“Despite extensive investigation, neither the mechanism nor the time of transmission has been firmly established. There is however compelling microbiological evidence that the infection was acquired in the operating theatre.”
“18.6.1 Surgeon D’s technical abilities have not been called into doubt his outcome statistics prior to this outbreak were entirely satisfactory, and his cardiac revascularisation outcomes are good, with not infective complications. 18.6.2 Surgeon D’s practice differs somewhat from his colleagues, but is, if anything, more consultant-delivered and more thorough, almost to the point of single-handed practice, with limited input by junior staff. 18.6.3 While Surgeon D’s practice differs in some elements from that of his colleagues, each element is well within the range of acceptable and ‘standard’ UK cardiac surgery practice. 18.6.4 The Panel neither heard nor found evidence of shortcomings in Surgeon D’s infection, prevention and control techniques and practices. Indeed there is much evidence that these were robust. 18.6.5 Surgeon D’s approach to clinical care is exemplary, but even if his reputation is unharmed, his confidence is damaged and his clinical skills are unused at a time when he is still gaining experience and confidence for more complicated cases. 18.6.6 Surgeon D has dissected his own practice, sought assurance from other units, co-operated fully with the investigation, and subjected himself to detailed microbiological scrutiny, occupational health assessment and attempts at decolonisation. 18.6.7 At some point Surgeon D became colonised by the antibiotic-resistant, outbreak Staphylococcus epidermidis. 18.6.8 Surgeon D remains colonised with this organism, despite attempts to eradicate it from him. While such eradication may be achieved, he might be recolonisation with this organism (or other flora). For this reason physical and microbiological barriers to the transmission of infection will remain the mainstay of measures to prevent this and similar infections in future.”
“Consider whether Mr Lu can continue to practise invasive cardiac surgery without risk to patients. The investigation will involve the participation of the Trust’s Occupational Health Service and an independent microbiological report to determine the level of that risk and the Trust will, with advice from National Clinical Assessment Service (NCAS), then determine whether that risk is acceptable and decide upon the position going forward.”
“John Lu acquired the outbreak strain between his appointment in October 2007 and recognition of the first cases of prosthetic valve endocarditis (PVE) in July 2009. The organism had been present in the Trust, notably the TCC and CICU for some time before his appointment. Strains similar to the outbreak strain have also been isolated from patients since the outbreak was recognised. In conclusion the evidence suggests that John Lu became colonised with the outbreak strain following his appointment. At the time of the outbreak there was clearly something unique about the biology of the organism, John Lu and his insertion of prosthetic heart valve material that conspired to cause infection in so many patients. The exact nature of this biological interaction between John Lu and the host valve material remains uncertain.”
“Despite the exemplary thoroughness of the investigation the exact mechanism whereby the outbreak strain contaminated the inserted cardiac valve remains uncertain. However, the most likely route of transmission would be from John Lu’s hands, which were shown to be colonised with the outbreak strain, to the operative site as a result of unrecognised perforation of the thinner (Biogel ® Super-Sensitive TM) gloves occurring during an operation which takes some 3-4 hours.”
“1. John Lu should return to full operative practice including prosthetic valve surgery. This should be managed as a staged process that will need to be planned and supervised by the cardiac surgical team and a mutually agreed mentor to allow John Lu to retrain and re-skill after a significant absence from operative practice. This process should be agreed and supported by Trust management and NCAS and proceed in accordance with recommended practice and with all necessary support. Allied to this will be the need to develop an appropriate communications and publicity management strategy to support this return to work. 2. This return of John Lu to surgical practice should initially exclude prosthetic valve surgery in order to monitor skin samples at monthly intervals to check for the possibility of his acquisition of the outbreak strain, recognising that this organism continues to circulate within the Trust. It is recommended that this period of monitoring be for 6 months. This monthly screening might most conveniently be completed during the period of retraining and before he commences valve surgery. He should then be screened at 3 monthly intervals for a further 18 months. It is recognised that screening John Lu at such intervals will provide only partial reassurance hence the importance that all practical and effective barrier precautions be adopted, in conjunction with other sound surgical practices within the theatre suite in order to provide optimal safeguards against post-operative infection. 3. The barrier precautions recommended by the SUI Report should be implemented and adopted by John Lu as far as is practical. In particular this applies to the use of thicker gloves, double gloving and down gloving during glove changing procedures.”
