Lab Quality Control Daily Run SOP
Daily laboratory QC run SOP for checking analyzer readiness, running control materials, documenting results, and deciding whether patient testing can proceed.
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Overview
This Lab Quality Control Daily Run SOP template documents the daily pre-release workflow for a laboratory analyzer or test system. It covers the checks that happen before patient specimens are reported: confirming prerequisites, verifying analyzer readiness, checking reagent and control material status, running the required QC materials, recording the results, reviewing Levey-Jennings trends, applying Westgard rules, and authorizing or stopping patient testing.
Use this template when your lab needs a repeatable daily record that shows QC was performed, reviewed, and accepted by a competent person. It is especially useful for chemistry, hematology, immunoassay, microbiology support systems, and point-of-care devices where control results must be within tolerance before release. The template also helps when multiple shifts share the same instrument and need a consistent handoff record.
Do not use this SOP as a substitute for manufacturer instructions, assay-specific acceptance criteria, or corrective action procedures. If the analyzer is under maintenance, calibration is overdue, controls are expired, or a result violates a Westgard rule, the run should move into deviation handling rather than patient release. This template is designed to make that decision clear and documented, not to bypass it.
Standards & compliance context
- Supports ISO 9001-style documented information by creating a controlled, traceable record of QC execution, review, and release.
- Aligns with laboratory quality system expectations for verification, deviation handling, and non-conformance documentation.
- Can be adapted to CLIA, CAP, GMP, or internal accreditation requirements by adding assay-specific acceptance criteria and sign-off fields.
- Helps reinforce manufacturer instructions for use by requiring documented analyzer readiness and control verification before patient testing.
General regulatory context for orientation only — verify current requirements with counsel or the relevant agency before relying on this template for compliance.
What's inside this template
Steps
This section matters because it turns the daily QC process into a repeatable sequence with clear actors, verification points, and release decisions.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
How to use this template
- 1. The lab manager configures the SOP with the analyzer name, assay list, control levels, acceptance limits, and escalation contacts before the first daily run.
- 2. The operator verifies prerequisites, confirms the instrument is available for use, and checks that required PPE, supplies, and documentation tools are ready.
- 3. The operator inspects analyzer status, reagent lot and expiration dates, and control material storage conditions, then runs the required QC materials exactly as defined for the assay.
- 4. The operator documents each QC result, compares it to the expected range, reviews Levey-Jennings trends, and applies the applicable Westgard rules without skipping any flagged deviation.
- 5. The reviewer or supervisor authorizes patient testing only when all QC criteria pass, or escalates the non-conformance and records corrective action before release.
- best_practices
Best practices
- Record QC results at the time of the run, not from memory after patient testing has started.
- Use assay-specific acceptance limits and Westgard rules rather than a generic pass/fail note.
- Check control storage temperature and expiration before opening the vial, especially after weekends or outages.
- Document the instrument serial number, reagent lot, and control lot so failures can be traced quickly.
- Escalate any out-of-tolerance result before releasing patient specimens, even if the trend looks minor.
- Require a second review for repeated shifts, borderline trends, or any rule violation that suggests drift.
- Photograph or attach the original analyzer printout when your lab uses paper-based QC records.
What this template typically catches
Issues teams running this template most often surface in practice:
Common use cases
Frequently asked questions
What does this SOP template cover?
This template covers the daily quality control workflow for a laboratory instrument or analyzer before patient testing begins. It includes prerequisite checks, analyzer status, reagent and control material inspection, QC execution, result documentation, Levey-Jennings review, Westgard rule evaluation, and release or escalation decisions. It is meant to produce a clear documented record of whether the run is acceptable or needs investigation.
Who should run this daily QC procedure?
A trained laboratory technologist, medical laboratory scientist, or other competent person assigned to the analyzer should run it. The person performing the SOP should understand the instrument, the control levels, the acceptable tolerance ranges, and the escalation path for non-conformance. A supervisor or lab director may need to review exceptions or repeated failures.
How often should this SOP be used?
Use it at the start of each testing day, before patient specimens are reported, and any time the analyzer has been restarted, serviced, or shows an abnormal condition. Some laboratories also run it after reagent changes, calibration events, maintenance, or shifts in environmental conditions. The exact cadence should match the analyzer manufacturer instructions and the lab's quality policy.
Does this template help with regulatory or accreditation expectations?
Yes, it supports documented information practices expected under ISO 9001-style document control and laboratory quality systems. It also helps create traceable evidence of verification, deviation handling, and release decisions, which are common expectations in accredited lab environments. If your lab follows CLIA, CAP, GMP, or internal quality policies, this template can be adapted to fit those requirements.
What are the most common mistakes this SOP helps prevent?
The most common failures are skipping analyzer readiness checks, using expired or improperly stored controls, documenting results after the fact, and applying Westgard rules inconsistently. Another frequent issue is releasing patient testing when a control is out of tolerance but the deviation was not escalated. This SOP makes those decision points explicit so the run is either accepted or formally investigated.
Can this template be customized for different analyzers or assays?
Yes, it should be customized for the specific analyzer, assay menu, control levels, and manufacturer acceptance criteria. You can add instrument-specific prerequisites, reagent lot verification, calibration status checks, and assay-specific Westgard interpretations. Many labs also tailor the escalation section to name the supervisor, pathologist, or service vendor responsible for follow-up.
How does this compare with an ad hoc QC checklist?
An ad hoc checklist may confirm that QC was attempted, but it often leaves gaps in verification, documentation, and escalation. This SOP creates a repeatable step-by-step process with clear actors, expected outcomes, and release criteria. That makes it easier to audit, train new staff, and investigate non-conformance when a run fails.
Can this SOP connect to LIS or analyzer middleware workflows?
Yes, the documentation steps can be adapted to include LIS entry, middleware review, or electronic sign-off. If your lab uses instrument middleware, you can add fields for lot numbers, control IDs, timestamps, and reviewer approval. The template should still preserve a human verification step for any out-of-range or rule-violating result.
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