Selected Investigations Completed October 1999 - March 2000

Parliamentary

Access to official information

Health

Parliamentary

Access to official information

Health

Hot topics

Cymraeg

Freedom of Information

Accessibility

Other Ombudsmen and complaint handlers

Feedback

Satisfied with our service?

Part II - Full Texts of Selected Investigations

Complaint against: Dewsbury Health Care NHS Trust (the Trust)

Complaint as put by Mrs X

1. The account of the complaint provided by Mrs X was that on 29 December 1997 she attended an antenatal appointment at Dewsbury and District Hospital, where a routine blood sample was taken. At her next appointment - on 15 January 1998 - she was told that the results of her blood test remained the same. On 17 January Mrs X was admitted to hospital, believing that her waters had broken, but after being examined was told they had not. Mrs X continued to experience a brown mucus discharge. A cardiotocograph (CTG) scan (a procedure for measuring fetal heart-rate) taken the next day showed that every time she had a contraction, her baby's heartbeat slowed. Mrs X was discharged on 19 January. She was readmitted the next day. After another CTG scan, which showed that her baby's heart beat continued to slow during contractions, she was given an emergency caesarian section.

2. After the birth - at approximately 10.30pm - Mrs X and her baby were transferred to the post-natal ward, where a midwife noticed that the baby looked jaundiced. A paediatrician was asked to attend. He said that he could not make a judgment under the artificial lights in the ward, and that he would arrange for tests to be carried out the next day. At 3.30pm on 21 January the baby was admitted to the neo-natal unit, where she was treated for severe jaundice. Later that week Mrs X was also informed that her baby would require a blood transfusion because she was anaemic. She was puzzled on being told that her baby's red blood cells had been attacked by her own antibodies, because she had been told that she and the baby shared the same blood group. She found out later that the hospital had incorrectly recorded her baby's blood group as rhesus negative when, in fact, it was rhesus positive. Subsequently, the baby was given three blood transfusions. At a later post-natal appointment, Mrs X was told that the blood test taken on 29 December had shown an increase in her antibodies. However, instead of being brought to the attention of a doctor so that another blood test could be taken, the results had been incorrectly filed away.

3. On 28 March Mrs X complained to the Trust about the treatment she and her baby daughter had received. She remained dissatisfied with their responses. On 21 July she asked for her complaints to be considered by an independent review panel. On 12 October her request was refused on the grounds that her concerns had been fully addressed and that remedial action taken where necessary.

4. The matters investigated were that:

(a) during the latter stages of Mrs X's pregnancy, hospital staff failed to monitor her or her baby's condition effectively; and

(b) after the birth, staff failed to treat Mrs X's baby promptly, or to record correctly her baby's blood group.

Investigation

5. The statement of complaint for the Ombudsman's investigation was issued on 3 March 1999. The Trust's comments were obtained and relevant papers, including Mrs X's and her baby's medical records, were examined. Mrs X and Trust staff were interviewed. Evidence was also obtained from the National Blood Service at Leeds, although their actions are not the subject of this investigation. Four independent professional assessors were appointed to advise on the clinical and midwifery issues. Their reports are at Annexes A and B.

Background information

6. Among the issues addressed in this investigation are monitoring and acting on possible incompatibility between the blood groups of a mother and her baby (rhesus incompatibility). Women with a rhesus negative blood group, who have already given birth to one child, can develop antibodies which, in subsequent births can cause haemolytic disease of the fetus or newborn. Haemolytic disease involves destruction of the red blood cells, anaemia, and often jaundice. Blood tests during pregnancy will determine the presence of antibodies in the mother. They also serve as a guide to the severity of the disease in the fetus, and whether further investigation is required. The presence of fetal cells in the maternal blood can be demonstrated by a test during which a film of maternal blood is mixed with a weak acid solution before staining. This process is known as titration. The terms antibody titre and anti D titre are used in this report.

7. Other issues covered include the need to monitor, and act on, possible signs of early labour and premature rupture of membranes, and fetal distress resulting from that. The symptoms and signs of the onset of labour include painful uterine contractions; a show - the expulsion of a plug of mucus from the cervix; a rupture of the membranes; and shortening and dilation of the cervix. Fetal distress can occur during labour and may have a number of causes. One of the most common is fetal hypoxia (diminished amount of oxygen in the fetal tissues). This can occur if labour is prolonged, and the placenta and cord become unduly compressed. Marked changes in the fetal heart rate can be an indication of distress. The use of CTG allows monitoring of the fetal heart rate and the relationship between changes in the fetal heart rate and uterine contractions.

(a) Failure to monitor effectively

Evidence from Mrs X's medical records

8. The following information relates to the last two weeks of Mrs X's pregnancy. Further details are contained in the reports of the Ombudsman's independent professional assessors.

29 December 1997 Mrs X attended an antenatal clinic. Her records for that date include: 'Repeat Antibody titre today - to be seen by [the consultant] next visit'.

14 January 1998 Mrs X was admitted to the delivery suite. She was discharged home later the same day after her CTG had been seen by a doctor. The midwifery notes include: '...advised to ring back if SROM [spontaneous rupture of membranes] /contractions more frequent'.

