Fig 2 - uploaded by Sandra Secchiero
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An example of a clinical case (survey 4-2008) showing the urinary findings observed in a 60-year-old man with nephrotic syndrome (albuminuria ++++, serum albumin 25 g/L, serum cholesterol 3.55 g/L) and normal renal function (serum creatinine 12 g/L). From top left clockwise: C-SU-29. A clump of lipid droplets (++/HPF, at 400×); C-SU-30. An oval fat body i.e., a macrophage gorged with fatty particles (1 every 3-5 HPFs); C-SU-31. A fatty cast (1 every 3-4 low power fields, at 160×); C-SU-32. A cholesterol crystal (1 every 20 HPFs). In the original, all images in colour by phase contrast and polarized light (insets).
Source publication
EQA programs on urinary sediment are rare. We describe an EQA Italian program which started in 2001 and involves today more than 300 laboratories.
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 asso...
Context in source publication
Context 1
... cases consist of a brief clinical history, which also include some key laboratory data and four phase contrast microscopy images of particles found in the urine sediment of the case presented (Fig. 2). Also for clinical cases the participants are asked to identify the particles shown and to choose one possible clinical diagnosis among 4 to 5 proposed. -The scoring system. For each survey the answers obtained are evaluated as correct, partially correct, incorrect or no answer and scored accordingly (5, 3, 0, and − 2 respectively). ...
Citations
... Laboratory professionals have long used quality assurance tools to control the steps in the intra-analytical phase. In fact, the availability of internal quality control procedures and external quality assessment programs, and of approved guidelines and recommendations developed by professionals for their effective use, has promoted the improvement of the intra-analytical performance, as shown by the dramatic decrease achieved in analytical errors [20][21][22][23][24]. Moreover, the impact of these activities on quality depends exclusively on laboratory staff with a sound knowledge of how to assess and monitor the performance characteristics. ...
In the last few decades, quality in laboratory medicine has evolved in concert with the transformation and the changes (technological, scientific and organizational) in this sector. Laboratory professionals have faced great challenges, at times being overwhelmed, yet also involved in this progress. Worldwide, laboratory professionals and scientific societies involved in laboratory medicine have raised awareness concerning the need to identify new quality assurance tools that are effective in reducing the error rate and enhancing patient safety, in addition to Internal Quality Control (IQC) procedures and the participation in the External Quality Assessment Schemes (EQAS). The use of Quality Indicators (QIs), specifically designed for laboratory medicine are effective in assessing and monitoring all critical events occurring in the different phases of Total Testing Process (TTP), in particular, in the extra-analytical phases. The Model of Quality Indicators (MQI), proposed by the Working Group “Laboratory Errors and Patient Safety” (WG-LEPS) of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and validated by experts in consensus conferences, is an important window of opportunity for the medical laboratory to demonstrate the use of an effective quality assurance tool fit for this purpose. Aim of this paper is to provide an update of the state-of-the-art concerning the most used QIs data collected in 2021 and the Quality Specifications (QSs) proposed for their evaluation. Moreover, a strategy for the future is proposed in order to improve the MQI and encourage its use in medical laboratories throughout the world.
... The smallest median values of between-laboratory CVs were obtained for the automated methods. This agrees with the other papers [13][14][15][16]. Automated methods enable one to avoid factors influencing the variation of results attained by manual methods, such as, for example, the loss of particles during centrifugation or inadequate review of the full coverslip area [11]. ...
and 75,4%, respectively. The major issues were observed: the low sensitivity for the detection of low-concentration samples and the incapacity of several methods to detect the positive sample. The assessment is needed to continuously evaluate the improvement proficiency of laboratories in Thailand.
... External Quality Assessment Programs are an essential tool to assist with the technology, identify problems, and to point training needs and it is valuable for laboratories, but even more for the benefit of the patients (10,11). Studies have reported the importance of continuing education and regulatory supervision in contributing to improve the performance in EQAP, and to decrease the number of errors in urine analysis (12,13). Failing laboratories must analyse the reasons for the failure, report the results, and initiate corrective action. ...
Introduction:
Epithelial cells (ECs) are structures regularly observed during urine microscopy analysis. The correct identification of EC subtypes can be useful since renal tubular epithelial cells (RTECs) are clinically relevant. We investigate the urinary ECs report and the judgement of its clinical importance by Brazilian laboratories.
