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CLIA: Test Ordering, Specimen Handling, and Result Reporting

CLIA · Work through your exam, one topic at a time.

All guide sections

Test Ordering, Specimen Handling, and Result Reporting

What this domain tests

This domain covers the preanalytic and postanalytic chain: who may order tests, how specimens are identified and handled, and how results are released and corrected.

Core rules

  • A test requisition must identify the patient and the ordered test; verbal orders must be documented and verified according to policy.
  • Specimens must be labeled with at least two patient identifiers at collection; unlabeled or mislabeled specimens must be rejected under laboratory policy.
  • The laboratory must have specimen acceptance/rejection criteria, including stability, volume, and collection requirements.
  • Results must be accurate, timely, and include reference ranges where applicable. Critical values must be reported immediately to the responsible clinician and documented.
  • Corrected reports must clearly identify the correction and be retained; records are kept per CLIA retention requirements.

Worked example

A potassium result of 6.9 mmol/L is verified at 2 a.m., but no one calls the clinician; the result is simply filed. Reasoning: the analytic phase was acceptable, but the postanalytic phase failed. A critical value requires immediate notification under laboratory policy, with documentation of who was called, time, and read-back. This is a reportable quality problem, not a minor paperwork issue.

Traps

Accepting a specimen labeled with only a room number. Releasing results before QC is complete. Omitting reference ranges. Failing to document critical-value notification. Correcting a report without an audit trail.