1 Monday, 12 December 2011 2 (10.00 am) 3 MR MACAULAY: 4 Good morning, my Lord. The next witness I would like to call is Dr Musa Al-Shamma. 5 DR MUSA AL-SHAMMA (sworn) 6 Examination by MR MACAULAY 7 MR MACAULAY: Dr Al-Shamma, good morning to you. 8 A. Good morning. 9 Q. Are you Musa Al-Shamma? 10 A. I am. 11 Q. What position do you hold at present? 12 A. I am a consultant physician in general and respiratory 13 medicine. 14 Hospital, but I am based at the Royal Alexandra 15 Hospital, but I am covering only for a few months, 16 several months, for the absence of a consultant in IRH. 17 Q. 18 LORD MACLEAN: 19 At the moment, I am in IRH, Inverclyde Royal You may have to adjust your microphone. Yes, would you adjust the microphone so you are actually speaking into it? 20 A. 21 MR MACAULAY: 22 That is better. That is better, yes. As I understand it, you are based, at present, in the Royal Alexandra Hospital. 23 A. That's correct, yes. 24 Q. But the position you hold is that of a consultant 25 physician at the Inverclyde Hospital. 1 1 A. That's correct, yes. 2 Q. For how long have you held that position? 3 A. I moved to IRH to cover the absence of another 4 consultant respiratory physician since 22 February this 5 year. 6 Q. 7 Previously, you had worked in the Vale of Leven Hospital; is that correct? 8 A. That's correct. 9 Q. When, then, did you leave the Vale of Leven Hospital? 10 A. I think it's the end -- towards the middle/end 11 12 of December 2010, went to IRH. Q. Can I then look at your curriculum vitae? This will be 13 put on the screen for you, Doctor. It is at 14 INQ03030001. 15 MBChB is from the medical school of Baghdad University; 16 is that right? Can we see here that your medical degree, 17 A. That's correct. 18 Q. That's a degree you obtained in 1973? 19 A. That's correct Baghdad. 20 Q. I think we then see that you obtained a degree of MSc 21 22 from Glasgow University in 1982; is that right? A. 23 24 25 That's correct. That was a Master of Science in Philosophy, MSc Phil. Q. You are a Fellow of the Royal College of Physicians and Surgeons since 1991; is that right? 2 1 A. That's correct. 2 Q. At the time of the preparation of this CV, you have 3 described your job as a consultant physician in 4 general/respiratory medicine at the 5 Vale of Leven Hospital. 6 interest in respiratory medicine? 7 A. 8 9 Did you have a particular Well, my main interest is asthma. That's where I did my MSc research degree, mainly about asthma. LORD MACLEAN: Could I ask you a question, Mr MacAulay? 10 said a Fellow of the Royal College of Physicians and 11 Surgeons. 12 MR MACAULAY: 13 You That's of Glasgow? Yes, in Glasgow, it is, yes. Just to clarify that, you are a Fellow of the Royal 14 College of Physicians and Surgeons, Glasgow? 15 A. That's correct, yes. 16 Q. In the next section of your CV, you set out the 17 positions you held previously, and if I turn to page 2, 18 you do give us there some details about your research 19 that led to your MSc degree at the University of 20 Glasgow; is that right? 21 A. That's correct. 22 Q. Just looking to that, you tell us this was a full-time, 23 two-year research degree; is that correct? 24 A. That's correct. 25 Q. You were doing research work at the respiratory unit and 3 1 the biochemistry department at the Western Infirmary in 2 Glasgow; is that right? 3 A. That's correct. 4 Q. You then give us some information about other posts, and 5 we can see that you were a registrar attached to the 6 Western Infirmary in Glasgow from 1981 through to 1982; 7 is that right? 8 A. That's correct. 9 Q. You were the registrar again, also, at Gartnavel General 10 Hospital in 1982; is that right? 11 A. That's right. 12 Q. I think also you tell us that you were registrar at 13 Saint Helens Hospital in Hastings? 14 A. That's correct. 15 Q. Similarly, you had a similar post, you were a registrar 16 in general and respiratory medicine at Castle Hill 17 Hospital and Royal Infirmary Hospital in Hull; is that 18 right? 19 A. That's correct. 20 Q. Then you became a consultant physician, and you held 21 that post from 1 May 1985 to 25 November 1989 at the 22 University Department of Medicine attached to the 23 Kufa Medical School; is that right? 24 A. That's correct. 25 Q. Kufa is in Baghdad, in Iraq? 4 1 A. 2 3 No, it is outside Baghdad. It is about 160km south of Baghdad. Q. You also tell us that you were an associate professor 4 and consultant physician attached to the Baghdad College 5 of Medicine from November 1989 to September 1993? 6 A. That's correct. 7 Q. Was it then, in 1993, that you returned to Scotland and 8 took up a position at the Western Infirmary and 9 Gartnavel General Hospital? 10 A. That's correct. 11 Q. You give us some information as to what your duties were 12 during that period and, in particular, you tell us that 13 you did three chest clinics per week on a regular basis, 14 and you also took part in the consultant oncall rota and 15 looked after inpatients; is that right? 16 A. That's correct. 17 Q. Then was it thereafter, in 1996, that you took up your 18 position at the Vale of Leven Hospital? 19 A. That's correct. 20 Q. We will look at your duties there in a moment, but can 21 I take it, then, that that is a position that you held 22 up until quite recently, when you moved to the 23 Royal Alexandra Hospital? 24 A. That's correct. 25 Q. You do give us some information in your CV as to what 5 1 your general duties were at the Vale of Leven. 2 perhaps elaborate upon that, Dr Al-Shamma? 3 A. Can you Basically, it was an inpatient and outpatient duty. 4 I was doing the clinics on Wednesday afternoon, which 5 starts from midday, about 12.30, until late in the 6 afternoon, until 5.00. 7 one clinic: a clinic and a half. 8 in Dumbarton Health Centre, which is five miles away 9 from Alexandria, from the Vale of Leven Hospital. 10 I would do also a general medical/respiratory So it is more than, you know, That is normally done 11 clinic, which is rotating between Vale of Leven, 12 Dumbartonshire and Helensburgh on Thursday afternoon. 13 I would do my regular ward rounds on Friday morning and 14 Tuesday morning -- well, all day Tuesday, I am on call, 15 so basically I start in the morning seeing new 16 admissions, all patients admitted to the Vale, from 17 Monday, 5.00 pm, until Tuesday morning, and then I do my 18 routine ward round after that, and then, in the 19 afternoon, I will come and see all admissions from that 20 morning, from Tuesday morning, until 5.00 pm. 21 So all Tuesday is spent on the ward; Friday morning 22 is the ward round; on Thursday morning, I do 23 a bronchoscopy session and Thursday lunchtime I have 24 a medical MDT meeting, which is the multidisciplinary 25 meeting, where we link with the surgeons, the 6 1 cardiothoracic surgeons, at the Golden Jubilee and we 2 will discuss all the cancer patients. 3 On Monday morning, I come to the ward to see all -- 4 well, some of my ill patients, so it is a short ward 5 round, to see the ill patients after the weekend, and in 6 the afternoon I will spend it mainly in the 7 respiratory -- sorry, the lung function test. 8 Wednesday morning, I would also nip on the ward and 9 see all of the admissions -- well, some of 10 the admissions, the ill patients who were admitted from 11 the day before, Tuesday, and the rest of the time, which 12 is Friday afternoon, is an admin time for me. 13 Q. I note in this, in the second-last paragraph on page 3 14 of your CV, that you have also been involved in the 15 teaching of undergraduate students and post-graduate 16 teaching and training; is that correct? 17 A. That's correct. We had two medical students until, 18 I think, 2007 attached to our unit regularly, so I used 19 to do a lot of teaching. 20 teaching, and also post-graduate teaching for the 21 doctors who are applying or attempting the MRCP 22 examination, the PACES, it is called, the clinical part 23 of the MRCP examination. 24 teaching. 25 interest for the post-graduate, which is our registrars, I have a special interest in So I try to do regular It depends on who is available and their 7 1 2 usually, middle grades. Q. If we turn to page 4 of your CV, you give us an idea 3 here of your involvement in publications, and I think, 4 as you indicated yourself, a number of these 5 publications certainly focus on asthma; is that right? 6 A. That's correct, yes. 7 Q. In relation to this Inquiry, Dr Al-Shamma, have you 8 provided the Inquiry with two statements: an initial 9 statement and then a supplementary statement? 10 A. Yes, I think so. 11 Q. If we look at the first of these, it is WTS00740001, 12 I think you will recognise this as the first statement 13 you provided. 14 page 16 of the statement, can we see that this is 15 a statement that you signed on 16 August 2010? Just to identify that, if you turn to 16 A. That's correct. 17 Q. More recently, if we look at WTS01850001, do we have 18 here a supplementary statement by you and, if we turn to 19 page 12 of this document, can we see that this is one 20 that you signed more recently, on 23 December 2010? 21 A. Yes. 22 Q. I will return to look at these at different points in 23 the course of your evidence, but you are aware, I think, 24 Dr Al-Shamma, that the Inquiry is concerned in 25 particular with events in the Vale of Leven 8 1 between January 2007 and, for present 2 purposes, June 2008? 3 A. Yes, I am aware. 4 Q. The Inquiry is also interested in what has happened 5 since then, but the particular focus is, so far as 6 looking at patients, and so on, at that period. 7 We have already looked at your CV and seen what your 8 position was at the relevant time. Can you tell me if 9 you had a line manager at that time in 2007/2008? 10 A. It was the clinical director, the CD, Dr Graham Curry. 11 Q. So far as assessments and appraisals, did you undergo 12 13 any assessments or appraisals during that time? A. 14 Yes, with Dr McCruden, who was the lead clinician at the Vale of Leven. 15 Q. I'm sorry, you are letting your voice drop. 16 A. Sorry, it is Dr McCruden, Douglas McCruden, who was the 17 18 lead clinician at the Vale of Leven Hospital. Q. 19 So in relation to clinical appraisal, would that be carried out by Dr McCruden? 20 A. That's correct, yes. 21 Q. Did that happen over the period that we are interested 22 in, 2007/2008? 23 A. Yes. 24 Q. At that time, were you aware that there had been C. diff 25 outbreaks at Stoke Mandeville in particular? 9 1 A. No, I wasn't aware. 2 Q. Can I just be clear, in relation to the prescribing of 3 antibiotics, what guidelines you would use at that time? 4 We have received a number of different documents in this 5 particular area, and can I just put them to you and see 6 whether or not they are relevant. 7 The first document I want to put to you is at 8 GGC18270001. This bears to be the Greater Glasgow and 9 Clyde formulary first edition for August 2007. Was this 10 a document you were familiar with at the time we are 11 concerned with? 12 A. Yes, I was. 13 Q. Would it be something you would have regard to if you 14 15 I think I was, yes. Yes. were considering prescribing antibiotics at that time? A. Yes. You try to follow what's in the formulary, but 16 there is always occasion where you have to deviate from 17 the formulary and use your clinical judgment. 18 Q. Indeed. The next document I want you to look at is at 19 GGC21790001. This, we understand, is the Argyll and 20 Clyde drug formulary for 2006. 21 this something that you had at the time? What about this? Was 22 A. Yes, sir. 23 Q. Would this be a document, in particular, since it seems 24 to be more specifically related to Argyll and Clyde, 25 that you would have regard to? 10 1 A. Well, you use both. I mean, I think they are very much 2 similar. 3 judgment, but try not to deviate far away from the 4 formulary as well. 5 Q. But, you know, again, it's always the clinical Could you also look at GGC22180001? You will see this 6 bears to be a document headed "Infection management 7 guideline: empirical antibiotic therapy", and although 8 it doesn't bear a date, I understand it may be about 9 2007. 10 A. Was this something you had available to you? Certainly not. Not before the outbreak happened. That 11 wasn't available to me during that period. 12 available on the ward as a poster, but not before the -- 13 or within the period which we are concerned about. 14 Q. It's now If we could also put on the screen GGC06380009, and if 15 we can just expand that a little bit, this may be the 16 2008 version of the other document. 17 a moment ago of a document that being on the ward. 18 Could this be the document that is now available on the 19 ward? 20 A. Yes, they change it many times. You made mention It has been changed 21 many times since then. 22 every 6 months or 12 months, but you get the updated one 23 and they are available on the wards now in IRH. 24 25 Q. We notice the changes perhaps If I could take you back to the previous document, GGC22180001. 11 1 This is different. Do I take it from you that this 2 was not something that you had seen prior to June 2008 3 in any form? 4 A. That's correct. 5 Q. The other document I want to take you to is at 6 GGC21760001. This, I understand, is the North Glasgow 7 Acute Hospital prescribing handbook for 2007/2008. 8 you tell me if this was something that was available in 9 the Vale of Leven at the relevant time? Can 10 A. Not to my knowledge, no. 11 Q. So far as you are concerned, then, if I can go back to 12 it, GGC21790001, we are back at the Argyll and Clyde 13 formulary for 2006, this was something, then, that you 14 would have access to at the time we are concerned with? 15 A. That's correct. 16 MR KINROY: My Lord, I wonder if we could clarify this? If 17 I have understood the evidence correctly, that was one 18 thing which was available to Dr Al-Shamma, but I think 19 also, at some stage, there was available to him the 20 Greater Glasgow and Clyde prescribing formulary first 21 edition, and I wonder if we are going to explore if he 22 used these in chronological sequence? 23 A. 24 LORD MACLEAN: 25 Well, obviously -No, don't answer the question, please. Mr MacAulay? 12 1 MR MACAULAY: 2 I will backtrack a little bit, my Lord, and just pick that point up. 3 LORD MACLEAN: 4 MR MACAULAY: All right. We are looking at the Argyll and Clyde 5 formulary. 6 next to it the Greater Glasgow and Clyde formulary, 7 which is GGC18270001. 8 I think, Dr Al-Shamma, that the Greater Glasgow and 9 Clyde formulary for August 2007 was a document that was 10 If we can keep that on the screen and put You did say a moment ago, available to you during the relevant period. 11 A. Yes. 12 Q. Before I ask you any more about that, apart from these 13 two documents that we have on the screen, what else, if 14 anything, would you use to assist you in prescribing 15 medications to patients, particularly antibiotics? 16 A. Well, textbooks and BNF. 17 Q. So far as the Greater Glasgow and Clyde formulary is 18 concerned, we see this is dated August 2007. Can you 19 remember when you started to have access to that 20 document? 21 A. I don't remember. 22 Q. In relation to the two documents we have on the screen, 23 the Argyll and Clyde drug formulary and the 24 Greater Glasgow and Clyde formulary, would you have 25 a preference for either of these, if you were to be 13 1 checking to see what advice was being given in the 2 guidelines? 3 A. I think they are very much similar, to be honest. There 4 isn't much difference. 5 of my clinical judgment, what's in the textbook, BNF, 6 and also refer to the formulary as well. 7 Q. I would just use the combination If we go then to the Argyll and Clyde drug formulary, 8 which is the one on the left, and pick up one or two 9 points from that, if we turn to page 39 of the document, 10 there's a section here headed "Principles of antibiotic 11 treatment", and I think the first point made is the 12 point you have made yourself: namely, that the 13 guidance -- and there is reference to appendix 5A -- is 14 based on the best available evidence, but its 15 application must be modified by professional judgment. 16 Is that the position in practice? 17 A. That's correct, yes. 18 Q. So far as 2 is concerned: 19 "Prescribe an antibiotic only when there is likely 20 to be a clear clinical benefit." 21 Would that be -- 22 A. That is very correct. 23 Q. At 5, it is suggested: 24 25 "Use simple generic antibiotics first whenever possible." 14 1 Is that a correct approach? 2 A. That's correct; very correct. 3 Q. At 10, what is suggested is: 4 "Where a 'best guess' therapy has failed or special 5 circumstances exist, local microbiological advice should 6 be obtained." 7 A. That's correct. 8 Q. At the relevant time, in 2007/2008, I think we 9 understand that you did not have a resident 10 microbiologist; is that right? 11 A. That's right. 12 Q. So if you required to access microbiological advice, 13 what would you do, in practice? 14 A. We will contact the oncall microbiologist. 15 Q. Did that vary: it just depended on who was on call? 16 A. That's right. 17 Q. We have seen in the records reference to Dr De Villiers, 18 and I think also Dr Biggs and Dr Weinhardt. 19 generally the microbiologists that were accessible to 20 you? 21 A. I think so, yes. Were these I mean, they would call the 22 microbiology department and usually the juniors would do 23 the call, the middle grade, and they would speak to 24 whoever was available, but, yes, I think Dr De Villiers 25 was the one who was mostly involved with the 15 1 2 Vale of Leven microbiology results. Q. If we then just look at some of the guidelines provided 3 in this document, and if we turn to page 145, towards 4 the bottom of the page, there is information given about 5 a community-acquired pneumonia, and reference is made to 6 appendix B of the document. Do you see that -- 7 A. Yes. 8 Q. -- towards the bottom? 9 A. Yes, I do. 10 Q. If we turn to appendix 5B that we find on page 153, can 11 we see here a schematic giving guidance as to, in 12 a particular instance, what antibiotics might be 13 prescribed for a community-acquired pneumonia? 14 A. That's correct. 15 Q. If we take, for example, the first column, are we 16 looking there at a non-severe community-acquired 17 pneumonia and what might be prescribed for that? 18 A. Yes. 19 Q. For example, the first line tells us that amoxicillin 20 oral could be given, and then "Review after 24 hours. 21 Consider adding clarithromycin orally". 22 Are you able to tell us, so far as your own practice 23 would be concerned, if that generally would be the 24 approach you would take for a non-severe, 25 community-acquired pneumonia? 16 1 A. Those cases would not be admitted usually to hospital. 2 They are treated by GPs in the community. 3 not to see them unless it is a complication of severe 4 COPD or COPD or other chronic lung diseases, yes, then 5 we would see them in the hospital. 6 they are treated in the communities. 7 more severe cases. 8 Q. 9 So we tend But most of the time We tend to see the The more severe cases, then, are we looking to the third column for that? 10 A. Usually, yes. 11 Q. The first line here that is proposed is co-amoxiclav or 12 ceftriaxone and clarithromycin; and the second line is, 13 or if there is a penicillin allergy, levofloxacin plus 14 advice from a consultant microbiologist. 15 own practice was concerned, would that be your practice? 16 A. Again, it depends on the individual case. So far as your But, 17 generally speaking, yes, the more severe pneumonia, 18 especially if the patient has been treated in the 19 community with amoxicillin, then the second-line 20 treatment will be co-amoxiclav plus clarithromycin. 21 That's my usual practice, yes. 22 Q. At page 156, we have here a table that gives us the 23 condition in the first column and then the recommended 24 treatment and alternative treatment in the other 25 columns, and if we are looking at uncomplicated and 17 1 severe pneumonia, can we see that for the severe 2 pneumonia the suggestion for the recommended treatment 3 is co-amoxiclav and clarithromycin; is that correct? 4 A. That's correct. 5 Q. Then the alternative treatment is levofloxacin? 6 A. Yes, that was the practice at that time. 7 Q. Is this for a hospital-acquired pneumonia? 8 A. No, I think they're talking about severe, 9 community-acquired pneumonia. 10 11 I would say, yes, it is correct. I'm not sure, but it looks like severe, community-acquired pneumonia. Q. 12 In your practice, did you require to deal with patients who had pneumonia, particularly severe pneumonia? 13 A. Yes. 14 Q. What about urinary tract infections? Was that, again, 15 something that you required to prescribe for in your 16 time in the Vale of Leven at the relevant time? 17 A. I'm sorry? 18 Q. What about urinary tract infections? 19 Did you require to prescribe antibiotics for that condition? 20 A. Yes, for certain patients who are symptomatic, yes. 21 Q. If we turn to page 146 of this document, there's 22 a section here dealing with urinary tract infections, 23 and there is some guidance given about asymptomatic 24 bacteriuria. 25 screen? Do you see that in the first box on the 18 1 A. Yes, I can see that. 2 Q. Was it within your knowledge that you would generally 3 not treat with antibiotics asymptomatic bacteriuria? 4 A. In a patient who was asymptomatic, yes. 5 Q. But do we see that for an uncomplicated urinary tract 6 infection where there is no fever or flank pain, the 7 suggestion is that the first-line treatment would be 8 trimethoprim or nitrofurantoin? 9 A. That's correct. 10 Q. Then, if we go back to the list we looked at earlier, at 11 page 156, so far as urinary tract infections are 12 concerned, again, can we see there is reference in 13 particular to trimethoprim as the recommended treatment; 14 do you see that? 15 A. Yes, I see that. 16 Q. Then, if it is a more serious infection, like 17 pyelonephritis, can we see that cefotaxime is the 18 recommended treatment -- 19 A. Yes. 20 Q. -- and ciprofloxacin is the alternative treatment? 21 A. Yes. 22 Q. Would that accord with your own approach? 23 A. Yes. 24 Q. Insofar as -- 25 DAME ELISH: My Lord, on this particular point, I wonder if 19 1 my learned friend has posed what the scenario would be 2 if the doctor was approaching two individual conditions? 3 I think it is important perhaps to take the doctor to 4 what would happen if it was not determined at that point 5 or it was a combination of the two potentially, and 6 might that alter the approach? 7 LORD MACLEAN: 8 DAME ELISH: What do you mean by "two"? For example, if the patient was suffering from 9 a respiratory condition and a suspected UTI, would that 10 in itself influence the decision as to what, from this 11 guidance, would be selected? 12 MR MACAULAY: Did you hear the question, Dr Al-Shamma? 13 A. Yes, I did. 14 Q. What is your answer to that? 15 A. Well, you'd try to find one single antibiotic which is 16 effective for both infections, and you might have to go 17 for a broader-spectrum antibiotic. 18 prefer to use one single antibiotic rather than 19 a combination of the two, in case there is, you know, 20 some interaction or lots of synergy, and so I will try 21 to find an antibiotic which is effective in both. 22 Q. I would normally If you have a patient and you are not clear what the 23 source of the infection is, but you suspect that it 24 might be a urinary tract infection, or indeed it might 25 be a respiratory problem, I think you are saying, are 20 1 you, that, in that circumstance, you would empirically 2 select a broad-spectrum antibiotic to try to cover as 3 much as possible, or have I misunderstood? 4 A. No, sorry, I meant an antibiotic which is effective for 5 both infections, not necessarily a broad -- it would 6 probably tend to be a bit broader spectrum than usual, 7 but trimethoprim is no good for chest infections or 8 nitrofurantoin, so either use this and another 9 antibiotic for a chest infection or use one antibiotic 10 11 which is effective for both. Q. 12 13 But do you then, by getting specimens and results from specimens, try to narrow down the antibiotic treatment? A. Well, yes. I mean, obviously, it has always been my 14 policy to do cultures before you start antibiotics, and 15 I would expect most of the time the juniors, the middle 16 grade, would have taken cultures when they suspect 17 infection and then start the antibiotic, unless, 18 obviously, the patient was already on antibiotics 19 started in the community. 20 of the culture and take it from there. 21 Q. 22 Then I wait for the results Once the culture results were available, would you then review the antibiotic treatment? 23 A. Yes, I would, yes. 24 Q. You mentioned junior doctors there, and that is what 25 I was going to move on to discuss with you. 21 Can I just 1 understand the medical setup in the Vale of Leven 2 Hospital? 3 relevant time. 4 it were? 5 A. You were a consultant physician at the Who would you have working under you, as Can you just help me on that? Yes, sure. Well, at that time, we were -- there was -- 6 you know, when I started first at the 7 Vale of Leven Hospital, there was only four consultants 8 taking part in the rota: myself, Dr McCruden, 9 Dr Carmichael and there was a cardiologist as well. 10 rota worked in a way that we are one in four on call 11 with cover when you are on holidays, so if you are on 12 holiday and somebody has covered -- I used to be on call 13 every Tuesday, so if I were to go on holiday for this 14 week and say, like, Dr Carmichael would cover for me on 15 that Tuesday, then, when I come back, I would have to do 16 his Monday. 