Preventing the Preventable: A Legal Guide to the CMS “Never Events.”

“Never Events” – What They Are and Why Nurses and Legal Nurse Consultants Need to Know and Understand Them.

⚠️ What Are “Never Events”?

“Never Events” is a term coined by the National Quality Forum (NQF) to describe serious, preventable, and clearly identifiable medical mistakes that should never occur in a healthcare setting. They represent the most egregious errors — the ones that signal a breakdown in safety systems.

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

1. 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

2. 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

3. 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

4. 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

5. 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

6. Radiologic events

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

7. 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 rare, except for surgical events. For example, a 2013 study estimated that more than 4,000 surgical never events occur yearly in the United States.

📋 The Centers for Medicare & Medicaid Services (CMS) also tracks these injuries through “Hospital-Acquired Conditions (HACs),” which overlap with Never Events. CMS will not reimburse facilities for costs related to Never Events, creating strong financial incentives to prevent them.

👩‍⚕️ Why Nurses Need to Know Never Events

Nurses are the clinicians most consistently at the bedside. Their actions—and documentation—often determine whether harm is prevented, detected early, or worsened.

Nurses need to understand Never Events because:

1. They are directly tied to patient safety.

Many Never Events occur when:

• Protocols aren’t followed
• Assessments are missed
• Communication breaks down
• Documentation is incomplete

Awareness allows nurses to stay alert to the most catastrophic, high-risk situations.

2. They carry serious legal consequences.

A Never Event almost always triggers:

• An internal investigation
• A root-cause analysis (RCA)
• Possible state reporting
• Potential malpractice litigation

If a nurse’s actions contributed—or documentation is incomplete—they may be named in a lawsuit or disciplinary process.

3. Proper documentation helps protect nurses.

In litigation, attorneys examine the record to determine:

• Whether policies were followed
• Whether the nurse recognized early signs of deterioration
• Whether communication up the chain of command occurred

Documentation is often the deciding factor in whether the nurse is found negligent.

4. Nurses are often the “last checkpoint” before a Never Event.

Examples:

• Verifying patient identity before medication or transfusion
• Ensuring surgical site is marked
• Recognizing pressure injury risk
• Noticing changes in patient condition early

Nurses are critical to preventing the most high-stakes errors.

⚖️ Why Legal Nurse Consultants (LNCs) Must Know Never Events

For LNCs, Never Events are generally clear liability cases because they involve:

• Clear standards of care
• Strong causation
• Significant damages
• Frequently multiple breaches of safety protocols

LNCs need to understand Never Events because they help in:

1. Screening cases

Never Events are often strong plaintiff cases due to their preventability. Defense LNCs also need to understand them to help evaluate facility liability and mitigation.

2. Identifying breaches in standards of care

Never Events often involve:

• Policy violations
• Inadequate staffing
• Failed assessments
• Poor communication

LNCs track these failures to standard-of-care expectations.

3. Organizing the medical records

LNCs look for:

• Documentation gaps
• Timeline inconsistencies
• Missed assessments
• Missing incident reports

Knowing the anatomy of a Never Event helps build (or defend) a case narrative.

4. Educating attorneys

Attorneys often rely on LNCs to explain:

• What should have happened
• How the system failed
• How the error caused harm
• Could the injury have been prevented

🔍 In Summary

• Never Events are catastrophic, preventable medical errors that indicate a profound lapse in patient safety systems.
• Nurses need to know them to prevent patient harm, protect their licenses, and avoid involvement in litigation.
• Legal Nurse Consultants must know them to evaluate the merits of a case, interpret the records and policies, and educate attorneys on how facility and system failures occurred.