The issue of analytical interference does not only affect immunoassays. Errors within the total laboratory testing process, from test selection to medical decision-making - A review of causes, consequences, surveillance and solutions Laboratory analyses are crucial for diagnosis, follow-up and treatment decisions. Schiff GD, Aggarwal HC, Kumar S, McNutt RA. Safe Laboratory Practices & Procedures - National Institutes of Health Plebani M, Sciacovelli L, Aita A, Pelloso M, Chiozza ML. Plebani In the late nineties, a body of evidence was accumulated which documented: a) a dramatic decrease in the analytical error rates from 162,116 errors per million laboratory tests (parts per million, ppm) to 447 ppm (5, 6); b) high rates of errors in the pre- and post-analytical steps (7-9); and c) the risk of adverse events and inappropriate care due to laboratory errors, mainly for errors in pre-pre-analytical steps (10, 11). AM Laboratories can also be accredited by the College of American Pathologists (CAP) and the Commission on Office Laboratory Accreditation (COLA), both of which also have deemed status with CMS.7,8,9, Traditionally, laboratory practice can be divided into 3 phases (pre-analytical, analytical, and post-analytical). E Howanitz During the past decade, after the publication of the Institute of Medicine (IOM) report, To Err Is Human (1), patient safety has finally become the object of medical and public attention. Below, I describe ten common mistakes (listed in no particular order) that occur in laboratory research settings: Mistakes can occur at many levels, and sometimes they turn out to be due to innocent reliance on common or specialized methods - even published protocols - that are less than optimal. Another one of the most common causes of error in laboratories is procedural error. American Society for Healthcare Engineering (ASHE) When we are using handwritten label than be sure that they are legit and when we use a physical label, then make sure they are appropriate for our requirements like withstanding the required temperature. Bethesda, MD 20894, Web Policies The .gov means its official. Front Bioeng Biotechnol. Clinical laboratory data analytics can be very useful to troubleshoot these challenges. MeSH 2016 Jul 1;54(7):1169-76. doi: 10.1515/cclm-2015-0897. Here are the types of errors which most commonly occur: Before specimen collection: Patient is misidentified, specimen tubes are incorrectly labeled or aren't labeled at all, patient did not follow proper procedures before test (such as fasting). Well-written laboratory testing procedures, validation of laboratory instruments and assays, strong quality control programs, and proper education and training of laboratory professionals are practices that will decrease common analytical laboratory system errors and reduce data variability. the pipette may not pick up the sample properly which can lead to an erroneous report/value. The Preanalytical Errors: a Continuous Challenge for Clinical - Ascls 2022 Oct 20;14(4):373-376. doi: 10.1055/s-0042-1757228. By recognizing untoward events In many studies of total testing errors, analytical errors are often <10% and their frequency is decreasing due to standardization of laboratory procedures and assays, automation within the clinical pathology laboratory, and advances in technology (Plebani 2006, 2010; Sakyi et al. Casalino LP, Dunham D, Chin MH, Bielang R, Kistner EO, Karrison TG, et al. (22). PJ Available at: http://www.ashe.org/advocacy/organizations/TJC/deemedstatus.html. For full access to this pdf, sign in to an existing account, or purchase an annual subscription. Clin Chim Acta. Although the causes of these errors are largely com-mon to all laboratory medicine specialties, it is important for the haematology labora - tory to understand the particular impact of some on automated counting. Every woman deserves to thrive. The journey towards a patient-centered view of errors in laboratory medicine. Some of the common factors that are responsible for most of the failures in a lab are not enough knowledge in the experiment, lack of experience and some of the very common, silly mistakes that we make in the process. G Ceriotti Pragmatically, this can be achieved using 3 complementary actions: preventing adverse events (error prevention), making them visible (error detection), and mitigating their adverse consequences when they occur (error management).24, Other methodologies can also be used to prevent errors. In both studies, the pre-analytic phase had the highest error rate, the most frequent problems arising from mistakes in tube filling, inappropriate specimen containers, and requesting procedures. Bethesda, MD 20894, Web Policies Carraro Ann Clin Biochem. Many mistakes in the Total Testing Process are called "laboratory errors", although these may be due to poor communication, action taken by others involved in the testing process (e.g., physicians . 