This maybe a long a boring looking post but it is very important because a woman who had her baby way back has finally got a ruling from the Health Service Ombudsman for England that the Trust was wrong to administer syntometrine for a manged third stage without her consent. The Trust’s argument was very simply put – that it was OK because the baby’s life was in danger and so it was emergency care. The Ombudsman’s supports the complainant: the woman’s life was not in danger, syntometrine administration would not save the baby’s life therefore consent could and should have been sought.
This woman has had immense courage and tenacity to keep going with this complaint over several years and many women should be saved from similar intervention because of her hard work and the ruling that has come out of it. We salute you Mrs T wherever you are.
Meanwhile, we should pass on the message of this ruling to providers and CCG leads, mothers and midwives alike. Women’s consent has to be sought for medical intervention.
Health Service Commissioners Act 1993
Report by the Health Service Ombudsman for England of an investigation into a complaint made by Ms T
Complaint about: the Trust
- This is the report on the investigation into Ms T’s complaint about the Trust. This report contains my findings, conclusions and recommendations with regard to her concerns.
- Ms T complains that the Trust have not provided her with an adequate explanation for administering Syntometrine to her without her consent.
- Ms T says that she has been denied an honest explanation in response to her complaint.
- In bringing this complaint, Ms T is seeking an acknowledgement from the Trust that there was no clinical basis for overriding the need to get her consent.
- Having considered all the available evidence related to Ms T’s complaint about the Trust, including her recollections and views, and taken account of the clinical advice we have received, I have reached a decision. I find that the Trust’s handling of Ms T’s complaint was maladministrative, which led to the injustice that she has experienced worry and concern that others might have the same experience as she did.
- I uphold Ms T’s complaint about the Trust.
The Health Service Ombudsman’s jurisdiction and role
- Our role is to consider complaints about the NHS in England. We start by considering whether there is evidence that there has been maladministration by an NHS organisation, a failure in a service it provided or a failure to provide a service it was empowered to provide.
- We then consider whether maladministration or service failure has led to an injustice or hardship that has not been put right. If we find an injustice that has not been put right, we will recommend action. Our recommendations might include asking the organisation to apologise or to pay for any financial loss, inconvenience or worry caused. We might also recommend that the organisation take action to stop the same mistakes happening again.
The relevant standards in this case
- When considering a complaint we begin by comparing what happened with what should have happened. We consider the general principles of good administration that we think all organisations should follow. We also consider the relevant law and policies that the organisation and any professionals involved should have followed at the time.
- If these actions, or lack of them, were not in line with what they should have been doing, we decide whether that was serious enough to be maladministration or service failure.
- The overall standard I have applied to this investigation is set out below.
The Ombudsman’s Principles
- Our Principles of Good Administration, Principles of Good Complaint Handling and Principles for Remedy are broad statements of what public organisations should do to deliver good administration, provide good customer service and respond properly when things go wrong.
- The same six key Principles apply to each of the three documents. These six Principles are:
- · Getting it right
- · Being customer focused
- · Being open and accountable
- · Acting fairly and proportionately
- · Putting things right, and
- · Seeking continuous improvement.
- One of the Principles of Good Complaint Handling is particularly relevant to this complaint:
- ‘Being open and accountable’ – which includes providing honest, evidence-based explanations.
- We telephoned Ms T on 20 November 2012 to discuss the nature of her concerns and the way in which we would investigate her complaint. We confirmed our understanding of the complaint and the issues we would investigate in our letter to Ms T dated 28 November 2012.
- We have looked at all the relevant evidence for this case, including Ms T’s clinical records and the papers showing how the Trust handled her complaint.
- We also obtained clinical advice from one of our clinical advisers, a registered midwife (the Midwife Adviser). Our clinical advisers are specialists in their field. In their roles as advisers, they are completely independent of the NHS.
- Ms T and the Trust have had the opportunity to comment on a draft of this report, and their responses have been taken into account in coming to the decision.
