A transfusion service supervisor for a hospital in Oregon would like to do away with having to chart the portion of the “bag tag” that goes with the unit of blood when it is transfused, as well as the portion that is returned to the transfusion service. He points out that in his hospital, often these forms are not charted, are incompletely filled out (date, time, two signatures, reaction, etc.), get contaminated with blood, or are not returned to the lab. Most of the labs that he has talked with have similar problems but everybody is still charting some portion of their form. He adds that the hospital computer system captures the issue data (sign-out date & time, person to whom it is released, final inspection of the unit, etc). Because their computer does the aforementioned documentation, they would like to modify the blood transfusion sheet for recording transfusion information in the patient’s chart to include verification that the patient’s name, & ID# matches the name and ID# on the blood unit, the two signatures, etc. He cannot find any regulation that says that the tag the transfusion service puts on the blood component unit has to be charted, so he is wondering why everybody seems to have these elaborate forms for charting transfusions. Would any e-Network colleague be willing to share the justification for their charting procedure?

The following replies have been received.

ADDENDA June 16, 2003

1. A colleague in Detroit reports that several years ago her institution used a computer-generated "tag" that had a sticky undersurface that could be used to adhere the tag in the patient chart after transfusion. This tag was a carbon copy of the tag attached to the component bag and contained blood product dispensing information. The Detroit colleague laments that half the time these tags never made it into the chart. About 3 years ago, when their medical record department began to scan patient records into the computer system, they were told that the computer-generated tags could no longer be used, since their print was too faint to be scanned. They came up with an 8.5 X 11 inch transfusion record form, pre-punched for 3-ring binder and printed at the time of issue, that includes issue data, transfusion verification and information, including vital signs, and directions for dealing with transfusion reactions and space for recording symptoms. In the event of a reaction, the form is faxed back to the blood bank with reaction information. The form also includes a peel-off adhesive label with patient name & ID #, date, component type, & unit number. This label is attached to the back of the unit at issue. They are using these paper forms because they previously had difficulty with insurers paying for transfusions (especially in cases of catastrophic claims review, ie, large numbers of transfusions) if it could not be "proven" that a blood product had actually been transfused. Some companies will not accept Lab Information System records that indicate the product was "issued", "issued final", or "transfused". The insurance companies apparently need to see hard evidence in the patient chart that transfusion actually took place. If tags from certain components are missing in the chart, the transfused component is not reimbursed.

2. A colleague in Michigan reports that 21 CFR 606.160 requires that there be distribution and disposition records and transfusion reaction reports. However, the CFR does not designate the specific way in which distribution or disposition records, or transfusion reaction reports are maintained or provide any further information about the detail required. All of the voluntary accrediting agencies directly, or by reference to the AABB Standards (i.e. JCAHO), require documentation of transfusion, specifically who got it, when they got it, what they got, and whether there a reaction. The CAP requirement is TRM.4450. The Michigan colleague concludes by saying that if you don't care if you get reimbursement from Medicare, then she supposes that you could stop at recording the final release information in the blood bank and not worry about the transfusion documentation.

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Ira A. Shulman, MD
CBBS e-Network Forum Editor & Moderator