Blood product segregation requirements

[maybe]

All of the transfusion services that I have worked at before have had separate fridges/freezers for blood products, reagents, and specimens, however, I've recently started as supervisor in a new facility and fridge and freezer space is at a premium.

 

The FDA, AABB, and CAP all talk about segregation requirements for blood products (autologous vs, allogeneic, crossmatched vs. available, viral-tested positive vs. viral-tested negative) however I can't find any specifics on what constitutes "segregated"- other than a mention of physically or electronically segregated in regards to autologous products. Are we talking separate shelves or would bins/divided and labeled sections on the same shelf be adequate?

 

From my training/background having crossmatched/available/autologous products in separate bins on the same shelf is acceptable, but reagents should never be on the same shelf as live blood products (as opposed to dead/expired products used for validation and training).

 

What is everyone's thought/experience with this topic? And have any of you found any guidance in the literature/regs?

 

Thanks!!

[Auntie-D]

In the UK blood products must have a dedicated fridge. Reagents may be kept in the same fridge as samples but samples must always be stored lower.

[Marianne]

You can have tested and untested blood in the same refrigerator, but as you stated, they must be clearly marked as such.

As for reagents, your big challenge having them in the same fridge is the temp requirements are different.  Reagents are 2-8, not 1-6, so where do you set your alarm points etc.  This is a very common AABB non-conformance.

[R1R2]

You can have tested and untested blood in the same refrigerator, but as you stated, they must be clearly marked as such.

As for reagents, your big challenge having them in the same fridge is the temp requirements are different.  Reagents are 2-8, not 1-6, so where do you set your alarm points etc.  This is a very common AABB non-conformance.

Agree with Marianne about segregation and you would set alarms for 2-5.5 unless RHIG is stored in same fridge then it would be 2.5-5.5

[Mabel Adams]

There used to be strict rules about segregation of specimens, reagents and units but about 20 years ago they loosened up--or at least got more vague.  I think now you need units segregated enough that people don't easily mix them up.  You need specimens not to leak or spill on units.  Lesser problem but still a bit of an issue if reagents spill on units.  Think of what bad things could happen and make a plan that limits them. If you can justify your plan you are probably safe at inspection time.  Of course, I don't remember ever having a specimen spill in a fridge--lots on the counter and floor or in a centrifuge, but not in the fridge.

[Malcolm Needs ☆]

In the UK, the have done the opposite, and really tightened up.

[tbostock]

We just have our shelves clearly labeled and have never had a problem with inspectors.