Dr Reid v Medical Council of NSW - [2014] NSWCATOD 152 - NSWCATOD 2014 case summary — Zoe

NSWNSWCATOD

Dr Reid v Medical Council of NSW

[2014] NSWCATOD 152

NCAT Occupational|2014-10-28

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NCAT Occupational

Decision date

2014-10-28

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Judgment (23 paragraphs)

[1]

Introduction 1This is an appeal brought by the appellant Richard Ian Reid from a decision of delegates of the respondent Medical Council of NSW which determined that he be suspended from practice as a medical practitioner. The appeal is brought under section 159 of the Health Practitioner Regulation National Law (NSW) ("the National Law"). The appeal involves a hearing de novo conducted on the basis of such evidence and other relevant information put by the parties before the Tribunal. There was tendered into evidence a large volume of documentary material and oral evidence was given by the appellant. The Tribunal had before it the decision of the delegates which excited these appeal proceedings, as well as a number of decisions and determinations of others who have had, over a period of time, some involvement with the appellant in terms of his professional conduct. 2Relevantly, Sec 159 and Sec 159C of the National Law are in the following terms; 159 Right of appeal [NSW] (1) A person may appeal to the Tribunal against any of the following decisions of a Council for a health profession-- (a) against a suspension by the Council for the health profession on the person's registration under Division 3 or a refusal to end a suspension; or (b) against conditions imposed by the Council for the health profession on the person's registration under Division 3 or 4 or the alteration of the conditions by the Council; or (c) against a refusal by the Council for the health profession to alter or remove conditions imposed by the Council under Division 3 in accordance with a request made by the person under section 150I; or (d) against a decision by the Council for the health profession to give a direction or make an order in relation to the person under section 148E; or (e) against a refusal by the Council for the health profession to alter or remove conditions imposed on the person's registration, or to end a suspension, imposed under Division 4 in accordance with a request made by the person under section 152K. (2) An appeal may not be made in respect of a request by a person that is rejected by a Council because it was made during a period in which the request was not permitted under section 150I or 152K. (3) The appeal is to be dealt with by reconsideration of the matter by the Tribunal and fresh evidence, or evidence in addition to or in substitution for the evidence that was before the Council when it considered the matter, may be given. 3159C Tribunal's powers on appeal [NSW] (1) On an appeal, the Tribunal may by order terminate, vary or confirm a period of suspension or revoke, vary or confirm the conditions, as it thinks proper. (2) The Tribunal's order must not cause a suspension or conditions imposed by a Council to have effect beyond the day on which a related complaint about the person is disposed of.

[2]

Background 4The narration which follows is based on the evidentiary material put before the Tribunal. The appellant is currently aged 72. He is a graduate in medicine of the University of Queensland and was admitted to practice in New South Wales in 1969. He has practised medicine as a specialist gynaecologist in Australia and in the USA. He has Board Certification in the USA and in Australia. He has held a number of academic appointments and has published widely both within Australia and internationally. He has specialised in undertaking surgical repair dealing with pelvic organ prolapse, urinary incontinence, and associated conditions, and has used a number of surgical techniques which are not commonly used, but which are used to some extent both in Australia and overseas. 5For present purposes the appellant first came to the attention of relevant authorities in connection with his registration following a complaint made by the husband of a patient in March 2009. The complaint was investigated. It was assessed by the Health Care Complaints Commission (HCCC) as not requiring investigation and was referred to the then Medical Board. The appellant was required to attend a Performance Interview. In its conclusions, the Interview Panel referred to the appellant as performing "non-standard procedures", although on audit the "complication rates were found to be low." There was reference to the appellant's "extensive complaint history with the Board". The appellant was said to be insightful regarding this history and was taking steps "to alter the way he relates to his patients." He was advised to take other steps to enhance his relationship with patients and to provide optimal treatment. Furthermore, there was a suggestion that the appellant "limit the type of procedures he performs" as part of a retirement plan. No further action was recommended. 6Further patient complaints were received in November 2009 and January 2010 relating to repairs for bladder prolapse. These were referred by the HCCC to the Board (now the Medical Council). On 27 April 2010 the Performance Committee arranged for a Performance Assessment to be undertaken concerning the applicant's professional performance which was considered to be "unsatisfactory in the areas of communication, technical capacity and clinical judgement." This action was taken following receipt of the Performance Interview referred to above. It was also taken having regard to the complaints by two patients and the appellant's response to those complaints, as well as his history with the Council. Assessors appointed to carry out the Performance Assessment reported on the 10th February 2011. They concluded that the appellant's professional performance was unsatisfactory and below the standard reasonably expected of a practitioner of an equivalent level of training and skills in obtaining informed consent or experience in the areas of firstly clinical judgement about choice of surgical procedures and pre-operative assessment and, secondly, patient management. 7A Performance Review Panel was convened as a result of these conclusions, and issued reasons for decision on 16 September 2011. That Panel had before it a volume of documentation covering the events which we have previously referred to including detailed information furnished by the appellant. The appellant also provided information orally to the Panel. 8In their reasons for decision, the members of the Panel embraced the conclusions of the assessors concerning the issue of consent. They had commented on the particular procedures used by the appellant to deal with certain conditions. The assessors had noted that there was considerable medical debate regarding the selection of certain sling procedures for patients with stress incontinence and that the world literature was "biased by a divide between the American (Urogynaecological) literature and the rest of the world." They said that "most specialist pelvic floor surgeons are well aware of this bias and weight the literature accordingly." They referred to the practice of "most of the world" in terms of the use of certain tapes, and to frequent complications of other procedures which might have "excellent results" in particular cases. The assessors had been critical of the procedure adopted by the appellant in the circumstances of the particular condition of one particular patient. They thought that his choice of the particular procedure being the "the more complicated and morbid procedure is acceptable" but that for the patient to have been fully informed when giving consent she would need to have been given much more information about the use of the complex procedure proposed by the appellant rather than the more simple alternative procedure which was also available. They commented that there was no evidence that the patient was offered a second opinion and there was no documented discussion of the alternative surgery available. Although the appellant had described a lengthy consent process which he went through with patients, which was basically given orally after making available certain brochures, they thought that this process was "unstructured and rambling". 9Before the Panel, the appellant conceded that he had not adequately recorded the specifics of each patient's consent in the past. However, the appellant was critical of other criticisms made by the assessors. He said that they had not observed his final consultation with the patient at the time that consent was taken, and in fact he did not undertake that particular operation which they had described because it was eventually assessed as being unsuitable for the patient. 10The Panel also embraced criticisms made by the assessors about deficiencies in the appellant's clinical judgement. This referred in part to the choice of surgical procedures referred to above and whether, in the case of one patient, the appellant should have carried out urodynamic investigations. The assessors expressed certain professional views which were not shared by the appellant. 11The Panel noted that although the assessors had described the appellant as being "technically very skilful" they thought he had a "selective, idiosyncratic approach to preoperative investigation and choice of operation." They referred to his "very strong views on the role of ultrasound, particular mesh types and certain surgical procedures." They were concerned that he had a particular personal bias in some matters. Some of the procedures used by the appellant were described as "by no means a maverick procedure," but the assessors thought that they were "undeniably more complex" than the more conservative approach. They also referred to one of the procedures used by the appellant as being "completely unproven." Certain aspects were said to be "experimental." 12The appellant had responded to these criticisms before the Panel by saying that there was a difference "within legitimate professional opinion." His approach was supported by eminent specialists in his field. 13The members of the Panel "substantially" agreed with the opinions of the assessors. They found that the appellant's professional performance was at that time "unsatisfactory" and imposed a number of conditions on his registration which they thought would "address his unsatisfactory professional performance." In addition to imposing conditions the Panel directed that there be a further assessment of the applicant's professional performance. 14The following 8 conditions were imposed; "1. For the purposes of a Council review of A/Prof Reid's understanding and application of the legal requirements associated with obtaining valid informed consent for the surgery which he performs he is to provide to the Council within three months of the date of this Decision: (a) a summary, prepared by him, which sets out the steps he takes in order to obtain a patient's valid informed consent to surgery (b) an overview of the changes, if any, he has made to his practice since the date of this Decision to ensure that he obtains and records valid informed consent to surgery. 2. before performing any colorectal procedure or any procedure on a patient with anorectal symptoms, A/Prof Reid is to obtain a second opinion from an appropriate specialist in the field of colorectal surgery which supports the procedure A/Prof Reid has in mind to perform. He is to keep a copy on the patient's file of these second opinions. 3. A/Prof Reid it is to keep a log book of his surgical procedures. (a) in this log book he is to record for each surgical procedure that he performs the following - the patient's symptoms and signs, what investigations he or others carried out, relevant past history (including surgical history), details of the operation and the outcome of the surgery. (b) he is to forward a copy of the entries he makes in this log book to the Council three months after receiving this decision and then at three monthly intervals after this. (c) it is envisaged that after nine months the Council will specifically review whether it still requires A/Prof Reid to keep (and to forward copies of) this log book. 4. Whenever A/Prof Reid is contemplating surgery upon a patient with symptoms of bladder dysfunction he is to refer that patient for urodynamic investigations. 5.Whenever A/Prof Reid relies upon 3D or 4D ultrasound investigations as the basis for surgery he is to send this material for review of his reporting, by an independent expert approved by the Council, prior to performing surgery. Alternatively, he may send the patient directly for ultrasound investigations and reporting by an independent expert approved by the Council, prior to performing surgery. He is to keep a copy on the patient's file of these independent reviews. 6. to authorise and consent to any exchange of information between the Council and Medicare Australia where such exchange is necessary to facilitate the monitoring of compliance with these conditions. 7. the Council may notifying his employer/s of any issues arising in relation to compliance with these conditions. 8. these conditions may be varied, amended or removed at the discretion of the Council." 15Subsequently, Condition 1 was removed by the Council and we need not be concerned with it further. 16The appellant commenced submitting case logs to the Medical Council in compliance with the Conditions. During the course of this period the appellant reviewed the surgery which he had performed and made a number of submissions about his practice. He described his practice as a "Pelvic Floor practice" with a widespread referral pattern from a number of areas. He said that his caseload was "skewed to the difficult side." He demonstrated this by reference to an analysis of the cases covered by the case logs. For example, in the period October 2011 to July 2012 he undertook 76 urogynaecology cases, 17 lower genital tract cases and 26 general gynaecology cases. Of the 76 urogynaecology cases, he assessed 18% as being advanced, that is "very complex problems", 74% as standard and 8% as basic. He described in some detail the reparative strategies which he utilised. His description of his case logs after these dates followed the same general pattern. He described a significant proportion of his cases as involving "salvage cases" where he was required to rectify the work of other surgeons. He said that to his knowledge, no other surgeon had been required to rectify any work that he had carried out. 17On 26 November 2013 the Performance Committee of the Council resolved that based on information before it, that the appellant was complying with Practice Conditions 2 and 3 (a). It further resolved that the appellant was permitted to conduct the urodynamic studies referred to in Condition 4 himself. He was requested to confirm that he had not carried out any surgery since 2011 based on 3D or 4D ultrasound in compliance with Condition 5. 18On 18 December 2013 the appellant wrote to the Council in connection with his use of 3D/4D ultrasound. He said that he had never used the results of these studies as the basis for surgery. It was his opinion that information gained from this type of imaging "is mainly of prognostic value". He supported his use of ultrasound imaging on his patients as explained in three published scientific articles of which he was either the sole or lead author. 19The Performance Committee of the Council determined at a meeting held on 28 January 2014 that it was satisfied that the appellant had complied with Practice Condition 5.

