Analyze process changes to identify system failures
Change analysis can identify contributing causes
By Patrice Spath, RHIT
Brown-Spath Associates
Forest Grove, OR
Undesirable patient incidents often are caused by slight changes in the usual process of patient care that disturb the "balance" of the system. Deviations in system operations can be planned, anticipated, and desired, or they can be unintentional and unwanted.
Change is an integral and necessary part of daily business; for example, requirements change, procedures change, policies and directives change, the personnel performing certain tasks change (i.e., staff turnover). Change can improve efficiency, productivity, and safety, or it can result in errors, loss of control, and accidents.
Change analysis is a tool used in industry to analyze the effect of process changes. This tool can be used to help people evaluate previously trouble-free activities that suddenly have problems. For example, why would a process that is correctly performed 99 times out of 100 fail to perform as expected one time? Change analysis also is a useful tool during a sentinel event investigation to help the team analyze events leading up to the incident. The root-cause analysis team uses change analysis to evaluate the difference between what was expected or planned (i.e., an event-free situation) and the actual sequence of events. Change analysis is particularly useful in identifying obscure contributing causes of sentinel events that result from planned or unplanned changes in a system. This article will discuss how to use change analysis during an accident investigation.
During the application of change analysis, the root-cause analysis team should be instructed to identify process changes, as well as the results of those changes. The distinction is important, because identifying only the results of change may not prompt the team to identify all causal factors of an event. To illustrate the steps of a change analysis, the following sentinel event will be examined:
A 40-year-old female patient was hospitalized for treatment of delirium. The patient was not considered to be a suicide risk and therefore was not placed on suicide precautions. Early one morning, the patient began talking to herself about cats and dogs being in her bed. In addition, she told the nursing staff that she was at a local country club and not in the hospital. When the patient was found in the hallway, a nurse attempted to reorient her, but these attempts failed. Because the patient was not on any close observation precautions, the nurse left her alone in the hallway. Approximately one hour after the nurse left the patient’s side, she wandered into a second-floor staff lounge, where she opened the window and jumped out. The patient fell into the bushes below and suffered serious injuries.
The team investigating this incident follows three steps to complete a change analysis.
1. Describe the event situation and describe the same or similar situation that did not result in an undesirable event.
To expand the team’s thinking, these descriptions are categorized into major factors that influence performance. In this example, the categories are defined as: What, Where, When, Who, and How. The factors listed in this example are only guidelines. They may be useful in directing lines of inquiry and analysis. However, other factors may be listed by the investigation team, depending on the event being investigated.
2. For each factor that is thought to have influenced the occurrence of the event, the team is asked to describe the "event-producing situation" relevant to that factor and the "ideal or event-free" situation.
Issues the team should consider as it identifies the error-producing and ideal situation are listed below:
WHAT
—What is the undesirable outcome?
—What occurred to create the undesirable outcome?
—What occurred prior to the event?
—What occurred following the event?
—What operational activities were under way when the tasks leading to the event occurred?
—What supplies/equipment were being used?
—What barriers should have been in place to prevent the undesirable outcome?
—What barriers were in place but failed to stop the undesirable outcome?
WHERE
—Where did the activities leading up to the event occur?
—What were the physical conditions in the area(s)?
—Where was the event first identified?
—Was location a factor in causing the event?
WHEN
—When did the activities leading up to the event occur?
—Was the facility on any special status at the time (e.g., fire drill, Code Blue, emergency admissions only, etc.)?
—Did the time of day have an effect on the event? Physician/staff availability?
—Did the event occur at shift change?
—For how many continuous hours had involved physicians/staff been working?
WHO
—Who were the direct/indirect caregivers involved in the event?
—Which staff witnessed the event?
—Which staff reported the event?
—Which staff were involved in caring for the patient following the event?
—What were the training/qualifications of the physicians/staff involved?
—Who was supervising patient care activities?
HOW
—Was the event caused by an inappropriate action?
—Did procedures exist for the activities/tasks involved?
—Did the procedures related to the tasks have sufficient detail?
—Did the procedure have sufficient fail-safe mechanisms?
—Did the procedure cover work tasks in proper sequence?
3. Once all of the event situations and event-free situations are described for each factor, the team evaluates the differences or variances to determine each item’s effect on the undesirable outcome.
By brainstorming all possible event-producing situations, the accident investigation team can clearly see where the process got out of balance. The results of a change analysis can stand alone, but they are most useful when they are incorporated with other accident investigation tools such as barrier analysis. Change analysis provides a structured way for the team to combine intuition and personal experience to identify the causal factors that contribute to an adverse patient occurrence.
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