MEDICAL BOARD OF AUSTRALIA and WOOLLARD
[2013] WASAT 101
•3 JULY 2013
JURISDICTION : STATE ADMINISTRATIVE TRIBUNAL
STREAM: VOCATIONAL REGULATION
ACT: HEALTH PRACTITIONER REGULATION NATIONAL LAW (WA) ACT 2010
CITATION: MEDICAL BOARD OF AUSTRALIA and WOOLLARD [2013] WASAT 101
MEMBER: JUSTICE J A CHANEY (PRESIDENT)
MS NATASHA OWEN-CONWAY (MEMBER)
DR H HANKEY (SENIOR SESSIONAL MEMBER)
DR M LEVITT (SENIOR SESSIONAL MEMBER)
HEARD: DETERMINED ON THE DOCUMENTS
DELIVERED : 3 JULY 2013
FILE NO/S: VR 182 of 2012
VR 31 of 2012
BETWEEN: MEDICAL BOARD OF AUSTRALIA
Applicant
AND
KEITH VICTOR WOOLLARD
Respondent
Catchwords:
Health Practitioner Regulation - Medical practitioner - Disciplinary action - Orders prepared by consent following mediation
Legislation:
Medical Practitioners Act 2008 (WA), s 76(1)(b)(i), s 76(1)(b)(ii), s 86(1), s 115(1)
Health Practitioner Regulation National Law (WA) Act 2010 (WA), s 17(1)(a), s 17(2)(b), s 31, s 35, s 193(1), s 193(1)(a)(i)
State Administrative Tribunal Act, s 56(1)
Result:
Proposed orders made
Summary of Tribunal's decision:
In two applications to the Tribunal, (VR 31 of 2012 and VR 182 of 2012), the Medical Board of Australia made a number of allegations against the respondent, Dr Keith Woollard in relation to his management and treatment of two patients. As commonly occurs in the Tribunal, the matters were referred for mediation. After an extensive period of mediation, involving several sessions, the parties reached agreement as to what they considered an acceptable outcome. They provided a minute of proposed consent orders, which set out the material facts agreed, the admissions made by Dr Woollard and proposed orders.
The Tribunal considered the admissions made by the practitioner and determined that the penalty proposed adequately achieved the proper purposes of vocational disciplinary penalties. Accordingly it made the orders proposed.
Category: B
Representation:
Counsel:
Applicant: N/A
Respondent: N/A
Solicitors:
Applicant: MDS Legal
Respondent: Clayton Utz
Case(s) referred to in decision(s):
Nil
REASONS FOR DECISION OF THE TRIBUNAL:
Introduction
In two applications to the Tribunal, (VR 31 of 2012 and VR 182 of 2012), the Medical Board of Australia made a number of allegations against the respondent, Dr Keith Woollard in relation to his management and treatment of two patients. As commonly occurs in the Tribunal, the matters were referred for mediation. After an extensive period of mediation, involving several sessions, the parties reached agreement as to what they considered an acceptable outcome. They provided a minute of proposed consent orders, which set out the material facts agreed, the admissions made by Dr Woollard and proposed orders.
In accordance with usual practice, the proposed consent orders were referred to a Tribunal constituted as required by s 115(1) of the Medical Practitioners Act 2008 (WA) which, by virtue of s 17(2)(b) Health Practitioner Regulation National Law (WA) Act 2010 (WA), governs the proceedings in matter VR 31 of 2012. In view of the complexity of the matters alleged in VR 182 of 2012, that matter was also referred to a Full Tribunal.
The minute of consent orders records the following:
The Tribunal notes:
On the applications referred for mediation before Members Carey and Spillane, the Medical Board of Australia alleges that there is proper cause for disciplinary action against the respondent pursuant to:
1.section 86(1) of the Medical Practitioners Act 2008 (WA) (MPA) because the practitioner has acted carelessly and incompetently for the purposes of section 76(1)(b)(i) and (ii) of the MPA; and
2.section 193(1) of the Schedule to the Health Practitioner Regulation National Law (WA) Act 2010 (the National Law) because the respondent has behaved in a way that constitutes professional misconduct for the purposes of section 193(1)(a)(i) of the National Law.
The parties have agreed to the following relevant facts in respect of VR 31 of 2012:
1.The applicant is established pursuant to section 31 of the Schedule (the National Law) to the Health Practitioner Regulation National Law (WA) Act 2010 (the National Law Act) and has the functions referred to in section 35 of the National Law including the referral of matters concerning health practitioners registered under a corresponding prior Act to responsible tribunals in participating jurisdictions.
2.The Medical Board of Western Australia received a complaint in relation to matters the subject of these proceedings in February 2009, which complaint was being dealt with by that Board for the purpose of section 17(1)(a) of the National Law Act immediately before the participation day in respect of the National Law Act (as proclaimed in the Western Australian Government Gazette dated 1 October 2010) being 18 October 2010.
3.Pursuant to section 17(2)(b) of the National Law Act these proceedings are commenced pursuant to section 86(1) of the Medical Practitioner's Act 2008 (repealed) as if that Act had not been repealed.
4.The respondent is and was at all material times a registered health practitioner practising as a cardiologist.
5.The respondent was consulted by Mrs C (Patient) on or about 16 March 2007 (the First Consultation).
6.At the First Consultation it was recorded in the respondent's clinical notes for the Patient that;
6.1the Patient walks for 90 minutes daily;
6.2the Patient had been a smoker but had ceased smoking 8 years previously;
6.3the Patient had experienced three episodes of tightness in her chest radiating into her left arm, each of 10 minutes in duration;
6.4two of the three episodes of tightness in her chest had occurred when the Patient was in bed;
6.5one of the three episodes of tightness in her chest occurred whilst the Patient was walking;
6.6the Patient had noticed increasing shortness of breath when exercising during the previous 3 months; and
6.7the shortness of breath on exercising was not accompanied by chest pain.
