The samples are received or rejected by the staff working in the sample reception unit. However, the latter requires simulation studies, so that for Passing-Bablok method it is suitable to use summarized results in tables available through original papers. The number of the rejected samples registered in the LIS was also determined for the same observation week so the observation period results could be compared with the LIS data. The present study shows the lack of comparability of the observation period and LIS data. government site. The total number of tubes, the number of errors, and the rejections rates are shown in Table Table4.4. 8 Barak . Should they? Carraro P, Zago T, Plebani M. The prevalence of pre-analytical errors in the laboratory of the Cantonal Hospital Zenica in Bosnia and Herzegovina. Laboratory Medicine Curriculum Clinical Laboratory - Fundamentals Preanalytical, Analytical and Postanalytical Variables Preanalytical, Analytical, and Postanalytical Variables Affecting Error: Variability with Phlebotomy; and Patient Identification These are errors that occur due to patient misidentification, improper sample, improper sample handling and the amount of . FOIA Application of the Bland-Altman plot for interpretation of method-comparison studies: a critical investigation of its practice. Simundic et al. Calculating and reporting effect sizes to facilitate cumulative science: a practical primer for t-tests and ANOVAs. Random variation and systematic error caused by various preanalytical variables, estimated by linear mixed-effects models. Pre-analytical errors. Results: There was a reduction in all types of preanalytical sample errors related to the improvement strategies adopted. Fibrin was seen in six of the gel tubes. It can handle both effects that can be experimentally replicated and have the same size for all tested subjects (namely fixed, like two different bore sizes or different stasis duration), and effects that lay outside the experimental control and have a certain variability (namely random, like the homeostatic point of each subject in the study) (66, 68). General recommendations of scientific writing are considered mandatorily applied to these studies (7). Inclusion in an NLM database does not imply endorsement of, or agreement with, venous stasis was induced applying an elastic tourniquet at 5 cm above the site of insertion, inducing an equivalent pressure to 60 mmHg, holding in place for 1 minute after 21G needle insertion instead of samples were collected after venous stasis was induced). Ottomano C. Pre-analytical workstations: a tool for reducing laboratory errors. For the hemolyzed sample, the incorrect fill volume and the clotted sample error types p-values were <0.05, while for the misidentification error, inappropriate tube and erroneous request significance value were >0.05. Federal government websites often end in .gov or .mil. The site is secure. Epub 2017 Mar 7. sharing sensitive information, make sure youre on a federal Federal government websites often end in .gov or .mil. Actually, this means attaining the unity in the methodological paradigm to achieve effectiveness, with a concise, consistent and efficient production of cumulative knowledge (96). Then, substituting for the adjusted testwise in Eq.2.1, it is possible to obtain the deflated experimentwise . In 4 papers (0.11) the authors used linear models to analyse their data, which were represented by parametric or non-parametric (Friedmans) 1-way ANOVA, or in 1 single case (0.03) by a linear mixed effect model (LMEM). Majid A, Heaney DC, Padmanabhan N, Spooner R. The order of draw of blood specimens into additive containing tubes not affect potassium and calcium measurements. LIS:laboratory information system; n: number; a: p value <0.05. Alcohol used as disinfectant before venipuncture does not lead to sample haemolysis or sample dilution. Falagas ME, Pitsouni EI, Malietzis GA, Pappas G. Comparison of PubMed, Scopus, Web of Science, and Google Scholar: strengths and weaknesses. 2016 Oct;146(4):456-61. doi: 10.1093/ajcp/aqw139. If CVI is the within-subject biological variability and CVA the method imprecision, then the RCV can be computed according to the formula (82): Where z is a constant for the level of statistical confidence (1.96 for = 0.05). It also describes strategies and tools available to detect pre-analytical errors and reduce sample rejection. Utilization of a healthcare failure mode and effects analysis to identify error sources in the preanalytical phase in two tertiary hospital laboratories. observed the pre-preanalytical period in three wards and found no significant error rate differences between the observation period and the overall six month study period [16]. Application of statistical procedures in analytical instrument testing. The methodological