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External quality assessment programs in Italy.

G Vicari1

  • 1Laboratorio di Immunologia, Istituto Superiore di Sanità, Roma.

Annali Dell'Istituto Superiore Di Sanita
|January 1, 1991
PubMed
Summary

Italy established regulatory control for diagnostic laboratory activities in 1984, mandating Quality Control (QC) programs nationwide. This formalized previous voluntary External Quality Assessment (EQA) efforts, enhancing laboratory quality across Europe.

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Area of Science:

  • Clinical Laboratory Science
  • Quality Management in Healthcare
  • Regulatory Affairs

Background:

  • Italy's 1984 act (DPCM 10/2/84) formalized regulatory control of diagnostic clinical laboratories.
  • Prior to 1984, External Quality Assessment (EQA) programs were voluntary, managed by CNR, scientific societies, or manufacturers.
  • The CNR Project "Biomedical and Health Technologies" (activated 1982) included EQA in immunoassays, hematology, and radiodiagnosis.

Purpose of the Study:

  • To outline the evolution of regulatory control and Quality Control (QC) programs in Italian diagnostic laboratories.
  • To highlight the expansion of EQA initiatives across European nations.
  • To inform about the European Community's plan for harmonizing EQA programs.

Main Methods:

  • Review of Italian legislation regarding diagnostic laboratory activities and QC programs.
  • Analysis of historical EQA initiatives at national and European levels.
  • Examination of European Community plans for EQA harmonization.

Main Results:

  • Mandatory QC programs were established nationwide in Italy starting in 1984.
  • EQA initiatives expanded significantly across European countries in the decade preceding the abstract's context.
  • Key fields covered by EQA include hematology, clinical chemistry, and microbiology.
  • European Community aimed for EQA program harmonization by 1993.

Conclusions:

  • The implementation of regulatory control and mandatory QC programs significantly advanced laboratory quality in Italy.
  • European-wide EQA efforts demonstrate a growing commitment to standardized laboratory practices.
  • Harmonization of EQA programs is crucial for the free trade of diagnostic materials within the European Community.

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