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S. Secchiero and G.B. Fogazzi

This chapter describes the Quality Control programs which can be used for urinary
sediment. The purpose of these programs is to obtain an examination of the urinary sediment
of good and reliable quality [1,2]. Internal Quality Control (IQC) and External Quality
Assessment (EQA) Programs integrate each other.

Internal Quality Control
An Internal Quality Control (IQC) for urine microscopy should be done each day the test
is performed and should adhere to the following recommendations [2]:
- All personnel should follow the same documented procedures using the same
equipment, use the same terminology and report results in the same standard format
- Duplicate urine sample examination should be used as a precision check for the
identification of the particles. Alternatively, control solutions containing erythrocytes
or leukocytes, which are commercially available could be used
- In case of disagreement about the presence or quantity of a microscopic element the
examination should be repeated and a shared conclusion should be reached
- Unexpected control results should be identified, and appropriate corrective action
should be taken
- Recent reference texts, atlases, papers or online documents should always be available
for consultation, and experts’ opinion should be asked for in case of difficult and/or
doubtful findings
In order to fulfil these recommendations, in the laboratory of the Renal Unit of Ospedale
Maggiore-Policlinico, Milano, where one of the authors of this chapter (F.G.B.) works:
-All the procedures and terminology used are standardized and written in detail in a
document which is kept on a shelf over the workbench.

- The exchange of opinions on difficult or doubtful findings is encouraged and regularly done among the four persons who rotate on urine sediment examination. The latter topic is included in the program run by Labquality. Secchiero and G. External quality control Medical laboratories have a long tradition in the organisation of external EQA programs. the College of American Pathologists (CAP) has recently introduced an EQA program focused on the new aspects of urinary sediment examination which are associated with the use of automated analyzers (see Chapeter 7). In while others also cover urinary sediment. Baltic states and Poland. Features of the Italian EQA Program “Urinalysis Performance” The Italian EQA program. Fogazzi - The microscope is adjusted according to Khöler principle (see Appendix) and phase contrast is centred every time the examination of the urinary samples is started. called “Urinalysis Performance” was set up in 2001 by a promoting Committee which included the representatives of the three Italian societies of . Today. some deal with test strips and quantitative clinical chemistry analytes [12]. which started in 1947. in spite of numerous documents and papers which stress the importance of designing appropriate EQA schemes [4-10]. several laboratory’s fields still lack EQA programs. However.Once or twice a week. - A specialized library containing several hundreds of scientific papers on various aspects of the urinary sediment examination and 16 atlases in different languages on the same subject is kept in shelves close to the microscope for consultation. EQA surveys on urinalysis are rare [11-13]. chosen among the most pathologic ones. and for some disciplines they are an integral part of laboratories’ overall quality assurance systems [4].centroricercabiomedica. some samples. a Finnish non-profit EQA scheme organisation which provides surveys also for Norway. . EQA programs are a key instrument for the improvement of laboratory quality. in the computer.2 S. Urinary sediment is also included in the program run in Italy by the Centre of Biomedical Research (CRB).B. which is an EQA scheme organisation with many programs in different fields of Laboratory medicine (www. - All special and interesting findings are documented through a digital camera permanently mounted on the microscope and filed though a dedicated program. Interestingly. are reviewed for a check by the most expert microscopist of the group. a regular servicing of the microscope is done once a year by a specialized technician. when Belk and Sunderman published the results of a clinical chemistry survey in the US [3]. Of the few existing programs.

