The Experts below are selected from a list of 183384 Experts worldwide ranked by ideXlab platform
Mario Pazzagli - One of the best experts on this subject based on the ideXlab platform.
-
THE PRE-Analytical Phase OF THE LIQUID BIOPSY
New Biotechnology, 2019Co-Authors: Francesca Salvianti, Stefania Gelmini, Filomena Costanza, Irene Mancini, Gemma Sonnati, Lisa Simi, Mario Pazzagli, Pamela PinzaniAbstract:Abstract The term ‘liquid biopsy’, introduced in 2013 in reference to the analysis of circulating tumour cells (CTCs) in cancer patients, was extended to cell-free nucleic acids (cfNAs) circulating in blood and other body fluids. CTCs and cfNAs are now considered diagnostic and prognostic markers, used as surrogate materials for the molecular characterisation of solid tumours, in particular for research on tumour-specific or actionable somatic mutations. Molecular characterisation of cfNAs and CTCs (especially at the single cell level) is technically challenging, requiring highly sensitive and specific methods and/or multi-step processes. The analysis of the liquid biopsy relies on a plethora of methods whose standardisation cannot be accomplished without disclosing criticisms related to the pre-Analytical Phase. Thus, pre-Analytical factors potentially influencing downstream cellular and molecular analyses must be considered in order to translate the liquid biopsy approach into clinical practice. The present review summarises the most recent reports in this field, discussing the main pre-Analytical aspects related to CTCs, cfNAs and exosomes in blood samples for liquid biopsy analysis. A short discussion on non-blood liquid biopsy samples is also included.
-
How standardization of the pre-Analytical Phase of both research and diagnostic biomaterials can increase reproducibility of biomedical research and diagnostics.
New biotechnology, 2019Co-Authors: Peter H.j. Riegman, Mario Pazzagli, Karl-friedrich Becker, Kurt Zatloukal, U. Schröder, Uwe OelmüllerAbstract:Comparison of published biomedical studies shows that a large proportion are irreproducible, causing severe damage to society and creating an image of wasted investments. These observations are of course damaging to the biomedical research field, which is currently full of future promise. Precision medicine and disease prevention are successful, but are progressing slowly due to irreproducible study results. Although standardization is mentioned as a possible solution, it is not always clear how this could decrease or prevent irreproducible results in biomedical studies. In this article more insight is given into what quality, norms, standardization, certification, accreditation and optimized infrastructure can accomplish to reveal causes of irreproducibility and increase reproducibility when collecting biomaterials. CEN and ISO standards for the sample pre-Analytical Phase are currently being developed with the support of the SPIDIA4P project, and their role in increasing reproducibility in both biomedical research and diagnostics is demonstrated. In particular, it is described how standardized methods and quality assurance documentation can be exploited as tools for: 1) recognition and rejection of ‘not fit for purpose’ samples on the basis of detailed sample metadata, and 2) identification of methods that contribute to irreproducibility which can be adapted or replaced.
-
Second SPIDIA-DNA External Quality Assessment (EQA): Influence of pre-Analytical Phase of blood samples on genomic DNA quality
Clinica chimica acta; international journal of clinical chemistry, 2015Co-Authors: Francesca Malentacchi, Mario Pazzagli, Ralf Wyrich, Paolo Verderio, Sara Pizzamiglio, Chiara Maura Ciniselli, Hady Ibrahim-gawel, Stefania GelminiAbstract:Abstract Background In order to develop evidence-based quality guidelines for the pre-Analytical Phase of blood samples used for DNA molecular testing, two pan-European External Quality Assessments (EQAs) were implemented within the European Commission funded project SPIDIA. Here we report the results of the 2nd SPIDIA EQA that has been implemented on the basis of the 1st DNA EQA with the inclusion of some stringent conditions related to blood storage temperature and time. Methods SPIDIA facility sent to all the participants the same blood sample to be processed by their own procedure following SPIDIA suggestion for time and temperature storage. Evaluated genomic DNA (gDNA) quality parameters were: purity and yield by UV spectrophotometric analysis, PCR interferences by Kineret software and integrity by a dedicated algorithm. Results/conclusions 188 applications have been collected from 26 European countries. A high variability of gDNA integrity was observed whereas purity, yield and PCR interferences had a narrow distribution within laboratories. A dedicated analysis on pre-Analytical variables and the evaluated gDNA quality parameters showed that blood storage and DNA extraction procedures influence gDNA integrity. The performances of the participants were improved in comparison with the 1st SPIDIA-DNA EQA, probably due to adopted more stringent pre-Analytical conditions.
