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In medicine, a never event is the "kind of mistake (medical error) that should never happen".[1] According to the Leapfrog Group never events are defined as "adverse events that are serious, largely preventable, and of concern to both the public and health care providers for the purpose of public accountability."[2]

A 2012 study reported there may be as many as 1,500 instances of one never event, a retained foreign object, per year in the United States. The same study suggests an estimated total of surgical mistakes at just over 4,000 per year in the United States, but these statistics are extrapolations from small samples rather than actual event counts.[1]

United States

[edit]

A list of events was compiled by the National Quality Forum and updated in 2012.[3] The NQF’s report recommends a national state-based event reporting system to improve the quality of patient care.

  1. Artificial insemination with the wrong donor sperm or donor egg
  2. Unintended retention of a foreign body in a patient after surgery or other procedure
  3. Patient death or serious disability associated with patient elopement (disappearance)
  4. Patient death or serious disability associated with a medication error (e.g., errors involving the wrong drug, dose, patient, time, rate, preparation or route of administration)
  5. Patient death or serious disability associated with a hemolytic reaction due to the administration of ABO/HLA-incompatible blood or blood products
  6. Patient death or serious disability associated with an electric shock or elective cardioversion while being cared for in a healthcare facility
  7. Patient death or serious disability associated with a fall while being cared for in a healthcare facility
  8. Surgery performed on the wrong body part
  9. Surgery performed on the wrong patient
  10. Wrong surgical procedure performed on a patient
  11. Intraoperative or immediately postoperative death in an ASA Class I patient
  12. Patient death or serious disability associated with the use of contaminated drugs, devices, or biologics provided by the healthcare facility
  13. Patient death or serious disability associated with the use or function of a device in patient care, in which the device is used or functions other than as intended
  14. Patient death or serious disability associated with intravascular air embolism that occurs while being cared for in a healthcare facility
  15. Infant discharged to the wrong person
  16. Patient suicide, or attempted suicide resulting in serious disability, while being cared for in a healthcare facility
  17. Maternal death or serious disability associated with labor or delivery in a low-risk pregnancy while being cared for in a health care facility
  18. Patient death or serious disability associated with hypoglycemia, the onset of which occurs while the patient is being cared for in a healthcare facility
  19. Death or serious disability (kernicterus) associated with failure to identify and treat hyperbilirubinemia in neonates
  20. Stage 3 or 4 pressure ulcers acquired after admission to a healthcare facility
  21. Patient death or serious disability due to spinal manipulative therapy
  22. 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
  23. Patient death or serious disability associated with a burn incurred from any source while being cared for in a healthcare facility
  24. Patient death or serious disability associated with the use of restraints or bedrails while being cared for in a healthcare facility
  25. Any instance of care ordered by or provided by someone impersonating a physician, nurse, pharmacist, or other licensed healthcare provider
  26. Abduction of a patient of any age
  27. Sexual assault on a patient within or on the grounds of the healthcare facility
  28. 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 the healthcare facility

As of 2019, 11 states have mandated reporting for never events, and an additional 16 states have mandated reporting for serious adverse events including never events.[4]

United Kingdom

[edit]

The National Patient Safety Agency produced a list of eight core never events in March 2009:[5]

  1. Wrong site surgery
  2. Retained instrument postoperation
  3. Wrong route administration of chemotherapy
  4. Misplaced nasogastric or orogastric tube not detected before use
  5. Inpatient suicide using non-collapsible rails
  6. Escape from within the secure perimeter of medium or high security mental health services by patients who are transferred prisoners
  7. In-hospital maternal death from post-partum haemorrhage after elective caesarean section
  8. Intravenous administration of mis-selected concentrated potassium chloride

NHS England produced a report on 148 reported never events in the period from April to September 2013 highlighting particular hospitals with more than one such event.[6] In 2021 there were still about 500 never events each year in the English NHS. According to Jeremy Hunt a hospital can get as many as 108 safety related instructions in a year.[7]

NHS Improvement has produced monthly and cumulative annual reports since 2015, when the definition of what constitutes a Never Event in the NHS also changed to require not only actual patient harm but also the potential for significant actual harm. Annual counts have therefore increased, and comparing recent with older data is misleading. The definition continues to undergo more minor change.[8] A provisional report for the 10 month period 1 April 2017 to 31 January 2018 acknowledged 393 never events within NHS England, including 172 wrong site surgeries, 97 retained foreign body post procedures, 60 wrong implants/prostheses and 31 medication administration errors.[9]

[edit]

The Leapfrog Group suggested four actions to be taken following a never event:[10]

  1. Apologize to the patient
  2. Report the event
  3. Perform a root cause analysis
  4. Waive costs directly related to the event

See also

[edit]