7.At the time of the First Consultation, the respondent had in his possession;
7.1an echocardiograph report of Dr O'Shea dated 11 January 2007 relating to an echocardiogram undertaken on the Patient on that date; and
7.2an exercise ECG report of Dr O'Shea dated 17 January 2007 relating to an exercise ECG test undertaken on the Patient on that date.
8.The echocardiograph report correctly concluded that the echocardiographic study on the Patient was normal and that no structural abnormality of the Patient's heart had been identified.
9.The exercise ECG report correctly concluded that;
9.1an abnormal baseline ECG pattern had been recorded;
9.2the exercise ECG was indeterminate for ischaemia; and that
9.3the Patient had not attained an adequate workload during the exercise ECG test.
10.During the First Consultation the respondent told the Patient that:
10.1some of the arteries to her heart may be blocked;
10.2blocked arteries were potentially lethal; and that
10.3she should undergo an angiogram to enable the respondent to ascertain whether her arteries were blocked.
11.On 22 March 2007 the respondent performed a coronary angiogram (the Angiogram) on the Patient.
12.The Angiogram demonstrated a severe calcific stenosis (the Stenosis) at the ostium of a modest-sized diagonal branch vessel (the Vessel) of the Patient's left anterior descending coronary artery (LAD).
13.The Patient's symptoms recorded in the clinical notes referred to in 6.3, 6.4, 6.5, 6.6 and 6.7;
13.1were not typical of angina;
13.2may have been wholly or partially caused by the Stenosis; and
13.3may have been wholly or partially caused by a respiratory condition, in particular because the Patient had been a smoker in the past.
14.The Angiogram demonstrated that the angulation of the Vessel was unfavourable to stenting without intervention in respect of the LAD which was free of disease.
15.Even with intervention in the LAD, the location of the Stenosis in the Vessel gave rise to a risk that angioplasty and stenting would not successfully clear the Vessel of the entirety of the Stenosis.
16.Angioplasty and stenting of the Vessel would give rise to a significant risk of early, late or very late stent thrombosis of the Vessel or the LAD or both, giving rise to a risk of acute myocardial infarction and/or death.
17.The Angiogram demonstrated that the nature of the Vessel and the Stenosis was such that there would be a significant risk of restenosis of the Vessel if stenting was carried out in the Vessel.
18.Having regard to the size and location of the Vessel, the Stenosis within the Vessel was not likely to be life threatening for the Patient, and angioplasty and stenting of the Stenosis was unlikely to provide any survival benefit or improved prognosis for the Patient.
19.After performing the Angiogram the respondent said to the Patient words to the effect that:
19.1she had a blockage in a vessel to her heart;
19.2she needed to have angioplasty to clear the blockage; and
19.3he was anxious to perform the angioplasty before the Patient left Perth for a holiday.
20.The advice referred to in 19.1 and 19.2 constituted advice that the Patient should undergo an angioplasty.
21.The advice referred to in 19.3 constituted an offer by the respondent to perform the angioplasty procedure on the Patient.
22.On 11 April 2007 the Patient gave her written consent to the respondent performing on her a coronary angioplasty procedure.
23.On 12 April 2007 the respondent performed an angioplasty and stenting procedure on the Patient in order to treat the Stenosis in the Vessel (the Angioplasty and Stenting Procedure).
24.As at 12 April 2007 the respondent had not:
24.1arranged functional testing of the Patient's heart;
24.2referred the Patient to her general practitioner or respiratory physician for consideration of differential diagnoses which may account for the Patient's symptoms of chest tightness and shortness of breath; or
24.3offered the Patient a trial of anti-anginal therapy or recommended to the Patient a trial of antianginal therapy or prescribed any anti-anginal therapy for the Patient.
25.As at 12 April 2007 angioplasty and stenting were not indicated for the Patient and should not have been offered to the Patient or performed having regard to the matters referred to in 14, 15, 16, 17 and 18 and;
25.1the fact that functional testing had not been carried out in order to ascertain whether the Stenosis in the Vessel was having any significant effect on the Patient's heart function;
25.2the fact that the respondent had not referred the Patient to her general practitioner or respiratory physician for consideration of differential diagnoses in respect of the symptoms reported at the First Consultation; and/or
25.3the fact that the Patient had not been offered or recommended, nor had she undergone, any or any adequate trial of medical therapy using anti-anginal drugs in order to ascertain whether her symptoms of chest tightness and shortness of breath would resolve with such therapy.
26.The respondent did not at any time between performing the Angiogram and performing the Angioplasty and Stenting Procedure inform the Patient and/or explain to the Patient:
26.1that the Stenosis in the Vessel was not likely to be life-threatening;
26.2that the only possible benefit of an angioplasty and stenting procedure would be the reduction or the cessation of symptoms of chest tightness and/or shortness of breath, if either or both of those symptoms were caused or contributed to by the Stenosis in the Vessel;
26.3that the Patient could, or that she should have a trial of anti-anginal medication to ascertain whether the medication would relieve symptoms of chest tightness and shortness of breath;
26.4that symptoms of chest tightness and shortness of breath may or may not be caused or contributed to by the Stenosis in the Vessel, and that functional testing of her heart should be undertaken before considering angioplasty and stenting;
26.5that chest tightness and shortness of breath may be due to the Patient's respiratory function and that this should be investigated before considering angioplasty and stenting; and/or that
26.6the location of the Stenosis and the angulation of the Vessel relating to the LAD meant that angioplasty and stenting:
26.6.1may not successfully clear the Stenosis;
26.6.2was likely to require intervention in the LAD, which was free of disease;
26.6.3gave rise to a significant risk of early, late or very late stent thrombosis of the Vessel or the LAD or both, giving rise to a risk of acute myocardial infarction and/or death; and
26.6.4gave rise to a significant risk of restenosis (if angioplasty and stenting was initially successful in clearing the Stenosis).