-
SPIDIA-RNA: second external quality assessment for the pre-Analytical Phase of blood samples used for RNA based analyses.
PloS one, 2014Co-Authors: Francesca Malentacchi, Lisa Simi, Mario Pazzagli, Claudio Orlando, Ralf Wyrich, Paolo Verderio, Sara Pizzamiglio, Chiara Maura Ciniselli, Kalle Günther, Hui ZhangAbstract:One purpose of the EC funded project, SPIDIA, is to develop evidence-based quality guidelines for the pre-Analytical handling of blood samples for RNA molecular testing. To this end, two pan-European External Quality Assessments (EQAs) were implemented. Here we report the results of the second SPIDIA-RNA EQA. This second study included modifications in the protocol related to the blood collection process, the shipping conditions and pre-Analytical specimen handling for participants. Participating laboratories received two identical proficiency blood specimens collected in tubes with or without an RNA stabilizer. For pre-defined specimen storage times and temperatures, laboratories were asked to perform RNA extraction from whole blood according to their usual procedure and to return extracted RNA to the SPIDIA facility for further analysis. These RNA samples were evaluated for purity, yield, integrity, stability, presence of interfering substances, and gene expression levels for the validated markers of RNA stability: FOS, IL1B, IL8, GAPDH, FOSB and TNFRSF10c. Analysis of the gene expression results of FOS, IL8, FOSB, and TNFRSF10c, however, indicated that the levels of these transcripts were significantly affected by blood collection tube type and storage temperature. These results demonstrated that only blood collection tubes containing a cellular RNA stabilizer allowed reliable gene expression analysis within 48 h from blood collection for all the genes investigated. The results of these two EQAs have been proposed for use in the development of a Technical Specification by the European Committee for Standardization.
-
SPIDIA-DNA: An External Quality Assessment for the pre-Analytical Phase of blood samples used for DNA-based analyses
Clinica chimica acta; international journal of clinical chemistry, 2013Co-Authors: Francesca Malentacchi, Lisa Simi, Mario Pazzagli, Claudio Orlando, Ralf Wyrich, C.c. Hartmann, Paolo Verderio, Sara Pizzamiglio, Chiara Maura Ciniselli, Ales TichopadAbstract:Abstract Background The EC-funded project SPIDIA is aimed to develop evidence-based quality guidelines for the pre-Analytical Phase of blood samples used for DNA molecular testing. To this purpose, a survey and a pan-European External Quality Assessment (EQA) were implemented. Methods SPIDIA facility sent to all the participants the same blood sample to be processed without time or temperature limitation. DNA quality parameters performed at SPIDIA facility included: UV spectrophotometric analysis of DNA purity and yield, PCR interferences study by Kineret software and DNA integrity analysis by pulsed field gel electrophoresis. Results 197 applications have been collected from 30 European countries. A high variability of DNA fragmentation was observed whereas purity, yield and PCR interferences had a narrow distribution within laboratories. A significant difference between the RNase P single copy gene quantity obtained in the DNA samples extracted with the precipitation-based method respect to those obtained with beads and column-based methods was observed. Conclusions The results of this study will be the basis for implementing a second pan-European EQA and the results of both EQAs will be pooled and will provide the basis for the implementation of evidence-based guidelines for the pre-Analytical Phase of DNA analysis of blood samples.
Lisa Simi - One of the best experts on this subject based on the ideXlab platform.