References

[edit]
Revisions and contributorsEdit on WikipediaRead on Wikipedia

Never event

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from Grokipedia
A never event is an occurring in healthcare that is serious in its consequences—typically resulting in death or significant —is unambiguous in identification, and is usually preventable through evidence-based practices. The term refers to errors indicative of systemic failures rather than isolated human mistakes, such as operating on the wrong or site, retaining a surgical object inside a , or administering the wrong type of blood. Introduced in 2001 by Ken Kizer, former CEO of the National Quality Forum (NQF), the concept aimed to spotlight egregious incidents like wrong-site surgery that defy standard safety protocols. The NQF formalized never events through its list of Serious Reportable Events (SREs), initially comprising 27 items in 2002 and expanded to 29 by 2016, categorized into seven groups: surgical or invasive procedural events (e.g., wrong procedure), product or device-related events (e.g., infections from contaminated devices), protection events (e.g., inpatient ), care management events (e.g., severe neonatal ), environmental events (e.g., burns from electric shocks), radiologic events (e.g., malfunctioning equipment causing metal to fly in MRI suites), and potential criminal events (e.g., abduction of a ). These events are distinguished by their preventability when safety systems function properly, prompting policies like mandatory reporting to accrediting bodies such as , which requires root cause analyses, and non-reimbursement by Medicare for associated treatment costs since 2009, with many states and private insurers adopting similar measures. Despite their designation, studies estimate over 4,000 surgical never events alone occur annually in U.S. hospitals, highlighting ongoing implementation gaps in prevention strategies. The framework has driven quality improvement initiatives but faces scrutiny for definitional variations across countries, which complicate global learning, and for the reality that "never" events persist due to complex care environments. As of 2024, the NQF is revising the SRE list through public input and expert panels to incorporate contemporary care modalities, such as , while maintaining criteria of seriousness, preventability, and systemic indicativeness.

Definition and Origins

Core Definition

A never event refers to a serious, largely preventable in healthcare that should not occur if standard safety protocols and evidence-based practices are consistently applied. These events are characterized as clearly identifiable, unambiguous in causation, and indicative of systemic failures rather than isolated human errors, with severe consequences for patients such as permanent harm or death. The concept emphasizes through mandatory reporting and measures like non-reimbursement by payers, aiming to incentivize root-cause and preventive redesigns in care delivery. The term "never event" originated in 2001, coined by Ken Kizer, MD, former CEO of the National Quality Forum (NQF), to highlight medical errors so egregious and avoidable that they demand zero tolerance within healthcare organizations. In 2002, the NQF formalized this by endorsing an initial list of 27 serious reportable events (SREs)—updated to 29 by 2006—grouped into categories including surgical or invasive procedures, product or device-related incidents, patient protection failures, care management lapses, environmental events, and potential criminal acts. Examples include performing surgery on the wrong site or patient, leaving foreign objects in the body post-procedure, or administering incompatible blood transfusions. This framework shifted focus from blaming individuals to addressing organizational and process vulnerabilities, influencing global patient safety standards. Never events differ from other adverse events by their predictability and preventability through existing checklists, verification steps, and interdisciplinary safeguards, yet persistence despite these tools underscores gaps in and . Empirical data from reporting systems indicate that while rare—estimated at 0.6 to 1.0 per 10,000 hospital admissions in the U.S.—they contribute disproportionately to litigation and trust erosion in healthcare. The NQF's criteria require events to be reportable across settings, not solely -based, to encompass and contexts.

Historical Development

The term "never event" was introduced in 2001 by Ken Kizer, MD, former CEO of the National Quality Forum (NQF), to denote unambiguously preventable medical errors of such severity—such as wrong-site surgery—that they should never occur in healthcare settings despite available safeguards. This framing built on prior efforts, including the Commission's 1995 sentinel event reporting recommendations, which highlighted similar high-risk incidents requiring root-cause analysis. In 2002, the NQF formalized the concept by endorsing a list of 27 "serious reportable events," divided into categories like surgical or invasive procedures, product or device-related issues, and patient protection failures, to standardize identification, reporting, and mitigation across U.S. healthcare providers. The list evolved through updates, expanding to 29 events by 2016 while maintaining criteria of seriousness, preventability, and clarity in attribution. Policy integration accelerated in 2007 when the U.S. Centers for Medicare & Medicaid Services (CMS) announced it would withhold reimbursement for treatment costs associated with certain never events, with implementation for eight specific conditions beginning October 1, 2008, to incentivize systemic prevention. Adoption extended internationally, with the UK's (NHS) launching its Never Events policy in April 2009 under the National Patient Safety Agency, following recommendations in Lord Darzi's 2008 NHS Next Stage Review; this included an initial list of eight events, later expanded, emphasizing mandatory reporting and investigation. These developments reflected a broader shift toward in , though critiques have noted that even "never" events persist due to human factors and organizational complexities.

