Purpose: Preanalytical errors comprise the majority of testing errors experienced by clinical laboratories and significantly impact the accuracy of therapeutic drug monitoring (TDM). Sampling time is also very important respective to the various diagnostic and therapeutic treatments that the patient may be receiving (e.g. According to the CLSI guidelines, blood drawing is not recommended from i.v. The postanalytical phase involves amongst others the reporting of results to clinicians, communication of critical values and turnaround time (TAT) [16]. Miler M, Simundic AM. the contents by NLM or the National Institutes of Health. National Library of Medicine Plebani M, Chiozza ML, Sciacovelli L. Towards harmonization of quality indicators in laboratory medicine. 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%). showed that a 24-hour urine sample was not properly collected in more than half of the informed outpatients, most of who were older than 65years and suffering from a chronic disease. Carraro P, Plebani M. Errors in a stat laboratory: types and frequencies 10years later. Procedures for collection of diagnostic blood specimens by venipuncture; approved guideline6th ed. Epub 2016 Oct 5. Intake of certain substances such as caffeine, nicotine and alcohol may also influence the levels of various analytes and the posture of the patient must also be considered [46]. If a patient is receiving parenteral nutrition (fat emulsions), sampling should be done preferably before the administration of the infusion, or 8 hours after the infusion. Heparinized WB is usually applied directly to the POCT instrument, thus eliminating the centrifugation step necessary to obtain plasma or serum. Incorrect sampling time; 2) Blood collection errors. Moreover, in patients suffering from severe dehydration and patients with poor peripheral circulation, capillary sampling should not be performed. The prescribed instructions were not followed, some volume of the urine sample was discarded or an improper container was used. The concept of EBM was first described by Sackett et al. Written and continuously updated standard operating procedures should be available to all users and should contain a detailed description of the best practices for procedures in use. Atay A, Demir L, Cuhadar S, Saglam G, Unal H, Aksun S, et al. A proposal for a standardized presentation of laboratory results. A total of 55,345 laboratory test requests and samples from different departments were evaluated for preanalytical errors. [7] Similar studies also found that inappropriate sample containers, insufficient sample volume, specimen handling, storage, and transportation were among the common errors. Preanalytical errors have a significant impact on the quality of laboratory results and patient safety. Recognizing and Reducing Analytical Errors and Sources of Variation in PDF Preanalytical Errors During Collection - Weebly A study by Atay et al. Enhanced educational efforts emphasizing specimen quality issues and training in sample collection among hospital staff must be carried out. The .gov means its official. If we capture data at every step with a proper checklist and analyse them in time, most of these pre-analytical errors can be easily avoided. If for some reason this is not possible, the sample may be drawn through an i.v. In contrast, literature studies provide excellent evidence that EDs have a higher incidence of hemolysis than other wards or outpatient phlebotomy services. Samples should not be mixed too vigorously, to avoid hemolysis. and recent interest in this phase has led to increased publications and congresses pertaining to this phase [17, 31]. Fryer AA, Smellie WSA. Simundic A, Lippi G. Preanalytical phasea continuous challenge for laboratory professionals. Bethesda, MD 20894, Web Policies An accepted practice in many laboratories is to repeat critical results to confirm them before they are communicated to the clinicians. Lippi G, Guidi GC. In a retrospective study conducted in Spain, Salinas et al. There are several actions that could trigger this block including submitting The person who performs the sampling must ensure that the information on the test request form is identical to the information obtained from the patient. For all sample types, appropriate CLSI guidelines exist which precisely define the procedure of sample collection. Noticeably, hemolyzed sample was the most common error in the OPD. The cost of poor blood specimen quality and errors in preanalytical processes. The introduction of transilluminating devices to assist with phlebotomy may help under these circumstances [9]. A study at our institution found a 10.8% error rate with the communication of critical results [56]. To assure proper patient identification, recommended practice is to use barcoding systems which may link sample, operator, instrument and test result to the patient record. Sampling should preferably be done after an overnight fast and preferably in the morning between 7 and 9 a.m. Certain contaminations such as K-EDTA contamination leading to spuriously increased potassium levels and decreased calcium levels are well described. 