- During her pregnancy Ms T made a birth plan for a home birth with the midwife responsible for her care (the Midwife); this birth plan said she ‘would like physiological 3rd stage – no drugs to be routinely given’. On 3 April 2010 Ms T went into labour and the Midwife attended her at home as arranged. During the birth, at 7.29pm, the Midwife recorded that the fetal heart rate was low (below 100 beats per minute). The Midwife also recorded seeing ‘thick meconium’ at 7.46pm and again at 7.50pm. At 7.50pm the Midwife called for a paramedic ambulance to attend, in anticipation of possible complications, following which she performed an episiotomy. The baby was born at 8pm in a good condition and the Midwife administered Syntometrine to Ms T. The Midwife clamped and cut the umbilical cord and Ms T delivered the placenta.
- Ms T contacted the Trust’s complaints department and discussed her concerns about the birth with the complaint manager. She followed this with a letter of complaint dated 19 January 2012. In this letter, Ms T complained that she had been given Syntometrine without her consent and described this as an assault. She said she had made it clear to the Midwife throughout her pregnancy that she did not want Syntometrine unless there was a risk of postpartum haemorrhage, and this was documented in her notes. She explained that, even if there was a risk of haemorrhage, she would still have expected the Midwife to obtain her consent before giving her Syntometrine. She said she also had stated during her pregnancy that she wanted the umbilical cord to be allowed to stop pulsating before being cut, but the administration of Syntometrine meant the cord had to be cut immediately. She felt this had resulted in her baby not receiving the full amount of oxygenated blood that she should have and that it had compromised her baby’s health. Ms T said the Midwife had apologised at the time and she asked whether the Midwife’s decision to give Syntometrine without Ms T’s consent had been discussed with the Midwife’s supervisor and whether the mistake had been recorded.
- On 2
1 March 2012 two midwives came to Ms T’s home to discuss her concerns and it was agreed that they would make enquiries and write to Ms T. The Trust wrote to her on 12 April. They conveyed the Midwife’s apologies for administering Syntometrine without Ms T’s consent and said the Midwife felt this was in part due to her lack of experience in attending home births. They acknowledged that the Midwife should have had a discussion with Ms T about giving her Syntometrine. However, they said the Midwife felt that, with the presence of meconium, she had correctly managed the third stage of Ms T’s labour in anticipation of an expected transfer to hospital. The Trust also explained that their midwives would be receiving supplementary training, which would include training for obstetric emergencies and managing the third stage of labour.
- Ms T replied to the Trust by email on 22 April. She asked them to further explain their comments about the Midwife’s lack of experience of home births contributing to her decision to administer Syntometrine. Ms T said that there had been no clinical need to give her Syntometrine and asked the Trust to explain why it had been given. She felt that, even if there had been a clinical need for Syntometrine, it would not have overridden her right to withhold consent. She noted that she had been conscious and able to make an informed decision during her labour. She also said that cutting a baby’s cord was not an indication for Syntometrine to be given and, had early cord cutting been necessary, she would still have declined Syntometrine. She requested a full and formal apology for being given Syntometrine and asked that her notes were amended to record that she had not consented to being given the drug.
- The Trust sent a further response on 9 May. They apologised that Ms T had been given Syntometrine without her consent. They clarified that the Midwife had been fully trained at the time. They said that the Midwife had anticipated that the baby might need to be resuscitated and she felt that, with the presence of meconium, she had correctly managed the third stage of Ms T’s labour in anticipation of her expected transfer to hospital. They said that she had acted in the interests of mother and baby in line with Rule 6 of the NMC’s Midwives rules and standards. They told Ms T that midwives were directed by National Institute for Health and Clinical Excellence (NICE) guidance, which advised that, for active management of the third stage of labour, oxytocin is given, followed by early cord clamping and cutting. They explained that, for physiological management of the third stage, no oxytocin is given and there is no cord clamping and cutting, and the placenta is delivered by the mother’s efforts. The Trust said the Midwife had followed the NICE guidance but that a midwife with more experience of attending home births may have chosen to combine the two methods (active and physiological management). The Trust said the Midwife was aware of Ms T’s preference not to be given drugs routinely, but this had been a potentially life-threatening situation. They told her that, for legal reasons, her notes could not be amended.
