Pooled Cryo labeling after thawing

[Eagle Eye]

How do you label thawed pooled cryo?

Do you change product code label? do you apply new label?

Can you just hand write expiration date and time?

 

Hoping that PAT or someone else from ICCBBA will also answer!

[pinktoptube]

Our LIS system creates a unique ISBT number for the pool, changes the product code to pooled open and the label prints out. We then label the pool with the printed ISBT label.

[Eagle Eye]

I think my question was misleading...

I have a question regarding pre pooled cryo?

 

[heathervaught]

Yes, just like thawed plasma, you can hand write the expiration date and time.

[Laurie Underwood]

We hand write the expiration date and time.

[goodchild]

We have electronic transfusion documentation which requires machine readable labeling. We print new ISBT labels for the thawed product and re-label only product type/expiration quadrants.

[mollyredone]

Same as goodchild.

[Eagle Eye]

BUT are we required to relabel product code or not? Is PAT or ERWIN around to answer our question...

[goodchild]

 

From 21CFR606 CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS

Sec 606.121(c) Container label.

(13) The container label of blood or blood components intended for transfusion must bear encoded information in a format that is machine-readable and approved for use by the Director, CBER.

(i) Who is subject to this machine-readable requirement? All blood establishments that manufacture, process, repack, or relabel blood or blood components intended for transfusion and regulated under the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act.

(ii) What blood products are subject to this machine-readable requirement? All blood and blood components intended for transfusion are subject to the machine-readable information label requirement in this section.

(iii) What information must be machine-readable? Each label must have machine-readable information that contains, at a minimum:

(A) A unique facility identifier;

(B) Lot number relating to the donor;

(C) Product code; and

(D) ABO and Rh of the donor, except as described in paragraphs (c)(9) and (i)(5) of this section.

[ESIZENSKY]

What is the expiration time for pooled thawed cryo?

[rmthorkelson]

AABB Standards 28th Edition

Reference Standard 5.1.8A

 

Cryoprecipitate, thawed, Single Unit: 6 hours

Cryoprecipitate, thawed, Pooled-Open System: 4 hours

Cryoprecipitate, thawed, Pooled using a sterile connection device (closed system): 6 hours

Storage and Transport for all three products: 20-24^o C

[mollyredone]

When we print our new ISBT label with current product (thawed) and expiration time it also states that it should be stored at room temp.

[Eagle Eye]

OK the smaller facility may not have ISBT printer capability, in that case they can order preprinted labels for thawed pooled cryo and hand write expiration date and time>....

[mollyredone]

We used to use preprinted labels and hand write the ex date and time before ISBT.  Our labels for FFP were from Shamrock.

[ECabana]

If all you are doing is thawing pre-pooled cryo and transfusing it, then you are not required to relabel the product and you only need to cross out the old expiration and hand write the new expiration date/time.  You can optionally choose to relabel the product as Thawed Pooled Cryo and bar code the new expiration date/time but this is not required.

If you are thawing individual cryo units and then pooling the thawed single units together, then you are required to relabel the product. 

Erwin Cabana

[Eagle Eye]

Thank you Erwin.