AABB Accepting Comments on Proposed BB/TS Standards Until July 21
June 29, 2021
The proposed draft Standards for Blood Banks/Transfusion Services, 33rd edition, is now available for public comment. The comment period began May 21 and will conclude on July 21.
A comprehensive description of the additions and edits in the draft is provided in a summary memo that accompanies the proposed standards. These significant changes include:
- Proposed Standard 184.108.40.206 has removed the note that “Blood obtained by earlobe puncture shall not be used…”. It should be noted that ear lobe puncture is no longer performed and that the standards should reflect that this practice is no longer in place.
- Proposed new Standard 220.127.116.11.1 was created, recognizing that there are components prepared from pathogen-reduced plasma that are processed and stored per manufacturer’s instructions. Included with this are thawed plasma, cryoprecipitated fibrinogen complex and plasma cryoprecipitated reduced, among others.
- Proposed new Standards 18.104.22.168.1, 22.214.171.124.1, 126.96.36.199.1 have been created requiring that apheresis platelets; apheresis platelets, leukocytes reduced; and apheresis platelets platelet additive solution add leukocytes reduced that contain less than 3.0 x 1011 platelets shall have the platelet content included on the label. This change was proposed with input from the Food and Drug Administration.
- Proposed Standards 5.8.6, 188.8.131.52, 5.8.7, Reference Standard 5.1.6A and Reference Standard 5.4.1A have been edited to remove the requirement that Zika virus testing be conducted on donor blood in accordance with the withdrawal of the guidance by FDA.
- Proposed Standard 5.14.5 has been edited to remove the clause “validated” from sub-number 3, which previously stated, “validated electronic identification system,” and added the clause “at the time of sample collection” for clarity.
The Blood Bank/Transfusion Service Standards Committee encourages all interested individuals to submit comments in the next 60 days. The standards in the 33rd edition are now in the proposed phase and will be finalized after the comment period has concluded. The Committee will review all comments submitted and provide a summary document that describes the committee’s rationale for its final decisions. The draft is available on the front page of the AABB website.