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Gian Cesare Guidi - One of the best experts on this subject based on the ideXlab platform.
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estimation of the imprecision on clinical chemistry testing due to fist clenching and maintenance during venipuncture
2016Co-Authors: Gabriel Limaoliveira, Gian Luca Salvagno, Gian Cesare Guidi, G Brocco, Elisa Danese, Giuseppe LippiAbstract:Abstract Objectives An experimental study was planned to assess the influence on routine clinical chemistry parameters of fist making prior to, and maintenance during, venipuncture. Design and methods Blood was collected from 16 healthy volunteers with two separate sequential procedures, entailing standard venipuncture with hand opened throughout blood collection, or clenching the fist 6 times before venipuncture and maintaining the fist until completion of blood collection. After separation of lithium-heparin plasma at Vacuum Tubes with gel separator, 28 routine clinical chemistry parameters and serum indices were measured on Roche Cobas 6000 〈c501〉 module. Results Fist clenching and maintaining were associated with significant variations of 8/26 (31%) analytes tested. Specifically, aspartate aminotransferase (+ 2.3%), calcium (+ 2.2%), chloride (+ 1.0%), creatine kinase (+ 2.0%), magnesium (+ 2.3%), potassium (+ 13.4%), and sodium (+ 0.7%) increased, whereas phosphate (− 5.0%) decreased. All variations except aspartate aminotransferase and creatine kinase exceeded the quality specifications for desirable imprecision. A remarkable increase of free hemoglobin in plasma (i.e., + 28.2%) was also observed. The ratio of plasma potassium was significantly associated with that of plasma CK (r = 0.55; p = 0.029), but not with variations of other analytes. No significant correlation was observed between the ratio of free hemoglobin and those of other analytes. Conclusions The results of our investigation demonstrate that repeated clenching and maintenance of fist during venipuncture may trigger acute variations of several routine clinical chemistry parameters, which may be attributable to muscle contraction, hemolysis or both. Accordingly, venipuncture should be performed avoiding fist clenching and maintenance.
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quality management of preanalytical phase impact of lithium heparin Vacuum Tubes changes on clinical chemistry tests
2013Co-Authors: Gabriel Limaoliveira, Martina Montagnana, Gian Luca Salvagno, Gian Cesare Guidi, Giuseppe Lippi, Geraldo Picheth, G Brocco, Monica VoiAbstract:The validation process is essential in accredited laboratory medicine, but is rarely regarded as an issue in the preanalytical management. The aim of this study was to validate five kinds of lithium heparin Vacuum Tubes for routine clinical chemistry laboratory testing. Blood specimens from 100 volunteers in five different plasma Vacuum Tubes (Tube I: VACUETTE®, Tube II: LABOR IMPORT®, Tube III: S-Monovette®, Tube IV: PST® and Tube V: PST II®) were collected by a single expert phlebotomist. The routine clinical chemistry tests were performed on a Cobas® 6000 module. The significance of the differences between samples was statistically assessed at p < 0.005. The biases from the different Tubes were compared with the current desirable quality specifications. Basically, significant differences could be confirmed by RM ANOVA for the results of the clinical chemistry tests on the following components: glucose, urea, creatinine, alkaline phosphatase, amylase, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, total bilirubin, phosphate, Ca, Mg, Fe and K. Clinically significant variations as compared with the current desirable quality specifications were found for glucose, creatinine, amylase, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, Ca, Mg and K. In conclusion, our results do not support arbitrary interchange among brands of plasma Vacuum Tubes. Future investigations are needed to understand the reasons of these observations; in the meantime, we suggest that laboratory managers standardize the procedures and frequently evaluate the quality of in vitro diagnostic devices.
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incorrect order of draw could be mitigate the patient safety a phlebotomy management case report
2013Co-Authors: Gabriel Limaoliveira, Martina Montagnana, Gian Luca Salvagno, Giuseppe Lippi, Geraldo Picheth, Gian Cesare GuidiAbstract:Procedures involving phlebotomy are critical for obtaining diagnostic blood specimens and represent a well known and recognized problem, probably among the most important issues in laboratory medicine. The aim of this report is to show spurious hyperkalemia and hypocalcemia due to inadequate phlebotomy procedure. The diagnostic blood specimens were collected from a male outpatient 45 years old, with no clinical complaints. The Tubes drawing order were as follows: i) clot activator and gel separator (serum Vacuum tube), ii) K3EDTA, iii) a needleless blood gas dedicated-syringe with 80 I.U. lithium heparin, directly connected to the Vacuum tube holder system. The laboratory testing results from serum Vacuum tube and dedicated syringe were 4.8 and 8.5 mmol/L for potassium, 2.36 and 1.48 mmol/L for total calcium, respectively. Moreover 0.15 mmol/L of free calcium was observed in dedicated syringe. A new blood collection was performed without K3EDTA tube. Different results were found for potassium (4.7 and 4.5 mmol/L) and total calcium (2.37 and 2.38 mmol/L) from serum Vacuum tube and dedicated syringe, respectively. Also free calcium showed different concentration (1.21 mmol/L) in this new sample when compared with the first blood specimen. Based on this case we do not encourage the laboratory managers training the phlebotomists to insert the dedicated syringes in needle-holder system at the end of all Vacuum Tubes. To avoid double vein puncture the dedicated syringe for free calcium determination should be inserted immediately after serum Tubes before EDTA Vacuum Tubes.
