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Gian Cesare Guidi - One of the best experts on this subject based on the ideXlab platform.

  • doi:10.5402/2012/875357 Research Article K3EDTA Vacuum Tubes Validation for Routine
    2016
    Co-Authors: Isrn Hematology, Geraldo Picheth, Gabriel Lima-oliveira, Hematological Testing, Gian Cesare Guidi
    Abstract:

    Copyright © 2012 Gabriel Lima-Oliveira et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Background and Objective. Some in vitro diagnostic devices (e.g, blood collection vacuum tubes and syringes for blood analyses) are not validated before the quality laboratory managers decide to start using or to change the brand. Frequently, the laboratory or hospital managers select the vacuum tubes for blood collection based on cost considerations or on relevance of a brand. The aim of this study was to validate two dry K3EDTA vacuum tubes of different brands for routine hematological testing. Methods. Blood specimens from 100 volunteers in two different K3EDTA vacuum tubes were collected by a single, expert Phlebotomist. The routine hematological testing was done on Advia 2120i hematology system. The significance of the differences between samples was assessed by paired Student’s t-test after checking for normality. The level of statistical significance was set at P < 0.05. Results and Conclusions. Different brand’s tubes evaluated can represent a clinically relevant source of variations only on mean platele

  • quality management of preanalytical phase impact of lithium heparin vacuum tubes changes on clinical chemistry tests
    Accreditation and Quality Assurance, 2013
    Co-Authors: Gian Luca Salvagno, Martina Montagnana, Gian Cesare Guidi, Giuseppe Lippi, Geraldo Picheth, G Brocco, Monica Voi
    Abstract:

    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.

  • The effective reduction of tourniquet application time after minor modification of the CLSI H03-A6 blood collection procedure
    'Croatian Society for Medical Biochemistry and Laboratory Medicine', 2013
    Co-Authors: Gabriel Lima-oliveira, Martina Montagnana, Gian Luca Salvagno, Giuseppe Lippi, Geraldo Picheth, Gian Cesare Guidi
    Abstract:

    Introduction: The Phlebotomists’ procedures are a still source of laboratory variability. The aim of this study was to verify the efficacy of minor modification in procedure for collection of diagnostic blood specimens by venipuncture from CLSI H03-A6 document is able to reduce the tourniquet application time. Materials and methods: Thirty Phlebotomists were invited to participate. Each Phlebotomist was trained individually to perform the new venipuncture procedure that shortens the time of tourniquet release and removal. The phlebotomy training program was delivered over 8h. After training, all Phlebotomists were monitored for 20 working days, to guarantee the adoption of the correct new procedures for collection of diagnostic blood specimens. After this time frame the Phlebotomists were evaluated to verify whether the new procedure for blood collection derived from CLSI H03-A6 document was effective to improve the quality process by decrease in tourniquet application time. We compared the tourniquet application time and qualitative difference of phlebotomy procedures between laboratories before and after phlebotomy training. Results: The overall mean ± SD tourniquet application time before and after this intervention were 118 ± 1 s and 30 ± 1 s respectively. Minor modifications in procedure for blood collection were able to reduce significantly the tourniquet application time (-88 s, P < 0.001). Conclusions: The minor modifications in procedure for collection of diagnostic blood specimens by venipuncture from CLSI H03-A6 document were able to reduce the tourniquet application time. Now the proposed new procedure for collection of diagnostic blood specimens by venipuncture could be considered usefulness and should be put into practice by all quality laboratory managers and/or phlebotomy coordinators to avoid preanalytical errors regard venous stasis and guarantee patient safety

  • impact of the phlebotomy training based on clsi nccls h03 a6 procedures for the collection of diagnostic blood specimens by venipuncture
    Biochemia Medica, 2012
    Co-Authors: Giuseppe Lippi, Martina Montagnana, Gian Luca Salvagno, Geraldo Picheth, Gian Cesare Guidi
    Abstract:

    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.

