Quality Assurance -DTBV

Quality and safety are uppermost in our mission and vision.  The Donor Tissue Bank of Victoria is licensed by the Therapeutic Goods Administration (TGA) to retrieve, process, store and distribute human allograft tissue in Australia.  In addition to TGA, DTBV's Microbiology Laboratory has NATA (AS4633, ISO 15189)

A number of steps are in place to ensure that tissue obtained from the Donor Tissue Bank of Victoria is of the highest quality and safety.  The following steps are undertaken with every tissue donor to ensure this:

Living tissue donors:

• Social and medical history questionnaire with the donor.
• Serological testing of blood at the time of donation and again at least 6 months following donation to reduce the risk of transmissible disease.
• Extensive microbiological analysis on representative tissue samples taken at donation, during processing and before final packaging.
• Histological analysis of sections of the tissue to assess pathology and graft suitability for transplant.
• Review of x-rays of bone by a Radiographer to assess pathology and graft suitability for transplant.
• Review of all tests and findings by both a pathologist and scientist before being deemed available for transplant.

Deceased tissue donors:

• Assessment of condition of the donor and review of past medical records.
• Social and medical history questionnaire with next-of-kin.
• Serological testing of blood using test kits validated in house for use on samples from the deceased. Sample also sent for HCV and HIV RNA testing to significantly reduce risk.
• Extensive microbiological analysis on representative tissue samples taken at donation, during processing and before final packaging.
• Full autopsy (including full donor CT Scan) is mandatory for tissue donors at the DTBV - this ensures that the donor did not have any diseases or disorders that may not have presented themselves to the donor which would prevent them from donating tissue
• Review of X-rays of bone by a Radiographer to assess pathology and graft suitability for transplant.
• Review of all tests and findings by both a pathologist and scientist before being deemed suitable for transplant.

   

Every step of the retrieval and processing of all tissue types is performed under sterile or aseptic conditions.  Deceased donors are moved to the dedicated retrieval suite, part of the DTBV, similar to an operating theatre. The scientist retrieving or processing the tissue must scrub, gown and glove as is done with any surgical procedure, prior to touching any tissue. 

All processing is performed under laminar flow (Grade A) cabinets within the cleanroom suite to maintain tissue quality and sterility.

The Microbiology Laboratory at the Victorian Institute of Forensic Medicine is located within the Donor Tissue Bank and is responsible for all serological and microbiological testing at the Institute, and hence plays a unique dual role in product and environment quality control and cause of death investigation and is licensed for both activities. Some more advanced testing is outsourced to specialist licensed laboratories. eg for HIV and HIV NAT testing and HLA typing.

All microbiological samples are cultured on appropriate media and identification of any pathogens is carried out. Techniques commonly used in identification are gram staining, catalase and oxidase tests, coagulase tests and standardised identification systems such as RAPID. Confirmatory testing, if needed, is carried out by external laboratories as well as any viral testing that may be required.

In order to reduce risk, most tissue is treated with antibiotics throughout retrieval and processing, and all bone and most other musculoskeletal tissue is irradiated to 25kGy prior to transplantation.

All methods used are validated and new methods and products developed via the DTBV's Research and Development Section.

Quality is assured at DTBV via VIFM's Quality and Improvement section. This assures independent oversight and management of quality and the quality system thus assuring compliance to TGA and NATA requirements which are incorporated into the DTBV Quality Manual.This includes corrective and preventive action, document control, independent self-audit, change control, trend analysis and overall quality review.

Systems are in place to enable all tissue is traceable from donor to recipient and vice versa. Utilisation report forms are completed by surgeons following transplantation of tissue. All materials and consumables are purchased as critical items, are are traceable to each procedure.