Old
New (2011)
Preventable
Unanticipated mortality with opportunity for improvement
Non-Preventable
Mortality without opportunity for improvement
Possibly Preventable
Anticipated mortality with opportunity for improvement
The Institute of Medicine in 1999 report “To Err is Human: Building a Safer Healthcare System” attributed over 100,000 preventable deaths to medical error each year [15]. Many surgeons felt that this report was erroneous, and there could not possibly be that many deaths attributable to errors. However, Healy and colleagues reporting in 2002, that in fact this may be an underestimation of preventable death rates. In their single-institution comprehensive review of a total hospital surgical services complication rate revealed that the total complication rate in a University combined vascular service (general, trauma, cardiothoracic, and vascular) had a total complication rate of 32 %. Furthermore, both major and minor complications were nearly 50 % avoidable. And finally, of the 128 deaths that occurred in this study, fully 30 % were felt to be avoidable [16]. These authors concluded that the complication rates in surgical patients are perhaps two to four times greater than those identified in the Institute of Medicine report.
This does not imply there are not events that are so egregious as that they should never be allowed to occur. Two distinct, but overlapping definitions of patient quality and safety events that are felt should never occur, regardless of the health care system are defined by the National Quality Forum (Never Events), and The Joint Commission (Sentinel Events). The National Quality Forum was originally conceptualized by the President’s Advisory Commission on Consumer Protection and Quality in the Health Care Industry in 1998, with the National Quality Forum established as a nonprofit, public benefit corporation and a unique public-private collaborative venture in 1999; it became operational in February 2000 [17]. The work products of the NQF have largely been adopted by the Centers for Medicare and Medicaid Services (CMS) and the Agency for Healthcare Research and Quality (AHRQ) [18]. Never Events were probably first coined by Dr. Ken Kizer, a former CEO of the National Quality Forum in 2001. Dr. Kizer originally called these events “adverse events,” although this list has subsequently become known as “never events.” [19] This is a list of adverse outcomes (complications, errors) that are unambiguous (clearly identifiable and measurable), serious (resulting in death or significant disability), and usually preventable. The National Quality Forum additionally identified 27 such events in 2002 and divided these into six categories (see Table 21.2).
Table 21.2
NQF “never events”
Event | Additional specifications |
|---|---|
1. Surgical events | |
A. Surgery performed on the wrong body part | Defined as any surgery performed on a body part that is not consistent with the documented informed consent for that patient. |
Excludes emergent situations that occur in the course of surgery and/or whose exigency precludes obtaining informed consent. | |
B. Surgery performed on the wrong patient | Defined as any surgery on a patient that is not consistent with the documented informed consent for that patient. |
C. Wrong surgical procedure performed on a patient | Defined as any procedure performed on a patient that is not consistent with the documented informed consent for that patient. |
Excludes emergent situations that occur in the course of surgery and/or whose exigency precludes obtaining informed consent. | |
Surgery includes endoscopies and other invasive procedures. | |
D. Retention of a foreign object in a patient after surgery or other procedure | Excludes objects intentionally implanted as part of a planned intervention and objects present prior to surgery that were intentionally retained. |
E. Intraoperative or immediately post-operative death in an ASA Class I patient | Includes all ASA Class I patient deaths in situations where anesthesia was administered; the planned surgical procedure may or may not have been carried out. Immediately post-operative means within 24 h after induction of anesthesia (if surgery not completed), surgery, or other invasive procedure was completed. |
2. Product or device events | |
A. Patient death or serious disability associated with the use of contaminated drugs, devices, or biologics provided by the health care facility | Includes generally detectable contaminants in drugs, devices, or biologics regardless of the source of contamination and/or product. |
B. Patient death or serious disability associated with the use or function of a device in patient care, in which the device is used for functions other than as intended | Includes, but is not limited to, catheters, drains and other specialized tubes, infusion pumps, and ventilators. |
C. Patient death or serious disability associated with intravascular air embolism that occurs while being cared for in a health care facility | Excludes deaths associated with neurosurgical procedures known to be a high risk of intravascular air embolism. |
3. Patient protection events | |
A. Infant discharged to the wrong person | |
B. Patient death or serious disability associated with patient elopement (disappearance) for more than four hours | Excludes events involving competent adults. |
C. Patient suicide, or attempted suicide resulting in serious disability, while being cared for in a health care facility | Defined as events that result from patient actions after admission to a health care facility. |
Excludes deaths resulting from self-inflicted injuries that were the reason for admission to the health care facility. | |
4. Care management events | |
A. Patient death or serious disability 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) | Excludes reasonable differences in clinical judgment on drug selection and dose. |
B. Patient death or serious disability associated with a hemolytic reaction due to the administration of ABO-incompatible blood or blood products | |
C. Maternal death or serious disability associated with labor or delivery in a low-risk pregnancy while being cared for in a health care facility | Includes events that occur within 42 days post-delivery. |
Excludes deaths from pulmonary or amniotic fluid embolism, acute fatty liver of pregnancy or cardiomyopathy. | |
D. Patient death or serious disability associated with hypoglycemia, the onset of which occurs while the patient is being cared for in a health care facility | |
E. Death or serious disability (kernicterus) associated with failure to identify and treat hyperbilirubinemia in neonates | Hyperbilirubinemia is defined as bilirubin levels >30 mg/dl. |
Neonates refers to the first 28 days of life. | |
F. Stage 3 or 4 pressure ulcers acquired after admission to a health care facility | Excludes progression from Stage 2 to Stage 3 if Stage 2 was recognized upon admission. |
G. Patient death or serious disability due to spinal manipulative therapy | |
5. Environmental events | |
A. Patient death or serious disability associated with an electric shock while being cared for in a health care facility | Excludes events involving planned treatments such as electric countershock. |
B. Any incident in which a line designated for oxygen or other gas to be delivered to a patient contains the wrong gas or is contaminated by toxic substances | |
C. Patient death or serious disability associated with a burn incurred from any source while being cared for in a health care facility | |
D. Patient death associated with a fall while being cared for in a health care facility | |
E. Patient death or serious disability associated with the use of restraints or bedrails while being cared for in a health care facility | |
6. Criminal events | |
A. Any instance of care ordered by or provided by someone impersonating a physician, nurse, pharmacist, or other licensed health care provider | |
B. Abduction of a patient of any age | |
C. Sexual assault on a patient within or on the grounds of the health care facility
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