DEFINING MEDICAL ERRORS

In 1999, the Institute of Medicine (IOM, 2000) defined a medical error as “the failure of a planned action to be completed as intended (i.e., error of execution) or the use of a wrong plan to achieve an aim (i.e., error of planning).” Errors can include problems in practice, products, procedures, and systems.

In 2008 the National Patient Safety Foundation defined medical errors as unintended healthcare outcomes caused by a deficit in the delivery of care to a patient, noting that there are two major types of medical errors:

• Errors of omission that occur as a result of actions not taken. Examples may include failure to put on the brakes of a wheelchair before transferring a patient from bed to chair.
• Errors of commission are the result of taking the wrong action. Examples may include administering a medication to a patient who has a known allergy.
  (Rodziewicz et al., 2021)

Errors can be further described as adverse events. Important subcategories of adverse events include:

• Preventable: Adverse events that can be avoided by any means currently available unless the means is not considered standard care. Preventable adverse events involve care that falls below the standard expected of healthcare professionals in their community.
• Unpreventable: Adverse events that result from complications that cannot be prevented. Example: A patient not known to have an allergy has an allergic reaction to a drug that was appropriately prescribed, dispensed, and administered.
• Ameliorable: An event that is not preventable but for which the severity of the injury could have been substantially reduced if different actions or procedures had been performed or followed. Example: A clinician fails to respond to a patient with medication-related symptoms.
  (AHRQ, 2019a)

The most common adverse events reported in the literature are:

• Related to surgical specialties
• Medication- and fluid-related
• Healthcare-associated infections
  (Skelly et al., 2020)

Other Terminology Associated with Medical Errors

In addition to adverse events, other terms used to describe medical errors include near misses, sentinel events, and never events.

NEAR MISSES

A near miss is any event that could have had adverse consequences but did not and was indistinguishable from fully fledged adverse events in all but outcome. In a near miss, an error was committed, but the patient did not experience clinical harm, either through early detection or sheer luck. Example: A nurse recognizes a potential drug overdose in a physician’s prescription and does not administer the drug but instead calls the error to the physician’s attention (AHRQ, 2019a).

SENTINEL EVENTS

The Joint Commission adopted a formal Sentinel Event Policy in 1996 to help hospitals that experience serious adverse events improve safety and learn from the events. A sentinel event is a safety event that reaches a patient and results in any of the following:

• Death
• Permanent harm
• Severe temporary harm and intervention required to sustain life
  (TJC, 2021a)

Not all sentinel events occur because of an error, and not all medical errors result in sentinel events. Sentinel events can include:

• Suicide of any patient receiving care, treatment, or services in a staffed, around-the-clock care setting or within 72 hours of discharge, including from the emergency department
• Unanticipated death of a full-term infant
• Discharge of an infant to the wrong family
• Abduction of any patient receiving care, treatment, or services
• Any elopement of a patient from a staffed, around-the-clock care setting leading to death, permanent harm, or severe temporary harm of the patient
• Rape, assault, or homicide of any patient receiving care, treatment, or services, or any staff member, licensed independent practitioner, visitor, or vendor while on site
• Surgery or other invasive procedure performed at the wrong site, on the wrong patient, or that is the wrong (unintended) procedure for the patient
• Unintended retention of a foreign object in a patient after an invasive procedure, including surgery
• Severe neonatal hyperbilirubinemia
• Prolonged fluoroscopy to a single field or any delivery of radiotherapy to the wrong body regions or delivery of the wrong radiotherapy dose
• Fire, flame, or unanticipated smoke, heat, or flashes occurring during direct patient care caused by equipment operated and used by the hospital (staff do not need to be present)
• Any intrapartum maternal death
• Sexual abuse/assault involving a patient and another patient, staff member, or other perpetrator while being treated or on hospital premises
  (TJC, 2021a)

NEVER EVENTS

The National Quality Forum has compiled a set of 29 serious reportable events (SREs), which are consequential, largely preventable, and harmful clinical events. This list is designed to help those in the healthcare field assess, measure, and report performance in providing safe care in a range of clinical settings. Also referred to as never events (events that should never happen), SREs are grouped into seven categories, as follows:

Surgical SREs

• Surgery/invasive procedure performed on the wrong site
• Surgery/invasive procedure performed on the wrong patient
• Wrong surgical/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/postprocedure death in an American Society of Anesthesiologists class I patient (an otherwise healthy person with no medical problems beyond those which the proposed surgery is intended to address)

Product/Device SREs

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

Patient-Protective SREs

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

Care Management SREs

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

Environmental SREs

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

Radiological SREs

• Patient/staff death/serious injury associated with the introduction of a metallic object into an MRI area

Potential Criminal SREs

• Any instance of care ordered or provided by someone impersonating a physician, nurse, pharmacist, or other licensed healthcare 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

(NQF, 2021a)

Active and Latent Errors

Active errors (human errors) are those that occur at the point of contact between a human and some aspect of a large system (e.g., a machine). They are generally readily apparent (e.g., pushing an incorrect button or ignoring a warning light) and almost always involve someone at the frontline. Active errors or active failures are sometimes referred to as errors “at the sharp end,” referring figuratively to a scalpel. They are noticed first because they are committed by the person closest to the patient. Example: A surgeon amputates the wrong foot.

Latent errors refer to a less apparent failure of organization or design that contributes to the occurrence of errors or allows them to cause harm to patients. Latent errors are those at the other end of the scalpel, the “blunt end,” referring to the many layers of the healthcare system that affect the person “holding the scalpel.” They are errors in system or process design, faulty installation or maintenance of equipment, or ineffective organizational structure. They are accidents waiting to happen. Example: A hospital does not follow a consistent system for stocking central supply carts.

When a latent error combines with an active human error, an event occurs. Example: The hospital’s lack of a consistent system for stocking central supply carts (latent error) may cause a nurse to select the wrong intravenous drip size tubing (active error), resulting in a drug overdose in a patient (AHRQ, 2019c).