Wisbech Magistrates Court, Wisbech, Cambridgeshire
Jill Challener continued to give evidence.
Barbara Hewson asked “are you aware that there were two previous incidents of near misses with diamorphine involving TCN doctors? You will note from the evidence of Dr Reynolds that he indicated that on 22 August 2007 a doctor gave 30 mgs of diamorphine to a patient with back pain and Dr Reynolds indicated that this was a dangerous and inappropriate dose. Again, on 17 August 2007 another doctor from TCN administered 30 mgs of diamorphine and once again Dr Reynolds was of the view that this was a dangerous and inappropriate dose. Were you made aware of these near misses? "
Jill Challener responded “I was aware that there was a question made about the inappropriate administration of diamorphine and this just demonstrates the problems with diamorphine that there was an accident waiting to happen.”.
Fennella Morris representing TCN indicated that according to regulations the PCT has a responsibility to all Healthcare providers to:
• Make clear what is required in relation to the safe management of controlled drugs.
• To check that those requirements are being complied with.
• To give a clear message to the provider as to what they are not satisfied with.
Fennella Morris stated “at the material time you were the accountable officer when the regulations came into force at the beginning of 2007. You were told to ensure that a body like TCN were operating a safe management of controlled drugs. Please tell me who you told at the beginning of 2007 that TCN should be compliant in operating a safe management of controlled drugs?”
Jill Challener responded “I relied on the medical system manager together with the Chief Pharmacist to ensure that there was a safe system in place. Furthermore, a safe system was already in place from 2006 and this had been circulated to all healthcare providers”.
Fenella Morris responded “You have not answered my question. Will you please tell me who you told at the beginning of 2007 that TCN should be compliant with drugs?”
Jill answered “I did not personally tell any individual that TCN should be compliant because the system was already in place from 2007.”
Fenella Morris responded “is it not the case that you took the view that the clinicians were already doing things and as the accountable officer you did not need to tell anyone?”
Jill answered “As I have said there were systems in place that were being improved.”
Fennalla Morris continued “A time came in October 2007 when you sent out guidance to GPs and Primary Care Trusts about the safer management of controlled drugs but you did not send it to out of hours providers even though you had a statutory duty to do so.”
Jill responded “We were sending to the GPs and doctors who worked for TCN who were also on the performance list.”
David Lock representing the PCT commented that the contracts that the Primary Care Trusts had was with Suffolk Doctors on Call and not Take Care Now and my learned friend is representing Take Care Now and not Suffolk Doctors on Call.
The Coroner queried “Are you saying that communication should have been between the PCT and Suffolk Doctors on Call as opposed to Take Care Now?”
Fennella Morris responded “In 2007 the PCT communicated with Take Care Now and Suffolk Doctors on Call. Therefore in 2007 the Primary Care Trusts treated them as one and the same company. The PCT had obligations to whoever it commissioned services from. It knew that TCN were providing services because they included them in correspondence. Therefore, it is quite obstructive for my learned friend to suggest that the PCT was not writing to TCN. Furthermore, I can confirm that I am representing both organisations.
I will continue cross examining this witness. The National Patient Safety Agency issued alert notice on 25 May 2006. I understand that the PCT sent this notice to Suffolk Doctors on Call and GP’s albeit that TCN were providing services to patients, it was therefore the responsibility of Suffolk to cascade responsibilities. Did you put in place a system for Suffolk to cascade the alert to Take Care Now? "
Jill responded “There was evidence that this happened.”
Fennella Morris continued “Turning to the notice, under the heading ensuring urgent access to palliative care drugs it states ‘whilst it is important to highlight and to provide practical advice to Healthcare professionals on how to minimise the risk of overdose with high dose diamorphine and morphine ampoules, it is just as important that Healthcare professionals are not discouraged from either carrying, or having access to, controlled drugs (particularly ‘out of hours’ periods), or from seeking alternative solutions to the longstanding problem of securing proper access to medicines for palliative care patients’. Would you expect that the guidance acknowledges that it is important to have access to 100 mgs of diamorphine for palliative care patients?”
Jill responded “This has never been about restricting the access of dosage for an overdose but ensuring that there is a safe separation of drugs to avoid an accident like this happening.”
Fennella Morris pointed out that in Jill Challeners letter of 14 August 2008 she raised concerns that TCN were still carrying palliative care boxes that contained all 3 doses of diamorphine and no Naloxone (the antedote for Diamorphine). She commented that this potentially dangerous associations of dosage of opiates in the same box which was frankly astonishing and potentially negligent. Fenella said “Would you be surprised to learn that 100 mgs of diamorphine and Naloxone were being carried in a separate black bag in the box and was therefore acceptable?”
Jill responded “I would still regard it as an accident waiting to be repeated as the 3 doses were still being carried in the same box. Furthermore, Naloxone would not have reversed the effect of the administration of 100 mgs of diamorphine”.
Fennella Morris said “But surely there is a need for doctors to carry 100 mgs of diamorphine in order to secure proper access to medicines for palliative care patients?”
