Clinical Laboratory Improvement Amendments (CLIA) - CMS
Per CMS - The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). In total, CLIA covers approximately 244,000 laboratory entities. The Division of Laboratory Services, within the Survey and Certification Group, under the Center for Clinical Standards and Quality (CCSQ) has the responsibility for implementing the CLIA Program.
Competency Guidelines for Public Health Laboratory Professionals - CDC
These competency guidelines outline the knowledge, skills, and abilities necessary for public health laboratory (PHL) professionals to deliver the core services of PHLs efficiently and effectively. As part of a 2-year workforce project sponsored in 2012 by CDC and the Association of Public Health Laboratories (APHL), competencies for 15 domain areas were developed by experts representing state and local PHLs, clinical laboratories, academic institutions, laboratory professional organizations, CDC, and APHL. The competencies were developed and reviewed by approximately 170 subject matter experts with diverse backgrounds and experiences in laboratory science and public health. The guidelines comprise general, cross-cutting, and specialized domain areas and are divided into four levels of proficiency: beginner, competent, proficient, and expert. The 15 domain areas are 1) Quality Management System, 2) Ethics, 3) Management and Leadership, 4) Communication, 5) Security, 6) Emergency Management and Response, 7) Workforce Training, 8) General Laboratory Practice, 9) Safety, 10) Surveillance, 11) Informatics, 12) Microbiology, 13) Chemistry, 14) Bioinformatics, and 15) Research.
Interpretive Guideline for Laboratories - CMS