NOTE (1) for
GREATER GLASGOW HEALTH BOARD in
THE VALE OF LEVEN PUBLIC INQUIRY
re. THE EVIDENCE OF PROFESSOR BRIAN DUERDEN
2012 Ref.: RW
NHS Scotland Central Legal Office NOTE (1) for
GREATER GLASGOW HEALTH BOARD in
THE VALE OF LEVEN PUBLIC INQUIRY
re. THE EVIDENCE OF PROFESSOR BRIAN DUERDEN
In terms of the GUIDANCE ON WITNESSES AND TAKING OF EVIDENCE, Greater Glasgow Health Board wishes the following lines of questioning to be put by Counsel to the Inquiry to the witness Professor Brian Duerden:-
1. Is it correct that Jean Murray and Helen O’Neill had not given evidence by the time you had written your first report? A. Yes
2. Can we take it that you have read the evidence of Jean Murray and Helen O’Neill? A. Yes
3. Do you agree that the evidence we have heard from Jean Murray and Helen O’Neill, which was not available when you prepared your first report, is a major change in the material available to inform your opinion on the cause of the outbreak? A. No
2 4. Would you agree that ideally, if time permitted, your first report should be re-written in the light of the evidence of Jean Murray and Helen O’Neill? A. No
5. When you wrote your first report were you aware that (see HPS01060001 at HPS01060003) in June 2008 HPS seemingly recognised that the draft CDAD guidance being prepared by the HPA (Health Protection Agency) was not applicable in Scotland in its then current form due to the different managerial and organisational arrangements in Scotland? A. Yes. When we began the revision of the guidance in England, the Department of Health asked the HPA to coordinate a group to undertake the revision. The appropriate professional bodies (which are UK-wide) were included and they were observers from all 4 UK countries. I represented DH England. We worked closely across the devolved administrations and it became clear that Scotland needed a separate document because of the different management structure in NHS Scotland. However, the clinical and infection control content was essentially the same and we worked closely to deliver those professional aspects which are the same in the Scottish guidance.
6. When you wrote your first report had you seen the HPS publication “HPS Guidance on Prevention and Control of CDAD in Healthcare Settings in Scotland” (HPS01970001), issued in October 2008? A. Yes
7. If so, were you aware that there was no previous Scottish guidance dealing specifically with the Prevention and Control of CDAD in Healthcare Settings in Scotland? A. There had been no specific Scottish guidance prior to that document. However, the Department of Health and PHLS report and guidance published in 1994 pre-dated devolution and was UK-wide in its application and recommendations. As is stated in the new English guidance, the recommendations of the 1994 guidance were appropriate but needed to be revised into a more
3 modern format and to reflect the changes in NHS organisation and structures in the intervening period.
8. Were you aware that the 2008 Guidance underwent a drafting process in 2008 in which the Board’s Dr. Andrew Seaton was involved? A. Yes.
9. When you wrote your report were you aware (see HPS01060001 at HPS01060003) that in June 2008 HPS intended that its CDAD guidance would provide advice on the prevention and control of CDAD in healthcare settings in Scotland; with specific advice on roles and responsibilities for various staff groups, and evidence-based guidance on a number of key areas of infection control, including: early diagnosis; surveillance; isolation precautions; hand hygiene; environmental cleaning/decontamination; protective clothing; use of medical care equipment; antibiotic stewardship and specific measures during outbreaks/situations with increased incidence; and advice on the antibiotic treatment of CDAD? A. Yes.
10. Do you think that it might have been helpful for there to have been a Scottish guidance dealing specifically with the Prevention and Control of CDAD in Healthcare Settings in Scotland before 2008? A. The 1994 guidance was still available but somewhat dated in its format, not in its content. With hindsight, it would have been better if the guidance had been updated and issued in each of the UK countries, including Scotland before 2008 but the timing reflects the upsurge in cases and of interest and concern in the period around 2005-6.
11. If so, in what way? A. The content of the 1994 guidance was appropriate, but the structures for implementation had changed. This was what was needed.
4 12. Can you see any reason why there could not have been a Scottish guidance dealing specifically with the Prevention and Control of CDAD in Healthcare Settings in Scotland by 2006? A. It had not come to the forefront of the medical and political agenda before 2005-6, so there was not the pressure to update the guidance.
13. If you were unaware when you wrote your first report that there was no Scottish guidance dealing specifically with the Prevention and Control of CDAD in Healthcare Settings in Scotland until October 2008, should your report be modified in some way to reflect that and, if so, in what way? A. No, see above.
14. You say in your first report at p3 (EXP02830003) that clinical microbiology advice to the hospital was the responsibility of Dr. de Villiers until the end of January 2008. Can we take it that when you wrote your first report you were unaware that Dr. de Villiers (Day 84) had said in evidence that in the period January 2007 to January 2008 he and Dr. Biggs provided the microbiology service to the Vale of Leven hospital, but it was only Dr. Biggs who was the Infection Control Doctor responsible for the Vale of Leven hospital, and that it was Dr. Biggs who was the head of the Clyde Directorate microbiology department? A. I had read Dr de Villiers’ evidence before I finalised my report. He confirmed that he was responsible for clinical microbiological advice but that Dr Biggs was the Infection Control Doctor and was head of the Clyde Microbiology laboratories. This was included in my report.
15. If the Inquiry accepts Dr. de Villiers’s evidence on this, does that affect your opinion that there was a “division of responsibility that was unlikely to provide a robust, secure and reliable situation for the laboratory, the hospital clinicians or the infection control staff” and if not, why is that? A. No. This confirms that there was a division of responsibility as I had indicated.
5 16. Can you say whether there was a requirement in Scotland in 2007/8 that samples tested positive for clostridium difficile should be retained for a period for ribotyping? A. I do not believe there was a requirement to retain positive samples. It was not a requirement in England at that time. It was advice following on from the 1994 guidance when typing became available in the late 1990s (around 1998) issued by the then PHLS as part of advice on how to use the new typing service in outbreak investigations.
17. If so, what was that requirement, and when did it come into force? A. See above
18. Would you accept that the role of Infection Control Managers in Scottish Health Boards was altered by HDL(2005)8 Funding for Inspection Control Manager Posts (GOV00440001)? A. This developed and formalised the requirement that had come out of the Code of Practice 2004. This strengthened the requirement to appoint an Infection Control Manager.
19. Are you aware that Dr. Kevin Woods was Director- General of Health in the Scottish Government and chief executive of NHS Scotland from January 2005 until November 2010? A. Yes.
20. Are you aware that in evidence Dr. Woods accepted (Day 97 pp45-46) that HDL(2005)8 could be understood not to require Scottish Health Boards to impose operational responsibilities on their Infection Control Managers? A. I am now aware of this.
21. Would you accept that it was common practice in 2007/8 for Scottish Health Boards to refrain from imposing operational responsibilities on their Infection Control Managers? A. I do not know what was common practice in Scotland at that time.
6 22. Do you accept that the Board’s Infection Control Manager was accountable to the Chief Executive through the Medical Director? A. Yes, although my reading of the GGCHB Infection Control structure document as revised in 2006 was that the Manager was accountable to the Medical Director and the Chief Executive.