-
THE PRE-Analytical Phase OF THE LIQUID BIOPSY
New Biotechnology, 2019Co-Authors: Francesca Salvianti, Stefania Gelmini, Filomena Costanza, Irene Mancini, Gemma Sonnati, Lisa Simi, Mario Pazzagli, Pamela PinzaniAbstract:Abstract The term ‘liquid biopsy’, introduced in 2013 in reference to the analysis of circulating tumour cells (CTCs) in cancer patients, was extended to cell-free nucleic acids (cfNAs) circulating in blood and other body fluids. CTCs and cfNAs are now considered diagnostic and prognostic markers, used as surrogate materials for the molecular characterisation of solid tumours, in particular for research on tumour-specific or actionable somatic mutations. Molecular characterisation of cfNAs and CTCs (especially at the single cell level) is technically challenging, requiring highly sensitive and specific methods and/or multi-step processes. The analysis of the liquid biopsy relies on a plethora of methods whose standardisation cannot be accomplished without disclosing criticisms related to the pre-Analytical Phase. Thus, pre-Analytical factors potentially influencing downstream cellular and molecular analyses must be considered in order to translate the liquid biopsy approach into clinical practice. The present review summarises the most recent reports in this field, discussing the main pre-Analytical aspects related to CTCs, cfNAs and exosomes in blood samples for liquid biopsy analysis. A short discussion on non-blood liquid biopsy samples is also included.
-
SPIDIA-RNA: second external quality assessment for the pre-Analytical Phase of blood samples used for RNA based analyses.
PloS one, 2014Co-Authors: Francesca Malentacchi, Lisa Simi, Mario Pazzagli, Claudio Orlando, Ralf Wyrich, Paolo Verderio, Sara Pizzamiglio, Chiara Maura Ciniselli, Kalle Günther, Hui ZhangAbstract:One purpose of the EC funded project, SPIDIA, is to develop evidence-based quality guidelines for the pre-Analytical handling of blood samples for RNA molecular testing. To this end, two pan-European External Quality Assessments (EQAs) were implemented. Here we report the results of the second SPIDIA-RNA EQA. This second study included modifications in the protocol related to the blood collection process, the shipping conditions and pre-Analytical specimen handling for participants. Participating laboratories received two identical proficiency blood specimens collected in tubes with or without an RNA stabilizer. For pre-defined specimen storage times and temperatures, laboratories were asked to perform RNA extraction from whole blood according to their usual procedure and to return extracted RNA to the SPIDIA facility for further analysis. These RNA samples were evaluated for purity, yield, integrity, stability, presence of interfering substances, and gene expression levels for the validated markers of RNA stability: FOS, IL1B, IL8, GAPDH, FOSB and TNFRSF10c. Analysis of the gene expression results of FOS, IL8, FOSB, and TNFRSF10c, however, indicated that the levels of these transcripts were significantly affected by blood collection tube type and storage temperature. These results demonstrated that only blood collection tubes containing a cellular RNA stabilizer allowed reliable gene expression analysis within 48 h from blood collection for all the genes investigated. The results of these two EQAs have been proposed for use in the development of a Technical Specification by the European Committee for Standardization.
-
SPIDIA-DNA: An External Quality Assessment for the pre-Analytical Phase of blood samples used for DNA-based analyses
Clinica chimica acta; international journal of clinical chemistry, 2013Co-Authors: Francesca Malentacchi, Lisa Simi, Mario Pazzagli, Claudio Orlando, Ralf Wyrich, C.c. Hartmann, Paolo Verderio, Sara Pizzamiglio, Chiara Maura Ciniselli, Ales TichopadAbstract:Abstract Background The EC-funded project SPIDIA is aimed to develop evidence-based quality guidelines for the pre-Analytical Phase of blood samples used for DNA molecular testing. To this purpose, a survey and a pan-European External Quality Assessment (EQA) were implemented. Methods SPIDIA facility sent to all the participants the same blood sample to be processed without time or temperature limitation. DNA quality parameters performed at SPIDIA facility included: UV spectrophotometric analysis of DNA purity and yield, PCR interferences study by Kineret software and DNA integrity analysis by pulsed field gel electrophoresis. Results 197 applications have been collected from 30 European countries. A high variability of DNA fragmentation was observed whereas purity, yield and PCR interferences had a narrow distribution within laboratories. A significant difference between the RNase P single copy gene quantity obtained in the DNA samples extracted with the precipitation-based method respect to those obtained with beads and column-based methods was observed. Conclusions The results of this study will be the basis for implementing a second pan-European EQA and the results of both EQAs will be pooled and will provide the basis for the implementation of evidence-based guidelines for the pre-Analytical Phase of DNA analysis of blood samples.
