K. Varettas MPH, FASM.
Bacteriology laboratories and musculoskeletal tissue banks in Australia
Article first published online: 9 AUG 2012
© 2012 The Author. ANZ Journal of Surgery © 2012 Royal Australasian College of Surgeons
ANZ Journal of Surgery
Volume 82, Issue 11, pages 775–779, November 2012
How to Cite
Varettas, K. (2012), Bacteriology laboratories and musculoskeletal tissue banks in Australia. ANZ Journal of Surgery, 82: 775–779. doi: 10.1111/j.1445-2197.2012.06145.x
- Issue published online: 4 NOV 2012
- Article first published online: 9 AUG 2012
- Manuscript Accepted: 18 MAY 2012
In Australia, there are six Therapeutic Goods Administration–licensed clinical bacteriology laboratories providing bacterial and fungal bioburden testing of allograft musculoskeletal samples sent from 10 tissue banks. Musculoskeletal swab and/or tissue biopsy samples are collected at the time of allograft retrieval and sent to bacteriology laboratories for bioburden testing, in some cases requiring interstate transport. Bacteria and fungi may be present within the allograft at the time of retrieval or contaminated from an external source. The type of organism recovered will determine if the allograft is rejected for transplant, which may include all allografts from the same donor. Bacteriology staff also provides unpaid support of tissue banks through meeting involvement, consultations, licence-related activities, validations and research funded by their organisation and not part of any contractual agreement. Bacteriology laboratories and tissue banks must be compliant to the Code of Good Manufacturing Practice – Human Blood and Tissues and regulated by the Therapeutic Goods Administration. Clinical bacteriology laboratories also require mandatory accreditation to Standards Australia International Organisation for Standardisation (ISO) 15189:2009 medical laboratories – particular requirements for quality and competence, and may also attain Standards Australia/New Zealand Standard ISO 9001:2000 quality management systems certification. Bacteriology laboratories and musculoskeletal tissue banks are integral partners in providing safe allograft musculoskeletal tissue for transplant.