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Mario Plebani - One of the best experts on this subject based on the ideXlab platform.
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Clinical Laboratories production industry or medical services
Clinical Chemistry and Laboratory Medicine, 2015Co-Authors: Mario PlebaniAbstract:The current failure to evidence any link between laboratory tests, Clinical decision-making and patient outcomes, and the scarcity of financial resources affecting healthcare systems worldwide, have put further pressure on the organization and delivery of laboratory services. Consolidation, merger, and laboratory downsizing have been driven by the need to deliver economies of scale and cut costs per test while boosting productivity. Distorted economics, based on payment models rewarding volume and efficiency rather than quality and Clinical effectiveness, have underpinned the entrance of Clinical Laboratories into the production industry thus forcing them to relinquish their original mission of providing medical services. The sea change in laboratory medicine in recent years, with the introduction of ever newer and ever more complex tests, including 'omics', which impact on Clinical decision-making, should encourage Clinical Laboratories to return to their original mission as long as payments models are changed. Rather than being considered solely in terms of costs, diagnostic testing must be seen in the context of an entire hospital stay or an overall payment for a care pathway: the testing process should be conceived as a part of the patient's entire journey.
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shop for quality or quantity volumes and costs in Clinical Laboratories
Clinical Chemistry and Laboratory Medicine, 2013Co-Authors: Giovanni Barletta, Martina Zaninotto, Diego Faggian, Mario PlebaniAbstract:BACKGROUND The increasing need to reduce the costs of providing diagnostic laboratory services has prompted initiatives based on the centralization and consolidation of laboratory facilities. However, the majority of papers and experiences reported in literature focus on "cost per test" thus overlooking the real value of a laboratory service, which requires more complex economic evaluations, such as cost-benefit, cost-effectiveness, and cost-utility analysis. It is important to perform cost analysis, which is no mean feat, by taking into consideration all variables affecting the final and true cost per test. METHODS The present study was conducted in order to evaluate the costs of delivering laboratory services in 20 Italian Clinical Laboratories using a widely accepted methodology, the so-called "activity-based costing analysis". RESULTS The finding of a trend towards a decrease in total costs - due to an increase in test volumes - attained statistical significance only for quantities of up to about 1,100,00 tests per year. For 1,800,00 tests and more, the cost per test appeared to range from 1.5 to 2.0 € irrespective of the different volumes. Regarding the relationship between volumes and number of staff, there is an evident linear relationship between the number of senior staff and volumes, whereas this trend is not observed in the case of medical technologists, the degree and type of automation strongly affecting this variable. CONCLUSIONS The findings made in the present study confirm that the relationship between volumes and costs is not linear; since it is complex, numerous variables should be taken into account.
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hemolyzed specimens a major challenge for emergency departments and Clinical Laboratories
Critical Reviews in Clinical Laboratory Sciences, 2011Co-Authors: Giuseppe Lippi, Mario Plebani, Salvatore Di Somma, Gianfranco CervellinAbstract:The term hemolysis designates the pathological process of breakdown of red blood cells in blood, which is typically accompanied by varying degrees of red tinge in serum or plasma once the whole blood specimen has been centrifuged. Hemolyzed specimens are a rather frequent occurrence in laboratory practice, and the rate of hemolysis is remarkably higher in specimens obtained in the Emergency Department (ED) as compared with other wards or outpatient phlebotomy services. Although hemolyzed specimens may reflect the presence of hemolytic anemia, in most cases they are due to preanalytical sources related to incorrect procedures or failure to follow procedures for collection, handling and storage of the samples; some of these are typical of the ED. Since hemolyzed specimens are often an important cause of relationship, economic, organizational and Clinical problems between the ED and the Clinical laboratory, it is essential to develop effective processes for systematically identifying unsuitable specimens (e.g. by using the hemolysis index), differentiating in vitro from in vivo hemolysis, troubleshooting the potential causes, and maintaining good relations between the Clinical laboratory and the ED.