  • is phlebotomy part of the dark side in the clinical laboratory struggle for quality
    Labmedicine, 2012
    Co-Authors: Gabriel Limaoliveira, Martina Montagnana, Gian Luca Salvagno, Gian Cesare Guidi, Giuseppe Lippi, Fabiane Gomes De Moraes Rego, Geraldo Picheth
    Abstract:

    Objective: Blood collection is a critical part of the preanalytical phase of laboratory testing. Only a few procedures are evaluable for detecting errors in this non-automatic activity. Information about potential sources of error is frequently absent from quality-control procedures and training materials. Objective: To evaluate the performance of Phlebotomists and to identify the major sources of errors during diagnostic blood collection. Methods: We evaluated the performance of 3 Phlebotomists each from 10 laboratories regarding tourniquet time, request for fist clenching, excessive friction during skin cleaning, sequence of vacuum-tube usage, and mixing of tube contents after specimen collection. The total number of these laboratories represented an equal number of private (ie, owned by private parties) and public (ie, administration by government organizations) settings. Results: An error rate of greater than 60% was observed in the performance of procedures we examined, and the error rate was not significantly different between public and private settings other than more adequate mixing of the contents of primary collection tubes in private facilities. Conclusions: Most facilities did not achieve adequate quality standards in phlebotomy. In procedural manuals, training materials and practices for Phlebotomists, greater emphasis should be placed on presenting information on possible sources of error and on the correct implementation of procedures that ensure the quality of diagnostic blood specimens collected for laboratory analysis.

Giuseppe Lippi - One of the best experts on this subject based on the ideXlab platform.

  • quality management of preanalytical phase impact of lithium heparin vacuum tubes changes on clinical chemistry tests
    Accreditation and Quality Assurance, 2013
    Co-Authors: Gian Luca Salvagno, Martina Montagnana, Gian Cesare Guidi, Giuseppe Lippi, Geraldo Picheth, G Brocco, Monica Voi
    Abstract:

    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.

  • The effective reduction of tourniquet application time after minor modification of the CLSI H03-A6 blood collection procedure
    'Croatian Society for Medical Biochemistry and Laboratory Medicine', 2013
    Co-Authors: Gabriel Lima-oliveira, Martina Montagnana, Gian Luca Salvagno, Giuseppe Lippi, Geraldo Picheth, Gian Cesare Guidi
    Abstract:

    Introduction: The Phlebotomists’ procedures are a still source of laboratory variability. The aim of this study was to verify the efficacy of minor modification in procedure for collection of diagnostic blood specimens by venipuncture from CLSI H03-A6 document is able to reduce the tourniquet application time. Materials and methods: Thirty Phlebotomists were invited to participate. Each Phlebotomist was trained individually to perform the new venipuncture procedure that shortens the time of tourniquet release and removal. The phlebotomy training program was delivered over 8h. After training, all Phlebotomists were monitored for 20 working days, to guarantee the adoption of the correct new procedures for collection of diagnostic blood specimens. After this time frame the Phlebotomists were evaluated to verify whether the new procedure for blood collection derived from CLSI H03-A6 document was effective to improve the quality process by decrease in tourniquet application time. We compared the tourniquet application time and qualitative difference of phlebotomy procedures between laboratories before and after phlebotomy training. Results: The overall mean ± SD tourniquet application time before and after this intervention were 118 ± 1 s and 30 ± 1 s respectively. Minor modifications in procedure for blood collection were able to reduce significantly the tourniquet application time (-88 s, P < 0.001). Conclusions: The minor modifications in procedure for collection of diagnostic blood specimens by venipuncture from CLSI H03-A6 document were able to reduce the tourniquet application time. Now the proposed new procedure for collection of diagnostic blood specimens by venipuncture could be considered usefulness and should be put into practice by all quality laboratory managers and/or phlebotomy coordinators to avoid preanalytical errors regard venous stasis and guarantee patient safety

  • impact of the phlebotomy training based on clsi nccls h03 a6 procedures for the collection of diagnostic blood specimens by venipuncture
    Biochemia Medica, 2012
    Co-Authors: Giuseppe Lippi, Martina Montagnana, Gian Luca Salvagno, Geraldo Picheth, Gian Cesare Guidi
    Abstract:

    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.

