Savita - staff may be held accountable

Individual staff members found to be at fault in the Savita Halappanavar case may be referred to their regulatory authorities, it has been confirmed.

The HSE review report into the death of Savita Halappanavar last October 28, published today, is to be referred to the Medical Council and the Nursing and Midwifery Board, Health Minister James Reilly has confirmed.

HSE officials and hospital management, at the launch of the report, indicated that the issue of considering disciplinary action against individual staff was unlikely to be dealt with until all the relevant reports into the Savita case, including the forthcoming HIQA report, and the coroner's inquest findings, had been considered.

However, the Minister today indicated he wanted this process to be speedier and that the regulatory bodies should be involved if necessary.

Minister Reilly said his Department was forwarding the report to both professional bodies 'for their early consideration and advice on any action considered appropriate, as the report raises several important issues in relation to professional practice.'

He is also calling in the Institute of Obstetricians and Gynaecologists, the professional body for maternity specialists, to discuss the implications of the report.

No individuals are identified or held individually accountable in the report.

The report identified major failures in the care of Savita at University Hospital Galway (UHG), specifically relating to poor monitoring of her rapidly deteriorating condition and failure to adhere to existing clinical guidelines for sepsis management, and also stressed the need for clear legal and clinical guidelines to provide clarity in cases such as Savita's.

The report says these guidelines include good practice rules in relation to expediting delivery for clinical reasons, including medical and surgical termination based on available expertise and feasibility consistent with the law.

The report says the interpretation of the law in relation to lawful termination in the Savita case, particularly the lack of clear guidelines and training, was a material contributory factor in the case. Clinical staff felt their hands were tied in relation to early termination of Savita's pregnancy because of the current law.

The report says similar incidents in a similar clinical context could happen again in the absence of such legal clarity as to where it may be necessary for a doctor to consider a termination in the clinical welfare interest of the patient.

The report says there was an immediate and urgent requirement for a clear statement of the legal context in which clinical judgement can be used in such cases in the best welfare interests of patients and for guidelines relating to this to be produced.

However, the Chair of the inquiry, Prof Sabaratnam Arulkumaran, indicated at the launch of the report that legal changes may need to go further than the Government's current proposals,in order to  to deal with cases where the patient's condition can deteriorate rapidly.

The report says a major causal factor in the Savita case was inadequate assessment and monitoring that would have enabled the clinical team to recognise and respond to signs that the patient's condition was deteriorating due to infection associated with failure to devise and follow a plan of care for Savita.

This plan should have been cognisant of the fact that the most likely cause of Savita's 'inevitable' miscarriage was infection, and the risk of infection and sepsis increased with time, especially following the spontaneous rupture of membranes.

The review group said there was a failure to offer all management options to a patient experiencing inevitable miscarriage at an early stage of her pregnancy, where the risk to the mother increased with time from the occasion where the membranes were ruptured.

There was a non-adherence by staff to clinical guidelines related to the prompt and effective management of sepsis, severe sepsis and septic shock when it was diagnosed.

Prof Arulkumaran, at the launch of the report, stressed how rapidly a patient can progress from sepsis to severe sepsis to septic shock over a very short period of time. He said sometimes, if an intervention was made at a later stage, it would be difficult 'to bring the patient back'.

Asked why guidelines for monitoring and managing severe infection were not followed in Savita's case, he said the fact that staff were not used to dealing with such cases on a daily basis would have been a factor.

"It is such a rare problem that people were not ready to act on it."

Ms Halappanavar died of severe sepsis at the Galway hospital last October 28, after being admitted at 17 weeks into her pregnancy and having been found to be miscarrying. She eventually miscarried before she died.

Savita and her husband Praveen asked repeatedly for a termination earlier on during her week-long hospital stay, but this was refused on the basis that the foetal heartbeat was still present.

