Posted March 20, 20169 yr comment_64979 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!
March 21, 20169 yr comment_64983 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.
March 21, 20169 yr Author comment_64984 I think my question was misleading... I have a question regarding pre pooled cryo?
March 21, 20169 yr comment_64985 Yes, just like thawed plasma, you can hand write the expiration date and time.
March 22, 20169 yr comment_65020 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.
March 23, 20169 yr Author comment_65047 BUT are we required to relabel product code or not? Is PAT or ERWIN around to answer our question...
March 24, 20169 yr comment_65050 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.
March 24, 20169 yr comment_65062 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: 20-24o C
March 24, 20169 yr comment_65064 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.
March 27, 20169 yr Author comment_65089 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>....
March 30, 20169 yr comment_65142 We used to use preprinted labels and hand write the ex date and time before ISBT. Our labels for FFP were from Shamrock.
March 31, 20169 yr comment_65169 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
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