Quality indicators in the clinical laboratory, calculated every month
Quality indicators in a clinical laboratory are numbers, tracked month by month, that show how well each step of testing works: how many samples are rejected, how many reports are late, how many critical values reach a doctor on time. This page gives the full list of 18 indicators with their formulas and data sources, explains how to set targets, and shows how PathLab Software calculates them from the work your lab already records.
What are quality indicators in a clinical laboratory?
A quality indicator (QI) is a defined measure, with a formula and a target, that a laboratory calculates at regular intervals to monitor its performance across the total testing process. ISO 15189, the standard NABL uses to accredit medical laboratories in India, asks labs to establish quality indicators, plan how they are monitored, review them and act when they show a problem. The standard does not prescribe one fixed list; the lab chooses indicators that fit its work.
Indicators are usually grouped by phase. Pre-analytical indicators cover everything before the sample is tested (requests, identification, collection, transport, receipt). Analytical indicators cover testing itself (internal QC, external quality assessment, repeats, instrument downtime). Post-analytical indicators cover reporting (turnaround time, critical results, amended reports, delivery, complaints). Studies of laboratory errors have repeatedly found that most errors arise outside the analytical phase, which is why a balanced set covers all three. The International Federation of Clinical Chemistry working group on laboratory errors and patient safety has published a model of harmonised indicators; see Quality indicators in laboratory medicine: from theory to practice and Harmonization of quality indicators in laboratory medicine.
In most labs the quality manager compiles the indicators each month, the laboratory director reviews them, and the year's trends feed the management review.
The 18 quality indicators, with formulas
These are the 18 indicators PathLab Software calculates automatically. The period is a calendar month. "Data source" says which record in the software each number comes from, so you can check any value against the underlying list.
Pre-analytical (6)
| Quality indicator | Formula | Data source | Review |
|---|---|---|---|
| Sample rejection rate (%, lower is better) | Rejected samples ÷ samples received × 100 | Sample rejection register, sample receipt times | Monthly |
| Recollection completed within 24 h (%, higher is better) | Recollections done within 24 h ÷ rejections needing recollection × 100 | Sample rejection register | Monthly |
| Identification errors (per 1,000, lower is better) | Rejections for unlabelled or mislabelled samples ÷ samples received × 1,000 | Sample rejection register | Monthly |
| Received outside stability or temperature (%, lower is better) | Rejections for delayed transport or temperature excursion ÷ samples received × 100 | Sample rejection register | Monthly |
| Home collections collected within slot (%, higher is better) | Visits collected before the booked slot ended ÷ visits collected × 100 | Home-collection visits | Monthly |
| Transfer-manifest discrepancies (%, lower is better) | Manifest items marked missing or rejected ÷ items dispatched × 100 | Transfer manifests | Monthly |
Analytical (6)
| Quality indicator | Formula | Data source | Review |
|---|---|---|---|
| IQC runs rejected (%, lower is better) | Rejected QC runs ÷ QC runs (not excluded) × 100 | Internal QC runs (Westgard) | Monthly (QC reviewed daily) |
| QC rejections with corrective action within 24 h (%, higher is better) | Rejected runs acknowledged with corrective action within 24 h ÷ rejected runs × 100 | Internal QC runs | Monthly |
| EQAS results unacceptable (%, lower is better) | Unacceptable EQAS/PT results ÷ results reported × 100 | EQAS / PT log | Per EQAS cycle, summarised monthly |
| Repeat-run rate (%, lower is better) | Results with a repeat run ÷ results × 100 | Results (run number) | Monthly |
| Analyzer results unmatched (%, lower is better) | Unmatched analyzer messages ÷ inbound analyzer messages × 100 | Analyzer message log | Monthly |
| Equipment downtime (h, lower is better) | Sum of breakdown downtime minutes ÷ 60 | Equipment breakdown log | Monthly |
Post-analytical (6)
| Quality indicator | Formula | Data source | Review |
|---|---|---|---|
| TAT outliers (%, lower is better) | Samples signed later than receipt + the longest test TAT on the sample ÷ samples signed × 100 | Sample receipt and sign-off times, test TAT | Monthly |
| STAT median TAT (min, lower is better) | Median minutes from receipt to sign-off for STAT orders | Orders (priority STAT), samples | Monthly |
| Critical values acknowledged within target (%, higher is better) | Critical alerts acknowledged within N minutes ÷ critical alerts × 100 | Critical-value call log | Monthly (watch weekly) |
| Amended reports (%, lower is better) | Reports amended ÷ reports signed × 100 | Signed reports | Monthly |
| Reports delivered within 30 min of sign-off (%, higher is better) | Reports sent to the patient within M minutes of sign-off ÷ reports sent × 100 (no data if messaging is off) | Report delivery times | Monthly |
| Complaints per 1,000 visits (per 1,000, lower is better) | Complaints logged ÷ orders × 1,000 | Complaint register, orders | Monthly |
Indicators the software has no data for, such as needle-stick injuries, staff training sessions or internal audit findings, can be added as manual indicators and entered each month. A patient satisfaction score fills in automatically from patient feedback.
