RRORS N HE ARE ND REATMENT F A OUNG OMAN ITH IABETES · "denial" involve assumptions drawn from...

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E R R O R S I N T H E C A R E A N DT R E A T M E N T O F A Y O U N GW O M A N W I T H D I A B E T E S

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Errors in the Care and Treatment of ayoung woman with Diabetes

1st REPORT – SESSION 2000-2001

Presented to Parliament Pursuant to Section 14(4)Of the Health Service Commissioners Act 1993

Ordered byThe House of Commons

To be printed on6 December 2000

HC 13 London : The Stationery Office



Contents

Page

Foreword Foreword by the Health Service Ombudsman i

Summary Summary of events, findings and recommendations ii

Glossary Glossary of terms v

Investigations

Investigation 1 The care provided to Ms J by Dr B, a general practitioner 1

Investigation 2 The conclusions reached by the Independent Review Panel 10

that examined the care provided by Dr B

Annex A The report made by the Panel 15

Investigation 3 The care provided to Ms J at Halton General Hospital 20

Contents



Investigations 47

Technical term Meaning

acidosis an abnormally high concentration of acid in the blood

catheter (urinary) a flexible tube inserted into the bladder to allow the removal of urine

cerebral oedema swelling of the brain within the skull

CVP - central venous pressure the pressure within the central veins returning blood to the heart

dehydration loss or deficiency of water in body, tissues and blood

fluid balance chart a chart which records and sums a patient's input and output of liquid on adaily basis

gastritis inflammation of the lining of the stomach

glycosuria glucose in the urine

HbA1c - haemoglobin an indirect measure of the effectiveness of blood glucose ('sugar') control in past two weeks

hyperglycaemia a high concentration of glucose in the blood

hypoglycaemia a low concentration of glucose in the blood

hyponatraemia a low concentration of sodium in blood, usually as a result of a relative excess of water but sometimes a result of salt loss

hypotension low blood pressure

hypothyroid reduced thyroid function

ketones substances arising in metabolism when there is insufficiency of insulin

mass lesion a solid abnormal appearance on scanning

pituitary apoplexy collapse as a result of severe pituitary gland failure

subarachnoid haemorrhage haemorrhage on the surface of the brain

subclavian under the collar bone

tachycardia rapid heart beat

type 1 diabetes insulin dependent diabetes - requires treatment with insulin

type 2 diabetes non insulin dependent diabetes - controlled with diet and/or tablets

Case No. E.171/98-99

Appendix BGlossary of Terms

Printed in the UK for The Stationery Office Limitedon behalf of the Controller of Her Majesty’s Stationery Office

Dd5069659 12/00 569486 19585 TJ003144


46 Investigations

should do, nevertheless fail to act as they should.

138 Under such circumstances, it is important to consideralternative explanations, among which might besomething akin to some form of denial. However,given the complexity of human abilities, beliefs,motivations and life circumstances, and thecomplexity of the concept, "denial" should never bethe sole initial conjecture.

139 In dealing with problems of adherence, healthcarestaff must attempt to glean reliable evidence onwhich to base a judgment about the degree ofadherence and then reach a decision as to whetheror not, in cases of poor adherence, further actionneeds to be taken.

140 The nature of this action will depend on gaining someunderstanding of why the individual is behaving in theway they do. In many instances, sensitive, individual-centred enquiry may lead to an identification of thereasons. Even when it is clear that the individual doesnot believe they have the illness, it is important to tryand understand why.

141 On occasions, it takes some time for the mentalrealisation to become fully integrated into theindividual's thinking about themselves and their dailylives. They have to create a new view of themselvesand make the corresponding behavioural changes,something that takes some time for most people.

142 To sum up, evidence of clinically unacceptable levelsof adherence should be a signal for furtherinvestigation rather than what can sometimes be areflexive labelling of an individual as being in "denial".

Conclusion143 In Miss J's case I have found no evidence that she

was in denial of her illness. It was, in my view,unwise for the IR panel to have introduced this issue.Denial, as I have explained, is a complex concept thatdoes not lend itself to reflexive labelling and shouldnot be advanced lightly as an explanation ofbehaviour.

Foreword i

Foreword

In September 2000, I completed the last of three investigations relating to the care of a youngwoman, Ms J. I have decided to publish the reports of those investigations together because Ibelieve they illustrate lessons that may be learned about the management of a commoncondition: diabetes. This was not, however, a common case. Diabetes is a serious and lifethreatening illness: correctly managed, the risk of premature death and complication can besubstantially reduced. Yet Ms J died.

A summary of the events, and of my findings and recommendations appear on pages ii-iv.Subsequent pages contain the full text of my investigation reports and the report of anIndependent Review Panel, which considered one of the complaints about Ms J's care. The namesof the patient, her brother (who made the complaints) and the doctors have been removed inorder to preserve confidentiality. I hope they will provide useful material for health professionals,educationalists and those involved in supporting and caring for people with diabetes.

The report is laid before Parliament in accordance with section 14(4)(b) of the Health ServiceCommissioners Act 1993. Two of the investigations relate to the health service in Wales; althoughthe events pre-date devolution of powers to the National Assembly for Wales, I have provided acopy of the report to the National Assembly.

M S BuckleyHealth Service Ombudsman for England

December 2000



Investigation 45

not wanting insulin and her relief at the diagnosis ofMODY as part of the evidence for his claim that shewas "in denial" about the transition in her diabetes toa state requiring insulin.

The case made by the first consultant:fear of insulin126 A fear of acquiring insulin-dependent diabetes was

introduced by the first consultant to explain why MissJ did not report the blood sugar level of 11 eventhough it was logged in her record card. We have noevidence that Miss J expressed such a fear.

127 The comments regarding her reaction to the MODYdiagnosis were taken to be evidence consistent withlater "denial". However, her relief reactions wereboth understandable and normal. We can safelyassume that most people faced with the prospect ofa diagnosis that would require life-long insulininjections would be very pleased at being told thatthey would not need to do so. Her 'relief at thediagnosis' is most likely a normal, understandableand presumably common reaction. Hence, this isunlikely to constitute a strong ground for implicating"denial".

The case made by the first consultant:transition denial128 It appears accepted that Miss J was, over most of the

period subsequent to the diagnosis, a "compliant"individual about whom there were no concernsregarding her diabetes management and monitoring.

129 The thrust of the first consultant's argument is thatshe in effect denied her transition from a form ofdiabetes that does not require insulin to a form thatwould. He expresses a concern that she did notcontact him or his team. The first consultant's viewwas supported by the IR panel.

130 If we accept that Miss J was a compliant individual,and we also accept, as we must, that by the 16 Julyshe was quite ill, it is not surprising that she did notgo to the diabetes service. Her GP did not refer herand did not implicate her diabetes in thepresentation; she was ill and likely to have beendistressed; and from other accounts of herbehaviour, it is likely that she would have attendedclinic had she been instructed to do so.

131 Underlying all this, Miss J had not been warned thatthere was a risk of transition from MODY to insulindependent diabetes and no questions had beenraised as to her previous adherence to the advice shehad been given. The evidence is that she did adhereto the self monitoring regime set for her.

Denial as an explanation 132 Miss J's case raises important specific as well as

general issues in relation to the use of psychologicalconcepts such as "denial" in attempts by clinicians tounderstand, account for and manage diabetes andother conditions requiring acceptance of thediagnosis and adherence to a prescribedmanagement regime. The terms "compliance" and"denial" involve assumptions drawn from behaviour,a better term is "adherence" which describes thebehaviour only.

133 We accept that it is common in diabetes services forclinicians to see what they regard as "denial"."Denial" is in fact an assumption or inference fromthe patient's action or inaction, that is, frombehaviour, in relation to the diagnosis or some otheraspect of care. It is however proffered as anexplanation for observed behaviour, why theindividual does not appear to take the diagnosisseriously or otherwise adhere to the careprescriptions advanced by the health careprofessionals who advise on management.

134 Nevertheless, the introduction of psychologicalexplanations to account for what is believed to be afailure to accept the diagnosis or inadequate self-management of illness, is a very serious matter. Tobegin with, it enables those in positions of power toattribute failure and blame to the patient, therebyexonerating themselves of responsibility for propercare. It colours attitudes towards the patient and,consequently, can adversely influence the motivationof healthcare staff and the adequacy and quality ofcare provided thereafter.

135 In particular, if "denial" is to be invoked to account forpoor adherence, it necessitates consideration offactors in the patient, the illness, the cliniciansinvolved in the patient's treatment and the patient'ssocial environment. In sum, it is not something thatshould be invoked lightly and then, only on the basisof good evidence gleaned from systematicinvestigation and the due consideration of alternativeexplanations.

136 The more neutral term "adherence" is current in theliterature on responsiveness to health care adviceand is used to refer to the behaviour of individualswho follow the advice given to them by healthcareprofessionals. Adherence, as a term describingbehaviour is different from other terms such as"denial" that are inferences from behaviour. It isrecognised that "adherence" allows for variations inthe extent of adherence.

137 There are well-established protocols to deal withsome of the more common reasons for pooradherence, such as information booklets, specialeducation programmes and the like. It is also well-recognised that despite such standard goodpractices, there will be individuals who continue tocause concern, those who, while knowing what they

ii Summary

The eventsIn February 1996 Ms J, who was 18 years old, went to see her GP because she felt faint after mid-daymeals. The GP tested her blood and found signs that she had developed diabetes. He referred her to seea consultant endocrinologist at Halton General Hospital and made arrangements for Ms J's diabetes to bemonitored by the practice.

Ms J saw the consultant for the first time in July 1996, when he recorded a diagnosis of mature-onsetdiabetes in youth (MODY). Ms J saw the nurse specialist in diabetes that day, and several times over thenext nine months.

In July 1997 Ms J planned to attend a family occasion in Wales. Feeling a little unwell, she went to herGP on 16 July complaining of muscle pain and lethargy. He recorded some limb girdle weakness in hershoulders and thighs, and a 'borderline' thyroid hormone level: he contacted the consultant after thisconsultation. Ms J travelled with her fiancé to Wales on 18 July. Feeling much worse when she arrivedthere, Ms J consulted a local general practitioner, Dr B, the next day, 19 July. Ms J explained that shehad MODY and said that she had had stomach pain, sickness and vomiting for a few days. The GP did nottest her blood or urine: he recorded a diagnosis of gastritis and prescribed an anti-nausea medication.

Ms J continued to feel very unwell: so much so that she and her fiancé cut short their stay and drove homeon 20 July. That day and the next, Ms J consulted GPs at her home practice. Both concurred with thediagnosis given by Dr B, the GP in Wales: they, too, did not test her blood or urine. Ms J's parents calledthe GP practice a third time, on the morning of 22 July saying that Ms J had been delirious. The GP askedthem to test Ms J's blood sugar, but they were unable to do so. The GP arranged Ms J's immediateadmission to Halton General Hospital.

Medical staff quickly diagnosed diabetic ketoacidosis, and identified, at the same time, an unusually lowlevel of sodium in her body. Ms J was clearly very unwell: treatment began and Ms J was admitted to theintensive care unit. Ms J remained unwell, and later that day began to complain of a severe headache.The simple pain relief given seemed to help only for a short time and Ms J continued to complain of a verysevere headache. Ms J collapsed in the early hours of 23 July, soon requiring full life support. A CT scanof her brain revealed cerebral oedema. Ms J died on 31 July, from cerebral oedema and diabeticketoacidosis.

Complaints about Ms J's careMs J's family complained about several aspects of her care:

• that the diagnosis of mature-onset diabetes in youth was incorrect;

• that insufficient information had been given to Ms J about the management of her diabetes, and inparticular the effect of minor illness. They complained that she had not been taught 'sick day rules',that is, blood should be tested more frequently in the event of even a minor illness, as it may drivesugar levels in the blood to a dangerously high level. They also said that she had been wrongly advisedthat she need not test her blood while on holiday;

• that the GP Ms J consulted in Wales should have tested her urine, at least, and arrived at the wrongdiagnosis because he did not do so;

• that the GPs at Ms J's home practice should have tested her urine, at least, and arrived at the wrongdiagnosis because they did not do so;

• that when Ms J was admitted to Halton General Hospital, her care and treatment were inadequate, andparticularly that excessive administration of fluids caused the cerebral oedema that led to her death;

• that the Independent Review Panel convened to examine the complaint about Ms J's care at HaltonGeneral Hospital said that she suffered a 'denial reaction' to the diagnosis of diabetes, and that waswrong, and unjust.

Summary


44 Investigations

impaired her functioning.

111 That the GP at the consultation on 16 July appearsnot to have initiated questions about her diabetes,may also have led her to believe that her diabetesand hence her blood sugar level were not of concernin relation to her then present condition. This in turncould be either because she did not know that sheshould report such findings or because doing somight have led to a disappointing change of plans.This latter possibility is dealt with shortly.

112 This behaviour - taking two readings and involvingher niece in the process, of both timing to ensureaccuracy and getting her to try and read the value,seems inconsistent with "denial". Further it is difficultto understand why, had she been in "denial" whenvisiting the GP the day before, she should then beinvolved in what appears to be a serious attempt thevery next day to get a public and accurate reading.

113 However, the possibility of missing the importantweek-end celebration could be a reason for her notdisclosing her high reading. The possibility that shemight miss the week-end celebration did not,however, stop her going to the GP on the 16 July nordid it stop her visiting a doctor while at the holidaysite.

114 It is also possible that, having been to her own doctor3 days before with no apparent diabetes-relatedaction, she did not attach any further significance tothe reading, whatever its level and therefore did notraise it with the doctor at the holiday park who alsoappears to not have checked her blood sugar level.

115 In sum, it is noteworthy that Miss J did take action tocommunicate that she was ill in the period, that shecontinued testing in a semi-public manner, and we donot have strong evidence that she tried to hide theearlier reading of 11. Her records showed a level of11 previously without any consequences and thereare some grounds for suggesting that for reasonsother than "denial", the level of 11 may not have hadthe significance for her that others might attach tosuch a reading.

Further developments116 According to her fiancé, Miss J did inform the doctor

at the holiday park that she was a controlled MODY.Again, this is not suggestive of someone in "denial"unless one is trying to assert that she wasdeliberately setting out to throw him off track.

117 Nevertheless, the earlier high reading wasapparently not brought to his attention. Again, onecould argue that the lower reading as reported by herniece might have been taken as evidence by Miss Jthat this was not the problem. She had also seen herown doctor several days earlier and as noted above,

he had not pursued anything in relation to thediabetes.

118 Miss J attended the celebration but by early thefollowing morning (20 July) was so ill that her fiancébrought her home.

119 She was seen again by a doctor on the 20 and 21 July.It was on the latter occasion that the note of "RBSabout 7" is noted, consistent with the niece's reportof the unrecorded reading 4 days earlier. Miss J washospitalised on the following day.

Impact of Miss J's Deteriorating State120 It is important to emphasise that Miss J was

becoming progressively more ill over the last weeksof her life. It is possible too that the progress of herillness and the discomfort made her increasingly lessable to focus on anything other than her on-goingstate. We know that by the night before heradmission, she was in great distress and probably atleast confused for periods, if not delirious.

121 Whether or not her mental state was sufficient forher to recollect a reading from a week previously,and associate it with her present state, especially if ithad been a "one-off" like the previous "one-off", canbe questioned.

122 It would, however, be surprising if her physicaldeterioration were not accompanied by somedeterioration in her ability to function normally interms of her mental capacities and emotions: shewas not just physically ill, it was likely that she wasalso in great discomfort and mental distress.

The case made by the first consultant:introduction123 It is not uncommon for diabetes services to have to

deal with a number of individuals who do not adhereto the self-management regime prescribed by theservice. This failure of adherence is sometimesattributed to "denial" that they are ill, or that theyneed to conform to the prescriptions for theirhealthcare. Most, if not all, practitioners in diabetesservices, will be likely to have encounteredindividuals in whom "denial" is regarded as a majorreason for poor adherence.

124 At the independent panel review, the first consultantintroduced the possibility that Miss J had been in"denial", a view subsequently picked up by andendorsed by the experts assisting the panel. Such anallegation, if supportable, would of course affect theextent to which the first consultant was responsiblefor what transpired.

125 The first consultant, in his interview with theinvestigating officer, commented again about Miss J

Summary iii

The Ombudsman conducted three investigations into Ms J's care. He investigated the care provided by DrB, and that provided at Halton General Hospital. He also investigated the way that the Independent ReviewPanel convened by North Wales HA had reached the conclusion it had about Dr B's care. He was not askedto investigate the care provided by Ms J's 'home' GPs: that had been done by Independent Review Panels,which had criticised the care provided to her by them on 20 and 21 July 1997.

FindingsThe Ombudsman found as follows:

(a) The consultant endocrinologist had recorded the diagnosis of MODY precipitately: the diagnosis waswrong; and Ms J most probably had slow onset type one diabetes. It was not possible to determinethe full extent of information given to Ms J because the clinical notes lacked sufficient detail. TheOmbudsman said that, while the standard of clinical notes was not below that often found, it wasclearly not good enough.

(b) It would have been good practice if Dr B had tested Ms J's urine, and his record keeping was notcomprehensive enough, nor in keeping with good practice. This was not the conclusion reached by theIndependent Review Panel which examined the complaint against Dr B. The Ombudsman found thatthe Panel failed to reach a conclusion about the standard of care provided or to explain its reasoning.It also left Dr B with no clear statement as to whether he had acted reasonably and, if not, how hemight improve his practice.

(c) Ms J had the right to expect better of Halton General Hospitals NHS Trust and its staff. In particular:

• Inadequate steps were taken to monitor Ms J's fluid balance, which included the failureto insert a central venous pressure line.

• Her care was divided between two consultants. This led to a degree of confusion, lack of focus on a care plan, and a lack of clear leadership to doctors still in training.

• Nursing staff paid inadequate attention to Ms J's complaint about headache and to her family's expressed concerns about her condition. There was also evidence of inadequate monitoring, record keeping, and communication with medical staff.

• While Ms J's treatment plan was consistent with the hospital's protocol for managing diabetic ketoacidosis, medical and nursing staff did not re-assess the relevance of the plan in the light of clinical circumstances. Ms J's condition did not improve as would have been expected, yet the approach to her treatment was not reviewed by a senior member of the medical staff

• The Independent Review Panel was wrong to say that Ms J had a denial reaction. The Ombudsman found evidence that Ms J was not 'in denial': indeed this was a complex concept that had been treated unwisely by the Panel.

Recommendations and responsesNHS staff and organisations involved in these complaints made a number of changes to practice both in thecourse of, and in response to, the Ombudsman's investigations. They included routine urine testing forpeople with diabetes consulting with Dr B, and in respect of Halton General Hospital:

• changed practice on clinical note-making on the part of the nurse specialist in diabetes and a revisededucation procedure for young people with diabetes

• the appointment of a second consultant with a special interest in diabetes at Halton

• development of a range of services for people with diabetes, including foot health, retinopathy,specialist nurse, and young persons' clinics

• improvements to literature for people with both type 1 and 2 diabetes, and to nursing documentation

• revised management arrangements in the Intensive Care Unit


Investigations 43

a week, no monitoring on holiday but more frequentmonitoring when ill.

Miss J's Self-monitoring Records96 From our examination of Miss J's written personal

records (kept from 12.7.96 to 14.7.97), it is clear thatat least up until about the time just before heradmission to hospital, she was taking readingsmainly at 3 to 4 day intervals.

97 A further notable feature is several extendedintervals between some of the recordings, forinstance, a 61 day interval between 8 January 1997and 11 March 1997 when, apparently, no readingswere taken. There were several other occasionswhen intervals of over 10 days occurred betweenreadings.

98 In the 3 months or so before Miss J's admission tohospital, most of the readings were taken in intervalsof 5 days or less, in line with the apparent advice.According to the record, the time of readings wasvaried, ranging between 8.00am and 11.00pm Inexamining Miss J's records over all the occasions oftesting, it is noted that 50 of the 63 recordings (79%)of blood sugar level are at 7, with the remaining 13(21%) either above or below that value. This degreeof consistency is likely to be an artefact of thestepwise system used to grade blood glucose levelsusing this method. The fact that about 20% of herreadings varied from 7 is evidence that she wasdiscriminating the levels where these appearedunusual. There were some occasions where she alsorecorded a range.

Adherence to the Advice on SelfMonitoring99 From the evidence of Miss J's own records, it would

appear that she was adhering fairly closely to theadvice described in the submission provided by herbrother, not that claimed by the diabetes nursespecialist during the Trust interview.

100 If Miss J was acting incorrectly - and her records areclear enough - it is of concern that no one seems tohave called her attention, or that of her family, tothis, or sought to educate and motivate her to adoptthe correct practice.

101 There appears to be no account of any action taken tomodify Miss J's recording procedures (for instancethe extended periods in which there were norecordings) or to address the high reading inSeptember 1996 which was followed by an extendedinterval when no reading was recorded. Presumablysuch action would have been called for if the regimeclaimed by the diabetes nurse specialist, in herevidence, was required for proper management.

102 As no such corrective action has been drawn to ourattention, then it would be appropriate to assumethat Miss J adhered fairly closely to the advice given,or what she had understood to have been advised,and had no reason to believe that she was behavingincorrectly.

103 The account given by Miss J's brother of the diabetesnurse specialist not having concerns about Miss Jpsychologically or physiologically is also consistentwith a view that Miss J was regarded as managingher condition acceptably.

104 The degree of consistency in the levels recorded alsoappears to have been un-remarked.

105 The clinic must have had some awareness of herrecord because of the comment that her readinglevels coincided with some of the more preciselaboratory tests.

106 In sum, the impression given is that the unusualfeatures in Miss J's personal records of her bloodsugar monitoring went unchallenged.

Blood Testing on 17 July107 Miss J's niece, with whom she had a special

relationship, gave an account of events on the 17 Julythat has an important bearing on the contention bythe IR panel that she was in "denial".

108 Although Miss J's written record ends on the 14 July,according to the statement of her 17-year-old niece,Miss J tested on two occasions on the morning of 17July, with the niece having been asked to act as atime-keeper and to give her opinion of the level asMiss J, according to her niece, was unable to make itout precisely.

109 We cannot be certain of the levels Miss J obtained onboth occasions of testing on the 17 July. Miss J'sniece states that she observed both instances and,when asked to look at the second sample, she - theniece - could not determine the level and in herevidence reports Miss J's statement that it wasbetween 7 and 9. There were 4 occasions before thiswhen she entered a somewhat similar range ratherthan a single figure in her records. This is the level("RBS around 7") recorded by her GP on the 21 Julyand is allegedly based on Miss J's report when heasked her on that occasion.

110 It is perhaps unusual that Miss J could not "read" thelevel despite two occasions of testing, especially asby this time she had had extensive experience ofmaking readings, including at least two at 11 andothers well below. It is possible that it was herphysical state - she had been ill for 3 or more days bythen and had been to see her GP the day before -

iv Summary

• revised policy on managing diabetic ketoacidosis

• review of ITU nurse staffing levels in preparation for the Unit's transfer to a purpose-built critical carefacility

• changed management protocol for diabetic ketoacidosis to include reference to cerebral oedema.