17 is quite a lot for a busy hospital. 18 The So it worked as out 3.5, one in 3.5, which During that period, the concerned period, 19 Dr Johnston and Dr Akhter were taking part in the rota, 20 so we improved a bit in that period, and it is 1 in 6, 21 but when we work it out with holidays, annual leaves and 22 days in lieu, it worked out as 1 in 4.5 or 4.6, as far 23 as I remember. 24 25 So we were practically on call every fourth day and every fourth weekend. The problem with our on call, 22 1 when we are on call, all patients admitted would be 2 under our care. 3 or liver disease, or whatever, endocrine, they would be 4 under my care until they are discharged, and I would 5 follow them up, unless they are really complicated and 6 require special input, I would follow them up at my 7 medical clinic. So if it was a cardiology problem or GI 8 The reason for that, because there is one consultant 9 in every speciality, and we could not, you know, sort of 10 divert the patient to the care of the other consultant, 11 which means that the consultants would have to do a ward 12 round every day. 13 Now, comparing that with the current situation in 14 IRH, so when I am on call, I would be in the medical -- 15 I would be based in the medical assessment unit and what 16 I normally do, when the patient is admitted, I would 17 manage him initially and then say "Divert to the" -- so 18 if it was a gastrointestnal problem, I would say, 19 "Divert this patient to the gastro ward", if it was 20 cardiology, "Send him to the cardiology ward", 21 respiratory, "Send him to my ward". 22 So I can get 30 admissions in IRH, but probably, of 23 those, three or four will end up on the respiratory ward 24 and the rest will be diverted to different wards, and my 25 sort of input towards those patients would finish by 23 1 that time. 2 Now, at the Vale, the situation was different. 3 I mean, during winter months, you could have 20, 25 -- 4 in one day I had 31 admissions in a 24-hour period from 5 Monday 5.00 pm to Tuesday 5.00 pm and all those patients 6 were mine. 7 hospital. 8 9 They would be scattered all over the The other problem with the juniors, that they were based on the ward, so they were not based -- they did 10 not work for one consultant. 11 and there would be, like, a middle grade and a junior, 12 an FY1, and they would do the ward round with me, but 13 then they would also do the ward round with 14 Dr Carmichael, with Dr McCruden and with the 15 cardiologist, Dr Forbat at that time. 16 on the ward and they are not based in a team. 17 So I would go to ward 3 So they are based In IRH, I have my own team, so I have three 18 registrars and one FY1 for a ward, which is about 19 17 patients. 20 patients. 21 the patient, they see the patient every day and they 22 know every particular issue about the patient. 23 On average, I would have between 17 and 20 Those are my three registrars, so they know In the Vale of Leven Hospital, because the juniors 24 are ward-based, and they could move from one ward to 25 another fairly quickly, so basically, like, you go to 24 1 ward 3 and there is a middle grade and an FY1. 2 later, because the middle grade has to go to cover the 3 MAU, the medical assessment unit, he would move from the 4 ward and a new SHO would come and cover, which he knows 5 very little about the patient, and that created 6 problems, because we only had, you know, the junior on 7 the ward or the middle grade for a week or two maximum, 8 and they were moved to another, to be on call or moved 9 to another ward. 10 A week But we couldn't afford, at that time, because of 11 the number of juniors, to work as a team. 12 had my team, like, an SHO who works for me and he knows 13 about my patient. 14 see the patient with me. 15 another SHO to look after the patient and a week later 16 he could move and there's a third person come in. 17 So I never So somebody would be on call, will The next day there would be This has created difficulty for us because there is 18 no continuity of care, as far as the middle grade, while 19 here, like in other hospitals, there is continuity of 20 care. 21 Q. It is the same junior doctor who looks after. I think the point you are making, just to try and 22 summarise it, is that because of the setup in the 23 Vale of Leven, there was this lack of continuity of 24 care, in that a doctor who might have been in one ward 25 at one particular time might be in another ward at 25 1 2 another point in time. A. That's correct, yes. Is that a fair assumption? So a new middle grade would not 3 know the patient and the other issues, the minor issues, 4 in those patients, they could easily be missed, you 5 know, some issues, drug or otherwise, and, as a result 6 of that, it has created some problems. 7 Q. Two points from that. The first point is this: did you 8 recognise at the time that there was this problem of 9 lack of continuity in care? 10 A. Oh, yes, it was recognised. It was raised many times in 11 our medical division meeting, but this is what we had, 12 obviously. 13 concern many times, but there was no other way around 14 this issue. 15 as far as the middle grade and the staffing and this is 16 what we could do and there was no other alternative. 17 This has been going on since I started, obviously. 18 wasn't something which happened after I started. 19 this is what was available. 20 DAME ELISH: There was no other way -- I raised my That is it. I mean, this is what we have It But My Lord, I wonder, before my friend moves on 21 from the composition, the contrasting composition of 22 the teams supporting the consultant, if my learned 23 friend could clarify the profile of the team? 24 referred to junior doctors in the Vale of Leven. 25 not sure whether or not the doctor has explained what 26 We have I'm 1 2 the composition of his team was in Inverclyde? MR MACAULAY: I will come to that, but just if I can finish 3 this particular point, you say that this lack of 4 continuity that you have described to the Inquiry was 5 raised by you on many occasions? 6 A. Is that correct? Well, it was raised, discussed, all my colleagues would 7 have agreed on that, but there was no way around this 8 problem, because that's what we have as far as the 9 number of the middle grade. 10 It was increasing over the years by one -- like, we 11 make a case for another middle grade, but even at the 12 very last -- you know, before my colleagues retired, 13 there was no way around this problem and we continued to 14 have the same sort of setup. 15 Q. But was it raised with anyone in management that, 16 because of the setup, there was a lack of continuity in 17 care? 18 A. I'm sure it was. It was Dr McCruden who was the lead 19 clinician. 20 management, but the answer, you know, always, "This is 21 what we have", sort of staffing. 22 Q. He would have taken the issues with the Before I pick up Dame Elish's point, would it be fair to 23 say that, because of this setup with different doctors 24 being in different wards, note-taking would become even 25 more important so that the incoming doctor would see 27 1 2 clearly what the position was with a particular patient? A. 3 4 I'm sorry, what was the -- I'm sorry, I missed the question. Q. Looking to what you have said about the lack of 5 continuity in care that you have described, does it 6 follow from that that note-taking by the doctors would 7 become particularly important so that the clinical 8 position was as clearly expressed as possible for the 9 incoming doctor who may not know the patient at all? 10 A. I think that's correct, yes. 11 Q. The point raised by Dame Elish is in connection with the 12 profile of the medical side. I don't want to call it 13 a team, because I understand you didn't really work as 14 a team? 15 A. Never worked as a team at the Vale. 16 Q. What was the profile, then, within the Vale of Leven? 17 A. There was a middle grade and an FY1 on every ward, and 18 obviously considering for the holidays, for the annual 19 leave and for the sickness absences, we had to obviously 20 staff the medical assessment unit and there was some 21 cover for the care of the elderly in ward F, which was 22 the rehab ward, so the best we could have is one medical 23 SHO covering each ward with an FY1, which is a very 24 junior doctor. 25 Q. At registrar level, what was the position? 28 1 A. We never had an experienced registrar. 2 was an ST1 and/or ST2. 3 far as I remember. 4 MR KINROY: The best we had So we never had beyond that, as My Lord, I think I may be correct to believe 5 that a grade FY2, which might figure in the deployment 6 of staff, if we are talking about registrars, FY1, ST1, 7 ST2, I think there is also a grade FY2. 8 explore that? 9 10 A. 12 FY2? LORD MACLEAN: 11 Are we going to You have just said you never had an experienced registrar. A. Which is ST3 or above. That is what we had, as far as 13 I remember. 14 registrar, because ST1 and ST2 is a core training, so 15 basically they are going into medicine, but they are 16 still at their core training, but we could have FY2 as 17 well as a middle grade, which is not very experienced 18 doctor, but I don't remember -- and my colleagues can 19 correct me if I am wrong -- having an ST3 or ST4, which 20 is a specialist registrar in one particular speciality. 21 They are training to become, like, consultants in 22 respiratory or cardiology. 23 LORD MACLEAN: 24 A. 25 Never had, you know, like a speciality That was the point you were making? Yes, they were middle grade but they were not very experienced. But then they were middle grade, 29 1 obviously. 2 concerned us, obviously, so we could never afford to 3 work in, like, a team base so I have my own registrar to 4 join me for the whole ward round wherever the patients 5 are located, whether ward 3, 6, or whether boarded to 6 the surgical ward. 7 MR MACAULAY: 8 It's the number, more, you know, which You have drawn attention to the position now that you have a team. 9 A. At the moment, yes. 10 Q. At the moment. 11 12 Does that then improve the position insofar as rendering patient care? A. Definitely, because the same doctor will look after the 13 same patient. 14 a 3 registrar, but considering the on call and the 15 holidays, there is at least two at any time, two 16 experienced registrars. 17 them is ST3, which is a speciality registrar, and one is 18 ST2, and the other two, and basically between the two of 19 them they would cover the two halves of the ward, the 20 respiratory ward. 21 So, like, on average, although there is Both of them are ST -- one of Considering there is, on average, 20 patients in the 22 respiratory ward, so each doctor will look after ten 23 patients, which is not a tremendous number, and they 24 would know everything about the patient, and when I come 25 to do the ward round, they would, you know, bring up any 30 1 points, any changes in drugs, antibiotics, and so on, 2 and even, you know, because there's continuity of care, 3 if there is any issues, they will call me or come to my 4 office or, you know, discuss things with me if there is 5 any other issue, because they know the patients and they 6 look after the patient for a fairly long period of time; 7 most of the time from admission right to the discharge. 8 Q. 9 That can be contrasted with the position at the Vale of Leven? 10 A. Very much indeed, yes. 11 DAME ELISH: My Lord, on that particular point, I wonder if 12 my learned friend could establish whether it is correct 13 that the junior doctors referred to by Dr Al-Shamma 14 were, in fact, there for a period of three months' 15 rotation? 16 their total period there would be one of three months' 17 duration? 18 LORD MACLEAN: 19 A. So apart from the movement between wards, Can you answer that? That's correct, yes. That period is usually three to 20 four months, and they will move on to another hospital, 21 because they come -- initially, we used to have them 22 from the Western, Gartnavel, infirmary rotation, and 23 they used to come for three months, and later on, after 24 we stopped taking the Western, Gartnavel, we had them 25 for the general rotation and they would spend maximum 31 1 four months. 2 and everything, they would almost finish there. 3 at least I have them for six months, sometimes for 4 a whole year, which is obviously a better way of looking 5 after patients. 6 MR MACAULAY: 7 8 Here, "Here", you mean in the Royal Alexandra Hospital? A. 9 10 So by the time they get to know the system I'm sorry, yes -- sorry, in IRH at the moment I am at, yes. Q. Just looking at the position of junior doctors, and the 11 junior doctors that would be under you in a particular 12 instance, insofar as prescribing antibiotics would be 13 concerned, did they use the same documentation as you 14 have pointed to or can you tell me what they were using? 15 A. I suppose yes, the same, because they would have been 16 given this documentation at the induction day, the first 17 day they start. 18 to follow what's in the formulary. 19 Q. They would have been informed or asked Generally, would junior doctors, before prescribing 20 antibiotics, consult with you, if the patient was your 21 patient, before prescribing antibiotics, or would they 22 just simply go ahead themselves? 23 A. It depends. I mean, sometimes if patients are admitted 24 after the working hours, after 6.00, for example, and 25 the registrar feels strongly that there is an ongoing 32 1 infection, then they will start the antibiotic. 2 are not going to call me on every time they start the 3 antibiotic, which is, you know -- unless, obviously, the 4 patient looked very septic and very ill and they are 5 struggling with him, then obviously we will get called 6 about him. 7 to see the patient at that time. 8 yes, out of hours, they would start the antibiotic and 9 things would be reviewed. 10 Q. 11 12 They We may or may not have to go to the hospital But most of the times, You mentioned registrars, but more junior doctors as well, would they start antibiotics? A. No, I mean, we're talking either FY1, who are 13 pre-registration doctors, or the rest -- I call them all 14 registrars, they are SHOs, middle grade, including FY2, 15 ST1 or ST2, this is the sort of middle grade, but I call 16 them all registrars. 17 they are out of hours, they are the only doctors at the 18 hospital, including FY2 sometimes, they are responsible 19 for all admissions, they would start the treatment and 20 the next day we would have a look at that. 21 You could call them SHOs. Because Now, during the week as well, if they feel sometimes 22 there is a need for a change of antibiotics, they might 23 change that as well, if we have a positive culture, for 24 example, indicating that the antibiotic being used is 25 not the right one or the bacteria is resistant to that, 33 1 or, on the other hand, if the microbiologist suggests 2 something different. 3 change the antibiotic because they feel they haven't -- 4 the patient has not responded to that particular 5 antibiotic. 6 Q. Some will take the initiative and Just to be clear, was it then your practice in 7 connection with one of your patients that you would 8 review the prescription of antibiotics if made by a more 9 junior doctor? 10 A. Yes, we would review the antibiotic the following day, 11 but if it was changed, like, say, on Friday afternoon 12 after I have finished my ward round, for whatever 13 reason -- a call from the microbiologist, a culture 14 result showed different antibiotic or the registrar 15 decided that this is not -- the patient is not 16 responding, then I won't know until the following week, 17 obviously. 18 DAME ELISH: My Lord, I wonder at this stage -- my learned 19 friend has established the numbers of doctors and the 20 rotas and the structure. 21 clarified what the position was that pertained at the 22 weekends in terms of the number of junior doctors 23 responsible for the total number of patients? 24 LORD MACLEAN: 25 A. I wonder if it could be Can you answer that, Doctor? There was, unfortunately, only one middle grade and one 34 1 FY1, and that is all we had over the weekend. We know 2 it was quite busy on Saturday mornings, especially on 3 Saturday afternoon, but, again, the rota was looked 4 at -- and I'm sure Dr McCruden will basically expand on 5 that, because he looked at the rota with HR and there 6 was no other way we could put two SHOs on call on 7 Saturday, for example, one until 5.00 and the other 8 until -- like, a long shift until 9.00 or 10.00 in the 9 evening. So there is only one on the weekend, one 10 middle grade and one very junior FY1, and that is both 11 Saturday and Sunday, and they were doing all the job on 12 their own. 13 MR MACAULAY: Just so I can understand that, are you saying 14 the two doctors that you mentioned would be in the 15 hospital available on the wards at the weekends? 16 that right? 17 call? 18 A. Is Or would one be in the hospital and one on Can I just understand? No, that includes the on call. When we talk about the 19 on call, we are talking about the medical assessment 20 unit at that time. 21 middle grade, would be based there most of the time. 22 he was free in the morning, he would do the ward round 23 with us, but if he was busy, then we would end up doing 24 the ward round with the most junior or, even if the most 25 junior is busy, you could end up doing the ward round So the most senior one, which is the 35 If 1 with a nurse. 2 would be available to join us. 3 Q. But most of the time one of the doctors Remind me, we have seen the Junior Doctors' Handbook 4 that suggests there were 180 beds in the Vale of Leven 5 at about this time. 6 to how many beds were in the hospital at the time we are 7 concerned about? Was that your own recollection as 8 A. Yes, I think so. 9 Q. Generally, as you have indicated, it was a busy 10 hospital? 11 A. Very busy. 12 Q. With most of the beds full; is that right? 13 A. That's very correct, yes. 14 Q. So at the weekends, with something approaching 180 15 patients to be cared for, you are telling the Inquiry 16 you had two doctors available in the hospital; is that 17 right? 18 A. That's correct. But you have also -- this number would 19 include the long-term, like, you know, care of 20 the elderly, rehab and obviously the acute medical beds 21 as well, and there were some surgical beds as well. 22 that is, yes, what was available. 23 Q. Was this something that was of concern to you? 24 A. Yes, it was. 25 So Because the middle grade had raised these issues many times with us, that they are under pressure, 36 1 but that was what was available at the time, you know. 2 Q. Did you raise your concerns? 3 A. Yes, we discussed that at the medical assessment unit. 4 I think, at one stage, they tried to put two on -- 5 whether that was in that period or not. 6 time -- I vaguely remember there was two of them for 7 a period of time. 8 because of the European Working Hours which couldn't, 9 you know, exceed the working hours of the juniors -- For a period of But, again, the rota did not -- 10 remember that was coming over the years, that then 11 restricted to 56 hours the juniors, and then 48 hours, 12 and then it was dropped further. 13 European Working Hours was coming into place, we had to 14 cut down on the number of hours the juniors were 15 working, and, as a result, you know, that has caused 16 a bit of problems, because you couldn't exceed that. 17 Otherwise, the Deanery will not give us, you know, 18 I think juniors anymore, and they will not recognise the 19 hospital for the junior training if you don't stick to 20 the European Hours. So, basically, as the 21 We had to cut down gradually on the number -- or the 22 hours, working hours, and also, remember, over the years 23 the number of patients admitted to the Vale was 24 increasing. 25 average number was 11, but I think over the years the So initially when I started, I was told the 37 1 number was increasing and increasing and, as I said, 2 winter time, you might get 20, 25, 30 patients over 3 a 24-hour period and over the weekend you could easily 4 admit 50, over 50 patients. 5 a lot of work. 6 LORD MACLEAN: 7 Could I ask you this: the middle grade doctor and the FY1 are hospital doctors, based in the hospital? 8 A. 9 LORD MACLEAN: 10 Obviously, that all creates A. 11 They are based in the hospital, yes. Did you have general practitioner cover? For the care of the elderly there was a general practitioner, but that is during the week. 12 LORD MACLEAN: 13 A. Not during the weekend? Not the weekends. Obviously, there is an outpatient 14 GP practice, but that is general practitioner, nothing 15 to do with the secondary care. 16 LORD MACLEAN: Overnight you had GP cover, did you? 17 A. I don't know whether that was during this Later on. 18 period or not, but later on, the GP start -- I think 19 that is after -- you know, started to cut down on the 20 hospital. 21 merged or as we moved to Royal Alexandra Hospital, there 22 was some GP cover, but I don't think that happened 23 during that period. 24 period. 25 MR MACAULAY: Because changes happened, you know, as we It would have been after that So far as the GP cover was concerned, did they 38 1 cover simply the rehab wards and not the acute ward, 2 medical wards, or did they cover both? 3 A. I think mainly the care of the elderly ward, rather than 4 ward F, which is the rehab ward. 5 any input during the working hours in the medical -- 6 acute medical wards, no. 7 Q. No, they did not have I think you did say that you had expressed concern about 8 the position that existed at the weekends with the two 9 doctors. 10 A. Were these concerns expressed to management? Well, it's not only me. I think all my colleagues 11 were -- you know, because the middle grade doctors and 12 the juniors, the very juniors, have raised these issues, 13 and, again, yes, I'm sure Dr McCruden has taken that to 14 the management, but -- 15 Q. 16 17 So you did not. Was this something, again, that you would see Dr McCruden doing? A. We had our medical division meeting between the 18 consultants only, which was running about six-weekly, 19 and then any concerns would be discussed at that meeting 20 and, you know, Dr McCruden, who was the lead clinician 21 at that time, would take the matter further. 22 Q. 23 24 25 Just so I'm clear, which consultants went to the medical division meeting? A. All of us: myself, Dr Carmichael, McCruden, the cardiologist, Dr Clarke, the haematologist, and 39 1 2 Dr Johnston and Dr Akhter as well. Q. So this is something we ought to explore with 3 Dr McCruden, then, to see to what extent this was 4 escalated to management? 5 A. I think so, yes. 6 LORD MACLEAN: 7 A. 8 LORD MACLEAN: 9 A. What is meant by "medical division"? It is just the name for that. Within the hospital? Within the hospital, yes. Within the hospital 10 consultants, yes. 11 us to discuss issues arising in the hospital. 12 MR MACAULAY: It is only for the consultants, for Can I just move on to a different topic for 13 the moment, Dr Al-Shamma? 14 antibiotics. 15 Again, I'm going back to What was your knowledge in the period January 2007 16 to June 2008 in relation to which antibiotics were more 17 likely to make a patient susceptible to C. difficile? 18 A. Well, I was aware that the broader spectrum the 19 antibiotic, the more likely it will cause C. diff. 20 classical undergraduate teaching was clindamycin, 21 obviously, is the one which is notoriously known to 22 cause C. diff infection, but then we know that all 23 antibiotics, including, like, the simple one, we call it 24 amoxicillin, which is quite commonly used in the 25 community, can cause, you know, C. diff infection. 40 The 1 Q. At the relevant time, it was within your own knowledge 2 that these antibiotics could make a patient more 3 susceptible to C. difficile? 4 A. Definitely, yes. 5 Q. We touched earlier upon asymptomatic bacteriuria. Are 6 you able to assist the Inquiry on this: to what extent 7 do you think that junior doctors were aware that 8 a patient could present with asymptomatic bacteriuria? 9 A. I think that, you know, you need to wait for the 10 microbiology results to come back and to confirm that 11 there is, like, bacteriuria, and the patient is 12 asymptomatic, but most of the time, if you were to send 13 an MSU, which is midstream urine, for culture and 14 sensitivity, the patient would be symptomatic, and quite 15 often they justify, especially in women, a three-day 16 treatment with trimethoprim, but, you know, quite often 17 they would clarify the -- not only with this issue, but 18 a lot of other issues, we'd clarify the matter with the 19 microbiologist and see what they feel, whether this 20 growth of bacteria was significant or not, and most of 21 the time the microbiologist would come back and say, "Is 22 the patient symptomatic? 