Preanalytical errors

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INTRODUCTION: The aim of this study was to determine the level of compliance of venous blood sampling (VBS) in Lithuania with the joint recommendations of the European Federation of Clinical Chemistry and Laboratory Medicine and the Latin American Confederation of Clinical Biochemistry (EFLM-COLABIOCLI) and to analyse possible causes of errors. A survey was conducted between April and September 2022. MATERIALS AND METHODS: A self-designed questionnaire was distributed to the Lithuanian National Societies...

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Lupus anticoagulant (LA) represents 1 of the laboratory criteria for classification of patients as having definite antiphospholipid syndrome (APS). The other 2 laboratory criteria are anticardiolipin antibodies and anti-beta2-glycoprotein I antibodies. At least 1 of these antiphospholipid antibody (aPL) tests need to be positive, with evidence of persistence, together with evidence of at least 1 clinical criterion for APS, before a patient can be classified as having definite APS. LA and other aPL assays are also important for diagnosis or exclusion of APS, as well as for risk stratification, with triple-positive patients carrying the greatest risk...

AIM: Blood Sampling Guidelines have been developed to target European emergency medicine-related professionals involved in the blood sampling process (e.g. physicians, nurses, phlebotomists working in the ED), as well as laboratory physicians and other related professionals. The guidelines population focus on adult patients. The development of these blood sampling guidelines for the ED setting is based on the collaboration of three European scientific societies that have a role to play in the preanalytical phase process: EuSEN, EFLM, and EUSEM...

Implementation of Quality indicators (QIs) plays an imperative role in improving the total testing process, as it provides a quantitative basis for evaluating the laboratory performance. Besides monitoring of analytical quality specifications, several lines of experimental and clinical evidence have alluded a pivotal role of extra-analytical phases in improving the quality of laboratory services and therefore a relevance of pre- and post-analytical steps have been speculated on the overall quality in the total testing process and consequently on clinical decision-making...

The accuracy of diagnostic results in clinical laboratory testing is paramount for informed healthcare decisions and effective patient care. While the focus has traditionally been on the analytical phase, attention has shifted towards optimizing the preanalytical phase due to its significant contribution to total laboratory errors. This review highlights preanalytical errors, their sources, and control measures to improve the quality of laboratory testing. Blood sample quality is a critical concern, with factors such as hemolysis, lipemia, and icterus leading to erroneous results...

Errors in laboratory diagnostics of viral infections primarily occur during the preanalytical phase, which is especially observed in sample collection. Hitherto, no efforts have been made to optimize oropharyngeal smears. An accurate method to analyze the necessary conditions for a valid oropharyngeal smear test is required, especially to avoid false negative results, which can lead to promotion of the spread of viruses such as SARS-CoV-2. In this study, a maximum-force failure analysis was performed on a swab, and the highest tolerable force was then measured on 20 healthy volunteers to obtain the dimensions of the possible force to be applied on a swab...

The use of artificial intelligence (AI) has become widespread in many areas of science and medicine, including laboratory medicine. Although it seems obvious that the analytical and post-analytical phases could be the most important fields of application in laboratory medicine, a kaleidoscope of new opportunities has emerged to extend the benefits of AI to many manual labor-intensive activities belonging to the pre-analytical phase, which are inherently characterized by enhanced vulnerability and higher risk of errors...

Although haemolysis is the most common source of preanalytical error in clinical laboratories, its influence on cattle biochemistry remains poorly understood. The effect of haemolysis and its clinical relevance were investigated in 70 samples in which haemolysis was artificially induced (by spiking with increasing amounts of haemolysate, yielding 0.0%, 0.2%, 0.5%, 1.0%, 2.5%, 5.0% and 10% haemolysis degree (HD)), focusing on key parameters for bovine metabolic health assessment, including albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), blood urea nitrogen (BUN), calcium (Ca), cholesterol, creatinine, creatine kinase (CK), gamma-glutamyl transferase (GGT), globulins, magnesium (Mg), phosphorus (P), total bilirubin (TBIL) and total proteins (TP)...

