Reduction of gross hemolysis in catheter-drawn blood using Greiner Holdex® tube holder

Introduction: Blood collection through intravenous lines frequently causes spurious hemolysis. Due to specific structure, the tube holder Holdex® (Greiner Bio-One GmbH, Kremsmuenster, Austria) is supposed to prevent erythrocyte injury in samples collected from catheters, so that we planned a specific study to support this hypothesis. Materials and methods: Blood was collected from emergency department (ED) patients with 20-gauge catheter. In patients with odd order numbers, first and second tubes were collected with conventional holder (BD Vacutainer One Use Holder, Becton Dickinson, Milan, Italy) and the third with Holdex, whereas in even patients first and second tubes were drawn with Holdex and the third using BD Vacutainer One Use Holder. The first tube was discarded, whereas the second and third were centrifuged and serum was tested for potassium, lactate dehydrogenase (LD) and hemolysis index. Results: The final study population consisted in 60 ED patients. Concentrations of potassium (4.25 vs. 4.16 mmol/L; P = 0.031), LD (498 vs. 459 U/L; P = 0.039) and cell-free hemoglobin (0.42 vs. 0.22 g/L; P = 0.042) were higher in samples collected with BD Vacutainer One Use Holder than with Holdex. The mean bias of cell-free hemoglobin was -0.4 g/L in samples collected with Holdex. Although the frequency of samples with cell-free hemoglobin > 0.5 g/L was identical (17/60 vs. 17/60; P = 1.00), the frequency of those with concentrations >3.0 g/L was higher using BD Vacutainer One Use Holder than Holdex (4/60 vs. 0/60; P = 0.042). Conclusions: The use of Holdex for drawing blood from intravenous lines may be effective for reducing gross hemolysis

Reduction of burden of hemolyzed specimens in a large urban emergency department: A real-world, five years’ experience

In vitro hemolysis may jeopardize patient care because tests results generated using unsuitable specimens may lead to inappropriate patient management. The prevalence of hemolyzed specimens is high in the emergency department (ED). We previously showed that collecting blood by means of a closed system entailing manual aspiration of blood instead of using conventional evacuated systems was effective to cut-down by nearly half the rate of hemolysis. Aim of this real world study was to verify whether longterm replacement of standard evacuated blood collection systems may be really effective to reduce the burden of spurious hemolysis. Starting from May 2014 in the ED of our Hospital vacuum tubes were replaced with S-Monovette serum tubes. We compared data about hemolyzed specimens entered in the two years before the implementation of the new device (i.e., 2012 and 2013) and the two years after introducing SMonovette in manual aspiration mode (i.e. 2015 and 2016). The year 2014 was not considered due to mixed data. The rate of hemolyzed specimens decreased from 4.36% to 3.07% with the use of S-Monovette in manual aspiration mode (Chi squared, 183.8; P<0.001). The likelihood of obtaining hemolyzed specimens was hence reduced by approximately 30% (relative risk, 0.707), with an expected economic saving of approximately 510€/year. The results of this real-world study demonstrate that the use of an alternative closed device encompassing manual aspiration for drawing blood from intravenous catheters may reduce hemolyzed samples by approximately 30%, so representing a valuable perspective for safeguarding patient safety and improving ED efficiency

