The Italian External Quality Assessment Program for Cystic Fibrosis Sweat Chloride Test: Does Active Participation Improve the Quality?

Marco Salvatore, Annalisa Amato, Giovanna Floridia, Federica Censi, Gianluca Ferrari, Fabrizio Tosto, Rita Padoan, Valeria Raia, Natalia Cirilli, Giuseppe Castaldo, Ettore Capoluongo, Ubaldo Caruso, Carlo Corbetta and Domenica Taruscio
Additional contact information
Marco Salvatore: Undiagnosed Rare Diseases Interdepartmental Unit, Istituto Superiore di Sanità, National Center Rare Diseases, 00161 Rome, Italy
Annalisa Amato: Undiagnosed Rare Diseases Interdepartmental Unit, Istituto Superiore di Sanità, National Center Rare Diseases, 00161 Rome, Italy
Giovanna Floridia: Unità di Bioetica, Istituto Superiore di Sanità, 00161 Roma, Italia
Federica Censi: Undiagnosed Rare Diseases Interdepartmental Unit, Istituto Superiore di Sanità, National Center Rare Diseases, 00161 Rome, Italy
Gianluca Ferrari: Undiagnosed Rare Diseases Interdepartmental Unit, Istituto Superiore di Sanità, National Center Rare Diseases, 00161 Rome, Italy
Fabrizio Tosto: Undiagnosed Rare Diseases Interdepartmental Unit, Istituto Superiore di Sanità, National Center Rare Diseases, 00161 Rome, Italy
Rita Padoan: Centro di Supporto Fibrosi Cistica, Dipartimento Pediatrico, Università di Brescia, ASST Spedali Civili, 25123 Brescia, Italia
Valeria Raia: Centro Regionale Fibrosi Cistica, Unità di Pediatria, Dipartimento di Scienze Mediche Traslazionali, Università degli Studi di Napoli, Federico II, 80145 Napoli, Italia
Natalia Cirilli: Centro di Riferimento Fibrosi Cistica, Dipartimento Materno Infantile, AOU Ospedali Riuniti, 60121 Ancona, Italia
Giuseppe Castaldo: Dipartimento di Medicina Molecolare e Biotecnologie Mediche, Università di Napoli Federico II; CEINGE-Biotecnologie avanzate, scarl, 80131 Napoli, Italia
Ettore Capoluongo: Dipartimento di Medicina Molecolare e Biotecnologie Mediche, Università di Napoli Federico II; CEINGE-Biotecnologie avanzate, scarl, 80131 Napoli, Italia
Ubaldo Caruso: LABSIEM—Laboratorio per lo Studio degli Errori Congeniti del Metabolismo, Università degli Studi di Genova—DINOGMI, 16132 Genova, Italia
Carlo Corbetta: SC Laboratorio di Riferimento Regionale per lo Screening Neonatale—Regione Lombardia, ASST Fatebenefratelli Sacco, 20157 Milano, Italia
Domenica Taruscio: Undiagnosed Rare Diseases Interdepartmental Unit, Istituto Superiore di Sanità, National Center Rare Diseases, 00161 Rome, Italy

IJERPH, 2020, vol. 17, issue 9, 1-12

Abstract: (1) Background: Diagnostic testing for cystic fibrosis (CF) is based on a sweat chloride test (SCT) considering the appropriate signs and symptoms of the disease and results of a gene mutation analysis. In 2014, the Istituto Superiore di Sanità (ISS) established a pilot Italian external quality assessment program for CF SCT (Italian EQA-SCT), which is now a third party service carried out by the ISS. (2) Methods: The ongoing scheme is prospective, enrollment is voluntary, and the payment of a fee is required. Results are shared through a dedicated web-facility. Assessment covers the analysis, interpretation, and reporting of results. (3) Results: Thirteen, fifteen, sixteen, and fifteen different laboratories, respectively, participated from 2015 to 2016 and from 2018 to 2019 in the Italian EQA-SCT scheme. Eleven different laboratories participated each year in all four rounds of the Italian EQA-SCT. (4) Conclusions: The overall results obtained from the laboratories participating constantly clearly show that their qualitative and quantitative performance improved significantly. This is due to the opportunity—after receiving the EQA results—to constantly review their performance and address any inconsistencies. We firmly believe that participation in the EQA program will improve the quality of participating laboratories and that EQA participation should become mandatory as a fundamental requirement for laboratory accreditation.

Keywords: cystic fibrosis; external quality assessment; quality; sweat test; diagnosis; choloride; active participation (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2020
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