“3.1 Of particular concern to the committee, articulated first by Mrs Tabreham, was that none of the reports supplied had given a definitive answer on the risk of Mr Lu infecting patients if he returned to prosthetic valve surgery. It was unclear to committee members whether a definitive answer could be given, but it was felt that the experts should be pushed to quantify the risks as patient safety was of paramount importance. 3.2 The committee acknowledged the uniqueness of the situation that had arisen and the enormity of the decision it was being asked to make, both in relation to Mr Lu’s career as a cardiac surgeon and for the safety of patients to which the Trust owed a duty of care. The Committee, through the Chairman, expressed enormous sympathy for Mr Lu and the very difficult situation being faced by a highly skilled surgeon that was not of his making. 3.3 None of the investigations to date had been able to give a concrete answer as to how the outbreak occurred and what mitigating actions would ensure no recurrence in the future. This made it doubly important to have some quantifiable risks to guide the committee’s decision making.”
“The committee was anxious not to introduce further delay in reaching its decision, but unanimously felt that in order to reach the correct decision for the safety of the patients in the care of NUH, it should seek to have its specific concerns addressed.”
“The evidence received by the committee from the three expert microbiologists suggests that the risk to patients of Mr Lu returning to cardiac surgery, including valve surgery, is minimal, provided he agrees to adhere to all practical measures recommended by the expert microbiologists, including the testing regime to ensure he remains free of the outbreak strain of Staphylococcus Epidermidis. The risk to patients with the control measures in place is estimated to be the same as for all the other cardiac surgeons in the TCC. The Committee members unanimously agree that based on the expert evidence received, there was no clinical reason why Mr Lu should not be allowed a phased return to cardiac surgery, subject to all practical recommendations being implemented. Before returning to work, the committee would require Mr Lu to be rescreened, in order to ensure that he currently remains free of the outbreak strain of Staphylococcus Epidermidis. Also, as recommended in Professor Finch’s report (para 9.2.2), following return to non-valve surgery, Mr Lu’s skin samples should be monitored at monthly intervals to check for the possibility of his acquisition of the outbreak strain and this should continue for a period of six months. After returning to work, the committee would require a report at the end of six months, and three monthly thereafter for a period of 18 months, of Mr Lu’s colonisation status (the screening intervals recommended by Professor Finch). In the remote possibility that Mr Lu becomes recolonised by the outbreak strain, the committee would be urgently reconvened to agree an appropriate course of action to ensure patient safety.”
“I write to confirm that the Trust Board received at its meeting on30th August 2012 the view of the special committee convened in March to consider the clinical risk of your returning to valve surgery. You are aware of the rigorous process the committee followed: four meetings were held, advice and assistance was received from counsel, all relevant reports were reviewed and the committee met directly with Professor R Finch, Professor S Eykyn and Dr T Boswell. The Board received and accepted the view reached by the committee that the evidence they received from the three expert microbiologists suggests that the risk to patients of your returning to Cardiac Surgery, including valve surgery, is minimal, provided you adhere to all practical measures recommended by the expert microbiologists, including the testing regime to ensure you remain free of the outbreak strain of Staphylococcus Epidermis. The risk to patients, the Board heard, with the control measures in place, is estimated to be the same for you as for all the other cardiac surgeons in the TCC. Based, therefore, on the expert evidence received, there was no clinical reason why you should not be allowed a phased return to cardiac surgery, subject to all practical recommendations being implemented. To be clear therefore the Board accepted that you should be able to return to the full range of cardiac surgical practice, subject to the recommendations set out by Professor Finch in his original report – certain of these were stressed by the Board in its conclusion. I recognise that this is an outcome which you have sought for some time but it is one which should, for a short time, be treated as confidential by both the Trust and you. The Board stressed that the planning of your return to practice must proceed with proper care and attention, particularly with regards to the need to carefully communicate the circumstances and way forward to commissioners, other units, fellow clinicians, patients and the public. They also noted the importance of the completion of the agreement of your return to work programme and our discussions regarding informed consent. It is important therefore that we work together with you to agree the way forward before any wider announcements are made by either you or the Trust. I am meeting your Consultant colleagues on Tuesday 4th September and I would ask that you allow them to be briefed via this forum: the same requirements requiring discretion and confidentiality will be placed upon them. I have arranged for us to meet on Tuesday 4th September at 3pm in the Trust HQ, City Hospital. Daniel Morimer, Director of Workforce will be present as will Dr K Girling, Clinical Director – DIRC. Mr R Mohammed, MDDUS Advisor has confirmed that he is able to phone in to join the discussion.”
“would be grateful for any comments from NCAS on the attached, and in particular any advice regarding the effectiveness of the proposals in supporting a return to practice. We expect a decision on valve surgery by the end of the month.”