How to set targets for laboratory quality indicators
A target turns a number into a decision: green, look closer, or act. The most reliable way to set one is from your own data.
- Measure a baseline first. Run the indicators for three to six months without targets. Your own median is the honest starting point.
- Set a target a little better than the baseline for indicators where you want improvement, and at the baseline for those that are already good.
- Use published studies as context, not as a copy. The IFCC papers above and later studies report ranges seen across labs, but their definitions and populations differ from yours. Copying someone else's benchmark, or a vendor's unsourced "best practice" number, gives a target you cannot defend to an assessor.
- Write the direction down. Rejection rate is better when lower; critical values acknowledged on time is better when higher. PathLab Software stores the direction with each target.
- Review targets yearly in the management review, and record why a target changed.
PathLab Software publishes no "standard" benchmark values: every target in the dashboard is entered by your lab.
How PathLab Software calculates them
Each indicator reads the records your staff already create while they work: sample receipt scans and the sample rejection register, Westgard QC runs and corrective actions, EQAS results, analyzer messages, the equipment breakdown log, sign-off and delivery times, the critical-value call log and the complaint register. Nobody counts registers at month end.
- RAG status. Green within target; amber within 20 % beyond it; red beyond that; grey when no target is set or the source has no data.
- No data is not zero. If the rejection register was never used, the rejection indicators show "no data", not 0 %.
- 12-month trend as a small chart on every card, drawn on the server, so it prints and works without JavaScript.
- Drill-down. Each card opens the indicator's 12-month table, which links to the list behind it: rejected samples, QC failures, critical alerts, complaints.
- Nightly recalculation of the current and previous month at 02:30 IST.
- Monthly freeze. A month freezes 10 days after it ends; changing it later needs an explicit Recompute by an administrator, which is written to the audit trail.
- Notes and corrective actions per indicator per month, printed on the report.
- Branch filter on the Network plan, to compare branches and collection centres.
A monthly QI report for your management review
The monthly report is an A4 print view: lab header and period, then one row per active indicator with its value, numerator and denominator, target, status, trend arrow against the previous month and the note or corrective action, followed by manual indicators and signature lines for the quality manager and laboratory director. It also exports as CSV. Open a sample monthly QI report (fictional numbers) to see the layout.
Worked example: sample rejection rate
The numbers below are an illustrative example, not data from any lab.
= 41 ÷ 3,120 × 100 = 1.31 %
Suppose 28 of the 41 rejections were haemolysed and 9 of those came from one home-collection phlebotomist. The overall rate looks acceptable against a 1.5 % target, but the breakdown by reason and by collector, which PathLab Software shows next to the indicator, points to one person who needs retraining on needle gauge and tube inversion. That is the point of an indicator: a number that leads to an action. The sample rejection criteria guide lists the criteria by sample type and the register columns behind this calculation.
