"Never Events": Exploring Medical Malpractice Implications of The Joint Commission’s Zero‑Tolerance List
- EvaluCare
- May 28
- 10 min read
Every time a patient undergoes surgery or invasive care, they, and their families, place absolute faith in the healthcare team’s competence. Yet on rare but devastating occasions, the system fails so catastrophically that the harm is unthinkable: operating on the wrong body part, leaving a surgical instrument inside a patient, or discharging a newborn to the wrong family. Such egregious errors are known as “never events”—incidents so serious, so unambiguous, and so preventable that they should literally never occur.
Since the early 2000s, The Joint Commission, America’s foremost healthcare accreditor—has partnered with the National Quality Forum (NQF) to define, track, and prevent these events. Today’s 29 “serious reportable events” range from surgery on the wrong patient to electric shocks from medical equipment, infant abductions, and hospital suicides PSNet. When a never event does occur, it not only shatters patient trust but also triggers regulatory sanctions, immediate jeopardy declarations, potential loss of Medicare/Medicaid reimbursement, and almost invariably forms the basis of a medical malpractice claim.
In this in‑depth look, we will:
Unpack exactly what constitutes a never event and why these incidents demand zero tolerance.
Trace the evolution of the never event concept and how The Joint Commission collaborates with the NQF on definitions.
Detail the seven categories of never events and highlight key examples
Describe the quality controls, safety protocols, and failure‑proofing (poka‑yoke) strategies that hospitals must deploy to prevent these errors.
Illustrate the regulatory fallout from a never event: immediate jeopardy, CMS conditions of participation, and potential decertification.
Examine how never events almost always reflect negligence and how families can seek accountability through malpractice claims.
Show how EvaluCare’s quality and clinical experts who have designed safe‑care protocols to avert never events, are a resource to review system failures when they occur, supporting patients, families, and attorneys in pursuit of justice
By the end, you will understand why never events are the “highest stakes” failures in healthcare, and how organizations like EvaluCare turn these tragic lapses into catalysts for safer care.
What Are Never Events, and Why “Never” Means...Yeah ... Never
Never events are defined by three core features:
Never events occupy healthcare’s most unforgivable territory, failures so clear, so harmful, and so wholly preventable that they should quite literally never occur. At their core, never events share three defining characteristics:
Unambiguous• Every never event is objectively identifiable and can be measured without controversy. There is no gray zone about whether it happened. For example:
A surgeon amputates the left, rather than the right, foot. The laterality error is indisputable.
A sponge is found on postoperative imaging weeks after a procedure. Retained foreign body.
A patient is discharged in the care of the wrong family. No subjective debate, an infant abduction or mix‑up.
Serious• These events always inflict harm that is either life‑threatening or leaves the patient with permanent impairment. Illustrations include:
A pump programming error delivers a lethal overdose of heparin, causing catastrophic bleeding and death.
A missed diagnosis of postpartum hemorrhage due to poor handoff leads to maternal hypoxic injury and long‑term neurologic deficits.
Radiation therapy delivered at more than 150% of the prescribed dose, resulting in irreversible organ damage.
Preventable• For each never event, there exist well‑established, evidence‑based safeguards, checklists, protocols, devices, or training, that, if followed, would eliminate the risk. Examples:
Wrong‑site surgery is stopped by the Universal Protocol’s sign‑in, time‑out, and sign‑out steps.
Retained surgical items prevented by dual‑person sponge and instrument counts, adjunct technologies (radio‑opaque sponges, RFID tags), and intraoperative X‑rays when counts do not reconcile.
Infant identification errors averted by standardized ID bands with barcodes, electronic crib‑to‑mother matching systems, and secure nursery access controls.
Below are the seven never‑event categories defined by the National Quality Forum’s current list of 29 Serious Reportable Events, each with detailed examples:
1. Surgical or Invasive Procedure Events
These involve errors in patient, procedure, or site selection or lapses in intraoperative safety processes.
Wrong Patient, Site, or Procedure
Shoulder arthroscopy performed on the asymptomatic side.
Biopsy of a benign mole instead of the suspicious lesion.
Central line placement in a patient who did not consent to the procedure.
Foreign Object Retention
A laparotomy sponge left behind in the abdominal cavity, later causing infection and bowel obstruction.
A small surgical instrument tip fractured and not retrieved during orthopedic surgery, leading to chronic pain.
Retained gauze pack in a deep wound causing abscess formation weeks later.