-
SPIDIA-RNA: First external quality assessment for the pre-Analytical Phase of blood samples used for RNA based analyses.
Methods (San Diego Calif.), 2012Co-Authors: Mario Pazzagli, Lisa Simi, Francesca Malentacchi, Claudio Orlando, Ralf Wyrich, C.c. Hartmann, Paolo Verderio, Sara Pizzamiglio, Kalle Günther, Chiara Maura CiniselliAbstract:The diagnostic use of in vitro molecular assays can be limited by the lack of guidelines for collection, handling, stabilization and storage of patient specimens. One of the major goals of the EC funded project SPIDIA (www.spidia.eu) is to develop evidence-based quality guidelines for the pre-Analytical Phase of blood samples used for molecular testing which requires intracellular RNA analytes. To this end, a survey and a pan-European external quality assessment (EQA) were implemented. This report is the summary of the results of that trial. With the European Federation of Laboratory Medicine (EFLM) support, 124 applications for participation in the trial were received from 27 different European countries, and 102 laboratories actually participated in the trial. Each participating laboratory described their respective laboratory policies and practices as well as blood collection tubes typically used in performing this type of testing. The participating laboratories received two identical blood specimens: in an EDTA tubes (unstabilized blood; n=67) or in tubes designed specifically for the stabilization of intracellular RNA in blood (PAXgene® Blood RNA tubes; n=35). Laboratories were requested to perform RNA extraction according to the laboratory's own procedure as soon as possible upon receipt of the tubes for one tube and 24h after the first extraction for the second tube. Participants (n=93) returned the two extracted RNAs to SPIDIA facility for analysis, and provided details about the reagents and protocols they used for the extraction. At the SPIDIA facility responsible for coordinating the study, the survey data were classified, and the extracted RNA samples were evaluated for purity, yield, integrity, stability, and the presence of interfering substances affecting RT-qPCR assays. All participants received a report comparing the performance of the RNA they submitted to that of the other participants. All the results obtained by participants for each RNA quality parameter were classified as "in control", "warning", "out of control" and "missing" by consensus mean analysis. From the survey data, the most variable parameters were the volume of blood collected and the time and storage temperature between blood collection and RNA extraction. Analyzing the results of quality testing of submitted RNA samples we observed a data distribution of purity, yield, and presence of assay interference in agreement with expected values. The RNA Integrity Number (RIN) values distribution was, on the other hand, much wider than the optimal expected value, which led to an "in control" classification, even for partly degraded RNA samples. On the other hand, RIN values below 5 significantly correlated with a reduction of GAPDH expression levels. Furthermore, the distribution of the values of the four transcripts investigated (c-fos, IL-1β, IL-8, and GAPDH) was wide and the RNA instability between samples separated by 24h were similar. Assuming the presence of at least two quality parameters "out of control" as an indication of a critical performance of the laboratory, 33% of the laboratories were included in this group. The results of this study will be the basis for implementing a second pan-European EQA and the results of both EQAs will be pooled and will provide the basis for the implementation of evidence-based guidelines for the pre-Analytical Phase of RNA analysis of blood samples.
Francesca Malentacchi - One of the best experts on this subject based on the ideXlab platform.
