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Urine albumin is a well-known biomarker of proven clinical utility for relevant pathological conditions and a risk factor for cardiovascular mortality. This paper is aimed to illustrate the state-of-art of albuminuria measurement and the adherence to the official recommendations in scientific writing. In spite of the urine albumin clinical importance, the standardisation of the analyte is not completed yet, but the adoption of decisional values (established in 2013) would require standardized methods to allow the correct classification of patients. The Italian EQA scheme for albuminuria shows variable bias to the consensus value, depending on the analytical system: a typical situation originating from the lack of international standardisation. The harmonisation of the measure is more advanced: the EQA data show that 74% of participants use the albumin/creatinine ratio to report the urine albumin excretion. A recent systematic review examined how the albuminuria data are reported in clinical studies. A sub-optimal situation is illustrated: the laboratory information is often lacking or incorrectly reported. The obsolete term "microalbuminuria" is used in >40% of the studies, only 20% of the studies uses the correct sample (first morning void). The data about the post-analytical are more encouraging: the measurement units and the decisional values are correctly reported in the majority of the studies. The correction of this situation, that makes it difficult to transfer the results from clinical studies to the daily practice, requires a stringent collaboration between laboratory professionals and clinicians: working together in multidisciplinary groups to understand the respective needs is to be promoted. [ABSTRACT FROM AUTHOR]

Introduction: in spite of the introduction of automated systems for urine sediment analysis, microscopy examination remains the gold standard. External Quality Assessment (EQA) programs on urine sediment are rare. This paper provides an analysis of results from 2012 to date of the EQA Italian program (Centro di Ricerca Biomedica, Regione Veneto) which involves today 255 laboratories. Methods: the EQA program includes four surveys/year. Participants are asked to identify and provide the clinical association of the presence of specific particles (2 surveys) and formulate the diagnosis of clinical cases presented (2 surveys). In 11 years, 202 images were proposed: 64 cells (9 types), 10 lipids (4 types), 59 casts (16 types), 36 crystals (13 types), 14 microorganisms (5 types), 19 contaminants (8 types) and 22 clinical cases were presented. Results: the correct identification rate (median; interquartiles) was very high for micro organisms (96.4; 91.9-99.9); high for crystals (92.2; 80.2-96.3) and lipids (91.1; 90.5-93.6); followed by casts (87.7; 80.1-91.8); contaminants (87.3; 77.2-96.0) and cells (82.8; 74.4-91.3). For clinical associations, the rate of correct answers was 96.5 (range 48.7- 100%). For clinical cases, due to the overall rate of particle misidentification throughout surveys, only 58.6% (44.9- 68.8%) of participants achieved access to clinical diagnosis. Of these, 92,0% (78.1-95.5%) were able to indicate the correct diagnosis. Conclusions: the program can be used as a tool to improve the identification of urine particles and the knowledge of their clinical significance and to encourage specialists of laboratory medicine to correlate urine findings with other laboratory data and the clinical history of the patient, an aspect that improves the value of the day by day work. [ABSTRACT FROM AUTHOR]

In spite of the introduction of automated systems for urinary sediment analysis, microscopy examination remains the gold standard, and it is more than ever important to perform it with a good and reliable quality. External Quality Assessment (EQA) programs on urinary sediment are rare. The present paper provides an analysis of results from 2001 to date of the EQA Italian program which involves today 230 laboratories. The program includes four surveys per year. Participants are asked the identification and clinical associations of urinary sediment particles, shown as phase contrast microscopy images in the website of the Center of Biomedical Research (CRB) (2 surveys), and the diagnosis of clinical cases presented by both images and a short clinical history (2 surveys). The results of each survey are then scored and commented. In 20 years, 298 images were presented: 90 cells (9 types), 23 lipids (5 types), 87 casts (21 types), 53 crystals (14 types), 22 microorganisms (5 types), and 23 contaminants (9 types). Moreover, 27 clinical cases, covering a wide spectrum of conditions with different degrees of complexity, were presented to participants. Identification: among urinary particle categories, the correct identification rate (obtained for each particle from the sum of correct + partially correct answers) was very high for micro-organisms (mean ± SD: 96.2 ± 3.5%), high for lipids (88.0 ± 11.8%) and crystals (87.0 ± 16.5%) followed, in decreasing order, by cells (82.1 ± 15.9%), casts (81.8 ± 14.8%), and contaminants (76.7 ± 22.1%). Clinical associations (n=67): the rate of correct answers was 93.5 ± 5.7% ranging from 75.0 to 100% for all but one clinical association (i.e., acute glomerulonephritis: 55.4%). Clinical cases: throughout surveys, due to the overall rate of particle misidentification, only 59.8 ± 17.1%, (range 32.5–88.7%) of participants achieved access to clinical diagnosis. Of these, 88.7 ± 10.6% (range 59.9–99.3%) were able to indicate the correct diagnosis. Our program can be used as a tool to improve the identification of urine particles and the knowledge of their clinical meaning and to encourage specialists of laboratory medicine to correlate urinary findings with other laboratory data and the clinical history, an aspect that improves the value of the day by day work. [ABSTRACT FROM AUTHOR]