All those complained about accepted the Ombudsman's findings, apologised for the shortcomings revealedby the investigations, and agreed to implement the following recommendations made by him:

Dr BDr B should keep full clinical notes for all his patients, including positive and negative findings fromexaminations.

Halton General Hospital(a) the revised education procedure for people with diabetes should be the subject of audit;

(b) nurse specialists should include the items of information and education provided to patients in theclinical record - not for defensive purposes, but to assure effective communication between health careprofessionals;

(c) the Trust should ensure that all people with diabetes, regardless of type or severity, are familiar with'sick day rules' and when to contact the diabetic clinic for advice;

(d) the Trust should reflect on nursing care provided to Ms J as part of a staff development programme.

ConclusionIn the conclusion to the third investigation, the Ombudsman said:

'There is no doubt that type 1 and type 2 diabetes are serious life threatening conditions. Equally, there isno doubt that if they are correctly managed the risk of premature death and complications can besubstantially reduced. Yet Ms J died. This investigation needs to be seen in the context of those previouslyconducted by my office and through the NHS complaints procedure into the entire course of Ms J's treatmentand care. From this it is clear that a number of mistakes were made beginning with the initial, undulydefinite, diagnosis of type 2 diabetes. Avoiding any one of these mistakes would have improved Ms J'schances of survival. It is not possible for me to say that one or more of these mistakes individually led toher death: but taken together they almost certainly did. If, for example, the diagnosis had been correct, orexpressed with sufficient caution; if we could be certain that Ms J received the information and educationshe needed; if any one of the three GPs involved in her care had tested her blood or urine; or if Ms J hadhad impressed upon her, in no uncertain terms, that she must test her blood daily when unwell, had done soand reported untoward results, she might have survived.

'This investigation revealed that Ms J's inpatient care could have been more expertly co-ordinated and thatshe had a right to expect better from the trust and its staff. I cannot say with any certainty whatcontribution, if any, these failings made to the tragic outcome of this case.

'An important lesson is the need for all those involved in diabetic care, not least patients themselves, to beaware that it is essential to test blood glucose and urine ketones more frequently during an intercurrentillness, whatever the type or severity of diabetes. This simple measure could have saved Ms J: I hope it willsave others.'

Office of the Health Service OmbudsmanDecember 2000


42 Investigations

made, but the education given to her would havevaried. This case highlights the extreme importanceof ensuring that everyone involved in diabetic care,patients, doctors, GPs and nurses are aware that it isessential to test blood glucose more frequentlyduring an intercurrent illness, regardless of the typeor severity of diabetes.

85 Following admission to hospital we have concludedthat the care and treatment provided was flawed.Cerebral oedema is a complex condition and thedirect causes are not understood. Cerebral oedemain association with diabetic ketoacidosis in adults is acomparatively rare but recognised condition. Once ithad developed the Trust did not mismanage her careto any significant extent. We do think, however, thatthe presence of hyponatraemia in association withsevere diabetic ketoacidosis should have ensuredthat Miss J's care was closely controlled by aconsultant because of the increased neurologicalrisk. We therefore conclude that her care shouldhave been better managed although we cannot saywhether this would have altered the outcome.

(b) the report of the independentreview panel inappropriatelyincluded a statement that Miss J wasin denial of her diabetes.

DenialContext86 Miss J was advised on the management of her

diabetes by the first consultant and diabetes nursespecialist. In the week or so before her death, Miss Jwas unwell and became increasingly ill, eventuallyrequiring emergency hospitalisation and intensivecare. Near the beginning of that period, she saw herown and other doctors several times beforeeventually being admitted to hospital. Miss J's care atthe Trust was considered by an independent review(IR) panel under the provisions of the national NHScomplaints procedure.

87 The first consultant in his evidence to the IR panelnoted that Miss J's "diabetic control had always beenextremely good", but said also that "he realises thathe did not understand [Miss J's] psychologicalmakeup and that she was probably frightened ofbecoming insulin dependent, and perhaps went intosome kind of denial when she realised her bloodsugar was rising".

88 The IR panel's clinical assessors said in their reportthat "denial" by Miss J could be implicated in whathappened to her. In their view, "Denial of diabetesand the need for insulin therapy is a common feature…. particularly in those young people of the patient'sage.".

89 It is the assessors' view that in the specialatmosphere created by the diagnosis of MODY, a "toorelaxed view" was engendered in many people and"the understandable fear of insulin on behalf of thepatient must also have contributed to the delay whichoccurred in seeking and achieving appropriatemanagement."

90 In his letter of 17 March one of the IR panel memberssaid that both he and his colleague were "inagreement that there was a strong likelihood thatsuch denial took place" and "possibly" led Miss J tofail to act in a way that would protect her from theadverse outcome of her illness.

91 These accounts are the context for the IR panel'spresumption that "denial" played a role in the eventsthat led to Miss J's death.

92 It also needs to be noted that in the period just priorto her hospitalisation and death, Miss J was lookingforward to a special event, going away for aweek- end, the first time with her fiancé, to join hiscousins at a holiday park to celebrate a birthday.

Self monitoring regime93 We have two accounts of the self monitoring regime

commended to Miss J. The diabetes nurse specialiststated that her advice to her would have been that for"values of blood sugar between 4 -7, she would beadvised to undertake fasting blood sugars, whilst [forvalues from] 7 to 9 she should do random bloodsugars. Generally, she should test her blood 4-5times a week, more often if she went on holiday orwas ill, or if anything else arose which disrupted herusual routine."

94 Miss J's brother reports that the diabetes nursespecialist at a Trust interview on 30 March 1999,confirmed that blood glucose monitoring "would beperfectly safe and acceptable every 4-5 days"; that ifgoing on holiday Miss J "would only need to carry outa blood glucose test before she went away and aftershe returned", "to monitor more frequently when ill"-an instruction refuted by the family; and that thediabetes nurse specialist confirmed that she had no"worries or concerns with [Miss J's] ability to monitorblood glucose levels indeed [Miss J's] diary entriescan be confirmed as being accurate by the HbA1creadings recorded at the [hospital]". The diabetesnurse specialist "did not have any concerns aboutMiss J's condition psychologically or physiologicallyat any of their meetings."

95 These two accounts attributed to the diabetes nursespecialist lead to substantially different managementregimes: one account requires monitoring everysecond day or more frequently, virtual dailymonitoring when on holiday or when ill. The otheraccount leads to a regime of monitoring about twice

Glossary v

Glossary of TermsTechnical term Meaning

acidosis an abnormally high concentration of acid in the blood

catheter (urinary) a flexible tube inserted into the bladder to allow the removal of urine

Cerebral oedema an excess of fluid in the brain

CVP - central venous pressure the pressure within the central veins returning blood to the heart

dehydration loss or deficiency of water in body, tissues and blood

diabetic ketoacidosis an excess of acid and ketones - an organic compound - which may be present in the body tissues and fluids, which develops in diabetics when their condition is getting out of control and may indicate approachingcoma

fluid balance chart a chart which records and sums a patient's input and output of liquid on a daily basis

gastritis inflammation of the lining of the stomach

glycosuria glucose in the urine

HbA1c - haemoglobin an indirect measure of the effectiveness of blood glucose ('sugar') control in past two weeks

hyperglycaemia an excess of sugar [glucose] in the blood

hypoglycaemia a low concentration of glucose in the blood

hyponatraemia a low concentration of sodium in blood, usually as a result of a relative excess of water but sometimes a result of salt loss

hypotension low blood pressure

hypothyroid reduced thyroid function

ketones substances arising in metabolism when there is insufficiency of insulin

mass lesion a solid abnormal appearance on scanning

pituitary apoplexy collapse as a result of severe pituitary gland failure

subarachnoid haemorrhage haemorrhage on the surface of the brain

subclavian under the collar bone

tachycardia rapid heart beat

type 1 diabetes insulin dependent diabetes - requires treatment with insulin

Type 2 diabetic non-insulin-dependent diabetic, whose pancreas has retained some ability to produce insulin but this is inadequate for the body's needs


Investigations 41

76 It is of concern that the fluid charts were notmaintained accurately. It is particularly important tokeep an accurate record of fluid balance in relation toany disorder where large volumes are infused andwhere the output (urine) materially alters the plansfor input.

77 There is no evidence that a care plan was drawn upfor Miss J, the care provided by nursing staff wascommensurate with the directions they received frommedical staff. It is a matter of concern that thecoordination and monitoring of Miss J's care was leftsolely to the SHO, even though she was a locum andunsure as to how the care should be fully managed.It is reasonable to expect ITU staff, particularly atsenior level and in charge of a unit, to be aware ofany patient where there is clear evidence thattreatment regimes are failing to have an impact onthe underlying clinical presentation. In this particularsituation where there was a significantlydeteriorating metabolic acidosis which was notresponding to treatment, it is reasonable to expectthat the nursing staff should equally take steps toaddress the issue which might necessitate thefacilitation of a more senior medical review. Suchaction should have been linked to an agreed formalplan of treatment and nursing care plan along withfrequent reviews of progress against outcomeobjectives.

78 Under the Code of Professional Conduct, nurses havea responsibility to raise issues of concern regardingpatients to more senior clinical staff if they see fit.Miss J's fluid replacement/balance and continualmetabolic derangement should have prompted suchaction.

79 The standard of nursing notes is reasonable. Wenote however, that the accounts of Miss J'sheadaches as recorded in the notes do not match thestaff's or family's descriptions given in evidence. Itwould have been helpful if they had recorded thelocation of the headache (occipital region) and thesensations of doom reported by the patient. Miss Jreported that she felt as if she was having a brainhaemorrhage and later that she felt that she wasgoing to die. With hindsight, it is clear that Miss Jwas suffering a neurological catastrophe. Theimpression given by the nursing notes is that shesuffered a relatively minor headache which settledwith Calpol and that was the impression gained bythe SHO. The charge nurse said that the patientsuffered a headache more or less continuously. Theheadache at 2.00am was not reported to medicalstaff. The first consultant said that he was not awareof the headache and that he would probably havesuggested a CT scan, although he would not havethought of cerebral oedema.

80 Of particular concern is the evidence which suggeststhat staff had formed a less than favourable view of

their patient and therefore to some extent appear tohave imposed value judgments upon the informationshe provided. She was viewed as a 'difficult' patientobstructing her care by refusing interventions. Itappears that this coloured the staff's response to herreports of pain; pain is a subjective experience and itis essential that the patient's experience is bothbelieved and acted upon, not interpreted bystaff. Miss J was extremely ill and the metabolicimbalances caused by her acidotic state were boundto affect her mental and emotional functioning. Itappears from the evidence, that staff did notunderstand how ill Miss J was or how this was likelyto make her feel. Although this was unlikely to haveaffected the outcome in this case it would be usefulfor staff to reflect upon this episode of care as partof developing professional practice.

81 We note that Miss J's care was allocated to anagency staff nurse with no formal training orqualifications in ITU. We accept the reasons forallocating her care to a female member of staff inview of Miss J's preference and note that the chargenurse, in his evidence, has stated that he maintaineda watching brief over her care. It was not however,entirely appropriate for such an ill patient to beallocated to a less experienced member of staff.There is no evidence in the notes that her care wasbeing supervised or reviewed. It must be incumbenton the nurse in charge of the unit to be awareparticularly of any patient whose condition is givingrise to concern.

Conclusion82 We are satisfied that the care provided was

adequate, save for the proviso in paragraph 79above. Nursing staff must be proactive in supervisingthe care of sick/deteriorating patients under theircare.

Recommendation83 We recommend that the nurse manager take steps to

address the shortfalls which we have identified,including through staff training, to improve thestandard of care.

Final conclusion84 We were asked to consider whether the care and

treatment provided by the Trust to Miss J wasinadequate. In providing our advice, we have had twoconsiderations in mind: first, whether the standard ofcare was that which might reasonably be expected ata District General Hospital; and second, whetherthere were any useful lessons to be learnt in terms of'best' practice for the future benefit of patients. Wehave concluded that the consultant was in error inmaking a diagnosis of MODY without first excludingslow onset type 1. Miss J's management in thediabetic clinic was adequate, and would not havebeen different even had the correct diagnosis been


40 Investigations

concentration which can occur in the presence ofhigh urine output. Neurological sequelae followingrapid correction of hyponatraemia include pontinedemyelination which is associated with shrinkage ofthe brain as the serum sodium concentration rises.The infusion of 0.9% saline does not cause anincrease in the intracellular compartment volume;infusion of excess saline does not cause brainswelling.

62 In this situation the measurement of the centralvenous pressure would have been most helpful inguiding the rate of fluid replacement.

Conclusion63 Miss J had significant hyponatraemia; more than

could be explained by hyperglycaemia. This was anadditional factor reflecting the severity of hermetabolic disorder. It increased the risks ofneurological problems occurring during correctivetreatment.

Recommendations64 A physician with experience of diabetic ketoacidosis

and hyponatraemia should manage a case of thisnature. A careful treatment plan is needed withestimates of the deficits of water, sodium andpotassium. Objectives should be set and progressmonitored frequently.

65 Regular neurological monitoring is required insevere diabetic ketoacidosis, particularly whenhyponatraemia is present.

Cerebral oedema66 At 8.00pm on 22 July Miss J developed a severe

headache. She was agitated. Her conscious level wassaid to be normal; she had been somewhat confusedwhen she was first admitted to the hospital.Treatment with insulin and intravenous fluids hadstarted about 9 hours before the headachedeveloped. Miss J was given some Paracetamol. Theheadache settled after about one half hour.

67 The headache recurred at about 2.00am the nextmorning. Within 10 minutes Miss J's conscious levelhad deteriorated and after 30 minutes she wasunable to sustain adequate respiration. At this pointthe neurological catastrophe was irreversible.

Discussion68 Children, occasionally, and young adults, rarely, die

suddenly from the rapid onset of neurological comaduring treatment for diabetic ketoacidosis. Thisneurological catastrophe - cerebral oedema - tendsto occur between 8 and 24 hours after the initiationof treatment. Treatment often appears to be goingwell. The outcome is usually death, occasionallyrecovery with severe neurological damage.

69 Brain swelling has been shown to occur generally indiabetic ketoacidosis. During treatment to reversethe dehydration, acidosis and hyperglycaemia thebrain swelling increases. The catastrophe occurswhen the cranium can no longer accommodate theexpanding brain. Why brain swelling occurs in allcases of ketoacidosis but the syndrome of cerebraloedema in very few is not understood.

70 There is no consensus as to the cause of cerebraloedema. It occurs in severe ketoacidosis not inhyperglycaemia per se, even with extremelyhigh glucose levels. Those who present withhyponatraemia and ketoacidosis have an increasedrisk of developing cerebral oedema. There is asuggestion that excessive fluid replacement may be acausative factor, (it should be noted that 0.9% salineand glucose solutions have quite different effects).Rapid correction of hyperglycaemia has beensuggested as a factor leading to brain swelling; manyadvise slow correction.

71 If diabetics with severe ketoacidosis and those withassociated hyponatraemia have regular neurologicalobservations close monitoring may pick up earlysigns of cerebral oedema. Treatment to reduce brainswelling can then be considered in suspect cases.Treatment could include intravenous Mannitol, areduced rate of fluid administration and mechanicalhyperventilation. There are, however, no studies toconfirm or refute the value of these interventions.

72 When Miss J developed severe headache at 8.00pmshe probably had early cerebral oedema. Shecertainly had cerebral oedema by 3.00am the nextmorning when the headache recurred.

73 The medical staff, who were involved in Miss J's carewere generally unaware of cerebral oedema as apotentially life-threatening problem and appeared tohave little idea of the action which could beconsidered if cerebral oedema was suspected.Eventually dexamethasone was given both forcerebral oedema and possible pituitary apoplexy.

Recommendations74 Young adults as well as children, with severe diabetic

ketoacidosis, should have regular neurologicalmonitoring with the aim of detecting the early signsof cerebral oedema.

75 Advice about cerebral oedema should be included inthe protocols used for the management of diabeticketoacidosis by all intensive therapy units that mightlook after young adult diabetics or children withdiabetes.

ITU nursing careDiscussion

Investigations 1

Chapter 1• Investigations

Case No. W.138/97-98

The care provided to Ms J by Dr B, a generalpractitioner

Complaint againstDr B, a general practitioner in the NorthWales HA area

Complaint as put by Mr J1. The account of the complaint provided by Mr J was

that on 18 July 1997, his sister, Miss J, travelled to aholiday centre for a short holiday. During thepreceding few days she had complained of musclepain and lethargy. She again felt unwell on thejourney; and on the following day, 19 July, sheattended Dr B's surgery at the centre. Dr B examinedMiss J, who complained of stomach pain and nauseaand that she had been vomiting for two days and wasslightly constipated. She also said that she had beendiagnosed as having Mature Onset Diabetes of theYoung (MODY) (a form of non-insulin dependentdiabetes) and had not tested her blood glucoselevels. Dr B diagnosed gastritis and prescribedMaxolon, an anti-nausea medication. Miss Jcontinued to feel unwell and, on 20 July, returned toher home in Widnes, where she was seen by a locumGP (the second GP) on 20 July and her own GP (thethird GP) on 21 July. She was admitted to hospital on22 July suffering from diabetic ketoacidosis (anexcess of acid and ketones - an organic compound -which may be present in the body tissues and fluids,which develops in diabetics when their condition isgetting out of control, and may indicate approachingcoma). She died on 31 July.

2. Mr J complained to the practice about the treatmentDr B gave his sister and subsequently requested anindependent review of his complaint. Theindependent review was held on 6 January 1998; butMr J remained dissatisfied. The conduct of theindependent review is the subject of a separateinvestigation by the Commissioner.

3. The matter subject to investigation was that Dr B's

clinical management of Miss J's condition wasunsatisfactory in that:

(a) he took insufficient steps to diagnose and treather condition, in particular, he failed to testglucose and ketone levels; and

(b) he failed to ensure that she had sufficientknowledge to manage her diabetes in the lightof her symptoms.

Investigation4. The context of this investigation is that Dr B was the

first of three GPs who saw Miss J between 19 and 22July 1997, when she was admitted to hospital. Theactions of the two GPs who saw her after herconsultation with Dr B were subject to complaint byMr J: in both cases the Health Authoritycommissioned independent reviews to consider theadequacy of the care they gave. Dr B's actions werealso subject to independent review, following whichMr J remained dissatisfied and approached theCommissioner. Dr B came to the same diagnosis asthe two GPs who saw Miss J later. The actions of thetwo GPs were criticised by the independent reviewpanels. The panel which considered the actions of thesecond GP who saw Miss J on 20 July, concluded thathe should have tested her blood and in failing to doso fell below the standard of a reasonable GP. Thepanel that considered the actions of the third GP, whosaw her on 21 July, concluded that he should haveestablished her current blood sugar level, preferablyby checking it himself, and that because he failed todo this his standard of care was not of an acceptablelevel.

5. The statement of complaint for the Commissioner'sinvestigation of the complaint against Dr B wasissued on 1 April 1998. I obtained Dr B's commentson the statement; and relevant documents wereexamined. One of the Commissioner's investigatingofficers took evidence from Mr J, Miss J's fiancé and



Investigations 39

intravascular volume and fluid requirements. The pHnever improved significantly during the first twelvehours of therapy. The use of 8.4% sodiumbicarbonate is debatable. Intensivists working in anITU would probably be confident in giving boluses ofsuch bicarbonate strength, but, in general, mostdiabetologists would err on the side of caution andgive only 1.26% or 2.8% at the most, and tentatively.The administration of bicarbonate runs the risk oflowering the potassium, producing a fall in the pH ofthe cerebrospinal fluid (increasing brain acidosis)and impairing the level of consciousness. The SHOwas unsure as to what to do with regards to Miss J'sacidosis. In fact, the 'front line' doctor care for Miss Jon the ITU was being supplied by three juniordoctors; a locum SHO, a locum Registrar and a locumanaesthetic SHO, all of whom acquitted themselveswell for their level of expected competence.

54 Neither of the senior doctors considered that he hadresponsibility for overseeing Miss J's total care,indeed each thought that the other was responsible.The first consultant, in his written statement, seemedunder the impression that the SHO was following thehospital protocol for the management of diabeticketoacidosis: this was not the case. As aconsequence, the SHO was unsure how to proceedwith Miss J's care at a time when she had beenreceiving therapy for over ten hours and yet heracidotic state had not improved and, despite theSHO's best efforts it was almost two hours after shewas called to the ITU at 8.00pm to review Miss J thatthe SHO finally received further instructionsconcerning a change in therapy for tackling thecontinuing acidosis. Only after Miss J's condition haddeteriorated did the consultant physician on call (thesecond consultant) review her himself. Whetherregular, at the bed, assessments by a senior doctorwould have altered the outcome of Miss J'sadmission is open to speculation.

Recommendations55 Any person admitted to hospital with a serious, life-

threatening condition such as diabetic ketoacidosisshould have their case reviewed by a doctor ofregistrar status or above. Where a case of diabeticketoacidosis does not respond to therapy in theexpected manner there should be available aconsultant with an over arching responsibility forcoordinating all aspects of medical care. Theconsultant on call should always adopt a 'need toknow' policy as to who has specific responsibility forthis over arching role. In this particular instance thisdoes not appear to have been the case. There mustbe a clear, consultant led, management plan.

56 Where a person in a state of diabetic ketoacidosis isnot, within a few hours of treatment starting,positively to progress with a steady rise in their pH,a senior doctor should be available, in person, toreassess the situation and look for causes of

continuing acidosis; for example lactate build up,hyperchloraemia or inadequate fluid replacement. Itshould never be the case that an on call SHO hasresponsibility for the ITU management of such aserious condition as diabetic ketoacidosis.

Hyponatraemia57 When Miss J was admitted to the hospital on the 22

July 1997 the initial tests in the minor injuries unitrevealed hyponatraemia in addition to acidosis(arterial pH 7.09). The serum concentration of sodiumwas 109 mmol/L, potassium 6.7 mmol/L, creatinine186µmol/L and glucose 38.8 mmol/L. Treatment withinsulin and with 0.9% saline solution, givenintravenously, was started at about 11.00am.

58 By 3.00pm the volume of saline infused was between2Þ and 3Þ L. The record of infused fluids over thisperiod was inadequate. By 1.30pm urine flow wasgood, suggesting that the extracellular compartmentvolume had been restored. By 3.00pm the serumconcentration of sodium was 122 mmol/L withpotassium 4.9 mmol/L, creatinine 108µmol/L andglucose 14.2 mmol/L. The central venous pressurewas not monitored; an attempt to insert a cannulahad failed. No explicit treatment plan was formulated.

