Patient safety is emerging as a key risk as the adoption of clinical information systems accelerates.
While technology is generally seen as the best way to reduce adverse outcomes, it is increasingly clear that IT also introduces new risks.
NSW Health is currently reviewing the use of Cerner’s FirstNet software in hospital emergency departments after concerns were escalated by Sydney University e-health expert Jon Patrick this year.
Professor Patrick found the software “increased risks to patient safety” due to data being lost during transfers between administration and clinical systems, “antiquated” messaging standards that did not alert users to non-received mail and a "practically unusable" electronic discharge system.
Other problems involved mislabelling of patient samples on the pathology orders system, and the deletion of forward orders for services like x-rays after three weeks when appointments were booked up to three months in advance.
Clinical safety work is intended to identify and mitigate situations that put patients at risk of e-health harm, and is generally conducted in parallel with the technical design and testing of new systems.
Key concerns also include the risk of patient misidentification, incorrect medical records or clinical reference data, and unavailability of health IT services.
Sources in the health systems development community say they have been seeking information on the CSU's work for over a year, but have been unsuccessful so far.
In particular, they want access to a patient safety risk assessment apparently conducted by Nehta a year ago, as well as other findings and recommendations that may involve remediation by software vendors as they prepare to support the $500 million national personally controlled e-health record system.
A Nehta spokesman said its clinical safety unit (CSU) has undertaken work as part of the organisation’s overarching responsibility for the nation’s e-health rollout.
"It is a legitimate expectation of software vendors that products developed by Nehta are safe and have clinical utility," he told The Australian.
"The CSU addresses safety."
The spokesman said the CSU "works across Nehta's programs to provide certainty to medical software developers, end-users and policymakers".
But recommendations and findings of potential risks are not separately documented by the unit.
"Any clinical safety findings as a result of reviews of specifications and standards are included in the overall review outcomes," he said.
"Mitigations are recommended for inclusion as part of any proposed changes in draft specifications or in the form of implementation guidelines."
The CSU comprises several Nehta clinical leads, a system safety engineer, a biomedical engineer and biomedical scientist, a test engineer, program co-ordinator and support officer.
"The aim is to identify circumstances that put patients at risk and document the evidence, where possible, in a safety case," the spokesman said.
"The unit is actively involved in reviews from a safety perspective of all specifications and products released, using defined processes under the Clinical Safety Management System."
Reports from around the world show IT-related problems affecting health systems are mounting.
In Britain, a computer virus shut down three London hospitals, forcing doctors to divert patients elsewhere, while a mapping error in National Health Service systems resulted in patients who were supposed to get a prescription for quit-smoking drug Zyban being prescribed Viagra instead.
And nearly one-third of 153 US Veterans' medical centres reported problems after an annual software upgrade. Stop order alerts were not clearly displayed, leading to medication errors, while electronic records showing one patient's information were pulled up under the next patient's name.
Other examples include the first line of a radiology report missing when viewed in another application, and saving an image in the picture archival system moving the annotations -- both errors could have led to misdiagnosis.
Nehta has been using British Telecom's Health Sentry clinical risk management system, under contract with BT, since late 2009.
Kathy Dallest, CSU manager and former nurse and public health practitioner with health informatics qualifications, has been working to embed the Clinical Safety Lifecycle across programs and establishing a Clinical Safety Case reporting system.
The Hazards Register notes causes of harm arise in three areas: internal failures or design flaws; human factors such as lapses, mistakes or violations by systems administrators and end-users; and external failures of systems or policy outside an organisation’s control.
"Mitigation of human factors can include controls that require the end-user to operate the system in a certain way,'' a recent Nehta presentation says.
"This may be achieved by effective user interface design, usability testing and training.
"Factors like the design or characteristics of other systems, policies, procedures and other external dependencies are likely to require management to reduce the residual risk of clinical risk.
"It is assumed that actions undertaken routinely by healthcare providers are done according to best practice."
Meanwhile, in the US this week, the Institute of Medicine will release a new report, Health IT and Patient Safety: Building Safer Systems for Better Care.
The institute's 1999 landmark report on medical errors, To Err is Human, had a vast impact on changing healthcare practices; now it is concerned about potential harms arising from the introduction of electronic health records.
"Concerns are emerging as healthcare providers increasingly rely on digital medical records, secure patient portals and other information technologies to deliver care,'' it says.
"This report examines a broad range of health information technologies and recommends actions the government, healthcare providers and technology vendors should take to improve patient safety."
At last month's scientific sessions of the American Medical Informatics Association, the need for a health IT equivalent of the National Transportation Safety Board was floated.
When the NTSB was founded in 1926, the car industry was in its infancy and few could foresee the need for safety measures like speed limits, seatbelts and crash test dummies.
A similar organisation charged with tracking and alerting e-health record and system errors could spur action on potentially life-threatening consequences of misuse, while assisting vendors to improve their products and medicos to improve their practices.
Voluntary notifications to the US Food and Drug Administration over e-health record incidents have been low in recent years, prompting concern that there should be stronger government or industry oversight.
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Autor(en)/Author(s): Karen Dearne
Quelle/Source: Australian IT, 09.11.2011
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