When to pause autoverification (and how to document it in the SOP)
Decision criteria for pausing AV by assay, instrument, or globally: QC failure, rule escapes, firmware change, hypercare — plus resume evidence and SOP language.
- autoverification
- SOP
- quality control
- lab middleware
- laboratory supervisor
- risk management
What pausing autoverification is
Autoverification (AV) is laboratory-owned policy that automatically releases results meeting predetermined criteria, and holds the rest for human review. Pausing AV is a planned control: stop auto-release when risk rises, while usually keeping connectivity and QC gates active.
Pausing is not a failure. Leaving AV on after an escape — or turning it off with no resume criteria — is the failure mode.
Audience: lab supervisors / QA (authority and SOP) and lab IT / middleware owners (how the switch is executed and recorded).
Pause triggers (examples)
Prefer the narrowest safe scope (assay family or instrument before global).
| Trigger | Typical scope | Notes |
|---|---|---|
| QC systematic failure / analyzer instability | Instrument or assay family | Keep QC gates on |
| Escape or near-miss on AV rules | Rule family or analyte | Investigate before resume |
| Major firmware or mapping change | Affected channel | After regression mini-pack |
| Hypercare instability (queue melt, unclear holds) | As needed | Staff the exception path |
| Specimen ID / interface integrity concern | Channel or global | Treat as patient-safety event |
| Exception queue cannot be staffed safely | Leadership call | Rare; document the decision |
While paused — expected behaviour
- Connectivity (orders/results pipe) usually stays up
- QC gating usually stays on
- Auto-release is off for the paused scope
- Manual verify path is staffed and communicated to the bench
SOP language (skeleton)
Include at least:
- Authority — roles who may pause / resume
- Scope — how to select assays, instruments, or global
- Communication — who is notified (bench, IT, leadership)
- While paused — manual path; QC gates still apply
- Resume criteria — evidence required (see below)
- Records — ticket ID, times, approver, rule versions
Resume evidence (examples)
- QC back in control for the affected assays
- Rule fix + mini-validation (or documented acceptance of risk)
- Escape review closed
- Named approver sign-off
Worked scenario (illustrative)
Parallel review finds a delta-check escape on an electrolyte family. QA pauses AV for that family only. Middleware keeps the LIS uplink and QC gates running. A rule revision is validated on a golden set, hold rates are reviewed for 48 hours, then AV resumes with a ticket attaching the validation summary.
Checklist before go-live
- Pause / resume documented in the SOP
- System procedure is clear (not tribal lore)
- Comms template ready for the bench
- Resume requires a named approver
- Drill once during validation or hypercare
FAQ
Should connectivity stay up while AV is paused?
Usually yes — keep the pipe and QC gates; pause only auto-release for the affected scope.
Who resumes AV?
Lab leadership accountable; QA typically responsible — after evidence, not informal consensus.
Is a global pause always required?
No. Narrow scope reduces clinical disruption. Escalate scope only as risk requires.
Related reading
- Autoverification without the anxiety
- Encode policy: QC gates and AV you can defend
- Audit-ready trails for lab middleware
- QC that doesn’t live in a spreadsheet
About TransLABtor
On-premise middleware can separate connectivity, QC gates, and AV controls so pause/resume is an operational switch with an audit trail. Formal SOP ownership remains with the laboratory. Book a technical discussion.