Incorrect Implant or Prosthesis
A left‑hip prosthesis implanted on the right side, necessitating revision surgery.
Mis‑sized cardiac valve placed in a patient, leading to hemodynamic failure.
Prevention Controls: Verified surgical counts, Universal Protocol (pre‑op briefing, site marking, time‑out), and intra‑operative X‑rays when counts are inconsistent.
2. Product or Device Events
These errors occur when drugs, biologics, or medical devices are contaminated or malfunction, or when devices are used incorrectly.
Contaminated Drugs, Devices, or Biologics
Administration of saline contaminated with bacteria due to improper aseptic technique during compounding.
Use of expired contrast media causing anaphylaxis.
Device Malfunctions Leading to Harm
Infusion pump air‑in‑line alarm ignored, resulting in an air embolism.
Defibrillator failing to deliver a shock during code blue because of a faulty capacitor.
Intravascular Air Embolism
Large air bubble introduced during central venous catheter insertion when backflow not properly clamped.
Heparin line primed incorrectly, delivering a bolus of air to the right heart.
Prevention Controls: Rigorous medication compounding standards, barcode verification of expiration dates, routine preventive maintenance of devices, and standardized device‑use protocols.
3. Patient Protection Events
When systems fail to keep patients from being harmed by misidentification or security lapses.
Discharge of Infant to Wrong Family Member
A newborn released to an unauthorized adult because ID bands were not scanned.
Twins switched by nursing staff, causing emotional trauma and wrongful custody concerns.
Patient Elopement or Wandering
A cognitively impaired patient left the psychiatric unit undetected and suffered a fatal traffic accident.
Alzheimer’s patient wandered out of the facility and drowned in a nearby pond.
Failure to Monitor or Rescue
A patient on telemetry not transferred off the floor when continuous monitoring indicated fatal arrhythmias.
Inadequate alarm response leading to unobserved respiratory compromise.
Prevention Controls: Electronic ID band scanning at every handoff, secure access doors, elimination of alarm fatigue through targeted settings, and enhanced observation for high‑risk patients.
4. Care Management Events
Failures in clinical decision‑making, treatment protocols, or care transitions.
Medication Errors
Prescription of methotrexate daily instead of weekly for rheumatoid arthritis, resulting in bone marrow suppression.
Administration of potassium chloride IV push—known to cause cardiac arrest—instead of dilute infusion.
Maternal Death in Low‑Risk Pregnancy
Failure to recognize preeclampsia signs in an otherwise healthy woman, leading to eclampsia and death.
Missed hemorrhage after vaginal delivery due to inadequate postpartum vital sign monitoring.
Discharge Without Follow‑Up
Heart failure patient discharged without scheduled cardiology appointment, readmitted in cardiogenic shock.
Diabetic patient not provided with insulin education or primary care follow‑up, leading to diabetic ketoacidosis.
Prevention Controls: Double‑check medication orders, standardized order sets, maternal safety bundles, and robust discharge planning with scheduled outpatient appointments.
5. Environmental Events
Hazards in the care environment causing harm.
Electric Shock
Patient death due to failure of hospital equipment grounding, resulting in fatal electrical current through a bed rail.
Burn injuries from defibrillator misuse or faulty wiring.
Burns
Thermal burns from malfunctioning warmers or hot compresses left unattended.
Radiation burns from x‑ray tube overheating during prolonged imaging.
Restraints‑Related Injuries
Suffocation or positional asphyxia caused by improper application of immobilization devices.
Prevention Controls: Regular maintenance and inspection of electrical equipment, environmental safety rounds, staff training on restraint application, and immediate hazard correction protocols.
6. Radiation Events
Overexposure or misadministration of therapeutic or diagnostic radiation.
Therapeutic Radiation Errors
Administering radiation doses exceeding the prescribed amount by more than 25%, causing irreversible tissue necrosis.
Treating the wrong anatomic site due to improper treatment field setup.
Diagnostic Radiation Misadministration
Multiple CT scans instead of the single ordered scan, resulting in unnecessary cumulative exposure.
Pediatric patient CT protocols not adjusted for size, delivering adult‑level radiation.
Prevention Controls: Strict radiation dose verification processes, independent treatment plan checks, and real‑time dosimetry alarms.
7. Criminal Events
Acts of violence or abuse by staff or visitors.
Patient or Staff Assault/Abuse
Physical assault of an elderly patient by a staff member resulting in fractures.
Sexual abuse perpetrated by a credentialed provider during an examination.
