Introduction

The National Quality Forum (NQF) introduced the term never event in the early 2000s, and it refers to a preventable error that may represent fundamental issues with the quality or safety of care within a medical setting.¹ This wording was initially selected because these events are situations that should never happen to any patient, such as surgery to the wrong leg or leaving a sponge in a patient after surgery.² In recent years, the NQF has adopted the term serious reportable events (SREs), but in many instances, the term never event is still used.²

Never Events in Wound Care

In wound care, the concept of a never event is complicated. In 2008, the Centers for Medicare and Medicaid Services (CMS) released a list of facility never events that are not covered under Medicare. Under that list were hospital-acquired stage 3 and 4 pressure injuries, along with unstageable pressure injuries.³ Several other hospital-acquired conditions are listed, including burns and certain surgical site infections.⁴

For those working in understaffed facilities or with patient populations at a higher risk of such injury, the inclusion of these conditions as never events may have serious consequences. In certain cases, wound care professionals who provide the standard of care or even care that exceeds expectations may receive repercussions when a patient develops a pressure injury. In addition to Medicare not providing coverage for these injuries, clinicians could face legal action from the patient or their family. Not all pressure injuries are avoidable. According to a literature review from 2019, certain injuries discovered at a patient's end of life may have unmodifiable intrinsic and extrinsic factors. For instance, Kennedy terminal ulcers (KTU), also referred to as Kennedy terminal lesions,⁵ and discussion around the skin failure concept resulted in an update by CMS in 2017.⁶

In the long-term care setting, CMS currently allows that certain injuries, including pressure injuries, which occur at end of life (6 weeks to 2 days before death) and receive appropriate treatment in line with the patient's end of life goals can be recorded as KTUs, terminal ulcers, or terminal lesions. Although different from the Minimum Data Set, The State Operations Manual Guidance to Surveyors for Long Term Care Facilities states that the facility is responsible for classifying and assessing an ulcer as a KTU, or another type of pressure injury, and the facility must also show that measures were taken to prevent non-KTU ulcers.⁷

Despite being a step in the right direction, this update does not apply to the acute care setting, rehabilitation facilities, home health setting, or long-term acute care hospitals.⁶ Even with the efforts of influential wound care professionals, there isn’t enough research regarding which specific intrinsic and extrinsic patient factors are unmodifiable.⁸ In addition, injuries documented as terminal are difficult to diagnose before a patient’s death because the time of injury development in relation to death cannot possibly be determined. Therefore, wound care professionals can best protect themselves from these scenarios by implementing best practices and thorough, constant documentation of any assessment and management. Moreover, current technology may help further prevention efforts. Technologies like databases and safety tools may not only help prevent hospital-acquired stage 3 and 4 injuries but may also aid in preventing several other never events and SREs that pose a risk to staff and patients.

How Are Never Events Categorized?

In 2008, CMS identified specific never events and conditions that can result in penalties for medical facilities. Since then, the list has grown to over 30 events.⁹ Never events, or SREs, fall into 7 categories, including the following¹⁰:

1. Surgical or invasive procedure events: A never event in this category may include performing surgery on the wrong site or patient, performing the wrong surgery, leaving a foreign object in the patient after surgery, and postoperative death in an ASA Class 1 patient.
2. Product or device events: This category includes patient death or injury associated with contaminated drugs, devices, or biologics. It is also associated with the use or function of a device in patient care when the device is used other than its intended purpose. Patient death due to intravascular air embolisms is also in this category.
3. Patient protection events: In this category, the patient’s safety has been compromised. These events include the discharge of a patient who is not able to make decisions in any way other than to an authorized caregiver and the disappearance of a patient. These events also include attempted suicide or self-harm in a health care setting.
4. Care management events: A few examples of care management never events include patient death or injury due to medication error(s), falls, the unsafe administration of blood products, artificial insemination using the wrong donor sperm or egg, and maternal or infant death during labor and delivery with a low-risk pregnancy. Patient death or serious injury resulting from the irretrievable loss of irreplaceable biological specimens or those resulting from a failure to follow up or communicate laboratory, pathology, or radiology test results are also in this category. Some hospital-acquired conditions are also included in this category, which encompasses Stage 3, Stage 4, and unstageable pressure injuries acquired while in the health care facility.
5. Environmental events: This category includes patient or staff death, or serious injury, associated with electric shock during treatment, those in which oxygen or other gas delivery systems fail or are contaminated, those associated with a burn incurred while in the health care setting, and those associated with physical restraints or bedrails.
6. Radiologic events: This category is for the death or serious injury of a patient or staff related to the presence of a metallic object in the MRI area.
7. Potential criminal events: This category includes any instance of impersonation of a physician, nurse, or another health care provider, the abduction of a patient of any age, sexual abuse of a patient or staff member, and the death or serious injury of a patient or staff member within the health care setting.

While it may be tempting to think that only some of these SREs listed above may occur when administering wound care, like in the care management category, the reality is that depending on the patient, the wound, and the care team, there may always be a risk that an SRE from any category could occur.

