Quality Control and Audit Trails for Small Clinic Labs

A small clinic lab is held to the same basic standard as a large laboratory: results must be accurate, traceable and defensible. Quality control and audit trails are how a lab shows that it is working correctly. They also protect the lab when a result is questioned.

What quality control records should show

What an audit trail should record

Protect results after approval

Once a result is approved, it should be locked. Any later change should be made as a new version with a reason, not by overwriting the original. Reports should show the version and the approval date, so that a reader can see what was released.

Reagents and consumables

Record lot numbers and expiry dates for reagents and controls, and check them before use. A simple register of what was opened, when, and by whom makes it much easier to trace a problem.

Preparing for inspection

Questions to ask a lab software vendor

Where MedeilPlus fits

MedeilPlus lab module records orders, results and approvals against the patient record, with access controls and an audit log for changes. Confirm the quality control, lot tracking and audit export features you need during the demo, and check them against the accreditation standard your lab follows. For the lab workflow, read clinic lab software essentials for small labs.

Frequently asked questions

Does a small clinic lab need quality control records?

Yes. Even small labs need evidence that their tests are working. The depth of records depends on the tests and the accreditation your lab pursues.

Can a result be changed after it is released?

Only through a recorded correction, with the reason and the approver. The original should remain in the audit trail.

How long should records be kept?

It depends on the record type and local rules. Confirm retention periods with your accreditation body or legal adviser.