Blind Specimen Program Management

The DOT regulations (49CFR Part 40) require a Quality Assurance / Quality Control Program . Blind Specimens are known quality control samples sent to challenge the laboratory to provide accurate results. To each laboratory to which you send at least 100 specimens in a year you must transmit a number of blind specimens equivalent to 1 percent (1 per 100) you send to that laboratory up to a maximum of 50 Blind specimens in each quarter.

Our blind quality controls are provided by drug free donors or purchased The blind samples are manufactured to our specifications (usually 2x the screening cutoff), using drug-free human urine. Blind specimens are manufactured from human urine derived from donors screened for Hepatitis and HIV by FDA required testing. Pure drug or their metabolites are added to represent a real donor urine specimen. The Chain of Custody forms are completed by NTS staff to emulate a “real” donor sample. The types of specimens will be submitted in accordance with CFR 49 Part 40 (Approximately 75% Negative, 15% Positive, and 10% Adulterated/Substituted). The number of samples will be prorated based on the number of DOT samples at the rate equivalent to one percent of the specimens sent in to that laboratory, up to a maximum of 50 blind specimens in each quarter.