Build items and records that can bear review

The CLIA six elements are direct observation of routine testing including specimen handling; monitoring and recording/reporting of results; review of intermediate results and records; direct observation of instrument maintenance and function checks; testing previously analyzed or blind samples; and assessment of problem-solving skills. Assess applicable elements for each person and each test system or method. Applicability is set by the person’s assigned testing, the test system or method (including primary and backup methods, different analyzer platforms, and manual versus automated methods), the test complexity, and the required assessment element.

A performance checklist should capture critical steps and decision points, not only task completion. For potassium testing, direct observation can include specimen identification, centrifugation, analyzer loading, result review, and release. A separate problem-solving scenario can require the employee to identify a QC failure, determine which results require review, notify the appropriate role, and document the action.

Write selected-response items around one clearly defined concept. Plausible distractors represent predictable misconceptions and remain homogeneous in category and grammar. Avoid negative lead-ins, hidden assumptions, and a key that is longer or more detailed than the distractors, because each lets a test-wise learner infer the answer without applying laboratory reasoning and so invalidates the inference that the item measured the claimed decision. A correct response should depend on laboratory reasoning rather than test-taking tricks.

At the bench, retain the supporting record for each element instead of treating a signature as the evidence itself.