Types of Never Events

Surgical Errors

Surgical never events encompass preventable errors occurring during invasive procedures, such as operating on the incorrect anatomical site, patient, or performing an unintended operation, which indicate fundamental failures in verification protocols. These incidents are deemed wholly avoidable through adherence to established safety measures, including pre-operative site marking, time-outs, and checklists, rendering their occurrence a marker of systemic lapses rather than inevitable risks. Retained surgical items, such as sponges or instruments left inside the post-procedure, also qualify as never events due to their unambiguous detectability via counting and imaging protocols. Common subtypes include wrong-site , estimated to occur in approximately 1 in 100,000 procedures based on surveys and institutional reports, though underreporting likely inflates the true denominator. Wrong-patient , involving misidentification during transfer or , and incorrect procedure execution, such as amputating the wrong limb or implanting an mismatched device, further exemplify this category. In the United States, a 2013 analysis extrapolated over 4,000 surgical never events annually from voluntary reporting and claims data, with a procedural rate of about 1 per 200,000 operations derived from high-volume hospital audits in states like . Consequences of these errors are severe, with one review of claims reporting mortality in 6.6% of cases, permanent harm in 32.9%, and temporary in 59.2%, often necessitating additional interventions and prolonging recovery. Factors contributing to such events include communication breakdowns in handoffs, which account for up to 80% of perioperative injuries per simulation studies, alongside fatigue and inadequate team training. Despite mandatory non-reimbursement policies by payers like Medicare since , incidence persists, underscoring limitations in deterrence absent robust enforcement and cultural shifts toward error disclosure.

Device and Medication Errors

Device and medication errors represent a key subset of never events, categorized under product or device-related incidents and care management failures in established frameworks such as the National Quality Forum's (NQF) Serious Reportable Events. These errors involve the unintended malfunction, , or misuse of devices and pharmaceuticals supplied within healthcare settings, leading to patient death or serious disability despite adherence to standard protocols. Product or device-related never events typically encompass harms arising from equipment or implements integral to patient care. Specific examples include patient death or serious injury associated with the use of contaminated drugs, devices, or biologics provided by the healthcare facility, such as infections from non-sterile endoscopes or intravenous lines. Other instances involve device malfunction causing electric shock, uncontained gas release, or burns during treatment, as well as intravascular air embolism from catheters or infusion devices used outside intended functions. In the United Kingdom, the National Health Service (NHS) identifies wrong implant or prosthesis as a never event, where mismatched or defective devices, such as pacemakers or joint replacements, are implanted due to selection or verification failures. Medication errors, often grouped under care management never events, occur when drugs are administered incorrectly, resulting in severe outcomes. These include errors in drug selection, dosing, patient identification, preparation, or route of administration, such as delivering a fatal overdose or incompatible medication. For instance, NQF criteria flag patient death or serious harm from anticoagulants given without proper monitoring or insulin overdoses due to miscalculations. In NHS policy, targeted medication never events comprise administration by the wrong route—exemplified by epidural drugs mistakenly given intravenously via compatible connectors—and overdoses of high-risk agents like midazolam (e.g., 10-fold excess in procedural sedation) or oxytocin during labor. Such errors persist despite safeguards like color-coded packaging or electronic prescribing, often stemming from look-alike/sound-alike drugs or lapses in double-checking.
CategoryExample Never EventsFramework
Device-RelatedContaminated device leading to ; electric shock from malfunctioning equipmentNQF Product/Device Events
Device-RelatedWrong / insertionNHS Never Events
MedicationWrong route administration (e.g., IV instead of epidural)NHS and NQF Care
MedicationOverdose of or insulinNHS and NQF
These classifications emphasize unambiguous preventability, with policies mandating root-cause analysis and non-payment for associated care in systems like U.S. Medicare to incentivize mitigation. However, variations exist across jurisdictions, reflecting differences in prioritized risks and reporting thresholds.

Patient Protection and Care Management Errors

Patient protection events refer to serious, preventable incidents where healthcare facilities fail to ensure the and of patients under their care, as defined in the National Quality Forum's (NQF) Serious Reportable Events (SREs) framework adopted in 2002 and updated through 2011. These events emphasize lapses in monitoring, verification, and environmental safeguards, distinct from clinical procedure errors. Examples include:
  • Discharge of an to the wrong person, resulting from inadequate identity verification processes at facility exits.
  • death or serious injury linked to , where individuals under supervision disappear from the , often due to insufficient or restraint protocols in behavioral health or vulnerable units.
  • suicide, attempted suicide, or causing serious injury during , despite mandated risk screening and mitigation strategies like constant observation for high-risk individuals.
  • Abduction of a of any age from within or around the facility grounds.
  • or assault of a on facility , highlighting failures in staff training, access controls, or incident response.
Care management events encompass errors in the ongoing coordination and delivery of non-surgical care, leading to avoidable through systemic or procedural breakdowns. These are rooted in deviations from evidence-based protocols for handling, mobility support, and perinatal oversight. Key instances involve:
  • death or serious from errors, such as administering the wrong drug, dose, , route, rate, or duration, which standard double-check systems are designed to prevent.
  • Unsafe blood product administration causing death or serious , including mismatches in type or identification.
  • or serious during labor or delivery in low-risk pregnancies, attributable to lapses in monitoring fetal distress or obstetric standards.
  • Neonatal death or serious associated with low-risk deliveries, often tied to failures in or control.
  • Death or serious from falls in facilities, where risk assessments and interventions like alarms or mobility aids should eliminate such outcomes.
  • Incidents where oxygen or gas delivery systems provide no gas, the wrong gas, or contaminated substances, due to maintenance oversights.
  • from contaminated drugs, devices, or biologics supplied by the facility, bypassing checks.
  • death or serious from intrinsic , resulting from unregulated fluid or electrolyte in controlled settings.
These categories, comprising 14 of the NQF's 29 SREs, underscore the expectation that robust administrative and clinical safeguards render such errors theoretically impossible, with reporting mandated to drive accountability and process improvements.

