Heart Valve Bank review shows extremely low to nil risk to patients
An independent, external review into the Queensland Heart Valve Bank, undertaken after four patients received tissue they should not have, has confirmed the risk to patients is extremely low or nil and that no other similar incidents have occurred.
The formal Health Service Investigation was ordered by Queensland Health Director-General Michael Walsh after an audit of the facility discovered the tissue, taken from a donor with a particular type of brain cancer, was incorrectly accepted and released for use.
Chief Health Officer Dr Sonya Bennett said the review was finalised this week, and the affected patients and families had been contacted about its findings.
“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.
“This is reassuring news, but we have reiterated to the families that it should not have happened and want to again apologise.”
“Further to the confirmation of this advice, the investigation also reviewed tissue released from the bank over the previous ten years, and found no similar occurrences.”
The report did identify a lack of adherence to quality assurance requirements and clinical protocol failures at the Heart Valve Bank.
Investigators, coordinated by the Australian Commission on Safety and Quality in Health Care, determined the incident occurred because the Heart Valve Bank’s policy of making complete donor files available to relevant reviewing clinicians, was not followed.
A separate investigation is underway into the conduct of some staff at the facility.
Dr Bennett confirmed that Queensland Health will implement all of the report recommendations, including merging all tissue bank operations in Queensland under one management structure.
“The investigators recommended Queensland Health merge all tissue bank operations in Queensland – including the Heart Valve Bank – under a single and accountable management structure,” Dr Bennett said.
“Metro South Hospital and Health Service has been tasked with merging all tissue banking operations under a single and accountable management structure.”
“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.”
It also recommended a review and update of all donation documentation and staff training at the Heart Valve Bank and the Queensland Tissue Bank to specifically exclude donors with these types of primary brain tumour.
A copy of the report will be forwarded to the Commonwealth Department of Health for consideration in the development of a national policy framework for tissue banking.
The Heart Valve Bank is operated by Metro South Hospital and Health Service on behalf of the entire state.
It has been closed since January and a separate investigation is underway into a range of staffing issues, following a number of internal complaints.
All patients that required access to heart valve tissue have been able to access it under current interstate supply arrangements.
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Health service investigation into the Queensland Health Valve Bank
Inquiry under Part 9 of the Hospital and Health Services Boards Act 2011
On 29 May 2018 an audit of records of the Queensland Heart Valve Bank (QHVB) identified that tissue from a donor with a rare type of brain tumour, a gliosarcoma, had been accepted and transplanted into four recipients. In response, the Director-General Queensland Health, appointed Health Service Investigators to investigate the circumstances under which the tissue from donor was accepted for implant; whether the tissue stored and released for implant by the Queensland Heart Valve Bank (QHVB) for the past ten years was safe, and the procedures and governance of the QHVB.
Summary of findings
Preliminary response to the event
- The investigators found that Queensland Health responded appropriately to the discovery that tissue from a donor with a rare brain cancer had been implanted.
- The investigators found that the advice provided to patients/families and the community during the open disclosure process was correct.
- The investigators found that the decision by the Director General to investigate the matter further and open the QHVB to investigation to ascertain the safety of the service will ensure remediation of clinical protocol failures.
- The report has affirmed that expert medical opinion regarding the risk of transmission of malignancy to recipients of tissue from donors with this type of brain tissue was extremely low to nil.
Breach of policy
The investigation found that tissue from Donor A was accepted in breach of QHVB procedures, specifically that the Medical Director was not provided with the full donor file when asked to authorise the acceptance of tissue.
Any other cases
The Health Service Investigators did not identify any other cases where tissue from a donor with a gliosarcoma had been assessed for implant by the QHVB.
Safety of the Queensland Heart Valve Bank tissue
The health service investigators found no evidence or likelihood of harm arising to any recipients due to cardio-vascular tissue from the Queensland Heart Valve Bank. Internal QHVB audits and TGA audits also found no such evidence. The breakdown of quality assurance processes, however, raises questions about the safety of tissue remaining in storage at the QHVB. These questions can be resolved by careful review of the assessment, processing and acceptance of the tissue remaining in storage at the QHVB.
Confirmation of previous advice
The health service investigators sourced expert advice, which confirmed the previous advice provided that the transmission of malignancy to recipients of tissue from the donor with a rare type of brain tumour was extremely low to nil.
Review of open disclosure processes
The investigation reviewed the open disclosure documentation, which was sound, and contacted the recipients/families, confirming the advice that they had been given that any risk was extremely low. In relation to the recipients of tissue, the records demonstrate an open disclosure process appears to have been handled carefully and sensitively.
Findings related to the practice of accepting tissue – Glioblastoma multiforme
The Health Service Investigators reviewed the QHVB donation criteria and associated forms and found them to be consistent with accepted operational standards but for one notable exception - the investigation has disclosed that the QHVB donation criteria and practice accepted tissue from donors with the primary brain tumour glioblastoma (GBM), specifically prohibited in the donation criteria of tissue banks in New South Wales and Victoria.
There is no current national standard regarding the use of cardiovascular tissue from donors with GBM; Australian heart valve banks (apart from the QHVB) determined to exclude tissue from donors with GBM on the basis of the evidence relating to whole organ transplant.
In summary, Australian heart valve banks (apart from the QHVB) determined to exclude tissue from donors with GBM on the basis of the evidence relating to whole organ transplant. The evidence with respect to the transmission of GBM or gliosarcoma by implant of heart valve tissue suggests the risk is either extremely low or nil.
Failure of clinical governance
The Health Service Investigators have considered that the clinical policy review practices of the QHVB are below an acceptable standard and that there was a clear failure of clinical governance within the QHVB.
Merger of all Queensland tissue banks
The QHVB formally became part of the Queensland Tissue Bank in July 2010, with a longer- term plan that it would merge staff and procedures with the Queensland Eye and Bone and Skin Banks. This was aligned with a national program to transition tissue banking from isolated, locally based units into a more professional, consistent and transparent service.
Eight years later the process of amalgamation is still underway.
The terms of reference of the review ask it to make recommendations to the Director General, Queensland Health. As such the investigation makes the following recommendations.
The failure to integrate the Queensland Heart Valve Bank into the Queensland Tissue Bank runs contrary to the national process of moving tissue banks from isolated local concerns on to a more professional, transparent and business-like basis. Metro South Hospital and Health Service and the Queensland Tissue Bank should act with urgency, to act in line with the recommendation flagged in the PricewaterhouseCoopers Australia (PwC) report and currently being progressed by the Council of Australian Governments, and effectively merge all tissue banking operations under a single and accountable management structure.
All policy and procedural documentation including donation criteria and staff training documentation of the QHVB/Queensland Tissue Bank should be reviewed consistent with comparable tissue banks in Australia.
The health service investigators recommend a copy of this report be forwarded to the Australian Government Department of Health for consideration in the development of a national policy framework for tissue banking.
The Health Service Investigators recommend that, before any tissue held in storage by the QHVB is used for implant:
- Advice be sought from the Therapeutic Goods Administration to confirm the production and quality at the time the tissue was procured and processed met the Code of Good Manufacturing Practice and the tissue is safe for release;
- Any tissue considered for implant be reviewed by a Production Nominee, Medical Officer and Quality Nominee independent of those carrying out the original work.
- Any tissue yet to be assessed by a Medical Officer for acceptance, be reviewed by a Production Nominee independently of the person who originally carried out this work.