Regulations and Accreditation of Processing Laboratories

Abstract

Cellular therapy products are highly regulated in the United States both at the state and federal levels. The Food and Drug Administration (FDA) and Centers for Medicare and Medicaid Services (CMS) are the main governing bodies that provide federal oversight. State health departments may also have local regulations for processing laboratories. Individuals and institutions involved in cellular therapy processing must be familiar with the requirements of these agencies. Cellular therapy processing laboratories may also be accredited by organizations such as the Foundation for the Accreditation of Cellular Therapy (FACT), Joint Accreditation Committee-ISCT and EBMT (JACIE), or American Association of Blood Banks (AABB). While regulations have the force of law, accreditation standards are not legally binding. Accreditation allows an organization or institution to be officially recognized as being highly qualified to perform cellular therapy activities and to have a high quality of operations. The federal government has granted deemed status to certain accreditation organizations that have standards and a survey process that meets or exceeds Medicare and Medicaid requirements. Laboratories that achieve accreditation through an organization’s “deemed status” survey are determined to meet or exceed federal requirements. In this chapter we discuss the regulations and accreditation steps of cellular processing laboratories by various organizations.