and to date the only. For each survey the answers obtained are then evaluated as correct. Each of these surveys present a clinical case. Today.G. Moreover. partially correct.. and -2 respectively). and the answers supplied by participants. Italian project for the standardisation of urine analysis. the other on urinary sediment. and to renal laboratories.2). The choice of showing the particles by the three types of microscopy has a twofold motivation: (i) bright field microscopy and the participants give their answers directly through it. a summary of all participants’ answers is supplied. containing the judgement and the scores obtained. together with a comment by the responsible of the program on the images shown. who prepares and selects the images and also evaluates the answers of the participants at each survey. This program is the first. in order to verify whether the program was able to achieve an improvement in the identification capability of the participants some particles were presented twice by the means of similar but not identical images. chosen among 4 or 5 possible options. the images of each survey are presented in the website of the program (www.Quality control programs for urinary sediment 3 Laboratory Medicine and of the Italian Society of Nephrology [14]. their main clinical correlates. Moreover.Surveys 1 and 3. For each survey. also by polarized light (Figure 8. . Over the years. both public and private. 3. and no answer.g. the training support to the participants. These cases were introduced because laboratory medicine is moving towards a clinical support service. . which also included some key laboratory data and four phase contrast microscopy images of particles found in the urine sediment of the case presented (Figure 8. 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. Clinical cases consist in a brief clinical history.Surveys 2 and 4.1). and still is.B. Today. Each particle is shown by both bright field and phase contrast microscopy and. crystals or lipids). Each of these surveys shows two urine sediment particles.). “Urinalysis Performance” includes two parts: one on test strips (which is not dealt with in this chapter). the CRB edits a report for each laboratory. and Guidelines and standards emphasise the importance of adding appropriate comments and interpretation of results to medical reports and their assessment (15-21). For each survey. the participants are asked to identify the particles shown. At the end of each annual cycle. incorrect.2). 0. the improvement of the efficiency and efficacy of urinary sediment examination. the method most widely used in routine practice and (ii) phase contrast microscopy and polarized light are the method recommended by international guidelines for everyday work (1. when indicated (e. the program consists in 4 surveys/year. for one of the two particles (selected by the responsible of the program). they are also asked to indicate one clinical association. and scored accordingly (5. . For clinical association the answer is considered and scored only if the particle (for surveys 1 and 3) or all four particles (for surveys 2 and 4) are correctly identified. urinalysis. The aims of the program are: the evaluation of the laboratories’ performances. It is addressed to Italian central laboratories. CRB prepares a report summarising the laboratory’s performances and annual score together with an overview of the results obtained by all laboratories. The part on urinary sediment is under the guidance and responsibility of one of us (F.

  Survey 2-2003 for the identification of particles. Note that for each particle the magnification was indicated and.1.4 S. For both particles. phase contrast microscopy. Bottom: an oval fat body. crystals also the urinary pH. right. polarized light. Fogazzi Figure 8. left. in the inset. for. Top: spindle-like uric acid crystals. . Secchiero and G. bright field microscopy and.B.

5 mg/dL (n. 0.2.2 mg/dL three months before hospitalisation) associated with the appearance of high blood pressure (160/95 mm/Hg) and urinary abnormalities. 15-50) Urinary output/24 hours 1.5 g (n.700 mL Possible clinical diagnosis (only one is correct) • Acute nephritic syndrome • Nephrotic syndrome • Hypovolemic acute renal failure • Acute pyelonephritis • Unilateral hydronephrosis due to ureteric stone .0) U-protein/24 hours 1.   Survey 2-2007 showing the particles associated with clinical case 1.v.v. Ultrasounds of the urinary system. right: renal tubular epithelial cells. <0.Quality control programs for urinary sediment 5 Figure 8. Top.14) BUN 95 mg/dL (n. normal. left: an erythrocytic cast. Bottom. The clinical case was presented as follows: a 45-year-old man hospitalised for rapidly progressive renal failure (S-creatinine 1.v. Laboratory findings at hospitalisation: S-creatinine 2. left: dysmorphic erythrocytes. right: a waxy cast.5-1.