27.The respondent ought to have informed the Patient of the matters in 26 prior to 12 April 2007, so that the Patient had sufficient information to enable her to make an informed decision, as at that date or any earlier date, as to whether to give her consent to undergo the Angioplasty and Stenting Procedure.
28.As a result of the placement of a stent in the Vessel during the Angioplasty and Stenting Procedure the Patient's LAD was compromised by the protrusion of part of the stent into the LAD and/or by plaque which had shifted into the bifurcation and/or the lumen of the LAD following placement of the stent in the Vessel.
29.By reason of the matter referred to in 28, the LAD required stenting, and the respondent placed a stent in the LAD.
30.Following the placement of stents in the LAD and the Vessel it was necessary to clear both the LAD and the Vessel, and the bifurcation, of any protrusion of parts of each of the two stents into the lumen of each of the LAD and the Vessel, and/or any plaque which had shifted into the bifurcation and/or the lumen of the LAD following placement of the stent in the Vessel.
31.If angioplasty and stenting had been indicated in respect of the Vessel, the appropriate manner in which to perform the procedure after placement of stents in the LAD and the Vessel was to achieve simultaneous balloon inflations, with balloons positioned in both the LAD and the Vessel, or to inflate two balloons sequentially in each of the LAD and the Vessel as either method would:
31.1protect the LAD and the Vessel;
31.2reduce the risk of stent thrombosis as a complication of the procedure; and
31.3reduce the risk of restenosis of the Vessel following the procedure by clearing the lumen of each of the LAD and the Vessel, and the bifurcation, of any parts of each of the two stents into the lumen of each of the LAD and the Vessel, and/or any plaque which had shifted into the bifurcation and/or the lumen of the LAD following placement of the stent in the Vessel.
32.The respondent failed to perform simultaneous or sequential balloon inflations in the LAD and the Vessel following placement of stents in each of the LAD and the Vessel by either method described in 31, thereby increasing the Patient's risk of:
32.1compromising the LAD and the Vessel by the intrusion of parts of each of the two stents into the lumen of each of the LAD and the Vessel, and/or any plaque which had shifted into the bifurcation and/or lumen of the LAD following placement of the stent in the Vessel;
32.2stent thrombosis; and
32.3restenosis of the Vessel as a result of tissue overgrowing the protrusion of parts of each of the two stents into the bifurcation and/or lumen of each of the LAD and the Vessel.
33.The respondent was consulted by the Patient on 8 June 2007 (the June 2007 Consultation).
34.At the June 2007 Consultation it was recorded in the respondent's clinical notes for the Patient that in May 2007 the Patient's respiratory physician, Dr Bremner, had diagnosed asthma in the Patient.
35.The respondent was consulted by the Patient on 19 December 2008 (the December 2008 Consultation).
36.At the December 2008 Consultation it was recorded in the respondent's clinical notes for the Patient that the Patient had some shortness of breath and, for the past 3 weeks, some tightness in her chest when walking.
37.On 21 January 2009 the Patient underwent a further angiogram procedure performed by the respondent (the 2009 Angiogram).
38.The 2009 Angiogram demonstrated a restenosis at the ostium of the Vessel (the Restenosis).
39.Following the 2009 Angiogram, the respondent advised the Patient that she should undergo a further angioplasty and stenting procedure in respect of the Vessel.
40.As at 21 January 2009 the respondent should not have offered the Patient further angioplasty and stenting in respect of the Vessel as further angioplasty and stenting was not indicated because:
40.1the patient's symptoms recorded in the clinical notes referred to in 36:
40.1.1were not typical of angina;
40.1.2may have been wholly or partially caused by the Restenosis; and
40.1.3may have been wholly or partially caused by a respiratory condition, in particular because the Patient had been a smoker in the past;
40.2at or during the June 2007 Consultation the respondent or his nursing staff had been informed, and it had been recorded in the respondent's clinical notes for the Patient, that the Patient had been diagnosed with asthma in May 2007, and this condition could have been the cause of some or all of the Patient's symptoms of chest tightness and shortness of breath and required investigation before any further angioplasty and stenting procedure was carried out;
40.3the angulation of the Vessel was unfavourable for further stenting without further intervention in respect of the LAD;
40.4even with intervention in the LAD, the location of the Restenosis in the Vessel gave rise to a risk that angioplasty and stenting would not successfully clear the Vessel of the entirety of the Restenosis;
40.5angioplasty and stenting of the Vessel would give rise to a significant risk of early, late or very late stent thrombosis of the Vessel or the LAD or both, giving rise to a risk of acute myocardial infarction and/or death;
40.6the Angiogram demonstrated that the nature of the Vessel and the Restenosis was such that there would be a significant risk of restenosis of the Vessel if stenting was carried out in the Vessel;
40.7because the area had previously been stented, restenting, particularly in light of the bifurcated nature of the affected area, would be more technically complex than the original procedure and would carry a higher than usual risk of primary failure and further restenosis which could have involved the LAD;
40.8having regard to the size and location of the Vessel, the Restenosis within the Vessel was not likely to be life threatening for the Patient, and angioplasty and stenting of the Restenosis was unlikely to provide any survival benefit or improved prognosis for the Patient;
40.9functional testing had not been carried out in order to ascertain whether the Restenosis in the Vessel was having any significant effect on the Patient's heart function;
40.10the respondent had not referred the Patient to her general practitioner or respiratory physician for consideration of differential diagnoses in respect of the symptoms reported at the December 2008 Consultation; and/or
40.11the Patient had not been offered or recommended, nor had she undergone any or any adequate trial of medical therapy using anti-anginal drugs in order to ascertain whether her symptoms of chest tightness and shortness of breath would resolve with such therapy.