Non-commutability of results of highly sensitive troponin I and T immunoassays

Introduction: The measurement of cardiospecific troponins is pivotal in the diagnostic and prognostic approach of patients with suspected acute myocardial infarction (AMI). However, no information is available on the commutability of results between the novel highly-sensitive (HS) troponin T (TnT) and I (TnI) immunoassays. Materials and methods: The study population consisted in 47 consecutive patients presenting at the emergency department (ED) of the Academic Hospital of Parma with suspected AMI. TnI was measu-red with the novel prototype Beckman Coulter HS-AccuTnI immunoassay on Access 2, whereas TnT was measured with the Roche HS-TnT immunoassay on Cobas. Results: Eight out of the 47 patients (17%) were finally diagnosed as having an AMI. The overall cor-relation between TnT and TnI for total patient group was acceptable (r = 0.944; P < 0.01). Neverthe-less, when the analysis of data was carried out in separate groups according to the final diagnosis of AMI, two different equation results were obtained, i.e., HS-TnT = HS-AccuTnI x 0.349 + 20 (r = 0.823; P < 0.01) in non-AMI patients, and HS-TnT = HS-AccuTnI x 0.134 + 67 (r = 0.972; P < 0.01) in those with AMI. Conclusions: This study suggests the existence of two biological relationships between TnI and TnT in plasma, depending on the source of release from the myocardium. Moreover, the non-commutability of data between HS-TnT and HS-AccuTnI jeopardizes the clinical decision making, makes it impossible to calculate the delta or reference change value using the two biomarkers and to finally establish a reliable kinetics of troponin release from the injured myocardium

Reduction of burden of hemolyzed specimens in a large urban emergency department: A real-world, five years' experience

In vitro hemolysis may jeopardize patient care because tests results generated using unsuitable specimens may lead to inappropriate patient management. The prevalence of hemolyzed specimens is high in the emergency department (ED). We previously showed that collecting blood by means of a closed system entailing manual aspiration of blood instead of using conventional evacuated systems was effective to cut-down by nearly half the rate of hemolysis. Aim of this real world study was to verify whether longterm replacement of standard evacuated blood collection systems may be really effective to reduce the burden of spurious hemolysis. Starting from May 2014 in the ED of our Hospital vacuum tubes were replaced with S-Monovette serum tubes. We compared data about hemolyzed specimens entered in the two years before the implementation of the new device (i.e., 2012 and 2013) and the two years after introducing SMonovette in manual aspiration mode (i.e. 2015 and 2016). The year 2014 was not considered due to mixed data. The rate of hemolyzed specimens decreased from 4.36% to 3.07% with the use of S-Monovette in manual aspiration mode (Chi squared, 183.8; P<0.001). The likelihood of obtaining hemolyzed specimens was hence reduced by approximately 30% (relative risk, 0.707), with an expected economic saving of approximately 510€/year. The results of this real-world study demonstrate that the use of an alternative closed device encompassing manual aspiration for drawing blood from intravenous catheters may reduce hemolyzed samples by approximately 30%, so representing a valuable perspective for safeguarding patient safety and improving ED efficiency

Analytical evaluation of Diazyme procalcitonin (PCT) latex-enhanced immunoturbidimetric assay on Beckman Coulter AU5800

Abstract Background: This study was aimed to evaluate the analytical performance of the novel Diazyme procalcitonin (PCT) immunoturbidimetric assay on Beckman Coulter AU5800. Methods: Diazyme PCT is a latex-enhanced immunoturbidimetric assay, developed for use on laboratory instrumentations with capability of reading absorbance at 600 nm. This analytical evaluation included the assessment of limit of blank (LOB), limit of detection (LOD), functional sensitivity, imprecision, linearity, carryover, and method comparison between Diazyme PCT and Kryptor PCT on 129 routine serum inpatient samples. Results: The LOB, LOD, and functional sensitivity of Diazyme PCT were 0.16, 0.26, and 0.28 ng/mL, respectively. The intra-and inter-assay imprecision of Diazyme PCT was between 2.9% and 7.8%. The linearity was excellent in the range of PCT values between 0.16 and 56 ng/mL, and the carryover was negligible (0.02%). A highly significant agreement was found between Kryptor PCT and Diazyme PCT in a range of concentrations between 0.16 and 111 ng/mL (Diazyme PCT = 1.10 × Kryptor PCT -0.89; r = 0.960; p &lt; 0.001). The mean bias was 0.48 ng/mL (95% CI, -0.58 to 1.54 ng/mL). The strength of agreement between Kryptor PCT and Diazyme PCT was between 85% and 96% at 0.50, 2.0, and 10 ng/mL cutoffs

Evaluation of sample hemolysis in blood collected by S-Monovette® using vacuum or aspiration mode