15 January Mrs X attended the antenatal clinic. She was seen by both the registrar and the consultant. The consultant noted: 'Allow vaginal delivery, see 2/52 [2 weeks] - see M/W 1/52 [midwife in one week]'.

17 January The records include : '23.55 Readmitted from home with a history of SROM at 22.45, clear liquor draining. Wearing a pad. Pains since 14.1.98 but irregular. No evidence of PV [vaginal] bleeding but has had blood stained shows ++'. The records go on to record that Mrs X continued to complain of back pain and was transferred to a ward overnight.

18 January The records include: '10.20 nil draining membranes intact on VE [vaginal examination] Irreg [irregular] tightenings - 1 in 10.' At 5.30pm the records include: 'Heavy dark brown mucoid show when [Mrs X] visits toilet. Tightenings subsided earlier but now becoming stronger 1-10 mostly back pain'.

19 January An untimed note by a midwife includes: 'Contractions 1-15 short 25.30secs. Mucoid show. FHHR FMF [fetal heart rate heard regular, fetal movements felt] Not established in labour'. Mrs X was seen by the registrar at 9.10am and 12.30pm. He noted that her membranes had not ruptured and that she could go home that day.

20 January The records state that at 11.30am Mrs X was re-admitted to the delivery suite looking 'stressed'. She had a history of 'continuous contractions 1-5 all night and yellow discharge PV... membranes feel absent but no liquor seen'. At 12.50 the records note decelerations in the baby's heart rate and at 1pm a 'yellow/green discharge'. At 2.10pm the discharge is described as 'meconium'. (Meconium is the name for the fluid material that collects in a baby's bowels before it is born. A sign of a baby's distress can be evacuation of the meconium from the bowels.) Mrs X was transferred to the anaesthetic room at 3.15pm and the baby was born by caesarian section at 3.58pm. The baby's birth records include: 'meconium ++ in larynx' (an indication that the baby had inhaled meconium in the womb).

Mrs X's evidence

9. In a letter to the Trust dated 28 March 1998 Mrs X wrote '...I gave my blood as usual on [29 December 1997] to check for the antibodies, when I went to my antenatal check on [15 January 1998], the day after my show and the second day of pains, I asked about the results and I was told that they remained the same. I have now found out... that the antibodies had increased and that another sample should have been submitted that day [15 January], instead someone had just filed my results into my records...'.

10. Mrs X told the Ombudsman's investigator that at the antenatal appointment on 15 January she explained to a doctor what had happened the previous day (paragraph 8), and described the brown mucus show. He did not carry out an internal examination. The midwife mentioned that her cervix was 'softening up and so things have started'. The doctor fetched a consultant, who told her that if nothing happened within the next two weeks they would 'start her off'.

11. Mrs X said that her waters broke on 17 January. There was a foul smell. When she arrived at the hospital she told staff about the smell. They said it could not be due to amniotic fluid as the Amniostix had not turned black. She had a contraction, and the midwife told her she was probably in the very early stages of labour. She was admitted to the ward. Every time she went to the toilet she passed murky brown jelly like blobs. She showed them to a midwife, who just said that that was normal. Nobody asked her about her previous pregnancy and caesarian.

12. Mrs X said that on the Sunday morning (18 January 1998) she was told the CTG reading was satisfactory. The pains continued all day, and were particularly bad in the evening. She sat up all that night, unable to make herself comfortable and with frequent pains. On 19 January the registrar and another doctor saw her. Although she explained the shows to them, they dismissed what she said. The staff carried out another CTG, which revealed the baby's heart decelerations. Mrs X was anxious as she knew by then that the decelerations had been happening since Saturday. The staff told her there was nothing they could do as 'nothing was happening', and to come back when labour had started. She was discharged without have been given anything to relieve her pain and with no advice as to what should prompt her to seek readmission.

13. Mrs X said that she found it difficult to sleep that night as the pains, mainly in her back, continued at 10 to 15 minute intervals. The next morning she went to her GP, who said he thought she was in labour and should go straight to the hospital. When she arrived there the midwife said she was in labour. There was a continual discharge, which had now turned yellow. When it turned green, staff prepared her for a caesarian operation.

14. Mrs X said that at the local resolution meeting the consultant had been dismissive, saying that the staff had been in a festive mood over Christmas and that was why the blood results were missed (paragraph 9). She said that she wanted a proper apology, and an acknowledgement that staff had not listened to her enough before the birth.

Guidelines

15. In 1995 the Trust issued 'Guidelines for the admission of a mother in labour'. This included: 'The midwife is required to keep accurate records and as a Practitioner is responsible for normal care of the patient in labour, any deviation from normal must be notified to the Medical staff concerned and a record made in the notes as to the time of calling.'

16. 'Guidelines for management of SROM after 37 weeks gestation', issued by the Trust in 1996, included: '...the patient who does not go into spontaneous labour 12 - 24 hours after the time of the spontaneous rupture of membranes, ...is transferred back to the Delivery Suite at 08.30 hours for augmentation with an Oxytocin infusion. In the case of the uneffaced closed cervix where clear liquor is draining, discuss with the Consultant whether or not Prostin is indicated. ...where there is no obvious liquor draining, the Amniostix may clarify the situation. If doubt remains the patient should be mobilised on the ward and all pv loss observed and reviewed in 24 hours re management.'

