Australia: Clinical governance update - Review of serious failures in reported test results...

Last Updated: 27 September 2016
Article by Alison Choy Flannigan

for Prostate Specific Antigen (PSA) Testing of Patients by SA Pathology; Bankstown-Lidcombe Hospital Medical Gas Findings Report

Clinical governance is the term used to describe a systematic approach to maintaining and improving the quality of patient care within a clinical care setting, health program or health system. It is about the ability to produce effective change so that high quality care is achieved. It requires clinicians and administrators to take joint responsibility for making sure this occurs.2

Australia has an excellent health care system, one of the best in the world. However, no health care system is perfect and on occasion, adverse events occur and errors are made. We have a positive obligation to prevent them from occurring. Clinical governance is the system tool which should act as a "safety-net" in order to prevent adverse events occurring and to effect change such that improvements can be made.

There have been two recent reports which have touched on the issue of clinical governance:

This article discusses each case briefly and draws out the clinical governance lessons for health and aged care providers, so that they may learn from these experiences to improve future patient outcomes.

  1. Review of Serious Failures in Reported Test Results or PSA

The Australian Commission on Safety and Quality in Health Care published its report titled "Review of Serious Failures in Reported Test Results for Prostate-specific Antigen (PSA) Testing of Patients by SA Pathology" in July 2016. The Report is discussed below.

1.1 Facts

  1. From March 2015, SA Pathology began reporting levels of Prostate-specific Aantigen (PSA) in patients at low levels following requests from urologists who found the results useful in monitoring their patients who had their prostates removed – as men without a prostate gland should have no detectable PSA. The presence of PSA, even at low levels, may indicate the need for further treatment.
  2. From 7 November 2015 the assay lots used by SA Pathology to detect PSA were inaccurate between the ranges of 0.03 – 0.08 micrograms per litre (ug/L) with a positive bias of 0.03 ug/L. Consequently, the PSA results for patients reported from this date, within this range, showed detectable PSA levels where PSA was undetectable, and higher levels of PSA where there were low detectable levels. From 17 March 2016 SA Pathology reported tests on two different methods simultaneously.
  3. The report states that SA Pathology failed to act on the inaccurate PSA results despite technical warnings generated by their laboratory systems. One potential warning was inadvertently switched off and another was noted without its potential to detect the error being realised.
  4. SA Pathology did not become aware of the inaccurate results it was producing until a complaint from a urologist at the end of January 2016. The complaint was wrongly classified with a low level of severity and, although SA Pathology did take the appropriate action to determine the cause of the inaccurate readings, that action was slow and not consistent with the urgency of the situation.
  5. Complaints continued to be made to SA Pathology about PSA results through February and March 2016. SA Pathology determined to discontinue the defective test from six months after dual reporting was introduced. Until then, SA Pathology continued to report the inaccurate results to clinicians. On 18 March 2016, SA Pathology wrote to all urologists explaining the problem with the test and the move to a new test, and placed a notice on the SA Pathology website. The public notice was framed as a routine notice without sufficient explanation to be considered as adequate notification to the public.
  6. The report found that SA Pathology's complaint handling, open disclosure, governance and accountability systems during this period was totally inadequate.
  7. Following media exposure of the issue in early April 2016, significant and appropriate action was taken by SA Pathology. A "lookback" process was commenced to identify the number of patients affected by the inaccurate tests.
  8. The review found the management structure of SA Pathology did not provide for sufficient clinical supervision of, and accountability for, laboratory process. The review was briefed regarding a separate management review of SA Pathology which considered SA Pathology's structure dysfunctional and different from contemporary management structures in place in pathology laboratories throughout Australia.
  9. The review's expert chemical pathologist analysed data from SA Pathology and determined that the test kits in question were inaccurate at levels of 0.03 – 0.08 ug/L. As these kits were distributed to a number of laboratories in Australia, the review has provided its expert advice to the manufacturer and the Therapeutic Goods Administration.

1.2. Summary of Major Findings

The review made the following findings:

  1. SA Pathology's internal quality assurance processes were inadequate. SA Pathology failed to act on technical warnings from the laboratory system that the tests were inaccurate in low level PSA test results from assay kits in use from 7 November 2015. No action was taken until a complaint from a urologist in late January 2016.
  2. The complaint was not given the appropriate level of attention and SA Pathology's investigations were slow. When SA Pathology did finally determine that the problem resulted from the test kits it was using, its action to notify affected users was totally inadequate and failed to appreciate the anxiety and distress of the inaccurate results on those patients who received the results.
  3. When the issue received public attention, appropriate action was, and has since been taken, to identify the patients affected and notify their treating clinicians.
  4. Management, governance and accountability at SA Pathology was seriously deficient. The review agrees with the findings and proposals of a separate management review recommended a restructure to bring SA Pathology in line with management practices in place at comparable Australian providers.