23 that is regardless of the number of bacteria they have. 24 25 Q. If he is, then treat", and Just to be clear on my question, to what extent do you think junior doctors were aware that a patient could 41 1 2 present with asymptomatic bacteriuria? A. I think that it's asymptomatic, the patient will not 3 have any symptoms, and quite often we don't send an MSU 4 sample for that reason, but if they are symptomatic and 5 there is some bacteriuria, then we will treat that. 6 I'm not sure about asymptomatic, because normally we 7 would not -- unless obviously there is an overwhelming 8 sepsis and you send cultures from everywhere -- sputum, 9 urine, blood, and so on -- and then, if the results come 10 back positive and we feel that the patient is having or 11 suffering from ongoing sepsis, then I still think we 12 will treat. 13 with the microbiologist to find out what they think. 14 But I think some of them were aware that there is 15 16 Well, we still discuss things sometimes asymptomatic bacteriuria. Q. This entity does exist. So you say some were aware. Was it within your own 17 experience of dealing with junior doctors that some 18 might not have been aware? 19 A. It's possible, to be honest. I mean, you don't test 20 everything with the junior doctors. 21 better than others, no question about that. 22 them are more knowledgeable and more interested. 23 I haven't asked, you know, specifically how many people 24 would know about this entity. 25 Q. Some of them are Some of Were there any restrictions in relation to the length of 42 1 time that an antibiotic could be prescribed without 2 review? 3 A. Without? 4 Q. Without review, yes. 5 A. You mean empirically? 6 Q. Yes, let's start with an empirical prescription. 7 8 9 When would you expect there to be a review of the antibiotic? A. So if you suspect there is an ongoing infection and you can't identify the source of the infection, you will 10 start empirically on antibiotic and, at the same time, 11 you culture, you send cultures or, before they start the 12 first dose of antibiotic, you try to culture everything. 13 It depends. 14 Normally, I would wait until I have the results of 15 the culture, and sometimes a blood culture can take -- 16 because they do subcultures -- more than two or three 17 days, four days sometimes, before we have the final 18 conclusion that there is no culture result, or there is 19 no bacteria being cultured. 20 21 So, basically, you know, by that stage, either the patient has improved or things have got worse. 22 MR KINROY: 23 LORD MACLEAN: 24 MR MACAULAY: 25 My Lord, I wonder if I might be allowed -Just a minute. Go on. I was just wanting to be clear about the answer to the question. When would you expect a review 43 1 to take place? 2 once the result of the culture had come through? 3 A. Would you expect a review to take place Yes, and also on the clinical response. So if we find 4 another cause for the patient's symptoms, then we might 5 say, "Look, this is not an infection. 6 something different which has caused these abnormal 7 blood results and the symptoms or the clinical features 8 of the patient". 9 Q. It is maybe Within the context of ongoing review, would you expect 10 the patient to be seen by the junior doctor at least 11 every day? 12 A. I would expect that, yes. That is what they do during 13 the -- because they are not involved in the clinics in 14 the mornings, so their duty is to see -- to do a ward 15 round on the day of the week when the consultant is not 16 doing the ward round. 17 ward 3, for example, so some of them are mine. 18 my ward round, they don't have to come back and do 19 the -- see the patients, because they would have seen 20 the patient with me, but if Dr McCruden's patients were 21 not seen by the consultant, by Dr McCruden, then I would 22 expect them to see the patient, yes. 23 LORD MACLEAN: 24 MR KINROY: 25 LORD MACLEAN: So there might be 30 patients in If I do Mr Kinroy? My Lord, I don't need to ask that question now. Thank you. 44 1 MR MACAULAY: Can I ask you a general question, 2 Dr Al-Shamma? 3 under reference to medical records you have had access 4 to in preparation for giving your evidence to the 5 Inquiry, do you consider that there was overprescribing 6 of antibiotics in the Vale of Leven at the relevant 7 time? 8 9 A. Not really. obviously. Only just looking at it in hindsight and I mean, you know, I have reviewed mine, I did not review all the medical records, 10 but I don't believe there was overprescribing of 11 antibiotics in that period of time, no. 12 DAME ELISH: My Lord, on that particular point, given that 13 my learned friend has mentioned hindsight and looking at 14 that period of time, could Dr Al-Shamma confirm that, if 15 we are looking back retrospectively, the patient profile 16 in the Vale of Leven changed after June 2008 and, 17 therefore, the proportion of elderly and acute patients 18 in the Vale of Leven in this period was different from 19 what took place later, if that is in the doctor's 20 knowledge? 21 22 23 LORD MACLEAN: Do you want to wait or are you going to go on to something else? MR MACAULAY: I am still on this topic, my Lord. 24 happy for that, if the doctor understood that. 25 understand that? 45 I am quite Did you 1 A. 2 3 No, I'm not sure about the change of the patient profile, I'm sorry, Dame Elish. Q. If we begin the discussion just post June 2008, we know 4 that, at about May/June 2008, it was realised there may 5 have been a problem in the Vale of Leven with 6 C. difficile? 7 A. Yes. 8 Q. Did the patient profile change, let's say, 9 between June 2008 and December 2008? 10 A. You mean the use of antibiotics? 11 Q. No, the patients, what patients you had in the hospital, 12 patients in the acute wards and rehabilitation wards: 13 did that remain generally the position, or did it 14 change? 15 A. I believe nothing changed, obviously, at that -- as far 16 as the admission at the medical assessment and the way 17 the admission was operating. 18 any major change at all. 19 Q. 20 21 I don't think there was But before you left the Vale of Leven Hospital, was there any change in the patient profile? A. Oh, yes, you know, because gradually we were, you know, 22 phasing out the closure or changing the profile of 23 the hospital and the profile of patients admitted. 24 gradually, the more ill patients were transferred to RAH 25 before coming to our hospital, but I don't think that 46 Yes, 1 happened immediately after the outbreak or after that 2 period, but gradually over the time because, ultimately, 3 we knew that there would be no anaesthetist cover for 4 the hospital, which is the case now. 5 to prepare ourselves -- or prepare the hospital for this 6 sort of profile. 7 Q. Therefore, we had If we focus, then, on the period of six months or so 8 after it was realised that there may have been a problem 9 at the Vale of Leven, did the practice in relation to 10 the prescribing of antibiotics change in that period? 11 A. It has, yes. 12 Q. What was the change? 13 A. Basically, there was very strict sort of guidelines, and 14 anything beyond the first-line antibiotic therapy needs 15 to be discussed with the microbiologist before, you 16 know -- unless, obviously, there are exceptional 17 circumstances, where you could see a patient with severe 18 pneumonia and he is very unwell, then you might jump to 19 the second-line treatment, but anything beyond that 20 would have been discussed with the microbiologist and 21 authorisation should come from the microbiologist. 22 Q. 23 24 25 Did that reduce the prescription of broad-spectrum antibiotics? A. That is, you know -- everything, you know, beyond, as I said, the first line of treatment would be authorised, 47 1 which would be a broader-spectrum antibiotic, yes, from 2 the microbiologist. 3 Q. I think you did probably, in that answer, broadly answer 4 my question, but the question I actually specifically 5 put to you was whether the change reduced the 6 prescription of broad-spectrum antibiotics? 7 A. It has, yes, in a sense, but, you know, that was coming 8 from the microbiologists, the full responsibility would 9 come from the microbiologists at that stage, yes. There 10 was more also to -- I add to that there was more sort 11 of -- the pharmacist was more, at that stage, basically 12 watching what antibiotic, and if there is something 13 which has deviated from the guidelines, they will come 14 and discuss that. 15 Q. The role of the pharmacist was something I did want to 16 discuss with you, and can I just explore briefly with 17 you the position as at 2007/2008? 18 pharmacist within the Vale of Leven at that time? There was a resident 19 A. Oh, yes, there was. 20 Q. Insofar as the pharmacist being involved in the 21 prescription of antibiotics, did the pharmacist play 22 a role at that time, or not? 23 A. Well, the antibiotic -- I mean, they would come and look 24 at the treatment in general if there is any drug 25 interaction, not necessarily with antibiotic. 48 If the 1 period of prescription of a certain drug has exceeded 2 the recommended period of time, they would also make 3 sure all the drugs are available on the ward. 4 wasn't, like, a strict input as what happened 5 after June 2008, where they would ring up immediately 6 and, you know, they would ask for a change of antibiotic 7 because that is not consistent with the strict 8 guidelines which were produced after the event. 9 MR MACAULAY: 10 11 But there My Lord, that might be an appropriate point to have a short break. DAME ELISH: My Lord, I am loath to postpone coffee for 12 everybody, but I wonder if I can provoke the Inquiry's 13 wrath by one additional issue about the change in the 14 regime for prescription of antibiotics, was that also 15 married with a change in the way in which the guidance 16 was brought to the attention of clinicians? 17 A. I mean, the guidelines, yes, the guidelines, yes, 18 I think, at that stage, we were made to sign for any 19 guidelines which was given to us, but before that, they 20 were sent in the post. 21 LORD MACLEAN: 22 23 You mean receipt of the actual guidelines, you had to sign for? A. The actual guidelines, so that when it is delivered by 24 the pharmacist, they would ask us to sign for it, just 25 to confirm that we have received the guidelines. 49 1 LORD MACLEAN: 2 (11.19 am) We will have a break. 3 (A short break) 4 (11.45 am) 5 MR MACAULAY: I want to ask you some questions now, 6 Dr Al-Shamma, about infection control. Were you aware 7 at the relevant time that there was an infection control 8 manual that was relevant to the Vale of Leven? 9 A. I was aware, yes. 10 Q. In relation to that, can we just clarify one point -- 11 before I come to that, can I just look at the contents 12 of it? 13 It is at GGC00780001. The particular policies in the manual I want to take 14 you to briefly are the C. diff policy that we find at 15 page 252, and you can see, Dr Al-Shamma, that this 16 policy is said to have been dated from October 2004 17 to October 2008. 18 C. difficile-associated diarrhoea and pseudomembranous 19 colitis policy. 20 the time? 21 A. If you read, it is described as Was this something you were aware of at I was aware of the pseudomembranous colitis policy, that 22 you need to wash your hand. 23 patient, you need to put gloves, gown when you see the 24 patient, yes. 25 Q. Following examining the Perhaps more specifically, do you know if you actually 50 1 ever looked at this particular document 2 before June 2008? 3 A. To be honest, I don't remember. I could have looked at 4 this document, but I know, you know, clearly the policy, 5 there is no question about that. 6 I have seen this document specifically or not. 7 Q. I'm not sure whether Just to take a point from the policy on page 256, the 8 box headed "Treatment", we see that towards the bottom 9 of the page, we read, first of all: 10 "If possible, discontinue all antibiotics." 11 So this is dealing with a patient who has been 12 diagnosed with C. difficile. 13 practice? Would that be good 14 A. It is a good practice, if possible, yes. 15 Q. At the very bottom, the very last point under this head: 16 "Do not give Imodium to control diarrhoea." 17 Would that be good practice, not -- 18 A. It is indeed, yes. 19 Q. The other policy I just want to take you to in this 20 manual is at page 258. 21 stools policy effective from March 2004. 22 also have another version, but I will just focus on 23 this. 24 25 A. Here you are looking at a loose I think we Did you look at this document before 2008? To be honest, I don't remember. I can't remember whether I have seen it specifically, but, again, I know 51 1 2 the guidelines for managing someone with a loose stool. Q. One of the guidelines in this document, if you turn to 3 page 259, it is the section headed "Accommodation 4 (patient placement)", can you see here that the advice 5 is to place a patient who could contaminate the 6 environment with faeces in a single room? 7 that as good advice? Do you see 8 A. I do, yes. 9 Q. If I can take you to your first statement, at 10 WTS00740001, and I think we touched upon this this 11 morning, if we go to paragraph 11 on page 3 of your 12 report, if I can just read what is written there, what 13 you say is: 14 "I am aware that following the outbreak there is an 15 infection control manual. 16 the infection control manual and I have no recollection 17 of ever seeing this document before. 18 knowledge if this was held on the wards at the relevant 19 time and do not believe there was any formal infection 20 control manual for staff at the time." 21 I have been shown a copy of I have no The suggestion there, if I read that correctly, is 22 that you were not aware of the manual or, indeed, did 23 not believe that there was any formal manual for staff 24 at the time. 25 I think, if we just leave that there and go to your 52 1 supplementary statement, and that is at WTS01850001, and 2 if we turn to page 3 of the supplementary statement, 3 paragraph 14, what is noted there is: 4 "I have been asked what was available on the wards 5 as guidance for infection control between January 2007 6 and June 2008. 7 infection control manual which was available on all the 8 wards. 9 the main reference document for infection control." 10 As far as I am aware, it was the I am sure that it was used by the staff and was I think you may agree, Dr Al-Shamma, these two 11 statements don't quite square up. 12 position, so I can understand, in your evidence? 13 A. What is the real Well, I was shown the infection control, you know, 14 manual at the -- you know, when I gave my statement, 15 and, you know, I was told that it was there available, 16 so I believe it was available. 17 that I have seen it, but I did see it on the day, 18 obviously, with the Inquiry team, but I'm aware of all 19 the guidelines anyway with regard to the C. diff or 20 loose stool or other infective conditions. 21 I have no recollection So it is difficult to remember what you have seen 22 and what you have not seen. 23 available, then it would have been on the ward available 24 for the nurses, but I think it is more for the juniors, 25 rather than for the seniors. 53 I mean, if that was That is my comment. I'm 1 afraid I don't have much, because there are so many of 2 these manuals and, you know, formulary and it is 3 difficult to remember what was available. 4 I have seen it, yes, but that probably was after 5 rather than before, and it is difficult for me to 6 remember everything at this stage. 7 Q. 8 9 Can I ask you this: had you, yourself, received any training in infection control prior to June 2008? A. No, there wasn't any sort of infection control training, 10 but, you know, you just have to educate yourself and 11 look at the guidelines and changes which happen, and 12 basically, it was all available on the internet, you 13 know, if there is an outbreak of a disease you will get 14 something, either hard copy -- I believe, at that time, 15 there was hard copies, rather than internet. 16 messages about how you try to prevent the spread of 17 the infection and what, basically, advice you get. 18 You get But, I mean, as far as diarrhoea and C. diff, we -- 19 I knew about it for a long period of time, and since 20 probably I was a medical student, and during the period 21 you get continuous sort of update, but there was no -- 22 definitely there was no infection control proper 23 training before June 2008. 24 25 Q. There are two documents I'd like you to look at for me, then, and the first is at INQ03020001. 54 This bears to be 1 a presentation. 2 Clostridium difficile", and it is dated January 2007. 3 I think the suggestion is that this presentation was 4 given by Dr Weinhardt, who was one of 5 the microbiologists at the Royal Alexandra Hospital. 6 The title is "Update on If you turn to page 10 of the document, you will see 7 here that there is a section dealing with risk factors, 8 and a number of bullet points, including reference to 9 antibiotic use, has been highlighted. 10 On page 12, there is also some information given about treatment. 11 The suggestion, I think, is that this was 12 a presentation made by Dr Weinhardt in the early part of 13 2007. Do I take it that you were not present? 14 A. I wasn't, no. 15 Q. The other document I want you to look at is at 16 INQ03010001. 17 'A Tale of Two Hospitals'". 18 a hospital in Quebec and also the hospital in 19 Stoke Mandeville that I asked you about earlier. 20 This is headed "Clostridium difficile: We see reference to Again, I think the suggestion is that this 21 presentation may have been presented by an infection 22 control nurse at about the same time. 23 again, that this was something you had not seen before? Do I take it, 24 A. No, I have not, not this presentation, no. 25 Q. You will see the presentation, this particular one, is 55 1 making reference to Stoke Mandeville and a number of, 2 I think, propositions have been taken from the 3 Stoke Mandeville Hospital outbreak, and these are set 4 out -- I needn't take you to them -- in different parts 5 of the presentation. 6 I will perhaps take you to page 4, just to give an 7 example, where the points raised relate to the 8 environment and facilities, including lack of 9 hand-washing facilities and lack of side rooms. 10 Looking to the internet, did you not become aware 11 that there had been an outbreak at Stoke Mandeville, for 12 example, some time prior to 2007? 13 A. No, I wasn't aware of this document at all. 14 Q. Or of the outbreak at Stoke Mandeville? 15 A. Or what, sorry? 16 Q. Or of the outbreak that had occurred at 17 Stoke Mandeville? 18 A. No. 19 Q. What knowledge did you have of an infection control 20 nurse presence in the Vale of Leven at the relevant 21 time? 22 A. I was aware there was an infection control nurse who 23 comes from Paisley, and my involvement with her was 24 mainly with suspected cases of pulmonary tuberculosis, 25 and she was an infection control nurse from 56 1 Royal Alexandra Hospital. 2 Helen O'Neill was on the ward available, but that is 3 what I was aware of, yes. 4 Q. 5 I was aware that If I take you back to your statement at WTS00740001, paragraph 14 on page 3, what you say there is: 6 "At the time of the outbreak, I believe there was an 7 infection control nurse who was based at the 8 Royal Alexandra Hospital in Paisley but would attend the 9 Vale of Leven Hospital if required." 10 Do I take it from what you have just said that, 11 notwithstanding that, you did know there was an 12 infection control nurse presence in the Vale of Leven 13 itself? 14 A. I think I was referring mainly for the tuberculosis in 15 this paragraph, because that's my main contact with the 16 infection control, where, you know, you need to discuss 17 things with them, but I believe I was aware that Helen 18 was available. 19 obviously. You don't see them because they are based in 20 an office. They would only come as and when required. 21 22 23 Q. But I don't see her all the time, Just while we have that section of your statement in front of us, at paragraph 13, you say: "I understand an outbreak, with particular reference 24 to C. diff, to be two or more cases on a ward where the 25 patient has not been admitted with the condition." 57 1 2 What was the source of that information? A. 3 4 I believe books, epidemiology books on what constitutes an outbreak. DAME ELISH: My Lord, I wonder if my learned friend could 5 clarify that, when this witness provided his statement, 6 was that question put to the witness, as to whether or 7 not he understood that that constituted an outbreak, or 8 was it an open question to elicit the knowledge of 9 the witness? 10 MR MACAULAY: 11 A. Yes, can you help on that? That was a question which I was asked during the 12 Inquiry, what's my understanding of an outbreak. 13 a specific question and I gave them the definition, to 14 the best of my knowledge, of what an outbreak is. 15 Q. It was In the infection control manual that we looked at 16 earlier there is a policy described as an outbreak 17 policy. 18 GGC00780145. 19 Perhaps I can take you to that. It is at Here we have a policy prescribed as an outbreak 20 policy, certainly dated from December 2007. 21 a document you had looked at prior to June 2008? 22 A. 23 24 25 Probably I have. Was this I don't remember, to be honest with you. Q. I had asked you what infection control training you had received prior to June 2008, and I think you had 58 1 indicated you had received no formal training. 2 the position been since then? 3 A. What has We had a formal sort of training in infection control. 4 It was done. I remember the name of the girl who did 5 the -- it was Helen O'Neill. 6 sort of, training covering hand hygiene and, you know, 7 all the issues regarding C. diff as well. It was about two hours', 8 Q. Can you assist me and tell me when that was? 9 A. I think it started after the event, and there was -- it 10 was running over a period of time, and I can't remember 11 exactly, but it would have been towards the end of 2008 12 when I attended. 13 session, so that would give us a chance to -- all the 14 employees to come and have a chance to listen. There was more than one training 15 Q. Did you find that beneficial? 16 A. I think so, yes. 17 Q. So far as C. difficile is concerned, at the relevant 18 time, did you see C. difficile infection as an important 19 clinical diagnosis in its own right? 20 A. Certainly it is, because there are so many complications 21 which can arise from the C. diff infection. 22 definitely it is important. 23 Q. 24 25 I take it you were aware that toxic megacolon was a potential consequence of the condition? A. Yes, Yes, I was. 59 1 MR KINROY: My Lord, I wonder whether we should clarify the 2 evidence. 3 the relevant time that C. diff infection is an important 4 clinical diagnosis in its own right?" and the answer 5 was, "Certainly it is", which I don't think quite met 6 the question. 7 LORD MACLEAN: 8 A. 9 LORD MACLEAN: 10 The question was, "Was Dr Al-Shamma aware at Do you understand the question? No, I'm sorry. Were you aware at the time that it was an important diagnosis? 11 A. Yes, I was, indeed. 12 LORD MACLEAN: 13 MR MACAULAY: That is what I thought. Thank you. To touch on something you mentioned earlier 14 this morning, I think if you wanted to obtain input from 15 a microbiologist, the microbiologist could be contacted 16 at the Royal Alexandra Hospital; is that right? 17 oncall microbiologist? The 18 A. The oncall, yes. 19 Q. This morning I think the suggestion you made -- you can 20 correct me if I am wrong -- was that, generally, it 21 would be the junior doctor who would do that? 22 A. The middle grade ones, yes. 23 Q. Do you recollect, yourself, during the relevant period, 24 having any contact with a microbiologist in connection 25 with a case involving a patient who had C. diff? 60 1 A. I don't remember, no. 2 Q. Were you working at the Vale of Leven Hospital when you 3 had a resident microbiologist in the hospital, and 4 I think particularly it was Dr Stephanie Dancer? 5 A. Yes, I was. 6 Q. Did that make a difference, from the point of view of 7 8 accessibility, from your perspective? A. 9 Yes, a great deal of difference, because Stephanie Dancer was a clinical microbiologist. She was 10 available on the ward a lot of times. 11 with the care and management of the patients. 12 continue to give advice. 13 the single rooms, the availability of single rooms, and 14 the availability of private facilities in the single 15 rooms, the ventilation of the single rooms and the 16 sinks, you know, the way you wash your hands, all that. 17 Then she was actively involved in the care of patients 18 as well. 19 conversations with Dr Stephanie Dancer when she was in. 20 Q. 21 22 25 She would She had a lot of input towards So I had many, many contact with her, many Can you remember when Dr Dancer left the Vale of Leven Hospital? A. 23 24 She was involved No, I don't remember, but probably 2004 or 2005, but, to be honest, I don't remember the exact date. Q. After she left, do I take it from your evidence that your contact with microbiologists significantly 61 1 2 diminished? A. That's correct, yes, because they were not available 3 onsite and they were not available to see the patients 4 and to take an active role in their management, yes. 5 Q. 6 7 But did you, from time to time, have a microbiologist who would come onsite or not? A. To be honest, I have only seen once -- whether that was 8 during this period or before or after, I don't remember, 9 but I have only seen once Dr De Villiers on the ward, 10 but he wasn't involved in management of a patient of 11 mine. 12 a T-SPOT test, which is a special test for tuberculosis, 13 but I don't remember seeing him -- seeing any 14 microbiologist on the ward. 15 Q. I think he was showing how to take blood for Do you have a view on this, Dr Al-Shamma? Do you 16 consider that, from the point of view of patient care, 17 it is desirable to have microbiologists on the ward or 18 present in the hospital? 