Evidence from the National Blood Service at Leeds

17. The consultant haematologist at Leeds Blood Centre provided written information to the Ombudsman's Office. She explained that according to national guidelines pregnant women should have blood samples tested at least twice in every pregnancy. One initial sample should be taken at between 10 and 16 weeks of gestation, and a second sample should be taken during the third trimester from about 28 weeks. She continued:

'...A small number of individuals do develop antibodies in pregnancy. Many of these antibodies are harmless... . However, some of these antibodies could cause problems in the foetus resulting in haemolytic disease of the newborn. ...and these are the women that we are keen to detect early on so that appropriate referrals to specialised obstetric teams can be made to ensure that the baby does not have problems from haemolytic disease of the newborn.

'With particular regard to [Mrs X] ...The second sample was received by us on 30th December, 1997 which is about four weeks from the previous sample. On this occasion she still had two antibodies Jka and D, however, on this occasion the anti-D level had gone up to 3 IU/ml. ...In this case the report has stated "in view of the rise in anti-D titre, further specimen in 2 weeks". This report was sent out on 31st December, 1997, 24 hours from receipt. No further samples were received from this woman. We did not receive a further sample during the third trimester either.'

Trust evidence

18. In his written response to the statement of complaint the Trust's chief executive said that a sample of Mrs X's antibodies taken on 2 December 1997 showed Anti D - but not at a level likely to cause haemolytic disease. On 31 December a rise in the Anti D titre was noted and a further specimen suggested in two weeks. He added:

'There is no evidence of this report having been brought to the attention of the Consultant Obstetrician. Certainly the test was not repeated. [The consultant] did see [Mrs X] in [the] antenatal clinic on 15 January 1998, but there is no mention of the antenatal serology. We can confirm that since [Mrs X's] complaint the Obstetricians have enforced the need to bring all investigation results to the attention of the senior medical team, and we are satisfied that there is evidence of this now being routine antenatal practice.

'With the exception of this one failure to monitor and repeat a serology test, all other suggested repeats were promptly carried out. Having investigated this complaint internally to the Trust, we have been reassured by our lead clinicians in Obstetrics and Paediatrics that there should have been no other requirement for monitoring given that Anti D titration (until 31.12.97) was <1 iu/ml...

'[Mrs X's] baby was delivered by emergency Caesarian Section, indicated due to failure to progress and fetal distress...'

19. The consultant haematologist described for the Ombudsman's investigator the usual procedures in relation to blood samples. Samples were taken at antenatal clinics and sent to the National Blood Service at Leeds. If a serious abnormality was identified, a consultant there would telephone the hospital. Otherwise three copies of the results were returned to the hospital, and they were normally examined within a day or two of receipt. One copy of the results was filed in the pathology department, and two copies were sent to the antenatal clinic. The consultant haematologist was on leave when Mrs X's results for the tests carried out on 29 December would have arrived. They would not have been classed as abnormal. Usually only a rapid rise in titre would be a cause for concern.

20. The sister in charge of the antenatal clinic (the sister) said that when the test results arrived from the pathology department she sorted them into separate piles for each consultant. She thought that it should have been noted that the results of the test undertaken on 29 December were missing.

21. The head of midwifery said that Mrs X was in the medium to high risk group because she was rhesus negative and had already had one caesarian section. The distinctive smell which she noticed when she thought her waters had broken on 17 January was not significant. The midwife involved at the time decided that Mrs X's waters had not broken after feeling her intact membranes. The Amniostix test was also taken as a precaution, and was negative. Although the midwife noted only one instance of deceleration in fetal heartbeat, it should have been discussed with a doctor. The head of midwifery said that documentation was poor. She had since issued two memoranda to staff to remind them of the need for proper documentation.

22. The registrar said that the medical record indicated that he saw Mrs X at three antenatal clinic sessions. The consultant also saw her on 15 January. The registrar confirmed that he (the registrar) would have been aware from the notes that Mrs X was rhesus negative, and that the pregnancy was 'a trial of scar' (first attempt at a normal vaginal delivery following a previous caesarian birth). In such pregnancies the patient must be seen by a registrar during labour; and if there were any concerns the consultant was contacted and a caesarian section would be done. The evidence suggested that on 15 January the 31 December test results were not on file. Had they been he would have seen them, and would have noted the tests would need to be repeated in two weeks.

23. The registrar said that it seemed likely that Mrs X was not examined by a doctor on 18 January. He saw her twice on 19 January. He had noted that if no contractions were recorded on the CTG she could go home as her membranes were intact and it was recorded that her pains were decreasing. The midwife later asked him to see Mrs X again because the CTG criteria were not met. He did so, but recorded that he was still content for her to go home. With hindsight, it seemed that there had been a hindwater rupture (that is, the membranes behind the baby's head had broken: the membranes across the top of her head, which, could be felt on vaginal examination, were intact). When the baby was born there was no evidence of infection. He believed there would have been if there had been prolonged inhalation of meconium as a result of earlier rupture of membranes. He felt the missing antibody titre results had not affected the final outcome.

