Rules for Detecting Possible Adverse Drug Events Using Automated Surveillance
Receiving new diphenhydramine AND no diphenhydramine within last 7 days AND patient not on paclitaxel AND no blood transfusion in last 1 day AND no diphenhydramine at bedtime
Receiving oral vancomycin
Blood alkaline phosphatase >350 units/liter (L)
Receiving phytonadione (vitamin K) AND on Coumadin
Receiving ranitidine AND platelet count has fallen to less than 50 percent of previous value or below 100,000
Serum carbamazepine >12.0 micrograms/milliliter (µg/mL)
Serum digoxin >1.7 nanograms (ng)/mL
Serum bilirubin >10 milligrams/deciliter
Serum cyclosporine >500 µg/L
Serum potassium >6.5 millimoles/L
Blood eosinophils >6 percent
Serum n-acetyl procainamide >20 µg/mL
Serum phenytoin results >20 µg/mL
Serum phenobarbital results >45 µg/mL
Receiving prednisone AND diphenhydramine
Serum procainamide >10 µg/mL
Serum aspartate amino transferase >150 U/L AND no prior result >150 U/L
Serum theophylline >20 µg/mL
Serum valproate >120 µg/mL
Serum quinidine >5 µg/mL
Serum alanine aminotransferase >150 U/L AND no result >150 U/L in last 7 days
SOURCE: Honigman et al., 2001.
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 list has been expanded to signify adverse events that are unambiguous (clearly identifiable and measurable), serious (resulting in death or significant disability), and usually preventable. The NQF initially defined 27 such events in 2002. The list has been revised since then, most recently in 2011, and now consists of 29 events grouped into 7 categories: surgical, product or device, patient protection, care management, environmental, radiologic, and criminal.
Source: Sentinel Event Statistics. September 30, 2009. The Joint Commission Web site.
Source: Adverse Health Events in Minnesota. Fifth Annual Public Report. St. Paul, MN: Minnesota Department of Health; January 2009. Available at: http://www.health.state.mn.us/patientsafety/publications/consumerguide.pdf. Accessed December 30, 2009.
|Table. Never Events, 2011|
|The National Quality Forum's Health Care "Never Events" (2011 Revision)|
|Surgery or other invasive procedure performed on the wrong body part|
|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 procedure|
|Intraoperative or immediately postoperative/postprocedure 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 health care 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 health care 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 disability associated with patient elopement (disappearance)|
|Patient suicide, attempted suicide, or self-harm resulting in serious disability, while being cared for in a health care facility|
|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 health care setting|
|Death or serious injury of a neonate associated with labor or delivery in a low-risk pregnancy|
|Artificial insemination with the wrong donor sperm or wrong egg|
|Patient death or serious injury associated with a fall while being cared for in a health care setting|
|Any stage 3, stage 4, or unstageable pressure ulcers acquired after admission/presentation to a health care facility|
|Patient death or serious disability 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|
|Patient or staff death or serious disability associated with an electric shock in the course of a patient care process in a health care 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 health care setting|
|Patient death or serious injury associated with the use of restraints or bedrails while being cared for in a health care setting|
|Death or serious injury of a patient or staff associated with introduction of a metallic object into the MRI area|
|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 within or on the grounds of a health care setting|
|Death or significant injury of a patient or staff member resulting from a physical assault (i.e., battery) that occurs within or on the grounds of a health care setting|
(Reprinted with permission from the National Quality Forum.)
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–71% of events reported to the Joint Commission over the past 12 years were fatal–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 "an unexpected occurrence involving death or serious physiological or psychological injury, or the risk thereof." 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. Since the NQF disseminated its original Never Events list in 2002, 11 states have mandated reporting of these incidents whenever they occur, and an additional 16 states mandate reporting of serious adverse events (including many of the NQF Never Events). 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.