QC controls

What a QC control is

A QC control is a control material lot used to check whether a test method is performing acceptably. In Fohosat, each control has English and Arabic names, manufacturer, lot number, expiry date, active status, and a list of target values. Targets connect the control to specific tests with Mean, SD, and unit.

Create a separate control record for each control lot and level when targets differ. For example, Bio-Rad Level 1 and Bio-Rad Level 2 should usually be separate controls because their expected values are different.

Control information

The Control Information section contains English and Arabic control names, manufacturer, lot number, expiry date, and active status. Include the material and level in both names so staff can select the correct lot in either interface language. Manufacturer and lot number help trace problems to a specific insert or supply batch. Expiry date is required because expired controls should not be used for routine release decisions.

Use active status to retire an old lot from result-entry lists without losing history. The Lab Panel intentionally does not offer control deletion because removing the parent record would hide linked QC history from normal review. Deactivate the control and create a new record for the replacement lot.

An active lot must be current and contain at least one certified target. If this lot is the last valid coverage for one of its tests, the system will not let you deactivate it or remove that target until another current lot is active. This prevents an apparently routine retirement from silently removing the QC gate from patient-result release.

Targets

The Targets (Mean/SD) section uses a repeater. Each row selects a test, mean, standard deviation, and unit. Test choices are limited to the current lab company's catalog, and the same test cannot be configured twice for one control. Removing a row only changes the form until the control is saved.

Mean and SD should come from the control insert or from validated lab-established targets. SD must be greater than zero so rule analysis is meaningful. Units should match the analyzer and test reporting unit. If the unit is left blank, staff may still enter numeric QC values, but review will be harder because the target context is incomplete.

Results relation

The control record includes a results relation manager. Use it to review QC results connected to that control. This is useful when a control lot starts showing repeated warnings or when the lab wants to compare performance before and after a reagent or calibration change.

If results for a control look wrong, check whether the target Mean/SD was entered correctly. A simple target typo can make normal QC appear rejected or make bad QC appear acceptable.

Table and filters

The QC Controls table shows the localized name, lot number, expiry date, number of configured tests, and an availability badge. Available, Expires soon, Expired, Inactive, and Setup incomplete distinguish lots that can be used from lots retained only for history. The active filter helps separate current controls from retired lots. Search supports both names, manufacturer, and lot number.

On Quality > Enter QC Results, unavailable lots stay visible but disabled, with the exact reason beside the lot. This makes an expired, inactive, or target-free lot diagnosable instead of leaving an unexplained empty selector. Lots expiring within 30 days are marked early so the replacement can be created, checked, and activated before coverage is lost.

Result release now requires a valid, active, unexpired target for every released test when the QC release gate is enabled. Missing coverage is a blocker, not a skipped check or a manager override. After fixing coverage, record a current acceptable QC run and retry release.

Use the configured test count as a setup check. A control with zero targets cannot accept results on the entry page. If a required analyte is missing, add its certified target before running the control; the result-entry page only creates fields for configured targets.

Checklist

• Control name identifies level and material clearly.
• Manufacturer and lot number match the package insert.
• Expiry date is current.
• Expiring-soon lots have a validated replacement plan.
• Active status is disabled for retired lots.
• A replacement lot is active before the last covering lot is retired.
• Every covered test has a Mean and SD target.
• SD is greater than zero.
• Units match the test's reporting units.