41.Throughout the respondent's performance of the 2009 Angiogram the Patient suffered, and complained of, extreme pain.
42.The Patient's complaint referred to in 41 should have caused the respondent to;
42.1administer a local anaesthetic or a further local anaesthetic into the Patient's groin;
42.2stop introducing or advancing a catheter or catheters until that anaesthetic had achieved its maximal effect; and/or
42.3administer intravenous analgesia and/or a sedating agent in order to provide adequate pain relief for the Patient during the procedure if the process outlined at 42.1 and 42.2 had not adequately alleviated the Patient's pain.
43.The respondent either;
43.1did not take any of the action outlined in 42 during his performance of the 2009 Angiogram; or
43.2to the extent that the respondent did give the Patient anaesthetic, the anaesthetic provided was not sufficient to adequately alleviate the Patient's pain or had not reached its maximal effect during the performance of the 2009 Angiogram.
Respondent's admissions in relation to VR 31 of 2012
44.The respondent admits that he acted carelessly and incompetently for the purposes of s 76(1)(b)(i) and/or (ii) of the Medical Practitioners Act 2008 (repealed) in that he:
44.1performed the Angioplasty and Stenting Procedure when that procedure was not indicated for the Patient having regard to any or all of the matters referred to in 25 and unnecessarily exposed the Patient to the risks associated with that procedure;
44.2failed to provide and explain to the Patient the information referred to in 26 before performing the Angioplasty and Stenting Procedure and/or before the Patient consented to undergo that procedure;
44.3performed the Angioplasty and Stenting Procedure without ensuring either sequential or simultaneous balloon inflations in both the LAD and the Vessel in order to clear both, and the bifurcation, of any protruding parts of the stents positioned in each and/or any plaque which had shifted into the bifurcation and/or lumen of the LAD following placement of the stent in the Vessel, thereby increasing the risks of:
44.3.1compromising the LAD and the Vessel;
44.3.2stent thrombosis; and
44.3.3restenosis of the Vessel;
44.4offered the Patient a further angioplasty procedure following the 2009 Angiogram when such a procedure was not indicated in the Patient for the reasons referred to in 40 and, had it been performed, would have unnecessarily exposed the Patient to the risks of that procedure; and
44.5failed to provide adequate pain relief for the Patient by giving adequate anaesthesia and/or sedation during the 2009 Angiogram or by allowing sufficient time for any anaesthetic provided to reach its maximal effect.
The parties have agreed to the following relevant facts in respect of VR 182 of 2012
1.The applicant is established pursuant to s 31 of the National Law and has the functions referred to in s 35 of the National Law, including the referral of matters concerning health practitioners registered under the National Law to responsible tribunals in participating jurisdictions from the date of operation of the National Law, being 18 October 2010.
2.On 5 December 2011 the applicant received a notification in relation to matters the subject of this application.
3.The respondent is and was at all material times a registered health practitioner practising as a cardiologist.
4.On 23 April 2009 Dr H (Patient) consulted the respondent (Initial Consultation).
5.At the Initial Consultation the Patient gave a history of:
5.1an episode of faintness accompanied by an increase in his heart rate; and
5.2otherwise being fit and well.
6.Prior to the Initial Consultation the Patient had undergone an exercise ECG at Bentley Hospital in respect of which the respondent had reported that:
6.1the test was positive for ischaemic heart disease; and
6.2the test demonstrated a fall in blood pressure during exercise, which was an additional adverse finding.
7.During the Initial Consultation the respondent advised the Patient that it was necessary for him to undergo an angiogram.
8.On 30 April 2009 the respondent performed an angiogram (the Angiogram) on the Patient.
9.The Angiogram demonstrated:
9.1a severe stenosis at the distal end of the left main coronary artery (Left Main) of the Patient;
9.2a severe stenosis in one sub-branch of the diagonal branch of the left anterior descending coronary artery (LAD) of the Patient or an intermediate branch of the Left Main;
9.3a possible aneurysm near the origin of the LAD of the Patient;
9.4a severe stenosis of the circumflex coronary artery (Circumflex) of the Patient;
9.5a 70% stenosis at the origin of the right coronary artery (Right) of the Patient; and
9.6a critical stenosis of the mid portion of the Patient's Right, proximal to an acute marginal vessel.
10.The Patient's LAD was inadequately visualised during angiography to determine whether or not the Patient had any or any significant disease in that artery.
11.On or about 30 April 2009 the respondent caused a letter to be sent to a cardiothoracic surgeon, Mr Gilfillan, referring the Patient to that surgeon for a coronary artery bypass grafting procedure (CABG).
12.On or about 5 May 2009 the Patient contacted the respondent by telephone (the Telephone Conversation) and discussed with the respondent his eligibility for an angioplasty and stenting procedure as an alternative to a CABG.
13.During the Telephone Conversation the respondent advised the Patient that he was eligible for an angioplasty and stenting procedure according to a study, which he referred to as the ‘Syntax Trial’.
14.The Syntax Trial was a clinical trial investigating the respective merits of coronary angioplasty and stenting and CABG for coronary artery disease.
15.On or about 5 May 2009 the respondent sent or caused to be sent to the Patient a letter of that date;
15.1advising that angioplasty would be arranged for the Patient; and
15.2enclosing a copy of an abstract of an article relating to the Syntax Trial, or alternatively an article relating to the Syntax Trial.