5-28% per survey).or bihydrated.6%.5%).4).3%). Subsequently.8 ± 5.9%). . among 125 laboratories out of 310 which correctly identified all the four elements shown (40. For 6 particles (25. there was a high rate of “no answer” (11. the correct diagnosis (ureteric stone) was given by 95.6% to 27.0%) there was a 4.2% (24. while it was the lowest for the leukocytic cast (9. the terminology used was often incomplete. the improvement between the first and second survey was statistically significant (Table 8. there was a substantial decrease of the rate of “no answer” (2. casts and contaminants (Table 8.6%).2% of participants (Table 8. The clinical cases.7 ± 19. The correct identification was the highest for bihydrated calcium oxalate crystals (100%) and triple phosphate crystals (99.B.1). among 168 laboratories out of 325 which correctly identified all four elements presented (51.2). and the answers were often of difficult interpretation mostly because of the arbitrary and vague terminology used.7%). Moreover. For the second clinical case.7). the correct clinical association was indicated by more than 80% of participants for all but one particle (i.e.. 84 images were sent.5%.2%) and the macrophage (10. with the introduction of multiple-choice answers. lipids. and squamous epithelial cells which were often defined as “cells from the high. For other particles such as erythrocytes and calcium oxalate crystals.2). For 11 out of 14 such particles (78. This happened especially with renal tubular epithelial cells. Fogazzi Results of “Urinalysis Performance” The identification of particles.3%). In the cycles from 2001 to 2003. when participants were free to indicate one association of their choice.6 S. intermediate.7% (14. without specification whether the erythrocytes were isomorphic or dysmorphic and calcium oxalate was mono. 0.6% per survey) (Table 8. cholesterol crystals). which showed 50 elements of urinary sediment (Table 8. Secchiero and G. a very high correct identification rate (obtained for each particle from the sum of correct + partially correct answers) was obtained for micro-organisms and crystals. the identification rate increased by 2. for 4 other particles (16. For the first case presented (Figure 8. or low urinary tract” respectively.0 to 5. The clinical association.6 ± 8.5 ± 1.6% to 77.2%). 58. This part of the program also showed that quite often participants used an inappropriate terminology to define some particles. transitional epithelial cells. a very wide spectrum of answers was supplied. The particles presented twice.5) decrease in the correct identification rate when the particle was presented for the second time. Twenty-four particles were presented twice.9% of participants.4). the correct diagnosis (acute nephritic syndrome) was given by 86.6%) there were non substantial differences between the first and the second survey (0 to + 0. for the majority of particles (14 out of 24. From 2001 to 2007. By urinary particle categories.3). Moreover. followed in decreasing order by cells.

9 0.6 2.9 2.0 327 Containing renal tubular epithelial cells (RTECs) 38.9 12.2 10.6 1.9 234 Finely granular 64.8 0.4 7.7 1.7 48.1 6.0 3.2 29.4 39.0 291 Squamous epithelial cells 88.8 361 Erythrocytic 61.9 0.5 1.6 38.4 291 Dysmorphic erythrocytes 45.9 1.4 0.6 16.6 250 Leukocytes 96.8 6.0 229 Erythrocytic + RTECs 66.8 0.7 90.0 0.0 31.2 41.0 2. The particles sent to participants for identification in the period 2001-2007 and the answers received. Urinary sediment particle Answers (%) Correct Partially No Incorrect correct answer Number of participants CELLS (N = 9) Isomorphic erythrocytes 89.4 1.3 83.9 14.0 250 Acanthocytes 52.5 0.8 22.2 41.9 1.4 16.7 0.5 6.3 2.0 229 Leukocytic 5.3 0.7 33.4 234 Coarsely granular 59.8 42.2 0.0 356 Haemoglobinic 91.1 5.3 234 Hyaline-granular 74.9 0.1 0.1 2.9 24.1.8 0.3 9.0 361 Aggregates of lipid droplets 61.4 229 Cholesterol crystals 53.4 234 Granular-waxy 45.7 0.6 12.1 291 Deep transitional epithelial cells 45.5 3.9 0.1 245 Fatty cast 74.0 11.4 0.3 1.0 20.4 19.7 33.2 0.0 24.Quality control programs for urinary sediment 7 Table 8.6 42.4 263 Leukocytic + RTECs 83.4 5.8 250 Superficial transitional epithelial cells 41.6 0.8 0.6 0.6 245 Hyaline 78.3 291 Macrophage 10.4 0.8 25.6 321 Waxy 88.7 309 Renal tubular epithelial cells 51.9 245 Oval fat body 55.4 0.0 44.9 1.9 1.6 13.0 355 LIPIDS (N = 4) CASTS (N = 15) .1 1.6 0.