- Ms T followed this up with a further letter and email sent on 15 May in which she reiterated her concerns and said that her notes could be amended, as long as it was clear that any addition was not part of the notes made at the time. She requested that her letter be attached to her notes, with an additional note stating that the Midwife had assaulted her by administering Syntometrine. The Trust sent their final response on 22 June. They restated their position that the Midwife had administered Syntometrine in Ms T’s best interest and said they would amend her notes to include that she had complained about this and that she had described being given Syntometrine without consent as an assault. Ms T remained dissatisfied and emailed the Trust again to express this on 29 June.
- Ms T complained to us on 26 July.
The complaint to us
- Ms T’s complaint is set out in paragraphs 2 and 3.
What the Trust said to us
- The Trust wrote to us on 7 November and 4 December. They said that they had discussed the administration of Syntometrine in these particular circumstances at the time of Ms T’s complaint to them, and they continued to fully support the action taken by the Midwife. But they acknowledged that the Midwife should have discussed her intention with Ms T before she gave her Syntometrine. They said they had written to Ms T to confirm this and had apologised to her. However, they remained satisfied that the Midwife had acted in the best interests of the baby, given the clinical situation at the time.
- The Trust said that the Midwife had been extremely concerned about the presence of meconium-stained liquor and knew her priority had to be the welfare of the baby and its potential resuscitation. They cited NICE guidance which recommends that, if significant meconium-stained liquor is identified, healthcare professionals trained in advanced neonatal life support should be readily available for the birth. They explained that, as this support was not available in Ms T’s home, the midwife called for an ambulance and made arrangements for the safe delivery and resuscitation of the baby, pending the ambulance’s arrival. The Trust said this preparation had included ensuring Ms T did not suffer a postpartum haemorrhage, so the Midwife could focus her attention on the baby.
- The Trust said that Ms T had stated in her birth plan that she would receive Syntometrine if it was necessary. They recognised that the Midwife should have had a discussion with Ms T about giving her Syntometrine prior to administration, but they said the Midwife felt she had been dealing with an emergency situation.
- The Trust clarified that the Midwife had been trained to administer Syntometrine in a competent manner, but confirmed that she had received additional training in relation to communication and consent, and had discussed actions to be taken in a variety of birthing situations with other community midwives.
What Ms T said to us
- Ms T told us that in their response to her complaint, the Trust had said the Midwife had been following NICE guidance. However, she said they could not provide her with the title of this guidance or with any evidence that the presence of meconium meant it was necessary to administer Syntometrine. Nor could they provide evidence that early cutting and clamping of the umbilical cord meant that Syntometrine should be given. Ms T felt the Trust had not provided her with any evidence to support the explanation they had given of why Syntometrine had been clinically indicated.
- Ms T acknowledged that the Trust had apologised that the Midwife had given her Syntometrine, however, she felt they had denied her an honest explanation in response to her complaint. She told us that she wanted the Trust to acknowledge that there had been no clinical basis for the Midwife to override the need to get her consent. Ms T said the Trust had told her that the Midwife believed that Syntometrine was necessary at the time. She said this worried her, as she felt it indicated that the Trust mistakenly believed they had the right to overrule a woman’s wishes simply because they believed a drug or procedure was necessary. She said the Trust did not accept that there had been a mistake and, because of this, she was concerned and worried that something similar could happen to other women.
- The Midwife Adviser said that NICE guidance recommends active management of the third stage of labour to reduce the risk of the mother suffering a haemorrhage. She explained that active management includes early cutting and clamping of the umbilical cord and administering a uterotonic drug (a drug that c
auses the uterus to contract) such as Syntometrine to the mother. The Midwife Adviser noted that the Midwife had recorded the presence of meconium, which could have been inhaled by Ms T’s baby, blocking its airway. She advised that, given the presence of meconium, early cutting and clamping of the cord was good practice, in anticipation that the Midwife might have needed to focus her attention on resuscitating the baby. However, she explained that, had the administration of Syntometrine been discussed with Ms T, and had she declined the drug, the Midwife could have unclamped the umbilical cord and allowed the placenta to birth physiologically, as Ms T was not bleeding.
