External quality assessment programs in Lombardy, Italy.

Abstract

In Italy, although a national decree (DPCM of 10/2/84) established that quality control programs involving clinical laboratories should be carried out on a regional basis, external quality assessment schemes (EQAS) are actually run only in some regions. Among these is Lombardy, where an EQAS in clinical chemistry concerning 20 analytes was set up in 1986, and where at present EQA programs (for clinical chemistry, haematology and coagulation) compulsory for both private and public laboratories, are under way. This was made possible by both regional laws and the constant care shown by the regional Committee on pathology department system (Comitato Regionale per l'Ordinamento dei Servizi di Patologia, CROSP). The participation in the schemes (including control material supply) is free of charge. The identity of participants is known only to officers in charge of quality control and analytical results are therefore managed anonymously. Consequently EQAS carried out in Lombardy are not exacting or punitive. In the EQAS for clinical chemistry the following analytes are considered: glucose, urea, proteins, albumin, chloride, sodium, potassium, total calcium, inorganic phosphate, iron, urate, creatinine, cholesterol, triglycerides, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, creatine phosphokinase, gamma glutamyl transferase and alkaline phosphatase. In the EQAS for haematology and coagulation the tests are: a) leukocytes, erythrocytes, haemoglobin, haematocrit, mean cell (erythrocyte) volume, platelets; b) prothrombin time, activated partial thromboplastin time, fibrinogen and antithrombin III. The general organization of the schemes, the statistical procedures adopted for the analysis of data, and some of the results obtained in the three EQA programs are reported in detail in the present article.