• External Quality Assessment as a tool to improve laboratory performances. • Inter-laboratory variability (CV%) concerning 14 specific proteins measurements. • Between method differences (bias%) among the most used analytical platforms. • Harmonization degree of units used to report specific proteins. To evaluate the state-of-the-art of 14 specific proteins measurement; to evaluate the laboratories' performance and the degree of harmonization in reporting results of participants in the External Quality Assessment Program of the Centre of Biomedical Research (CRB). Overall and system-related inter-laboratory analytical variability (mean CVs%) and between-system differences (mean bias%) were evaluated from data of six EQA cycles 2013–2018. Moreover, we evaluated the analytical performance of participants as well as the units used to express proteins results. Overall inter-laboratory variability ranged from 3.8% for haptoglobin (HPT) to 12.5% for α 1 -antitrypsin (AAT) and decreased for IgA, α 2 -macroglobulin (A2M) and transferrin (TRF). Mean CVs% were generally higher for Siemens BN and Beckman Immage immunonephelometric systems, but <7.0% for all proteins. Mean bias > 7.0% was observed for BN (IgA, C4, AAT, transthyretin TTR), Siemens Vista (IgA, C4) and Immage (C4), whereas mean bias < −7.0% was found for Immage (AAT), Beckman AU (IgM) and Roche Cobas (C4, TTR, C-reactive protein). The laboratories' performance within the limits ranged from 85.1% of albumin (ALB) to 97.2% of HPT. The census of units employed in 2018, demonstrated that ~ 70% of laboratories still express the results in mg/dL. Despite a reduction in inter-laboratory variability for some proteins, different analytical systems showed both proportional and constant bias between methods. Units used by participants have not been substantially changed and dL is still largely used. The CRB EQA Program, with its performance data sets, is a valuable resource for laboratories and IVD manufacturers and support the goals of harmonization. [ABSTRACT FROM AUTHOR]

Background: The need to harmonize laboratory information is particularly intense in the field of plasma proteins, considering their clinical impact and relevance in monitoring diseases. Methods: We evaluated units and reference intervals (RIs) utilized by participants of the External Quality Assessment Scheme (EQAS) for plasma proteins of the Centre of Biomedical Research. Moreover, we evaluated inter-laboratory analytical variability from 2001 to 2017. Results: The census of participants' units employed in 2017 showed that for albumin (ALB), ~66% of laboratories still used dL instead of L, and for most other proteins, ~70% still expressed the results in mg/dL. Laboratories primarily used the RIs reported in the packaging inserts of their analytical systems, but for each protein, there was a wide variability of RIs, also among laboratories using the same analytical method. Mean CVs% of the 13 certified proteins in the last five EQA cycles ranged from 3.8% of haptoglobin (HPT) to 12.4% of α1-antitrypsin (AAT) and decreased from 2001 to 2017 for most of them, in particular for C3, ALB, α2-macroglobulin (A2M), HPT and transferrin (TRF). Conclusions: In the face of a reduction in inter-laboratory variability for a lot of proteins, there has not been a substantial change in the units and in the RIs used by the participants. To change old habits is difficult and requires coordination and collaboration. The EQAS plays an important role in the assessment and monitoring of all elements that contribute to the formulation of laboratory information and may be useful to contribute to their harmonization. [ABSTRACT FROM AUTHOR]

