FDA vs LDT's

[Bet'naSBB]

So, my manager (I'm the asst. mgr) has me looking at ALL our reagent IFU's to make sure that our SOP's are in line with the IFU's since this new FDA thing is coming up stating that anything used outside of the IFU is an LDT.....(or something to that effect).  We are a large academic medical center and do 95+% of our own abid's.  As I'm reading these IFU's for screen and panel cells they are all saying "Do not use beyond expiration".  We often use expired panel cells to help R/in or R/out antibodies - does this new ruling mean that we can no longer do that....?  Even if we run +/- controls?  I'm stressing just a little!

We also freeze some of the more "rare" antiseras - but we don't "report" those reactions or interpretations............so, basically that's just for "information"

[ElinF]

We are a small hospital.  We were cited for this a few years ago by the Joint Commission and were kind of shocked.   Several years before that they asked us for our daily Qc on our panels. We never did QC on panels we only QC'ed the method (gel or tube) with screen cells.  (our reference lab was confused with QCing panel cells as well, I mean what antibody to you QC? all? 2? 3?)  So we had to start doing on receipt QC and every day of use and we can no longer use outdated panels.  I just  use the Ortho antibody in the QC kit and test Cells 1 and 5 (pos and neg for D and little c) We currently stock a panel for tube and gel. If we can't rule out based on those 2 we need to special order blood or send the specimen out.  I am not really sure what the pathologist can or can't sign off on as far as validating anything as far as using outdated cells.  Since you are a larger facility maybe see what your reference lab does. 

 

 

[Townsend]

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.”

[RRay]

Would this be something an IQCP could take care of?

[jshepherd]

The caveat for using expired cells is if you are a reference lab and the cell is rare. You do have to QC it before using it for rule outs, and I've always been told that you should QC it based on an antigen that is known to evanesce over time, like Fy. 

We stopped using expired panel cells more than 10 years ago when this became part of the IFUs. We just stock more options of panels in order to do all rule outs. (Also a large academic center that performs 95+% of ABIDs.  )

To Randi's point, you might be able to write an IQCP and get away with it that way, it will probably depend on your inspector, and if your medical director is okay with blatantly going against the IFU.