Finding into death of Gurpal Sandhu

IN THE CORONERS COURT OF VICTORIA AT MELBOURNE Court Reference: COR 2007 126

FINDING INTO DEATH WITH INQUEST!

Form 37 Rule 60(1) Section 67 of the Coroners Act 2008

Inquest into the Death of: GURPAL SANDHU

Hearing Dates: 2-3 March 2011 and 20 —22 June 2015

Appearances: Mr S.J. Moloney of Counsel on behalf of Austin Health

Mr McClosky of Counsel on behalf of Melbourne Health (20-22 June only)

Counsel Assisting the Coroner s Fiona Ellis of Counsel

Ms Monika Pekevska, Instructing Solicitor, Victorian Government Solicitor’s Office

(VGSO) Findings of: AUDREY JAMIESON,CORONER Delivered On: "7 May 2013 Delivered At: Level 11, 222 Exhibition Street

Melbourne, 3000

1 the finding docs not purport to refer to all aspects of the evidence obtained in the course of my investigation. The material relied upon included statements and documents tendered in cvidence together with the transcript of proceedings and submissions of legal representatives/counsel. Notes taken by myself and the written submissions of Counsel from 22 June 2011 were also utilised as there was a loss of transcription from that day due to a technical error.

The absence of reference to any particular aspect of the evidence, eithcr obtained through a witness or tendered in evidence does not infer that it has not been considered.

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I, AUDREY JAMIESON, Coroner having investigated the death of GURPAL SANDHU

AND having held an inquest in relation to this death on

at Melbourne

find that the identity of the deceased was GURPAL SANDHU

born on 9 July 1949

and the death occurred 3 January 2007

at the Austin Hospital, 145 Studley Road, Heidelberg 3084

from: l(a) LYMPHOCYTIC CHORIOMENINGITIS VIRUS (LMCY) — LIKE VIRUS 1(b) POST LIVER TRANSPLANT

in the following summary of circumstances:

On 4 December 2006, Ms Gurpal Sandhu underwent a cadaveric liver transplant at the Austin Hospital. The donor was Mr Jovo Vranjescvic who had died at Dandenong Hospital from a cerebral haemorrhage, Ms Sandhu and the two other recipients of Mr Vranjesevic’s organs died within 6

days of each other.

I, BACKGROUND CIRCUMSTANCES

1, Ms Gurpal Sandhu was 64 years of age at the time of her death.

2. Ms Sandhu had becn a patient at the liver transplant unit of the Austin Hospital since 2004.

Her medical history included liver cirrhosis, Hepatitis C and Hepatitis B virus infection and hepatoma (malignant tumour of the liver) with liver failure, pneumonia and E-coli sepsis. In addition she had intractable encephalopathy with fluid overload.’ She had been on the transplant waiting list since December 2005, By December 2006 Ms Sandhu had been

admitted to the Austin 35 times, had undergone 107 radiological procedures and was

suffering from repeated complications of liver failure affecting renal, respiratory and brain function, Her need for transplant had started to become urgent* and she was at risk of the

carcinoma within her liver becoming uncontrollable.’

Exhibit 12 — Statement of Professor Robert Jones dated 3 June 2010, Transcript (T) @ p 128 3 T @ ppl44 -145

“T@ 145

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IL.

As Ms Sandhu was Hepatitis B positive she would require additional treatment post

transplantation regardless of a donors hepatitis status.”

SURROUNDING CIRCUMSTANCES

On 3 December 2006, Mr Jovo Vranjesevic was admitted to the Dandenong Hospital

Emergency Department (ED) by ambulance following his collapse at home, CT examination

of the brain showed a large thalamic haemorrhage, with extension into the ventricular system

and midline shift. ’ormal brainstem testing confirmed brain death, Mr Vranjescvic’s family

agreed to organ donation,

On 4 December 2006, Transplant Surgeon Mr Michael Fink, performed the organ retrieval

operation. Mr link stated:

The liver appeared to be of good quality macroscopically, with no evidence of any infective process or other parenchymal problem. There was a common anatomical variant.,.these findings were non-specific and would not normally preclude transplantation.... The kidneys perfused well, There was severe atheroma including the orifice of the renal artery in each kidney. This can potentially increase the risk of vascular thrombosis following transplantation and therefore [ contacted the recipient surgeons and alerted them to this issue and advised that they asses the kidneys prior to implantation. There were multiple small renal cysts. This would not normally preclude transplantation... The heart was not retrieved because there was no suitable recipient,,.and because there was evidence of poor left ventricular function and sclerotic heart valves. The lungs were not retrieved because there was no suitable recipient and because the donor was a smoker, with recent weight loss and was Iepatitis B core antibody positive. The pancreatic islets were not

transplanted following isolution because of insufficient islet number... °

There were three solid organ recipients:

Ms Sandhu received a liver transplant at the Austin Hospital on 4 December 2006;

'T @ pp 148-149 6 Exhibit 9 — Statement of Mr Michael Fink dated 25 September 2008

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TW.

ll.

• Ms Karen Wilkinson’ received a renal transplant at the Royal Melbourne Hospital on 4

December 2006; and

• Mrs Catmelina (Lina) Sirianni® received a renal transplant at the Austin Hospital on 4

December 2006.

Ms Sandhu’s operation was straightforward, completed within seven hours and she was making an excellent carly recovery in the Intensive Care Unit (ICU)? From 11 December 2006, Ms Sandhu was noted to be febrile and by 20 December 2006, she had diagnoses of delirium, fever, septicaemia and hyperglycaemia. She developed encephalopathic septic illness but the reason for this was unclear, This was complicated by the development of intra-abdominal wound infection that required her to go back to surgery on 21 December for drainage of bacterially infected haematoma.'° Her clinical course continued to decline and s

he died on 3 January 2007.