Effective management of clinical laboratories participating in external quality assessment schemes (EQAS) is of fundamental importance in ensuring reliable analytical results. The International Standard ISO 15189:2012 requires participation in interlaboratory comparison [e.g. external quality assessment (EQA)] for all tests provided by an individual laboratory. If EQAS is not commercially available, alternative approaches should be identified, although clinical laboratories may find it challenging to choose the EQAS that comply with the international standards and approved guidelines. Great competence is therefore required, as well as knowledge of the characteristics and key elements affecting the reliability of an EQAS, and the analytical quality specifications stated in approved documents. Another skill of fundamental importance is the ability to identify an alternative approach when the available EQAS are inadequate or missing. Yet the choice of the right EQA program alone does not guarantee its effectiveness. In fact, the fundamental steps of analysis of the information provided in EQA reports and the ability to identify improvement actions to be undertaken call for the involvement of all laboratory staff playing a role in the specific activity. The aim of this paper was to describe the critical aspects that EQA providers and laboratory professionals should control in order to guarantee effective EQAS management and compliance with ISO 15189 accreditation requirements. [ABSTRACT FROM AUTHOR]

The article presents a study which discusses analytical performance of general chemistry analytes across countries and across manufacturers in the INPUtS project of external quality assessment (EQA) organizers. Topics include reference measurement procedures (RMPs), evaluation of general chemistry analytes according to performance specifications derived from biological variation (BV), and minimum performance specification for cholesterol and high-density density (HDL) cholesterol.

Background: Manual microscopy still represents the gold standard for urinary sediment (US) examination. We report the results obtained in the period 2012-2015 by the EQA Italian program on US, which today involves about 260 laboratories. Methods: The program includes four surveys per year. In two surveys, participants are asked to supply identification and clinical association of US particles. In two other surveys, they are asked to supply the diagnosis of clinical cases, presented with images, some key laboratory findings and a short clinical history. Sixty-six images of US particles (21 cells, 2 lipids, 21 casts, 10 crystals, 3 microorganisms, 15 contaminants) and seven clinical cases were presented. Results: The correct identification rate for each category of particles, in decreasing order, was: micro-organisms (mean±SD: 92.4%±4.5%), lipids (92.0%±1.8%), casts (82.8%±8.8%), crystals (79.4%±29.8%), cells (77.3%±13.5%), and contaminants (70.9%±22.2%). For 13 particles, a correct clinical association was indicated by 91.5%±11.7% of participants, while it was 52.7% for particles associated with urinary tract infection. For clinical cases, due to a high rate of particles misidentification, only 44.3%±10.1% of participants achieved access to clinical diagnosis, which was then correctly indicated by 92.5%±5.3% of them. Conclusions: The results of the EQA program confirm that, while some US particles are well known in terms of identification, clinical association and clinical meaning, others particles still are not, and this represents an important reason to encourage EQA programs on US. [ABSTRACT FROM AUTHOR]

Background: The few available External Quality Assessment (EQA) programs on urinary sediment rarely include an evaluation of clinical cases. The present paper provides a descriptive analysis of clinical cases included in the Italian EQA program on urinary sediment. Methods: Ten cases were presented over a 5-year period (2007-2011). Each clinical case included a brief clinical history, some key laboratory data and four key urinary sediment particles obtained by phase contrast microscopy. The clinical diagnoses indicated by participants, chosen among four or five proposed, were evaluated only for those who had been able to correctly identify all four urinary sediment particles. The results of each survey were then evaluated, scored and commented on. Results: The numbers of participants for the 10 surveys ranged from 268 to 325. Throughout surveys, only 63.9%±17.0% (range 39.6%-88.7%) of participants achieved access to clinical diagnosis. Of these, 90.2%±8.5% (range 73.7%-98.1%) were able to indicate the correct diagnosis. Conclusions: Our findings demonstrate that once the correct identification of urinary sediment particles is obtained, most participants are able to associate urinary findings with the respective clinical conditions, thus establishing the correct diagnosis. [ABSTRACT FROM AUTHOR]