  • is phlebotomy part of the dark side in the clinical laboratory struggle for quality
    Labmedicine, 2012
    Co-Authors: Gabriel Limaoliveira, Martina Montagnana, Gian Luca Salvagno, Gian Cesare Guidi, Giuseppe Lippi, Fabiane Gomes De Moraes Rego, Geraldo Picheth
    Abstract:

    Objective: Blood collection is a critical part of the preanalytical phase of laboratory testing. Only a few procedures are evaluable for detecting errors in this non-automatic activity. Information about potential sources of error is frequently absent from quality-control procedures and training materials. Objective: To evaluate the performance of Phlebotomists and to identify the major sources of errors during diagnostic blood collection. Methods: We evaluated the performance of 3 Phlebotomists each from 10 laboratories regarding tourniquet time, request for fist clenching, excessive friction during skin cleaning, sequence of vacuum-tube usage, and mixing of tube contents after specimen collection. The total number of these laboratories represented an equal number of private (ie, owned by private parties) and public (ie, administration by government organizations) settings. Results: An error rate of greater than 60% was observed in the performance of procedures we examined, and the error rate was not significantly different between public and private settings other than more adequate mixing of the contents of primary collection tubes in private facilities. Conclusions: Most facilities did not achieve adequate quality standards in phlebotomy. In procedural manuals, training materials and practices for Phlebotomists, greater emphasis should be placed on presenting information on possible sources of error and on the correct implementation of procedures that ensure the quality of diagnostic blood specimens collected for laboratory analysis.

  • K(3)EDTA Vacuum Tubes Validation for Routine Hematological Testing.
    International Scholarly Research Notices, 2012
    Co-Authors: Gabriel Lima-oliveira, Martina Montagnana, Gian Luca Salvagno, Giuseppe Lippi, Giovanni Poli, Giovanni Pietro Solero, Geraldo Picheth, Gian Cesare Guidi
    Abstract:

    Background and Objective. Some in vitro diagnostic devices (e.g, blood collection vacuum tubes and syringes for blood analyses) are not validated before the quality laboratory managers decide to start using or to change the brand. Frequently, the laboratory or hospital managers select the vacuum tubes for blood collection based on cost considerations or on relevance of a brand. The aim of this study was to validate two dry K3EDTA vacuum tubes of different brands for routine hematological testing. Methods. Blood specimens from 100 volunteers in two different K3EDTA vacuum tubes were collected by a single, expert Phlebotomist. The routine hematological testing was done on Advia 2120i hematology system. The significance of the differences between samples was assessed by paired Student's t-test after checking for normality. The level of statistical significance was set at P < 0.05. Results and Conclusions. Different brand's tubes evaluated can represent a clinically relevant source of variations only on mean platelet volume (MPV) and platelet distribution width (PDW). Basically, our validation will permit the laboratory or hospital managers to select the brand's vacuum tubes validated according to him/her technical or economical reasons for routine hematological tests.

Gian Luca Salvagno - One of the best experts on this subject based on the ideXlab platform.

  • quality management of preanalytical phase impact of lithium heparin vacuum tubes changes on clinical chemistry tests
    Accreditation and Quality Assurance, 2013
    Co-Authors: Gian Luca Salvagno, Martina Montagnana, Gian Cesare Guidi, Giuseppe Lippi, Geraldo Picheth, G Brocco, Monica Voi
    Abstract:

    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.