[3]

Performance re-assessment 3 & 5 December, 2013 20A further performance assessment was carried out by two specialist urogynaecologists. They first interviewed the appellant on 3 December 2013 at the premises of a hospital in Sydney where he exclusively operates, and at the same time observed a surgical procedure which he undertook, and reviewed certain patient records. This took in all 4 ½ hours. On 5 December 2013 the assessors attended the appellant's rooms and during a period of five hours interviewed him, reviewed his records and facilities, observed consultations that he conducted with four patients and spoke to him about his clinical practice. The assessors issued a performance re-assessment report on 26 March 2014. 21The assessors concluded that the operative procedure which they observed was "definitely indicated and very well performed" although they had some reservations about part of the procedure. They thought that a less complex procedure could have been undertaken. Also, there were certain aspects of the procedure which they felt must be discussed with the patient, but there was no evidence in the clinical notes that such a detailed discussion had taken place, nor did it appear that the appellant had "specifically explained to the patient that the TFS sling he planned to insert is not widely used, there is limited data and that in general these "mini-slings" have a poorer outcome than the standard mid-urethral slings." 22The assessors pre-operatively discussed with the appellant surgery to be undertaken on another patient. He indicated that he was intending to place a mini-sling type tape with a barb at each end to anchor the tissues, with the tape being placed down low in the vagina. The assessors thought that the placement of a tape in this area was "a novel approach. There is little literature on the subject. It is not performed commonly in Australia." In discussing obtaining the consent of the patient to this procedure, the appellant told them that he informed the patient that this was a new procedure and not well tested yet. He conceded that he had not written this down in the patient's consent form. The failure to record this in writing was said to be unsatisfactory. 23Overall the assessors were of the view that although the appellant's documentation of consent had improved since the last assessment, it remained unsatisfactory because of the lack of documentation "about the novelty of the procedure." 24The assessors spoke to the anaesthetist and others used by the appellant in the operating theatres at the hospital, especially concerning the high rate of blood transfusions. They thought that this might be caused by the isolation of the hospital where blood products were ordered "just in case", and the blood was possibly being used rather than being discarded. 25On the second occasion, the assessors observed 4 consultations by the appellant with patients. These were all post-operative or for results and none of them had attended for initial or preoperative visits. Thus, the assessors were unable to directly observe any explanation of surgical options or the consent process given by the appellant. In general terms the consultations were assessed as either being satisfactory or superior. 26The assessors reviewed eight hospital records drawn from a surgical log submitted by the appellant. All but one of these patients had had two or more procedures, and the eighth patient had been urgently transferred to another hospital for life threatening bleeding following removal of a drain. 27The assessors observed that there was "minimal documentation in any of the notes by (the appellant), with many days having no record of review, and some days having a visit by him noted only in the nursing notes. 28The assessors also reviewed 8 patient records from the appellant's clinical notes in his rooms. They concluded that the patient files "consisted of a combination of handwritten notes...., letters to and from referring doctors, and results of various investigations. Of note, the majority of patients had ultrasounds and urodynamic studies reported by (the appellant) rather than by external experts. Some patients had no documentation of the consent process, some have a brief handwritten note and some had signed copies of the detailed printed consent form for anterior or posterior repair." 29In the course of their clinical practice interview, the appellant was asked to respond to a number of issues raised by the assessors. It seemed to the assessors that the appellant "mostly" undertook 3 types of procedures. It was noted that patients who had been referred to the appellant had often seen other surgeons, had had other procedures, and that the appellant often seemed to be the "surgeon of last resort". One of the procedures undertaken involved the placement of a "short polypropylene mesh tape in various parts of the pelvis" using an Australian product known as TFS. The appellant was questioned about why he employed techniques "that are less frequently done and not necessarily tested over time." The appellant acknowledged to them that "there was very little published evidence reporting either the short or long term outcomes for the placement of TFS tapes in complex pelvic repair surgery, though he believes the surgery is highly effective." This caused "significant concern" for the assessors because firstly the TFS meshes had not been widely used and there was very little published data on outcomes, and secondly they had some doubts about the material from which the meshes was made. The appellant told them that the mesh techniques which he promoted had been used in other countries, including Japan and Germany since about 2004. The assessors were concerned that it did not appear that the appellant explained to patients "the relatively untested nature of the TFS measures he prefers," although he believed that his patients have generally benefited from his surgery where others had failed. The assessors engaged in a conversation with the appellant about a number of technical issues arising out of the techniques utilised by him. 30The assessors expressed concern that the appellant was in breach of conditions 4 and 5 because he continued to report on his own 3D/4D ultrasounds and urodynamic studies, despite his lack of formal qualifications in this area. They noted the explanation proffered that the appellant was not in breach because he did not use 3D or 4D ultrasound investigations as the basis for surgery. 31In terms of the consent process, the appellant said that he was happy to document the proposed procedures more carefully given the concern of the assessors about the novelty of his procedures, the availability of "conventional alternatives" and their doubts about the suitability of the mesh product. 32The assessors thought that there was a very high rate of repeat procedures with many of the appellant's patients. Furthermore, that between 20 September 2012 and 17 September 2013, 8 procedures out of 38 undergone by 16 patients had not been listed in the appellant's submitted surgical log book. 33The assessors thought that the appellant should benchmark his practice against others so that he could identify any undue pre-operation rate and complication rate. The appellant was unable to identify any process by which he could do this. 34The assessors noted that the appellant had no formal process for peer review and feedback, although the appellant had regular informal conversations with a number of colleagues named as Dr Carl Zimmerman, Dr Lew Lander, Dr Darren Gold a colorectal surgeon, and Dr Vincent Tse a urologist. The assessors noted that there were no formal morbidity and mortality meetings at the hospital at which the appellant exclusively operated and there was no formal quality or audit activities undertaken by the appellant. Neither did the appellant use a number of databases established by certain Urogynaecological Societies. The assessors also questioned the appellant about how he would know when the time would come when he should stop operating. The appellant told them that he had not yet lost his surgical skills, that he felt competent to keep operating but that the aim was to wind down his surgical practice "in the next two - three years" and he would train up someone to continue his work. 35When asked why he had a higher than usual number of complaints made against him, the appellant responded that they had been incited by "professional adversaries" who had encouraged patients to complain. 36The assessors noted that the appellant had an adequate academic grasp of the medical literature and appeared to keep up-to-date academically. They thought that he was deficient in his knowledge of management "of incontinence in the low pressure urethra". They said that they were concerned more "over the inconsistent, at times illogical and almost capricious way he chooses to use his knowledge. His enthusiasm for relatively untested products (TFS) and unorthodox procedures (tight slings) seems to lead him to ignore evidence-based medicine and his own disturbingly high rate of surgical failure/repeat surgery. There is some evidence of poor clinical judgement - for example Patient 4 in the hospital notes suffered a urethral tear during excision of a previous eroded sling and insertion of a second mid-urethral sling. Two months later, with ongoing incontinence, she was scheduled for a third sling procedure. There was a persistent urethral defect found but despite this the sling was inserted and the patient remained incontinent. This is not clinically appropriate or wise management of a complication." 