Table 5.
IQC practice | Proportion of laboratories | Allowable imprecision specifications based on NACB and biological variationb | |||||||
---|---|---|---|---|---|---|---|---|---|
2012 | 2013 | 2014 | 2015 | 2016 | NACBc | Minimum | Desirable | Optimal | |
IQC rules | |||||||||
Single IQC rule | 18.3 | 18.5 | 10.9 | 7.9 | 7.6 | 30.8 | 21.7 | 5.6 | 0 |
12s/13s | 4.0 | 3.3 | 2.5 | 8.2 | 9.3 | 50.8 | 40.2 | 19.5 | 5.1 |
13s/22s | 10.8 | 14.4 | 14.2 | 20.0 | 19.0 | 60.1 | 39.8 | 18.6 | 0 |
12s/13s/22s | 2.2 | 3.3 | 5.5 | 8.6 | 10.1 | 63.2 | 43.2 | 16.5 | 6.9 |
13s/22s/R4s | 5.0 | 4.5 | 8.0 | 12.1 | 15.6 | 65.2 | 42.1 | 17.9 | 5.4 |
One or more from the rules of 12s, 13s, 22s, R4s, 41s and | 15.1 | 18.1 | 16.7 | 37.5 | 32.9 | 59.5 | 39.9 | 13.2 | 6.5 |
Other rules | 2.2 | 0.8 | 0.4 | 2.5 | 4.2 | 48.9 | 30.2 | 8.9 | 5.3 |
Unclear | 42.4 | 37.0 | 41.8 | 3.2 | 1.3 | 35.6 | 20.5 | 6.8 | 0 |
IQC frequency | |||||||||
One QC run every more than 2 days | 27.5 | 14.7 | 12.4 | 14.7 | 7.9 | 33.2 | 25.6 | 0 | 0 |
One QC run every 1‐2 days | 71.9 | 84.5 | 85.9 | 82.4 | 57.7 | 61.2 | 39.4 | 18.9 | 5.2 |
More than one QC run per day | 0.6 | 0.8 | 1.8 | 2.8 | 34.4 | 67.8 | 40.3 | 20.1 | 7.9 |
The subgroup analyses of the current CVs, mass fraction and pass rates were all for level 1.
The pass rates against four criteria were for the 2016 data.
Analytical imprecision criteria based on National Academy of Clinical Biochemistry (NACB) was set as <2% within laboratory.