Disposizioni normative in Italia per la gestione dei Point of Care Testing: un’indagine SIBioC nelle regioni italiane

AUTORI

ABSTRACT

Regolatory rules for the Point of Care Testing in Italy: a survey of the Italian Society of Clinical Biochemistry

Regolatory rules for the Point of Care Testing in Italy: a survey of the Italian Society of Clinical Biochemistry. Point-of-care testing (POCT) is a form of laboratory testing aimed to perform the analysis where healthcare is provided, close to or near the site of the patient care. It is a very common mode of providing laboratory testing, but concerns over the quality and errors of POCT have emerged from various sources. Regulations in different Countries and POCT operational guidelines have been produced by many professional groups and stakeholders, with the scope of minimizing testing errors and to built an efficient process. Since a national regulatory rule is lacking in Italy, a survey on the available local regulations has been conducted by the study group on POCT of the Italian Society of Clinical Biochemistry and Clinical Molecular Biology in all the Italian Regions; the results are reported in the present paper. Local regional rules are rather divergent: some of them contain only essential indications while others are too detailed and difficult to apply. The lack of harmonization and regulation among Italian regions makes necessary the issuing of a national rule aimed to minimize the problems associated with POCT management to deliver to patients the best outcome

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