How to Create a Sampling Plan for Reviewing AI-Assisted Laboratory Output

Name the approved use, current version, users, inputs, outputs and decisions the AI-assisted step can influence. Sampling cannot compensate for an undefined or unvalidated process.

Qualified laboratory leadership must determine whether sampling is appropriate under applicable quality, regulatory and professional requirements.

Separate routine cases from unusual inputs, changed configurations, corrected records, escalations and situations with greater consequence. Do not sample only the easiest successful output.

Human review remains mandatory wherever procedure or professional responsibility requires it, regardless of the sampling plan.

Define checks for source traceability, completeness, units, dates, context, unsupported statements, privacy and required approvals. Use observable acceptance criteria.

Fluent language is not evidence of accuracy. Reviewers must be able to inspect underlying records.

Document the authorised frequency, sample size rationale and who selects records. Add event-driven review after model, workflow, data or policy changes and after incidents.

Increase or suspend use when predefined thresholds or unexpected risks are reached.

Capture the reviewer, date, version, sample, result, correction, escalation and decision. Protect sensitive information under approved access and retention controls.

Trend recurring issues without hiding individual serious findings inside an average.

Reassess whether the plan detects meaningful problems and still reflects current use. Qualified owners should approve changes and any return to routine monitoring.

BioInsight Labs can support controlled workflows and records; qualified professionals remain accountable for validation, oversight and laboratory decisions.

Can sampling replace required review? No. Should only random samples be used? Risk-based and triggered samples may also be necessary. Is a low error rate proof of safety? No; severity, blind spots and context also matter.