On the laboratory report, results must be provided with the correct measuring unit, preferentially SI units (22, 87). Primary care physicians challenges in ordering clinical laboratory tests and interpreting results. Towards a new paradigm in laboratory medicine: the five rights. Bek G, Butz H, Berta K, Tisler A, Olajos F, Vasarhelyi B, et al. For further information we refer to CLSI document C28-A3c or the recommendation of the Working Group Accreditation and ISO/CEN standards (WG-A/ISO) of the EFLM (92, 93). 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). Compliance of blood sampling procedures with the CLSI H3-A6 guidelines: An observational study by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) working group for the preanalytical phase (WG-PRE). The use of computerized physician order entry (CPOE) systems coupled with barcodes for patients and blood tubes are advisable for reducing the intrinsic risks associated with paper-based test requests (33, 35). Reported proportions of unsuitable samples due to inappropriate time and temperature conditions can be as high as 3.4% and 1.2% of all samples received (Figure 5), respectively, and 1.9% in relation to the errors analysed (Figure 4) (7, 44). Miyakis S, Karamanof G, Liontos M, Mountokalakis TD. 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, defining laboratory error as failure of 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 (15). This type of sample delivery has been shown to induce cellular rupture of fragile blood cells, thereby potentially biasing test results (62, 63). A final thought Making sense of conflicting priorities in the laboratory We've often heard the opinion that the Quality Control of laboratory testing isn't the biggest problem we're facing. Post-analytical laboratory processes have been considered to be less prone to error than preanalytical processes because of the widespread adoption of laboratory automation and interfaced laboratory reporting. Frequency of failure to inform patient of clinically significant outpatient test results. While the frequency of laboratory errors varies greatly, depending on the study design and the specific steps of the total testing process (TTP) investigated, a series of papers published between 1989 and 2007 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. due to haemolysis), Lippi et al. Lippi G, Brambilla M, Bonelli P, Aloe R, Balestrino A, Nardelli A, et al. We believe that laboratory specialists will need to refocus on many process steps belonging to the extra-analytical phases, intensifying collaborations with clinicians and supporting test selection and interpretation. Collection of Diagnostic Venous Blood Specimens. Following the Plan-Do-Check-Act (PDCA) cycle is a widely used tool to improve certain processes (12). (in German). Clerico A, Belloni L, Carrozza C, Correale M, Dittadi R, Dotti C, et al. Federal government websites often end in .gov or .mil. Mistakes in a stat laboratory: types and frequency, Errors in a stat laboratory: types and frequencies 10 years later, Exploring the iceberg of errors in laboratory medicine, Errors in laboratory medicine: practical lessons to improve patient safety, Exploring the initial steps of the testing process: frequency and nature of pre-ana-lytic errors, Factitious biochemical measurements resulting from hematologic conditions, Harmonization in laboratory medicine: the complete picture, The reporting, classification and grading of quality failures in the medical laboratory, Medical laboratories - reduction of error through risk management and continual improvement. In our opinion, the core duty of medical laboratories is not only to provide high quality analytics but also to aid in finding the right diagnosis of patients. The internal quality control (IQC), as well as EQA schemes, are cornerstones of quality assessment in the analytical phase (78, 79). 8600 Rockville Pike found that although laboratory consultations are rated as helpful by 35% of surveyed primary care physicians, only 6% approach laboratory professionals in case of uncertainty during test interpretation (11). Plebani M, Astion ML, Barth JH, Chen W, de Oliveira Galoro CA, Escuer Ml, et al. Kachalia A, Gandhi TK, Pupolo AL, Yoon C, Thomas EJ, Griffey R, et al. Possible causes include: Graves' disease, trophoblastic tumour, hyper functional adenoma, toxic nodular soreness, and in rare cases excessive TSH formation . Using the same study design in 1996 and 2006, Carraro and Plebani attributed the decline of the error rate of samples contaminated by infusion fluids from 20.6% to 1.9% to corrective actions. Underutilization, i.e., failure to order the correct diagnostic test, is comprised within the leading causes of missed or delayed diagnoses, and should hence be considered a major threat of patient safety (23). However, the advantages and disadvantages have to be considered before implementation (103). 2007; 45:712 . In particular, a high frequency of errors and risk of errors that could harm patients has been described in both the pre-pre- and post-post-analytical steps of the cycle that usually are not under the laboratory control. Identification errors involving clinical laboratories: a College of American Pathologists Q-Probes study of patient and specimen identification errors at 120 institutions. Simundic AM, Church S, Cornes MP, Grankvist K, Lippi G, Nybo M, et al. Furthermore, different analytical methods or instruments often provide non-comparable results of the same analyte (e.g. Sciacovelli L, OKane M, Skaik YA, Caciagli P, Pellegrini C, Da Rin G, et al. 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. Reflective testing: adding value to laboratory testing. Errors did occur though, and deviation from procedures were separated into preanalytical, analytical and post-analytical errors. As timestamps necessary to calculate these intervals are often missing (see chapters Sample collection and Transport), laboratories often refer to the intra-laboratory TAT, intended as the time from sample reception in the laboratory to release of test results. : Comments on the Consensus Statement From the European Atherosclerosis Society/European Federation of Clinical Chemistry and Laboratory Medicine. official website and that any information you provide is encrypted ensuring appropriate transport conditions), and sample preparation (e.g. 