Motions

Chemotherapy Treatment Error

Adjourned debate on motion of Hon. J.A. Darley:

1. That a select committee of the Legislative Council be established to inquire into and report on the chemotherapy dosing errors at the Royal Adelaide Hospital and Flinders Medical Centre in 2014 and 2015, with a focus on—

(a) the extent, if any, to which the culture, governance and management of the relevant hospital departments and their associated statewide services contributed to the risk of errors and the risk of similar errors in the future;

(b) SA Health's and the government’s response to the errors, including the inquiry led by Professor Marshall and the interaction with the inquiry;

(c) the impact of risk management, including management of legal risks, on the support of victims and the transparency of the health system, in particular the use of confidential agreements in this context; and

(d) any other related matter.

2. That standing order 389 be so far suspended as to enable the chairperson of the committee to have a deliberative vote only.

3. That this council permits the select committee to authorise the disclosure or publication, as it sees fit, of any evidence or documents presented to the committee prior to such evidence being presented to the council.

4. That standing order 396 be suspended to enable strangers to be admitted when the select committee is examining witnesses unless the committee otherwise resolves, but they shall be excluded when the committee is deliberating.

(Continued from 24 February 2016.)

The Hon. T.T. NGO (16:16): The government opposes this motion. As the Minister for Health has previously stated in the middle of last year, the government became aware that, over a period of six months during 2014 to 2015, five patients at the Royal Adelaide Hospital and five patients at the Flinders Medical Centre were given an incorrect dosage of the chemotherapy drug cytarabine, receiving one dose a day instead of two during their treatment.

As a result of this, an independent panel of experts was commissioned in August 2015, led by Professor Villis Marshall, to review the events and decisions that led to the underdosing. Professor Marshall is the chair of the Australian Commission on Safety and Quality in Health Care—a government agency that leads and coordinates national improvements in safety and quality in health care across Australia. He also has an extensive background as both a clinician and manager. The panel included members with expert knowledge, skills and experience in a number of key areas, all of whom are highly respected in their fields. The panel included:

Professor Robert Lindeman, Consultant Haematologist, Prince of Wales Hospital, New South Wales;

Ms Elizabeth Newman, Senior Nurse Practitioner Haematology, Concord Repatriation General Hospital, New South Wales;

Dr Christine Carrington, Senior Consultant Pharmacist—Cancer Services, Princess Alexandra Hospital, Queensland;

Ms Ellen Kerrins, Health Consumers Alliance, South Australia; and

Ms Julie Marker, Cancer Voices SA.

The review undertaken by the panel was extensive and their report, which is publicly available on the SA Health website, was damning. The panel found that the underdosing was caused by a series of significant clinical governance failures at the Royal Adelaide Hospital haematology unit. Among them was the failure to follow routine clinical processes and procedures and not advising patients that the chemotherapy protocol was a non-standard protocol that required approval from the relevant committee and informed patient consent.

In addition, the panel found that certain clinical staff did not comply with SA Health incident management and open disclosure policies, including not conducting timely and appropriate open disclosure with patients. The panel made four recommendations, all of which have been accepted by SA Health.

Following this review's recommendations, I have been advised that eight clinicians have been referred to the Australian Health Practitioner Regulation Agency (AHPRA). AHPRA has sweeping powers embedded in legislation to investigate concerns about health practitioners' conduct and practice on behalf of national boards, including the Medical Board of Australia. AHPRA has the authority to make recommendations to the Medical Board of Australia, including deregistration of medical practitioners.

Taking into account the findings of the review, SA Health is also conducting a further internal investigation into this issue. This serious high-level inquiry is focusing on all relevant material and documents to provide a comprehensive insight into this complex case. As in any similar investigation, should adverse conduct be discovered a range of actions, including disciplinary measures, will be available.