16.On or about 9 May 2009 the Patient consented to undergo a coronary angioplasty procedure to be performed by the respondent at the Mount Hospital.
17.On 14 May 2009 in a laboratory at the Mount Hospital Catheterisation Laboratory (CCL) the Patient underwent an angioplasty procedure performed by the respondent (the Procedure).
18.In preparation for the Procedure, on 14 May 2009;
18.1at approximately 4.50 pm a nurse prepared for the Patient an anti-thrombotic agent, bivalirudin, which was known as 'Angiomax' (Angiomax) to be delivered to the Patient intravenously during the Procedure;
18.2at approximately 4.53 pm, the Patient was brought into the CCL;
18.3at approximately 4.55 pm a nurse wrote on a whiteboard in the CCL the bolus dose and infusion rate for Angiomax having regard to the Patient's weight.
19.During the Procedure:
19.1at 5.06 pm and 5.07 pm respectively the respondent punctured the Patient's left and right femoral arteries at his left and right groin respectively;
19.2at or about 5.07 pm nurse Lum:
19.2.1informed the respondent that Angiomax had been prepared for the Patient;
19.2.2informed the respondent that an intravenous line had been connected to the Patient in order to deliver the Angiomax; and
19.2.3made an enquiry of the respondent as to whether she should commence the administration of Angiomax to the Patient;
19.3at or about 5.07 pm, in response to the enquiry of nurse Lum referred to at 19.2.3, the respondent replied to nurse Lum by saying 'No, not yet';
19.4between about 5.07 pm and 5.15 pm the respondent inserted three guide wires via a catheter that had been inserted into the Patient's right femoral artery and:
19.4.1placed one guide wire into the Patient's LAD;
19.4.2placed one guide wire into an intermediate vessel branching from the Patient's Left Main (the intermediate vessel); and
19.4.3placed one guide wire into the Patient's Circumflex;
19.5at or about 5.16 pm the respondent introduced a 3 x 10 mm Sprinter balloon which was placed into the Patient's Circumflex along the guide wire that he had placed in the Patient's Circumflex;
19.6at approximately 5.21 pm the balloon referred to in 19.5 was inflated to 10 atmospheres, either by, or at the request of, the respondent;
19.7at approximately 5.31 pm the respondent deployed a 3 x 24mm Taxus drug-eluting stent (the Stent) in the Patient's Left Main, extending into the Circumflex;
19.8at approximately 5.35 pm - 5.38 pm the distal end of the stent referred to in 19.7 was twice post-dilated with a Durastar 3.0mm balloon inflated to 20 atmospheres either by, or at the request of, the respondent;
19.9at some time after 5.35 pm and prior to 5.44 pm an Apex 3.5 x 8mm balloon was post-dilated in the proximal end of the Stent to 6 atmospheres, either by, or at the request of, the respondent;
19.10at some time prior to 5.44 pm the Patient had developed a thrombus or thrombi within his Left Main;
19.11at some time prior to 5.44 pm (but after 5.35 pm) the respondent attempted aspiration of the guide catheter inserted into the Patient's Left Main and found that he could not do so, and therefore withdrew the catheter to the descending aorta of the Patient and began attempting to aspirate the guide catheter within the descending aorta;
19.12at or about 5.44 pm;
19.12.1the respondent inserted a diagnostic catheter via the Patient's left femoral artery into the Patient's Left Main, and found that the Patient's Left Main was occluded by thrombus formation throughout that vessel;
19.12.2the respondent reintroduced the guide catheter into the Left Main from the descending aorta and made a further attempt or attempts to aspirate the Patient's Left Main with the guide catheter;
19.12.3Nurse Coutts advised the respondent that Angiomax had not been administered to the Patient;
19.12.4the respondent asked for Angiomax to be administered to the Patient;
19.12.5a bolus of 11 ml of Angiomax was given intravenously to the Patient;
19.13at or about 5.45 pm an Angiomax infusion was commenced delivering Angiomax to the Patient at a rate of 25.6 ml per hour;
19.14between about 5.44 pm and about 6.08 pm:
19.14.1the respondent continued to attempt to aspirate the Patient's Left Main with the guide catheter but was unable to establish any sustained blood flow in the Patient's Left Main; and
19.14.2Nurse Coutts asked the respondent if he wanted an Export catheter, and the respondent replied that he did not;
19.15between about 6.01 pm and 6.08 pm an Apex 3.5 x 8 mm balloon was inflated to 6 atmospheres on multiple occasions within the Patient's Left Main by, or at the request of, the respondent in an attempt to establish blood flow in the Patient's Left Main;
19.16during the period between 5.44 pm and 6.06 pm;
19.16.1the Patient became bradycardic and hypotensive, and Nurse Hellmrich informed the respondent of these matters;
19.16.2ECG recordings for the Patient became abnormal;
19.16.3Nurse Hellmrich informed the respondent:
(a)that the Patient had 6 beats of ventricular tachycardia; and then
(b)that the Patient was in asystole;
19.16.4Nurse Coutts asked a member of the CCL's nursing staff to press the emergency bell in order to summon an emergency resuscitation team; and
19.16.5the Patient began to receive cardiopulmonary resuscitation;
19.17at or about 6.06 pm 600ug of Atropine was administered to the Patient;
19.18despite the administration of Atropine referred to in 19.17 the Patient continued to exhibit signs of profound bradycardia and hypotension;
19.19at or about 6.07 pm an emergency resuscitation team attended and the patient continued to receive cardiopulmonary resuscitation;
19.20at or about 6.10 pm the respondent sought the assistance of the cardiologist Dr Hockings who attended on the Patient in the CCL;
19.21upon Dr Hockings attending on the Patient Dr Hockings immediately;
19.21.1ascertained that there was occlusion of the Patient's Left Main; and
19.21.2requested the radiographer in attendance to call a cardiothoracic surgeon;
19.22at or about 6.15 pm two anaesthetists attended in the CCL, who thereafter provided the Patient with ventilation and heart massage;
19.23at or about 6.21 pm the Patient received adrenaline for the first time during the Procedure;
19.24between about 6.15 pm and about 6.27 pm or alternatively about 6.34pm the Patient received two or alternatively three defibrillation shocks; and
19.25at or about 6.27 pm or alternatively at or about 6.34 pm the Patient was transferred to an operating theatre for open heart surgery whilst continuing to receive cardiopulmonary resuscitation, which resuscitation continued in the operating theatre until the Patient was placed on a heart bypass machine.