Discussion59 Hyponatraemia is defined as a serum sodium of less

than 136 mmol/L. Hyperglycaemia causestranslocational hyponatraemia; the presence of ahigh concentration of glucose in the extracellularcompartment decreases the serum sodiumconcentration by shifting water from the intracellularcompartment to the extracellular compartment. [Thisreduction is 3.0 mmol/L of sodium for each 10mmol/L increase of glucose. This leads to a netincrease in osmolality of approximately 3.6 mOsm/Kgfor each 10 mmol/L increase of glucose.]

60 Miss J was clearly much more hyponatraemic thanexpected purely on account of the translocationaleffect of hyperglycaemia. Her serum osmolality wasbelow normal. The probable cause of this componentof the hyponatraemia was that she drank a lot ofwater when she was dehydrated and sodiumdeficient. Hypotonic hyponatraemia does cause brainswelling. It is of considerable interest thathyponatraemia has been reported in a highpercentage of patients with diabetic ketoacidosiswho develop cerebral oedema.

61 Treatment of ketoacidosis with insulin and therestoration of the extracellular compartment volumewith 0.9% saline solution take precedence toconcerns about hyponatraemia per se in diabeticketoacidosis. However, it is prudent to avoid rapidadministration of 0.9% saline after the extracellularfluid volume has been restored to normal in order toavoid a rapid increase in the serum sodium

2 Investigations

Dr B. Two external professional assessors (theCommissioner's clinical assessors) were appointed togive independent advice on the clinical issues centralto this case, which are about whether, when he sawMiss J on 19 July, Dr B acted in a way consistent withreasonable clinical practice (see paragraph 7). Theassessors have expressed an opinion on thereasonableness of Dr B's actions given theinformation he had or might have elicited when hesaw Miss J. They have not, rightly, taken account ofsubsequent events, including Miss J's later care inhospital. The assessors were unable to say whetherMiss J would have survived had Dr B acteddifferently. The assessors' report is at Appendix A. Anote on technical terms used recurringly in thisreport is at Appendix B. I have not put into this reportevery detail investigated; but I am satisfied that nomatter of significance has been overlooked.

Complaints (a) - Dr B tookinsufficient steps to diagnose andtreat Miss J's condition, inparticular, he failed to test herglucose and ketone levels; and (b) -he failed to ensure that Miss J hadsufficient knowledge to manage herdiabetes in the light of hersymptoms.

Relevant legislation and nationalguidance6. The National Health Service (General Medical

Services) Regulations 1992, include at section 26(1)that "A person requiring treatment who .... is not onthe list of a doctor providing general medical servicesin the area of the locality where he [she] istemporarily residing .... may apply to any doctorproviding services in the locality in which he [she] istemporarily resident to be accepted by him as atemporary resident". The regulations interpret`treatment' to mean `medical attendance andtreatment .... ' but to exclude health surveillance,contraceptive, maternity, medical and minor surgeryservices.

7. Schedule 2 of those regulations contains the terms ofservice for doctors, which include:

`Where a decision whether any, and if so what,action is to be taken under these terms of servicerequires the exercise of professional judgment, adoctor shall not, in reaching that decision, beexpected to exercise a higher degree of skill,knowledge and care than -

` .... that which general practitioners as a classmay reasonably be expected to exercise.Õ

Professional guidance8. Guidance from the General Medical Council entitled

`Good Medical Practice', in the edition published in1995 (before the events subject to complaint),describes good clinical care as including:

`- an adequate assessment of the patient'scondition, based on the history and clinicalsigns including, where necessary, anappropriate examination;

- providing or arranging investigations ortreatment where necessary .... .

- [keeping] .... clear, accurate, andcontemporaneous patient records which reportthe relevant clinical findings, the decisionsmade, information given to patients and anydrugs or other treatment prescribed.'

Evidence of Mr J and Miss J's fiancé9. On 23 October 1997, Mr J wrote to Dr B's practice

manager making a formal complaint against Dr B. Hesaid that Miss J had presented at Dr B's surgery withsigns of hyperglycaemia (an excess of sugar in theblood) - vomiting, nausea, stomach pains and thirst.She told him she was diabetic, but Dr B failed to carryout a blood or urine test.

10. On 23 January 1998, Mr J complained to theCommissioner that his sister had attended Dr B'ssurgery as a temporary resident, and clearlyidentified herself as a diabetic who had beenvomiting for two days. Mr J wrote:

`Knowing that [Miss J] was a diabetic Dr Bfailed to enquire about or test diabetic control.The only safe way for Dr B to have proceededwas to have actually tested blood glucose levelsand urine ketone levels .... knowing [Miss J] wasa diabetic he failed to ensure that [Miss J]understood the implications of this vomiting andunderstood how to manage her diabetes duringillness. These measures are widely accepted asgood clinical practice ....

`It is our position that to fail to test diabeticcontrol in an identified diabetic patient if thepatient is vomiting .... is acting without regardfor the danger of the loss of diabetic controlwhich can be fatal. We feel that .... had Dr Bchecked diabetic control .... he would havefound definitive signs of hyperglycaemia anddiabetic ketoacidosis. Had this been the caseand [had] appropriate treatment beencommenced then .... [Miss J] would be alivetoday.'

11. When interviewed Mr J said that his mothertelephoned him on 20 July (the day his sister


38 Investigations

her locum post nor was she made aware of anyprotocols for the management of common medicalemergencies until 11.00pm that night. Hermanagement was based on her previous experienceof caring for people with diabetic ketoacidosis.

Conclusion44 The SHO's initial assessment and management of

Miss J cannot be criticised. She gave exemplary careto Miss J and her immediate family.

Recommendation45 All new and locum personnel should receive formal

induction into the working practices of the medicaldepartment which should be centrally co-ordinated.This should include protocols for the management ofcommon medical emergencies which should beavailable in all areas where such emergencies arelikely to present for care.

Admission to ITU and furthermanagement of diabeticketoacidosis46 Following admission to ITU, the first registrar

attempted to insert a CVP line to monitor Miss J'sfluid balance but she was unsuccessful. She decidedthat a CVP line was not essential partly to avoidfurther distress to Miss J and because her pulse,blood pressure and urine output were consideredsatisfactory. Miss J declined a urinary catheter andthe first registrar complied as her urine output wascopious. The consultants were aware of her decisionand did not reverse it. The first registrar also askedan anaesthetic SHO to insert an arterial line but thistoo was unsuccessful.

47 The first consultant told the investigator that heviewed his role as advisory. He saw Miss J on threeoccasions during the day and provided telephoneadvice during the evening. The second consultantsaid that he understood the first consultant to havetaken over clinical responsibility for Miss J and as aresult did not assess her himself until after hercollapse at 3.00am. He had indirect involvement inthe patient's care.

48 The first consultant's notes were of an advisorynature. There was no clear documented managementplan. The SHO was not aware that there was adiabetic ketoacidosis management protocol until11.00pm. The first consultant was not aware that theSHO did not have access to this protocol according tohis written statement.

49 At 6.00pm the SHO resumed responsibility for MissJ's care. There was a locum registrar (the secondregistrar) on duty but he had no direct involvementbefore Miss J's collapse apart, from one telephonediscussion with the SHO.

50 At 8.00pm the SHO was called to ITU because Miss Jhad developed a severe headache. The SHO notedthat her metabolic state had not improved and wasunsure which advice to follow. She called the secondconsultant who advised her to call the first consultantat home. She successfully contacted him at 9.40pmand he advised a change in treatment (see paragraph18 main report). By 11.30 Miss J appeared settled. At3.30am she was called urgently to ITU because MissJ had collapsed.

Discussion51 When a patient presents with severe diabetic

ketoacidosis in a state of mental confusion,significant dehydration and a high urine flow mostdiabetologists and critical care physicians wouldconsider a CVP line a prerequisite for the properassessment of intravascular fluid status and the rateof fluid replacement needed. Likewise, the necessary,frequent measurement of electrolytes, pH and bloodpressure to monitor the effects of therapy oftennecessitates the use of an arterial line. The firstregistrar initially, correctly concluded that both weredesirable. She was deflected from achieving herobjective by the practical difficulties of insertingthem, which may have been the result ofinexperience in practical procedures, and a desirenot to cause her patient further distress. Herconsultant colleagues concurred with her decisionand should have realised that this made their ownactive role in the supervision of Miss J's monitoringand management all the more important.

52 By late afternoon the patient's acidosis was notsignificantly better, nor had she received adequatefluid replacement. The consultant was clearlyconcerned about her potassium level and pH. Hisnotes, however, are of an advisory nature. There wasno clear, detailed plan of management entered in thenotes with set parameters, targets and relatedinstruction. As a consequence, the SHO who hadreceived conflicting advice, was unclear what actionto pursue and was unaware that there was atreatment protocol.

Conclusion53 Overall, the ITU management of Miss J's diabetic

ketoacidosis was satisfactory from the point of viewof her electrolyte status but her fluid balance andacid-base derangement were never adequatelyassessed or fully and rigorously attended to. In acase of diabetic ketoacidosis there may be a deficit tothe equivalent of five or more litres of normal saline.In Miss J's case, according to the available fluidrecords, and (allowing for inaccuracies in the nursingfluid charts), there was a negative balance (ifinsensible loss is taken into account) during the firstnine hours of treatment and even by the twelfth hourof care there was less than a litre positive balance.Thus the use of a CVP line would have beeninvaluable in assessing both the status of her

Investigations 3

returned home from the holiday camp), and said thatMiss J was unwell and had been seen by a doctor(the second GP). His mother had put her concernsabout a link between diabetes and her daughter'sillness to the doctor, but the second GP said that herdaughter had a viral infection. On 21 July, Mr J'smother told him that a doctor (the third GP) wascoming to see his sister. On 22 July his mother toldhim that his sister was being taken to hospital. Mr Jvisited his sister in the intensive care unit (ITU). Shetold him that she had seen a doctor whilst on holidayand had told him that she was diabetic, was vomiting,and had tummy pain. The doctor (Dr B) had not toldher what he thought was wrong, but had given hersome medicine. The next day Mr J spoke to Miss J'sfiancé, who told him that he had accompanied her tosee a doctor whilst on holiday. Mr J told theinvestigator that Dr B knew that Miss J was adiabetic and was vomiting. He said that Dr B askedher whether she was testing her blood and she saidshe was not. [Note: a test record maintained by MissJ and seen by the investigating officer records thatMiss J did test her blood sugar levels. Her lastrecorded reading was taken on 14 July 1997 and was11 millimoles]. Mr J thought that `giving safety netadvice' [`come and see me if you are not better'] wasnot enough for a diabetic at risk of losing diabeticcontrol. Mr J considered that Dr B should have testedMiss J's blood and urine and ensured that she knewhow to manage her diabetes during illness.

12. On 23 November 1997, Miss J's fiancé (the fiancé)made a signed statement which includes:

Òn the way to the holiday park [Miss J] ....began to feel ill with tummy pains and feelingsick. Shortly after arrival at the park [Miss J]was actually sick a number of times and wasunable to keep any food or drink down. Theminute she ate or drank it just came back.

ÔAs she had not got any better I asked her to goto the doctor's at the camp ....

` .... we went into the room .... the doctor asked[Miss J] what the problem was. [Miss J] toldhim that she was a diabetic, she told him shewas MODY and was diet controlled .... that shehad been feeling unwell for 2 days, she had beenfeeling sick, she had vomited, she had a tummyache and was feeling thirsty. I added that shehad been unable to keep any food or drink down.... the minute she ate or drank she would throwit straight back.

` .... At no time did the doctor enquire about[Miss J's] diabetes nor did he carry out a bloodtest or anything really .... The doctor certainlydid not tell [Miss J] to come back and see himnor did he tell her that she could call him out inthe night if her illness continued ....

Àt about 4 o'clock in the morning on the 20thJuly 1997 [Miss J] woke up constantly vomiting

and crying .... I took her home.'

13. When interviewed, the fiancé said that he and Miss Jwent to the holiday centre with his cousin, hiscousin's partner, and their baby to celebrate hiscousin's 21st birthday. Miss J had begun to complainduring the car journey that she was feeling à bit ill'.They arrived at the centre at 10.30 am, got their keys,unpacked, and then walked around to see the shopsand arcade. They went to the centre's club in theevening. Miss J was feeling a little unwell, but did notwant to spoil the evening and so `put up with it'. Theyleft the club early because of the baby and went tobed. During the early hours of the morning Miss Jwas `being sick constantly'. The fiancé did not seeMiss J being sick, but heard her retching. Hepersuaded her to visit the camp doctor, and theywalked to the surgery at about 4.00pm. Miss J filledout a form. In the surgery she told the doctor that shehad been vomiting, was `constantly thirsty', andcould not keep anything down. The fiancé told thedoctor that Miss J's diabetes was diet-controlled. DrB asked no questions about Miss J's diabetes and didnot ask her whether she tested her blood or urine. DrB examined Miss J's abdomen and she told him thatsome areas were tender to the touch. She said shewas slightly constipated. Dr B gave Miss J aprescription, instructed her to take the syrup, andsaid that she `would be right as rain in the morning'.Dr B did not give Miss J his diagnosis, but the fiancétold the investigating officer that he thought hementioned `gastritis' and that that was why he waschecking her stomach. Dr B did not tell Miss J what todo if she continued to feel unwell.

14. Miss J took the medicine, but it did not help. Shecontinued retching, and was either sick or retchedwhenever she tried to eat or drink. At about 4 o'clockthe following morning Miss J awoke and wascontinuously vomiting and crying. Her fiancé heardher retching; and she asked him to take her home.The fiancé said that he did not know how to contactDr B: there was no notice in their caravan, and hethought the surgery would not open again until4.00pm. He took Miss J home.

Documentary evidence15. Dr B completed a temporary resident record for Miss

J, as follows (see explanations in paragraph 24):

`Vomiting 2/7 ab[domen] (tick) `BO [bowels open] (tick) M.O.D.Y. `Rx [treatment] Maxolon Syr[up]'

`21/8/97 - message from brother`Mr J ....`S/B [seen by] locum Widnes 20/7` own GP 21/7àdmitted 22/7`Died in hosp[ital] 31/7 .... '

16. On 20 July 1997, Miss J was seen at home by a locum


Investigations 37

that when teaching someone, like Miss J, to test theirblood she would tell them what the normal range wasand that they would expect their fasting blood sugarto be 4-7, their pre-meal reading to be 4-7 and herrandom blood sugar to be not above 9. If theirreadings were regularly above that (i.e. more than 2-3) or if there seemed to be a different pattern to theresults they should let the clinic know. Miss J wastold to test 2-3 times a week. If they got a highreading, for example 11, they would be advised totest again the next day if they felt well or later thatday if they felt unwell. They would always be asked toconsider how they were feeling. She would explainthat the reason they were testing was to avoidhyperglycaemia; they would be encouraged tounderstand their normal levels so that they had apattern against which to compare.

Conclusions35 It is possible that by April 1997, more frequent

monitoring could have been advised because of therising HbA1c. This could have produced anopportunity to further discuss any appropriatetreatment changes but the change was relativelysmall and the nurse was not in error to continue withthe regime already implemented.

36 We do not find the diabetes nurse specialist remissfor not teaching ketone testing and its relationship todiabetic ketoacidosis in this situation of educationbased on type 2 principles. It may be argued thatshould this information have been imparted it isunlikely that it would have been remembered.Therefore the awareness of change if unwell or not isa more important message. We can not tell from theevidence whether or not this information was givento Miss J.

37 What clinicians are looking for, is an altered patternof results, not a single deviation from the norm. Thediabetes nurse specialist did not remark upon anearlier instance of a reading of 11 in the notes, butshe did record 'one odd one of 9mmols' whichindicates that the reading had significance for her.We cannot determine, from the evidence, preciselywhat Miss J was told. All we can be sure of is that thediabetes nurse specialist did not fully document herdiscussions with her patient. 'Info. given' and 'generalchat' are not sufficiently specific.

38 If one were to speculate, however, it would seemunlikely that Miss J would have been told to report asingle high reading but would rather have beenadvised to report more than one. She recorded asingle high reading on 14 July and when she tried totest again, she thought, according to her niece'sevidence, that the reading was between 7-9. By thetime she might next be considered due to test, shewas feeling unwell and had consulted GPs on fouroccasions who did not themselves test her bloodsugar or advise her to do so. The fact that Miss J did

not report a single high reading of 11mmols is,therefore, not evidence that she received inadequateeducation.

39 The diabetes nurse specialist has accepted that herdocumentation was insufficient and she has takensteps to improve it. The standard of her note keepingis not in fact any less than that of many nurses inpractice and falls within the norm. However, this casehas demonstrated that that standard, in diabeticcare, is not itself adequate. On balance, and beingcareful not to judge her actions with hindsight, we donot think that the diabetes nurse specialist providedinadequate care to Miss J. Clearly, if the diagnosishad been different, so too would the level ofinformation provided to Miss J.

Recommendations40 As there is a diverse range in the quality of printed

diabetes educational materials as provided bycompanies, it may be more prudent for a diabetesteam to agree to standardise and print their own.This has financial implications but would preventinappropriate or out dated material being used.

41 We recommend that nurses should record that theyhave taught normal/abnormal parameters of control;advised the patient to contact them if they record xnumber of results which deviate from the norm at alevel of x, and told them to test x times when feelingill. We understand that nurses find it difficult to findtime to document their care as well as deliver it, butrecords are a vital nursing tool - they act as aneffective check-list against which a nurse canevaluate whether they have provided all thecare/information they intended. They are the meansby which a nurse can act as a fully accountablepractitioner and demonstrate the fact.

Admission and initial management ofdiabetic ketoacidosis

Clinical careDiscussion42 Miss J was seen by the SHO within 15 minutes of

admission on the morning of 22 July. The SHO madea rapid, detailed assessment of her patient,diagnosed severe diabetic ketoacidosis, requested allappropriate investigations and instituted initialresuscitation measures. Within the hour she haddiscussed the situation with her immediate seniorcolleague, the first registrar, and met the parents toexplain that their daughter was seriously ill and, onthe registrar's advice, would be transferred to ITU.The SHO had no further involvement with Miss J'scare until late afternoon.

43 The SHO was employed as a locum and was new tothe hospital. The SHO told the investigator that shehad not received any formal induction on taking up

4 Investigations

GP (the second GP). He recorded:

`HistoryÀbdo[minal]-pain : vomiting since lastFri[day]`Bowels (tick)`Diabetic on diet control

`Clinical examinationÀnaemia (nil) Jaundice (nil)`Well hydratedÀbdo[minal] tenderness [a diagram sitedpain in the lower left quadrant] no guarding,no lumps LKKP [no lumps felt in liver, spleenor kidneys]`Temperature 35.7C Pulse 80bpm [beats perminute] BP [blood pressure](no entry).`Diagnosis - Gastritis'

17. On 21 July 1997, Miss J was attended by the third GPwho recorded the following in her clinical notes:

21.7.97 Vomiting 3/7. Given stemetil liquid bylocum. Makes her sick. O/E [on examination]Not dehydrated. [Abdomen] soft non tender.RS [respiratory system] NAD [no abnormalitydetected] No genito-urinary or gastrointestinalsymptoms. RBS [glucose level] around 7. PU[passing urine] normally. Diagnosis Gastritis.'

18. The transcript of evidence to the independent reviewpanel which considered Mr J's complaint about thethird GP includes a statement by him that he did notassociate Miss J's symptoms with diabetes becauseshe did not look ill, did not appear to be vomiting, herbreath did not smell of ketones, she was not clinicallydehydrated, she denied passing large amounts ofurine, and was normal mentally. Miss J's mother toldhim that her daughter's blood sugar was around 7millimoles per litre.

19. The post-mortem report, dated 1 August 1997, listsMiss J's cause of death as acute cerebral oedema [anexcess of fluid in the brain] and diabetic ketoacidosis.

20. The conclusions of the report of the independentreview of Mr J's complaint against Dr B include:

` .... whilst MODY was recognised in [Miss J],no specific steps were taken by Dr B to establishthe precise nature of [Miss J's] diabeticcondition ....

Ìf [Dr B's notes] do not record relevantnegative findings which were drawn [by him]then we conclude that they would fall below therequirements of good practice.'

Dr B's evidence21. In his formal response to the Commissioner,

conveyed in a letter from Solicitors, Dr B said that hehad a `normal, intelligent' conversation with Miss Jabout her illness. She told him that she had been

vomiting on and off since the previous day, that shewas a diet controlled diabetic, and that MODY hadbeen diagnosed by a hospital consultant. Dr Bexplained to her that an upset stomach could be asign that her diabetes was not under proper control.He wanted to establish, therefore, whether she hadany symptoms of ketoacidosis or hyperglycaemia. Heasked her whether her diabetes was `playing up'.Miss J told Dr B that she was not testing her bloodsugar levels. Dr B added:

ÔMiss J did not tell [me] she had "tummy pain"and "thirst" as set out in Mr J's letter .... If shehad complained of these symptoms [I] wouldimmediately have suspected a diabetic cause ....and arranged further investigation. These areclassic symptoms of diabetes which simply werenot present at the time .... [I] did specifically askher whether she was drinking more than normaland whether she was passing water more oftenthan normal. Her answer .... was no .... '

22. The statement said that Dr B examined Miss J'sabdomen which was unremarkable. She said that shedid not have any pain; that her bowels had beenopen; and that she had had no diarrhoea. She wasable to climb on and off the examination couchwithout difficulty. Dr B smelt Miss J's breath andexcluded any smell of ketones and fetor (anunpleasant smell). She was not dehydrated and didnot appear lethargic. Dr B's clinical assessment wasthat her diabetes was not relevant to the presentingcomplaint of vomiting. She denied any symptomsassociated with hyperglycaemia or ketoacidosis. Dr Bwas also reassured by the diagnosis of MODYbecause type 2 diabetics (non-insulin dependent)were very unlikely to develop a ketoacidotic state inthe absence of severe illness or infection. He said:

ÔIt is admitted that [I] did not test glucose andurine ketone levels but it is denied that thepatient's clinical condition or history given atthe time of the consultation required such steps'.

23. Dr B also denied that he failed to ensure that Miss Jhad sufficient knowledge to manage her diabetes inthe light of her symptoms.

24. Dr B told the Commissioner's investigating officerthat his practice had an agreement with the holidaycentre to provide medical cover seven days a week.When Miss J walked into his surgery she did notappear at all ill. Dr B had not been called out to visitMiss J, as he would have expected had she felt veryill. Dr B said that Miss J was not sick whilst in hissurgery and was well enough to fill out a form onarrival. She was not clutching a bowl or receptacle tobe sick in, as Dr B would have expected if she wasnauseous. Miss J said that she had been vomiting andwas MODY. Dr B questioned her about her diabeticcontrol. She was unable to tell him what her sugar


36 Investigations

approximately three times each week. The exactadvice was not recorded. Miss J did measure herblood glucose frequently. The most common intervalbetween tests was four days, followed by three, andthen five days. There were occasional intervals ofseveral weeks when she did not record any results.These appear to have occurred when she was onholiday - and feeling well. As far as we can ascertainMiss J was very careful with her diet. Her compliancewith the advice she had received was good until shebecame unwell in July 1997.

