Testing Autologous Blood Units - Q and A

The AABB has provided insight into the testing and labeling of autologous units via a Q&A format that recently appeared in the AABB Regulatory Update - June 2002.

Q. Do autologous units have to be tested for infectious disease markers?

A. According to 21 CFR 610.40, blood establishments are required to test autologous units for infectious disease agents as follows:

• All tests must be performed and found negative if the blood establishment allows autologous units to be crossed over into allogeneic inventory.

• All tests must be performed and found negative if one blood establishment ships the autologous unit to another blood establishment that allows autologous units to be crossed over into allogeneic inventory.

• If the autologous unit is shipped to a blood establishment that does not cross over autologous units to allogeneic inventory, the first donation in each 30-day time period must be fully tested and found negative.

• If the facility is using the units internally only (i.e., not shipping them out), testing depends on whether the facility allows autologous units to be crossed over into allogeneic inventory. If the facility crosses over, all testing must be done.

A.

1) If the facility does not cross over, testing is not required, and the units must be labeled "Donor Untested."

2) If a facility only uses the autologous unit internally and does not cross over into allogeneic inventory, it may elect to test autologous units as follows:

1. Test each unit, in which case no special additional labeling is required; and
2. Test first donation in each 30-day time period, in which case the untested units collected within the 30 days must be labeled "Donor Tested Within the Last 30 Days."

Q. Where should the "Donor Untested" or "Donor Tested Within the Last 30 Days" label be placed?

A. Because the statement "Donor Tested Within the Last 30 Days" is really a testing statement, described in 21 CFR 610.40 (the new testing regulation), it should be applied directly to the container, and not on a tie tag. This is because:

• The tie tag could come off and the container would not have a test statement on it; and
• The new 21 CFR 610.40(d)(4) states that autologous units must be labeled as required in 606.121. (606.121 describes requirements for container labels and 606.121(h)(2) and (3) state that the results of any tests done on autologous units prescribed under 610.40 must be on the label.

Tie tags may not be used for the test statements described above. All viral marker test statements for a product that is not fully tested must be on the label. That means that "Donor Untested" and "Donor Tested Within the Last 30 Days" must be on the container label, not on a tie tag.