-
Second SPIDIA-DNA External Quality Assessment (EQA): Influence of pre-Analytical Phase of blood samples on genomic DNA quality
Clinica chimica acta; international journal of clinical chemistry, 2015Co-Authors: Francesca Malentacchi, Mario Pazzagli, Ralf Wyrich, Paolo Verderio, Sara Pizzamiglio, Chiara Maura Ciniselli, Hady Ibrahim-gawel, Stefania GelminiAbstract:Abstract Background In order to develop evidence-based quality guidelines for the pre-Analytical Phase of blood samples used for DNA molecular testing, two pan-European External Quality Assessments (EQAs) were implemented within the European Commission funded project SPIDIA. Here we report the results of the 2nd SPIDIA EQA that has been implemented on the basis of the 1st DNA EQA with the inclusion of some stringent conditions related to blood storage temperature and time. Methods SPIDIA facility sent to all the participants the same blood sample to be processed by their own procedure following SPIDIA suggestion for time and temperature storage. Evaluated genomic DNA (gDNA) quality parameters were: purity and yield by UV spectrophotometric analysis, PCR interferences by Kineret software and integrity by a dedicated algorithm. Results/conclusions 188 applications have been collected from 26 European countries. A high variability of gDNA integrity was observed whereas purity, yield and PCR interferences had a narrow distribution within laboratories. A dedicated analysis on pre-Analytical variables and the evaluated gDNA quality parameters showed that blood storage and DNA extraction procedures influence gDNA integrity. The performances of the participants were improved in comparison with the 1st SPIDIA-DNA EQA, probably due to adopted more stringent pre-Analytical conditions.
-
SPIDIA-RNA: second external quality assessment for the pre-Analytical Phase of blood samples used for RNA based analyses.
PloS one, 2014Co-Authors: Francesca Malentacchi, Lisa Simi, Mario Pazzagli, Claudio Orlando, Ralf Wyrich, Paolo Verderio, Sara Pizzamiglio, Chiara Maura Ciniselli, Kalle Günther, Hui ZhangAbstract:One purpose of the EC funded project, SPIDIA, is to develop evidence-based quality guidelines for the pre-Analytical handling of blood samples for RNA molecular testing. To this end, two pan-European External Quality Assessments (EQAs) were implemented. Here we report the results of the second SPIDIA-RNA EQA. This second study included modifications in the protocol related to the blood collection process, the shipping conditions and pre-Analytical specimen handling for participants. Participating laboratories received two identical proficiency blood specimens collected in tubes with or without an RNA stabilizer. For pre-defined specimen storage times and temperatures, laboratories were asked to perform RNA extraction from whole blood according to their usual procedure and to return extracted RNA to the SPIDIA facility for further analysis. These RNA samples were evaluated for purity, yield, integrity, stability, presence of interfering substances, and gene expression levels for the validated markers of RNA stability: FOS, IL1B, IL8, GAPDH, FOSB and TNFRSF10c. Analysis of the gene expression results of FOS, IL8, FOSB, and TNFRSF10c, however, indicated that the levels of these transcripts were significantly affected by blood collection tube type and storage temperature. These results demonstrated that only blood collection tubes containing a cellular RNA stabilizer allowed reliable gene expression analysis within 48 h from blood collection for all the genes investigated. The results of these two EQAs have been proposed for use in the development of a Technical Specification by the European Committee for Standardization.
-
SPIDIA-DNA: An External Quality Assessment for the pre-Analytical Phase of blood samples used for DNA-based analyses
Clinica chimica acta; international journal of clinical chemistry, 2013Co-Authors: Francesca Malentacchi, Lisa Simi, Mario Pazzagli, Claudio Orlando, Ralf Wyrich, C.c. Hartmann, Paolo Verderio, Sara Pizzamiglio, Chiara Maura Ciniselli, Ales TichopadAbstract:Abstract Background The EC-funded project SPIDIA is aimed to develop evidence-based quality guidelines for the pre-Analytical Phase of blood samples used for DNA molecular testing. To this purpose, a survey and a pan-European External Quality Assessment (EQA) were implemented. Methods SPIDIA facility sent to all the participants the same blood sample to be processed without time or temperature limitation. DNA quality parameters performed at SPIDIA facility included: UV spectrophotometric analysis of DNA purity and yield, PCR interferences study by Kineret software and DNA integrity analysis by pulsed field gel electrophoresis. Results 197 applications have been collected from 30 European countries. A high variability of DNA fragmentation was observed whereas purity, yield and PCR interferences had a narrow distribution within laboratories. A significant difference between the RNase P single copy gene quantity obtained in the DNA samples extracted with the precipitation-based method respect to those obtained with beads and column-based methods was observed. Conclusions The results of this study will be the basis for implementing a second pan-European EQA and the results of both EQAs will be pooled and will provide the basis for the implementation of evidence-based guidelines for the pre-Analytical Phase of DNA analysis of blood samples.