21 After recording a blood glucose result of 11 mmol/Lon the 14th of July Miss J attempted to test again on17 July but could not read the result and then did nottest her blood glucose again even though she becameprogressively unwell.

22 Why Miss J did not test her blood glucose betweenthe 17th and the 22nd of July is not known.

Discussion23 In general Miss J followed the advice that she was

given. What happened after the 17th of July 1997 isa mystery. We do not know for sure what she wasadvised to do if she became unwell; the right advicewas to check the blood glucose at least once daily.We do not know what she was advised to do if theblood glucose results were high; the right advice wasto contact the practice nurse or her generalpractitioner. We do not know if she knew thesymptoms of uncontrolled diabetes: thirst, frequenturination, tiredness and weight loss.

Conclusion24 We can come to no clear conclusion about

compliance during the week before Miss J presentedwith severe diabetic ketoacidosis. Before then hercompliance was good.

Nursing care25 We have been asked to consider the role of the

diabetes nurse specialist in the initial diagnosis ofMODY, the subsequent educational programme andmonitoring of diabetic control.

26 Miss J was diagnosed as a type 2 diabetic (MODY).

Discussion27 The diabetes nurse specialist, with less than two

years experience in this post, would have had littleexposure to the management and possibleprogression of MODY. Although more information isnow being published about MODY, in 1996 we wouldconsider that the diabetes nurse specialist would nothave had easy access to this little reported yetcomplex subject. A more experienced nurse may haveasked for further clarification but we do not find itunreasonable that the diabetes nurse did not

challenge the consultant's diagnosis.

Conclusion28 We do not consider that the diabetes nurse specialist

can be held accountable for the diagnosis.

Recommendation29 It is useful for members of the diabetes team to have

regular meetings to discuss unusual or complexpatients. This acts as an educational process for thehealth professionals and ensures that there isagreement about the advice given to the patients, thetreatment plan and parameters of control beforefurther intervention.

The education programme andmonitoring30 Diabetes education began at the GP surgery and by

the time Miss J saw the diabetes nurse at thehospital, she had been subject to severalconsultations concerning diabetes. The educationprogramme initiated by the diabetes nurse specialistwas that related to type 2 diabetes. Although notpresent during the first consultation, she saw Miss Jat the clinic and once at home.

Discussion31 The diabetes nurse specialist's records were very

brief and it is not possible to determine preciselywhat information was given to Miss J. She said thatshe gave both verbal and written information aboutdiabetes: Mr J disputes the content of both. Over theyears there has been a wealth of diabetes literaturepublished by many of the pharmaceutical and productcompanies concerned in diabetes care. Leaflets andbooklets covering a wide range of diabetes topicshave been renamed and redesigned and have readilybeen used by diabetes nurse specialists for patienteducation. If Miss J received "Diabetes, Diet andTablets" (although no longer published, it was in printthroughout the early nineties), then there is a sectionon illness and deterioration of diabetes control.

32 The diabetes nurse specialist did not record the levelat which Miss J was supposed to contact them. Theevidence given, at various times during the differentstages of investigation of Mr J's complaint, hasvaried. The consultant and the nurse have said thatMiss J would have been told to report a reading of 9,10 or 11 and that she was told to test 2-3, 3-4, or 4-5times a week. In the event she tested approximatelyevery 3-5 days which roughly accords with the advicestated to have been given.

33 Miss J contacted GPs when unwell and told them thatshe had MODY. She does not appear to have toldthem that her last recorded reading was 11mmols.

34 The diabetes nurse specialist told the investigator

Investigations 5

level was. Dr B asked about polydipsia (excessivethirst) and polyuria (excess urine production) andused this as a crude screening process to excludehyperglycaemia in a type 2 diabetic. He asked Miss Jif she was thirsty and she said no. If she had been atrue type 2 diabetic Dr B believed that she would havebeen very unlikely to develop diabetic ketoacidosis inthe absence of acute infection or serious illness -which she did not have. Had Miss J appeared ill, Dr Bsaid that he would have tested her blood sugar; buthe saw no indication that such a test was needed. DrB said he was surprised when Miss J told him thatshe did not test her own blood or urine; and hesuggested to her that she should contact her GPabout this as, if she was a true type 2 diabetic and didnot monitor her sugar levels, she might developproblems in the long term. Dr B said that, withhindsight, he would have tested her; but at the timeshe looked well, the vomiting appeared to havestopped, and she appeared quite comfortable. Shewas a type 2 diabetic MODY, and Dr B did notconsider her to be at particularly high risk ofdeveloping diabetic ketoacidosis.

25. Dr B said that he wrote short notes of theconsultation as an ‘aide memoire’. He was on callthat weekend, and so could have seen Miss J again ifshe had needed a doctor. Dr B usually recordedimportant facts in his notes. The degree of detailvaried from patient to patient according to need. Heexplained that, in Miss J's case, ‘abdomen - tick’ (seeparagraph 15) meant that nothing abnormal had beenfound; if her abdomen had been tender he wouldhave drawn a diagram to indicate where. `BO(bowels open) - tick' meant that there was nodiarrhoea or constipation. `Vomiting 2/7' meant thatshe had been vomiting for two days - the day of theconsultation and the day before. Dr B said that he haddiagnosed gastritis based on a history of vomitingwith no obvious cause, where the vomiting hadceased and the patient recovered - which Dr Bbelieved was what appeared to have happened inMiss J's case. He had established during theirconversation that she was keeping some fluid downand did not appear dehydrated. Dr B said that hesmelt Miss J's breath during the examination toexclude the presence of ketones or fetor. At the timeof the consultation it seemed reasonable not to testMiss J's blood sugar. Dr B said that he was now`extra cautious' and tested all diabetics he saw.However, his judgment at the time was that therewas no need for him to test Miss J.

Clinical Assessors' advice26. The Commissioner's assessors' report (at Appendix

A) concludes:

` - Dr B took a reasonable history for someonewho at the time of being seen did not presentas particularly ill;

- Dr B should have recorded both positive and

negative findings in view of Miss J's pastmedical history and diagnosis;

- There is a range of views as to whether urineor blood should be tested for glucose in adiabetic with a history of vomiting. If it isaccepted that Miss J was not particularly ill atthe time she was seen it may not have beennecessary in her case. However, it wouldprobably be considered good practice to testurine in a diabetic patient, presenting withvomiting, when this was not being undertakenby the patient;

- Dr B's note-keeping was not comprehensiveenough;

- It was not Dr B's responsibility to educate MissJ about diabetic management.'

Findings (a)27. Mr J has complained that Dr B should have tested

Miss J's urine and blood when he saw her as atemporary resident patient at the holiday centre on19 July 1997 and that, had he done so, she might bealive today. I recognise the distress and anger thefamily have experienced as a result of that belief. Myfindings in this case focus on whether Dr B did all thatcould reasonably be expected of a competent generalpractitioner in the circumstances.

28. Having accepted Miss J as a temporary patient at theholiday centre, under the provisions of section 26(1)of the General Medical Services Regulations(paragraph 6), Dr B had a responsibility to provide noless a standard of care and treatment to her than toa patient seen in his own practice. Miss J presentedon 19 July as a patient Dr B did not know and whotold him that she had been vomiting and was diabeticin the form of the relatively unusual condition MODY.

29. There is no dispute that Dr B did not test Miss J'sblood sugar or urine. His reason for not doing so wasthat MODY carried a low risk of ketoacidosis in theabsence of severe illness or infection, and he did notconsider that Miss J presented as particularly illwhen he saw her. It is certainly true that Miss J wasable to go out with friends the night before; was ableto walk to the surgery; and was not sick while there.Had Miss J not been diabetic it is unlikely that therewould have been reason to question Dr B's diagnosisand treatment of what he deduced was gastritis - adiagnosis also made later by the second and thirdGPs (paragraph 4). However, Dr B knew that Miss Jwas diabetic and was unwell, and he believed thatshe was not testing her own blood sugar. My findingsmust turn on whether he paid sufficient attention tothese factors when he saw her.

30. There is a conflict of evidence between Dr B's and thefiancé's accounts of what happened in the course ofthe consultation on 19 July. Dr B maintained that heconsidered the possibilities of hyperglycaemia and


Investigations 35

not show significant worsening of her diabetes apartfrom the final result, which was 11 mmol/L. Thediabetic clinic haemoglobin A1c results show slightworsening of her diabetes in 1997 compared with1996.

Discussion6 When Miss J, a 19 year-old, presented with diabetes

mellitus it was not necessary to make a diagnosticchoice as to the type of diabetes as her diabetescould have been managed quite satisfactorily as'diabetes mellitus, type unspecified'. In time the truediagnosis would have become apparent.

7 There were two possible further diagnoses: Maturity-onset diabetes of the young (MODY) and type 1diabetes. Type 1 diabetes is also known asinsulin-dependent diabetes mellitus (IDDM). Thesediagnoses are mutually exclusive. Maturity onsetdiabetes or non-insulin-dependent diabetes mellitus(NIDDM) is now referred to as type 2 diabetes.

8 MODY is an inherited type of diabetes with onset inadolescence to young adulthood. It is genetically andphenotypically heterogeneous. Some phenotypes arenot benign as the diabetes may progress with age,requiring treatment with insulin and causingmicrovascular complications. Ketoacidosis does notoccur in MODY.

9 Type 1 diabetes is more common than MODY inadolescents and young adults. The underlyingpathology is autoimmune destruction of the insulin-secreting beta-cells in the pancreas. If the diagnosisof diabetes is made when a considerable number ofbeta-cells are intact the diabetes may be wellcontrolled without treatment until such time as asignificant decline in beta-cell numbers occurs.Progressive loss of beta-cells is associated withdeterioration in metabolic control, which, whensevere, results in ketoacidosis. In most type 1diabetics dependence on insulin develops within oneyear of diagnosis; in some it may take years todevelop.

10 These two types of diabetes cannot be distinguishedwith certainty on clinical grounds at the time ofdiagnosis. If diabetes can be managed for aprolonged period - several years - without insulinMODY becomes the more likely diagnosis.

11 Laboratory tests can aid diagnosis: in some, but notall forms of MODY genetic defects can be identified,and in type 1 diabetes circulating antibodies to insulinand pancreatic islet cell components can be detected.These tests are not routinely available.

12 A diagnosis of MODY could only have been madewhen Miss J presented with diabetes if type 1diabetes could have been excluded. She was,

however, given a diagnosis of MODY without type 1diabetes having been excluded.

13 By being given the diagnosis of MODY Miss J was notmade aware of the risk of metabolic deterioration toketoacidosis which can occur in type 1 diabetes. Shewas not told about testing for ketones in urine if theblood glucose is high. She was given adviceappropriate for a type 2 diabetic. It is not known ifthe symptoms of uncontrolled diabetes wereexplained to her.

14 In fact, regular monitoring of the blood glucose withregular checks of the haemoglobin A1c was anappropriate way to monitor Miss J's diabetesprovided she was not unwell. In both type 1 and type2 diabetes metabolic deterioration occurs duringintercurrent illness so that all types of diabetesrequire frequent blood glucose monitoring duringillness of any sort. In Miss J's case blood glucosemonitoring alone would have been sufficient to revealthe serious metabolic deterioration after the 14th ofJuly 1997.

Conclusions15 It was an error for the consultant to give Miss J a

diagnosis of MODY in July 1996. The consultantshould not have excluded the possibility of type 1diabetes developing slowly. If he had included thispossibility Miss J would have been made aware ofthe risk of ketoacidosis. This might have altered theway she responded when she became unwell in July1997. It might also have altered the way the generalpractitioners, whom she saw when she was unwell,responded. The HbA1c results revealed that therewas a slight deterioration in diabetic control whichwould not require anything other than a continuationof a watch and wait policy and monitoring.

Recommendations16 The diagnosis of maturity-onset diabetes of the

young should be made only when type 1 diabetes has,essentially, been excluded.

17 Both general practitioners and physicians should bevigilant as a small number of diabetics considered tohave MODY or type 2 diabetes may in time turn out tohave type 1 diabetes.

18 Diabetics and general practitioners must be aware ofthe risk of metabolic deterioration in association withintercurrent illness. Appropriate monitoring of thediabetes is mandatory.

Compliance19 Compliance in medical usage means acting in

accordance with rules, plans or advice.

20 Miss J was advised to measure her blood glucose

6 Investigations

ketoacidosis, but excluded them on the basis ofquestions he put to Miss J and the answers she gave;the fact that she was not dehydrated, had no smell ofketones on her breath and no report of thirst orexcessive urine production; and the diagnosis ofMODY. Dr B said that Miss J told him that she was nottesting her blood sugar levels. On the basis of thehistory he took, Dr B diagnosed gastritis, for which heprescribed Maxolon and advised Miss J to return orcall him out if she continued to feel unwell. The fiancésaid that Dr B asked no questions about Miss J'sdiabetes and that she gave a different account of hersymptoms.

31. Unfortunately, Dr B did not make a full record of thequestions he asked Miss J and the answers she gave.Dr B said that his practice was to vary the content ofhis notes according to the needs of each patient butto record important detail. In Miss J's case the solereference to diabetes in Dr B's notes is `MODY'. Hisnotes are brief in the extreme (paragraph 15)indicating negative findings only by a tick against`abdomen' and `bowels open'. There is no tickagainst `MODY' to indicate that Dr B excludedsymptoms associated with diabetes. Theselimitations make it impossible for me to decidebetween the two accounts of what happened at theconsultation. The Commissioner's assessors haveadvised that Dr B's note-keeping was notcomprehensive enough and that he should haverecorded both positive and negative findings, in viewof Miss J's past medical background and diagnosis. Iagree; and I recommend that Dr B should ensurethat he keeps a full record for all his patients,including temporary residents, which includes bothpositive and negative findings.

32. Should Dr B have tested Miss J's blood sugar andketone levels? The Commissioner's assessors advisethat there is a range of views within the medicalprofession on the need to test routinely diabeticpatients who present with vomiting. They add that ifit is accepted that Miss J did not appear particularlyill at the time she was seen, it follows that it mightnot have been necessary to test her blood and urine.However, Dr B was not faced with a routine situation.Miss J was seen as a temporary patient, and Dr B hadno more information available than he elicited in thecourse of the consultation. On the question of testingblood sugar, Dr B says (paragraph 22) that Miss Jsaid that she was not testing her own blood or urine,and that he was surprised about that. Although theinvestigation has revealed a record (paragraph 11)that Miss J did test herself, I have no reason to thinkthat Dr B knew that. At best (according to his ownaccount) he was surprised to be told that she had nottested. At worst (according to the fiancé's account)the subject did not come up at the consultation.Whichever account is true, according to theCommissioner's assessors it would have been goodpractice for Dr B to have acted with greater cautionand at least tested Miss J's urine, in the absence of

knowledge that Miss J was testing herself. I acceptthat advice. I conclude that it would have been goodpractice for Dr B to have tested Miss J; and I upholdthis aspect of the complaint to that extent. I note thatDr B now routinely tests the blood sugar of diabeticpatients.

33. In upholding this aspect of Mr J's complaint I shouldlike to make two observations. First, neither I nor theCommissioner's assessors are able to say whetherhad Dr B, or any of the GPs who saw Miss J, acteddifferently she would have been alive today. To do sowould be speculative for the reasons set out inparagraphs 4 and 5 above. Secondly, the totality ofMiss J's care in the period between 19 July and 31July, when sadly she died, has been the subject ofinvestigation through the complaints procedure orwill be the subject of investigation by theCommissioner. He intends to consider when all theinvestigations are complete whether there are issuesrelated to the general question of diabetic care whichhe should draw to the attention of the Secretary ofState. He, his advisers and the medical professionmight wish then to consider whether there is a needfor review of the guidance on professional practice inthe management of acute diabetes.

Findings (b)34. Mr J also complained that Dr B had a responsibility to

ensure that Miss J understood how to manage herdiabetes during an episode of illness. Dr B disagreed,and said that he advised Miss J to speak to her ownGP about testing her blood glucose because of the riskof long-term complications for type 2 diabetics. Healso said that he told Miss J to come back to see him,or call him out, if she remained unwell. The fiancédenied that Dr B gave advice on either matter. Again,in the absence of contemporaneous records, it is notpossible to decide between these accounts. TheCommissioner's assessors have advised that, in theirview, it was not Dr B's responsibility to attempt toprovide diabetic management advice to Miss J. Iagree. She was a temporary patient who was feelingunwell and, therefore, might not have been in the bestposition to be receptive to or retain such information.I do not uphold this aspect of the complaint.

Conclusion35. This report is of one of a series of investigations into

aspects of the care of Mr J's sister and how hiscomplaints were handled. I have set out my findingsin paragraphs 27 to 34 on his complaints against DrB. Dr B has agreed to implement my recommendationin paragraph 31 and has asked me to convey to Mr J- as I do through my report - his apology for theshortcomings I have identified.

March 1999

569486_60pp / sig10 / plateA

34 Investigations

Case No. E.171/98-99

Appendix A

Report by the External Professional Advisers toThe Health Service Ombudsman on Complaintsfrom Mr J

First external professional assessorMrs P - MA RGN HV Cert

Relevant experienceDiabetes Nurse Specialist.

Second external professionalassessorDr U - MB BS

Relevant experienceConsultant Physician

Third external professional assessorProfessor E

Relevant experienceProfessor of Clinical Psychology

Fourth external professionalassessorDr S - PLD, FRCP

Relevant experienceEmeritus Consultant Physician

Fifth external professional assessorMs J - RGN MSc

Relevant experienceClinical Risk Manager

Introduction1 We have been asked to consider whether the care

and treatment provided to Miss J was adequate interms of what might reasonably be expected of staffat a District General Hospital.

2 Our advice in relation to specific issues is set outbelow; one or more external professional assessorshave contributed to each section. We have examinedthe nursing and medical records in detail; the papersprovided by Mr J, the Trust and the investigator's

interview notes.

Complaint (a) the care andtreatment provided to Miss J byHalton General Hospital NHS Trustwas inadequate

Miss J's care at the Diabetic Clinic

Clinical careInitial diagnosis of maturity-onsetdiabetes of the young (MODY)1 Miss J saw the first consultant in the general diabetic

clinic in July 1996. She was not overweight and hadnot lost weight. The plasma glucose concentrationand the haemoglobin A1c (HbA1c) percentage wereboth in the normal range. The consultant understoodthat two family members were diabetic: Miss J'smother and her maternal grandfather. The consultantdiagnosed maturity-onset diabetes of the young(MODY). Miss J was told that the diagnosis wasMODY; her clinic card had written on it "I have MODYdiet controlled diabetes". The general practitionerwas told that the diagnosis was MODY.

2 Miss J understood that a diagnosis of MODY meantthat she would never require insulin. The diabetesnurse specialist taught her to test her blood glucoseusing reagent strips. She was advised to test herblood glucose about three times each week. She didnot take any medications.

3 The diabetes nurse specialist and the first consultantrecollect that Miss J was advised to test her bloodglucose frequently - at least daily - if she was in anyway unwell. Miss J's brother states that she did notreceive this advice. Miss J was not advised to testher urine for ketones if she was unwell.

4 The first consultant saw Miss J at intervals in theyoung persons diabetic clinic. When she was seen atthe clinic the haemoglobin A1c (HbA1c) percentagewas measured.

5 Miss J measured her blood glucose reasonablyregularly up to the 14th of July 1997. Her results do

Investigations 7

Case No. W.138/97-98

Appendix A

Report by the Professional Assessors to the HealthService Ombudsman for Wales of the clinicaljudgments of staff involved in the complaint madeby Mr JProfessional Assessors

First AssessorDr L - MB BS DTM&H D.ObstRGOG

General Practitioner for 29 yearsSenior Partner in a four doctor, seaside townpractice

Second AssessorDr N BSc MB ChB

General Practitioner for 11 yearsSenior Partner in a four doctor, inner city practice

Matters considered36. The matter subject to investigation is that Dr B's

clinical management of Miss J's condition wasunsatisfactory in that:

a) he took insufficient steps to diagnose and treather condition, in particular, he failed to testglucose and urine ketone levels (a ketone is achemical which is present in the urine whendiabetes is not in good control); and

b) he failed to ensure that she had sufficientknowledge to manage her diabetes in view ofher symptoms.

Basis of report37. In formulating our report, we have perused a set of

documents and reports which have been madeavailable to us by the Office of the Health ServiceCommissioner, and which have included:

Report of the independent review panelregarding the late [Miss J], dated January1998.

Papers considered by the independent reviewpanel on 6 January 1998, including:

1. the original complaint

2. the response from the GP, Dr B

3. a copy of the Temporary Resident Clinical Record

4. correspondence requesting the

independent review

5. the statement from [the fiancé]

6. additional information to support the complaint by [Mr J]

7. Letter to the Health Service Commissioner for Wales from [Mr J], dated 23 January 1998.

8. Response to the complaint against Dr B, prepared by Solicitors, dated 5 May 1998.

9. Notes of the interview between the Commissioner's investigator and [Miss J's] fiancé dated 29 July 1998.

10. Notes of the interview between the Commissioner's investigator and [Dr B] in the presence of the first and second assessor dated 19 August 1998.

Assessors' comments on the actionsof Dr B38. We have noted that Miss J was diagnosed MODY in

July 1996.

On 18 July 1997, Miss J complained of `tummyache'and nausea on a journey to [the holiday centre].

In the early hours of 19 July 1997, Miss J startedvomiting.

At 4pm on 19 July, she attended a surgery, and sawDr B at approximately 4.30pm.

According to the clinical record made by Dr B, Miss Jgave a history of vomiting for 12 hours (he actuallywrote `vomiting for two days' by which weunderstand that he meant `yesterday and today').

Dr B noted that she had Maturity Onset Diabetes ofthe Young.

Dr B noted that her bowels were normal.

Dr B examined her abdomen and found no

569486_60pp / sig10 / plateB

Investigations 33

67. Many changes have also taken place in the delivery ofcritical care services at the hospital. These rangefrom the introduction of a specific policy on themanagement of ketoacidosis and the modificationand updating of fluid charts and results sheets. Areview of nurse staffing levels has also taken placewhich has resulted in strengthened nurse leadershipwithin the unit and robust plans for further nurserecruitment. This will support the transfer to apurpose built critical care facility with additional bedcapacity and the provision of a high quality patientenvironment including relatives accommodation.

68. The Trust has asked me to offer to Mr J and his familyits apology for the shortcomings I have identified. Ido so through the medium of this report. The Trusthas also agreed to act upon my recommendations inparagraphs 36, 37, 45, 46 and in Appendix A whereaction has not already been taken, including in thecourse of the service developments described above.I have also recommended, and am pleased thatthe Trust has accepted, that a meeting betweensenior officers of the Trust and Miss J's family wouldbe a helpful way forward in deciding how the Trustmight respond to the findings in my report.

M S BuckleyHealth Service Ombudsman

August 2000

abnormality.

