Section 1 — Risk-Based QC Design
Does your QC plan reflect real patient risk — or just habit?
1.1
Our QC rules (e.g., Westgard rules) were selected based on the analytical performance of each specific assay — not applied as a one-size-fits-all default across all instruments.
1.2
We have documented the maximum allowable probability of releasing an erroneous patient result for each high-risk test (i.e., we have defined our acceptable risk threshold).
1.3
Our QC frequency is based on the volume of patients tested and the risk of harm from an undetected error — not solely on manufacturer recommendations or tradition.
1.4
We have reviewed and updated our QC plans in the last 12 months to reflect any changes in instruments, reagents, or test volume.
1.5
We have formally assessed the risk of reporting erroneous patient results as required under ISO 15189:2022 §7.3.7.2.
Section 1 Score
0 / 5
Section 2 — Pre-Analytical Risk Controls
Most errors originate before the sample reaches the analyzer.
2.1
We have a documented process for identifying and rejecting unsuitable samples (hemolysis, lipemia, clots, incorrect tube) before analysis begins.
2.2
Sample collection, transport, and storage conditions are monitored and recorded — and non-conformances are logged and trended, not just corrected in the moment.
2.3
Patient identification and sample labelling errors are tracked as a quality indicator — with a defined threshold that triggers a formal review.
2.4
Staff performing phlebotomy or sample receipt have documented, current competency assessments on file.
2.5
We have reviewed pre-analytical error rates in the last 6 months and identified at least one improvement action.
Section 2 Score
0 / 5
Section 3 — Analytical Phase Consistency
Inconsistency between shifts, staff, and instruments is where invisible errors live.
3.1
QC procedures are performed consistently across all shifts and by all staff — we have evidence this is the case, not just a policy that says so.
3.2
When a QC rule violation occurs, a documented root-cause investigation is completed before patient results are released — every time, without exception.
3.3
We monitor for QC trends and shifts (gradual drift) — not only for sudden rule violations that breach hard limits.
3.4
Calibration verification and reagent lot-to-lot comparisons are formally documented and reviewed when new lots are introduced.
3.5
Instrument-to-instrument comparability (where multiple analyzers run the same assay) is measured and within acceptable limits — with data to prove it.
Section 3 Score
0 / 5
Section 4 — Post-Analytical & Reporting Controls
A correct result reported wrongly — or too late — still harms the patient.
4.1
Critical value notification processes are documented, timed, and audited — we can demonstrate that clinicians were reached within our defined turnaround target.
4.2
When results are amended or corrected after release, a formal process is followed that notifies the requesting clinician and logs the correction.
4.3
Reference intervals in use have been validated for our patient population — they are not simply copied from a kit insert or a previous SOP from a decade ago.
4.4
Result interpretation comments (where applicable) are standardized and reviewed for clinical appropriateness.
4.5
We track and trend turnaround time as a quality indicator, with defined targets and a review process when targets are missed.
Section 4 Score
0 / 5
Section 5 — ISO 15189:2022 Risk Management Readiness
The new standard requires proactive, documented risk thinking — not reactive firefighting.
5.1
Our laboratory has a formal, documented risk register that identifies potential harms to patients across the full testing cycle (pre-, analytical, and post-analytical).
5.2
We conduct periodic risk reviews — not just after an incident occurs, but as a scheduled, proactive activity.
5.3
Staff at bench level are aware of the concept of risk-based QC and can explain why their QC procedures are designed the way they are.
5.4
Our laboratory director or quality manager can demonstrate to an accreditation assessor how risk management is integrated into our QC planning — with documented evidence.
5.5
We have identified at least three specific opportunities for improvement in patient care as a result of our risk management activities in the past year.
Section 5 Score
0 / 5
You can check more items after viewing your results — the score will update.
Your Audit Results
QC Gap Self-Audit Score
0
/ 25
Section Breakdown
| Section | Topic | Your Score |
|---|---|---|
| 1 | Risk-Based QC Design | 0 / 5 |
| 2 | Pre-Analytical Risk Controls | 0 / 5 |
| 3 | Analytical Phase Consistency | 0 / 5 |
| 4 | Post-Analytical & Reporting | 0 / 5 |
| 5 | ISO 15189:2022 Readiness | 0 / 5 |
| Total | 0 / 25 | |
What Your Score Means
| Total Score | What It Means |
|---|---|
| 23–25 | Strong foundation. Your lab is operating with mature, risk-aware QC practices. Use RiskGator to quantify your performance and identify the remaining hidden gaps before an assessor does. |
| 16–22 | Moderate risk exposure. You have solid QC habits, but several structural gaps exist that leave patient results — and your accreditation status — more vulnerable than they need to be. |
| 8–15 | Significant gaps present. Your lab’s QC program is likely built on habit rather than risk analysis. These are the conditions under which erroneous results are released undetected. |
| 0–7 | High risk. Your current QC approach does not meet the intent of ISO 15189:2022. Patient safety and accreditation are both at risk. Action is needed now. |
What Happens Next?
Most labs score lower than they expect — because the gaps are structural and invisible, not the result of carelessness. RiskGator Suite is built specifically to surface these gaps, quantify the risk in each one, and guide your lab through a risk-based QC redesign — without requiring you to be an expert in ISO 22367 or statistical QC design.
RiskGator Suite • awesome-numbers.com • This checklist references ISO 15189:2022 Clause 5.6 and Clause 7.3.7.2. It is designed for educational purposes and does not constitute a formal accreditation assessment.