Misc.
Examination of materials derived from the human body for purpose of providing info for diagnosis, prevention, or treatment of any disease or impairment of, or assessment of the health of, human beings
What is the CLIA definition of a laboratory?
Public authority/government agency (administrative law) responsible for autonomous authority in a regulatory or supervisory capacity.
What is a regulatory agency?
CMS approved organizations with voluntary standards that meet or exceed federal requirements
What are accreditation agencies/organizations?
Education and experience based
What are CLIA defined roles?
Enforces regulatory compliance, Issues CLIA certificates and publishes CLIA rules and regulations
What is CMS?
A2LA, AABB, AOA, ASHI, CAP, COLA and TJC
What are CMS approved accreditation organizations?
Regulatory agency that focuses on patient and donor care and safety.
What is AABB?
Conducts lab quality improvement studies, monitors PT practices, develops and distributes professional information and educational resources, provides analysis, research and technical assistance
What is the CDC?
An internationally recognized program that utilizes teams of practicing lab professional as inspectors.
What is CAP?
Labs are required to establish and follow written policies and procedures to assess employee and, if applicable, consultant competency.
What is the #1 CLIA deficiency in 2021?
Categorizes tests based on complexity, develops rules and guidance for CLIA test complexity categorization
What is the FDA?
A regulatory agency with CMS deemed authority that accredits labs, healthcare facilities including hospitals, outpatient clinics and behavioral health facilities.
What is TJC?
Personnel qualification and QC requirements differ because of these
Why specialties/subspecialties matter?
Minimum standards required for healthcare facilities to participate in Medicare and Medicaid programs
What are Conditions of Participation (COPs)?
Organization inspecting on behalf of a regulatory body such as CMS
What is deemed authority?