Rubeca Tiziana, Rapi Stefano, Deandrea Silvia, Malaspina Morena, Passamonti Basilio Ubaldo, Grassi Elena, Cioccarelli Anna Maria, Marchetti Enrico, Boni Michela, Cellai Filippo, Pradella Marco, Gattafoni Franco, Rotolo Sabrina
S.C. Laboratorio regionale prevenzione oncologica, ISPO, Firenze.
responsabile del progetto SIBioC-GISCoR sull'armonizzazione della fase preanalitica dei test fecali; curatore processi pre-esame (fase pre-analitica) e fase analitica; AOU Careggi, Firenze.
Epidemiol Prev. 2017 Sep-Dec;41(5-6 (Suppl 1)):1-31. doi: 10.19191/EP17.5-6S1.P001.101.
in Italy, colorectal cancer screening is included as part of the Italian National Health Service - SSN (Servizio Sanitario Nazionale) Essential Levels of Care - LEA (Livelli Essenziali Assistenziali) and the European Guidelines, which specify quantitative FIT-Hb testing as the best strategy for organised screening programmes. To ensure consistent operating standards in Member States, European regulations require the implementation of certification and accreditation requirements for diagnostic and care-related processes. The requirement, based on ISO 17021 accreditation standards, includes ISO 9001 certification for systems and ISO 15189:2012 accreditation for laboratories.
various phases of the analytical process (pre-test, test, post-test) were evaluated in detail and provided operational guidelines for adjusting analytical and managerial procedures using: (a) feedback from members of GISCoR screening labs; (b) performance data obtained via a systematic review of the literature and the Osservatorio Nazionale Screening (ONS) Survey; (c) recommendations for laboratory practice issued by the World Endoscopy Organization "FIT for Screening" Working Group; (d) selected guidelines from the National Guidelines Clearinghouse database; and (e) Canadian, Australian and European screening programme websites. With respect to ISO 15189:2012 standards for accreditation of medical laboratories, GISCoR's guidance has been re-evaluated and revised by auditors from the Italian certification body (ACCREDIA) to assess its compliance and completeness with the aim of finalising operating procedures.
the implementation and maintenance of operational standards required by complex systems (e.g. screening programmes) involving constant interaction between facilities and the supporting organisational structure are not easy to achieve. The guide aims to provide laboratories with the necessary guidance for proper process management.
在意大利，结直肠癌筛查是意大利国家卫生服务体系（SSN，Servizio Sanitario Nazionale）基本医疗服务水平（LEA，Livelli Essenziali Assistenziali）以及欧洲指南的一部分，这些指南将定量血红蛋白粪便免疫化学检测（FIT-Hb）指定为有组织筛查项目的最佳策略。为确保成员国的操作标准一致，欧洲法规要求对诊断和护理相关流程实施认证和认可要求。该要求基于ISO 17021认可标准，包括系统的ISO 9001认证和实验室的ISO 15189:2012认可。
详细评估了分析过程的各个阶段（检测前、检测、检测后），并使用以下方法为调整分析和管理程序提供操作指南：（a）GISCoR筛查实验室成员的反馈；（b）通过对文献的系统回顾和国家筛查观察站（ONS）调查获得的性能数据；（c）世界内镜组织“适合筛查”工作组发布的实验室实践建议；（d）国家指南交换中心数据库中选定的指南；以及（e）加拿大、澳大利亚和欧洲筛查项目网站。关于医学实验室认可的ISO 15189:2012标准，意大利认证机构（ACCREDIA）的审核员对GISCoR的指南进行了重新评估和修订，以评估其合规性和完整性，目的是确定操作程序。
涉及设施与支持组织结构之间持续互动的复杂系统（如筛查项目）所需操作标准的实施和维护并非易事。本指南旨在为实验室提供适当流程管理的必要指导。