19 A. I think it is essential to have a microbiologist, and 20 I would like to see a clinical microbiologist who is 21 actively involved, who is quite happy to come and see 22 patients, and actively involved in their management, 23 especially the very toxic septic patients, and would 24 provide advice and provide -- regarding, you know, 25 further investigation and further management. 62 Then 1 I would have a great trust in the microbiologist, in 2 what the advice of the microbiologist is. 3 Q. After Dr Dancer left the Vale of Leven Hospital, then, 4 the kind of input that you have described that was 5 obtained from her, was that then lacking or how was that 6 managed? 7 A. It came to an end, obviously. There wasn't much input 8 from a microbiologist, the clinical one, obviously. 9 tried her best so far as the private rooms, the private 10 11 She facilities and the basin and sinks. Q. Do you know if any concerns were expressed? Did you 12 express any concerns about there not being a resident 13 microbiologist in the Vale of Leven? 14 A. That would probably have been, you know, discussed at 15 the medical division meeting. 16 concerns at that time, obviously. 17 Q. 18 Yeah, we all raised our Yes. Is that something one would again explore with Dr McCruden? 19 A. I think so, yes. 20 Q. So far as the management of a patient with 21 Clostridium difficile is concerned, do you consider 22 that, if it is at all possible, such a patient should be 23 isolated? 24 A. Definitely, yes. 25 Q. Isolation -63 1 A. Single room. 2 Q. In a single room? 3 A. With private facilities. 4 Q. Did you have any view at the time in relation to the 5 6 availability of single rooms at the Vale of Leven? A. Yes. I mean, there are single rooms in ward F. There 7 is more than one single room -- a few single rooms in 8 ward F, which is the rehab ward, and quite often, if 9 patients require isolation, they have to go to ward F. 10 There are a couple of single rooms in ward 6 and ward 3, 11 I think two on each ward -- one I think in ward 3 and 12 two in ward 6. 13 have changed the structure, but, yes, there was some 14 single rooms, yes. 15 Q. 16 17 I can't remember the details now, they Did you consider you had sufficient by way of single rooms, again at the relevant time? A. Again, at times you feel, you know, when there is 18 a pressure on you, there might not have been enough 19 single rooms, but I believe that happens in all 20 hospitals when you have an outbreak. 21 Q. Did you consider that a clinical assessment of 22 the patient to assess the severity of C. difficile was 23 important at the relevant time? 24 25 A. Yes. It is always important, not only at the relevant time, but at any other time it is important, yes. 64 1 Q. How would you approach, then, the assessment of 2 the nature of the infection, whether it would be 3 categorised as severe or not, at the relevant time? 4 A. You go by the history first, the frequency of the bowel 5 motions, the size of the motion. Then you go -- that's 6 by history, and the duration as well is important. 7 you go by clinical examination, see if the patient was 8 hypotensive, peripherally shut down, tachycardic, 9 febrile, and then you look at the abdomen and see it, Then 10 make sure it is soft, it is not distended or tender, and 11 then you go by the -- this is all clinical criteria, 12 history and physical examination. 13 results, biochemical criteria, to see if the patient has 14 developed acute kidney injury as a result of the low 15 blood pressure and decreased kidney perfusion, and you 16 go by the CRP, which is an inflammatory marker, 17 C-reactive protein and, you know, you go by all these 18 criteria and look at the -- and then you can assess the 19 severity. 20 Q. You go by the blood Was it your practice at the relevant time to employ 21 these criteria to allow you to assess the severity of 22 the infection? 23 A. 24 25 Yes. Yes, I mean, up to an extent, obviously, as much as time can allow me, yes. Q. To what extent did you consider at the time that fluid 65 1 and nutritional management were important aspects of 2 the care of a patient with C. diff? 3 A. It is quite important, very important, to make, you 4 know, a good fluid -- make sure a good fluid balance is 5 maintained and good nutrition, because they tend to lose 6 protein from their GI tract and, you know, maintain -- 7 the vast majority of the time it is a short -- unless it 8 is a relapsing chronic C. diff infection, it is a short 9 sort of illness, and you would hope that treatment -- 10 with the right treatment, you will overcome the 11 infection. 12 Q. As a matter of practice, did you, on your ward rounds, 13 check the fluid balance charts that were being 14 maintained by nursing staff? 15 A. In severe cases, yes, I would always look. For those 16 with mild, really, and where their oral intake is 17 satisfactory, then probably I would not. 18 I mean, fluid balance is more important when you have 19 multi-organ failure. 20 kidney failure and he became hypotensive, yes, it is 21 essential, because it is a delicate balance at that 22 time, at that stage, to treat, you know, or to look at 23 the fluid balance and maintain a good fluid balance, not 24 to over- or under-hydrate the patient. 25 Q. It depends. Like, if the patient has developed If you have an elderly patient who develops 66 1 C. difficile, might such a patient become dehydrated 2 quite quickly and, therefore, is it important to ensure 3 that fluid balance is being maintained? 4 A. Yes, that's correct, especially if they have a comorbid 5 condition, like a degree of chronic renal disease or 6 heart failure. 7 Q. 8 9 Yes, it is important. At the relevant time, did you form any view on how well the nursing staff were maintaining fluid balance charts? A. I think yes, reasonably good, yes, for ill patients, for 10 really sick patients. 11 you know, then it could be some, because they -- it's 12 always -- there's, like, a delicate balance between when 13 you have to maintain a very accurate, precise fluid 14 balance chart. 15 eating and drinking, you might not be able to monitor 16 precisely the amount of fluid he is taking or losing, 17 but, yes, for ill patients, I think the fluid charts in 18 my patients were reasonable. 19 Q. As I said, in less ill patients, When you think the patient is improving, What about stool charts, then? You did mention that 20 assessment of the amount of bowel products I think was 21 something you would look at. 22 maintenance of a stool chart as something that would be 23 important in the management of a C. diff patient? 24 25 A. Would you see the In the relevant period, I did not look for a stool chart. I will ask the nurse to tell me, you know, more 67 1 about the frequency, the quantity and the consistency of 2 the stool. 3 that time. 4 Q. 5 6 So I did not look at the stool charts at So far as you understood, were stool charts being maintained by the nursing staff? A. The answer is, I don't know, because I don't look at 7 them. 8 consistency of the stool, and obviously of the oral 9 intake if the patient started to eat. 10 Q. I would only ask the nurse about the frequency, If you were to attend a patient who had been diagnosed 11 with C. difficile at the relevant time, would you use 12 personal protective equipment in doing so? 13 A. I will always do that. Whether the patient has been 14 confirmed to have C. diff or is only having diarrhoea of 15 unconfirmed cause or origin, I would still use, yes, the 16 personal protective equipment, definitely. 17 Q. What would that involve? 18 A. That would involve gloves and apron. 19 Q. At that time, did you have any knowledge as to how 20 possible it might be that a result of a stool specimen 21 might, in fact, be a false negative? 22 A. Yes, I was aware of that, and that's why I would not be 23 satisfied with one stool sample. 24 say, "Send another stool sample for C. diff". 25 Q. Quite often, I would In relation to the treatment of C. difficile, and by 68 1 that I mean the antibiotic treatment, what was your 2 general practice at the relevant time? 3 A. Using metronidazole as a first-line treatment. 4 Q. Would that generally be after diagnosis? 5 By that, I mean after the positive result from the lab? 6 A. Yes. 7 Q. Would you consider starting metronidazole if there was 8 9 a high suspicion of C. difficile? A. 10 At that time, no, but at the present, yes, I have changed my practice. 11 Q. What has caused you to change your practice? 12 A. Just because there is more evidence now. I think a lot 13 of microbiologists agree that -- well, and clinicians 14 agree that starting treatment -- which would do no harm, 15 to be honest, metronidazole for a day or two until the 16 result is positive, and then I will, yes. 17 Q. How, then, would you review -- 18 DAME ELISH: 19 LORD MACLEAN: 20 DAME ELISH: 21 MR MACAULAY: I wonder, my Lord, if my learned friend -Just let him finish his question. Certainly. If I just move on to one point, if you started 22 a patient on metronidazole, what sort of review would 23 you carry out on the patient to see whether or not the 24 metronidazole was being effective? 25 A. In a positive case? 69 1 Q. Yes. 2 A. Basically, see the clinical response, see if the 3 diarrhoea has stopped, has improved, the blood pressure 4 has improved, the abdomen remains soft, and also 5 important the biochemical profile, to look at the urea 6 and creatinine and the electrolyte disturbances. 7 Q. Looking at the timescale that might be involved, then, 8 if you had a patient who was on metronidazole and, at 9 a point in time, it was clear that it was not being 10 effective, how long would you give before you would make 11 a decision to perhaps change the therapy? 12 A. I would expect some improvement within 72 hours, and if 13 that is the case, I would continue, but if, after five 14 days, the patient is no better, then probably I would 15 consider discussing things with the microbiologist. 16 Q. Was that your practice at the time? 17 A. That was my practice, yes. 18 Q. But in relation to a discussion with the microbiologist, 19 do I take it from what you said earlier that it would be 20 the junior doctor who would, in fact, carry out the 21 discussion? 22 A. The middle grade, yes. 23 Q. The middle grade. 24 25 I'm sorry, I interrupted. DAME ELISH: My Lord, regarding the earlier point on 70 1 empirical prescription on suspicion of C. difficile, 2 could my learned friend confirm with the witness whether 3 or not he was aware of Dr Warren's contrary view 4 regarding the empirical prescription on suspicion only, 5 as given to this Inquiry? 6 LORD MACLEAN: 7 MR MACAULAY: 8 A. 9 Mr MacAulay? Have you any knowledge of any other evidence? At that time, that wasn't my practice, to start metronidazole immediately if I suspect C. diff 10 infection. 11 weeks ago, two weeks ago, who had diarrhoea and she had 12 finished a course of antibiotics in the community, and 13 there was another case of positive C. diff in IRH, so 14 I said, let's -- because the suspicion ended, she put 15 everything together, there was another case in the ward, 16 the patient had a course of antibiotics, she was 17 severely ill with severe COPD, I felt, you know, it 18 would be appropriate to start metronidazole for a day or 19 two until we had the results, and the results indeed 20 came back negative and we stopped the metronidazole. 21 But that is a change of practice. 22 practice at that time. 23 Q. Now, I had a case in IRH just a couple of That wasn't my If there was a recurrence or relapse of C. diff, what 24 was your practice at the time in relation to drug 25 therapy? 71 1 A. 2 3 Usually, start vancomycin. That is, after the second episode of C. diff, you start vancomycin right away. Q. What was your view as between vancomycin and 4 metronidazole as to effectiveness? 5 view as to whether or not, for example, vancomycin was 6 superior to metronidazole as a therapy? 7 A. Did you have any It is indeed superior, but you try to, you know, start 8 with the -- it is very effective, metronidazole, but you 9 try to start with that and reserve vancomycin for the 10 more severe infections, or relapsing infections. 11 Otherwise, if you treat everybody with vancomycin, you 12 get to a stage where, you know, when the disease is 13 relapsing, you have very little to offer the patient, 14 apart from perhaps immunoglobulin, which is still of 15 doubtful significance. 16 Q. I think we perhaps touched upon this earlier, but if you 17 had a patient who was confirmed to be positive for 18 C. diff, what was your practice generally in relation to 19 dealing with any other antibiotic treatment that the 20 patient might have been on at the time? 21 A. It depends, but if I feel that the toxic state is the 22 result of the C. diff, I will stop the antibiotic, and 23 it is always a difficult, you know, sort of medical 24 decision, it is not an easy one. 25 it, you know, twice, thrice, until I make sure that that 72 I tend to think about 1 is the right decision, but there are circumstances where 2 I know the site of the infection is not the GI tract or 3 C. diff infection, and I would have continued with the 4 antibiotic and treat the C. diff infection at the same 5 time, just to act for the best interests of the patient. 6 If your clinical impression is that the infection is 7 more serious than the -- or the underlying infection 8 which you have identified and diagnosed will cause more 9 harm to the patient than the C. diff infection, then you 10 11 would continue with the antibiotic. Q. If there was a positive result for a patient under your 12 care for C. diff, was it your practice to have that 13 recorded in the clinical notes? 14 A. You try your best, yes. Yes. But most of the time, it 15 would have been recorded by the juniors, but if it 16 happened, you know, like you were on the ward round and 17 just get a phone call that this is a positive C. diff, 18 yes. 19 Q. At the relevant time, to what extent were you aware -- 20 if we take ward 6, for example, which I think was one of 21 the wards that you might visit -- that there were 22 a number of patients at different times who were 23 suffering from C. diff? 24 A. At different times, or at the same time? 25 Q. Well, at the same time. 73 1 A. At the same time, I wouldn't have been aware, you know, 2 because -- we said before that we all share the beds in 3 ward 3, ward 6 and ward 4, so if I were to come and see 4 my patients, I would not see other consultants' 5 patients, so I wouldn't be aware if -- like, if I have 6 a C. diff patient, that there would be other patients on 7 the ward with C. diff infection. 8 Q. 9 would you ask the nurses on the ward if there were any 10 11 But if one of your patients was diagnosed with C. diff, other patients who may have C. diff at about that time? A. 12 No, that wasn't my practice. It is my practice now, but it wasn't, at that time, my practice. 13 Q. Why have you changed your practice? 14 A. Because we are more aware, obviously, of C. diff. Like, 15 as I said, that patient who was in IRH, I started him 16 on -- started her on metronidazole, I specifically asked 17 the nurse if there was another case, and she said 18 "Yes" -- the ward is shared between respiratory and 19 gastro, and she said, "Yes, there is one who has 20 acquired the infection in hospital", so then I put 21 everything together and I felt the suspicion index is 22 high at that stage, at that time, which is two weeks 23 ago, and I started, but, no, that wasn't my practice 24 I should admit, yes, that is true, but -- it might not 25 be the best practice, but I do accept that, but I do it 74 1 2 now, yes. Q. I think you're aware that, in about May or June 2008, it 3 was appreciated that there had been a number of patients 4 who had suffered from C. diff in the Vale of Leven. 5 I take it from your answer that you had not become aware 6 of there being a problem with C. diff until about that 7 time? 8 A. That's correct. 9 Q. Were you at all aware that there were incidences of Do 10 C. diff in the hospital, let's say from December 2007 11 through to May 2008? 12 A. No, I wasn't. I believe a lot of cases happened in care 13 of the elderly wards, which are at the other end of 14 the hospital, and we don't visit them at all unless 15 there is a patient who is -- unless there is a request 16 for a consultation for a difficult respiratory case and, 17 therefore, no, I wasn't aware that there was multiple 18 cases of C. diff in wards 14/15 because we don't go 19 there, we don't see the patients there. 20 Q. Were you aware if there had been a number of cases of 21 patients suffering from C. difficile in ward 6, which 22 I think was one of the wards you would visit? 23 A. No, I wasn't aware of that. 24 anyway. 25 cases of C. diff. Certainly not my patients, But, no, I wasn't aware that there was multiple 75 1 DAME ELISH: I wonder, my Lord, if my learned friend could 2 clarify, when he asks the witness if he was aware, 3 whether or not he is referring to contemporaneous 4 conditions or whether it was over a period sequentially, 5 or an extended period, if he was aware? 6 LORD MACLEAN: 7 MR MACAULAY: I don't know what that means. It may be I haven't made it clear. But I am 8 always, as you have probably gathered, focusing on the 9 relevant period, that's from January 2007 through 10 to June 2008, and more recently I have been asking you 11 questions that focus on December 2007 to May 2008, in 12 particular in relation to ward 6. 13 I had understood you to say you had no awareness of 14 there being a number of cases of C. diff during that 15 period. 16 A. Have I understood that correctly? I wasn't aware, I mean, except of my patients, 17 obviously, I would have been aware. 18 expected, obviously, that if we had an infection control 19 consultant or we had somebody to raise the issues, but 20 myself, I wasn't aware of that, no. 21 22 MR MACAULAY: I would have I don't know whether that has clarified my learned friend's point, or not. 23 LORD MACLEAN: 24 DAME ELISH: 25 LORD MACLEAN: Is that what you meant by the question? Yes, my Lord. So if I understand you correctly, because you 76 1 talked about the "outbreak" -- we have yet to determine 2 what that really means, actually, in the context of 3 the relevant period -- but you were not aware of an 4 outbreak at the Vale of Leven Hospital until May 5 or June 2008 because you were looking at C. diff only 6 through those patients that you had? 7 A. 8 9 Yes, that's correct. I only look after my own patients. I don't look after other consultants'. LORD MACLEAN: I appreciate that, but you didn't become 10 aware that there was a serious state of affairs in the 11 hospital, so far as C. diff was concerned, until May 12 or June 2008? 13 A. Yes, I wouldn't have been aware that there is more 14 than -- I mean, obviously, I gave a definition, but that 15 is only a definition from textbooks, but I -- you know, 16 I don't believe I had two patients at the same time with 17 positive C. diff, so I wasn't aware of that, no. 18 I had, probably I would be more concerned, but, no, 19 I wasn't aware. 20 MR MACAULAY: If Did you at all discuss any patient of yours 21 who had C. diff with the infection control nurse? 22 have mentioned Helen O'Neill as someone who held that 23 position. 24 25 A. You No, because most of them, as far as I remember, as I can see from the case notes, they were mild when they were 77 1 under my care, and there weren't that many, to be 2 honest, under my care, when we come to discuss the 3 cases, and most of them were responding to treatment and 4 there were -- you know, the proper precautionary 5 measures have been taken. 6 a need to discuss things with Helen O'Neill, or 7 infection control. 8 MR KINROY: 9 So I did not feel there was My Lord, I wonder if we can clarify what were the proper precautionary measures which had been taken, 10 according to Dr Al-Shamma's knowledge? 11 LORD MACLEAN: 12 A. Yes, what were they? As far as I remember, all the patients who had C. diff 13 under my care were in a single room and nurses and 14 doctors were taking the required precautionary measures, 15 using the personal protective equipment. 16 MR MACAULAY: 17 One of the patients that I think was under your care was Mrs Valentine; is that correct? 18 A. That's correct, yes. 19 Q. I think she remained under your care for a considerable 20 part of her time in the Vale of Leven; is that correct? 21 A. Yes, that's correct. 22 Q. I know you have spent some time looking at her medical 23 records, and I do propose to look at the detail of that 24 with you, but she did test positive for C. diff 25 in February 2008; is that correct? 78 1 A. 2 3 21 February, following colonoscopy, yes, she was found to have C. diff colitis, yes. Q. I will look at the report from the lab in a few moments, 4 but did you not consider when you discovered that your 5 patient, Mrs Valentine, had tested positive for C. diff, 6 as to how she had contracted the infection? 7 A. This lady, she had problems with her bowel for a couple 8 of weeks prior to admission. She was suffering from 9 loose motions from 23 January, and she was seen by 10 Dr Carmichael, who arranged or organised a colonoscopy, 11 and she was also known to suffer from rheumatoid 12 arthritis and polymyalgia rheumatica, and she was on 13 prednisolone for -- long-term prednisolone for 14 polymyalgia rheumatica, which obviously would compromise 15 her immune system. 16 When she was admitted, the reason for her admission 17 was high calcium level, which was extremely high, it was 18 3.3 or something. 19 high level of calcium in her blood, and this required 20 immediate attention. 21 Q. 22 This, in medical terms, is a very I'm sorry to interrupt you, and I do want to look at the detail of the patient with you in due course -- 23 A. Sorry, okay. 24 Q. -- but my specific question was -- I was using 25 Mrs Valentine as an example; there are other examples 79 1 I could use -- once you knew one of your patients did 2 test positive for C. diff, did it not occur to you to 3 consider how it came to be that that patient contracted 4 the infection? 5 A. As I said, this lady had bowel problems before 6 admission, so she could have like a chronic relapsing 7 C. diff because she was seen by Dr Carmichael prior to 8 admission for loose bowel motion. 9 thought it's cancer of the colon, because I was trying So when -- and we 10 to say that the commonest -- by far, the commonest cause 11 of high calcium is cancer and, basically, we were 12 focusing on that. 13 the colon, which probably has caused the high calcium 14 after it has spread outside the colon, and as a result 15 of that, we were not thinking of C. diff. 16 LORD MACLEAN: 17 A. We thought she had cancer of But she did have C. diff? Yes, but that is only after she had the colonoscopy, 18 when Dr Carmichael looked at her colon and he found 19 extensive pseudomembranous colitis at that stage. 20 whether she had a chronic relapsing C. diff, she 21 acquired it in the community before she came into 22 hospital -- it is difficult to say, but that is 23 a possibility, but then there is other causes for 24 C. diff infection obviously in this case. 25 MR MACAULAY: So Again, I used her as an example, but it is 80 1 a general question I am putting to you, because there 2 were other patients you saw in the hospital over this 3 period of time, particularly from December through 4 to May, who had C. diff. 5 putting to you is: did you not consider how it came to 6 be that the particular patient you were dealing with 7 contracted C. diff? 8 A. 9 Multiple causes. The general question I'm Obviously, the commonest cause is antibiotic, use of antibiotic, but age, presence of 10 cancer, immunosuppressive therapy, like prednisolone, 11 all these can cause C. diff as well. 12 Q. The Inquiry has heard that a significant, if I can put 13 it in that way, cause of C. diff is a combination of 14 antibiotics and the ingestion of spores? 15 A. That's correct. 16 Q. Did it occur to you -- this is really what I am putting 17 to you -- once you had come across one of your patients 18 who was seen to have contracted the infection, whether 19 or not that patient had contracted the infection from 20 another patient in the ward that you were dealing with? 21 A. It's always a possibility, obviously, but, you know, 22 there are patients who are carriers of C. diff, there 23 are things which you can acquire in the community 24 before, and it is possible that she has acquired it in 25 hospital, but, you know -- it is a possibility, yes. 81 1 Q. But what is the answer to my question, then, which was: 2 did it occur to you at the time that the patient that 3 you were dealing with may have contracted the 4 C. difficile infection in the hospital? 