FINAL REPORT Investigation of Incident 50278 from time of patient’s self referral to hospital on the 21 st of October 2012 to the patient’s death on the 28 th of October, 2012. Investigation Commencement and Completion Dates Details of this investigation including the terms of reference overseen by an Independent External Chair were agreed on Monday 19 th of November, 2012. Investigation Completed 7th of June 2013 JUNE 2013 2 Contents Page Foreword 4 Acknowledgement 7 Glossary of Terms 8 Executive Summary 11 Methodology 19 Section 1 Background to the Investigation 21 Section 2 Chronology of Events 22 Section 3 Aftermath of Incident 54 Section 4 Key Causal Factors, contributory factors, incidental 55 factors and linked recommendations. References 82 Appendix A: Summary Outline of the legal position in Ireland with 85 respect to the regulation of the termination of pregnancy and, in particular, as regards the protection of the right to life of the pregnant woman and of the unborn. Appendix B: Terms of Reference 97 Appendix C :Interim recommendations conveyed to hospital 99 Appendix D: Sources of Information Reviewed by the Investigation 101 Team Appendix E: Framework of Contributory Factors 103 Appendix F: Patient Observation Scores (transposed by the 104 investigation team onto the modified obstetric early warning score chart not in use at the time for pregnant women on the gynaecology ward) 3 Foreword This investigation undertook to provide a methodical, accurate and impartial report on the events which took place between the 21 st of October and the 28 th of October, 2012 relating to this tragic maternal death which had a devastating affect on the patient’s husband and her family. The staff who cared for this patient were also deeply saddened by the patient’s tragic and untimely death. The investigation team established that this was the first direct maternal death 1 to have occurred at the hospital in 16 years. 51,440 births were recorded at the hospital from the time in 1996 when the last direct maternal death occurred - to December 2012. We set out to be thorough in our approach and to establish if any aspect of the care this patient received may have contributed to this maternal death and if so, to identify the key causal and contributory factors. We also set out to make any necessary recommendations for hospital and national level, to address any contributory factors or causes identified so as to prevent future harm arising from these causes and to improve the safety of services for future service users. A post-mortem examination was performed on the 30 th of October, 2012. The cause of death established by the Coroner’s Inquest in this case in April, 2013 was: “1(a) Fulminant septic shock from E. coli bacteremia. 1(b) Ascending genital tract sepsis. 1(c) Miscarriage at 17 weeks gestation associated with chorioamnionitis. (2) There were no co-morbidities”. Sepsis is a common cause of death in the general population. In the United States, sepsis contributes to more than 200, 000 deaths per year. Sepsis is also the most common cause of maternal mortality identified in the UK Centre for Maternal and Child Enquiry (CMACE) 2006-2008 report (2011). Sepsis is a systemic illness that complicates severe infection which is caused by the invasion and multiplication of microbes in normally sterile sites in the body. Sepsis causes a systemic inflammatory response with evidence or suspicion (pending the results of tests) of an underlying infection. When accompanied by evidence of organ/tissue hypoperfusion or dysfunction, sepsis becomes severe sepsis. When severe sepsis is accompanied by hypotension (low blood pressure) despite adequate fluid resuscitation, a patient is considered to have septic shock. Progression from sepsis to severe sepsis to septic shock can occur within hours and correlates with increasing mortality. Early diagnosis and management is essential to reduce the mortality rate. Sepsis is difficult to diagnose in pregnancy due to the associated natural physiological changes and this calls for efficient assessment and monitoring of the patient by the clinical team to enable them to promptly recognise and respond to the signs of infection and clinical deterioration. 1 A maternal death is defined within the UK Confidential Enquiry as: “Deaths of women while pregnant or within 42 days of the end of the pregnancy from any cause related to or aggravated by the pregnancy or its management, but not from accidental or incidental causes”. Maternal deaths are sub- divided into four further groups, including direct maternal deaths. Direct maternal deaths are those that result from obstetric complications of the pregnant state (pregnancy, labour and puerperium), from interventions, omissions, incorrect treatment or from a chain of events resulting from any of the above (classification 8 of the ninth revision of the International Classification of Diseases, Injuries and Causes of Death). 