While in principle the government would support a parliamentary inquiry into this matter given its gravity, such an inquiry should be deferred until, in particular, AHPRA has concluded its investigation. It is important that ongoing investigations, including any disciplinary proceedings, are not compromised in any way. A parliamentary inquiry would not be run in parallel to either a police investigation or a trial. As an investigation by AHPRA is a serious investigation embedded in legislation the same principles should be applied.

As the review led by Professor Marshall stated, this has been a serious failure in clinical governance. Patients need to feel safe when they are being treated in our health system, and the fact that the systems put in place to protect patients have not been followed is unacceptable. The referral of clinicians to AHPRA is a significant and serious outcome and this investigation must be allowed to run its course; therefore, the government at this stage opposes this motion.

The Hon. S.G. WADE (16:22): I appreciate that the Hon. Tung Ngo is speaking on behalf of the government, so this is a comment against the government's response rather than holding Mr Ngo accountable personally, but I think the victims of the chemotherapy dosing bungle will be very disappointed with that speech. They had been led to believe by the minster himself that the government was going to support this inquiry. I will refer the honourable member and the government to the minister's comments in the House of Assembly on 25 February 2016. The minister said:

I have met with Mr Knox, and my office in fact has been in constant contact with Mr Knox since that meeting to check on his welfare and his general satisfaction with the actions we are taking…Now, there is no doubt that Mr Knox has a particular view with regard to…the parliament undertaking a review. I have said to him, as I have said publicly, I'm quite comfortable with a parliamentary inquiry into this matter; it is of sufficient seriousness to warrant a parliamentary inquiry. However, I do caution members opposite, and members in the other place: they shouldn't take any action which in any way compromises either the investigations currently underway within SA Health, the disciplinary processes in place within SA Health or, more importantly, the AHPRA investigations.

Clearly in that statement on 25 February the minister was fully accepting that a parliamentary inquiry could be undertaken on the terms of reference that the Hon. John Darley had already filed. The caveat was as long as the inquiry was conducted in a way which was respectful of other investigations.

I think that the minister was right on 25 February when he implied that it was possible to conduct a parliamentary investigation in an orderly fashion without compromising those—and let me explain some of the reasons why I think the minister on 25 February was right and the government today is wrong. A lot of the material in the Villis Marshall report has nothing to do with individuals. The Hon. Tung Ngo's comments particularly focused on the disciplinary procedures against eight individual practitioners as a result of the Villis Marshall report. The Villis Marshall report is extremely strong in highlighting cultural issues. I will quote one clause:

The review panel found the underlying cause that led to the incorrect protocol being used was a failure of the RAH Haematology Unit to have appropriate governance systems in place and the lack of adequate processes and procedures for the development, review and publication of their chemotherapy protocols.

No individual practitioner would ever be sent to AHPRA for something like that. It is an issue of culture, governance, and that is why I think the Hon. John Darley is very wise to put in subparagraph (a), which provides:

The extent, if any, to which the culture, governance and management of the relevant hospital departments and their associated statewide services contributed to the risk of errors and the risk of similar errors in the future;

The importance of organisational reviews and system reviews is highlighted in SA Health's own procedures in relation to incident reviews. One of the review mechanisms available to SA Health is root cause analysis. One of the reasons why that is confidential is because of the importance that the system places on the system itself learning from incidents. If you like, it stands in counterpoint to the more adversarial charging of individuals and identifying the individual at fault.

It is the system, if you like, learning from itself. I think paragraph 1 is an opportunity to look at organisational and cultural issues. It has nothing to do with AHPRA and nothing to do with interfering with current investigations. The second paragraph in the Hon. John Darley's motion talks about SA Health's and the government's response to the errors, including the inquiry led by Villis Marshall and the interaction with the inquiry. I think one of the issues here which is extremely important is the way the system, as soon as an error occurred, seemed to almost distance itself from the people who, up until now, it had been caring for.

