Christie Loe

All, Thank you for the ongoing discussion of syringe aliquot outdates and for calling attention to generalizations of the AABB Technical Manual. As a representative of Charter Medical as well as a meticulous blood banker myself, I have discussed this issue with AABB Accreditation on behalf of our many customers. Posters in the thread have indicated that they refer to manufacturer's instructions as the recommendation in the abscence of a documented syringe storage standard from AABB, and per my discussions as well as Standards, that is appropriate. Charter Medical recommends open system dating for products when they are placed into a syringe, even if the syringe was filled via sterile connection processes. Open system storage for red cells, whole blood and plasma is 24 hours when stored at the appropriate temperatures (as opposed to 4 hours for platelets). My contact information is included below and any who wish to have further discussion on this issue are invited to inbox me directly. Charter Medical appreciates the support of our user group and I look forward to working with you all for years to come. Kind regards, Christie

To the best of my knowledge, there are no commercially available closed-system processes for adding saline during donor center manufacture of pre-pooled cryo as saline is only available for purchase in bags (and maybe vials depending on country). BioPharm would add saline through a 0.2 micron sterilizing grade filter and consider it a closed process but these filters are not commonly used in the component lab. They are typically found in Apheresis equipment disposables where the "fluids" do not come pre-attached.

Hi all, Christie from Charter Medical here. If you have any questions surrounding validation or filtration of blood for neonates, please contact me directly. Best regards, Christie Loe, MT(ASCP)SBB Sr Key Account Manager Charter Medical Ltd. cloe@lydall.com

Hi Gil, You may want to refer to the most recent version of AABB's Handbook for Pediatric Transfusion Therapy for recommendations as to washing for pediatric aliquots and maintenance volume transfusions.

Hi everyone, As a former AABB Assessor and Children's Hospital transfusion service employee, labeling neonatal aliquots is a topic I am very passionate about. With the advent of FDA's barcode requirement and their very specific guidance that even a syringe set should contain the appropriate unit and recipient information, Charter Medical has focused on increasing awareness of labeling requirements and suggested approaches at meeting the standards. Please do take a few minutes to view the attached photos and for additional information, you are all wecome to visit our website to view presentations from our 2007 AABB Industry Workshop, "Best Practices in Neonatal Transfusion Medicine." http://www.chartermedical.com/products/transfusion-cell-therapy/syringe-sets.html CharterMed Syringe Set labeling.pdf

Hi Everyone, Christie from Charter Medical here and I am certainly happy to answer your questions regarding our neonatal syringe sets. Our most frequently used product is a 150 micron filter set with either a 30 or 60 cc BD syringe--it can be used with sterile connection devices or spiked into an aliquot bag/whole blood derived platelet, and is FDA cleared for use with platelets (store in syringe for up to 4 hours), plasma and red cells (store in syringe for up to 24 hours in refrig). I have an extensive reference list of customers, of which I myself was before joining the company in 2005. My email is cloe@lydall.com please contact me directly if you have any specific product questions. Thanks to all of you who are current customers!

Hi Marilyn, Even the few months the profession was without you was too long. So glad you're back--hard still to believe you're there at LifeShare and now I'm not! Thanks for all you've taught the many of us who hang on your every word. All the best to you and your family, Christie

Monique, I'm curious if you have evaluated Factor VIII and Fibrinogen content in this product that since the beginning of manufacturing has been frozen, thawed, centrifuged, separated, frozen, thawed, pooled, frozen, and thawed?

Have you searched for blood suppliers who manufacture pre-storage pooled cryo? You might find any additional cost well worth the benefit and be able to avoid this undertaking in your facility.

Yes sir, I agree completely. Providing neonatal aliquots to NICU in the final storage/transfusion container eliminates or at least limits "creativity" in the nursing unit. It also provides a way for transfusion services to provide a customer service that just so happens to help keep the transfusion service in regulatory compliance!

Thanks David. You asked if they had a policy/process addressing blood administration. Since I work for a manufacturer, let's assume facilities do indeed have a practice in place that is defined by nursing. This question stems more from the disconnect between transfusion services and nursing blood administration practices. In actuality, many times the blood component is transferred into a syringe that IS NOT labeled nor is the aliquot bag (compliantly labeled by transfusion service) still attached to the syringe during transfusion. Additionally, final filtration may also be in question.

Thanks in advance for your opinions on this topic--- In Neonatal Transfusion when blood is transported to NICU, etc. in an aliquot bag then transferred by nurses into a syringe for pump administration, is the transfusion service responsible for ensuring this process meets regulatory requirements? Please elaborate your opinions. Christie

Regarding the use of diluted monoclonal antisera: after sitting in many presentations from Immucor/Gamma, I understand that only the original diluent or resuspension media should be used to dilute monoclonal antisera. Rh Control, for example, is the only proper diluent for monoclonal Anti-D. Additionally, I understand that each diluent is different, so using diluted monoclonal antisera turns into a difficult proposition.