Biomedical subjects

Laura Sciacovelli

Publications and source records attributed to Laura Sciacovelli.

3 recordsLinked to original sources

PubMed2004

Quality specifications in EQA schemes: from theory to practice.

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.

Alkaline Phosphatase↗

PubMed2003

Interpretative comments and reference ranges in EQA programs as a tool for improving laboratory appropriateness and effectiveness.

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.

Clinical Laboratory Techniques↗

PubMed2003

Appropriateness of cholesterol and triglycerides reporting checked by External Quality Assessment programs.

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.

Cholesterol↗