Implementation and Policy Frameworks

In the United States

The National Quality Forum (NQF) formalized the never events framework in the United States by endorsing an initial list of serious reportable events in 2002, which was revised and expanded over time to include 29 unambiguously preventable adverse incidents by 2016, categorized into surgical or invasive procedural events, product or device-related events, patient protection events, care management events, environmental events, radiologic events, and potential criminal events. These events, such as wrong-site , mismatched blood transfusions, and patient suicide, are defined by criteria emphasizing preventability, seriousness of harm, clear identifiability through medical records, and potential for learning and system improvement. In response to the NQF framework, the (CMS) announced in August 2007 a policy to withhold Medicare for the additional costs of certain hospital-acquired never events, with implementation beginning in fiscal year 2008 under the Inpatient Prospective Payment System and expanding to specific events like wrong-site by 2009. This non-payment mechanism, authorized under the Deficit Reduction Act of 2005, applies to selected conditions from the NQF list, such as certain surgical errors and severe pressure ulcers, thereby shifting financial accountability to providers to encourage preventive measures without covering treatment for the error itself. Policy implementation extends to reporting and accountability structures, with some states like mandating hospitals to report all NQF never events to centralized systems, conduct root cause analyses, and publicly disclose findings. The , which accredits most U.S. hospitals, designates overlapping incidents as sentinel events requiring internal root cause analysis and corrective action plans since 1995, though direct reporting to the Commission remains voluntary to promote self-analysis over punitive oversight. Advocacy groups such as the Leapfrog Group further promote standardized hospital policies for never events, including timely patient disclosure, apology, external reporting within 10 days, and waiver of related costs, integrated into performance metrics for transparency and quality improvement.

In the United Kingdom

In the , never events are implemented primarily within the (NHS), with establishing the core policy framework applicable to NHS-funded care in . The framework defines never events as serious incidents that are wholly preventable through adherence to existing national guidance or safety recommendations incorporating strong systemic protective barriers, such as uniquely designed connectors. These incidents must demonstrate potential for serious patient harm or death, evidence of prior occurrences, and clearly delineated specifications to qualify. The policy, initially outlined in 2012 and revised in 2020 following stakeholder consultation, prioritizes systemic learning over individual blame, explicitly avoiding automatic financial penalties for providers while mandating root cause analysis or equivalent systems-based investigations. The current list, updated in 2018, comprises 15 specified events categorized into surgical (e.g., wrong-site surgery, retained foreign object post-procedure), medication (e.g., administering the wrong insulin due to vial similarity), product or device-related (e.g., wrong-side chest or neck drain insertion), and other areas like mental health (e.g., in-patient suicide using non-collapsible ligatures). Providers and commissioners jointly determine if an incident meets never event criteria, with NHS leadership accountable for prevention through robust protocols, including pre-procedure verification checklists and device compatibility checks. Reporting requires immediate notification as a serious incident via the Strategic (StEIS) and the National Reporting and Learning System (NRLS), followed by comprehensive investigation under the NHS Serious Incident Framework, patient and family engagement, and public disclosure where applicable under the statutory . Learning outcomes must be disseminated nationally, with providers incorporating anonymized data into annual quality accounts; commissioners oversee compliance through contract monitoring and performance reviews. NHS periodically reviews the list and framework, as evidenced by a 2024 consultation assessing effectiveness amid persistent occurrences.

International Variations

In , the concept of never events was formalized in 2015 through a consensus list developed by Healthcare Excellence Canada (formerly the Canadian Patient Safety Institute), identifying eight specific hospital-based incidents, such as wrong-patient blood transfusions and wrong-site surgeries, deemed preventable via organizational checks and balances. Unlike the U.S. and U.K. models, Canadian policy emphasizes system-wide learning and disclosure without mandatory non-reimbursement by payers, focusing instead on root cause analysis and cultural shifts to reduce blame. This approach aligns with broader provincial variations, where reporting is encouraged but not uniformly penalized, reflecting a prioritization of collaborative improvement over financial deterrence. Australia employs the term "sentinel events" rather than "never events," with a national list established by the Australian Commission on Safety and Quality in Health Care in 2010 and updated in 2020, encompassing 17 categories including wrong-procedure surgeries and medication errors leading to death. Reporting is mandatory for accredited facilities under the National Safety and Quality Health Service Standards, but implementation varies by state; for instance, requires open disclosure and investigations, while financial penalties are limited to private sector agreements rather than universal payer non-payment. This framework draws from international lists but adapts to 's federated health system, stressing prevention through accreditation rather than absolute zero-tolerance enforcement. In , never events are integrated into the Health Quality & Safety Commission's Serious framework, updated in 2022, which lists preventable incidents like retained surgical items and wrong-patient procedures, mandating reporting to a central registry for analysis and public reporting. Policy lessons from comparisons highlight a shift toward systemic reviews without automatic blame, similar to , though district health boards face accountability through funding adjustments tied to safety performance metrics. , influenced by U.K. models post-2009 adoption, maintains a national never events list via the , including 17 items with requirements for root cause analysis and service-level suspensions, but critiques note persistent underreporting due to voluntary elements outside acute settings. European variations diverge further, with countries like lacking a unified national never events policy; instead, voluntary hospital-based registration occurs under the National Association for Quality in Healthcare, focusing on management protocols for incidents like wrong-site operations without mandatory penalties. The World Health Organization's Global Patient Safety Observatory, launched in , promotes standardized indicators across member states but does not enforce never events lists, allowing nations such as and to prioritize broader reporting under EU directives like the Cross-Border Healthcare Directive, often integrating them into without the "never" absolutism. These approaches underscore a global trend toward adaptable frameworks that balance prevention with contextual healthcare structures, contrasting stricter U.S./U.K. punitive measures.

