Quality and Risk Management

It is a complex organisation reporting to the Medical Director.

The unit is responsible for designing the framework of roles, processes, methods and tools for the implementation, monitoring and refinement of the Quality Management System and clinical risk management.

The areas of activity relate to:

• implementing internationally validated models and programmes for quality assessment and continuous improvement, based:
  • organisationally, on the principles of Total Quality Management, with particular reference to the requirements of the current UNI EN ISO 9001 standard and the principles of Clinical Governance, as set out in the ministerial programme “Clinical Governance and Safety of Care”;
  • professionally, on the standards of excellence in oncology defined in the “Accreditation and Designation” programme of the Organisation of European Cancer Institutes (OECI);
• drafting, monitoring and reporting, in collaboration with the Clinical Risk Coordination Group and in accordance with the operational guidelines of the Lombardy Region, the Annual Risk Management Plan, including projects consistent with strategic priorities;
• manage the risks associated with any healthcare activity;
• ensure the integration into the Quality System of NHS Accreditation and national and international certifications/accreditations of treatment programmes and national requirements for research accreditation;
• develop a decentralised quality management structure, effectively managing:
  • the networks of Quality and Clinical Risk Officers (RGQeR) within departments and/or units;
  • the network of internal quality system auditors;
• define and monitor the prescriptive quality documentation system, involving professionals in ex-ante quality planning through:
  • process procedures
  • clinical pathways for specific conditions
• promote the assessment of the system’s risks and opportunities, in accordance with the UNI ISO 31000 standard “Risk Management” and the FMECA/FMEA proactive analysis technique;
• ensure the conduct and reporting of third-party audits (Certification Body, OECI) for the renewal or surveillance of quality compliance certificates;
• plan, conduct and report on first-party audits (internal audits) in accordance with the UNI EN ISO 19011 standard and the Tracer methodology; assess the need for second-party audits at suppliers;
• draw up post-audit improvement action plans, assign responsibilities, monitor timelines, costs and results, and evaluate their effectiveness over time;
• implement methods and tools for managing reports of adverse events, developing the information system for:
  • collection
  • correction
  • reactive analysis (RCA)
  • improvement actions and reporting
• feed information flows relating to the reporting of confirmed sentinel events (via the SIMES IT system);
• promote a culture of quality management and risk analysis through staff training and functional networks (RGQeR and Internal Auditors);
• propose the establishment of working groups dedicated to specific topics, whether temporary or ongoing;
• coordinate the work of the Risk Management Coordination Group (GCCR);
• participate in company committees, in accordance with national and regional regulations (e.g. Accident Assessment Committee, Hospital Infections Committee, Committee for the Proper Use of Blood);
• collaborate with the Strategic Management Team on the development and implementation of organisational projects promoted by the Foundation;
• support the Strategic Management Team in preparing the annual Management Review document;
• prepare the Integrated Organisational Improvement Programme (Pr.I.M.O.), ensuring its integration with the P.A.R.M., as well as the monitoring of the improvement actions initiated;
• manage institutional information flows for the collection of Quality System data (self-assessment process of the clinical departments, analysis of customer satisfaction results);
• assist the Medical Directorate in monitoring the following indicators:
  • quality
  • clinical risk
  • appropriateness and outcomes of healthcare services (PNE and the Regional REL Portal);
• support the Medical Directorate in verifying the adequacy, in terms of quality, of the clinical documentation in use within the Clinical Units, with particular attention to:
  • completeness of the medical record
  • hospital discharge summary

Research and experimental projects on the effectiveness of new methodologies and tools for promoting quality and safety, including in collaboration with national and international scientific bodies.

Internal

• Strategic Management
• Management Board
• Staff Units reporting to Strategic Management
• IRCCS administrative and cross-organisational departments

(including with a view to sharing and enhancing multidisciplinary clinical and research pathways)

External

• Lombardy Region – Directorate-General for Welfare (in particular the Risk Management Network)
• University of Milan and other universities in the region
• Communities and networks for quality and clinical risk (e.g. Joint Commission International Network)
• Quality certification and accreditation bodies