I have been transplanted from Transfusion Medicine Services (TMS) to Perioperative Services as Biovigilance Program Manager. In this position I am responsible for biological products put into humans. For years we worried about human blood and tissue products but have become aware that the human recipient is the issue not just the human donor source. I was amazed when I heard at the AABB Assessor CE session in Montreal that biological products would be assessed if the blood bank was documented as the responsible head for tissues and such products. Our Transfusion Committee is actually the responsible reporting authority since TMS does not have direct control of tissues. Numerous Biological Products are ordered, stored and given in through Perioperative Services, therefore we created this new program/ position to gain control of all biological products.

We have discovered that sales people had lead our surgical friends with phrases such as "this is not a human tissue so Joint Commission standards do not apply but 21 CFR ... do apply'. Do you think a surgeon knows those are human plasma product requirements including donor qualifications, tracking and tracing. Such products would contain human thrombin to be mixed with a variety of matrixes/ compounds, for example TMS controlled Tisseel (fibrin sealant) but not BioGlue or the numerous hemostatic agents in use in the OR. We were not aware such products were in the OR!

Anybody else have this dilema? What about human albumin, bovine product, porcine products?

Edited December 30, 200816 yr by TStec

Over the past couple of years I have been made aware of these issues by default, I am the Transfusion Service Supervisor and am now also responsible for the tissue bank.

It had been a struggle with OR to find out all of the biologics they have been using. Now we treat ALL of the biologics the same, regardless of source, that way there is no confusion. Amazingly the OR has come on board with this concept and things are working out well. The threat of negative assessments by JCAHO etc. is pretty powerful sometimes.

Our Surg folks will have to be cited by Joint Commission before they 'get it'. Blood Bank controls frozen tissues because we own the freezer, but everything else goes through surgery and they don't think that is any of our business.

I think the sales people are clueless, so they sell the docs a bill of goods. And the docs don't care, as in 'not my problem'. The nursing staff with responsibility for such things in surgery tell me, with finality, that product XYZ does not have to be tracked and that's that! They roll their eyes and talk about 'more stupid government regulations'. My favorite response is the one where they say..."we documented that in the surgical record" and then I ask them which surgical records (dozens? hundreds?) they are going to search through when they get a lot recall and have no record when they started using that lot.

Of course the bad part about being cited is that the whole mess - problem people (like surgeons) included - will get dumped in my lap. :cries:At least I have a system in place to deal with it when that happens.

Does anyone have a system (procedure) for notification of recipients of recalled tissues or a recall due to cell-saver use that they would be willing to share?

I just created a tissue bank manual that we share with the surgical services. In it I included the same policy/procedure for tissues that we have been using for blood product look back.

We have been very lucky in that we have a great relationship with the OR. I walked into a job in which I am responsible for both BB and some tissue/skin products. We have a very functional tissue committee that meets monthly and consists of personnel from the lab, OR, Infection Control, and purchasing/materials management departments. It is lead by a pathologist (AKA Director of Tissue and Biological Implant). We also have a tissue coordinator who is in charge of all biological products and implants in the OR. The committee spent quite a bit of time creating a set of policies and procedures for dealing with all things implant.

Initially, I think it was a challenge was to limit who can order tissue into the hospitals, surgery center, clinics, etc. Materials management has been very good about helping with that. We have a list of approved vendors for certain products to ensure that we have all of their licensing information on file. There are a few people who have the privilege of ordering. We also have a process to follow if a product happens to show up. If a physician wants to add a new product, he/she must first request approval from the Tissue Committee and then VAT committee. Our tissue coordinator tracks Tisseel, room temp products, and those products with special requirements (ie....can't open the shipping box until you are ready to implant, etc.). Blood bank tracks all frozen bones and skin.

Help! I am a Transfusion Service Supervisor dealing only with blood and blood products (and RhIg). Tissues was handled by OR. We just had a bad JCAHO inspection regarding tissues. I know this is going to end up in my lap, but I know nothing about tissues. WHAT SHOULD I READ? Where do I start to learn the products and the related regs?

There is a white paper that talks about the regulations and why the hospital needs to centralize tissue management. It is free and available for download at http://www2.mediware.com/bb/future/. In the report, Docs from Hopkins, Georgetown, Moores UCSD Cancer Center and NYU speak to the changing role of the blood bank and the need for a computer system to trace, track and report (recalls). This might be of use for you.

I don't want to come across as too much of a vendor, but Mediware recently launched a system (BiologiCare) that addresses this need. It supports bones/tissues/etc; manages multiple storage locations/types; manages vendor qualifications; monitors inventories; etc.

The company does periodic web casts on the product and you can express interest in these when you download the paper. If you just want to speak with someone, send an email to info@mediware.com and I'm sure they will get right back to you.

Help! I am a Transfusion Service Supervisor dealing only with blood and blood products (and RhIg). Tissues was handled by OR. We just had a bad JCAHO inspection regarding tissues. I know this is going to end up in my lap, but I know nothing about tissues. WHAT SHOULD I READ? Where do I start to learn the products and the related regs?

The quickest (20 pages) AABB 2006 publication "Guidelines foe Managing Tissue Allografts in Hospitals", ISBN# 1-56395-240-8.

While dealing with tissues is a new thing and working with OR people has it's challenges it isn't a difficult as you might think.

Make a tissue bank manual that is almost the same as a BB manual, only the names are changed. I used the AABB Standards as a guide. I also did a lot of copying and pasting from my BB manual.

First get a list of all the implanted products from you OR people.

Then obtain package inserts for all of these products.

From the inserts you can determine required storage temps and preparation requirements.

Write procedures for how you will store products at room temp, refrigerator temp and frozen. Include how the temps of these storage areas will be monitored. We started using a wireless temperature recording device, so OR can continue to store the room temp products in their storage room.

Write some procedures for the preparation of each product. This is not as daunting as it may sound. For instance MTF is a big supplier. Three prparation proceudures will cover ALL of their products. All MTF frozen are the same, all MTF freeze dried are the same etc. The same goes for Regeneration Technologies.

If you found any of this helpful I would be happy to provide more specifics since I just went through this and it's still pretty fresh.

Anyone in this thread still wondering why I retired?? I took the easy way out and it's things like this that assure me that I made the right decision. Good luck folks.

:imslow:

It's things like this that keep work interesting!

I recently purchased the AABB publication "Hospital Tissue Management: A Practitioner's Handbook". (ISBN 978-1-56395-268-5) It is awesome! My only complaint is that the new Transplant Safety chapter of 2009 Joint Commission standard were not included. It does have the PC.17.10-PC.17.30 and the QC.5.300-QC.5.320 which can be cross referenced with new TS standards.