Tarangnan Community Hospital — Clinical Laboratory
New Method? Verify First.
Method verification — no patient testing until the Pathologist approves (LAB-QM-ANA-003 Figure 1).
INFOGRAPHIC IG-26 Source: LAB-QM-ANA-003 Version V0 — DRAFT
The rule: patient testing commences only after the Pathologist's formal approval. If the claims are not reproduced, patient testing shall not commence — the method undergoes comprehensive validation.
1 · The studies
Trigger: a new, modified, or relocated test method is proposed for clinical use.
First, define acceptance criteria from the manufacturer's performance claims.
Repeatability (within-run precision) and between-day reproducibility.
Accuracy verified against a validated comparative method.
Linearity verified across the analytical measurement range.
Manufacturer reference intervals verified before adoption.
2 · The decision
Decision: do the studies confirm the manufacturer's performance claims are reproduced?
Compile the comprehensive Method Verification and Validation Report.
Prepare the validation summary dossier for Pathologist review and sign-off.
3 · Approval — then patients
The Pathologist signs the formal approval report.
Train staff and verify competency on the new method.
