Donor vigilance and hemovigilance

Reporting and learning systems in general The ability to learn from adverse events and near misses is a cornerstone for improving safety in different high-risk areas such as the aviation and oil industries. Commercial passenger aviation has become extremely safe partly due to extensive use of reporting and learning systems (RLS). A system for reporting adverse events and learning from these events is a general requirement in all quality work today, and a written procedure (standard operating procedure [SOP]) for reporting deviations is one of six required SOPs in ISO 9001 standards. In healthcare, it has been more difficult to prove that RLS have improved safety. A World Health Organization (WHO) guideline on adverse event reporting and learning systems emphasized that the effectiveness of an adverse event reporting system is measured not only by accurate collection and analysis of data, but also by its use for making recommendations that improve patient safety. The guideline outlined the following core concepts: • The fundamental role of patient safety reporting systems is to enhance patient safety by learning from failures of the healthcare system. • Reporting must be safe. Individuals who report incidents must not be punished or suffer other ill effects from reporting. • Reporting is of value only if it leads to a constructive response. At a minimum, this entails feedback of findings from data analysis. Ideally, it also includes recommendations for changes in healthcare procedures and systems. • Meaningful analysis, learning, and dissemination of lessons learned require expertise and other human and financial resources. The agency that receives reports must be capable of disseminating information, making recommendations for changes, and informing the development of solutions. When Canada prepared for a reporting and learning system in Canadian healthcare, the Canadian Patient Safety Institute (CPSI) performed a review of RLS to better understand such systems. The review found that for RLS to be successful, healthcare workers need incentives to use the systems and these incentives must be stronger than the disadvantages. The systems should be voluntary and confidential. They should be transparent, but at the same time protect the reporter. The users should be invited to take part in the development and maintenance of the system. The system should prove to be able to prevent, detect, and reduce the effect of adverse events due to bad planning, bad practice, or other unfavorable circumstances. In well-functioning RLS, one commonly found that: • Adverse events and near misses were analyzed by an independent organization with enough competence; • Feedback to the reporter was given in a timely manner; • Suggestions on how to improve the system were given; • The healthcare system is open for suggestions for system improvement; and • The system is nonpunitive.