Jill responded “The need of 100 mgs of diamorphine could be utilised by using 10 mgs or 20 mgs and making it up to 100 mgs. Therefore, there is never a need to carry 100 mgs of diamorphine.”
David Lock began to cross examine Jill Challener and said “I would like you to look at an email sent by Tom Rainford of the PCT on 26 June 2006. I would like to distinguish:
1) What the system was for cascading alerts.
2) What the PCT established.
3) What the PCT was told but you cannot establish.
What is your understanding of the content of the email?
Jill responded “This email has been printed from the archive email trail from the individual who sent out the cascading information. It was the National Patients Safety Agency Alert 2006. The trail shows individual recognition that had gone out to Trust leads”.
David Lock said “Turning to another email dated 18 January, what does this show?”
Jill responded “It is a response from me providing evidence that I cascaded responsibility to Suffolk Doctors who in turn cascaded responsibly to Trust leads."
David Lock said “You were the accountable officer for the PCT in 2007 and the beginning of 2008. We see the emergency of TCN providing out of hours services but yet the commissioning contract was with Suffolk Doctors. Was it clear to you or did anyone approach you from Suffolk Doctors to explain the nature of TCN?”
Jill responded “No”.
Second witness
Dr Christine Macleod, Medical Director and Consultant in Public Health for NHS Cambridgeshire.
She gave evidence to this effect “At the time I became involved with the serious untoward incident relating to Dr Ubani the PCT was coming to the end of phase 1 of the investigations. The aim was to identify the root causes of the incident and to do a healthcare governance review of safety systems. Phase 1 lasted from February 2008 until august 2008.
Phase 2 began in early September 2008 and this involved the quality improvement phase which aimed to remedy and improve the issues identified during phase 1. At this point an improvement plan was being put in place to hold TCN to account and where appropriate work collaboratively with them to ensure a level of systems improvement by December 2008.
Phase 3 began in January 2009 to test the effectiveness of the systems put in place in phase 2. We would do regular unannounced spot checks to identify quality gaps and to test the new TCN systems and their service delivery and these continued until NHS Cambridgeshire terminated the out of hours contract with TCN on 1 December 2009.
On 10 June 2009 the Care quality Commission announced an inquiry into Take Care Now’s provision of out of hours services. This inquiry was triggered by the death of Mr Gray although its focus was wider than this.
The Quality Care Commission (QCC) visited Cambridgeshire Primary Care Trust as well as the 4 other PCT’s using services from TCN. On 2 October 2009 the QCC published an interim report in its inquiry into issues relating to TCN’s provision of out of hours services. This report noted that “Removing 100 milligram ampoules of Diamorphine has significantly reduced the chance of the original mistakes being repeated”. In respect of TCN particularly, it noted that TCN had at times difficulty in filling shifts and needed to complete its work on its policy for managing medicines.
As a result of the QCC interim report on 2 October 2009 the Department of Health published ‘Dear colleague’ letter which urged all PCTs to take note of recommendations set out by the QCC in its interim review of out of hours GP services.
The PCTs monitoring of TCN was ongoing and continued until late 2009. We started to become concerned about TCN’s ability to fill shifts during the pandemic flu period together with the fact that 2 unannounced visits were made to TCN’s offices after the death of David Gray and they were still carrying 100 mgs of Diamorphine. TCN also failed to ensure by 2 October 2009 that safe doses of Naxolone (the antidote to Diamorphine) were available for patients. The situation did not improve sufficiently and we decided to terminate our contract for the TCN contract for out of hours services with effect from 1 December 2009.”
Fennela Morris representing TCN queried “Can I ask you about arrangements on the PCT’s performers list. At the beginning of 2008 was English language a requirement for the performers list?"
Christine Macleod responded “Yes it was actually a requirement from 2004. It was our policy that all applicants references were looked at by a trained GP who would check their references and it was also desirable that they had a knowledge of the NHS service."
Fenella Morris then questioned Christine Macleod about the changes to the cascading system after the incident. She said “I understand that a specific letter was sent to out of hours providers, did this also include any clinical governance?"
Christine Macleod responded “The PCT has always included out of hours providers as part of the cascading system. I have had subsequent conversations with Jim Kennedy of TCN as to what he required in relation to the cascading system. He indicated that he was satisfied with the cascading system with Suffolk doctors as they would pass the information on to TCN. I tested out the system myself to see what would happen and sent information on the alert provided by the National Patients Safety Agency and it went to individual names at TCN. I explained that this was unsatisfactory and it needed to go to a specific department email that could be checked on a regular basis."
David Lock representing the PCT enquired “Do you still require applicants to pass the International English Language Testing score of 7 or above?”
Christine Macleod responded “Yes and applicants must obtain a score of 7 for reading and speaking English.”
David Lock said “We know that Dr Ubani scored below 7. If he applied to Cambridgeshire with those scores in 2007 would he have been refused and if so does the situation remain the same today?”