Theft of Patient Property
Misappropriation of controlled substances from patient or unit supplies.
Stealing personal valuables entrusted to the hospital.
Patient Abduction
Infant kidnapped from the maternity ward due to inadequate nursery security.
Psychiatric patient abducted from an unlocked treatment room.
Prevention Controls: Comprehensive background checks, controlled‑substance monitoring, secure access badge systems, visitor verification protocols, and zero‑tolerance workplace violence policies.
Why “Never” Means Never
Each of these events is backed by evidence‑based prevention strategies—checklists, dual‑person verification, technology safeguards, environmental design, staff training, and robust policies. When a never event occurs, it signals that multiple layers of these defenses have failed. In that context, occurrence of a never event is not an “accident” but a systemic lapse—and in legal terms, almost always negligence.
In medical malpractice litigation, never events serve as powerful proof that a facility failed to meet the standard of care. Families can point to the clear, codified definitions from the NQF and Joint Commission, the existence of established safety protocols, and the hospital’s own failure to implement them—creating an almost irrefutable case for accountability and compensation.
The Regulatory Weight Behind Never Events
Never events are more than unfortunate statistics—they carry immediate and severe regulatory consequences:
Immediate Jeopardy: The Joint Commission may declare an immediate jeopardy when a never event indicates an imminent risk of harm to patients Joint Commission. This triggers expedited surveys and mandatory corrective actions.
Sentinel Event Reporting: Accredited organizations must report never events under The Joint Commission’s Sentinel Event Policy, conduct root cause analyses (RCA2), and share improvement plans.
CMS Financial Sanctions: Since 2008, the Centers for Medicare & Medicaid Services (CMS) refuses to pay for costs associated with many never events—including falls with injury, wrong‑site surgery, and certain infections—effectively penalizing hospitals $1,000s to $100,000s per event.
Civil Monetary Penalties: Beyond lost reimbursements, CMS can impose civil monetary penalties for conditions of participation violations.
Loss of Certification & Licensure: Repeated or egregious never events risk a hospital’s deemed status, disabling its ability to bill federal programs.
Public Reporting: Some states now require public disclosure of never event rates, intensifying reputational risk.
This regulatory ecosystem underscores that never events are not merely academic categories; they carry tangible legal, financial, and licensure stakes.
Quality Controls: Building Fail‑Safe Systems
Preventing never events demands multiple, overlapping layers of protection—often referred to as the “Swiss cheese” model of patient safety. Key defenses include:
Standardized Checklists & Protocols
Universal Protocol for preventing wrong‑site, wrong‑procedure, and wrong‑person surgery: pre‑procedure verification, site marking, and time‑out Informa TechTarget.
Surgical Count Policies: dual‐person verification of instrument and sponge counts before and after any procedure.
Technology‑Enabled Safeguards
Barcode Medication Administration (BCMA) to prevent drug administration errors.
Radio‑opaque Surgical Sponges and RFID Tracking to detect retained items.
Smart Infusion Pumps with drug libraries and soft/hard limits to avoid overdoses.
Human Factors and Team Training
Crew Resource Management (CRM)–style training to flatten hierarchies and empower any team member to speak up.
Simulation Drills for rare but critical events (e.g., wrong transfusion blood type).
Environment & Equipment Checks
Regular inspection of electrical outlets, defibrillators, and resuscitation equipment to prevent environmental never events like shocks.
Data Monitoring & Feedback
Real‑time dashboards tracking compliance with NPSGs (e.g., hand hygiene, ventilator bundle adherence).
Automated alerts for overdue counts, missing signatures, or anomalous vital sign trends.
When these controls are fully embedded, supported by leadership, audited regularly, and reinforced by a just culture, never events become truly “never.” Conversely, when any slice of cheese is misaligned, counts skipped under time pressure, BCMA not used, or time‑outs treated as box‑checking exercises, the system’s defenses collapse.
Never Events in the Courtroom: Medical Malpractice Implications
Because never events are unambiguous and preventable, they almost invariably implicate negligence. In malpractice litigation, plaintiffs’ attorneys seize upon:
Violation of Standard of Care: Demonstrating that established protocols (e.g., Universal Protocol) were not followed.
Notice of Risk: Citing PSO and NQF data showing widespread adoption of preventive measures.
Regulatory Findings: Leveraging Joint Commission citations, immediate jeopardy declarations, and CMS penalty notices as evidence of system failures.
Root Cause Analyses: Uncovering systemic deficiencies (staffing levels, training gaps, policy inadequacies) that courts view as institutional negligence.
