Serological diagnostic for SARS-CoV-2: an experimental External Quality Assessment Scheme.

Objectives: 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 Italian External Quality Assessment (EQA) program on urinary sediment by microscopy examination: a 20 years journey.

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.

Performance evaluation of 14 specific proteins measurement checked by an External Quality Assessment Scheme.

Aims Of The Study: 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).

Methods: 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.

[PHYSICAL, CHEMICAL AND MORPHOLOGICAL URINE EXAMINATION: RECOMMENDATIONS FOR THE POST ANALYTICAL PHASE FROM THE INTERDISCIPLINARY URINALYSIS GROUP (GIAU)].

With these recommendations the Interdisciplinary Urinalysis Group (GIAU) aims to stimulate the following aspects : improvement and standardization of the post analytical approach to physical, chemical and morphological urine examination (ECMU); emphasize the value added to ECMU by selection of clinically significant parameters, indication of analytical methods, of units of measurement, of reference values; improvement of interpretation of dip stick urinalysis with particular regard to the reconsideration of the diagnostic significance of the evaluated parameters together with an increasing awareness of the limits of sensitivity and specificity of this analytical method. Accompanied by the skills to propose and carry out in-depth investigations with analytical methods that are more sensitive and specific;increase the awareness of the importance of professional skills in the field of urinary morphology and their relationships with the clinicians. through the introduction, in the report, of descriptive and interpretative comments depending on the type of request, the complexity of the laboratory, the competence of the pathologist;implement a policy of evaluation of the analytical quality by using, in addition to traditional internal and external controls, a program for the evaluation of morphological competence.

Harmonization of units and reference intervals of plasma proteins: state of the art from an External Quality Assessment Scheme.

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.

[Physical, chemical and morphological urine examination guidelines for the Analytical Phase from the Intersociety Urinalysis Group].

With these guidelines the Intersociety Urinalysis Group (GIAU) aims to stimulate the following aspects: Improvement and standardization of the analytical approach to physical, chemical and morphological urine examination (ECMU). Improvement of the chemical analysis of urine with particular regard to the reconsideration of the diagnostic significance of the parameters that are traditionally evaluated in dipstick analysis together with an increasing awareness of the limits of sensitivity and specificity of this analytical method. Increase the awareness of the importance of professional skills in the field of urinary morphology and the relationship with the clinicians.

Post-standardization of routine creatinine assays: are they suitable for clinical applications.

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.

Analytical performance of 17 general chemistry analytes across countries and across manufacturers in the INPUtS project of EQA organizers in Italy, the Netherlands, Portugal, United Kingdom and Spain.

Background: Optimum patient care in relation to laboratory medicine is achieved when results of laboratory tests are equivalent, irrespective of the analytical platform used or the country where the laboratory is located. Standardization and harmonization minimize differences and the success of efforts to achieve this can be monitored with international category 1 external quality assessment (EQA) programs.

Methods: An EQA project with commutable samples, targeted with reference measurement procedures (RMPs) was organized by EQA institutes in Italy, the Netherlands, Portugal, UK, and Spain.

The Italian External Quality Assessment (EQA) program on urinary sediment: results of the period 2012-2015.

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.

Evaluation of clinical cases in External Quality Assessment Scheme (EQAS) for the urinary sediment.

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).

An Italian external quality assessment (EQA) program on urinary sediment.

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.

Risk management in laboratory medicine: quality assurance programs and professional competence.

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.

External Quality Assessment: an effective tool for Clinical Governance in laboratory medicine.

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.

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.

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.

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.

Recommendations for the routine use of pancreatic amylase measurement instead of total amylase for the diagnosis and monitoring of pancreatic pathology.

This document reviews the scientific evidence expected to persuade clinical laboratories to substitute pancreatic amylase measurement for total amylase in cases of suspected pancreatic pathology. A substantial evidence is now available to support such change. The measurement of pancreatic amylase in serum is: 1.