A review was conducted at the Clinical Chemistry Laboratory of a hospital in Saudi Arabia from January 2019 to December 2020. Certain analytes such as cortisol have a circadian rhythm and should be taken at a specific time. 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. Detection of haemolysis, a frequent preanalytical problem in the serum of newborns and adults. If the patient is not conscious or is not able to speak (children, foreigners, etc. 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 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. Vasikaran SD, Lai LC, Sethi S, Lopez JB, Sikaris KA. ), information should be obtained from the person who is responsible for the patient (relative, caregiver, friend). An example of a preanalytical error made at the time of collection is failing to mix the tubes RFID, as used in healthcare, is a method of specimen identification The "order inquiry" function allows the user to retrieve all test orders on a patient Processing specimens requires various types of protection, but this PPE is unneccessary Excessive massage may cause falsely decreased concentrations (up to 10 %) of some parameters due to the dilution of the blood sample with tissue fluid and falsely increased concentration of potassium due to sample hemolysis. Lundberg GD. Increased TAT is one of the most common postanalytical errors and causes of customer complaints in the laboratory [4]. The impact of repeat-testing of common chemistry analytes at critical concentrations. Preanalytical quality improvement. official website and that any information you provide is encrypted 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. Codagnone FT, Alencar SMF, Shcolnik W, et al.. Study of the errors in hematology laboratory in a tertiary care hospital. If possible, sampling should always be done prior to the interfering diagnostic procedure or drug administration. A review of medical errors in laboratory diagnostics and where we are today. Furthermore, a decline was also observed over the 2 years in the following: nonreceived samples, insufficient sample quantity, specimen broken, leaked, compromised, etc, duplicated test requests, labeling errors, and incomplete test request data. Pre-Analytical, Analytical, & Post-Analytical Phases of Lab Testing in 2022 Skip to main Products PRODUCT Notebook Inventory Dashboard Molecular biology FEATURE Consumables Live-editing Protocols Insights Solutions GENEMOD FOR Biopharma Startups Academia Non-profit BY TEAM FUNCTION R&D Managers Admins IT Resources COMPARE vs Excel vs Quartzy A preanalytical error may contribute to 0.0231.2% of total hospital operating costs [33]. Challenges in Preanalytical Phase of Laboratory Medicine: Rate of Blood However, analysis showed a significant decline in this error over the 2 years from 40.1% to 17.2%. Quality indicators to detect pre-analytical errors in laboratory testing. Preanalytical errors in medical laboratories: a review of the available Plebani M, Sciacovelli L, Aita A, Padoan A, Chiozza ML. Moreover, quality control and calibration are quite often not performed according to the manufacturers instructions. This study underscores the need for quality controls and quality assurance in the preanalytical phase to monitor existing errors to improve patient safety and laboratory diagnosis. Using the laboratory information system, the data of all canceled tests and requests were retrieved and evaluated for preanalytical errors. Fryer AA, Hanna FW. Vanker N, van Wyk J, Zemlin AE, Erasmus RT. Plebani M, Lippi G. Improving the post-analytical phase. Errors in this phase pose serious consequences and potentially compromise the correct diagnosis and management of patients. 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. Samples should not be mixed too vigorously, to avoid hemolysis. Erasmus RT, Zemlin AE. Rensburg MA, Nutt L, Zemlin AE, Erasmus RT. nurses and physicians), who are neither so skilled nor educated for laboratory work as laboratory professionals. Incorrect patient identification c. Transposition of a numeric critical value in transmitting a report d. Use of the wrong anticoagulant in the patient sample tube a. How good is the evidence base for test selection in clinical guidelines? support@mdpi.com. The data in this study cover the period from January 2019 to December 2020. Inexperienced phlebotomist/staff, insufficient training and education on sample collection and quality, and heavy workload are other factors that could contribute to these errors. The first step is to add 4 drops of reagent A to each small test tube. A retrospective study of quality improvement in clinical biochemistry laboratory. 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]. Dr. Ravi Gaur (Director & Chair Medical Advisory Committee, Oncquest laboratories Ltd) shares his expertise and suggests-, Quality is never an accident. Incorrect patient information on the request form (a preanalytical error) may lead to incorrect interpretative comments (a postanalytical error) [52]. line and choosing the venipuncture site below the tourniquet (distally). As already mentioned, to prevent hemolysis during capillary blood sampling, excessive massage should be avoided as this will cause sample hemolysis. Sonntag O. Most errors affecting laboratory test results occur in the pre-analytical phase (50 -75% of total errors). The recognition of these errors is important as they may influence patient care [12]. Sandhaus LM. Review of the Preanalytical Errors That Impact Therapeutic Drug [7,15,16] Variation of the quality indicators used, sample acceptance and rejection criteria, length of the study periods, reporting and recording system, sample size, and laboratory facilities are factors that contribute to the disparity of results. First of all, POCT testing is usually performed by clinical staff (i.e. 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. Quality of interpretative commenting on common clinical chemistry results in the Asia-Pacific region and Africa. Salinas M, Lpez-Garrigs M, Flores E, Santo-Quiles A, Gutierrez M, Lugo J, et al. To decrease the number of errors in the preanalytical phase, laboratory staff, general practitioners and patients should be educated and active promoting of preanalytical procedures by the laboratory staff should be encouraged. 