23. At p6 (EXP02830006) of your first report you comment on the background and experience of Tom Walsh, the Infection Control Manager. Are you aware that Mr Walsh was the Assistant Director of Nursing for Argyll and Clyde Health Board from 2002 to 2006? A. Yes
24. You say in your first report at p5 (EXP02830005): “From this chart, the Infection Control Manager did not appear to have direct responsibility for the infection prevention and control staff delivering the service in the various parts of the Board's organisation, and did not seem to have a clear line of accountability for the infection control services to the Chief Executive. The creation of this post was in line with the Code of Practice but the organisational chart suggests that the strategy set out in the Code may not have been implemented effectively in GGCHB. The manager was a senior clinician (a nurse) although this was not a requirement of the Code, which required only that this post be within the management structure. The job description for the Infection Control Manager focused specifically on the managerial responsibilities and did not require the manager to be a clinician and it appears that the Infection Control Manager did not have clinical responsibility for the activities of the infection control staff.” A. This is not a question. The question follows and has been replied to.
25. Are you there referring in that passage to The NHS Scotland Code Of Practice For The Local Management Of Hygiene And Healthcare Associated Infection (GOV00090001)? A. Yes.
7 26. If so, are you saying that it was in breach of that Code for a Scottish Health Board to refrain from imposing operational responsibilities on its Infection Control Manager? A. No. My concern was that the Manager did not appear to have the management responsibilities that would have been necessary for him to fulfil his responsibilities as set out in the GGCHB document.
27. If so, where is that required by the Code? A. It is not required in the Code.
28. You say in your first report at p3 (EXP02830003) that uncertainty over the future of the Vale of Leven Hospital “resulted in a lack of attention to the organisational structure for infection control.” Is that a reference to the Infection Control Manager having no operational responsibility for infection control? A. In part, but it refers to the full structure, particularly at the local level in Vale of Leven, then through the hierarchy of committees to the Infection Control Manager.
29. Or is it a reference to what you have understood (at p5 of your first report (EXP02830005)) from the organisational charts referred to in the following passage? “The organisation for infection prevention and control throughout GGCHB is shown on organisational charts provided by the Inquiry team. These charts show a rather confused structure without clear lines of reporting and accountability between infection control staff at ward, laboratory or hospital level, the Infection Control Manager, and the executive management team of the Board. This would suggest that infection prevention and control did not have a high priority in the new structure.” A. Yes. See above.
30. If so, might it just be that what the charts represent require further explanation, rather than that there actually was a lack of attention to the organisational structure for infection control? A. No. I believe the charts show inappropriate gaps in the structure and the Infection Control organisation at Vale of Leven was clearly inadequate.
8 31. What is the evidence for the statement that uncertainty over the future of the Vale of Leven Hospital resulted in a lack of attention to the organisational structure for infection control? A. This was stated in the External Investigation (Prof. Cairns Smith) and is mentioned in general in several witness statements.
32. You refer in your first report (at p6 (EXP02830006)) to the conditional CPA accreditation of the Vale of Leven Hospital laboratory. Would you accept that it was relatively common in 2007/8 for hospital laboratories to have conditional CPA accreditation? A. It was not uncommon for laboratories to have conditional accreditation, but the number of non-compliances was unusual in my experience.
33. Would you accept that there is an important difference between non-compliances and critical non-compliances? A. Yes.
34. Would you accept that critical non-compliances generally need to be addressed very quickly, whereas more time is allowed for non-compliances which are not critical to be addressed? A. Yes.
35. Were there any critical non-compliances in the Vale of Leven hospital laboratory? A. No.
36. Do you accept that even though none of them was a critical non-compliance, the non-compliances in the Vale of Leven hospital varied in their materiality? A. I do not understand the question.
37. Would you accept that if we want to gauge the seriousness of the non-compliances at the Vale of Leven Hospital laboratory we should look at more than just their number and the period between inspections? A. Yes. My comments were based not only on the number of non-compliances but their content and what they showed
9 about the management of the laboratory. I read every non-compliance. Many non-compliances showed that there was poor attention to the management and organisation of the laboratory. Job descriptions, training records, appraisals and responsibilities were not properly documented. The laboratory methods had not been reviewed and updated as required by the laboratory’s own internal policies as well as by the accreditation inspectors. With the experience of the previous inspection visit in 2002 that resulted in conditional accreditation, I would have expected most of these issues to have been put in place by the laboratory management in preparation for the 2007 inspection.
38. Do you accept that, among other things, we should look at the substance of the non-compliances, how long was allowed by the inspectors for them to be addressed and, if there was a breach of the time limit in the case of any non- compliance, the reason for that? A. Yes. I did review the substance of all the non-compliances and the time limits. They were finally cleared by the end of 2008 (15 months after the inspection and after the intense scrutiny of the outbreak investigation).
39. In your first report you say (at p6 (EXP02830006)), “However, this large number of non- compliances on a second inspection visit indicates significant and worrying gaps in organisation, management and clinical services in the laboratory.” A. This is not a question. The question follows and has been replied to.
40. Would you agree that the second inspection visit to which you refer is plainly the visit in 2007 and that the first visit is therefore the visit in 2002? A. Yes,
41. Have you seen any evidence that a non-compliance in 2002 remained unaddressed at the time of the 2007 inspection and, if so, what is that evidence? A. I have not seen the list of non-compliances from 2002 but neither is there any evidence provided that they were
10 cleared and I understand that the laboratory did not gain full accreditation between 2002 and 2007.
42. Would you accept that Dr. Weinhardt was well- equipped to know what the non-compliances were, how material they were to the functioning of the laboratory, and the reasons for them? A. Yes. She had the experience and the qualifications to do her job.
43. When she was asked about the non-compliances in 2007 Dr. Weinhardt (Day 86 p7) said, “I wasn't particularly concerned. I have experienced accreditation at other laboratories, and there's always a list.” A. This is not a question. The question follows and has been replied to.
44. Can you fairly criticise her judgment on this and, if so, what are the reasons for this criticism? A. I agree that there are often some non-critical compliances after an inspection. I disagree with her lack of concern. In my view this number is excessive and indicates deficiencies in the management and oversight of the laboratory.
45. Have these reasons been put to Dr. Weinhardt, so far as you know? A. I do not know.
46. You say in your first report at p6 (EXP02830006) that “If a test was positive, the result was reported to the ward and a "post-it note" was put on the computer screen for the Infection Control Nurse, Helen O'Neill.”
Can we take it that when you wrote your first report you were unaware that the laboratory manager Charles Kinloch (Day 86 p140) had said the following in evidence?
“If they were a positive result -- the process was, with a positive result, we would firstly try to contact the infection control team. If they were not available, then we would contact the ward. So there was a possibility that the ward were informed, but the infection control team were not. So this was basically a belts-
11 and-braces exercise, to ensure the infection control team were informed of all positives.” A. I was not aware of Charles Kinloch’s evidence when I wrote this sentence. It was my understanding from witness statements.
47. If the Inquiry accepts Mr. Kinloch’s evidence on this, would that affect your view on the significance of the use of the post-it notes and, if so, how? A. If they were only a “back-up” system and information was given directly on most occasions, I would have been more reassured about the system.
