CLIA EXAM QUESTIONS & ANSWERS SOLVED 100% CORRECT!!

Accreditation - is a process whereby a professional association or nongovernmental agency grants recognition to a school or healthcare institution facility for demonstrated ability to meet predetermined criteria for established standards, such as the accreditation of hospitals by the Joint Commission (JC). Analytic testing phase, information that must be included in each procedure comprises, Procedure Manual: - how to perform the procedure step-by-step (analytic phase), materials needed, conditions required (e.g.,incubate at 4°C), instrument calibration and verification, use of controls, reportable range, and limitations of the procedure. Troubleshooting (e.g., test system fails) is also incorporated in the procedure. CDC - is concerned with public health and safety, provides education and information to enhance healthcare decisions, including addressing best practices in laboratory medicine. In this role, the CDC was charged with developing a Model Embryology Laboratory under Public Law 102-493 (Fertility Success Rate and Certification Act of 1992), which includes semen preparation for assisted reproductive technology (ART) procedures. Certification - is a process indicating that an individual or institution has met predetermined standards. Many specialty areas have professional organizations that provide certification to individual practitioners. National associations may control the process and development of certification examinations conducted by their specialty interest groups.CLIA regulations - apply to any site examining "materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease..." (USDHHS, 1992). CLIA requirements are based on - test complexity and include: 1) laboratory registration and inspection; 2) facilities; 3) personnel qualifications and responsibilities; 4) quality systems for general laboratory and the preanalytic, analytic, and postanalytic testing phases, which address proficiency testing, quality control, and quality assurance, and test method verification; and 5) a quality management program.