A laboratory automation purchase needs an acceptance plan

What ADLM recommends

ADLM's July 10, 2026 policy report on artificial intelligence in laboratory medicine emphasizes validation, transparency, accountability, interoperability, and monitoring. It recommends independent assessment and responsible oversight. These policy recommendations should not be presented as a universal new legal mandate.

The practical question for a buyer is specific: what decision or workflow will this tool influence, and what evidence will show that it is suitable for that use? An administrative scheduling aid, a reporting calculator, and a clinical interpretation system require different review teams and evidence.

Set acceptance before installation

Write the intended use and exclusions, identify the data and access required, and define a representative test set. Confirm how the tool handles missing inputs, unusual values, changes in assay or instrument, and unavailable services. Agree what a reviewer will see when the tool is uncertain or fails.

Acceptance should cover calculations and workflow, not just a visually polished report. Record the version tested, expected outputs, observed results, discrepancies, approvals, and monitoring owner. A later upgrade should have a defined change review rather than silently inheriting the previous approval.

• Who owns technical, clinical, security, and operational approval?
• Which errors could affect decisions, and how will they be detected?
• What triggers reassessment, rollback, or a pause in use?
• What training and support are included in the contract?

Corporate standards need local testing

Corporate procurement can establish common expectations for a vendor and require evidence before purchase. Each participating lab still needs to confirm its intended workflow, local configuration, and approval responsibilities. Network scale makes clear version records and site acceptance more valuable.

AssayIQ can scope workflow mapping, acceptance-plan documentation, reporting-tool evaluation, and implementation coordination within a corporate project. Clinical AI validation, cybersecurity assessment, or specialist regulatory interpretation requires appropriately qualified experts and a separate agreed scope. The service is not a claim of an already validated clinical AI product.