48. If there is a hierarchy of committees for reporting infection control issues from all over the Greater Glasgow & Clyde Health Board area right up to board level, would you accept that it is undesirable for the more elevated committees to be presented with excessive detail? A. No. I believe each committee in the hierarchy needs to see the detail of what is happening in each part of Board’s responsibilities. Detail is not excessive when it is needed to show the overall picture of infection numbers, rates and possible outbreaks.
49. Would you accept that it is reasonable for there to be a degree of summarising and focusing of information as reporting proceeds up through the hierarchy? A. There should be some summarising as information passes up through the hierarchy but this should not obscure the picture of what is happening. The senior levels should be assured by the data that infection prevention and control is satisfactory at all levels.
50. Would you accept that in a hierarchy of committees for reporting infection control issues it may be difficult to pick up deficient reporting if there is a malfunction in lower level committees? A. No. It is a function and responsibility of the higher levels to ensure they receive and consider reports from the lower level and take action if there is deficient reporting.
12 51. Would you accept that in a hierarchy of committees for reporting infection control issues it may be difficult to pick up quickly that there is an issue about why some lower level committee meetings have not taken place? A. No. It should be obvious from the lack of reports if lower level meetings have not taken place and this should trigger an investigation as to why.
52. When you wrote your first report, were you aware that an IT system was introduced just before June 2008 to monitor staff training? A. No.
53. In your first report you say at p10 (EXP02830010) that the Infection Control Manual “was a high level document that required local interpretation and adaptation into practical applications. It appears likely that although the policy document was available in a file on all units/wards at Vale of Leven Hospital the effective application to day to day practice was not made.” A. This is not a question. The question follows and has been replied to.
54. By the standards expected of Scottish Health Boards at the time, what local interpretation and adaptation into practical applications was lacking? A. By the professional standards expected at the time, it is my view that the key points and actions for the procedures and protocols should have been converted into easy to use, single sided sheets, that could be used as posters and would give the staff a clear set of key actions when they were performing their duties in relation to infection prevention and control.
55. Do you accept that the Infection Control Manual contained detailed standard operating procedures? A. Yes.
56. Are you aware that posters were available for clinical staff in relation to hand hygiene, segregation of laundry, sharps injury prevention (and action if an injury was sustained), segregation of clinical waste and decontamination of blood spills?
13 A. I am now aware of that.
57. What evidence have you seen that a lack of local interpretation and adaptation into practical applications was lacking played a material part in the outbreak occurring and going undetected? A. As I explained in my oral answers, when I visited the Vale of Leven Hospital I could see little or no evidence of such posters or single page instructions in use and there was nothing equivalent to the English DH “Saving Lives” high impact interventions in use.
58. Your fellow expert witness Christine Perry says in her report at p34 (EXP02820034) that HAI surveillance systems can operate in simple forms as colour coded T cards. Are you aware that this is also the view of others who have given evidence to this Inquiry? A. Yes.
59. Are they just wrong about this? A. No. The T-cards can be a simple form of showing surveillance data when displayed in a wall rack that puts together the individual types of infection grouped according to ward. However, T-cards show only a snapshot of the current position, they do not show rates and trends in infections over time because the cards are removed from the rack when the patient is discharged or dies.
60. In her report Christine Perry says at p30 (EXP02820030) that, “A simplistic surveillance system for C. difficile should include the numbers of laboratory confirmed C. difficile positive cases per ward or unit over a time period, which is typically a month. This information will usually be collated and analysed by the infection control team and fed back to relevant clinical areas as well as being reported at relevant meetings, for example, infection control committee or clinical governance committee.” A. This is not a question. The question follows and has been replied to.
61. Would you agree with that? A. Yes.
14 62. Are you aware that it was possible for the Infection Control Team to do these things in 2007-8, and that they had been doing so until early 2008? A. I am aware that it was possible to do this from the Access database but I have seen no evidence that it was done and reported back to the wards.
63. Is it correct that proper use of colour coded T cards should at least tell Infection Control staff how many cases of infection there are concurrently, and where they are to be found? A. Yes.
64. Christine Perry says in her report at p26 (EXP02820026) that 100% compliance with various hygiene precautions is not to be expected, and that an audit score of below 70% requires immediate remedial action. Do you agree with that? A. Yes, although my trigger point would have been below 80%.
65. Do we see that some of the audit scores in Figure 8 of her report (at p26 (EXP02820026)) were good, or very good? A. Yes.
66. Do we see from the Figure 8 figures (at p26 of her report (EXP02820026)) that there was quite a big variation in the audit scores from time to time, including in the state of the environment? A. Yes.
67. Would it be wrong to conclude that the state of the environment reported in May 2008 (at p26 of her report (EXP02820026)) necessarily reflects the state of the environment throughout 2007-8? A. No, that supposition is reasonable but the direct evidence is not there.
68. Would it be reasonable for someone seeing the audit results for isolation listed in Figure 8 (at p26 of her report (EXP02820026)) to think that they were good or even better?
15 A. Yes, if these represented a regular programme of audit and review. I have not seen a set of regular and repeated audit reports.
69. Christine Perry says in her report at p65 (EXP02820065) that although the results of the isolation audits in Figure 13 (seven audits of various wards in the period April- October 2007) are in many cases not 100%, that is attributable to fluctuations in practice due to the human factors involved in providing care, and that overall the results are acceptable. A. Yes, with the same caveat as above.
70. Can we take it that, whatever failures in isolation were in fact happening, anyone reading those audit results would have been unlikely to conclude that they were a cause for concern? A. Yes, if they were regarded as an adequate and regular audit programme.
71. You say in your first report at p12 (EXP02830012) that “GGCHB had produced a high level antibiotic prescribing policy as part of the Infection Control Manual that included all of these elements. However, as with other aspects of the infection control policy, it required adaptation for specific application in individual clinical areas. The prescribing policy had been distributed to all clinical areas but had not been turned into simple and specific guidance for junior medical staff, in particular at Vale of Leven Hospital. The junior staff appear to have lacked guidance…..” A. This is not a question. The question follows and has been replied to.
72. Is it correct that when you wrote that, you were unaware that there had been a series of specific prescribing guidances circulated by the Board in 2007/8? A. No.
73. Is what you wrote in that passage superseded if, in fact, the Board issued a series of specific prescribing guidances in 2007/8 quite separate from the Infection Control Manual? A. No.
16 74. In a short summary of its position, it was intended by the Board that the prescribing guidance for the doctors at the Vale of Leven hospital should have been the “North Glasgow: Prescribing Guidance for Doctors 2006-2007” (not on the database); and then (from August 2007) the Prescribing Guidance for Doctors booklet (GGC21760001); and then (from early 2008) the first NHSGG&C-wide antimicrobial guidance (Infection Management Guideline: Empirical Antibiotic Therapy: GGC22180001), which was issued to all wards in poster format; and then (from June 2008) the Infection Management Guideline: Empirical Antibiotic Therapy (GGC06380009). A. This is not a question. The question follows and has been replied to.
75. If the Inquiry accepts that was the position, does it supersede what you wrote in the passage we have quoted to you? A. No. 76. When you wrote your first report had you seen the letter (GOV00360001) from the deputy chief medical officer and others dated 5 September 2005 and the document "Antimicrobial prescribing policy and practice in Scotland. Recommendations for good antimicrobial practice in acute hospitals." (GOV00360003 and following)? A. Yes.
77. If you had not, please can you look at it now? A. This is not a question. The question follows and has been replied to.
