The tragic death of Savita

The facts about the tragic death of Savita Halappanavar

Savita Halappanavar died in Galway University Hospital on October 28th 2012. Three separate inquiries into her death found that she died of sepsis – an infection of the blood caused by an extremely virulent bacteria, Ecoli ESBL, rarely seen in Irish maternal health services. The HSE inquiry also found that the bacteria was also the most likely cause of Savita’s miscarriage.

The inquiries found that Savita’s case had been medically mismanaged in the hospital, with the HIQA inquiry pointing to 13 missed opportunities to save her life. The evidence that emerged from those inquiries is presented below, and is a clear and factual account of this tragic case.

Note

The reports referred to in this summary are:

The HIQA Report – the findings of the investigative report by the Health Information and Quality Authority

The HSE Report – the findings of the investigative report by the Health Service Executive

The Coroner's Court - the findings of the Coroner ’s Court inquest into the death of Ms Halappanavar

Savita presents at Galway University Hospital

On the 21st of October 2012, 31 year old Indian woman Savita Halappanavar, who was 17 weeks pregnant with her first baby, presented at University Hospital Galway. She was initially assured that everything was normal and sent home. However, she later returned after feeling “something coming down” and the midwife and Senior House Officer who examined her found a dilated cervix and bulging membranes. They concluded that she was   miscarrying and she was admitted for observation.

Standard international practice in this type of situation is to adopt a “watch and wait” approach, and not to intervene unless deemed necessary. According to the HIQA report (page 59) this was also the approach taken in Savita’s case. At the same time, a blood test was taken for a complete blood count. The result showed an elevated white cell count of 16.9 which is well above the upper limit of normal of 10 or 11. In what would turn out to be a key system failure identified by the Coroner in this case, this result was not noted in Savita’s chart. This meant that the first indication that an infection could be brewing somewhere in Savita’s body was missed.

Savita was brought to a single room on St. Monica’s ward, and given pain relief. According to the testimony of staff, she did not have the appearance of a sick woman, and her level of pain was normal for a woman suffering inevitable miscarriage. (Page 27 - HSE report)

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Checking the fetal heartbeat

At approximately 00.30 hrs in the morning of her first night of admission, the call bell in Savita’s room was activated. When the midwives came running, they found Savita standing in the bathroom. She had vomited and there was a pool of clear liquid on the floor. A spontaneous rupture of membranes had occurred and she was leaking amniotic fluid. The miscarriage process was underway. She was made comfortable by the nurses and they confirmed she had no pain but she slept fitfully that night.

The following morning, Savita’s vital signs were recorded during the nursing care round, and found to be normal. Later that morning, Savita met with Consultant Obstetrician Dr. Astbury for the first time since she had presented in the hospital. Dr. Astbury recommended that Savita be given an ultrasound scan, to confirm the presence of a fetal heartbeat. She would later explain to the Coroner’s Court that her reason for checking this was in order to ensure that Savita wasn’t left on the ward with a dead foetus in her womb, which could give rise to infection.  

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The infection was missed – a termination was possible if infection was observed

At this point, the care team were still unaware of the raised white cell count and, therefore, no repeat tests were ordered to see if the result was trending towards progressive infection. Later that day, Savita’s antibiotic care was discussed, and it was decided to administer an antibiotic called Erythromycin as a prophylactic measure. This treatment recognised the fact that there was now an opening for bacteria to enter, as the membranes had ruptured. What the medical team did not realise, however, was that at this point Savita was already carrying an infection, caused by a bacteria which is resistant to this type of antibiotic. It was another 72 hours before this realisation was made, during which time the infection spread and Savita’s condition deteriorated.

That night Savita’s vitals were recorded again, and she stated that she was not in pain.

On Tuesday morning, the consultant saw Savita again, and explained to her the need to monitor for a fetal heartbeat, in order to ensure she was not carrying a dead baby. Savita was very upset, and enquired about the possibility of receiving medication in order to bring on the miscarriage. The consultant later testified that she explained to Savita that the legal position in Ireland did not permit her to terminate the pregnancy in her case, as she did not see that there was a threat to her life. Unfortunately, Dr. Astbury was still unaware of the elevated white cell count - and the infection - at this point. She told the Coroner ’s Court that if she had been aware of the infection she would have terminated the pregnancy - as was permissible under Irish law.

