Quality Control Software
for Diagnostic Labs
ClinikPe's quality control module gives every diagnostic lab — from single-room to multi-branch — the tools to run IQC systematically, apply Westgard rules automatically, generate Levey-Jennings charts, and maintain the complete audit trail required for NABL ISO 15189:2022.
Quality Control Is Not Optional — It's What Separates Reliable Labs from the Rest
In 2023, a Maharashtra consumer forum ordered a diagnostic lab to pay ₹1.2 lakh in damages to a patient after a falsely elevated creatinine result led to unnecessary treatment — the lab could not produce any IQC records to show their analyzer was in control on the day of testing. This is not an isolated case. Without documented quality control, labs face medico-legal risk and cannot achieve NABL accreditation.
ClinikPe makes running daily IQC as simple as entering the control result. The software applies Westgard rules, plots the Levey-Jennings chart, flags violations, and stores the record automatically. A complete 90-day QC audit trail is always ready — for NABL assessors, for regulatory inspections, and for the lab's own quality review meetings.
Quality Control Challenges in Indian Diagnostic Labs
Most mid-size labs in India run IQC on paper or Excel — creating compliance gaps and medico-legal risk.
Paper-Based QC Records Are Incomplete
Handwritten Levey-Jennings charts in a register are the norm in most Indian labs. They're incomplete, cannot be searched, are lost in audits, and make trend analysis impossible.
Westgard Rules Not Applied Consistently
Most lab technicians know Westgard rules in theory but apply them inconsistently under workload pressure. Without automatic flagging, violations are missed.
QC Data Not Connected to Patient Results
If an IQC run fails but no one checks before releasing patient results, erroneous reports go out. Without integrated QC, there's no automatic hold on patient results when controls fail.
EQAS Participation Not Tracked
NABL requires participation in external quality assessment. Most labs have EQAS certificates but don't systematically track their performance scores or trend their EQAS data over time.
No Analyzer Comparison Data
Labs with multiple analyzers (e.g., two HbA1c methods) have no easy way to compare analyzer performance — CV%, bias, drift — without manual calculations.
QC Reagent Lot Changes Not Managed
When a QC control lot changes, new mean and SD must be established. Without software guidance, labs often continue using old means — causing spurious Westgard violations.
ClinikPe QC Module — Full Feature Set
Everything a diagnostic lab needs to run quality control systematically — and document it for NABL.
IQC Data Entry & Auto-Evaluation
Enter control results directly in ClinikPe. The system automatically calculates whether the result is within the expected range and flags any Westgard rule violation — no manual chart plotting needed.
All Six Westgard Rules
ClinikPe implements all six core Westgard rules: 1-2s (warning), 1-3s (rejection), 2-2s (rejection), R-4s (rejection), 4-1s (rejection), and 10x (rejection). Each violation shows the specific rule violated and recommended action.
Levey-Jennings Charts
Automatic Levey-Jennings chart generated for every analyte-control combination. Visual trend display shows the last 30 runs. Violations marked in red. Downloadable as PDF for NABL documentation.
Multi-Analyte, Multi-Analyzer
Track QC for every analyzer in the lab — CBC, biochemistry, coagulation, urine, immunoassay, HbA1c, thyroid, blood gas. Each analyzer tracked separately with its own QC chart and performance metrics.
EQAS Result Recording
Record your EQAS cycle results (CMC Vellore, AIIMS, NEQAS India, Bio-Rad, Randox) — sample ID, expected value, your result, z-score, and performance rating. Track EQAS performance trends over time by analyte.
QC Lot Management
Manage control lot changes with guided mean and SD establishment (using the recommended 20-day run-in protocol). Prevents the common error of using incorrect means after a lot change.
Patient Result Hold on QC Fail
Configure ClinikPe to require QC review before authorising patient results for any analyte where IQC has failed that day — preventing erroneous reports from reaching doctors.
CV% and Bias Trending
Monthly and quarterly CV% and bias calculations per analyte — the two primary metrics for analyzer performance evaluation. Track drift over time, compare analyzers, benchmark against CLIA requirements.
NABL QC Documentation Export
Export complete QC documentation in NABL-ready format: daily QC log, monthly summary, Levey-Jennings charts, Westgard violation log with corrective actions, EQAS participation records. 90-day archive always available.
QC Documentation That Satisfies NABL Assessors
ClinikPe's QC module generates documentation aligned with NABL ISO 15189:2022 requirements. Note: ClinikPe is software — NABL accreditation is awarded to the lab, not the software. ClinikPe's NABL-specific documentation features are targeted for Q3 2026.
Measurement Uncertainty
ClinikPe's CV% calculations directly support estimation of measurement uncertainty — a mandatory NABL ISO 15189:2022 requirement.
Quality Assurance
ClinikPe's IQC records, Westgard violation logs, and corrective action records directly satisfy NABL Clause 5.9 (Quality Assurance of Examination Results).
External QA Participation
NABL requires labs to participate in EQAS for all tests they perform. ClinikPe tracks EQAS registration, participation, and performance scores for each EQAS programme.
Frequently Asked Questions
What is IQC in a diagnostic lab?
IQC (Internal Quality Control) is a continuous process where labs run known-concentration control samples alongside patient samples on every analyzer. Results are plotted on Levey-Jennings charts and evaluated against Westgard rules. If a control falls outside acceptable limits, it indicates a potential analyzer error and patient results must be held. IQC is mandatory for NABL ISO 15189:2022 accreditation.
What are Westgard rules in laboratory quality control?
Westgard rules are statistical criteria to evaluate whether an analytical run is in control. The six core rules: 1-2s (warning), 1-3s (reject run), 2-2s (reject run), R-4s (reject run), 4-1s (reject run), 10x (reject run). ClinikPe implements all six automatically — technicians see which rule was violated and the recommended action without manual calculation.
Is ClinikPe NABL accredited?
ClinikPe is diagnostic lab software, not a lab — NABL accreditation is awarded to labs, not software. ClinikPe's QC module is designed to help labs meet NABL ISO 15189:2022 quality control requirements: IQC, Levey-Jennings, Westgard rules, EQAS tracking, and full documentation. ClinikPe's NABL-specific documentation features are targeted for Q3 2026.
What is EQAS for diagnostic labs?
EQAS (External Quality Assessment Scheme) sends identical blind samples to multiple labs for testing and compares results. Major Indian EQAS providers include CMC Vellore, AIIMS Delhi, and NEQAS India. NABL requires labs to participate in EQAS for all tests they perform. ClinikPe allows labs to record and track EQAS results, scores, and trends per analyte within the QC module.
Can ClinikPe hold patient results when QC fails?
Yes. ClinikPe can be configured to require QC review before authorising patient results for any analyte where IQC has failed that day. This prevents erroneous results from reaching doctors — the most important function of an integrated QC system.