An Action Plan is the result of Root Cause Analysis. The Action Plan addresses system and process deficiencies; improvement strategies are developed and implemented. The plan includes outcome measures to indicate that system and process deficiencies are effectively eliminated, controlled, or accepted.
The goal of the Action Plan is to find ways to prevent repeat of adverse events or close calls.
Adverse events are untoward incidents, therapeutic misadventures, iatrogenic injuries or other adverse occurrences directly associated with care or services provided within the jurisdiction of a medical center, outpatient clinic or other facility. Adverse events may result from acts of commission or omission (e.g., administration of the wrong medication, failure to make a timely diagnosis or institute the appropriate therapeutic intervention, adverse reactions or negative outcomes of treatment, etc.). The type of review that the event receives is determined through the Safety Assessment Code (SAC) Matrix scoring process. Some examples of more common adverse events include: patient falls, medication errors, procedural errors/complications, completed suicides, parasuicidal behaviors (attempts/gestures/threats), and missing patient events.
Adverse Drug Events (ADE) are those specifically associated with medication or therapeutic agents. For an example of ADE analysis see Anticoagulation Vulnerability.
Using the Five Rules of Causation* *Adapted for patient safety from David Marx.
The five rules of causation are designed to improve the RCA process by creating minimum standards for where an investigation and the results should be documented. The rules are created in response to the very real biases we all bring to the investigation process.
- Rule 1 - Causal Statements must clearly show the "cause and effect" relationship.
This is the simplest of the rules. When describing why an event has occurred, you should show the link between your root cause and the bad outcome, and each link should be clear to the RCA Team and others. Focus on showing the link from your root cause to the undesirable patient outcome you are investigating. Even a statement like "resident was fatigued" is deficient without your description of how and why this led to a slip or mistake. The bottom line: the reader needs to understand your logic in linking your causes to the outcome.
- Rule 2 - Negative descriptors (e.g., poorly, inadequate) are not used in causal statements.
As humans, we try to make each job we have as easy as possible. Unfortunately, this human tendency works it way into the documentation process. We may shorten our findings by saying "maintenance manual was poorly written" when we really have a much more detailed explanation in our mind. To force clear cause and effect descriptions (and avoid inflammatory statements), we recommend against the use of any negative descriptor that is merely the placeholder for a more accurate, clear description. Even words like "carelessness" and "complacency" are bad choices because they are broad, negative judgments that do little to describe the actual conditions or behaviors that led to the mishap.
- Rule 3 - Each human error must have a preceding cause.
Most of our mishaps involve at least one human error. Unfortunately, the discovery that a human has erred does little to aid the prevention process. You must investigate to determine WHY the human error occurred. It can be a system-induced error (e.g., step not included in medical procedure) or an at-risk behavior (doing task by memory, instead of a checklist). For every human error in your causal chain, you must have a corresponding cause. It is the cause of the error, not the error itself, which leads us to productive prevention strategies.
- Rule 4 - Each procedural deviation must have a preceding cause.
Procedural violations are like errors in that they are not directly manageable. Instead, it is the cause of the procedural violation that we can manage. If a clinician is violating a procedure because it is the local norm, we will have to address the incentives that created the norm. If a technician is missing steps in a procedure because he is not aware of the formal checklist, work on education.
- Rule 5 - Failure to act is only causal when there was a pre-existing duty to act.
We can all find ways in which our investigated mishap would not have occurred - but this is not the purpose of causal investigation. Instead, we need to find out why this mishap occurred in our system as it is designed today. A doctor's failure to prescribe a medication can only be causal if he was required to prescribe the medication in the first place. The duty to perform may arise from standards and guidelines for practice; or other duties to provide patient care.
A close call is an event or situation that could have resulted in an accident, injury or illness, but did not, either by chance or through timely intervention. Such events have also been referred to as near miss incidents.
Close Call example: surgical or other procedure almost performed on the wrong patient due to lapse in verification of patient identification but caught at the last minute by chance.
Close Calls are opportunities for learning and afford the chance to develop preventive strategies and actions. Close Calls receive the same level of scrutiny as adverse events that result in actual injury. As with adverse events, all Close Calls require reporting and documentation in the NCPS Patient Safety Information System, and the SAC Matrix scoring process determines the type of review done on a close call.
Heuristics are rules of thumb - wisdom gained by experience - through trial and error. Analysis of close calls allows learning from experience and may prevent an adverse event from occurring.
Design that is human-centered supports or even enhances human performance. The opposite is a design that forces the user to stretch, to make extra effort, in order to interact successfully with the interface or device. Dangerous devices may trip users into unintentional error.
Usability is a measure of the success of the design in supporting or enhancing human performance. Maximally usable human-centered devices are easy to use, friendly, intuitive devices. With regard to patient safety, the best devices and interfaces are produced in accordance with the principles of human-centered design and pass usability testing before implementation.
Intentional unsafe acts, as they pertain to patients, are any events that result from:
- a criminal act
- a purposefully unsafe act
- an act related to alcohol or substance abuse
- impaired provider/staff
-or- events involving alleged or suspected patient abuse of any kind.
Intentional unsafe acts should be dealt with through other methods, i.e., Administrative Investigation (AI) or other administrative channels as determined by the facility.
Root Cause: A root cause is the most fundamental reason an event has occurred
Contributing Factor: Contributing factors are additional reasons, not necessarily the most basic reason that an event has occurred.
From the work of Sue LeGrett, VISN 2
Root Cause Analysis is a process for identifying the basic or contributing causal factors that underlie variations in performance associated with adverse events or close calls. RCAs have the following characteristics:
- The review is interdisciplinary in nature with involvement of those closest to the process.
- The analysis focuses primarily on systems and processes rather than individual performance.