Ms Karen Wilkinson had dicd on 1 January 2007 and Mrs Carmelina Sirianni died on 7 January 2007.

The death of Ms Gurpal Sandhu was not initially reported to the Coroner. Her death was reported to the State Coroner’s Office (as it then was) on 11 January 2007. No autopsy had

been performed.

JURISDICTION

At the time of the death of Ms Gurpal Sandhu, the Coroners Act 1985 applied. From 1 November 2009, the Coroners Act 2008 (the new Act) has applied to the finalisation of

investigations into deaths that occurred prior to the commencement of the new Act,"

ln the preamble to the new Act, the role of the coronial system in Victoria is stated to involve the independent investigation of deaths for the purpose of finding the causes of those deaths and to contribute to the reduction of the number of preventable deaths and the

promotion of public health and safety and the administration of justice. Reference to

• Case No. 2007 125 5 Case No. 2007 67

° Exhibit 12 ~ Statement of Professor Robert Jones dated 3 June 2010 ' exhibit 12 — Statement of Professor Robert Jones dated 3 June 2010, T @ p 130 | Seetion 119 and Schedule 1 — Coroners Act 2008

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IV.

preventable deaths and public health and safety are referred to in other sections of the new Act."

Section 67 of the new Act describes the ambit of the coroners’ findings in relation to a death investigation. A Coroner is required to find, if possible, the identity of the deceased, the cause of death and, in some cases, the circumstances in which the death occurred."? The ‘cause of death’ generally relates to the medical cause of death and the ‘circumstances’

relates to the context in which the death occurred.

A Coroner may also comment on any matter connected with the death, including matters relating to public health and safety and the administration of justice." A Coroner may also report to the Attorney-General and may make recommendations to any Minister, public statutory authority or entity, on any matter connected with a death which the Coroner has investigated including recominendations relating to public health and safety or the

administration of justice.'*

INVESTIGATION

Identity

The identity of Ms Gurpal Sandhu was without dispute and required no additional

investigation.

Medical Investigation

Dr Michael Burke, Forensic Pathologist at the Victorian Institute of Forensic Medicine was

advised of the three organ recipient deaths from the one donor on 7 January 2007.

Dr Burke performed an autopsy on the body of Mrs Carmelina Sirianni on 11 January 2007.

Before reporting to the Coroner, Dr Burke initiated a number of investigations and reviewed the medical records of all the recipients and the donor, Mr Vranjesvic, The investigations included the delivery of tissue samples to the CSIRO Australian Animal Health Laboratory

for viral testing, comprehensive microbiological series of investigations at the Victorian

"2 See for example, sections 67(3) & 72 (1) & (2) '. Section 67(1)

"4 Section 67(3)

'S Section 72(1) & (2)

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19,

Infectious Diseases Reference Laboratory (VIDRL) from where material was sent to the United States of America for further testing. Neuropatholgical examination of the tissue showed no evidence of an encephalitis and no agent had been identified in the

microbiological investigations.

Dr Burke reported!® that from his review of the medical records of the three transplant recipient deaths, he could sec no common therapeutic medication to link the three deaths.

Similarly, although each recipient had an enterococcus isolated at sometime during the period of hospitalisation, antibiotic sensitivity testing suggested separate sources of the

bacteria in two of the recipients, Dr Burke commented:

From my reading of the literature with respect to transplantation medicine, deaths are relatively uncommon in individuals undergoing solid organ transplantation.

Deaths following liver transplantation are more frequent than following renal transplaniation, In most instances of deaths following solid organ transplantation, infection is the most common cause of death,...The deaths of three solid organ transplant recipients, each occurring approximately one month following

transplantation, raises the prospect of a transplant associated infectious agent.

At the time of completing his report, Dr Burke indicated that some results (rickettsial serology) were still pending and that upon receipt of the results, he would complete a

supplementary report.

Dr Burke completed a medical examiners report on Mrs Sandhu following a review of the Death Certificate and the medical records from the Austin Hospitat.!” Dr Burke noted that

the cause of death on the death certificate was: 1 (a) Pneumocystis pneumonia with antecedent causes of 1(b) Immunosuppression due to liver transplant

L(c) Chronic liver failure secondary to Hepatitis B and Hepatitis C.

6 Exhibit 2-- Autopsy Report on Carmelina (Lina) Rachela Sirianni - Dr Michael Burke signed in the presence of a witness on 15 February 2011

7 Exhibit 4 -- Report of Dr Michael Burke signed in the presence of a witness on 15\February 2011

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Other significant conditions contributing to the death but nol related to the disease or condition causing it of: Type IT diabetes mellitus causing chronic renal impairment.’

At the time of preparing his report, Dr Burke did not suggest an alternative cause of death.

20. Ina supplementary report dated 5 February 2008," Dr Burke reported that the expert viral investigations showed the presence of a lymphocytic choriomeningitis virus (LCMV) type virus and that the LCMV had been isolated in prior deaths of recipients of solid organ

transplants,”° Dr Burke revised the cause of death for each of the organ recipicnts. He stated:

Whilst the deaths of the three organ recipients ...in isolation could have the individual causes of death proposed by autopsy and/or the treating clinicians, the ‘prior reporting of post transplant deaths associated with LCMV and the temporal relationship between the three deaths would suggest the LCMV-like virus is the

underlying cause of death in each case.

