One check sample result that is determined to be a statistical outlier (according to Grubbs Test for statistical outliers) will result in a letter asking the laboratory to review its process and make any necessary corrections. If corrections are found necessary, they and their corrective action will be reported to the Program Manager.
Two consecutive unsatisfactory (outliers) results in 8 consecutive check samples, regardless of the approval year, and the laboratory will be required to analyze an additional sample. If the result of the additional sample is also unsatisfactory, a discussion between the laboratory and the Program Manager will be held and an on-site review may follow. If an on-site review is necessary in addition to the yearly review, the laboratory will be responsible for the travel and per diem expenses of the reviewer.
Three consecutive unsatisfactory analyses in 8 consecutive check samples, regardless of the approval year, will result in the suspension of USDA approval until corrective action has been taken and the laboratory has demonstrated its ability to correctly analyze samples.
Three intermittent unsatisfactory analyses in 8 consecutive check samples, regardless of the approval year, will result in a discussion between the laboratory and the Program Manager. An on-site review may follow as may an involuntary removal from the program if a resolution cannot be found and implemented.
Annual On-site Laboratory Review
All participating laboratories will have an annual announced or unannounced laboratory review by S&T personnel. The review will include all of the elements of the initial on-site review. The laboratory will receive a laboratory review report, and when required, must provide a written response to the Program Manager within 90 days.
Payment of Maintenance Fee
A non-refundable maintenance fee of $5,000.00 is due in December of each approval year. The fee must be paid in full in order for the laboratory to continue operating as an approved laboratory. This fee permits the laboratory to operate as an approved laboratory for one year. The fee will be reviewed yearly, and if necessary, adjusted to meet USDA operational costs.