24. The consultant said that the test results for 29 December were filed after the results for 22 January. It was impossible to say when they had been received. They had most likely been delayed due to the holiday period, and no effort had been made to track them down. Although Mrs X had been seen by a number of different midwives and doctors, nobody had noticed the matter. He relied on the midwives to follow up missing results; but the registrar should have realised that they were needed. Since Mrs X's complaint he had insisted that all results should be initialled by a registrar before being filed.

25. The consultant said that the trace for 18 January showed fetal heart rate decelerations, and that he would not have been satisfied with that. The CTG trace for 19 January also did not appear to be totally normal due to a lack of contact at one point. In the circumstances, he had reservations about the decision to discharge Mrs X on 19 January. He noted that the registrar had advised that a further CTG should be carried out in three days time. However, he considered that leaving it for that long was open to doubt. In any event, if mothers were sent home in such circumstances, they should be advised to look for further shows, contractions or leaking. The consultant said that, in retrospect, he thought Mrs X's concerns were genuine, and that there had been a lack of communication.

Findings (a)

26. In reaching my findings I have taken full account of the advice provided by the Ombudsman's independent professional assessors (Annexes A and B).

27. It has not been possible to establish the cause of the delay in filing the 31 December 1997 report on Mrs X's blood sample. It is disturbing that, even though Mrs X's pregnancy was classified as 'high risk', none of the staff who examined her realised that the test results were missing and could be significant. Since Mrs X's complaint, the obstetricians have reaffirmed the need to bring all investigation results to the attention of the senior medical team. The consultant has also insisted that, before they are filed, all results should be initialled by a registrar. However, it seems to me that the matter goes beyond that. I recommend that the Trust, taking account of the comments of the Ombudsman's independent professional assessors, decide - in relation to local circumstances - with whom prime responsibility should rest for ensuring that test results are received on time and are acted upon. The Trust should also ensure that the process is audited. In addition, I invite the Trust to consider the assessors' comments about consultant cover in the haematology laboratory (Annex A paragraph 10).

28. This investigation has revealed a number of other shortcomings in the care given to Mrs X during the latter stages of her pregnancy. The Ombudsman's independent professional assessors consider that a more explicit labour plan should have been recorded in the antenatal notes. They have concluded that there can be little doubt that Mrs X's membranes spontaneously ruptured during the evening of 17 January; and they believe that more credence should have been given to her clear account. I agree. It is evident that further examinations should have been undertaken at the time.

29. The Ombudsman's independent professional assessors are also of the view that Mrs X should not have been discharged on 19 January 1998 without enquiries having been made about her last rhesus negative antibody result, and without an ultrasound scan having been undertaken to assess liquor volume. In the light of concerns about the CTG results, the consultant has expressed reservations about the decision to discharge Mrs X. I am also concerned by Mrs X's evidence - which I have no reason to doubt - that she was not given adequate advice and support when she was sent home. I note with approval that the consultant has acknowledged that Mrs X's concerns were genuine, and that there had been a lack of communication. The Trust will wish to consider the lessons to be learned from this case. I recommend, in particular, that, in circumstances such as this, a more detailed labour plan should be prepared and carefully monitored. I uphold this complaint.

(b) Failure to treat Mrs X's baby promptly, or to record correctly her baby's blood group

Mrs X's evidence

30. Mrs X told the Ombudsman's investigator that, shortly after her baby's birth, she and her family thought she had an 'orange' complexion. They mentioned it to the staff, but they said that the baby was all right. Later that night, after the baby was transferred to Ward 2, a nurse informed Mrs X that she had called for a paediatrician as she thought the baby looked jaundiced. The paediatrician said he could not tell whether the baby was jaundiced under the artificial lights, and that he would arrange for tests the next morning. At about 3.30pm on 21 January 1998, the baby was transferred to the neonatal unit. Mrs X considered that, initially, the doctors did not know how to treat the baby because of the mistake over her blood grouping (see paragraph 33). She said that she was not satisfied with the explanation she had been given. She had discovered from the medical records that the baby was on the verge of being anaemic, and that no-one had brought that - or her antibody state - to the doctors' attention. She did not want anyone else to suffer as she and her baby had.

Guidelines

31. The Trust's guidelines for management of the jaundiced baby were drawn up in 1997, and updated in November 1998. They include: 'The paediatrician will evaluate the term newborn with jaundice. If the jaundice is clinically significant measure the serum bilirubin [the level of bilirubin in the blood - a high level of which results in jaundice]. Manage with phototherapy according to graphs on the Neonatal Unit. ...Assess each baby individually. ...Any jaundice presenting in the first 24 hours is abnormal and will require full investigations...'.

Trust evidence

32. In his formal response (paragraph 18), the chief executive stated:

'...At 22.15 hours, the midwives contacted the Neonatal Unit due to the presence of jaundice. They are clearly at this time aware of [the mother's] antibodies and the transfusion report forms indicating that the antibodies were unlikely to cause haemolytic disease.