37The assessors concluded that the appellant's practice was unsatisfactory in the areas of clinical judgement and patient management skills - treatment and advice. They were concerned that because of his extreme enthusiasm about the procedures which he used that there was a greater possibility of choosing the wrong procedure and that his decisions on patient management were not always based on "the best available evidence and still appear to be determined by his particular enthusiasms." They thought the appellant found it difficult to be impartial and "scientific" in his assessment of products and procedures and was unable to contemplate that his initial impressions of a medical device may be inaccurate and that new devices "should only be adopted when there is a strict audit process and the patients are fully aware of the circumstances." They concluded that this represented a continuation of the deficiencies noted at the original performance assessment in October 2010. 38Furthermore, the assessors concluded that the appellant had failed to comply with previously imposed conditions by reporting on 3D/4D ultrasounds and by reason of omissions in his surgical log books. Finally, although there had been a degree of improvement in his consent processes, they were still inadequate. There was also very poor general documentation in the appellant's hospital files. 39The assessors recommended that a Performance Review Panel be convened to review the appellant's professional performance and that certain protocols should be introduced at the hospital at which he operated for the purpose of reviewing the outcome of the appellant's cases. 40The appellant provided a written response to the Performance Re-assessment report by letter dated 14 April 2014. Relevantly, and by way of summary, the appellant; 1. said he has "extensive pre-operative discussions with patients which involve lengthy discussions of advantages, disadvantages, options and risks and the nature and extent of this discussion can be established from the written documentation." He said that he had developed detailed documentary material to be given to patients and to be signed by them in consultation with his professional insurer. 2. said the criticisms of the assessors of his operative procedures were unwarranted. He provided some details with respect to each of the patients. In terms of the more complex technique which he had used and which was criticised by the assessors, he gave three reasons why the more complex procedure was appropriate and the simpler procedure was inappropriate. In terms of the placement of the sling, he did so on the specific recommendation of a colorectal consultant, Dr Darren Gold, and attached a letter from him. 3. responded to the concerns about breach of conditions 4 and 5, and we note that these have been addressed in any event by the Council. 4. denied using the TFS mesh for all cases and said that it was " only suitable for patients with ligament weakness but not hammock defects." He said he explains the use of this mesh to patients in an hour-long preoperative consultation in which he tells the patient that it is a new procedure and not yet exhaustively tested. He accepted that he did not write this part of the informed consent conversation down, acknowledged that it was preferable to specifically document such discussions and said that he was in the process of developing documentary material to enable this to be done. 5. said there was moderate literature available about TFS. He is enthusiastic about his initial experience with this product because it reduces hospital stays among other things. He denies being blindly zealous about its use and said that the criticisms made were "subjective and inaccurate". Furthermore; "in the process of the assessment I was challenged repeatedly about TFS and it is not surprising or unreasonable that I would therefore feel the need to explain and justify my use of it. This is not indicative of my giving patients a one sided or overoptimistic view about TFS." It is presented to patients as a new procedure with limited testing data at this stage. He also makes clear that there are only a small number of centres in Australia currently using TFS. He attached a bibliography and other references concerning use of the TFS system. He said that the representation by the assessors of this technique as being "something revolutionary, bizarre or totally unreviewed" is exaggerated. "TFS represents an evolutionary development of the TVT mid-urethral sling and the posterior infracoccygeal sacropexy devices, upon (sic) which have been used in large numbers for more than a decade." 6. referred to the assessors having noted complications with a particular patient. These had arisen from earlier surgery conducted by another surgeon interstate. 7. said the deficiencies in the hospital records arose because entries were made principally by nursing staff and not surgeons. The hospital management has now changed the procedure so that entries are made by the surgeons. 8. referred to the comments of the assessors about the number of procedures undertaken on each patient. He said that there was a need for patients to return for mid-urethral tapes splitting. He said that the cases should be looked at objectively and many of them were complex. In more straightforward cases he usually left a gap between the tape and the urethra, "making it relatively easy to avoid chronic retention. But standardly-tensioned tapes have a lower success rate in women with such adverse prognostic factors as low urethral pressure leakage or a scarred immobile urethra. To protect against failure when difficulty is perceived, it is not uncommon in US gynaecological practice to err on the side of placing the tape more snugly - rather than to risk placing it too loosely." 9. attached a detailed analysis of 8 cases in which there was said to be a lack of clinical records. In connection with some of them the appellant said that he had a prolonged work absence in May - June 2013 when he had injured his hand and was unable to operate, and his marriage had broken down in September - October 2013. The resultant " grief " caused him to overlook some June cases. Some of the omissions were caused by the fact that further operative work was not included within the "office operating room schedule" which he used as the basis for the compilation of his log records. 41There is a vast gulf between the views of the assessors and the approach of the appellant to the type of surgery which he conducts. The assessors call it "novel" and this no doubt has influenced their concerns about the nature and extent of the patient consents and about what information the appellant should properly have given them. The appellant disagrees with these views, and in particular as to the novelty of the procedures which he uses. He has provided detailed and very technical reasons why the opinions expressed by the assessors, in particular, concerning 2 operative procedures are wrong. 42We, and anyone else who has considered the available information would have no way of establishing and expressing an opinion about who is right and who is wrong without access to someone with undoubted authority in this area familiar not only with the orthodox approach which we assume is propounded by the assessors, but also with the approach and techniques used by the appellant and others. At the least, it would have been helpful if the assessors had been able to respond to the detailed reply provided by the appellant to the Council, but this does not appear to have occurred. There is no information available to us that would allow us to make any informed decision about this controversy, and whether there are sufficient deficiencies in the approach and technique of the appellant to be able to characterise what he does as creating some relevant concern for the health and safety of his patients. Certainly, there is nothing in the report of the assessors which deals with information given to them by the appellant to the effect that he often undertakes repairs of work carried out by others, is seen by some to be a "surgeon of last resort" and that the technique which he uses is a staged process involving a number of procedures. Even if the assessors had not been given an opportunity of taking into account the detailed reply of the appellant, at the least they could have dealt with some of these matters in their report because they were alluded to in the oral exchanges which occurred when they interviewed the appellant on two occasions. As will be seen, the concerns which we have expressed will apply again when we come to consider the section 150 proceedings which resulted in the suspension of the applicant's registration.

