pre analytical laboratory procedure

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. Indeed, the choice of the inappropriate statistical test is responsible of a deflation of sensitivity, that is already an issue of small-sized studies (51). Any subsequent alteration of this printed form, such as the addition of handwritten information, is considered to be unauthorised. How to conduct External Quality Assessment Schemes for the pre - PubMed the effect of a factor on a median value). Preanalytical Automation Systems & Solutions for Clinical Labs. 10 Quality improvement initiatives must . Roraas T, Stove B, Petersen PH, Sandberg S. Biological variation: the effect of different distributions on estimated within-person variation and reference change values. Falagas ME, Pitsouni EI, Malietzis GA, Pappas G. Comparison of PubMed, Scopus, Web of Science, and Google Scholar: strengths and weaknesses. Application of the Bland-Altman plot for interpretation of method-comparison studies: a critical investigation of its practice. A wide range of variables that affect the result for a patient from whom a specimen of blood or body fluid has been collected, including the procedure for collection, handling, and processing before analysis, constitute the preanalytic phase. 629, Pakramau, Kursi road, Practical recommendations for statistical analysis and data presentation in Biochemia Medica journal. In a patient-centred approach to the delivery of health-care services, there is the need to investigate, in the TTP, any possible defect that may have a negative impact on the patient. There are pre-analytical, analytical and post analytical factors that contribute to accurate test results in clinical laboratories.Pre-analytical variables account for 32-75% of laboratory errors, and encompass the time from when thetest is ordered bythe physician until the sample is ready for analysis. Immunoassay and molecular testing solutions across a broad spectrum of instruments have been designed to provide solutions for any size laboratorys infectious disease testing needs. Common Errors Occuring in the Preanalytical Phase, Preanalytical Automation in Clinical Labs The Need of the Hour. Another critical point to highlight is implementation of pre-analytical standard operating procedures in the interest of quality laboratory practice [9, 10]. Pre-analytical, analytical, and post-analytical considerations while processing samples of COVID-19 patients: Perspective from a clinical chemistry laboratory in India September 2020 Asian Journal . And this would be an impossible task to complete if clinical labs are not automated. With all the data being stored in one place intra laboratory traceability of samples is made easy and efficient. The site is secure. Maybe, since laying in between clinics and laboratory, phlebotomy has long struggled to gain in scientific literature its own identity and the same reputation as laboratory assays. In this regard, phlebotomy is addressed as a crucial process in the pre-analytical phase, in which a large part of laboratory errors is thought to arise, having the potentialities to affect largest part of medical decisions ( 2, 3 ). For each topic searched, suitable papers were extracted by deciding on the bases of the abstract content. sharing sensitive information, make sure youre on a federal Pre-Analytical Phase - an overview | ScienceDirect Topics A report by Bonini and colleagues found that pre-analytical errors predominated in the laboratory, ranging from 31.6% to 75%. Performance of Deming regression analysis in case of misspecified analytical error ratio in method comparison studies. For instance, the choice of the statistical test (parametric or not) was carried out independently from any assessment of the dataset structure (e.g. Finally, selected papers were evaluated with respect to the experimental set up, sample size (N), kind of population used for the study (volunteers, donors, inpatients, outpatients), number of individual laboratory tests evaluated, number of factors assessed, testing of data normality, descriptive measures provided (central tendency, dispersion), measure of association between paired observations, methodology used for agreement and bias estimation, clinical significance assessment. Lima-Oliveira G, Salvagno GL, Lippi G, Gelati M, Montagnana M, Danese E, et al. Bias estimation in method comparison studies. Biochem Med (Zagreb) 2014;24:6. Pre-analytical phase management: a review of the procedures from Rics C, Alvarez V, Cava F, Garcia-Lario JV, Hernandez A, Jimenez CV, et al. In 28/36 papers (0.78) no normality test was mentioned or reported, while in 5/36 (0.14) the Kolmogorov-Smirnov or DAgostino-Pearsons test was used (without specifying which kind in one case), and in 3/36 (0.08) the paper was unclear regarding whether the test was performed and which one was adopted (15, 19, 25). Invasive procedures naturally tend to rely on a small cohort, and in phlebotomy, some of the experiments even require multiple vein accessioning (e.g. A new biometrical procedure for testing the equality of measurements from two different analytical methods. Whether you're in a research or healthcare setting, in hematology or microbiology, you can measure the quality of a laboratory's procedures by the reliability, accuracy, and promptness of the . In 4/36 papers (0.11) the investigation regarded 1 laboratory test, in 15/36 (0.42) from 2 to 5 tests, in 12/36 (0.33) from 6 to 24, while in 5/36 (0.14) 25 or more tests. However, when the clinical significance of bias was used as grouping criterion, the effect size significantly differed in median magnitude (P < 0.001, effect size = 0.59) (Figure 2) (21, 22, 25-29). Interestingly, it should be noticed that the celebrated simplicity was already recognized not a guarantee of appropriateness and homogeneity regarding its use and diffusion (101). 