BACKGROUND: To investigate the current status of IQC practice of neonatal screening in China. METHODS: The IQC data of Phe and TSH testing were collected. Coefficient of variations (CVs) and cumulative CVs of every month in 2014 were compared with the 1/3 and 1/4 TEa. RESULTS: Of the 219 laboratories, the return rates ranged from 71.23% to 89.95% of 12 months in 2014. The rates of CVs for 2 lots less than 1/3 TEa were 60.27% and 68.78% (Phe), 67.05% and 65.68% (TSH); less than 1/4 TEa were 32.10% and 35.99% (Phe), 32.35% and 27.55% (TSH); rates of cumulative CVs less than 1/3 TEa were 57.89% and 65.98% (Phe), 61.21% and 60.93% (TSH); less than 1/4 TEa were 29.61% and 30.74% (Phe), 27.48% and 22.41% (TSH). CONCLUSIONS: The testing capabilities and performances of neonatal screening laboratories can be objectively evaluated by the quality specifications of acceptable imprecision.
BACKGROUND: To investigate the current status of IQC practice of neonatal screening in China. METHODS: The IQC data of Phe and TSH testing were collected. Coefficient of variations (CVs) and cumulative CVs of every month in 2014 were compared with the 1/3 and 1/4 TEa. RESULTS: Of the 219 laboratories, the return rates ranged from 71.23% to 89.95% of 12 months in 2014. The rates of CVs for 2 lots less than 1/3 TEa were 60.27% and 68.78% (Phe), 67.05% and 65.68% (TSH); less than 1/4 TEa were 32.10% and 35.99% (Phe), 32.35% and 27.55% (TSH); rates of cumulative CVs less than 1/3 TEa were 57.89% and 65.98% (Phe), 61.21% and 60.93% (TSH); less than 1/4 TEa were 29.61% and 30.74% (Phe), 27.48% and 22.41% (TSH). CONCLUSIONS: The testing capabilities and performances of neonatal screening laboratories can be objectively evaluated by the quality specifications of acceptable imprecision.