Angioplasty and stenting contraindicated
20.Treatment of the Patient's coronary artery stenoses by stenting was a very difficult and complex procedure involving a particularly high risk of complication because;
20.1there was disease in the distal end of Left Main close to the trifurcation comprised of the branches of;
20.1.1the LAD;
20.1.2the sub-branch of the diagonal branch of the LAD of the Patient or an intermediate branch of the Left Main; and
20.1.3the Circumflex;
20.2there was significant disease in at least three major coronary arteries; the Patient's Left Main, the Circumflex and the Right;
20.3there was a possible aneurysm in the LAD; and
20.4there may have been significant disease in the LAD.
21.The Patient did not have any comorbidities which presented any contraindications for CABG.
22.For the reasons referred to in 20 and 21;
22.1coronary angioplasty was contra-indicated for the Patient to treat his coronary artery disease; and
22.2CABG was the safer treatment for the Patient's coronary artery disease.
23.The respondent did not advise or explain to the Patient at any time prior to performing the Procedure that, for the reasons referred to in 20 and 21;
23.1coronary angioplasty was contra-indicated; and/or that
23.2CABG was the safer method of treating the Patient's coronary artery disease.
Failure to stent Right before attempting to stent the Left Main
24.Stenting of the Patient's Left Main and associated vessels was more difficult and incurred a greater risk of complications than stenting the Patient's Right.
25.For the reason referred to in 24, the Patient's Right should have been stented before attempting to stent the Patient's Left Main and associated vessels in order to provide some protection for the Patient's heart in the event of a complication which could result in the occlusion of the Patient's Left Main.
26.The Patient did not undergo stenting of his Right before or during the Procedure.
Failure to ensure timely systemic anticoagulation
27.The use of guide wires, the deployment of stents and the inflation of balloons within vessels disrupts the lining of those vessels giving rise to the likelihood of development of a thrombus or thrombi within the vessels and/or within a stent deployed in a vessel (a stent thrombosis) and/or within a guide catheter, which thrombus or thrombi can occlude a vessel or vessels because thrombi can;
27.1increase in size rapidly;
27.2propagate; and
27.3embolise.
28.In order to avoid the formation of thrombi as a result of the placement of wires, the deployment of stents and/or the inflation of balloons in vessels, it is standard practice for cardiologists performing angioplasty procedures to order the administration of an anticoagulant agent, such as Angiomax, following the percutaneous puncture of the Patient's femoral artery or arteries.
29.The Patient should have received Angiomax (or another appropriate anticoagulant agent) immediately after 5.07 pm on 14 May 2009; that is, following the percutaneous puncture to the Patient's left and right femoral arteries at his left and right groin.
30.It was the responsibility of the respondent to ensure the commencement of the administration of Angiomax (or another appropriate anticoagulant agent) at the appropriate time during the Procedure.
31.During the Procedure the respondent failed to order the commencement of administration of Angiomax (or any other anticoagulant agent) to the Patient at any time prior to about 5.44 pm.
32.The respondent's failure to order the commencement of administration of Angiomax (or another appropriate anticoagulant agent) to the Patient after puncturing the Patient's femoral arteries at approximately 5.07 pm on 14 May 2009, and the respondent's continued failure to order the commencement of the administration of Angiomax (or another appropriate anticoagulant agent) to the Patient at all times from approximately 5.07 pm until approximately 5.44 pm on 14 May 2009;
32.1caused the Patient to suffer thrombosis in the Patient's Left Main as a result of:
32.1.1the passage of a guide wire within the Patient's Left Main at some time between 5.07 pm and 5.15 pm; and/or
32.1.2the deployment of the Stent in the Patient's Left Main extending into the Circumflex at about 5.31pm; and/or
32.1.3the inflation of a balloon or balloons within the Left Main or Circumflex before and after the deployment of the Stent,
when neither Angiomax nor any other anticoagulant agent had been administered to the Patient;
32.2led to the occlusion of the Patient's Left Main;
32.3led to the cessation of blood flow to a large portion of the Patient's heart; and
32.4led to bradycardia, loss of blood pressure and the cessation of the Patient's heart beat,
thereby placing the Patient at risk of death or severe morbidity.
Failure to use an aspiration catheter (such as an Export catheter), to attempt to aspirate the thrombus
33.In the circumstances pertaining to the Patient and the Procedure, upon the development of thrombus in the Patient's Left Main, it was necessary for the respondent to, inter alia, attempt to aspirate the thrombus.
34.Guide catheters are not designed to aspirate thrombus.
35.An aspiration catheter (such as an Export catheter) is designed to aspirate thrombus.
36.In the circumstances pertaining to the Patient and the Procedure, for the purpose of attempting to aspirate the thrombus;
36.1it was acceptable for the respondent to attempt to use the guide catheter to aspirate the thrombus for a period of about 30 seconds; and
36.2upon that attempt being unsuccessful it was mandatory for the respondent to discontinue that attempt at aspiration and instead attempt to aspirate the thrombus using an Export catheter or another aspiration catheter.