'At midnight the baby was seen by the Paediatrician and it was decided to test the baby's blood (serum bilirubin) in the morning if jaundice persisted. This was duly completed. [Mrs X's] baby was subsequently transferred to the Neonatal Unit on 21.01.98 at 15.30 hours.

'We have sincerely apologised for the fact that the baby was not transferred to the Neonatal Unit earlier. We cannot justify, nor explain why this did not happen, but accept (with hindsight) that on the advice of our Paediatrician, the baby should have been transferred during the night or early morning when the jaundice was noted.

'In addition, we also reported the baby's blood group as A Negative on 21.01.98, and subsequently discovered that a mistake had occurred.

'We accept that the reassurance which [Mrs X] should have received is not apparent. Once the mistake was detected, all laboratory procedures were examined in order to prevent a similar mistake ever happening. This will have been a very distressing time for [Mrs X] and we did not handle our communications well.

'These two mistakes were made, and I can confirm that Trust Officers have apologised to [Mrs X] in person and attempted to reassure her of prompt actions taken to avoid repeat...'.

33. The midwife on duty in ward two told the investigator that she recalled the events of the night of 20 January. Although she thought that the baby looked a little jaundiced she was not sure. She therefore arranged for a paediatrician to examine her. He too found it difficult to tell if she was jaundiced under artificial light. He decided to see her again in the morning.

34. The paediatric senior house officer (the SHO) said that at the time of the baby's birth he was first on call for the post-natal ward. Although he did not recall the events of the night of 20/21 January, he accepted that it was likely that he saw the baby then. He must have considered that either the baby was not jaundiced or the matter could wait until the morning. He acknowledged he should have noted the records to that effect.

35. The consultant paediatrician said that, as the artificial lighting in ward 2 was poor for diagnostic purposes, it was understandable that the SHO had found it difficult to assess whether the baby was jaundiced. The consultant paediatrician explained that any jaundice on the first day of life was clinically significant, and she considered that the bilirubin test should have been done straightaway the next morning. It was possible that there had been a failure in communication between doctors, and that the paediatrician on duty on 21 January did not know that the test was needed urgently. The consultant paediatrician said that antibiotics were administered at 11.00am on 21 January. However, the management of the blood sample was probably not treated as urgent. The result showed raised bilirubin, but that was not recorded until 3.30pm on 21 January. It would have triggered the baby's rapid transfer to the neonatal unit.

36. The consultant haematologist said that the blood grouping mistake was discovered when the pre-transfusion sample and the historical blood grouping were checked on the computer. She had discussed the mistake with the member of staff responsible - an experienced biomedical scientist. The cause was not clear. Checks showed that the controls were working, and there was no evidence of a 'straight swap' with another patient's blood. External quality assurance controls revealed that one or two errors of this type occurred each year. The consultant haematologist said that as the baby had already been diagnosed as having haemolytic disease the error had not affected her treatment. She explained the tighter safeguards which had been put in place as a result of the error in the baby's case.

Findings (b)

37. Mrs X complained that staff failed to treat her baby promptly or to record her blood group correctly. The evidence supports the complaint.

38. The consultant has confirmed that any jaundice on the first day of life is clinically significant. At the outset, concerns were expressed by Mrs X and her family about the baby's complexion. The midwife was also sufficiently concerned to call out a paediatrician. The Ombudsman's independent professional assessors consider that it was unreasonable that a bilirubin test was not carried out on 20 January. I accept that advice. I find it is particularly unacceptable that investigations were not carried out immediately the next morning.

39. The Trust have apologised for the fact that the baby was not transferred to the neonatal ward at an earlier stage. The initial incorrect reporting of her blood group is also a matter for concern. The Ombudsman's independent professional assessors have commented, however, that this 'very troubling error' did not, in the event, alter the baby's management. The Trust will wish to take careful note of the comments made by the Ombudsman's independent professional assessors including those in paragraph 26 of Annex A. In particular, I recommend that a more formal handover procedure between paediatricians is introduced; and that the changes in laboratory procedure, which have been introduced to prevent a similar occurrence, should be closely monitored and audited. I uphold this aspect of the complaint.

Conclusions

40. I have set out my findings in paragraphs 26-29 and 37-39. The Trust has agreed to implement my recommendations in paragraphs 27, 29, and 39 and have asked me to convey to Mrs X - as I do through this report - their apologies for the shortcomings I have identified.

Annex A to E.1520/98-99

Report by three Independent Professional Assessors

Matters considered

1. The matters investigated were that:

(a) during the latter stages of Mrs X's pregnancy hospital staff failed to monitor her or her baby's condition effectively;

(b) after the birth, staff failed to treat Mrs X's baby promptly, or to record correctly her baby's blood group.

2. We were asked to address the following specific matters:

i) failure to obtain the result of a test for Rhesus antibody level, taken in the Antenatal clinic on 29 December 1997, prior to the onset of labour and to act on that report;

ii) failure to identify spontaneous rupture of membranes and onset of labour;

iii) the incorrect recording of the baby's blood group at birth; and

iv) delay in recognising the baby's jaundice as being due to Rhesus incompatibility and the delay in her being transferred to the neonatal unit.

