policy on DoC) All cases that require a formal case review will invoke Duty of Candour. These include SIs and cases that have resulted in an unexpected or unintended outcome. There will also occasionally be cases that fit the Duty of Candour criteria but do not require a formal case review. It is important that the woman (and her family) are seen and debriefed by a Consultant / Risk Management lead and apologies offered. Any discussion should be written in the woman s notes and a datix form submitted. The named Consultant or Risk Management Midwife will ensure that a formal letter is written to the woman outlining the incident and the investigation that will be held (ideally within 10-14days of the incident). Once the investigation has been held the Consultant should meet with the woman and her family and discuss the findings. A formal letter is then sent to the family after the meeting to clarify events. (See appendix 2 for example of letter) 10. Complaints and Claims (This section must be read in conjunction with the Trust Concerns and Complaints Policy and the Claims Management Policy available on the Intranet.) In line with nationally recognised best practice, an attempt is made to make immediate contact with any complainant to gain a deeper understanding of their concerns, prior to undertaking any investigation. Any complaints are sent directly to the Directorate Manager who will review the notes with the appropriate matron and request statements. A response is drafted and a formal reply is made from the Chief Executive (CE). DM, HoM and matrons will encourage face-to-face meetings with complainants to understand more fully the nature of their complaint and attempt to resolve the complaint in a more meaningful way for the complainant. These meetings are held in line with the Trust s Early Resolution Meeting standards. Complaints and responses are monitored and discussed at the Complaints Panel, which is held monthly. An overview of complaints is given each month by the Directorate Manager to the Q&S group. Individual staff members are counselled as appropriate. Any new claims will be sent to the Directorate Manager and reviewed by the senior risk management midwife. A brief response is provided to the legal department after consultation with other appropriate leads regarding whether or not the claim can be defended. The NHS Resolution (formally NHSLA) advises that parents should be informed when such a case is referred. Page 16 of 27

17 11. Training All staff employed in Women s Services will be informed as part of their induction about the Trust Risk Management Strategy and how it is implemented in Women s Services. They will be encouraged to familiarise themselves with this document and will be informed that it is son the intranet 12. Equality and diversity This document has been appropriately assessed and does not discriminate against individuals or groups on any grounds. 13. Monitoring compliance The organisation continually strives to achieve 100% compliance with this procedural document and its intended purpose. Please see the table below for standards and monitoring arrangements: Standards All staff are familiar with the document and aware of how risk management issues are managed in this Directorate Updated risk register Share lessons learnt / datix incidents/ minutes from case reviews That the QAF document will be updated on a regular basis Monitoring and audit Method By Group / Committee At induction Ensure this is done every 3-4 months Risky Business newsletter and departmental meetings Feedback to Q&S each month Risk Management Midwives/ Team leader Governance lead/ DM/ HoM/ CD Risk Management Midwives/ Heads of Department Governance leads Quality and Safety Group CIRG CIRG, SOM monthly meeting, DMT Q&S Frequency If problems with delivering the service arise Monthly Next available meeting Twice a year Page 17 of 27

18 14. Consultation and review The procedural document was been circulated for consultation to all members of the Quality and Safety Group. 15. Implementation Staff will be informed of updated versions of the previous Women s Services Risk Management Strategy. 16. Associated documentation Appendix 1. Trigger Lists Appendix 2. Example of DOC letter Appendix 3. Supporting Staff Appendix 4. Corporate Quality Governance structure Appendix 5. Antenatal and Newborn Screening Quality Governance Structure Page 18 of 27

19 Appendix 1. Directorate of Women s Services Gynaecology Adverse Events Trigger List Please note that staff are encouraged to report any unexpected care outcomes even if not on the following list. Please also notify any cases where there was a near miss even if the outcome was satisfactory Clinical Incidents Organisational Incidents Delayed or missed diagnosis of ectopic Delay following call for assistance pregnancy Moderate/severe ovarian hyperstimulation (assisted conception) Intra-operative damage to structures (e.g. uterine perforation, bowel, vessel, ureter) Unpredicted need to involve another surgical discipline Peri-operative death Omission of planned procedures (failure to insert planned intrauterine contraceptive device after a hysteroscopy) Procedure performed without consent (e.g. removal of ovaries at hysterectomy) Unexpected operative blood loss >500 ml Need for blood transfusion after elective surgery Anaesthetic complications Unplanned intensive care admission Unplanned return to theatre Unplanned re-admission following elective surgery Venous thromboembolism Significant post-operative infection Post-operative wound breakdown Failed procedures (medical termination of pregnancy, medical management miscarriage, sterilisation) Failure to give anti-d when indicated Delayed access to emergency theatre Failure of anaesthetic review-epac Failure of medical assessment-epac Non on-call consultant called to attend or unable to contact on-call consultant Equipment failure Unavailability of equipment Conflict over case management Potential service user complaint Drug error prescription, dispensing, administration Retained swab or instrument Violation of local protocol Communication error Unavailability of health records Failure to act on an abnormal result MRSA infection/cpe infection Pressure Sore Delayed discharge of elective admission >10 days Inappropriate admissions to Gynaecology Emergency Admission Unit (GEAU) Boarders compromising care to gynaecological patients Unsafe staffing numbers Page 19 of 27