Background: In vitro hemolysis can be induced by several biological and technical sources, and may be worsened by forced aspiration of blood in vacuum tubes. This study was aimed to compare the probability of hemolysis by drawing blood with a commercial evacuated blood collection tube, and S-Monovette used either in the “vacuum” or “aspiration” mode. Materials and methods: The study population consisted in 20 healthy volunteers. A sample was drawn into 4.0 mL BD Vacutainer serum tube from a vein of one upper arm. Two other samples were drawn with a second venipuncture from a vein of the opposite arm, into 4.0 mL S-Monovette serum tubes, by both vacuum an aspiration modes. After separation, serum potassium, lactate dehydrogenase (LD) and hemolysis index (HI) were tested on Beckman Coulter DxC. Results: In no case the HI exceed the limit of significant hemolysis. As compared with BD Vacutainer, no significant differences were observed for potassium and LD using S-Monovette with vacuum method. Significant increased values of both parameters were however found in serum collected into BD Vacutainer and S-Monovette by vacuum mode, compared to serum drawn by S-Monovette in aspiration mode. The mean potassium bias was 2.2% versus BD Vacutainer and 2.4% versus S-Monovette in vacuum mode, that of LD was 2.7% versus BD Vacutainer and 2.1% versus S-Monovette in vacuum mode. None of these variations exceeded the allowable total error. Conclusions: Although no significant macro-hemolysis was observed with any collection system, the less chance of producing micro-hemolysis by S-Monovette in aspiration mode suggest that this device may be used when a difficult venipuncture combined with the vacuum may increase the probability of spurious hemolysis

Development of a preanalytical errors recording software

Uvod: Iako je doprinos laboratorijskoj dijagnostici od integralne važnosti u procesu donošenja kliničkih odluka, kvaliteta rada i sigurnost tijekom dijagnostičkih analiza od ključnog su značaja za unaprjeđenje zdravstvene zaštite koja je na visokom stupnju što se kvalitete i sigurnosti tiče. Unatoč izvanrednom napretku u kvaliteti cjelokupnog procesa laboratorijske analize, prijeanalitička varijabilnost predstavlja vodeći izvor pogrešaka i nesigurnosti. Uvođenje sistematične politike bilježenja prijeanalitičkih pogrešaka uvelike bi poboljšala definiranje ključnih aktivnosti tog procesa, planiranje i praćenje učinkovitih radnji s ciljem poboljšanja cjelokupnog procesa. U ovom članku želimo dati opis kompjuterskog programa razvijenog za bilježenje prijeanalitičkih pogrešaka u našem laboratoriju. Materijali i metode: Naš smo program razvili na temelju Microsoftovog programa Access. Glavna polja uključena u program obuhvaćala su brojač za progresivno brojanje uzoraka, datum primitka uzorka, identifikacijski broj uzorka, ime bolesnika, tip pretrage, odjel s kojeg je bolesnik upućen, matriks uzorka, tip nesukladnosti, radnja koja je poduzeta kako bi se riješio problem, drugo polje za moguće radnje koje su dodatno poduzete, identifikacijski broj operatera. Baza podataka nalazi se na središnjem računalu unutar našeg laboratorijskog informatičkog sistema, tako da se do nje može doći s bilo kojeg računala u laboratoriju, što omogućuje kontinuirani i standardizirani unos podataka. Rezultati i rasprava: Uvođenje kompjuterskog programa za sistematično bilježenje prijeanalitičkih pogrešaka donosi velika poboljšanja, kao što su harmonizacija protokola za bilježenje incidenata, jednostavnost digitalnog bilježenja, eliminaciju rukom pisanih izvješća, uključivanje mjera učinkovitosti ključnih segmenata laboratorijskog rada, jednostavna prilagodba korisniku (laboratoriju), korištenje tablica s podacima za opsežne statističke analize, poboljšano pretraživanje i obrada podataka kao i poboljšana izrada statističkih izvješća.Background: Although the contribution of laboratory diagnostics is integral to the clinical decision making, quality and safety in diagnostic testing are essential to furthering the goal of high-quality and safe healthcare. Despite remarkable advances in the quality of the total testing process, the preanalytical variability is the leading source of errors and uncertainty. As such, the implementation of a systematic policy for recording preanalytical errors would grant major benefits for identifying critical activities of this process, planning and monitoring effective actions for improvement. The aim of this article is to describe the software developed for the recording of preanalytical errors in our laboratory. Materials and methods: We have developed error recording software based on Microsoft Access. The main fields included in the software comprehend a numerator for progressive enumeration of the samples, the date of receipt of the specimen, the Sample ID, the patient\u27s name, the type of request, the referring ward, sample matrix, the type of non-conformity, the action undertaken to solve the problem, a second field for possible additional actions undertaken, and the operator ID. The database is stored on a common repository in our laboratory information system, so that it can be accessed by any computer in the laboratory, allowing continuous and standardized input of the data. Results and discussion: The implementation of a software for systematical recording of preanalytical errors grants major benefits, including harmonization of incident reporting practices, simplicity of digital recording, elimination of handwritten reports, inclusion of validated measures of laboratory performance, handily customization, exportation on worksheets for comprehensive statistical analyses, improved data searching and processing, as well as production of improved statistical reports

