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2026-10-23 · 5 min read

How to Run a Periodic Review of a Laboratory AI Workflow

Structure a periodic laboratory-AI workflow review around intended use, versions, evidence, incidents, human oversight and an authorised decision.

Confirm the approved intended use

Compare the workflow actually used with its approved scope, users, inputs and decisions. Record any drift rather than silently normalising it.

Qualified laboratory leadership must determine whether the workflow remains authorised.

Identify the active versions

Record the application, model, prompt, integration and controlled reference versions relevant to the workflow.

Do not assume an unchanged interface means the underlying system or behaviour is unchanged.

Review performance evidence in context

Examine approved monitoring, exception, sampling and human-review records for the defined period.

A simple average or vendor claim does not replace evaluation of the laboratory's own intended use and acceptance criteria.

Reconcile incidents and changes

Connect incidents, complaints, software updates, procedure changes and corrective actions to the workflow record.

Keep unresolved questions visible and assess whether continued use, restriction or suspension is appropriate.

Check access and competence

Confirm that current users retain appropriate authority, training and review responsibilities. Remove or correct obsolete access through the authorised process.

Automation must not obscure who remains accountable for decisions.

Record an authorised outcome

Document the evidence, reviewers, decision, conditions and next review trigger. Preserve dissent or limitations where relevant.

BioInsight Labs supports controlled operations; qualified professionals remain accountable. This is not diagnosis, treatment or clinical advice.

Frequently asked questions

Does a quiet period mean no review is needed? Follow the approved schedule and triggers. Can vendor assurance replace local review? No. Must every review approve continued use? No.

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