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The methodology for a review into a major glitch in a system for storing medical images is expected to be finalised by the Health Service Executive early this week.
HSE staff are taking advice from radiologists and other clinical experts on how to conduct a review into the software problem, which may result in thousands of people having to have medical tests redone.
The problem spotted in the HSE’s system for storing scans means the “less than” symbol (<) was omitted when records were archived. This could lead to a doctor overestimating the seriousness of a patient’s condition and ordering unnecessary procedures.
HSE director-general Tony O'Brien told staff in a memo earlier this month that the supplier of the National Integrated Medical Imaging System (Nimis) knew about the issue for 18 months but did not inform the organisation.
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The flaw was known to the company, Change Healthcare, in January 2016, according to the HSE.
Some 23,302,968 records have been created on the system for 6,109,043 people in the last six years. A total of 21,131 records were impacted by the “<” error over that time.
Risk to patients
In a statement, the executive said its initial assessment, based on expert advice, was that the risk to patients, consequent to the omission of the symbol, was “relatively low”.
“However, we need to progress to the planned review to confirm that this is the case. The first phase of activity involves defining the exact methodology of the review,” it said.
“We are taking advice from the Faculty of Radiologists and other clinical experts to ensure that the methodology is correct and sensitive before we embark on the review.
“Should any cases be identified where recall is necessary, patients will be informed and guided appropriately,” the HSE added.
The issue in relation to the omission of the symbol in the imaging system was fixed in the days after the issue was discovered by a radiologist in Cavan on July 26th.
Change Healthcare had issued a fix for the problem in August last year, but the HSE said the company did not inform it that the software patch was to fix a clinical issue.
Ongoing engagement
The executive said at the weekend that ongoing engagement with the company continued “at every appropriate level within the organisation”.
In a memo to the HSE leadership team on August 4th, Mr O’Brien described the response by Change Healthcare to the matter during a conference call as “worrying”.
He said he had told the company "in no uncertain terms" that he would have no option but to inform the World Health Organisation and other relevant bodies of the global patient safety issue should a field safety notice not be issued to all affected jurisdictions before 6pm on August 3rd.
That notice was subsequently issued, but Mr O’Brien said the HSE had raised issues with the company “around the completeness of the notice issued”.
Change Healthcare has said it will provide further information as soon as it can once its own internal investigation is complete.