Basis of report

3. The Ombudsman's Office made the following documents available to us:

a) the statement of complaint for the investigation;

b) the interview notes with Mrs X;

c) the medical and midwifery notes from Dewsbury Health Care NHS Trust;

d) a variety of medical protocols from the Trust relating to Departments of Obstetrics, Paediatrics and Haematology;

e) correspondence and protocols from the Regional Blood Centre at Leeds; and

f) notes of interviews with the Trust staff involved. (Note: the first assessor was involved with the interviews with the paediatricians and the midwife on duty in the post natal ward; the second assessor was involved with the interviews with the staff involved in the ante natal care of Mrs X and the haematologist; and the third assessor was involved with the interviews with midwives who cared for Mrs X prior to the birth of her daughter.)

Failure to obtain the result of a Rhesus antibody level test

Findings

4. Mrs X was booked for her second confinement under the care of the consultant obstetrician at the Trust. The first entry in the antenatal clinic notes is of the Booking Clinic on 8 August 1997, when routine blood tests, including Rhesus antibodies, were taken. The pregnancy then appears to have proceeded uneventfully until 29 December at 36 weeks' gestation. The blood samples were taken at this time for Rhesus antibodies and the previous result reported on 2 December 1997 was recorded in the notes to be entirely satisfactory at <1 iu/ml.

5. On the 14 January 1998, Mrs X went to the toilet and noticed some vaginal bleeding which she thought was a show, but at that point there was no pain. Later the same morning, uterine contractions were experienced and Mrs X telephoned the Labour Ward at approximately 11.00am as the contractions were coming every 40 to 60 minutes. She was told to ring back again when contractions were coming every 10 minutes. At 5.00pm the contractions were coming every 10 to 15 minutes and were much stronger and Mrs X was advised to come to the labour ward. Vaginal examination was performed at 7.00pm when she was told that she was not in labour and the cervix not dilated and she was sent home later that evening.

6. Mrs X was seen in the antenatal clinic the next day by the registrar. She was still experiencing uterine contractions and was told that this was a 'practice run', and that she was not in labour. The registrar had asked the consultant to see Mrs X as he had not seen her up to that time. The consultant saw no reason at that time to intervene with the pregnancy but told her that if nothing happened within the next two weeks, she would be induced. It would appear that, at that clinic appointment, the results from the previous Rhesus antibody level tests taken at the clinic on 29 December 1997, were not entered in the notes. It would be expected that such results normally should be filed within a two week interval of when the blood was originally taken. It would appear that neither the medical staff nor the midwives who saw Mrs X on 15 January made any enquiries to obtain the result from either the local Haematology Laboratory or from the National Blood Service regional centre at Leeds.

7. Mrs X was admitted to the labour ward on 17 January 1998, with a history of ruptured membranes. Staff thought the membranes were intact, and she was discharged home on 19 January. Mrs X was then re-admitted the following day on 20 January, now in established labour. Again it would appear that none of the medical staff or midwives who attended Mrs X between 17 January and the onset of her established labour on 20 January realised that the results of the Rhesus level antibodies blood test taken on 29 December 1997 had not been entered in the notes. They also did not make any effort to obtain the result.

Comments

8. The National Blood Service regional centre at Leeds confirmed that the Rhesus antibody sample taken on the 29 December 1997 was received in the Leeds laboratory on 30 December. Their computer records show that the report on this sample was issued on 31 December 1997. The report recorded a significant rise in the Rhesus antibody levels to 3.0 iu/l with the comment of "Risk of haemolytic disease of the new-born, refer patient to Consultant Obstetrician, transfusion hazard. In view of rise of anti-D level, further specimen required in 2 weeks". No further samples were received by the Leeds laboratory for estimation of Rhesus antibody levels. We were unable to determine whether the report from Leeds was lost in transit between Leeds and the Trust, or whether it was subsequently mislaid within the Trust. It was on Mrs X's file, out of chronological order, by the time we viewed her records. We are reasonably confident that the sister in charge of the antenatal clinic never received this report prior to Mrs X's next appointment on 15 January 1998. It was, however, the joint responsibility of the registrar and the midwife who was working with the registrar in the antenatal clinic to follow up the missing result, having noted that the Rhesus antibody levels of the clinic two weeks earlier were not filed in the notes.

9. The registrar asked the consultant to see Mrs X at the 15 January antenatal clinic appointment but this was merely a courtesy visit. It was reasonable to assume that the registrar did not inform the consultant that the antibody result from 29 December was not in the notes and, therefore, it was quite reasonable for the consultant to assume that he was only seeing Mrs X as a courtesy attendance. The consultant has since told us that all results must now be signed by the registrar before being filed in the notes. In this case however, no difference in the outcome could have been obtained, as we are reasonably confident that the report was not received until after the baby's birth on 20 January 1998. During the time Mrs X was admitted to the labour and antenatal wards between the 17 and 20 January, there was also ample opportunity for both the medical staff and the midwives looking after Mrs X to get the results of the Rhesus antibody level tests taken on the 29 December. They should have realised that those results ought to have been filed in the notes by that time, and followed that up.