We believe that Dr B formulated a diagnosis ofgastritis, although this is not recorded in the clinicalrecord.

Dr B prescribed maxolon syrup.

We have noted that Miss J did not vomit whilst withDr B, and probably did not vomit again until 4am thenext morning, when it was decided that Miss J shouldtravel home, rather than call a doctor out at [theholiday centre].

We have noted that there is some discrepancy as towhether Dr B did ask Miss J whether she checked herown blood or urine. Unfortunately, this is notrecorded on the clinical record.

We have noted that Dr B neither tested her blood norurine during the consultation.

Although it is not recorded in the clinical record,there is nothing to suggest that at the time that MissJ was seen, she had ketones.

Conclusion39. (i) In considering all the evidence, we are of the

opinion that Dr B took a reasonable history of someone who, at the time of being seen, was not particularly ill.

(ii) We believe that, in view of her past medical history and diagnosis, Dr B should have recorded both positive and negative findings.

(iii) It would be fair to say that there is a range of views as to whether urine or blood should be tested for glucose in a diabetic with a history of vomiting. If we accept that Miss J was neither particularly ill nor vomiting at the time that she was seen, then it may not have been necessary. However, it would probably be considered as good practice to test the urine in a diabetic patient, presenting with vomiting, when this was not being undertaken by the patient.

(iv) We generally feel that Dr B's note keeping was not comprehensive enough.

(v) We do not feel that it was the responsibility of DrB to educate Miss J, a temporary resident, consulting when she was not feeling well, on the management of diabetes.

8 Investigations

569486_60pp / sig11 / plateA

32 Investigations

advice it had been given. I do not criticise the panelfor doing so. It is important however, that in reachinga conclusion a panel should consider carefullywhether it is supported by the evidence and whetherall reasonable opportunities have been taken to testthat evidence. I have done so in the course of myinvestigation and have taken account of the views ofmy adviser in clinical psychology (Appendix A) asdenial is a psychological concept, an inference frombehaviour. I am advised that it is generally acceptedthat particular patterns of behaviour can arise for avariety of psychological and other reasons. The firstconsultant invoked (during the IRP panel), and thepanel accepted, a psychological account for Miss J'spresumed failure to act. It was, therefore,appropriate for me to seek a psychologist's view onthe evidence that a particular psychological processwas implicated in Miss J's alleged failure to act. Theconsultant cited no independent evidence other thanthe presumed failure to act as the grounds forinferring denial. He did not at the time cite, let alonetest, other possible explanations for Miss J'sbehaviour. I have concluded that Miss J was not indenial. The panel chairman has recognised that thepanel's views on this matter were expressedunwisely. I am pleased that this is accepted. I do notbelieve that there was any deliberate attempt by theTrust to mislead the panel or to fabricate evidence. Iuphold the complaint.

Conclusions61. I have set out my findings in paragraphs 34 - 47 and

60.

62. There is no doubt that type 1 and type 2 diabetes areserious life threatening conditions. Equally, there isno doubt that if they are correctly managed the riskof premature death and complications can besubstantially reduced. Yet Miss J died. Thisinvestigation needs to be seen in the context of thosepreviously conducted by my office and through theNHS complaints procedure into the entire course ofMiss J's treatment and care. From these it is clearthat a number of mistakes were made beginning withthe initial, unduly definite, diagnosis of type 2diabetes. Avoiding any one of these mistakes wouldhave improved Miss J's chance of survival. It is notpossible for me to say that one or more of thesemistakes individually led to her death: but takentogether they almost certainly did. If, for example,the diagnosis had been correct or expressed withsufficient caution; if we could be certain that Miss Jreceived the information and education she needed;if any one of the three GPs involved in her care hadtested her blood or urine; or if Miss J had hadimpressed upon her, in no uncertain terms, that shemust test daily when unwell, and had done so andreported untoward results, she might have survived.

63. This investigation has revealed that Miss J's inpatientcare could have been more expertly co-ordinated and

that she had a right to expect better from the Trustand its staff. For example, I have commented on thefailure to insert a CVP line, on the failure to keepaccurate fluid balance charts and on the lack of clearconsultant leadership in ITU. I have also commentedon nurse staffing and supervision in ITU and on thenurses inappropriate reaction to Miss J's behaviour.I cannot say with any certainty, what contribution, ifany, these failings made to the tragic outcome in thiscase. It is not understood why some patients developthe rare condition of cerebral oedema and I cannotbe certain whether different clinical managementwould have prevented this condition. I am advisedthat once Miss J collapsed as a result of cerebraloedema her death, or severe neurological damagewas inevitable. I have also commented, however,that, in these circumstances, the diagnosis ofcerebral oedema and the use of a trial of Mannitolshould have been considered.

64. An important lesson from this case, is the need for allthose involved in diabetic care, not least patientsthemselves, to be aware that it is essential to testblood glucose and urine ketones more frequentlyduring an intercurrent illness, whatever the type orseverity of diabetes. This simple measure could havesaved Miss J: I hope it will save others.

65. The Trust has advised me that significantdevelopments have taken place in diabetes care andeducation at the hospital in the last three years. Thedrivers for these developments have been acombination of the issues highlighted in Mr J'scomplaint and a wider series of significant serviceenhancements, which include:

-the appointment of a further consultant physicianwith a special interest in diabetes working with bothsecondary and primary care;

-successful primary and secondary care partnershipsincluding for:

á diabetic foot clinics

á retinopathy clinics

á specialist nurse clinics

á pre-conception clinics

á ante-natal clinics

á young persons clinics

66. In relation to diabetic nursing, service developmentin the last three years, has included nursingdocumentation including the introduction ofeducation check lists and follow up plans. Diabetesliterature has been improved for both type 1 and type2 diabetics which highlights greater awareness ofsick day rules, pre-conception and pregnancy careand patients new to insulin therapy.

Investigations 9

Case No. W.138/97-98

Appendix BGlossary of Terms

Technical term Meaning

MODY (Mature Onset Diabetes of the Young) a form of non-insulin dependent diabetes (first used in paragraph 1)

Diabetic ketoacidosis an excess of acid and ketones - an organic compound - which may be present in the body tissues and fluids, which develops in diabetics when their condition is getting out of control and may indicate approaching coma (paragraph 1)

Hyperglycaemia an excess of sugar [glucose] in the blood (paragraph 7)

Cerebral oedema an excess of fluid in the brain (paragraph 17)

Type 2 diabetic non-insulin-dependent diabetic, whose pancreas has retained some ability to produce insulin but this is inadequate for the body's needs (paragraph 20)

569486_60pp / sig11 / plateB

Investigations 31

might have happened and to help the family come toterms with events. The panel certainly did not intendto add to the family's anguish.

53. The lay chairman could not recall precisely whatevidence the panel had been given. She rememberedseeing [the SHO's] letter, but could not recall seeinga written statement from the first registrar whichcontained similar information. The panel was not toldthat Miss J's mother did all the tests. The chairmanbelieved that the clinical assessors had assumed thatthat was so. Denial had been a fundamental tenet ofthe clinical assessors' view and not one the panelcould disregard or overrule. However, the chairmanwas clear that, in future, she would be more cautiousand would ensure that conclusions expressed inpanel reports were founded on the evidence.

Evidence of Trust staff54. On 28 November 1998, the first registrar wrote in

a signed statement:

' É At about 5.15pm I rechecked the bloodgases, again with difficulty in obtaining thesample. [Miss J] was very unhappy abouthaving yet another needle. At this stage herrelatives were visiting, and while her Motherwas present I asked [Miss J] if she had beenchecking her blood sugars at home in view ofthe fact that she had been unwell for severaldays. [Miss J] said that she had not checked herown blood sugar, and [her mother] said that shehad been trying to encourage her to do so, but[Miss J] was unwilling to do so as she did notfeel well enough, even having returned from aholiday in Wales after only two days as she feltunwell. [Her mother] said that she also isdiabetic, and had offered to check the blood forher, but that [Miss J] had refused.'

55. The first registrar said when interviewed that shehad gained the impression that Miss J's motherintended to convey that her daughter had refused onmore than one occasion. She thought her mother wassaying that she had known something was wrong, butthat her daughter would not let her test her blood.

56. The SHO explained that the Trust's medical directorhad asked her to provide a written statement andinformation about her communication with Miss J'sfamily. She provided a written statement which setout her clinical involvement and, in a covering letter,dated 2 December 1997, her recollection ofconversations she had had with the family. The letterincluded:

On admission I gained information from both[Miss J] and her mother about the precedingillness. Amongst other things, [Miss J's] motherinformed me that she ([Miss J's mother) hadattempted to take BM Stix measurements in the 2

or 3 days prior to admission however [Miss J]herself had refused to let her mother do this andher mother had not forced [Miss J] to comply.'

57. The SHO told the investigator that she had talked toMiss J's mother when she admitted her and that shehad asked questions about Miss J's blood monitoringhistory in order to establish the pattern prior to heradmission to hospital. Her recollection in December,was that Miss J's mother had told her that she hadwanted to test her daughter's blood sugar, but thatMiss J had become upset and she had not wanted toforce her. She understood this situation to havespanned a 2 or 3 day period. She was unable at thisdistance in time to recall the incident with anygreater clarity. She would have needed to establishwhat Miss J's blood sugar levels had been over thepreceding few days to determine whether hercondition was a sudden onset or a gradualdeterioration. She certainly had the impression thatMiss J's refusal to allow her mother to test her bloodrelated to a period of time rather than one specificoccasion.

58. The nurse specialist said when interviewed that MissJ had been a shy person and generally came to clinicwith her mother. She was co-operative; seemed totake information on board; was happy to receive itand to engage in conversation. She did not observeany behaviour that might indicate to her that Miss Jwas in denial; she thought she understood her role inthe management of her own condition. Miss Janswered questions appropriately, accepted herdiagnosis, attended clinic regularly and tested herblood. There had been no 'no shows' or excuses notto attend clinic. The diabetes nurse specialist did notnotice any changes in Miss J's emotional state overthe period that she saw her.

59. The first consultant said when interviewed that hetold the panel that he thought Miss J was in denial.He did not think she was in denial of diabetes, butthought she was in denial of transition from type 2 totype 1. She did not test her blood sugars when shewas ill and would not let her mother do so. Miss Jhad told the GP that her blood sugars were '7'ish'when her last reading had been 11. She was vomitingfor four days, ill for ten, and yet failed to contact theclinic. She was an educated and compliant woman.

Findings60. Mr J has complained that the independent review

panel's finding on the question of denial was bothincorrect and unjust. He and his family had beenupset by the implication that Miss J had contributedto her own death. Mr J believes that there wereinsufficient grounds to support the panel's conclusionand he contends that the panel did not test theevidence. The lay chairman accepts that the panel'sconclusion should have been expressed differently:but she felt it important for the panel to reflect the

Body complained againstNorth Wales Health Authority

Complaint as put by Mr J 1. The account of the complaint provided by Mr J is that

on 18 July 1997, his sister, Miss J, travelled to aholiday centre for a short holiday. During thepreceding few days she had complained of musclepain and lethargy. She again felt unwell on thejourney to the holiday centre and on the followingday, 19 July, she attended a surgery held by a GP.The GP examined Miss J, who said that she hadstomach pain and nausea, had been vomiting for twodays and was slightly constipated. She also said thatshe had been diagnosed as having mature onsetdiabetes in youth (MODY) [a form of non-insulin-dependent diabetes] and that she had not tested herblood glucose levels. The GP diagnosed gastritis[inflammation of the lining of the stomach] andprescribed Maxolon, an anti-nausea medication. MissJ continued to feel unwell and, on 20 July, returnedto her home in Widnes. She was admitted to hospitalon 22 July suffering from diabetic ketoacidosis (anexcess of acid and ketones [a particular group oforganic compounds] in body tissues and fluids whichdevelops in diabetics when their condition is gettingout of control, and may indicate approaching coma).She died on 31 July.

2. Mr J complained to the practice about the treatmentgiven to his sister by the GP, and subsequently askedthe North Wales Health Authority for an independentreview of his complaint. The independent review washeld on 6 January 1998, but Mr J remaineddissatisfied.

3. The matter subject to investigation was that theindependent review panel failed to follow nationalDirections and guidance on the reporting ofindependent reviews in that it did not adequatelyaddress and reach conclusions on its findings of factand on the advice of its clinical assessors, related tothe matters specified in the panel's terms ofreference.

Investigation4. The statement of complaint for the investigation was

issued on 1 April 1998. The Commissioner obtainedthe Health Authority's comments and relevantdocuments were examined. One of theCommissioner's investigating staff took evidencefrom Mr J, the GP, members of the independentreview panel (with the exception of the convener who

was ill, and could not be interviewed) and the twoclinical assessors who gave advice to the panel. Ihave not put into this report every detail investigated;but I am satisfied that no matter of significance hasbeen overlooked. The Commissioner is conducting aseparate investigation of Mr J's complaint against theGP. It is not my remit, in this report, to considerwhether the panel reached correct conclusions intheir consideration of the GP's actions, but toconsider whether the panel acted reasonably indrawing up its report.

National legislation and guidance5. The Secretary of State for Health, in exercise of

powers conferred on him by section 17 of theNational Health Service (NHS) Act 1977, issued`Directions to Health Authorities on dealing withcomplaints about family health service practitioners'(1996). The Directions include the followingprovisions in respect of the independent reviewprocedure:

`30 The functions of the panel shall be -

`(a) to investigate the complaint; and

`(b) to make a written report to the Health Authority of the findings of its investigation.

`31(1) The functions of the assessors shall be -

`(a) to advise the panel on matters relatingto the exercise of clinical judgment by the person subject to complaint; and

`(b) to make a written report to the panel oftheir advice.

(2) The assessors may make a joint report .... or eachassessor may make a separate report.

`33(1) The report of the panel shall include -

`(b) the opinion of the panel on the complaint having regard to the findings of fact.

`(c) the reasons for the panel's opinion ....

`(e) where the panel disagrees with any matter included in the report of the

10 Investigations

Case No. W.125/97-98

The conclusions reached by the Independent Review Panel that examined the care provided by Dr B

569486_60pp / sig12 / plateA

30 Investigations

an earlier complaint hearing against a generalpractitioner came to light in the course of thereview (Note: this was subsequently proved byMr J not to have been used at that review). Thisinformation was in the form of a letter of 2ndDecember 1997 from [the SHO] who writes,"Amongst other things, [Miss J's] motherinformed me that she (the mother) hadattempted to take BM [Stix] measurements in the2 or 3 days prior to admission however [Miss J]herself had refused to let her mother do this andher mother had not forced [Miss J] to comply".The home blood glucose testing record bookshows good values which are very consistentuntil the last entry of 14th July 1997 whichshows a value of 11mmol. Thereafter there areno tests. We were told that [Miss J] did not doher own tests but that all of her tests were doneby her mother. We consider that two inferencescan reasonably be drawn from this information.Firstly it suggests that the patient had difficultyin coming to terms with diagnosis of diabetes,had realised that control was poor and that aprogression of the diabetes had taken place sothat insulin treatment was likely to be advised.This kind of anxiety is recognised to cause areaction of denial of the diabetes in somesubjects. Secondly [it] tends to support the viewthat she did understand the signs and symptomsof deteriorating diabetic control and recognisedtheir significance.'

49. The panel concluded that:

ÔMiss J's home blood glucose testing recordbook shows values consistently around 7mmoluntil the last entry of 14th July 1997 when itshows a value of 11mmol. After this it seems thatno further tests were done, and, according to[the SHO's] written statement, Miss J refused toallow her mother to take any blood samples fortesting after this date. The Panel considers thatit is reasonable to deduce from this that Miss Jhad difficulty in coming to terms with thediagnosis of diabetes, and had realised (whenthe blood glucose began to rise) that the diseasewas progressing and that insulin treatment waslikely to be advised. This kind of anxiety isrecognised to cause a denial reaction to thediabetes in certain people.'

Evidence of Mr J and his family50. Mr J believes that the panel's conclusion that his

sister was in denial of her diabetes was unjustifiedand unfair. He said that he had not been shown theSHO's letter, and had therefore not been given anopportunity to refute the assertion upon which it wasbased. He was annoyed that the consultant appearedto have 'floated' the idea that Miss J was in denial asa mitigating factor and that the panel had quicklylatched on to it. Mr J said that his sister did not testher blood sugar more frequently when she was ill, or

contact the clinic, not because she was in denial butquite simply because she had not been instructed todo so. He produced a number of signed statementsfrom members of his family testifying that his sisteralways tested her own blood sugar and that familymembers had observed her doing so. The signedstatements included one from Miss J's niece that heraunt had tried to test her blood twice on 17 July andhad asked her to assist with timing and trying to readthe result. They had, however, been unable todetermine a reading, though the result seemed to liebetween 7 and 9. Mr J said in evidence that hismother did not know how to test blood sugar and hesupplied a letter from her GP confirming that she wasnot diabetic but merely had impaired glucosetolerance. His mother confirmed that she tried to testMiss J's blood sugar on only one occasion and thatwas when her daughter's GP asked her to do soshortly before the ambulance arrived to take her tohospital. She denied having told any of the doctors atthe hospital that she tested her daughter's bloodsugar; except on that one occasion, when herdaughter was clearly feeling very ill and had refusedto allow her to do so (see paragraph 20). Mr Jthought that the method by which the evidence ofdenial was produced at the panel was unfair, and thatthe Trust had fabricated it.

The panel chairman's evidence51. The panel chairman said that this was only the third

panel she had chaired. She had not been providedwith any training for her role before hearing thiscase, which was complex and involved theassimilation of a great deal of information. She andthe other panel members tried very hard to dealthoroughly and fairly with the case. The panelchairman commented that, with hindsight, althoughshe would still have included comment about denialshe would have used slightly different language andmade it very clear that it was just a theory and wasnot supported by hard evidence. She accepted that,as written, it did seem quite dogmatic and had notbeen expressed quite as she had intended.

52. The clinical assessors had expressed their verystrong opinion that Miss J had been in denial. Thechairman accepted, now, that the panel had got'swept along' with this theory and made assumptionswhich, in retrospect, they probably should not havedone. The panel had heard Miss J described as shy,innocent and naïve. She had been a late arrival to thefamily and was obviously cherished and 'protected' byher older brothers. It seemed from the lettersubmitted by [the SHO] that her mother tested herblood sugars for her. Miss J had apparently stoppedtesting her blood sugar when she became ill, and hadbeen described as fearful of diabetes. She appearedto have refused to let her mother test her blood sugarwhen she was ill. On that basis, it seemed reasonableto conclude that Miss J was in denial. The panelwanted to try to understand, to explain how this

Investigations 11

assessors, the reason for its disagreement.'

6. In March 1996 the Welsh Office issued guidance onthe operation of the complaints procedure whichincluded at paragraph 7.30:

`Panel's final reportThe panel may find it helpful to provide thecomplainant and any people complained againstwith the opportunity to check a draft report - whichmay not necessarily include the final conclusions ....- for factual accuracy .... The assessors' reportsshould be made available in time for .... circulationwith the panel's draft report.'

The Health Authority's formalresponse7. On 27 April 1998, the Health Authority's chief

executive explained in a letter to the Commissioner'soffice that the panel chairman had incorporatedcomments from the panel members and assessors ona draft of the report into a final version. Mr J wantedthe report to be issued quickly, and there was nodispute about the factual evidence. The panelchairman decided, therefore, not to circulate anamended draft report to the parties to the complaintbut immediately issued the final report, including theassessors' reports which had been receivedsubsequently. The chief executive pointed out that theHealth Authority had no authority to question thepanel chairman's report and that it was notappropriate for the Health Authority to jeopardise theindependence of the panel by seeking to influence it.

The Independent Review Panelreport 8. The panel's report is dated 21 January 1998. The

Terms of Reference set for the panel required it toconsider (a) whether the GP, knowing Miss J was adiabetic, observed proper professional standardswhen he saw her on 19 July; and (b) whether he keptan accurate record of the consultation. There is nodefinition of `proper professional standards'. Thepanel's report, to which are appended the clinicalassessors' reports, contains detailed findings of factand two paragraphs headed `conclusion'. These readas follows:

(a)`CONCLUSION`The GP knew that [Miss J] was diabetic andhad been diagnosed as MODY. He also knewthat this was extremely unusual and that heonly had one case, where the patient wasobese, which [Miss J] was not.

`The GP made no tests specifically geared to[Miss J's] diabetes but proceeded on the basis ofsuspected gastritis.

`The GP did not make an examination in depthon 19 July 1997 ....

(b)`CONCLUSION`The Panel found that the notes did recordcertain findings and the prescribed medicine. Ifthey are a true record of the consultation thenthey would indicate that whilst MODY wasrecognised in [Miss J], no specific steps weretaken by the GP to establish the precise natureof [Miss J's] diabetic condition.

`If they do not record relevant negative findingswhich were drawn by the GP then we concludethat they would fall below the requirements ofgood practice.

ÔThis finding is consistent with the expertevidence of the Clinical Assessors .... '

The clinical assessors' reports9. The first clinical assessor said in her report:

`It is good practice to check blood sugars and/orurine of diabetics who are ill; and that

Ôkeeping accurate records is of primeimportance in good practice. The recording ofnegative findings, probable diagnosis and futuremanagement should, where possible, beincluded'

The first assessor also observed that the `panel feltthat [the GP's] record of the consultation wasaccurate but not very helpful. There was very littlehistory, nor were all the symptoms or examinationfindings recorded'.

10. The second clinical assessor's report included nineobservations about the GP's management of hispatient:

1 `There are only scanty details of thecomplaints and examination in the note

2 `No record about the smelling of breath for"Ketone or Fetor (an unpleasant smell)"

3 `[The GP] failed to take and enter family history

4 `No record of advice regarding diet in view ofthe vomiting

5 `No record regarding enquiry of her blood test

6 `No record of advice to do the test regularly

7 `[The GP] carried out necessary examinationand came to a reasonable conclusion afterconsidering acceptable differential diagnosis

8 `Treatment provided was adequate

9 `The record keeping appears to fall below thelevel of good practice regarding the pointsmentioned above.'

569486_60pp / sig12 / plateB

Investigations 29

developed cerebral oedema. She was clearly severelyill as evidenced by her profound hyponatraemia onadmission. I am advised that the reason why cerebraloedema develops in some patients but not others isnot clearly understood, but that it is recognised thatfluid balance is not the only determining factor. TheTrust's staff had little awareness of cerebral oedemain adults with diabetic ketoacidosis, and acknowledgethat they did not perceive it as a risk in Miss J's case.I am advised that cerebral oedema is rare but widelyrecognised as a cardinal danger of diabeticketoacidosis and it occurs more commonly in childrenthan adults: I accept that advice.

