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I'm working with our surgical service on a policy to improve bone/tissue/biological handling and oversight. We aren't a large facility, but have a surprisingly large number of types of bone/tissue/biological materials available for use. After going through the latest JC checklist, surgery realized that there was a big need for improvement in policies they had in place. We are going to place everything bone/tissue/biologicals related under the oversight of the blood bank medical director. As part of this process, we are writing several policies that will be used by both blood bank (frozen bone/tendons) and surgery (everything else) - to make sure that we are all following the same game plan. Our medical director has been reviewing our proposed new policies and has a couple of questions that I need help with. Which is where you all come in. I'd appreciate any help you can give me.

 

1. Lookback and notification - will someone please point me to the part of the CFR that deals specifically with lookback and notification for tissues? Is there a separate section or is it the same as used for blood products?

 

2. My medical director says he remembers reading somewhere (sorry - he can't remember where) that anyone who has been diagnosed with HIV/HCV within 6 months of receiving a bone/tissue implant should be physician reported for investigation. Is there a specific citation for this in the CFR? I've based the lookback section on a blood lookback policy that has passed a CLIA inspection because that's what I (blood bank) know, but maybe that's not the best approach? What is missing/different for tissue?

 

We are CAP and JC inspected, but not AABB inspected. (I think one of the things I need to do - pronto - is order a copy of the AABB Tissue Standards.)

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We store bone/tissue for surgery and track it. However, if there is an adverse event dealing with infection we have the Infection Control officer do all of the reporting. We have in our procedure that they will deal with anything and we can provide documentation that the bone/tissue was delivered at proper temp, stored at proper temp, etc.

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We store bone/tissue for surgery and track it. However, if there is an adverse event dealing with infection we have the Infection Control officer do all of the reporting. We have in our procedure that they will deal with anything and we can provide documentation that the bone/tissue was delivered at proper temp, stored at proper temp, etc.

 

I'd loved to have Infection Control do the lookbacks - I might suggest that :devilish: (unfortunately, I don't think it will get me anywhere).

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I wrote a look back and adverse reaction policy for tissues and bones years ago. I used the standards from the American Association of Tissue Banks. At that time it was an infection control procedure. It was before AABB got involved with tissues. Sorry I don't remember the CFR sections. http://www.aatb.org/aatb-standards-for-tissue-banking

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TJC has pretty specific standards for Tissue lookback and notification.  Fortunately we have never had anything recalled.

 

Yes, they do and I have those. I found some information floating in the electronic world that looks like good stuff to add to our protocol, but none of it cites sources unfortunately. I did find that the Guidance to Industry for tissue points specifically to the lookback requirements we use for HIV and HCV for blood products. That helps. We've never received a recall notice either and I hope it stays that way!

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How often does your blood bank supervisor or medical director review tissue records or do they?

What is the requirement for checking the temps on storage devices for temperature? Our tissues are kept in a monitored freezer in the OR where the OR staff checks the temp daily. Our blood bank supervisor reviews these records, but that's as much review as is happening right now. I am wondering of the blood bank needs to be more involved. I am interested in what other hospitals are doing.

Thanks.

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Even if not required I would want to have an alarm on a tissue freezer just to save the many thousands of dollars worth of tissues if there was a failure.  TJC does not require temperature monitoring for tissues that have only an "ambient" temperature requirement.  If it states a range, they want proof that it was maintained in that range.  I can't quite remember if constant monitoring and alarms are required but we do that.

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More Blood Banks seem to be taking over tissues.  We just took over tissues completely: we order, store, track, and issue them from the Blood Bank.  It's been a monster to take on, but we're just starting to become more comfortable with it.

 

Constant monitoring is required for any tissue unless it says the word "ambient".  But the ones that say "store at room temperature" need to be monitored, oddly.  So we continuously monitor every tissue (we have a wireless Temperature Monitoring System).

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Terri be careful with that general rule. There are a number of products that are described as "ambient" storage but if you look at the packaging/manufacturer inserts there's a temperature range. AATB's guidance under those circumstances is you have to follow the established range.

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Terri be careful with that general rule. There are a number of products that are described as "ambient" storage but if you look at the packaging/manufacturer inserts there's a temperature range. AATB's guidance under those circumstances is you have to follow the established range.

Thank you; yes I found that out when we scrutinized all of the package inserts.  My LIS (SoftBank) requires a range anyway so for the ambient ones that have no defined range we set it at 15-30.

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Pretty sure you are looking at FDA inspections every 2 years if you are storing and keeping track of stuff like this.  See 21 CFR 1270.

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We've had tissue for 5-6 yrs now. 21 CFR 1270 generally applies to recovery and manufacture of tissue and tissue products.

Most of the standards for storage/dispensing are Joint Comm and AATB.

For lookback, we use the same policy as for blood.

For adverse events however, there is a larger emphasis on post-op infections, which the Joint Comm is VERY interested in.  You will need to convince Inf Control that they MUST be involved.  Most of the reporting necessary has to go through Inf Control as it also involves the OR and the method of preparation and implantation.  I'm sure they are already following infection rates for all the ORs and each surgeon and reporting these to the state DPH and perhaps as well as CDC on line.  At least in my state (MA) there is a requirement to report and the DPH is using the CDC National Healthcare Safety Network for all adverse events and infection rates.  This is just another aspect of that.

Joint Comm has a whole chapter on human and non-human tissue.

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You need not register with the FDA unless you manufacture or distribute tissue to another facility.  I just discovered that we need to be registered because we store frozen tissues for another hospital in our same organization. It doesn't matter that we are the same organization or that they purchase the tissue that we store for them. They are at a different physical address so we have to be registered to transfer the tissue to them.

 

We just lived through JC surveys at these 2 hospitals (plus AABB showed up within a half hour of TJC at our main site).  One of the JC surveyors said that just because the standards say that the "ambient" temperatures need not be monitored that does not mean that they can be stored without any temperature recording; it just need not be continuous monitoring.  That was not how one of my ORs wanted to interpret the JC standards.

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