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haemolysis an overview of the leading cause of unsuitable specimens in Clinical Laboratories
Clinical Chemistry and Laboratory Medicine, 2008Co-Authors: Giuseppe Lippi, Norbert Blanckaert, Pierangelo Bonini, Sol Green, S Kitchen, Vladimir Palicka, Anne Vassault, Mario PlebaniAbstract:Prevention of medical errors is a major goal of healthcare, though healthcare workers themselves have not yet fully accepted or implemented reliable models of system error, and neither has the public. While there is widespread perception that most medical errors arise from an inappropriate or delayed Clinical management, the issue of laboratory errors is receiving a great deal of attention due to their impact on the quality and efficiency of laboratory performances and patient safety. Haemolytic specimens are a frequent occurrence in Clinical Laboratories, and prevalence can be as high as 3.3% of all of the routine samples, accounting for up to 40%-70% of all unsuitable specimens identified, nearly five times higher than other causes, such as insufficient, incorrect and clotted samples. This article focuses on this challenging issue, providing an overview on prevalence and leading causes of in vivo and in vitro haemolysis, and tentative guidelines on identification and management of haemolytic samples in Clinical Laboratories. This strategy includes continuous education of healthcare personnel, systematic detection/quantification of haemolysis in any sample, immediate clinicians warning on the probability of in vivo haemolysis, registration of non-conformity, completing of tests unaffected by haemolysis and request of a second specimen for those potentially affected.
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research translation a new frontier for Clinical Laboratories
Clinical Chemistry and Laboratory Medicine, 2006Co-Authors: Mario Plebani, Francesco M MarincolaAbstract:Translational research and translational medicine (referred to hereafter as translational research) are interchangeable terms that underline the pressing need to translate into practical benefits for those affected by disease the extensive investments divested by the private and public sectors in biomedical research. For people more directly involved in Clinical practice (physicians, Clinical laboratory professionals and patients), translational research responds to the need to accelerate the capture of benefits of research, closing the gap between what we know and what we practice. This basically means the transfer of diagnostic and therapeutic advances proven effective in large, well-conducted trials (and, therefore, evidence-based) to daily medical practice. Translational research should be regarded as a two-way road: bench to bedside, and bedside to bench. In particular, to make possible a more effective translation process, a new road map should be implemented through interaction and cooperation between basic researchers, clinicians, laboratory professionals and manufacturers. Some examples of recent developments in Clinical laboratory testing, including markers of cardiovascular diseases, Clinical proteomics and recombinant allergens, may explain the importance of careful evaluation of all variables that allow the introduction of such new insights into Clinical practice to assure better Clinical outcomes. The vital role of laboratory medicine in the delivery of safer and more effective healthcare requires more careful evaluation not only of the analytical characteristics, but also of any other variable that may affect the Clinical usefulness and diagnostic performances of laboratory tests, thus allowing more accurate interpretation and utilization of laboratory information.
Paul N Valenstein - One of the best experts on this subject based on the ideXlab platform.
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staffing benchmarks for Clinical Laboratories a college of american pathologists q probes study of staffing at 151 institutions
Archives of Pathology & Laboratory Medicine, 2009Co-Authors: Paul N Valenstein, Rhona J Souers, David S WilkinsonAbstract:Abstract Context.—Inadequate staffing of Clinical Laboratories may compromise quality and throughput, whereas excess staff unnecessarily increases the cost of testing. Objectives.—To measure productivity of technical staff and management span of control in a large number of Laboratories and to determine factors associated with favorable staffing ratios. Design.—A total of 151 Clinical Laboratories provided information about technical and management staffing and output (workload) for 4 laboratory sections: anatomic pathology, chemistry/hematology/immunology, microbiology, and transfusion medicine. Results.—For each laboratory section, there was wide variation in labor productivity (output per nonmanagement full-time equivalent) and in management span of control (nonmanagement full-time equivalent per manager). Productivity ratios for the 10th- and 90th-percentile Laboratories varied more than 3-fold. Except in histology, laboratory sections with higher test volumes had higher labor productivity (P < .001 f...
