Some tidbits as I understand them (unfortunately, I am never brief). This info is for ALL CLINICAL Flow labs; you must add the required comment to your reports, or else! (what? to be determined...) Any reagent / application that is FDA approved needs no comment (i.e. our FDA approved CD4 / CD8 reagents on peripheral blood). Stop here if you only use FDA approved reagents for clinical assays on peripheral blood. The rest of you... Remember the letters that you had to sign promising that you were not using "for research use only" reagents for clinical purposes? The ASR reagent category replaces that system and puts the burden of proving reactivity on the labs for clinical assays. We attach the required comment (modified as indicated below) to all leuk reports as no reagents I know of are FDA approved for doing leuk panels. (Please, someone, correct me if this is incorrect ) Also, I add it to clinical results without FDA clearance i.e. our CD34 and HLA PRA screens. Becton Dickinson sent out a "bright-green" pamphlet explaining the ASR regulations in pretty clear terms. I even shared it with our special chem and sendout labs as the original federal regulations are longer and more difficult to interpret. Call your BD rep to get a copy: pub. # 11/98 23-3886-00. Then read the federal regulation. The pamphlet also lists "for further reading" articles. Nice job, guys! This is our modified version of the required comment: "These tests were developed and their performance characteristics were determined by the Sentara Norfolk General Hospital flow cytometry laboratory, a CLIA-certified high complexity testing facility, using Class I Analyte Specific Reagents (ASRs). These tests have not been cleared or approved by the U.S. FDA; Class I ASRs do not require FDA clearance or approval." You must be a high complexity testing facility to use homebrew reagents for clinical assays (homebrew = non-FDA approved assays = your leuk results). See CLIA regulations for high complexity testing requirements; your CAP inspection may qualify for certification. The last sentence is added to avoid misinterpretation or refusal of payment by insurance companies "for research use only". We began this comment in December 98 and expected a huge resistance / response from our clients. I have yet to receive the first call. I also worried that this would jeopardize our market share with the competition. But I figured being shut down or having to scramble to fix it after being discovered, and maybe even fined, would be worse. We haven't lost any clients. The vendors I contacted (Caltag, Coulter, BD) told me that the inserts have been changed and that the labels on the reagent bottles have been changed. As their old-labelled stock is rotated off their shelves, I was told we would see the new labelling. Reactivity of reagents without FDA approval which we are currently using have been established through the years for leuks. Any new reagents we begin using will have to have their reactivity established. I plan to place new reagents in "quarantine", and run them on all specimens received to establish reactivity and staining patterns. I will have a separate folder for each new reagent containing all titer info, histograms, and supporting literature pertaining to this reagent. Hmmm, but we all do this already, right? These folders will be very helpful when the lab is questioned or inspected. Note: "They" are not just picking on flow labs. These regulations effect many immuno tests using in-house antibodies or unestablished kit testing. Our institution even attaches comments to sendout results performed in reference labs because the original testing was performed by someone else using ASRs. The only testing using ASRs that are exempt from adding a comment is immunohistochemistry testing because, best as I can determine, the reactive pattern must be reviewed by a pathologist together with morphology. I called 20 antibody vendors in January for our IHC lab to document ASR policies, and only 2 had even heard of ASRs. I sent them the BD pamphlet info. Cheers! Cathy Fritschi Norfolk, VA
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