  • The effective reduction of tourniquet application time after minor modification of the CLSI H03-A6 blood collection procedure
    'Croatian Society for Medical Biochemistry and Laboratory Medicine', 2013
    Co-Authors: Gabriel Lima-oliveira, Martina Montagnana, Gian Luca Salvagno, Giuseppe Lippi, Geraldo Picheth, Gian Cesare Guidi
    Abstract:

    Introduction: The Phlebotomists’ procedures are a still source of laboratory variability. The aim of this study was to verify the efficacy of minor modification in procedure for collection of diagnostic blood specimens by venipuncture from CLSI H03-A6 document is able to reduce the tourniquet application time. Materials and methods: Thirty Phlebotomists were invited to participate. Each Phlebotomist was trained individually to perform the new venipuncture procedure that shortens the time of tourniquet release and removal. The phlebotomy training program was delivered over 8h. After training, all Phlebotomists were monitored for 20 working days, to guarantee the adoption of the correct new procedures for collection of diagnostic blood specimens. After this time frame the Phlebotomists were evaluated to verify whether the new procedure for blood collection derived from CLSI H03-A6 document was effective to improve the quality process by decrease in tourniquet application time. We compared the tourniquet application time and qualitative difference of phlebotomy procedures between laboratories before and after phlebotomy training. Results: The overall mean ± SD tourniquet application time before and after this intervention were 118 ± 1 s and 30 ± 1 s respectively. Minor modifications in procedure for blood collection were able to reduce significantly the tourniquet application time (-88 s, P < 0.001). Conclusions: The minor modifications in procedure for collection of diagnostic blood specimens by venipuncture from CLSI H03-A6 document were able to reduce the tourniquet application time. Now the proposed new procedure for collection of diagnostic blood specimens by venipuncture could be considered usefulness and should be put into practice by all quality laboratory managers and/or phlebotomy coordinators to avoid preanalytical errors regard venous stasis and guarantee patient safety

  • impact of the phlebotomy training based on clsi nccls h03 a6 procedures for the collection of diagnostic blood specimens by venipuncture
    Biochemia Medica, 2012
    Co-Authors: Giuseppe Lippi, Martina Montagnana, Gian Luca Salvagno, Geraldo Picheth, Gian Cesare Guidi
    Abstract:

    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.

  • is phlebotomy part of the dark side in the clinical laboratory struggle for quality
    Labmedicine, 2012
    Co-Authors: Gabriel Limaoliveira, Martina Montagnana, Gian Luca Salvagno, Gian Cesare Guidi, Giuseppe Lippi, Fabiane Gomes De Moraes Rego, Geraldo Picheth
    Abstract:

    Objective: Blood collection is a critical part of the preanalytical phase of laboratory testing. Only a few procedures are evaluable for detecting errors in this non-automatic activity. Information about potential sources of error is frequently absent from quality-control procedures and training materials. Objective: To evaluate the performance of Phlebotomists and to identify the major sources of errors during diagnostic blood collection. Methods: We evaluated the performance of 3 Phlebotomists each from 10 laboratories regarding tourniquet time, request for fist clenching, excessive friction during skin cleaning, sequence of vacuum-tube usage, and mixing of tube contents after specimen collection. The total number of these laboratories represented an equal number of private (ie, owned by private parties) and public (ie, administration by government organizations) settings. Results: An error rate of greater than 60% was observed in the performance of procedures we examined, and the error rate was not significantly different between public and private settings other than more adequate mixing of the contents of primary collection tubes in private facilities. Conclusions: Most facilities did not achieve adequate quality standards in phlebotomy. In procedural manuals, training materials and practices for Phlebotomists, greater emphasis should be placed on presenting information on possible sources of error and on the correct implementation of procedures that ensure the quality of diagnostic blood specimens collected for laboratory analysis.