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sodium citrate Vacuum Tubes validation preventing preanalytical variability in routine coagulation testing
2013Co-Authors: Gabriel Limaoliveira, Martina Montagnana, Gian Luca Salvagno, Giuseppe Lippi, Geraldo Picheth, Gian Cesare GuidiAbstract:Sometimes in-vitro diagnostic devices (e.g. blood collection Tubes) are not validated before use or when the producer's brand is changed. The aim of this study was to validate five brands of sodium citrate Vacuum Tubes. Blood specimens from 50 volunteers were collected in five different tube brands (I: Venosafe, II: VACUETTE, III: BD Vacutainer, IV: LABOR IMPORT and V: S-Monovette). Routine coagulation tests [activated partial thromboplastin time (aPTT), prothrombin time (PT), and fibrinogen (FIB)] were performed on ACL TOP instrument using HemosIL reagents. The significance of the differences between samples was assessed by paired Student's t-test, set at P < 0.005. Significant differences were observed for: PT when comparing I vs. II, I vs. III, I vs. V, II vs. III, II vs. IV, II vs. V, III vs. IV, III vs. V and IV vs. V; aPTT when comparing I vs. II, I vs. III, I vs. IV, II vs. IV, III vs. IV and IV vs. V. No differences were observed among brands for FIB determination. We suggest that every laboratory management should both standardize the procedures and frequently evaluate the quality of in-vitro diagnostic devices.
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Effects of vigorous mixing of blood Vacuum Tubes on laboratory test results
2012Co-Authors: Gabriel Lima-oliveira, Martina Montagnana, Gian Luca Salvagno, Giuseppe Lippi, Geraldo Picheth, Matteo Gelati, Waldemar Volanski, Katia Cristina Boritiza, Gian Cesare GuidiAbstract:Abstract Objective To evaluate the effect of Tubes mixing (gentle vs. vigorous) on diagnostic blood specimens collected in Vacuum tube systems by venipuncture. Design and methods Blood was collected for routine coagulation, immunochemistry and hematological testing from one hundred volunteers into six Vacuum Tubes: two 3.6 mL Vacuum Tubes containing 0.4 mL of buffered sodium citrate (9NC) 0.109 mol/L: 3.2 W/V%; two 3.5 mL Vacuum Tubes with clot activator and gel separator; and two 3.0 mL Vacuum Tubes containing 5.9 mg K 2 EDTA (Terumo Europe, Belgium). Immediately after the venipuncture all Vacuum Tubes (each of one additive type) were processed through two different procedures: i) Standard: blood specimens in K 2 EDTA- or sodium citrate-Vacuum Tubes were gently inverted five times whereas the specimens in Tubes with clot activator and gel separator were gently inverted ten times, as recommended by the manufacturer; ii) Vigorous mix: all blood specimens were shaken up vigorously during 3–5 s independently of the additive type inside the Tubes. The significance of the differences between samples was assessed by Student's t -test or Wilcoxon ranked-pairs test after checking for normality. The level of statistical significance was set at P Results No significant difference ( P Conclusion Our results drop out a paradigm suggesting that the incorrect primary blood Tubes mixing promotes laboratory variability. We suggest that similar evaluation should be done using other brands of Vacuum Tubes by each laboratory manager.
Giuseppe Lippi - One of the best experts on this subject based on the ideXlab platform.