VY. INQUEST

21. At the Directions Hearing and at the opening of this inquest a number of issues were identified so as to give direction to the scope of the Court’s inquiry. Those issues/questions

posed were:

(i) ° The cause of death of each of the four deceased;

(ii) Donor and recipient screening — processes in place, potential to have picked up virus or

anomaly in donor pre transplantation;

(iii) Informed consent of recipients (did the general advice incorporate knowledge of the 2003 & 2005 clusters reported in the NEJM and now that these deaths have occurred what changes if any have occurred in relation to what a recipient is told in the consent

process);

(iv) What opportunities were there, whether by intra or inter hospital communication, to have learnt earlier of the common deterioration among the recipients and whether this would

have changed the outcome for any of the recipients; and

18 Op cit 19 lixhibit 3 — Supplementary Report on Case No. 0067/2007 — Dr Michael Burke, dated 5 February 2008

20 See: Fischer SA et al. “!'ransmission of lymphocytic choriomeningitis virus by organ transplantation.” New England Journal of Medicine 2006; 354(21):2235-2249

Tal 26

@)

What capacity is there now to screen for the recently detected arenavirus.

22. Viva voce evidence was obtained from the following witnesses:

Dr Michael Burke, Forensic Pathologist Ms Rae Moran (partner of Ms Wilkinson)

Ms Francesca Rourke, President, Australasian Transplant Coordinators Association,

ATCA

Mr Michael Fink, Transplant Surgeon, Austin & Repatriation Medical Centre Mr Sam Sirianni (son of Mrs Sirianni)

s Gordana Vranjesevic (daughter of Mr Jovo Vranesevic, donor) Professor Robert Jones, Director, Liver Transplant Unit, Austin Hospital

Associate Professor Denis Spelman, Head of Department of Microbiology, The Alfred Hospital

Professor Rowan Walker, Deputy Director Department of Nephrology, Royal elbourne Hospital

Miss Amanda Robertson, general & renal Transplant Surgeon, Royal Melbourne Hospital

s Julie (Julijana) Pavlovic, Liver Transplant Co-ordinator, Austin Hospital Associate Professor Francesco lerino, Deputy Director of Nephrology, Austin Hospital

Mr Ian Michell, Renal Transplant Unit, Austin Hospital

Ms Violet Marion, Organ Donor Co-ordinator, DonateLife

Dr Michael Catton, Medical Virologist & Director, Victorian Infectious Discases Reference Laboratory (VIDRL)

VI, FINDINGS and COMMENTS pursuant to section 67(1) and (3) of the Coroners Act 2008

@ Cause of death of Ms Sandhu, Ms Wilkinson, Mrs Sirianni and Mr Vranjesevic

23. Only Mrs Sirianni underwent a full post mortem examination performed by Dr Burke,

Forensic Pathologist at the VIFM.

24, ‘In relation to the deaths of the three organ donor tecipients, Ms Sandhu, Ms Willcinson and

Mrs Sirianni, Dr Burke gave evidence”! confirming his opinion as expressed in his

2. Transcript (T) @ p 15 and 17

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supplementary report of 5 February 2008 that is, that the LCMV-like virus is the underlying

cause of death in each case,

25, The cause of death of Mr Vranjesevic however remained unchanged — he died of a stroke,,..with the virus as opposed to “of the virus’?

26. Associate Professor Spelman, Head of Microbiology, Deputy Director Infectious Diseases Unit, at The Alfred Hospital, gave evidence that was consistent with the evidence of Dr Burke but qualified in that he said:

The recipients had other possible causes from a clinical point of view and they had bad bacterial sepsis and that could be at least a part of their death as well. So, my opinion would be that I couldn't be as firm as this that this was the only cause contributing to their death.**

27. The evidence supports a finding that the LCM like virus was a contributing cause to the deaths of Ms Garpul Sandhu ,Ms Karen Wilkinson and Mrs Lina Siriani. The cause of death for each of the donor recipients will be amended to reflect this finding and the Registrar of Births, Deaths and Marriages will be requested to re-register the cause of each of the deaths accordingly. .

28. In relation to Mr Vranjesevic’s death, Dr Burke gave evidence that the cause was thalamic haemorrhage with ventricular extension,”®

29. Professor Jones, Director, Liver Transplant Unit, Austin Hospital who performed the liver transplant on Ms Sandhu gave evidence that the LCM virus usually causes a relatively benign illness and that it was extremely unlikely that the LCM virus caused the cerebral haemorrhage in Mr Vranjesevic.”°

30. In the absence of any evidence that the LCMV caused Mr Vranjesevic’s death, I accept and adopt the cause of death as identified by Dr Michacl Burke and find that Mr Jovo

% Exhibit 3

3 T @p 15

4 T @p 170

=T@pl4

°° T @p 150, 14-28

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Gi)

Vranjesevic died from natural causes being thalamic haemorrhage with ventricular

extension.

Donor And Recipient Sercening - processes in place, potential to have picked up

virus or anomaly in donor pre-transplantation

Confidential Donor Referral Form

Ms Francesca Rourke, President of the Australasian Transplant Coordinators’ Association (ATCA) gave evidence” that the donor co-ordinator from the relevant State Agency (in this case LifeGift, now known as DonateLife,) attends at the hospital for the purpose of completing the Confidential Donor Referral Form (CDRF).

The CDRF requires the donor co-ordinator to review the patient’s medical records, past and present, perform a medical chart review, family interview, physical examination and where possible, to contact the general practitioner of the prospective donor, It is also routine

practice that prospective virology/scrology screening is performed on all potential donors.”