8600 Rockville Pike Inappropriate tests not only lead to increased costs and wasted labour, but may also lead to unnecessary further investigation of the patient with associated anxiety. Samples with visible clots should be rejected for analysis and sampling should be repeated. The pre-analytical phase which consists of specimen collection, transport and sample preparation for processing is the most important step and involves variables that are not under the control of the laboratory. Biochemia Medica 2007; 17(1): 5-9. Hemolysis is preventable, i.e. The synthetic indicator results summarized overall preanalytical sample errors. 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. Clin Chem Lab Med. administration of various intravenous fluids (electrolytes, glucose). Doctor misinterprets the results. Study of the errors in hematology laboratory in a tertiary care hospital. Sanchis-Gomar F, Lippi G. Physical activityan important preanalytical variable. Sources of errors in coagulation testing. Spanish Preanalytical Quality Monitoring Program (SEQC), an overview of 12 years experience. The discussion of errors in POCT is out of the scope of this review, but must be mentioned, as POCT is the fastest growing segment of the current clinical laboratory testing market [14]. Reports indicate that up to 70% of laboratory errors occur in this phase [10, 11]. On top of that, the composition of the blood undergoes significant changes after food consumption. Demand management within a health-care system can be defined as manipulating the use of health resources to maximise their utility and it ensures the right test on right patient at right time. Clinical Laboratory Standards Institute. 7 While patient preparation and sample collection (including patient and sample identification, and specimen . Such patient conditions could have a substantial influence on some parameters like: pH, pO2, pCO2, glucose, lactate, cortisol, white blood cells (WBC) and some other. If more than one tube is to be collected, the recommended order of draw must be followed during the blood sampling. PDF Preanalytical Errors and their Impact on Tests in Clinical Laboratory I believe, if we have relevant data for it, we can have better graphics or charts then better will be our understanding of errors. Clinical chemistry laboratory errors at St. Pauls Hospital Millennium Medical College (SPHMMC), Addis Ababa, Ethiopia. Irregular analytical errors in diagnostic testing - a novel concept How are pre-analytical errors prevented in your laboratory? Division of Chemical Pathology, National Health Laboratory Service (NHLS) and University of Stellenbosch, Tygerberg Hospital, Cape Town, 7505 South Africa. government site. Laboratory professionals mainly focused on analytical errors and mistakes in the past. Pre-Analytical, Analytical, & Post-Analytical Phases of Lab - Genemod If more than one tube is to be collected, the recommended order of draw stated below must be followed during the blood sampling. Quality improvement in clinical laboratories: a six sigma concept. Writing original draft: Jerold C. Alcantara, Khalid Alshaghdali, Bandar Alharbi, Mohammad Jahoor Alam. Up until recently, accreditation focussed mainly on the analytical phase of laboratory testing. The field of POCT holds approximately of the global IVD market and is expected to show continuous rapid growth in the next decade. Inadequate patient information may confuse interpretation of the result. Clinical biochemistry laboratory rejection rates due to various types of preanalytical errors. Venous, arterial and capillary blood samples may be used for POCT testing. The second step is to add 4 drops of Reagent B to the same tube. catheter (proximally) should never be done. It is estimated that a majority of all laboratory medicine errors are errors that occur during the by To prevent hemolysis during venous blood sampling, care must be taken to match the size of the needle and tube with the size of the vein. If a blood sample has to be obtained from a patient who is receiving an i.v. The occurrence of these errors was found to be highest in the emergency department (21%). Preanalytical Errors in a Hematology Laboratory: An Experience from a Tertiary Care Center by Mohammad Shahid