Conclusion

10. The blood sample taken on 29 December was clearly recorded as being received by the Leeds laboratory the following day and a written report was issued on 31 December. This report, with a significant elevation of the Rhesus antibody levels, clearly gives a warning that the consultant should be made aware of the result and possible hazards of Rhesus incompatibility and request a further sample in two weeks. We have not found a satisfactory explanation why the report from Leeds Blood Centre was not filed in Mrs X's notes by 15 January. The responsibility for this delay lies with the consultant haematologist in charge of the Trust's haematology laboratory, who works single-handed and for much of the period in question she was absent on annual leave. We would recommend that the Trust consider ways of ensuring consultant cover at all times in the haematology laboratory, so that there is always a consultant available for routine and out of hours work. [Note: in the light of this conclusion, further advice was obtained from a consultant haematologist.

His advice is at Annex B.]

Failure to identify spontaneous rupture of membranes and onset of labour

Findings

11. On the evening of 17 January 1998, whilst in bed, Mrs X suddenly felt a pop, and increase in abdominal pain followed by a gush of a large amount of fluid which she thought was the rupture of her membranes. The amount of fluid was clearly excessive as she describes that it went all over the bedroom floor and had an offensive smell. A second admission to the labour ward occurred that evening at 23.55 hours. The admitting staff midwife recorded irregular contractions and no evidence of vaginal bleeding, but noted Mrs X's statement of a considerable blood stained show with the onset of the fluid loss. Vaginal examination was performed by the staff midwife at 00.10 hours and the cervix was said to be not fully effaced, 2cms in diameter and posterior. An Amniostix test is recorded as being negative. A CTG was performed by the staff midwife which demonstrated a deceleration in the baby's heart rate, but a member of the medical team was not called to view the tracing. There appeared no records of any further observations until the following morning, at 10.20 hours, when uterine contractions were noted to be coming in 1 in 10 but there was no obvious liquor draining.

12. The registrar saw Mrs X twice on 19 January. At 09.10 hours he thought there was no evidence of ruptured membranes, and a CTG at that time demonstrated no contractions. At 12.30 hours he discharged her, to be seen in the antenatal clinic on 22 January 1998. Mrs X was readmitted on 20 January at 11.30 hours, by then in established labour.

Comments

13. The vaginal examination performed by the staff midwife on 17 January at 00.20 hours recorded the cervix as being posterior, not fully affaced and only 2 cms dilated. We doubt that the membranes could be confirmed as intact, with any confidence, on a vaginal examination alone. To be certain of ruptured membranes with undulated cervix, one would need to perform a speculum examination to observe whether any liquor was extruding through the cervix. The Amniostix indicator for ruptured membranes relies on a change of Ph in the vagina and is only considered reasonably reliable when an excess amount of liquor is present in the vagina, which could not be accurately ascertained without performing a speculum examination.

14. With such a clear history of a large amount of fluid as described by Mrs X the previous day, it would have been appropriate to have organised an ultrasound scan to confirm liquor volume. Mrs X's labour in this pregnancy must have been considered high risk, in view of the caesarean section for her first delivery and the fact that she was Rhesus negative. A more explicit labour plan should therefore have been recorded in the antenatal notes. Certainly Mrs X should not have been discharged on 19 January 1998, without making enquiries regarding her last Rhesus antibody levels taken in the antenatal clinic on 29 December 1997, which were not filed in the notes at that time.

Conclusion

15. There can be little doubt that Mrs X's membranes did in fact spontaneously rupture on the evening of 17 January 1998, and more credence should have been given to her clear history of a large amount of fluid escaping from the vagina associated with abdominal pain and an offensive smell. There was no evidence that the offensive smell at that stage indicated infection; but it was highly suggestive of a spontaneous rupture of membranes. With a posterior positioned, undulated cervix, confirmation of intact membranes could not be confidently diagnosed on a vaginal examination alone, even though accompanied by a negative Amniostix which should have been undertaken with a speculum examination while observing any fluid issuing from the cervical canal.

16. Mrs X should not have been discharged from the antenatal ward without making enquiries about her last Rhesus negative antibody results which were not in the notes and also arranging an ultrasound scan to assess liquor volume.

The management of the baby's jaundice

Findings

17. The baby was born by caesarean section at 3.58pm on 20 January 1998. The medical notes state that she was in good condition at birth: however, meconium was present in the larynx. This is a risk factor for infection and in view of this and prolonged rupture of membranes it was arranged that she should have intravenous antibiotics. At 5.00pm she was transferred to the neonatal unit where a blood culture and skin swabs were taken and she was started on intravenous antibiotics.

18. The baby was then nursed with her mother on the postnatal ward. Her relatives thought that she was tanned. At 23.25 the midwife noted that the baby appeared to be slightly jaundiced. She looked at Mrs X's notes and was reassured to find that the antibody result was reported as not likely to cause haemolytic disease. When interviewed, the midwife reported that the lighting on the postnatal ward was poor. She therefore took the baby to the examination light in the nursery. As she remained uncertain she called the paediatrician.