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identification errors involving Clinical Laboratories a college of american pathologists q probes study of patient and specimen identification errors at 120 institutions
Archives of Pathology & Laboratory Medicine, 2009Co-Authors: Paul N Valenstein, Stephen S Raab, Molly K WalshAbstract:● Context.—Misidentified laboratory specimens may cause patient injury, but their frequency in general laboratory practice is unknown. Objectives.—To determine (1) the frequency of identification errors detected before and after result verification, (2) the frequency of adverse patient events due to specimen misidentification, and (3) factors associated with lower error rates and better detection of errors. Design.—One hundred twenty Clinical Laboratories provided information about identification errors during 5 weeks. Results.—In aggregate, 85% of errors were detected before results were released; one quarter of Laboratories identified more than 95% of errors before result verification. The overall rate of patient identification errors involving released results was 55 errors per 1000000 billable tests. A total of 345 adverse events were reported. Most of the adverse events caused material inconvenience to the patients but did not result in any permanent harm. On average, adverse events resulted from 1 of every 18 identification errors. Extrapolating the adverse event rate observed in this study to all United States hospital-based Laboratories suggests that more than 160000 adverse events per year result from misidentification of patients’ laboratory specimens. Conclusions.—Identification errors are common in laboratory medicine, but most are detected before results are released, and only a fraction are associated with adverse patient events. Even when taking into consideration the design of this study, which used imperfect case finding, institutions that did a better job of detecting errors within the laboratory released a smaller proportion of results that involved specimen misidentification. (Arch Pathol Lab Med. 2006;130:1106‐1113)
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the origin of reference intervals a college of american pathologists q probes study of normal ranges used in 163 Clinical Laboratories
Archives of Pathology & Laboratory Medicine, 2007Co-Authors: Richard C Friedberg, Elizabeth A Wagar, Rhona J Souers, Ana K Stankovic, Paul N ValensteinAbstract:Abstract Context.—Standards have been developed for establishing reference intervals, but little is known about how intervals are determined in practice, interlaboratory variation in intervals, or errors that occur while setting reference intervals. Objectives.—To determine (1) methods used by Clinical Laboratories to establish reference intervals for 7 common analytes, (2) variation in intervals, and (3) factors that contribute to establishment of “outlier” intervals. Design.—One hundred sixty-three Clinical Laboratories provided information about their reference intervals for potassium, calcium, magnesium, thyroid-stimulating hormone, hemoglobin, platelet count, and activated partial thromboplastin time. Results.—Approximately half the Laboratories reported conducting an internal study of healthy individuals to validate reference intervals for adults. Most Laboratories relied on external sources to establish reference intervals for pediatric patients. There was slight variation in intervals used by the ...
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six year trends in productivity and utilization of 73 Clinical Laboratories a college of american pathologists laboratory management index program study
Archives of Pathology & Laboratory Medicine, 2001Co-Authors: Paul N Valenstein, Amy H Praestgaard, Ronald B LepoffAbstract:○ Objectives.-To describe longitudinal trends in the efficiency, labor productivity, and utilization of Clinical Laboratories in the United States. Methods.-Financial and activity data were prospectively collected from 73 Clinical Laboratories continuously enrolled in the College of American Pathologists Laboratory Management Index Program from 1994 through 1999. Each laboratory reported quarterly on its costs, labor inputs, and test activity using uniform data definitions. Results.-During the 6-year study period, there was a significant increase in laboratory labor productivity (2.1% more tests/full-time equivalent/y; P <.001). Productivity increases were offset by increasing labor expense (1.5%/ full-time equivalently; P <.001), consumable expense (1.7%/on-site test/y; P =.005), and blood expense, which comprised more than 10% of laboratory expenses by 1999 (4.4% increase/y; P <.001). As a result, overall expense per test showed no significant change in non-inflation-adjusted dollars. Reference laboratory expense per test did not change significantly during the study period; the proportion of tests sent to reference Laboratories grew slightly (0.06% increase/y; P <.001). Test volume of the median laboratory grew by 5442 tests per year (2.3% annual increase; P <.001), while the proportion of testing from inpatients declined by 1.7% per year (P <.001). Inpatient test utilization declined on a discharge basis (annual decline of 1.2 tests/inpatient discharge; P <.001) and on a per diem basis (annual decline of 0.08 tests/inpatient day; P =.002). Inpatient laboratory expense declined on a discharge basis (annual decline of $2.40 or 1.3% per discharge; P <.001), but did not change significantly per inpatient day. Most of the reduction in the expense per discharge occurred during 1994-1996. Conclusions.-Between 1994 and 1999, Clinical Laboratories in the United States experienced significant changes in the cost of operations, utilization, and labor productivity. Laboratory administrators who compare local institutional performance with that of peers are advised to use current or forward-trended peer data. Quarter-to-quarter improvement in many measures of laboratory financial activity may not signal a superior operation, as performance of the whole industry appears to be improving.
Giuseppe Lippi - One of the best experts on this subject based on the ideXlab platform.