According to the evidence of Ms Rourke the CDRF is a national document developed by ATCA and reviewed and endorsed by TSANZ, (Transplantation Society of Australia and New Zealand), The review process of the CDRF is undertaken in collaboration with

TSANZ and a medical specialist in infectious diseases.”’

In order to fully understand the screening process that took place in respect of Mr Vranjesevic, statements were obtained from Ms Violet Marion and Ms Bernie Dwyer — both

whose initials appear on the CDRF,

Ms Marion was called to give evidence as she was the donor co-ordinator wlio completed the CDRF and engaged in the family interview as required by the CDRF. She said that the

donor co-ordinator has two priorities when they attend hospital:

..to meet with the donor family and obtain their consent, and equally to send off bloods for tissue typing, because that’s one of the major delays to organ

donation. It takes somewhere between six to eight hours....then in amongst

27 ‘Exhibit 8 — Statement of Francesca Rourke dated 9 September 2010 and T @ pp 50-71 8 1@ p52 2B

T@p52

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(sic) juggling of ordering different tests, assessing the medical records, (sic) and just obtaining all the information that we need to complete this form and

make the organ referral,

36. At the time she gave evidence it became evident that the CDRF in this case was beyond the six pages in the Inquest Brief! In the CDRF proffered at inquest and completed by Ms Marion it became apparent that Ms Marion was informed that Mr Vranjesevic had been both lethargic and vague since his return from Serbia” Ms Marion gave evidence that she would have, as per her usual practice, passed this information onto Ms Pavlovic, liver transplant co-ordinator, at the time she made initial contact with her. Ms Pavlovic however, gave evidence that she was not informed that the donor had had a recent history of lethargy but

rather was told that he had been unwell.

37. The evidence of Ms Marion was that it was apparent at the time that she was initially contacted by the ICU Registrar, Dr Mée al Dandenong Hospital, that the issue of weight loss | had been identified.4 Ms Marion raised this issue with Dr Helen Opdam, medical consultant on-call that night and sought guidance from her in respect of it? The issue of weight loss was specifically explored in the interview conducted by Ms Marion with Mr Vranjesevic’s daughter, Daniella, who had been nominated as the family spokes person.”* It was apparent to Ms Marion that Mr Vranejesevic’s wife was in the room and contributed to

Daniella’s responses over the telephone.”

38. ‘The CDRF sets out the information obtained by the donor co-ordinator during the interview with the family member. Whilst the donor co-ordinator spoke to Mr Vranjesevic’s daughter Daniella it was Gordana (another daughter) who gave evidence at the inquest, The risk

identified on the CDRF was “15 kg weight loss over past 3 months while on holiday

® T@p 405

31 Exhibits 30 & 32. For a blank copy of the CDRF formulated in December 2004 and that was in use in December 2006, see Exhibit 27

% exhibit 32 — Full CDRE

31 @ p 253

34 Exhibit 30 — ‘Donor Referral Checklist’

thid, T @ pp 376-377,382

TT @p38l

37 Exhibit 26 -- Statement of Violet Marion dated 23 May 2011 @ p6

“of

39,

40,

o/seas.”*® The CDRF reveals that the donor co-ordinator had also been informed that Mr Vranjesevic had spent 3 months in Serbia returning a week carlicr.? In the additional

comments section of the CDRF the donor co-ordinator notes:

Daughter states that her father was more active while overseas on holiday. He stayed in a small village and did a lot of walking. Was away for 3 months and

returned last week.”

Whilst Ms Marion spoke to the liver transplant co-ordinator about the donor (who then completes in this case the ARMC Liver Transplant: Donor Referral Form)”’ she spoke directly to the renal physicians in respect of the kidneys. This divergence relates to the fact that the allocation of kidneys is according to NOMS (National Organ Matching System) and the fact that kidney transplant co-ordinators usually work normal office hours. A hard copy of the CDRF is provided with the organ and at that time made available to the

transplant physician and/or surgeon.

Of import to the question of whether there was a potential to have picked up the virus or anomaly in donor pre-transplantation is the evidence of A/P Spelman in respect of the mechanism of the virus. His evidence was that it is not possible to say how the LCM virus behaved in the donor and thus it is.difficult to conclude that it was responsible for the

symptoms Mr Vranjesevic complained of or exhibited, particularly his weight loss.

Ms Julie Pavlovic, Liver Transplant Co-ordinator, Clinical Nurse Consultant at the Victorian

Liver Transplant Unit at the Austin Hospital also gave evidence. Her statement‘

summarises the screening process and annexes the Liver Transplant Work Up Assessment

Booklet for 2005 in respect of Ms Sandhu.

38 Tixhibit 31, Inquest Brief (IB) @ p102

» Exhibit 31, 1B @ p98

Exhibit 31, IB@ p 99

“| Exhibit 19 - Statement of Julie Pavlovic dated 13 October 2010 and attachment JPOL’

® Exhibit 24 — National Organ Matching System Allocation Final List (and is part of the CDRF document) 8 T @ pl8l-2 “4 Exhibit 19

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42. There were other matters known about Mr Vranjesevic but were not reflected in the CDRF

and

which may well have been of assistance to those conducting the transplantation process,

Yhese matters included:

43. Pro

At the Dandenong Hospital Mr Vranjesevic had a temperature of 38.3°C.5 Professor Jones stated: certainly fever is a significant marker. of infection, however, it is also unusual perhaps to be febrile with chronic sepsis if this is a low grade illness, It is also quile common to have temperature derangemenis with intracerebral haemorrhage. So

again - ...fever is not uncommon in our donor population,”®

Whilst in Serbia Mr Vranjesevic apparently complained of headache. Professor Jones gave evidence that: Jn retrospeci a new onset of unusual headaches over a sustained period would have been I guess an issue to have been aware of and certainly would have

added to perhaps us thinking bout what was going on with this particular donor.

