Most patient safety reporting systems concentrate on analyzing adverse events; injury has already occurred before any learning takes place. Progressive systems exemplified by the aviation industry also concentrate on analyzing close calls, which affords the opportunity to learn from an event that did not result in a tragic outcome. Failure Mode and Effect Analysis (FMEA) is a method long in use in engineering to proactively evaluate system and product vulnerabilities. FMEA is a new way of looking at problem-prone, high-risk processes before an error occurs. By proactively identifying potential failures, actions can be taken to prevent or minimize the effect of an error. As an engineering tool, FMEA is used during product or process design and is intended to inform designers of any changes to the product that will prevent errors from occurring after launch.
A hospital laboratory can be viewed as an existing process (e.g. already launched) with many observed, preventable errors. FRACAS (Failure Review and Corrective Action System) and RCA (Root cause analysis) are additional Engineering tools that have specifically been designed to deal with observed errors. Preventing errors that have never occurred is also an important purpose of FMEA.
Errors occur in the clinical laboratory, some with potentially devastating consequences for the patient. Traditionally, these errors have been thought to be because of individual human failure. We assume that, with adequate training, education, and orientation, technologists and other lab personnel will perform flawlessly. Laboratory processes are designed on the premise that nothing will go wrong. Most labs have in place processes to identify, capture, assess, and investigate events that deviate from accepted policy or procedure. We have methods for tracking and trending incidents, errors, and accidents.
Now, based on long experience in the engineering field, health-care workers are looking at new theories of error prevention. These are based on the assumption that everything will fail, humans err frequently, and the cause of an error is often beyond the individual's control.
TO ERR IS HUMAN
In 1999, in United States of America, the Institute of Medicine released a report entitled, ‘To Err Is Human’, that detailed significant problems with patient safety in our health-care system. The report cited two large studies, one conducted in Utah and Colorado and the other in New York that found adverse events occurred in 2.9% and 3.7% of hospitalizations. In Colorado and Utah hospitals, 6.6% of adverse events led to death, as compared with 13.6% in New York hospitals. In both of these studies, more than half of these adverse events resulted from medical errors and could have been prevented.
When extrapolated to the more than 33 million admissions to United States hospitals each year, the results imply that between 44,000 and 98,000 Americans die each year as a result of medical errors. These studies show that more people die because of medical errors than from motor vehicle accidents, breast cancer, or AIDS. Total national costs including lost income, lost household production, disability, and health-care costs of medical errors resulting in injury are estimated to be between $17 billion and $29 billion.
The Institute of Medicine report made several major points. The cause of accidental injury is most often not careless people but faulty systems. These systems must be redesigned, and patient safety must become a national priority. The concept that errors result largely from the failures of systems, not from individual carelessness or inadequacy, is fundamental to the new effort to address safety. This runs counter to the traditional focus of medical training on individual performance.