Statistical Data and Rates

, surgical never events are estimated to occur in more than 4,000 cases annually, derived from analyses of malpractice claims and literature. Subsets such as wrong-site surgery are rarer, with a 2006 study estimating one occurrence every 5 to 10 years per typical hospital. These figures likely understate true incidence, as voluntary reporting systems like those from The Joint Commission capture only sentinel events amid incentives for non-disclosure due to financial penalties under CMS non-payment policies implemented in 2008. Recent federal audits, including a 2025 Office of Inspector General review, indicate hospitals fail to document up to half of broader patient harm events, suggesting similar gaps for never events. In , NHS data from the Strategic show 370 never events reported for the 2023/24 fiscal year (April 1, 2023, to March 31, 2024), a slight decline from 384 in 2022/23 and following 364 in 2020/21. Provisional figures for 2024/25 indicate 235 incidents designated as never events through October 2024, though final tallies remain pending. These absolute counts reflect wholly preventable incidents across NHS trusts, but no standardized rates per admission or procedure are routinely published; with approximately 17 million inpatient episodes annually, implied rates remain low yet highlight persistent systemic vulnerabilities. Underreporting persists due to cultural barriers and definitional inconsistencies, as noted in policy reviews. Internationally, comparable data are sparse and vary by framework; for instance, Canadian efforts define never events without centralized incidence tracking, while WHO estimates underscore that unsafe care contributes to over 3 million annual deaths globally, though never events form a preventable subset without quantified rates. Cross-national variations in reporting mandates limit precise rate comparisons, with studies emphasizing that absolute numbers underrepresent prevalence due to detection challenges.

Influences on Underreporting and Overreporting

Underreporting of never events is prevalent due to punitive financial and regulatory consequences, such as Medicare's non-reimbursement policy implemented in 2008, which discourages hospitals from disclosing incidents to avoid payment denials averaging thousands of dollars per case. A 2025 U.S. Department of Health and Human Services Office of Inspector General report found that hospitals failed to capture approximately 50% of patient harm events among Medicare inpatients, including serious errors akin to never events, primarily because staff did not recognize certain outcomes as harmful, applied narrow internal definitions of harm, or lacked standardized practices for documentation. This undercapture limits systemic learning, as few documented events trigger investigations or improvements like staff training. Additionally, a blame-oriented culture exacerbates underreporting, with healthcare workers citing fear of punishment, lack of institutional support, and disproportionate disciplinary responses as barriers, based on surveys of nurses and physicians. Operational and cultural factors further contribute to underreporting, including high workloads, time constraints, insufficient on incident recognition, and suboptimal investigation processes that fail to identify causes beyond individual fault. The "never" designation itself fosters a of inevitability in non-occurrence, leading to inconsistent definitions across institutions and voluntary reporting systems that prioritize self-protection over transparency. For instance, studies on reporting highlight how emphasis on personal over systemic analysis discourages disclosure, particularly for near-misses that could signal never event risks. Overreporting of never events is less documented but can arise from incentives in certain reporting frameworks designed to boost overall incident disclosure, such as financial rewards for meeting reporting thresholds, which one study linked to a fivefold increase in surgeon-reported incidents without of actual proliferation. Ambiguous or evolving definitions of never events may also prompt over-classification, where borderline incidents are labeled as such to demonstrate compliance with regulatory scrutiny or metrics, potentially inflating official tallies without reflecting true severity. However, empirical data on overreporting remains sparse compared to underreporting, with most analyses attributing discrepancies to concealment rather than exaggeration.