Iqbal 1,*, Aisha Tabassum 1, Ahmad Fawzi Arbaeen 2, Ahmed H. Qasem 2, Adel G. Elshemi 2 and Hibah Almasmoum 1 1 Department of Laboratory Medicine, College of Applied Medical Sciences, Umm al Qura University, Makkah 21955, Saudi Arabia 2 Jones GD, Barker T. Reference intervals. And finally, the post-postanalytical phase refers to the clinicians response a laboratory test result. The pathology request-test-report cycleguidelines for requesters and pathology providers. Supervision: Jerold C. Alcantara, Khalid Alshaghdali, Bandar Alharbi. The use of contrast media such as organic iodine molecules and gadolinium contrast agents is commonplace in diagnostic imaging. Preanalytical Phase Errors: Experience of a Central Laboratory Comment on Types and origins of diagnostic errors in primary care settings [published correction appears in JAMA Intern Med. Lang T. Laboratory demand management of repetitive testingtime for harmonisation and an evidence based approach. The lack of quality systems used by laboratories may lead to errors and it is often untrained staff who perform the tests [11]. One of the most important factors in this step is capturing correct data. 27509185, Explore selected articles curated by biochemist and journalist Chris Higgins, Presented by Ana-Maria Simundic, PhD, Prof. of Medical Biochemistry, Zagreb University, Zagreb, Croatia, Preanalytical errors in Point-Of-Care Testing, Testing is performed by clinical staff (nurses, physicians). Get a hint. True or False: a specimen arrives with less volume than is needed for the test. Sonntag O. Likewise, data from this study can serve as guides in defining new approaches and strategies in decreasing the errors in the preanalytical phase. Up to 73% of laboratory errors may be preventable [5]. Accessibility Laboratory professionals must therefore ensure that all possible efforts are made to minimize the potential risk of errors and predicted waste. Narayanan S, Guder WG. [17] In another study, nonreceived samples (25.5%) were reported as the major preanalytical errors. Strictly speaking, this phase should also not fall under the laboratorys responsibility, however if the laboratory is sending out incorrect results, it may contribute to post-postanalytical errors. Literature studies have revealed that 60% to 70% of medical diagnostic decisions are made based on accurate laboratory tests. Educating medical students in laboratory medicine. Errors in this phase pose serious consequences and potentially compromise the correct diagnosis and management of patients. Hemolysis causes interference with many assays, due to the release of the blood-cell components from the lysed blood cells. Lundberg first reported the importance of critical result communication in 1972 [53] and ISO 15189 requires that critical results be communicated as quickly as possible to the treating clinician [54]. Evidence-based guidelines are useful for appropriate test selection [14, 22, 23]. [11] The rates of preanalytical error in the present study revealed that ED exceeded those from IPD and OPD. Nutt L, Zemlin AE, Erasmus RT. [11] Hence, the present study aimed to evaluate the errors in the preanalytical phase of testing in a clinical chemistry diagnostic laboratory in Saudi Arabia. Managing the demand for laboratory testing: options and opportunities. An increased occurrence of hemolyzed samples in the OPD was noted. line and choosing the venipuncture site below the tourniquet (distally). Other cause are clotted specimen and insufficient volume [35]. The overall leading preanalytical errors were nonreceived sample (3.7%) and hemolysis (3.5%). Diagnostics | Free Full-Text | Preanalytical Errors in a Hematology The risk of errors may be minimized by simplifying and standardizing the processes, implementing process automation wherever possible and continuous education of all who are involved in the POCT. 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 . Underfilled tubes must be rejected for analysis. PDF Pre and postanalytical errors in haematology - Fondation Mrieux An overall rate of 12.1% (6705) was determined as preanalytical errors. With improvements in analytical techniques and efficient quality control programmes, most laboratory errors now occur in the extra-analytical phases. How to cite this article: Alcantara JC, Alharbi B, Almotairi Y, Alam MJ, Muddathir ARM, Alshaghdali K. Analysis of preanalytical errors in a clinical chemistry laboratory: A 2-year study. A test sample that is not recommended to be sent in a pneumatic tube is. The aim of this review is to highlight the importance of these errors for the requesting clinician. Click the card to flip . Harmonization of processes in this phase and the introduction of a quality monitoring system may lead to a decreased risk of errors. Project administration: Jerold C. Alcantara, Khalid Alshaghdali. This led to the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) launching a working group in 2008 named Laboratory Errors and Patient Safety (LEPS) whose primary goal was to identify quality indicators pertaining to the total testing process [66]. Preanalytical errors in Point-Of-Care Testing 10.11613/bm.2012.017 Abstract in English, Croatian Preanalytical phase is the most vulnerable part of the total testing process and is considered to be among the greatest challenges to the laboratory professionals. Ehrmeyer SS, Laessig RH. 