20 Obstetrics and Neonatal Adverse Events Trigger List Please note staff are encouraged to report any unexpected outcomes even if not on the following list Lost instruments/ swabs Failure to act on an abnormal result Conflict over case management MRSA or C Difficile infection Failure to follow a Trust guideline All specialities Drug error prescription, dispensing, administration Equipment failure Unavailability of equipment Unavailability of health records Maternal events Death Convulsions/ Eclampsia Transfer to ITU Antenatal/MAU Failure to refer high risk pregnancy to a specialised clinic Failure to give antenatal anti-d when indicated High risk delivery other than on delivery suite Screening incident Undiagnosed SGA Unexpected fetal death Safeguarding children plan not up-to-date Inability to transfer to D/S due to workload/ staff High risk delivery other than on delivery suite Prenatal and fetal medicine Misdiagnosis antenatal test Undiagnosed fetal abnormality Complications (including fetal death) following an invasive procedure Failure to obtain a sample during an invasive procedure Failure to achieve embryo reduction or fetocide Unexpected fetal death Incomplete/inaccurate data for screening tests Postnatal Failure to give anti-d when indicated Failure to give heparin when required Perineal wound breakdown Return to theatre Readmission of mother with perineal problems Readmission of mother (other) Urinary retention requiring urogynae referral Failure to notify discharge to community Pressure sore Transfer from NBC MEWS trigger (pyrexia/ hypertension Neonatal Bone fracture Skin injury (e.g. cut at caesarean delivery) Nerve palsy (VII nerve, brachial) Injury, whether traumatic or due to tissue ischemia Seizures in an inborn baby >32 weeks Neonatal death >32 weeks Unexpected transfer of term baby to Special Care Excessive bruising following assisted delivery Clinical situation requiring maternal resuscitation DVT/PE (Confirmed) Bleeding requiring transfusion 3 or more Intrapartum Intrapartum fetal death 2 nd stage longer than 4hrs Undiagnosed malpresentation Misinterpretation of a CTG Loss of CTG record (paper copy) Ruptured uterus / scar dehiscence Trauma to bladder More than one instrument used to attempt vaginal delivery Failed instrumental delivery 4 th degree lacerations Cord blood ph <7.05 arterial Apgar <6 at 5 mins Shoulder dystocia with internal manoeuvres Return to theatre Pressure Sore Significant delay in treatment/ management due to excessive workload/ staffing issues Blood loss > 1500mls Hysterectomy Laparotomy Intrapartum transfer of a booked home birth Postpartum transfer following home birth High risk delivery in community Anaesthetic Failure to refer (Antenatally) for anaesthetic review Failure of intubation Awareness during general anaesthesia Severe hypertension or hypotension Excessive spinal or epidural analgesia Severe drug reaction Inadvertent dural tap Inadequate analgesia or anaesthesia Neurological complications Delayed anaesthetic consultation leading to increased fetal or maternal morbidity Transfer of hypothermic baby from D/S to ward Baby fall Baby with absent identification bands EBM error Newborn blood spot screening incident Readmission of baby with feeding problems Readmission of baby (other) Transfer from NBC cold baby Transfer from NBC feeding problems ) Page 20 of 27

21 Appendix 2. Duty of Candour Letter Directorate of Women s Services Risk Management Midwife Tel: / (Secretary) Rhona.Collis@nuth.nhs.uk Sec: Susan.sullivan@nuth.nhs.uk Our Ref:RC/SS st March 2016 Address Dear Ms X My name is X, I am a Senior Midwife at the Royal Victoria Infirmary. I have been made aware by Consultant, Dr X that you had an emergency caesarean section and your baby, Xt was quite poorly at birth. My role is to investigate cases whereby we have an unexpected outcome and this includes baby s born in a poorly condition. I will therefore be organising a meeting whereby several senior members of staff and those directly involved in your care on the night of delivery, will attend and we will review the care you received. The purpose of this is to ensure we are satisfied that the care provided was to an appropriate. After the case review Dr X will arrange a meeting with you and your partner X to explain our findings. This will also be an opportunity for you to raise any concerns you may have had. As it takes a while to organise the case review I would hope that the meeting with yourselves will be in the next 6-8 weeks. If you feel you would like to discuss anything with me before the case review then please feel free to contact me on the above number. Yours faithfully X Risk Management Midwife CC File Page 21 of 27