Expert Opinion: Evalucare with its quality and clinical expertise form an independent review of care that draws care conclusion by comparing care delivered to know care standards and practice guidelines.
For families, a never event case can highlight both individual accountability and organizational responsibility—supporting claims for damages and driving systemic fixes.
Case Spotlight: Wrong‑Site Surgery
One of the most notorious never events, wrong‑site surgery, historically occurred in hospitals lacking rigorous site marking or time‑out procedures. In Smith v. Regional Hospital, a seemingly routine knee arthroscopy was performed on the left knee instead of the right. The court awarded $4.5 million, finding that the hospital had no enforced policy for preoperative site verification and that the surgical team failed to conduct a proper time‑out. Subsequent state legislation mandated explicit site‑marking protocols across all hospitals.
EvaluCare’s Role: Building Safety and Accountability
For decades, EvaluCare’s quality and medical experts have implemented and continuously improved systems to prevent never events. We can assess:
Design and Implement Safe‑Care Protocols
Assess if organizations followed accepted standards, such as Universal Protocol,
Embraced Lean management system processes and reduce workarounds.
Assess System Failures When Never Events Occur
Conducting in‑depth medical care reviews to map precisely how controls failed, whether policy gaps, training lapses, or cultural barriers.
Producing root cause analyses that align with Joint Commission expectations and serve as credible expert evidence in malpractice proceedings.
Support Patients, Families, and Attorneys
Evaluating whether an organization met its never event prevention obligations and identifying deviations from accepted standards.
Advising on whether to pursue direct settlement negotiations or formal legal action, based on rigorous clinical findings.
Referring families to experienced malpractice counsel when litigation is appropriate.
By transforming never event tragedies into engines for learning—and by supporting justice for harmed patients—EvaluCare closes the loop on safety and accountability.
Resources for Patients, Families, and Attorneys
The Joint Commission Never Event Resources: Sentinel Event Policy & never event definitions Joint Commission
CMS Never Events & Hospital‑Acquired Conditions: Official list and payment policy
National Quality Forum Serious Reportable Events: Full list of 29 SREs PSNet
Patient Safety Network (AHRQ): Evidence summaries on never events and prevention strategies
Leapfrog Group: Reporting on never event rates and hospital safety grades
Conclusion: Zero Tolerance Demands Zero Lapses
Never events occupy healthcare’s highest‑stakes frontier, the catastrophic failures that should never occur in any modern hospital. Thanks to rigorous definitions, robust safety controls, and regulatory enforcement, the incidence of many never events has declined, yet they continue to occur too often. Each event represents not an unavoidable risk but a preventable breach of trust and duty.
For healthcare leaders, the imperative is clear: build multilayered defenses, cultivate a just culture, and relentlessly audit compliance. For patients and families, understanding never events empowers informed choices and supports advocacy when systems falter. And for attorneys, never events provide unambiguous evidence of negligence and system breakdown.
Through its deep expertise in quality improvement, regulatory standards, and forensic medical review, EvaluCare stands ready to help hospitals eradicate never events, and to support those harmed when these “never” mistakes tragically happen. Because safe care is not optional—it’s every patient’s right.
Learn more at www.EvaluCare.net or email info@EvaluCare.net
References and Further Reading
National Quality Forum. List of Serious Reportable Events. Available at: http://www.qualityforum.org/Topics/SREs/List_of_SREs.aspx PSNet
The Joint Commission. Sentinel Event Policy and Procedures. Available at: https://www.jointcommission.org/resources/sentinel-event/sentinel-event-policy-and-procedures/ Joint Commission
TechTarget. “Never Events vs. Sentinel Events: Assessing Patient Safety.” Published: 6 months ago. Informa TechTarget
PSNet. “Never Events.” AHRQ Patient Safety Network. 2019. PSNet
Gawande A. The Checklist Manifesto: How to Get Things Right. Metropolitan Books; 2009.
Haynes AB, et al. “A Surgical Safety Checklist to Reduce Morbidity and Mortality.” N Engl J Med. 2009;360(5):491–499.
Institute for Healthcare Improvement. “Never Events: A Team Approach.” IHI White Paper; 2011.
CMS. “Hospital-Acquired Conditions and Never Events.” 2024.
Leapfrog Group. “Never Events Fact Sheet.” 2015. Leapfrog
Rogers EM. Diffusion of Innovations. 5th ed. Free Press; 2003.
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