The local technical validation of new plasma tube with a mechanical separator

BackgroundUnsuitable samples are common problem for laboratories. The blood collection tubes need to be validated or verified prior to their being used in the routine laboratory for reducing this situation.ObjectiveWe aim to compare the technical qualifications of routinely used BD Vacutainer® Serum Separator Tubes™ II Advance Plus with BD Vacutainer® Barricor™ LH Plasma Tubes for local technical validation.Materials and methodsApparently healthy 150 voluntary subjects were enrolled in the study. Samples were collected in two separated tubes by a single phlebotomist. Twelve quality indicators were used to compare these two different types of tubes for local technical validation. Differences (%) between them were calculated with the formula proposed by EFLM. In case of any difference of less than 1% for each indicator, the evaluated tube was considered as non-inferior.ResultsIndicators, such as tubes with physical defects, that fail to create vacuum, not properly fitting into the blood collection device, under filling (10%), cracked tubes, tubes exterior surface contaminated with blood, hemolysed specimens, including fibrin strand/mass in the sample, red blood cell adhesion, poor/incomplete barrier formation were found non-inferior in Barricor™ tubes. White particulate matter (WPM) was observed in 24.6% of Barricor™. Therefore, the last indicator (tubes including gel/foreign material/WPM in sample after centrifugation) was found inferior for Barricor™.ConclusionTechnical local validation studies should be encouraged in terms of quality management. It was thought that WPM would not cause any interference in a properly filled tube. In addition to, Barricor™ was also found to be technically acceptable when evaluated through using all other indicators.

Nonconformities in Veterinary Cytopathological Examinations: A Retrospective Study of Unsuitable Samples for Analysis

The aim of this study was to evaluate the main nonconformities that result in cytopathological samples inappropriate for diagnosis in veterinary medicine. All cytopathological samples, obtained from different canine and feline tissues/lesions, included in the study were received and classified as inconclusive by a single public laboratory of veterinary pathology, located in Pernambuco State, Brazil, between 2012 and 2016. Nonconformities regarding the smear quality, cellularity, presence or absence of hemorrhage, cellular overlapping, desiccation, and presence or absence of necrotic debris and/or artifacts were evaluated. Data were tabulated using Microsoft Excel 2007; absolute and relative frequencies were calculated using EPIINFO 3.5.2. From the 3268 cases received between 2012 and 2016, 190 cases were selected and comprised 514 inconclusive slides. The most frequent nonconformities detected were insufficient/absence of cellularity in 100% (514/514), inadequate submacroscopic presentation in 87% (446/514), and hemorrhage in 69% (356/514) of samples. Other features identified were cellular overlapping in 34% (175/514), inadequate staining in 31% (175/514), artifacts in 30% (154/514), desiccation in 28% (145/514), and necrotic debris in 26% (133/514) of samples. The implementation of laboratory standard operational procedures aimed at maintaining quality is essential. It is necessary to initially identify the main errors occurring in the processing stages as a way to guide and design strategies to avoid them.

Microbiological quality of colonial cheese sold in Porto Alegre-RS

Colonial cheese is a traditional dairy product in southern Brazil and is commonly purchased by the citizens of Porto Alegre. However, there is still a lack of technical regulation of colonial cheese, and there is little information about the microbiological quality of this product at the retail level. Thus, the objectives of this study were to (i) evaluate compliance with the legal microbiological standards of colonial cheese sampled from street fairs and the central market of the city of Porto Alegre; (ii) statistically test the hypothesis of an association between noncompliance with the standards and local purchasing (street fairs or central market); (iii) estimate the number of Listeria spp. and Listeria monocytogenes in the positive samples; and (iv) characterize the L. monocytogenes strains by serotyping and macrorestriction (PFGE). For this purpose, 205 cheese samples belonging to 17 different brands were analyzed. The microbiological analyses were conducted according to ISO standardized protocols for the detection of L. monocytogenes and Salmonella spp. or by enumeration of coagulase-positive Staphylococcus and coliforms at 45°C. Among the samples, 47.31% did not comply with at least one of the microbiological standards established by the Brazilian legislation and were thus unsuitable for human consumption. Regarding the coliforms at 45ºC and coagulase-positive Staphylococcus, 10.73% and 40.48% of the samples presented higher counts than the legal parameter, respectively. There was no association between the frequency of samples with coagulase-positive Staphylococcus counts above the legal parameter and local of purchasing; however, the commercial brand influenced the frequency of unsuitable samples. This may indicate failures of hygiene during cheese production. Salmonella spp. were not detected. Listeria monocytogenes was isolated from 2.9% of the samples. The estimated average populations of Listeria spp. and L. monocytogenes were low in the positive cheese samples at -3.3 log CFU g?1 and -2.26 log CFU g?¹, respectively. The strains of L. monocytogenes belonged to serovars 1/2a, 1/2b and 1/2c and could be grouped into five pulsotypes with no evident epidemiological relation among them. The results demonstrate the need to improve the hygiene procedures during colonial cheese production and to strengthen monitoring at the dairy plants and retail levels.

