Lab Quality Control Daily Run SOP

Daily laboratory quality control procedure for documenting QC results, reviewing Levey-Jennings trends, applying Westgard rules, and checking analyzer and reagent status.

Steps

• Verify the QC run prerequisites
  The operator verifies that the correct analyzer is selected, the current QC lot and target ranges are available, and the daily QC record is ready for documentation. The operator confirms that the previous run has been closed out and that no unresolved non-conformance prevents testing.
• Check analyzer status and readiness
  The operator verifies that the analyzer is powered on, self-checks have passed, required maintenance is current, and any calibration status meets laboratory acceptance criteria. The operator records any active alerts, flags, or downtime conditions before proceeding.
• Inspect reagent and control material status
  The operator verifies reagent lot numbers, expiration dates, open-vial stability, storage conditions, and control material integrity. The operator confirms that the materials match the analyzer method and that no reagent or control is rejected for use.
• Run the required QC materials
  The operator prepares and loads each required QC level according to the analyzer procedure. The operator runs the controls in the order required by the laboratory method and records the raw results or confirms that the results were captured in the electronic system.
• Document the QC results
  The operator records each QC result in the approved laboratory record, including date, time, analyzer ID, control level, result, units if applicable, and operator identification. The operator ensures that documentation is complete, legible, and traceable to the run.
• Review Levey-Jennings trends
  The operator reviews the current QC result against the Levey-Jennings chart for shifts, trends, bias, or other unusual patterns. The operator compares the result to prior runs and confirms whether the pattern indicates stable performance or a developing deviation.
• Apply Westgard rules to the QC run
  The operator evaluates the QC results against the laboratory-approved Westgard rules for the assay. The operator determines whether the run is in control or whether a rule violation requires rejection, investigation, and escalation.
• Authorize the run for patient testing
  The operator documents QC acceptance and releases the analyzer for patient testing according to laboratory policy. The operator records any required sign-off in the QC log or electronic system.
• Quarantine the run and escalate the non-conformance
  The operator stops patient testing on the affected analyzer, documents the deviation, and records the specific rule violation or out-of-tolerance condition. The operator notifies the laboratory supervisor or designated competent person, follows the laboratory escalation procedure, and initiates corrective action per policy.