Ms Gordana Vranjesevic refers to the pain that her father complained of in his right arm and leg. To this, Professor Jones gave evidence: ...this is a unique and unusual viral infection. I don’t think any of us understands what it causes, So, 1 suspect again, if we had heard that story from his mother or while he was in Serbia it perhaps would have

added to our concern that the weight loss may be due to something else. 48

Over approximately 10 days from Mr Vranjesevic’s return from Serbia and his death he had been complaining of lethargy.” To this information, Professor Jones stated: /t certainly would have added to our concern if there was a known risk that the patient was

unwell in addition to weight loss.°°

fessor Jones says that whilst the above additional information would have made them

more concerned as to what was happening with Mr Vranjesevic, it possibly would not have

alicred their decision to proceed to transplant:

“8 Exhibit 30

‘Southern Health — Dandenong Emergency Department notes Mr Vranjesevic’s temperature — this

document was within the bundle of documents provided at inquest by DonateLife and came from the file of DonateLife

® T@ p 140, 'T @p 139

9-14

®T @p 139 49 Exhibit 32 — this matter is noted on the CDRF that was provided by DonateLife Victoria at the Inquest

OT @ p 135

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44,

(iii)

45,

46,

wit may have influenced our decision. Whether it would have influenced our decision to the point we said we should not use this donor because of a hidden potential risk, I’m less certain of that. I think with that information I would certainly be more concerned — and I would've been looking for explanations to explain ... this

illness that he had!

Again, with reference to the evidence of Professor Jones, the additional information, if

provided, may not have influenced the post operative management of the recipients,”

Communication to the transplant team of the information obtained by the donor co-

ordinator and contained in the CDRF,

Professor Jones pave evidence about the role of the CDRF and donor co-ordinators. He said that for the purposes of transplant they are very dependant on the organ donation agency for the information they provide. The transplant team do not however receive the CDRF or any

other material in hard or soft copy:

We actually do not get any paper copy, this is all done by telephone, so it's relayed by telephone to our recipient co-ordinator who documents it by hand and then relays

it by telephone usually to the transplant team or the responsible person.?

In the present case enquirics were made to find out more about the weight loss. Professor Jones gave evidence that ... it was clearly a significant issue that registered as something

that should be explained, we needed an explanation.”

State of organs offered for donation

47,

Dr Fink, surgeon who performed the retrieval of organs from the donor, noted severe athcromas to the renal artery of both the left and the right kidney. He noted this on the CDRF and believes that he contacted the transplanting surgeons about his concern in respect

of the arterics.*> Dr Michele gave evidence that he does not recall such contact and Miss

17 @p l4i 27 @ p 142 3 °T @p 132 41 @p 134 ST @p 83

140826

Amanda Robertson, too did not recall such contact however did not dismiss it as having

occurred.

48. In terms of the atheromas to the kidneys identified by Dr Fink the risk is that they can potentially increase the risk of thrombosis following transplantation.® The issue is technical and Dr Fink was concerned that the atheromas would make the arterial anastamosis difficult and thus it was important that the surgeons performing transplantation should be made aware of this macroscopic finding.” From Mr Fink’s perspective, the presence of atheroma

did not render the kidneys unsuitable for transplant.®

The liver appeared good macroscopically with no evidence of any infective process or other parietal problem. There was an anatomical variant left...rising from the left gastric artery which does not preclude transplantation, There was severe aortic atheroma, A biopsy was performed and this revealed normal architecture, mild portal fibrosis (State 1), mild portal triaditis, no interface hepatitis and macro vesicular steatosis of less than five per cent. These findings were non-specific and

would normally not preclude transplantation Confining his evidence as to the quality of the liver, Professor Jones gave evidence that:

This particular liver donor from our donor in Dandenong was in fact a very good

: . 39 organ and it worked very well and so there was certainly no concern.

Fle went on to say;

.we would have to feel there was a significant risk in the donor before we would turn the donor down, As I say, every donor we accept we're accepting risks that this organ may not work or it may transmit disease or it may cause other problems and

we're weighing that against a recipient who may die otherwise.”

rT @p 7s

tp @ pp 77-8; see also T @ pp 83-4

• -T @ pp 83-84

° T @p 143

7 @p 144

49. In Professor Jones’ opinion, Ms Sandhu’s need for transplant was starting to become

urgent,®!

50, Miss Amanda Robertson gave evidence that she would not accept a kidney whose main artery was 95% occluded. The assessment of occlusion is performed macroscopically.

When Miss Robertson was taken to the histopathology report in respect of the grafted kidney which describes: “The main renal artery and its branches” showing “severe atherosclerosis with focal calcification, narrowing the lumen to less than 5% of normal”™she stated that that finding was inconsistent with her own visual assessment of the kidney and could have been caused by clamping of the artery. Dr Michele gave evidence that the renal

artery post operatively may undergo changes that render the lumen of the artery narrow.

51. In terms of the operation that Mr Michele performed on Mrs Sirianni he gave evidence that he trimmed back the atheromatous scction of the artery and proceeded to anastomosis

without difficulty.”

Extended Donor Criteria

52. The report of Professor Walker™ refers to ‘extended donor criteria’ (HDC), These extended criteria have evolved in response to the evidence-base underpinning the desirability of transplanting patients rather than leaving them for long periods of maintenance dialysis.

