This talk will preview new software to manage risk in medical laboratories and beyond. Risk is the combination of the PROBABILITY of occurrence of harm and the SEVERITY of that harm (ISO/IEC Guide 51). In the medical laboratory, PROBABILITY of harm can be measured as the number of failures (Medically Unreliable Results) per year that place patients at risk of missed or delayed diagnosis or treatment and place institutions at risk of litigation. SEVERITY of harm from laboratory results can be measured as the healthcare cost spent on unnecessary tests and delayed diagnosis.
Risk drivers include the target/true value for control sample results, the current mean and standard deviation, allowable error limits – and acceptable risk as the number and cost of errors produced.
Zoe Brooks has devoted her career to improving healthcare by improving the practice of medical laboratory quality control. Zoe served as an active advisor for the creation of CLSI EP 23A “Laboratory Quality Control Based on Risk Management.” She is a popular speaker, author, and advocate for risk management with a penchant for software creation.