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]. eJIFCC, vol 13 no 1. 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]. 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. Clin Biochem 2013; 29 (. the contents by NLM or the National Institutes of Health. For example, coagulation tubes contain 3.2 % liquid sodium citrate as the anticoagulant. Methods: Specific preanalytical factors in sample timing, collection, transport, processing, and storage that lead to errors in TDM were reviewed. Misra S, Barth JH. If the internal and external QC is satisfactory, this practice is unnecessary as results in the normal range are accepted without being repeated. CLSI Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture (H03-A6); Approved Standard Sixth Edition, CLSI Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens (H04-A6); Approved Standard Sixth Edition. Evidence based medicine: what it is and what it isnt. The high rate of this error implies that ED clinical staff were not fully oriented to this criteria or policy. Analysis of the annual preanalytical errors revealed an increasing rate in the OPD and IPD, whereas a decreasing rate was observed in the ED (Table (Table3).3). Lippi G, Simundic AM, Mattiuzzi C. Overview on patient safety in healthcare and laboratory diagnostics. Lippi G, Banfi G, Church S, Cornes M, De Carli G, Grankvist K, et al. The cost of poor blood specimen quality and errors in preanalytical processes. The https:// ensures that you are connecting to the 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. Generally, blood sampling should be done at least one hour after the i.v. Writing original draft: Jerold C. Alcantara, Khalid Alshaghdali, Bandar Alharbi, Mohammad Jahoor Alam. In that case, the opposite arm should be used for blood sampling. Preanalytical Errors in a Hematology Laboratory: An Experience from a Volume 54, Issue 1 https://doi.org/10.1177/0004563216669384 PDF / ePub More Abstract Preanalytical errors have previously been shown to contribute a significant proportion of errors in laboratory processes and contribute to a number of patient safety risks. For example, falsely high . 2007; 45(6): 766-73. However, a protocol for removing lipids from the sample has to be chosen carefully, since it is dependent on the analytes that have to be determined [38]. Having that in mind, it is quite understandable that laboratory errors may have serious consequences to patient health and outcome. EDTA tubes should be drawn before tubes with glycolysis inhibitor (oxalate or fluoride) to prevent alterations in cell morphology due to the disruptive effect of oxalate and fluoride to cell membranes. Rustad P, Felding P, Franzson L, Kairisto V, Lahti A, Mrtensson A, et al. Measuring diagnostic errors in primary care: the first step on a path forward. Click the card to flip . 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. [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. Preanalytical errors in medical laboratories: a review of the available Brain-to-brain turnaround loop. Low level of adherence to instructions for 24-hour urine collection among hospital outpatients. INTRODUCTION Much of the improvement in the quality of laboratory testing in re-cent decades has focused on what happens to the specimen during the analytical or laboratory testing phase, which lends itself to stan-dardised processing, statistical internal quality control (IQC) and ex-ternal quality assessment or proficiency testing (EQA/PT). a certain word or phrase, a SQL command or malformed data. government site. 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. As these three types have different focus and different challenges regarding implementation, it is suggested that a combination of the three is probably necessary to detect the wide range of errors that occur in the preanalytic phase [75]. Also, the data capturers or preanalytical staff may be unfamiliar with medical terms and abbreviations and may not be used to interpreting clinicians hieroglyphics. Received 2016 Nov 12; Accepted 2017 Apr 28. Clinical chemistry laboratory errors at St. Pauls Hospital Millennium Medical College (SPHMMC), Addis Ababa, Ethiopia. If you ended up on this page doing normal allowed operations, please contact our support at This phase describes the phase before the test is even ordered where the clinician decides which test to order [18]. Unfortunately, there is still a lack of harmonization in extra-analytical phases of laboratory testing [11, 78]. Nowadays, modern health facilities, next to the central laboratory, also offer various testing services provided at the point of the patient care, fulfilling the ultimate aim to provide the best result for the right patient at the right time. Those patients are quite often not conscious and venipuncture is very often difficult due to fragile veins, hypotension and many other conditions. However, many preanalytical errors may be unrecognised as there is no process of sample rejection [65]. A total of 55,345 laboratory requests and samples from different departments and wards were evaluated for preanalytical errors. Altitude. The use of indicators in the pre-analytical phase as a laboratory management tool. Although ISO 15189:2012 recommends EQA programs for the entire testing process, including pre-and postanalytical procedures [72], EQA schemes currently focus on the analytical phase. Sampling time relative to the biological variation and time of treatment administration has to be taken into account when interpreting the test results. Underfilled tubes must be rejected for analysis. You do not have enough reagent B for the last two tests. In case that sampling is done at some other time, the exact time needs to be recorded on the test request. These increases may be due to an aging population with more patients with chronic diseases, better informed patients due to self-diagnosis by Dr Google requesting