45. When Miss J developed severe headache at 8.00pmon 22 July, I am advised that she probably had earlycerebral oedema. Once cerebral oedema develops itusually results in death or severe neurologicaldamage. My advisers have commented that the staffwho were involved in Miss J's care in the ITU weregenerally unaware that cerebral oedema inassociation with diabetic ketoacidosis is a potentiallylife threatening problem or what to do if it issuspected. I appreciate that levels of knowledge varyabout the relationship between cerebral oedema anddiabetic ketoacidosis and my advisers recommend,and I agree, that advice about cerebral oedemashould be included in the protocols for themanagement of diabetic ketoacidosis. I am pleasedto note that the Trust has now included this in itsprotocols. They also advise regular neurologicalmonitoring with the aim of detecting the early signsof cerebral oedema. Again, I agree. My adviserscomment that cerebral oedema in association withdiabetic ketoacidosis is a rare, but recognisedcondition in adults. Given that the Trust accepts forcare patients with diabetic ketoacidosis and has onits staff a consultant with a special interest indiabetes (the first consultant), I consider that thefirst consultant at least should have been aware ofthe risk in relation to diabetic ketoacidosis withhyponatraemia and should have considered it. HadTrust staff made a provisional diagnosis of cerebraloedema appropriate to Miss J's symptoms andtreated her accordingly, for example by a trial ofMannitol as my advisers suggest in paragraph 71 oftheir report, she might possibly have survived. Inreaching this conclusion I realise that there are nostudies to confirm or refute the value of thisintervention. But an opportunity was, I believe,missed, in circumstances where once cerebraloedema developed death or severe neurologicaldamage was the likely outcome.

46. I do have some concerns about the nursing caregiven to Miss J and I believe that there are importantlessons to be learned. First, the standard ofdocumentation was poor. Fluid charts were notcompleted accurately, yet they are vital when thepatient is seriously ill as was Miss J and whererestoration of fluid balance is an essential part of apatient's management; and a care plan was not

completed. In addition, it was not entirelyappropriate to allocate Miss J's care to a nursewithout an ITU qualification. At the very least thereshould have been regular review and supervision bythe charge nurse: but there is no evidence of this inthe notes. Greater efforts should also have beenmade to ensure senior clinical review: and the SHOshould have been made aware earlier of thetreatment protocol. I am also concerned by thegeneral tenor of remarks made about Miss J, whilstshe was in intensive care. I do not consider that staffwere aware of just how ill she was, nor did they fullyunderstand the effect of severe diabetic ketoacidosisupon a person's mental and emotional functioning.Although I do not think it affected the outcome I dothink the views nursing staff expressed about Miss Jcoloured, to some extent, their responses to herreports of pain and her behaviour. The first staffnurse, despite her personal reservations, respondedappropriately by calling the SHO; and the SHOreported the headache to the second consultant. Shedid not mention it to the first consultant when shecalled him later, presumably because the secondconsultant had not considered it especiallynoteworthy being unaware of the risk of cerebraloedema in association with diabetic ketoacidosis.The second staff nurse did not report the onset ofheadache at 2.00am. The charge nurse said that MissJ suffered a headache more or less continuouslythroughout the shift and yet the impression gained bythe SHO was that it was settling with paracetamoland, therefore, was not serious. I recommend thatthe nurse manager should reflect, with his staff, uponthis episode of care as part of staff development.

47. I have considered all aspects of Miss J's inpatientcare by the Trust. Taken together, the shortcomingsI have identified indicate that her inpatient care couldand should have been more expertly co-ordinated.However, I do not infer that these shortcomingscaused or substantially contributed to her death. Iuphold the complaint.

(b) the report of the independentreview panel included,inappropriately, a statement thatMiss J was in denial of her diabetes.

Documentary evidence48. The report of the independent review panel that

considered Mr J's complaints included the followingadvice from its clinical assessors:

'The complainant describes his sister as na�veand painfully shy. He said that she wasextremely fearful when she attended the clinicfor the first time and thought that she might die.He describes her as having a great weight liftedfrom her after being told that she would not needinsulin injections. Information which had notbeen previously submitted but had been used in

12 Investigations

Comments on the panel chairman'sdraft report11. Documents sent to the Commissioner's office by the

Health Authority in response to the Statement ofComplaint included the convener's and lay member'swritten comments on a draft of the panel's report. On15 January 1998, the Health Authority's assistantboard secretary (the secretary) conveyed thesecomments in a letter to the panel chairman asfollows:

`I have received the following comments on theDraft Report.

`[The convener] - Agreed, except with finalconclusion. This seems to end suddenly!

ÔI [the secretary] said .... that you [the panelchairman] had not completed the conclusionuntil you had the Assessors' Report to hand.

Ô[The lay member] .... felt that the report endedrather abruptly thus appearing damning of [theGP]. Again, I [the secretary] explained that youwere awaiting the Assessors' Report beforecompleting.'

The secretary also conveyed in her letter minor,detailed, additions to the text of the draft reportwhich were incorporated in the final version.

12. On 17 January, the convener commented further onthe draft report. In a letter to the Health Authority,which was forwarded to the panel chairman, shesaid:

`We have not concluded whether or not [the GP]observed proper professional standards on the19th [July 1997] .... '

13. The secretary also wrote to Mr J on 22 January 1998,to let him know that the final report of the panel hadbeen passed to the Health Authority chief executivefor circulation. The secretary said:

` .... having compiled the report, received theAssessors' reports and discussed the content ofeach with the Panel Members, he [the panelchairman] has decided not to circulate a draftfor comment, but to issue the Final Reportimmediately. This is in accordance with theGuidance, which does not require the chairmanto circulate a draft report'.

14. The secretary added that the report would be sent toMr J within the next five working days. On the sameday Mr J wrote to the Health Authority and asked forthe report to be released immediately. On 23January, the chief executive sent a copy of the reportto Mr J who commented the same day as follows:

`Having very carefully read the report I amsorry to say that I find the report and,

specifically, the findings, worded in such amanner as they could quite literally mean allthings to all men.

`I am assuming by the content of the report thatthe panel found the care offered to [Miss J] to beof an unacceptable standard, however this issomewhat confused given the comments of oneof the clinical assessors .... '

Mr J's evidence15. When interviewed, Mr J told the Commissioner's

investigating officer that the panel's report wasambiguous: it was not clear whether they werecriticising the GP or exonerating him. He also saidthat the clinical assessors' reports reached differentconclusions (see paragraphs 9 and 10).

Evidence of the panel chairman andmembers16. The panel chairman told the Commissioner's

investigating officer that he had compiled the panel'sreport and that copies had been sent to the HealthAuthority, the panel members and the clinicalassessors. Before the hearing began he had decidedthat the panel would need to take the clinicalassessors' advice as to what could reasonably havebeen expected of the GP in the circumstances inwhich he saw Miss J on 19 July 1997. The clinicalassessors' opinion had been that the same standardsof care should be expected from a consultation in aholiday surgery as in a normal practice surgery.Following the panel hearing the members discussedwhat their preliminary conclusions should be. At thatstage they did not have the assessors' reports. Themembers were in agreement that the GP had notexamined Miss J for either blood sugar or ketones;but that it was for the clinical assessors to saywhether that had been reasonable. The first clinicalassessor had told the chairman that she and thesecond assessor could not agree: but it was not clearto the chairman why that was so. The chairmansurmised that the assessors were operatingindependently of one another, and considered thatwith hindsight he should have commissioned a jointreport.

17. When the chairman received the assessors' reportshe thought they were 'a bit thin' but believed that theyconfirmed the panel's views as expressed in the draftreport. He was aware that the assessors hadreached differing conclusions. He thought they wereirreconcilable but not inconsistent with the panel'sdraft report, which the assessors had seen. With thebenefit of hindsight the chairman believed that heshould have followed up the detail of the assessors'advice. The panel had not felt able to reach aconclusion as to whether the GP had observed properprofessional standards. The members felt that itwould have been good practice for the GP to havetested Miss J's blood and urine, knowing that shewas diabetic, but that it was not unreasonable for

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28 Investigations

with approval that the nurse specialist has now takensteps to improve the standard of her record keepingand I recommend that she should follow the advicegiven by my advisers (Annex A - paragraph 41). I alsourge the nurse specialist to take note of the advicegiven at the conclusion of the advisers' report (AnnexA - paragraph 84) and that it is essential that alldiabetic patients, regardless of type or severity, aretaught to test their blood sugar at least once a day ifthey are unwell, and that it should be made very clearto them in what circumstances they should contactthe diabetes clinic for advice.

38. Mr J also complains that the first consultant and thenurse specialist failed to monitor his sister'scondition adequately. He maintains that Miss J'sblood glucose and HbA1c measurements clearlyindicated declining diabetic control and that, as aresult, action should have been taken to alter hermanagement. The first consultant has said that, evenhad he diagnosed type 1 diabetes at the outset, MissJ's care would not have been managed differently.My advisers agree, and have said that her HbA1cresults revealed a slight deterioration in diabeticcontrol, but that this would not have required achange in monitoring procedure. In Miss J's case Iam advised that blood glucose monitoring would havebeen sufficient to reveal the serious metabolicdeterioration that occurred after 14 July 1997. I amsatisfied, therefore, that Miss J's diabetic monitoringby the first consultant and the diabetes clinic waswithin acceptable bounds. I do not comment in thisreport on the actions of the other clinicians who sawMiss J between 14 July 1997 and her eventualadmission to hospital.

Inpatient care39. I turn now to the care provided to Miss J during her

admission to hospital. Mr J has complained thathospital staff should have been aware of the risk ofcerebral oedema in association with diabeticketoacidosis; that they failed to treat diabeticketoacidosis appropriately; and that theyadministered too much fluid so causing cerebraloedema. He believes that staff should haveresponded differently to the onset of headache andshould have observed his sister more closely.

40. Miss J was admitted with diabetic ketoacidosis; shealso had hyponatraemia and was clearly seriously ill.In view of that, a consultant should have taken anactive role in planning, managing and evaluating hercare. Neither the first nor the second consultantconsidered himself to be actively directing andmonitoring Miss J's care over the first 24 hours. Theyconsidered they were sharing care but did not meettogether with the SHO to lead the management; theywere content with the SHO variously contacting eachof them for advice. If the first consultant was unableto be fully involved because he was not on call,consideration should have been given to transferring

the patient to another unit. I understand that the ITUmanagement arrangements in place at the time weredesigned to ensure the involvement of specialists inthe care of patients being cared for there. However,one consultant should have had clear over-archingresponsibility for coordinating all aspects of Miss J'scare. I find it wholly unsatisfactory that that did nothappen with the result that there was a degree ofconfusion, a lack of focus on a care plan, and a lackof clear leadership to doctors who were still intraining. I am pleased to learn that ITU managementarrangements have now been changed.

41. I acknowledge that Miss J's care was in accordancewith the hospital protocol for the management ofpatients with diabetic ketoacidosis. However,protocols provide no more than guidelines for clinicalmanagement, and have to be seen in the context ofthe patient's developing condition. Miss J was anexceptionally difficult case and her condition did notimprove as expected. There is no evidence that shewas overloaded with fluid; but it is clear that stafffailed to bring the acidosis under control. In suchcircumstances, a senior member of the medical staffshould have considered whether other approaches totreatment were necessary. As it was, it was onlyafter Miss J's condition had deteriorated that thesecond consultant reviewed her himself. I find thiswholly unsatisfactory. I cannot say with anycertainty, however, whether regular bedsideassessment by an appropriately experienced seniorclinician would have altered the outcome in Miss J'scase.

42. Mr J has complained that his sister was over-hydrated and that that caused cerebral oedema. I amadvised that the state of a patient's hydration,particularly in the absence of a central venouspressure line, is a complex matter to determine. Myadvisers differed slightly in their views as to whetherMiss J's fluid balance was restored or remained indeficit. They agree however, that she was not over-hydrated.

43. I am advised that the insertion of a central venouspressure line is considered a pre-requisite if fluidbalance and the rate of fluid infusion are to bemonitored effectively, particularly when a patienthas, as in this case, both hyponatraemia and diabeticketoacidosis. I understand that unsuccessful effortsto insert a line caused Miss J distress and that, as aresult, the first registrar decided not to proceed. Iconsider that the absence of a CVP line made it all themore important for an experienced consultant tohave been actively directing treatment and personallymonitoring progress with the SHO until the patientwas out of danger. The first and second consultantsdid not counter the first registrar's decision: I findthat that was unsatisfactory.

44. It is not possible to determine precisely why Miss J

Investigations 13

him not to have done so in the circumstances. Thechairman felt that the panel's report had been a'qualified criticism' of the GP. He said, wheninterviewed, that he felt the report was 'as damningas it could be in the circumstances'. It was difficult,like 'walking a tightrope', between the need to be fairto the GP, in view of Mr J's anger against him, whilstrecognising the family's grief.

18. The chairman added that since this case, he had triedto reach conclusions which were directly geared tothe Terms of Reference and had tried to get theconvener to sharpen up Terms of Reference. He nowalso tried to persuade the clinical assessors toproduce a joint report where possible, or if not, iftheir views do not coincide, to explain why in thepanel report. In this case, the panel had tried toproduce a conclusion which encompassed theconclusions of both clinical assessors who had notagreed.

19. The panel's lay member told the Commissioner'sinvestigating officer that she thought the assessors'reports had been clear, brief and to the point. She didnot believe that they had reached differentconclusions. She did not see the assessors' reportsas in conflict because they related to the standard ofcare that could be expected in the circumstances ofthe case - a consultation in a holiday camp surgeryrather than in 'a standard general practitionersurgery'. The lay member said that the first clinicalassessor had been of the view that it would havebeen good practice to test blood and urine; thesecond clinical assessor advised that, in thecircumstances, it was reasonable for the GP not tohave done so. The lay member's own view was that itwould have been good practice for the GP to havetested Miss J's urine; but she did not think that in thecircumstances in which the GP had been practising,he had been irresponsible. She said it had beendifficult to achieve a balance between the family's'extreme grief' and the need to be fair to the GP in theknowledge of Mr J's 'extreme anger'.

The clinical assessors' evidence20. The first clinical assessor said, when interviewed by

the Commissioner's investigating officer, that she andthe second assessor had been in broad agreement. She had not stated her own conclusions boldly in herreport because she understood that the assessors' role was to give advice on what a reasonable doctorwould have done in a particular circumstance; but not on whether the doctor had erred in the particular case. That was for the panel to judge. She said that her role was to describe good and poor practice, not to be judgmental. When she received the panel's draft report she telephoned the Health Authority andsaid that she was `not unhappy' with any aspects of it. She thought that the GP had observed proper

professional standards and that his account of hisconsultation was that of a reasonable GP. However, he did fall short by failing to recognise that Miss J had a potentially serious condition. He had not givensufficient consideration to the fact that she was diabetic. Standards for the treatment of diabetic patients were different to those which applied to thetreatment of illness in other people.

21. The second assessor said, when interviewed, that hebelieved his role to be to provide independent advice,not necessarily to 'reach a consensus'. He believedthat the first six points in his report (see paragraph10) were 'statements of fact with negativeconnotations', and related to his conclusions aboutthe GP's record keeping (that it appeared to fallbelow the level of good practice). He thought thatthere were areas where the GP could have donebetter. He said that after he had considered theevidence the GP gave at the hearing and theinformation provided by Mr J (including the recordsof two GPs who had seen Miss J after the 19 Julyconsultation) he had concluded that the GP hadcarried out the necessary examination, considereddifferential diagnoses and given reasonabletreatment. The GP's account of events was supportedby the records of the two other GPs who saw Miss Jon her return home and who had similarly diagnosedgastritis and prescribed similar treatment.

Findings22. Independent review panels are required in their

reports to provide the parties to a complaint with anopinion, with reasons, having regard to findings offact and taking account of the clinical assessors'views on any clinical issues involved. The opinionexpressed in the report must be that of the panel. Inthis case, the panel's Terms of Reference as agreedwith the complainant, were to consider whether theGP had 'observed proper professional standards' inthe care of Miss J and whether his records were anaccurate reflection of his consultation with her on 19July 1997. It is not the purpose of this report to reachconclusions on these matters, but to considerwhether the panel did so. I have concluded that thepanel did not do so in any meaningful sense. The twoparagraphs in the panel's report headed 'Conclusion'(paragraph 8) are, for the most part, findings of factas to what the GP did and did not do, and what he didand did not record. I concede that the second couldbe read as critical of his record keeping, although thecriticism is expressed in hypothetical terms.However, the panel failed to express an opinion onthe adequacy of the care he gave to Miss J. That factis borne out by the convener's statement (paragraph12) that the panel had not concluded 'whether or notthe GP observed proper professional standards ....'.

23. Mr J complained that the panel's report was

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Investigations 27

the case and that she responded better to femalestaff. He therefore assigned her care to the agencynurse, though he would otherwise have cared for herhimself. The charge nurse was satisfied that theagency nurse's experience and ability were sufficientand he oversaw the care of all patients on ITU thatnight. The admitting (second) consultant technicallyhad patient ownership; but endocrine patients werenormally referred immediately to the first consultant.Diabetic ketoacidosis cases were usually handled bythe on call registrar who liaised with the on call(second) consultant. He was not present on the wardwhen, at 8.00pm, Miss J developed a headache, butwas informed about it at handover. Miss Jcomplained of a headache persistently during theshift and this indicated to the charge nursedehydration or toxicity. He drew his concerns aboutMiss J's persistent acidosis to the attention of theSHO, who contacted the first and second consultants.He tested baseline reflexes a number of times, butthere were no changes. Miss J was able cognitivelyand could count backwards.

32. The second staff nurse was a D grade agency nurse.She usually worked 4 or 5 shifts a week for the Trust,had done so for about a year and worked the nightshift on 22 July. She normally cared for coronarypatients. She was not aware of any treatmentprotocols on the ward. She administered fluids on theoral instructions of medical staff. Miss J had refusedto be catheterised and had to be coaxed intoaccepting an arterial line. She talked about herboyfriend and how they were planning to marry. Sheasked for a commode, appropriately, and showed noevidence that she was confused. Miss J was verytired, but if she fell asleep she woke instantly: therewas no change in her level of consciousness. Thesecond staff nurse was not present at 8.00pm, whenMiss J developed a headache, but was informedabout it at handover. The SHO was in almost constantattendance. At about 2.00am Miss J went to thetoilet, and then said that her head was 'awful' and atone point, 'quite out of the blue', said that she thoughtshe was going to die. The second staff nurse said thatshe did not attach any particular significance to MissJ's headache. She thought it was simply theconsequence of her high sugar levels, and it seemedto settle. She did not smell ketones on Miss J's breathuntil 3.00am. The second staff nurse wrote up thenursing notes and fluid chart after the shift ended.Staff had no break on the night shift.

33. Some of the staff interviewed commented that Miss Jhad refused some medical and nursing interventionsduring her admission. Her behaviour was describedin evidence to the investigator in terms such as'demanding', 'immature' and 'difficult'.

Findings34. Mr J has complained that his sister's death could

have been avoided and that mismanagement by the

Trust and its staff contributed to the sad outcome.Specifically, he complains that Miss J wasmisdiagnosed; that she received inadequateeducation about management of her diabetes andmonitoring in the diabetes clinic; and that her finalillness was mismanaged in hospital including by over-administration of fluids causing cerebral oedema. Myfindings address each of these concerns.

Diabetic clinic35. I consider first the first consultant's diagnosis of

MODY. Mr J has complained that the diagnosis wasincorrect. The first consultant said that although heentered a firm diagnosis of MODY in his notes, he stillhad in mind the possibility that Miss J might haveslow onset type 1 diabetes. The external professionaladvisers in this case are clear that the diagnosis ofMODY reached by the first consultant was wrong andthat Miss J most probably had slow onset type 1diabetes. They also advise that such a diagnosis cansafely be reached only after a significant period oftime. The first consultant did not record that he hadan alternative diagnosis under consideration; and thediagnosis he did record was unequivocal. It is clearfrom the evidence, and is wholly unsatisfactory, thatMiss J believed that she had MODY and that that wasa firm diagnosis rather than a working hypothesiswhich would need to be kept under review.

36. Mr J also complained that his sister did not receivethe education and information she needed: inparticular, that she was not told about the differencebetween type 1 and type 2 diabetes, abouthyperglycaemia and about diabetic ketoacidosis. Thefirst consultant is clear, on the other hand, that hecovered all but diabetic ketoacidosis. The nursespecialist also maintains that she providedinformation and education appropriate to type 2diabetes, but was unable to demonstrate this fromher records. At the very least, Miss J understoodfrom what she was told that she had MODY; that shedid not require insulin; and how to test her bloodsugar. I am unable to determine with any degree ofcertainty, however, the full extent of the informationthe first consultant provided to Miss J and, as aconsequence, whether important information was notprovided. I note with approval that the diabetes clinicnow operates a revised educational procedure toensure that young persons receive the informationand instruction they need and that this isdocumented. I recommend regular audit of theeffectiveness of these measures.

37. Following my investigation I am satisfied that, giventhe diagnosis, the actions of the nurse specialist fellwithin the accepted standards for a nurse of herexperience and I do not consider that she was in aposition to challenge the first consultant's diagnosis.However, it is a matter of concern that inadequaciesin her records mean that neither I nor she can becertain what information she gave to Miss J. I note

14 Investigations

ambiguous and could be read as 'all things to all men'.I agree. At interview the panel chairman said thatcompiling the report had been like 'walking atightrope' between the need to be fair to the GPwhilst recognising the complainant's anger and thefamily's grief. I recognise the need to be fair to allparties to a complaint; but this should not prevent apanel from expressing an opinion on its findings offact. The chairman said that he believed the panel'sreport was as damning as it could be in thecircumstances. Mr J on the other hand was left withthe understandable feeling that the panel had failedto decide one way or the other whether the GP hadgiven his sister a reasonable standard of care. Theambiguities apparent within the panel and assessors'reports also emerged in the evidence the panelmembers and assessors gave to this investigation.

24. There will be occasions when an independent reviewreveals a conflict of evidence which a panel cannotresolve, even on the balance of probability, withoutbeing unfair to one of the parties. If this happens apanel should explain why it is unable to reach aconclusion. I do not believe that was the case here.Neither do I believe that the differences of viewexpressed by the clinical assessors were so great asto prevent the panel forming a view on the GP'sactions. I conclude that the panel failed to reach aconclusion on the standard of care the GP gave to hispatient and failed to explain why. Mr J was left withthe belief that this stage of the complaints procedurehad failed him. The GP was given no clear statement(save in the area of record keeping) as to whether hehad acted reasonably and, if not, of how he mightimprove his practice. I uphold this complaint.

25. I have considered whether the deficiencies in thepanel's report are sufficient to consider it a nullityand, if so, the recommendation I should make. TheDirections require a panel to provide an opinion, withreasons, on its findings of fact. In this case the panelfailed to do so for at least one - important - part of itsTerms of Reference. To that extent it did not, in myview, complete its work. However, I have decided notto invite the Health Authority to ask this panel or afresh one to reconsider Mr J's complaint. TheCommissioner is conducting an investigation of theGP's actions and this should satisfy the complainant'sdesire for an independent investigation of hisconcerns.

