Quality Assurance / Quality Control

To further ensure that specimens are properly handled and tested, Alere maintains a Quality Control and Assurance Program that encompasses all steps in the testing process, including:

• specimen accessioning and handling
• chain of custody
• maintenance of equipment
• personnel performance
• specimen analysis
• laboratory procedures
• reporting of results

Alere’s internal quality control program meets and exceeds all standards set by the federal government. In fact, 10% of our daily volume is made up of quality control specimens, including blind specimens from regulatory agencies, clients, Medical Review Officers, and our own QC Department. To make certain that we are fulfilling all requirements to perform substance abuse testing, Alere is inspected twice a year by SAMHSA, once a year by CAP-FUDT and the state of Florida, and once every two years by the state of New York.

Beyond the inspections, our internal Quality Control Department regularly inserts one or more specimens into a batch for proficiency testing. The results of these specimens are unknown to our testing staff but known to our certifying scientists who later review the testing data for certification and release to the client. In addition, Alere receives proficiency testing samples from external agencies, clients, and Medical Review Officers. These results are compared to the known results to validate lab performance and/or as a condition of licensure. We participate in proficiency testing programs conducted by SAMHSA, CAP-FUDT, New York, Florida, and Pennsylvania.