The ‘Catholic comment’

During the Coroner’s inquest, a midwife testified that she had made a comment at this time, to the effect that a termination could not be carried out because “we don’t do that here dear, it’s a Catholic thing”. She apologised for the controversy that this had caused, and explained that she was trying to shed light on Irish culture, rather than trying to be hurtful or insensitive. She also emphasised that this comment was part of a “normal chat” and had no bearing whatsoever on Savita’s medical care.

The Coroner also confirmed that Irish public hospitals do not follow any religious tenets or dogma.

Dr. Astbury’s understanding of the law in this case was quite clear – professional medical guidelines, and the law, permitted a pregnancy to be terminated if it was seen that there was a risk to a woman’s life. In the case of sepsis, in the second trimester, where the focus of the infection is in the womb, the foetus would be induced and delivered where a risk to the woman’s life arose, but at this time, the consultant had no indication that any of this applied to Savita’s condition.

Savita was showing classic signs of sepsis

Later that night a student midwife took Savita’s vital signs and realized they were abnormal – her pulse was racing at 114 beats per minute. An elevated pulse is one of the four classic signs of sepsis.

Later testimonies in the Corner’s Court would show some confusion as to what exactly happened next. The midwife testified that she bleeped the Senior House Officer on call and made him aware of the elevated pulse rate. The Senior House Officer, however, stated that he was never made aware of this. At this point, Savita had ruptured membranes for almost 48 hours, an elevated white cell count and a tachycardia (elevated pulse rate). She now had two of the four classic signs of sepsis.

Savita’s vital signs were taken again later that night, and she expressed a feeling of weakness. Her pulse rate was still above 100 beats per minute. As the ward was busy, and the Senior House Officer was, he claimed, unaware of the elevated pulse rate, he still did not go to see Savita. When he did arrive, Savita was sleeping and he did not wake her.

During the night Savita’s husband, Praveen, realised that she was cold and that the radiator in the room was not working. A nurse brought blankets and noticed she was shivering. She took her temperature and discovered that it was raised at 37.7 degrees. Savita was developing a fever – this was the third of the four classic signs of sepsis. Even though medical guidelines state that in the case of miscarriage, all vital signs should be taken every four hours, it was not done at this point and in fact there was a gap of nine hours between the last and next check.

Savita was given paracetamol to lower her temperature – the midwife would later testify that Savita seemed one of the healthiest patients on the ward that night.

At 05.15 the midwife returned and took her temperature again – the paracetamol had lowered it to 37.5, the upper limit of normal. At 6.30 am Savita was seen again, during normal rounds, and complained of weakness and body aches. At this point her vitals were taken again, and all were abnormal. Her fever was now at 39.6, her heart was racing at 160 beats per minute and her blood pressure had fallen to well below normal. It was now obvious that Savita was very ill. The Senior House Officer was called and came immediately. He ordered a range of blood tests, including blood cultures, as staff now recognised that infection was likely.

It was these blood cultures that finally identified the type of bacteria that Savita was infected with, but unfortunately, due to the nature of these tests, this result would not be known for another 48 hours. The doctor also noted a foul-smelling discharge at this time, and made a diagnosis of probable chorioamnionitis – which is inflammation of the fetal membranes due to infection. Savita’s condition deteriorated rapidly.

Information was not passed on

The Senior House Officer changed her antibiotic to a drug called Co-Amoxiclav and informed the Specialist Registrar of the situation, but the Registrar was busy with a caesarean section and did not review Savita. It was also later claimed that the Obstetric Registrar coming on duty that night was made aware of the situation and the foul smelling discharge, but that Registrar said she had no recollection of it.

