The RCV has hence been proposed for better reflecting the (clinically) significant change of serial results (94). government site. The rate of samples rejected for contamination with fluids from intravenous infusions can be as high as 2.2% of overall samples (44). An international study of how laboratories handle and evaluate patient samples after detecting an unexpected APTT prolongation. Institute of Medicine (US) Committee on Quality of Health Care in America Kohn LT, Corrigan JM, Donaldson MS, editors. When sample tubes were labelled after phlebotomy, labelling was not carried out in the presence of the patient in nearly one-third of cases (Figure 6) (42). 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. Post-analytical Issues in the Clinical Laboratory | SpringerLink Defining a roadmap for harmonizing quality indicators in Laboratory Medicine: a consensus statement on behalf of the IFCC Working Group Laboratory Error and Patient Safety and EFLM Task and Finish Group Performance specifications for the extra-analytical phases. The majority of errors in laboratory medicine occur in the pre- and postanalytical phases of the testing process. PDF Pre and postanalytical errors in haematology - Fondation Mrieux Unlike most currently available reviews on this topic, we also include errors in test-selection, reporting and interpretation/action of test results. A preliminary consensus. Clin Chem Lab Med. Although most pre-analytical errors are discovered before the samples reach the lab, if they are not spotted, they can cause serious problems further down the line. Additional errors within the ordering process may occur during the test requesting procedure itself. Introduction. official website and that any information you provide is encrypted National Library of Medicine A Black Swan in clinical laboratory practice: the analytical error due to interferences in immunoassay methods. To avoid delays in diagnosis and treatment, patient samples should be processed as quickly as possible (22). Post-analytical laboratory work: national recommendations from the In general, every step of sample preparation which can be automated by pre-analytical workstations is effective to mitigate the risk of human errors (33, 45, 64). The Six Sigma approach would be another way to document and compare errors (20). In: Guder WG, Narayanan S, eds. When the presence of lipemia cannot be eliminated, additional centrifugation steps, sample dilution or specific clearing reagents might be helpful (66). appropriate force and time of centrifugation) (65, 67, 72). EN ISO 15189 - Medical laboratories - Requirements for quality and competence (ISO 15189:2012). In selected cases (e.g. Missed hypothyroidism diagnosis uncovered by linking laboratory and pharmacy data. The number as well as the reasons of revised reports should be assessed to identify and improve error-prone steps throughout the TTP (18, 80, 87). HHS Vulnerability Disclosure, Help Buchta C, Coucke W, Mayr WR, Muller MM, Oeser R, Schweiger CR, et al. Inappropriate use of laboratory tests may present as over- or underutilization. The use of pneumatic tubes systems (PTS) for sample transportation is commonplace in many hospitals (59). using of appropriate needles or low vacuum tubes, avoiding excessive shaking) to transport (e.g. Lima-Oliveira G, Guidi GC, Salvagno GL, Brocco G, Danese E, Lippi G. Estimation of the imprecision on clinical chemistry testing due to fist clenching and maintenance during venipuncture. Identification errors involving clinical laboratories: a College of American Pathologists Q-Probes study of patient and specimen identification errors at 120 institutions. This inspired a patient-centred evaluation of errors in laboratory testing and an increased concern to identify weaknesses and vulnerability in procedures and processes, so that corrective and preventive actions can be activated before any adverse event or patient harm may occur. Collecting blood in the appropriate tubes and with the appropriate order of draw is crucial to avoid additive carryover. The issue of analytical interference does not only affect immunoassays. After analysis, results have to be entered into the LIS. Potassium-EDTA contamination of heparin samples may result in spurious hyperkalaemia and low concentrations of calcium due to EDTA sequestration (4). In fact, over the past decades, a ten-fold reduction in the analytical error rate has been achieved thanks to improvements in the reliability and standardization of analytical techniques, reagents, and instrumentation. Badrick T, Gay S, McCaughey EJ, Georgiou A. Yet another study revealed that of 1,095 discharged patients, almost half had pending laboratory and radiology test results, 9% of which potentially required action (25). sterreichisches Normungsinstitut (NORM). 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. In-vitro hemolysis and its financial impact using different blood collection systems. Since the adherence to available recommendations seems to be low, the laboratory should provide local indications, for example based on guidelines of the EFLM WG-PRE and COLABIOCLI WG-PRE-LATAM, the CLSI or the World Health Organization (WHO), in the national language and establish a system to guarantee that all phlebotomists are trained correctly (40, 42, 52, 57). Review of Medical Errors in Laboratory Diagnostics and Where We Are However, these systems must be validated to prevent the release of erroneous test results (87). QI quality indicators. For implementation and maintenance of such a system, the EFLM WG-PRE provides guidelines in several languages, as well as freely accessible tools, available at https://www.eflm.eu/site/page/a/1194. In this review, we hence want