Errors In Laboratory Medicine Research Articles

SFBC Working Group on sources of errors in laboratory medicine: objectives and key areas of work

Laboratory medicine plays a crucial role in patient care, contributing to approximately 70% of clinical decisions. In collaboration with clinicians, laboratory medicine specialists perform analyses that are useful for diagnosis, screening and prevention. Laboratories are known for their efficiency, which is reached through a rigorous quality system. However, errors can occur, especially given the complexity of the total testing process. These errors may lead to severe consequences, such as incorrect diagnoses or delays in treatment. Errors can occur at every stage of the total testing process, those related to the pre-analytical phase being the most prevalent. To reduce medical errors related to laboratory processes, it is essential to provide training for medical and paramedical staff, optimize production automation, and leverage technological advancements. These considerations have led to the creation of a French Working Group on Sources of Errors in Laboratory Medicine, under the aegis of the French lean society of clinical chemistry and laboratory medicine (Société Française de Biologie Clinique - SFBC). The objectives of this working group are to produce an educational handbook on sources of errors in laboratory medicine, provide training for clinical chemists, and conducting applied research projects to better understand the mechanisms behind specific errors. Ultimately, the aim is to minimize errors and enhance the quality of laboratory tests.

Diagnosis of severe anaemia and positive antibody screening as consequences of pre-analytical error.

The pre-analytical phase is the principal source of errors in laboratory medicine and continues to pose a challenge to laboratory professionals. We present the case of a 73-yearold female patient with a very low hemoglobin level (69 g/L) and positive indirect antiglobulin test result that indicates the key role of phlebotomy as an important error-prone process in which mistakes can have serious consequences for the patient's diagnosis and treatment. We conclude that there is still an urgent and continuous need to provide educational activities for healthcare professionals involved in blood collection, improve blood collection guideline adherence, and eliminate the errors which can affect diagnosis and treatment, thus jeopardising patient safety.

Evaluation of 18 quality indicators from the external quality assurance preanalytical programme of the Spanish Society of Laboratory Medicine (SEQCML).

Most errors in laboratory medicine occur in the pre- and post-analytical phases of the total testing process (TTP). In 2014, the Spanish Society of Laboratory Medicine (SEQCML) started the current Preanalytical Phase EQA Programme, with the objective of providing a tool for the improvement of the preanalytical phase. The aim of this study was to review the evolution of quality indicators (QI) and the comparability of established performance specifications (PS) with other EQA programmes. In the SEQCML programme, participants were asked to register rejections of the main specimens and the causes for rejections. Data collected from 2014 to 2017, and then reviewed biennially (2018-2019), was used to calculate the percentiles; p25, p50, p75, and p90 for every round, and their means were set as PS. These PS were compared with the results of other programmes. The evolution of QI results for 2018-2019 period showed general maintenance or improvement, e.g., a significant decrease in the number of serum samples with a haemolytic index≥0.5g/L, except for EDTA and citrate samples handle, maybe for an improvement in detection. The comparison with PS for the QI of the IFCC Working Group "Laboratory Errors and Patient Safety" and the Key Incident Management and Monitoring System (KIMMS) programme of the RCPA showed comparable results, supporting the validity of the established specifications. The PS obtained are a helpful tool for benchmarking and to identify processes of the preanalytical phase whose improvement should be set as a priority.

Incidents in Molecular Pathology: Frequency and Causes During Routine Testing.