5 A. May have, yes, but not in this particular patient, 6 because she had the loose bowel motion prior to 7 admission. 8 Q. 9 But in relation to any patient, did you consider that this patient may have contracted the infection in the 10 hospital? 11 A. May, yes, it is possible. 12 Q. Did that occur to you at the time? 13 A. It's possible -- oh, yes. 14 Q. Did that cause you, as far as you can tell, any concern 15 that there might have been some cross-contamination 16 within the hospital? 17 A. When you see one case, you know, it's possible, but you 18 see C. diff all the time. It is not only in that 19 relevant period. 20 in IRH, but that doesn't mean, you know, you would -- 21 yes, it's possible that she has acquired it from the 22 hospital environment, but at the same time, you know, 23 you just have to treat and hope that the patient will 24 improve. 25 Yes. I mean, as I said, we just had a case It is a combination of more than one factor. It is possible, yes, is the answer to that, yes. 82 1 Q. 2 I think you did say to me that you did consider at the time C. diff to be a serious infection? 3 A. It is indeed, yes. 4 Q. I think I have seen, even in the Inquiry here, it can 5 lead to death? 6 A. It can. 7 Q. It can be fatal. Did it at all occur to you at the 8 relevant time, if you had a patient who had contracted 9 C. diff, whether or not that had happened within the 10 11 hospital? A. As I said, we see C. diff all the time and, basically, 12 the -- it is possible that these spores were acquired in 13 hospital, but it is also possible they were acquired in 14 the community and, basically, you hope to treat the 15 patient and make sure the patient will not spread the 16 infection to other patients in the ward. 17 Q. 18 But was it part of your thought process at the time that this patient may very well have been cross-contaminated? 19 A. It's possible, yes. 20 Q. No, but was it part of your thought process at the time 21 that this patient may very well have been 22 cross-contaminated by another patient in the ward or in 23 the hospital? 24 25 A. Well, spores are present in the environment, in the hospital, yes, it is possible. 83 1 2 3 Q. Can I move on to something associated with that, and that is this -- DAME ELISH: My Lord, before my friend moves on to that 4 point, regarding the doctor's state of awareness of 5 C. difficile and how serious a matter it was, I wonder 6 if my learned friend could explore with the witness what 7 his own experience of C. diff had been up until that 8 point, and whether it had been as serious in its 9 consequences as eventually it turned out to be in this 10 11 12 13 outbreak, given what the witness has indicated. LORD MACLEAN: He wasn't aware it was serious until May or June 2008, whatever his previous experience. DAME ELISH: Yes, my Lord, but the witness has given an 14 indication of his understanding of what the nature of 15 C. difficile was at that time and confirmed that, at 16 that time, he understood it could be a serious illness, 17 but in terms of the witness's own experience, which he 18 said they were treating C. difficile all the time, 19 whether or not it had proved to be as serious in terms 20 of its outcome as we know it was in this outbreak? 21 is particularly relevant regarding the ribotype which 22 was identified. 23 MR MACAULAY: This If I can put it to you, I think you agreed 24 with me that you looked upon C. difficile, at the time 25 we were talking about, as a serious infection? 84 1 A. Yes, that's true. Yes, it is true. 2 Q. Looking to any previous experience you had of 3 C. difficile in the Vale of Leven Hospital, did you also 4 look at the infection previously as a serious matter? 5 A. It's always a serious matter, yes. We see C. diff all 6 the time. 7 period, but C. diff was there. 8 antibiotic is the likely cause of the C. diff. 9 see it. 10 11 I mean, it is not only during that particular I mean, we know that We do I mean, it wasn't the first time and it's not going to be the last time we see C. diff infection. Q. We have been focusing here on the period, of course, 12 2007 through to 2008, and I think your evidence is that, 13 certainly, during that period, you looked upon 14 C. difficile as a serious infection that could lead to 15 death? 16 A. That's correct, yes. 17 MR KINROY: My Lord, I wonder if I can clarify this? 18 I think we may be at cross-purposes. 19 said, "We see C. diff in the hospital all the time", and 20 I think the issue here may be: did Dr Al-Shamma suspect 21 at the time that there was an outbreak; that is, 22 a transmission from one patient to another, of 23 the illness, and if he did not suspect that, why not? 24 25 Dr Al-Shamma has His answer appeared to rely on this: that he said he was seeing only a single case at a time. 85 That is 1 2 a partial answer. LORD MACLEAN: I wonder if that can be explored? I'm not sure he said that, but he only saw it 3 amongst his own patients, I think is what he said, and 4 they were a limited number. 5 MR KINROY: Yes. 6 LORD MACLEAN: That is why, if I understand his evidence 7 correctly, he didn't appreciate the extent of 8 the outbreak until May or June 2008. 9 MR KINROY: That is part of it, but I divine my learned 10 friend is asking, "If you had one patient with C. diff, 11 why did you not fear that that was, in fact, one 12 component of an outbreak, there being a patient 13 somewhere else with C. diff?", and the answer was, 14 "Because I had only one patient". 15 LORD MACLEAN: 16 MR MACAULAY: Is that what you put? I have been exploring that with Dr Al-Shamma, 17 and I understood his position to be that his thought 18 process at the time did not truly focus on 19 cross-contamination, but I may be wrong about that. 20 A. What I said, to have an outbreak, you should have more 21 than -- you should have two or more cases on the ward, 22 and I don't remember having two cases of positive 23 C. diff on the ward of my own. 24 that, you know, there is more than one, but it was all 25 shared, we never worked on a ward-based sort of patient 86 Yes, I would accept 1 admission, we had shared wards and I am responsible for 2 my own patients, and that is my answer. 3 LORD MACLEAN: I also think -- sorry, I'm interrupting 4 you -- Dame Elish's question is not fully answered, 5 because what she was asking, I think, was what prior 6 experience had you had, not just in the Vale of Leven 7 Hospital, but in your medical experience you had with 8 C. diff. 9 A. We do see C. diff cases all the time. I don't remember 10 when I was a registrar, like, any of my consultants had 11 a concern when we had a positive, single C. diff case in 12 the ward, but that's how things were and obviously -- we 13 have to also remember, I mean, it is not only we deal 14 with C. diff, we deal with all sorts of medical -- acute 15 medical emergencies and, you know, there are so many ill 16 patients, and one of them -- I mean, only I had a few 17 cases during this period, and that wasn't -- did not 18 raise my concerns about an epidemic or anything. 19 all. 20 MR KINROY: That's My Lord, I wonder if I can ask through my 21 learned friend why a single C. diff case is not a cause 22 for fearing an outbreak, apparently? 23 24 25 LORD MACLEAN: That is the question that you put to the witness? MR KINROY: That's the question I would like put to the 87 1 witness, yes: why is that so? 2 A. Because it is not an outbreak. 3 LORD MACLEAN: 4 A. It is not an outbreak. You get isolated cases every now and then, yes. As long 5 as you try to isolate them and put them in a single 6 room, you should be -- you should stop the infection 7 being transferred to another patient and prevent an 8 outbreak. 9 MR MACAULAY: I think what I had raised with you, 10 Dr Al-Shamma, is, notwithstanding that one patient does 11 not constitute an outbreak, whether, if you have one 12 patient, you would think, "Where has this patient 13 contracted the C. diff?", and whether or not there may 14 be someone else on the ward with C. diff. 15 Now, I think your position was that you hadn't 16 approached it in that way during the relevant time, but 17 I may have misunderstood you. 18 A. That's correct. No, you are absolutely right. I mean, 19 it was only -- see, if that was my ward, if I had, like, 20 ward 6 of mine, then I would know better on the ward 21 what was happening, because they were all my patients, 22 but at that stage, all patients were separated between 23 four or five consultants, so just, you know, you don't 24 know what's happening with other patients. 25 Q. Do you recollect if, at the relevant time, there was any 88 1 discussion amongst the consultants -- you have told us 2 that you met on a regular basis -- that focused on there 3 being C. diff in the hospital generally? 4 A. The medical meeting was not a clinical meeting so we 5 wouldn't have discussed clinical cases, we would only 6 have discussed issues regarding general things -- rotas 7 and staffing, and so on -- so, no, we haven't discussed 8 that. 9 Q. Just generally, are you able to say to the Inquiry 10 whether there was any discussion amongst your colleagues 11 that there were cases of C. diff in the hospital? 12 A. 13 14 No, there wasn't at all. No-one has raised concern that there is a number of C. diff cases in the hospital. MR PEOPLES: My Lord, I wonder, before we go on, is it 15 possible to clarify whether there was any forum at the 16 time other than the medical meeting for discussing 17 clinical issues between consultants, or would that just 18 be an informal conversation? 19 A. No, there was a clinical meeting as well on Thursday 20 lunchtime, but this is for -- most of the time, the 21 middle grade and the junior will present the -- a case, 22 but as far as I remember, C. diff was not presented. 23 MR MACAULAY: Were there minutes kept of these meetings? 24 A. The clinical meeting? 25 Q. Yes. 89 1 A. No. 2 Q. I propose to return to that shortly, and perhaps we will 3 do that after lunch, but if I can just move on to 4 a separate topic for the moment, and that is just to 5 focus specifically on the frequency of medical review, 6 and I think we have already touched upon this, but 7 I just want to be clear what your position is. 8 So far as the consultant review would be concerned, 9 and I am looking at your practice, as a matter of 10 11 practice, how regularly would you review a patient? A. Twice a week regularly, where I document my findings 12 and, as I said, on Monday morning, I will nip to the 13 ward and see if there is any sick patient or if any of 14 my patients have become sick, unwell, over the weekend, 15 the same on Wednesday morning, I will nip on the wards 16 and see the ill patients who were admitted in the 17 previous 24 hours. 18 Q. In relation to a patient who becomes sick and becomes 19 much more unwell, would you tend to review such 20 a patient more regularly yourself? 21 A. Yes, or I would be in touch as well with the juniors as 22 well. If I do say to them, "Do this test and let me 23 know about the results", they will let me know about the 24 results even if I am in Dumbarton clinic, which is 25 outside -- 5 miles away from the hospital, yes. 90 1 Q. If a patient is admitted and that patient is being 2 admitted under your care, how soon would you expect to 3 see the patient after admission? 4 A. All patients admitted from Monday after 5.00 pm will be 5 mine, so I will see them on Tuesday morning, and all 6 patients admitted on Tuesday from 9.00 to 5.00 will be 7 mine, and I will see them on the same day. 8 24 hours. 9 Q. So less than Just to be clear on this, was it your practice to write 10 in the patient's clinical notes when you had reviewed 11 and assessed a patient? 12 A. 13 14 The junior will write on my behalf, yes, the middle grade or the junior. Q. When we see references in the records to a ward round by 15 Dr Al-Shamma, do I take it that you have dictated the 16 note? 17 A. That's right, yes. 18 MR KINROY: My Lord, I wonder if we could clarify through my 19 learned friend whether Dr Al-Shamma dictated the note 20 and expected it to be written down verbatim, or merely 21 set out the general lines which should be entered into 22 the notes? 23 A. Most of the time, I dictate, but sometimes, you know, 24 the -- if it is an experienced registrar, I will just 25 say the main headlines and he will write them down. 91 1 LORD MACLEAN: 2 A. Yes. Is he with you at the time? Well, if there is handwriting from another doctor, 3 yes, he would have been with me, yes. 4 ward round, you would have the middle grade or the 5 junior -- it depends on who is available on the ward -- 6 joining you in the ward round, yes. 7 LORD MACLEAN: 8 A. 9 LORD MACLEAN: 10 A. 11 When you do your You never wrote it yourself, or did you? Very little. Otherwise, you dictate it to the junior -- Dictated most of the time, but sometimes, you know, general -- 12 LORD MACLEAN: 13 A. 14 MR MACAULAY: 15 -- or give headings? That's right, yes. Would the doctor with you usually be a junior doctor? 16 A. Middle grade or junior, yes. 17 Q. Just to be clear, would the doctor be writing at the 18 19 time when you are with the doctor and the patient? A. So normally, what we do -- you know, we are outside the 20 ward, you know, in the main sort of ward area. 21 discuss the patient first. 22 example, we will have a presentation or read through the 23 notes if the SHO who admitted the patient was not with 24 us, and then we will go and see the patient and examine 25 him and finish with him, and then we'll go back -92 We will If he is a new patient, for 1 instead of me writing, we will go back to the main area 2 where it is far away from the patient and either -- you 3 know, normally the consultant, either he will write or 4 dictate to the juniors. 5 the patient, no. So it is not in front of 6 Q. Would you check what is written and sign it, or not? 7 A. I don't sign it, but in sick patients, yes, I will make 8 sure they write what I have dictated to them, yes, but 9 not all the time. 10 11 Sometimes, as I said, I just point out the headlines and ... Q. So far as junior doctor review would be concerned, 12 I think you did say to me this morning that you would 13 expect the junior doctors to review the patient on 14 a daily basis? 15 A. That's correct. 16 Q. Would you expect the junior doctor to note the outcome 17 of the review? 18 A. You mean when they do the ward round on their own, yes? 19 Q. Yes. 20 A. Yes. 21 DAME ELISH: My Lord, to clarify this point on the nature 22 and the status of the ward round, I wonder whether my 23 learned friend could clarify, when Dr Al-Shamma 24 describes "nipping into the ward", was that part of this 25 routine which has just been described or whether it is 93 1 something different from the formal ward round which he 2 describes on the Tuesday morning? 3 LORD MACLEAN: 4 A. Yes, could you answer that? Sorry, the ward round, I will do the writing, but the 5 other two ward rounds, on Monday and Wednesday, I won't 6 do, you know, unless the patient is really sick and 7 merits some more notes to be entered. 8 your question? 9 Sorry, was that So Monday and Wednesday, when I nip on the ward to 10 see the sick patients, probably unless the patient is 11 very sick and something is going to happen, then we will 12 write the notes. 13 instruction to the middle grade what to do next. 14 LORD MACLEAN: 15 A. Otherwise, I will just give What to do? Well, if things have changed, obviously, within 24 -- 16 like, the patient was admitted on Tuesday, he was sick 17 and I know that he was sick, I will come on Wednesday to 18 have a look. 19 LORD MACLEAN: 20 21 I wondered if the "doing" included making a note? A. Sometimes they do, yes, if the patient is very sick, but 22 if the patient has improved, then probably we'd say, you 23 know, "He is improving well, responding to treatment". 24 LORD MACLEAN: 25 A. But if the patient hasn't improved? If the patient hasn't, then we try to write some notes, 94 1 yes, especially if he is becoming more sick and we need 2 to discuss things with the family, yes. 3 a courtesy. 4 everybody would do that. 5 the juniors, "If you have any queries, anything, just 6 contact me wherever I am, just page me". 7 MR MACAULAY: I go to see the patients. This is just Not necessarily But I would also always tell Looking to the position of patients who would 8 not be for active treatment, were you aware that there 9 was a Vale of Leven resuscitation policy in place at the 10 relevant time? 11 A. Yes, I was. 12 Q. I think we have seen in the records that you, yourself, 13 had some involvement with some DNAR forms; is that 14 correct? 15 A. That's very correct. 16 Q. In relation to a patient who was suffering from 17 C. difficile and you took the view that this patient was 18 not for active treatment, what about the treatment for 19 C. diff? 20 treatment? 21 A. Would it be your practice to continue the Yes, I would continue for the C. diff. See, there is 22 a difference between no active treatment or DNAR form or 23 end of life or Liverpool care plan protocol or plan 24 protocol. 25 management, then you would stop everything except See, when you get to the end of life 95 1 oxygen, IV fluid and painkillers. 2 going to die and there is no point in giving them -- or 3 treating an infection, but that doesn't include an 4 infectious condition like C. diff. 5 That's the patient is But when you talk about DNAR, it means the patient's 6 comorbid conditions are so morbid and clear that 7 a resuscitation is not going to give him a quality of 8 life or would be successful, but you still continue 9 treating actively for any infections, so there is 10 a difference between, you know, end of life care and 11 DNAR form. 12 should the heart or the lungs stop working, but you 13 would continue with active treatment. DNAR just simply means you don't resuscitate 14 End of life, that means the patient is going to die, 15 has advanced carcinomatosis, keep comfortable, but then, 16 if the patient still had C. diff, I would treat that 17 because it is an infectious condition. 18 Q. So just to be clear, are you saying that, even in the 19 palliative situation, you would still treat for C. diff, 20 or have I misunderstood you? 21 A. Yes, that's correct. Although I haven't come across 22 this situation, but I would normally, yes, I would treat 23 that, make sure the patient remains in isolation to stop 24 infecting others. 25 Q. What about medication? Would you still treat them from 96 1 2 the point of view of providing such a patient -A. If it is end of life, no. Normally, the Liverpool end 3 of life protocol is you just -- you can give fluids, 4 oxygen and painkillers, that's all, and you stop all 5 other medications. 6 Q. 7 8 life policy? A. 9 10 That is when you put into place the Liverpool end of End of life policy, like, talking about patients with advanced carcinomatosis, yes. MR KINROY: My Lord, I wonder if we can clarify if the 11 Liverpool end of life protocol was in use at the 12 relevant time and whether or not we see records of that 13 in the notes? 14 A. 15 No, it wasn't used. It wasn't applied in Vale of Leven at that time. 16 LORD MACLEAN: 17 A. What wasn't? The Liverpool care plan. That's end of life, sort of. 18 But, you know, with discussion -- following discussion 19 with the family and the MacMillan nurses or the cancer 20 nurse specialist, we would probably make a decision to 21 stop everything. 22 LORD MACLEAN: 23 A. 24 MR MACAULAY: 25 Without making a note about it? Yes, we will, definitely. My Lord, that might be an appropriate point at which to adjourn for lunch. 97 1 LORD MACLEAN: 2 (1.00 pm) 3 Very well. 2 o'clock. (The short adjournment) 4 (2.00 pm) 5 MR MACAULAY: 6 A. Good afternoon. 7 Q. Just before lunch, his Lordship had asked you a question Good afternoon, Dr Al-Shamma. 8 about palliative care, and I think you said that at 9 a point in time there could be a decision made in 10 relation to palliative care, but that that would not be 11 noted? 12 A. No, it would be noted, yes. 13 Q. It would be noted? 14 A. It would be noted, yes. 15 Q. Once the decision for palliative care was made, then 16 17 that would be noted in the medical records? A. That's correct, yes, but that's -- we're talking about 18 the end of life and, you know, care, Liverpool care 19 plan -- LCP, it is called -- but which wasn't at that 20 time in action in the Vale of Leven Hospital. 21 MR KINROY: My Lord, I hope it is not just me, but I still 22 don't think I understand the full position on this. 23 Through my learned friend, we understand that the 24 Liverpool care plan was not in use at the Vale of Leven 25 at the time, but the question was: once there was 98 1 a decision to proceed to palliative care, would that 2 decision be noted in the medical records? 3 think the answer met the question. 4 LORD MACLEAN: 5 A. 6 LORD MACLEAN: 7 A. And I don't I think the answer to that question is yes. Yes, that is correct. How was it recorded? Just basically discussed with the family, you know, 8 agreed on palliative care and stop antibiotic, you know, 9 continue with painkiller or morphine. Usually, the 10 cancer nurse specialist will be involved actively in 11 these cases. 12 LORD MACLEAN: 13 A. If it was cancer? Usually it's cancer, but then, if it was multi-organ 14 failure and the prospect, as well, of, you know, good 15 recovery, or unlikely that there was any recovery, that 16 will be also, yes. 17 LORD MACLEAN: 18 MR KINROY: 19 Does that answer? My Lord's question was, "How was it recorded?", and the answer was: 20 "Answer: 21 Just basically discussed with the family, you know ..." 22 Again, it does not appear that the question -- 23 A. Sorry, documented in the notes. 24 LORD MACLEAN: 25 a record? It would be written in the records, as in He has just said, what would usually be 99 1 2 written? A. It is because there is no specific form, like the DNAR 3 form, which you sign; it's just basically a decision, 4 which is usually made after discussion with the family. 5 MR KINROY: Yes. 6 MR MACAULAY: What, then, did palliative care mean at that 7 time? 8 What did it mean in practice? 9 A. You say you weren't using the Liverpool pathway. It's end of life, you know, sort of care protocol, 10 where -- you know, there's a bit more flexibility. 11 you were to say "Liverpool care plan", then you are not 12 allowed to give anything apart from fluid, oxygen and 13 painkiller. 14 that all -- you know, it comes back to the treating 15 physician, as to what to give and not to give. 16 You know, there is always flexibility, in So at that stage, we know that the patient is dying 17 and there is no point in pursuing further active 18 treatment. 19 If Q. Before lunch, I was asking you about your state of 20 knowledge in relation to cases of C. diff in the 21 Vale of Leven at the relevant time. 22 lunch you had indicated that one of the wards that you 23 would attend to see patients would be ward 6; is that 24 correct? 25 A. That's correct. 100 I think before 1 Q. When you were conducting ward rounds at the frequency 2 you mentioned, ward 6 would be one of the wards you 3 would visit on a regular basis? 4 A. That's correct. 5 Q. Can we just look, then, at a chart that has been 6 prepared for the Inquiry in connection with patients who 7 tested positive for C. diff in ward 6, if you could have 8 in front of you INQ02620001? 9 MR KINROY: My Lord, can I just check to see whether 10 Dr Al-Shamma has seen this chart or any other charts in 11 the same vein? 12 LORD MACLEAN: 13 MR KINROY: 14 15 Do you represent Dr Al-Shamma? No, my Lord, but the board wishes to vindicate the reputations of its employees insofar as it can. LORD MACLEAN: I know. I think there was an anxiety about 16 this I expected to come primo loco, as they say, from 17 Dame Elish, however, he has seen the chart. 18 DAME ELISH: 19 A. 20 MR MACAULAY: 21 Yes, I am aware of that situation. Yes, I have just seen the chart now, at lunchbreak. We have it on the screen, but I think you also have a copy in front of you. 22 A. It's the coloured one I have got, but it doesn't matter. 23 Q. It is possibly easier to work off the coloured copy in 24 front of you, it might be clearer to you, but it is 25 entirely up to you. 101 1 A. Sure. 2 Q. But you can see, if we just focus on the period, and you 3 can see this towards the top right section of the chart, 4 where we see the first name at the top in red is 5 Annie Shaw, in the red oval; do you see that? 6 A. Yes, I can. 7 Q. Beneath that, we see the patient we touched upon briefly 8 I do. before lunch, Elizabeth Valentine? 9 A. That's right. 10 Q. Then there is another reference to another patient, 11 Martha McGregor, and then another patient, 12 Moira McWilliams. 13 this chart either mean the date the ward was aware or 14 the date of the official report. 