Quality Control

February 2026 · 7 min

Overview

Quality Control (QC) ensures that your laboratory results are accurate, precise, and reproducible before they are reported to clinicians. Bio-Ecko's QC module supports Internal Quality Control (IQC) with Levey-Jennings charts and Westgard multi-rule analysis, as well as External Quality Assessment Scheme (EQAS) participation tracking.

QC is not optional -- it is a mandatory requirement for NABL accreditation (ISO 15189), NABH standards, and CAP accreditation. Even small labs running point-of-care tests must maintain QC records to demonstrate result reliability.

Internal Quality Control (IQC)

IQC involves running control materials (with known target values) alongside patient samples to verify that the analytical system is performing correctly.

Daily QC Workflow:

1. At the start of each shift (or as per your QC schedule), run control materials at two levels -- Normal (Level 1) and Abnormal (Level 2).
2. Navigate to Laboratory > QC > Enter QC Results.
3. Select the analyzer, test, and control material lot.
4. Enter the observed values.
5. The system plots the values on the Levey-Jennings chart and evaluates against Westgard rules.
6. If QC passes -- proceed with patient testing.
7. If QC fails -- the system flags the violation, blocks patient result release for that test (configurable), and prompts corrective action.

Control Material Management:

• Register control materials with lot number, target values, SD ranges, and expiry date.
• When a new lot is received, enter the new target values. The system starts a new L-J chart.
• Track control consumption and reorder levels.

Levey-Jennings Charts

The Levey-Jennings (L-J) chart is the primary visual tool for monitoring QC performance:

• X-axis -- Date/run number.
• Y-axis -- Control value.
• Lines -- Mean, +/-1SD, +/-2SD, +/-3SD.
• Data Points -- Each QC run plotted as a dot. Color-coded: green (within 2SD), yellow (between 2-3SD), red (beyond 3SD).

Patterns on the L-J chart indicate specific types of error:

• Shift -- 10 consecutive points on one side of the mean (systematic error, e.g., reagent deterioration).
• Trend -- 7 consecutive points moving in one direction (progressive calibration drift).
• Random scatter -- Points randomly distributed beyond 2SD (imprecision, e.g., pipetting error).

Bio-Ecko auto-detects these patterns and alerts the QC coordinator.

Westgard Rules

Westgard multi-rules evaluate QC data for specific violation patterns:

• 1-2s -- Warning: One control value exceeds +/-2SD. Not a rejection, but triggers review.
• 1-3s -- Reject: One control value exceeds +/-3SD. Random error likely.
• 2-2s -- Reject: Two consecutive values exceed +/-2SD in the same direction. Systematic error.
• R-4s -- Reject: Range between two control levels exceeds 4SD. Random error.
• 4-1s -- Reject: Four consecutive values exceed +/-1SD in the same direction. Systematic shift.
• 10x -- Reject: Ten consecutive values fall on the same side of the mean. Systematic bias.

You can configure which rules are active per test. For high-volume chemistry, enable all rules. For point-of-care, 1-3s and 2-2s may suffice.

When a Westgard rule violation occurs, the system logs the violation, suggests corrective actions (recalibrate, new reagent, new control lot), and tracks the resolution.

External Quality Assessment (EQAS)

EQAS (also called proficiency testing) involves testing samples from an external agency and comparing your results with peer labs:

• Enrollment -- Register your EQAS participation (e.g., CMC Vellore EQAS, AIIMS EQAS, Bio-Rad EQAP, RIQAS).
• Sample Receipt -- Log receipt of EQAS samples with cycle number and due date.
• Result Entry -- Enter your results before the submission deadline. The system reminds you 3 days before the deadline.
• Report Tracking -- When the EQAS provider publishes results, enter your performance score (SDI, bias percentage, pass/fail).
• Corrective Action -- For unacceptable results, document the root cause analysis and corrective action taken.
• NABL Compliance -- EQAS participation records are organized in the format required for NABL assessors.

QC for Point-of-Care Testing

For clinics running point-of-care instruments (glucometers, rapid test kits, urine dipsticks):

• Run electronic/liquid QC as per manufacturer guidelines (typically daily or with each new test kit lot).
• Log QC results in Bio-Ecko with the instrument ID and operator name.
• The system flags if QC has not been run today (or within the configured interval) and can block patient testing.
• Maintain lot-to-lot comparison records when switching to a new test kit batch.
• Even for rapid tests (malaria, dengue, pregnancy), document QC kit results for accreditation.

Reports & Accreditation

• QC Dashboard -- Real-time status of all tests: QC run today? Pass/Fail? Violations this week?
• L-J Charts -- Printable charts per test, per analyzer, for any date range. Required for NABL documentation.
• Westgard Violation Log -- All violations with corrective actions and resolution status.
• QC Compliance Rate -- Percentage of days/shifts where QC was run on time. Target: 100%.
• EQAS Performance Trend -- SDI/bias trends over multiple EQAS cycles.
• Corrective Action Register -- All QC failures and their documented resolutions, organized for auditor review.
• NABL Assessment Package -- One-click export of all QC records in the format required for NABL assessment visits.

Notes

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