title: Clinical Assessment of Risk Management: an INtegrated Approach (CARMINA).
abstract: Purpose - The European Union recommendations for patient safety calls for shared clinical risk management (CRM) safety standards able to guide organizations in CRM implementation. The purpose of this paper is to develop a self-evaluation tool to measure healthcare organization performance on CRM and guide improvements over time. Design/methodology/approach - A multi-step approach was implemented including: a systematic literature review; consensus meetings with an expert panel from eight Italian leader organizations to get to an agreement on the first version; field testing to test instrument feasibility and flexibility; Delphi strategy with a second expert panel for content validation and balanced scoring system development. Findings - The self-assessment tool - Clinical Assessment of Risk Management: an INtegrated Approach includes seven areas (governance, communication, knowledge and skills, safe environment, care processes, adverse event management, learning from experience) and 52 standards. Each standard is evaluated according to four performance levels: minimum; monitoring; outcomes; and improvement actions, which resulted in a feasible, flexible and valid instrument to be used throughout different organizations. Practical implications - This tool allows practitioners to assess their CRM activities compared to minimum levels, monitor performance, benchmarking with other institutions and spreading results to different stakeholders. Originality/value - The multi-step approach allowed us to identify core minimum CRM levels in a field where no consensus has been reached. Most standards may be easily adopted in other countries.
authors.affiliation: Department of Medical and Biological Sciences, University of Udine, Udine, Italy.
authors.forename: Pierfrancesco
authors.initials: P
authors.lastname: Tricarico
authors.affiliation: Department of Diagnostics and Public Health, University of Verona, Verona, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Tardivo
authors.affiliation: Department of Biomedical Sciences, University of Sassari, Sassari, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Sotgiu
authors.affiliation: Department of Diagnostics and Public Health, University of Verona, Verona, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Moretti
authors.affiliation: CEREF, Padova, Italy.
authors.forename: Piera
authors.initials: P
authors.lastname: Poletti
authors.affiliation: Policlinico Universitario "Agostino Gemelli", Rome, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Fiore
authors.affiliation: European Institute of Oncology, Milan, Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Monturano
authors.affiliation: Department of Biomedical Sciences, University of Sassari, Sassari, Italy.
authors.forename: Ida
authors.initials: I
authors.lastname: Mura
authors.affiliation: Department of Translational Research on New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.
authors.forename: Gaetano
authors.initials: G
authors.lastname: Privitera
authors.affiliation: Department of Medical and Biological Sciences, University of Udine, Udine, Italy.
authors.forename: Silvio
authors.initials: S
authors.lastname: Brusaferro
mesh_terms: D019985:Benchmarking; D032921:Consensus; D003697:Delphi Technique; D005069:Evaluation Studies as Topic; D005240:Feasibility Studies; D006268:Health Facilities; D006801:Humans; D007558:Italy; D061214:Patient Safety / Q000592:standards*; D012308:Risk Management / Q000592:standards*; D017751:Safety Management
keywords: Benchmarking; Clinical governance; Clinical risk management; Patient safety; Risk management; Self-assessment