[4]

Prior complaints 43Reference has been made in the reports of the assessors to the suggested large number of complaints made against the appellant. There is included in the documentary evidence before us a Complaints Summary Report. This sets out in very much summary form the fact that as at 15 July 2014, 14 complaints have been made against the appellant dating from 5 August 2002. They include complaints about clinical care, incorrect or misleading communication, treatment, failure to obtain consent, "other" and "general". We have been provided with details about one of these complaints, which has been referred to the HCCC, (the "HCCC complaint"). Other than this complaint, we have no details except those which are referred to most briefly in the summary document. We have no means of determining whether and to what extent there is any validity in them, whether and to what extent they reflect adversely on the appellant's practice of medicine, and whether they are indicative of an unusually large number of complaints given the nature of the appellant's practice. 44There is a lot of detail in the documentation which has been provided to us about the HCCC complaint. The appellant has provided a most detailed response to the complaint. It is currently before the HCCC for investigation. Both parties submitted at the hearing before us that we should note the fact that the complaint has been made, but we should not take into account the allegations contained within it in determining these proceedings. We agree that this is the appropriate manner of dealing with this particular complaint for the purpose of our determination. 45The section 150 suspension proceedings The Council, having received the report arising out of the December 2013 performance assessment, which concluded that the appellant was in breach of his practice conditions and that his practice was unsatisfactory in the areas determined, resolved to proceed against the appellant to suspend his registration as a health practitioner under section 150 of the National Law. In doing so it took into account the HCCC complaint, which included allegations of breach of practice conditions and the performance of "inappropriate and experimental procedures" without consent. Two persons were appointed as delegates of the Council to determine this matter. In addition to the provisions of section 150, the delegates also had regard to section 41O of the National Law. 46These provisions are in the following terms; (1)41O Other matters to be taken into account [NSW] (2)In the exercise of any of its functions under Subdivision 2 or 7 of Division 3 of Part 8 with respect to a complaint about a registered health practitioner or a student, a Council must have regard to any of the following matters, to the extent the Council reasonably considers the matter to be relevant to the complaint-- (a) another complaint or notification about the practitioner or student made to the Council or the National Agency, or made to a former Board under a repealed Act, including a complaint-- (i)in respect of which the Council, the Commission or a National Board has decided no further action should be taken; and (ii)that is not required to be referred, or that the Council or the Commission decides not to refer, under Division 3 of Part 8; (b)a previous finding or decision of a Council inquiry in relation to the practitioner or student; (c)a previous finding or decision of a board inquiry, professional standards committee or a tribunal established under a repealed Act in respect of the practitioner or student; (d)a written report made by an assessor following an assessment of the practitioner's professional performance; (e)a recommendation made, or written statement of decision on a performance review provided, by a Performance Review Panel in relation to the practitioner. 47150 Suspension or conditions of registration to protect public [NSW] (1)A Council must, if at any time it is satisfied it is appropriate to do so for the protection of the health or safety of any person or persons (whether or not a particular person or persons) or if satisfied the action is otherwise in the public interest-- (a)by order suspend a registered health practitioner's or student's registration; or (b)by order impose on a registered health practitioner's registration the conditions relating to the practitioner's practising the health profession the Council considers appropriate; or (c)by order impose on a student's registration the conditions the Council considers appropriate. (2)A suspension of a registered health practitioner's or student's registration under subsection (1) has effect until the first of the following happens-- (a)the complaint about the practitioner or student is disposed of; (b)the suspension is ended by the Council. (3)If a Council for a health profession is satisfied a health practitioner or student registered in the profession has contravened a critical compliance order or condition, the Council must-- (a)suspend the practitioner's or student's registration until a complaint concerning the matter is dealt with by the Tribunal for the health profession for which the Council is established; and (b)refer the matter to the Tribunal as a complaint. (4)A Council for a health profession may take action under this section-- (a)whether or not a complaint has been made or referred to the Council about the practitioner or student; and (b)whether or not proceedings in respect of a complaint about the practitioner or student are before a Committee or the Tribunal for the profession. (5)Without limiting the conditions that may be imposed under subsection (1)(b), a Council may impose a condition requiring the registered health practitioner to undergo a performance assessment, but the condition has no effect unless the Commission agrees with the imposition of the condition. (6) A Council must give written notice of action taken under this section to the registered health practitioner or student concerned. (7)If a Council delegates any function of the Council under this section to a group of 2 or more persons, at least one of those persons must be a person who-- (a)is not a registered health practitioner or student in the health profession for which the Council is established; and (b)has not at any time been registered as a health practitioner or student in that health profession under this Law or a corresponding prior Act. 48The delegates conducted a hearing on 17 July 2014. They had before them documentary material, much of which is also before us. The appellant gave evidence at the hearing. It appears that no other person was called to give oral evidence. We have a transcript of the proceedings before the delegates. The proceedings commenced at 10:20 am and concluded at 12:09 pm that day. The delegates suspended the appellant's registration on 18 July 2014 and gave written reasons for their decision on 8 September 2014. As the appeal proceedings before this Tribunal are a rehearing of the matter before the delegates, it is strictly speaking not necessary that we refer to or analyse in any detail the reasons for decision of the delegates. However, in the proceedings before us counsel for the respondent Council relied substantially on that reasoning. For this reason it is necessary to refer to the reasons for decision. We would add that one of the two delegates was a registered medical practitioner, and although a professor of medicine, we are unaware as to whether he has practised in a specialty area which covered the work of the appellant. The other delegate is not a registered health practitioner. He has a Ph.D., although we do not know in which discipline. Presumably, therefore, in the case of at least one of the delegates there must have been total reliance on the opinions expressed by the assessors in testing anything which the appellant said at the hearing. 49The proceedings were conducted on the basis that the delegates would primarily be seeking responses from the appellant to the issues raised in the performance reassessment conducted in December 2013. They said that the HCCC complaint was also a trigger for the proceedings and that that complaint required further investigation. The hearing, therefore, consisted substantially of dialogue between the appellant and the assessors, predominantly the assessor with medical qualifications. 50The appellant was asked firstly about the finding of the assessors of unsatisfactory performance in the areas of clinical judgement, patient management skills, treatment and advice. In response the appellant first referred to the operative procedure at which the assessors were present. The assessors had criticised the volume of graft which he had used. He explained to the delegates precisely why he used a larger piece of mesh than they had suggested consistent with this technique. This was to avoid a very high rate of prolapse. The assessors had prevailed upon the appellant not to use a sling on this occasion so he did not. However, as he told the delegates this particular patient "was very highly incontinent and I had to put a sling in a month later." The assessors had also questioned why the appellant had just not undertaken an orthodox colporrhapy repair. The appellant told the delegates that he did not do this repair for three reasons. Firstly, she had already failed a couple of such repairs, secondly "she has a genetic issue with the neutrophils and a chronic cough" and thirdly "in terms of our consenting, she had indicated she had wanted a repair that was potentially a bit more trouble to do but probably more likely to give a lasting result - and in particular the worst part of the mesh pain was at the top of the vagina." He went on to explain the structure of the vagina and why he thought that the more orthodox approach was "probably not a good idea biomechanically". 51Prima facie, the response of the appellant is a measured attempt to rebut the criticism of the assessors concerning the inappropriateness of the surgery undertaken by the appellant on this patient. It will be remembered that this is the only surgery which they observed. Unfortunately there is no evidence of any dialogue between the assessors and the appellant which might assist in the elucidation and understanding of the significance of the controversy, nor is there any external, independent expert opinion available to us. Nor was it available to the delegates. 52In the course of his oral evidence, and in response to questioning from the delegates the appellant repeated much of the material in his written response, which we have earlier summarised in some detail. 53The appellant told the delegates that he had been unfairly categorised as being overzealous about the use of TFS and about the particular grafts which he had used. He told them that he tried very hard not to be overzealous with patients and that it was the needs of the patients that drove his decisions about what treatment to apply. He described to delegates the results of a summary of comparative studies of site specific repairs which he conducted in which he found a 75% success rate versus the traditional repair, being colporrohaphy. He said that he had about a 5% complication rate in the course of the year of approximately 120 cases using TFS. He told the delegates that TFS allows "minimally invasive surgery; good anatomic and functional results." He denied that the use of TFS was "experimental". 