to describe the types and frequencies of errors, which may occur during the TTP (i.e., the brain-to-brain loop), including test selection and interpretation/medical action. Quality specifications for the extra-analytical phase of laboratory testing: Reference intervals and decision limits. To ensure the right sample transportation, local requirements have to be defined and distributed to all clinicians, nursing staff and carriers (22, 59). A Retrospective Analysis of Corrected Laboratory Results in a Large Academic Medical Center. Available at: Greiner Bio-One Gmb H. VACUETTE(R) Preanalytics Manual - Preanalytics Handling Recommendations. Pre-analytical errors damage an institution's reputation, diminish confidence in healthcare services, and contribute to a significant increase in the total operating costs, both for the hospital and laboratory. Sung S, Forman-Hoffman V, Wilson MC, Cram P. Direct reporting of laboratory test results to patients by mail to enhance patient safety. Ideally, a visualization technique that meets the local requirements is selected in collaboration with clinicians, for ensuring appropriate assessment of crucial results. The time of sample collection should always be documented, to verify whether laboratory analyses are performed within the time of stability of the respective parameter. A survey carried out by the External Quality Assurance Providers in Laboratory Medicine (EQALM) recently confirmed that this practice is considerably variable across many European laboratories (60). due to haemolysis), Lippi et al. Recognizing and Reducing Analytical Errors and Sources of Variation in 2007; 45:712 . In this review, we aim to discuss the types and frequencies of potential errors in the total testing process, quality management options, as well as tentative solutions for improvement. Determination of catecholamines in plasma and urine. However, it must be kept in mind, that RIs only cover the central 95% of the studied population. Coskun A, Oosterhuis WP, Serteser M, Unsal I. Sigma metric or defects per million opportunities (DPMO): the performance of clinical laboratories should be evaluated by the Sigma metrics at decimal level with DPMOs. Therefore, the main message is the need to improve the quality of laboratory services, avoiding errors and improving patient safety, employing a global approach across the TTP, according to the seminal concept of the brain-to-brain loop (35). A survey focusing on potentially actionable results, which were not available at the patients discharge, revealed that the rate of unawareness was as high as 61.6% (Figure 2). Lippi G, Blanckaert N, Bonini P, Green S, Kitchen S, Palicka V, et al. Nevertheless, interferences may even be clinically plausible, thus making their identification really challenging (84). 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. Other biasing conditions include unchangeable interferences of the specimen itself, such as leucocytosis or hyperproteinaemia (see chapter Analysis), or deviations from recommendations on blood collection (see chapter Sample collection). Pre-analytical workstations: a tool for reducing laboratory errors. Federal government websites often end in .gov or .mil. The use of inappropriate containers accounts for 0.03% to 3.6% of overall sample, or 2.6% to 8.1% of all errors analysed (6, 7, 43, 44). In a retrospective analysis, only 0.01% of the reported results had to be corrected (Figure 1) (80). Preliminary data from the IFCC Working Group Project Laboratory Errors and Patient Safety, Towards harmonization of quality indicators in laboratory medicine. However, several studies showed that shorter centrifugation time at a higher speed may not significantly alter specific tests results, while being effective to lower the turnaround time (76, 77). Since manual procedures seem to be especially vulnerable to clerical errors, automation of result transfer from analyzer to LIS should be preferred, and manual transcription errors monitored (18, 33, 80). Simundic AM, Bolenius K, Cadamuro J, Church S, Cornes MP, van Dongen-Lases EC, et al. Kachalia A, Gandhi TK, Pupolo AL, Yoon C, Thomas EJ, Griffey R, et al. Unlike haemolysis, lipemia and icterus may be considered in vivo interferences. In addition, intra-laboratory sample processing should be continuously monitored with color-coded alarms when individual samples are processed too slow. 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). catecholamines, may be influenced by the type of aliments ingested recently (48). An interesting meta-analysis has recently shown that the mean rates of overutilization can be as high as 20.6% (Figure 1) (23). This, in turn, is the main driver for the increasing awareness and concern regarding the need of standardization and harmonization projects in laboratory medicine (13). EN ISO 9001 - Quality management systems - Requirements (ISO 9001:2015). Managing Post-analytical Errors. Again, collaboration with clinicians is necessary to understand their expectations and to assess where improvements outside the laboratory are most feasible. Casalino LP, Dunham D, Chin MH, Bielang R, Kistner EO, Karrison TG, et al. Analytical interferences are still a huge challenge. Preanalytical requirements of urinalysis. Physician survey of a laboratory medicine interpretive service and evaluation of the influence of interpretations on laboratory test ordering. However, the advantages and disadvantages have to be considered before implementation (103). In addition, the vast majority of laboratories have now implemented a quality management system according to the requirements of ISO 15189, ISO 9001, or other national standards (13, 14). Austrian Standards Institute. Even if Emerson et al.