A crucial part of the report states that there was an apparent over-emphasis on the need not to intervene (ie. carry out a termination) until the fetal heart stopped altogether, with an under-emphasis on the need to focus appropriate attention on monitoring for and managing the risk of infection and sepsis in the mother.

The report states that UHG's own guidelines on the management of sepsis, which had been in operation at the time, outlined the importance of attempting to establish the focus of infection and to treat any obvious source.

"This guideline states that it is imperative that any infective focus should be identified, with the removal of the source of infection to be completed as quickly as possible. In this clinical context, that would be termination of pregnancy."

Elsewhere in the report, it is stated that a blood test on Savita on October 21 last, the day she was admitted, showed that her white blood cell count was at a level which, according to the hospital's own guidelines, was indicative of suspected sepsis or sepsis.

However, these blood test results, which could have prompted further tests on how seriously ill Savita was, were never followed up.

There was found to be a lack of clarity on who was responsible for this follow-up, but the review says it is the duty of the doctor leading the clinical assessment of the patient to review all test results.

The report outlines other gaps in Savita's assessment and monitoring. These deficiencies included poor communication leading to failure to process a key lactate test on October 24th, the results of which could have expedited immediate and aggressive management of Savita's worsening condition.

The report also details deficiencies in communications between staff on results of temperature, pulse rate and blood pressure measurement.

On October 24th, the report notes that the very serious condition of sepsis secondary to chorioamnionitis was diagnosed in Savita. This, the review said, would merit expediting delivery of the fetus to reduce the risk of the mother developing severe sepsis and septic shock by removing the source of the infection (ie. the fetus).

"The gravity of the situation was increasing but appears not to have been recognised and acted upon." The review accepts that concern about the law on termination, whether clear or not, impacted on the exercise of doctors' clinical professional judgement.

The report says a consultant did not contact the microbiology department until around 2pm that day to discuss the best antibiotic option for Savita, who was then in in septic shock and was not responding well to antibiotics already prescribed.

The report notes that the UHG guidelines on the management of severe sepsis state that appropriate antibiotics for these infections must be commenced without awaiting test results and the microbiologist must be contacted as soon as possible to discuss further treatment.

Savita's doctors at that stage were awaiting test results before deciding on using stronger antibiotics.

These delays, the report states, represented a missed opportunity for earlier intervention to treat Savita's worsening condition. Every hour of delay in administering an appropriate antibiotic worsens the prognosis in septic shock, the report stresses.

As Savita's condition deteriorated around midday on the 24th, two consultants decided she needed a termination, even though a fetal heartbeat was present. Earlier in the afternoon, the fetal heartbeat had stopped and shortly afterwards Savita had a spontaneous miscarriage.

The report notes that shortly before this a new antibiotic regime had been started on Savita, 10 hours following the initial signs of sepsis and eight hours after a diagnosis of this by a junior doctor. Savita died four days later.

Prof Arulkumaran indicated that if there had been no potential legal obstacles, as an obstetrician he would have terminated Savita's pregnancy at an earlier stage.

He stressed however, that there was a lack of legal clarity here and because of this, some doctors would have performed the termination much earlier and others much later.

The HSE and UHG management has apologised to Praveen Halappanavar and his family for the events that contributed to Savita's death.

UHG said it was committed to operating to the highest standards.

The HSE said it was working to implement recommendations from the Savita report, which, the review Chairman said, should be applied nationally.

These include implementation of an early warning chart for deteriorating patients; education of staff on recognition and management of sepsis; development of national guidelines on infection in pregnancy; developing guidelines in cases of early second trimester inevitable miscarriage where there is possible rapid deteriorating of a patient from sepsis to septic shock; and improved staff communications practices.

The HSE said the early warning score system had just been introduced for maternity services.

The report also calls for legal clarification on the context in which clinical professional judgement can be exercised in the best medical welfare interests of patients.

View the full report here

Savita - notes on a scandal

 

[Posted: Thu 13/06/2013]

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