The next morning Dr. Astbury came to see Savita and put her on another antibiotic, Metronidazole, as her vitals were still abnormal. She informed Savita that she suspected Chorioamnionitis, but wanted to rule out other sources of infection. She told her that there was a possibility that they might have to terminate the pregnancy early. The fetal heartbeat was checked again, and found to be still present.

However, as no note had been made on Savita’s chart regarding the foul smelling discharge, it emerged at the Coroner ’s inquest that the Registrar quite likely forgot to mention it to Dr. Astbury, who testified that had she known about it she would have taken steps to commence the medical termination earlier.

   

Savita is now very seriously ill

Savita's blood pressure began to fall and she developed severe sepsis. Blood tests indicated her white cell count had plummeted. By lunchtime her pulse was racing, blood pressure was dropping, and she was sweaty and having difficulty breathing. At this point the doctor realised that Savita's life was in real danger and that delivery was required immediately. She got agreement from the clinical director and also spoke with a Consultant Microbiologist and received antibiotic advice – Tazocin and Gentamicin were now administered. When Savita was moved to the theatre, she spontaneously delivered the baby and Praveen was called to be with her.

Savita was transferred to Intensive Care during the night. Her medical records would later show that she was suffering from severe septic shock and multi organ failure. She required a tube in her lungs to help her breathe. She remained critically ill throughout the day.

It was at this point that her blood culture tests returned, and it was finally revealed that Savita was infected with an E.coli ESBL bacteria, rare in pregnancy, and highly resistant to many of the commonly used antibiotics. The expert microbiologist at the Coroner ’s inquest said that this type of infection would never have been expected in a young, healthy woman with no recent medical complications.

The medical team now started Savita on the appropriate treatment, but she failed to respond as the infection had already spread and her organs were affected. A consultant at the inquest, Dr. Peter Kelahan, said that her level of infection was incredibly high and exceedingly rare and that Savita had the worst case of sepsis he had seen in 30 years.

Her condition continued to deteriorate throughout Saturday and on the morning of Sunday, 28th October 2012, Savita Halappanavar passed away. Her cause of death was documented as multi-organ failure from E.coli ESBL septicaemia.

What the investigations said...

Coroner ’s Inquest

• On 19 April 2013, after seven days of evidence from 36 witnesses, Dr. Ciarán McLoughlin returned a verdict of medical misadventure in the case of Savita Halappanavar. He highlighted deficiencies in her care which included;
• Blood tests indicating possible infection were not collected
• Savita’s pulse rate was elevated at 114 but the on-call doctor was not aware of this
• Savita’s vital signs were not checked for more than nine hours, in breach of hospital guidelines
• Although Savita’s pulse rises to 160, with a fever and a foul smelling discharge, the discharge was not relayed to Savita’s consultant

The Coroner made 9 National Recommendations in his report including: 

• following up of blood samples
• following protocols for the management of sepsis
• proper and effective communication between staff
• protocols for antibiotic use in sepsis
• early communication with patients to ensure their treatment plan is understood 
• use of warning scores to be used in all State hospitals.

HSE report

On Thursday 13th June 2013, the HSE published the report of the investigation into the death of Ms. Savita Halappanavar.

Overall the investigation team found three key causal factors.

1. Inadequate assessment and monitoring of Ms. Halappanavar that would have enabled the clinical team in UHG to recognise and respond to the signs that her condition was deteriorating. Ms. Halappanavar’s deteriorating condition was due to infection associated with a failure to devise and follow a plan of care for her that was satisfactorily cognisant of the facts that:

• the most likely cause of her inevitable miscarriage was infection and
• the risk of infection and sepsis increased with time following admission and especially following the spontaneous rupture of her membranes.

2.  Failure to offer all management options to Ms. Halappanavar who was experiencing inevitable miscarriage of an early second trimester pregnancy where the risk to her was increasing with time from the time that her membranes had ruptured.

3.  UHG’s non-adherence to clinical guidelines relating to the prompt and effective management of sepsis, severe sepsis and septic shock from when it was first diagnosed.

