Urinary sediment examination is an important diagnostic test for the diseases of the kidneys and of the urinary tract. EQAS on urinary sediment evaluation are very rare worldwide. The “Urinalysis Performance” managed by the Centre of Biomedical Research (CRB) an EQA scheme organization with many programs in different fields of Laboratory Medicine was established in 2001 by a promoting Committee which included the representatives of the three Italian Societies of Laboratory Medicine (AIPaC, SIBioC, SIMeL) and of the Italian Society of Nephrology (SIN). This program is the first, and till today, the only Italian project of standardisation of urine analysis and is conceived with an educational aim. It is conducted on voluntary and confidential basis. The aims of the program are: the evaluation of the laboratories’ performances; the training support to the participants; the improvement of the efficiency and efficacy of urinary sediment examination. The program is addressed to Italian central laboratories, both public and private, and to renal laboratories. However, since 2004 also Slovenian laboratories participate in the program, with the official support of the Slovenian Association for Clinical Chemistry (SACC) and the Slovenian National External Quality Assessement Scheme (SNEQAS). I C I

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.

Article Reply to W.G. Wood. Questionable results – who directs the EQAS organisers? Clin Chem Lab Med 2004;42:1073 was published on March 1, 2005 in the journal Clinical Chemistry and Laboratory Medicine (CCLM) (volume 43, issue 3).

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.

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.

Programs for Accreditation of clinical laboratories consider participation in External Quality Assessment Schemes (EQAS) a key element in the evaluation of testing procedures and improving them. One of the main functions of EQAS is to assess whether laboratories perform tests competently. It is therefore of utmost importance for laboratories to participate in EQAS that are in line with formally recognised requirements. Specific proposals have been made on how to design and execute EQAS by International Working Groups, but there seems to be no consensus on the best strategies to use and quality specifications to set out. The Clinical Pathology Accreditation (CPA) Program for EQA Scheme Accreditation (CPA-EQA) is the only program in Europe to provide a formal recognition of the quality of EQAS activities. The present paper reports on the experience of the Centre of Biomedical Research which is following an accreditation process for their own schemes in line with the CPA-EQA program and a proposal to set requirements that Italian schemes must follow to be recognised as valid and effective.

In laboratory medicine, analytical results and their relative reference intervals (RI) represent the terms of a binomial that makes a report effective. If gross errors are neglected, an analytical result is subject to two kinds of error: inaccuracy and imprecision. A hierarchy of models has to be applied to set analytical specifications, starting from the evaluation of the effect of analytical performance on clinical outcomes in specific clinical setting (1). This now applies only to few analytes. Instead, the evaluation of the effect of analytical performance on clinical decision and, in particular, data based on components of biological variation is applicable to a wide range of analytes (2). The reference intervals may be related to the results, which means that they are compromised by the same degree of relative inaccuracy. It has been proven that only with the adoption of an appropriate reference range we can obtain a clinically effective report. The recommendation that the single laboratory should calculate the “proper” RI springs from the need to make the relative RI “appropriate”. To verify the appropriateness of RI we evaluated data from the External Quality Assessment scheme (EQA) managed by the Biomedical Research Centre (160 laboratories, mainly in the Veneto area). To identify homogeneous groups of methods, the Centre requires from participant laboratories not only methodological information, but also the reference ranges used (in fact the results are sent from laboratories to the Centre as a patient report). Only a few analytes, are presented and discussed as examples. Despite its importance as risk factor for atherosclerosis and myocardial infarction, there are significant differences in the reference intervals used for cholesterol by the laboratories that use the same analytical methods (Table 1). About a third of the laboratories use the so-called “desirable value” (5.18 mmol/l) as the upper limit, but others use an upper limit as high as 7.25 mmol/l. These differences would be less serious if they were related to a different relative accuracy. However, the results from laboratories participating in the EQA were very similar. For instance, for the control sample 6B, the mean value (consensus value) was 6.79 mmol/l and standard deviation (SD) was 0.28 mmol/l. If this had been a sample from a real patient, the report would have been “normal” according to some laboratories and “abnormally high” according to others. Clearly, many laboratories erroneously use the populationbased reference intervals. Although to a lesser extent, some differences were found for glucose. In some laboratories the lower limit is so high (Table 2) that they should classify the control sample 5A (mean ± SD = 3.33 ± 0.17 mmol/l) as “hypoglycemia.” The differences in reference intervals used for sodium are large (Table 3) ranging from 130–140 mmol/l to 130–160 mmol/l. The most widely used range is 135–145 mmol/l (17% of the laboratories), but the second most widely used is 50% larger (135–150 mmol/l). Also in this case, the low interlaboratory inaccuracy is not consistent with different reference values, Tab. 1 Values for cholesterol obtained on control sample 6B: mean ± SD = 6.79 ± 0.28 mmol/l.