Objectives: This study aimed to objectively assess the potential severity of harm associated with erroneous results in 195 laboratory tests by surveying 514 specialist physicians and medical biochemistry experts. Methods: The survey obtained participants’ (75 medical biochemists, 439 clinicians) opinions on severity of harm for the erroneous results of 195 tests. The comprehensive list of errors and their effects on test results were obtained from the literature, and then matched with severity of harm scores, from 1 (negligible effect) to 5 (life-threatening injury/death), obtained from the survey responses. Results: Participants perceived tests such as cardiac biomarkers, blood gases, coagulation parameters (activated partial thromboplastin time, prothrombin time, international normalized ratio, and dimerized plasmin fragment D), critical ions (potassium, sodium), toxic trace elements (lead, mercury), and specific serum drug levels (lithium, digoxin) to have a greater potential for patient harm in case of errors. Medical biochemistry specialists assigned higher severity scores to some laboratory tests, including total bilirubin, pseudocholinesterase, platelet indices, and some drug levels (cyclosporine, methotrexate, vancomycin). Conclusions: A substantial agreement (91%) was observed between medical biochemists and clinicians in terms of the most frequently chosen severity of harm score. The study provided objective severity scores and identified high-risk tests for targeted quality improvement.

Objectives: Value in healthcare has been defined as the ratio between clinical outcomes and costs, providing a valuable framework for laboratory medicine as well. Implementing this concept in laboratory medicine – referred to as Value-Based Laboratory Medicine (VBLM) – requires a shift from volume-driven activities to outcome-oriented practice. In particular, the value-based score (V-BS) represents a pragmatic tool for assessing and benchmarking laboratory performance. Methods: The V-BS was designed by the experts of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Committee on the Value-Based Score (C-BS) and piloted in 12 European clinical laboratories of different sizes. Participating laboratories completed a structured Excel-based questionnaire covering five domains. Scores were assigned from 0 to 1 for each requirement and weighted to generate a final score out of 100. Descriptive statistics were used to summarize total and domain-specific performance. Results: All invited laboratories completed the pilot evaluation. Total scores ranged from 44.64 to 86.18, with a mean of 68.90 and a median of 71.21. The highest scores were observed for indicators related to traceability throughout the total testing process and quality of laboratory information, whereas clinical interaction was consistently the weakest domain. Conclusions: The data reported by the clinical laboratories participating in the pilot study demonstrate strong interest in this initiative. Although relevant differences in value-based laboratory performance were observed across the 12 participating sites, overall satisfactory performance was achieved for most indicators related to traceability and quality of laboratory information. In contrast, indicators related to clinical interaction consistently received the lowest scores.

Measuring uncertainty (MU) is crucial to ensure the accuracy and precision of laboratory results. This study compares the ISO 20914 and Nordtest guidelines to analyze the MU values for 20 clinical chemistry analytes over six months. The researchers calculated MU components, including within-laboratory reproducibility (Rw), laboratory analytical performance bias (u(bias)), and combined standard uncertainty (u_c), based on internal quality control and external quality assessment data. The final expanded uncertainty (U) values were determined by multiplying the combined uncertainty with a coverage factor (k = 2 for 95% Confidence Interval), following each guideline's respective procedures. Clinical chemistry analytes were analyzed on Roche Cobas 6000 c501 auto analyzer (Roche Diagnostics, Mannheim, Germany) and manufacturer's kits were used analysis. The results show that 11 out of 20 clinical chemistry analytes met the targeted maximum allowable measurement uncertainty (MAU) values when calculated according to ISO 20914 guideline. Also, 11 out of 20 clinical chemistry analytes' MU values met the MAU values with the Nordtest guideline's recommended calculations. However, some tests met the MAU in the ISO 20914 approach but not in the Nordtest guideline, and vice versa. The study found that intermediate precision (u_Rw) in the ISO 20914 approach and performance bias (u(bias)) in the Nordtest approach significantly impacted MU values. The research highlights the importance of standardization in MU calculation approaches across clinical laboratories. These findings have implications for patient care and clinical decision-making, emphasizing the importance of selecting appropriate laboratory guidelines for routine use.

This survey study aims to evaluate knowledge of centrifuge operation and adherence to centrifugation protocols among laboratory personnel. These aspects are crucial in preventing pre-analytical errors. Additionally, the study seeks to assess the equipment infrastructure and staffing status within the participants' institutions. The study involved 397 participants from various medical laboratories. A 16-item survey, using a 5-point Likert scale, was utilized to assess theoretical and practical knowledge of centrifuge operation. Two groups of subscales were developed, with one focusing on theoretical and practical knowledge and the other on pre-centrifugation, centrifugation, and post-centrifugation processes. Demographic data were collected, and the reliability of the survey was analyzed using Cronbach's alpha (0.94). Validity was assessed through factor analysis. The majority of participants were female (63%) and worked as laboratory technicians (72%). Approximately 71% had never received formal centrifuge training, and significant differences were observed between theoretical and practical knowledge, particularly among laboratory technicians (P < 0.001). Education level and job title also influenced knowledge scores (P < 0.001). The developed survey scale demonstrated high reliability and validity, indicating its potential as a valuable reference for future studies assessing centrifugation competency and usage in laboratory environments. These findings underline the need for improved training programs to reduce pre-analytical errors and enhance overall laboratory performance.

Objectives: The study aimed to estimate the biological variation (BV) of routine coagulation tests, including prothrombin time (PT), activated partial thromboplastin time (aPTT), and fibrinogen, in a healthy population to enhance the accuracy of laboratory results and improve diagnosis and treatment decisions. Methods: The study included 26 healthy volunteers over 10 weeks; samples were collected weekly. The within-subject BV (CV _I ) and between-subject BV (CV _G ) were calculated for each parameter, and the index of individuality (II) and reference change values (RCV) were determined. All tests were performed in duplicate on the Roche Cobas T-711 coagulation analyzer. Results: Fibrinogen exhibited the highest BV, with a CV _I of 11 % and CV _G of 17.4 %. The aPTT test had a CV _I of 5.8 %, a CV _G of 8.4 %, and an II of 0.91. The PT test had a CV _I of 3.2 %, a CV _G of 5.8 %, and an II of 0.73. The RCV values ranged from −7.5 to 8.1 for PT, −12.7 to 14.6 for aPTT, and −22.7 to 29.4 for fibrinogen. Conclusions: The study underscores the significant biological variation in routine hemostasis parameters, such as PT, APTT, and fibrinogen, which impacts clinical diagnoses and treatment decisions. Despite certain limitations, the findings offer valuable insights for clinicians and suggest that future research should include more parameters for a comprehensive understanding of biological variations in hemostasis testing.