37.An Export catheter was available to the respondent at all material times during the Procedure.
38.The respondent did not at any time during the Procedure use an aspiration catheter (including an Export catheter which was offered to him) to attempt to aspirate the Patient's Left Main.
Failure to administer adrenaline or a similar drug within an appropriate time
39.Upon Atropine being administered to the Patient as referred to in 19.17, it was appropriate for the respondent to allow a period of approximately 1 minute to ascertain whether that drug would effectively relieve the Patient's bradycardia and hypotension, and if it did not do so it was then mandatory for the respondent to order the administration of adrenaline or a similar drug which may have raised the Patient's blood pressure.
40.Despite the matter referred to in 19.18 the respondent failed at any time prior to 6.21 pm to order the administration to the Patient of adrenaline or a similar drug which may have raised the Patient's blood pressure.
Failure to call for emergency resuscitation team, anaesthetist or cardiothoracic surgeon
41.By reason the matters referred to in 19.11, 19.12.1 and 19.12.2 and the matter referred to in 19.12.3, the respondent knew by about 5.46 pm on 14 May 2009 that;
41.1there was significant thrombus in the Patient's Left Main;
41.2the respondent's attempts at aspiration had been unsuccessful over a period of more than 2 minutes; and
41.3the Patient, who had significant disease in his Right as set out in 9.5 and 9.6, had not received adequate systemic anticoagulation at the commencement of the Procedure and no anticoagulation agent had been given prior to 5.44 pm.
42.By reason of the matters referred to in 41, the respondent should have requested the attendance of an emergency resuscitation team, an anaesthetist and a cardiothoracic surgeon by about 5.46 pm on 14 May 2009.
43.Despite the matters referred to in 41, the respondent did not at any time during the Procedure call for, or request that a call be made for, the attendance of an emergency resuscitation team, an anaesthetist or a cardiothoracic surgeon.
Failure to inform Dr Hockings of the late administration of an anticoagulant agent to the Patient
44.The fact that the Patient had not received Angiomax or another anticoagulant agent until after a stent had been deployed and a balloon or balloons had been inflated in the Left Main was relevant to the treatment of the Patient after the formation of thrombus in the Left Main.
45.By reason of the matter referred to in 44, the respondent should have ensured that as soon as Dr Hockings became involved in the Patient's care he was made aware of the fact that the Patient had not received Angiomax or another anticoagulant agent until late in the procedure, specifically until after a stent had been deployed and a balloon or balloons had been inflated in the Left Main.
46.The respondent did not at any time during the Procedure inform Dr Hockings or cause Dr Hockings to be given any information whatsoever to the effect that there had not been a timely administration of Angiomax, or that the administration of Angiomax had occurred late in the procedure following the deployment of the Stent and the inflation of balloon catheters within the Left Main.
Advising the Patient that a nursing error had led to the failure to provide timely systemic anticoagulation
47.In August 2009 the Patient visited the respondent (the First PostProcedure Consultation).
48.At the First Post-Procedure Consultation the respondent advised the Patient that:
48.1anticoagulant had not been given at the commencement of the Procedure; and
48.2this was the fault of a member of the nursing staff working in the CCL.
49.The respondent's advice referred to at 48.2 was wrong for the reason referred to at 30.
50.Further to 49, the respondent's advice referred to at 48.2 was wrong by reason of the interchange between nurse Lum and the respondent referred to at 19.2.3 and 19.3.
51.The respondent gave the advice referred to at 48.2 to the Patient at the First Post-Procedure Consultation knowing that the advice was wrong for the reasons referred to at 49 and/or 50 and knowing that such advice could:
51.1mislead the Patient by causing him to believe that the respondent was not responsible for ensuring the administration of an anticoagulant agent to him; and
51.2potentially unfairly damage the reputations of nursing staff who were involved in the Procedure.
52.Alternatively to 51, the respondent gave the advice referred to at 48.2 because he failed to appreciate the matter referred to in 30.
Advising the Patient that there had been a 'dissection'
53.In or about February 2010 the Patient and the Patient's wife, … visited the respondent (the Second PostProcedure Consultation).
54.At the Second Post-Procedure Consultation the respondent advised the Patient and [the Patient's wife] that:
54.1the thrombosis suffered by the Patient during the Procedure was not the cause or alternatively was not a significant cause of the Patient's cardiac arrest; and that
54.2rather, the cause or the significant cause of the cardiac arrest was 'a dissection'.
55.The advice referred to at 54 was wrong in that:
55.1there was no or no significant dissection of any of the Patient's vessels during the course of the Procedure; and
55.2if, which is denied, there had been a significant dissection within any of the Patient's vessels during the Procedure, the likely effect of such a complication would be lifethreatening thrombosis if there had also been a failure on the part of the respondent to ensure timely and adequate systemic anticoagulation by ensuring the appropriate administration of Angiomax (or another anticoagulant agent) to the Patient at the appropriate time during the Procedure.
56.At the time of the First Post-Procedure Consultation, the respondent ought to have appreciated that there was no significant dissection of any of the Patient's vessels during the Procedure from either or both of:
56.1his knowledge and recollection of the Procedure; and/or
56.2the video record of the Procedure.
57.The respondent gave the advice referred to in 54 to the Patient and to [the Patient's wife] at the Second PostProcedure Consultation;
57.1knowing that the advice was wrong in that the Patient did not suffer any or any significant dissection during the Procedure; and/or
57.2knowing that the advice could mislead the Patient and his wife by causing them to believe that the thrombosis suffered by the Patient during the Procedure could not have been avoided or ameliorated by the respondent ensuring adequate and timely systemic anticoagulation irrespective of its underlying cause.
