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LIMS Admin Investigation Validation
Validation rules are configured at the investigation item level and control whether a report can be approved when certain conditions are not met. They act as quality gates that prevent the release of incomplete or physiologically implausible results. This article explains the available validation rules and how to configure them.
Without validation rules, an MLT could approve a report with:
- An empty mandatory field (e.g., approving a creatinine report without entering a value).
- A result typed incorrectly (e.g., 1240 g/dL instead of 12.4 g/dL — physiologically impossible).
- A calculated field not yet run (approval before the Calculate button was clicked).
Validation rules catch these errors before the report reaches the patient.
Effect: The Approve button shows a warning and approval is blocked if this parameter has no value entered.
Use for: Parameters that must always have a value before the report can be released — for example, the primary result field in any investigation.
How to enable:
- Open the investigation item.
- Tick the checkbox Cannot approve if value is empty.
- Optionally, enter a custom warning message (e.g., "HGB cannot be empty — please enter the result before approving").
- Save.
Effect: Approval is blocked if the entered value is below a configured lower limit.
Use for: Catching values that are physiologically impossible (e.g., a negative WBC count, a haemoglobin of 0 for a live patient). This is different from the reference range low value — the absolute minimum is a hard physiological floor, not a clinical alert.
How to configure:
- Open the investigation item.
- Tick Cannot approve if value is below absolute minimum.
- Enter the Absolute minimum value (e.g., 0.1 for WBC, 3.0 for haemoglobin in g/dL).
- Enter a custom warning message (e.g., "WBC value below minimum — please recheck before approving").
- Save.
Effect: Approval is blocked if the value exceeds a configured upper limit.
Use for: Catching clearly erroneous entries (e.g., a haemoglobin of 300 g/dL, or a platelet count of 99,000 when entered without the correct units).
How to configure:
- Open the investigation item.
- Tick Cannot approve if value is above absolute maximum.
- Enter the Absolute maximum value (e.g., 25 for haemoglobin in g/dL, 1000 for WBC in 10³/µL).
- Enter a custom warning message.
- Save.
Multiple validation rules can be active on the same parameter simultaneously. For example:
- Cannot approve if empty AND
- Cannot approve if below 0.5 AND
- Cannot approve if above 1,200
All active rules are checked when the approver clicks Approve. If any rule is violated, the system displays all relevant warnings and prevents approval until every issue is resolved.
When an approver clicks Approve and a validation rule is violated:
- A dialog appears listing all validation warnings (e.g., "HGB: Cannot approve — value is empty").
- The approver cannot proceed until each warning is cleared.
- To clear a warning, the MLT must either:
- Enter the missing value, or
- Correct the out-of-range value, or
- (In exceptional cases, for authorised users) override the validation — if the system is configured to allow overrides with a justification note.
- Set absolute limits conservatively — they should catch obvious data entry errors, not flag borderline clinical values.
- For calculated fields, adding "Cannot approve if empty" ensures the MLT always clicks Calculate before approving.
- Review validation rules when adopting new test methods — the absolute limits for the same analyte may differ between methods (e.g., a POC glucose meter vs. a laboratory analyzer).