7 0.9 0.7 6.2 0.0 223 Trichomonas vaginalis 93.4 36.0 15.6 263 Amorphous urates 86.3 1.0 243 Triple-phosphate 99.0 0.5 4.8 1.0 5.3 0.0 17.0 265 Amoxycillin 12.B.1 12.7 8.0 291 Fungal spore (Alternaria) 61.4 1.2 0.3 0.3 0.7 263 Fibre 91.8 243 Calcium oxalate bihydrated 58.3 324 Pseudocast 22.3 26.1.4 0.6 0.1 0.0 365 Uric acid 99.0 0.0 0.8 0.8 3.0 265 Calcium phosphate plate 71.4 243 Calcium oxalate monohydrated 66.5 0.5 229 CRYSTALS (N = 13) MICRO-ORGANISMS (N = 4) CONTAMINANTS (N = 5) .4 223 Starch 50.1 0.3 8.3 0.4 1.4 0.5 355 Indinavir 63.0 243 Calcium phosphate 91.4 41.2 0.0 0.4 0.0 223 Candida 99.1 29.2 0.2 245 Glass fragment 79.6 26.0 223 Eggs of Schistosoma haematobium 87.8 16.8 31.5 0.9 1.4 3.0 291 Ammonium biurate 90.5 0.4 0.0 265 Amorphous phosphates 80.0 0.3 0.6 0.0 291 Cylindroid containing erythrocytes 48. Continued Urinary sediment particle Answers (%) Correct Partially No Incorrect correct answer Number of participants Hyaline-granular cylindroid 68.8 S.5 344 Ciprofloxacin 25.0 8.6 0.4 73.1 8.4 16.7 0.1 50.1 47.4 42.0 1.2 0.4 47.4 0.4 5.8 2.0 27.7 365 Cystine 94.0 1.0 3.1 1.3 1. Fogazzi Table 8. Secchiero and G.2 0.2 9.3 327 Bacteria 97.

3 Lipids 4 70.5 66.6 86.5 22.0 Casts 15 69.5-91.6 ± 27.2-93.4 90.7 ± 21.1 Crystals 13 85.7 62.8 10.Quality control programs for urinary sediment 9 Table 8.6 ± 14.2.9-98.3 91.7-91.0 96.9 55.7 79.8 . Correct identification rates observed for each of the 6 categories of urinary particles presented during the period 2001-2007.4 74.5-100 Cells 9 71.2-99.0 ± 29.5 Contaminants 5 67.5 ± 4. Particle Number presented Mean ± sd Median Range Micro-organisms 4 95.1 ± 16.3 9.

2 -4.001 RTECs cast 51.1 0.2 82.8 85.001 Isomorphic erythrocytes 91.3 83.9 44.123 Deep transitional cells 86.6 <0.5 -27.B.6 0.1 99.807 Dysmorphic erythrocytes 86.4 +2.2 +24.10 S.4 +10.7 <0.4 +77.5 +31.6 83.001 Uric acid crystals 99.9 69.001 Calcium oxalate bihydrated crystals 100 100 0 - Leukocytes 98.3 98.4 +0.6 0.5 <0.7 64.9 <0.001 RTECs 52.001 Macrophage 10.7 +44.2 93.8 82.2 <0.9 <0.6 +3.001 Starch 51. Urinary sediment particle Correct + partially correct identifications (%) I II Change (%) p-value Waxy cast 89.001 Leukocytic cast 9.7 60.4 +33.0 <0.001 Cholesterol crystals 55.5 99.9 -5.3 +29.9 <0.2 0.2 <0.4 0.0 -18.9 0.4 +0.4 +16.001 Oval fat body 58.7 <0.2 <0.001 Erythrocytic cast 66.7 89. First and second answers concerning the identification of the particles which were presented twice.3.6 0.6 <0.001 CORRECT IDENTIFICATION: DECREASE CORRECT IDENTIFICATION: UNCHANGED CORRECT IDENTIFICATIONS: INCREASE . Fogazzi Table 8.6 +3.001 Finely granular cast 65.1 -14.6 86.5 <0.054 Bilirubinic cast 74.8 89.6 +16.8 96.2 0.1 +32.129 Calcium oxalate monohydrated crystals 93.359 Egg of Schistosoma haematobium 90.001 Superficial transitional cells 56.3 -16.8 0.2 +19.0 61.924 Candida 99.6 99. Secchiero and G.0 70.066 Fatty cast 75.762 Triple-phosphate crystals 99.3 +0.4 <0.2 86.8 80.001 Hyaline cast 79.0 96.

