Protocol “failures” were behind a major breach that led to four Queensland patients being given tissue donations from a donor with a rare brain cancer, a review of the state’s Heart Valve Bank has found.
- The person authorising the donation did not know the donor had an agressive form of brain cancer
- The report found clear failures of clinical protocol at the Queensland Heart Valve Bank
- It said the incident “raises questions” about whether the Heart Valve Bank’s remaining donations are safe
The report said the incident raised questions about whether the other tissue donations being held at the bank could be contaminated.
An urgent external review was ordered into the facility in June after Queensland Health reported that one adult and three children under the age of one were recipients of heart-valve grafts from a person with Gliosarcoma, an aggressive brain tumour.
The bungle happened in 2017 but was not discovered until more than a year later during an unrelated audit.
The review found the tissue was incorrectly accepted because the full donor file was not given to the medical director when they were asked to authorise the donation.
A summary of the review has been released.
Investigators from the Australian Commission on Safety and Quality in Health Care identified the bank’s practices as “below an acceptable standard” and said there were clear failures in clinical protocol and governance.
Despite the review finding it was an isolated incident, the report said it “raises questions” about whether remaining tissue in storage was safe.
Chief Health Officer Sonya Bennett said it was reassuring the review found the risk to the four patients was minimal.
“The investigative team has reaffirmed with both Queensland Health and the affected families that the initial advice provided is correct — the risk of transmission of malignancy is extremely low to nil,” Dr Bennett said.
“We have reiterated to the families that it should not have happened and want to again apologise.”
The review made four recommendations that will be sent to the director general of Queensland Health.
Dr Bennett confirmed that Queensland Health would be adopting all of them, including merging all donor tissue banks into a state-wide service.
“A quality review will also be undertaken of the tissue currently stored in the bank to determine if it is appropriate for implant, as per the investigators’ recommendations,” she said.
Staff training and a review and update of documentation have also been recommended.
The bank has been closed since January and a separate investigation is underway following a number of internal complaints.