Non-commutability of results of highly sensitive troponin I and T immunoassays

Introduction: The measurement of cardiospecific troponins is pivotal in the diagnostic and prognostic approach of patients with suspected acute myocardial infarction (AMI). However, no information is available on the commutability of results between the novel highly-sensitive (HS) troponin T (TnT) and I (TnI) immunoassays. Materials and methods: The study population consisted in 47 consecutive patients presenting at the emergency department (ED) of the Academic Hospital of Parma with suspected AMI. TnI was measu-red with the novel prototype Beckman Coulter HS-AccuTnI immunoassay on Access 2, whereas TnT was measured with the Roche HS-TnT immunoassay on Cobas. Results: Eight out of the 47 patients (17%) were finally diagnosed as having an AMI. The overall cor-relation between TnT and TnI for total patient group was acceptable (r = 0.944; P < 0.01). Neverthe-less, when the analysis of data was carried out in separate groups according to the final diagnosis of AMI, two different equation results were obtained, i.e., HS-TnT = HS-AccuTnI x 0.349 + 20 (r = 0.823; P < 0.01) in non-AMI patients, and HS-TnT = HS-AccuTnI x 0.134 + 67 (r = 0.972; P < 0.01) in those with AMI. Conclusions: This study suggests the existence of two biological relationships between TnI and TnT in plasma, depending on the source of release from the myocardium. Moreover, the non-commutability of data between HS-TnT and HS-AccuTnI jeopardizes the clinical decision making, makes it impossible to calculate the delta or reference change value using the two biomarkers and to finally establish a reliable kinetics of troponin release from the injured myocardium