This review discusses the profound impact of artificial intelligence (AI) on breast cancer (BC) diagnosis and management within the field of pathology. It examines the various applications of AI across diverse aspects of BC pathology, highlighting key findings from multiple studies. Integrating AI into routine pathology practice stands to improve diagnostic accuracy, thereby contributing to reducing avoidable errors. Additionally, AI has excelled in identifying invasive breast tumors and lymph node metastasis through its capacity to process large whole-slide images adeptly...

Free ionized calcium (fCa) is considered the gold standard for assessing calcium status in patients, but it is relatively expensive and is associated with several preanalytical and analytical error sources. We investigated the feasibility of using a reflex test that involves first measuring total calcium (tCa) and if out of reference range, then measure fCa, with expectation of reducing the number of fCa measurements. We used data from 1815 unique patients with concurrent measurement of fCa, tCa and albumin adjusted calcium (aCa)...

OBJECTIVES: The storage of serum tumor markers (STM) at -18 °C for one year has been a legal requirement in France since 1999, but has been abolished in 2022. This raises the question of the relevance of maintaining these biobanks in terms of conditions of storage. These should only be implemented after validation; in order to maintain the integrity of the biological sample and must be controlled over time according to the laboratory's procedures. The aim of the study was to assess the suitability of storing 10 STMs by evaluating their stability after one year of storage at -18 °C...

Nearly seventy percent of diagnostic lab test errors occur due to variability in preanalytical factors. 1-4 These are the parameters involved with all aspects of tissue processing, starting from the time tissue is collected from the patient in the operating room, until it is received and tested in the laboratory. While there are several protocols for transporting fixed tissue, organs, and liquid biopsies, such protocols are lacking for transport and handling of live solid tumor tissue specimens. There is a critical need to establish preanalytical protocols to reduce variability in biospecimen integrity and improve diagnostics for personalized medicine...

BACKGROUND: The tumor-agnostic indication of immune checkpoint inhibitors to treat cancers with mismatch repair deficiency (dMMR)/microsatellite instability (MSI) increased the demand for such tests beyond Lynch syndrome. International guideline recommendations accept immunohistochemistry (IHC) for dMMR or molecular techniques (PCR or NGS) for MSI status determinations considering the two tests are equal, although there are scattered reports contradicting to this presumption. MATERIALS AND METHODS: Here we have directly compared four protein MMR immunohistochemistry (IHC) to MSI Pentaplex PCR test in a large cancer patient cohort (n = 1306) of our diagnostic center where the two tests have been run parallel in 703 cases...

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BACKGROUND: An erroneously high tacrolimus level was reported to a clinician. A root cause analysis investigation failed to determine the cause of the error. It was suspected that the incorrect preanalytical extraction reagent and procedure was used during testing; however, how this would affect the assayed drug concentration was unclear. Here we investigated the effect of the substitution of sirolimus, tacrolimus, and cyclosporine extraction reagents on assayed drug concentration. METHODS: Tacrolimus, sirolimus, and cyclosporine concentration were measured on the Abbott Architect i2000 analyzer...

OBJECTIVES: Artificial intelligence-based robotic systems are increasingly used in medical laboratories. This study aimed to test the performance of KANKA (Labenko), a stand-alone, artificial intelligence-based robot that performs sorting and preanalytical quality control of blood tubes. METHODS: KANKA is designed to perform preanalytical quality control with respect to error control and preanalytical sorting of blood tubes. To detect sorting errors and preanalytical inappropriateness within the routine work of the laboratory, a total of 1000 blood tubes were presented to the KANKA robot in 7 scenarios...

OBJECTIVES: Prevention of pre-analytical issues in coagulation testing is of paramount importance for good laboratory performance. In addition to common issues like hemolysed, icteric, or lipemic samples, some specific pre-analytical errors of coagulation testing include clotted specimens, improper blood-to-anticoagulant ratio, contamination with other anticoagulants, etc. Prothrombin time (PT) and activated partial thromboplastin time (aPTT) are very commonly affected tests due to pre-analytical variables...

BACKGROUND: Laboratories across the world are successfully using quality indicators (QIs) to monitor their performance. We aimed to analyze the effectiveness of using the peer group comparison and statistical tools such as sigma metrics for periodic evaluation of QIs and identify potential errors in the preanalytical, analytical, and postanalytical phases. METHODS: We evaluated the monthly QIs for 1 year. A total of 11 QIs were evaluated across the three phases of the total testing process, using percentage variance, and sigma metric analysis...