58.Alternatively to 57, the respondent gave the advice referred to in 54 because;
58.1the respondent erroneously believed that the Patient had suffered a significant dissection during the Procedure; and/or
58.2the respondent failed to appreciate that a dissection could lead to a life threatening thrombosis if the Patient had not received adequate systemic anticoagulation at the appropriate time during the Procedure.
Respondent's admissions in relation to VR 182 of 2012
59.The respondent admits that he has behaved in a way that constitutes professional misconduct for the purpose of section 193(1)(a)(i) of the National Law in that he:
59.1attempted to treat the Patient's coronary artery stenoses by angioplasty and stenting when for the reasons referred to in 20 and 21;
59.1.1coronary angioplasty and stenting was contraindicated for the treatment of the Patient's coronary artery disease; and
59.1.2CABG was a safer method of treating the Patient's coronary artery disease;
59.2failed to advise or explain to the Patient at any time prior to performing the Procedure that, for the reasons referred to in 20 and 21;
59.2.1coronary stenting was contraindicated for the treatment of the Patient's coronary artery disease; and/or that
59.2.2CABG was a safer method of treating the Patient's coronary artery disease;
59.3undertook stenting of the Patient's Left Main prior to undertaking stenting of the Patient's Right when stenting of the Right was likely to have provided some protection for the Patient's heart in the event of complications resulting in occlusion of the Left Main and in circumstances in which stenting of the Left Main was a more difficult procedure than stenting the Patient's Right and incurred a greater risk of complications than was the case in respect of stenting of the Patient's Right;
59.4failed to order the commencement of the administration of Angiomax or another appropriate anticoagulant agent to the Patient immediately after puncturing the Patient's femoral arteries at approximately 5.07 pm on 14 May 2009;
59.5failed to order the commencement of the administration of Angiomax (or another appropriate anticoagulant agent) to the Patient at any time between puncturing the Patient's femoral arteries at approximately 5.07 pm and approximately 5.44 pm on 14 May 2009, by which time thrombus formation had become evident;
59.6failed to use an Export catheter, or any other aspiration catheter, to attempt to aspirate the thrombus or thrombi in the Patient's Left Main;
59.7failed to order the administration to the Patient of adrenaline or a similar drug which may have raised the Patient's blood pressure within about 1 minute of the administration of Atropine during the Procedure despite the Patient remaining bradycardic and hypotensive within 1 minute of the administration of Atropine;
59.8failed to call any of an emergency resuscitation team, an anaesthetist or a cardiothoracic surgeon (or to request that they be called) by about 5.46 pm on 14 May 2009;
59.9failed to give Dr Hockings any information, or cause Dr Hockings to be given any information at any time during the Procedure to the effect that there had not been a timely administration of Angiomax or that there had been a late administration of Angiomax to the Patient, specifically that Angiomax had not been administered until after a stent had been deployed and balloons had been inflated within the Left Main;
59.10gave the advice referred to in 48.2 knowing that the advice was wrong and knowing that the advice could mislead the Patient by causing the Patient to believe that the respondent was not responsible for ensuring the administration of an anticoagulant agent to the Patient and knowing that the advice could potentially unfairly damage the reputations of the nursing staff who were involved in the Procedure;
59.11alternatively to 59.10 gave the advice referred to in 48.2, when that advice was wrong because he had failed to appreciate that it was his responsibility, as the treating cardiologist, to ensure the administration at the appropriate time of Angiomax (or another anticoagulant agent) to the Patient during the Procedure; and
59.12gave the advice referred to in 54 when that advice was wrong, or alternatively misleading for the reason referred to in 55.2, either;
59.12.1knowing that the advice was wrong or that the advice could mislead the Patient and his wife in the manner referred to in 57.2; or
59.12.2erroneously believing that the Patient had suffered a significant dissection during the Procedure when he ought to have appreciated that the Patient had not suffered any or any significant dissection during the Procedure and failing to appreciate the matter referred to in 55.2.
THE TRIBUNAL ORDERS
Being satisfied by reason of the respondent's admissions that proper cause exists for disciplinary action against the respondent (referred to in these orders as the practitioner) and in order to give effect to the agreed terms of the proceedings it is on 12 June 2013 ordered pursuant to section 56(1) of the State Administrative Tribunal Act 2004 (WA) that:
(i)The practitioner is reprimanded in relation to his conduct referred to in paragraphs 44 (concerning VR 31 of 2012) and 59 (concerning VR 182 of 2012), including each subparagraph of those paragraphs.
(ii)From the date of this order the practitioner’s registration is subject to the condition that the respondent is prohibited from performing any angiogram procedure and is prohibited from performing any angioplasty and stenting procedure on any person.
(iii)The review period in respect of the condition referred to in (ii) is 5 years from the date of this order.
(iv)Within 14 days of the date of this order the practitioner must pay to the applicant a fine in the sum of $75,000.00.
(v)The practitioner must pay the applicant's costs and disbursements of these proceedings to be assessed by the Tribunal if not agreed.
Conclusion
Having considered the allegations and admissions made by the practitioner and having regard to the principles to be applied in the imposition of vocational disciplinary penalties, the Tribunal is satisfied that the orders proposed fall within the range of appropriate penalties in relation to the conduct which is admitted. In particular, the imposition of a substantial fine recognises the seriousness of the conduct, and the imposition of a condition on the practitioner's registration prohibiting him from engaging in the procedures undertaken on the two patients concerned provides adequate protection of the public.
Accordingly, the Tribunal will make the orders proposed by the parties.
I certify that this and the preceding [5] paragraphs comprise the reasons for decision of the State Administrative Tribunal.
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JUSTICE J A CHANEY, PRESIDENT
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