How to Document a Go-or-No-Go Decision After a Laboratory AI Pilot

State the intended operational use, users, inputs, outputs and workflow boundary. Compare the work actually tested with the original approved scope. A useful demonstration may still leave the intended task unanswered.

Qualified laboratory leadership must decide which governance, validation and professional requirements apply. A pilot decision is not permission to introduce a new clinical use.

List each acceptance criterion and link it to the relevant controlled evidence. Include normal, unusual, missing-data and failure cases where they were part of the plan.

Avoid rewriting thresholds after seeing the results merely to obtain a positive conclusion. If the original criteria were unsuitable, document the issue and obtain approval for the revised evaluation.

Record demonstrated behaviour, limitations, missing tests and findings that need further work. Distinguish a supplier claim from an observation made in the laboratory’s own controlled context.

Do not let an average result conceal a consequential failure. The severity, detectability and context of exceptions may matter more than a single summary measure.

Check whether authorised users, procedures, human review, training, access controls, incident routes and fallback arrangements are ready for the proposed next stage. Assign owners to remaining actions.

A tool can perform promisingly in a pilot while the organisation is not ready to use it routinely. Keep technical results and operational readiness as separate parts of the decision.

Use a clear approved status such as stop, extend the pilot, proceed with restrictions or proceed within the validated scope. Explain the evidence supporting that outcome and the conditions that limit it.

Record who can authorise the next step, when the decision must be reviewed and what change or incident would trigger reconsideration. Do not treat silence or the passage of time as approval.

Keep the signed or otherwise authorised decision with the evidence versions, actions, owners and review dates. Ensure affected staff can find the current status without relying on informal messages.

BioInsight Labs can support controlled operational workflows. Qualified people remain accountable for validation, oversight and laboratory decisions. This guide provides operational information, not diagnosis, treatment or clinical advice.

Does a successful demo mean go? No; compare approved criteria and readiness. Can a restricted pilot become routine automatically? No; use the authorised decision process. Who approves the outcome? The qualified roles defined by the organisation’s governance.