Errors in laboratory medicine could compromise patient safety. Good laboratory practice includes identifying and managing nonconformities in the total test process. Varying error percentages have been described in other fields but are lacking for molecular oncology. To gain insight into incident causes and frequency in the total test process from 8 European institutes routinely performing biomarker tests in non-small cell lung cancer and colorectal cancer. All incidents documented in 2018 were collected from all hospital services for pre-preanalytical entries before the biomarker test, as well as specific incidents for biomarker tests. There were 5185 incidents collected, of which 4363 (84.1%) occurred in the pre-preanalytical phase (all hospital services), 2796 of 4363 (64.1%) related to missing or incorrect request form information. From the other 822 specific incidents, 166 (20.2%) were recorded in the preanalytical phase, 275 (33.5%) in the analytical phase, and 194 (23.6%) in the postanalytical phase, mainly due to incorrect report content. Only 47 of 822 (5.7%) incidents were recorded in the post-postanalytical phase, and 123 (15.0%) in the complete total test process. For 17 of 822 (2.1%) incidents the time point was unknown. Pre-preanalytical incidents were resolved sooner than incidents on the complete process (mean 6 versus 60 days). For 1215 of 5168 (23.5%) incidents with known causes a specific action was undertaken besides documenting them, not limited to accredited institutes. There was a large variety in the number and extent of documented incidents. Correct and complete information on the request forms and final reports are highly error prone and require additional focus.

Errors in laboratory medicine: The role of quality indicators

Errors in laboratory are heterogeneous in nature as it involves various complex procedures and a variety of persons preforming all the processes, starting from ordering of tests to reporting of result to its influence on ultimate patient care. The core job of a laboratory is to produce the correct test result. If we can't get the test results right, then we aren't doing our core job. It's our profession to know all the details of testing and instrumentation and quality control. It's our profession to assure that test results are correct. Improvements need not be only at pre or post or -it should be at all three stages, as the consequence of error in any of the stage is the same: poor patient care. No error is worse than the other. We must make efforts on all fronts. Even if this means making small improvements in each area, a unified improvement effort will achieve better test results and better patient care than narrow efforts in either the pre-, post-or analytical area. To have a uniform consensus, the laboratories should have certain quality indicators to have control over the procedures that tend to generate errors.

Frequency and classification of errors in laboratory medicine at a veterinary teaching hospital in the United States.

The accuracy of laboratory data is of utmost importance. Data regarding laboratory error in human laboratories are often extrapolated into veterinary settings. One study investigated the rate and type of errors in a European commercial veterinary laboratory, but that data might not directly apply to an educational setting. This study determined the frequency and type of errors in laboratory medicine at a veterinary teaching hospital. Errors associated with clinical pathology samples were recorded over two 60-day periods. The first period included a time when new students and house officers started at the veterinary school. The second time period was 6months later. The errors were assigned to categories, and the frequency of each was calculated. Sample hemolysis, icterus, and lipemia were evaluated separately using an automated index, as these conditions could be pathologic or the result of error. Frequencies of error and hemolysis, icterus, and lipemia were assessed between the groups. Total error rates were 4.7% and 3.5% for the first and second periods, respectively. The frequency of each error subclassification was similar to those observed in the veterinary and human literature, with preanalytic error predominating. Statistically significant differences in the overall error rate and percentage of preanalytic errors that occurred outside of and within the laboratory were observed comparing differences between the two periods. The overall error rate in this veterinary teaching hospital was slightly higher than that previously reported in other settings, although a proportion of errors was as expected. Areas needing improvement were identified, and strategies to reduce error could be developed.

Einfluss einer maßgeschneiderten Präanalytik-Fortbildung auf die Qualität der Laboruntersuchungen