framework of pre-analytical investigations should maximize the reliability and consistency of the achieved information. However, often papers did assess neither bias (12/36) nor agreement (24/36). Automated phlebotomy tray preparation provides a complete set of labeled blood tubes and labels for hand labeling in a single tray . Therefore, the patient-side perspective should be preferred over the laboratorian-side perspective, even if the investigation concerns a technical aspect of laboratory pre-analytics. All these steps were observed during the blood sample collection by the nurses. *Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Biochem Med (Zagreb) 2014;24:6. Also for the comparison of one-week LIS data, the data for a one-year period were also collected from LIS. Rejection rates were calculated by the total number of tubes. Did the collector place a clean gauze or cotton ball over the venipuncture site? However, the adherence to strict requirements represents an additional effort in managing a study, that can be experienced as impractical if the peer-reviewing process does not encourage to comply with it and the research quality is not exalted by an increased citation rate (103-105). Epub 2017 Feb 27. the agreement analysis treated as complementary rather than fundamental for a pre-analytical investigation, and therefore often ignored or sometimes carried out with inappropriate methodologies. Another similarity with the study of Sumindic et al. Hemostasis involves activation of the clotting factors and platelets [1]. The two major concerns arising from the use of multiple methods are homogeneity of calibration and robustness. Similar to our results, the most correct step of the phlebotomy was the venipuncture site collection [11]. Effect of drawing a discard tube on PT and APTT results in healthy adults. Statistical analyses were performed by the Statistical Package for the Social Sciences (SPSS) version 20.0 (SPSS Inc., Chicago, IL) program. Careers. Abstract. It was observed that the identification of the patient which seemed to be erroneous in the present study, was performed by the secretaries rather than nurses before blood drawing. No influence of a butterfly device on routine coagulation assays and D-dimer measurement. Actually, we need to challenge the safe zone of customaries to follow that growth. Also after drawing, mixing was not performed properly by the nurses; the mixing cycle was inadequate. Salvagno GL, Danese E, Lima-Oliveira G, Guidi GC, Lippi G. Avoidance to wipe alcohol before venipuncture is not a source of spurious hemolysis. Significant Reduction in Preanalytical Errors for Nonphlebotomy Blood Draws After Implementation of a Novel Integrated Specimen Collection Module. Statistical methods for assessing agreement between two methods of clinical measurement. Only one citrated tube was overfilled (above the acceptable limit), whereas the 27 citrated tubes had fill volume <90%. Accessibility Therefore, data validation should be mandatorily carried out as strictly as possible. Is statistical significance always significant? A practical way of properly sizing a study consists in starting from an expected magnitude of the effect, that for instance could be estimated by means of retrospective calculations using previously available data (54). Although the majority of the nurses (78%) used safety needles, the safety mechanism was properly activated only in 38% of the interventions. 2015). For the erroneous request, misidentification, improper container or tube, and incorrect fill volume criteria, rejection rates were calculated with the total number of the tubes that were accepted. However, two special recommendations concern the section reporting the study discussion. The https:// ensures that you are connecting to the The preanalytical errors decreased significantly, from 3.20 to 1.93 errors per 1000 specimens (P .001). As a library, NLM provides access to scientific literature. Biochem Med (Zagreb) 2016;26:150-63. Notably, with respect to the median sample size, it was N = 88 (IQR: 54.5 - 220.5) for studies using outpatients and N = 20 (IQR: 17.5 - 30.0) for studies using volunteers, with the difference being statistically significant (P < 0.001, effect size = 0.69). In the clinical laboratory testing process, preanalytical, analytical, and postanalytical phases are the three phases of laboratory practice and named as total testing process (TTP) [2-5]. However, the median effect size (ES) resulted significantly larger if the associated factor was clinically significant instead of non-significant (ES = 1.140, IQR: 0.815-1.700 and ES = 0.349, IQR: 0.228-0.531 respectively, P < 0.001). Results: For each topic searched, suitable papers were extracted by deciding on the bases of the abstract content. Results: The process of blood sample