Using failure mode and effects analysis to improve patient safety - Home Study Program

AORN Journal,  July, 2003  by Patrice L. Spath

• E-mail
• Print
• Link

Safety is an immense public concern for the health care industry. Whether health care is less safe today than it was 10 years ago is a debatable question; however, there certainly is a loss of public confidence in the ability of the health care system to provide safe services. Striving for safety during the delivery of health care services is not a new idea. Even before the American College of Surgeons formed the Hospital Standardization Program in 1917, health care facilities had safety programs in place. These programs were intended to provide a secure and healthy environment in which hazards were minimized for employees, staff members, patients, and visitors. The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) assumed responsibility for the accreditation of hospitals in 1951, at which point, the standards continued to promote a safe environment. In response to increasing public attention to the problem of medical errors and patient injuries, JCAHO strengthened its commitment to patient safety. Beginning in 1996, JCAHO introduced several new standards that are intended to support continuous improvement in the safety of care provided to the public.

To protect patients from being harmed unintentionally by the effects of health care services, the health care industry has relied traditionally on two factors--competent individuals and well-defined processes. Individual competency is ensured through initial and continuing education, licensure and credentialing activities, and periodic performance evaluations.

Patient care processes are documented precisely in detailed policy and procedure manuals. The expectation has been that competent health care providers, acting in accordance with defined policies and procedures, will create a safe environment for patients. This expectation, although laudable, has proven to be unrealistic. Studies of safety in health care and other sociotechnological industries have demonstrated repeatedly that human error is the cause of many accidents in complex systems. In air traffic control, for example, 80% to 90% of accidents have been found to be caused by human malfunctions rather than technical causes. (1) Statistics for health care services are similar. One researcher reported human-related causes in 82% of anesthesia-related mishaps. (2) Some of the same causes of human failure (eg, distraction, mental overload, misdirected attention, misinterpretation of information) apply to health care and other industries. (3)

The first of three recent Institute of Medicine reports on the quality of health care in America, To Err is Human: Building a Safer Health System, states "health care is a decade or more behind other high-risk industries in its attention to ensuring basic safety." (4 (p4)) It has become obvious that the health care industry's traditional reliance on competent people to do the right thing has not fulfilled the intended purpose, because patients continue to experience adverse events and medical mishaps at alarmingly high rates. (5,6) The health care industry must employ additional methods of risk reduction to provide adequate levels of safety during the delivery of health care services. The need to ensure individual competence and create detailed procedures will never be eliminated totally; however, systems must be redesigned to catch and correct inevitable human errors and process failures. Human errors generally are the result of circumstances that are beyond the conscious control of those committing the errors. (7) Health care processes that depend on perfect human performance, therefore, are fatally flawed.

APPLYING SAFETY TECHNIQUES FROM OTHER INDUSTRIES

Much of what needs to be done to improve patient safety already is being done in other industries. When JCAHO executives considered standard changes to encourage a proactive approach to risk reduction, they researched various safety improvement techniques used in other high-risk industries to find one that would be adaptable to health care services. Failure mode and effects analysis (FMEA) was selected as the basis for the JCAHO proactive patient safety improvement standards added in 2001. (8) Failure mode and effects analysis is an analytical method that has been used for decades in engineering to identify and reduce hazards. (9) This technique examines the individual components of a system to determine the variety of ways each component could fail and the effect of a particular failure on the stability of the entire system. There are two distinct types of FMEA risk analyses: design FMEA and process FMEA. It is common to find both types of FMEA analyses being used in manufacturing, aviation, computer software design, and other industries to evaluate system safety.

DESIGN FMEA. A design FMEA is used to examine the components of a product to identify potential failures. For example, in the automotive industry, a design FMEA is conducted on all components and subsystems of a new car during the design and manufacturing phases. The FMEA tool is used to evaluate the correctness of the materials, accuracy of specifications, and all other elements of design required to make a safe automobile. Problems, such as air bags that require excessive inflator force to deploy, are identified and, optimally, are fixed before the first car leaves the assembly line.