Materials and methods:
A survey with four questions was made available to participants of the Urinalysis External Quality Assessment Program (EQAP) from Controllab. Laboratories composed 3 groups: (1) differentiating ECs subtypes: "squamous", "transitional" and "RTECs"; (2) differentiating ECs subtypes: "squamous" or "non-squamous" cells; (3) without ECs subtype identification. Participants did not necessarily answer to all questions and the answers were evaluated both within the same laboratory's category and within different categories of laboratories.
Results:
A total of 1336 (94%) laboratories answered the survey; Group 1, 119/140 (85%) reported that ECs differentiation is important to the physician and 62% want to be evaluated by EQAP, while in Group 3, 455/1110 (41%) reported it is useful to them, however only 25% want be evaluated by EQAP. Group 2 laboratories 37/51 (73%) reported that the information is important, but only 13/52 (25%) are interested in an EQAP with differentiation of the 3 ECs subtypes.
Conclusion:
Most of the laboratories do not differentiate ECs in the three subtypes, despite the clinical importance of RTECs. Education of laboratory staff about the clinical significance of urinary particles should be considered a key priority.
... In addition to conventional Internal Quality Control (IQC) programs, External Quality Assessment Schemes (EQAS) represent a key tool for the improvement of laboratory quality and are mandatory requirements in accreditation programs in all fields of laboratory medicine [3]. EQAS on urinary sediment are rare [4][5][6][7][8][9][10][11][12]. ...
... Period 2001-2011: The methods and results of the program, which in this period was under the responsibility and guidance of one of us (G.B.F.), a nephrologist with an expertise in urinary sediment and urinalysis [18][19][20][21][22][23][24][25], has been described in details elsewhere [6,21,22]. In this period, the descriptive identification of particles were evaluated as correct, partially correct, incorrect or no answer and scored accordingly (5, 3, 0, and −2 respectively). ...
Objectives
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.
Methods
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.
Results
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.
Conclusions
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.
... We also recruited many expert nephrologists known for their interest in urine sediment examination and teaching. Notably, studies by Secchiero et al,18 and Fogazzi et al19,20 from Italy, in which images of urine sediment particles were interpreted by laboratory personnel, reported variable but often excellent percent agreement. In Secchiero et al,18 the percentages of reviewers who correctly identified isomorphic RBCs, hyaline casts, and granular casts were 84.7%, 89.5% and 74.9%, respectively.Our report of the concordance between nephrologists' identification of the underlying disease process and the biopsy results should be understood as exploratory given the small number and selected nature of urine samples. ...
Importance
Urine sediment microscopy is commonly performed during the evaluation of kidney disease. Interobserver reliability of nephrologists’ urine sediment examination has not been well studied.
Objective
Assess interobserver reliability of the urine sediment examination.
Design, Setting, and Participants
In this diagnostic test study, urine samples were prospectively collected from a convenience sample of adult patients from an academic hospital in the United States undergoing kidney biopsy from July 11, 2018, to March 20, 2019. Digital images and videos of urine sediment findings were captured using a bright-field microscope. These images and videos along with urine dipstick results were incorporated in online surveys and sent to expert nephrologists at 15 US teaching hospitals. They were asked to identify individual sediment findings and the most likely underlying disease process.
Exposures
Urine dipstick results and urine sediment images from patients undergoing native kidney biopsy.
Main Outcomes and Measures
Interobserver reliability of urine sediment microscopy findings estimated by overall percent agreement and Fleiss κ coefficients. Secondary outcomes included concordance of diagnoses suspected by nephrologists with corresponding kidney biopsy results.
Results
In total, 10 surveys from 10 patients containing 76 study questions on individual features were sent to 21 nephrologists, 14 (67%) of whom completed them all. Their combined 1064 responses were analyzed. Overall percent agreement for casts was an estimated 59% (95% CI, 50%-69%), κ = 0.52 (95% CI, 0.42-0.62). For other sediment findings, overall percent agreement was an estimated 69% (95% CI, 61%-77%), κ = 0.65 (95% CI, 0.56-0.73). The κ estimates ranged from 0.13 (95% CI, 0.10-0.17) for mixed cellular casts to 0.90 (95% CI, 0.87-0.94) for squamous epithelial cells.
Conclusions and Relevance
In this study, substantial variability occurred in the interpretation of urine sediment findings, even among expert nephrologists. Educational or technological innovations may help improve the urine sediment as a diagnostic tool.