- The analysis digs deeper by asking what and why until all aspects of the process are reviewed and all contributing factors are identified (progressing from looking at special causes to common causes).
- The analysis identifies changes that could be made in systems and processes through either redesign or development of new processes or systems that would improve performance and reduce the risk of event or close call recurrence.
To be thorough, an RCA must include:
- A determination of the human and other factors most directly associated with the event or close call and the processes and systems related to its occurrence; (there is rarely only one underlying cause)
- Analysis of the underlying systems through a series of why questions to determine where redesigns might reduce risk
- Identification of risks and their potential contributions to the event or close call.
- Determination of potential improvement in processes or systems that would tend to decrease the likelihood of such events in the future, or a determination, after analysis, that no such improvement opportunities exist.
To be credible, an RCA must:
- Include participation by the leadership of the organization (this can range from chartering the RCA team, to direct participation on the RCA team, to participation in the determination of the corrective action plan) and by individuals most closely involved in the processes and systems under review.
- Be internally consistent (i.e., not contradict itself or leave obvious questions unanswered).
- Include consideration of relevant literature.
The Safety Assessment Code (SAC) is a method for determining whether any further definitive action is required concerning a particular incident based on the severity of the incident and its probability of occurrence. While there is undoubtedly and necessarily a level of subjectivity/judgment involved in this classification it provides a yardstick, from a systems perspective, by which to prioritize actions. It is certainly possible that the level of severity and the probability that is assessed at the outset of this process may be found to be in need of revision in cases where a root cause analysis (RCA) is subsequently performed. The utility of the SAC is at the start of the process so that resources are applied where they have the greatest opportunity to improve the level of safety from a systems perspective.
It should be noted that the SAC score is also of value for incidents that did not actually result in an actual adverse event such as close calls. This is a valuable feature since close calls generally occur far more frequently than actual adverse events and provide an opportunity to improve the system without having had to experience an actual untoward event.
While either the severity or probability of occurrence could be determined first, it is usually more productive to assess the severity first. This is true since until one has determined the severity of an incident it would be difficult if not impossible to assess an appropriate probability level.
The SAC Matrix is a tool for combining severity and probability.
Sentinel events are a type of adverse event. Sentinel events, as defined by Joint Commission, are unexpected occurrences involving death or serious physical or psychological injury, or risk thereof. Serious injury specifically includes loss of limb or function. Major permanent loss of function means sensory, motor, physiologic, or intellectual impairment not previously present that requires continued treatment or life-style change. The phrase risk thereof includes any process variation for which a recurrence would carry a significant chance of serious adverse outcomes. Sentinel events signal the need for immediate investigation and response.
Some examples of sentinel events include:
- death resulting from a medication error or other treatment related error
- suicide of a patient in a setting where they receive around-the-clock care
- surgery on the wrong patient or body part regardless of the magnitude of the operation
- and hemolytic transfusion reaction involving the administration of blood or blood products having major blood group incompatibilities
(Note: Events considered to be Joint Commission sentinel events are included in the catastrophic cells of the SAC Matrix).
Human Factors/Communication: Questionsthat help assess issues related to communication, flow of information, and availability of information as needed. These questions also reveal the importance of communication in use of equipment and application of policy and procedure, unintended barriers to communication, and the organization's culture with regard to sharing information.
For example: A patient without an identifying bracelet is administered medication based on the nurse's memory of the patient's identity. The hospital has a policy requiring that wrist bracelets be checked before every dose of medicine, but because the dose is overdue, the nurse delivers the medicine without confirming the patient's identity.
Human Factors/Training: Questions that help assess issues related to routine job training, special training, and continuing education; including the timing of that training. Training issues may concern application of approved procedures, correct use of equipment, or appropriate manipulation of protective barriers. These questions also focus attention on the interfaces between people, workspace, and equipment.
For example: A new group of physicians in residency training arrived this week to start a rotation at your facility. A lab error occurs when the wrong form is submitted with a blood vial.
Human Factors Fatigue/Scheduling: Questions that weigh the influence of stress and fatigue that may result from change, scheduling and staffing issues, sleep deprivation, or environmental distractions such as noise. These questions also evaluate relationships to training issues, equipment use, management concern and involvement.
For example: Renovation is taking place in adjoining space making it difficult for staff to converse and to hear patient call alarms.
Environment/Equipment: Questions to help evaluate factors related to use and location of equipment; fire protection and disaster drills; codes, specifications and regulations; the general suitability of the environment; and the possibility of recovery after an error has occurred. These questions show that what appears to be equipment failure may relate to human factors issues, policy and procedure questions and training needs.
For example: Housekeeping staff is thorough in their care of bedding material. While the patient is in physical therapy they flip a patient's air-filled anti-decubitis mattress inadvertently reversing the correct alignment of the air chambers.
Rules/Policies/Procedures: Questions that help assess the existence and ready accessibility of directives including technical information for assessing risk, mechanisms for feedback on key processes, effective interventions developed after previous events, compliance with national policies, the usefulness of and incentives for compliance with codes, standards, and regulations. The qualifications of the facility and employees for the level of care provided; orientation and training for compliance with safety and security measures including handling of hazardous material and emergency preparedness; and the availability of information to all part time, temporary, or voluntary workers and students are also considered.
For example: A nurse hired for the day through the local registry is not familiar with your facility's policy against unlocking the door to the balcony in order to smoke while taking a break.
Barriers: Barriers protect people and property from adverse events. Questions assess barrier strength, fault tolerance, function and interaction/relationship to Rules/Policies/Procedures and Environment/Equipment.
For example: A negative pressure room for an infectious patient is a barrier to the spread of the disease. If the ventilation in the room stops working a critical barrier has been compromised.