Question 1 · Hard
A laboratory reviews its monthly peer-group report for a TSH control. Laboratory: 30 results, mean 2.38 mIU/L, SD 0.048 mIU/L. Peer group (same analyzer, reagent and control lot): mean 2.20 mIU/L, SD 0.07 mIU/L. The SDI is (laboratory mean - peer mean) / peer SD, and the CV ratio is laboratory CV / peer CV. The laboratory investigates bias when the SDI is beyond ±2.0, and imprecision when the CV ratio is above 1.5. Internal QC showed no rule violations this month. Which conclusion is correct?
- AInvestigate bias and precision (SDI +2.6, CV ratio 1.58)
- BNo investigation needed (SDI +1.3, CV ratio 0.63)
- CInvestigate bias only (SDI +2.6, CV ratio 0.63)
- DNo investigation needed (SDI +0.08, CV ratio 0.63)
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Answer: C · Investigate bias only (SDI +2.6, CV ratio 0.63)
The SDI is (2.38 - 2.20) / 0.07 = +2.6, beyond the ±2.0 limit, so the laboratory reads high against its peers and the bias must be investigated, starting with calibration. The laboratory CV is 0.048 / 2.38 × 100 = 2.0% and the peer CV is 0.07 / 2.20 × 100 = 3.2%, so the CV ratio is 2.0 / 3.2 = 0.63: the laboratory is more precise than its peers. Internal QC can stay in control while a bias like this persists, because the control limits are built around the laboratory's own mean. Peer comparison is how such a bias is found between EQA events.
- A: 1.58 is the inverted ratio; the laboratory CV is lower than the peer CV.
- B: Dividing the difference by twice the peer SD halves the SDI and hides the bias.
- D: 0.08 is the difference divided by the peer mean, a relative bias, not an SDI.