The FDA’s 2024 final rule on LDTs is hitting another phase-in this quarter, so we’re tightening verification plans and data traceability on each method. For our respiratory PCR LDT, we added a 40-specimen split-comparison for lot bridging and are reviewing LIS audit trails weekly to confirm result integrity. How are you adjusting QC frequency and documentation to stay ahead of the deadlines?
LIS audit trails weekly to confirm result integrity. How are you adjusting QC frequency and We bumped QC to two levels per shift for the first 10 days post-lot on our resp PCR and trended median Ct by target daily; if the LJ charts stay tight and your 40-split agrees, we drop back to daily. We still do the weekly LIS audit, but in that post-lot window we review exceptions daily and log it into an EP23 risk file so the documentation’s airtight.
My take: I’d lean toward the simplest next step and see if it changes anything this week — if not, you’ve got a clear case to escalate. What would block you from trying that?
On our resp PCR LDT, we tighten to 1-2s/2-2s for the first week after a lot change and trend Ct medians by target; a >0.7 Ct nudge triggers a rerun using your “40-specimen split-comparison.” We also queue a once-per-shift low-positive third‑party control and require e‑sign on any template tweak in the LIS QA module — adds about 2 minutes but caught a primer lot drift. If that’s too heavy, @d_morrison92, at least watch IC Ct and invalid rate daily; it’s cheap and surprisingly sensitive to reagent hiccups.