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Can anyone cite any regulations that stipulate what must be documented in an electronic transfusion record?  I am looking at times when the usual electronic documentation wasn't used, and they manually document in a note or on a form that gets uploaded.  I can't see any Joint Commission standards that state that they must document the DIN, product code, who transfused it and when.  I see medication regulations for the time and "dose" which may apply because the FDA considers blood a drug, but nothing says specifically that they need to include the product code or even the DIN.  This isn't the old days when paper transfusion records were returned to Blood Bank for record keeping. 

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  • jshepherd
    jshepherd

    Well, there are several things you can reference, besides AABB standard 5.29.1, which nursing won't care about.   Joint Commission (Hospital): PC.02.01.01 Ep 10. Before initiating a blood or

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comment_92725

I found this in the AABB standards but can't find anything from a regulator that Nursing is guaranteed to think is definitive. 

9.1, 7.5 Patient’s medical record: transfusion order, documentation of patient consent, component name, donation identification number, donor ABO/Rh type, date and time of transfusion, pre- and posttransfusion vital signs, the amount transfused, identification of the transfusionist, and, if applicable, transfusion-related adverse events
comment_92739

Well, there are several things you can reference, besides AABB standard 5.29.1, which nursing won't care about. :) 

Joint Commission (Hospital): PC.02.01.01

Ep 10. Before initiating a blood or blood component transfusion, the hospital follows a process to correctly identify patients that includes the following:
- Matching the blood or blood component to the order
- Matching the patient to the blood or blood component
- Using a two-person verification process or a one-person verification process accompanied by automated identification technology, such as bar coding

By logic, you can't match the blood component to the patient or order without documenting the "lot number", in this case the DIN. 

 

eCFR :: 42 CFR 482.27 -- Condition of participation: Laboratory services. See (b)(5) on this page regarding recordkeeping. For lookbacks, the HOSPITAL must maintain records, therefore a DIN must be documented from receipt to final disposition, including in the transfusion record. 

eCFR :: 21 CFR Part 606 -- Current Good Manufacturing Practice for Blood and Blood Components this is a general list of all the required records, but you can say that (c) is the most helpful for requiring a DIN documentation

Hope these help! 

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