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estimation of the imprecision on clinical chemistry testing due to fist clenching and maintenance during venipuncture
2016Co-Authors: Gabriel Limaoliveira, Gian Luca Salvagno, Gian Cesare Guidi, G Brocco, Elisa Danese, Giuseppe LippiAbstract:Abstract Objectives An experimental study was planned to assess the influence on routine clinical chemistry parameters of fist making prior to, and maintenance during, venipuncture. Design and methods Blood was collected from 16 healthy volunteers with two separate sequential procedures, entailing standard venipuncture with hand opened throughout blood collection, or clenching the fist 6 times before venipuncture and maintaining the fist until completion of blood collection. After separation of lithium-heparin plasma at Vacuum Tubes with gel separator, 28 routine clinical chemistry parameters and serum indices were measured on Roche Cobas 6000 〈c501〉 module. Results Fist clenching and maintaining were associated with significant variations of 8/26 (31%) analytes tested. Specifically, aspartate aminotransferase (+ 2.3%), calcium (+ 2.2%), chloride (+ 1.0%), creatine kinase (+ 2.0%), magnesium (+ 2.3%), potassium (+ 13.4%), and sodium (+ 0.7%) increased, whereas phosphate (− 5.0%) decreased. All variations except aspartate aminotransferase and creatine kinase exceeded the quality specifications for desirable imprecision. A remarkable increase of free hemoglobin in plasma (i.e., + 28.2%) was also observed. The ratio of plasma potassium was significantly associated with that of plasma CK (r = 0.55; p = 0.029), but not with variations of other analytes. No significant correlation was observed between the ratio of free hemoglobin and those of other analytes. Conclusions The results of our investigation demonstrate that repeated clenching and maintenance of fist during venipuncture may trigger acute variations of several routine clinical chemistry parameters, which may be attributable to muscle contraction, hemolysis or both. Accordingly, venipuncture should be performed avoiding fist clenching and maintenance.
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quality management of preanalytical phase impact of lithium heparin Vacuum Tubes changes on clinical chemistry tests
2013Co-Authors: Gabriel Limaoliveira, Martina Montagnana, Gian Luca Salvagno, Gian Cesare Guidi, Giuseppe Lippi, Geraldo Picheth, G Brocco, Monica VoiAbstract:The validation process is essential in accredited laboratory medicine, but is rarely regarded as an issue in the preanalytical management. The aim of this study was to validate five kinds of lithium heparin Vacuum Tubes for routine clinical chemistry laboratory testing. Blood specimens from 100 volunteers in five different plasma Vacuum Tubes (Tube I: VACUETTE®, Tube II: LABOR IMPORT®, Tube III: S-Monovette®, Tube IV: PST® and Tube V: PST II®) were collected by a single expert phlebotomist. The routine clinical chemistry tests were performed on a Cobas® 6000 module. The significance of the differences between samples was statistically assessed at p < 0.005. The biases from the different Tubes were compared with the current desirable quality specifications. Basically, significant differences could be confirmed by RM ANOVA for the results of the clinical chemistry tests on the following components: glucose, urea, creatinine, alkaline phosphatase, amylase, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, total bilirubin, phosphate, Ca, Mg, Fe and K. Clinically significant variations as compared with the current desirable quality specifications were found for glucose, creatinine, amylase, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, Ca, Mg and K. In conclusion, our results do not support arbitrary interchange among brands of plasma Vacuum Tubes. Future investigations are needed to understand the reasons of these observations; in the meantime, we suggest that laboratory managers standardize the procedures and frequently evaluate the quality of in vitro diagnostic devices.
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incorrect order of draw could be mitigate the patient safety a phlebotomy management case report
2013Co-Authors: Gabriel Limaoliveira, Martina Montagnana, Gian Luca Salvagno, Giuseppe Lippi, Geraldo Picheth, Gian Cesare GuidiAbstract:Procedures involving phlebotomy are critical for obtaining diagnostic blood specimens and represent a well known and recognized problem, probably among the most important issues in laboratory medicine. The aim of this report is to show spurious hyperkalemia and hypocalcemia due to inadequate phlebotomy procedure. The diagnostic blood specimens were collected from a male outpatient 45 years old, with no clinical complaints. The Tubes drawing order were as follows: i) clot activator and gel separator (serum Vacuum tube), ii) K3EDTA, iii) a needleless blood gas dedicated-syringe with 80 I.U. lithium heparin, directly connected to the Vacuum tube holder system. The laboratory testing results from serum Vacuum tube and dedicated syringe were 4.8 and 8.5 mmol/L for potassium, 2.36 and 1.48 mmol/L for total calcium, respectively. Moreover 0.15 mmol/L of free calcium was observed in dedicated syringe. A new blood collection was performed without K3EDTA tube. Different results were found for potassium (4.7 and 4.5 mmol/L) and total calcium (2.37 and 2.38 mmol/L) from serum Vacuum tube and dedicated syringe, respectively. Also free calcium showed different concentration (1.21 mmol/L) in this new sample when compared with the first blood specimen. Based on this case we do not encourage the laboratory managers training the phlebotomists to insert the dedicated syringes in needle-holder system at the end of all Vacuum Tubes. To avoid double vein puncture the dedicated syringe for free calcium determination should be inserted immediately after serum Tubes before EDTA Vacuum Tubes.
