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Plebani, M. and Carraro,P. Mistakes in a StatLaboratory: Types andFrequency. ClinicalChemistry. Vol 43:8.1348-1351. 1997.Signori, C. et al. Processand Risk Analysis toReduce Errors in ClinicalLaboratories. ClinicalChemistry andLaboratory Medicine.Vol 45:6. 742-748. 2007.especially in manually intensivepre-analytical processes. Mostpre-analytical errors result fromsystem flaws and insufficientaudit of the operators involved inspecimen collection and handlingresponsibilities, leading to anunacceptable number ofunsuitable specimens due tomisidentification, in vitrohemolysis, clotting, inappropriatevolume, wrong container orcontamination from infusiveroutes. Detection andmanagement of unsuitablesamples are necessary toovercome this variability. Thisdocument reviews the majorcauses of unsuitable specimens inclinical laboratories, providingconsensus recommendations fordetection and management.This paper evaluated thefrequency and types of mistakesfound in the “stat” section of theDepartment of LaboratoryMedicine of the University-Hospital of Padova by monitoringfour different departments(internal medicine, nephrology,surgery, and intensive care unit)for 3 months.Five Italian hospital laboratoriescooperated in a project in whichmethodologies for process andrisk analysis, usually applied infields other than health care(typically aeronautical andtransport industries), wereadapted and applied to laboratorymedicine. The collaboration of aboard of experts played a key rolein underlining the limits of theproposed techniques and adaptingthem to the laboratory situation. Adetailed process analysisperformed in each center was thestarting point, followed by riskanalysis to evaluate risks andfacilitate benchmarking amongthe participants.a) Documentation of interferenceb) Prompt notification of the problemencountered in the specimen tohealthcare staff in charge of thepatientc) Management of unsuitable specimensfor the presence of interferingsubstancesd) Management of unsuitable specimensdue to inappropriate sample volumee) Management of unsuitable specimensfor clottingf) Management of unsuitable specimensfor wrong or misidentificationApplication of Total Quality Management conceptsto laboratory testing requires that the total process,including pre-analytical and post-analytical phases,be managed so as to reduce or, ideally, eliminate alldefects within the process itself.Among a total of 40,490 analyses, we identified 189laboratory mistakes, a relative frequency of 0.47%.The distribution of mistakes was: pre-analytical68.2%, analytical 13.3%, and post-analytical 18.5%.Most of the laboratory mistakes (74%) did not affectpatients’ outcome. However, in 37 patients (19%),laboratory mistakes were associated with furtherinappropriate investigations, thus resulting in anunjustifiable increase in costs. Moreover, in 12patients (6.4%) laboratory mistakes were associatedwith inappropriate care or inappropriate modificationof therapy. The promotion of quality control andcontinuous improvement of the total testing process,including pre- and post-analytical phases, seems tobe a prerequisite for an effective laboratory service.Improving laboratory quality will require definitionof indicators to be monitored as measures of alaboratory trend. The continuous observation ofthese indicators can help to reduce errors and risk oferrors, thus enhancing the laboratory outcome. Inaddition, the standardization of risk evaluationtechniques and the definition of a set of indicatorscan eventually contribute to a benchmarking processin clinical laboratories.The study involves an attempt to adapt some of thetechniques of process and risk analysis, usuallyapplied in fields different from healthcare, to theorganization of clinical laboratories, with thefollowing aims:1. To set up an efficient and objective procedure toquantify the risk of errors;26
Silverstein, Marc. AnApproach to MedicalErrors and Patient Safetyin Laboratory Services.Prepared for the QualityInstitute Meeting‘Making the Laboratory aPartner in Patient Safety’,Atlanta, April 2003.Stahl, M. et al. Reasonsfor a Laboratory’sInability to ReportResults for RequestedAnalytical Tests. ClinicalChemistry. Vol 44: 10.1998.Studies have documentedinappropriate utilization oflaboratory tests and interventionsare effective in improving theutilization of laboratory tests.Laboratory practice uses manymethods to reduce errors, assurepatient safety, and improvequality including quality controlprocedures, quality assuranceprograms, certification ofeducation programs, licensing oflaboratory professionals,accreditation of laboratories, andfederal regulation of laboratorypractices.There is increasing understandingof the importance of the preanalyticalcircumstances onlaboratory quality, includingfailures to report requestedresults. In the past, why thelaboratory was unable to deliver aresult was not investigated.Accordingly, when looking intothe computer system fordiscrepancies between number oftests requested and number oftests reported, only the volume ofthe problem, not the reasons,could be seen.2. To use such a procedure for uniform detectionof errors in clinical laboratories and for thedefinition of a benchmark strategy;3. To measure the impact of errors/risk of errorson the clinical laboratory outcome.Although errors still occur through all phases of thetesting cycle, the proportion of errors in the analyticphase of testing is lower than the proportion of errorsin the pre-analytic and post-analytic phases oftesting. This suggests that collectively the methods toreduce errors in laboratory medicine practice havebeen effective and that further efforts to reduceerrors and assure patient safety will requirepartnerships with providers.The Quality Institute, by focusing on thedevelopment of better ways to measure theeffectiveness of laboratory service (qualityindicators) and by holding the laboratory serviceindustry publicly accountable (national report) forachieving these goals could lead to substantialimprovements in patient safety and in the quality oflaboratory services. The benefits of having acoalition that addresses major policy questions andoffers solutions to issues before legal or regulatoryaction is required, and which acts as a clearinghousefor information could protect patient safety whiledealing effectively with the important issue ofaccess, cost, and quality of laboratory services.The laboratory has focused on solving the majorproblems and has reduced the specimen- andtransport-related problems. However, there are stillproblems:• microcoagulation in tubes;• general practitioners do not always follow theinstructions and rules on mailing and stability ofthe components;• the four laboratories in the county exchangespecimens for rare tests - during this procedure,specimens or results can be lost;• the intensity of diagnostic work and treatmentof the patients in the hospital per time unit hasgrossly increased, hence a new problem is thatpatients frequently are not available at the timefor specimen sampling because of other medicalprocedures. In 1996, this problem accounted for13% of all request failures.The authors’ goal is to detect the failures and preventthem to reduce report failures to
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