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RECENT Artery Conversations

Immunosuppressant drugs: interference compounds LC-MS

For those who are currently reporting Immunosuppressants (Cyclo, Tacro, Siro, and Everolimus) using LC-MS/MS, I would like to know what interference compounds did you test during method validation on LC-MS/MS. What is your rationale for the choice of your compounds tested for interference? Help by responding online.

CAP Checklist Item COM. 10000

Many of our technical procedures refer to a vendor-provided manual for an instrument. This reference in our SOP also includes the version number of that vendor manual to be clear which version is being referred to in the event the vendor makes an revision. CAP checklist item COM.10000 requires that a complete procedure manual is available at the workbench and that all procedure manuals are document controlled. We have been cited by CAP for not placing these vendor-provided manuals under document control. Because there are several such manuals (many are hundreds of pages long) in place in any one lab, I'm curious to know how others are handling the document control of these vendor-provided instrument manuals. Share your thoughts.

Calibration verification and AMR verification: Qualitative Assays

I am wondering how everyone interprets the Calibration verification evaluation when it comes to Qualitative Tests (Eg, Hepatitis testing- Reactive, Non reactive)? When I read CLIA CFR rule, i got a different interpretation. Do you all perform Cal verification every six months for qualitative assays? I believe it is not required to perform cal verification for qualitative assays (POS/ NEG; Reactive / Non Reactive). Like to hear how everyone addressing this at each individual labs. Give your contribution online.