Townsend

This came up at our facility as well (in addition to PRP eye drop preparations!) - glad to hear that you agree Neil!

We also use opaque/colored bags, but they do not have the biohazard symbol on them. Our QA team also confirmed that was not needed for blood products - thanks for the reference applejw!

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That's a good suggestion sgoertzen. I have been attempting to comment on risk as it relates to sample/rgnt/patient testing/product quality in the summary of our incident reports, but that does sound a lot more thorough. I really would rather not complete the entire form and score (as int he commendable practice) for every occurrence or deviation. I get the intent though...

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.”

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