Summary

A fundamental challenge in establishing high quality drug-testing laboratories is to determine the extent of the QA program based on cost/benefit. Many factors influence this decision, including the consequence for an unacceptable laboratory result. Donors who receive a positive drug test can lose their job or in some cases be sent to prison. Therefore, it is important to pass a drug test with authentic results. Otherwise, these harsh consequences demand a strong QA system to prevent false positive or legally unsupportable results. Despite this demand for QA, there is a limit to the cost of implementation. The system must be realistic. Many of the controls and limits are subjective and are established by consensus of experienced toxicologists in the field. Others are required by regulatory agencies. The authors’ guidance to laboratory directors is to comply with regulatory requirements, stay abreast of the recommendations of experts on laboratory QA, and implement the practices that fit your laboratory so that the employees undergoing tests pass drug testing conveniently.