78. Do you see that at page 8 (GOV00360008) of the document it is said: “5. The core components of the current guidance are: a. Development of prescribing policies b. Monitoring of compliance c. Structures and responsibilities d. Training e. Audit and performance management.”? A. Yes.
79. Would you accept that the document recognises that its recommendations cannot be implemented forthwith? A. No. I take it to indicate that measures should be put in place as soon as is reasonably practicable and that a start should be made on this forthwith.
17 80. Would you accept that the recommendations in the document would take time to implement? A. Yes.
81. Would you accept that implementing a system of monitoring compliance with prescribing policies cannot be done until the prescribing policies have been developed? A. Yes.
82. Would you accept that not all of the recommendations in the document could be implemented simultaneously, and that some sequential implementation would have been needed? A. Yes.
83. Would you accept that implementing auditing of compliance with prescribing policies was a very time consuming process, and that in the period until June 2008 the priority had been to get a unified pan-Glasgow prescribing guidance accepted and into use? A. I accept that the priority was to get the prescribing policy in place, then it could be audited; but this was 3 years after the national policy had been issued. Auditing takes some time, not necessarily “very time consuming”; it requires attention to detail and clinical commitment.
84. Would you dispute that Greater Glasgow Health Board was ahead of all other Health Boards in Scotland in appointing a Professional Antimicrobial Team? A. No, if that can be shown. I do not know the time-frame in other Boards in Scotland.
85. Would you dispute that between 2005 and the antimicrobial management team being established in June 2007 much of the antimicrobial management team work specified in the document "Antimicrobial prescribing policy and practice in Scotland. Recommendations for good antimicrobial practice in acute hospitals." (GOV00360026 at part 2.6) was being done in practice by the Board’s Dr. Andrew Seaton?
18 A. I know that Dr Seaton was taking the lead role in developing the antimicrobial prescribing activities in Glasgow.
86. In relation to the criticisms in your first report at p16 (EXP02830015) of infection control audits, do you accept that all clinical areas carried out infection control safe patient environmental audits, which included most of the elements of Standard Infection Control Precautions? A. I saw evidence of intermittent audits from most wards and they did include the main elements of standard infection control practice. I did not see evidence of action plans to remedy deficiencies and then re-audits.
87. Do you accept that hand hygiene audits were carried out in accordance with the national protocol (set out in HPS’s “National Hand Hygiene NHS Campaign Protocol and Resource Pack” (3rd edition, May 2008)) and that the requirement for each clinical area to carry these out monthly did not come into place until 2009 (pursuant to the Chief Nursing Officer’s letter of 26 January 2009 (CEL 5 (2009))? A. Yes.
88. You say in your first report at p16 (EXP02830016) that “None of this complies with the requirements of the national strategy as set out in the HCAI Code of Practice.” A. This is not a question. The question follows and has been replied to.
89. Is that a reference to the English Code of Practice for the Prevention and Control of Healthcare Associated Infections (generally known as the Hygiene Code) which is listed in Annex 1 of your first report? A. No. It refers to the Scottish Code of Practice.
90. Christine Perry seems to suggest (see her report at p36 (EXP02820036)) that one of the responsibilities of any competent Infection Control Nurse in 2007-8 was to see that any available explanatory leaflet about clostridium difficile was communicated to patients’ relatives. Would you agree with that? A. Yes.
19 91. From the evidence you have seen, would you accept that the part played by the Infection Control Doctor in what went wrong seems to have gone beyond merely not being onsite? A. Yes.
92. Would you accept that she seems not to have been a functioning part of the Vale of Leven Hospital Infection Control Team at all? A. Yes.
93. Would you accept that Jean Murray’s evidence on why she did not declare an outbreak is very hard to understand? A. Yes.
94. Have you seen the "Bug of the Month" leaflet (GGC17790003)? A. Yes.
95. Do you know that Jean Murray gave evidence that at least by April 2007 she was aware of, and understood, the Bug of the Month leaflet? A. Yes.
96. Have you seen that, among other things, it says, "Although some people can be healthy carriers of C. difficile, in most cases it develops after cross-infection from another patient, either through direct patient contact, via healthcare staff, or via a contaminated environment"? A. Yes.
97. Do you know that in evidence Jean Murray accepted that the suggestion there is that in most cases you're looking for cross-infection as the explanation? A. Yes.
98. The Inquiry may hold that Jean Murray was an experienced and qualified senior Infection Control Nurse, equipped from her training and experience with the knowledge proper to her post of the microbiology and epidemiology of clostridium difficile. On that hypothesis, would you have foreseen as a material risk that Jean Murray would become aware at various times in 2007/8 that a
20 number of patients were simultaneously symptomatic for clostridium difficile in the same ward, but would conclude that there was no reason to suspect that there was cross-infection between those patients? A. No.
99. Would you agree that, if that is what happened, it is a factor quite separate from “ineffective leadership from the lead infection control nurse”? A. No. Failures in the practice of individual staff members should be picked up by the system of reporting and review and more senior levels.
100. Would you accept that Jean Murray’s conclusion, despite the evidence, that there was no possibility of cross- infection is so difficult to understand that it is not something that a Health Board would expect to have to guard against specifically? A. Yes. Her conclusion is difficult to understand. However, reporting and review of surveillance data on a regular basis in the hierarchy of committees would have shown up her serious error of judgement.
101. Would you have expected that other members of the Infection Control Team, if they had substantially the same information about the prevalence in the wards of clostridium difficile as Jean Murray, would have realised that there was cross-infection and, in fact, an outbreak or outbreaks? A. Yes.
102. Would you agree that a normally functioning Infection Control Team will ordinarily result in a large measure of monitoring of the work of one member of the team by the other members of the team? A. Yes.
103. Would you have expected that to occur in this case, if the Infection Control Team had been functioning normally? A. Yes.
104. Helen O’Neill gave evidence that she alerted Jean Murray in April 2007 and in January 2008 that there were such numbers as to constitute an outbreak, even if she did
21 not use that word. She accepted that it must have been patent from the rack containing the T cards that, at various times and in various wards, there was an outbreak. She could not explain why an outbreak was not declared. Are you surprised by that? A. Yes.
105. Were you aware when you wrote your first report that according to GGC13340004 the incidence of clostridium difficile cases in the quarter July to September 2007 was markedly down from the previous quarter, and down also from the quarter January to March 2007? A. Yes. To me that should have emphasised the fact that there had been increased numbers in the earlier part of the year.
106. Were you aware when you wrote your first report that the minutes of the Acute Infection Control Committee on 24th July 2007 record the trend of clostridium difficile infection in Clyde was now downwards (see GGC02330004)? A. Yes – see above.
107. Were you aware when you wrote your first report that the minutes of the Clyde Acute Infection Control Support Group on 9th May 2007 record that (see GGC13260006) at that meeting Dr. Biggs tabled the Clyde Acute Infection Control Support Group Report for Vale of Leven Hospital For period February - April 2007, which included the statement that “Numbers of C diff had increased in March and April causing some concern. The ICT are continuing to monitor this”? A. Yes.
108.If we look at GGC02350001 do we see that according to the minutes of the Acute Infection Control Committee for 29th January 2008 Jean Murray was in attendance but reported no concern about the prevalence or incidence of clostridium difficile in any of the Clyde Directorate hospitals? A. Yes.