The report also made recommendations based on -

• The implementation of early warning scoring systems;
• The education of all staff in the recognition, monitoring and management of sepsis and septic shock; and
• The introduction of a new multi-disciplinary team-based training programme in the management of obstetric emergencies, including sepsis.

A copy of the full REPORT is available here...

HIQA Investigation

HIQA released their report on their investigation into the standard of services provide to Savita Halappanavar on Wednesday, 9 October 2013.

The Terms of Reference had been approved by the Board of the Authority on 27 November 2012 and the Investigation Team was announced on 19 December 2012. The Authority identified, through a review of Savita Halappanavar’s healthcare record, a number of missed opportunities which, had they been identified and acted upon, may have potentially changed the outcome of her care.

In all they identified 13 different points at which interventions could have made a difference to saving Savita’s life.

In summary, of the care provided there was a:

• general lack of provision of basic, fundamental care, for example, not following up on blood tests as identified in the case of Savita Halappanavar
• failure to recognise that Savita Halappanavar was at risk of clinical deterioration
• failure to act or escalate concerns to an appropriately qualified clinician when Savita Halappanavar was showing the signs of clinical deterioration.

It noted that the Hospital had a guideline in place for the management of ‘Suspected sepsis and sepsis in obstetric care’. However, the clinical governance arrangements were not robust enough to ensure adherence to this guideline. In addition, clinical staff had not received specific sepsis training in relation to the application of this policy and/or the specific management of a maternity patient with sepsis.

The Authority also found that consultants on call for the labour ward were not present on the labour ward but, rather, engaged in other clinical activities. This is at variance with national and international best evidence.

The Investigation Team also reviewed the healthcare record of Savita Halappanavar which indicated that the results of blood tests had identified a particular strain of Escherichia coli (E.coli) called ESBL- (Extended-Spectrum Beta-Lactamase) producing E. coli. ESBL. ESBL producing E. coli are antibiotic resistant and consequently make the infections harder to treat. They found that there was no national laboratory-based alert system that enabled real-time analysis of data from local laboratory information systems, or from other healthcare information systems (such as the national Computerised Infectious Disease Reporting [CIDR] system for notifiable infectious diseases) thereby facilitating timely recognition of emerging national microbial threats including antimicrobial resistance.

In conclusion, their findings "reflect a failure in the provision of the most basic elements of patient care to Savita Halappanavar and also the failure to recognise and act upon signs of her clinical deterioration in a timely and appropriate manner".

They also noted that the findings relating to the HSE inquiry into the death of Tania McCabe and her son Zach in 2007, have a disturbing resemblance to the case of Savita Halappanavar.

A copy of the full REPORT is available here...

Had terminations previously been carried out in Ireland where sepsis arose in pregnancy?

Yes. Under Irish medical council guidelines, it was clear that the law permitted interventions to save the life of the mother where life-threatening conditions arose in pregnancy. In fact, Irish doctors are always obliged to intervene to save the life of a mother - even if that risks the life of her baby.

Dr Sam Coulter-Smith confirmed to an IMO conference in 2013 that, in the previous year in the Rotunda Maternity Hospital, four interventions had been carried out to save the mother’s life where sepsis occurred in pregnancy. In all these cases the baby’s life had sadly been lost, but the life of the mother was saved.

Dr Coulter Smith also pointed out in a radio interview that these interventions were not considered an abortion, saying “we are talking about a termination of pregnancy, bringing a pregnancy to a conclusion in order to save a mother’s life - I don't think we should call that an abortion”.

Ireland has an excellent record on caring for women in pregnancy

According to the United Nations, Ireland is one of the safest places in the world for a woman to be pregnant. Our maternal mortality rate – the rate of women dying in pregnancy and childbirth – is very low. Clearly, if abortion was required to save women’s lives, that would not be the case.

A major Oireachtas hearing in 2013 heard from senior Irish Obstetricians, who, when asked if they were aware of instances where there had been “needless maternal deaths” because of Ireland’s ban on abortion, confirmed that they did not know of ANY situation where a woman had lost her life in Ireland because she was denied life-saving treatment when required.