The Use of Healthcare Failure Mode and Effect Analysis to Reduce Percutaneous Injuries in the Operating Room
By Stacy Boone, RN, BSN, MSN; Leigh Ann Overstreet, RN, BSN, MSN; Kay Lindgren, PhD,RN; Harriet Wichowski, PhD, RN; and Scott Madaris, MSN, RN
Healthcare workers (HCWs) are at risk of occupational exposure from a variety of hazards. One risk is coming in contact with pathogenic microorganisms that are present in human blood and can cause disease.
Transmission of bloodborne pathogens to workers exposed at hospitals primarily results from percutaneous injuries. Percutaneous injuries are those injuries that occur as a result of a puncture wound to the skin. It is estimated that 35 percent to 40 percent of all percutaneous injuries occur in the operating room (OR).1
To continuously improve the safety and quality of care in hospitals, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) evaluates and accredits nearly 18,000 healthcare organizations and programs in the United States. JCAHO standard leadership section LD.5.2 states that leaders must ensure an ongoing proactive program for identifying risks to patient safety and reducing medical/healthcare errors. The intent of this standard is to reduce the risk of sentinel events and medical/healthcare system error-related occurrences within an organization by conducting its own proactive risk assessment and using the available information about sentinel events known to occur in healthcare.
The organization is to identify and prioritize high-risk processes and select one annually to perform a Healthcare Failure Mode and Effects Analysis (HFMEA).2 Thus, an HFMEA will be conducted to reduce percutaneous injuries in the OR.
Few workplaces have as many safety concerns for the employees as the hospital setting. HCWs are at risk of occupational exposure from a variety of hazards. One risk is contracting a bloodborne pathogen or pathogenic microorganisms that are present in human blood and can cause disease. These pathogens include hepatitis C virus (HCV) and human immunodeficiency virus (HIV) and various other diseases. Transmission of bloodborne pathogens to workers exposed at hospitals primarily results from percutaneous injuries. Percutaneous injuries are those injuries that occur as a result of a puncture wound to the skin.3
HCV is a bloodborne virus that causes inflammation of the liver and is estimated by the Centers for Disease Control and Prevention (CDC) to account for as many as 10,000 deaths annually. The CDC also estimates 3.9 million Americans have HCV, but most people are unaware of this due to the silent incubation period that can last for years. It has only been since 1992 that routine blood donor screening for HCV antibodies has identified cases and greatly reduced transmission via blood transfusion.4
Repeated or substantial exposure to percutaneous blood exposure is the most common route of exposure to HCV. The screening test called the enzyme immunoassay (EIA), detects the anti-HCV antibodies an average of eight to 10 weeks post exposure. Currently there is no vaccine available for HCV. The ultimate therapeutic treatment is a liver transplant.5
Many hospital workers use various sharp devices such as syringes with needles, suture needles and scalpels when providing care.
While nurses normally report an exposure to bloodborne pathogens from percutaneous injury, other personnel such as housekeeping staff, laboratory workers and physicians also are exposed. Most of these percutaneous injuries are preventable with the careful handling and disposal of contaminated sharps and with the use of safer sharps devices.3
It is estimated that 35 percent to 40 percent of all percutaneous injuries occur in the OR.1
Research has shown that percutaneous injuries by contaminated instrument sharps and needles occur in 6.9 percent of observed surgical procedures.6 These facts have fueled the drive for safer sharps and needleless devices.5
HCWs must practice safety measures, as they have an ethical obligation as well as a legal obligation to do so. The ethical obligation is to the individual, family, coworkers and the patients for whom they assume responsibility.
The legal obligation stems from a federal standard mandated by the Occupational Safety and Health Administration (OSHA) from the U.S. Department of Labor, and is known as Universal Precautions. This standard requires that gloves should be utilized for all patient contact.
Gowns, masks and protective eyewear should be worn when in contact with blood and body fluids regardless of presumed infection status.7
This standard also prohibits bending, recapping or removing contaminated needles or other sharps unless required by a procedure.3
Various organizations, including JCAHO, are working to support these safety measures.
JCAHOs accreditation is recognized nationwide as a symbol of superiority that reflects the commitment of an organization in meeting certain criteria. To earn and maintain accreditation a healthcare organization must endure a JCAHO survey team site visit every three years.8 There are many benefits of obtaining JCAHO accreditation.
The first and most important of these benefits is the utilization of procedures leading to improved patient care. Second, it supports and enhances safety and quality improvement efforts. It also helps secure managed-care contracts and may substitute for federal certification surveys for Medicare and Medicaid. Lastly, JCAHO provides a competitive advantage by enhancing the organizations image to the public, purchasers and payors.8
Accidents and human error are inevitable and will occur. Historically in healthcare, accident prevention has not been a primary focus.
There has been a misguided reliance on the healthcare professional being faultless. Hospitals did not prevent incidents. They waited until an incident occurred and then reacted to it by changing the process. These accidents can be addressed and prevented with the use of HFMEA.
HFMEA has evolved into a hybrid prospective risk analysis for healthcare developed by the VA National Center for Patient Safety (NCPS)s Prospective Risk Analysis System in 2001. FMEA is defined as a systematic method of identifying and preventing product and process problems before they occur. This process is used worldwide in a variety of different disciplines, including aviation, nuclear power, food processing and the automotive industries. It has been around for more than 30 years but has just reached the realm of healthcare.
In the development of the HFMEA, the NCPS reviewed the process and found that the generic definitions used in scoring the severity applied to healthcare always concluded with a score of 10. This score correlated with the definition of causing death or injury because if a process in healthcare fails, it usually causes patient injury. Thus the need for modification and the application of a new name was identified by NCPS.9 The goal has been and will always be to prevent failure from occurring.
Even the most diligent, experienced healthcare worker will make mistakes. The HFMEA serves to minimize or eliminate the possibility of a potentially catastrophic event.10
OR personnel are placed at risk from percutaneous injury by contaminated instrument sharps and needles, which is an identifiable, high-risk and a catastrophic event as defined by HFMEA. The purpose of this article is to identify situations that cause percutaneous injuries in an OR environment and to redesign the process to minimize the risk of this failure mode.