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sodium citrate Vacuum Tubes validation preventing preanalytical variability in routine coagulation testing
2013Co-Authors: Gabriel Limaoliveira, Martina Montagnana, Gian Luca Salvagno, Giuseppe Lippi, Geraldo Picheth, Gian Cesare GuidiAbstract:Sometimes in-vitro diagnostic devices (e.g. blood collection Tubes) are not validated before use or when the producer's brand is changed. The aim of this study was to validate five brands of sodium citrate Vacuum Tubes. Blood specimens from 50 volunteers were collected in five different tube brands (I: Venosafe, II: VACUETTE, III: BD Vacutainer, IV: LABOR IMPORT and V: S-Monovette). Routine coagulation tests [activated partial thromboplastin time (aPTT), prothrombin time (PT), and fibrinogen (FIB)] were performed on ACL TOP instrument using HemosIL reagents. The significance of the differences between samples was assessed by paired Student's t-test, set at P < 0.005. Significant differences were observed for: PT when comparing I vs. II, I vs. III, I vs. V, II vs. III, II vs. IV, II vs. V, III vs. IV, III vs. V and IV vs. V; aPTT when comparing I vs. II, I vs. III, I vs. IV, II vs. IV, III vs. IV and IV vs. V. No differences were observed among brands for FIB determination. We suggest that every laboratory management should both standardize the procedures and frequently evaluate the quality of in-vitro diagnostic devices.
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Effects of vigorous mixing of blood Vacuum Tubes on laboratory test results
2012Co-Authors: Gabriel Lima-oliveira, Martina Montagnana, Gian Luca Salvagno, Giuseppe Lippi, Geraldo Picheth, Matteo Gelati, Waldemar Volanski, Katia Cristina Boritiza, Gian Cesare GuidiAbstract:Abstract Objective To evaluate the effect of Tubes mixing (gentle vs. vigorous) on diagnostic blood specimens collected in Vacuum tube systems by venipuncture. Design and methods Blood was collected for routine coagulation, immunochemistry and hematological testing from one hundred volunteers into six Vacuum Tubes: two 3.6 mL Vacuum Tubes containing 0.4 mL of buffered sodium citrate (9NC) 0.109 mol/L: 3.2 W/V%; two 3.5 mL Vacuum Tubes with clot activator and gel separator; and two 3.0 mL Vacuum Tubes containing 5.9 mg K 2 EDTA (Terumo Europe, Belgium). Immediately after the venipuncture all Vacuum Tubes (each of one additive type) were processed through two different procedures: i) Standard: blood specimens in K 2 EDTA- or sodium citrate-Vacuum Tubes were gently inverted five times whereas the specimens in Tubes with clot activator and gel separator were gently inverted ten times, as recommended by the manufacturer; ii) Vigorous mix: all blood specimens were shaken up vigorously during 3–5 s independently of the additive type inside the Tubes. The significance of the differences between samples was assessed by Student's t -test or Wilcoxon ranked-pairs test after checking for normality. The level of statistical significance was set at P Results No significant difference ( P Conclusion Our results drop out a paradigm suggesting that the incorrect primary blood Tubes mixing promotes laboratory variability. We suggest that similar evaluation should be done using other brands of Vacuum Tubes by each laboratory manager.
Gabriel Limaoliveira - One of the best experts on this subject based on the ideXlab platform.
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estimation of the imprecision on clinical chemistry testing due to fist clenching and maintenance during venipuncture
2016Co-Authors: Gabriel Limaoliveira, Gian Luca Salvagno, Gian Cesare Guidi, G Brocco, Elisa Danese, Giuseppe LippiAbstract:Abstract Objectives An experimental study was planned to assess the influence on routine clinical chemistry parameters of fist making prior to, and maintenance during, venipuncture. Design and methods Blood was collected from 16 healthy volunteers with two separate sequential procedures, entailing standard venipuncture with hand opened throughout blood collection, or clenching the fist 6 times before venipuncture and maintaining the fist until completion of blood collection. After separation of lithium-heparin plasma at Vacuum Tubes with gel separator, 28 routine clinical chemistry parameters and serum indices were measured on Roche Cobas 6000 〈c501〉 module. Results Fist clenching and maintaining were associated with significant variations of 8/26 (31%) analytes tested. Specifically, aspartate aminotransferase (+ 2.3%), calcium (+ 2.2%), chloride (+ 1.0%), creatine kinase (+ 2.0%), magnesium (+ 2.3%), potassium (+ 13.4%), and sodium (+ 0.7%) increased, whereas phosphate (− 5.0%) decreased. All variations except aspartate aminotransferase and creatine kinase exceeded the quality specifications for desirable imprecision. A remarkable increase of free hemoglobin in plasma (i.e., + 28.2%) was also observed. The ratio of plasma potassium was significantly associated with that of plasma CK (r = 0.55; p = 0.029), but not with variations of other analytes. No significant correlation was observed between the ratio of free hemoglobin and those of other analytes. Conclusions The results of our investigation demonstrate that repeated clenching and maintenance of fist during venipuncture may trigger acute variations of several routine clinical chemistry parameters, which may be attributable to muscle contraction, hemolysis or both. Accordingly, venipuncture should be performed avoiding fist clenching and maintenance.
