Up to 15,000 patients may have to be recalled after information in their medical scans was wrongly stored, according to an initial assessment of the problem by the Health Service Executive.
The recall is likely to be expensive and to have a significant impact on waiting lists and available capacity across the health system, HSE director-general Tony O’Brien has warned.
Change Healthcare, the Canadian IT company that installed the faulty system, was aware of the specific glitch 18 months ago, but failed to tell the HSE or other customers, Mr O'Brien claimed yesterday.
The company issued a patch in August 2016 that included a fix for the problem but the HSE failed to install it.
This was because the fix to resolve problems with the storage of the “less than” character (<) on patient scans was “invisibly included” in the patch, Mr O’Brien told senior colleagues in a memo yesterday.
“The release note for this August 2016 fix made no reference to an issue with characters or indeed that this could potentially have been a clinical issue. While the patch could have fixed the issue the company failed to, or chose not to, disclose this important information concerning potential clinical safety within the release note.”
New hardware
Applying the patch would have needed additional work and new hardware costing between €2 million and €4 million, according to the HSE's chief information officer Richard Corbridge.
Asked if he believed Change Healthcare had buried the problem, as suggested by Mr O’Brien, he said: “If you haven’t told customers something is broken in the first place, you can’t tell them you’re fixing it.”
Change Healthcare did not respond yesterday to questions. Earlier this week, it told The Irish Times it was working "collaboratively" with the HSE to investigate and resolve the issue.
Mr O’Brien said the investigation undertaken by the HSE into how the error had occurred had unveiled a number of “very worrying process and reporting failings and has raised significant questions that have, as yet, not been answered to our satisfaction by Change Healthcare”.
The company, after it was contacted by the HSE last week, seemed to have no plan to issue a safety notice “as they are obliged to do in the circumstances,” he said.
It was only after Mr O'Brien threatened to report the company to the World Health Organisation that it issued a worldwide safety notice on Thursday, according to the memo. The HSE has since raised concerns with Change Healthcare about the completeness of this notice.
The HSE is continuing to investigate the size of the problem, though it has established 21,131 scans out of 23.3 million stored on the system since 2011 are affected.