22 109. Do we see in the HPS Quarterly CDAD report - First Quarter 2007 (HPS03090001), which was issued in June 2007, the following passage (at HPS03090007): “This is the second quarterly pilot data report based on CDAD data collected in Scotland under the mandatory surveillance scheme from January 2007 – March 2007. When comparing the total number of cases obtained this quarter with the previous quarter a nearly 50 % increase in number of cases is seen. The reasons for this large increase are currently unknown. The lack of baseline data on CDAD precludes us from making any firm interpretations of these data. Not knowing the natural seasonal variation of CDAD it is not possible to assess whether this increase is significant. This quarter an increased number of noro virus outbreaks were observed in hospitals across Scotland relative to the previous quarter. In the last quarter of 2006 a total of 25 noro virus outbreaks and 247 individual cases were reported to HPS while 88 outbreaks and 546 cases were reported to HPS in the first quarter of 2007. The impact of noro virus outbreaks on CDAD figures is currently unknown. Increased numbers of diarrhoeal patients will lead to increased CDAD testing activity with an increased risk of over- reporting CDAD. Since little is known about the pathology of co- infected patients (infected with both noro virus and C. difficile), diagnosis of CDAD in these patients is therefore not straightforward. In England a seasonal peak of CDAD was observed in January 2006 -March in 2006 and in previous years (HPA, 2007). Enhanced surveillance results from Germany suggest an association between winter peaks in respiratory diseases, increased prescribing of antibiotics and development of CDAD as a consequence of the antimicrobial therapy (Borgmann, 2007). Whether seasonal variations in respiratory and other diseases have an impact on the CDAD incidence in Scotland is unknown. Increased awareness of the mandatory surveillance programme in hospital wards and primary care could also have resulted in increased testing and reporting activity. During the first quarter of the mandatory surveillance programme the number of cases went up 20 % relative to the level before the introduction of the mandatory surveillance. The recent further 50 % increase, from the first quarter to the second quarter of the mandatory
23 surveillance, could be a delayed effect of implementing the mandatory surveillance protocol.”? A. This is not a question. The question follows and has been replied to.
110. Would you agree that this passage suggests that in early 2007 even HPS was unsure whether a national increase of 50% in the number of clostridium difficile cases was significant and unsure whether it necessarily implied that there had been cross-infection of patients? A. I agree that HPS was unsure of all the reasons for the 50% increase in numbers, e.g., better reporting and more diagnostic testing, greater awareness and the impact of the norovirus outbreaks, but this section does not indicate that cross-infection was not an issue in the spread of CDI as this had been well established over several years.
111. Would you agree that if the Board’s staff were aware that there was a significantly increased prevalence of clostridium difficile nationally in Scotland, it could have made them less likely to suspect that an increased prevalence CDI within the Vale of Leven Hospital was caused by preventable cross-infection? A. They may have been less likely to think they were outwith the general trend in Scotland, but again, this does not mean that cases were not resulting from cross-infection as cross-infection in hospital settings was by then well established as important in the spread of CDI.
112. You are aware that Jean Murray and Helen O’Neill did not detect there was clostridium difficile cross-infection within the Vale of Leven hospital. If the clinicians and ward staff at the Vale of Leven hospital had no reason to doubt the competence of Jean Murray and Helen O’Neill as Infection Control nurses, would you agree that this would make them less likely to suspect themselves that there was clostridium difficile cross-infection within the hospital? A. Yes, but I would have expected clinicians to be concerned about the numbers of cases in their patients.
24 113. We see from p1 of your first report (EXP02830001) that you had one day of background briefing with the Inquiry team on 19 July 2010; you visited the Vale of Leven Hospital on the morning of 23 August 2010; you attended a meeting with the Inquiry Team to discuss the scope and extent of your report on 22 November 2010; you attended a meeting with the Inquiry team on 7 October 2011 to discuss the reports and for a discussion on the statistical analysis of the outbreak; and you attended a meeting with the Inquiry Team to discuss your reports on 13 February 2012. We also see that you finalised your reports on 16th March 2012. We also see from Annex 3 of your first report that you were supplied with a great deal of evidence, including expert reports and transcripts of evidence, by the Inquiry Team. The most recent transcript was the evidence of Dr. de Villiers taken on 2.2.12 (Day 84 of the Inquiry). A. This is not a question. The question follows and has been replied to.
114. Can we take it that, perfectly properly, you were given a great deal of assistance by the Inquiry in finding the evidence which informed your reports? A. Yes.
115. Do you agree that despite that assistance, when you wrote your reports you could not have foreseen the evidence that Jean Murray actually gave concerning what she knew about the prevalence and incidence of clostridium difficile, and why she had not declared an outbreak – and yet it is very material to what went wrong at the Vale of Leven Hospital? A. Yes.
116. It is no surprise that by Day 84 of the hearings, and assisted by many expert witnesses, the Inquiry had enabled a far more informed view to be taken of what went wrong at the Vale of Leven Hospital than was possible for the authors of the Internal Investigation Report in mid-July 2008 – would you agree? A. Yes.
25 117. Would you agree that enquiring into the adequacy of the way the authors of the report went about their work is quite different from considering whether any of the Internal Investigation Report remains valid today, after all the investigation the Inquiry has undertaken? A. No. This was the first opportunity taken to examine what had happened in the outbreak. I would have expected it to be less detailed than subsequent deeper investigations but still to have reached valid conclusions and those conclusions helped define the initial response and possible corrective measures.
118. Is your second report intended to any material extent to support a criticism of the way the authors of the Internal Investigation Report went about their work? A. Yes
119. Would you agree that such criticism should be fair? A. Yes
120. Would you agree that before making such criticism one would have to consider what was the purpose of the Internal Investigation Report and the means, including time, its authors had to produce it? A. Yes.
121. Would you agree that before making such criticism one would have to consider the expertise and experience its authors had? A. Yes.
122. Would you agree that before making such criticism one would have to consider how experienced its authors were in carrying out such an investigation and writing a report of it? A. Yes, but that in itself could be a valid criticism if the authors were not sufficiently experienced or competent to produce the report to the standard that could be expected.
123. Would you agree that it would have been wrong for its authors to reach a concluded view before they had carried out the last of their interviews? A. Yes.
26 124. Would you dispute that the authors of the Internal Investigation Report were inexperienced in carrying out such an investigation and writing a report of it? A. I would not dispute it because I do not know the detailed background of the authors, but they were senior managers in GGCHB. It was the Board’s responsibility to appoint an Internal Investigation Team with the experience and competence to undertake the task properly.
125. Would you accept that the purpose of the Internal Investigation Report was to "review all correspondence from April 2006 with regards to the Vale of Leven C Difficile issue and, in particular, from December 2007 with regards to who knew about the C Diff cases, what action did they take and who did they report matters to" (see GGC00610002)? A. Yes
126. Would you agree that the purpose was not to enquire generally into what had gone wrong? A. Yes, but I do not see how they could review reports and correspondence as to who knew what about the outbreak without first establishing what had actually happened during the outbreak and where any breakdowns in actions and communications could have happened.
127. Would you dispute that the authors of the report were first instructed on 12th or 13th June 2008 to do their work, and submitted their report on 11th July? A. No.