From the evidence of A/P Ierino, Professor Walker and Dr Michele it can be said that the determination of what features give rise to a kidney falling into the extended donor criteria is contentious. Clinical features or circumstances such as hypertension, death as a result of cerebral hacmorrhage and Hepatitis B core antibody positive, may or may not cause a donor to fall into the EDC. Where however a donor docs fall into the EDC then those features are

conveyed by the accepting physician to the potential transplant physician,

“1 @p 144 213 @ p 464 §3 yixhibit 25 84 Exhibit 16 8 ibid @p2

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, f

(iv) Informed Consent of Recipients (did the general advice incorporate knowledge of the 2003 & 2005 clusters reported in the NEJM and now that these deaths have occurred what changes if any have occurred in relation to what a recipient is told in the consent

process)

53. I accept that the general risks as they relate to mortality and morbidity were explained to each of the recipients. The specific issue that arose in respect of the deaths of the three

recipients stems from the fact that the donor was Hepatitis core antigen positive.

54, Attached to the statement of Scott Campbell® are the Guidelines on Hepatitis B testing and

use of HBV core antibody donors. This document includes the following statement:

Non-liver organ recipients of organs from donors known to be Hepatitis B surface antigen negative but Hepatitis B core antibody positive should ideally be immune and/or vaccinated to Hepatitis B and must be transplanted only after specific

informed consent has been obtained.

55. Dr Stephen Munn, Chairperson, Liver Transplant Standing Committee, TSANZ, provided a statement in which he says that at the time of these events the guidelines for serological testing for transmissible infectious disease section did not refer to arena viruses given that its discovery is only recent. The extent of information to be provided to potential recipients to enable informed consent has not been standardised within the auspices of the TSANZ Liver Transplant Standing Committee however all units would provide advice about the origins of the organ (living or deceased), the fact that such donors undergo tests to try to exclude

transmissible diseases and the fact that such testing can never be exhaustive.”

(iv) Was There An Opportunity Through Intra Or Inter Hospital Communication To Learn Earlicr Of The Common Deterioration Among The Recipients And Whether This Would Have Changed The Outcome For Any Of The Recipients

56. Professor Jones gave cvidence that in the last week of Ms Sandhu’s illness enquiries were

being made of the renal unit regarding the progress of the Austin Hospital recipient of one of

®8 Chairman of the Renal Transplant Standing Commitice TSANZ 1B @p 114 8 1B @p 116 1B @ p 109

170i

57,

58,

the donor kidneys. As Ms Sandhu died on 7 January this suggests that this communication may have commenced in late December 2006 or early January 2007, Professor Jones gave evidence that the donor kidney recipient, Mrs Sirianni, was reported to be deteriorating with an encephalopathic illness. At the same time a medical enquiry from the Royal Melbourne

Hospital suggested a similar deterioration with the second renal transplant recipient.”

A/P lerino stated that there were discussions inter and intra hospital in relation to the progress of the recipients. He does not recall the precise date.”! Once it was known that all of the patients had neurological symptoms then consideration was given as to a common cause of their decline. Alternative diagnoses noted in the history by the Infectious Disease

Unit included but were not limited lo LCMV.” In her statement”, Ms Pavlovic says:

Once it was discovered that the renal transplant recipient was also not doing well a meeting was arranged to discuss the situation, I think that this occurred before

Christmas in 2006.

Ms Pavlovic gave evidence that she bclicves notes of this meeting would have been taken

although none were produced at the inquest.

Ms Marion in her statement” and in the CDRF she completed, refers to contact being made with her by the RMH in relation to the progress of the patient. She believes that contact is made with the donor co-ordinator as transplant teams are often not aware to what other

hospitals organs from the same donor may go to.”

1 accept that when reference is made to the notes of Ms Marion in the CDRF, the most likely and probable explanation is that the contact from RMH on 29 December 2006 to her was the first time (both inter and intra hospital) at which enquiry was made about the progress of

recipients from the same donor. Ms Marion gave evidence that she could not be absolutely

7 @p 130

"| Exhibit 21- Statement of Associate professor Francesco Ierino dated 21 October 2010

® ibid

® Yxhibit 19 4 Uxhibit 26 @ p 7 and Exhibit 32

• ‘There are 6 hospitals that perform transplants in Victoria,

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(vi)

63,

certain that this was the case, It was Ms Marion who then contacted the NUM from the Austin Renal Unit with the information she had received about the condition of the recipient at RMH — Ms Wilkinson. Ms Marion then contacted the Austin liver transplant team. She passed on advice received internally at DonateLife that the transplant teams were to communicate with each other, Ms Marion also briefed A/P Terino and Professor Walker on the same date, She gave evidence that she believed that she was telling each of them

something that they previously had not known before.

Capacity To Screen For The Recently Detected Arenavirus

On 15 January 2007, Dr Michael Catton Medical Virologist, Director of VIDRL, received specimens from each of the three organ recipients with a request from the Coroner for

testing. He said:

Because of the striking epidemiological features of the incident, notably 3 fatalities within days of one another, among 3 recipients of tissue from a common donor, 1 , considered the involvement of a novel or difficult to characterise infectious agent to

be possible, and worth pursuing. 16

The VIDRL in collaboration with the Greene Laboratory in New York led to the discovery of an arenavirus with properties similar to, but distinct from lymphocytic choriomeningitis virus (LCMV), Evidence of infection with this virus was obtained from testing of samples of

the three transplantation recipients and the donor.”

From the investigation, Dr Catton concluded:

(i) A hitherto unknown arenavirus infected the donor and each of the three recipients.

(ii) Infection with this arenavirus cannot be demonstrated in other Victorian transplant

patients unrelated to this cluster.