54The appellant gave to the delegates a detailed demonstration of the use and application of the TFS tapes. They asked the appellant if he takes patients through the same explanation and he replied that he did. The delegates then expressed the opinion that the appellant "was unable to provide substantive verbal or written evidence to demonstrate that he has countered his zealousness towards TFS." We are not sure how the delegates could have come to such a conclusion. The appellant had denied to them that he was overzealous about the use of TFS and that he was overzealous in the manner in which he presented its use to his patients. The opinion expressed by the delegates assumes that the appellant was guilty of his overzealousness in circumstances where he denied it. Presumably the delegates were relying, in some way, on the opinions expressed by the assessors in the performance review. However, as we read the factual material which was available to the assessors, there can be no basis for them having reached any such conclusion other than one based on some unsupported assumption or apprehension concerning the appellant and his practice. Even if this were the case, then surely in some way it would have been appropriate for the delegates to make some informed assessment about whether, in fact, the appellant had been overzealous in the manner described. At the very least, the assessors who had expressed the opinion in circumstances which were categorically denied by the appellant should have been available in some way for the purpose of those proceedings so that the delegates and/or the appellant could have tested their basis for any such assertion. Apart from the material in the HCCC complaint, there does not seem to us to be any material in all of the documentation that would indicate that in some way the appellant had been overzealous in the manner alleged by the assessors. We fail to see how the delegates could have expressed such an opinion for the purpose of the proceedings, bearing in mind that they were conducting an inquiry which was not only primarily concerned for the overall protection of the health and safety of the public but also involved the ability of the appellant to continue to practice medicine. 55Much of the focus of the reasons for decision of the delegates concentrated on the area of patient consent and understanding of the surgery which the appellant was contemplating. They said, in their reasons, that the appellant "then went on to replicate for the delegates the type of information he would cover in consultation with the patient." 56The evidence provided by the appellant was in response to a question; "so, Professor, once you explain to patients that the vagina is like a house, can you go on and describe a little bit more about what you would tell patients through the information disclosure?" In reply the appellant said; "I have tried to point out firstly that there are three quite different parts to the pelvis, and in terms of their technical names, John DeLancey is the doyen of pelvic anatomy, probably of all time. He pointed out that the connective tissue above the top of the vagina which is called DeLancey level I is organised like the roof gables, and they hold up a pair of latch suspensory hammock-like sheaths which is DeLancey 2 which goes into a condensation level of DeLancey 3. So I point out that the roof is suspended by strong ligaments that go up to the pelvic bone just where it joins your backbone, and that they can easily be stretched during childbirth. If that happens, it allows the "tent pole" that is holding up the top of the vagina to sag. That may involve the uterus presenting at the (indistinct) or more commonly it doesn't usually get that far. But more commonly if the uterus is able to fall down bends the bladder and it tends to cause obstruction of the urethra, and that's a primary cause emergency. And also, if it destabilises the hammock at back, in order to defecate you have to get relative movement of the stool relative to the rectal wall." The appellant went on using language of a similar kind and in his description he also said; "I point out that - and that can go into various detail: some of them are very interested, some aren't......." 57In discussing this evidence the delegates thought that the appellant had described the anatomy of the pelvis and vagina "using either highly technical terms such as "DeLancey level I, 2 and 3" or prosaic terms such as "tent pole" and "hammock". The delegates were concerned that the terminology was either overly technical or verging on overly simplistic. In our opinion in order to consider whether and to what extent a patient may have been capable of understanding information of this kind, and if so actually understood it, it would have been preferable to have asked the appellant to endeavour to replicate the exact words that he generally used for patients. Furthermore, we have difficulty in accepting the view of the delegates about whether the explanation was overly technical or overly simplistic without having a complete explanation of what is usually said within the overall environment and context of the consultation, including use of the pelvic model which the appellant said he always utilised for this purpose, coupled with his oral explanation. It would be helpful to be able to compare the documentation used by the appellant with something which the assessors or the Council said complied with their understanding of requirements which were consistent with good medical practice in this area. No such documentation has been made available to us. 58In their discussion with him the delegates focused on the appropriate choice of procedure. The appellant told them that he always operated in a patient centred manner. He said that he encourages patients to make a choice between more simple and more complex surgery pointing out the advantages and disadvantages of each. He reminded the delegates that two thirds of his cases were patients who "are in real trouble with what's gone wrong or who were at least had several failures. So by the time people have had a couple of failures from a traditional colporrhaphy, I usually say - it makes less and less sense to keep doing the same operation which failed a couple of times before and I pointed out that site-specific repair which not many people do in Australia where (indistinct) States not very common here. It's a different approach and it has the prospect of fixing something that didn't get fixed in the previous times." He regarded his patients as being both vulnerable and "desperate." He thought that if patients required more information about alternative treatment he would send them to specialists who, we perceive, carry out the same surgical techniques." 59In further examination by the delegates, the appellant was asked what information he gives to patients. He advised them that upon making a first appointment a patient receives a detailed document and a questionnaire. He was asked; "How, or do you assess that they have understood this quite comprehensive and somewhat technical document?" He responded that he used the document mainly for the diagrams, he talked through it and that this all occurred during the course of a lengthy consultation. The document shown to the delegates was said to be deficient in that it referred to a mesh type, but not TFS. 60The delegates asked the appellant some brief questions about his "apparently very high rate of repeat procedures", his confidence in TFS, ongoing education and peer review and audit, and the number of previous complaints. The exchange about these matters, as revealed in the transcript, was brief. 61A delegate then raised with the appellant some evidence of poor clinical judgement. The delegate said that a patient in hospital "had suffered a urethral tear during excision of a previous eroded sling and surgical second urethral sling two months later with ongoing incontinence. She was scheduled for a third procedure. There was a persistent urethral defect found but in spite of this the sling was inserted and the patient remained incontinent. This is not clinically appropriate or wise management of a complication." The appellant responded that the statement was factually incorrect. The appellant said that he inserted a simple easy sling that began to erode on the left side. In performing the surgery he at first thought that he had penetrated the bladder but later found that she had an erosion. He said it was really hard to repair and that he got a good result. He further said that the patient was very incontinent. He put in a second sling which he said was about 75% effective as opposed to an artificial sphincter which he said was not a very good operation at the best of times. He denied ever putting a third sling into that or any other patient. 62In answer to a question concerning complex surgery, the appellant said that he sometimes performed it on his own but when available he was assisted by another specialist who performed the same operative techniques. 63In the course of questioning the appellant repeated that he had failed to properly complete his log books over a short period because of the personal difficulties which he had previously recounted, namely a hand injury and a breakup of his marriage. 64During the course of several exchanges with the delegates the appellant referred to his patients as not being in a "life or death" situation when assessing what type of surgery they should have. In the course of their reasons for decision the delegates said that they were "at a loss to know the meaning of this statement." We do not share this concern of the delegates. 65In their reasons for decision the delegates outlined a number of issues of "most concern." These covered undocumented informed consent, lack of full disclosure, ensuring patient understanding, professional isolation and high reoperation rates. Finally, the delegates were also concerned that the appellant had failed to address in any meaningful manner the issues raised by the assessors. "He did not provide evidence at the hearing of documenting consent; of rewriting the pamphlet; of providing a complete array of information to patients; of having organised regular professional meetings; or of seeking multidisciplinary support." 66We will consider each of these reasons for decision when setting out our own reasons for decision because they are all matters relied upon by the Council for the purpose of these proceedings. However before doing so we need to refer to some additional evidentiary material some of which was put before us during the hearing before this Tribunal, but some of which was available to the delegates, but to which they have not referred and therefore, apparently, not taken into account.

