如何进行医学实验室风险评估.pptx
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1、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,USAjames.h.nicho
2、lsvanderbilt.edu 1Objectives1.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 2Medical ErrorAn a
3、dverse 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
4、 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
5、$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 pos
6、t 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 labs control.Medical errors occur in prevention,
7、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 55%involved avoidable delay in diagnosis.Leape LL,Brennan TA,Laird N,et al.N Eng J Med 1991;324:377-84.7Historical Quality ControlQuality control histori
8、cally used to reduce errors and prevent the release of incorrect results from the laboratory!Born from the 1950s industrial model of quality in analytical and factory processesQuality control is a stabilized surrogate sample analyzed like a patient sample containing known amount of measured analyte.
9、If the analytical test system can achieve the desired result using a QC sample,then the system is stable and quality patient results are assumed to be produced.8Quality ControlAdvantagesQC has target values,if assay recovers target,then system is assumed to be stable(instrument,reagent,operator,samp
10、le)Shift in QC=Shift in quality patient results!Warns of test result problems before release to physicianQuality ControlDisadvantagesIf QC not analyzed frequently enough or lab fails to take action when QC fails,quality of patient results affected!With new autoverification or continuous release of r
11、esults by chemistry and hematology analyzers-Possible to release patient results before a problem is detectedWhen a problem is detected,lab must go back and reanalyze patients since last“good”QC and possibly send out corrected results.Clinical action could be taken on erroneous results in the interi
12、m of correcting an unrecognized issue!Despite its limitations,QC remains an important means of detecting and preventing laboratory errors!1011Systematic ErrorsLiquid QC does a good job at detecting systematic errors,like:Reagent deterioration or preparationImproper storage or shipment conditionsInco
13、rrect operator technique(dilution,pipette setting)Calibration errors wrong setpoint,factorsErrors which affect every test in a constant and predictable mannerErrors that occur from one point forward or for a limited period of time12Random ErrorsLiquid QC does a poor job at detecting random errors un
14、less the error specifically occurs with the QC sample or increased result variability is noted.Errors which affect individual samples in a random and unpredictable fashion,like:ClotsBubblesInterfering substances13QC and Lab ErrorsQCQC09:0009:00Line Leak11:0001:15Hemolyzed sampleQC daily at 09:00,two
15、 levelsLine leak occurs at 11:00,dispenses partial reagent causing 25%decrease in values,not detected until next day QC at 09:00.(Systematic Error),must reanalyze all specimens since previous QC at 09:00,the previous day.Hemolyzed specimen(Random error)affects one sample14History of Quality ControlQ
16、uality control has been traditional means of managing error in the laboratory!CLIA 67 required daily QC as integral part of testing processCLIA 88 -reaffirmed“two levels of QC per test per day”(blood gases every 8 hours)CAP advocates daily QC through inspection and accreditationThe Joint Commission
17、focuses on patient safety and preanalytic,analytic and postanalytic processesISO QC Recommendations15ISO 15189 5.6.1 The laboratory shall design internal control systems that verify the attainment of the intended quality of results.Special attention should be paid to elimination of mistakes in the p
18、rocess of handling samples,requests,examinations,reports,etc.Documentation should include quality control procedures based on manufacturer instructions for use.Internal Quality Control(internal to the laboratory)is defined as a set of procedures undertaken by laboratory staff for the continuous moni
19、toring of operation and the results of measurements in order to decide whether results are reliable enough to be released.The regular analysis of QC materials can serve as an essential component of a laboratorys internal control system.16Quality in Laboratory TestingDespite analyzing the minimum req
20、uired 2 levels QC/day,we have all experienced erroneous laboratory results!Quality is more than QC!Quality is:Testing that is safe and reliableAppropriate use of technology to meet medical needsTest results that can be trusted for medical managementA labs reputation depends on quality of its results
21、!What should be the lab goals for errors?Unacceptable ErrorsDeaths/106 enplanements0.2 PPMDeaths/106 general anesthesia inductions2-5Viral transmissions/106 transfusions29Results 7 SD/106 automated chem tests100Lost bags/106 airplane passengers5000Failures/106 proficiency tests14,000Difference 5%/10
22、6 hematocrit testsup to 190,000Witte D&VanNess S.Frequency of Unacceptable Results in Point-of-Care Testing.Arch Pathol Lab Med 123:761,1999Sigma MetricsSigma metrics are an industrial measure of quality in a factory process -estimates rate of defects in productsGoal of sigma metrics:Improve custome
23、r satisfactionBalance number of rejected products with the increased cost required to improve processes(to lower defect rates)Six sigma consensus for balancing rejection against the increased costs of improving errors for industrial processes Six sigma was adopted and popularized into the clinical l
24、aboratories in 1990s18Sigma PerformanceNeed for Quality Laboratory TestingLaboratory testing influences 70%of all medical decisions.7 billion lab tests conducted in the U.S.annuallySilverstein MD.An approach to medical errors and patient safety in laboratory services.A white paper prepared for the Q
25、uality Institute Meeting,Making the Laboratory a Partner in Patient Safety.Division of Laboratory Systems,Centers for Disease Control and Prevention,April 2003.http:/www.phppo.cdc.gov/mlp/qiconference/Beyond Six SigmaWith 7 billion tests conducted in the US annually,six sigma(3.4 defects/million tes
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