26. I note that lessons have been learned from this caseabout the conduct of panels and the process forobtaining and handling independent clinical advice.The Commissioner accepts the comment by theHealth Authority chief executive that there is limitedscope for a health authority to influence the conductof independent reviews. The complaint which I haveupheld is against the Health Authority as theindependent review panel was formally a committeeof that Authority. However, the Commissioner isrequired by statute to copy his reports to the

Secretary of State for Wales and I look to the WelshOffice to take steps to ensure that lessons from thisreport are learned for future independent reviewpanels, whether in this health authority or others inthe Principality.

27. I am concerned about some other aspects of thepanel's construction and handling of its report. Theguidance and Directions governing the operation ofthe complaints procedure do not, it is true, require apanel chairman to circulate a report in draft to theparties to a complaint. They do, however, state thatthe assessors' reports should be made available intime for circulation with the draft report. If, as in thiscase, the draft report purports to containconclusions, it is only reasonable to wait for theassessors' report(s) before arriving at thoseconclusions. That was not done on this occasion.

Conclusions28. This report considers one aspect of a compendium of

complaints from Mr J about the care his sister wasgiven and how his complaints were handled. I haveset out my findings in paragraphs 22 to 27 on hiscomplaints about the report of the review panelestablished by the North Wales Health Authority. TheAuthority has asked me to convey - as I do throughmy report - its apology to Mr J for the shortcomingsI have identified.

March 1999

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26 Investigations

care: he did not feel he needed to because it was wellknown that he would do so in such cases and wouldmake quite clear what the patient's futuremanagement plan should be. The Trust's practice wasthat patients were managed by the consultantspecialist relevant to their condition under a 'sharedcare' arrangement.

28. The SHO and the second consultant had an eveningward round. They discussed Miss J's care, but thesecond consultant did not formally assess and reviewher, as responsibility for her care had been acceptedby the first consultant. The registrar had updated theSHO and she in turn updated the second consultant.The SHO telephoned the second consultant at 8.46pmto tell him that Miss J had not been well. The SHOwas concerned that the diabetic ketoacidosis had notresolved as anticipated and sought advice on howthis might be improved. She also mentioned that MissJ had had an episode of headache and agitation, butthat this was responding to simple analgesia. She feltthat Miss J possibly had a low pain threshold. Thesecond consultant advised the SHO to telephone thefirst consultant at home for advice. The secondconsultant telephoned the SHO at 11.30pm to checkthat all was well. The SHO said that Miss J wasgetting better and that she (the SHO) had talked tothe first consultant. The alteration in treatment hadimproved Miss J's diabetic ketoacidotic state and atthat time her headache was not presenting aproblem. The onset of her headache struck thesecond consultant as unusual; but as it seemed torespond to simple analgesia it did not give rise toconcern at that time. He did not know about theassociation of cerebral oedema with diabeticketoacidosis. At 3.57am the SHO telephoned thesecond consultant and said that Miss J haddeteriorated suddenly, was unconscious and neededto be ventilated. The second consultant instructed theSHO to ventilate the patient and telephone theconsultant anaesthetist. The second consultant thenwent straight in and after assessing Miss Jtelephoned the first consultant at 5.15am.

29. The first consultant told the investigator that he sawMiss J on 22 July at 1.30pm in ITU. She wasconfused, although her mental state had improvedsince admission. She was not able to give him ahistory. She was very breathless, lying flat anddrowsy. He noticed that her sodium was very low,but it rose quickly. Miss J was under the care of thesecond consultant, but the first consultant advisedhim. The first consultant saw Miss J three timesduring the day: she improved dramatically, and by5.45pm was a lot better. He thought that her care hadbeen managed appropriately. Clinical managementfell within accepted protocols (guidelines for thetreatment of particular conditions) for the treatmentof diabetic ketoacidosis and was well understood bythe staff concerned. The first registrar had followedthe protocol, with minor variations. Miss J hadpersistent acidosis and it was consistently improving.

The first consultant would have preferred to havebeen told about her headache at 8.00pm, but was nottelephoned between 5.50pm and 9.45pm. If he hadbeen contacted he might have considered pituitaryapoplexy. He would have ordered a CT scan, butwould not have considered cerebral oedema. In 15years as a consultant he had had only three deaths,including Miss J's; and he had never seen cerebraloedema in an adult patient with diabetic ketoacidosis.The protocol has since been amended to add the riskof cerebral oedema and to emphasise the use of 10% dextrose.

Nursing staff30. The first staff nurse explained that on 22 July she

was in charge of the ITU day shift and took charge ofMiss J's care. She had no experience of cerebraloedema associated with diabetic ketoacidosis.Protocols were kept on the ward including diabeticketoacidosis guidelines. They were often referred to,and senior staff were aware of them. The first staffnurse would have had the protocol open by thepatient's bedside for reference purposes. Miss J hadbeen quite a difficult patient to manage, as she keptrefusing nursing interventions and did not seem toappreciate the seriousness of her condition. Miss Jreported a headache at about 8.00pm. She held herhead and said, "I'm having a brain haemorrhage".The first staff nurse was unsure of the significance ofMiss J's headache and unsure whether she wasbeing 'over dramatic'. However, she contacted theSHO at once. Miss J's conscious level was constantand the first staff nurse did not suspect herneurological functioning. She told the second staffnurse on the night shift that Miss J's mother hadasked for her daughter to be nursed by a femalemember of staff because she was a very privateperson and had not been an inpatient before. (Note:Miss J's mother disputes this account.) The first staffnurse could not recall writing a care plan. (Note:There is no care plan in the notes.) She commentedthat it had been a very busy shift and she had not hada break. There were three patients in ITU, and fourstaff, including one nursing auxiliary.

31. The charge nurse said that the skill mix that night hadbeen inadequate. He was a G grade nurse and wasworking with two D grades. One was a junior who hadworked in ITU for only a few months and had no ITUqualifications; the other an agency nurse who hadworked in ITU before. The agency nurse had noformal ITU qualifications, but the charge nurse had areasonable knowledge of her skills. He was the onlyqualified nurse on duty and was working with a locumSHO. The charge nurse said in evidence that he haddrawn his concerns about the skill mix on that shift tothe nurse manager in advance. The charge nurse alsocommented in his evidence on the absence of seniorconsultant management in ITU and that there was noclear policy on senior clinical patient ownership. Hewas told at handover that Miss J did not like to becared for by male nurses. He observed that that was

Investigations 15

DATE OF PANEL - 6 JANUARY 1998

CONTENTS

Page

TERMS OF REFERENCE 1

Original complaint 2 - 3

Response from GP 4 - 5

Copy of Temporary Resident Clinical Record 6

Correspondence and request for IRP 7 - 10

Statement from Miss J's fiancé 11- 12

NHS Independent Review Panel

Independent Review - Mr J Regarding the Late Miss J

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Investigations 25

referrals. Responsibility was split after 5.30pm withthe medical registrar. The medical staff on duty at thetime of Miss J's admission were: consultant on call(the second consultant); the SHO, a house officer;and a staff grade doctor, acting as registrar on dutyfrom 9.00am - 5.00pm (the first registrar), who wasreplaced from 5.30pm by a locum medical registrar(the second registrar). The SHO had a first dayinduction to duty. A ward sister took her round theward and explained the routine. The first registrarexplained the SHO's responsibilities. The SHO couldnot recall having been shown treatment protocols.There was no central figure co-ordinating herinduction to duty; and no written package ofinformation was given to her. (Note: Despite thesereservations my advisers have complimented theSHO on the exemplary care she gave at this time.)

23. When Miss J was admitted, the SHO saw her andrealised that she was very unwell. She had dealt withdiabetic ketoacidosis before and was familiar withthe standard treatment; and so she commencedinvestigations and treatment and contacted seniorstaff. Miss J was more unwell than any patient withdiabetic ketoacidosis the SHO had seen before.(Note: personal notes written by the SHO on 4 August1997 recorded that Miss J was 'intermittentlyhysterical, screaming "I want a drink"'. She alsorecorded that Miss J's GP had told the parents thatshe was not dehydrated, to which the SHO hadreplied, 'well, she is now'.) The first registrar arrivedand carried out her own assessment of the patient;she confirmed the SHO's diagnosis and management.The hospital's own diabetic ketoacidosis treatmentprotocol was not drawn to the SHO's attention until11.00pm, when the charge nurse in intensive care didso. The first registrar confirmed her diagnosis,decided to admit Miss J to intensive care overnight,and took over her care until 5.00pm that evening.

24. At 8.00pm the SHO was bleeped by the nurse incharge and was asked to review Miss J urgentlybecause she was very agitated and complaining ofheadache. She went to see her. Miss J was verypanicky and crying, "I'm having a brain haemorrhage,please do something, please help me". The SHO hadobserved previously that she was a nervous patientand that staff had found it difficult to reassure her.There was no fluctuation in her level ofconsciousness. The SHO thought Miss J's headachewas due to dehydration and gave her Calpol (liquidparacetamol) as she did not like swallowing tablets.That seemed to settle her down. The SHO checkedMiss J again at 9.00pm and found that the Calpolseemed to have worked.

25. The SHO said that she was 'vaguely aware' ofcerebral oedema from her paediatric training threeyears before; but it was not mentioned to her by anyof the senior doctors or nurses. She contacted thefirst consultant at 9.30pm who gave her amanagement plan. She understood that the second

consultant, in liaison with the first consultant, was incharge of Miss J's care. The SHO stayed in ITU until1.30am. She was not informed of any resumption ofheadache until 3.30am when she was bleeped andtold that Miss J had collapsed.

26. The first registrar said that when she saw Miss J inthe minor injuries unit she was conscious and talking.A drip had been inserted; and her heart rate andblood pressure were stable. Bloods samples hadbeen sent to the laboratory. She took another sampleto test Miss J's electrolytes. She saw and endorsedthe SHO's care plan and arranged for Miss J'sadmission to ITU. She did not refer to the writtenprotocol but to her own knowledge. She attempted toinsert a CVP line by the subclavian route; but couldnot get a vein. Miss J was 'very fed up', her vital signswere satisfactory, and urine output was good. Thefirst registrar did not think Miss J would acceptanother attempt being made at that time. If she hadthought the procedure essential she would havecalled an anaesthetist. The consultants arrived justbefore the abortive attempt at insertion. Theyreviewed the care plan, made no changes to it, andinstructed the first registrar to carry on. She spoke tothe SHO before she went off duty, but not to thesecond consultant. She viewed the first consultant asthe consultant in charge of Miss J's care at this time.The first registrar was worried about Miss J'scondition because her pH had stayed at 7.1; andbecause she had passed as much fluid as she hadbeen given and attempts were being made torehydrate her. The first registrar was aware of therisk of cerebral oedema as she had workedpreviously for a consultant who had an adult patientwho had developed diabetic ketoacidosis; but it wasnot discussed in this case and there was no reason tosuspect it might be a factor. The use of Mannitol wasnot considered.

27. The second consultant said that he was a consultantphysician with a special interest in respiratorymedicine. He confirmed that the on call consultantarrangements entailed 24 hour shifts. In Miss J'scase, he was the on call consultant that day and soshe was admitted to his care; but as she had diabeticketoacidosis and was the first consultant's patient hedecided to refer her to him. The first consultant hadasked to be informed immediately when diabeticpatients were admitted and took a keen interest inthem. The second consultant was notified of Miss J'sadmission by the first registrar who told him thatthey had a diabetic patient with diabetic ketoacidosis,that she was getting better, but that they intended totransfer her to ITU for monitoring and management.He was told that he was not needed immediately andhe said he would see her after a staff meeting. He soinformed the first consultant and they both went toITU. He asked the first consultant to take over MissJ's management and he agreed to do so. The secondconsultant did not notify staff formally that the firstconsultant had assumed responsibility for Miss J's

16 Investigations

Terms of ReferenceTo investigate the facts and reach conclusions on thefollowing:

1 Whether Dr B, knowing that the late Miss Jwas a diabetic, observed proper professionalstandards in dealing with her on the 19 July1997.

2 Whether he kept an accurate record of theconsultation on the 19 July 1997.

NHS Independent Review Panel - MrJ Re the Late Miss J

Terms of Reference1. The Panel was convened on 18 December 1997,

following formal complaint by letter from Mr J,brother of the late Miss J, dated 13 November 1997.The Panel was convened, after consultation with thelay Chairman.

2. The Terms of Reference had been agreed with Mr Jand were:

To investigate the facts and reach conclusions on thefollowing:

1. Whether Dr B, knowing that the late Miss Jwas a diabetic, observed proper professionalstandards in dealing with her on 19 July 1997

2. Whether he kept an accurate record of theconsultation on 19 July 1997

Membership3. Panel members were:

ChairmanConvenerIndependent Review Panel Member

Clinical Assessors were:GP 1GP2

Evidence4. Written evidence, consisting of correspondence and

Dr B's clinical notes, totalling 12 pages, was madeavailable to all members, assessors and partiesbefore the hearing, which took place at H M StanleyHospital, St Asaph, Denbighshire at 9.30am onTuesday, 6 January 1998.

Evidence in person was heard fromMr JFiancé of the late Sarah JaneDr B - General PractitionerDr G - as friend to Dr B representing the GMC

5. Prior to the hearing, Mr J had made available to Panel

Members a comprehensive bundle setting out thehistory of the case, totalling 39 pages, withappendices of diabetic treatment and protocol,together with extracts from medical journalsexplaining current medical opinion on the subject.Much of this material was not germane to thePanel's Terms of Reference, but it provided usefulbackground information and enabled the Panel toconsider the Terms of Reference within a wholepicture.

6. The evidence given by Mr J was supported by a 20page written statement made available to the Panelat the hearing.

Agreed Facts7. Miss J died tragically in her 21st year on 31 July

1997 when life support was terminated followingcollapse on 23 July 1997. Cause of death wascertified as "acute cerebral oedema" and "diabeticketoacidosis".

8. On 12 July 1996 Miss J had been diagnosed asMODY i.e. Mature Onset Diabetes of the Young. Atthis time Miss J was aged 19 years and fourmonths. Such condition would not requireadministration of insulin and would thus bedescribed as NIDDM, or type two diabetic, asopposed to IDDM or type one diabetic.

9. The Panel received evidence, confirmed by bothClinical Assessors and by Dr B, that MODY is anextremely rare condition. Both Clinical Assessorshave been in practice for many years but neitherhad come across a case. Dr B gave evidence that hehad heard of it at Medical School and had one obesepatient with the condition.

10. The Panel accepted as fact that it is unlikely that ayoung person with diabetes would be NIDDM.

11. The Panel therefore concluded that, in fact, Miss Jwas probably not NIDDM but that, even if she hadbeen, her condition would require utmost care andcontrol. This opinion is based on evidentialprobability and on the tragic outcome of Miss J'scase. The circumstances of the diagnosis as MODYare beyond the Panel's Terms of Reference.

Holiday Centre12. Miss J arrived at the Holiday Centre, accompanied by

her Fiancé, on Friday, 18 July 1997. Records indicatethat she had been feeling unwell before her journey.Her fiancé gave evidence that, during the evening andnight of 18 July, Miss J was "actually sick a numberof times".

13. She continued to feel unwell and attended theSurgery at the Holiday Park at 4.00pm on Saturday,

569486_60pp / sig15 / plateA

24 Investigations

23 July 1997At 3.30am the SHO was called urgently to ITU,where she was told that Miss J's condition hadsuddenly deteriorated. The SHO noted a reducedconsciousness level, reduced respiratory rate, andhypotension (low blood pressure) with tachycardia(rapid heart rate). Staff reported that Miss J hadbeen complaining of increased headache sinceapproximately 2.00am.

A CT scan of Miss J's brain was performedapproximately four and a half hours after she hadbecome comatose, requiring ventilation. Theconsultant radiologist's report says, 'Generally thebrain appears "tight" and I suspect a degree ofcerebral oedema. There is no convincing evidence ofa subarachnoid haemorrhage. No mass lesion isdemonstrated'.

During the afternoon of 23.7.97 a consultantneurologist reviewed matters and wrote, '…. the CTdoes not show any focal lesion, haemorrhage etc.There may be some mild symmetrical swelling of thecerebral hemispheres, but in someone of her agethe scan may well be normal. In particular I notethat the lateral ventricles are easily visible. She hasbeen exceedingly unwell from the metabolic/electrolyte/acid-base viewpoints, with shifts insolutes and fluids. I think this may have played arole, and certainly myelinolysis may sometimes bemore extensive than just the pons ….'.

Thereafter Miss J never regained consciousness,requiring ventilation until her death on 31.7.97.

All possible reasons for her comatose state weresought; but no specific cause was found. Empiricaltreatment for any reversible condition was given.Cerebral oedema was considered to be the mostlikely explanation for her sudden deterioration.

Mr J's evidence19. Mr J contends that staff failed to manage his sister's

acidosis adequately; over-infused fluids to asignificant extent, failed to keep an accurate fluidchart; did not insert a central venous pressure line(CVP); did not observe his sister's neurologicalfunctioning following her headache at 8.00pm on 22July; and, most significantly in his view, wereunaware of the risk of cerebral oedema in relation todiabetic ketoacidosis and did not initiate treatmentwith mannitol which might have averted the onset ofcerebral oedema. He was certain that his sister'sheadache at 8.00pm, in which she clutched the backof her head, (occipital region) indicated the onset ofcerebral oedema. He pointed out that the firstconsultant's written statement described the samesymptoms at 3.00am on 23 July and that the earlieroccurrence must, therefore, have been the start. Iftreatment had commenced at that time Mr J believesthat his sister's death could have been prevented.

Evidence from Miss J's parents.20. Miss J was admitted to the hospital's A&E

department on 22 July 1997 - her speech wasslurred. A doctor [the SHO] put up a drip and a nurseasked how far she wanted it opened. The doctorreplied, 'fully because she needs this quickly'. Thedoctor [SHO] told Miss J's parents that she was verypoorly; but that they were 'getting her stabilised'.Miss J's mother told the doctor [SHO] that the GP hadasked her to test her daughter's blood just before theambulance had arrived to take her to hospital, butthat Miss J had not wanted her to. At the hospital adoctor told them that Miss J was to be transferred tointensive care overnight to stabilise her condition.Miss J was anxious about this; but a nurse reassuredher and said that she was simply going to intensivecare overnight as a precaution and would go to anordinary ward in the morning. Staff wanted to inserta catheter; but Miss J refused to let them. She didnot seem to be herself. At about 7.45pm Miss J beganto scream 'unmercifully'. She held the back of herhead and kicked off her bedding. A staff nurse (thefirst staff nurse) ran up and asked Miss J what wasthe matter. Miss J's mother apologised on her behalf,and explained that her daughter was not normallylike that. The family were ushered out but could stillhear Miss J screaming. Then it suddenly went quiet.They went back in and believed Miss J to have beensedated. She appeared to be asleep, but her face wassweaty and her breathing shallow. Another nurse(the second staff nurse) joined them. The first staffnurse told the family to go home, and that they would'find a different person in the morning'.

21. At 2.55am on 23 July, Miss J's mother awokesuddenly with a premonition that something waswrong. She telephoned the hospital and was told thatsomething had gone badly wrong, and that theywould call her back when the doctor had seen Miss J.About 5.30am Miss J's mother spoke to a doctor (thesecond consultant) who told her that Miss J hadcollapsed and had been put on a ventilator. Theylater met the first consultant at the hospital, who saidthat he did not think Miss J's collapse was related toher diabetes. He told them the situation was verygrave. He also asked why they had not got her tohospital earlier. A nurse also talked to them and toldthem about diabetic ketoacidosis. They had neverheard anything about it before. If they had known itwas a risk, they would have been on their guard.(Note: the family was told later that Miss J's brainhad swelled a little.)

Evidence of Trust staffMedical staff22. The senior house officer (SHO) who first saw Miss J

on admission, said when interviewed that she hadbeen employed at the Trust as a locum, and that 22July had been her second day at the Trust. She hadbeen responsible for one ward, which was for acuteadmissions through the minor injuries unit and for GP

Investigations 17

19 July, accompanied by her fiancé. There wereother people attending the Surgery - evidenceindicates their number as two.

Surgery14. The Surgery is held at the Holiday Park.

Hours are displayed prominently at the Surgery andare:

Monday - Friday 12.30pm -1.00pm

Saturday & Sunday 4.00pm -4.30pm

Nurse on duty

Monday - Friday 10.00am -4.00pm

Emergencies - contact security

15. Whilst hours appear to be minimal Dr B stated inevidence that they were adequate since most peoplewho come on holiday were in good health. Those thatwere not tended to stay at home. Saturdays wereparticularly quiet since Saturday appears to bechangeover day.

Dr B16. Dr B is a General Practitioner having qualified at a

London teaching hospital. He has been in generalmedical practice for some 12 years and is SeniorPartner of three in his current practice. The Practicehas approximately 5,000 patients and the work at theHoliday Park, where there are 1000 caravans(approx.) is undertaken during the holiday season.

Consultation on 19 July 199717. Miss J was seen by Dr B at between 16.15 and 16.30

hours on Saturday, 19 July 1997. On arrival at theSurgery she had been asked to complete a visitorform. The form appears to have been completed byMiss J and there is no evidence that she was actuallysick during her visit to the Surgery.

18. Evidence was received from Miss J's fiancé that heattended the consultation with Miss J. Dr B was notcertain about this, could not recollect it, and did not"see it as an issue". The Panel therefore acceptedthat the fiancé was present at the consultation.

Examination19. The Panel found that Miss J indicated to Dr B that she

was MODY. This is evidence from Dr B's notes of theconsultation and he recalled the fact since it was sounusual.

20. Miss J also informed Dr B that she had been vomiting

for the last two days, but Dr B indicated that she wasnot sick during the surgery visit.

21. Dr B gave evidence that Miss J appeared to be ahealthy young woman, and discussed Miss J's testingfor blood sugar with her. She indicated to him thatshe had not done a test. Dr B did not test specificallyfor diabetic control.

22. The Panel found that Dr B did not considerhyperglycaemia nor diabetic ketoacidosis. Heexamined Miss J for appendicitis and gastritis andformed the opinion that she was probably sufferingfrom gastritis.

23. Accordingly he prescribed Maxolon, an anti-nauseamedicine, and as is standard practice asked Miss J toreturn the next day if she were no better.

24. The Panel found that Dr B had no access to Miss J'sMedical Records and did not make enquiry into thedetail of her medical history. He did state that therewas no smell of ketones on her breath, detectableduring the course of his examination, but he did notspecifically make this test and did not record anythingin the medical notes.

25. It appears that the examination carried out by Dr Bwas based on his observation that she appeared tobe a healthy young woman. He did not consider itnecessary to arrange admittance of Miss J tohospital.

26. Miss J left the Holiday Park early on Sunday, 20 July1997, having continued to be unwell. She was seenby her GP at 10.45am on that day.

