The goal of the Action Plan is to find ways to prevent repeat of adverse events or close calls. Return to top of page

Adverse Drug Events (ADE) are those specifically associated with medication or therapeutic agents. For an example of ADE analysis see Anticoagulation Vulnerability. Return to top of page

• 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.

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. Return to top of page

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. Return to top of page

• a criminal act
• a purposefully unsafe act
• an act related to alcohol or substance abuse
• impaired provider/staff

Intentional unsafe acts should be dealt with through other methods, i.e., Administrative Investigation (AI) or other administrative channels as determined by the facility. Return to top of page

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 Return to top of page

• 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.

1. 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)
2. Analysis of the underlying systems through a series of why questions to determine where redesigns might reduce risk
3. Identification of risks and their potential contributions to the event or close call.
4. 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.

• 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.

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. Return to top of page

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

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.

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.

For example: Renovation is taking place in adjoining space making it difficult for staff to converse and to hear patient call alarms.

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.

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.

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. Return to top of page

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