- The Midwife Adviser said that the Midwife should have gained Ms T’s consent before giving her Syntometrine, in line with the NMC’s The code: Standards of conduct, performance and ethics for nurses and midwives (the NMC Code of Conduct). She explained that the NMC Code of Conduct says that a midwife must be able to demonstrate that she has acted in someone’s best interests if they provide care in an emergency. She advised that, in this case, emergency care was potentially needed for the baby, not for Ms T, so the administration of Syntometrine should have been discussed with Ms T.
Responses to our enquiries
- As part of our investigation, we asked the NMC for clarification of Rule 6 of its Midwives rules and standards (paragraph 22). The NMC wrote to us on 17 January 2013. It explained that Rule 6 sets out the responsibility of a midwife to provide care and says that, except in an emergency, they may only provide care and treatment which they have been trained to give.
- The NMC explained that the NMC Code of Conduct (paragraph 34) states that midwives must ensure they gain consent before beginning any treatment or care; and they must be able to demonstrate that they have acted in someone’s best interests if they have provided care in an emergency. They clarified that an adult who becomes temporarily unable to consent because of, for example, becoming unconscious, may receive treatment necessary to preserve life. However, they said that medical intervention considered as being in the person’s best interests, which can be delayed until they can consent, should be carried out when consent can be given.
- Ms T complains that the Trust have not provided her with an adequate explanation for administering Syntometrine to her without her consent.
- I have explained the approach we take to determining complaints in paragraphs 9 and 10. In order to be ‘open and accountable’ in line with the Ombudsman’s Principles (paragraphs 12 to 14), the Trust should have provided Ms T with honest, evidence-based explanations in response to her complaint.
- In their initial letter to Ms T dated 12 April 2012, the Trust said the Midwife felt her decision to administer Syntometrine was in part due to her lack of experience in attending home births. As this is a somewhat vague statement, I can understand why Ms T queried it. However, the Trust provided her with a more detailed explanation in their letter of 9 May. The Trust said that NICE guidance advises that, for active management of the third stage of labour, oxytocin (Syntometrine) is given followed by early cord clamping and cutting. But they clarified that a midwife with more experience of attending home births may have combined active and physiological management of the third stage of labour. I have taken account of the Midwife Adviser’s comments that NICE guidance recommends active management of the third stage of labour to reduce the risk of the mother suffering a haemorrhage. She also said that, given the presence of meconium, early cutting and clamping of the cord was good practice, in anticipation that the Midwife might have needed to focus her attention on resuscitating the baby. However, she explained that, had Ms T declined Syntometrine, the Midwife could have unclamped the umbilical cord and allowed the placenta to be delivered naturally, as Ms T was not bleeding, thus combining active and physiological management. In the interests of being more open, the Trust should have explained more fully how the two methods could have been combined, and provided more specific detail (including the title of the NICE guidance they referred to). Nevertheless, I am satisfied that their comments were evidence-based.
- Ms T accepts that the Trust have apologised that she was given Syntometrine without her consent, but she wants them to acknowledge that there was no clinical basis for the Midwife to override the need to get her consent. The Trust told Ms T the Midwife felt that, with the presence of meconium, she had correctly managed the third stage of Ms T’s labour, in anticipation of an expected transfer to hospital. They described the incident as a potentially life‑threatening situation and said the Midwife felt that she had acted in the interests of mother and baby in line with Rule 6 of the NMC Midwives rules and standards.