-
SPIDIA-RNA: First external quality assessment for the pre-Analytical Phase of blood samples used for RNA based analyses.
Methods (San Diego Calif.), 2012Co-Authors: Mario Pazzagli, Lisa Simi, Francesca Malentacchi, Claudio Orlando, Ralf Wyrich, C.c. Hartmann, Paolo Verderio, Sara Pizzamiglio, Kalle Günther, Chiara Maura CiniselliAbstract:The diagnostic use of in vitro molecular assays can be limited by the lack of guidelines for collection, handling, stabilization and storage of patient specimens. One of the major goals of the EC funded project SPIDIA (www.spidia.eu) is to develop evidence-based quality guidelines for the pre-Analytical Phase of blood samples used for molecular testing which requires intracellular RNA analytes. To this end, a survey and a pan-European external quality assessment (EQA) were implemented. This report is the summary of the results of that trial. With the European Federation of Laboratory Medicine (EFLM) support, 124 applications for participation in the trial were received from 27 different European countries, and 102 laboratories actually participated in the trial. Each participating laboratory described their respective laboratory policies and practices as well as blood collection tubes typically used in performing this type of testing. The participating laboratories received two identical blood specimens: in an EDTA tubes (unstabilized blood; n=67) or in tubes designed specifically for the stabilization of intracellular RNA in blood (PAXgene® Blood RNA tubes; n=35). Laboratories were requested to perform RNA extraction according to the laboratory's own procedure as soon as possible upon receipt of the tubes for one tube and 24h after the first extraction for the second tube. Participants (n=93) returned the two extracted RNAs to SPIDIA facility for analysis, and provided details about the reagents and protocols they used for the extraction. At the SPIDIA facility responsible for coordinating the study, the survey data were classified, and the extracted RNA samples were evaluated for purity, yield, integrity, stability, and the presence of interfering substances affecting RT-qPCR assays. All participants received a report comparing the performance of the RNA they submitted to that of the other participants. All the results obtained by participants for each RNA quality parameter were classified as "in control", "warning", "out of control" and "missing" by consensus mean analysis. From the survey data, the most variable parameters were the volume of blood collected and the time and storage temperature between blood collection and RNA extraction. Analyzing the results of quality testing of submitted RNA samples we observed a data distribution of purity, yield, and presence of assay interference in agreement with expected values. The RNA Integrity Number (RIN) values distribution was, on the other hand, much wider than the optimal expected value, which led to an "in control" classification, even for partly degraded RNA samples. On the other hand, RIN values below 5 significantly correlated with a reduction of GAPDH expression levels. Furthermore, the distribution of the values of the four transcripts investigated (c-fos, IL-1β, IL-8, and GAPDH) was wide and the RNA instability between samples separated by 24h were similar. Assuming the presence of at least two quality parameters "out of control" as an indication of a critical performance of the laboratory, 33% of the laboratories were included in this group. The results of this study will be the basis for implementing a second pan-European EQA and the results of both EQAs will be pooled and will provide the basis for the implementation of evidence-based guidelines for the pre-Analytical Phase of RNA analysis of blood samples.
Hui Zhang - One of the best experts on this subject based on the ideXlab platform.
-
SPIDIA-RNA: second external quality assessment for the pre-Analytical Phase of blood samples used for RNA based analyses.
