Licensing and Accreditation of the Andrology Laboratory

Abstract

This chapter provides a general overview of the licensing and accreditation of andrology laboratories in the United States. Andrology laboratories are considered high-complexity clinical laboratories and as such are regulated under the Clinical Laboratory Improvement Amendments (CLIA). All states require andrology laboratories to possess a CLIA certificate, and certain states require a separate state issue clinical laboratory license. Most notably, New York, Florida, California, and Maryland require a state clinical laboratory license besides a CLIA certificate. Laboratories may also choose accreditation by a private accrediting organization, such as CAP, COLA, or JCAHO, although this accreditation does not negate the need for a CLIA certificate or a state license where required. Andrology laboratories that are involved in sperm banking and/or sperm preparation for assisted reproductive procedures are also required to register with the FDA and may also be required to obtain a state tissue bank license or a state tissue bank registration. This chapter is not to be considered all inclusive of the federal and state regulations for andrology laboratory. The reader is encouraged to read the references and websites at the end of this chapter and to solicit assistance from specific states as appropriate.