A number of elements have come together over the last few weeks to have me thinking about the expectations we should have of the software and systems we deploy to aid the delivery of clinical care.
First there was a very lively discussion that emerged on the GP_TALK e-mail list which discussed the various issues that surround the handing of clinical results arriving into Patient Management Systems. The discussion was triggered by a question on just what the legal responsibilities were to monitor the incoming areas for arriving results from pathologists, radiologists etc and who was legally liable if an important result went astray and just what the dividing line, if any, was between the test orderer, the result provider and the result receiver / reviewer.
The interest in this topic is considerable because of previous legal liability decisions which make it clear it is the court's view that when a clinician orders an investigation which has the possibility to reveal 'clinically significant' information the practitioner has a considerable legal onus upon them to ensure they have systems in place to ensure that they will, within a reasonable period of time, note and act on the results as they are received.
Second there have been a number of concerns expressed by a range of authorities considering what expectations should be held for the functionality, reliability, usability and clinical safety of software designed to be used by clinicians. This is seen as encompassing areas such as scope, currency, accuracy and reliability of clinical decision support, the aspects of the system design that facilitate safe and consistent use of the software as well as the overall functionality offered.
Third the CEO of HealthLink (Mr Tom Bowden) recently wrote a discussion paper highlighting the problems that can arise if there is not 'end to end' accountability for the entire investigation ordering cycle – covering ordering, processing, resulting and review. This paper clearly recognises the need for substantive co-operation between clinical messaging providers and developers of clinician systems to ensure highly effective integration and the practical removal of any risk of important information 'falling between the cracks'.
This paper – in its current version – can be found at the following URL
http://www.healthlink.net/healthlink_documents/brochure/Electronic%20messaging%20safety%20Issues%20-%20HealthLink%20viewpoint.pdf
Fourth, as best I can tell, NEHTA has articulated no policies or plans in the area of clinical software quality and safety to date, and has not been sponsoring any publicly announced programs in the area.
Fifth, if discussions in GP e-mail forums are to believed, there are some real issues regarding to responsiveness of providers of GP software to both functional gaps and ‘bugs’.
Lastly, to date, while there has been medical software industry contribution work to support the health information Standards development process, there have been limited real outcomes in terms of data portability and interoperation between GP applications. We lack any Australian Standards for patient data portability, for medical software quality and for the quality of functionality and decision support provided.
None of these issues are exactly new, but their emergence does serve to highlight that there are considerable risks associated with having an e-health environment which is fragmented in terms of how quality and safety issues are addressed.
What is needed is really quite clear – a clear division of labour as to who is responsible for which part of the information chain and accountability on the part of all to deliver as fail-safe and reliable solutions as is humanly possible.
It seems to me there needs to be some form of national round table convened which brings together the patient management system developers, the messaging providers, result providers, expert clinicians and health informaticians to develop a framework under which responsibility for each part of the chain can be identified and those involved can then work to develop approaches and solutions which will solve the problem and obviate the risk of computerisation of General Practice being seen as a cause of patient harm.
Ideally all this could be handled in the form of a range of Industry Codes of Practice perhaps combined with appropriate Standards in the relevant areas. There is also a place for entities like the Australian Health Messaging Laboratory (AHML) to provide certification of conformance to agreed Standards to ensure safe inter-operation can be essentially guaranteed. Additionally the round table could consider the role of standardised approaches to interoperation between the various systems involved. Certification of GP systems may also need to be considered if progress in this area does not follow reasonably soon.
It is important for all involved to be very clear that we are only one Coroner's Case or Supreme Court decision away from compulsory application of solutions that may be neither ideal or in-expensive, so delay would be unwise. Recognition of the problem on the part of Medical Defence organisations is also likely to result in pressure to ensure safe and reliable systems are available and used.
It is also clear that well designed practice management systems can greatly assist in ensuring all important results are received (or followed up if not) and actioned appropriately once received. The issue is not if GP computing is needed or not – it clearly is. The issue is to be sure what is functional, safe and reliable and fully meets the needs of its users. I am not yet convinced the ‘market’ has sorted these issues out adequately and the patience of the GP community of users should not be too elastic.
Hopefully the area of the quality and safety of GP computing will be one that will be incorporated in the National E-Health Strategy, which I believe the new Australian Health Information Council should be developing. They should not see taking their time on this issue as an option!
David.
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