如何进行医学实验室风险评估.pptxVIP

How to Evaluate Risk in theMedical LaboratoryJames H. Nichols, PhD, DABCC, FACBProfessor of Pathology, Microbiology and ImmunologyMedical Director of Clinical Chemistry and Point-of-Care TestingVanderbilt University School of MedicineMedical Director, Clinical ChemistryNashville, Tennessee, USAmailto:james.h.nichols@james.h.nichols@ Objectives1. Discuss the sources of error in the medical lab2. Review QC as a means of controlling analytical error3. Identify risk management as a total quality assurance of the testing process4. Describe regulatory changes adopting risk management in the laboratory Medical ErrorAn adverse event or near miss that is preventable with the current state of medical knowledge. (the Quality Interagency Coordination Task Force)Medical ErrorsInstitute of Medicine of the National Academies report 1999Medical errors kill 44,000 - 98,000 patients in US hospitals each year.“Number one problem facing health care” Lucien Leape, Harvard Professor of Public HealthMedical Errors2002 Commonwealth Fund report estimated that 22.8 million people have experienced a medical error, personally or through at least one family memberReinforces the 1999 IOM report, “To Err is Human”Annual costs estimated at $17 – 29 billionUS Agency for Healthcare Research and Quality (AHRQ) estimate medical errors are the 8th leading cause of death in the US – higher than:Motor Vehicle Accidents (43,458)Cancer (42,297)AIDS (16,516)Laboratory ErrorsA review of the literature found the majority of errors occur in the pre and post analytical phases. Bonini P, Plebani M, Ceriotti F, Rubboli F. Clin Chem 2002;48:691-698.Many mistakes are called “lab error”, but actually due to poor communication, actions by others involved in the testing process, or poorly designed processes outside the lab’s control.Medical errors occur in prevention, diagnosis and drug treatment occur. Among errors in diagnosis; 50% were failure to use indicated tests, 32% were failure to act on results of tests, and