External Quality Assessment (EQA) and Proficiency Testing (PT) are valuable tools in the quality improvement process. They provide objective evidence of laboratory competence for customers, accrediting bodies, and regulatory agencies, and serve as a unique source of information that is not obtainable in other ways. Traditional EQA/PT schemes tend to address only the analytical process (examination procedures), but some innovative schemes have been recently introduced to evaluate both pre- and post-analytical activities of the medical laboratory. The most important considerations in selecting an EQA/PT program include the evidence that: (i) samples are commutable (i.e. they behave like patient samples), (ii) reference values are traceable, (iii) method comparability with available peer groups is allowable, (iv) the size of peer group is statistically appropriate, and (v) both the timeliness and the usefulness of reports is granted. Careful evaluation of a single EQA/PT result should be coupled with active tracking of all results over time, and monitoring performances represent a challenging issue for medical laboratories. It is also important to consider that every EQA/PT scheme presents some limitations and that it is not appropriate to use EQA/PT as the sole means for evaluating laboratory quality. Therefore, there is the need to underline that internal quality control (IQC), EQA/PT and other tools have to be implemented and used to monitor and improve the quality in laboratory diagnostics. [ABSTRACT FROM AUTHOR]

Abstract: Background: EQA programs on urinary sediment are rare. We describe an EQA Italian program which started in 2001 and involves today more than 300 laboratories. Methods: The program, which started with a questionnaire about the methodological aspects on urinary sediment, includes today four surveys per year. These ask the participants the identification and clinical associations of urinary sediment particles shown by colour images (surveys 1 and 3) and the diagnosis of clinical cases presented by both images and a short clinical history (surveys 2 and 4). The results of each survey are then scored and commented. Results: Questionnaire (participants = 287): most methodological aspects were not dealt with properly. Identification: cells, lipids, casts and some contaminants were poorly known. However, when 27 particles were presented for the second time and 16 particles for the third time, the correct identification rate for most of them increased significantly. Clinical associations (No presented = 16): a correct answer was indicated by ≥84% of participants for all particles but one. Clinical cases (No presented=4): lowest correct identification for urine contamination from genital secretion (77.3%), highest for ureteric stone (94.4%). Conclusions: Our program shows that EQA programs are both useful and needed. [Copyright &y& Elsevier]

To guarantee excellent performance and service, the process of identifying and treating error risks must be integrated into the total testing process. Quality Assurance Programs (QAPs) represent an important tool that allows us to identify errors and pinpoint any need for further systematic investigations, and to rectify procedures to improve the inputs and processes by which the service is delivered. The models used by the laboratory to assure quality and manage the risk of errors have been modified in line with an approach in which the identification of quality goals and the redefinition of professionals duties and responsibilities are indispensable. Error risk is currently high in some areas of laboratory activity, and QAP is needed now more than ever. The present paper provides some descriptive examples of an approach that can be followed to manage an External Quality Assessment Scheme (EQAS) and quality indicators (QIs), the main tools used by laboratories to assure the quality of their service, for the prevention of error risk. In particular, we describe the correct approach to choose EQAS, to use information from the EQAS report, to design a QI model, and to analyze any QI data. The examples highlight that any well-designed quality system can be ineffective if it is not managed by highly competent professionals with a deep sense of responsibility. Clin Chem Lab Med 2007;45:756–65. [ABSTRACT FROM AUTHOR]

The implementation of Clinical Governance will require a redefinition of duties and accountability as a prerequisite to develop and achieve an overall improvement in clinical care through a culture of assessment and monitoring of quality. External Quality Assessment Schemes (EQAS) are the main tool enabling laboratories to measure the quality of their results; they must carefully assess and monitor all elements contributing to the formulation of laboratory information (results, reference ranges/decisional levels, interpretative comments and diagnostic algorithms). There are different ways to design and manage a Scheme and EQAS coordinators are mainly responsible for its effectiveness. The present paper reports, as an example, some experiences of the Centre of Biomedical Research (CRB), which manages EQAS according to high quality specifications and laboratories' needs, that can reflect the Clinical Governance philosophy. Our findings show that EQAS are able to control all the above aspects and, if organisers are committed to fulfilling the responsibility and accountability principles, they will be of great value in quality assessment and in developing an External Quality Assurance Program (EQAP). This is an inter-laboratory comparison designed and conducted to assure the following: evaluation of participants' performance (by evaluating not only analytical performance, but also test interpretation, and advice for clinicians on laboratory requests and diagnosis); evaluation of method performance; and continuous education, training and help. The main aim of the activities of an EQAP in Laboratory Medicine is to sustain improvements in the quality of services provided by participating laboratories for the benefit of patients. [ABSTRACT FROM AUTHOR]