128. Would you dispute that the authors of the report met and interviewed in excess of 40 staff from 16th June 2008 until 26th June 2008? A. No.
129. Would you agree that, at most, the authors of the report had about two weeks to analyse all the evidence they had gathered, reach conclusions and write a joint report? A. Yes.
27 130. Would you agree that the recommendations at part 2 of the Internal Investigation Report were all justified, even if they were not, with hindsight, a complete and detailed statement of all that was necessary? A. Yes.
131. Do you contend that the recommendations at part 2 of the Internal Investigation Report were intended to be a complete remedy for what went wrong, rather than a preliminary suggestion for what might be required? A. There was no indication that the report was a series of preliminary suggestions. It was set out as a definitive report and in those terms was inadequate.
132. Would you accept that the Internal Investigation summarised its findings as follows: “ In summary, the key individuals who were in possession of information in relation to C Diff were the local infection control team on the Vale of Leven site, namely the local infection control nurse and the lead nurse for infection control who, at that time, was also based on the Vale of Leven site, who both appear to have been aware that there were problems across the site. Unfortunately, the lead nurse at that time has now retired and she has, therefore, not been interviewed but, during the interview process with other staff, including the local infection control nurse, it was stated that the lead infection control nurse had been made aware of the numbers of cases across the site. The manual colour-coded system as described would also have allowed a view of the level of infection throughout the hospital site to be evident to the local infection control team. While others were aware of issues within their own areas, including ward managers, Lead Nurses and Clinical Service Managers, they appear not to have been made aware of the hospital-wide position in a formal manner. Detailed discussions took place on a regular basis in relation to bed management issues but they were not specific about the issue of C Diff but merely identified the overall infection control pressures relating to MRSA, Norovirus and CDiff.”? A. Yes.
133. Would you accept that the tenor of your consideration of the Internal Investigation Report was to see whether it adequately addressed causes and response to the outbreak?
28 A. Yes.
134. Would you accept that the purpose of the report was more limited than that? A. Yes, but I do not believe it could adequately address its remit without looking into the causes and response to the outbreak.
135. Can we agree that it would be unfair to reach a concluded view on the adequacy of the way the authors of the report went about their work without examining that question in a lot more detail than you were able to do? A. No.
136. In reference to the Outbreak Control Team report you say at p5 of your second report (EXP02810005) that “The clinical environment was considered to be inadequate for good IP&C procedure, which agrees with witness statements from staff, patients and relatives, but contradicts the Internal Investigation Report.” A. This is not a question. The question follows and has been replied to.
137. Would you agree that the contributors to the Outbreak Control Team report had considerable expertise in infection control, while that was not the expertise of the authors of the Internal Investigation report? A. Yes. This was part of my oral evidence.
138. Do you think that might be one explanation for the different conclusions on the state of the environment reached in the Internal Investigation report and in the Outbreak Control Team report? A. Yes. They reviewed the outbreak and the factors involved in more detail and with more expertise.
139. Can we take it that you are aware that Greater Glasgow Health Board is an amalgamation of various NHS Trusts?
A. Yes.
29 140. Would you dispute that North Glasgow University Hospitals NHS Trust, South Glasgow University Hospitals NHS Trust and Greater Glasgow Primary Care NHS Trust were amalgamated into Greater Glasgow Health Board in 2004?
A. No.
141. Would you dispute that those three trusts had themselves been an amalgamation of earlier smaller trusts (8 in total, mostly single site based) in 1999?
A. No.
142. Would you dispute that Argyll and Clyde NHS Board took over three trusts in June 2003 (Argyle and Clyde Acute Hospitals NHS Trust, Renfrewshire and Inverclyde Primary Care NHS Trust and Lomond and Argyll Primary Care NHS Trust) and that those had been an amalgamation in 1999 of five earlier trusts?
A. No.
143. Do you know that the merger of Greater Glasgow Health Board and the Clyde part of Argyll and Clyde NHS Board took effect in April 2006?
A. Yes.
144. Would you accept that the merger of Greater Glasgow Health Board and the Clyde part of Argyll and Clyde NHS Board was at the behest of the Scottish Government?
A. Yes
145. Would you accept that the various amalgamations and mergers culminating in the one in April 2006 required careful regard for staff morale when undertaking any further managerial or system changes?
A. Yes.
30 146. Can we take it that you have a good understanding of Greater Glasgow Health Board’s single system management (by directorates) structure?
A. I have seen the documents setting out the management structure and understand their approach.
147. Would you accept that Greater Glasgow Health Board’s single system management structure had been planned to, required to, and did come into effect in April 2006?
A. Yes.
148. Would you accept that, for this reason among others, senior officers and planners did not have an entirely free hand in deciding how to structure the new Greater Glasgow Health Board?
A. I do not know what constraints were placed on senior officers and planners. I have only seen the outcome.
149. Would you accept that it was decided that there should be a transitional phase in the merger of Greater Glasgow Health Board and the Clyde part of Argyll and Clyde NHS Board?
A. Yes, that would be a reasonable approach.
150. Would you accept that, broadly speaking, the transition was to be by the creation of a separate Clyde Directorate, to endure for a two-year period?
A. Yes.
151. Would you dispute that part of the rationale for a separate Clyde Directorate was to avoid any suspicion that the merger would mean a draining of resources from the Clyde part, and that keeping it separate from the other directorates meant it was always clear to the staff and public what resources were inherited from A&CHB and that they were being allocated to Clyde?
A. I would not dispute it if that were the reason. I have not reviewed any material to that effect.
31 152. Would you accept that the separate Clyde Directorate had a management structure which, notwithstanding its smaller size, mirrored the management structure of the remaining part of the new Greater Glasgow Health Board?
A. Yes.
153. Would you accept that the Clyde Directorate was frequently given representation on committees equal in weight to that afforded to the remaining part of the new Greater Glasgow Health Board?
A. Yes, if that was the case. I have not counted the numbers represented on the various committees.
154. Would you accept that there was bound to be a bedding-in period for the merged Health Board?
A. Yes.
155. Would you accept that in the early stages of the merger, there was an inevitable need to harmonise procedures and procure uniform practices across the whole of the new Board’s area?
A. Yes.
156. Would you accept that in the early stages of the merger, there was bound to be a necessary adjustment of resources and responsibilities within the merged Board?
A. Yes.
157. Would you accept that because of the bedding-in process, occasional difficulties in communications between the parts of the merged Board would be inevitable?
A. Difficulties could arise in communication. My own experience of mergers is that this is one aspect that requires a great deal of attention to detail.
158. Would you accept that how all these things (the bedding-in, the harmonisation of practices and procedures, the adjustment of resources and responsibilities, and occasional difficulties in communications) operated in practice is not easily discovered from paper records?
32 A. Not entirely. Paper records can show where their were breakdowns in the systems of reporting and communication when there were absences meant areas were not represented and where there were gaps in reporting.
159. Would you accept that all these things (the bedding-in, the harmonisation of practices and procedures, the adjustment of resources and responsibilities, and occasional difficulties in communications) are relevant to your two reports?
A. Yes.
160. Would you accept that the evidence of the managers who had to deal with those things would be of significant assistance in discovering how all these things operated in practice?
A. Yes.
161. Since they were written before we heard the evidence of the managers in question, would you accept that your reports are really expressing opinions on facts yet to be established, or at least without hearing all the evidence?
