Townsend

Yes, you can bill for all three if needed.  We perform the poly DAT first, then follow-up with the IgG and C3b/d if positive, charging for each DAT performed.  The cpt code 86880 has an CMS MUE limit of 3 charges per date of service, so this follows those rules.

I am sure there will be a lot more discussion and clarification on this, but this what the guidance currently says (these reagents could be considered to fall into this category).
The information below is from the guidance document issued on June 25, 2024 - Laboratory Developed Tests: Small Entity Compliance Guide - Guidance for Laboratory Manufacturers and Food and Drug Administration Staff
For questions about this document, contact LDTFinalRule@fda.hhs.gov
 
“FDA intends to exercise enforcement discretion and generally not enforce premarket review and quality system (QS) requirements (except for requirements under 21 CFR part 820, subpart M (Records)7) for:
 Non-Molecular Antisera LDTs for Rare Red Blood Cell (RBC) Antigens for Transfusion Compatibility. These are non-molecular antisera LDTs for rare RBC antigens, when such tests are manufactured and performed by blood establishments, including transfusion services and immunohematology laboratories, and when there is no alternative IVD available to meet the patient’s need for a compatible blood transfusion. This policy does not apply to molecular tests used for genotyping RBC antigens.
 
7-On February 2, 2024, FDA issued a final rule amending the device QS regulation, 21 CFR part 820, to align more closely with international consensus standards for devices (89 FR 7496, available at https://www.federalregister.gov/d/2024-01709 ). When the final rule takes effect, FDA will also update the references to provisions in 21 CFR part 820 in this guidance to be consistent with that rule.”

These are the requirements for THE LABEL according to AABB Standard 5.1.8A (Requirements for Labeling of Blood and Blood Components):
Approximate volume is listed as R3 (required) for the final component label - see superscript 3 below:
"3For platelets, low-volume Red Blood Cells, plasma, pooled components, and components prepared by apheresis, the approximate volume in the container"
NOTE that is for the label on the component.  If you are referring to what is entered into your Lab IS system, I am not aware of any requirements for that volume.
Stephanie