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Is the site specific repair technique used by the appellant "novel"? 75There was tendered into evidence 4 published, peer reviewed articles which deal specifically with the site specific repair technique used by the appellant and which was said by assessors to be "novel", a conclusion which was adopted by the delegates. Two of the articles were published in 2010, and two in 2011. The authors conducted their research in the UK, Belgium, Australia and the USA. 76A survey conducted in the UK of approximately 200 practitioners to assess "trends in the surgical management of pelvic organ prolapse" showed a significant increase in the use of site specific repair. For posterior vaginal wall prolapse, 18% of respondents chose site specific repair and 66% chose posterior colporrhaphy, whereas five years previously the respective percentages had been 11% and 75%. For recurrent posterior wall prolapse, 14% used site specific repair and 23% used posterior colporrhaphy. Five years previously the respective percentages had been 6% and 38%. 77A survey of current management of prolapse in Australia and New Zealand written up in 2008 said that pelvic organ prolapse affects up to half of women over the age of 50. Of women undergoing surgery, about one third need a second procedure within two years of primary repair. The high failure rate had led to the introduction of a "plethora of new procedures." The survey was complicated in that it was sent to generalist as well as specialist gynaecologists, and about 200 responded. The authors noted "a significant rise in graft usage" for recurrent prolapse (56%) when compared with five years previously. For posterior vaginal prolapse in primary care, in Australia and New Zealand 56% of practitioners chose colporrhaphy and 24% chose site specific repairs. This was compared to practice in the UK where the respective percentages were 75% and 11%. For recurrent rectocoele, 18% of practitioners used colporrhaphy and 12% used site specific repair in Australia and New Zealand. The respective percentages in the UK was 38% and 6%. 78A study of a small group of about 100 women in the USA commented that "successful treatment of anterior vaginal prolapse remains one of the most challenging aspects of pelvic reconstructive surgery. Although anterior colporrhaphy is commonly used to correct anterior vaginal prolapse, high recurrence rates have been consistently reported. This high failure rate has led to increased use of biologic and synthetic materials in the surgical correction of anterior vaginal prolapse. The study found that those patients who had been treated with mesh "have a significantly lower anatomic failure rate (18%) than both the porcine (46%) and colporrhaphy groups (58%)." 79The fourth article deals with the use of Surgisis mesh, which we understand is no longer used by the appellant. It does indicate, however, that there are a small number of surgeons using that material in Australia as an alternative to colporrhaphy. 80These articles demonstrate that the site specific repairs advocated by the appellant as a technique to be used in appropriate cases as an alternative to colporrhaphy cannot be characterised as "novel" and provided that an appropriate explanation is given canvassing the pros and cons of using it, there is nothing to suggest that its use would demonstrate an inappropriate or undue risk to the health or safety of any patient.

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Overall competency 86There was tendered into evidence a letter addressed to the Council dated 1 July 2014 from Dr P Petros. Dr Petros stated that he had written the letter of his own volition because "it would be a major injustice for a surgeon of this skill to be prevented from helping the many women who come to him for assistance as a last resort." Dr Petros's letterhead states that he is a reconstructive pelvic floor surgeon and certified urogynaecologist. He also holds University appointments and postgraduate qualifications at Doctoral level. 87He said he was asked by the appellant to assist with some pelvic floor reconstruction cases about 18 months previously and during that period has continued to assist him one day a week on most weeks. He commenced his opinion about the appellant by saying; "Let me say at the outset, if Dr Reid was a poor, unethical, incompetent or dangerous surgeon, I would not be writing this letter and I certainly would not have continued assisting him for 18 months." He said that more than 80% of the appellant's cases were " complex, difficult cases often with painful mesh complications and multiple surgeries by other doctors." Some patients had been told by other urogynaecological colleagues that nothing further could be done for them. 88Dr Petros praised the work of the appellant in following "a site-specific ligament paradigm. This made it possible to address these complex cases, especially the mesh complications, in a proper anatomical way, to achieve good results in anatomical restoration and with symptoms such as pain, urgency and nocturia which are generally considered difficult to cure." He continued by stating that the appellant was "a safe, competent, skilful surgeon of last resort. His patients come from all over Australia with typical conditions and usually multiple failed operations. The surgery is difficult to do and sometimes can be quite bloody. Failed mesh surgery which infiltrates bladder or rectum requires a very high degree of skill and care. Perhaps 20 to 30% of Dr Reid's cases fall into this category. He is certainly not a threat to patient welfare..... he has truly excellent results with women who had no other hope for cure." 89Dr Petros thought that the appellant's age was no impediment to his work, that all patients were exhaustively assessed, that he had good surgical techniques and a superb knowledge of the anatomy of the pelvic floor.

[15]

