Erring Humans and Medical Malpractice

Transplants of HIV-positive organs, explosions of decompression chambers, these are some of the notorious events that in recent years have occurred in Italian hospitals and have inflicted death or permanent injury to the patients involved. Problematic situations and errors occur in many high-risk industries, where human fallibility interacts with sophisticated technology in conditions of operational complexity. The management of safety, aimed at the reduction and control of risk and malfunctions here becomes a crucial variable for the success of the firm.
The health care sector is part of the set of so-called "high-risk industries" and hospital managers have been entrusted with improving safety and security at all levels, for patients, operators, and companies. The relevance of the phenomenon has been explored in the 2000 report of the Institute of Medicine, titled "To Err Is Human: Building a Safer Health System". Since then, numerous studies and experimentations have been conducted in Italy and internationally, contributing to the development of safety governance models in the health sector.
Safety has now been set as a priority for health governance also in the Italian health care system. The provisional draft of the 2011-13 National Health Plan puts the promotion of patient safety and the management of clinical risk among the primary guidelines for the development of a system of clinical governance. It now falls on Italian Regions to orient their health care systems and facilities toward the management of safety and risk in their jurisdictions, by assessing and certifying their quality.

Besides clinical risk affecting patient safety, health care firms have to face other areas of risk (operational, asset-related, financial) of uncertain and overlapping boundaries amid fragmented responsibility for managing them. For an effective governance of safety, the culture and operations of management need to be strongly improved. In companies, risk management needs to be integrated in the normal business planning process. Coordinating safety management activities are also crucial in regional governance, where often various areas of risk in health care firms are vertically supervised by scattered organs and functions.

Safety should be perceived as a major issue by everybody, and not be seen as just the responsibility of few people: it's fundamental for top management to engage in the difficult task of nurturing the culture of pervasive safety inside the health care firm, by locating weak spots in the attitudes and practices of health operators.

Finally, the design of safe processes requires the knowledge of sources of error: this is done mainly by retrospective analysis of adverse events or quasi-events that have occurred in the recent past. Methodologies of error analysis clearly require the compiling and archiving of clinical data according to satisfactory, accredited qualitative standards. Relevant to this analysis are also the number of patients involved in the complaint, the entity of the lawsuits currently under way, and the value of damages requested and paid out.