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What are ‘never events’? Why they should ‘never, never, never’ occur

By Rob Lewis

When you raise kids, you have "rules" and then you have "RULES". I know that when my kids were little, we made them share, pick up their toys, eat what was on their plate etc. and if they failed to do it, we would give them a gentle reminder. Occasionally, though, they would do something really bad--like try to escape from us in a parking lot and they would get a screaming, "NEVER, NEVER, NEVER" from my wife or me. Safety rules were "RULES".

Similarly, with medical errors, there are some violations of care that are so clear and so dangerous that they warrant a "NEVER, NEVER, NEVER." There are some mistakes that are so serious and whose consequences are so severe, that they should never happen. These errors are called "Never Events." "Never Events" were first introduced by the National Quality Forum in 2002. See https://psnet.ahrq.gov/primers/primer/3/never-events. The initial list consisted of 27 events and has since been expanded to 29 events grouped into 6 categories: surgical, product or device, patient protection, care management, environmental, radiologic, and criminal. See id.

The following is the complete list of these events published by the National Quality Forum (See http://www.qualityforum.org/Topics/SREs/List_of_SREs.aspx):

SURGICAL OR INVASIVE PROCEDURE 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/postprocedure death in an ASA Class 1 patient (updated)

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 or 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 injury associated with an 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 contains no gas, the wrong gas, or are 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 the 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 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

In 2007, the Centers for Medicare and Medicaid Services (CMS) gave the list some teeth by announcing that it would no longer compensate hospitals for the costs of care resulting from the occurrence of some of these Never Events (See http://www.nytimes.com/2007/08/19/washington/19hospital.html). In 2008, CMS refused to compensate providers for care associated with the following:

  • Pressure ulcer stages III and IV;
  • Falls and trauma;
  • Surgical site infection after bariatric surgery for obesity, certain orthopedic procedures, and bypass surgery (mediastinitis);
  • Vascular-catheter associated infection;
  • Catheter-associated urinary tract infection;
  • Administration of incompatible blood;
  • Air embolism; and
  • Foreign object unintentionally retained after surgery.

Later CMS added other conditions such as deep vein thrombosis (DVT), pulmonary embolus (PE) and wrong site surgery. See id.

Although not all Never Events made the list of non-compensable events, CMS acknowledged that all of items on the National Quality Forum's list of errors "are of concern to both the public and health care professionals and providers, clearly identifiable and measurable (and thus feasible to include in a reporting system), and of a nature such that the risk of occurrence is significantly influenced by the policies and procedures of the health care organization." See https://downloads.cms.gov/cmsgov/archived-downloads/SMDL/downloads/smd073108.pdf ) (emphasis added)

Again, there are "rules" and then there are "RULES". And in the world of medical error prevention, there are "errors" and then there are "ERRORS". Injuries on the list of "Never Events" are ERRORS that should never happen. When they do occur, they are indicative of a failure of the system in which they occurred. And if these events occur today, in the context of a hospital or provider that should have been aware of the risks of these events as early as 2002 (when Never Events were introduced by NQF) and certainly as early as 2008 (when CMS stopped compensating for them), "Never Events" are particularly egregious. Every hospital should have policies and procedures in place to prevent Never Events from occurring. Unfortunately, these events often are not properly prevented. According to a 2015 Survey by The Leapfrog Group, 1 in 5 hospitals did not have a policy in place for "Never Events". See http://www.leapfroggroup.org/news-events/one-five-us-hospitals-fail-adopt-crucial-"never-events"-policies. If you are about to receive treatment from a hospital, it is certainly worth asking what your doctors and nurses will be doing to prevent Never Events from occurring.   

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