15 The dates that have been inserted in You can see, I think, at a glance, the close 16 proximity that there is in relation to patients in 17 ward 6, because this is dealing with ward 6, who tested 18 positive for C. diff. 19 So if we focus on Elizabeth Valentine, for example, 20 can we see that, at the time that she was positive, 21 there were other patients positive at about the same 22 time; do you see that? 23 A. Yes, I do. 24 Q. Before lunch, we had a discussion about your state of 25 knowledge, and certainly I understood your position to 102 1 be that, although you had patients who did test positive 2 for C. diff, you had no knowledge in relation to whether 3 or not there were other patients in the ward or in the 4 hospital who had C. diff. 5 your evidence? Is that a fair summary of 6 A. That is very correct indeed, yes. 7 Q. Can you explain to the Inquiry why that should be? If 8 there were patients who did test positive for C. diff in 9 close proximity in time to one of your patients, how 10 would you not know that there was C. diff in any event 11 on the ward? 12 A. Basically, I would expect the infection control nurse or 13 the microbiologist to pick up this sort of sequence: 14 four patients diagnosed with C. diff within a matter of 15 eight days. 16 I don't know how that was missed from the infection 17 control or the microbiologist. 18 I think that is too much. Basically, So, basically, I look only after my patients. 19 I will give you an example. 20 and on the other side there is G North -- that's the 21 name of the ward -- so I wouldn't know if there are 22 patients with C. diff in G North, I would only see 23 patients in G South of mine and I would only report that 24 or I would only treat and actively treat and, perhaps, 25 if there is more than two, I would report that. 103 I work in IRH in G South 1 But at that stage, you know, I would expect the 2 infection control and the microbiologist to inform us, 3 as the consultant physician, that there are four cases 4 diagnosed in a matter of nine days. 5 Q. Would it be of interest to you, as the doctor in whose 6 care a patient has been entrusted, to be made aware 7 whether or not in the ward in which the patient is 8 a patient there are other patients with C. difficile? 9 A. Well, as I said, we work on patient base, rather than 10 ward base, and I wouldn't be able to look after -- 11 I mean, we had plenty of work to do. 12 you know, you could be looking after 25 patients 13 scattered all over the hospital, and your aim is to look 14 after your patient and manage them appropriately. 15 I'm talking about, There is other people who should -- who must have 16 this job of identifying how many patients with C. diff 17 are identified or have happened in the ward, and they 18 should tell us and they should inform us that there is 19 four patients diagnosed in nine days. 20 the infection control nurse to tell us that, and I would 21 expect the microbiologist. 22 from microbiology and not -- but for me to look after 25 23 patients scattered all over the hospital, that is a big 24 job, much bigger than any other hospital at that time, 25 and being on call every fourth day or every fourth 104 I would expect Because the results all came 1 weekend is a lot of job, and I had enough of that, 2 obviously. 3 Q. Two points from your answer: first of all, you said you 4 would expect infection control and microbiology to tell 5 you. 6 A. Yes. 7 Q. Is that because it is of interest to you, as the doctor 8 who is caring for a patient, to know whether or not that 9 patient might be exposed to C. diff in the ward? 10 A. No, because that is an outbreak, and outbreaks should be 11 reported. 12 spores. 13 matter how clean the ward is, the spores are there, and 14 no matter how hard we try to clean the ward or stop 15 antibiotics, we still have C. diff cases. 16 Then we need to take -- yes, there will be Spores are there in the wards. I mean, no Basically, it's not surprising to see every now and 17 then, like Mrs Valentine, who was immunocompromised from 18 steroids, who suffered from advanced carcinomatosis, it 19 is not unusual, with the antibiotics she was given, to 20 get C. diff, and then the spores will be everywhere, in 21 the community, in the ward. 22 I have one patient at a time with C. diff, but I would 23 expect other people to come and tell me what's going on 24 in the ward. 25 Q. So I wouldn't worry when You would expect that because it would be of interest to 105 1 you in the caring of your patients -- 2 A. Well -- 3 Q. -- to know if the patient is exposed to -- may be 4 5 exposed to other patients who have C. diff? A. Well, it would be of interest to all of the consultants 6 at the Vale of Leven Hospital to know that there is an 7 outbreak, there is two or more cases, of C. diff 8 diagnosed at the same time or in a matter of days. 9 Then we can -- obviously, not only treating that 10 particular -- because we're going to treat the patient 11 anyway, but also to prevent further, you know, sort of 12 cases being contracted at the ward -- on the ward. 13 Q. But just to be clear so that we are on the same 14 wavelength, from the perspective of your patient, it 15 would be important for you to know whether or not there 16 was C. diff on the ward, just looking to the care of 17 your own patient? 18 A. Well, from the perspective of other patients contracting 19 the disease, other, you know, patients on the ward 20 contracting the disease as well, as a result of the -- 21 whatever the cause of the -- that small outbreak which 22 happened in February 2008. 23 to everybody, indeed. 24 25 Q. Yes, it would be of interest And important to you in your care of your patient to know? 106 1 2 3 A. All my patients, yes, because other patients are likely to contract the infection if we have an outbreak, yes. DAME ELISH: My Lord, on this particular point, my learned 4 friend has explored to some extent what the doctor's 5 knowledge was of responsibilities, and he's referred to 6 other people and, in particular, the infection control 7 team and the microbiologists. 8 friend could explore what Dr Al-Shamma's understanding 9 was of the role of Dr Biggs and, subsequently, 10 11 I wonder if my learned Dr Bagrade? LORD MACLEAN: We are going to come to that. He obviously 12 has said -- I don't know if we go into that -- he would 13 have expected them to have informed him. 14 DAME ELISH: He has mentioned the infection control nurse, 15 but I don't think he has made any reference to the 16 infection control doctors. 17 LORD MACLEAN: Well, he said infection control. He said, 18 "I would expect infection control and the 19 microbiologists to tell me about it", and I take it that 20 was the infection control doctor. 21 22 23 DAME ELISH: I'm satisfied if that is the Inquiry's understanding, my Lord. LORD MACLEAN: The microbiologist, of course, is the person 24 you mentioned, or may have been the person you 25 mentioned? 107 1 DAME ELISH: There are two different sets of 2 microbiologists. 3 understanding of that: the laboratory microbiologists 4 and the clinical infection control microbiologists. 5 MR KINROY: 6 That is why I was looking for an If I can put my tuppence worth in, my Lord, I do think this is an important matter myself. 7 LORD MACLEAN: 8 MR KINROY: 9 LORD MACLEAN: 10 MR MACAULAY: 11 Well, that settles it. I don't suppose it does. Mr MacAulay? I'm happy to pick up this particular ball and see where it goes. 12 At the relevant time, if I can just backtrack 13 a little bit, what was your understanding as to who was 14 the infection control doctor responsible for the 15 Vale of Leven Hospital? 16 A. As far as I know, there wasn't, but, same as the 17 microbiologists, there was no microbiologist responsible 18 except Dr De Villiers, but then we were also asked to 19 contact any microbiologist in case of emergency or 20 indeed, you know, sort of a burning question regarding 21 a patient. 22 Q. But were you aware that any doctor, any microbiologist, 23 had been allocated the task of infection control doctor 24 for the Vale of Leven in particular? 25 A. I'm not aware of that. 108 1 Q. When you mention infection control as a source that 2 might bring to your attention that there may have been 3 another case or cases of infection on the ward, are you 4 focusing there on the infection control nurse in the 5 Vale of Leven, Helen O'Neill, or -- 6 A. Probably she would have a consultant to contact, and 7 I would probably expect that to happen, and obviously 8 the microbiologist, who would probably raise the issue 9 of more than -- because they deal with our stool 10 specimens, raise the issue that there is few, now, cases 11 of C. diff diagnosed in a short period of time. 12 Q. Do I take it from what you have been saying to the 13 Inquiry so far that it was never drawn to your attention 14 that there were cases of C. diff in any of the wards in 15 which you had patients? 16 A. No. 17 Q. If one of your patients did contract C. diff, how would 18 19 you become aware of that? A. Probably during the ward round or, if the patient was 20 unwell, I would be contacted anytime, you know, during 21 the working hours. 22 Q. Who would make the contact in the second instance? 23 A. The middle grade who was looking after the patient. If 24 he feels the patient is becoming unwell as a result of 25 the C. diff infection, and we have confirmation that it 109 1 is C. diff, then he probably would contact me and take 2 some advice, especially if the blood results came back 3 showing a high urea and abnormal electrolytes. 4 Q. Just to be clear, do you have any recollection of having 5 been contacted directly by infection control in 6 connection with a case of C. difficile? 7 A. Not at all. 8 Q. Just to be clear, did you have any contact directly from 9 a microbiologist to let you know that one of your 10 patients had contracted C. difficile? 11 A. No. 12 Q. If, in a given case, the ward and the infection control 13 nurse became aware of the positive C. diff diagnosis, do 14 I take it from what you have said that the earliest you 15 would find out would be either on the ward round or if 16 the junior doctor contacted you to let you know? 17 A. That's correct, yes. 18 Q. Do I take it from that the junior doctor, then, would -- 19 well, how would the junior doctor learn of 20 the C. difficile positive result? 21 A. Usually through telephone calls from the microbiology. 22 Q. Would that be documented, that the junior doctor had 23 received a call from microbiology to confirm a positive 24 result? 25 A. It depends on the junior or the middle grade doctor, but 110 1 I would expect that to be documented, yes. 2 a serious condition, yes. 3 Q. It is In the period that we are concerned with, Dr Al-Shamma, 4 did you see the Vale of Leven as a hospital being under 5 threat, by that I mean being closed or reduced in size? 6 A. Yes, definitely, during that period, there was a lot of 7 talk about closing the hospital. I think the matter was 8 almost quite imminent at that time, in that period of 9 time, yes. 10 Q. How did that impact upon the staff morale, if at all? 11 A. Well, it did have an impact on the staff morale, 12 obviously, the morale was low. 13 what's going to happen after the hospital is reduced in 14 size or shut down completely. 15 Q. 16 17 You know, not knowing Insofar as recruiting medical staff, did you see the threat to the Vale of Leven as causing a difficulty? A. I don't remember, no. I mean, we did not increase -- or 18 there was no increase in our medical staffing at that 19 period, but I think they were replaced if they were to 20 go or to leave for any reason. 21 be times when there is unexpected absences because of 22 sickness, and it's always the case very difficult to 23 find a locum on that particular day or couple of days, 24 but generally speaking, no. 25 Q. Obviously, there would Did the nursing staff ever ventilate any concerns to you 111 1 that they felt that their jobs might have been under 2 threat? 3 A. No, not directly to me, no. 4 Q. I want now to look at a number of patients with you, and 5 we have already touched briefly on Mrs Valentine's case, 6 and perhaps I can just begin with that. 7 records for Mrs Valentine are at GGC00800001. 8 turn to page 42 of the records, do we note here that 9 Mrs Valentine was admitted to the Vale of Leven on 10 8 February 2008 and that you were noted to be the 11 admitting consultant; is that correct? The medical If we 12 A. Yes, that's correct. 13 Q. Perhaps we can just focus on what the position was on 14 admission and, in particular, was Mrs Valentine taking 15 any antibiotics as at the time of her admission to 16 hospital? 17 we see that, in the list of medications listed, 18 ciprofloxacin is mentioned? If you turn to page 43, this might help. Can 19 A. That's correct. 20 Q. Did you understand from your perusal of the records that 21 Mrs Valentine was receiving ciprofloxacin at the time of 22 her admission? 23 A. 24 25 No, I wasn't aware of that. I have to admit that, yes. I wasn't aware that she was on cipro. Q. If we turn to page 44 of the records, can we see the 112 1 plan that's been made by the junior doctor towards the 2 bottom of the page includes chest X-ray, but also to 3 stop antibiotics currently; do you see that? 4 A. 5 Yes, I can see that, yes, "Stop antibiotics currently", yes. 6 Q. Why would the junior doctor make that decision? 7 A. I mean, he wasn't -- perhaps he was not sure why she was 8 on such a small dose of cipro. 9 and that is not the usual dosing for ciprofloxacin. 10 Q. It was 250 once daily, Would he be influenced possibly by any conclusion he may 11 come to as to whether or not there was any real signs of 12 infection? 13 A. I don't know. Presumably, he thought that there was no 14 infection and, if you notice, the main reason for 15 admission was the very high calcium level, so probably 16 he felt there was no ongoing infection. 17 Q. 18 That would be good practice, then, to stop the antibiotics in those circumstances? 19 A. Yes, especially when the dose is not the right dose. 20 Q. Then, if we look to your initial involvement with 21 Mrs Valentine, and you turn to page 45 of the records, 22 is there a note there of a ward round made by yourself 23 on 9 February 2008? 24 A. Yes. 25 Q. At that time, then, what conclusion did you arrive at as 113 1 2 to what the treatment should be? A. Well, at that time, we were very much concerned about 3 the high calcium level, so there is a treatment which 4 tried to lower the calcium level fairly quickly, and 5 that is called pamidronate infusion, and she would have 6 received that either the day before or on the day I saw 7 the patient, plus you need to give a lot of fluids to 8 make sure that the high calcium or the calcium itself 9 will not deposit in the kidney tubules to cause -- we 10 call it calcium nephropathy (sic), and, therefore, 11 I recommended fluids, first four-hourly and then 12 six-hourly. 13 Q. 14 There is no suggestion in that note that you were recommending the commencement of antibiotics? 15 A. Not in that note, no. 16 Q. Then I think the next note we see on the same page again 17 appears to be one of your ward rounds, this is on the 18 10th, the following day. 19 where a number of entries have been made? 20 A. Yes, that's true. Again, is this your ward round You can get distended abdomen as 21 a result of the hypercalcaemia. 22 I said to give her frusemide, which is a diuretic, with 23 the IV fluid to enhance the excretion of the calcium and 24 to lower the serum calcium level. 25 start to give her the pamidronate, she already had 114 So at that stage, And I also said to 1 2 pamidronate, 30mg. Q. 3 4 There is no suggestion there, though, that you were proposing the starting of antibiotics? A. That's correct. I felt that the confusion was simply -- 5 she was very confused and I felt it's simply due to the 6 high calcium level. 7 Q. 8 DAME ELISH: 9 If we then turn to page -My Lord, I wonder if, before we move off this particular diagnosis, my learned friend has made 10 reference to -- or the witness has referred to the 11 administration of a diuretic in combination with an IV 12 fluid. 13 that there has been some comment about that combination 14 from some of the experts. 15 opportunity to explore this with Dr Al-Shamma, as to why 16 that combination was deployed? 17 I wonder if this is an I think he's given his explanation, but it is just 18 19 My learned friend and the Inquiry will be aware given what has been said before about that. MR MACAULAY: Yes, am I right in understanding there is 20 a specific reason why you would want to have this 21 combination for this patient? 22 A. Yes, it is the usual recommended treatment after 23 pamidronate, which is a biphosphonate given. 24 is known to prevent the reabsorption of calcium from the 25 kidney tubules, and it does enhance the excretion of 115 Frusemide 1 calcium and, hence, it does help to lower the serum 2 calcium level. 3 You give fluid to rehydrate and, at the same time, you 4 give frusemide to prevent the reabsorption of 5 the calcium. 6 Q. So it is the combination of the two. I was moving on to page 46 of the records where there is 7 another entry on 10 February by a junior doctor on call; 8 is that right? 9 A. 10 11 Is that what we see towards the top? Yes, that is probably an FY2 on call, yes. That is the middle grade who was on call on that evening. Q. What is the position now, then? This is clearly after 12 your ward round, although it is the same date. 13 read the third line, we read: 14 "Patient feeling better than this am. 15 lethargic. 16 distended." 17 No abdominal pain. If we Not as Thinks abdomen is less Does this reflect some improvement since the time of 18 your ward round? 19 A. That's correct, yes. 20 Q. What do we take from this entry, as to what the junior 21 22 doctor was thinking? A. Probably, at that stage, I would have recommended that 23 the patient is reviewed again, because the abdomen was 24 distended, and in case there is a surgical issue. 25 Although my feeling was the abdominal distension was 116 1 2 simply due to the high calcium level in the blood. Q. 3 We don't see any reference in this entry to the prescription of antibiotics; is that correct? 4 A. That's correct. 5 Q. Is there any basis set out in the entry to justify the 6 prescribing of antibiotics? 7 A. No, at that stage, no. 8 Q. If we turn to page 328 of the records, we are looking at 9 the drug Kardex for ciprofloxacin, which is the third 10 entry on the page. 11 doctor has prescribed ciprofloxacin and, indeed, 12 thereafter the drug is administered to the patient? 13 Can we see that, on the 10th, the I think, as you indicated a moment ago, you didn't 14 see any evidence in the note as to why ciprofloxacin 15 should be commenced? 16 A. That's correct, yes. 17 Q. Can you help us as to why the junior doctor prescribed 18 19 ciprofloxacin for this patient? A. 20 No. At that stage, I wasn't aware that the patient was on ciprofloxacin. 21 Q. Should this have happened? 22 A. That shouldn't have happened, yes. Again, this stems 23 from the fact that junior doctors, middle grade, will 24 change all the time and somebody will take an action 25 without passing on the message to another person. 117 1 Q. 2 So this decision I think you're telling us would have been made without your knowledge? 3 A. Without my knowledge, exactly, yes. 4 Q. I think we can see on the Kardex itself that the 5 instruction seems to be, "for UTI". 6 evidence of a UTI? Have we seen any 7 A. At that stage, no. 8 Q. At any stage was there any suggestion of UTI in this 9 10 patient that you can recall? A. 11 12 There was later on. yes. Q. There was evidence of infection, But the source was not identified. In any event, whatever may have been written on the 13 Kardex, if we go back to page 46 of the records, I think 14 you would agree that there is no indication in that 15 entry we looked at for 10 February of antibiotics being 16 commenced for a urinary tract infection? 17 A. I do agree, and I can only assume that, at that stage, 18 the junior doctor thought that the patient was confused 19 because of ongoing infection and the junior doctor 20 started the antibiotic. 21 Q. But that hasn't been noted? 22 A. No. 23 Q. I think a midstream specimen of urine was taken from the 24 patient on 8 February, that's the date of admission. 25 we look at page 177 of the records, I think we see here 118 If 1 the results of that specimen. It bears to have been 2 taken on 8 February, received by the lab on the 11th, 3 and can we see from that that that is not an abnormal 4 result? 5 A. Yes, there is no growth on that specimen. 6 Q. Was it as a matter of course that a urine specimen would 7 be taken, particularly from an elderly patient, if such 8 a patient were admitted? 9 that was adopted? 10 A. Was that the general practice I think, because of the confusion and the general 11 deterioration, you always think of underlying infection, 12 because elderly people may not present with the 13 classical symptoms of infection, so they might not run 14 a temperature, they might just become confused. 15 MR KINROY: 16 My Lord, I wonder if I can just get a complete answer to the question: 17 "Question: Was it as a matter of course that 18 a urine specimen would be taken, particularly from an 19 elderly patient, if such a patient were admitted? 20 that the general practice that was adopted?" 21 Was I think the answer probably implies what the 22 position was, but perhaps it is not expressly an answer 23 to the question. 24 MR MACAULAY: 25 A. Can you help me, then, Doctor? I mean, if you suspect infection, you'd need to do 119 1 cultures before you start antibiotics, and it depends on 2 the -- well, how much you think the infection is 3 serious, then you may consider starting antibiotics 4 empirically if you feel the infection is serious. 5 depends on the seriousness of the infection. 6 I mean, a sample was sent to exclude underlying 7 infection as a cause of confusion. 8 MR KINROY: 9 It So, My Lord, I think it is not just me, but the question was: was it routine to take a urine specimen, 10 particularly from an elderly patient? 11 or a "no" question, but I don't think we have that yet. 12 LORD MACLEAN: 13 A. That is a "yes" The answer is yes, isn't it? Routine in someone who is confused, yes, because it 14 could be an infection. 15 confusion. 16 patient. 17 have identified the cause of it. 18 congestive cardiac failure or acute myocardial 19 infarction, there is no reason to send an MSU unless you 20 suspect infection or if the patient is symptomatic. 21 it is not routine, but in a confused, elderly lady, it 22 is almost a routine, yes. 23 LORD MACLEAN: 24 A. 25 This lady presented with But we don't do it as routine for every If there was a reason -- another reason, or we Like, somebody with So It is recorded that she was confused, is it? She was confused, yes. cause the confusion. But the high calcium level can At the same time, you cannot rule 120 1 2 out an infection, underlying infection. MR MACAULAY: Whatever the junior doctor might have been 3 thinking -- and I think you disagree with the 4 prescription of ciprofloxacin when it was prescribed -- 5 once the result of the urine specimen has been obtained 6 to show that there was no abnormality, would that be the 7 opportunity at least to stop the antibiotics? 8 A. 9 on antibiotics, at that stage; no-one has told me that 10 11 The problem's that I wasn't aware that the patient was the patient was put on antibiotics. Q. Indeed, I understand your position, but if the doctor, 12 or a doctor, who is caring for the patient becomes aware 13 that the result is not abnormal, then that would give 14 the doctor the opportunity of stopping the antibiotics? 15 A. Yes, if the suspicion was a UTI and ascending infection 16 and there is no reason to continue the antibiotic, but 17 then ciprofloxacin -- assume that the junior doctor has 18 considered that the ciprofloxacin was given for another 19 reason, like infection of the gall bladder, ascending 20 cholangitis, we call it, cholecystitis, that's where 21 cipro is also -- but, to be honest, yes, it should have 22 been stopped, even if it was started on the assumption 23 that the patient had UTI. 24 25 Q. If we look at the drug Kardex at page 328, the only information we have as to the purpose behind the 121 1 ciprofloxacin being started was for a UTI, because that 2 is what's been written on the drug Kardex? 3 A. Well, it should have been stopped, yes. 4 Q. I think what we see is that the ciprofloxacin is 5 certainly continued for some days after the results of 6 the specimen are made available; is that right? 7 A. That's correct. 8 Q. I think, if we go back to the medical records, page 47, 9 you have another ward round, according to what's been 10 noted towards the bottom half of this page, on 11 12 February 2008; is that right? 12 A. Yes. 13 Q. The position here, the conclusion appears to be that she 14 was to be referred to the breast clinic -- is that 15 right? -- to check tumour markers, is it? 16 A. That's quite right. By far the commonest cause in 17 elderly people of high calcium is -- malignancy is 18 cancer. 19 site of the cancer, where is the primary site, whether 20 it has spread or not. 21 examine thoroughly -- you know, I examined her neck and 22 everything and, at that time, I had the opportunity to 23 examine the breast, and I felt some thickening at the 24 left upper quadrant of the breast. 25 thing, obviously, to send her to the breast clinic, they All our attention was focused on finding the So part of the examination is to 122 So I said, the best 1 can do all the steps, they can do mammograms, biopsy, on 2 the spot, which she did went to, and, also, we looked 3 for a tumour marker to see where is the primary tumour, 4 it might give us an indication as to the site of 5 the primary tumour. 