The following article appeared today.
Patient safety a mystery at Health
- by: Karen Dearne
- From: Australian IT
- December 23, 2011
THE federal Health department is in the dark about patient safety implications in its introduction of the personally controlled e-health record program.
The department is responsible for the rollout of the Gillard government's half-billion-dollar system, and is now in a rush to have it operational by July 1.
Sharon McCarter, head of the eHealth Systems and Implementation branch, has told The Australian the department does not have any patient safety risk assessments in relation to the huge IT and change management project.
The Australian recently lodged a Freedom of Information request for "any document of any name performing the function of examining risks to patient safety and/or examining the risks from the perspectives of patients".
Clinical risk assessments should contain detailed analysis of all potential software error scenarios, provide a guide to identifying and reporting flaws and address mitigation procedures.
But the FOI request has been declined by Ms McCarter "as the documents do not exist".
"We have undertaken reasonable steps to identify any documents relevant to your request held in the department, including a thorough search of the department's electronic and paper records and the department's contracts listed on AusTender,” she wrote in the rejection letter.
"The department has been unable to identify any document we hold at this time (that is) relevant."
Instead, Ms McCarter said, Nehta was responsible for ensuring patient safety.
"As part of Nehta's role to develop, maintain and assure the PCEHR solution architecture and high-level design of the system, Nehta conducts ongoing clinical safety assessments," she said.
Nehta has previously insisted that its two-year-old clinical safety unit is "fully embedded" into all areas of software product development, despite not having produced any formal reports on IT systems and patient safety.
The authority is exempt from Freedom of Information laws, despite taxpayers funding it through both state and federal taxes.
But Australia’s Information Commissioner, John McMillan, has said that any Nehta documents held by the commonwealth in its capacity as shareholder would be subject to FOI requests.
“Any document in the possession of a government agency or minister, no matter where it came from, that document is subject to the FOI Act,” Professor McMillan told a Senate estimates hearing earlier this year.
Health department secretary Jane Halton is a director of Nehta, and the federal government provides half of its funding.
Liberal Senator Sue Boyce this year called for an overhaul of Nehta's structure, citing its lack of public accountability, and for a pause in the PCEHR rollout.
"The board of Nehta is currently all the secretaries of the jurisdictional Health departments. An independent chair, David Gonski, has been appointed as a nod towards the lack of commercial experience amongst the other directors,” she said.
"I would prefer to see a board similar in structure to the Australian Institute of Health and Welfare, with a mix of stakeholder and government appointees.
"The answer to getting an e-health system ready to 'burst out the front door' will not be easy but it starts with accountability and transparency," Senator Boyce said.
Health would not confirm whether any staff members had seen any patient safety documentation, nor whether there were any concerns about potential adverse events.
A department spokeswoman said the PCEHR system "is being built on the basis that integration to the system will be governed by a range of defined specifications and standards".
But The Australian understands the fast-track "tiger teams" process is in disarray, following delays in finding volunteers and the late release of thousands of pages of both old and new documentation still to be pulled into shape as useable specifications.
Key specifications were due for completion by November 30, as they are needed by the Accenture consortium for its build of the core PCEHR infrastructure, and by the lead implementation sites.
Reliance on a large number of entirely new and untested specifications will inevitably heighten clinical risk factors.
The Australian asked the department whether its lack of information on safety issues represented inadequate oversight, a poor understanding of the risks and unacceptable project management practice.
The Health spokeswoman replied: "Clinical safety is one of a number of important elements to ensure that the system will be safe to use when it is implemented.
"Nehta has embedded clinical safety assessment throughout their design process and holds the relevant documentation to support those assessments."
However, Nehta has not made that documentation available to software vendors and has previously refused to provide any such information to The Australian.
Lots more here:
I alerted readers to the issue being recognised in the US a month or so ago - see here:
In this article I pointed out there was serious concern in the US about this issue and the impact on their national Health IT Program - and that the issue had been highlighted by the prestigious Institute of Medicine.
The purpose of e-Health is to improve patient safety and to improve the quality of care. Essentially what we are told here is that DoHA and NEHTA simply do not know if their planned systems will actually provide that outcome!
This really is mismanagement, stupidity or worse on a really grand national scale. Just why there is no documentation of the processes and efforts NEHTA / DoHA have employed to address system and patient safety issues available really beggars belief. Maybe we, as patients, are not entitled to know so we won’t worry or some such. Talk about treating the public like mushrooms!
This sort of issue really has to cause a major rethink of the quality of management involved with all this! I really think such material must be seen as signalling systemic problems that must be addressed and fast!
Back off to a Christmas break now!
David.
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