Background: The recommendations of the Second Joint Task Force of European and Other Societies on Coronary Prevention and the third Adult Treatment Panel report (ATPIII) released by the National Cholesterol Education Program are based on accumulating evidence concerning the contribution of lipoproteins and other risk factors in the development of coronary heart disease (CHD). The laboratories play an important role in the successful adoption of these guidelines. Methods: In External Quality Assessment (EQA) programs managed by the Center of Biomedical Research, results and respective reference intervals (RI) are sent as laboratory''s medical form. We assessed how well the 200 participants to EQA scheme 2002 for clinical biochemistry reported total cholesterol (TC) and triglycerides (TGs) results according to either European or National Cholesterol Education Program (NCEP) guidelines. Results: Only 18% of laboratories reported total cholesterol concentrations correctly in terms of desirable, borderline-high, and high risk for the CHD development, 12% reported a single desirable value (180, 190, or 200 mg/dl), and 70% reported the RI (85 laboratories in the whole interval, 34 are the only upper reference limit and 15 are the desirable value in addition to RI). The upper reference limit was 200 mg/dl in 65% of cases, but 32% of laboratories presented higher limits, reaching values as high as 250–260 mg/dl. Only the 3.7% of laboratories reported triglyceride concentrations in terms of risk-oriented ranges for the CHD development, 6.8% the single desirable value, and 89.5% the RI. Conclusion: Our study demonstrates that the current practice of reporting results for cholesterol and triglycerides does not follow the guidelines, and appropriate changes are required to be made. [Copyright &y& Elsevier]

The article comments on the paper "The Empower project--A new way of assessing and monitoring test comparability and stability" by L. M. Thienpont and colleagues. Topics discussed include the call for the harmonization and standardization of clinical laboratory testing, a project which creates collaboration between manufacturers and laboratories to monitor the stability and test comparability of laboratory results and the four pillars of the Empower project.

Presents a letter to the editor about External Quality Assessment schemes.

Numerous analytical systems, rapidly made available on the market throughout the SARS-CoV-2 pandemic, aim to detect COVID-19, and to continuously update and improve the same systems. Medical laboratory professionals have also developed in-house analytical procedures in order to satisfy the enormous volume of requests for tests. These developments have highlighted the need control the analytical procedures used in order to guarantee patient safety. The External Quality Assessment (EQA) Scheme, an important quality assurance tool, aims to guarantee high standard performance for laboratory and analytical procedures. The aim of the present study was to report on the results collected in an experimental EQA scheme for the serological diagnosis of SARS-CoV-2. All qualitative results collected in the different EQA surveys were summarized in order to identify the percentage of laboratory results in relation to typology of antibodies, results and samples. A total of 4,867 data sets were collected. The analysis of EQA data made, demonstrates a better agreement among laboratories results for total Ig than single immunoglobulins (IgG, IgM, IgA) in the case samples positive for SARS-CoV-2, and a wide divergence between IgM results for positive samples (only 34.9% were correct). Results for negative controls and specificity controls demonstrated a better overall agreement than results for positive samples. Working in collaboration with the IVD manufacturers, laboratory professionals must strive to achieve harmonization of results, and to develop well-defined protocols complying with the ISO 15189 requirements. [ABSTRACT FROM AUTHOR]

Background: External quality assessment (EQA) is a tool for quality management in clinical laboratories and its main objectives are assessment of participants and methods performance, training and advice. This paper describes the quality specifications used in EQA schemes of the Centre of Biomedical Research (CRB), in order to design schemes that can assess laboratory reliability performances, meet the changing needs and quality recommendations. Methods: Quality specifications for control materials, statistical procedures and goals to assess laboratory performance have been applied and introduced in EQA schemes managed by CRB. Results: The application of well-defined quality specifications has demonstrated effective. In particular, we report results on alkaline phosphatase and cholesterol obtained using commercial control materials and human serum controls, in two different EQA surveys; the inter-laboratory variability (CVinter%) for troponin I analysed with a diagnostic system and assigned values of CK-MB mass obtained using four different diagnostic systems; the percentage of acceptable performances obtained by means of the application of goals based on clinical criteria, biological variation, state-of-the-art and used for EQA schemes, and referring to some analytes with significant clinical values such as cholesterol, glucose, glycated hemoglobin and sodium. Conclusions: The design of reliable EQA schemes based on evidence-based quality specifications is a pre-requisite for supporting the quality improvement of clinical laboratories. [Copyright &y& Elsevier]