- Rule 6 of the NMC Midwives rules and standards states that, except in an emergency, midwives may only provide care and treatment that they have been trained to give. It says nothing about giving treatment without consent in emergency situations. The Trust’s statement that the Midwife’s actions were in accordance with Rule 6 was inaccurate. The NMC Code of Conduct says that midwives must ensure they gain consent before beginning any treatment or care; and they must be able to demonstrate that they have acted in someone’s best interests if they have provided care in an emergency. The Trust have accepted that the Midwife should have gained Ms T’s consent before giving her Syntometrine. But they have attempted to justify her actions by saying that the administration of Syntometrine constituted emergency treatment in her best interests. I have taken account of the advice of the Midwife Adviser that meconium could have blocked the baby’s airway. However, this was an emergency situation for the baby, but not for Ms T. Thus, there was no basis for the Midwife to administer Syntometrine to Ms T without her consent and the Trust’s explanation of the Midwife’s actions was not evidence-based.
- To summarise, the Trust’s comments about why the Midwife felt that Syntometrine was appropriate in the circumstances were evidence-based. However, they did not provide an adequate explanation of why Syntometrine was given to Ms T without her consent. In this respect, the Trust were not ‘open and accountable’. The Trust’s handling of Ms T’s complaint that there was no clinical basis for the Midwife to override the need to get consent fell far below the applicable standards and was maladministration.
- In accordance with the approach explained in paragraph 8, having found maladministration, I now consider whether Ms T has suffered an injustice.
- I have identified that the Trust did not provide an adequate explanation of why Syntometrine was given to Ms T without her consent. Ms T says that she has been denied an honest explanation in response to her complaint. She told us that the Trust’s response worried her, as she believed it indicated that they mistakenly believed they had the right to overrule a woman’s wishes simply because they believed a drug or procedure was necessary. She felt the Trust did not accept that the Midwife had made a mistake and she was concerned that something similar could happen again.
- I acknowledge that the Trust have apologised that Syntometrine was given to Ms T without her consent. However, their continued insistence that this constituted an emergency situation and therefore the Midwife acted appropriately demonstrates a failure to accept their mistake and learn lessons from this. I can fully appreciate why this worries Ms T and has left her with concerns that something similar could happen
- Having considered all the available evidence related to Ms T’s complaint about the Trust, including her recollections and views, and taken account of the clinical advice we have received, I have reached a decision.
- I find that the Trust’s handling of Ms T’s complaint was maladministrative, which led to the injustice that she has experienced worry and concern that others might have the same experience as she did.
- I uphold Ms T’s complaint about the Trust.
- In view of the injustice sustained by Ms T in consequence of the maladministration I have found, I am making a number of recommendations to the Trust, in line with our Principles for Remedy. The Principles say that public organisations should ‘put things right’ and, if possible, return the person affected to the position they would have been in if the poor service had not occurred. If that is not possible, they should provide compensation. Public organisations should apologise for poor service, and use the lessons learnt from complaints to ensure that poor service is not repeated.
- With these Principles in mind, I recommend that, within one month of the final report, the Trust should provide Ms T with a full written acknowledgement of the maladministration identified. They should also provide a sincere apology for the injustices we have identified, which are that Ms T has experienced worry and concern that others might have the same experience as she did. The Trust should send a copy of this correspondence to the Ombudsman.
- I also recommend that the Trust pay Ms T £250 to compensate for the injustice that she has suffered (paragraph 45).
- Finally, in order to ensure continuous improvement and demonstrate that changes have been made to prevent a recurrence of these events, I recommend that, within three months of the date of the final investigation report, the Trust prepare an action plan that:
- describes what they have done and/or plan to do to ensure that the organisation, and the individuals involved, have learnt the lessons from the failings identified by this upheld complaint (paragraph 41); and
- details what the Trust have done, and/or plan to do, including timescales, to avoid a recurrence of these failings.
The Trust should send a copy of the action plan to Ms T, their Clinical Commissioning Group, the Ombudsman, Monitor and the Care Quality Commission. The Trust should ensure that Ms T, the Care Quality Commission, Monitor and South Cheshire and their Clinical Commissioning Group are updated regularly on progress against the action plan.
The response to the outcome of the investigation
- In response to our draft report, Ms T said she hopes that the Trust will act upon the recommendations we made to prevent mistakes like this from happening in the future. She also hopes that, as a result of her complaint, all staff employed by the Trust will fully understand and practice the concept of informed consent, both within the hospital setting and in the community.