16 In 2008 to 2009, Chawla and colleagues performed a 1-year study in the clinical chemistry laboratory on the frequency of pre-analytical errors observed in both inpatients and outpatients. Some papers dealt with more than one topic in the same experimental set up, so with respect to each single topic we found: Thus, it resulted 6/36 (0.17) papers issued by 1996-2000, 5/36 (0.14) by 2001-2005, 7/36 (0.19) by 2006-2010 and 18/36 (0.50) by 2011-2016 (up to March), issued in 17 different journals (Figure 1). laboratory test, pre-analytic, biological OR individual). 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. Effect of tourniquet pressure and intra-individual variability on plasma fibrinogen, platelet P-selectin and monocyte tissue factor. At this pathology service, there are two methods by which a pathology test order can be created. saline lock devices or intravenous catheters) as well as those assessing the effect of particular devices or materials (e.g. adjective. Thus, issuing recommendations (a summarization of which is displayed in Table 2) should be regarded as the first step in such a cultural growth. Effect of drawing a discard tube on PT and APTT results in healthy adults. All employees should be required to take Preanalytical quality improvement. 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. Alcohol used as disinfectant before venipuncture does not lead to sample haemolysis or sample dilution. We found that the largest part of studies had a cohort of healthy volunteers (22/36) or outpatients (11/36), with the former group showing a significantly smaller median sample size (N = 20, IQR: 17.5-30 and N = 88, IQR: 54.5-220.5 respectively, P < 0.001). Assess the clinical significance of bias at different levels, preferably the same of the internal quality control performed on the laboratory tests used for the study. Thus, the approach based on assessing the effect of factor, the bias and the agreement within the same design as separate entities through distinct statistical methods should be discouraged since inappropriate and unnecessary. Lippi G, Salvagno GL, Montagnana M, Brocco G, Guidi GC. In 22/36 papers (0.61) the study population was represented by healthy volunteers, in 11/36 (0.30) by outpatients, in 1/36 by inpatients (0.03), in 1/36 by blood donors (0.03) and in 1/36 it was not specified (0.03). Int J Nephrol 2011;2011:759749. 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. The https:// ensures that you are connecting to the 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. Conversely, in 4/36 (0.11) paper it was used a more statistically structured approach based on the total change limit (TCL) or the reference change value (RCV) (13, 14, 19, 41). Preanalytical phase comprises of test selection, patient identification, collection of the sample, handling of the sample, sorting out, pipetting and centrifugation ( 2, 3 ). Lippi G, Salvagno GL, Lima-Oliveira G, Danese E, Favaloro EJ, Guidi GC. the comparison of butterfly versus straight needle). Thus, combining these two factors, a research might show redundant tests producing even discordant evidences (see further in this section). Phlebotomy is often addressed as a crucial process in the pre-analytical phase, in which a large part of laboratory errors take place, but to date there is not yet a consolidated methodological paradigm. 9th ed. A clinical lab plays an instrumental role in providing healthcare services to patients. Preanalytical phase - a continuous challenge for laboratory Once the data entry process is complete, test order forms are sent for archive and the specimens are delivered to the relevant pathology department for processing and analysis. (PDF) Pre-analytical, analytical, and post-analytical considerations 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). Furthermore, with respect to phlebotomy, there are some more specific issues arising on the choice of the appropriate cohort, the standardization of procedures and the deliver-ability of results to non-academic readers. Faul F, Erdfelder E, Lang AG, Buchner AG. A major (and technically the only one) limitation to the use of LMEM is the methodological complexity, that demands the appropriate level of statistical knowledge to properly set-up the experimental design, transferring data into the statistical frame and interpreting the results (66). Brigden ML, Graydon C, McLeod B, Lesperance M. Prothrombin time determination. However, with a CV as high as 5% with all other terms being equal, the same sensitivity would be achieved basing on 90 subjects. Blood sampling: is fasting properly defined? The LMEM (or multilevel model) is a general case of multiple regression (i.e. Could light meal jeopardize laboratory coagulation tests? At this pathology service, there are two methods by which