Chapter 121 : Clinical Immunology Laboratory Accreditation, Licensure, and Credentials

Abstract:

Today's clinical immunology laboratories have emerged from research laboratories as new assays became available to researchers and clinician-scientists. However, in today's hospital and reference laboratory environment, many governmental regulations and professional guidelines mandate defined education levels of individuals who oversee and perform patient testing, recommend test procedures, and define acceptable ordering, result reporting, and billing practices. Among these organizations is the Centers for Medicare and Medicaid Services (CMS), previously known as the Health Care Financing Administration (HCFA). CMS is a federal agency within the U.S. Department of Health and Human Services (DHHS) that administers the Medicare program and works in partnership with state governments to administer Medicaid. CMS also regulates billing practices and has a significant impact on the manner in which laboratories must be structured and managed. Today's successful clinical immunology laboratory practitioners must be knowledgeable about current guidelines and regulations and keep abreast of the constant changes in order to ensure compliance and professionalism in all areas of the laboratory. This chapter provides a broad overview of the major governmental agencies and regulations that impact on clinical laboratory practices. Various agencies and regulations are discussed in this chapter. To assist the reader, a list of their abbreviations is provided. In addition, an extensive list of websites is given in Table 1 to enable the reader to obtain further information regarding specific agencies, regulations, and programs.