Chapter 2 · Calibration

Calibration verifies that the measurement output of equipment is traceable to a reference standard. Calibration must be performed: on installation, after maintenance, after equipment failure, and at defined intervals. Calibration records must document: date, result, reference used, tolerance, and who performed it. If calibration fails, all results produced since the last successful calibration must be reviewed for potential impact on patient results.

Practical example

An analyser fails its calibration check on Monday morning. Good practice: The analyst halts patient testing, reviews all results issued since Friday’s last successful calibration, notifies the section head, and issues a hold notification to the requesting clinicians while the calibration issue is investigated and resolved. Poor practice: The analyst re-runs calibration, gets a pass on the second attempt, and continues without reviewing the results issued between the failure and the pass.

What this means for your practice: Calibration failure does not disappear when the next calibration passes. All results issued in the interval must be reviewed.