ESTABLISHING QUALITY CONTROL MEANS & LIMITS

Initial Steps for Establishing Lab Means and Limits:

1. Create QC file for each level using control manufacturer’s means and ranges.
2. Run each level of QC 10-20 times over multiple days using manufacturer’s means and limits.
a. Recommendation is to perform a minimum of ten runs collected over five days. (Two
runs/day for five days.)
b. Alternately, twenty runs performed over ten days may be used. If time allows for a longer
data collection period, this alternate approach is beneficial as it includes more QC replicates
and includes data from multiple vials of control material.
3. During the data collection period:
a. Include multiple operators in the data collection process.
b. Do not delete out-of-range results from the QC file when there is not an assignable cause for
those results. Statistically, outliers are expected with multiple runs of any QC product.
c. Delete out-of-range results in the QC files when there is an assignable cause for those
results. Out-of-range examples could include QC level run into incorrect file, patient sample
run into QC file or sampling errors.
4. Temporary means and limits may be calculated from data generated.
a. Parameter means must recover within the manufacturer’s range.
Example: 20 runs in QC file have a mean hemoglobin value of 13.7 g/dL. Control manufacturer’s range
is 13.0-14.0. 13.7 recovery is within the manufacturer’s range and is acceptable.

b. Temporary limits may be calculated from the Standard Deviation (SD) or Coefficient of
Variation (CV%) calculated in the QC file.
Example using SD:
1 SD for hemoglobin is 0.2 g/dL. 2 SD’s would be 0.2 x 2 or 0.4.
The calculated limit is 13.7 +/- 0.4.

Example using CV%:

Mean % CV x Current Assay Mean x 2 = +/- 2 SD for control material
100

File Hemoglobin % CV = 1.5 Hemoglobin Mean = 13.7 1.5 x 13.7 x 2 = 0.4

100
The calculated limit is 13.7 +/- 0.4

5. Each level of QC and each parameter will have unique means and limits.
6. Submit QC data monthly to eQC program.
7. After 6 months, use lab specific cumulative eQC data (historic) to calculate limits employing above
procedures with either SD or CV%.
8. Once established, the historic limits will remain the same for new lot numbers.

Once historic limits have been established, for each new lot number of QC:
1. Establish new means as described in the above procedure.
2. Utilize the historic limits previously established.
3. Submit data monthly to eQC and monitor SDI’s.

After implementing Historic limits:

1. Re-evaluate periodically to ensure limits are still appropriate.
2. Employ Westgard rules to supplement QC limits and evaluate outliers.

205814-101 ESTABLISHING QUALITY CONTROL MEANS & LIMITS (April. 2009) Page 1 of 1
Copyright 2009 Abbott Laboratories, Abbott Park, Ill.