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biosafety measures for preventing infection from covid 19 in Clinical Laboratories ifcc taskforce recommendations
Clinical Chemistry and Laboratory Medicine, 2020Co-Authors: Giuseppe Lippi, Khosrow Adeli, Maurizio Ferrari, A R Horvath, David Koch, Sunil Sethi, Cheng Bin WangAbstract:Coronavirus disease 2019 (COVID-19) is the third coronavirus outbreak that has emerged in the past 20 years, after severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). One important aspect, highlighted by many global health organizations, is that this novel coronavirus outbreak may be especially hazardous to healthcare personnel, including laboratory professionals. Therefore, the aim of this document, prepared by the COVID-19 taskforce of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), is to provide a set of recommendations, adapted from official documents of international and national health agencies, on biosafety measures for routine Clinical chemistry Laboratories that operate at biosafety levels 1 (BSL-1; work with agents posing minimal threat to laboratory workers) and 2 (BSL-2; work with agents associated with human disease which pose moderate hazard). We believe that the interim measures proposed in this document for best practice will help minimazing the risk of developing COVID-19 while working in Clinical Laboratories.
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hemolyzed specimens a major challenge for emergency departments and Clinical Laboratories
Critical Reviews in Clinical Laboratory Sciences, 2011Co-Authors: Giuseppe Lippi, Mario Plebani, Salvatore Di Somma, Gianfranco CervellinAbstract:The term hemolysis designates the pathological process of breakdown of red blood cells in blood, which is typically accompanied by varying degrees of red tinge in serum or plasma once the whole blood specimen has been centrifuged. Hemolyzed specimens are a rather frequent occurrence in laboratory practice, and the rate of hemolysis is remarkably higher in specimens obtained in the Emergency Department (ED) as compared with other wards or outpatient phlebotomy services. Although hemolyzed specimens may reflect the presence of hemolytic anemia, in most cases they are due to preanalytical sources related to incorrect procedures or failure to follow procedures for collection, handling and storage of the samples; some of these are typical of the ED. Since hemolyzed specimens are often an important cause of relationship, economic, organizational and Clinical problems between the ED and the Clinical laboratory, it is essential to develop effective processes for systematically identifying unsuitable specimens (e.g. by using the hemolysis index), differentiating in vitro from in vivo hemolysis, troubleshooting the potential causes, and maintaining good relations between the Clinical laboratory and the ED.
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haemolysis an overview of the leading cause of unsuitable specimens in Clinical Laboratories
Clinical Chemistry and Laboratory Medicine, 2008Co-Authors: Giuseppe Lippi, Norbert Blanckaert, Pierangelo Bonini, Sol Green, S Kitchen, Vladimir Palicka, Anne Vassault, Mario PlebaniAbstract:Prevention of medical errors is a major goal of healthcare, though healthcare workers themselves have not yet fully accepted or implemented reliable models of system error, and neither has the public. While there is widespread perception that most medical errors arise from an inappropriate or delayed Clinical management, the issue of laboratory errors is receiving a great deal of attention due to their impact on the quality and efficiency of laboratory performances and patient safety. Haemolytic specimens are a frequent occurrence in Clinical Laboratories, and prevalence can be as high as 3.3% of all of the routine samples, accounting for up to 40%-70% of all unsuitable specimens identified, nearly five times higher than other causes, such as insufficient, incorrect and clotted samples. This article focuses on this challenging issue, providing an overview on prevalence and leading causes of in vivo and in vitro haemolysis, and tentative guidelines on identification and management of haemolytic samples in Clinical Laboratories. This strategy includes continuous education of healthcare personnel, systematic detection/quantification of haemolysis in any sample, immediate clinicians warning on the probability of in vivo haemolysis, registration of non-conformity, completing of tests unaffected by haemolysis and request of a second specimen for those potentially affected.
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recommendations for detection and management of unsuitable samples in Clinical Laboratories
Clinical Chemistry and Laboratory Medicine, 2007Co-Authors: Giuseppe Lippi, Giuseppe Banfi, M Buttarello, Ferruccio Ceriotti, Massimo Daves, A Dolci, Marco Caputo, Davide Giavarina, Martina Montagnana, Valentino MiconiAbstract:A large body of evidence attests that quality programs developed around the analytical phase of the total testing process would only produce limited improvements, since the large majority of errors encountered in Clinical Laboratories still prevails within extra-analytical areas of testing, especially in manually intensive preanalytical processes. Most preanalytical errors result from system flaws and insufficient audit of the operators involved in specimen collection and handling responsibilities, leading to an unacceptable number of unsuitable specimens due to misidentification, in vitro hemolysis, clotting, inappropriate volume, wrong container or contamination from infusive routes. Detection and management of unsuitable samples are necessary to overcome this variability. The present document, issued by the Italian Inter-society SIBioC-SIMeL-CISMEL (Society of Clinical Biochemistry and Clinical Molecular Biology-Italian Society of Laboratory Medicine-Italian Committee for Standardization of Hematological and Laboratory Methods) Study Group on Extra-analytical Variability, reviews the major causes of unsuitable specimens in Clinical Laboratories, providing consensus recommendations for detection and management.
