pre analytical error definition

Traditionally, pre-analytical errors are grouped into identification and sample problems. The definition of what constitutes a pre-analytical and post-analytical error can also be confusing. Therefore, targeted intervention including a quality improvement program and its continuous maintenance should be conducted to reduce pre-analytical errors and to improve patient safety. Statistically, no significant difference exists between the different departments (P = .128). 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. Sol Green, PhD, FACB, serves as the Director of Clinical Solutions and Global Technical Services for Becton, Dickinson, and Company, and is Assistant Professor of Clinical Pathology at Stony Brook University Medical Center, Stony Brook, NY. Bowen RA, Hortin GL, Csako G, Otaez OH, Remaley AT. [22] Based on this, it appears that specimen or blood collections from the other departments (ED and IPD) were done by more trained and experienced clinical staff. Labs should keep a record of pre-analytical errors observed. 2012;32:516. sharing sensitive information, make sure youre on a federal Pre-analytical Error. 2023 Endeavor Business Media, LLC. may email you for journal alerts and information, but is committed [18] Difficulties in blood sample collection, absence of assigned unit to receive and distribute samples, low automation in the routine preanalytical phase, and the low level of integration in a laboratorys divisions are the possible sources of these errors. Data curation: Jerold C. Alcantara, Bandar Alharbi, Khalid Alshaghdali, Yasser Almotairi. Fortunately, many of these errors can be detected by the laboratory analyst so that corrections can be made before testing begins or before resulting and . Baron JM, Mermel CH, Lewandrowski KB, Dighe AS. [7]. as a more stable barrier, which facilitates specimen storage and transport and removes the need for aliquoting.10 For some analytes, separation of serum or plasma is required quickly, and this can be achieved with gel. An increased rate of errors was also noted for the 2-year study period from 11.3% to 12.9%. We are sorry that this post was not useful for you! Recognition and documentation of these errors are crucial phases in enhancing the quality of laboratory medicine. Preanalytical errors in medical laboratories: a review of the available Therefore, medical laboratory professionals have taken the responsibility to advocate for the development of quality control procedures at the preanalytical phase. The data of serum indices and lab errors also help to monitor the quality of blood collection process and assess the efficacy of measures taken. [18]. The site is secure. . CLSI has published a step-by-step guidance document to help with validation of blood collection tubes.17 In addition, validation is a formal requirement to meet accreditation standards. Arneson W, Brickell J. While the frequency of laboratory errors varies greatly, depending on the study design and steps of the total testing process (TTP) investigated, a series of papers published in the last two decades drew the attention of laboratory professionals to the pre- and post-analytical phases, which currently appear to be more vulnerable to errors than the analytical phase. Risk Manag Healthc Policy. Comment on Types and origins of diagnostic errors in primary care settings [published correction appears in JAMA Intern Med. Key factors influencing the incidence of hemolysis: a critical appraisal of current evidence. An increased occurrence of hemolyzed samples in the outpatient department was noted. Each rejected specimen should be recorded in a log book with relevant details. [5] Underreported and undervalued influence of preanalytical is due to inadequate attention on what occurs to samples before reaching the laboratory. The preanalytical phase has a significant impact on the quality of laboratory results. 5 Pre-analytical errors include all errors that occur prior to analysis. However, recent studies have shown that up to 70% of analytical errors reflect the pre-analytical phase. Here are some recommended strategies. Post-analytical laboratory work: national recommendations from the declared the most common definition of errors in clinical laboratory as the following "failure of planned action or procedures to be achieved as intended, or use incorrect . An observational study conducted in 12 European countries by the European Federation of Clinical Chemistry and Laboratory Medicine reported unacceptably low compliance of phlebotomy procedures following the Clinical and Laboratory Standards Institute H3-A6 guidelines.