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. triggered the security solution. National Library of Medicine It is therefore critical that coagulation tubes are adequately filled. Preanalytical Errors in a Hematology Laboratory: An Experience from a A large source of postanalytical error involves the communication of critical results to the clinician and standardization of which critical values need to be communicated [16, 22, 54]. Laboratory errors are defined by the International Organization for Standardization (ISO) as failure of a planned action to be completed as intended, or use of a wrong plan to achieve an aim, occurring at any part of the laboratory cycle, from ordering examinations to reporting results and appropriately interpreting and reacting to them [7]. Turnaround time (TAT) is crucial to bedside testing. To avoid the risk of potential errors, all procedures need to be standardized and automated wherever possible. Zemlin AE, Nutt L, Burgess LJ, Eiman F, Erasmus RT. Due to improvements in laboratory assays, automation, improved quality control (QC) practices and calibration, the least errors now occur in this phase [4, 1315]. University Hospital SESTRE MILOSRDNICE It is well established that many analytes and blood parameters vary with time during the day, month or even between seasons. Lippi G, Chance JJ, Church S, Dazzi P, Fontana R, Giavarina D, et al. Hemolysis also interferes in most troponin assays, routine coagulation and hematology analyses. Interestingly, preanalytical errors range from 50% to 75% of the total errors registered in diagnostic laboratories. Unfortunately this error is difficult to detect and may be to the detriment of the patient. ); Patients are often not conscious nor contactable; Inadequate sample mixing (clotted sample, microclots, incomplete clotting fibrin interference). As mentioned, incorrectly filled in request form or untidy handwriting may precipitate errors at this stage, especially where non-medically trained staff try to interpret these forms. Preanalytical errors can lead to loss of patient trust in diagnostic services, can dent the laboratory's reputation, and lead to an increase in the overall operating expenses, both for laboratories as well as the hospitals. Validation: Jerold C. Alcantara, Khalid Alshaghdali, Bandar Alharbi, Yasser Almotairi, Abdel Rahim Mahmoud Muddathir, Mohammad Jahoor Alam. Blood sampling should be done at least 1 hour after the i.v. Carraro P, Zago T, Plebani M. Exploring the initial steps of the testing process: frequency and nature of pre-preanalytical errors. Examples of errors that arise in the preanalytical phase include errors in test ordering, patient identification, patient preparation, collection of samples, quality of collected sample (diluted, clotted, and hemolyzed sample), inappropriate containers and anticoagulants, and sample transportation and storage. The total testing process consists of various phases from the pre-preanalytical to the post-postanalytical phase, the so-called brain-to-brain loop. ISO 15189:2012 recommends quality indicators to monitor and evaluate laboratory performance [13]. The exact number of inversions varies and is usually declared by the tube manufacturer. The data in this study cover the period from January 2019 to December 2020. CLIA Compliance for Pre-Analytic, Analytic, and Post-Analytic Testing CLSI document H3A6. An increased midnight value (when levels should be low) is one of the screening tests for Cushings syndrome. Methodology: Jerold C. Alcantara, Khalid Alshaghdali, Bandar Alharbi, Yasser Almotairi, Abdel Rahim Mahmoud Muddathir, Mohammad Jahoor Alam. Underfilled tubes are among the most common preanalytical errors in POCT. Errors within the analytical phase are usually few, and results indicated that the number of errors within the analytical phase has continued to decrease over the last decade ( Plebani 2006 . Bonini P, Plebani M, Ceriotti F, Rubboli F. Errors in laboratory medicine. By shifting the point of the laboratory service