The statutory matrix 94This is a statutory Tribunal and its powers and jurisdiction are mandated by statute. The relevant legislation for the purpose of these proceedings is the National Law. 95Relevantly, the objectives and guiding principles of the statute are contained within sections 3 and 3A which are in the following terms; 963 Objectives and guiding principles (1)The object of this Law is to establish a national registration and accreditation scheme for-- (a)the regulation of health practitioners; and (b)the registration of students undertaking-- (i)programs of study that provide a qualification for registration in a health profession; or (ii)clinical training in a health profession. (2)The objectives of the national registration and accreditation scheme are-- (a)to provide for the protection of the public by ensuring that only health practitioners who are suitably trained and qualified to practise in a competent and ethical manner are registered; and (b)to facilitate workforce mobility across Australia by reducing the administrative burden for health practitioners wishing to move between participating jurisdictions or to practise in more than one participating jurisdiction; and (c)to facilitate the provision of high quality education and training of health practitioners; and (d)to facilitate the rigorous and responsive assessment of overseas-trained health practitioners; and (e)to facilitate access to services provided by health practitioners in accordance with the public interest; and (f)to enable the continuous development of a flexible, responsive and sustainable Australian health workforce and to enable innovation in the education of, and service delivery by, health practitioners. (3) The guiding principles of the national registration and accreditation scheme are as follows-- (a)the scheme is to operate in a transparent, accountable, efficient, effective and fair way; (b)fees required to be paid under the scheme are to be reasonable having regard to the efficient and effective operation of the scheme; (c)restrictions on the practice of a health profession are to be imposed under the scheme only if it is necessary to ensure health services are provided safely and are of an appropriate quality. 973A Objective and guiding principle [NSW] In the exercise of functions under a NSW provision, the protection of the health and safety of the public must be the paramount consideration. 98As is obvious, the overriding concern is for the protection of the health and safety of the public. Registration is to be confined to practitioners who are suitably trained and qualified to practice in a competent and ethical manner. 99We have previously set out the provisions of section 150 (1). The overriding concern here is the necessity to protect the health and safety of persons, although there is power to suspend if it is otherwise in the public interest to do so. These are the matters that will inform us in determining these appeal proceedings. 100In applying these provisions and in considering this appeal from a decision made under Sec 150, as is obvious, it is necessary to consider the protection of the health and safety of any person and the public generally. Counsel for the Council submitted that one could determine whether there was any affect or impact upon the protection of the health and safety of any person or the public generally by considering whether or not there was created any risk to health and safety arising out of the practice of the appellant. 101A difficulty with this approach is that there are varying degrees of uncertainty which constitute risk, because risk deals with things that are not certain, whether measurable or unmeasurable. Philosophically a risk of some adverse event which is measurable may lack the degree of uncertainty for it to constitute a risk. 102We are uncertain as to whether or not this is the appropriate approach. It seems to us, from the plain words of the legislation, that the ability to suspend under section 150 responds to any situation where suspension is necessary to protect the health and safety of any person or persons, or the public generally. Where the conduct of a medical practitioner whether by act or omission adversely affects health and safety of those protected by the legislation, then the ability to suspend under the legislation is enlivened. This requires an identification of the adverse impact on health and safety and the establishment of a causal relationship between that adverse impact and the conduct of the medical practitioner. It is not necessary, in our opinion for there to be actual harm suffered by any person. Because the concept is one of protection, it is sufficient if it can be demonstrated that there is a potential for harm. This approach is fortified by the alternative test of a consideration of the public interest. It would be in the public interest to prevent harm being suffered by a person or persons if it could be predicated that this may occur. 103However, this raises the further question about the qualitative aspect of potential for harm. This further question leads, by this circuitous route, to a consideration of risk and the quantification of the risk. As an extreme, if a medical practitioner utilised a particular technique where the preponderance of patients suffered harm, then it could be said that there was a real risk of harm rather than something that was remote or fanciful. At the other extreme, almost every operative procedure has some risk of adverse consequences attached to it. Even a simple operation such as an appendectomy, or the removal and insertion of a new lens in cataract surgery involves some element of risk, which is statistically measurable. However, any attempt by the Council to prevent operations of this kind because they are accompanied by a risk of adverse consequences would arguably represent an abuse of the process. For example, the work of neourosurgeons in dealing with cases of trauma creating bleeding in the brain will almost always involve a risk of adverse consequences for a patient. We would hope that a competent neurosurgeon undertaking this work in circumstances where there can be no guarantee of a successful outcome would not ordinarily come to the attention of the Council. On this basis, the fact that a surgeon may in these circumstances create a risk of harm is not per se sufficient to attract the provisions of sec 150. 104This conclusion may be fortified by considering the approach taken by statute and the common law to the type of risk which will found a cause of action. The Civil Liability legislation is a ready example. This legislation, and the common law speak of liability for harm caused in failing to take precautions against the risk of harm unless it was foreseeable, a not insignificant risk, and the precautions that would have been taken in all the circumstances by a reasonable person. In considering what a reasonable person would have done to take precautions against the risk of harm a court considers the probability that the harm would occur if care were not taken, the likely seriousness of the harm, the burden of taking precautions to avoid the risk of harm, and, in some cases, "the social utility of the activity that creates the risk of harm." (See the Western Australian Civil Liability Act). This also involves consideration of the magnitude of the risk and the degree of the probability of its occurrence. Some cases consider whether there is a risk which is not fanciful or remote. We take the approach that there is always an attendant risk of an adverse consequence when undergoing surgery, albeit at the hands of the surgeon, the anaesthetist or assisting medical professional personnel, or by reason of some failure in any of the equipment used or in the facility generally. Accordingly, applying by some form of analogical reasoning the approach to the characterisation of risk which is contained within the legislation or common law which we have referred to would involve a detailed qualitative analysis of the particular risk in a manner which we would not find helpful in endeavouring to apply the provisions of section 150. 105Thus there needs to be some additional element to enable a risk of harm to be characterised as justifying suspension under Sec 150. The protection of the health or safety of any person must extend beyond the risk of harm created by an appropriately trained and competent surgeon undertaking surgery in a manner, and using techniques which are capable of being defended as appropriate in all the circumstances and which is carried out within an appropriate facility. Accordingly, surgical treatment which trespasses outside these parameters may arguably attract the application of Sec 150. And of course, any such assessment can only be made by reference to appropriate evidence or information which is before this Tribunal. 106This is the approach which we intend to take in dealing with these proceedings. In our discussion we have focused predominantly on the surgery itself, because this has provided a convenient focus on which to undertake the reasoning process. However, we acknowledge that other matters which were relied upon by the delegates are also capable of creating an attendant risk of harm to a person, including a failure to properly warn a patient about all of the risks associated with the proposed surgery, the availability of alternative forms of treatment (if available), the taking of informed consent, and the keeping of appropriate clinical and other records. We will have regard to these matters also in determining these proceedings.