2015 May;53(6):943-8. doi: 10.1515/cclm-2014-1124. Many mistakes in the Total Testing Process are called "laboratory errors", although these may be due to poor communication, action taken by others involved in the testing process (e.g., physicians, nurses and phlebotomists), or poorly designed processes, all of which are beyond the laboratory's control. Bookshelf The importance of incident reporting in laboratory diagnostics, The Conceptual Framework for the International Classification for Patient Safety, Using health care Failure Mode and Effect Analysis: The VA National Center for Patient Safetys prospective risk analysis system, American Society of Clinical Pathologists, A novel high-resolution melting analysis strategy for detecting cystic fibrosiscausing variants, Clinical impacts of the rapid diagnostic method on positive blood cultures, Nitrate Reductase Assay for Rapid Determination of Methicillin-Resistant Staphylococcus aureus Clinical Isolates, Relationship between the systemic immune-inflammatory index and the severity of acute bronchiolitis in children, About the American Society for Clinical Pathology, Incident Reporting in Laboratory Diagnostics, http://www.ashe.org/advocacy/organizations/TJC/deemedstatus.html, http://www.cap.org/apps/cap.portal?_nfpb=true&cntvwrPtlt_actionOverride=%2Fportlets%2FcontentViewer%2Fshow&_windowLabel=cntvwrPtlt&cntvwrPtlt%7BactionForm.contentReference%7D=laboratory_accreditation%2Faboutlap.html&_state=maximized&_pageLabel=cntvwr, http://www.who.int/patientsafety/taxonomy/icps_statement_of_purpose.pdf, Receive exclusive offers and updates from Oxford Academic, A Reflex Protocol for Creatinine Testing Reduces Costs and Maintains Patient Safety, A Trend Analysis of Quality Indicators of Patient Safety in the Clinical Laboratory Over 21 Months, Quality-Improvement Measures as Effective Ways of Preventing Laboratory Errors. The detection and prevention of errors in laboratory medicine. mistakes, blunders, defects, outliers, unacceptable results, quality failure) have negative connotations involving blame, individual failure and culpability and, even worse, pertain to studies focusing on a limited number of total testing process (TTP) steps. College of American Pathologists (CAP) . There must be ongoing training for these employees and competencies must be assessed annually.21, Modern robotic technologies and information systems can also help reduce pre-analytical errors. A further step in the journey towards improved understanding of the issue is the recent demonstration that errors in laboratory medicine are part of a much wider issue, commonly known as diagnostic error, thus definitively linking laboratory-associated errors to patient safety problems. The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) launched in 2004 a new project, implementing a Working Group on Laboratory Errors and Patient Safety (WG LEPS) that promoted and developed a model of quality indicators (MQI) (29, 30). Instrument interfacing issues also play a very important role. Dean The reasons for this neglect are complex, but the difficulties largely arise from the number of steps and the time lapse which separate laboratory testing, physicians actions and patient outcomes (2). So the laboratory has only 3-6 hours of processing time for such samples. Reducing the occurrence of errors in a laboratory's specimen receiving Unable to load your collection due to an error, Unable to load your delegates due to an error. Clinical laboratories have long focused their attention on quality control methods and quality assessment programs dealing with analytical aspects of testing. -, Bucurescu S. Pre-analytical Laboratory Error in a Stroke Patient due to Blood Collection from another Stroke Patient: A Case Report. Centers for Medicare and Medicaid Services Potential conflict of interest: None declared. The role of EQA and proficiency testing (PT) is to provide reliable information allowing laboratories to assess and monitor the quality status of internal procedures and processes, the suitability of the diagnostic systems, the accountability and competence of the staff, along with the definition of measurement uncertainty in laboratory results. It is a systematic process for identifying potential process failures before they occur, with the aim to eliminate them or minimize the relative risk. We and our partners use data for Personalised ads and content, ad and content measurement, audience insights and product development. . . The frequency of this type of error is variable and probably underreported (12). Impact of Time Delay in the Analysis of Serum Ionized Calcium, Sodium, and Potassium. 2016 Jul 1;54(7):1169-76. doi: 10.1515/cclm-2015-0897. Accessed June 16, 2011. Laboratory testing is a highly complex process and, although laboratory services are relatively safe, they are not as safe as they could or should be. From a risk management viewpoint, the great majority of laboratory errors have little direct impact on patient care but provide important learning opportunities. The current awareness of the nature of laboratory testing-associated errors, in particular the link between appropriate test ordering and result interpretation/utilization, and their potential in reducing diagnostic errors, should herald a change in the old paradigm which was focused only on errors detected within the laboratory walls. The consent submitted will only be used for data processing originating from this website. Hickner J, Graham