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). Incorrect interpretation of diagnostic or laboratory tests in the end stages of the TTP loop was found to underlie a large percentage of errors in the ambulatory setting and in emergency departments. In addition, the appropriate reference intervals (RI) or decision limits (DL), taking into account age and gender of the population must be provided for appropriate data interpretation (87, 91). Hospital quality: a product of good management as much as good treatment. Wollowitz A, Bijur PE, Esses D, John Gallagher E. Use of butterfly needles to draw blood is independently associated with marked reduction in hemolysis compared to intravenous catheter. Laboratories must ensure that results cannot be released when internal quality control is out of range, as this mistake is reported by Carraro et al. Nevertheless, up to 70% of requests may have questionable clinical significance in single studies (9, 10). Laposata M, Dighe A. The site is secure. Physicians may receive up to 1000 laboratory test results each week (98). Walz SE, Smith M, Cox E, Sattin J, Kind AJ. recollection) (87). Institute of Medicine (US) Committee on Quality of Health Care in America Kohn LT, Corrigan JM, Donaldson MS, editors. Published data on error rates (reference numbers are indicated in brackets) related to samples. However, these systems must be validated to prevent the release of erroneous test results (87). Case report of unexplained hypocalcaemia in a slightly haemolysed sample. Up to 85% of reported identification errors may be noticed before results are made available to clinicians or patients, once again highlighting the importance of correct patient result validation (22, 88). According to ISO 15189 requirements and other recommendations, critical values must be clearly defined, along with a detailed process on how stakeholders will be informed in a timely manner (13, 87). These values may be released accompanied by a comment, when the deviation of the test results is unlikely to exceed clinical significance, which may be assessed with calculation of the reference change value (RCV) (68). Published data on error rates (reference numbers are indicated in brackets) related to survey responders. https://doi.org/ 10.1515/9783110334043 [. The Preanalytical Errors: a Continuous Challenge for Clinical - Ascls The latter might even have an educational impact on test selection and ordering behaviour or a positive effect on the health care budget (28, 108). 1 Clearly, at least some of these errors will have a major impact on patient care. 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. EN ISO 9001 - Quality management systems - Requirements (ISO 9001:2015). Errors, mistakes, blunders, outliers, or unacceptable results: how many? Quality of Diagnostic Samples. appropriate force and time of centrifugation) (65, 67, 72). In addition, according to this Technical Specification (15), any clinical laboratory should employ processes for: a) identifying high risk processes where the potential error could lead to a safety risk for patients; b) detecting actual incidents associated with deviations from standard requirements; c) estimating and evaluating the associated risks to patient safety; d) controlling the risks; and e) monitoring the effectiveness of the measure taken. HIL - haemolysis, icterus, lipemia. Further evidence of inappropriate response to laboratory information is provided in a study evaluating the prescription of potassium in cases of hyperkalemia (23). Krleza JL, Dorotic A, Grzunov A, Maradin M. Capillary blood sampling: national recommendations on behalf of the Croatian Society of Medical Biochemistry and Laboratory Medicine. Heparin and citrate additive carryover during blood collection. and transmitted securely. However, the concept of such RI does not take preceding values into account. Clinical and Laboratory Standards Institute (CLSI). light exposure). The low error rates in the intra-laboratory parts of the TTP can be attributable to the fact that these are under strict control of highly trained laboratory personnel. This would hence lead to conclude that laboratories are still focusing on the TTP from Sample collection onwards, thus overlooking the first and essential step Test ordering/test selection, where laboratory specialists could initiate collaborations with clinicians to overcome inappropriate test requesting habits. Laposata ME, Laposata M, Van Cott EM, Buchner DS, Kashalo MS, Dighe AS. However, different approaches to measurement and definition of turnaround time (TAT) makes data comparison often challenging (97). Pre-analytical practices for routine coagulation tests in European laboratories. Identification errors were noted too, although the appropriateness of test request was not considered in the study design. for circadian hormones and proteins) (18). official website and that any information you provide is encrypted Failure in the ordering of appropriate laboratory test and the application of laboratory test results are major contributors to diagnostic errors, along with residual problems in test performances (analytical errors) (34). Pre-analytical workstations: a tool for reducing laboratory errors. While the mechanisms of communication vary from verbal to digital, the end goal remains the same: provide accurate, timely, informative results to the physician. In cases of implausible results, re-testing needs to be conducted. 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). Centrifugation of serum samples need to be delayed until clot formation is completed, otherwise fibrin strands may clog the pipetting needle, so leading to inaccurate aspiration and even temporary malfunction of the analyzer (59). Despite thoughtful validation, errors may be detected after the report has already been made available to clinicians or patients. CLSI standard GP41. 