... Following major developments in methods and programmes designed to achieve internal quality control (IQC), and external quality assurance/proficiency testing (EQA/PT) focussing on analytical quality, evidence of vulnerability in the pre-and post-analytical phases of laboratory testing led to the development and implementation of a model of quality indicators (MQI) covering both the intra-and extra-analytical phases of the testing cycle [2]. A body of evidence collected in the last five decades highlights the importance of defining analytical performance characteristics (analytical quality specifications) and using them in IQC and EQA/PT in order to decrease analytical error rates and improve analytical quality [3][4][5][6][7]. A more comprehensive, patient-oriented view of quality and safety, now needed in laboratory medicine, should be achieved through the assessment of risk and its prevention, and the measurement and monitoring of quality indicators (QIs) [8][9][10][11]. ...
... Laboratory professionals have long used quality assurance tools to control the steps in the intra-analytical phase. In fact, the availability of internal quality control procedures and external quality assessment programs, and of approved guidelines and recommendations developed by professionals for their effective use, has promoted the improvement of the intra-analytical performance, as shown by the dramatic decrease achieved in analytical errors [20][21][22][23][24]. Moreover, the impact of these activities on quality depends exclusively on laboratory staff with a sound knowledge of how to assess and monitor the performance characteristics. ...
A large body of evidence collected in recent years demonstrates the vulnerability of the extra-analytical phases of the total testing process (TTP) and the need to promote quality and harmonization in each and every step of the testing cycle. Quality indicators (QIs), which play a key role in documenting and improving quality in TTP, are essential requirements for clinical laboratory accreditation. In the last few years, wide consensus has been achieved on the need to adopt universal QIs and common terminology and to harmonize the management procedure concerning their use by adopting a common metric and reporting system. This, in turn, has led to the definition of performance specifications for extra-analytical phases based on the state of the art as indicated by data collected on QIs, particularly by clinical laboratories attending the Model of Quality Indicators program launched by the Working Group “Laboratory Errors and Patient Safety” of the International Federation of Clinical Chemistry and Laboratory Medicine. Harmonization plays a fundamental role defining not only the list of QIs to use but also performance specifications based on the state of the art, thus providing a valuable interlaboratory benchmark and tools for continuous improvement programs.
... I programmi di VEQ per l'analisi della frazione corpuscolata delle urine sono ancora meno sviluppati rispetto ai programmi di VEQ per l'analisi chimica, quantitativa o semiquantitativa delle urine, poiché i risultati di tipo qualitativo per l'analisi morfologica in generale non possono essere suddivisi in rank e il giudizio su ogni singola risposta richiede la consulenza di un professionista esperto nella disciplina [128][129][130][131][132][133]. ...
... Nel report del programma di VEQ, oltre alla valutazione delle risposte del Laboratorio con il relativo punteggio, vengono forniti commenti esaustivi sul significato clinico di ogni elemento proposto. L'analisi delle risposte, raccolte in più di 15 anni di esperienza su questo tipo di VEQ, ne ha mostrato la grande utilità anche in termini educazionali [130][131][132][133]. In questo tipo di schemi di VEQ, infatti, per la refertazione dei risultati è richiesta una valutazione soggettiva da parte del professionista di Laboratorio; questi esercizi sono pertanto utili al Laboratorio per evidenziare eventuali necessità di formazione/aggiornamento e rappresentano uno stimolo per il personale preposto ad approfondire le conoscenze su una determinata patologia. ...
... Insieme ai corsi teorico-pratici sull'argomento, questo programma di VEQ costituisce quindi un supporto indispensabile alla formazione dei partecipanti e ha quindi un suo spazio e un suo ruolo nell'educazione continua nella Medicina di Laboratorio italiana [130][131][132][133]. ...
With these guidelines, the Intersociety Urinalysis Group (GIAU) aims to stimulate the following aspects: A) improvement and standardization of the analytical approach to physical, chemical and morphological urine examination (ECMU); b) to emphasize the value added to ECMU by automated analyzers for the study of the morphology of the corpuscular fraction urine; c) improvement of the chemical analysis of urine with particular regard to the reconsideration of the diagnostic significance of parameters that are traditionally evaluated in dipstick analysis, together with an increasing awareness of the limits of sensitivity and specificity of this analytical method; d) to increase the awareness of the importance of professional skills in the field of urinary morphology and of the relationships with clinicians; e) implementation of a policy for the evaluation of the analytical quality by using, in addition to traditional IQC and EQA, a program for the evaluation of morphological competence; f) to stimulate the diagnostic industry to focus research efforts and development methodology and instrumental catering to the needs of clinical diagnosis. The hope is to revalue the enormous diagnostic potential of ECMU, by implementing an urinalysis based on personalized diagnostic needs.