Strategies for Never Event Prevention

Regardless, never events can profoundly impact the clinician. Wound care professionals often experience profound psychological effects, such as anger, guilt, inadequacy, depression, and risk for suicide or self-harm due to real or perceived errors, and the threat of legal ramifications can compound these feelings.¹¹ Therefore, reducing the risk of never events or SREs should be a top priority. In many instances, medical technologies can be used to reduce human error. For instance, one method for reducing medication errors involves physician computerized order entry. This procedure has not only helped reduce errors for materials such as prescriptions for patients, but it has also made information easily available and accessible, thus helping to reduce potential errors.¹³ Tools for streamlining information are all vital components in creating a culture of safety to ensure that errors are caught before any harm is done. And, often, reducing the risk of a never event includes the following elements¹²:

• Review operations and make changes that reduce errors: This review of systems includes enhancements to the identification, documentation, and coding of conditions present upon admission and changes in medical practice, such as ordering additional tests at admission to adequately gauge each patient’s condition. Systems should ensure that wound care professionals assess and document the patient extensively upon admission. If the patient presents with a pressure injury and it is not documented appropriately, that could result in complications for the provider and the facility. Enhancements here can include incorporating safeguards that increase accuracy, facilitate better communication, and reduce the risk of medical errors.
• Create a culture of safety: Most medical errors are systems-related rather than due to individual negligence or misconduct. System improvements should acknowledge the adage that “to err is to be human" and, as a result, create fail-safe mechanisms that can catch errors before harm occurs or have procedures in place to mitigate the level of harm to the patient or health care professional.
• Implement safety tools, such as checklists, communication tools, handoff check sheets, and briefing guides: Checklists can be a huge asset that may reduce never events and SREs. The use of a 5-step checklist with reminders for clinicians to wash their hands and put on sterile gloves before performing an associated procedure, for example, may decrease the level of infection correlated with a particular treatment.

Conclusion

Never events and SREs represent a huge risk to patients, clinicians, and health care facilities. These events cost facilities thousands of dollars and, most importantly, often put both providers and patients in harmful situations. For wound care professionals, thorough documentation, and adherence to their facility’s standard of care are the first line of defense against financial and legal repercussions for unavoidable injury. For the myriad of other never events and SREs, clinicians can review operations, integrate fail-safe and mitigation procedures for anticipated events, and use various tools and technology to streamline documentation and procedures. These actions can significantly reduce the risk of never events and SREs, which benefits patients and clinicians alike.

References

1. Chokshi DA, Beckman AL. A New Category of “Never Events”—Ending Harmful Hospital Policies. JAMA Health Forum. 2022;3(10):e224703. doi:10.1001/jamahealthforum.2022.4703
2. Leving JM. Does the term ‘never event’ apply to pressure injuries? WoundSource. Published October 7, 2016. Accessed January 5, 2023. https://www.woundsource.com/blog/does-term-never-event-apply-pressure-i…
3. Medicare and medicaid move aggressively to encourage greater patient safety in hospital and reduce never events. CMS. Published July 31, 2008. Accessed January 9, 2023. https://www.cms.gov/newsroom/press-releases/medicare-and-medicaid-move-…
4. Hospital-Acquired Conditions. Centers for Medicare and Medicaid Services. Updated August 12, 2022. Accessed January 9, 2023. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalA…
5. Kennedy-Evans KL, Ritter L. Science Catches Up with the Kennedy Terminal Ulcer. Oral Presentation at: WOCNext. June 2022; Fort Worth, TX. https://www.wocnext.org/WOCN2022/Custom/Handout/Speaker0_Session976_1.p…
6. Centers for Medicare & Medicaid Services. Appendix PP—Guidance to Surveyors for Long Term Care Facilities. CMS. Published 2017. Accessed January 10, 2023. www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107a….
7. State Operations Manual: Appendix PP - Guidance to Surveyors for Long Term Care Facilities. CMS. 2007;117. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads…. Updated October 21, 2022. Accessed September 23, 2022.
8. Ayello EA, Levine JM, Langemo D, Kennedy-Evans KL, Brennan MR, Gary SR. Reexamining the Literature on Terminal Ulcers, SCALE, Skin Failure, and Unavoidable Pressure Injuries. Adv Wound Care. 2019;32(3):109-121. Doi: 10.1097/01.ASW.0000553112.55505.5f
9. Torrey T. There’s More ‘Never Events’ Than Patient Safety. Verywellhealth. Published June 24, 2022. Accessed January 5, 2023. https://www.verywellhealth.com/what-is-medicares-never-events-policy-26…
10. List of SREs: List of Serious Reportable Events (aka SRE or ‘never events’). National Quality Forum. Accessed January 5, 2023. https://www.qualityforum.org/Topics/SREs/List_of_SREs.aspx#sre1.
11. Rodziewicz TL, Houseman B, Hipskind JE. Medical error reduction and prevention. StatPearls. Updated December 4, 2022. Accessed January 5, 2023. https://www.ncbi.nlm.nih.gov/books/NBK499956/
12. Bates DW. Using information technology to reduce rates of medication errors in hospitals. BMJ. 2000;320(7237):788-791. doi:10.1136/bmj.320.7237.788
13. Harden S. Six things you must know about never events. Lifewings. Published March 2012. Accessed January 5, 2023. https://qprinstitute.com/pdfs/SixThingsYouNeed.pdf