6 2.9 7.3 3. indinavir) 95. naftidrofuryl oxalate) 91.0 Macrophage 158 Active glomerulonephritis 86.8 2.3 3.4 0.0 4.4 Cast containing RTECs 269 Acute Renal failure associated with acute tubular necrosis 89.3 Granular-waxy cast 165 Renal disease with deterioration of renal function 90..7 4.6 Bilirubinic cast 140 Jaundice associated with increased conjugated bilirubin 94.4 201 Damage to the deep layers of the uroepithelium 99.7 2..3 Egg of Schistosama haematobium 300 Infection of the urinary system due to a parasite 91.0 Haemoglobinic cast 323 Haematuria of renal origin (glomerular) 83.g.4 Indinavir crystals 218 Urolithiasis from inhibitors of HIV-1 protease (e.9 5. Urinary sediment particle N with access to clinical association Correct clinical association (Chosen among 4 to 5 options) Dysmorphic erythrocytes 248 Deep transitional cells Answers (%) Correct Incorrect No Answer Glomerular haematuria 97.4 Leukocytic cast 276 Active proliferative glomerulonephritis 84.3 7.9 1.8 Calcium oxalate monohydrated crystals 212 Crystalluria due to drugs (e.8 21.4 .5 5.5 0.0 5.0 1.6 Cholesterol crystal 317 Severe proteinuria/ Nephrotic syndrome 74.4 3.9 10. Answers concerning the clinical association in the period 2004-2007.9 2.5 0.7 12.0 12.5 2.3 2.7 Starch 225 Urine contamination from environment 92.Quality control programs for urinary sediment 11 Table 8.0 0. vitamin C.g.1 Erythrocytic cylindroid 345 Haematuria of glomerular origin 89.4.2 10.6 2.