[25]. The participation of various professionals, such as nursing, physicians, laboratory scientist, laboratory technicians, and phlebotomists, makes the preanalytical phase the most essential and challenging to regulate and monitor. [5]. How important are pre-analytic and post-analytic errors, anyway? Sources of errors in coagulation testing. Assessment of data and all statistical analyses were done using SPSS version 21. A total of 55,345 laboratory requests and samples from different departments and wards were evaluated for preanalytical errors. Bookshelf The series "Reducing errors in the pre-analytical phase" was commissioned by the editorial office without any funding or sponsorship. Review of Medical Errors in Laboratory Diagnostics and Where We Are The data in this study cover the period from January 2019 to December 2020. This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial License 4.0 (CCBY-NC), where it is permissible to download, share, remix, transform, and buildup the work provided it is properly cited. Wayne, PA: Clinical and Laboratory Standards Institute, 2012. HHS Vulnerability Disclosure, Help [2]. Beginning with test ordering and ending with result reporting, TTP encompasses the pre-analytical, analytical, and post-analytical phases of testing . Clinical laboratory should make efforts to reduce pre-analytical errors in order to report accurate and expeditious results. Background: Most errors in the clinical laboratory occur in the preanalytical phase. These errors are associated with sample collection and handling; thus, suggesting that enhanced and continuing educational efforts emphasizing specimen quality issues and training in sample collection among hospital staff must be carried out. [7] Emergency and inpatient departments represent a large number of samples received, high workload pressures, more challenging group, and more difficulty in collecting blood samples. [14]. Cornes MP, Atherton J, Pourmahram G, et al. The medical laboratory scientist learned this patient serum sample was contaminated by EDTA-K2 because the tested sample was a combination of his blood from a purple top tube (with EDTA-K2 as coagulant) and a red top tube. sharing sensitive information, make sure youre on a federal Available at: [10]. CLIA Compliance for Pre-Analytic, Analytic, and Post-Analytic Testing Analytical errors are often 10% of all errors in diagnostic testing, and the frequency of these types of errors has decreased in the last decade. Many experts think that plastic tubes offer significant advantages over glass tubes, such as minimizing exposure to blood by reducing the chance of shatter, increasing shock resistance, increasing centrifugation speed tolerance, and decreasing shipping weights.10 Plastics also help the facility to comply with the Occupational Safety and Health Administration (OSHA) guidelines to minimize the risk of blood exposure.10 Closed blood collection systems are seen as safer and thus preferable to syringe and needle for collecting blood.11. Conclusions: Such communication can facilitate the definition of further procedures, such as resampling, and guide the decision whether to release the laboratory test report with or without the unexpected test result. Campana GA, Oplustil CP, Faro LB. Case Five A physician ordered several tests on a patients stool samples. The pre-analytical phase is a crucial part of the analysis and is equally important as the analytical component. However, some preanalytical errors are not detectable at the laboratory end, which might cause significant impacts on test results. Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any . Unable to load your collection due to an error, Unable to load your delegates due to an error. Authors Jamie West 1 , Jennifer Atherton 2 , Sen J Costelloe 3 , Ghazaleh Pourmahram 4 , Adam Stretton 4 , Michael Cornes 5 Affiliations Please enable it to take advantage of the complete set of features! Errors in the Total Testing Process in the Clinical Chemistry Laboratory at the University of Gondar Hospital, Northwest Ethiopia. The Preanalytical Errors: a Continuous Challenge for Clinical - Ascls This study was conducted to investigate and analyze pre-analytical errors. EDTA is widely known as a chelator to electrolytes, including Mg2+, Zn2+, and Ca2+. Harmonization of pre-analytical quality indicators - PMC The occurrence of these errors was found to be highest in the ED (21%) as compared to the inpatient department (IPD; 13.4%) and the outpatient department (7%). Accordingly, since the problems tend to be unique, the solutions