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quality management of preanalytical phase impact of lithium heparin Vacuum Tubes changes on clinical chemistry tests
2013Co-Authors: Gabriel Limaoliveira, Martina Montagnana, Gian Luca Salvagno, Gian Cesare Guidi, Giuseppe Lippi, Geraldo Picheth, G Brocco, Monica VoiAbstract:The validation process is essential in accredited laboratory medicine, but is rarely regarded as an issue in the preanalytical management. The aim of this study was to validate five kinds of lithium heparin Vacuum Tubes for routine clinical chemistry laboratory testing. Blood specimens from 100 volunteers in five different plasma Vacuum Tubes (Tube I: VACUETTE®, Tube II: LABOR IMPORT®, Tube III: S-Monovette®, Tube IV: PST® and Tube V: PST II®) were collected by a single expert phlebotomist. The routine clinical chemistry tests were performed on a Cobas® 6000 module. The significance of the differences between samples was statistically assessed at p < 0.005. The biases from the different Tubes were compared with the current desirable quality specifications. Basically, significant differences could be confirmed by RM ANOVA for the results of the clinical chemistry tests on the following components: glucose, urea, creatinine, alkaline phosphatase, amylase, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, total bilirubin, phosphate, Ca, Mg, Fe and K. Clinically significant variations as compared with the current desirable quality specifications were found for glucose, creatinine, amylase, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, Ca, Mg and K. In conclusion, our results do not support arbitrary interchange among brands of plasma Vacuum Tubes. Future investigations are needed to understand the reasons of these observations; in the meantime, we suggest that laboratory managers standardize the procedures and frequently evaluate the quality of in vitro diagnostic devices.
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incorrect order of draw could be mitigate the patient safety a phlebotomy management case report
2013Co-Authors: Gabriel Limaoliveira, Martina Montagnana, Gian Luca Salvagno, Giuseppe Lippi, Geraldo Picheth, Gian Cesare GuidiAbstract:Procedures involving phlebotomy are critical for obtaining diagnostic blood specimens and represent a well known and recognized problem, probably among the most important issues in laboratory medicine. The aim of this report is to show spurious hyperkalemia and hypocalcemia due to inadequate phlebotomy procedure. The diagnostic blood specimens were collected from a male outpatient 45 years old, with no clinical complaints. The Tubes drawing order were as follows: i) clot activator and gel separator (serum Vacuum tube), ii) K3EDTA, iii) a needleless blood gas dedicated-syringe with 80 I.U. lithium heparin, directly connected to the Vacuum tube holder system. The laboratory testing results from serum Vacuum tube and dedicated syringe were 4.8 and 8.5 mmol/L for potassium, 2.36 and 1.48 mmol/L for total calcium, respectively. Moreover 0.15 mmol/L of free calcium was observed in dedicated syringe. A new blood collection was performed without K3EDTA tube. Different results were found for potassium (4.7 and 4.5 mmol/L) and total calcium (2.37 and 2.38 mmol/L) from serum Vacuum tube and dedicated syringe, respectively. Also free calcium showed different concentration (1.21 mmol/L) in this new sample when compared with the first blood specimen. Based on this case we do not encourage the laboratory managers training the phlebotomists to insert the dedicated syringes in needle-holder system at the end of all Vacuum Tubes. To avoid double vein puncture the dedicated syringe for free calcium determination should be inserted immediately after serum Tubes before EDTA Vacuum Tubes.
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sodium citrate Vacuum Tubes validation preventing preanalytical variability in routine coagulation testing
2013Co-Authors: Gabriel Limaoliveira, Martina Montagnana, Gian Luca Salvagno, Giuseppe Lippi, Geraldo Picheth, Gian Cesare GuidiAbstract:Sometimes in-vitro diagnostic devices (e.g. blood collection Tubes) are not validated before use or when the producer's brand is changed. The aim of this study was to validate five brands of sodium citrate Vacuum Tubes. Blood specimens from 50 volunteers were collected in five different tube brands (I: Venosafe, II: VACUETTE, III: BD Vacutainer, IV: LABOR IMPORT and V: S-Monovette). Routine coagulation tests [activated partial thromboplastin time (aPTT), prothrombin time (PT), and fibrinogen (FIB)] were performed on ACL TOP instrument using HemosIL reagents. The significance of the differences between samples was assessed by paired Student's t-test, set at P < 0.005. Significant differences were observed for: PT when comparing I vs. II, I vs. III, I vs. V, II vs. III, II vs. IV, II vs. V, III vs. IV, III vs. V and IV vs. V; aPTT when comparing I vs. II, I vs. III, I vs. IV, II vs. IV, III vs. IV and IV vs. V. No differences were observed among brands for FIB determination. We suggest that every laboratory management should both standardize the procedures and frequently evaluate the quality of in-vitro diagnostic devices.
