Regulatory Issues in Laboratory Medicine

Compliance with regulatory requirements is a key element of clinical laboratory management. Although the regulatory agencies overseeing clinical laboratory testing and pathology services generally work separately, there is some overlap in their oversight. The Clinical Laboratory Improvement Act of 1967 initiated federal licensure, inspections, and proficiency testing for all laboratories engaged in interstate commerce and all hospital and independent laboratories receiving Medicare funds. The Food and Drug Administration regulates in vitro diagnostic tests as medical devices. The chapter also presents an overview of the regulatory oversight of transfusion medicine. The Health Insurance Portability and Accountability Act signed in 1996 by President Bill Clinton had three main purposes: to improve the efficiency of healthcare delivery and health information, to address constraints to healthcare access, and to create a set of standards for transmission of health information records.