4 Our investigation established that hospital guidance assumes four-hour monitoring of patient observations for patients with premature rupture of membranes. However, in this case monitoring of the patient who had prolonged rupture of membranes was less frequent (See Appendix F). There was inadequate assessment and monitoring that would have enabled the clinical team to recognise and respond to the signs that the patient’s condition was deteriorating due to infection, together with non adherence to guidelines for the prompt and effective management of sepsis, severe sepsis and septic shock when it was suspected or diagnosed. The modified Obstetric Early Warning Score (mOEWS) observation chart was not in use in some hospitals at the time of this incident for pregnant women on gynaecology wards. We considered that the patient’s condition involved prolonged rupture of membranes, which is associated with increasing risk of infection with the progress of time. In this case, the patient’s condition was rare and serious. There was a lack of recognition of the gravity of the situation and of the increasing risk to the mother which led to passive approaches and delays in aggressive treatment. This appears to have been either due to the way the law was interpreted in dealing with the case or the lack of appreciation of the increasing risk to the mother and the earlier need for delivery of the fetus. When the patient and her husband enquired about the possibility of having a termination, this was not offered or considered possible by the clinical team until the afternoon of the 24 th of October due to their assessment of the legal context in which their clinical professional judgement was to be exercised. The Irish constitution Article 40.3.3 (as inserted by the eight amendment in 1983) states that: ‘the state acknowledges the right to life of the unborn and, with due regard to the equal right to life of the mother, guarantees in its laws to respect, and, as far as practicable, by its laws to defend and vindicate that right’ (See Appendix A for a summary outline of the legal position in Ireland with respect to the regulation of the termination of pregnancy and, in particular, as regards the protection of the right to life of the pregnant woman and of the unborn). From the time of her admission, up to the morning of the 24 th of October - the clinical management plan for the patient centred on the approach to “await events” and to monitor the fetal heart in case an accelerated delivery might be possible once the fetal heart stopped. Awaiting events is clinically appropriate provided it is not a risk to the mother or the fetus. Appropriate monitoring and evaluation of the changing clinical presentation with appropriate clinical investigations would likely have lead to reconsideration of the need to expedite delivery. Monitoring and adherence to guidelines for the prompt and effective management of sepsis would likely have helped to prevent rapid deterioration of the patient. Delaying adequate treatment including expediting delivery in a clinical situation where there is prolonged rupture of the membranes and increasing risk to the mother can, on occasion, be fatal. The investigation team is aware that clinical circumstances can and have arisen in Ireland where a termination of pregnancy is an appropriate and necessary clinical step in the medical treatment and care of a patient. In this regard the investigation team notes the evidence which was given to the Oireachtas Joint Committee on Health and Children to discuss the implementation of the Government decision following the publication of the 5 expert group report on matters relating to the case A, B and C v. Ireland on the 8 th of January, 2013. 2 We strongly recommend and advise the clinical professional community, health and social care regulators and the Oireachtas to consider the law including any necessary constitutional change and related administrative, legal and clinical guidelines in relation to the management of inevitable miscarriage in the early second trimester of a pregnancy including with prolonged rupture of membranes and where the risk to the mother increases with time from the time that membranes are ruptured including the risk of infection and thereby reduce risk of harm up to and including death. These guidelines should include good practice guidelines in relation to expediting delivery for clinical reasons. We recommend the use of the mOEWS, or a nationally agreed equivalent, for such patients, along with mandatory induction and continuous education of staff on the recognition, monitoring and management of infection, sepsis, severe sepsis and septic shock. We emphasise that early warning score charts cannot replace professional clinical judgement and the importance of considering the entire clinical context. mOEWS are useful to assist and focus multidisciplinary care teams on potential derangement of physiology and act to alert, not diagnose.