19. The paediatrician attended within the hour, although the midwife could not now remember who the paediatrician was. The paediatrician did not write in the medical notes; but the midwife commented that he instructed that a bilirubin measurement be carried out the next morning "if jaundice persists". The paediatric senior house officer (SHO) gave evidence that it was usual for the SHO to cover the labour suite and postnatal wards whilst the middle grade doctor (registrar or senior clinical medical officer) covered the neonatal unit. The SHO performed a discharge examination dated 20 January, noting a mark on the baby's right cheek (possible bruise) and also the positive antibody screen. The bilirubin test planned for the next day was not done.

20. At 11.10am on 21 January 1998 the second dose of Gentamycin and Amoxil (antibiotics) was given, probably on the neonatal unit. It is regrettable that jaundice was not observed on that occasion. At 15.30 hours the results of the cord blood test, taken at birth, became available. These showed jaundice caused by haemolytic disease of the new-born. Full investigation and appropriate treatment was then started.

21. The baby's blood group was incorrectly reported as A Rhesus negative.

Comments

22. It is likely that the SHO was the paediatrician on duty on the 21 January 1998. The midwife was aware of the potential seriousness of jaundice on the first day of life. If she had been certain that the baby was jaundiced she would not have been satisfied with the paediatrician's action and would have sought a further opinion. It was not clear who was responsible for taking blood for the bilirubin test. The SHO thought that midwives could take the blood for a serum bilirubin although the midwife said that was not the case. The consultant paediatrician thought it reasonable to leave the bilirubin test to the next day. The SHO felt that if he had realised that the baby was jaundiced he would have organised a bilirubin test straightaway. He did comment that there might be difficulties in obtaining laboratory tests at night. He was aware that a protocol for the management of neonatal jaundice existed. He was also aware that jaundice in the first 24 hours is always pathological. He said that it was usual for midwives on day duty to bring babies about whom there was concern to the attention of the medical staff.

Conclusion

23. Mrs X was known to be Rhesus negative. We believe it is unreasonable not to have carried out a bilirubin test on the 20 January. It is also unreasonable that the baby was not investigated on the morning of 21 January.

24. The Trust should ensure that there is a more formal handover system between paediatricians to ensure that day staff are aware of babies who have caused concern the previous night.

25. The baby's blood group was reported as A Rhesus negative. This was later shown to be incorrect. Although this is a very troubling error it did not alter the baby's management.

26. The British Blood Transfusion Society has recommended that prophylactic anti-D be given at 28 and 34 weeks gestation to reduce the rate of haemolytic disease of the newborn. We believe that had these recommendations been taken up the baby's problems would have been prevented.

Annex B to E.1520/98-99

Report by a fourth Independent Professional Assessor

Fourth Assessor - Consultant Haemotologist

1. I was asked to comment, firstly, on where I considered responsibility lay for checking that the blood test result for the sample taken on 29 December 1997 was received and filed on Mrs X's medical records; and secondly on the procedure in place at the time, for receiving test results from Leeds and passing them to the ante-natal clinic.

Responsibility for checking that results are received and filed

2. I think that the responsibility of ensuring blood test results are available and filed in patient notes lies with the requesting physician. Every effort should be made to ensure that all results of blood tests or other investigations requested for patients are back to a central point and filed in the notes appropriately as soon as the results are received. It is also important that these results are screened in order to identify any serious abnormalities that may require any immediate action. It is obvious that the laboratory and the blood bank try their best to help requesting physicians identify these abnormalities by bringing them to their attention depending on the seriousness of the result. In this instance it was not thought that the abnormality found on the blood test requested on 29th December 1997 for this patient required an urgent communication with the requesting consultant. In this particular case it is obvious that after the result of an important blood test was not acted upon the system has been changed so that the registrar in the department will initial every result that arrives back. This is a positive change in order to ensure that the above is implemented. It should also be the responsibility of the requesting physicians to ensure that they follow up on certain blood investigations if the results were not available in a timely fashion, especially when such results will make a difference to the management of the patient.

Procedure in place

3. The procedure that is in place is workable as far as sending the results of the antenatal serology back to the laboratory in Dewsbury and then for these results to be sent to the antenatal clinic. However, it seems to me that it would be better for results to be sent directly from Leeds to the antenatal clinic with copies sent to the blood bank ensuring minimal delay in receipt of results in the antenatal clinics. Usually copies of abnormal results are highlighted to the attention of the haematologist in case input for management of the patient is required. Such a system works well in my own hospital, and to my knowledge there has not been any difficulties in implementing it.

4. As far as the practice that occurred in the antenatal clinic at the time this incident happened, it is quite acceptable for the sister in charge of the clinic to highlight any abnormal results for the treating obstetricians and, in fact, this system is operational in many other antenatal clinics and works very well. This system is applied in my own hospital and our senior obstetricians assure me that it has been a successful way of monitoring abnormal blood results. As long as the system ensures prompt review and recognition of the abnormal results and acting upon them I do not think a significant difference will exist between registrars or senior experienced nurses, in the final outcome.

Previous < Contents > Next

Short text of this investigation

Last updated: 18 December 2005