  • K(3)EDTA Vacuum Tubes Validation for Routine Hematological Testing.
    International Scholarly Research Notices, 2012
    Co-Authors: Gabriel Lima-oliveira, Martina Montagnana, Gian Luca Salvagno, Giuseppe Lippi, Giovanni Poli, Giovanni Pietro Solero, Geraldo Picheth, Gian Cesare Guidi
    Abstract:

    Background and Objective. Some in vitro diagnostic devices (e.g, blood collection vacuum tubes and syringes for blood analyses) are not validated before the quality laboratory managers decide to start using or to change the brand. Frequently, the laboratory or hospital managers select the vacuum tubes for blood collection based on cost considerations or on relevance of a brand. The aim of this study was to validate two dry K3EDTA vacuum tubes of different brands for routine hematological testing. Methods. Blood specimens from 100 volunteers in two different K3EDTA vacuum tubes were collected by a single, expert Phlebotomist. The routine hematological testing was done on Advia 2120i hematology system. The significance of the differences between samples was assessed by paired Student's t-test after checking for normality. The level of statistical significance was set at P < 0.05. Results and Conclusions. Different brand's tubes evaluated can represent a clinically relevant source of variations only on mean platelet volume (MPV) and platelet distribution width (PDW). Basically, our validation will permit the laboratory or hospital managers to select the brand's vacuum tubes validated according to him/her technical or economical reasons for routine hematological tests.

Geraldo Picheth - One of the best experts on this subject based on the ideXlab platform.

  • doi:10.5402/2012/875357 Research Article K3EDTA Vacuum Tubes Validation for Routine
    2016
    Co-Authors: Isrn Hematology, Geraldo Picheth, Gabriel Lima-oliveira, Hematological Testing, Gian Cesare Guidi
    Abstract:

    Copyright © 2012 Gabriel Lima-Oliveira et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Background and Objective. Some in vitro diagnostic devices (e.g, blood collection vacuum tubes and syringes for blood analyses) are not validated before the quality laboratory managers decide to start using or to change the brand. Frequently, the laboratory or hospital managers select the vacuum tubes for blood collection based on cost considerations or on relevance of a brand. The aim of this study was to validate two dry K3EDTA vacuum tubes of different brands for routine hematological testing. Methods. Blood specimens from 100 volunteers in two different K3EDTA vacuum tubes were collected by a single, expert Phlebotomist. The routine hematological testing was done on Advia 2120i hematology system. The significance of the differences between samples was assessed by paired Student’s t-test after checking for normality. The level of statistical significance was set at P < 0.05. Results and Conclusions. Different brand’s tubes evaluated can represent a clinically relevant source of variations only on mean platele

  • quality management of preanalytical phase impact of lithium heparin vacuum tubes changes on clinical chemistry tests
    Accreditation and Quality Assurance, 2013
    Co-Authors: Gian Luca Salvagno, Martina Montagnana, Gian Cesare Guidi, Giuseppe Lippi, Geraldo Picheth, G Brocco, Monica Voi
    Abstract:

    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.

  • The effective reduction of tourniquet application time after minor modification of the CLSI H03-A6 blood collection procedure
    'Croatian Society for Medical Biochemistry and Laboratory Medicine', 2013
    Co-Authors: Gabriel Lima-oliveira, Martina Montagnana, Gian Luca Salvagno, Giuseppe Lippi, Geraldo Picheth, Gian Cesare Guidi
    Abstract:

    Introduction: The Phlebotomists’ procedures are a still source of laboratory variability. The aim of this study was to verify the efficacy of minor modification in procedure for collection of diagnostic blood specimens by venipuncture from CLSI H03-A6 document is able to reduce the tourniquet application time. Materials and methods: Thirty Phlebotomists were invited to participate. Each Phlebotomist was trained individually to perform the new venipuncture procedure that shortens the time of tourniquet release and removal. The phlebotomy training program was delivered over 8h. After training, all Phlebotomists were monitored for 20 working days, to guarantee the adoption of the correct new procedures for collection of diagnostic blood specimens. After this time frame the Phlebotomists were evaluated to verify whether the new procedure for blood collection derived from CLSI H03-A6 document was effective to improve the quality process by decrease in tourniquet application time. We compared the tourniquet application time and qualitative difference of phlebotomy procedures between laboratories before and after phlebotomy training. Results: The overall mean ± SD tourniquet application time before and after this intervention were 118 ± 1 s and 30 ± 1 s respectively. Minor modifications in procedure for blood collection were able to reduce significantly the tourniquet application time (-88 s, P < 0.001). Conclusions: The minor modifications in procedure for collection of diagnostic blood specimens by venipuncture from CLSI H03-A6 document were able to reduce the tourniquet application time. Now the proposed new procedure for collection of diagnostic blood specimens by venipuncture could be considered usefulness and should be put into practice by all quality laboratory managers and/or phlebotomy coordinators to avoid preanalytical errors regard venous stasis and guarantee patient safety

