Expert training for healthcare, with emphasis on the diagnostic laboratory.
Jinna Ralston, a Laboratory Learning Solutions Instructor is an ASCP-licensed Medical Technologist with a history of more than 35 years of experience in the clinical laboratory settings in hospitals, physician office laboratories, a community blood bank, a national reference laboratory and as the Quality Control Supervisor for a Bio-tech company. She held many positions throughout her career; Quality and Compliance Coordinator II, Clinical Laboratory Accreditation Inspector, Quality Assurance Officer, Lab Manager, Technical Supervisor, Technical Consultant, Lab Director, Quality Control Supervisor, Project Improvement Designee, and Laboratory generalist. Jinna has extensive experience in the following areas; FDA and CLIA inspections and regulations, laboratory management, quality and compliance coordination, quality management system (QMS), personnel training, and physician and clinical laboratory consultation. She worked alongside many talented and dedicated ARUP Laboratories personnel to earn the first ISO 15189 accreditation for ARUP Laboratories. She was the Quality and Compliance Coordinator for the first three FDA-approved Laboratory Developed Tests (LDTs) at ARUP Laboratories, a national reference laboratory. Her experience and knowledge include the regulatory requirements for Medical Device Quality Management System, Device Manufacturer (GMP), Companion Diagnostics, and GDP. She also led or played a strategic quality role at ARUP for many process improvements and initiatives, including the development and training for IQCP, the expansion of the Quality Control program and enhancement of a Supplier Qualification program. While Accreditation Surveyor for COLA, she received frequent client reviews attesting to her thoroughness, knowledge sharing and supportive resources. Jinna has successfully established and or expanded and managed several clinical laboratories. Her years of experience delivers extensive laboratory license and accreditation regulatory compliance knowledge for CLIA, CAP, NY, CA, COLA, ISO 15189 and FDA. As Quality Control Supervisor for a Bio-tech company, she supervised the value assignments for hematology controls, calibrators, verification and linearity materials. Here she teamed with other professionals to prepare for ISO certification and provide technical support to product users across the country. Jinna holds a Bachelor of Science in Medical Technology from South Dakota State University and a Master of Science in Healthcare Administration from the University of South Dakota.