Infection Control Today - 07/2003: The Use of Healthcare Failure Mode andEffect Analysis to Reduce Percutaneous Injuries in the Operating Room

July 1, 2003

The Use of Healthcare Failure Mode and EffectAnalysis to Reduce Percutaneous Injuries in the Operating Room

The Use of Healthcare Failure Mode and EffectAnalysis to Reduce Percutaneous Injuries in the Operating Room

By Stacy Boone, RN, BSN, MSN; Leigh AnnOverstreet, RN, BSN, MSN; Kay Lindgren, PhD,RN; Harriet Wichowski, PhD, RN; andScott Madaris, MSN, RN

Healthcare workers (HCWs) are at risk ofoccupational exposure from a variety of hazards. One risk is coming in contactwith pathogenic microorganisms that are present in human blood and can causedisease.

Transmission of bloodborne pathogens to workersexposed at hospitals primarily results from percutaneous injuries. Percutaneousinjuries are those injuries that occur as a result of a puncture wound to theskin. It is estimated that 35 percent to 40 percent of all percutaneous injuriesoccur in the operating room (OR).1

To continuously improve the safety and quality ofcare in hospitals, the Joint Commission on Accreditation of HealthcareOrganizations (JCAHO) evaluates and accredits nearly 18,000 healthcareorganizations and programs in the United States. JCAHO standard leadershipsection LD.5.2 states that leaders must ensure an ongoing proactive program foridentifying risks to patient safety and reducing medical/healthcare errors. Theintent of this standard is to reduce the risk of sentinel events andmedical/healthcare system error-related occurrences within an organization byconducting its own proactive risk assessment and using the available informationabout sentinel events known to occur in healthcare.

The organization is to identify and prioritizehigh-risk processes and select one annually to perform a Healthcare Failure Modeand Effects Analysis (HFMEA).2 Thus, an HFMEA will be conducted to reducepercutaneous injuries in the OR.

Few workplaces have as many safety concerns forthe employees as the hospital setting. HCWs are at risk of occupational exposurefrom a variety of hazards. One risk is contracting a bloodborne pathogen orpathogenic 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 toworkers exposed at hospitals primarily results from percutaneous injuries.Percutaneous injuries are those injuries that occur as a result of a puncturewound to the skin.3

HCV is a bloodborne virus that causesinflammation of the liver and is estimated by the Centers for Disease Controland Prevention (CDC) to account for as many as 10,000 deaths annually. The CDCalso estimates 3.9 million Americans have HCV, but most people are unaware ofthis due to the silent incubation period that can last for years. It has onlybeen since 1992 that routine blood donor screening for HCV antibodies hasidentified cases and greatly reduced transmission via blood transfusion.4

Repeated or substantial exposure to percutaneousblood exposure is the most common route of exposure to HCV. The screening testcalled the enzyme immunoassay (EIA), detects the anti-HCV antibodies an averageof eight to 10 weeks post exposure. Currently there is no vaccine available forHCV. The ultimate therapeutic treatment is a liver transplant.5

Many hospital workers use various sharp devicessuch as syringes with needles, suture needles and scalpels when providing care.

While nurses normally report an exposure tobloodborne pathogens from percutaneous injury, other personnel such ashousekeeping staff, laboratory workers and physicians also are exposed. Most ofthese percutaneous injuries are preventable with the careful handling anddisposal of contaminated sharps and with the use of safer sharps devices.3

It is estimated that 35 percent to 40 percent ofall percutaneous injuries occur in the OR.1

Research has shown that percutaneous injuries bycontaminated instrument sharps and needles occur in 6.9 percent of observedsurgical procedures.6 These facts have fueled the drive for safer sharps andneedleless devices.5

HCWs must practice safety measures, as they havean ethical obligation as well as a legal obligation to do so. The ethicalobligation is to the individual, family, coworkers and the patients for whomthey assume responsibility.

The legal obligation stems from a federalstandard mandated by the Occupational Safety and Health Administration (OSHA)from the U.S. Department of Labor, and is known as UniversalPrecautions. This standard requires that gloves should be utilized for allpatient contact.

Gowns, masks and protective eyewear should beworn when in contact with blood and body fluids regardless of presumed infectionstatus.7

This standard also prohibits bending, recappingor removing contaminated needles or other sharps unless required by aprocedure.3

Various organizations, including JCAHO, areworking to support these safety measures.

JCAHOs accreditation is recognized nationwideas a symbol of superiority that reflects the commitment of an organization inmeeting certain criteria. To earn and maintain accreditation a healthcareorganization must endure a JCAHO survey team site visit every three years.8There are many benefits of obtaining JCAHO accreditation.

The first and most important of these benefits isthe utilization of procedures leading to improved patient care. Second, itsupports and enhances safety and quality improvement efforts. It also helpssecure managed-care contracts and may substitute for federal certificationsurveys for Medicare and Medicaid. Lastly, JCAHO provides a competitiveadvantage by enhancing the organizations image to the public, purchasers andpayors.8

Accidents and human error are inevitable and willoccur. Historically in healthcare, accident prevention has not been a primaryfocus.

There has been a misguided reliance on thehealthcare professional being faultless. Hospitals did not prevent incidents.They waited until an incident occurred and then reacted to it by changing theprocess. These accidents can be addressed and prevented with the use of HFMEA.

HFMEA has evolved into a hybrid prospective riskanalysis for healthcare developed by the VA National Center for Patient Safety (NCPS)sProspective Risk Analysis System in 2001. FMEA is defined as a systematic methodof identifying and preventing product and process problems before they occur.This process is used worldwide in a variety of different disciplines, includingaviation, nuclear power, food processing and the automotive industries. It hasbeen around for more than 30 years but has just reached the realm of healthcare.

In the development of the HFMEA, the NCPSreviewed the process and found that the generic definitions used in scoring theseverity applied to healthcare always concluded with a score of 10. This scorecorrelated with the definition of causing death or injury because if a processin healthcare fails, it usually causes patient injury. Thus the need formodification and the application of a new name was identified by NCPS.9 The goalhas been and will always be to prevent failure from occurring.

Even the most diligent, experienced healthcareworker will make mistakes. The HFMEA serves to minimize or eliminate thepossibility of a potentially catastrophic event.10

OR personnel are placed at risk from percutaneousinjury by contaminated instrument sharps and needles, which is an identifiable,high-risk and a catastrophic event as defined by HFMEA. The purpose of thisarticle is to identify situations that cause percutaneous injuries in an ORenvironment and to redesign the process to minimize the risk of this failuremode.