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impact of the phlebotomy training based on clsi nccls h03 a6 procedures for the collection of diagnostic blood specimens by venipuncture
2012Co-Authors: Gabriel Limaoliveira, Martina Montagnana, Gian Luca Salvagno, Giuseppe Lippi, Geraldo Picheth, Gian Cesare GuidiAbstract:Introduction: The activities involving phlebotomy, a critical task for obtaining diagnostic blood samples, are poorly studied as regards the major sources of errors and the procedures related to laboratory quality control. The aim of this study was to verify the compliance with CLSI documents of clinical laboratories from South America and to assess whether teaching phlebotomists to follow the exact procedure for blood collection by venipuncture from CLSI/NCCLS H03-A6 - Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture might improve the quality of the process. Materials and methods: A survey was sent by mail to 3674 laboratories from South America to verify the use of CLSI documents. Thirty skilled phlebotomists were trained with the CLSI H03-A6 document to perform venipuncture procedures for a period of 20 consecutive working days. The overall performances of the phlebotomists were further compared before and after the training program. Results: 2622 from 2781 laboratories that did answer our survey used CLSI documents to standardize their procedures and process. The phlebotomists’ training for 20 days before our evaluation completely eliminated non-conformity procedures for: i) incorrect friction of the forearm, during the cleaning of the venipuncture site to ease vein location; ii) incorrect sequence of Vacuum Tubes collection; and iii) inadequate mixing of the blood in primary Vacuum Tubes containing anticoagulants or clot activators. Unfortunately the CLSI H03-A6 document does not caution against both unsuitable tourniquet application time (i.e., for more than one minute) and inappropriate request to clench the fist repeatedly. These inadequate procedures were observed for all phlebotomists. Conclusion: We showed that strict observance of the CLSI H03-A6 document can remarkably improve quality, although the various steps for collecting diagnostic blood specimens are not a gold standard, since they may still permit errors. Tourniquet application time and forearm clench should be verified by all quality laboratory managers in the services. Moreover, the procedure for collecting blood specimens should be revised to eliminate this source of laboratory variability and safeguard the quality.
Hitesh Panchal - One of the best experts on this subject based on the ideXlab platform.
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annual performance analysis of various energy storage materials in the upper basin of a double basin solar still with Vacuum Tubes
2020Co-Authors: Hitesh PanchalAbstract:A double-basin solar still with Vacuum Tubes showed impressive distillate output due to getting potable water from lower and upper basins. But it is also true that distillate output of the upper ba...
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investigation on performance analysis of a novel design of the Vacuum tube assisted double basin solar still an experimental approach
2016Co-Authors: Hitesh Panchal, P K ShahAbstract:In this present work, the lower basin is connected to the conventional Vacuum Tubes, hence the temperature of water remains higher throughout the day and the distillate output also remains higher and always releases the latent heat of condensation to the upper basin for heating of water and enhancement of the distillate output. In this research paper, the double basin solar still with Vacuum Tubes fabricated wastested in climate conditions of Mehsana, (23.6000°N, 72.4000°E), Gujarat, with three different water depths 0.03, 0.04 and 0.05 m inside the lower basin and upper basin for one year time period of January 2012 to December 2012. It has been found that the double basin solar still with 0.03 m depth produced more compared with 0.04 kg and 0.05 m. It has also found that the average distillate output of the present system was found to be 8 with the monetary value of produced water being around 0.37 Rs/kg.
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enhancement of upper basin distillate output by attachment of Vacuum Tubes with double basin solar still
2015Co-Authors: Hitesh Panchal, P K ShahAbstract:AbstractGenerally, the distillate output of a solar still is low; hence it is not practicable for the solution of drinkable water in the universe today. Here, a new concept is utilized to increase distillate output of a solar still in use, the double-basin solar still integrated with Vacuum Tubes. In this research paper, an analysis of the top basin of present solar still with different energy absorbing materials like calcium stones, black granite gravel and pebbles for enhanced surface area of water is performed. Numerous experiments have been conducted in climate conditions of Mehsana (23.6000° N, 72.4000° E) Gujarat, from April to September 2013 with a constant depth of 2 cm inside top basin. Six months’ result shows that, the distillate output of basing material with calcium stones found were more when compared with black granite gravel and pebbles.