The EFLM strategy for harmonization of the preanalytical phase

The Working Group for the Preanalytical Phase (WG-PRE) was officially established by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) in 2013, with the aim of improving harmonization in the preanalytical phase across European member societies. Since its early birth, the WG-PRE has already completed a number of projects, including harmonizing the definition of fasting status, patient and blood tubes identification, color coding of blood collection tubes, sequence of tubes during blood drawing and participation in the development of suitable preanalytical quality indicators. The WG-PRE has also provided guidance on local validation of blood collection tubes, has performed two European surveys on blood sampling procedures and has organized four European meetings to promote the importance of quality in the preanalytical phase. The future activities entail development and validation of an external quality assessment scheme focused on preanalytical variables, development and dissemination of a survey about the local management of unsuitable samples in clinical laboratories, as well as release of EFLM phlebotomy guidelines. This article summarizes all recent achievements of the WG-PRE and illustrates future projects to promote harmonization in the preanalytical phase.

Recommendations for detection and management of unsuitable samples in clinical laboratories

A large body of evidence attests that quality programs developed around the analytical phase of the total testing process would only produce limited improvements, since the large majority of errors encountered in clinical laboratories still prevails within extra-analytical areas of testing, especially in manually intensive preanalytical processes. Most preanalytical errors result from system flaws and insufficient audit of the operators involved in specimen collection and handling responsibilities, leading to an unacceptable number of unsuitable specimens due to misidentification, in vitro hemolysis, clotting, inappropriate volume, wrong container or contamination from infusive routes. Detection and management of unsuitable samples are necessary to overcome this variability. The present document, issued by the Italian Inter-society SIBioC-SIMeL-CISMEL (Society of Clinical Biochemistry and Clinical Molecular Biology-Italian Society of Laboratory Medicine-Italian Committee for Standardization of Hematological and Laboratory Methods) Study Group on Extra-analytical Variability, reviews the major causes of unsuitable specimens in clinical laboratories, providing consensus recommendations for detection and management.Clin Chem Lab Med 2007;45:728–36.

Preanalytical variability in laboratory testing: influence of the blood drawing technique

The predominant technique used to draw blood for laboratory testing is a conventional straight needle attached to an evacuated tube system. However, alternative tools might be advantageous in exceptional circumstances. The use of butterfly devices has been traditionally discouraged for reasons of costs and due to the high risk of obtaining unsuitable samples, but there is no convincing evidence to support the latter indication. The purpose of this study was to compare results of hematological and clinical chemistry testing, after drawing blood into evacuated tubes, employing either a traditional 21-gauge straight needle or a 21-gauge butterfly device with 300-mm-grade polyvinyl chloride tubing. Blood samples and complete sets of data were successfully obtained for 30 consecutive outpatients. Of the 43 hematological and clinical chemistry parameters measured, means for paired samples collected by the two alternative drawing techniques did not differ significantly, except for serum sodium, white blood cells and platelets counts. Bland-Altman plots and limits-of-agreement analysis showed mean bias of between −7.2% and 1.7% and relative coefficients of variation ranging from 0.2% to 21.2%. The 95% agreement interval in the set of differences was acceptable and was mostly within the current analytical quality specifications for desirable bias. The rate of hemolysis in plasma was not statistically different between the two collection techniques. Taken together, the results of the present investigation suggest that, when a proper technique is used and within certain limitations, the butterfly device may be a reliable alternative to the conventional straight needle to draw blood for laboratory testing.

Determination of Total Dietary Fiber in Japanese Foods

Total dietary fiber was determined In Japanese foods by the Prosky-AOAC method. To accomplish the analyses of unsuitable samples, we Introduced a few minor modifications to the versions for (I) seaweed and fruits, (II) cereals, and (ill) fish and meats. These modified methods were used together with the standard method to obtain results with reasonably good relative standard deviation for 231 foods and 21 groups of mixed foods. In this study, dietary fiber was defined so as not to exclude the nondlgestlble polysaccharide portions of animal foods. A method was proposed which could estimate more accurately the fiber components of animal foods by measuring the "nondlgestlble protein" of the fiber sample by the Biuret colorimetric method, Instead of the Kjeldahl method, to avoid deducting the values for aminopolysaccharides. In Japanese diets, the amount of fiber obtained from animal foods was less than 5 % of the total Intake of dietary fiber.