The sign-off that did not show competency

A training record can show that instruction occurred. It does not, by itself, show that a person can perform assigned testing correctly under routine conditions. A general performance evaluation also has a different purpose from a documented competency assessment. The assessment question is specific: does the evidence demonstrate the required knowledge, skill, and problem-solving performance?

For nonwaived testing personnel, CLIA requires documented competency assessment using six elements at least annually. During the first year of patient testing, the cadence is at least twice, semiannually. High-complexity personnel also require reevaluation when methodology or instrumentation changes. Local policy may set additional requirements and roles.

A common weak record lists completed tasks without showing an observed decision point. For example, a checklist that says QC reviewed does not show whether the employee recognized a failed QC rule, stopped release, or selected the correct escalation. The record should identify the test system, assessor, date, evidence method, result, and the specific element assessed.

At the bench, write the assessment claim first, then choose evidence that could support or refute that claim.