PloS one, 2014Co-Authors: Francesca Malentacchi, Lisa Simi, Mario Pazzagli, Claudio Orlando, Ralf Wyrich, Paolo Verderio, Sara Pizzamiglio, Chiara Maura Ciniselli, Kalle Günther, Hui ZhangAbstract:One purpose of the EC funded project, SPIDIA, is to develop evidence-based quality guidelines for the pre-Analytical handling of blood samples for RNA molecular testing. To this end, two pan-European External Quality Assessments (EQAs) were implemented. Here we report the results of the second SPIDIA-RNA EQA. This second study included modifications in the protocol related to the blood collection process, the shipping conditions and pre-Analytical specimen handling for participants. Participating laboratories received two identical proficiency blood specimens collected in tubes with or without an RNA stabilizer. For pre-defined specimen storage times and temperatures, laboratories were asked to perform RNA extraction from whole blood according to their usual procedure and to return extracted RNA to the SPIDIA facility for further analysis. These RNA samples were evaluated for purity, yield, integrity, stability, presence of interfering substances, and gene expression levels for the validated markers of RNA stability: FOS, IL1B, IL8, GAPDH, FOSB and TNFRSF10c. Analysis of the gene expression results of FOS, IL8, FOSB, and TNFRSF10c, however, indicated that the levels of these transcripts were significantly affected by blood collection tube type and storage temperature. These results demonstrated that only blood collection tubes containing a cellular RNA stabilizer allowed reliable gene expression analysis within 48 h from blood collection for all the genes investigated. The results of these two EQAs have been proposed for use in the development of a Technical Specification by the European Committee for Standardization.
Mario Plebani - One of the best experts on this subject based on the ideXlab platform.
-
Performance criteria and quality indicators for the post-Analytical Phase.
Clinical chemistry and laboratory medicine, 2016Co-Authors: Laura Sciacovelli, Elisa Piva, Ada Aita, Michela Pelloso, Maria Laura Chiozza, Andrea Padoan, Giorgia Antonelli, Mario PlebaniAbstract:Background Quality indicators (QIs) used as performance measurements are an effective tool in accurately estimating quality, identifying problems that may need to be addressed, and monitoring the processes over time. In Laboratory Medicine, QIs should cover all steps of the testing process, as error studies have confirmed that most errors occur in the pre- and post-Analytical Phase of testing. Aim of the present study is to provide preliminary results on QIs and related performance criteria in the post-Analytical Phase. Methods This work was conducted according to a previously described study design based on the voluntary participation of clinical laboratories in the project on QIs of the Working Group "Laboratory Errors and Patient Safety" (WG-LEPS) of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). Results Overall, data collected highlighted an improvement or stability in performances over time for all reported indicators thus demonstrating that the use of QIs is effective in the quality improvement strategy. Moreover, QIs data are an important source for defining the state-of-the-art concerning the error rate in the total testing process. The definition of performance specifications based on the state-of-the-art, as suggested by consensus documents, is a valuable benchmark point in evaluating the performance of each laboratory. Conclusions Laboratory tests play a relevant role in the monitoring and evaluation of the efficacy of patient outcome thus assisting clinicians in decision-making. Laboratory performance evaluation is therefore crucial to providing patients with safe, effective and efficient care.
-
pre Analytical Phase the automated protube device supports quality assurance in the phlebotomy process
Clinica Chimica Acta, 2015Co-Authors: Elisa Piva, Francesca Tosato, Mario PlebaniAbstract:Abstract Background Most errors in laboratory medicine occur in the pre-Analytical Phase of the total testing process. Phlebotomy, a crucial step in the pre-Analytical Phase influencing laboratory results and patient outcome, calls for quality assurance procedures and automation in order to prevent errors and ensure patient safety. Methods We compared the performance of a new small, automated device, the ProTube Inpeco, designed for use in phlebotomy with a complete traceability of the process, with a centralized automated system, BC ROBO. Results ProTube was used for 15,010 patients undergoing phlebotomy with 48,776 tubes being labeled. The mean time and standard deviation (SD) for blood sampling was 3:03 (min:sec; SD ± 1:24) when using ProTube, against 5:40 (min:sec; SD ± 1:57) when using BC ROBO. The mean number of patients per hour managed at each phlebotomy point was 16 ± 3 with ProTube, and 10 ± 2 with BC ROBO. No tubes were labeled erroneously or incorrectly, even if process failure occurred in 2.8% of cases when ProTube was used. Conclusions Thanks to its cutting edge technology, the ProTube has many advantages over BC ROBO, above all in verifying patient identity, and in allowing a reduction in both identification error and tube mislabeling.