“Our discussion focused on two particular areas relating to your return to work: consent of patients and your re-entry to surgical practice programme (‘re-familiarisation’). These factors were discussed in the context of an acceptance by all parties referred to in this letter of the conclusion were reached by the Trust Board regarding your return to surgical practice. In relation to the area of consent, we agreed that the Trust would agree an instruction to Mr Michael Mylonas QC, with the input of your advisors (Mr Mitchell provided this on 12th October). This would comment on the approach to consent that you had set down, following discussions with colleagues including Mr Ian Robertson, Chair of the Trust’s Consent Committee. Mr Mylonas’ response would of course be shared with you. We discussed the response of your colleagues to your programme of re-familiarisation. I noted that they had welcomed the resolution of matters, particularly for you and your family, at our meeting with them on 4th September. There was however a discussion which pointed out the need for the re-entry programme to withstand any future scrutiny. Concerns were raised by two of your colleagues that Mr Naik was not an accredited trainer; that the mentorship arrangments were the same as the time of the outbreak: and that re-training elsewhere might be desirable. In relation to the last of these points I had explained to your colleagues (an am happy to confirm again to you) that the Trust accepted that it would not only be difficult for you to work elsewhere, but that Professor Finch’s recommendations required for you to be working in the Trent Cardiac Centre. We also noted that the involvement of Mr G Cooper from Sheffield Teaching Hospitals FT ensured that there was a different mentorship arrangement than in 2009. Whilst a number of elements of the concerns raised by your colleagues had been addressed we did agree that it was important for the programme to command their confidence involvement and support. We agreed, therefore, that a meeting of the consultant cardiac surgeons would be convened to discuss the programme and to seek consensus as to the way forward. Mr Cooper would be invited to attend the meeting as would Dr Girling as Head of Service. Mr Mohammed and you supported the step of meeting with your colleagues, and Mr Mohammed reminded us that the MDDUS would vigorously challenge any steps which sought to prevent your return to work. Subsequently, Mr Mortimer has written to Mr Cooper confirming the Trust’s approach to his indemnity (you received a copy of this letter).”
“As a new consultant who has been unable to operate for around 3 years (twice as long as his experience as a practicing consultant surgeon) John will surely now require an exceptional retraining programme which is sensitive to his particular set of circumstances. This will be a very stressful time for him and he will be exposed to unprecedented levels of scrutiny. I would hope therefore that the retraining would require, at the very least, mentoring and training from an experienced, credible and accredited trainer(s). We do have a range of training experience amongst the consultant surgeons here, as in most units. At one end of this training spectrum is a surgeon who is not, and has never been, an accredited trainer and who has a local and national profile as a surgeon who does not train. In my opinion it would not therefore be appropriate to ask this individual to have a role in the retraining programme.”
“In these circumstances, and given my concerns, I must please ask that my colleagues should not be told tomorrow that David Richens is going to be my mentor and assessor”
“Following an adjournment, when you consulted with Mr Mohammed, you confirmed your agreement as follows (and I quote your words as indicated): 1. The need for a ‘robust’ re-entry programme 2. Mr Richens would be ‘in charge’ of all aspects of your re-entry programme 3. Mr Naik would have ‘no formal role’, and would provide ‘help only’ 4. An external expert would be identified to address off-pump specific assessments.”
“Discussion was had about these issues in some depth. Based on the evidence presented to them and the resulting discussion, the committee felt that Mr L should not have to specifically tell patients about his part in the outbreak as external advisors to the Trust had concluded that the risk to patients undergoing this type of surgery was now estimated to be same for whichever cardiac surgeon was performing the procedure, given that Mr L was no longer carrying the outbreak strain and had agreed to adhere to all the recommendations made by the external advisors.”
“3 General Mutual Obligations Whilst it is necessary to set out formal employment arrangements in this contract, we also recognise that you are a senior and professional employee who will usually work unsupervised and frequently have the responsibility for making important judgments and decisions. It is essential therefore that you and we work in a spirit of mutual trust and confidence. You and we agree to the following mutual obligations in order to achieve the best for patients and to ensure the efficient running of the service: • To co-operate with each other; • To maintain goodwill; • To carry out our respective obligations and operating a Job Plan; • To carry out our respective obligations in accordance with appraisal arrangements; • To carry out our respective obligations in devising, reviewing, revising and following the organisation’s policies, objectives, rules, working practices and protocols.”
“In a case where it is being alleged that a plaintiff has been deprived of the opportunity to make a proper decision as to what course he or she should take in relation to treatment, it seems to me to be the law, as indicated in the cases to which I have just referred, that if there is a significant risk which would affect the judgment of a reasonable patient, then in the normal course it is the responsibility of the doctor to inform the patient of that significant risk, if the information is needed so that the patient can determine for him or herself as to what course he or she should adopt.”