Christine Macleod responded “Yes”.
David Lock continued with his questions and said “In relation to Dr Ubani’s references would those have been approved by the clinical team?"
Christine Macleod responded “Absolutely. We would have asked for more information and his application would have been seen by a doctor. In addition if an application was received from a doctor from a foreign country it would be checked with our deanery who would also query whether the doctor had worked in the UK before, whether he was a qualified GP and if the doctor had applied to any other performers list. His training and experience would also have been taken into account. This is the system that was in place in 2007. If a doctor applied to work for Cambridgeshire PCT one of the questions we ask is whether they are on any other performers list. If they indicate that they are we contact that PCT in order to query whether there are any past incidents or history in relation to the applicant."
Third witness
Dr Andrew Saywood. He is a qualified GP. He was instructed by Cambridgeshire Constabulary to write a report concerning a number of visits made by Dr Ubani to patients namely, David Gray, Iris Edwards and Sandra Banks on 16 February 2008. In relation to his evidence on David Gray (Deceased) he said:
“Dr Ubani gave injections Buscopan 4 mgs and diamorphine 100mgs. The diamorphine was 10 times the recommended dose. Mr Gray died following an overdose of diamorphine and the effects of this would have been exacerbated by his alcohol consumption”.
Barbara Hewson representing the gray Family indicated that the Court had already heard evidence that the effects of the diamorphine was not exacerbated by Mr Gray’s alcohol consumption.
Dr Saywood continued “In my opinion Dr Ubani was not fully competent in his dealing with this patient. He failed to examine appropriately, prescribed inappropriately and gave a substantial overdose of diamorphine that caused the death of Mr Gray. He failed to monitor Mr Gray following the administration of the diamorphine and failed to remove syringes, needles and phials, causing danger of possible needle stick injuries”.
In my opinion Dr Ubani was incompetent in dealing with this patient and caused his death by an overdose of diamorphine”.
Barbara Hewson interrupted and asked the Coroner to dissuade Dr Saywood from commenting on any demands that Mr Gray placed on the GP Service or out of hours service for pethidine as she felt that it was outside the scope of the Coroner’s enquiries.
The Coroner disagreed then said that Dr Saywood should continue to give his evidence.
Dr Saywood continued his evidence “In mitigation, Mr Gray undoubtedly abused the GP Service and the “Out of Hours” service in his demands for pethidine. It would appear that Dr Ubani was under some pressure to give an injection of a strong painkiller to Mr Gray. In the heat of the moment Dr Ubani may have just made a mistake, especially if Mr Gray was aggressive. It is clear from the medical records that Mr Gray had a history of disagreements with doctors and was very manipulative”.
The Coroner interrupted and said “Hang on. In respect of your last comment about the history of disagreements with doctors I am going to ask everyone to disregard that comment and I am going to take it as your opinion and also take into account the other evidence that I have heard in this enquiry. Please continue”.
Dr Saywood continued “This level of error was catastrophic and no doctor should make such a mistake, not even a medical student or a nurse”.
Barbara Hewson queried “Dr Saywood, where in doctor Ubani’s notes does it imitate that David Gray put him under pressure to give him this particular dose of diamorphine?”
Dr Saywood responded that Dr Ubani had not made a note to this effect”.
Barbara Hewson continued “Surely if no note was made by Dr Ubani then you cannot infer that Dr Ubani was under pressure to give him this dose”.
Dr Saywood disagreed.
Barbara indicated that his own GP Dr Hirson gave evidence that Mr Gray made 9 calls to the ‘Out of Hours’ service in 6 years and it was therefore not unreasonable.
Dr Saywood commented “I would say that it is unreasonable”.
Barbara replied it was not reasonable for someone who was experiencing chronic renal pain, was it?
Dr Saywood replied “very well, if you say so”.
Turning to his report on Iris Edwards, Dr Saywood indicated:
a) Dr Ubani failed to assess this lady fully.
b) Dr ubani failed to conduct/record a full clinical examination or investigation.
c) Dr Ubani did not show full competence.
d) Dr Ubani failed to take appropriate action. This should have been admission to hospital.
e) Dr Ubani did not consult colleagues.
In my opinion Dr Ubani was not fully competent in his dealing with this patient. He prescribed inappropriately and did not admit Mrs Edwards to hospital. This was inadequate care”.
Turning to his report on Sandra Banks he concluded that:
a) Dr Ubani failed to assess this lady fully.
b) Dr Ubani failed to conduct/record a full clinical examination or investigation.
c) Dr Ubani did not show full competence.
d) Dr Ubani failed to take appropriate action. This should have been admission to hospital.
e) Dr Ubani did not consult colleagues.
“In my opinion Dr Ubani was not fully competent in his dealing with this patient. He failed to take an adequate past history, failed to examine appropriately, prescribed inappropriately and appears to have given unclear advice concerning medication for high blood pressure. The required standard of medical care that Miss Banks was entitled to expect was compromised”.
The inquest continues.
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