In 31 to 75 percent of cases, errors in laboratory medicine have preanalytical causes such as erroneous blood sampling. Erroneous blood sampling may lead to false test results and additional laboratory cost; it may increase analyzing time and endanger the health of patients and employees. In particular, under- and overfilling of blood sampling tubes can considerably distort laboratory values. So far there has been a lack of studies investigating the effect of a tailored training for ward staff to improve preanalytical procedures on blood sampling. Can a tailored preanalytical training significantly reduce the number of commented under- and overfilled coagulation samples, reduce the number of hemolytic serum and lithium heparin samples and increase the number of standards-compliant blood sampling? In an intervention study we compared the number of commented under- and overfilled coagulation tubes and the number of hemolytic serum and lithium heparin samples on the basis of laboratory data and, using participant observation, compared the blood sampling quality on a surgical ward before and after participation in a training course. Based on prior results of participant observation, a 20-minute training was conceptualized and conducted. Target criteria were a) the number of commented under- and overfilled coagulation tubes and b) the number of hemolytic serum and lithium heparin samples in a before/after comparison (Oct-Dec 2017 and Jan-Mar 2018 compared with Jun-Aug 2018) and an annual comparison (Jun-Aug 2017 compared to Jun-Aug 2018), and c) a standards-compliant performance of blood sampling in a before/after comparison (Apr 2018 and Jun 2018). The number of commented under- and overfilled coagulation tubes in the annual comparison was compared using the Chi-square test. After the training (Jun-Aug 2018) the number of commented under- and overfilled coagulation tubes decreased significantly in annual comparison to Jun-Aug 2017 (-68.07%, p<0.001). The number of commented under- and overfilled coagulation tubes and of hemolytic serum and lithium heparin samples decreased in the before/after and in the annual comparison, and the number of standards-compliant blood samplings increased in the before/after comparison. The training contributed significantly to reducing the number of commented coagulation samples and hemolytic serum and lithium heparin samples and to increasing standards-compliant blood sampling. There is a need to investigate to what extent this concept can be transferred to other wards, and in which intervals further trainings should be conducted in order to maintain these positive effects.

Monitoring and capturing patient identification errors in laboratory medicine

Specimen labelling and patient identification are significant contributors to the rate of error in the preanalytical phase of laboratory medicine. This study aimed to investigate the prevalence and nature of preanalytical quality monitoring practices for patient identification and specimen labelling errors in Irish clinical laboratories. A survey was developed by the Clinical Biochemistry Unit, Trinity College Dublin and the Irish External Quality Assessment Scheme (IEQAS), with the intention of gathering key information from each laboratory. Thirty-nine questions were organized into seven subsections covering general information, labelling requirements, information availability, rejection criteria, error monitoring, error reporting and interest in participation in an external quality assessment scheme. The survey was sent electronically to 63 laboratory quality managers at 55 laboratories in Ireland. A total of 39 responses (61% response rate) provided information on 94 separate laboratory departments or disciplines. Laboratories reported varying practices and requirements for labelling specimens and all accepted handwritten preprinted request forms. All (100%) respondents had defined rejection criteria both for specimen labelling and request form completion. Unsurprisingly, the rejection criteria differed between the various laboratory disciplines. Almost all respondents provided information to clinical staff on labelling requirements, but just over half provided training on the same. A large percentage of laboratories (74%) monitored the rate of specimen-labelling errors; however, only 46% had defined target limits for acceptable rates of error. The survey observed a wide variation in collection, recording and monitoring of errors but also confirmed significant interest in improving preanalytical monitoring and data collection.

Pre- and postanalytical errors in haematology.

The majority of errors in laboratory medicine occur in the pre- and postanalytical phases of the testing process. Although the causes of these errors are largely common to all laboratory medicine specialties, it is important for the haematology laboratory to understand the particular impact of some on automated counting. The preanalytical phase is the stage of greatest risk but preanalytical errors may go undetected until postanalytical validation and interpretation. The challenges in the postanalytical phase include the standardisation of reference intervals against which results can be interpreted and the impact of just a small difference in reference interval for a key analyte such as haemoglobin concentration. Quality indicators against which pre- and postanalytical error incidence are measured are a source of information that can be used to improve services but laboratories struggle to collect good quality data.

System-related and cognitive errors in laboratory medicine.

Current efforts focusing on better defining the prevalence of diagnostic errors, their causes and remediation strategies should address the role of laboratory testing and its contribution to high-quality care as well as a possible source of diagnostic errors. Data collected in the last few years highlight the vulnerability of extra-analytical phases of the testing cycle and the need for programs aiming to improve all steps of the process. Further studies have clarified the nature of laboratory-related errors, namely the evidence that both system-related and cognitive factors account for most errors in laboratory medicine. Technology developments are effective in decreasing the rates of system-related errors but organizational issues play a fundamental role in assuring a real improvement in quality and safety in laboratory processes. Educational interventions as well as technology-based interventions have been proposed to reduce the risk of cognitive errors. However, to reduce diagnostic errors and improve patient safety, clinical laboratories have to embark on a paradigmatic shift restoring the nature of laboratory services as an integral part of the diagnostic and therapy process.

