CLS 5110 Clinical Laboratory Laws, Regulations, Accereditations and Ethics
Lectures, discussions and presentations will provide a comprehensive understanding of laboratory laws, regulations, accreditation and certification. This will provide for sufficient knowledge and understanding of compliance with Federal laws as implemented by the Clinical Laboratory Improvement Amendment (CLIA) and Federal Drug Administration (FDA); California Laws and Regulations as outlined in Health and Safety Code and Business and profession Coe; laboratory safety laws including pertinent California and Federal Occupational Safety and Health administration (Cal OSHA and OSHA) and California and Federal Privacy laws including discussion on Health Insurance Portability and Accountability Act (HIPPA); Laboratory Accreditation and Certification agencies such as The Joint Commission (TJC), College of American Pathologists, Association of Public Health Laboratories (APHL). This course will also explore acceptable and ethical research practices in advanced biological and clinical laboratory sciences - 3 lecture hours.