must often be customized. Bookshelf They are not ways of achieving perfection, but they can go a long way toward the goal of eliminating pre-analytical errors. Results: Carraro et al. In: Accurate Results in the Clinical Laboratory. Plebani M, Carraro P. Mistakes in a stat laboratory: Types and frequency. Preanalytical errors were carefully determined and recorded. JAMA Intern Med. The laboratory must validate all products and methods to ensure that they are compatible and acceptable for the specified tests. Plebani M. Exploring the iceberg of errors in laboratory medicine. Formal analysis: Jerold C. Alcantara, Khalid Alshaghdali, Bandar Alharbi, Abdel Rahim Mahmoud Muddathir, Mohammad Jahoor Alam, Yasser Almotairi. The findings of the present study provide a critical and valuable source of information that could systematically support quality management of the laboratory testing process to promote diagnostic excellence in the laboratory and patient care settings. Clipboard, Search History, and several other advanced features are temporarily unavailable. Please enable scripts and reload this page. 2018;64:10758. The least among the preanalytical errors from all the departments was specimen contamination (0.01%) that occurred in the IPD only (Table 1). Specific protocols and operating procedures (SOPs) in the lab help to reduce the heterogeneity in process and streamline the lab workflow. Copyright 2019. [16]. The pre-analytical phase. Validating any new instrument or procedure. Moreover, it was noted that transportations of laboratory specimen were done by untrained hospital staff. The most common pre-analytical error was 'improper volume' (41.5%), followed by 'undue clotting' (32.8%). . To access the private area of this site, please log in. The department of Clinical Laboratory provides clinical chemistry services throughout the hospital apart from the routine and special laboratory tests from other sections of the clinical laboratory. This makes it more challenging to describe guidelines for pre-analytical and post-analytical problems. Clin Lab. Pre-analytical variation includes all the steps that occur from test ordering until right before sample analysis. Clipboard, Search History, and several other advanced features are temporarily unavailable. Each clinical laboratory has various types of pre-analytical errors due to the complexity of the healthcare environment. to maintaining your privacy and will not share your personal information without The activities for quality improvement including education and training programs on the phlebotomy teams were also accomplished to reduce these errors. The pre-analytical phase also includes physiological variables specific to the animal, such as age, gender, pregnancy, and endogenous variables such as medication the animal may be taking or recent meals when the patient is not fasted. Post-analytical: reporting test results, interpretation, follow up, storage, retesting if needed. Preanalytical errors (PAEs) are errors which occur prior to the analytical stage in the total testing process (TTP) and can occur both before and after receipt of specimens in the laboratory. The results of laboratory tests play a critical role in patient management, so the clinical laboratory is obligated to report accurate results. Pre-Analytical Variation | AACC.org 2013;28:22734. Substantial error rates consistently occur in clinical laboratories, even with advanced automation in diagnostic laboratories. The frequency of preanalytical errors was determined and the rate of errors was calculated and expressed as frequencies and percentages as compared to the total samples received. clinical chemistry; laboratory errors; preanalytical errors; Saudi Arabia. Careers. Medicine 2022;101:27(e29853). For more information, please refer to our Privacy Policy. Test order accuracy (% of test orders correctly entered into a laboratory computer). Institutions serve different patient populations and have different needs, and must choose types of products accordingly. Patient safety and the medical diagnosis of patients are mainly influenced by laboratory results. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). There was no focus on this error or data, but the decline can be credited to appropriate communication with the laboratory department, increase experience of staff, and proper orientation of test requisition system to new hospital staff. MeSH The cost of poor blood specimen quality and errors in preanalytical processes. For this reason, in the last decade there has been an intense focus on the preanalytical phase leading to the development of recommendations and standards. Patient safety and medical diagnosis of patients are mainly influenced by laboratory results. In a study conducted in Makkah, Saudi Arabia, a rate of 2.07% preanalytical errors was reported, of which hemolysis and clotted sample were the leading causes. Quality improvement in laboratory medicine: extra-analytical issues. Pothula1 Y, Al-Marzooq YM, Salem RAL, AL-Jasem W, AlHajji A. Prevalence of Pre-Analytical Errors in Clinical Chemistry Diagnostic Preanalytical Definition. Pre-analytical phase is most important in testing process and involves variables that are not under the control of the laboratory. The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request. Would you like email updates of new search results? Devising and following corrective strategies can gradually free a lab from such errors. Background: Please try again soon. Source: Pal Bela Szecsi, Lars Odum, Error Tracking in a clinical biochemistry laboratory, Clin Chem Lab Med 2009;47(10):1253-1257. Lab Med. PMC Quality improvement in clinical laboratories: a six sigma concept. Monitoring and reporting of preanalytical errors in laboratory medicine 2013 Apr 8;173(7):599]. The detection and prevention of errors in laboratory medicine. In laboratories, analytical errors are mostly all alike: every method has some amount of analytical error, in the form of systematic and random error. [19]. Lippi G, Becan-McBride K, Behlov D, Bowen RA, Church S, Delanghe J, et al. And often the return of the test result also has its own unique path and ends up on a one-of-a-kind report. Wolters Kluwer Health Notably, nonreceived samples were the most prevalent in ED (6.1%) and IPD (4.8%), while hemolysis (4.2%) was predominantly observed in OPD. The site is secure. A review of medical errors in laboratory diagnostics and where we are today. Tadesse H, Desta K, Kinde S, et al. [22]. 2004 Dec 1;88(3):161-81. doi: 10.1002/jso.20125. Hemolyzed specimens: major challenge for identifying and rejecting specimens in clinical laboratories. An increased rate of errors was also noted for the 2-year study period from 11.3% to 12.9%. Barak M, Jaschek R. A new and effective way for preventing preanalytical laboratory errors. A similar finding was reported in the study by Zaini et al. The https:// ensures that you are connecting to the Frequent clinical chemistry tests that are most sensitive to hemolysis include lactate dehydrogenase, creatine kinase, MB isoenzyme of creatine kinase, potassium, conjugated bilirubin, alanine aminotransferase, aspartate aminotransferase, and iron. The .gov means its official. Analysis of preanalytical errors in a clinical chemistry - LWW Some are predictable, whereas others are beyond control and must be understood in order to resolve and interpret appropriately (eg, cold agglutinins in winter seasons). Copyright 2019 The Canadian Society of Clinical Chemists. . [26]. Geneva: World Health Organization; 2010. Quality Indicators to Detect Pre-Analytical Errors in Laboratory EDTA, oxalate or citrate cannot be used for routine chemistry testing since they have commonly measured counterions (sodium, potassium).13 Finally, large institutions should try to standardize their products across various collection sites. This definition process includes . Preanalytical errors in medical laboratories: a review of the available methodologies of data collection and analysis Ann Clin Biochem. Crit Rev Clin Lab Sci. Nitin Kaushik, MD, MBA, serves as the U.S. Marketing Manager for Blood Collection tubes for Becton, Dickinson, and Company, provider of the BD Vacutainer Blood Collection Tubes. Furthermore, assessing the impact of laboratory errors is difficult and often leads to inaccurate clinical decisions, delayed diagnoses, prolonged hospitalization, and increased demand for resources. PDF Preanalytical Errors and their Impact on Tests in Clinical Laboratory Establishing robust processes to ensure quality . FOIA [17]. 2013;173:4256. How do I become a laboratory professional? 2019;34:948. Many phlebotomists prefer to use wingsets over blood collection needles due to the better patient experience.12 However, when collecting blood for coagulation testing while using a wingset, one should be aware of the need to collect blood into a discard tube prior to collecting coagulation specimens to avoid a decrease in blood-to-additive ratio due to the presence of blood in the tubing. Bethesda, MD 20894, Web Policies Newman-Toker DE, Makary M. Measuring diagnostic errors in primary care: the first step on a path forward.
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