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By Patrice Spath
Health Care Quality Consultant
Forest Grove, OR
A 49-year-old woman was admitted to the hospital to undergo repair of a left cervical internal carotid artery aneurysm. Before surgery, a resident started an intravenous line in the patient’s left hand. The surgery lasted approximately six hours. During that time a number of IV fluids and medications, including continuous pentothal, were administered. Throughout the procedure, the IV appeared to remain patent because it was a gravity infusion and the flow was adequate.
The patient’s hand was under the surgical drape and was not seen from the time the surgical drapes were placed until the surgery was completed. When the drapes were removed, a significant IV infiltration was noted on the dorsum of the patient’s left hand, causing blistering and redness. Within 24 hours of the surgery, the left hand was without sensation and remained blistered and ecchymotic.
Five days after the surgery, it was determined the patient had full thickness necrosis of the skin on the dorsum of her left hand. She required three additional procedures for debridement and full thickness skin grafts.
The incident resulted in a major loss of function that required continued treatment, so it met the Joint Commission on the Accreditation of Healthcare Organizations’ definition of a sentinel event. Accordingly, the hospital had to perform a root cause analysis.
Some of the same people involved in peer review or risk assessment activities may serve on the root cause analysis team. As team members it is important, however, that everyone is clear on the intent of the root cause analysis. It is not conducted for the purpose of assessing individuals’ competency, nor is it a forum for strategizing about how to defend the organization in a lawsuit. While these are important tasks, they are not a part of the root cause analysis discussions. If peer review and/or liability control issues creep into the discussions they can, in fact, threaten the success of the root cause analysis.
Patient care mistakes, such as those that occurred during the incident described on p. 104, are rare. However, when mistakes happen and a patient is harmed, a series of events is usually set in motion. Patients are increasingly willing to sue health care professionals when mistakes are made. Not surprisingly, following this incident, the patient filed a lawsuit against the anesthesiologist, the resident, and the hospital. The allegation was failure to monitor the IV adequately.
The hospital’s governing board has ultimate responsibility for the competency of practitioners; therefore, peer review investigations should take place. These reviews focus on answering the question, "Was a standard of practice breached by one or more professionals?" Both medical staff and nursing groups, as well as the hospital’s quality manager, would be involved in these investigations. Disciplinary actions may be necessary if one or more individuals are found to have violated a professional standard of practice.
The risk manager’s primary responsibility is to identify where the facility may be at risk for losing money and reduce exposure to this risk. To meet this responsibility, the risk manager will conduct an analysis of the incident, gathering facts from the people involved and reviewing documentation. One of the goals of this analysis is to prepare a defensible case should a lawsuit be initiated. Although an effective incident analysis can result in quality improvements, the primary goal of risk management is to identify actual or potential sources of financial loss and minimize those losses.
The purpose: Correct the problem
The root cause analysis, however, is a systematic investigation technique that uses information gathered during an intense assessment of an undesirable event to determine the underlying reasons for the deficiencies or failures. The goal of a root cause analysis is to identify the basic deficiencies or failures in a process that, if eliminated or corrected, would prevent a similar event from recurring. Root causes involve both process problems (localized) or problems within the entire system (systemic) that allow or create deficiencies that cause or could cause unwanted occurrences.
The IV incident illustrates how easy it is to find a culprit to blame. Initially, the cause of the event may appear to be the lack of attention to the patient’s IV during surgery. However, often these "surface" or easily recognizable issues are the tip of the iceberg. When developing a legally defensible case, the risk manager may deal primarily with the surface issues.
For example, the anesthesiologist may say he believed the IV was patent because the flow remained adequate throughout the procedure. The risk manager would want to determine if it is usual practice to monitor the patency of IVs by checking the flow rate rather than the insertion site. Would expert testimony support this practice in the event of a lawsuit? The risk manager might find there was a lack of documentation of which professional started the IV, as well as insufficient information about the specific location of the IV and the size and type of device used. Scanty documentation may make the case difficult to defend in court.