(iii) | Transmission of such an agent by transplantation is biologically plausible, based on the known properties of arenaviruscs and two similar episodes of transmission

occurring in the USA.

76 Exhibit 28 — Statement of Dr Michael Catton dated 10 June 2008. See also article: “A New Arenavirus in a Cluster of . Fatal Transplant- Associated Diseases”, The New England Journal of Medicine — 1B @ pp26-33

” ibid

19 uf 26

67,

(iv) The time course of the recipient’s illness and death are consistent with arenavirus

infection in general and with those recipients infected with LCMV in the USA;

In an addendum” to his first statement Dr Catton responded to a number of queries about the availability of testing for the new virus, about research being undertaken to develop such

a test and the practicality and utility of such testing. He stated:

Laboratory tests for the novel arenavirus were developed during the investigation of the 2007 deaths. Based on their performance during that exercise, and our understanding of the general performance capability of the underlying technology, I believe that they are capable of detecting clinical cases of infection with this virus with acceptable accuracy. I believe that this represents as much laboratory testing

capability as we are reasonably able to develop, and are currently likely to need.

A much higher degree of accuracy is required of tests used to screen a blood or organ donor population. | do not believe that data is available or is likely to be available to validate current diagnostics tests for the novel arenavirus as sufficiently accurate for this purpose...We lack evidence of ongoing risk to transplantation patients from this arenavirus,,..in my opinion an unquantifiable potential for harm would be associated with donor screening, and validation tests to better refine this risk is nol likely to be possible. Balanced against this potential harm is a lack of evidence regrading the existence of a significant risk that donor screening might be

intended to mitigate,”

Dr Catton in his evidence confirmed his view in relation to the ability (or rather impediments) to screen for the virus. The ability to detect the virus is not the same as the capacity to screen for the same. ‘The fact that the incidence of the virus occurring is so low in turn means that there is insufficient evidence wpon which any screening process can be

scientifically validated.

The discovery of the LMCV-like virus occurred some months after the deaths of the three

recipients of Mr Vranjesevic’s donated organs. Until that discovery I accept that it was a

® Txhibit 29 — Statement of Dr Michael Catton dated 6 April 2010

® ibid

"20 of 26

VU.

68,

strain of virus that was unknown in humans and thus not capable of being identified at the

time of retrieval and transplantation by those involved with either of those processes.

CONCLUSION

There is no evidence to suggest that earlier nephrectomy or the provision of antiviral therapy would have altered the tragic outcome for each of the recipients in this case. In this respect the evidence of Dr Catton was of assistance, With reference to Dr Catton’s first report®? it is apparent that the virus had extended into organs other than the grafted organs of the recipients. Having reference to the NEJM and the evidence of Dr Catton treatment with the antiviral agent Ribavarin®! cannot be said to be responsible for the positive outeome in the patient referred to in that study. According to Dr Catton. consideration however may be given to the administration of Ribavarin (which has not inconsequential side effects)

together with all other relevant matters in relation to clinical treatment and management.

Counsel Assisting, Ms Ellis submitted that the evidence highlighted the potential for

recommendations based on the following:

The information obtained from the family by the donor coordinator is recorded on a form.

The donor co-ordinator is not a member of the transplant team and for reasons morc cogent than logistic is not on site at the hospital at which transplantation is to occur, The hand-over from the donor co-ordinator to the recipient co-ordinator is by telephone. The recipient coordinator they relays the information obtained to the transplant team, In such circumstances there is the real potential that information may be lost. With this in mind Professor Jones

gave the following evidence which may be the basis of a like recommendation:

. it would be ideal if we did have access to them (CDRI's) because we would see exactly what’s written and it would not be filtered and in fact there is an attempt to do that in the transplant community, So if these documents, for example, were online and the co-ordinator in the donor hospital..,would put them into the computer centrally and we could go and look at that document. In other words we would be seeing without filtering exactly what was there. There would have been attempts and

discussions about whether that would be feasible, I think it would be an ideal

• Exhibit 28 5! see NEJM, 2005 Cluster, Kidney recipient A - IB @ p 142

AL oF 26-

arrangement and it would allow the entire transplant community who are involved with that donor to log and look at those documents and not have it filtered by telephone calls which, in my case, its second and becoming third hand information.

It would be an ideal situation to actually see that document.

2. A/P Spelman referred to the recommendations in the United States that transplant recipients should minimise their contact with rodents/hamsters.” When asked himself whether donors should be screened by enquiring as to their contact with such pets he answered: “...1’m not a member of the transplant team but to me it does make some sense to ask that question,” Dr

Catton gave evidence that was consistent with this.

3. In order to ensure that there is routine and regular post operative communication between and within hospitals who reccive organs from the same donor enquiries should be made and recorded by the donor co-ordinator as to the progress of the recipients on days 7, 14, and 18.

In the event that any unusual signs and or symptoms are noted then the donor co-ordinator is to inform each of the transplant teams of the existence of the other and requests that they

communicate directly with cach other about their patient’s progress,

FINDINGS

I accept and adopt the conclusions of Dr Michael Burke that the temporal relationship between the deaths of Ms Gurpal Sandhu, Ms Karen Wilkinson and Mrs Carmelina Sirianni and the underlying cause of death in cach case, is the LCMV-like virus. Ms Gurpal Sandhu, Ms Karen Wilkinson and

. Mrs Carmelina Sirianni were the recipients of organs donated by Mr Jovo Vranjesevic.

The LCMV-like virus is a novel arena virus — not previously seen or seen since, in Victoria.