Effectiveness, Criticisms, and Debates

Claimed Reductions in Errors

Proponents of never event policies have attributed reductions in certain medical errors to targeted interventions like surgical safety checklists and procedural pauses. A 2009 multicenter study involving eight hospitals across diverse economic settings found that implementing the World Health Organization Surgical Safety Checklist was associated with a decline in the rate of surgical complications from 11.0% to 7.0% and in-patient mortality from 1.5% to 0.8% across 3,758 procedures, with sustained effects observed in follow-up data from 3,955 additional procedures. These checklists, designed to mitigate risks such as wrong-site surgery—a core never event—have been credited by advocates with preventing identifiable errors through standardized pre-, intra-, and post-operative verifications. In specific institutional contexts, claims of elimination have emerged post-policy adoption. For instance, a quality improvement initiative in a orthopaedic theatre implemented mandatory surgical and imaging pauses from 2017 onward, resulting in zero reported never events through 2023, compared to one incident in the preceding period; this was linked to enhanced adherence to verification protocols. Similarly, the U.S. (CMS) no-payment policy for hospital-acquired conditions, effective from and encompassing several never events, correlated with increased nurse-led interventions and a significant rise in bed alarm usage post-implementation, measures aimed at averting harm events like unanticipated deaths or injuries. Reported national trends have occasionally supported claims of decline, though often fluctuating. In , annual never event reports fell from 496 in 2018–19 to 364 in 2020–21, which some analyses attribute to heightened safety protocols amid evolving reporting frameworks introduced since 2012. However, such figures reflect notified incidents, and proponents caution that improvements in detection may confound raw counts, with certain subtypes like wrong dosing showing a "noticeable decline" in trends analyzed up to 2025. These claims emphasize systemic shifts toward but remain contested regarding causal attribution to never event designations alone.

Evidence of Persistent Occurrence

Despite policies designating certain medical errors as "never events" and implementing non-reimbursement mechanisms, such as those by the since 2008, these incidents continue to occur with regularity. A 2021 study in the International Journal for Quality in Health Care analyzed surgical contexts and found that never events persist routinely, suggesting they have become normalized within complex healthcare systems despite focused policy interventions. In the , data from the Strategic Executive Information System (StEIS) reveal ongoing reports: 496 never events were documented in the 2018-19 financial year, decreasing to 364 in 2020-21 amid the but rebounding thereafter, with 2,272 total events recorded from April 2016 to March 2021 across 15 categories. Provisional figures for 2024-25 indicate continued incidence, including 334 events reported between April 2024 and January 2025, primarily wrong-site surgery and retained foreign objects. United States estimates similarly underscore persistence, with a analysis of malpractice claims projecting over 4,000 surgical never events annually, including wrong-site procedures and unintended retained objects. A 2023 systematic review of global reports identified 125 unique never events, noting their continued frequency in causing harm, extended stays, and costs, even as lists expand. A July 2025 U.S. Department of Health and Human Services Office of report on Medicare hospitalizations found that providers failed to document approximately half of patient harm events, many preventable, thereby limiting systemic learning and perpetuating risks associated with never event categories like medication errors and falls with . This under-capture aligns with broader evidence from a 2020 , which linked ongoing surgical never events to recurrent factors such as handover communication breakdowns, unaffected by blame-oriented policies. A 2024 analysis in BMJ Quality & Safety critiqued the framework, observing that despite two decades of regulatory emphasis since the concept's introduction, never events endure due to over-reliance on punitive measures rather than addressing entrenched process vulnerabilities.

Critiques of the "Never" Label and Blame Dynamics

Critics contend that the "never" designation imposes an unrealistic absolutism on , given the inherent complexities of human factors, resource constraints, and systemic interdependencies in healthcare delivery, which render absolute prevention improbable even with rigorous protocols. This framing, originating from the National Quality Forum list, prioritizes rhetorical emphasis on over nuanced probabilistic , potentially distorting priorities by conflating rare but inevitable errors with willful . Empirical persistence of such events—despite two decades of policy enforcement—underscores the label's aspirational rather than evidentiary basis, as rates have not approached zero; for instance, England's reported 1,014 never events in the 2022/23 , up from prior years amid increased scrutiny. The dynamics embedded in never event policies exacerbate reporting disincentives, as non-payment mechanisms and mandatory disclosures tied to these incidents shift focus from root-cause to individual , fostering defensive behaviors among clinicians. A 2024 NHS consultation on framework revisions revealed stakeholder concerns that the label's punitive connotations drive a , where staff prioritize evasion of sanctions over transparent disclosure, thereby impeding aggregate learning and systemic reforms. Proponents of "just culture" paradigms, which differentiate reckless actions from at-fault but honest errors, argue this approach aligns better with causal realism by encouraging voluntary reporting—evidenced in models where error normalization without has reduced incident rates—contrasting the healthcare model's adversarial stance that correlates with underreporting rates estimated at 90-96% for adverse events overall. Such critiques highlight a tension between accountability and improvement, with peer-reviewed analyses warning that over-reliance on the never event binary discourages investment in probabilistic safeguards like redundant checks, favoring instead that overlooks upstream failures in , , or . While intended to deter complacency, the label's inflexibility may inadvertently sustain error cycles by eroding trust in reporting systems, as evidenced by qualitative surveys indicating heightened anxiety over career repercussions post-incident.