6 Q. Did I understand from an answer you gave a moment ago 7 that, at this time, you were not aware that the patient 8 had been started on ciprofloxacin? 9 A. That's correct. 10 Q. We can go back to the drug Kardex at page 328. We have 11 noted the ciprofloxacin is given on the 10th, the 11th, 12 the 12th, and possibly the 13th and 14th. 13 that the patient was receiving ciprofloxacin at this 14 time and may have continued to receive ciprofloxacin 15 after you had seen her; is that correct? It would seem 16 A. That's correct, yes. 17 Q. Why were you not made aware that the patient was 18 19 receiving ciprofloxacin? A. It all goes back to the standard of the middle grade 20 and, you know, how committed they are, and also this 21 change of the middle grade from one ward to another with 22 lack of continuity of care. 23 I think that is all reflected as to why nobody has 24 brought that to my attention. 25 practice is to look at the Kardex as well, but 123 It is usual -- my routine 1 sometimes, you know, you miss things, and because, in 2 that particular case, I was mainly focused on finding 3 out the primary cancer site rather than, you know, 4 treating an infection, I probably did not look at the 5 Kardex. 6 If I had looked at the Kardex, like on these dates, 7 and I had realised that she was an cipro, I would have 8 stopped it when we had the negative urine culture 9 result. 10 Q. I suppose, if we go back to page 46 of the notes, you 11 could say that, if the doctor had recorded on the date 12 that he or she prescribed the ciprofloxacin, then that 13 would have made you aware of it? 14 A. Of course I would, yes. 15 Q. Was it your normal practice to take it upon yourself to 16 ask junior doctors whether or not the patient was in 17 receipt of medication? 18 A. On what, sorry? 19 Q. Can you say whether or not it was your normal practice 20 at the time to enquire from the junior doctors as to 21 whether or not the patient was, in fact, in receipt of 22 medication? 23 A. Received medication? 24 Q. Yes. 25 A. Yes, you try to, yes, of course. 124 You look at the drug 1 history and, you know, the past medical history when the 2 case is presented to you, so you try your best to look 3 at all the details of the patient, including the drug 4 history as well. 5 I mean, these things do happen, obviously. There is 6 no way you could be in control of 25, 30 patients 7 scattered. 8 grade and the doctors to help you out with that, and 9 sometimes they do, you know, do some things without 10 11 You count very much as well on the middle consulting. Q. So far as the antibiotic itself would be concerned, that 12 is the ciprofloxacin, was that generally an antibiotic 13 that would be given for a complicated urinary tract 14 infection? 15 A. It is something for complicated or ascending UTI, yes. 16 Q. If it was an uncomplicated UTI, then you would be 17 looking at a more specific antibiotic; is that correct? 18 A. That's correct, like trimethoprim. 19 DAME ELISH: I wonder if my learned friend could clarify 20 that the two first-line antibiotics might not have been 21 available if there was a kidney issue, as there appeared 22 to be with this patient, as I understand it, potential 23 calcium levels and deposits in the kidneys? 24 25 A. Yes, I mean, there is a possibility, obviously. have a negative urine culture. 125 We did Whether that was started 1 on the assumption that the patient had -- because of 2 the abdominal tenderness, whether they felt, the junior, 3 that this is a UTI which has ascended to the kidneys, 4 I don't know, obviously, because, as I said, the cipro 5 was prescribed without my knowledge or approval. 6 MR MACAULAY: 7 There are no such symptoms described certainly in the records we have looked at? 8 A. No, not to my knowledge, no. 9 Q. At that time, we are now in February 2008, was it within 10 your own knowledge -- or what was your knowledge as to 11 whether or not there was an association between 12 ciprofloxacin and the 027 strain of C. difficile? 13 A. 14 15 I was aware that ciprofloxacin can and does enhance the growth of the C. diff in the intestine. Q. But, more particularly, can you say whether or not, at 16 that time, you were aware of any relationship between 17 the ciprofloxacin and the 027 strain? 18 A. Oh, yes, I was, sorry, yes. 19 Q. Just to be clear, although junior doctors were caring 20 for the patient in the way we have seen in these 21 records, you, as the consultant in charge, would be in 22 overall charge of the patient's care; is that right? 23 A. That's correct. 24 Q. If we go back to the clinical notes, then, Dr Al-Shamma, 25 at page 51, I think we'd seen previously that -- yes, we 126 1 have a record here for 14 February that there is a ward 2 round by you and a number of notes have been made; is 3 that right? 4 A. Yes, that's correct. 5 Q. Can we see that you have noted "Variable confusion; 6 7 That is mine. afebrile" -- is that the next entry? A. 8 Sorry, it is a variable confusion, so she was still confused at that stage, yes. 9 Q. But the next entry is "afebrile"; is that right? 10 A. Sorry? 11 Q. Line 2, what is line -- 12 A. Afebrile, apyrexial, there was no temperature. 13 Q. But you have noted that the CRP is -- 14 A. Increasing. 15 Q. -- increased? 16 A. And the calcium -- 17 Q. Sorry? 18 A. The calcium was coming down. 19 Q. Sorry, thank you for that. The note here is -- when the 20 arrow goes up, does that mean increase ciprofloxacin; is 21 that right? 22 A. That's correct, yes. 23 Q. That tends to suggest that, at that time, you may have 24 had some knowledge that the patient was receiving 25 ciprofloxacin? 127 1 A. Right. Initially, we thought that the confusion was 2 simply due to the hypercalcaemia. At that stage, when 3 the calcium has come down to normal, almost normal, and 4 she remained confused, and at that stage CRP has 5 increased, I recommended the increase of 6 the ciprofloxacin and also recommended to speak to the 7 microbiologist. 8 The reason for that, because -- one of the reasons 9 as to why antibiotic may fail to clear an infection -- 10 I was now convinced that there is an ongoing infection. 11 The reason why antibiotic does not clear an infection, 12 it is either the wrong antibiotic or the wrong dose. 13 Then it came to my attention, at that stage, that the 14 patient has been on ciprofloxacin, rather a small dose, 15 so I said to increase it and to discuss with the 16 microbiologist to find out if that would be the most 17 appropriate thing. 18 Q. 19 So the inference, then, that, at that point in time, you became aware that ciprofloxacin was being prescribed -- 20 A. At that time, yes. 21 Q. -- is fair? 22 A. Yes. 23 Q. If we turn to the drug Kardex, then, at page 328, can we You knew at that point? 24 see the second prescription, we see the date in the 25 second date box, 14 February, which I think coincides 128 1 with your ward round note? 2 A. That's right. 3 Q. What had happened then, insofar as the 14th was 4 concerned? Had doses been given on the 14th? 5 A. She was given 500mg on that morning. 6 Q. One dose? 7 A. One dose, yes, and that's it. 8 Q. That has been given, I think you have said, on the basis 9 that, because the CRP is raised, there may very well be 10 11 an infective process? A. The CRP was raised, the patient remained confused and 12 the calcium has come down to almost normal. 13 the confusion is partly due to infection with the 14 increase in the CRP. 15 started on ciprofloxacin in the wrong dose, I said, 16 "Let's try the full dose and see if that helps", but at 17 the same time, I also recommended to speak to the 18 microbiologists. 19 Q. So I assume And because she was already Is it logical, if you have a patient, albeit on a lower 20 dose of a particular antibiotic, who doesn't appear to 21 be responding to that over a period of days, to proceed 22 with the same antibiotic, albeit at a higher dose? 23 A. 24 25 In the right dose, yes: it is quite logical, yes. Because a smallish dose may not eradicate the infection. Q. Were you leaving it, then, to the junior doctor to 129 1 consult with the microbiologist to see what the course 2 of action should be? 3 A. That's correct, yes. 4 Q. Were any tests instructed at this point in time to see 5 whether or not the source of the infection could be 6 identified? 7 can we see if there's been any instruction to -- If we go back to page 51 of the records, 8 A. No, there wasn't, but we already had some. 9 Q. Sorry? 10 A. Some cultures done, you know. 11 Q. Do you consider that there should have been an 12 instruction at this point in time to see whether or not 13 the infection could be identified? 14 A. 15 Yes, probably I did say -- I mean, I can't be certain of that -- "Rescreen her for sepsis", but it wasn't there. 16 Q. I think what you are saying is you probably did? 17 A. Yes, I can't remember. 18 Q. If you did, you can't remember, and it certainly hasn't 19 been noted in the records? 20 A. 21 LORD MACLEAN: 22 23 24 25 No, that's correct. There is no reference to a consultant microbiologist being consulted. A. No, that's true, but I would have said that, because the antibiotics were changed after that. LORD MACLEAN: It is not because you remember, but you would 130 1 have said it? 2 A. Oh, yes, yes. 3 MR MACAULAY: We see the approach at this point in time, the 4 last entry in the note for the 14th is "?Low grade 5 infection"; is that correct? 6 A. That's correct, yes. 7 Q. Would you consider, at that time, that prescribing 8 ciprofloxacin in the dose you mentioned would be 9 appropriate treatment? 10 A. Yes, I think it is reasonable to do that and see the 11 response and, at the same time, you know, to contact the 12 microbiologist to see if there was any suggestion or any 13 positive results. 14 Q. So what happened here, then, was that the 15 microbiologist -- although we don't see it -- you think 16 would have been consulted and that resulted in a change 17 of antibiotic? 18 A. That's correct. 19 Q. Would you have been informed that the antibiotic was to 20 21 be changed? A. 22 23 Next ward round, I would have been informed. I mean, if the advice came from a microbiologist, we would. Q. If we go to page 329 of the records and look at the 24 Kardex, can we see that what seems to have happened on 25 what looks like the 14th -131 1 A. That's correct, yes. 2 Q. -- is that Augmentin has been prescribed? 3 A. That's correct, yes. 4 Q. Do I take it, then, at the time that happened, you would 5 not have known at that time and the junior doctor would 6 be working on the basis of an instruction from the 7 microbiologist? 8 A. 9 10 Yes, but that was on my instruction to contact the microbiologist. Q. So if we go back to page 51 of the records, do we see 11 any evidence for the 14th that the co-amoxiclav has been 12 commenced? 13 A. No, there isn't anything. 14 Q. Is this something that junior doctors should have noted? 15 A. Indeed, yes. 16 Q. The prescription of the higher dose of ciprofloxacin, 17 you have explained why you went down that route. 18 an alternative have been simply not to prescribe or 19 continue with the ciprofloxacin and to wait until one 20 had received the advice of the microbiologist? 21 A. Would I mean, I felt there is an infection, and basically the 22 microbiologist would give us the advice, "You only 23 receive one dose of 500mg of cipro". 24 opinion, different opinions, but it could have been, 25 yes, but not necessarily that would be the right thing 132 I leave that for 1 2 to do. Q. If we look at the note on page 51 that was made during 3 your ward round on 14 February, you have drawn attention 4 to the confusion and to the raised CRP, but what other 5 markers were there that persuaded you that you should 6 prescribe some further ciprofloxacin rather than waiting 7 for the microbiologist input? 8 A. 9 Basically, the increase in CRP is quite a serious biochemical sign, and it's -- you know, rather than 10 leaving things without treatment, we want to treat until 11 the microbiologist is contacted. 12 Q. A raised CRP can be quite unspecific; is that fair? 13 A. This degree of CRP is almost certainly consistent with 14 an infection. We might be talking about 20mg, 25mg to 15 30mg of -- increase, like, of milligramme per litre of 16 the C-reactive protein. 17 stressful events. 18 fairly significant. That could be caused by other But as high as 125, I think it's 19 Q. Could it be caused by another inflammatory process? 20 A. Inflammatory? 21 22 Very unlikely, no. It is usually an infective process, yes. DAME ELISH: I wonder if my learned friend could clarify 23 whether or not, if the patient had cancer at that stage, 24 would she have been immunosuppressed as a result of 25 that? Would that be a factor that would be taken into 133 1 account in dealing with any likely infection? 2 A. 3 LORD MACLEAN: 4 A. 5 Yes, she would be very immunocompromised. Calcium -- the cancer, you mean? The presence of a cancer -- 6 LORD MACLEAN: 7 A. 8 9 Did you consider that? Oh, yes. You knew that? Right from the very first day, we suspected cancer. LORD MACLEAN: But the question is: would the fact that she 10 was immunosuppressed be a factor to be taken into 11 account in dealing with any likely infection? 12 A. Yes. 13 MR MACAULAY: I think, just to follow that through, then, as 14 we have the note on the screen, was that something 15 that's been noted as a consideration at that time? 16 A. The ciprofloxacin? 17 Q. No, the fact that she was immunosuppressed was a factor 18 to be taken into account? 19 A. Yes, definitely. 20 Q. Has that been noted? 21 A. No, but we did not have, at that time, a definite 22 confirmation of the presence of cancer, but it was 23 highly suspicious, because we ruled out 24 hyperparathyroidism, which is another cause for high 25 calcium, by checking the parathyroid hormone level, 134 1 2 which was normal. Q. If we go on to page 51 and look at the next entry after 3 14 February, we can see here there is an entry where 4 there is a ward round that doesn't include yourself, 5 Dr Al-Shamma. 6 Can we see there is reference here -- it is about 7 four or five lines down -- that she's apyrexial and that 8 a colonoscopy had been rearranged for Thursday at 1 pm; 9 do you see that? 10 A. Yes, that's correct. She was very confused and 11 Dr Carmichael could not do the colonoscopy on the same 12 day, so it was rearranged for the 21st. 13 Q. 14 Did you consider this patient to be quite unwell at this point? 15 A. I think she was quite unwell, yes. 16 Q. If we go on to page 52 of the records, can we see that 17 the next clinical note following upon 15 February is 18 dated 18 February? 19 A. That's correct. 20 Q. So there is a two-day gap in the records? 21 A. That's the weekend, yes. 22 Q. Have you checked that out? 23 A. Yes, it is in front of me. 24 25 It is a weekend. The 16th and 17th was Saturday and Sunday. Q. Even though you have a patient who I think you mentioned 135 1 a moment ago was quite unwell, such a patient would not 2 be reviewed? 3 A. That all relates to the middle grade on call, to come 4 and see the patient and to ask, if required, the 5 consultant on call to come and review the patient. 6 Obviously, that is triggered usually by the nurse in 7 charge. 8 would call. 9 If she feels the patient was unwell, then she But there is no -- I should make that clear -- 10 routine ward round over the weekend to see all patients. 11 No way one middle grade and one FY1, who are receiving 12 and looking after all the patients on the ward, to do 13 a proper ward round on Saturday and Sunday. 14 middle grade would be downstairs most of the time in the 15 medical assessment unit. 16 Q. Because the I understand the difficulties that you had at the 17 weekend from our discussion earlier, but I had also 18 understood from what you had said earlier that you would 19 expect the junior doctors to review the patients on 20 a daily basis. 21 that may not happen? 22 A. But are you saying at the weekends that No, definitely it doesn't happen. All patients, no way 23 you could, you know, review, what, 70, 80, 90 patients 24 in the medical ward by one middle grade who is looking 25 after the MAU and also seeing the difficult problems on 136 1 the ward as well, helping the FY1. 2 regular ward round. 3 Q. No, there was no No way. Even though you have a patient who is quite unwell, then 4 you're saying to the Inquiry that, because of the setup 5 in the Vale of Leven, such a patient would not generally 6 be seen at the weekend for -- 7 A. If the patient is unwell, he would be reviewed on the 8 request of the nurse in charge of the ward, so she would 9 call the oncall middle grade and ask him or her to come 10 and see the patient. 11 Q. So it would -- 12 A. So presumably, there was no problem over the weekend. 13 Q. If I can then just move on to when this patient started 14 to present with diarrhoea, I think we see from the 15 nursing notes that she started to develop loose stools 16 on 16 February 2008. 17 page. 18 Perhaps I can take you to the It is page 223 of the records. Certainly by the evening of 16 February, can we note 19 towards the bottom of the page that "Mobile to toilet" 20 and then "One in attendance. 21 would appear she's now certainly developing signs of 22 C. difficile; is that correct? 23 A. Diarrhoea + + +". So it No, I don't think that is quite correct, because the 24 patient has been suffering from frequent or loose bowel 25 motion from, I think, 23 January, and that was the 137 1 reason why she was seen by Dr Carmichael at the 2 outpatient clinic. 3 So she had an altered bowel motion and, basically, 4 as I said, we were focusing on carcinomatosis in this 5 case, and all our thought was that this patient suffers 6 from colonic tumour, which has caused the altered bowel 7 motion, and ultimately has resulted in an increase in 8 the serum calcium level. 9 So it did not come as a surprise, because she did 10 have history of, you know, loose bowel motions for 11 almost a month prior to this event on 16 February. 12 Q. But does it appear that the nursing staff were certainly 13 considering C. difficile because they sent a sample away 14 for C. diff testing? 15 A. Yes. I mean, you would have to send a sample for 16 culture and for C. diff every time you have a patient 17 with diarrhoea, and regardless whether you suspect 18 cancer or an infective process. 19 Q. If we turn to the clinical notes, first of all, at 20 page 53, towards the top of the page, for the 19th, 21 there is an entry that relates to your ward round. 22 you see that, Dr Al-Shamma? 23 A. Yes. 24 Q. "Ward round Al-Shamma". 25 It begins: "No longer confused, oral input still poor." 138 Do 1 Is that correct? 2 A. That's correct, yes. 3 Q. I think you have obviously advised to push oral fluids; 4 is that what we read? 5 A. Yes. 6 Q. There is no reference there to diarrhoea. Would you 7 have seen diarrhoea as an important aspect of her 8 position at this time, or not? 9 A. Obviously, if I was told that there was a problem with 10 diarrhoea, I would have noted that, but the patient did 11 not mention that, none of the nurses had mentioned that. 12 So I can only assume there was no problem with that. 13 Q. We then see two more entries -- 14 MR KINROY: My Lord, I wonder if we might have a chance to 15 clarify, is this an example of an entry being written by 16 someone else other than Dr Al-Shamma when a ward round 17 took place? 18 LORD MACLEAN: 19 20 not written by Dr Al-Shamma, but by a junior doctor. MR KINROY: 21 I'm obliged to have that clarified, my Lord. I understood that some of them were written by him. 22 LORD MACLEAN: 23 A. 24 LORD MACLEAN: 25 I rather thought that all the entries were Is that your writing? No. Did you actually make entries yourself? we seen any of your own entries? 139 Have 1 A. 2 LORD MACLEAN: 3 A. 4 LORD MACLEAN: 5 A. 6 LORD MACLEAN: 7 A. 8 LORD MACLEAN: 9 MR KINROY: 10 Sorry? No. So this is a junior doctor? Yes. That was the norm, wasn't it? For me, yes. MR MACAULAY: 11 Have we seen any -- Okay? I'm obliged, my Lord. We see on that page another two entries, one for the 19th and one for the 20th; is that correct? 12 A. Yes. 13 Q. Then, if we move on to page 54, we have again 14 a reference to your ward round on 21 January; is that 15 right? 16 A. That's correct, yes. 17 Q. I think you have noted here, "Awaiting colonoscopy 18 today", and the plan is to await the colonoscopy, 19 monitor bloods and that she may need a CT of her 20 abdomen; is that right? 21 A. Yes, that's correct. 22 Q. This is a lengthy entry, but, again, there is no 23 reference to diarrhoea at this point in this part of 24 the records; is that fair comment? 25 A. Yes, that's correct. 140 1 Q. Then, if we turn on to page 55, is the instruction, part 2 of the instruction, to continue with ciprofloxacin; is 3 that right? 4 A. Sorry? Where? Ciprofloxacin? 5 Q. "CW", is that "continue with"? 6 A. No, that is "CT". If colonoscopy inconclusive, CT scan. 7 What I was saying, if colonoscopy does not show any 8 cancer in her colon, then we go for CT. 9 LORD MACLEAN: 10 Look three lines above that. 11 A. 12 LORD MACLEAN: 13 A. 14 LORD MACLEAN: 15 LORD MACLEAN: 18 It says Yes. "BD", bidaily, "500mg". 21 February. 19 A. 20 LORD MACLEAN: 21 25 What is the next word, then? "cipro", doesn't it? 17 24 What is that? I don't know. A. 23 What is that? Yes, that's right. 16 22 I think you are looking at something else. What does "CW" mean? "Continue with". counsel. A. That is on That is exactly what was put to you by What is the answer? She wasn't on cipro. We know that for sure. She wasn't on ciprofloxacin. MR MACAULAY: That is why I'm asking you the point. says, "Continue with ciprofloxacin". 141 This 1 A. There must be a mistake there. That would be a mistake. 2 It is meant to be continue with, I think, at that stage, 3 Augmentin, co-amoxiclav. 4 Q. I think what we take from this, though, is that you're 5 awaiting the results of the colonoscopy that's been 6 carried out by Dr Carmichael; is that correct? 7 A. That's correct. 8 Q. I think we see an entry for the 23rd, which doesn't make 9 mention either to C. diff or to the results of 10 the colonoscopy; is that right? 11 A. Yes, at the end, it says "metronidazole". 12 Q. Sorry? 13 A. At the end, it says -- I think it is "Patient on 14 15 I didn't quite hear that. metronidazole. Q. Encouraged to take" -- You have moved on to the entry for the 24th. The entry 16 for the 23rd, I think there is no reference there to 17 C. diff or to the results of the colonoscopy; is that 18 fair comment? 19 A. I can't see anything, no. 20 Q. Similarly, for the 24th, that you have just moved on to, 21 again, there is no mention there to C. difficile or the 22 colonoscopy, although, as you point out, there is 23 reference to taking metronidazole? 24 A. That's correct, yes. 25 MR KINROY: My Lord, I may be off on a tangent here, but 142 1 I see on the 23rd there is an entry, "Commence 2 intravenous vancomycin". 3 something other than C. diff, is it? 4 LORD MACLEAN: 5 6 I imagine that is for Do you know why -- I spotted that, actually. Why is vancomycin prescribed? A. It says here "Microscopy shows" -- positive blood 7 culture results shows staph which is sensitive to 8 vancomycin. 9 10 LORD MACLEAN: A. 11 12 It says "Culture results awaited". Oh, "should condition deteriorate", it says. "Should condition deteriorate", that is the message from the microbiologist, I assume. MR MACAULAY: 13 This is intravenous vancomycin, which I think we understand now is not used for C. difficile. 14 A. No, not for C. diff. 15 MR MACAULAY: My Lord, I am going to move on to another 16 point, albeit within the same context, so this might be 17 an appropriate point to have a short break. 18 LORD MACLEAN: 19 (3.15 pm) 20 Yes. (A short break) 21 (3.30 pm) 22 MR MACAULAY: We had seen from the clinical notes we had 23 been looking at, Dr Al-Shamma, that there was to be 24 a colonoscopy examination of Mrs Valentine, and I take 25 it that would be something that you would be waiting 143 1 for, for the results of that colonoscopy? 2 A. That's correct, yes. 3 Q. If we look at page 67 of the records, do we have on the 4 screen here the results of the colonoscopy that was 5 carried out by Dr Carmichael? 6 A. That's true. 7 Q. Can we see that the diagnosis that he has made is that 8 there is a "pseudomembranous colitis (severe, entire 9 colon)"; that is right? 10 A. 11 12 It is, yes. Pseudomembranous colitis is always a serious condition. Q. I think at about this time there was also a C. diff 13 positive result, if we look at the microbiology at 14 GGC00800173. 15 We are here looking at a lab report that relates to 16 a specimen collected on 21 February 2008. It bears to 17 have been received by the lab on 25 February, and this 18 is a positive result; is that right? 19 A. That's right. 20 Q. I think if we look at the nursing notes at page 227, can 21 we see towards the bottom of the page for 22 February at 22 1645, it is the last line for that entry at 1645: 23 "Informed staff C. diff positive." 24 Can you see that? 25 A. Yes. 144 1 Q. Does it appear that, whatever the lab report may say, 2 the ward staff were aware that Mrs Valentine was C. diff 3 positive as at 22 February? 