- Ms T felt that if the Trust and their staff members had been open and honest in admitting that a mistake had been made from the outset, the complaints process could have been avoided. She felt the Midwife should have reported her mistake in administering a drug that Ms T had not consented to as soon as she returned from Ms T’s home to the hospital. She believed this should have been recorded in her clinical notes at the time and the Trust should have sent her a letter admitting the mistake and apologising. Had this been the case, Ms T said she would have accepted that both the Midwife and the Trust had acted correctly in acknowledging what had happened to her and she would have taken no further action. However, she felt that at all stages there was an attempt to cover up the Midwife’s mistake, both in her failure to report it in the first instance; and then in the Trust’s insistence that the Midwife acted in accordance with guidelines and their continued support for her actions. She felt she had no option but to report these actions to us and she was very pleased with the outcome of our investigation.
- Ms T emphasised that just because a person has no medical training, this does not mean that they are not able to access relevant, correct information regarding their medical treatment. She said she was repeatedly told by the Trust that the Midwife was following guidelines, which they subsequently failed to provide her with.
- Ms T told us that she hopes that lessons have been learnt as a result of her complaint and actions taken to ensure that women giving birth at the Trust, or attended at home by the Trust’s midwives, have a better birth experience than she did.
I hope this report will provide Ms T with the explanations she seeks and will reassure her that lessons will be learnt and the learning shared as a result of her complaint so that others are now less likely to suffer the same experience she did.
 A drug that causes the uterus to contract. An injection of Syntometrine is often given in the third stage of labour, after the birth of the baby, to help the mother deliver the placenta and to prevent postpartum haemorrhage (the loss of 500ml or more of blood from the vagina within 24 hours of the birth of a baby) by causing the blood vessel walls to narrow, thereby reducing blood flow.
 Our role is formally set out in the Health Service Commissioner’s Act 1993.
 You can find more detail about our Principles at www.ombudsman.org.uk/improving-public-service/ombudsmansprinciples.
 Meconium may be a sign of inadequate oxygen supply and can cause meconium aspiration syndrome, which is a serious condition in which a newborn breathes a mixture of meconium and amniotic fluid into the lungs around the time of delivery.
 A surgical cut made at the opening of the vagina during childbirth, to aid delivery and prevent rupture of tissues.
 The Nursing and Midwifery Council (the NMC – the organisation responsible for the professional regulation of nurses) publishes the Midwives rules and standards (2004), which says that, except in an emergency, a practising midwife shall not provide any care, or undertake any treatment, which she has not been trained to give.
 Now known as the National Institute for Health and Care Excellence.
 NICE provides guidance, sets quality standards, and manages a national database to improve people’s health, and prevent and treat ill health. The NICE Clinical Guideline 55 (2007) Intrapartum care: Care of healthy women and their babies during childbirth (the NICE guidance on intrapartum care) states:
‘If significant meconium-stained liquor is identified, healthcare professionals trained in FBS [fetal blood sampling] should be available in labour and healthcare professionals trained in advanced neonatal life support should be readily available for the birth …
‘Active management of the third stage is recommended, which includes the use of oxytocin [Syntometrine is the trade name for oxytocin] (10 international units [IU] by intramuscular injection), followed by early clamping and cutting of the [umbilical] cord and controlled cord traction [maintaining even tension on the umbilical cord] …
‘ … Women should be informed that active manage
ment of the third stage reduces the risk of maternal haemorrhage and shortens the third stage …
‘ … Women at low risk of postpartum haemorrhage who request physiological management of the third stage should be supported in their choice.’
 The NMC Code of Conduct contains general and specific guidance on how nurses should approach their work. This represents the standards which the NMC expects nurses to meet. It states that midwives must ensure that they gain consent before they begin any treatment or care and must uphold people’s rights to be fully involved in decisions about their care. It also says that midwives must be able to demonstrate that they have acted in someone’s best interests if they have provided care in an emergency.