DG, Elder NC, Brandt E, Emsermann CB, Dovey S, et al. The overall rate of failure to inform the patient or to record communication of information was 7.1%, in different practices, ranging from 0 to 26% (21). If a new sample cannot be obtained, it is the responsibility of the laboratory specialist to communicate the problem to the clinician. By organizing the tests based on their processing TAT (analytical TAT) we can optimize the, process. Lippi Most of those are picked from a doctors clinic or healthcare setting. et al. 2013;4:178. Plebani For laboratory errors caused by organizational problems outside the laboratory . The site is secure. Kachalia A, Gandhi TK, Pupolo AL, Yoon C, Thomas EJ, Griffey R, et al. Improving communication among health care professionals and fostering interdepartmental cooperation.18,19,20, Types and Rates of Error in the 3 Stages of the Laboratory Testing Process9,20, Written procedures must clearly explain how to identify a patient, collect and label a specimen, and subsequently transport the specimen and prepare it for analysis. J Cytol. The https:// ensures that you are connecting to the To prevent this form of error from occurring, its important to stabilize the conditions of an experiment or test and minimize the influence that the environment has on the experiments final result. Gawande 2011;136:82933. DM can help to know if there is any problem with machines or are ready for testing. The lesson we learnt is that the entire system (TTP) should be designed to consider not only the real patient harm sustained, but also the potential worst clinical outcome if such an error were to recur. . Preanalytical Phase Errors: Experience of a Central Laboratory Types of analytical errors in laboratory are often 10% but frequency has decreased in the last decade in diagnostic testing. In an automated lab, good laboratory information management software should be able to red-flag these errors and create alerts for the technician. Rics C, Garca-Victoria M, de la Fuente B. Clin Chem Lab Med. Laboratory medicine sets high quality standards. However, a growing body of evidence accumulated in recent decades demonstrates that quality in clinical laboratories cannot be assured by merely focusing on purely analytical aspects. As you probably guess from the name, percent error is expressed as a percentage. That means handling stress, getting good women's health care, and nurturing yourself. Accessibility In the post-analytical phase of the testing process, results are released to the clinician, and s/he interprets them and makes diagnostic and therapeutic decisions accordingly. FOIA The most common error calculation is percent error, which is used when comparing your results against a known, theoretical, or accepted value. Tayal The brain-to-brain loop concept for laboratory testing 40 years after its introduction. G . Of course, everybody makes a mistake and its part of our learning process. Plebani In 2008, the release of a Technical Specification (ISO/TS 22367) by the International Organization for Standardization played a key role in collecting the evidence and changing the perspective on laboratory errors, emphasizing the need for a patient-centred approach to errors in laboratory testing. About the CAP Accreditation Program. Leape Missed and delayed diagnoses in the ambulatory setting: a study of closed malpractice claims, The frequency of missed test results and associated treatment delays in a highly computerized health system. . . Errors in Surgical Pathology Laboratory | IntechOpen Secchiero The list of Qls is available on line at www.ifcc-mqi.com. have fewer challenges as compared to the pre-analytical, but they can be very damaging and cost a life too. Goswami Performance criteria and quality indicators for the pre-analytical phase. Stalhandske . To prevent instrumental errors from skewing your experiment and test results, its imperative to maintain your equipment properly, keep an eye out for signs of potential damage, and replace or repair faulty equipment as needed. Clin Chem Lab Med. Deemed Status. Failure to inform patients of clinically significant abnormal test results or to record the delivery of relevant information is relatively common, occurring in 1 out of every 14 tests; for example, patients not being informed of a total cholesterol value of 8.2 mmol/L (318 mg/dL), hematocrit of 28.6% or a potassium level of 2.6 mmol/L. Event reporting in laboratory medicine. Review of Medical Errors in Laboratory Diagnostics and Where We Are 2012;43(2):41-44. Compared with other types of medical error, however, errors in laboratory medicine received little attention and the reasons for this neglect are complex, as shown in Table 1. The receipt and processing of specimens is . Epub 2022 Aug 17. J Mass Spectrom Adv Clin Lab. mistakes, blun-ders, defects, outliers, unacceptable results and . Is there something we are missing? Heterogeneous and ambiguous definition of what a laboratory error really is; 2. Interferograms plotted with reference change value (RCV) may facilitate the management of hemolyzed samples. For example, if a piece of laboratory equipment was not calibrated properly, instrumental error would likely occur.