... I programmi di VEQ per l'analisi della frazione corpuscolata delle urine sono ancora meno sviluppati rispetto ai programmi di VEQ per l'analisi chimica, quantitativa o semiquantitativa, delle urine poiché i risultati di tipo qualitativo per l'analisi morfologica in generale non possono essere suddivisi in "rank" e il giudizio su ogni singola risposta richiede la consulenza di un professionista esperto nella disciplina (128)(129)(130)(131)(132)(133). In Italia è attiva una VEQ per il sedimento urinario, basata sull'interpretazione di immagini degli elementi corpuscolati, per alcuni dei quali è richiesta una correlazione clinica; nel programma annuale è prevista anche la valutazione di casi clinici. ...
... Nel report del programma di VEQ oltre alla valutazione delle risposte del laboratorio con il relativo punteggio, vengono forniti commenti esaustivi sul significato clinico di ogni elemento proposto. L'analisi delle risposte, raccolte in più di 15 anni di esperienza su questo tipo di VEQ, ne ha mostrato la grande utilità anche in termini educazionali (130)(131)(132)(133). In questo tipo di schemi di VEQ, infatti, per la refertazione dei risultati è richiesta una valutazione soggettiva da parte del professionista di laboratorio; questi esercizi sono pertanto utili al laboratorio per evidenziare eventuali necessità di formazione/aggiornamento e rappresentano uno stimolo per il personale preposto ad approfondire le conoscenze su una determinata patologia. ...
... In questo tipo di schemi di VEQ, infatti, per la refertazione dei risultati è richiesta una valutazione soggettiva da parte del professionista di laboratorio; questi esercizi sono pertanto utili al laboratorio per evidenziare eventuali necessità di formazione/aggiornamento e rappresentano uno stimolo per il personale preposto ad approfondire le conoscenze su una determinata patologia. Insieme ai corsi teorico-pratici sull'argomento, questo programma di VEQ costituisce quindi un supporto indispensabile alla formazione dei partecipanti e ha quindi un suo spazio e un suo ruolo nell'educazione continua nella Medicina di Laboratorio italiana (130)(131)(132)(133). ...
Mediante queste linee guida (LG) il Gruppo Intersocietario Analisi delle Urine (GIAU) mira a stimolare i seguenti aspetti: miglioramento e standardizzazione dell’approccio analitico all’esame chimico-fisico e morfologico delle urine (ECMU);sottolineare il valore aggiunto all’ECMU derivante dall’introduzione di analizzatori automatizzati per lo studio della morfologia delle frazione corpuscolata delle urine;miglioramento dell’analisi chimica delle urine, con particolare riguardo al riesame del significato diagnostico dei parametri tradizionalmente valutati nell’analisi mediante dip-stick insieme con una crescente consapevolezza dei limiti di sensibilità e specificità di questo metodo analitico;aumentare la consapevolezza dell’importanza delle competenze professionali nel campo della morfologia urinaria e dell’importanza dell’interazione con i clinici;implementare una politica di valutazione della qualità analitica utilizzando, oltre ai tradizionali controlli interni ed esterni, un programma per la valutazione della competenza morfologica;stimolare l’industria diagnostica del settore a concentrare gli sforzi sulla ricerca e sullo sviluppo di metodologie strumentali sempre più idonee alle esigenze di diagnosi clinica. La speranza è rivalutare l’enorme potenziale diagnostico dell’ECMU, attraverso l’esecuzione di un esame delle urine personalizzato in base alle esigenze diagnostiche di ogni paziente.
... The methods -and the results -of the program, which in this period was under the responsibility and guidance of one of us (GBF), a nephrologist with an expertise in urinary sediment and urinalysis [12][13][14][15], has been described in detail elsewhere [16][17]. ...
... The system adopted for the evaluation of the answers supplied by the participants is today the same as that used in the period 2001-2011 [16]. Thus, for each survey the answers obtained are evaluated as correct, partially correct, incorrect or no answer and scored accordingly (5, 3, 0, and -2, respectively). ...
... Actually, contaminants may be important too, both because their presence can suggest an inaccurate sample collection and some of them may be confused with other particles such as casts (cellulose fibers) or crystals (starch structures). Another important finding observed in this period, as in the past [16], concerns the incorrect terminology at times used by participants to name the particles. This aspect was highlighted several times in the comments sent to participants in each survey, for which reason for epithelial cells, we strongly recommended to replace obsolete and misleading terms such as "cells from the high, intermediate, or low urinary tract" with the terms of renal tubular cells, transitional cells (either superficial or deep) and squamous cells, respectively [15]. ...
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.