Systemic Responses and Prevention

Investigation and Disclosure Protocols

Investigation of never events generally follows structured root cause analysis (RCA) protocols designed to uncover systemic vulnerabilities contributing to the incident, rather than focusing solely on individual accountability. The , accrediting body for U.S. hospitals, mandates that accredited facilities conduct RCA for sentinel events—including never events such as wrong-site —within days of occurrence, involving multidisciplinary teams to review timelines, processes, and human factors through methods like event timelines, flowcharting, and causal factor identification. In the UK, the (NHS) requires never events to trigger a full investigation under the Serious Incident Framework, which incorporates RCA elements to analyze preventability and recommend actions, with reports submitted to oversight bodies like the Healthcare Safety Investigation Branch for national learning. These processes emphasize from records, staff interviews, and, where feasible, patient or family input to prioritize process improvements over punitive measures. Disclosure protocols prioritize timely, empathetic communication to patients and families, recognizing that transparency mitigates legal risks and fosters trust. Full disclosure entails acknowledging the event, providing a factual of its occurrence and consequences, expressing or offering an apology, detailing immediate remediation efforts to address harm, and outlining organizational steps to prevent recurrence. The Agency for Healthcare Research and Quality (AHRQ) endorses models like Communication and Optimal Resolution (CANDOR), which include checklists for initial disclosures within hours of awareness, ensuring plain-language updates and involvement of patient advocates. Empirical data from programs implementing such disclosures, such as the University of Michigan's model, indicate reduced filings and costs, with claims dropping by up to 66% post-adoption, though challenges persist in standardizing without admitting liability in litigious environments. Critics note that while RCA and disclosure aim for learning, incomplete investigations or delayed disclosures can undermine effectiveness, as evidenced by persistent never event rates despite protocols; for instance, RCA failures often stem from superficial analyses that overlook latent system errors like understaffing or poor handoffs. Regulatory bodies enforce reporting—e.g., (CMS) non-reimbursement for certain never events since 2008—to incentivize rigorous adherence, yet variability across institutions highlights the need for standardized tools like the Institute for Healthcare Improvement's RCA2 framework to enhance actionability.

Broader Reforms and Alternatives to Never Event Policies

Critics of never event policies argue that the absolute "never" framing fosters a punitive blame culture, discouraging error reporting and learning by attributing incidents primarily to individual failings rather than systemic contributors such as understaffing or flawed protocols. This approach has led to , including staff anxiety, resource misallocation toward low-frequency events, and media-driven distortions that overshadow broader improvements. In response, healthcare systems like the UK's (NHS) have initiated reforms to integrate never events into wider incident response frameworks, such as the Patient Safety Incident Response Framework (PSIRF), emphasizing proportionate investigations focused on learning and systems-level prevention over disciplinary measures. A 2024 NHS consultation revealed that 66% of respondents viewed the existing framework as unfit for purpose, prompting proposals for a "" that distinguishes honest errors from willful and redirects efforts toward strengthening preventive barriers like standardized checklists and leadership accountability. Alternatives to rigid never event classifications include adopting context-specific categorizations of serious reportable events, which prioritize continual through human factors engineering and high-reliability organization principles—drawing from aviation models like —rather than aspirational zero-harm guarantees. Consensus efforts advocate standardizing a core list of recurrent incidents (e.g., wrong-site , wrong patient, retained foreign objects, incorrect procedure) while abandoning inconsistent definitions to enable cross-organizational research and targeted interventions, such as enhanced training and policy reforms addressing root causes like or communication breakdowns. These reforms aim to cultivate reporting cultures that treat errors as opportunities for empirical , with from persistent event rates—such as stable or rising wrong-site surgeries post-2002—underscoring the limitations of blame-centric policies and the need for causal, systems-oriented strategies.