-
performance criteria and quality indicators for the post Analytical Phase
Clinical Chemistry and Laboratory Medicine, 2015Co-Authors: Laura Sciacovelli, Elisa Piva, Ada Aita, Michela Pelloso, Maria Laura Chiozza, Andrea Padoan, Giorgia Antonelli, Mario PlebaniAbstract:The definition, implementation and monitoring of valuable Analytical quality specifications have played a fundamental role in improving the quality of laboratory services and reducing the rates of Analytical errors. However, a body of evidence has been accumulated on the relevance of the extra-Analytical Phases, namely the pre-Analytical steps, their vulnerability and impact on the overall quality of the laboratory information. The identification and establishment of valueable quality indicators (QIs) represents a promising strategy for collecting data on quality in the total testing process (TTP) and, particularly, for detecting any mistakes made in the individual steps of the pre-Analytical Phase, thus providing useful information for quality improvement projects. The consensus achieved on the developed list of harmonized QIs is a premise for the further step: the identification of achievable and realistic performance targets based on the knowledge of the state-of-the-art. Data collected by several clinical laboratories worldwide allow the classification of performances for available QIs into three levels: optimum, desirable and minimum, in agreement with the widely accepted proposal for Analytical quality specifications.
-
Performance criteria and quality indicators for the pre-Analytical Phase.
Clinical chemistry and laboratory medicine, 2015Co-Authors: Mario Plebani, Laura Sciacovelli, Ada Aita, Michela Pelloso, Maria Laura ChiozzaAbstract:The definition, implementation and monitoring of valuable Analytical quality specifications have played a fundamental role in improving the quality of laboratory services and reducing the rates of Analytical errors. However, a body of evidence has been accumulated on the relevance of the extra-Analytical Phases, namely the pre-Analytical steps, their vulnerability and impact on the overall quality of the laboratory information. The identification and establishment of valueable quality indicators (QIs) represents a promising strategy for collecting data on quality in the total testing process (TTP) and, particularly, for detecting any mistakes made in the individual steps of the pre-Analytical Phase, thus providing useful information for quality improvement projects. The consensus achieved on the developed list of harmonized QIs is a premise for the further step: the identification of achievable and realistic performance targets based on the knowledge of the state-of-the-art. Data collected by several clinical laboratories worldwide allow the classification of performances for available QIs into three levels: optimum, desirable and minimum, in agreement with the widely accepted proposal for Analytical quality specifications.
-
Quality indicators to detect pre-Analytical errors in laboratory testing.
The Clinical biochemist. Reviews, 2012Co-Authors: Mario PlebaniAbstract:Pre-Analytical steps, the major source of mistakes in laboratory diagnostics, arise during patient preparation, sample collection, sample transportation, sample preparation, and sample storage. However, while it has been reported that the pre-Analytical Phase is error-prone, only recently has it been demonstrated that most errors occur in the ‘pre-pre-Analytical Phase’. This comprises the initial procedures of the testing process performed by healthcare personnel outside the laboratory walls and outside the direct control of the clinical laboratory. Quality indicators (QIs) should therefore cover all steps in the pre-Analytical Phase, from test requesting to sample storage. In the present paper, the state-of-the-art of QIs in laboratory testing is described. The focus is on the experience of a working group of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) in developing a model of QIs, 16 of which concern the pre-Analytical Phase.