collection from 337 patients taken into 1347 tubes was observed. Training programs were performed repeatedly to the medical secretaries to avoid patient identification errors. In some studies where N > 30, the sample was partitioned into two or more subgroups on which the analysis was repeated independently, so that the actual sample size varied according to the stratification (28, 32, 33, 38, 43, 45). Thus, merging the search results of different sources would have meant deviating from the perspective of largest part of potential readers, introducing a bias of liberality instead. HHS Vulnerability Disclosure, Help Effects of tourniquet technique, order of draw, and sample storage on plasma fibrinogen. Limitations of the paired t-test for evaluation of method comparison data. In the observation period, the order of drawing according to the tube type was found to be wrong, and the tube fill volume was ignored by the nurses, while the coagulation and EDTA tube fill volume errors were lower than the serum tubes. Thus, issuing recommendations (a summarization of which is displayed in Table 2) should be regarded as the first step in such a cultural growth. Lippi G, Guidi GC, Mattiuzzi C, Plebani M. Preanalytical variability: the dark side of the moon in laboratory testing. Simundic AM. Learn key terms, names, and much more related to Phlebotomy 4 Analytical Errors, Complications, Special Venipuncture with the help of our flashcards . Hemolysis occurred especially in the tubes collected by the syringe and catheter route.The results of the phlebotomy observation period survey are shown in Table Table33. the contents by NLM or the National Institutes of Health. Biochem Med (Zagreb) 2013;23:64-9. Evaluation of platelet events may include a CBC, examination of the peripheral smear, bleeding time (BT), PFA-100 and platelet aggregation tests. Is phlebotomy part of the dark side in the clinical laboratory struggle for quality? Thus, such studies should grant the highest reliability, whereby dispelling any doubt of misleadingness. Second, we observed certain specific drawbacks, some of which strictly related to the conceptual and statistical framework that characterized this kind of studies, and that can be resumed as follows: Particularly, regarding the last three points, the pre-analytical factor, the bias and the agreement were usually treated as if there was no relationship between them, leading to use multiple tests (often redundant) that resulted in a fragmented statistical framework. Instead, the Mann-Whitney U test was used to assess the association between a continuous and a qualitative variable (i.e. 1 Clearly, at least some of these errors will have a major impact on patient care. Accessibility Beside calibration, a study should also rely on an accurate data validation, achieved assessing the dataset shape. Lastly, we also noticed a certain lack of standardization in operative procedures reported in the various investigations, and a general inhomogeneity regarding how presenting data and delivering results to the reader. Did the collector appropriately sanitize hands? Smidt N, Overbeke J, de Vet H, Bossuyt P. Endorsement of the STARD Statement by biomedical journals: survey of instructions for authors. When were the sample tubes labeled? observed high rates of patient identification errors at the time of blood sampling, similar to the results of the present study [16]. Necessary sample size for method comparison studies based on regression analysis. However, the human factor in the specimen collection and transport procedure are the root cause of these preanalytical phase errors. Errors in a stat laboratory: types and frequencies 10 years later. Lastly, in 2/36 (0.06), along with Bland-Altman analysis, the bias was estimated through Passing-Bablok regression with 95% confidence intervals (21, 41). Background: Pseudohyperkalemia in patients with chronic lymphocytic leukemia. However, other previously published studies in the literature reported that their rejection error types were mostly due to the hemolyzed and clotted sample [17,20,21]. Appl Bionics Biomech. The number of observations according to the departments is shown in Table Table11. For clotted samples we used the total number of samples with an anticoagulant checked for clots whereas the calculation of hemolysis rejection rate was done with the number of samples rejected due to hemolysis per total number of checked samples for hemolysis. 