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Enhancement of distillate output of double basin solar still with Vacuum Tubes
2015Co-Authors: Hitesh PanchalAbstract:Abstract In this research paper, attempts are made to make a double basin solar still. The overall size of the lower basin used is 1006 mm × 325 mm × 380 mm and the outer basin is 1006 mm × 536 mm × 100 mm. Black granite gravel is used to increase the distillate output by reducing the quantity of brackish or saline water in both basins. Several experiments have been conducted to determine the performance of a solar still in climate conditions of Mehsana (latitude of 23°59′ and longitude of 72° 38′), Gujarat. Here, three conditions used to determine the performance of double basin solar still like a double basin solar still alone, double basin solar still with black granite gravel, double basin solar still with Vacuum Tubes and double basin solar still with Vacuum Tubes and black granite gravel. Experimental results and comparison with other researchers show that, the daily distillate output increases by coupling Vacuum Tubes and by coupling Vacuum Tubes and black granite gravel to 56% and 65% respectively.
Gian Luca Salvagno - One of the best experts on this subject based on the ideXlab platform.
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estimation of the imprecision on clinical chemistry testing due to fist clenching and maintenance during venipuncture
2016Co-Authors: Gabriel Limaoliveira, Gian Luca Salvagno, Gian Cesare Guidi, G Brocco, Elisa Danese, Giuseppe LippiAbstract:Abstract Objectives An experimental study was planned to assess the influence on routine clinical chemistry parameters of fist making prior to, and maintenance during, venipuncture. Design and methods Blood was collected from 16 healthy volunteers with two separate sequential procedures, entailing standard venipuncture with hand opened throughout blood collection, or clenching the fist 6 times before venipuncture and maintaining the fist until completion of blood collection. After separation of lithium-heparin plasma at Vacuum Tubes with gel separator, 28 routine clinical chemistry parameters and serum indices were measured on Roche Cobas 6000 〈c501〉 module. Results Fist clenching and maintaining were associated with significant variations of 8/26 (31%) analytes tested. Specifically, aspartate aminotransferase (+ 2.3%), calcium (+ 2.2%), chloride (+ 1.0%), creatine kinase (+ 2.0%), magnesium (+ 2.3%), potassium (+ 13.4%), and sodium (+ 0.7%) increased, whereas phosphate (− 5.0%) decreased. All variations except aspartate aminotransferase and creatine kinase exceeded the quality specifications for desirable imprecision. A remarkable increase of free hemoglobin in plasma (i.e., + 28.2%) was also observed. The ratio of plasma potassium was significantly associated with that of plasma CK (r = 0.55; p = 0.029), but not with variations of other analytes. No significant correlation was observed between the ratio of free hemoglobin and those of other analytes. Conclusions The results of our investigation demonstrate that repeated clenching and maintenance of fist during venipuncture may trigger acute variations of several routine clinical chemistry parameters, which may be attributable to muscle contraction, hemolysis or both. Accordingly, venipuncture should be performed avoiding fist clenching and maintenance.
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quality management of preanalytical phase impact of lithium heparin Vacuum Tubes changes on clinical chemistry tests
2013Co-Authors: Gabriel Limaoliveira, Martina Montagnana, Gian Luca Salvagno, Gian Cesare Guidi, Giuseppe Lippi, Geraldo Picheth, G Brocco, Monica VoiAbstract:The validation process is essential in accredited laboratory medicine, but is rarely regarded as an issue in the preanalytical management. The aim of this study was to validate five kinds of lithium heparin Vacuum Tubes for routine clinical chemistry laboratory testing. Blood specimens from 100 volunteers in five different plasma Vacuum Tubes (Tube I: VACUETTE®, Tube II: LABOR IMPORT®, Tube III: S-Monovette®, Tube IV: PST® and Tube V: PST II®) were collected by a single expert phlebotomist. The routine clinical chemistry tests were performed on a Cobas® 6000 module. The significance of the differences between samples was statistically assessed at p < 0.005. The biases from the different Tubes were compared with the current desirable quality specifications. Basically, significant differences could be confirmed by RM ANOVA for the results of the clinical chemistry tests on the following components: glucose, urea, creatinine, alkaline phosphatase, amylase, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, total bilirubin, phosphate, Ca, Mg, Fe and K. Clinically significant variations as compared with the current desirable quality specifications were found for glucose, creatinine, amylase, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, Ca, Mg and K. In conclusion, our results do not support arbitrary interchange among brands of plasma Vacuum Tubes. Future investigations are needed to understand the reasons of these observations; in the meantime, we suggest that laboratory managers standardize the procedures and frequently evaluate the quality of in vitro diagnostic devices.