from the central laboratory to the patient bedside, the laboratory therefore meets ever increasing difficulties in managing the quality in that area. [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. That is the reason why blood gases are sampled first. If the sample has to be obtained after a drug (which has a potential interfering effect on the requested tests) has already been administered, blood should be obtained only after the peak concentration has been reached and the patient is in the so-called steady state. Besides the fact that concentration of some parameters may change due to the direct effect of food consumption and intestinal absorption, it should also be emphasized that blood may become lipemic (turbid sample) postprandially. support@mdpi.com. The analytical phase involves the actual performance of the laboratory test, i.e. The decrease in pathology training of undergraduate medical training and unfavourable career options has led to a decrease in the amount of staff being trained as laboratory professionals which will have a detrimental effect on laboratory medicine [64]. Please answer the provided captcha challenge in order to proceed. Incompletely filled in laboratory request forms may also have a negative influence on the communication of critical results [55]. There are many such finer things, and which are overlooked several times which further can lead to testing errors. Patient identification should always contain full patient name, date of birth, address and unique identification number (hospital-based ID numbers, or some other number according to the policy of the hospital). If small-volume tubes are used for capillary sampling, the tubes must be filled to the mark, to required volume. Authors An increased rate of errors was also noted for the 2-year study period from 11.3% to 12.9%. Nikolac N. Lipaemia: causes, interference mechanisms, detection and management. For the above mentioned reasons, blood should never be combined from two tubes even if they contain the same anticoagulant. government site. However, we may have underestimated haemolysis as a rejection factor, as haemolysed samples are automatically rejected when they get to our laboratory. [3], A distinct and intricate process within laboratory medicine includes laboratory procedures, instruments, technology, and human skills intended to warrant accurate, precise, and appropriate diagnosis and treatment decisions. This will encourage managers, quality officers, and administrative leaders to participate or engage in quality monitoring systems and become more open to scrutiny and challenge. The action you just performed Plebani M, Lippi G. Improving the post-analytical phase. There is a chance of errors in any of these phases and there is a need for studies of errors specifically in the extra-analytical phases of laboratory testing. An example for this is the 21day progesterone level used to screen for the presence of ovulation. Federal government websites often end in .gov or .mil. Pre analytical errors - SlideShare Biochemia Medica 2010; 20(2): 131-43. Major characteristics which contribute to the increasing quality demands in the POCT are: To minimize the risk of errors all those issues need to considered and a total quality management system covering the complete POCT process should be established. HHS Vulnerability Disclosure, Help Recognition and documentation of these errors are crucial phases in enhancing the quality of laboratory medicine. When to panic over abnormal values. The .gov means its official. Laboratory requests and patient samples from the emergency, outpatient, and inpatient departments that were received from the 2-year retrospective analysis period were included in the study. e Molecular Diagnostic and Personalized Therapeutic Unit, University of Hail, Hail, Saudi Arabia. EBLM provides evidence for best laboratory practice and laboratory audits are essential to monitor if standards being set by EBLM are being adhered to [76, 77]. University Department of Chemistry Numerous working groups have now been established to monitor the extra-analytical phase, such as the Association for Clinical Biochemistry and Laboratory Medicine Preanalytical Working Group ACB-WG-PA) in the United Kingdom. The difference between relative frequencies of errors observed in the different departments was tested using the chi-square test. Most errors affecting laboratory test results occur in the pre-analytical phase (50 -75% of total errors). Another potential error at this stage is incorrect patient identification or when the sample is drawn on the wrong patient.
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an example of a preanalytical error is