a pathology test order can be created. No influence of a butterfly device on routine coagulation assays and D-dimer measurement. Is phlebotomy part of the dark side in the clinical laboratory struggle for quality? The academic research has a pivotal role in this, and pursuing standardization should be considered part of the consolidation process undertaken by any research field aware of its scope. Post-Analytical Phase - an overview | ScienceDirect Topics Quality assurance of the preanalytical phase - complying with ISO 15189 Thus, such studies should grant the highest reliability, whereby dispelling any doubt of misleadingness. Pre-analytic stage of the laboratory process. For paper orders, the LIS-linked test order episode barcode is scanned electronically but the remaining information (patient details and the list of tests ordered) must be manually typed into the computerised LIS data entry form. The LMEM is an observation-centred rather than a factor-centred framework like ANOVA and repeated-measures ANOVA (70, 71). Your email address will not be published. Any regression model requires to be calibrated on the applied range of values, the size of slope change to detect and the variability in observations, and this holds for both parametric and non-parametric methods (72, 73, 112). As well as any other regression method it shows the agreement between paired observations, that is the way they scatter around a line with no prevailing effect of one procedure over the other. Belmont, CA: Wadsworth Cengage Learning; 2013. p. 767. Biochem Med (Zagreb) 2013;23:201-5. 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). Korevaar DA, van Enst WA, Spijker R, Bossuyt PM, Hooft L. Reporting quality of diagnostic accuracy studies: a systematic review and meta-analysis of investigations on adherence to STARD. CLIA and Quality Assurance | AAFP This adds an additional layer of safety to the reported results. Particularly, 26/36 (0.72) assessed 1 pre-analytical factor, while the remaining 10/36 (0.28) assessed 2 factors (e.g. Such human errors are a major cause for peoples losing trust in the healthcare services. General recommendations of scientific writing are considered mandatorily applied to these studies (7). Moreover, the largest part investigated one pre-analytical factor (26/36) and regarded more than one laboratory test (29/36), and authors preferably used paired Students t-test (17/36) or Wilcoxons test (11/36), but calibration (i.e. Int Sch Res Notices 2016;2016:1346026. 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. Lippi G, Salvagno GL, Montagnana M, Poli G, Guidi GC. Obviously, there must be correspondence between authors, peer-reviewers and journals to let any new concept reaching acceptance and spreading (110-113). As they both depend on the underlying assumption of statistical normality (same probability of getting an equally large positive or negative variation), they can be reformulated using a robust non parametric model in order to better resemble the structure of data and gain the appropriate sensitivity (84, 85). inhomogeneity of variance) of data, that may arise due to an underlying heterogeneity of the cohort (65). The procedure has the major advantage of computational simplicity and visual immediacy, but in order to emphasize the random component of bias it constrains the modelling of the systematic and proportional components (90). Influence of a light meal on routine haematological tests. (2017) e Lee (2019), existem trs fases que envolvem todo o processo laboratorial de um paciente: 1) fase pr-analtica, que consiste na coleta, transporte e processamento. Simundic AM, Cornes M, Grankvist K, Lippi G, Nybo M, Kovalevskaya S, et al. Accessibility Business Place Ibirapuera, 9th Floor, Number 93, In this regard, we found a lack of association between the appropriateness of summarization and the journal issuing the paper, suggesting that this kind of flaws probably depends on a scarce attention paid by authors to that kind of guidelines. sample size calculation for a detectable effect) was addressed only in one manuscript. Number of issued papers by publication year. The Genesis FE500 Workcell an outstanding solution for - Tecan Hence, preanalytical automation in the clinical labs is the solution. However, being a linear model of relationship, it decomposes the observed effect into a constant (intercept c) and a proportional (slope b) bias (77, 78). Use a statistical framework in order to give consistency and unity to the analysis of data, avoiding multiplication of methods and inhomogeneous calibration (i.e. The investigation of pre-analytical factors in laboratory medicine is pivotal to improve the overall clinical laboratory quality, and in turn to ensure the patient safety (1). Pre- pre-analytical procedures performed outside the laboratory and strategies to prevent errors The pre-pre-analytical phases performed outside the laboratory are: formulating a clinical question and selecting appropriate examinations, ordering, collecting, handling and transporting samples. Hum Comm Res 2006;32:385-410. Meysamie A, Taee F, Mohammadi-Vajari M, Yoosefi-Khanghah S, Emamzadeh-Fard S, Abbassi M. Sample size calculation on web, can we rely on the results? Pre-Analytical, Analytical, & Post-Analytical Phases of Lab Testing in 2022 Second, they should avoid mentioning