22 Appendix 3. Providing Staff Support: Guidance for Line Mangers, Supervisors of Midwives, Departmental Heads and Supervising Consultants (This section must be read in conjunction with the Trust Supporting Staff involved in a traumatic/stressful Incident, Complaint or Claim Policy available on the Intranet.) Introduction Whether or not a member of staff feels personally culpable for any events surrounding an adverse incident, the possibility of blame or criticism, whether public or private, is extremely stressful. Even without such a possibility, involvement at any level in an adverse incident gives rise to substantial anxiety. Anxious or stressed members of staff seldom perform at their best while matters remain unresolved and it is therefore in the interests of patients, staff and line managers to provide close support for individuals who have been involved in a serious adverse incident. The Guidance deals with the roles of line manager, supervising consultants, departmental heads, and the individual staff concerned in managing the situation. The purpose is: To give line managers practical suggestions for support for the staff for whom they are responsible To give everyone in the Directorate the expectation that in such circumstances there is a culture of care and support, not victimisation and recrimination. The guidance relates only to providing staff support, and does not replace, supersede or involve personnel guidelines, professional responsibilities, circumstances in which there may be disciplinary action, issues relating to patient protection, or internal enquiries. Immediate Debriefing One of the most important functions of middle grade or senior members of staff, whether Medical, Nursing or Midwifery, is to give close support in the immediate aftermath of an adverse incident. This may mean sitting down in a private room over a cup of coffee and just listening to what happened. This is the most important investment of the time that can be made, but is an opportunity that is all too seldom taken. Assistance with preparing Statements or Reports It is helpful to identify the person with whom the individual concerned should liaise, for assistance with checking the content of statements or reports. Group debriefings These are sometimes useful when there are individuals who would value such a discussion, but a formal case review (which performs much the same function) has not been thought necessary. Such a session requires strong chairmanship to avoid Page 22 of 27

23 an atmosphere of recrimination or blame. It can usefully be based around a presentation of the case and a reappraisal of the options, judgements and decisions that were made or could have been made. It must have a primarily education focus. It is particularly helpful that it should take place before the incident is discussed in a broader forum such as a perinatal morbidity & mortality meeting. Group debriefings in no way substitute for the need of individual care for the parties concerned. Inquests Where an inquest is scheduled, the prospect of having to give evidence in a Coroner s Court can be extremely daunting. The Trust Legal Department is available to advise and support persons who are summoned to give evidence at an inquest. A pre-inquest meeting for all those giving evidence can be extremely useful. It may be helpful to arrange a visit to the Coroner s Court. It may also be helpful to identify people within the Directorate who have personal experience of the Coroner s Court. They can relate their own experiences to those faced with prospect of attending the court for the first time. Statement writing The Trust has a guideline on how to write a statement the correct way (available on the intranet). Please refer to this if you do need to write a statement. Managing Incidents Effectively That May Lead To A Claim Despite good management and compliance with guidelines some incidents will not have a good outcome and will inevitably lead to a claim. When such an incident occurs it is imperative that all valuable information is collected as soon as possible after the incident. Although it is difficult to know which incidents will lead to a claim there are some incidents listed on the trigger list, which you should familiarise, yourself with that may lead to a claim. The following section will consider some of these incidents and list recommended actions to be undertaken so that the relevant information is available and collated appropriately. In general: Ensure documentation in notes (and on partogram) prior to event occurring is thorough and includes who attended when help requested. Ensure documentation is good regarding the actual delivery. The Operative delivery record should be as descriptive as possible including any assistance requested. Ensure any retrospective entries to notes are written as soon as possible. Statements are started as soon as possible by all key staff involved in the care and resuscitation of the baby (ideally before the end of the shift). Check CTGs has been archived. If it has not been archived then the original CTG should be scanned in and filed electronically with midwifery administration. Ensure original CTG is stored in the Trust approved resealable CTG envelope Placenta should be sent for histopathology. Page 23 of 27

24 Cord ph < 7.0 baby unwell and transferred to SCBU Ensure paired cord sample results are obtained and results written on the partogram and filed in the appropriate envelope. Intrapartum fetal death Ensure accurate documentation in the notes regarding examination of placenta and cord i.e. true knot evident, cord entanglement. Bone fracture / nerve palsy If shoulder dystocia occurred SD proforma should be completed. The X-ray of the fracture should be saved / archived appropriately. Consider photographing the injury if appropriate (by Medical Photography Department). Cut and/ or excessive bruising to face/ head following instrumental delivery or Caesarean section Document the discussion with the parents. Consider photographing the injury (by Medical Photography Department). Ensure that a clear explanation is in the notes as to how the injury was sustained. If a cut to the face occurs which warrants suturing (including steri strips) ensure referral to plastics on-call Trainee. Ensure clear documentation regarding sutures used and subsequent care plan copies to be filed in both maternal and baby notes. Severe shoulder dystocia / symphysisiotomy Ensure paired cord sample results are written on the partogram and filed in the appropriate envelope. The SD proforma should be fully completed with accurate timing of manoeuvres required. An early referral should be made to an uro-gynae consultant (if symphysisiotomy performed). Uterine rupture Ensure paired cord sample results are written on the partogram and filed in the appropriate envelope. Bladder damage with voiding complications Ensure partogram has thorough documentation including bladder care given in labour (retrospective entry to notes may be required). If operative procedure, undertaken ensure thorough documentation of any complications. Ensure documentation regarding postnatal voiding and management is clearly documented. File safely fluid balance charts and any bladder scan reports. Involve early input from an Uro-gynae nurse specialist / physiotherapist. Drug error leading to woman/ maternal and or fetal /baby compromise Page 24 of 27