Conclusion27. Dr B knew that Miss J was diabetic and had been

diagnosed as MODY. He also knew that this wasextremely unusual and that he only had one case,where the patient was obese, which Miss J was not.

28. Dr B made no tests specifically geared to Miss J'sdiabetes but proceeded on the basis of suspectedgastritis.

29. Dr B did not make an examination in depth on 19 July1997.

Records30. A copy of notes of Miss J's consultation with Dr B was

made available to the Panel.

31. The NHS temporary services record appears to havebeen completed in a mature and firm hand by Miss Jbut there was a discrepancy in the spelling of herChristian name.

569486_60pp / sig15 / plateB

Investigations 23

vomiting for two days. She told the GP that she was adiet controlled MODY patient, and that she had nottested her blood glucose level. The GP did not test itor her urine: he diagnosed gastritis, and prescribedan anti-nausea medication.

On 20 July, Miss J returned home, still feeling unwell,and was visited by a locum GP who noted abdominaltenderness and vomiting 'since last Friday'; that shewas a diet controlled diabetic; and that she was notdehydrated. The locum GP also diagnosed gastritis.He did not test her blood sugar or her urine. On 21July, Miss J was seen at home by her own GP, whorecorded that she had been vomiting for 3 days, wasbeing made sick by the anti-nausea medication shehad been given, was passing urine normally and wasnot dehydrated and that her random blood sugarlevel was around 7. (Note: The GP has said that MissJ's mother told him this, though Miss J's motherdenies that she did.) Miss J's GP also diagnosedgastritis and did not test her blood or urine. On themorning of 22 July, Miss J's family called her GP, whorecorded that she had been delirious all night andthat her 'parents were unable to check her bloodsugar'. The GP arranged Miss J's immediateadmission to hospital by ambulance.

Hospital admissionSummary of clinical and nursing notes18. Miss J's notes contain detailed entries specifying

tests carried out and the results. My advisers haveconcluded that the records show that she wasdiagnosed as having diabetic ketoacidosis; that hersodium level was unusually low on admission tohospital, (hyponatraemia); that the acidosis had notbeen brought under control; and that her fluidbalance was negative, rather than positive. Myinternal professional adviser has concluded that,judged from the composite evidence of fluid intake,urinary output, likely initial volume deficit, insensibleloss from skin and lungs, plasma creatinine and ureaconcentrations, the absence of leg or back oedema(swelling) and the first CVP measurement (on 23July), the initial fluid deficit was corrected and therewas no evidence of material fluid overload by thetime the intravenous fluid intake was reduced on 24July. All the evidence taken together, acceptinginaccuracies in charting, indicates that by the end of24 July her total fluid volume was effectively inbalance. The notes record three episodes ofheadache at 8.00pm on 22 July and at 2.00am and3.00am on 23 July. The post mortem report listedthe cause of Miss J's death as 1) cerebral oedema,and 2) diabetic ketoacidosis. In view of the volume oftechnical information, I have included only key pointsfrom the notes, but they have been considered intheir entirety by my external clinical advisers inconjunction with comments made by Mr J. The notesinclude the following information:

22 July 1997

At 1.30pm hrs the first consultant wrote thefollowing advice noting high potassium and acidosis:'…. Check potassium again, if high again and pHstill 7.1 or less suggest small bolus [bicarbonate]50mls over Þ hr, this will reduce potassium' ….Following later discussion with the first consultant,the registrar did not administer bicarbonate.

At 3.45pm the first consultant returned. Hisassessment was that Miss J was better, noting thather potassium and glucose had improved but that shewas still acidotic. He wrote, '…. Still vomiting butbetter …. pH still 7.1 may need small amount of[bicarbonate] 50mls of 8.4% [sodium bicarbonate]over Þhr will probably need to give a small amount of[potassium chloride] at same time to ensurepotassium doesn't drop significantly'

At 6.00pm the first consultant reviewed Miss J againand concluded that she was 'better still', neverthelesshe suggested switching the intravenous infusion to10% dextrose and giving a bolus of bicarbonate tocorrect the acidosis.

At approximately 8.00pm Miss J suffered a headacheand became increasingly agitated. Physicalexamination revealed no objective neurological signs:the SHO noted that her metabolic status was notimproving. Following a review of the notes, the SHOin her written statement says, '…. unsure whichadvice in notes to follow, therefore decided to askboth the [second] Registrar as senior, [the second]Consultant physician as knew case and [the firstconsultant] as knew case but not on call ….' Thesecond registrar advised giving intravenousbicarbonate 100mls of 8.4%. The second consultantadvised the SHO to contact the first consultant for hisadvice before administering the bicarbonate. Thepossibility of cerebral oedema was not suspected asa possible cause of headache and agitation.

At 8.55pm the SHO began giving a small amount of10% dextrose pending the first consultant's advice.The SHO then requested the locum anaesthetic SHOto place an arterial line: this was achieved after threeattempts.

At approximately 9.40pm the SHO spoke with the firstconsultant on the telephone. He advised her to give50mls of intravenous sodium bicarbonate andsupplementary potassium and to discontinue the10% dextrose. He also gave further instructionsregarding a revised insulin sliding scale and how andwhen to use 10% dextrose if the acidosis shouldcontinue.

By 11.30pm Miss J appeared settled: her pH was7.14.

At midnight, following the bicarbonate, the pH hadrisen to 7.25.

18 Investigations

32. A note was also made of the name of Miss J's GP, andof his address.

33. The clinical notes indicate

(1) that Miss J had been vomiting for the last twodays out of seven.

(2) that she was MODY

(3) that her abdomen had been examined andappeared normal

(4) that her bowels had been reported as open

(5) that she had been prescribed Maxalon.

34. Other notes had been made but these were notconsidered relevant, since they had been made afternotification of Miss J's death by her brother.

35. The notes make no reference to any other findings,nor of any negative ones which would be relevantwhen considering problems specific to diabetes.Thus no reference is made to the absence of a smellof ketones on Miss J's breath, nor any other negativeindications.

36. The form appears to have been signed and dated byDr B.

Conclusion37. The Panel found that the notes did record certain

findings and the prescribed medicine. If they are atrue record of the consultation then they wouldindicate that whilst MODY was recognised in Miss J,no specific steps were taken by Dr B to establish theprecise nature of Miss J's diabetic condition.

38. If they do not record relevant negative findings whichwere drawn by Dr B then we conclude that theywould fall below the requirements of good practice.

39. This finding is consistent with the expert evidence ofthe Clinical Assessors, whose Reports are attachedverbatim.

CHAIRMAN21 January 1998

Independent Review Regarding TheLate Miss J : 6 January 199840. The review panel was asked to consider:-

1. Whether Dr B, knowing that Miss J wasdiabetic, observed proper professionalstandards in dealing with her on 19 July 1997.

2. Whether Dr B kept accurate records of theconsultation.

41. It was very obvious that Mr J, the complainant, wasstill grieving and had not come to terms with thedeath of a dearly-loved sister. He had done a greatdeal of research into diabetes and the factors leadingto her death. Both the quantity and quality of hisresearch were recognised, but some of hisconclusions were open to different interpretations.

The Consultation42. Dr B's recollection of the consultation between

himself and Miss J differed from the account given byMiss J's fiancé, who said that he was present duringthe consultation. Dr B said that Miss J had waitedabout 20 minutes in the waiting room without obviousdiscomfort. She had filled in the Temporary Residentform clearly and legibly, a factor which he consideredto be an indication that she was not too distressedphysically. He said she told him she was a diabetic -MODY (which is controlled by diet alone) - and thatshe had been vomiting off and on for 2 days. He saidthat he examined her abdomen. He did not notice anysmell of ketones on her breath. He asked herquestions about her condition. He elicited the factthat she had not tested her blood sugar recently andthat she never tested her urine. He was satisfiedthat Miss J was only slightly unwell.

43. He felt that given his findings he treated herappropriately and he told her to make contact thenext day if she became worse.

44. Her condition worsened during the night of 19 - 20July and she felt that return home was her bestoption. It seemed that while Miss J was not very illwhen she saw Dr B, her condition deteriorated aftershe left the camp.

45. It is good practice to check blood sugars and/orurine of diabetics who are ill. A simple urine test canbe a guide to the seriousness of the condition and towhether other tests should be carried out.

The Record46. The Panel felt that Dr B's record of the consultation

was accurate but not very helpful. There was verylittle history, nor were all the symptoms orexamination findings recorded.

569486_60pp / sig16 / plateA

22 Investigations

diabetic history over three generations; that heronset was at under 25 years of age; and that she wassymptomatic, but had not lost weight. The firstconsultant acknowledged that he had written to MissJ's GP with a diagnosis of MODY, but stressed that hehad referred her to the young persons clinic (usuallyattended by people with type 1 diabetes) where shecould be monitored more closely. He saw Miss J fourtimes over the next 9 months. He also explained toher what type of problems she might experience as aresult of her diabetes. The consultant was sure thatMiss J understood the difference between type 1 andtype 2 diabetes and he explained to her the risk ofhyperglycaemia. Her HbA1c was under 7.5 at everyvisit; at the last visit it was 7.3. The first consultanthad referred Miss J to the nurse specialist. Theguidelines recommended by the British DiabeticAssociation had been followed - that non-insulinpatients should not routinely be taught ketonetesting. Miss J was told to contact the clinic if herblood sugar exceeded a reading of 9. The firstconsultant recognised that there was an increasedrisk of decompensation with diabetes andautoimmune thyroid disease.

13. The nurse specialist said, when interviewed, that shewas employed as a specialist nurse and had held thispost for just under two years when she saw Miss J.She was responsible for the young persons clinic.She usually sat in on consultations with patients.However, as Miss J was seen first at the adult clinicshe had not been privy to the conversation with thefirst consultant. Miss J saw the first consultant andthen came to see her. The nurse specialist said thather understanding at the time was that MODY wouldbe managed in the same way as for a type 2 diabetic- ie taught to be aware of normal blood sugar levels,about monitoring and the need to be aware ofchanges. She would not have told Miss J aboutdiabetic ketoacidosis as she would not be usinginsulin in the short term. She told the investigatorthat when teaching a patient such as Miss J to testtheir blood she would tell them what the normalrange was; that she would expect their fasting andpre-meal blood sugars to be between 4 and 7; andthat random blood sugar should not exceed 9. Shewould have told Miss J to test 2-3 times a week(Note: this figure varies in the evidence between 2-3,3-4, 4-5). If patients recorded a high reading, 11 forexample, they would be advised to test again the nextday if they felt well, or later that day if they feltunwell. They would always be told to consider howthey were feeling. She would explain that the reasonfor testing was to avoid hyperglycaemia. She wouldnot be concerned about one high reading in isolation,but would have been looking for a general change inthe pattern of results when reviewing Miss J's self-tested blood results. (Note: it is not possible from thedocumentary evidence to determine precisely whatwas or was not said to Miss J in this regard.)

14. The nurse specialist would normally give out two

forms of literature: a Balance (diabetes information)magazine and a type 1 or type 2 diabetes leaflet asappropriate; and she thought she had given them toMiss J. The diabetes record card was a 'stand alone'document containing personal details and a record ofeach visit. Record cards were filled out by the nursespecialist and kept in the clinic office. There was nocare plan system at that time. Doctors made entriesin the case notes and patients kept diaries to recordtheir blood testing results. The nurse specialistaccepted that her standard of documentation had notthen been good enough; she had since madeimprovements. She accepted that if she had at leastwritten 'sick day rules explained' instead of simply'info. given' or 'all well' she might not now be facing acomplaint as she would have been able to draw ondocumentary evidence as confirmation of the advicewhich she believed she gave to Miss J.

15. The clinic also now operates a revised educationalprocedure. There is a mini check list for type 1 youngpersons which they tick to indicate they have beengiven an education update. Those with type 2diabetes are taught about targets for control; theirunderstanding of HbA1c results is checked; and theireducation review is tailored to their individual needs.Young persons are also subject to an annualeducation review which is signed off by both patientand nurse. Records are now more detailed and clear.The nurse specialist agreed that she would have toldMiss J that she need test only at the beginning andend of a holiday; but she would have added theproviso that she should take her equipment with herand test more frequently if she felt unwell. Miss Jwas last seen in the clinic on 22 April 1997.

Events in the week before admission 16. On 14 July 1997, Miss J recorded a higher than

average blood sugar reading in her record book(11mmol); and on 16 July she saw her GP,complaining of muscle pain and lethargy. The GPrecorded that she had limb girdle weakness in hershoulders and thighs, and that her thyroid hormonelevel was 'borderline'. The GP passed this informationto the consultant. (Note: the GP's notes reveal nomore than that he contacted the first consultantfollowing this consultation.) The GP did not test MissJ's glucose levels or urine and there is no mention ofdiabetes in his record of the consultation. On 17 July,Miss J tried to test her blood on two occasions, butwas unable to read the result. Her niece, who waspresent, also tried, at Miss J's request. The niecethought that the reading was between 7 and 9, butcould not be certain. Miss J made no entry in herbook. On 18 July, Miss J travelled with her fiancé, hiscousin and his cousin's wife, to a holiday campintending to celebrate the cousin's 21st birthday.

17. During the journey Miss J began to feel unwell. Thefollowing day she saw a GP at the holiday campcomplaining of stomach pain and that she had been

Investigations 19

47. Keeping accurate records is of prime importance ingood practice. The recording of negative findings,probably diagnosis and future management should,where possible, be included.

Report of the Independent Assessor- GP1

The report should be read in conjunction with theTerms of Reference.

48. I carefully read what Mr. J submitted in his letter andalso took into account his verbal deposition.

49. I also had the opportunity to read through the lettersubmitted by Dr B and carefully noted what he had tosay during the interview.

50. My conclusions are as follows:

1. There are only scanty details of the presentingcomplaints and examination in the note.

2. No record about the smelling of breath for"Ketone or Fetor".

3. Dr. B failed to take and enter family history.

4. No record of advice regarding diet in view ofthe vomiting.

5. No record regarding the enquiry of her bloodtest.

6. No record of advice to do the test regularly.

7. Dr. B carried out necessary examination andcame to a reasonable conclusion afterconsidering acceptable differential diagnosis.

8. Treatment provided was adequate.

9. The record keeping appears to fall below thelevel of good practice regarding the pointsmentioned above.

569486_60pp / sig16 / plateB

Investigations 21

1996, Miss J consulted her GP, complaining of feelingfaint about one hour after her mid-day meal. Hergrandmother had tested her urine which showedglycosuria. The GP diagnosed asymptomatic reactivehypoglycaemia. On 13 March, the GP explained thediagnosis to Miss J and arranged a referral to aconsultant endocrinologist (the first consultant). On29 March, the notes of Miss J's GP record thatdiabetic diet was discussed, and that she wasreferred to a chiropodist and advised to see anoptician in six months time. At this stage, herdiabetes was being monitored by the practice.

Diabetic clinic8. Miss J's clinical and nursing records show that on 12

July 1996, Miss J was seen by the first consultant atthe Trust's diabetes clinic. He entered a diagnosis ofMODY in her notes. He wrote to her GP and told himthat she 'is a most interesting MODY' and he alsothought her thyroid gland was enlarged; that sheshould manage well on diet; and that he would reviewher notes with the nurse specialist in two months andsee her in the young persons' diabetes clinic in 4months. She was seen separately by the nursespecialist that day, who recorded that Miss J was'diet only'; that they had had a 'general chat aboutdiabetes'; that she had taught Miss J how to test herblood; and that 'info.' had been given. Miss J thencontinued to be monitored at intervals by the nursespecialist, and the first consultant at the youngpersons diabetes clinic

Miss J's blood result diary9. Miss J's record card shows that she tested her blood

at approximately 3-5 day intervals. There are someextended periods during which she did not recordresults in her diary, and which appear according toevidence supplied by Mr J to coincide with holidayperiods. Her results ranged between 4 and 7. On 26July 1996, she recorded 9mmols which was noted bythe nurse in her records as 'odd one at 9mmols'. MissJ also recorded a reading of 11mmols on 6September 1996 and ceased testing for a period. Thereading was highlighted by a circle, but wasotherwise not remarked upon.

Mr J's evidence10. Mr J contends that the first consultant should not

have reached an initial diagnosis of MODY and thathis sister did not fit the criteria for such a diagnosis.Mr J believes that the first consultant should havebeen more cautious and considered whether Miss Jmight have been a slow onset type 1 - a much morecommon form of diabetes in the young. If the firstconsultant had reached a correct diagnosis Miss Jwould have received education relating to type 1diabetes; and would have been taught to test herurine for ketones and about the signs to watch for ofdeveloping diabetic ketoacidosis. He thought thenurse specialist should have questioned thediagnosis of MODY and taken steps to ensure that

she was sufficiently well-informed about thecondition to care for his sister appropriately. He alsocomplains that neither the first consultant, nor thenurse specialist gave his sister appropriateeducation; and that they failed to tell her what to doin the event of illness, what action to take in the eventof hyperglycaemia, and how to recognise thesymptoms of diabetic ketoacidosis. Mr J maintainsthat Miss J's blood glucose and HbA1cmeasurements during the period of monitoring at theclinic clearly indicated declining diabetic control andthat action should have been taken to alter hissister's management.

Evidence of Miss J's parents 11. Miss J's mother explained that her daughter saw the

first consultant on her own. She then saw the nursespecialist who told her that she need test her bloodonly every 4-5 days. The nurse specialist taught herhow to use a diabetic pen (for testing her bloodsugar) and gave her a diary to record the results.She also told her to have her eyes and feet checkedregularly, and that she would be referred to adietician. The first consultant had said to Miss J that'if she stuck by him and did what he said she wouldnever need insulin', which pleased her. On 22 August1996, the nurse specialist came to see Miss J athome (she lived with her parents). She asked howshe was, and she said she was fine. She again saidthat Miss J should test every 4-5 days and, when sheasked what she should do while on holiday for twoweeks, the nurse specialist told her that she shouldtest before she went and again when she returned.Conversation then turned to general matters. Herdaughter was not given any literature by the nursespecialist other than a British Diabetic Associationmembership form, and a price list. Miss J's diabetesclinic card was shown to the investigator. Miss J hadwritten 'I have MODY diet controlled diabetes'.

Evidence of Trust staff12. The first consultant is a consultant physician in

diabetes, endocrinology, and general medicine. Heran two diabetes clinics: an adult clinic and a youngpersons clinic where he saw young patients (betweenthe ages of 18 and 30) frequently. Miss J was seenfor her first appointment in the main (adult) diabetesclinic. The first consultant explained what diabeteswas. She had been quite worried, and thought shemight have type 1 diabetes. The first consultantexplained the difference between type 1 and type 2diabetes, and told her that he did not think she hadtype 1 but that he would keep 'a close eye' on her. Hethought type 1 was a possibility but, based on thehistory she had given him and his clinical findings,thought she actually had MODY. Miss J told him thather mother was diabetic and that her grandfatherhad also been diabetic and had used insulin. The firstconsultant did not know whether he was type 2insulin treated or not. The first consultant concluded,therefore, that Miss J was from a family with a

20 Investigations

Case No. E.171/98-99

The care provided to Ms J at Halton GeneralHospitalComplaint againstHalton General Hospital NHS Trust

Complaint as put by Mr J1. The account of the complaint provided by Mr J was

that in July 1996 his sister, Miss J, was diagnosedwith Maturity Onset Diabetes in Youth (MODY). Herdiabetes was controlled by diet. On 22 April 1997,Miss J attended the diabetic clinic at Halton GeneralHospital where she saw a consultant (the firstconsultant) and a diabetes nurse specialist (the nursespecialist). Her blood glucose reading was10.3mmols. Her treatment was not altered. On 14July, Miss J tested her blood glucose and recordedthat it was 11. During July Miss J felt unwell andconsulted three general practitioners on fouroccasions. On 22 July, Miss J was admitted to HaltonGeneral Hospital (the hospital) with diabeticketoacidosis (an excess of acid and ketones in bodytissues and fluids which develops in diabetics whentheir condition is getting out of control, and mayindicate approaching coma). She appeared, initially,to respond to treatment, but at 8.00pm developed asevere headache, which recurred at 3.00am shortlybefore she collapsed. She had developed cerebraloedema (swelling of the brain within the skull) andlapsed into coma on 23 July. On 29 July, brain stemdeath was diagnosed and on 31 July, Miss J'sventilator was switched off.

2. On 18 February 1998, an independent panel reviewwas held at the hospital to consider complaints madeby Mr J about his sister's care and treatment. Thepanel subsequently issued a report, which included astatement that the panel considered that Miss J hadhad 'difficulty in coming to terms with the diagnosis ofdiabetes' and suggested that she had suffered a'denial reaction'. Mr J remains dissatisfied andcomplains that staff at the hospital mismanaged hissister's care and that the panel was wrong to assertthat his sister was in denial of her illness.

3. Mr J believes that his sister's death could have beenavoided and that it was caused by a combination ofmisdiagnosis; inadequate education aboutmanagement of diabetes; poor monitoring of hercondition in the Trust's diabetes clinic; the failure ofgeneral practitioners to check Miss J's blood sugarwhen she reported symptoms including vomiting,which he contends indicated the onset of diabeticketoacidosis (and should, of themselves havetriggered testing even if diabetic ketoacidosis had notbeen suspected); and mismanagement of diabeticketoacidosis during her admission to hospital,including over-administration of fluids, which he

believes caused cerebral oedema and thereby herdeath.

4. The matters investigated were that:

(a) the care and treatment provided to Miss J byHalton General Hospital NHS Trust wasinadequate; and

(b) that the report of the independent reviewinappropriately included a statement that MissJ was in denial of her diabetes.

Investigation5. The statement of complaint for the investigation was

issued on 8 June 1999. Comments were obtainedfrom Halton General Hospital NHS Trust; andrelevant documents, including Miss J's clinical andnursing records, were examined. My investigatortook evidence from Mr J, Miss J's parents and Truststaff. Clinical advice was provided by five externalprofessional assessors; and their report is atAppendix A. I have not included in this report everydetail investigated, but I am satisfied that no matterof significance has been overlooked. This was adetailed and complex investigation; and, for reasonsof brevity, the evidence contained within this report isa summary of that considered most pertinent to thecase. In addition, my Office has previouslyinvestigated two other complaints from Mr J, relatingto his sister's diabetic care by a general practitionerand the handling of his complaint by the relevanthealth authority. The reports of these investigationshave been published (W.138/97-98), (W.125/97-98).The actions of the two other general practitionersconcerned were considered and criticised byindependent review under the provisions of the NHScomplaints procedure. I have included informationabout events which were external to Miss J'sinvolvement with the Trust to set matters in context;and to facilitate a clearer view of the events leadingto Miss J's death. I emphasise, however, that inmaking my findings, I have considered the actions ofthe Trust staff on the basis of information to whichthey had access. A glossary of terms is at AppendixB.

(a) The care and treatment providedto Miss J by Halton General HospitalNHS Trust was inadequate6. I set out the evidence below in chronological

sequence.

Background information7. The notes of Miss J's GP record that on 26 February

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