PSNet primers are regularly reviewed and updated by the PSNet Editorial Team to ensure that they reflect current research and practice in the patient safety field.

Background

The term "Never Event" was first introduced in 2001 by Ken Kizer, MD, former CEO of the National Quality Forum (NQF), in reference to particularly shocking medical errors—such as wrong-site surgery—that should never occur. Over time, the term's use has expanded to signify adverse events that are unambiguous (clearly identifiable and measurable), serious (resulting in death or significant disability), and usually preventable. Since the initial never event list was developed in 2002, it has been revised multiple times, and now consists of 29 "serious reportable events" grouped into 7 categories:

National Quality Forum List of Serious Reportable Events, 2016¹

Surgical or invasive procedural events

• Surgery or other invasive procedure performed on the wrong site
• Surgery or other invasive procedure performed on the wrong patient
• Wrong surgical or other invasive procedure performed on a patient
• Unintended retention of a foreign object in a patient after surgery or other invasive procedure
• Intraoperative or immediately postoperative/post-procedure death in an American Society of Anesthesiologists Class I patient

Product or device events

• Patient death or serious injury associated with the use of contaminated drugs, devices, or biologics provided by the healthcare setting
• Patient death or serious injury associated with the use or function of a device in patient care, in which the device is used for functions other than as intended
• Patient death or serious injury associated with intravascular air embolism that occurs while being cared for in a healthcare setting

Patient protection events

• Discharge or release of a patient/resident of any age, who is unable to make decisions, to other than an authorized person
• Patient death or serious injury associated with patient elopement (disappearance)
• Patient suicide, attempted suicide, or self-harm that results in serious injury, while being cared for in a healthcare setting

Care management events

• Patient death or serious injury associated with a medication error (e.g., errors involving the wrong drug, wrong dose, wrong patient, wrong time, wrong rate, wrong preparation, or wrong route of administration)
• Patient death or serious injury associated with unsafe administration of blood products
• Maternal death or serious injury associated with labor or delivery in a low-risk pregnancy while being cared for in a healthcare setting
• Death or serious injury of a neonate associated with labor or delivery in a low-risk pregnancy
• Patient death or serious injury associated with a fall while being cared for in a healthcare setting
• Any stage 3, stage 4, and unstageable pressure ulcers acquired after admission/presentation to a healthcare setting
• Artificial insemination with the wrong donor sperm or wrong egg
• Patient death or serious injury resulting from the irretrievable loss of an irreplaceable biological specimen
• Patient death or serious injury resulting from failure to follow up or communicate laboratory, pathology, or radiology test results

Environmental events

• Patient or staff death or serious disability associated with an electric shock in the course of a patient care process in a healthcare setting
• Any incident in which a line designated for oxygen or other gas to be delivered to a patient contains no gas, the wrong gas, or is contaminated by toxic substances
• Patient or staff death or serious injury associated with a burn incurred from any source in the course of a patient care process in a healthcare setting
• Patient death or serious injury associated with the use of physical restraints or bedrails while being cared for in a healthcare setting

Radiologic events

• Death or serious injury of a patient or staff associated with introduction of a metallic object into the MRI area

Potential criminal events

• Any instance of care ordered by or provided by someone impersonating a physician, nurse, pharmacist, or other licensed health care provider
• Abduction of a patient/resident of any age
• Sexual abuse/assault on a patient or staff member within or on the grounds of a healthcare setting
• Death or serious injury of a patient or staff member resulting from a physical assault (i.e., battery) that occurs within or on the grounds of a healthcare setting

Most never events are very rare. For example, a 2006 study estimated that a typical hospital might experience a case of wrong-site surgery once every 5 to 10 years. However, when Never Events occur, they are devastating to patients and may indicate a fundamental safety problem within an organization. Although individual events are uncommon, on a population basis, many patients still experience these serious errors. A 2013 study estimated that more than 4000 surgical never events occur yearly in the United States.

The Joint Commission has recommended that hospitals report "sentinel events" since 1995. Sentinel events are defined as "a patient safety event (not primarily related to the natural course of a patient's illness or underlying condition) that reaches a patient and results in death, severe harm (regardless of duration of harm), or permanent harm (regardless of severity of harm)." The Joint Commission publishes an annual report of sentinel events reported during the prior year. The NQF's Never Events are also considered sentinel events by the Joint Commission. The Joint Commission mandates performance of a root cause analysis after a sentinel event. The Leapfrog Group recommends that in addition to an RCA, organizations should disclose the error and apologize to the patient, report the event, and waive all costs associated with the event.

Because Never Events are devastating and preventable, health care organizations are under increasing pressure to eliminate them completely. The Centers for Medicare and Medicaid Services (CMS) announced in August 2007 that Medicare would no longer pay for additional costs associated with many preventable errors, including those considered Never Events. Since then, many states and private insurers have adopted similar policies. Since February 2009, CMS has not paid for any costs associated with wrong-site surgeries.

Never Events are also being publicly reported, with the goal of increasing accountability and improving the quality of care. Health care facilities are accountable for correcting systematic problems that contributed to the event, with some states (such as Minnesota) mandating performance of a root cause analysis and reporting its results.

Current Context

While the concept of reporting and learning from serious reportable adverse events is widely accepted, there is variation in the types of events to include, definitions, and terminology between countries. These variations prevent comparisons and learning from the international patient safety community. Commonly accepted criteria include being usually preventable, causing serious harm or death, easily identifiable and measurable, have the potential for significant learning, and running the risk of recurrence.

References

1. National Quality Forum. List of Serious Reportable Events. [Available at]