1 On these evidences, we discussed some recommendations for improving methodological consistency, delivering reliable results, as well as ensuring accessibility to practical evidences. Gimnez-Marn A, Rivas-Ruiz F, Prez-Hidalgol M, Molina-Mendoza P. Quality indicators in the preanalytical phase of testing in a stat laboratory. When evaluated in the one-week observation period the rejection rates for fill volume, clotting, and hemolysis were 14.9%, 0.53%, and 2.24%, respectively. For instance, one may plan to investigate the rate of pseudohyperkalemia due to needle bore size, and simultaneously investigating the effect of age (random effect), MCV (random effect) and gender (fixed effect) of the subjects adding the appropriate terms. A study should be meant to detect the meaningful effect size of a factor, avoiding both excessive (over-powered) or scarce (under-powered) sensitivity (49). Indeed, phlebotomy constitutes the essential connection between the clinics and the laboratory diagnostics, with venepuncture prompted by a precise medical question (4). The paired Students t-test was the most used statistical test for assessing the effect produced by the pre-analytical factor and it appeared in 17/36 papers (0.47), while the non-parametric equivalent Wilcoxons paired-ranks test was used in 11/36 (0.31). and transmitted securely. Three more papers, which resulted potentially suitable, were not available through our local library service, and thus were excluded from this study. The Benefits and Challenges of an Interfaced Electronic Health Record and Laboratory Information System: Effects on Laboratory Processes. The https:// ensures that you are connecting to the Fixed and random eects selection in mixed eects models. Objective: Errors in clinical laboratories have a great impact on safety and care of patients. Indeed, the lack of standardization could introduce uncontrolled confounding factors that might lead to contradictory findings, as it was shown happening for the fasting condition or the venous stasis induction (24, 62). Incorrect least-squares regression coefficients in method-comparison analysis. Did the collector clean the venipuncture site? Therefore, although statistically significant, no clinical significance was produced by the alternative collection procedure. Preanalytical error types especially occur outside the laboratory, and the root cause of the error is human [4,14]. Estimation of the minimal preanalytical uncertainty for 15 clinical chemistry serum analytes. FOIA Lund F, Petersen PH, Fraser CG, Soletormos G. Different percentages of false-positive results obtained using five methods for the calculation of reference change values based on simulated normal and ln-normal distributions of data. Survey of national guidelines, education and training on phlebotomy in 28 European countries: an original report by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) working group for the preanalytical phase (WG-PA). Short-term venous stasis influences routine coagulation testing. Received 2016 Apr 27; Accepted 2016 Nov 25. While a significant decrease in laboratory errors, particularly analytical errors, has been achieved in last decades, laboratory services are not as safe as they should be and we should not become complacent. This study emphasizes the importance of the nurse and laboratory staff training during the preanalytical phase and showed that periodic auditing is essential for implementing the existing procedures. Thus, based on these evidences, we have developed a set of recommendations presented in part II of this document, aimed to ensure the adequate quality level to researches dealing with pre-analytical issues related to phlebotomy. It should be remarked that the use of 2-sample location tests (e.g. However, we were concerned with the way the scientific information was produced and delivered, and not with its use for generating meta-analytical results. When the consumables were checked, it was found that three clinics were using expired citrate tubes (only six tubes), while all the other consumables were stored in appropriate conditions. This might be random, or can be linked to the increased awareness in the one-week period due to the presence of observation. This study was conducted in Dr. Abdurrahman Yurtaslan Oncology Education and Research Hospital, Ankara, Turkey, which has 600 beds and was equipped to treat surgery and oncology patients. Limitations of the Passing-Bablok model are that it cannot handle multiple factors and missing data, as well as it necessitates a high correlation between paired observations to hold. Discard first tube for coagulation testing. Evaluating agreement between two analytical methods in clinical chemistry. Lima-Oliveira G, Volanski W, Lippi G, Picheth G, Guidi GC. 2021 Jul 9;15:1537-1543. doi: 10.2147/PPA.S320163. Context 1 . This may be attributed to the habitual procedures applied by the staff and the nurses in the preanalytical phase and failure to implement the written quality procedures. In plain words, it corresponds to asking whether the population has at least one statistically significant characteristic among those tested with respect to the same factor. Simundic