Nccls.. ILAC-G13. especially if one considers the clinical implications they have.. Nccls. Pennsylvania: NCCLS. 2002.C. Second edition 2001. However. July 1996. . especially bi scientific society of Laboratory medicine.5% when it was presented for the second time. Urinalysis and collection. Clin Chim Acta 2001..W. our program demonstrates that only some particles such as micro-organisms and the most common types of crystals are known to participants. 60 (Suppl 231): 39-47. European Urinalysis Guidelines. which are a marker of active glomerular disease. Wayne. Libeer J. Ifcc/Emd/C-AqQ. Sunderman P. it is worth noting that the highest and more significant improvements were obtained for particles of clinical importance such as the erythrocytic and leukocytic casts. Guidelines for the requirements for the competence of providers of proficiency schemes. 34: 665-78. Am J Clin Pathol 1947. ILAC. Guidelines on improving analytical quality by establishing and managing EQA schemes.C. Gant V. Approved guideline (GP27-A). 19: August N. Eur J Clin Chem Clin Biochem 1996.B. Approved guideline. and preservation of urine specimens. the results obtained by “Urinalysis Performance” show that there is a great need for such programs. version 3. transportation. Our results also show that EQA programs can improve the skills of the participants. EQA programs may also be used as a tool to improve the knowledge of the clinical implications of the laboratory tests. Fogazzi Comments to “Urinalysis Performance” The EQA programs which also include the examination of the urinary sediment are few. Example from basic clinical chemistry using limited resources. On the contrary. 2000.P. Fogazzi G.B. References [1] [2] [3] [4] [5] [6] [7] [8] [9] Kouri T. In fact. and lipids is unsatisfactory. 17: 853-96. which was almost totally misidentified when it was presented for the first time. A survey of the accuracy of chemical analyses in clinical laboratories. and the participation to them should encouraged and sustained. Guidelines for the requirements for the competence of EQAP organizers in medical laboratories. Using Proficiency Testing (PT) to improve the clinical laboratory.12 S.14. The results obtained by our program with the first two clinical cases presented confirm the validity of this statement. Secchiero and G. In our program this is clearly demonstrated by the results obtained with the macrophage. but whose correct identification increased by 33.C. Scand J Clin Lab Invest 2000. 309: 173-7. For all these reasons more EQA programs on urinary sediment should be set up. et al. et al. Libeer J. In this respect. Ilac. Role of external quality assurance schemes in assessing and improving quality in medical laboratories. 15. EQA programs may be a valuable tool also to expand the knowledge about particles which are known only to specialists. as shown by the results obtained for particles which were presented twice. IFCC. 1999.. Baadenhuijsen H. the knowledge of particles such as renal tubular epithelial cells. Fraser G. International Federation of Clinical Chemistry (IFCC) fundamentals for External Quality Assessment (EQA). Belk W. GP 16-A2: 6.. Characterization and classification of Externals Quality Assessment Schemes (EQA) according to objectives such as evaluation of method and participant bias and standard deviation.

Clin Chim Acta 2001. Zardo L. Southeast Asian J Trop Med Public Health 1999.. Crozier M. et al. Clinical Pathology Accreditation (Uk). Interpretative comments and reference ranges in EQA programs as a tool for improving laboratory appropriateness and effectiveness.B. Vasikaran S..C. Risk management in laboratory medicine: quality assurance programs and professional competence. Boisson R.Quality control programs for urinary sediment 13 [10] Sciacovelli L. 333: 209-19. et al.. 39: 250-60. et al.C.C. External quality assessment schemes: need for recognised requirements. Seeon.. Final draft. Quality control in urinalysis. Clin Chem 2004.. Sciacovelli L... [11] Takubo T..G. . Mun Lim E. September 18-20. Ann Clin Biochem 2002. Tatsumi N. Anno 2001-2003. et al. Secchiero Set al. Clin Chim Acta 2000. 50: 632-7. Zardo L. Quality assessment of interpretative commenting in clinical chemistry.. Gill J. Zardo L. et al. 297: 275-84.. Pisa: Pacini.. 2002. Secchiero S. 45: 756-65. Results of a round table discussion during the Symposium ‘From uroscopy to molecular analysis’. Germany.. Eynard J. Penberthy L.B.D. French experience about quality assessment of quantitative urinary analysis. Version 1. Bull R Coll Pathol 1998. International Standard Iso/Fdis 15189. Gill J. Scheffield. 2001 January. [13] Guder W. Sikaris K.A. “Urinalysis Performance” Programma di Valutazione Esterna di Qualità sul sedimento urinario. 309:183-99.. 30 (Suppl 3): 136-48.E. Medical laboratories-particular requirement for quality and competence. Clin Chem Lab Med 2007. Standards for the medical laboratory. Review of a pilot quality-assessment program for interpretative comments. et al. Chim Clin Acta 2000. Secchiero S. 1999. UK: CPA. 104: 25. Fogazzi G. 2006.. The Royal College of Pathologists. Guidelines for the provision of interpretative comments on biomediacal reports. Sciacovelli L.297:285-95.. [12] Boisson R. Fogazzi G. External quality assessment of urine analysis in [14] [15] [16] [17] [18] [19] [20] [21] Europe. Clin Chim Acta 2003.