1.3. Clinical Governance Lessons

  1. The review found that SA Pathology failed to properly monitor and respond to the alerts from its automated testing.
  2. Whilst concern was mounting among urologists and their patients who were calling SA Pathology to express their concern, these calls were not formally treated as complaints as they should have been, and consequently there were no entries in Q-Pulse and the Safety Learning System.
  3. The classification of the first complaint with a severity assessment code of 4 was inconsistent with the serious nature of the issue and the potential number of patients affected. The low classification also had the result that more senior staff in both SA Pathology and SA Health were not notified and did not have the opportunity to consider how it should be managed.
  4. The clinical significance of the inaccurate low level PSA readings was not appreciated and action to investigate the cause was not pursued with any sense of urgency.
  5. The severity of the problem was underrated resulting in no senior level notification and investigation as required by policies. There was no attempt to identify affected patients and no attempt to develop a comprehensive plan to notify them despite the knowledge that the inaccurate tests result could lead to misdiagnosis and unnecessary treatment.
  6. During the review it became apparent that the structure of the organisation did not provide sufficient clinical input and management accountability at appropriate levels, and quality assurance procedures were not sufficient to identify emerging issues and problems and ensure appropriate management.
  7. The review included a recommendation to engage an appropriately qualified and experienced person to implement an organisation structure for SA Pathology that:
    1. aligns appropriately skilled staff placement with the operational needs of the service;
    2. provides adequate clinical expertise to monitor and inform the production of results;
    3. clearly defines the responsibilities and accountabilities of staff; and
    4. ensures the requirements of referring clinicians are re?ected in the work rules of the service.
  1. Bankstown-Lidcombe Hospital Medical Gas Findings Report

2.1 Facts

  1. The NSW Chief Health Officer's Final Report into the Bankstown-Lidcombe Hospital medical gas incident was released on 27 August 2016 and found a series of tragic errors led to the failed resuscitation of two babies.
  2. One of the babies died and the other has been left with serious health issues.
  3. Dr Kerry Chant's report was provided to the families of the two babies on Friday morning, 26 August.
  4. The two babies were born at Bankstown-Lidcombe Hospital earlier this year – one in June and the other in July. Both babies needed resuscitation after birth.

2.2 Major Findings

  1. Dr Chant's report found that mislabelling of existing gas pipes resulting in incorrect installation of additional medical gas pipes in one of the Bankstown-Lidcombe Hospital's operating theatres, which was not picked up during installation or by the testing and commissioning of the pipes, led to the two babies being resuscitated with nitrous oxide instead of oxygen. The process of testing for gas purity is the ultimate test to ensure that the right gas comes out of the right outlets.

2.3 Clinical Governance Lessons

  1. The report also found broader clinical and corporate governance issues at the Hospital, specifically around the project planning and risk management of the commissioning of clinical infrastructure.
  2. A recommendation was to review senior management's role in the broader governance (both clinical and corporate) of the commissioning of clinical infrastructure at the hospitals.

Commentary and Summary of Clinical Governance Lessons Learnt

There are some common clinical governance themes which run through these two cases, including as follows:

  1. In each case, there was an indicator that there was an issue, however, for one reason or another, the issue was not escalated appropriately to senior management. Health care providers must ensure that there is adequate ability for staff to notify their concerns to senior management, through a number of alterative avenues and staff should be trained on severity indicators.
  2. Involving a multi-disciplinary team is important because the team provides peer review and a check and balance.
  3. It is really important to check that what you are doing is in accordance with a manner that (at the time the service was provided) was widely accepted in Australia by peer professional opinion as competent professional practice. This was an issue in both cases.
  4. In one of the cases disharmony in culture appears to be a contributing factor.
  5. In one of the cases, for various reasons, there was a delay in dealing with the issue once it was raised to senior management. If there is a significant issue, then the matter needs to be escalated and dealt with urgently by senior management.
  6. Adverse event reporting, investigation, root cause analysis, look back, open disclosure and communication and media policies should be in place and followed.
  7. In both cases, management accountability is raised.
  8. In both cases, the use of technology, such as software, could have been used to identify the issue.


2 Definition derived from the Clinical Governance web page on the NSW Ministry of Health website (

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on

Click to Login as an existing user or Register so you can print this article.

Some comments from our readers…
“The articles are extremely timely and highly applicable”
“I often find critical information not available elsewhere”
“As in-house counsel, Mondaq’s service is of great value”

Mondaq Advice Centre (MACs)
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at and we will use commercially reasonable efforts to determine and correct the problem promptly.