HELP!!! need to know regs on tissues

[LaraT23]

Our surgery dept has been the overseer of tissues but they are now not compliant so the Blood Bank is being asked to consider oversight. I am finding that it is not much different from blood products in that the monitoring is still every 4 hours and that different tissue types have different storage requirements. There is also a "lookback" in place and the final recipent is to be tracked. Am I missing anything?

[RR1]

Hi Lara, who would take responsibility for the training of staff handling the tissues ie thawing femoral heads etc ?

Also, I presume you would have to be the main focus of your tissue regulators and undergo their inspection process/ compliance reports and fees?

Do you have sufficient storage capacity and also will the surgery dept help with the cost of maintenance, repair and replacement of equipment...and what else can you get from them before you agree to anything?!!

In the UK tissues are regulated by the Human Tissue Authority (HTA)- you might find some useful info there- but i'm sure the US has adequate info on their site.

[bbbirder]

Joint Commission tissue regulations can be found on their web page:

http://www.jcrinc.com/common/pdfs/csr/forms%20and%20tools,%20newsletters/transplant%20safety/TS%20TissueManagementTracerTool2009.doc

They also have several FAQs related to tissues.

Linda Frederick

[kate murphy]

American Association of Tissue Banks (AATB.org) is also helpful.

AABB has AATB Standards available for sale.

We've just taken this on as well - the variety of tissue and many different sizes of tissue is daunting. We spent nearly a year planning before we accepted the responsibility, and we were still surprised.

[Franklyn]

Just break it down and start small. The JC Tissue regs simply apply inventory management controls and traceability requirements that have been standard fare in blood banks for decades, to tissue products. That is all they do. The regs do not impact solid organs or non-biologic implants (like stents). Unless your facility is active harvesting and manufacturing tissues, it is straight forward inventory management and doesn't even require an MT staff to make it work.