statistical aspects related to results for not distracting the reader, leaving such aspects to footnotes or appendices to the main text. The experience maturated with the STARD has shown how much all such factors hindered the consolidation of such a new paradigm, despite the wide resonance it had in the scientific literature (106-109). Students t-test or Wilcoxons test) as a screening approach to a factor in the study, the prevalent use of Bland-Altman plot, without a regression analysis of trend of individual differences to assess a proportional effect. In summary, the exploratory analysis consists of Features type identification, Identification of missing values, outliers and possibly other errors (often caused by humans), Identification of interconnections/relationships between individual features, and Selection of useful features. Influence of a regular, standardized meal on clinical chemistry analytes. 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. The choice of the population in a phlebotomy study can make the difference when the results are generalized to a different population. Lastly, the comparison of achieved bias with desirable values obtained from databases is another alternative to the use of statistically derived boundaries, but it does not take into consideration the actual imprecision of the methods used to perform experiments (86). All test order forms and specimens are received in CSR where they are time-stamped by CSR staff to register the time of receipt. In a future perspective, the critical process initiated issuing these recommendations should culminate in the development of a complete chart dedicated to pre-analytical investigations (and not only strictly concerning phlebotomy) similar to the Standards for Reporting Diagnostic Accuracys (STARD) chart. Discard first tube for coagulation testing. Suite 600, Iselin, NJ 08830, USA. From: Accurate Results in the Clinical Laboratory (Second Edition), 2019 View all Topics Add to Mendeley About this page There are some aspects of this work that should be addressed as possible limitations, and for which we would provide a justification. t-test and non-parametric equivalents) as a means to assess statistical significance of a factor, alone or beside regression analysis, should be discouraged. On these evidences, we discussed some recommendations for improving methodological consistency, delivering reliable results, as well as ensuring accessibility to practical evidences. It should be remarked that the use of 2-sample location tests (e.g. The clinical significance of any procedure should be always assessed within the statistical framework adopted to test the factor, and reported alongside the statistical significance. Lippi G, Ippolito L, Zobbi V, Sandei F, Favaloro EJ. outliers) and variability (i.e. The effect of outliers on the relative power of parametric and nonparametric statistical tests. Thank you for taking the time to provide feedback. Pre-analytical investigations of phlebotomy resulted constituting a heterogeneous body of investigations based on the general framework of within-subjects repeated measures design, in which the methodological approach showed a certain variability even among papers issued by the same group of authors. The Bonferroni correction for deflating is achieved through: Instead, the idk correction is achieved through: Thus, for 10 independent tests the adjusted testwise returned by both methods would be = 0.005, but in case of 20 tests it would get as low as = 0.0025 for Bonferroni and = 0.003 for idk. Statistical significance level was set at P < 0.05. Ialongo C, Bernardini S. Phlebotomy, a bridge between laboratory and patient. It has long played a role in pre-analytical and analytical phases of laboratory work, and its role in the post-analytical phase has been increasing, especially in the automatic selection and reporting of test results (Procedures 1-4). Then, the required sample size can be achieved inputting the value thereby obtained into stand-alone freely-available dedicated software as well as on-line web tools, choosing the statistical test that is going to be used (55-57). Effect size estimates: current use, calculations, and interpretation. 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. Short-term venous stasis influences routine coagulation testing. The first uses a handwritten paper test order form on which patient demographic data (e.g., name and date of birth) the tests, and relevant clinical details are recorded by the ordering clinician. How is Microlit E-Burette better than a Digital Burette? This phase may include specimen handling issues that occur even prior to the time the specimen is received in the laboratory. Lippi G, Salvagno GL, Brocco G, Guidi GC. Data were analysed with Microsoft Excel (Microsoft Corporation, USA) spreadsheet and StatsDirect 2.7.2 (StatsDirect Ltd., UK) statistical package, representing relative frequencies as proportions according to the author guidelines (7). The impact of the implementation of electronic ordering on hospital pathology services(PDF 2082 KB). PubMed represented our objective being a comprehensive health information resource that is preferably queried by academic readers over other databases (99, 100). Pre-analytic stage of the laboratory process
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