Charan Singh Rayat - One of the best experts on this subject based on the ideXlab platform.
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Statistical Quality Control in Clinical Laboratories
Statistical Methods in Medical Research, 2018Co-Authors: Charan Singh RayatAbstract:The perceptions about quality, methods of its evaluation, and control have undergone a great evolution during the twentieth century. The need of the hour is the “total quality management” (TQM). In the middle of the twentieth century, the need for necessary degree of accuracy in Biomedical Laboratories worldwide was realized. Belk and Sunderman (Am J Clin Path 17:853, 1947) and Wootton and King (Lancet 1:470, 1953) were the pioneers in reporting discordant results of constituents of blood and biological fluids returned by various Clinical Laboratories participating in the “quality control study.” Statistical quality control (SQC) is the way used to describe the set of statistical procedures and tools used by “quality control professionals.” For “medical professionals,” the word “quality” refers to the degree of accuracy of a Clinical investigation in a biomedical laboratory. Just talking about solving quality issues is not enough. We need specific tools and protocols for making right quality decisions. In industry the quality is important in three main areas of production process, namely, (1) quality of design, (2) quality of conformance to design, and (3) quality of performance.
Ana K Stankovic - One of the best experts on this subject based on the ideXlab platform.
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specimen labeling errors a q probes analysis of 147 Clinical Laboratories
Archives of Pathology & Laboratory Medicine, 2008Co-Authors: Elizabeth A Wagar, Ana K Stankovic, Stephen S Raab, Raouf E Nakhleh, Molly K WalshAbstract:Abstract Context.—Accurate specimen identification is critical for quality patient care. Improperly identified specimens can result in delayed diagnosis, additional laboratory testing, treatment of...
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critical values comparison a college of american pathologists q probes survey of 163 Clinical Laboratories
Archives of Pathology & Laboratory Medicine, 2007Co-Authors: Elizabeth A Wagar, Richard C Friedberg, Rhona J Souers, Ana K StankovicAbstract:Abstract Context.—Critical laboratory values are values that may be indicative of life-threatening conditions requiring rapid Clinical intervention. Designation of critical values by Clinical Laboratories is required by the Clinical Laboratory Improvement Amendments and regulatory agencies. The development of critical values often involves consultation with Clinical services. Also, questions are frequently asked about how critical values compare between institutions. Objective.—To examine and compare critical value ranges for selected common critical value analytes. Additional specific questions addressed the source of these values, the inclusion of specific items on a critical values list, and the procedures for establishing such lists. Design.—A total of 163 Clinical Laboratories provided critical values for potassium, calcium, magnesium, thyroid-stimulating hormone, hemoglobin, platelet count, and activated partial thromboplastin time. Collected data were subjected to analysis for statistical variation...
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the origin of reference intervals a college of american pathologists q probes study of normal ranges used in 163 Clinical Laboratories
Archives of Pathology & Laboratory Medicine, 2007Co-Authors: Richard C Friedberg, Elizabeth A Wagar, Rhona J Souers, Ana K Stankovic, Paul N ValensteinAbstract:Abstract Context.—Standards have been developed for establishing reference intervals, but little is known about how intervals are determined in practice, interlaboratory variation in intervals, or errors that occur while setting reference intervals. Objectives.—To determine (1) methods used by Clinical Laboratories to establish reference intervals for 7 common analytes, (2) variation in intervals, and (3) factors that contribute to establishment of “outlier” intervals. Design.—One hundred sixty-three Clinical Laboratories provided information about their reference intervals for potassium, calcium, magnesium, thyroid-stimulating hormone, hemoglobin, platelet count, and activated partial thromboplastin time. Results.—Approximately half the Laboratories reported conducting an internal study of healthy individuals to validate reference intervals for adults. Most Laboratories relied on external sources to establish reference intervals for pediatric patients. There was slight variation in intervals used by the ...