Which quality indicators do NABL assessors look at?
NABL assesses laboratories against ISO 15189 and its own specific criteria documents. In practice assessors check that your quality indicators are defined (with a formula), monitored at a planned frequency, reviewed by management and acted on when they miss a target, with the evidence on file. Check the current NABL specific criteria for medical laboratories for any indicators they name, and make sure every indicator you choose can be traced back to records. PathLab Software supports the quality indicators and records that NABL assessors commonly ask for; your accreditation is yours to obtain. The clause-by-clause view is on the NABL software page, internal QC is on the QC software page, and uncertainty from the same QC data is explained in the measurement uncertainty guide.
What the dashboard cannot do
- An indicator is only as complete as the data recorded in PathLab Software: rejections must be logged through the rejection register, and samples must be scanned as received.
- Targets are your lab's own; the software publishes no benchmark values.
- Manual indicators need someone to enter them each month.
- The report supports your management review; it does not replace it.
Pricing
The quality indicator dashboard, targets, monthly snapshots and the printable QI report are included in the Complete plan at ₹3,290 a month and Network at ₹6,490 a month (Network adds the branch filter), plus 18% GST. The registers that feed several indicators, namely sample rejection, equipment and calibration, and patient feedback and complaints, are on every plan, including Essential. See the pricing page and the features page, or book a free setup call.
Frequently asked questions
What are quality indicators in a clinical laboratory?
Quality indicators are measures a laboratory tracks over time to see how well its processes work, such as the sample rejection rate, turnaround-time outliers or the share of critical values communicated on time. ISO 15189 expects labs to define indicators, set targets, monitor them and act on the results.
What are pre-analytical, analytical and post-analytical quality indicators?
Pre-analytical indicators cover the steps before testing, such as rejected or mislabelled samples. Analytical indicators cover testing itself, such as rejected QC runs or unacceptable EQAS results. Post-analytical indicators cover reporting, such as turnaround-time outliers, critical-value communication and amended reports. PathLab Software calculates six of each.
How is sample rejection rate calculated?
Sample rejection rate = rejected samples ÷ samples received × 100 for the period. For example, 41 rejected out of 3,120 received in a month is 1.31 %. PathLab Software counts rejections from its rejection register and samples received from receipt scans, and also shows rates by reason, collector and centre.
What is a turnaround time quality indicator?
A turnaround-time (TAT) quality indicator measures how often reports are late. PathLab Software uses the share of samples signed later than receipt plus the longest test TAT on that sample, and separately the median TAT of STAT orders in minutes. Targets for both are set by the lab.
Which quality indicators does NABL ask for?
NABL assesses labs against ISO 15189 and its own specific criteria; assessors check that quality indicators are defined, monitored, reviewed and acted on. Check the current NABL documents for any indicators they name. PathLab Software supports the indicators and records assessors commonly ask for; your accreditation is yours to obtain.
How often should laboratory quality indicators be reviewed?
Most labs review quality indicators monthly and summarise them in the periodic management review; urgent ones such as critical-value communication may be watched weekly. PathLab Software recalculates the current and previous month every night, freezes a month 10 days after it ends and prints a monthly QI report.
Can quality indicators be calculated automatically from lab software?
Yes, when the data is already in the software. PathLab Software calculates 18 indicators from rejections, receipt and sign-off times, QC runs, EQAS results, analyzer messages, equipment downtime, critical-value logs, report delivery and complaints. Indicators it has no data for, such as needle-stick injuries, are added as manual entries.
Which plan includes the quality indicator dashboard?
The quality indicator dashboard and monthly QI report are included in the Complete plan at ₹3,290 a month and Network at ₹6,490, plus 18% GST; Network adds a branch filter. The registers that feed several indicators (sample rejection, equipment and complaints) are on every plan.
Stop counting registers at month end
Start the 21-day free trial: set targets for the indicators you already track, and next month the report is ready before the management review.