Development of a preanalytical errors recording software

Uvod: Iako je doprinos laboratorijskoj dijagnostici od integralne važnosti u procesu donošenja kliničkih odluka, kvaliteta rada i sigurnost tijekom dijagnostičkih analiza od ključnog su značaja za unaprjeđenje zdravstvene zaštite koja je na visokom stupnju što se kvalitete i sigurnosti tiče. Unatoč izvanrednom napretku u kvaliteti cjelokupnog procesa laboratorijske analize, prijeanalitička varijabilnost predstavlja vodeći izvor pogrešaka i nesigurnosti. Uvođenje sistematične politike bilježenja prijeanalitičkih pogrešaka uvelike bi poboljšala definiranje ključnih aktivnosti tog procesa, planiranje i praćenje učinkovitih radnji s ciljem poboljšanja cjelokupnog procesa. U ovom članku želimo dati opis kompjuterskog programa razvijenog za bilježenje prijeanalitičkih pogrešaka u našem laboratoriju. Materijali i metode: Naš smo program razvili na temelju Microsoftovog programa Access. Glavna polja uključena u program obuhvaćala su brojač za progresivno brojanje uzoraka, datum primitka uzorka, identifikacijski broj uzorka, ime bolesnika, tip pretrage, odjel s kojeg je bolesnik upućen, matriks uzorka, tip nesukladnosti, radnja koja je poduzeta kako bi se riješio problem, drugo polje za moguće radnje koje su dodatno poduzete, identifikacijski broj operatera. Baza podataka nalazi se na središnjem računalu unutar našeg laboratorijskog informatičkog sistema, tako da se do nje može doći s bilo kojeg računala u laboratoriju, što omogućuje kontinuirani i standardizirani unos podataka. Rezultati i rasprava: Uvođenje kompjuterskog programa za sistematično bilježenje prijeanalitičkih pogrešaka donosi velika poboljšanja, kao što su harmonizacija protokola za bilježenje incidenata, jednostavnost digitalnog bilježenja, eliminaciju rukom pisanih izvješća, uključivanje mjera učinkovitosti ključnih segmenata laboratorijskog rada, jednostavna prilagodba korisniku (laboratoriju), korištenje tablica s podacima za opsežne statističke analize, poboljšano pretraživanje i obrada podataka kao i poboljšana izrada statističkih izvješća.Background: Although the contribution of laboratory diagnostics is integral to the clinical decision making, quality and safety in diagnostic testing are essential to furthering the goal of high-quality and safe healthcare. Despite remarkable advances in the quality of the total testing process, the preanalytical variability is the leading source of errors and uncertainty. As such, the implementation of a systematic policy for recording preanalytical errors would grant major benefits for identifying critical activities of this process, planning and monitoring effective actions for improvement. The aim of this article is to describe the software developed for the recording of preanalytical errors in our laboratory. Materials and methods: We have developed error recording software based on Microsoft Access. The main fields included in the software comprehend a numerator for progressive enumeration of the samples, the date of receipt of the specimen, the Sample ID, the patient\u27s name, the type of request, the referring ward, sample matrix, the type of non-conformity, the action undertaken to solve the problem, a second field for possible additional actions undertaken, and the operator ID. The database is stored on a common repository in our laboratory information system, so that it can be accessed by any computer in the laboratory, allowing continuous and standardized input of the data. Results and discussion: The implementation of a software for systematical recording of preanalytical errors grants major benefits, including harmonization of incident reporting practices, simplicity of digital recording, elimination of handwritten reports, inclusion of validated measures of laboratory performance, handily customization, exportation on worksheets for comprehensive statistical analyses, improved data searching and processing, as well as production of improved statistical reports

Studies on in vitro hemolysis and utility of corrective formulas for reporting results on hemolyzed specimens

Introduction: Spuriously hemolyzed specimens are the most common preanalytical problems in clini-cal laboratories. Corrective formulas have been proposed to allow the laboratory to release test re-sults on these specimens. This study aimed to assess the influence of spurious hemolysis and reliability of corrective formulas. Materials and methods: Blood collected into lithium heparin vacuum tubes was divided in aliquots and subjected to mechanical injury by aspiration with an insulin syringe equipped with a thin needle (30 gauge). Each aliquot (numbered from “#0” to “#5”) was subjected to a growing number of passa-ges through the needle, from 0 to 5 times. After hematological testing, plasma was separated by cen-trifugation and assayed for lactate dehydrogenase (LD), aspartate aminotransferase (AST), potassi-um and hemolysis index (HI). Results: Cell-free hemoglobin concentration gradually increased from aliquot #0 (HI: 0) to #5 (HI: 76±22, cell-free hemoglobin č 37.0 g/L). A highly significant inverse correlation was observed between HI and red blood cell count (RBC), hematocrit, mean corpuscular volume (MCV), LD, AST, potassium, whereas the correlation was negative with mean corpuscular hemoglobin (MCH). No cor-relation was found with hemoglobin, platelet count and glucose. A trend towards decrease was also observed for white blood cells count. The ANCOVA comparison of analyte-specific regression lines from the five subjects studied revealed significant differences for all parameters except potassium. In all circumstances the sy,x of these equations however exceeded the allowable clinical bias. Conclusions: Mechanical injury of blood, as it might arise from preanalytical problems, occurs dishomogeneously, so that corrective formulas are unreliable and likely misleading