  • impact of the phlebotomy training based on clsi nccls h03 a6 procedures for the collection of diagnostic blood specimens by venipuncture
    Biochemia Medica, 2012
    Co-Authors: Giuseppe Lippi, Martina Montagnana, Gian Luca Salvagno, Geraldo Picheth, Gian Cesare Guidi
    Abstract:

    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.

  • is phlebotomy part of the dark side in the clinical laboratory struggle for quality
    Labmedicine, 2012
    Co-Authors: Gabriel Limaoliveira, Martina Montagnana, Gian Luca Salvagno, Gian Cesare Guidi, Giuseppe Lippi, Fabiane Gomes De Moraes Rego, Geraldo Picheth
    Abstract:

    Objective: Blood collection is a critical part of the preanalytical phase of laboratory testing. Only a few procedures are evaluable for detecting errors in this non-automatic activity. Information about potential sources of error is frequently absent from quality-control procedures and training materials. Objective: To evaluate the performance of Phlebotomists and to identify the major sources of errors during diagnostic blood collection. Methods: We evaluated the performance of 3 Phlebotomists each from 10 laboratories regarding tourniquet time, request for fist clenching, excessive friction during skin cleaning, sequence of vacuum-tube usage, and mixing of tube contents after specimen collection. The total number of these laboratories represented an equal number of private (ie, owned by private parties) and public (ie, administration by government organizations) settings. Results: An error rate of greater than 60% was observed in the performance of procedures we examined, and the error rate was not significantly different between public and private settings other than more adequate mixing of the contents of primary collection tubes in private facilities. Conclusions: Most facilities did not achieve adequate quality standards in phlebotomy. In procedural manuals, training materials and practices for Phlebotomists, greater emphasis should be placed on presenting information on possible sources of error and on the correct implementation of procedures that ensure the quality of diagnostic blood specimens collected for laboratory analysis.

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  • quality management of preanalytical phase impact of lithium heparin vacuum tubes changes on clinical chemistry tests
    Accreditation and Quality Assurance, 2013
    Co-Authors: Gian Luca Salvagno, Martina Montagnana, Gian Cesare Guidi, Giuseppe Lippi, Geraldo Picheth, G Brocco, Monica Voi
    Abstract:

    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.

  • The effective reduction of tourniquet application time after minor modification of the CLSI H03-A6 blood collection procedure
    'Croatian Society for Medical Biochemistry and Laboratory Medicine', 2013
    Co-Authors: Gabriel Lima-oliveira, Martina Montagnana, Gian Luca Salvagno, Giuseppe Lippi, Geraldo Picheth, Gian Cesare Guidi
    Abstract:

    Introduction: The Phlebotomists’ procedures are a still source of laboratory variability. The aim of this study was to verify the efficacy of minor modification in procedure for collection of diagnostic blood specimens by venipuncture from CLSI H03-A6 document is able to reduce the tourniquet application time. Materials and methods: Thirty Phlebotomists were invited to participate. Each Phlebotomist was trained individually to perform the new venipuncture procedure that shortens the time of tourniquet release and removal. The phlebotomy training program was delivered over 8h. After training, all Phlebotomists were monitored for 20 working days, to guarantee the adoption of the correct new procedures for collection of diagnostic blood specimens. After this time frame the Phlebotomists were evaluated to verify whether the new procedure for blood collection derived from CLSI H03-A6 document was effective to improve the quality process by decrease in tourniquet application time. We compared the tourniquet application time and qualitative difference of phlebotomy procedures between laboratories before and after phlebotomy training. Results: The overall mean ± SD tourniquet application time before and after this intervention were 118 ± 1 s and 30 ± 1 s respectively. Minor modifications in procedure for blood collection were able to reduce significantly the tourniquet application time (-88 s, P < 0.001). Conclusions: The minor modifications in procedure for collection of diagnostic blood specimens by venipuncture from CLSI H03-A6 document were able to reduce the tourniquet application time. Now the proposed new procedure for collection of diagnostic blood specimens by venipuncture could be considered usefulness and should be put into practice by all quality laboratory managers and/or phlebotomy coordinators to avoid preanalytical errors regard venous stasis and guarantee patient safety