A. No. My reports and the opinions expressed therein were written on the basis of the material recorded at the time and the witness statements of officers, managers and clinical staff.
162. Would you agree that the future of the Vale of Leven Hospital was in issue for years before the merger between Greater Glasgow Health Board and the Clyde part of Argyll and Clyde NHS Board?
A. Yes.
163. Would you accept that this was a factor with which the newly merged Board had to contend?
A. Yes.
164. Have you read the evidence of Dr. Kevin Woods (Day 98) on this topic?
Yes.
33 165. Would you accept that the process of settling the future of the Vale of Leven Hospital was an involved task for the newly merged Health Board?
A. Yes.
166. Would you accept that this task was only recently completed?
A. Yes.
167. Would you agree that the uncertain future the Vale of Leven Hospital had in 2007/8 and in the years preceding that must have contributed significantly to the problems of organisation and accountability which you identify in your reports?
A. Yes. That is why I included it in my report.
168. Would you agree that the amalgamations and mergers that were taking place in 2006 and the years preceding that must have contributed significantly to the problems of organisation and accountability which you identify in your reports?
A. Yes. That is true of all mergers and amalgamations and measures to mitigate the problems are a prime responsibility of those responsible for managing the process.
34 Questions on behalf of patients and families for Professor Brian Duerden (revised 9 May 2012)
1. During the focus period [1/12/07 to 30/6/08] 62 patients tested positive for C. diff, 34 of whom died in that period, and of those dying 23 had C. diff on their death certificate. During the earlier part of the relevant period [1/1/07 to 30/11/07] 68 patients tested positive, 39 of whom died in that period, and of those dying only 3 had C. diff on their death certificate. Can any conclusion be drawn from the marked difference in the number of patients dying in each period who had C. diff on their death certificate?
A. I believe it is most likely that doctors did not record C. difficile on death certificates because they were not alert to the issue of CDI and were not aware of the impact of CDI and the contribution it makes to the death of patients even when they have other serious underlying diseases. By 2008, there was probably greater awareness and greater likelihood that they would think to record the fact that the patient had had CDI that had contributed to their death. In England, CMO had been reminding doctors to remember healthcare associated infections such as CDI when completing death certificates. I doubt that the difference reflects a true difference in mortality from CDI between the two years.
2. For the avoidance of doubt is it correct that you gave no, or at any rate no detailed consideration to whether there was a single outbreak or several outbreaks of C. diff infection at VOLH during the relevant period?
A. I considered the overall pattern of CDI at VOLH during the whole period. There were two extended periods of increased incidence in the early parts of 2007 and 2008, within which there were several clusters of cases. I did not examine in detail whether there were several outbreaks showing up as these clusters but the overall pattern was of several outbreaks of transmission between 2 or more patients.
3. Was that issue outwith the remit given to you by the Inquiry team?
35 A. It was not the main focus of my remit but I did discuss with the Inquiry team the need to establish epidemiological timelines to show the pattern of transmission and confirm which cases were linked and represented clusters, which could be regarded as individual outbreaks.
4. In your report EXP02830001 at Section 6(a) on page 6 you comment on the Microbiology Laboratory Service at the VOLH. Who within NHSGGC should have addressed the large number of non-compliances found during the second accreditation inspection in September 2007?
A. This should have been the responsibility of the Laboratory Manager, Charles Kinloch, and the Medical Head of the Laboratory, Dr Weinhardt.
5. At section 6(h) on page 10, you describe the Infection Control Manual as “a high level document that required … adaptation into practical applications” and a document “not necessarily in a format that could be used to implement procedures and protocols at ward level”. What would you have liked to have seen in use at ward level during the relevant period to ensure that appropriate infection prevention and control practices were consistently adopted within VOLH?
A. As I explained in oral evidence, I would have expected single A4 sheets, preferably laminated so that they could be used as posters, setting out the key requirements for implementing the policies in operational practice. They would be obviously on display and “to hand” when they were dealing with potentially infected patients. The manual was not in such a format.
6. As regards surveillance of numbers and rates of infection [dealt with at Section 6(i) on pages 10 and 11], during the relevant period would you have expected the Acute Control of Infection Committee for NHSGGC at each of that group’s meetings to have reviewed numbers and rates of C. diff infection at VOLH and indeed at other acute hospitals within NHSGGC using surveillance data provided by the ICTs for these hospitals?
36 A. Yes, I regard such a review as a key function of Infection Control Committees.
7. Would you have expected the Board Infection Control Committee also to have carried out a similar review of its own and, if so, how frequently?
A. Yes. I would have expected a report on overall healthcare associated infection rates in all parts of the Board’s units at each meeting. That is the only way they can provide the assurance required that all is in order.
8. Was it standard practice in England during the relevant period for patients diagnosed with C. diff and their relatives to be given information leaflets on C. diff?
A. Yes. This was part of DH guidance and was part of the Code of Practice.
9. The Health Act 2006 imposes specific statutory duties on NHS bodies in England that are set out on pages 17 and 18 of your report. Why was it considered necessary in England to resort to this approach?
A. The Government and senior Department of Health officials considered that this was such an important aspect of patient safety that there should be specific requirements placed on all NHS bodies in England. The numbers of cases of MRSA and CDI in particular had reached unacceptable levels and it was considered that responsibility should be placed very clearly and explicitly on Boards, Chief Executives and senior officers in each Trust.
10.In your view has the introduction in England of a mandatory Code of Practice and a series of specific statutory duties imposed on NHS bodies made an appreciable difference in combating healthcare associated infections such as C. diff infection?
A. Yes. I believe it was a very important part of the programme to combat healthcare associated infections in England and made a
37 major contribution to the success of the programme in reducing numbers and rates of infection.
11.What are the sanctions in England for breach of the statutory duties under the Health Act 2006 or non-compliance with the mandatory Code of Practice?
A. At that time, the sanctions were related to the inspections and investigations by the Healthcare Commission. They inspected against the requirements of the Code and any shortcomings were published and Trusts had to put matters right within a designated period. They were then subject to re-inspection. Failure could result in fines (funding withheld by PCT commissioners) and/or to senior officers of trusts being removed from their posts. In the two outbreaks subject to major investigations by the healthcare commission (Stoke Mandeville and Maidstone & Tunbridge Wells), the Chief Executive and Chairman of each Trust were removed from their posts.
12.Would you commend the use in Scotland of improvement teams (referred to on pages 19 and 20 of your report)?
A. Yes, I would at that time. They were a key element of our reduction programme in England and were very successful. The programme in England was stood down at the end of 2010
13.Prior to the introduction of the Health Act 2006 and the mandatory Code of Practice, did NHS Trusts in England have arrangements similar to the arrangements for infection prevention and control identified in your report EXP02830001?
A. All Trusts in England had to have infection control surveillance and control of infection protocols and procedures but they were not uniform. However, most would cover the main elements that I describe in my report as being necessary.
14.What particular aspects of the arrangements for infection prevention and control at VOLH in 2007-08 did you find the most disturbing?
38 A. The lack of involvement of the designated Infection Control Doctor (Dr Biggs), the lack of any effective surveillance system for healthcare associated infections, and the failure of the reporting line up the hierarchy of committees to fulfil the requirement for oversight of numbers of cases, rates and potential outbreaks.
