What Quality Assurance Rules Apply to Alcohol Screening Devices?

Under 49 CFR 40.235, each alcohol screening device (ASD) used for DOT tests has a quality assurance plan (QAP) that the manufacturer submits for NHTSA approval before NHTSA approves the device and ODAPC places it on its web page for Approved Screening Devices to Measure Alcohol in Bodily Fluids.

Under 40.235(a) and (b):

• The QAP specifies the methods used for quality control checks
• The QAP specifies the temperatures at which the ASD must be stored and used
• The QAP specifies the shelf life of the device
• The QAP specifies environmental conditions, such as temperature, altitude and humidity, that may affect the performance of the device
• The manufacturer includes with each ASD instructions for its use and care consistent with the QAP, including, where applicable, the time within which the device must be read and the manner in which the reading is made

Under 40.235(c) and (d), the user of the ASD, such as an employer or STT, follows the QAP instructions and does not use an ASD that fails the specified quality control checks or has passed its expiration date. Under 40.235(e), employers also follow the use and care requirements of 49 CFR 40.233 for breath ASDs.

Footnotes on ODAPC's ASD page show how these limits apply to particular devices. One footnote states that storage of a saliva device at temperatures above 27 °C (80 °F), for even brief periods of time, may result in false negative readings. Another sets reading times of one, two or five minutes after a sample is introduced, depending on the testing temperature.

Using an expired device is one of the problems covered in When Is a DOT Alcohol Test Cancelled?. The listing process is covered in How Does a Manufacturer Get an Alcohol Screening Device on NHTSA's List?.

Learn Laws® offers DOT Saliva Alcohol Testing Training for Alco-Screen 02, an online DOT STT course for the Alco-Screen 02 saliva screening device, with qualification training and five live mock tests under 49 CFR 40.213.

Background Checks is named on some supplier profiles in the MyDrugTesting.com directory, either as a category label or among the other categories offered.