4 A. According to these notes, yes. I'm not sure whether -- 5 I suspect Dr Carmichael contacted us. 6 contact us. He would normally 7 Q. I will come to the medical notes in a moment. 8 A. Right. 9 Q. If we look at the infection control card, at 10 SPF00770001, there is an entry for the 22nd: 11 "Admitted with history of loose stools so nursed in 12 isolation and commenced on metronidazole following 13 colonoscopy which showed colitis." 14 Does it appear that certainly the infection control 15 nurse is proceeding on the basis that, certainly as at 16 the 22nd, she is suffering from C. diff? 17 A. Yes, that's correct, according to this card, yes. 18 Q. If we return to the clinical records, then, and we go 19 back to page 55, I think we'd noted that on page 55 20 there's no mention in the entries from the 22nd through 21 to the 24th of C. diff; is that correct? 22 A. 23 24 25 Yes, apart from the indication that the patient was on metronidazole on the 24th. Q. Is there any mention there of the results of the colonoscopy? 145 1 A. No, apart from the printed report from Dr Carmichael. 2 Q. But there is no entry in the clinical notes independent 3 of that report to discuss the findings of the report? 4 A. No, I can't see one. 5 Q. If we turn on to page 56, we have, on the 25th, a ward 6 round by you, and I think you can read what is there. 7 Again, is there any mention in the course of your ward 8 round to the findings of the colonoscopy? 9 A. I can't see one, no. 10 Q. If you look at the 26th -- 11 DAME ELISH: I wonder if my learned friend could ascertain 12 where the report from Dr Carmichael would have been 13 filed on the colonoscopy? 14 A. 15 It would be filed in the notes. Dame Elish -- 16 LORD MACLEAN: 17 A. 18 LORD MACLEAN: 19 A. 20 21 Sorry, the report, You said a private report -- Filed in the notes, yes. Sorry? The report would have been filed in the notes. Was that your question, sorry? LORD MACLEAN: Apart from the printed report from 22 Dr Carmichael -- it is not "private" at all, the printed 23 report -- where would that go? 24 25 A. To the notes. It would be filed immediately, because the notes will be sent with the patient to the 146 1 colonoscopy theatre and, once he finishes, he will 2 immediately put that in the notes. 3 MR MACAULAY: As I understand it, if we go back to page 67 4 of the records, just to clarify this point, the actual 5 report of the colonoscopy, and that is dated 6 21 February, you have told us would be filed with the 7 medical records; is that right? 8 A. That's correct. 9 Q. When would the report be generated? Would it be 10 generated at the time of the examination or would it be 11 sometime subsequent to the examination? 12 A. At the time of examination. 13 Q. Would you expect some verbal information to be sent to 14 the ward, in particular to the doctor, that this finding 15 has been made? 16 A. It depends on Dr Carmichael, obviously how busy he was 17 in the theatre. 18 "Could you start on metronidazole?", but I can't answer 19 this question in this particular patient. 20 wasn't any mention that he has contacted the ward. 21 Q. He might, you know, phone and say, But there I think, as you have indicated to me, this particular 22 diagnosis reflects a serious and, indeed, 23 life-threatening condition? 24 A. That's correct, yes. 25 Q. Would you expect the clinician carrying out the 147 1 procedure to contact the doctor to let the doctor know 2 that this finding has been made? 3 A. Normally, the report will be left on the top page, sort 4 of, in the clinical notes, and probably Dr Carmichael 5 expected the junior to have looked at the report 6 immediately and act accordingly, because he put at the 7 end, metronidazole 400mg three times a day to be 8 started. 9 Q. 10 Should this finding have been recorded in the clinical notes prior to 25 February? 11 A. Yes, it should have been, yes. 12 Q. So far as one can read, up to 25 February in the 13 14 clinical notes, there is no indication there at all? A. 15 16 metronidazole, yes. Q. 17 18 Yes, apart from the entry that the patient was on There is no indication that the medical staff were aware that she had been diagnosed with this serious condition? A. No, they were aware, but they hadn't documented that. 19 That is why they started the patient on metronidazole. 20 They would have been aware, definitely. 21 been aware as well. 22 antibiotic was stopped as well, the co-amoxiclav. 23 Q. I would have Because, at that stage, the Do I take it, then, if we look back to page 56 of 24 the records, the entry for 25 February, a number of 25 matters have been noted following upon your ward round, 148 1 but there is no mention there to the pseudomembranous 2 colitis that had been diagnosed several days beforehand? 3 A. No, but I would have been aware obviously. I know the 4 patient was on metronidazole, and I have examined the 5 abdomen, which was still distended. 6 accumulated. 7 pseudomembranous colitis. 8 in this lady was to find out what's causing -- what has 9 caused the hypercalcaemia, so we were focusing on Now the fluid has But, yes, I did not make a mention of As I said, our main concern 10 that -- in that direction, to be honest with you, and 11 the pseudomembranous colitis came as a surprise to us, 12 because we expected to find a colonic tumour in this 13 situation, especially the patient has presented with 14 altered bowel habit for a good few weeks prior to 15 admission. 16 So at that stage, I've examined the abdomen and said 17 "It's distended, but there is ascites, and we will go 18 ahead for CT scan". 19 whether Mrs Valentine suffered from malignant disease or 20 just simply it was something else causing the 21 hypercalcaemia, although malignancy was the most likely. 22 Q. We were just trying to find out If we go back to page 55 of the records, and we looked 23 at these entries previously, the entry that makes 24 reference to metronidazole is the one on 24 February; is 25 that right? 149 1 A. That's correct, yes. 2 Q. Is there any indication in the other previous entries 3 after the diagnosis had been made that the medical staff 4 were aware of the diagnosis? 5 A. Not as far as I can see from this, no. 6 Q. Is there any indication in the other entries that any 7 treatment was being given to this patient for the 8 diagnosis of pseudomembranous colitis? 9 A. That's the metronidazole on the 24th. 10 Q. Indeed, but there is no indication on the 22nd or on the 11 23rd? 12 A. No, there wasn't. 13 Q. Why wasn't treatment started on the 21st? 14 A. I'm not sure when treatment was started. 15 Can we look at the Kardex? 16 Q. 17 DAME ELISH: 18 MR MACAULAY: 19 A. It was started on the 21st. 20 Q. What was the reasoning given for the starting of 21 Yes, certainly. Page 330, I understand. Thank you. the metronidazole at that time? 22 A. Just say for stool sample, positive. 23 Q. So that is dealing with the C. diff result? 24 A. Yes. 25 So presumably they received the results from the lab and at the same time we have the colonoscopy results 150 1 2 coming on the same day. Q. I think you agree, do you, that the pseudomembranous 3 colitis really should have been addressed in the 4 clinical notes? 5 A. Yes, I think the junior should have, when the patient 6 came back, which was Thursday -- the 21st was 7 a Thursday. 8 with the colonoscopy, but he was doing extra sessions. 9 Yes, I would expect the junior to write down the results An unusual time for Dr Carmichael to deal 10 and to confirm that the patient has been started on 11 metronidazole. 12 LORD MACLEAN: 13 14 report? MR MACAULAY: 15 Yes, I am going to go there, my Lord. It is at page 67 of the records. 16 LORD MACLEAN: 17 MR MACAULAY: 18 LORD MACLEAN: 19 A. 20 LORD MACLEAN: 21 22 Could I see the report again, the printed The date? The date, towards the top right, is the 21st. It would be available then, I think you said? Yes. You see, of course, metronidazole was actually prescribed by Dr Carmichael on that. A. 23 Yes, he had recommended it and it would have been prescribed by the junior, yes, on the same day, yes. 24 LORD MACLEAN: 25 A. On the same day? Yes. 151 1 MR MACAULAY: I think the prescription would have been done 2 by the junior doctor. 3 Dr Carmichael is that the patient should receive 4 metronidazole 400mg orally three times a day; is that 5 correct? 6 A. 7 8 The prescription was made by the junior doctor, yes. LORD MACLEAN: 9 Was there any particular reason why the content of this report, abbreviated, at least, wasn't 10 11 Yes, that's correct. The recommendation by included in the clinical notes? A. No, there wasn't. Basically, I would expect the junior 12 to have written that the colonoscopy had shown features 13 consistent with pseudomembranous colitis and, on the 14 recommendation of Dr Carmichael, metronidazole was 15 started. 16 MR MACAULAY: This diagnosis, I think you have told us, is 17 a serious illness. Is there evidence of the patient 18 being assessed clinically in the ensuing period, in 19 particular from 21 February? 20 the records. If we turn to page 55 of 21 A. I did see the patient on the 25th, I believe. 22 Q. That is four days down the line. If we look on page 55, 23 there is an entry on the 22nd by the dietician. 24 I think, from what you have said, the report would have 25 been available at that time. 152 Now, Is there any entry on 1 2 21 February -A. 3 4 This is on the top. I think that was 21 February. Q. 5 6 That was the 21st. That is when you are awaiting the result of the colonoscopy; is that right? A. Yes. Can I just say that if I were to go on, like, 7 a study leave, or on holiday on Friday, I would normally 8 come and do the ward round on Thursday to make sure all 9 patients are seen twice-weekly. So on this occasion, 10 I came to do my ward round on the 21st, which is 11 Thursday, which was the last time I saw the patient 12 before the weekend. 13 Now, I would have been on holiday or on study leave 14 on the 22nd, and then I came back on the 25th, 15 I believe, to see the patient, if you go to the next 16 page later on. 17 Q. I will come to that. If I could just press you on this 18 one point, Dr Al-Shamma, as we are looking to the page 19 we have on the screen, we see, on the 21st, you are 20 awaiting the results of the colonoscopy -- 21 A. Yes. 22 Q. -- which we know has come through on the 21st. The next 23 entry we have is from the dietician. 24 appear to have been any assessment made of the patient 25 on the 21st, or indeed on the 22nd. 153 There doesn't Is that fair? 1 A. Well, no, the 21st -- the patient was seen by myself. 2 Q. By anybody, by any doctor? 3 A. Well, because I did my ward round, there is no need for 4 another doctor to come and see the patient. 5 already seen the patient. 6 doctor should have written down that the colonoscopy 7 results came back showing pseudomembranous colitis and 8 metronidazole was started, but that did not happen, and 9 I really can't explain why, on the 22nd, the patient was 10 11 I have Yes, I accept that the junior not seen by a junior doctor. Normally, I would expect that to happen on the 22nd 12 when I am away on holiday. 13 ward round prematurely to make sure that the patient -- 14 all patients would have been seen twice a week, 15 according to the, you know, GMC recommendation. 16 DAME ELISH: But on the 21st, I did my My Lord, my learned friend has suggested was it 17 a reason for the patient not being clinically assessed 18 on the 21st. 19 explore whether or not the detailed colonoscopy by the 20 consultant Dr Carmichael would have been a very thorough 21 form of clinical assessment on the same day and, given 22 that Dr Carmichael prescribed metronidazole at that 23 stage, what would have been anticipated on that first 24 day, or the following day, that would require 25 a response, given that we know it is five to seven days I wonder whether my learned friend would 154 1 2 for response? LORD MACLEAN: 3 4 Yes, what do you mean by "clinical assessment"? MR MACAULAY: 5 Can I just come to that, and just clarify this? 6 A. Sure. 7 Q. What Dr Carmichael did was an investigation, 8 a procedural investigation; is that right? 9 A. That's correct, yes. 10 Q. He was able to ascertain, because of what he could see 11 from the colonoscopy, what the diagnosis was; is that 12 right? That's correct, isn't it? 13 A. That's correct, yes. 14 Q. When I talk about a clinical assessment, I mean, for 15 example, assessing the patient clinically, by taking 16 bloods, temperature and so on and so forth. 17 what you would do, would you not, if you are carrying 18 out a clinical assessment of a patient who has this 19 serious condition? 20 A. I agree with you. That is The patient was not seen on the 22nd 21 and I don't know why the patient was not seen by 22 a junior on the 22nd. 23 short of doctors, there was no cover, there was perhaps 24 one middle grade covering wards 3 and 6. 25 impossible for me to answer this question. Again, it could be that we were 155 It is I do accept 1 there was no review by a middle grade on the 22nd, but 2 then, on the 23rd, when there was some message from, 3 I think, microbiology, that was noted in the case notes. 4 LORD MACLEAN: 5 do you have the -- 6 A. 7 LORD MACLEAN: 8 9 Still looking at this page, from the 21st -- Yes. Can you tell me what is meant in the entry for the 21st, "Once off cipro"? A. No, continue with cipro. That was a mistake. 10 it was meant to be continue with co-amoxiclav, 11 Augmentin. 12 LORD MACLEAN: I will make the question more accurate. 13 Count five lines. 14 mean? 15 A. 16 I think It is now circled. Again, I think it is a mistake here. What does that We are probably talking about Augmentin, rather than cipro. 17 LORD MACLEAN: 18 actually. 19 A. 20 LORD MACLEAN: 21 A. 22 LORD MACLEAN: 23 A. 24 LORD MACLEAN: 25 A. There was a one-off -- no, there wasn't, She was on cipro anyway -- Not at that time. -- when you increased it. No, that was on the -I know when it was. -- 14th. What does that mean? It is a mistake in the notes. 156 1 LORD MACLEAN: 2 DAME ELISH: Pardon? I wonder if it would assist if my learned 3 friend was to look at the record of the prescription, 4 which I think was by Dr Chan for this particular date 5 for the cipro. 6 LORD MACLEAN: 7 DAME ELISH: 8 MR MACAULAY: 9 Yes. Do you have the reference? Sorry, my Lord, it is at 330. We are looking at the second entry, I think, Dr Al-Shamma, for ciprofloxacin. Looking at that, there 10 appears to be prescribed a dose of 500mg by Dr Chan. 11 there any evidence -- 12 A. That wasn't given, and I don't know when -- that was on 13 the 21st. 14 given. 15 It looks like the 21st. My Lord, I don't think that would be a single dose, because the timings are twice a day. 17 LORD MACLEAN: 18 MR PEOPLES: 19 LORD MACLEAN: I know. I saw that. So it wouldn't fit with the first entry. I'm just puzzled. I don't know what it 20 means: "One off cipro". 21 that in your hands, Mr MacAulay. 22 MR MACAULAY: 23 24 25 But it was never It must be a mistake there. MR PEOPLES: 16 Is Anyway, carry on. I will leave I think your position, Dr Al-Shamma, seems to be that there are mistakes here that you can't explain. A. Well, I can't explain, you know, the mistakes of the juniors, no. 157 1 Q. Then, if we can move on from that -- 2 A. You see, that entry was made, I believe, by the junior, 3 and he was just messing up with everything. 4 was saying "On cipro", "Once cipro", but certainly that 5 is not correct from what the junior has written down. 6 Obviously, I can't go through the notes of every 7 junior's handwriting -- 8 DAME ELISH: 9 I mean, he I wonder, my Lord, if I could draw the Inquiry's attention to page 324, which is the "once 10 only" chart which has an entry for that date of 11 ciprofloxacin as a "once-off"? 12 LORD MACLEAN: That is what I think it means, of course. 13 When it says "One off cipro", that is what it is 14 referring to. 15 DAME ELISH: 16 MR MACAULAY: 17 A. Yes. Does that make any sense to you? No, not to me. That wasn't given on my approval or my 18 instruction. 19 My entry does not say anything about cipro or another 20 antibiotic. 21 Q. I don't know why it was started anyway. Can I take you back to page 55, then, of the records? 22 As we see, there is no further entry for the 21st, and 23 there is no entry on the 22nd that can provide us with 24 any medical input or insight into the patient's 25 condition; is that right? 158 1 A. 2 3 22nd. Q. 4 5 No, I can't see any entries on the 21st -- sorry, the Should the patient have been reviewed by a doctor once the diagnosis had been made? A. Yes, she should have been reviewed, but I don't know why 6 she was not reviewed by -- because that's the routine, 7 you have to see all the patients, the juniors should see 8 all the patients in their ward in the day, except when 9 the consultant was doing the ward round, so there is no 10 11 need for another review by the junior. Q. If we go on to page 56, can we see the first mention in 12 the clinical notes for the severe pseudomembranous 13 colitis is for 26 February? 14 A. That's right. 15 Q. In the period that she was having loose stools, I think 16 we saw that she was receiving ciprofloxacin and you say 17 that should not have been happening; is that correct? 18 A. You mean on admission? 19 Q. No, the period we have been looking at, from about 20 21 16 February onwards? A. 22 She wasn't on ciprofloxacin, she was on Augmentin at that time. 23 Q. Indeed. That's right. 24 A. Yes. 25 Q. Should she have continued with the Augmentin? 159 1 A. I think so. There was good evidence of infection. If 2 we look at her CRPs: on the 14th, it was 127; on the 3 15th, it was 221, which means the infection was raging; 4 and then, on the 18th, it dropped to 82; and on the 5 22nd, it was 50, which clearly indicated that she did 6 have an infection and the antibiotic was the correct 7 antibiotic. 8 Q. 9 10 Could it have been C. diff that was causing the infective process at that time? A. No, I don't think so, because, at that stage, she was 11 responding to the antibiotic without specific treatment 12 for C. diff. 13 Q. If we look at page 328 of the records -- we are back to 14 the Kardex -- do we note that in the second entry she 15 has been receiving lactulose, and that was prescribed, 16 I think, first on 10 February. 17 a time when it should have been stopped, or not, or can 18 you say under reference to -- Is that continued or at 19 A. I think it was withheld most of the time. 20 Q. I think we saw she had certainly diarrhoea on the 16th. 21 It is not clear, but she was given -- I think number 14 22 has been written into that box. 23 may have received lactulose on the 21st and the 22nd, 24 judging by what's on the Kardex? 25 A. It's possible, yeah. Does it seem that she I don't know. 160 This could be 1 2 a signature of -- a nurse signature, yes. Q. 3 If that is right, should she have been given lactulose on these two days, if that's what happened? 4 A. No, the nurse would have noted that. 5 Q. I'm sorry? 6 A. The nurse should have noted that she's having diarrhoea 7 at that stage and she's diagnosed with C. diff. Maybe 8 on the 21st she was given that before she had her 9 colonoscopy, it was given in the morning, but certainly 10 on the 22nd there is no excuse for giving -- if she was 11 given that. 12 Q. There may also have been a dose given on the 23rd? 13 A. It's difficult to say. 14 Q. Would this be a patient, particularly after the 15 diagnosis of C. diff had been made, for whom fluid 16 balance charts should have been properly kept? 17 A. You would expect, yes, to have some input and output 18 chart, yes. 19 and the other criteria, like low blood pressure, kidney 20 function, and so on, but, generally speaking, yes, you 21 should have a fluid chart. 22 Q. 23 24 25 It depends on the severity of the condition Was there any assessment of the severity of the condition made? A. Well, yes. I mean, basically, you look at the blood pressure chart, the temperature chart, abdominal 161 1 2 examination and renal function as well. Q. If we go to the clinical notes after the diagnosis, 3 I think that would probably take us to page 55 of 4 the records, we don't see any reference -- I think we 5 have touched upon this already -- to C. diff itself. 6 there evidence there of an examination being made to 7 assess the severity of the C. diff? 8 A. That was a weekend. 9 Q. Although she was seen by a doctor, it would appear? 10 A. Well, there was a message, that's all. Is The 23rd and 24th was a weekend. Somebody called 11 to say that blood culture has shown staph and treat if 12 symptomatic. 13 no. I suspect she was not seen by a doctor, 14 Q. I'm sorry? 15 A. I don't think she was seen by a doctor. It was only 16 a note written in the case notes to indicate that there 17 was a call I suspect from microbiology. 18 Q. In any event, does the diagnosis of pseudomembranous 19 colitis that was made really indicate that this was 20 a severe disease? 21 A. Sorry, it is a severe disease if -- it depends, 22 obviously -- no, there was no sort of indication that it 23 was severe from these notes at the moment, but then she 24 wasn't seen by any doctor until the 25th, was seen by 25 myself, so I'm not sure what you mean by "severe". 162 1 2 I don't think it was severe in any case in this case. Q. 3 is involved here on page 67 of the records? 4 We have noted that diagnosis of "pseudomembranous 5 6 Have we not seen from the report that her entire colon colitis (severe, entire colon)". A. That is obviously a colonoscopic finding. You have to 7 go by clinical findings as well to assess the severity 8 of the condition. 9 you hardly diagnose pseudomembranous colitis on That is not a common way -- because 10 colonoscopy. 11 Generally speaking, it affects the whole colon. 12 Q. 13 14 It is not something you diagnose there. If we go back to page 55, is there anything, at that stage in the process, to indicate what the clinical -- A. 15 No, if you go to the next page, when I saw her on the 25th, on Monday -- 16 Q. But -- 17 A. No, there wasn't anything over the weekend. We go back 18 to the same issue: the staffing was very short over the 19 weekend and there is no way for an SHO to come and see 20 all patients on the ward unless specifically he is asked 21 to come to an ill patient by -- well, usually the 22 request is triggered by the nurse in charge of the ward. 23 Q. Then, if we look at the page you have invited me to take 24 you to, page 56, where we have reference to your ward 25 round, have you then, in that -- does that indicate to 163 1 us that the clinical examination has been carried out to 2 assess the severity of the C. diff? 3 A. Yes, both the severity and the cause of 4 the hypercalcaemia, looking for cancer. 5 now, the abdomen was distended and there was 6 a significant amount of fluid in her tummy. 7 Q. What does this tell us, then? At this stage Where do we categorise 8 her C. difficile infection under reference to this 9 entry? 10 A. Is it severe or not? At this time, there was something else happening in her 11 abdomen. Fluid was accumulating as a result of 12 the cancer process. 13 at that stage, we were more concerned about the type of 14 the cancer which she has, because we were keen and eager 15 to get a diagnosis. So at that stage -- to be honest, 16 Q. Does she have a serious infective process at this point? 17 A. She was on the right treatment for that infective 18 process. 19 was no mention that she was hypotensive or she was, you 20 know, pyrexial or her renal function has deteriorated. 21 Our main concern was focused on what's going on as far 22 as the hypercalcaemia and the cancer process and where 23 is the primary, where is the cancer, are we definitely 24 dealing with cancer. 25 I don't think it was serious, because there Sometimes patients die without a definite diagnosis 164 1 and you end up doing a post-mortem. 2 get a diagnosis before that. 3 Q. We were eager to If you look at page 95 of the records, this is a report 4 from the biochemistry department. Do we note that, at 5 this time, on the 21st, her CRP certainly is high, at 6 306? 7 A. Yes. 8 Q. Sorry? 9 A. That's the C. diff infection. 10 Q. Does that help in relation to categorising the severity 11 12 That is the C. diff infection. of the infection? A. No. I would probably look at the urea and the 13 creatinine, and they were fairly normal, slightly raised 14 urea. 15 Q. 16 So far as the malignant peritonitis is concerned, do we have evidence of that in this case? 17 A. It's on the CT scan. 18 Q. So is that what you are basing that conclusion on? 19 A. Sorry? 20 Q. Is that what you are basing your conclusion on? 21 A. Yes. 22 Q. Would this be a case that you might have considered 23 surgical review of the patient, standing the diagnosis 24 of pseudomembranous colitis? 25 A. No, there was no indication for surgical review. 165 1 2 MR MACAULAY: My Lord, that might be an appropriate point to adjourn for today. 3 LORD MACLEAN: 4 (4.10 pm) Very well. Tomorrow morning, 10 o'clock. 5 (The hearing was adjourned to 6 Tuesday, 13 December 2011 at 10.00 am) 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 166 1 I N D E X 2 3 DR MUSA AL-SHAMMA (sworn) ............................1 4 5 Examination by MR MACAULAY ....................1 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 167