tests from the treating clinician, the availability of more tests with quick turnaround times, and fear of litigation by the clinician and therefore defensive testing [2426]. To avoid the risk of potential errors, all procedures need to be standardized and automated wherever possible. It is essential that laboratory professionals and clinicians work together closely to ensure the smooth implementation and monitoring of POCT. Notably, nonreceived samples were the most prevalent in ED (6.1%) and IPD (4.8%), while hemolysis (4.2%) was predominantly observed in OPD. IFCC WG-LEPS. To avoid some most common preanalytical errors in POCT, the following 20 tips are recommended: May contain information that is not supported by performance and intended use claims of Radiometer's products. For samples that must be collected from the patient and transported to the POC device, the small size of the sample container can make properly labeling the specimens a challenge. Christopher P. Price. Analytical errors and specimen journey Flashcards | Quizlet Hemolysis causes interference with many assays, due to the release of the blood-cell components from the lysed blood cells. Sampling from the site above the i.v. Phlebotomy Variability may be introduced during phlebotomy: using the wrong specimen tube (e.g., wrong type and concentration of anticoagulant for specimen collection) and the effect of drawing blood from an infusion site. Although the laboratory approximately spends only up to 10 % of the total hospital budget, it delivers almost up to 70 % of the diagnostic information per patient. official website and that any information you provide is encrypted Some laboratories in the developed world use electronic request forms which may prevent many of these errors occurring, however in developing countries this is still a far off dream. Specimen rejection in laboratory medicine: necessary for patient safety? The aim of this article is to review the causes and corrective procedures for some of the most common preanalytical errors in POCT. Unfortunately, the evidence shows that most of the laboratory errors (60-80 %) occur outside of the analytical phase and most often outside of the laboratory (i.e. If a patient is receiving parenteral nutrition (fat emulsions), sampling should be done preferably before, or 8 hours after the administration of the infusion. Chemistry and haematology sample rejection and clinical impact in a tertiary laboratory in Cape Town. The study was conducted at the Clinical Chemistry Laboratory of a hospital in Saudi Arabia, a 200-bed capacity with inpatient, outpatient, and emergency services. Why is the sampling time so important? And yet others, such as vitamin D levels may be influenced by seasonal factors. 2). This review focuses on potential errors in the extra-analytical phases of clinical chemistry laboratory testing, some of the studies performed to assess the severity and impact of these errors and processes that are in place to address these errors. Biological variation (between and within subject) is also a potential preanalytical influence on laboratory testing and needs to be considered [11]. Manufacturers instructions for routine instrument operation and maintenance as well as instructions for handling and storage of reagents are often not followed. Laboratory errors, Preanalytical phase, Postanalytical phase, Quality indicators, Quality assessment. Simundic AM, Cornes M, Grankvist K, Lippi G, Nybo M. Standardization of collection requirements for fasting samples For the Working Group on Preanalytical Phase (WG-PA) of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM). Kristensen GB, Aakre KM, Kristoffersen AH, Sandberg S. How to conduct external quality assessment schemes for the pre-analytical phase? The second step is to add 4 drops of Reagent B to the same tube. Ideally, to minimize the error regarding the sampling time, sampling should preferably be done after an overnight fast and preferably in the morning between 7 and 9 a.m. Besides coagulations tests, underfilled tubes are also inappropriate for measuring hematocrit and mean cell volume (red blood cells shrink due to the effect of EDTA) as well as in some immunoassays (heparin interference). Detecting Preanalytical Errors Using Quality Indicators in a - LWW barcode and multiple IDs) Training. [19,20], Another leading preanalytical error in this present study was hemolysis (29.2%). This field is therefore rapidly changing the traditional structure and organization of the laboratory service from large centralized laboratories to a more decentralized structure. Tate JR, Johnson R, Barth J, Panteghini M. Harmonization of laboratory testingcurrent achievements and future strategies. catheters in patients who receive any kind of medication. Demand management: an audit of chemical pathology test rejections by an electronic gate-keeping system at an academic hospital in Cape Town. Pre-pre-examination errors include: inappropriate test request, order entry, patient/specimen mis-identification or haemolysis; pre-examination include sorting, aliquoting, pipetting; examination errors include equipment failure, sample mix-ups, interference; post-examination include erroneous data validation, excessive turn-around-time, data en. The only available reagent is in a new box received on a different date than the one you are using. Jones GD, Barker T. Reference intervals. Blood sampling should be done at least 1 hour after the i.v. Unlike other interferences, lipaemia can be removed and measurement can be performed in a clear sample. In pursuit of harmony, on behalf of the European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for Preanalytical Phase (WG-PRE). Is the result interpreted correctly by the clinician? Heparinized WB is usually applied directly to the POCT instrument, thus eliminating the centrifugation step necessary to obtain plasma or serum. Managing demand for laboratory tests: a laboratory toolkit. 2017 Jan;54 (1):14-19. doi: 10.1177/0004563216669384. The concept of EBM was first described by Sackett et al.
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