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Consideration 107Because the Council relied on the reasoning of the delegates, this is an appropriate place to commence our consideration of the evidence before the Tribunal and the application of the statutory provisions to that evidence. As this is a hearing de novo, our ultimate decision must be based on the state of the evidence as it exists at the time of the hearing of the appeal proceedings. 108There appears at the bottom of page 15 of the written reasons for decision of the delegates a sub heading entitled "Discussion". We shall assume that the material which follows represents the reasoning process of the delegates. 109The first matter considered in their reasons concerns "undocumented informed consent". There is no explanation contained in the single paragraph as to what the delegates are referring to in describing the appellant's consent process as being both undocumented and not informed. Some clue is provided by reading the narration which appears earlier in the document and in particular the comments of the assessors. On a number of occasions there is reference in the assessors' report to the fact that the documentation of the appellant is lacking in that it does not describe the procedure which he intends carrying out as being "novel". We understand that what the assessors intended to convey by the use of this adjective is something which is not only new but unusual. This seems to us to be the context in which the assessors have referred to the techniques employed by the appellant. 110We should first observe that, in our opinion, in view of the evidentiary material, including the published papers to which we have referred and the references provided by Drs Haverfield, Petros and Zimmerman, that the techniques used by the appellant are neither new nor unusual. Obviously, the more orthodox techniques continue to be used by most practitioners, but such statistical evidence as is available indicates an increasing use of site specific repairs. 111As we have previously commented, we conclude on all of the available evidence that it has not been demonstrated that it is necessary for the appellant to describe his techniques as novel in order to characterise the consent of patients as being informed. Indeed, it appears on the evidence that many patients approach the appellant in order to have surgery carried out which is different from that which they have previously undertaken and which has failed. The published articles make it clear that there is a relatively high rate of failure with current orthodox techniques. It is this failure rate that has motivated some surgeons to explore other techniques. Indeed, this has been a feature of the practice of medicine since the beginning of medicine as a science. Techniques such as keyhole surgery are now commonplace, but their development was motivated by a desire to achieve a better outcome with less attendant complications for patients. 112We cannot conclude on the evidence and information before us that there has been any relevant failure on the part of the appellant to inform his patients about proposed or intended surgery with any attendant risk to their health or safety. Nor is there any suggestion that the health or safety of any existing or prior patient has been compromised as a result of the consent process utilised by the appellant, save for the HCCC complaint, the details of which we do not take into account. 113The next matter contained in the reasons of the delegates is entitled "lack of full disclosure". Again, this focuses on the alleged "novelty" of TFS. The delegates comment that "the use of TFS must be supported by research and therefore evidence-based". We are not sure what is intended by this statement. Does it mean that no medical practitioner can use this product unless there is conclusive research that it is appropriate in all circumstances? In some cases, material used in surgical work may not be found to be inappropriate for some years, despite the best intentions of the surgeons, and perhaps also the manufacturer. Breast implants are a good example. There is no suggestion that the appellant has gone off on a frolic of his own not considering the appropriateness of the material being used. On the evidence as given by the appellant, and referred to in the published articles, there is no suggestion of the material being unsuitable for the purpose for which it is used by the appellant and of any particular failures because of some inherent problem with the material. We are unable to conclude that there is any risk to the health or safety of any patient whether past or present, or likely to be any such risk to any future patient by reason of the use of TFS by the appellant. 114The delegates were also critical of the appellant because he does not identify or offer "alternative sources of information for patients with unanswered questions, nor does he refer patients to colleagues who perform alternative procedures." They are critical because the appellant refers patients to "like-minded colleagues." These criticisms seem to be based upon an assumption that a medical practitioner consulted by a patient should always refer the patient to another colleague who utilises a different method of treatment. The fact is that many of the patients who are referred to the appellant, presumably always by a general practitioner, come to him because he is known to offer an alternative technique to one that has already failed. The position of the delegates would force the appellant to refer the patient back to the surgeon who performed the original surgery, or someone who would have done it the same way. 115The delegates also made a reference to alternative sources of information provided to patients with unanswered questions. There is simply no evidence of any kind that there are any such patients, and any consideration of any such potential patients is a matter purely of speculation. 116We do not agree with the conclusion reached by the delegates on this matter. 117The delegates next referred to "ensuring patient understanding". They said that the appellant "was unable to describe to delegates how he ensures his patients understand the information he has given them." We are not sure how one can "ensure", in the sense of guarantee, that someone has understood something in the manner contended for by the delegates, save perhaps by conducting some form of rigourous examination. We have previously set out the contents of the consent form which the appellant intends using. It contains a section where a patient is asked to consider whether she understands what she has been told and whether she has any questions. In our opinion this is a satisfactory means of ensuring patient understanding. 118The delegates repeat under this subheading that the appellant described the surgery he performs as not being "life or death". If one reads the transcript of his discussion with the delegates, it is clear that the appellant is intending that his surgery is directed to the quality of life of his patients. 119Under the heading "professional isolation" the delegates conclude that the appellant "fails to understand the utility of multi-disciplinary professional support for himself or for his patients." It is clear that the appellant is a sole practitioner and does not work as part of a practice. However it is also clear from the evidentiary material that he has access to a number of surgeons who perform the same techniques, access to a colorectal surgeon and to a urologist, and the presence of an experienced surgeon on a regular basis to assist in operations if necessary. We cannot detect that the circumstances in which the appellant practiced prior to his suspension could in some way impact adversely upon the health or safety of any past, present or future patient on the basis of such evidence as is before us. 120Under the same heading the delegates have questioned how the appellant uses 3-D/4D imaging, and they " cannot exclude the possibility that (the appellant) continues to rely on 3-D/4D imaging in contravention of both his statement of 18 December 2013 and Practice Condition 5". We have had the benefit of oral evidence from the appellant who has explained clearly that he does not use this imaging to determine whether to operate, but as indicating in appropriate cases the site of the operation, and in providing some assistance to the patient to understand her circumstances. We cannot conclude that there has been a breach of condition 5 on the evidence before us. 121The next subheading is entitled "high re-operation rates". The delegates have assumed that the practice of the appellant is marked with high re-operation rates. The only reference to this matter in the earlier part of the decision document is when the delegates asked the appellant to respond to the assessors' comments "the assessors observed an apparently very high rate of repeat procedures for many of the patients in the medical record reviews." Such an observation was not accompanied by any material of any kind by which one could benchmark the "apparent" rate of repeat procedures. Such an observation ignores, and certainly does not engage with, the evidence of the appellant that his operative technique often involves a staged process with more than one procedure. In the absence of any evidence or information of any kind to justify the observation of the assessors and the conclusion of the delegates based upon it, it is our opinion that it is inappropriate to rely on this matter to substantiate in any way the existence of a risk to the health or safety of any person. 122The delegates then proceed to discuss "other issues" including the ordering of blood, unnecessary transfusions, the exposure of patients to unnecessary risk and the waste of this very scarce resource. It was acknowledged by the delegates that these matters "were sheeted home to the anaesthetist" that works with the appellant. We are not sure how, in these circumstances, it can be deduced that there is some risk to the health or safety of any person caused by the appellant. There is no evidence that the appellant has, in some way, inappropriately influenced an anaesthetist to order blood in circumstances where this is not warranted. There is some suggestion in the evidence that the fact that the hospital at which the appellant operates is remote from a close blood source renders it necessary to have blood on hand. But we do not understand that this matter would, alone, or in association with any other matter cause any undue risk of harm to any person or necessitate suspension in the public interest. 123The delegates said that they were "perplexed" by the fact that the appellant took a minimum of two hours with each patient. To the extent that this influenced their ultimate decision, such an observation is without merit in the context of any risk to health or safety of any person, or in the public interest. 124The delegates referred to the fact that the appellant was "still highly emotional about his marriage breakdown, despite his protestations to the contrary". In his dialogue with the delegates the appellant told them that he was in a new relationship. We are not sure how the delegates could still make an observation about the appellant's emotional state in circumstances where he had denied this. We are unsure as to whether the delegate who is medically qualified has specialist psychiatric qualifications. In any event, there is no hint in any of the material before us that in some way the appellant suffers from some emotional state which would impact upon his ability to practice medicine in a way which would in turn create a risk to the health or safety of any person. 125The delegates then considered the evidence about breach of conditions by the appellant. It is clear, from the evidence of the appellant himself, that the consent processes which he adopted were not ideal. However he has now modified them, and we are satisfied on the basis of the evidence before us that not only do they comply with the conditions which existed at the time of his suspension, but they do not pose any risk to the health or safety of any person if applied in the manner asserted by the appellant. 126The delegates finally referred to the extent of the HCCC complaint as causing them to conclude that the appellant "posed a risk to the public and it was necessary to suspend his registration." 127In expressing their conclusion under the heading "determination" the delegates referred to the provisions of section 150 of the National Law, said that they had had regard "to whether any action is appropriate for the protection of the health or safety of any person or persons or for reasons otherwise in the public interest" and then said that after considering all of the material "and for the reasons outlined" that they were satisfied that it was " appropriate" to suspend the registration of the appellant. In making this statement we assume that the delegates had regard to each of the matters referred to in the Discussion which we have identified. However they have not said how and why any of these matters has created a risk to the health and safety of any person and why in the aggregate it is in the public interest to suspend the registration of the appellant in all the circumstances. 128For the reasons which we have already canvassed, we reject any argument that there is or has been a risk to the health or safety of any person caused by the appellant, sufficient to justify suspension of registration on the basis of such evidence and information as is before us. 129Therefore, it is necessary to consider why the appellant's registration should be suspended in the interests of the public. Obviously, if the appellant had left a trail of destruction behind him, or if, on the evidence, to use the words of Dr Petros he was a poor, unethical, incompetent or dangerous practitioner then, in the public interest, his registration should arguably be suspended pending the clarification of the HCCC complaint, and any other outstanding matter. However the evidence is to the contrary. The appellant enjoys the glowing support of those of his colleagues who have provided written material, and especially those who have worked or currently work with him. He is, by all accounts before us, a world expert in his field. Certainly no evidence has been led to the contrary. 130We conclude that there is simply no evidence upon which this Tribunal could appropriately suspend the registration of the appellant. Accordingly, these reasons are given to support the order which we made at the conclusion of the hearing, late on 28 October 2014 that the suspension of the appellant was lifted with effect from 4 pm that day.