  • impact of the phlebotomy training based on clsi nccls h03 a6 procedures for the collection of diagnostic blood specimens by venipuncture
    Biochemia Medica, 2012
    Co-Authors: Giuseppe Lippi, Martina Montagnana, Gian Luca Salvagno, Geraldo Picheth, Gian Cesare Guidi
    Abstract:

    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.

  • is phlebotomy part of the dark side in the clinical laboratory struggle for quality
    Labmedicine, 2012
    Co-Authors: Gabriel Limaoliveira, Martina Montagnana, Gian Luca Salvagno, Gian Cesare Guidi, Giuseppe Lippi, Fabiane Gomes De Moraes Rego, Geraldo Picheth
    Abstract:

    Objective: Blood collection is a critical part of the preanalytical phase of laboratory testing. Only a few procedures are evaluable for detecting errors in this non-automatic activity. Information about potential sources of error is frequently absent from quality-control procedures and training materials. Objective: To evaluate the performance of Phlebotomists and to identify the major sources of errors during diagnostic blood collection. Methods: We evaluated the performance of 3 Phlebotomists each from 10 laboratories regarding tourniquet time, request for fist clenching, excessive friction during skin cleaning, sequence of vacuum-tube usage, and mixing of tube contents after specimen collection. The total number of these laboratories represented an equal number of private (ie, owned by private parties) and public (ie, administration by government organizations) settings. Results: An error rate of greater than 60% was observed in the performance of procedures we examined, and the error rate was not significantly different between public and private settings other than more adequate mixing of the contents of primary collection tubes in private facilities. Conclusions: Most facilities did not achieve adequate quality standards in phlebotomy. In procedural manuals, training materials and practices for Phlebotomists, greater emphasis should be placed on presenting information on possible sources of error and on the correct implementation of procedures that ensure the quality of diagnostic blood specimens collected for laboratory analysis.

  • K(3)EDTA Vacuum Tubes Validation for Routine Hematological Testing.
    International Scholarly Research Notices, 2012
    Co-Authors: Gabriel Lima-oliveira, Martina Montagnana, Gian Luca Salvagno, Giuseppe Lippi, Giovanni Poli, Giovanni Pietro Solero, Geraldo Picheth, Gian Cesare Guidi
    Abstract:

    Background and Objective. Some in vitro diagnostic devices (e.g, blood collection vacuum tubes and syringes for blood analyses) are not validated before the quality laboratory managers decide to start using or to change the brand. Frequently, the laboratory or hospital managers select the vacuum tubes for blood collection based on cost considerations or on relevance of a brand. The aim of this study was to validate two dry K3EDTA vacuum tubes of different brands for routine hematological testing. Methods. Blood specimens from 100 volunteers in two different K3EDTA vacuum tubes were collected by a single, expert Phlebotomist. The routine hematological testing was done on Advia 2120i hematology system. The significance of the differences between samples was assessed by paired Student's t-test after checking for normality. The level of statistical significance was set at P < 0.05. Results and Conclusions. Different brand's tubes evaluated can represent a clinically relevant source of variations only on mean platelet volume (MPV) and platelet distribution width (PDW). Basically, our validation will permit the laboratory or hospital managers to select the brand's vacuum tubes validated according to him/her technical or economical reasons for routine hematological tests.