title: International recommendations for national patient safety incident reporting systems: an expert Delphi consensus-building process.
abstract: Patient safety incident reporting systems (PSRS) have been established for over a decade, but uncertainty remains regarding the role that they can and ought to play in quantifying healthcare-related harm and improving care.
  
  
  
  To establish international, expert consensus on the purpose of PSRS regarding monitoring and learning from incidents and developing recommendations for their future role.
  
  
  
  After a scoping review of the literature, semi-structured interviews with experts in PSRS were conducted. Based on these findings, a survey-based questionnaire was developed and subsequently completed by a larger expert panel. Using a Delphi approach, consensus was reached regarding the ideal role of PSRSs. Recommendations for best practice were devised.
  
  
  
  Forty recommendations emerged from the Delphi procedure on the role and use of PSRS. Experts agreed reporting system should not be used as an epidemiological tool to monitor the rate of harm over time or to appraise the relative safety of hospitals. They agreed reporting is a valuable mechanism for identifying organisational safety needs. The benefit of a national system was clear with respect to medication error, device failures, hospital-acquired infections and never events as these problems often require solutions at a national level. Experts recommended training for senior healthcare professionals in incident investigation. Consensus recommendation was for hospitals to take responsibility for creating safety solutions locally that could be shared nationally.
  
  
  
  We obtained reasonable consensus among experts on aims and specifications of PSRS. This information can be used to reflect on existing and future PSRS, and their role within the wider patient safety landscape. The role of PSRS as instruments for learning needs to be elaborated and developed further internationally.
authors.affiliation: Department of Surgery and Cancer, Imperial College London, London, UK.
authors.forename: Ann-Marie
authors.initials: AM
authors.lastname: Howell
authors.affiliation: Department of Biosurgery and Surgical Technology, Imperial College London, London, UK.
authors.forename: Elaine M
authors.initials: EM
authors.lastname: Burns
authors.affiliation: Division of Surgery, Imperial College London, London, UK.
authors.forename: Louise
authors.initials: L
authors.lastname: Hull
authors.affiliation: Department of Surgery and Cancer, Imperial College London, London, UK.
authors.forename: Erik
authors.initials: E
authors.lastname: Mayer
authors.affiliation: Department of Surgery and Cancer, Imperial College London, London, UK.|Health Service and Population Research, Centre for Implementation Science, King's College, London, UK.
authors.forename: Nick
authors.initials: N
authors.lastname: Sevdalis
authors.affiliation: Department of Surgery and Cancer, Imperial College London, London, UK.
authors.forename: Ara
authors.initials: A
authors.lastname: Darzi
mesh_terms: D032921:Consensus; D003625:Data Collection / Q000379:methods; D003697:Delphi Technique; D006801:Humans; D038622:Internationality; D007407:Interviews as Topic; D019300:Medical Errors / Q000706:statistics & numerical data; D061214:Patient Safety; D012308:Risk Management / Q000458:organization & administration*
keywords: Health policy; Incident reporting; Patient safety; Safety culture; Significant event analysis, critical incident review