Mr Andrew Knox, one of the victims, talks about repeated promises of what I would call pastoral care that just were not fulfilled. It is almost as though the institution became self protective and turned from being a caring, clinical agency into a distant, cold agency. Certainly Mr Knox speaks positively about the interactions with a number of individuals, but I think it would be fair to say that he regards the local health network that he was dealing with as not providing the support they promised. That has nothing to do with AHPRA. That has nothing to do with the eight individuals who are being reported as a result of the Villis Marshall review.

Subparagraph (c), which I would also suggest to the Hon. Tung Ngo and to the government can proceed without any inhibitions, is the actual subparagraph that the Hon. John Darley first raised in the context of a matter that required investigation. Significantly, this was, as I understand it, before Mr Knox raised his concerns publicly. Public concerns were raised in relation to the McRae family, I believe, in relation to a gag on victims in relation to confidentiality agreements.

The Hon. John Darley rightly expressed outrage that people who are subject to adverse outcomes in our health system can be drawn in to a legalistic process whereby they are gagged and not able to express their concerns. After all, not only do they have the right, within bounds, to freedom of speech but also the public has a right to know. We saw the government admit recently that there have been 21 patient record breaches in the last year, none of which the public had been made aware of. The first 13 cases were as a response to a media revelation and then another eight in response to the minister making a ministerial statement in the other place.

My point here is that we need to balance the right of the victims themselves to speak freely with the right of the public to know and hold its own health system accountable for the quality of care that it provides. At this point, I will move the amendment standing in my name, because I would like to speak to that as another example of how this inquiry can proceed without in any way breaching the caveat. I move:

After paragraph (b) add new paragraph (ba)—

'(ba) the suitability of SA Health's incident management processes in terms of patient safety, transparency and institutional risk management;'

This amendment comes out of more recent events. The Villis Marshall report does highlight on page 16 the issue of failure to use the SA Health incident reporting system. Again, it highlights that there are significant issues in SA Health that have nothing to do with the eight individuals in relation to AHPRA. Let me read paragraph 84 of the review panel report:

The SA Health Incident Management Policy requires an incident of this type be reported in the SLS and managed in a timely manner.

My understanding is that SLS is the Safety Learning System. Paragraph 85 says:

This policy was not followed by the RAH staff who became aware of the incidents on 19 January 2015, but did not finish reporting the incidents into the SLS until 17 February 2015.

To be fair, up until that point, that is probably an AHPRA matter. In terms of those particular incidents, the committee should be careful looking at those, so that it would not prejudice an investigation. The review panel report goes on:

The review panel formed the opinion that this was not a one off occurrence of non-compliance as the panel was informed that medical staff the RAH did not frequently lodge incidents in the SLS and were slow to respond, if at all, when asked to review an incident that had been lodged by someone else.

The government might want to avoid an investigation by saying, 'Well, it's only eight people and they've been referred to AHPRA.' What the review panel found is that we have systematic noncompliance with the incident reporting system at our major hospital. I, for one, think that is worth looking at. I would suggest to members that this term of reference join a worthy bundle of issues worth looking at that have already been put on the record in the Hon. John Darley's motion.

In closing, I will mention that this term of reference, I believe, would also give the committee an opportunity to consider the concerns raised by the State Coroner in relation to the operation of the root cause analysis process in SA Health. Root cause analyses do get a mention in the Villis Marshall report. They get a mention only because it did not happen. Paragraph 88 of the Villis Marshall report states:

It appears to the review panel that when the error was discovered, the RAH considered the underlying cause to be that of a transcription error which required no stringent investigation. They did not undertake the level of investigation required by the SA Health Incident Management Policy and did not conduct a root cause analysis investigation as requested by the South Australian Department for Health and Ageing.

I find that statement concerning because, if the Department for Health thought a root cause analysis was important enough to be conducted in this case and they requested that specifically, why did it not happen? Presumably, the local health network had a reason not to comply with that request, but there is nothing there as to what led to the root cause analysis not being proceeded with. That said, it is a non-use of the root cause analysis process, but the State Coroner recently raised his concerns publicly about the potential for SA Health's incident management process, and particularly root cause analyses, in actually depriving other mechanisms for review, such as the state coronial processes.

