Clinical Risk Management

The healthcare system is a complex system and, by its very nature, it is impossible to eliminate all errors and adverse events. However, it is possible to implement strategies to control and reduce the number of preventable events by redesigning the organizational, clinical, and care processes to “make it easy to do the right thing.”

Risk management therefore aims to adopt strategies to enhance patient safety and reduce errors, to implement methods for monitoring critical issues, and to promote a culture of safety.

In this perspective, Clinical Risk Management, as one of the key components of Clinical Governance, requires healthcare organizations to develop a strategic vision of risk—also in response to the growing impact of insurance costs on their budgets.

On January 25, 2022, the Lazio Region, with Resolution G00643, deemed it appropriate—based on recent experience—to adopt a single Annual Health Risk Plan (PARS), combining the contents of the Annual Risk Management Plan (PARM) and the Annual Plan for Healthcare-Associated Infections (PAICA). This unified plan, in addition to representing regional commitment, allows healthcare institutions to make their policies public and promotes an integrated view of health risk, emphasizing the alignment of quality and safety requirements with licensing and accreditation standards.

Within the PARS, aspects concerning the management of infectious risk are harmonized with the objectives and activities of the Regional Prevention Plan (PRP) and the National Plan to Combat Antimicrobial Resistance (PNCAR), also in line with the Regional Intervention Plan on Hand Hygiene. The aim is to focus the attention and resources of healthcare facilities on the most relevant and qualifying aspects of infectious risk management.

In February 2015, the Lazio Region specifically mandated the implementation of a process to incorporate the Ministerial Recommendations, with the goal of adopting dedicated organizational procedures in a short timeframe.

The Ministerial Recommendations on patient safety, applicable to the IRCCS Fondazione G.B. Bietti, a specialized ophthalmology institute without an emergency department, have been implemented through specific procedures. These aim to standardize professional behaviors, draw attention to potentially risky procedures, provide effective tools to reduce risk, and promote accountability among staff members, fostering system-wide improvement.

The IRCCS Fondazione G.B. Bietti has promoted initiatives and activities in the field of patient safety and clinical risk management, implementing governance tools, preventive assessment, and follow-up verification of activities in accordance with current regional and national regulations, with the goal of promoting a no-blame safety culture.

By Presidential Decree No. 1 of 10/03/2020, the Foundation established the Claims Evaluation Committee (CVS), under a dedicated operating procedure, composed of:

• Administrative Director or delegate

• Medical Director

• Corporate Risk Management Representative

• Legal Advisor appointed by the Foundation/IRCCS

• Insurance Company Representative

• Insurance Broker

• Forensic Physician

Subsequently, on January 29, 2021, the Foundation appointed a Clinical Risk Manager.

On February 23, 2021, a Unified Commission for Clinical Risk Management and Healthcare-Associated Infections (ICA) was established. This multiprofessional and multidisciplinary body includes the heads of Units/Departments/Services (UOC, UOS, and Centers), the Nursing Coordinator, the Health and Safety Officer (RSPP), the Quality Manager, the Clinical Engineering Manager, the Pharmacist, the Heads of Analysis and Research Laboratories, and an Administrative Management Representative.

Through the active involvement of professionals collaborating with the Risk Manager, the Commission facilitates not only the reporting of sentinel events and near misses, but also the planning and implementation of audits and the early identification of critical points within clinical care pathways, defining corrective actions to reduce risks and improve quality of care. Furthermore, the Commission monitors and oversees issues related to the surveillance and control of healthcare-associated infections, and promotes best practices aimed at reducing their occurrence.

The main activities of the Clinical Risk and ICA Commission include:

• Dissemination of clinical and care best practices, implementing the Recommendations of the Ministry of Health, which provide healthcare professionals with guidance on conditions that may represent a risk to patients and indicate preventive measures to avoid adverse events.

• Management of the internal reporting system (incident reporting, falls) and data collection for the monitoring of Sentinel Events, in accordance with the guidance of the Regional Clinical Risk Center (CRRC) of the Lazio Region and the Ministerial Protocol.

• Planning and implementation of Clinical Risk Management (GR.C) audits as needed.

• Support to Senior Management in defining policies and tools for patient safety.

• Drafting of the Annual Clinical Risk Management Plan (PARM) and Annual Plan for Healthcare-Associated Infections (PAICA), both incorporated into the Annual Health Risk Plan (PARS), adopted annually by the President’s resolution by February 28, in accordance with regional guidelines.

• Definition of the Local Action Plan on Hand Hygiene, with a network of observers and tutors for staff training.

• Laboratory surveillance of microorganism circulation and monitoring of multidrug-resistant organisms (MDROs).

• Monitoring of antimicrobial use (DDD analysis).

• Monitoring of disinfectant and antiseptic use.

• Monitoring of Legionellosis.

• Prevention and surveillance of community-acquired infectious diseases in hospital, including influenza.

• Participation in the activities of the Claims Evaluation Committee (CVS).

• Identification of training and continuous education needs to strengthen the culture of patient safety.

Increasing the level of awareness across the entire organization regarding the potential risks of care processes—and understanding how detected or manifest errors can become valuable learning opportunities—is one of the greatest challenges in achieving true cultural change.

Training is undoubtedly the most effective tool to strengthen staff competencies, particularly when it encourages reflection on the need to achieve a level of knowledge and skill that supports the adoption of strategies to ensure patient safety.

The Commission actively participates in all institutional training activities and promotes specific educational initiatives aimed at improving clinical practice and proposing organizational and management models capable of positively influencing clinical and care processes.