Introduction: Laboratory information is generated when a meaning is given to certain data. This is usually achieved by comparing a laboratory test result with the reference range/decisional limit (RL), and by providing consultation for the interpretation of data, advice, and follow-up testing. Aim: In this paper, we investigate factors affecting the conversion of data into useful information with regard to biochemical markers of myocardial damage (CK-MB mass, myoglobin, and troponins), in view of their importance in detecting myocardial necrosis. Our aim was to report results obtained in order to verify the consensus between laboratories with reference to interpretative comments and the reference ranges/decisional limits added to clinical reports. Methods: A questionnaire and simulated medical reports on three different patients were distributed to participants (94 laboratories) in the 2001 cycle of the External Quality Assessment (EQA). Moreover, we analysed 113 medical reports sent by laboratories during the most recent EQA cycle 2002, and checked the number of different RLs used, both independent and within the diagnostic system used. We also compared each laboratory result of a control sample, obtained in the 2002 cycle, with declared RL in order to verify the clinical significance of results (“normal” or “pathological”) for troponin I and CK-MB. Results: Our findings show that few laboratories regularly add interpretative comments to medical reports. On the contrary, they cooperate with clinicians who require consultation, advice, and information for the appropriate use of biochemical markers. There is a general consensus among participants regarding probable syndromes suggested by the interpretation of the same result and most laboratories also agree on further investigations to be carried out for several diseases. Concerning RL, the data demonstrate that numerous different RLs are used to report the results of the biochemical markers evaluated, both when considered independent of the diagnostic system used and within the diagnostic system used. Discussion and conclusions: The biochemist does not have the opportunity to verify the efficacy of the interpretation that he/she provided. An audit of this activity is therefore required to allow the laboratory to monitor its own performance and to assure good practice. The evaluation of interpretative comments, through specific surveys, should be a prime objective of EQA organisers.Well-designed EQA programs can, moreover, support laboratories in establishing appropriate RL and in verifying the clinical significance of their results with respect to that of other laboratories.Our survey on interpretative comments and the analysis of the RLs further demonstrate how laboratory medicine can contribute to the objective evaluation of the patients'' health status. [Copyright &y& Elsevier]

Introduction Reliable serum creatinine measurements are of vital importance for the correct classification of chronic kidney disease and early identification of kidney injury. The National Kidney Disease Education Programme working group and other groups have defined clinically acceptable analytical limits for creatinine methods. The aim of this study was to re-evaluate the performance of routine creatinine methods in the light of these defined limits so as to assess their suitability for clinical practice. Method In collaboration with the Dutch External Quality Assurance scheme, six frozen commutable samples, with a creatinine concentration ranging from 80 to 239  μmol/L and traceable to isotope dilution mass spectrometry, were circulated to 91 laboratories in four European countries for creatinine measurement and estimated glomerular filtration rate calculation. Two out of the six samples were spiked with glucose to give high and low final concentrations of glucose. Results Results from 89 laboratories were analysed for bias, imprecision (%CV) for each creatinine assay and total error for estimated glomerular filtration rate. The participating laboratories used analytical instruments from four manufacturers; Abbott, Beckman, Roche and Siemens. All enzymatic methods in this study complied with the National Kidney Disease Education Programme working group recommended limits of bias of 5% above a creatinine concentration of 100  μmol/L. They also did not show any evidence of interference from glucose. In addition, they also showed compliance with the clinically recommended %CV of ≤4% across the analytical range. In contrast, the Jaffe methods showed variable performance with regard to the interference of glucose and unsatisfactory bias and precision. Conclusion Jaffe-based creatinine methods still exhibit considerable analytical variability in terms of bias, imprecision and lack of specificity, and this variability brings into question their clinical utility. We believe that clinical laboratories and manufacturers should work together to phase out the use of relatively non-specific Jaffe methods and replace them with more specific methods that are enzyme based. [ABSTRACT FROM AUTHOR]