2010. (Figure 4) (7). As a library, NLM provides access to scientific literature. Preanalytical and postanalytical variables: the leading causes of A further step in the journey towards a better understanding of the issue is the recent proof 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, as shown in Table 1. European survey on preanalytical sample handling - Part 2: Practices of European laboratories on monitoring and processing haemolytic, icteric and lipemic samples. 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). The numbers in brackets indicate references. Alternatively, DLs, which are established by consensus for lipids and glycated haemoglobin (HbA1c), may be provided for interpretation. Saber Tehrani AS, Lee H, Mathews SC, Shore A, Makary MA, Pronovost PJ, et al. Guder WG, Narayanan S. Variables during Sampling. Casalino LP, Dunham D, Chin MH, Bielang R, Kistner EO, Karrison TG, et al. Laboratories can log in for free through the web-portal (www.ifcc-mqi.com), enter local process-specific QIs and benchmark them to other national and international laboratories (18). To mention only a few examples, the specimen may be drawn from the wrong patient; erroneous low calcium and alkaline phosphatase may be misinterpreted when potassium-ethylenediaminetetraacetic acid (K-EDTA) contamination is not identified; pseudohyperkalaemia due to extreme leucocytosis may lead to unnecessary and even potentially dangerous treatment (3-5). Influence of centrifugation conditions on the results of 77 routine clinical chemistry analytes using standard vacuum blood collection tubes and the new BD-Barricor tubes. 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). Sung S, Forman-Hoffman V, Wilson MC, Cram P. Direct reporting of laboratory test results to patients by mail to enhance patient safety. 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). Campbell CA, Georgiou A, Westbrook JI, Horvath AR. In order to provide a quick overview, we additionally summarized these issues in a supplemental table (Appendix 1), categorized by the TTP phase, the TTP step and the sources of error, including respective quality indicators (QI) measurement options as well as possible solutions for improvement. 8600 Rockville Pike Nevertheless, to get an overview of the numbers mentioned in the review, we plotted them in figures, separated in percentages related to analyses/tests, survey responders, missed diagnoses of malpractice claims, errors, samples, and phlebotomies of an observational study (Figure 1-61-6). Produktkatalog - BD Diagnostics - Preanalytical Systems. Missed hypothyroidism diagnosis uncovered by linking laboratory and pharmacy data. WHO Press, Geneva, Switzerland. De Plato F, Fontana C, Gherardi G, Privitera GP, Puro V, Rigoli R, et al. In this phase, lab results are communicated to physicians. van Dongen-Lases EC, Cornes MP, Grankvist K, Ibarz M, Kristensen GB, Lippi G, et al. In general, doubtful results should be replaced by a comment providing appropriate information and recommendation for further sample management (i.e. An interesting meta-analysis has recently shown that the mean rates of overutilization can be as high as 20.6% (Figure 1) (23). Types and origins of diagnostic errors in primary care settings, When diagnostic testing leads to harm: a new outcomes-based approach for laboratory medicine, The brain-to-brain loop concept for laboratory testing 40 years after its introduction, http://creativecommons.org/licenses/by-nc/3.0/. Most possibilities aiming to reduce identification errors encompass some form of automation: barcoding system for identification and labelling, occasionally with automated systems for labelling of tubes or pre-labelled tubes (33, 35, 45). Initial studies, starting from the seminal paper by Belk and Sunderman in 1947 (4), as well as other articles published before the 1990s, focused only on the analytical phase and demonstrated high rates and severity of analytical errors. Presentation of clinical laboratory results: an experimental comparison of four visualization techniques. Managing inappropriate utilization of laboratory resources. Published data on error rates (reference numbers are indicated in brackets) related to analyses/tests. A preliminary consensus. Laboratory errors have a reported frequency of 0.012% to 0.6% of all test results. Reducing Post Analytical Error: Perspectives on New Formats for the Despite a high degree of standardization and implementation of quality management systems, errors in the analytical phase can still be operator-dependent, a consequence of deviations from recommendation/guidelines or attributable to instrumental malfunctioning (Figure 4) (6, 80). Clin Chem Lab Med. In addition, the defects per million opportunities (DPMO) should be stated. As a proportion of errors analysed, patient identification account for approximately 9% (Figure 4) (7). As previously mentioned, well-known and prior-to-analysis measureable interferences (e.g., HIL), which are also referred to as type 1 interferences, should be checked by automated HIL assessment (65, 66, 68, 81, 82). Quality indicators encompass unacceptable quality control (QC) results as well as the number of tests uncovered by QC (18). A survey among European laboratories on preanalytical practices for coagulation tests recently found that only 42% of participating laboratories are actually monitoring temperature during transportation (60). Potassium-EDTA contamination of heparin samples may result in spurious hyperkalaemia and low concentrations of calcium due to EDTA sequestration (4). Most frequent sources of errors in the pre-pre- and pre-analytical steps (accounting for 48%-62% of total errors in laboratory medicine). Understanding and managing interferences in clinical laboratory assays: the role of laboratory professionals.
