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.
- 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.
- 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.
- 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.
- 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.
- 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.
- The report found that SA Pathology’s complaint handling, open disclosure, governance and accountability systems during this period was totally inadequate.
- 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.
- 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.
- 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:
- 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.
- 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.
- When the issue received public attention, appropriate action was, and has since been taken, to identify the patients affected and notify their treating clinicians.
- 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
- The review found that SA Pathology failed to properly monitor and respond to the alerts from its automated testing.
- 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.
- 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.
- 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.
- 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.
- 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.
- The review included a recommendation to engage an appropriately qualified and experienced person to implement an organisation structure for SA Pathology that:
- i. aligns appropriately skilled staff placement with the operational needs of the service;
- ii. provides adequate clinical expertise to monitor and inform the production of results;
- iii. clearly defines the responsibilities and accountabilities of staff; and
- iv. ensures the requirements of referring clinicians are reﬂected in the work rules of the service.
2. Bankstown-Lidcombe Hospital Medical Gas Findings Report
- 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.
- One of the babies died and the other has been left with serious health issues.
- Dr Kerry Chant’s report was provided to the families of the two babies on Friday morning, 26 August.
- 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
- 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
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.
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:
- 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.
- Involving a multi-disciplinary team is important because the team provides peer review and a check and balance.
- 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.
- In one of the cases disharmony in culture appears to be a contributing factor.
- 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.
- Adverse event reporting, investigation, root cause analysis, look back, open disclosure and communication and media policies should be in place and followed.
- In both cases, management accountability is raised.
- In both cases, the use of technology, such as software, could have been used to identify the issue.