Clinical Immunology Laboratory Accreditation, Licensure, and Credentials

Abstract

This chapter provides a broad overview of the major agencies and regulations which have had an impact on laboratory practices. Laboratory personnel must be kept constantly updated by reading appropriate professional articles and reviewing the appropriate Web pages of the responsible agencies and organizations for the latest information. Various governmental agencies, regulations, organizations, etc., are referred to in this chapter. In addition, an extensive list of websites is provided to help the reader obtain further information regarding specific agencies, regulations, and programs. Clinical laboratory improvement amendments (CLIA) has established four categories of testing,: waived, moderate complexity, provider-performed microscopy, and high complexity. The CLIA regulations issued by the federal government have mandated that all laboratories performing clinical testing must undergo regular inspections by an agency or organization with deemed status, e.g., the CAP, JCAHO, or New York State. The process to become accredited by the College of American Pathologists (CAP) begins with the submission of an application. Generally a medical technologist surveyor is assigned to review the laboratory’s activities and policies. A significant ongoing requirement of all accrediting agencies is the regular performance of testing on blinded samples. A number of organizations are involved in issuing credentials or licenses for individuals who demonstrate technical and management skills in clinical immunology. Several professional and voluntary organizations have developed standards for the testing of clinical specimens and provide reagents for the standardization of assays.