The Health Service Executive (HSE) has said the supplier of one of its main computer systems kept it in the dark for18 months about a major glitch.
The flaw, which may result in thousands of patients having to have medical tests redone, was known to the company Change Healthcare in January 2016, according to the HSE.
It says the size of any recall of tests is likely to be expensive and will have a significant impact on waiting lists and capacity across the health service.
"Of grave concern to me, Change Healthcare did not inform us about this issue at this time," says HSE director general Tony O'Brien in a memo to colleagues, seen by The Irish Times.
“As far as we are aware, no other customers in other jurisdictions were informed. There are 54 hospitals in the USA using this solution in the same way as we do in Ireland and many other organisations around the world.”
The glitch spotted in the HSE’s system for storing scans means the “less than” symbol (<) is omitted when records are archived. This could lead to a doctor over-estimating the seriousness of a patient’s condition and ordering unnecessary procedures.
In August 2016, according to Mr O’Brien, Change Healthcare issued one of its regular patches to fix a range of technical issues. The fix for the problem was “invisibly included” in the patch, he says, and an accompanying release note made no reference to an issue with characters.
“While the patch could have fixed the issue the company failed to, or chose not to, disclose this important information concerning potential clincial safety within the release note.”
This was an “oversight”, Mr O’Brien said the company told the HSE this week, after the error was reported in The Irish Times on Thursday.
“One would consider that anything that concerns clinical safety would be of the highest priority and that all efforts would be made to minimise potential harm. This includes being open and tranparent and providing sufficient information to allow us as clients to infom our patients.”
“Such an oversight, if it was one (burying a clinically significant ’fix’ among discretionary technical upgrades) - is inexcusable.”
According to Mr O’Brien, the patch from the company was provided on the basis that it did not contain any clinical safety issues. As a result, it was not installed by the HSE, as it would have needed additional work to be carried out.
“Had we been made aware of the potential clinical risk, this patch would have been applied as a matter of priority.”
Change issued a worldwide safety notice about the flaw on Thursday, after the controversy broke, but Mr O’Brien says it was “obliged” to have done this when it first became aware of the problem.
He says he told the company this week he would report it to the World Health Organisation if it failed to issue the notice.
Change, based in Nashville, Tennessee, has told The Irish Times it is working "collaboratively" with the HSE to investigate and resolve the issue, which has affected 25,000 X-rays, ultrasounds and scans stored on the system since 2011.
Some 23,302,968 records have been created in the last six years on the National Integratate Medical Imaging System for 6,109,043 people. A total of 21,131 records were impacted by the “<” error over that time.
Change Healthcare has declined to answer questions about the cause of the problem, why it went undiscovered for six years and whether it accepts responsibility for it.
Radiologists said they were working with colleagues in the HSE to fully investigate the issue.
"It is important to note that the majority of radiology reports are viewed by clinicians and GPs either on paper or electronically within the Radiology Information System (RIS), and are not affected by the symbol issue," said Prof Max Ryan, dean of the faculty of radiologists of the Royal College of Surgeons of Ireland. "The issue identified is not related to human error or a mistake by a radiologist."
The HSE is working to establish what effect the error had on patient outcomes in 2,500 of the affected scans. It says it will widen the investigation to cover more affected scans if it turns out that large numbers of patients were affected.
