Roche OMNI C, Instructions For Use Manual

Page: 90 / 152

5 Quality control
5-12
Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002
5.6.1 Overview of the Multirules
Run ................ time between two 2-point calibrations
N
T
.................. number of individual measurements of all levels (T=total)
N
L
.................. number of individual measurements per level (L=Level)
m ................... QC measurement value of one level and one parameter
.................... mean value, taken from the insert sheet or calculated based on at least 20 and
no more than 100 individual measurements
σ
.................... standard deviation
TIP: The Multirule process is applied after each individual measurement.
Multirules are only applied to the corresponding control material
(e.g. COMBITROL TS).
Rule Description
1. 1
2
σ
QC measurement value (m) is outside
±
2
σ
2. 1
3
σ
QC measurement value (m) is outside
±
3
σ
3. (2 of 3)
2
σ
Two of three QC measurement values are outside
±
2
σ
Observation time period: 1 series (within run)
N
T
= 3
4. 2
2
σ
2 QC measurement values (m) are outside
±
2
σ
Observation time period: 2 series
N
L
≥
2
5. 6
1
σ
6 QC measurement values (m) are outside
±
1
σ
Observation time period: 3 series
N
T
≥
6
6. 9
m
9 QC measurement values (m) are on the same side as
the mean value.
Observation time period: 5 series
N
T
≥
9
2SD range Defined target values (ranges)
x
x
x
x
x
x