AM, Cornes M, Grankvist K, Lippi G, Nybo M, Kovalevskaya S, et al. Unable to load your collection due to an error, Unable to load your delegates due to an error. Results: The overall rate of pre-analytical errors was 0.40%. If the observed bias is larger than the expected combined effect of analytical and biological variability, then clinical significance is achieved. An official website of the United States government. Regarding the clinical significance of the pre-analytical factor, in 16/36 (0.44) papers the authors preferred the direct comparison of the corresponding bias with the value of biological variability reported in databases. Presentation Presenter Simundic AM. Dilauro M, McInnes MD, Korevaar DA, van der Pol CB, Petrcich W, Walther S, et al. Preanalytical QIs were chosen according to the 2019 IFCC Working Group Laboratory Errors and Patient Safety project criteria [13]. (6 citrated tube), Did the collector identify the patient according to CLSI or local guidelines, Did the collector put a new fresh clean pair of gloves. Most studies demonstrated that alarge percentage of laboratory errors occur in the preandpost analytical phases, with fewer mistakes occurring inanalytical phase.2efforts to ensure compliance with standardizedidentification routines should be prioritized.Mistakes in patient identification beforespecimen collection is responsible for up to 25% of. 8600 Rockville Pike The labeling of the tubes was done before blood collection (80%). Pre-analytical errors were categorized into four main . eCollection 2022. This makes accessibility a major objective, and the author should take into consideration the impact in the decision-making of the phlebotomist accessing his research. For inpatients, seven clinical departments and the emergency department were observed. With respect to laboratory tests used as part of the experimental procedures, the recommendation concerns the way they should be arranged when the study deals with a panel of multiple analytes. inhomogeneity of variance) of data, that may arise due to an underlying heterogeneity of the cohort (65). With respect to the sample size, 14/36 papers (0.39) had N 20, 6/36 (0.17) had N 30, and 16/36 (0.44) had N > 30. Comparison of several regression procedures for method comparison studies and determination of sample sizes. All the studies relied on the within-subjects or single-group repeated-measures design. Influence of posture on routine hemostasis testing. Fourteen of the tubes with EDTA had fill volume <75%, whereas the remaining 14 tubes fill volume was <50%. The 70% claim: what is the evidence base? Clotted samples and platelet clumps were seen in 1% of EDTA tubes. In the preliminary study, when the rejection types and rates were checked, in the one-week observation period especially, the fill volume error, hemolysis, and clotting, and rejection rates were found higher than the LIS data. A new biometrical procedure for testing the equality of measurements from two different analytical methods. The site is secure. As far as pre-analytics is a major concern in current laboratory medicine and an issue for practitioners and researchers, this field of investigation should be fostered in order to produce evidences for best practice (5, 6). Thus, combining these two factors, a research might show redundant tests producing even discordant evidences (see further in this section). The LIS data for one week and one year had similar types and rates. (Pre-Post). Ialongo C. Understanding the effect size and its measures. Methods: Visual hemolysis grading charts (+) hemolysis corresponds to >2g/L free hemoglobin. Lippi G, Banfi G, Church S, Cornes M, De Carli G, Grankvist K, et al. It was performed in two stages: the observation of blood collection up to the receipt of the samples, and the receipt of the samples up to the analytical phase. Was the collector using a closed system for venipuncture? In the observation period of the study, the identification of the patient and the labeling of the tubes were found improper according to the EFLM WG-PRE recommendations. A pre-analytical investigation of phlebotomy should aim to deliver information of practical relevance, and thus it should be meant to reach also non-academic recipients. The statistical association between qualitative variables was assessed by means of the Fishers exact test or Fisher-Freeman-Halton test, or by the Spearmans between quantitative continuous variables. 2019 Jul 1;137(7):729-735. doi: 10.1001/jamaophthalmol.2019.0864. Fu S, Wu XG, Zhang L, Wu LF, Luo ZM, Hu QL. The preanalytical errors refer to all of the inappropriate performances before the specimens are measured by analyzers, such as improper sample collection, transport delays, illegible handwriting on requisition, and so on.
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