(b) However, if a breast milk bank chooses to use a nutritional analyzer, it is used within the following parameters:

1. (1) The instrument is maintained following manufacturer's directions;
2. (2) The breast milk bank reports annually to recipient hospitals about what instrument it is using for analysis;

3. (3) The instrument uses data based on credible scientific statistical analysis, with attention to:

   1. (A) False-positive and false-negative values;
   2. (B) Variation from the mean and median; and
   3. (C) Standard deviation;

4. (4) Breast milk banks that use human breast milk analyzers:

   1. (A) Are responsible for the accuracy of results; and
   2. (B) Should ensure they follow the Food and Drug Administration Good Laboratory Practice regarding regular calibration and recordkeeping;
5. (5) The Food and Drug Administration states in its 2013 Food Labeling Guide, "FDA has not stated how a company should determine the nutrient content of their product for labeling purposes...Regardless of its source, the company is responsible for the accuracy and the compliance of the information presented on its label."