System failures must be examined
Failure of an individual to follow professional standards of practice and inadequate documentation may be the issues of greatest importance from a risk management standpoint; however, correction of these "surface" issues is not likely to prevent a similar event from occurring. When a root cause analysis is conducted, it becomes obvious that the individuals involved inherited the effect of several underlying system failures. While human errors may have occurred, the root cause is likely to be found in the design of the system that permitted such errors to be made. Likewise, once the errors occurred, there was no system in place to catch them before patient harm occurred.
The teams that work in the operating theater (nurses, anesthetists, surgeons, technicians) do not function in isolation. The activities of perioperative caregivers are influenced by multiple factors, including personal characteristics, attitudes, qualifications, the composition of teams, organizational culture and climate, physical resources, and the condition of the patient. These factors have an effect on technical procedures as well as decision making, task prioritization, and conflict resolution. If a root cause analysis is not conducted, the latent failures probably will not be discovered. Thus, the information necessary for taking appropriate preventive actions will not be obtained.
While the risk manager may be concerned primarily with preventing or reducing financial losses that may result from an untoward incident, this concern should not be brought to the table at the root cause analysis team meetings. The most valuable piece of information the risk manager has to offer is the information gathered during the initial investigation of the event. The team needs a thorough understanding of the interaction of events and causal factors, and the chronological chain of events developed by the risk manager is a perfect place to start. Once the time line of activities is clear, the team can begin to ask "why" questions about each action. It’s not enough to say, "The person made a mistake." The team must dig into the processes/systems that allowed the mistake to be made in the first place. Consider these questions:
• Are people overworked?
• Are people being given responsibilities that are beyond their capabilities?
• Are professional staff adequately overseeing the work of technical staff?
• Are physician and/or staff orientation and training possible causes of the error?
• Are staff given the information and technical backup they need to permit them to detect hazardous situations?
• If the event involved a new or significantly changed process, was an adequate review of operational readiness done before the process started?
• Do the vertical and horizontal lines of interface, communication, and support have any impact on the event?
Develop a list of all possible causes
Answering the "why" question about each step in the process and using root cause investigation techniques will help the team develop a list of all possible contributing causes of the event. At this point in the investigation, the team begins to narrow its list of causes. This is done by gathering data to substantiate or nullify assumptions. Although most undesirable patient care incidents are the result of a series of very complex events, the team is likely to find only one to three root causes for a particular event. If it comes up with more, it should ask more "why" questions to get at the underlying reasons for the event.
It is important that the risk manager not impede the team’s investigation by expressing concerns about confidentiality. All too often I’ve seen teams stop when they identify the causal factors and not go on to find the root causes because they are afraid a plaintiff’s attorney could gain access to their discussions. While there is no guarantee that such information is protected from discovery, it is highly likely that another untoward event will occur someday if the root causes are not found and eliminated. The team’s highest priority must be to protect the lives of future patients while conducting its business in the most secure environment possible. We can’t afford to let fear of malpractice or disclosure prevent us from improving processes that put patients at risk.
Once the team is satisfied it has identified the root causes of the event, action plans must be developed to fix the process to prevent similar undesirable events. For example, if the root cause is "human error in judgment," the action plan should be directed at reducing or eliminating the chance of future judgment errors by everyone involved in the process, not just the one person who made the error that resulted in a sentinel event. Further, because of the assumption that errors occur, cross-check and verification systems should be put into place to attempt to catch errors before they cause too much harm.
These process improvements may involve changes in policy, procedures, equipment, training, etc. Finally, the effectiveness of the action plans must be monitored to ensure improvement goals are achieved and results are long-lasting. Risk management likely will be involved in gathering data necessary for evaluating the success of the action plans.
The risk manager has a very important role in minimizing financial losses that might result from a sentinel event. Those people involved in peer review functions have the vital responsibility of ensuring that individual performance meets professional standards of practice.
However, both groups of people must learn to leave their primary concerns at the door when participating in root cause analysis activities. Although untoward events often are initially attributed to the action of one or more individuals, there is usually a set of external forces and preceding events that leads to the errors. A good root cause analysis focuses on the error-prone patient care systems that need to be changed to prevent future mishaps.
[Editor’s note: Spath is author of Investigating Sentinel Events: How to Find and Resolve Root Causes, published by Brown-Spath and Associates. This publication can be ordered on-line at http://www. brownspath.com or by calling (503) 357-9185. The price is $40 plus postage.]