My understanding is that the State Coroner, not in relation to a public hospital but in relation to a private hospital, understood that there is a case where there is evidence that a reportable death was not reported to the Coroner in accordance with the Coroners Act. I do not know the details, but on the face of it that is a very concerning situation. The whole point of the Coroners Act existing is to make sure that we maintain safe processes in a whole range of contexts so that future deaths can be avoided.

I bring my remarks to a close by saying that I am very disappointed that the government, contrary to the commitments the minister gave in the House of Assembly, has chosen not to support this committee. I believe that there are a number of important matters on which a parliamentary inquiry can shed light. I am disappointed that the minister and the government have not acceded to the request, particularly of Mr Andrew Knox, and convened a judicial inquiry, but in the absence of the government's willingness to facilitate that I think parliament needs to step up and do what it can.

The Hon. J.A. DARLEY (16:36): I thank honourable members for their contributions and for the opposition's support on this motion. I would also like to thank Mr Andrew Knox, who has been tireless in his efforts in getting to the bottom of this matter. As mentioned when I introduced this motion, Mr Knox was one of the 10 people who were affected by this bungle. He had been very vocal in wanting to find out who was responsible and he believes that a parliamentary inquiry is integral to that.

The Minister for Health has publicly stated that, whilst he is supportive of a parliamentary inquiry, his preference would be to wait for an outcome from the Australian Health Practitioner Regulation Agency's inquiry. AHPRA is conducting an investigation as a result of complaints they received against eight practitioners who were allegedly involved in the matter. However, Mr Knox has been advised that AHPRA's investigation may take more than a year. Notwithstanding that the terms of reference for this inquiry differ quite significantly from what AHPRA will be looking at, some people affected by the underdosing simply do not have 12 months up their sleeve. They face the very real possibility of not being here in a year's time, and I believe they deserve all the answers they can get.

Allegations have been made that the culture amongst staff at SA Health allowed for this matter to be covered up, even when the mistake was uncovered. If this is true, this is absolutely disgusting and needs to be exposed immediately. More importantly, if such a culture exists, it needs to be urgently addressed and rectified. Those affected by the underdosing deserve this.

The issue of confidentiality clauses which attempted to gag affected patients is also concerning, as a matter of this magnitude would clearly have great public interest and, frankly, the people of South Australia have a right to know about these things. They should not be dealt with in a cloak-and-dagger way, and further investigation of risk management procedures is warranted. Not only do those affected by the underdosing deserve this, but the people of South Australia deserve this.

I have previously stated my dismay at the government's reaction to this matter, especially when compared with its response to privacy breaches within SA Health. I understand that two SA Health employees have been dismissed for the unauthorised access of patient records, and SA Health's chief executive, Mr David Swan, has stated that anyone else who has been found to be accessing records without authority will be dismissed immediately.

The minister has also made a statement that SA Health would publish details of SA Health staff who had been disciplined for inappropriately accessing patient records. It astounds me that he is not equally outraged about the underdosing of 10 patients, which may cost them their lives. I am also dumbfounded that the minister waited over two months to refer complaints about the eight practitioners to AHPRA, given that this was a key recommendation in the report by Professor Marshall. The government's response to this serious matter needs further investigation. Having a parliamentary inquiry is the least that those who have been affected by the underdosing deserve. With that, I urge honourable members to support this motion.

Amendment carried; motion as amended carried.

The Hon. J.A. DARLEY (16:40): I move:

That the select committee consist of the Hon. John Dawkins, the Hon. Andrew McLachlan, the Hon. Gail Gago and the mover.

Motion carried.

The Hon. J.A. DARLEY: I move:

That the select committee have power to send for persons, papers and records and to adjourn from place to place and to report on 6 July 2016.

Motion carried.