Blood sample quality.

Several lines of evidence now confirm that the vast majority of errors in laboratory medicine occur in the extra-analytical phases of the total testing processing, especially in the preanalytical phase. Most importantly, the collection of unsuitable specimens for testing (either due to inappropriate volume or quality) is by far the most frequent source of all laboratory errors, thus calling for urgent strategies for improving blood sample quality and managing data potentially generated measuring unsuitable specimens. A comprehensive overview of scientific literature leads us to conclude that hemolyzed samples are the most frequent cause of specimen non-conformity in clinical laboratories (40-70%), followed by insufficient or inappropriate sample volume (10-20%), biological samples collected in the wrong container (5-15%) and undue clotting (5-10%). Less frequent causes of impaired sample quality include contamination by infusion fluids (i.e. most often saline or glucose solutions), cross-contamination of blood tubes additives, inappropriate sample storage conditions or repeated freezing-thawing cycles. Therefore, this article is aimed to summarize the current evidence about the most frequent types of unsuitable blood samples, along with tentative recommendations on how to prevent or manage these preanalytical non-conformities.

Systematic review as a tool to propose a terminology of preanalytical errors in laboratory medicine

Systematic review as a tool to propose a terminology of preanalytical errors in laboratory medicine

Quality in laboratory medicine: 50 years on

The last 50years have seen substantial changes in the landscape of laboratory medicine: its role in modern medicine is in evolution and the quality of laboratory services is changing. The need to control and improve quality in clinical laboratories has grown hand in hand with the growth in technological developments leading to an impressive reduction of analytical errors over time. An essential cause of this impressive improvement has been the introduction and monitoring of quality indicators (QIs) such as the analytical performance specifications (in particular bias and imprecision) based on well-established goals. The evolving landscape of quality and errors in clinical laboratories moved first from analytical errors to all errors performed within the laboratory walls, subsequently to errors in laboratory medicine (including errors in test requesting and result interpretation), and finally, to a focus on errors more frequently associated with adverse events (laboratory-associated errors). After decades in which clinical laboratories have focused on monitoring and improving internal indicators of analytical quality, efficiency and productivity, it is time to shift toward indicators of total quality, clinical effectiveness and patient outcomes.

Pre-analytical phase: The automated ProTube device supports quality assurance in the phlebotomy process

BackgroundMost errors in laboratory medicine occur in the pre-analytical phase of the total testing process. Phlebotomy, a crucial step in the pre-analytical phase influencing laboratory results and patient outcome, calls for quality assurance procedures and automation in order to prevent errors and ensure patient safety. MethodsWe compared the performance of a new small, automated device, the ProTube Inpeco, designed for use in phlebotomy with a complete traceability of the process, with a centralized automated system, BC ROBO. ResultsProTube was used for 15,010 patients undergoing phlebotomy with 48,776 tubes being labeled. The mean time and standard deviation (SD) for blood sampling was 3:03 (min:sec; SD±1:24) when using ProTube, against 5:40 (min:sec; SD±1:57) when using BC ROBO. The mean number of patients per hour managed at each phlebotomy point was 16±3 with ProTube, and 10±2 with BC ROBO. No tubes were labeled erroneously or incorrectly, even if process failure occurred in 2.8% of cases when ProTube was used. ConclusionsThanks to its cutting edge technology, the ProTube has many advantages over BC ROBO, above all in verifying patient identity, and in allowing a reduction in both identification error and tube mislabeling.

Monitoring and reporting of preanalytical errors in laboratory medicine: the UK situation.

