Tolerance Rule Guidelines

Pass/Fail: Tolerance Rule

A specimen is marked Correct when the analyzer-reported INR and the calculated INR agree within a tolerance of one unit in the last decimal place. This tolerance accounts for rounding that occurs inside the analyzer's internal calculation, which may differ slightly from the externally computed value depending on intermediate precision:

INR PrecisionToleranceExample
2 decimal places (e.g., 1.25)±0.01Analyzer reports 1.25 → Correct if Calculated INR is 1.24, 1.25, or 1.26
3 decimal places (e.g., 1.248)±0.001Analyzer reports 1.248 → Correct if Calculated INR is 1.247, 1.248, or 1.249

The calculated INR is always rounded to the same number of decimal places as the analyzer-reported INR before comparison, using at minimum 2 decimal places.

Worked example

Analyzer reports PT = 13.5 s and INR = 1.25 (2 decimal places). Using ISI = 1.10 and Normal Patient Mean PT = 11.8 s, the module computes:

Calculated INR = (13.5 / 11.8)^1.10 = 1.24

The difference is |1.25 − 1.24| = 0.01. Tolerance at 2 decimal places is 0.01. Since the difference equals the tolerance, this specimen is marked Correct.

A specimen marked Incorrect does not mean the analyzer produced a wrong result for that specific patient — it means the analyzer's programmed ISI or NPM does not match the values entered in this study. The verification cannot determine which parameter is wrong or by how much without additional investigation.