References

  1. https://psnet.ahrq.gov/primer/never-events
  2. https://www.qualityforum.org/en/key-initiatives/updating-the-serious-reportable-events-sre-list/
  3. https://www.cms.gov/newsroom/fact-sheets/eliminating-serious-preventable-and-costly-medical-errors-never-events
  4. https://health.mountsinai.org/blog/never-events-medical-errors-that-should-never-happen/
  5. https://pmc.ncbi.nlm.nih.gov/articles/PMC10314656/
  6. https://qualitysafety.bmj.com/content/33/9/559
  7. https://pmc.ncbi.nlm.nih.gov/articles/PMC2814808/
  8. https://bmjopenquality.bmj.com/content/12/2/e002264
  9. https://journalofethics.ama-assn.org/article/medicares-never-event-initiative/2008-05
  10. https://www.commonwealthfund.org/publications/newsletter-article/new-list-never-events-ensure-patient-safety-nhs
  11. https://www.whittington.nhs.uk/document.ashx?id=2313
  12. https://qualitysafety.bmj.com/content/33/9/613
  13. https://www.sciencedirect.com/science/article/pii/S1322769622001536
  14. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2779420
  15. https://www.surgjournal.com/article/S0039-6060%2812%2900623-X/abstract
  16. https://www.norcal-group.com/library/preventing-surgical-never-events-case-studies-and-best-practices
  17. https://www.fha.org/FHA/FHA/Health-Care/Serious-Events.aspx
  18. https://digitalassets.jointcommission.org/api/public/content/4534bbaaee4f4bd280c2054765f37f4b
  19. https://www.england.nhs.uk/wp-content/uploads/2020/11/2018-Never-Events-List-updated-February-2021.pdf
  20. https://www.tozers.co.uk/insight/articles/never-events-what-are-they-and-why-do-they-happen/
  21. https://www.ncbi.nlm.nih.gov/books/NBK20598/
  22. https://www.hssib.org.uk/patient-safety-investigations/never-events-analysis-of-hsibs-national-investigations/investigation-report/
  23. https://www.leapfroggroup.org/sites/default/files/Files/Castlight-Leapfrog_Never_Events_Final.pdf
  24. https://www.england.nhs.uk/wp-content/uploads/2020/11/Revised-Never-Events-policy-and-framework-FINAL.pdf
  25. https://assets.publishing.service.gov.uk/media/5a7c90ae40f0b62aff6c2903/dh_124988.pdf
  26. https://www.england.nhs.uk/long-read/provisional-publication-of-never-events-reported-as-occurring-between-1-april-2024-and-31-march-2025/
  27. https://www.healthcareexcellence.ca/en/resources/never-events-for-hospital-care-in-canada/
  28. https://www.healthcareexcellence.ca/media/eceoshdc/never-events-for-hospital-care-in-canada.pdf
  29. https://www.hqontario.ca/what-is-health-quality/never-events-for-hospital-care-in-canada
  30. https://www.safetyandquality.gov.au/sites/default/files/2020-05/australian_sentinel_events_list_version_2_review_summary_april_2020.pdf
  31. https://www.safetyandquality.gov.au/sites/default/files/migrated/APPENDIX-B-International-sentinel-and-never-events.pdf
  32. https://academic.oup.com/intqhc/article/33/Supplement_1/25/6087586
  33. https://www.researchgate.net/publication/349734330_Never_Events_in_Acute_Care_Policy_Lessons_from_International_Comparisons
  34. https://pmc.ncbi.nlm.nih.gov/articles/PMC8612887/
  35. https://www.who.int/data/gho/data/themes/global-patient-safety-observatory
  36. https://oig.hhs.gov/reports/all/2025/hospitals-did-not-capture-half-of-patient-harm-events-limiting-information-needed-to-make-care-safer/
  37. https://www.england.nhs.uk/wp-content/uploads/2023/07/provisional-never-events-april-23-31-march-24.pdf
  38. https://www.england.nhs.uk/long-read/provisional-never-events-2024-25-data-1-april-2024-31-october-2024/
  39. https://www.england.nhs.uk/statistics/statistical-work-areas/patient-safety-data/
  40. https://www.gov.uk/government/publications/review-of-patient-safety-across-the-health-and-care-landscape/review-of-patient-safety-across-the-health-and-care-landscape
  41. https://www.who.int/news-room/fact-sheets/detail/patient-safety
  42. https://pmc.ncbi.nlm.nih.gov/articles/PMC9470911/
  43. https://pmc.ncbi.nlm.nih.gov/articles/PMC11347247/
  44. https://bmcnurs.biomedcentral.com/articles/10.1186/s12912-023-01376-9
  45. https://www.sciencedirect.com/science/article/abs/pii/S0022480421007423
  46. https://www.nejm.org/doi/full/10.1056/NEJMsa0810119
  47. https://bmjopenquality.bmj.com/content/14/1/e002971
  48. https://pmc.ncbi.nlm.nih.gov/articles/PMC6002153/
  49. https://www.beenletdown.co.uk/insights/never-events-and-the-nhs/
  50. https://academic.oup.com/intqhc/advance-article/doi/10.1093/intqhc/mzaf109/8277003
  51. https://www.hudgellsolicitors.co.uk/advice/nhs-records-2272-never-events-in-five-years-but-what-are-they
  52. https://www.williamsons-solicitors.co.uk/advice-and-article/334-never-events-recorded-between-april-2024-and-january-2025/
  53. https://pubmed.ncbi.nlm.nih.gov/31916908/
  54. https://www.england.nhs.uk/patient-safety/patient-safety-insight/revised-never-events-policy-and-framework/2024-consultation-findings/
  55. https://pmc.ncbi.nlm.nih.gov/articles/PMC11740813/
  56. https://academic.oup.com/milmed/article/188/7-8/1596/6589441
  57. https://www.frontiersin.org/journals/health-services/articles/10.3389/frhs.2025.1581516/full
  58. https://www.jointcommission.org/en-us/knowledge-library/support-center/standards-interpretation/sentinel-event-policy-and-procedures
  59. https://www.leapfroggroup.org/influencing/never-events
  60. https://psnet.ahrq.gov/primer/disclosure-errors
  61. https://www.ahrq.gov/patient-safety/settings/hospital/candor/modules/checklist5.html
  62. https://www.ncbi.nlm.nih.gov/books/NBK570638/
  63. https://www.ihi.org/library/tools/rca2-improving-root-cause-analyses-and-actions-prevent-harm
  64. https://www.england.nhs.uk/blog/evolving-our-approach-to-patient-safety-the-future-of-never-events/
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