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incorrect order of draw could be mitigate the patient safety a phlebotomy management case report
2013Co-Authors: Gabriel Limaoliveira, Martina Montagnana, Gian Luca Salvagno, Giuseppe Lippi, Geraldo Picheth, Gian Cesare GuidiAbstract:Procedures involving phlebotomy are critical for obtaining diagnostic blood specimens and represent a well known and recognized problem, probably among the most important issues in laboratory medicine. The aim of this report is to show spurious hyperkalemia and hypocalcemia due to inadequate phlebotomy procedure. The diagnostic blood specimens were collected from a male outpatient 45 years old, with no clinical complaints. The Tubes drawing order were as follows: i) clot activator and gel separator (serum Vacuum tube), ii) K3EDTA, iii) a needleless blood gas dedicated-syringe with 80 I.U. lithium heparin, directly connected to the Vacuum tube holder system. The laboratory testing results from serum Vacuum tube and dedicated syringe were 4.8 and 8.5 mmol/L for potassium, 2.36 and 1.48 mmol/L for total calcium, respectively. Moreover 0.15 mmol/L of free calcium was observed in dedicated syringe. A new blood collection was performed without K3EDTA tube. Different results were found for potassium (4.7 and 4.5 mmol/L) and total calcium (2.37 and 2.38 mmol/L) from serum Vacuum tube and dedicated syringe, respectively. Also free calcium showed different concentration (1.21 mmol/L) in this new sample when compared with the first blood specimen. Based on this case we do not encourage the laboratory managers training the phlebotomists to insert the dedicated syringes in needle-holder system at the end of all Vacuum Tubes. To avoid double vein puncture the dedicated syringe for free calcium determination should be inserted immediately after serum Tubes before EDTA Vacuum Tubes.
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sodium citrate Vacuum Tubes validation preventing preanalytical variability in routine coagulation testing
2013Co-Authors: Gabriel Limaoliveira, Martina Montagnana, Gian Luca Salvagno, Giuseppe Lippi, Geraldo Picheth, Gian Cesare GuidiAbstract:Sometimes in-vitro diagnostic devices (e.g. blood collection Tubes) are not validated before use or when the producer's brand is changed. The aim of this study was to validate five brands of sodium citrate Vacuum Tubes. Blood specimens from 50 volunteers were collected in five different tube brands (I: Venosafe, II: VACUETTE, III: BD Vacutainer, IV: LABOR IMPORT and V: S-Monovette). Routine coagulation tests [activated partial thromboplastin time (aPTT), prothrombin time (PT), and fibrinogen (FIB)] were performed on ACL TOP instrument using HemosIL reagents. The significance of the differences between samples was assessed by paired Student's t-test, set at P < 0.005. Significant differences were observed for: PT when comparing I vs. II, I vs. III, I vs. V, II vs. III, II vs. IV, II vs. V, III vs. IV, III vs. V and IV vs. V; aPTT when comparing I vs. II, I vs. III, I vs. IV, II vs. IV, III vs. IV and IV vs. V. No differences were observed among brands for FIB determination. We suggest that every laboratory management should both standardize the procedures and frequently evaluate the quality of in-vitro diagnostic devices.
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Effects of vigorous mixing of blood Vacuum Tubes on laboratory test results
2012Co-Authors: Gabriel Lima-oliveira, Martina Montagnana, Gian Luca Salvagno, Giuseppe Lippi, Geraldo Picheth, Matteo Gelati, Waldemar Volanski, Katia Cristina Boritiza, Gian Cesare GuidiAbstract:Abstract Objective To evaluate the effect of Tubes mixing (gentle vs. vigorous) on diagnostic blood specimens collected in Vacuum tube systems by venipuncture. Design and methods Blood was collected for routine coagulation, immunochemistry and hematological testing from one hundred volunteers into six Vacuum Tubes: two 3.6 mL Vacuum Tubes containing 0.4 mL of buffered sodium citrate (9NC) 0.109 mol/L: 3.2 W/V%; two 3.5 mL Vacuum Tubes with clot activator and gel separator; and two 3.0 mL Vacuum Tubes containing 5.9 mg K 2 EDTA (Terumo Europe, Belgium). Immediately after the venipuncture all Vacuum Tubes (each of one additive type) were processed through two different procedures: i) Standard: blood specimens in K 2 EDTA- or sodium citrate-Vacuum Tubes were gently inverted five times whereas the specimens in Tubes with clot activator and gel separator were gently inverted ten times, as recommended by the manufacturer; ii) Vigorous mix: all blood specimens were shaken up vigorously during 3–5 s independently of the additive type inside the Tubes. The significance of the differences between samples was assessed by Student's t -test or Wilcoxon ranked-pairs test after checking for normality. The level of statistical significance was set at P Results No significant difference ( P Conclusion Our results drop out a paradigm suggesting that the incorrect primary blood Tubes mixing promotes laboratory variability. We suggest that similar evaluation should be done using other brands of Vacuum Tubes by each laboratory manager.
