National and regional regulations on minimal requirements, quality control and accreditation for clinical laboratories in Italy.

The national law concerning minimal requirements and quality control for clinical laboratories, dating back to 1984, is a decree of the President of the Council of Ministries (DPCM). Minimal requirements are established regarding general organization of the laboratory, instrumental equipment's, the personnel, the list of analytical tests, the director of the laboratory and its responsibilities, and quality control systems. Concerning regional legislation, since 1978 eighteen regions and the two autonomous provinces of Trento and Bolzano have issued--in the matter of minimal requirements and quality control for clinical laboratories, and point of specimen collection--laws, decrees, resolutions, deliberations, regulations and circulars that have determined in Italy a disparity of situations and a non-homogeneous regulation. The prerogative of the regions has been recently confirmed (laws 502/1992 and 517/1993): the introduction of appropriate procedure for the accreditation of both public and private services who want to operate within the National Health Service is defined as impelling. The homologation to operate may be acquired if the structure or the service actually has the instrumental, technical, and professional endowment corresponding to criteria established on a national basis. The national legislator deemed it necessary to establish a coordination on a national basis to uniform and standardize protocols, operating procedures, and methods of evaluations. The Istituto Superiore di Sanità (ISS) can have a key role in this coordination activity, mainly concerning technical/scientific aspects.(ABSTRACT TRUNCATED AT 250 WORDS)