Most errors in the clinical laboratory occur in the preanalytical phase. This study aimed to comprehensively describe the prevalence and nature of preanalytical quality monitoring practices in UK clinical laboratories. A survey was sent on behalf of the Association for Clinical Biochemistry and Laboratory Medicine Preanalytical Working Group (ACB-WG-PA) to all heads of department of clinical laboratories in the UK. The survey captured data on the analytical platform and Laboratory Information Management System in use; which preanalytical errors were recorded and how they were classified and gauged interest in an external quality assurance scheme for preanalytical errors. Of the 157 laboratories asked to participate, responses were received from 104 (66.2%). Laboratory error rates were recorded per number of specimens, rather than per number of requests in 51% of respondents. Aside from serum indices for haemolysis, icterus and lipaemia, which were measured in 80% of laboratories, the most common errors recorded were booking-in errors (70.1%) and sample mislabelling (56.9%) in laboratories who record preanalytical errors. Of the laboratories surveyed, 95.9% expressed an interest in guidance on recording preanalytical error and 91.8% expressed interest in an external quality assurance scheme. This survey observes a wide variation in the definition, repertoire and collection methods for preanalytical errors in the UK. Data indicate there is a lot of interest in improving preanalytical data collection. The ACB-WG-PA aims to produce guidance and support for laboratories to standardize preanalytical data collection and to help establish and validate an external quality assurance scheme for interlaboratory comparison.

The journey toward quality and patient safety in laboratory medicine continues.

Errors in laboratory medicine have a completely different meaning today than they had a century ago. At that time, the term referred to defects in the analytical performance of the test itself, the so-called analytical phase.[1] A dramatic change in addressing the issue of errors in laboratory medicine started at the end of the 1990s, when a body of evidence has been accumulated demonstrating vulnerability in the pre- and postanalytical phases.[2,3] The study by Abdollahi and co-workers confirms that more than 50% of errors are related to preanalytical steps, with 23.2% of errors in the intraanalytical and 11.7% in the postanalytical phase, respectively.[4] In addition, this study provides further evidence that the frequency of errors in inpatients is significantly higher than in outpatients due to several problems: Not always standard operating procedures (SOP) for test request, sample collection, handling, and transportation are followed by healthcare personnel who are not under the direct control of the laboratory; The complexity of some preanalytical steps (namely blood drawing) is higher for inpatients, due to age and disease issues; The trend toward consolidation and commoditization of laboratory services is decreasing the quality of communication between clinicians and laboratory professionals. The “take-home” message is the need to consensually develop and adopt SOP for safely performing patient identification and preparation, test requesting, sample collection and handling and that harmonization initiatives should be performed to improve procedures and processes at the laboratory–clinical interface. It seems likely that only a small proportion of laboratory errors results in actual patient harm and adverse events thanks to the several barriers and defensive layers present between the release of laboratory information, the decision-making process and, ultimately, the action on the patient. However, from a risk management viewpoint, even the great majority of laboratory errors with little direct impact on patient care provide important learning opportunities. In fact, any error, regardless of its apparent triviality, might indicate weaknesses in policies and procedures that may not lead to adverse events in their particular context, but might cause the patient harm in slightly different circumstances. An important step in the journey toward the reduction of the error rates in laboratory medicine is the implementation of a valuable quality system according to the International Standard ISO 15189:2012 and of reliable quality indicators (QIs) covering all steps of the intra- and extra-analytical phases of the total testing process (TTP).5 It has been demonstrated that performance and outcome measures improve the quality of patient care and, in particular, QIs represent valuable tools for quantifying the quality of selected aspects of care by comparing it against a defined criterion. The measurement and monitoring of QIs in laboratory medicine serve many purposes as they make possible to: Document the quality of the service provided; Improve performance and patient safety; Make comparison (benchmarking) over time between laboratories; Make judgments and set priorities (corrective actions to be performed); and Support accountability, quality improvement and accreditation. Recently a set of QIs has been consensually defined to allow clinical laboratories to measure and improve the quality of all steps of the TTP. The journey toward quality and patient safety continues.