15.Would it be fair to say that you are highly critical of senior management within NHSGGC for putting in place the arrangements for infection prevention and control that are described in your report?
A. Yes.
39 Additional questions on behalf of patients and families for Professor Brian Duerden
Background to additional questions The questions below reflect the fact that (a) some of the patients who tested positive and in some cases died during the focus period (1 December 2007 to 30 June 2008) were admissions from home, others from the RAH (and occasionally other hospitals), and others from nursing or care homes; (b) some (the majority) had prior to testing positive for C. diff recently received antibiotics (often a number of different antibiotics) in VOLH or elsewhere; (c) some had been using PPIs; (d) some had a number of recent admissions to hospital prior to testing positive; (e) some during an admission when they tested positive had spent periods in more than one ward prior to testing positive; (f) some who tested positive in VOLH were symptomatic on admission whilst others were asymptomatic on admission, became symptomatic after admission (some shortly after, others only after a longer period of time) and tested positive; (g) some (probably the great majority) shared a room or bay with other patients after admission to VOLH prior to testing positive for C. diff; (h) some (probably the majority) spent periods on wards in which there were or had recently been other C. diff positive patients; and (i) a number of patients died within 30 days of testing positive for C. diff.
Questions 1. Where a patient tests positive for C. diff during a hospital admission and you wish to trace the source, or most probable source, of the infective organism, what information (if available) would you want to know?
A. Time of onset of symptoms and where the patient had been prior to the symptoms developing: were they at home, in the same hospital ward, in another ward in the same hospital or in another hospital, or in a nursing/care home. In particular I would want to know the patient’s movements in the 72 hours before symptoms started.
2. In particular, would you want to know whether the patient was symptomatic or asymptomatic when admitted?
A. Yes.
3. If symptomatic on admission, would you want to know when and where symptoms had first occurred?
A. Yes.
4. If asymptomatic on admission, would you want to know the time interval between admission and the onset of symptoms?
40 A. Yes. This is important.
5. If so, would there be any time interval beyond which you would regard it as probable that the source of infection was the hospital environment?
A. The usual time interval is regarded as 48 to 72 hours. If the patient has been in hospital for that period, the case is regarded as a hospital acquired case.
6. Would there be a time interval less than which you would regard it as probable that the source of infection was other than the hospital environment (e.g. if symptoms developed within 24 or 48 hours of admission)
A. If symptoms start within 48 hours of admission, it is usual to regard this as a case where infection occurred before admission to that ward. This is a time frame I accept and work with.
7. Would you want to know whether the patient had recently been in hospital prior to the admission during which they tested positive?
A. Yes.
8. If so, how far back in time, prior to the current admission, would you go as part of your investigation given the current state of knowledge about the pathology of C. diff infection?
A. The minimum time prior to the current admission that I would want to know about is 1 month but there is evidence that admissions earlier than that may be significant so I would like to know about a 3-month period if possible.
9. Would you want to know whether the patient, prior to admission, had been a resident in a nursing or care home?
A. Yes.
10.Would you want to know whether the patient, prior to testing positive, had spent time during their current admission in other wards of the hospital?
A. Yes.
41 11.If the patient had been in ward X and then ward Y prior to testing positive but became symptomatic only after transfer to ward Y, would there be any time interval between transfer and onset of symptoms after which you would regard it as probable that the source of the infection was ward Y rather than ward X or some other place?
A. If symptoms started within 48 hours, or possibly 72 hours of transfer to Y, it is probable that the source of infection was the initial ward X.
12.Would you want to know whether there were or recently had been other C. diff positive patients in the ward or wards occupied by the patient during their current admission?
A. Yes.
13.Would you want to know whether the patient during their current admission was sharing or had shared a room or bay with another or other patients who were or had recently been C. diff positive?
A. Yes.
14.Would you want to know whether the patient had previously tested positive for C. diff?
A. Yes.
15.If so, how far back in time would you be interested in and why?
A. I would be interested in any previous test positive for C. difficile. Once a patient has had CDI, they are at greater risk of recurrence in circumstances of risk, e.g. antibiotic treatment.
16.What other information would you want to know if looking to identify the most probable place of exposure to the C. diff spores or bacteria that caused the patient to become symptomatic?
A. Time and place of admissions; contact with other known CDI patients; time of isolation of that patient and of others who were symptomatic in relation to onset of symptoms. Procedures and treatments given to the patient in the period leading up to the symptoms on that ward or elsewhere.
42 17.In what circumstances would you consider it probable that the patient had developed the infection as a result of cross-infection whilst receiving in-patient care in the hospital where the positive result was obtained?
A. If symptoms had started more than 48-72 hours after admission and there was potential contact with other patients with CDI in the same ward or unit.
18.If the patient had prior to testing positive recently received antibiotics, whether during or prior to their current admission, would you consider it most likely that those antibiotics triggered the infection?
A. Yes.
19.If the patient had recently received a number of different antibiotics, would it be more difficult, in the current state of knowledge, to be confident of the relative contribution of each of them to the development of the infection?
A. Yes. All antibiotics can trigger CDI, but some are more likely to do so than others.
20.If the patient prior to testing positive was using a PPI, would you consider it likely that the PPI would have made some contribution to the development of the infection particularly if the patient had not had recent antibiotic therapy?
A. It may have contributed. There is dispute in the literature as to whether PPI use is a significant risk factor. My personal view is that PPIs probably contribute to the risk of developing CDI, especially when the patient has also been prescribed antibiotics.
21.Assuming that the recent use of antibiotics and/or a PPI could explain why a particular patient developed C. diff infection and assuming that these risk factors were present, would you be looking for the presence of any other factors (and if so which ones) if seeking an explanation for the development of the infection?
A. I would want to know about any pre-existing bowel condition such as colitis or inflammatory bowel disease.
43 22.If a patient tests positive for C. diff and dies during the same hospital admission within 30 days, in what circumstances would you expect C. diff to appear on their death certificate?
A. C. difficile infection should appear on the death certificate if the doctor responsible for certification (and for the treatment of the patient before death) considered that the CDI had either caused the patient’s death directly or had contributed to the patient’s death, e.g. by the general weakening and debilitating effect of the CDI, when the primary cause was some other condition.
23.If the patient was symptomatic at the time of death, can we take it that C. diff ought to appear on the death certificate?
A. I would expect so, even if there was a serious other underlying condition.
24.What if the patient was asymptomatic at the time of death?
A. The CDI may have weakened the patient and made them more likely to die from other causes. This would make it a contributory cause. That is a decision that must be made by the doctor signing the certificate and the clinical team who were looking after the patient.
25.Would there be any time interval between the last symptoms and death beyond which it would be reasonable not to include C. diff infection on the death certificate?
A. Not specifically, but if a patient had recovered from the CDI symptoms and had been well from that aspect for a few weeks, it would be less likely to consider it to be a contributory factor.
26.Is there a time interval between the last symptoms and death less than which it would be appropriate to include C. diff infection on the death certificate?
A. Not specifically. It is a clinical decision as to whether the CDI symptoms had debilitated the patient to the extent of contributing to their death. If symptoms had been present up the few days before death, it would be probable that CDI should be recorded on the death certificate as a contributory factor.
44 45