AND I accept the evidence of Dr Burke that Mr Vranjesevic died with the LCMV-like virus as

opposed to “of the virus’”™,

• note: evidence of A/P Spelman (@ T p 182) LCMY has been identified, in colonies of rodents including hamsters 3-1 @ p 182

“ DonateLife in any event albeit for a different purpose make contact with the recipients. In this case initial contact oceurred on 12 December — some 8 days post transplant

ST @pis

22 of 26

AND I find that the screening process which identified Mr Vranjesevic as a suitable donor was reasonable and appropriate in the circumstances and of itself could not have added any additional information that was likely to have altered the outcome, The history of recent significant weight loss as it was understood by the family was communicated to the transplant team. As Mr Fink

stated:

The potential clues in this donor that some infective process may have occurred were the facts that he had spent 3 months in Serbia and that he had lost 15 kg in weight over 3 moths. However, our unit was informed that his weight loss had been deliberate. The decisions regarding whether a donor organ should be used or not are complex and involve an assessment of the balance of risks to the potential recipient of transplanting the organ versus the risk of waiting for the next suitable

organ,*®

The real or actual significance of the weight loss remains speculative.

AND [heard no evidence that the organ donation and transplantation procedures in Victoria are not rigorous, Potential donors and their families and recipicnts and potential recipients and their families have no reason not to have confidence in organ donation and transplant procedures arising from the circumstances of these tragic deaths. Mr Vranjesevic’s death was sudden and unexpected yet his family altruistically consented to the donation of his organs at a time when they had barely come to terms with their own loss. The three recipients all required transplantation, They had all provided consent to the procedure once a donor became available. The potential opportunities for improvements to quality of life and prolongation of life that a transplant offered each of them was

not realised and instead tragically, they succumbed to the novel virus.

As Dr Fink stated:

We need to bear in mind that we don’t want to lose potential good organ donors because there is a great need in the community for transplantation and we have quite a low donor rate in this country, so we need to do everything we can for the transplant side while

maintaining safety. 7

86 Exhibit 9 — Statement of Mr Michael Fink dated 25 September 2008 "T @ p87

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AND I find that the deaths from this novel arena virus of the three organ recipients, Ms Garpul

Sandhu, Ms Karen Wilkinson, and Mrs Carmelina Sirianni was neither foreseeable nor in all

probability, preventable. Earlier identification and communication of the like complications being

experienced by the three recipients in the post operative period would have lead the clinicians to

consider sooner that the likely cause of deterioration emanated from the donated organs and enabled

better and more accurate communication with the familics, however, it is not possible to say that it

would have in fact altered the tragic outcomes.

RECOMMENDATIONS

Pursuant to section 72(2) of the Coroners Act 2008, I make the following recommendation(s) connected with the death:

1. Inter and intra hospital communication post transplant

(a)

(b)

(c)

To improve on intra and inter hospital communication and minimise the risk of adverse outcomes, I recommend that DonateLife be authorised by the hospitals performing transplant surgery to extend their liaison role in the post transplant period to accept responsibility for intra and inter hospital communication regarding the progress and /or usual/unusual symptoms and/or complications of donor organ recipients in

circumstances where there are more than one recipicnt of organs from one donor.

AND having regard to the evidence of Mr Michell who stated:

. the average length of stay would be seven days, that if there are significant issues around about a week after transplant, that (sic) we should be sure to communicate

with the other teams,*®

T recommend that DonateLife commence this liaison with the transplant teams seven days post operatively and continue with this intra and inter hospital communication

every 48 hours thereafter until the discharge of the recipients,

AND to facilitate this intra and inter hospital liaison and commumication in circumstances where the sage physician” is considered more appropriate than the

transplant co-ordinator, T recommend that on the occasion of each recipient organ

87 @ p 322

© T @p 324

2A al 26

transplant procedure the hospital nominate who is to be the designated contact person for

DonateLife to communicate/liaise with.

FURTHER CONCLUDING COMMENTS Although the following further comments arises from evidence touching upon the death of Mrs

Carmelina Sirianni they are of sufficient importance to repeat them here.

Poor communication to a paticnt’s family is a constant theme which was highlighted in the evidence

of Sam Sirianni,

Nobody communicated anything to us unless we demanded information, It seemed that

nobody was doing anything. *

A confounding concern for Mrs Sirianni’s family was their distress observing her deterioration during her post operative period and their perception of the lack of concern and lack of attention to her care by the health care providers. Unfortunately, similar such reporting by family members of a deceased is not uncommon in this jurisdiction, Complaints of poor communication and/or the lack thereof from the professionals to a family arises with such frequency that it compels comment. The comment may appear trite but cannot be underestimated in importance. Health care providers need to improve on the time and attention they give to family members concerned for the welfare of their loved ones with whom they have trusted to the health professional’s for care. Regular communication in plain language cannot be underestimated in importance particularly when care is prolonged, complicated and critical, But I am confident that health care providers per se appreciate the power of knowledge but often fail to deliver. If a family actually know and understand what is happening during the course of hospitalisation their ability to come to terms with the death of their

loved one greatly improves. Anger and allegations of poor care are too, often diminished,

Pursuant to section 73(1) of the Coroners Act 2008, I order that this Finding be published on the internet.

» Exhibit 10 — Statement of Sam Sirianni dated 26 February 2010, T @ p 97

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Pursuant to section 73(1) of the Coroners Act 2008, I order that this Finding be published on the internet.

I direct that a copy of this finding be provided to the following: Mr Sanjit Singh DLA Piper Australia

DonateLife Victoria

Signature:

va a

AUDREY.JAMIESON CORONER =~

Date: 7 May 2013

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