Hematology point of care testing and laboratory errors: an example of multidisciplinary management at a children&amp;#39;s hospital in northeast Italy

Involvement of health personnel in a medical audit can reduce the number of errors in laboratory medicine. The checked control of point of care testing (POCT) could be an answer to developing a better medical service in the emergency department and decreasing the time taken to report tests. The performance of sanitary personnel from different disciplines was studied over an 18-month period in a children’s hospital. Clinical errors in the emergency and laboratory departments were monitored by: nursing instruction using specific courses, POCT, and external quality control; improvement of test results and procedural accuracy; and reduction of hemolyzed and nonprotocol-conforming samples sent to the laboratory department. In January 2012, point of care testing (POCT) was instituted in three medical units (neonatology, resuscitation, delivery room) at the Children’s Hospital in Trieste, northeast Italy, for analysis of hematochemical samples. In the same period, during the months of January 2012 and June 2013, 1,600 samples sent to central laboratory and their related preanalytical errors were examined for accuracy. External quality control for POCT was also monitored in the emergency department; three meetings were held with physicians, nurses, and laboratory technicians to highlight problems, ie, preanalytical errors and analytical methodologies associated with POCT. During the study, there was an improvement in external quality control for POCT from −3 or −2 standard deviations or more to one standard deviation for all parameters. Of 800 samples examined in the laboratory in January 2012, we identified 64 preanalytical errors (8.0%); in June 2013, there were 17 preanalytical errors (2.1%), representing a significant decrease (P<0.05, χ2 test). Multidisciplinary management and clinical audit can be used as tools to detect errors caused by organizational problems outside the laboratory and improve clinical and economic outcomes.

Plan for Quality to Improve Patient Safety at the Point of Care

The U.S. Institute of Medicine (IOM) much publicized report in “To Err is Human” (2000, National Academy Press) stated that as many as 98 000 hospitalized patients in the U.S. die each year due to preventable medical errors. This revelation about medical error and patient safety focused the public and the medical community's attention on errors in healthcare delivery including laboratory and point-of-care-testing (POCT). Errors introduced anywhere in the POCT process clearly can impact quality and place patient's safety at risk. While POCT performed by or near the patient reduces the potential of some errors, the process presents many challenges to quality with its multiple tests sites, test menus, testing devices and non-laboratory analysts, who often have little understanding of quality testing. Incoherent or no regulations and the rapid availability of test results for immediate clinical intervention can further amplify errors. System planning and management of the entire POCT process are essential to reduce errors and improve quality and patient safety.

Errors in medicine and errors in laboratory medicine: what is the difference?

Errors in medicine and errors in laboratory medicine: what is the difference?

The detection and prevention of errors in laboratory medicine

The last few decades have seen a significant decrease in the rates of analytical errors in clinical laboratories. Evidence demonstrates that pre- and post-analytical steps of the total testing process (TTP) are more error-prone than the analytical phase. Most errors are identified in pre-pre-analytic and post-post-analytic steps outside of the laboratory. In a patient-centred approach to the delivery of health-care services, there is the need to investigate, in the TTP, any possible defect that may have a negative impact on the patient. In the interests of patients, any direct or indirect negative consequence related to a laboratory test must be considered, irrespective of which step is involved and whether the error depends on a laboratory professional (e.g. calibration/testing error) or non-laboratory operator (e.g. inappropriate test request, error in patient identification and/or blood collection). Patient misidentification and problems communicating results, which affect the delivery of diagnostic services, are recognized as the main goals for quality improvement. International initiatives aim at improving these aspects. Grading laboratory errors on the basis of their seriousness should help identify priorities for quality improvement and encourage a focus on corrective/preventive actions. It is important to consider not only the actual patient harm sustained but also the potential worst-case outcome if such an error were to reoccur. The most important lessons we have learned are that system theory also applies to laboratory testing and that errors and injuries can be prevented by redesigning systems that render it difficult for all health-care professionals to make mistakes.