The X Factor: A Paradigm Shift in Mitigating Severe Pressure Ulcer Malpractice Claims
By Caroline E. Fife, MD
Despite the Herculean efforts focused on pressure ulcer prevention in acute and subacute care settings, severe pressure injuries continue to occur with predictable frequency. The presence of severe pressure ulcerations (e.g., Stage 4 and deep tissue injuries), even when the best of care is known to have been provided, suggests there may be an unidentified factor contributing to their formation, which is not mitigated by current prevention protocols.
We are calling this the “X factor”—the risk factor that explains why some pressure ulcers are medically unpreventable. If there is, as evidence suggests, an “X factor” (or factors) contributing to severe pressure ulcer formation, then they have important clinical and malpractice implications.
Ulcers vs. injuries: What’s in a name?
The terminology around pressure related skin breakdown is confusing and contradictory. The National Pressure Injury Advisory Panel (NPIAP) states that all skin changes that result from “prolonged pressure” should be labeled or documented as “pressure injuries”, regardless of whether the lesion is open or closed.1 However, the ICD-10-CM code book classifies Stage 1, 2, 3, and 4 pressure ulcers as “ulcers” and uses the term “deep tissue damage” for the clinical condition referred to as a “deep tissue injury” (DTI).2 The Centers for Medicare and Medicaid Services (CMS) adheres to even different guidelines: Stage 1 pressure injuries and DTIs are termed “pressure injuries” because they are closed lesions. Stage 2, 3, 4 and unstageable pressure ulcers are all termed “pressure ulcers” because they are open wounds.3 For the rest of this article, I will refer to any area of open tissue breakdown as a pressure ulcer because that conforms to the common medical meaning of a chronic open wound and adheres to both the ICD-10 code descriptors and CMS terminology.
Pressure ulcers are NOT “never events”
In 2005, as part of the Deficit Reduction and Reconciliation Act (DRA), CMS took action to reduce the cost of what they termed “hospital acquired conditions” (HACs). Four of the eight HACs were sub-classified as “Serious Preventable Events,” which have since been referred to as “never events,” although this is not an official regulatory term. Pressure ulcers are NOT on the list of Serious Preventable Events, which means they are NOT “never events.” In fact, in the Federal Register describing HACs, CMS acknowledged that some pressure ulcers are unavoidable.
Research reveals pressure ulcers are not evidence of substandard or negligent care
Pressure ulcer formation is often linked to elder abuse. In 2010, a fascinating study was funded by the California Department of Justice under the leadership of Laura Mosqueda, MD, with the goal of determining whether the development of a severe pressure ulcer was evidence of neglect, or whether pressure ulcers could happen even under the best of care.4 The prospective study involved 63 top-performing skilled nursing facilities.
Despite confirmation that excellent preventive care was provided in the form of turning, mobilization, physical therapy, skin care and diet, 24 elderly residents still developed a Stage 3 or 4 pressure ulcer. Investigators concluded that a pressure ulcer could happen in the absence of neglect or abuse and suggested that the patients’ underlying medical condition(s) hindered medical prevention efforts. In this study, associated medical conditions included cardiovascular disease (92%), dementia (83%) and renal disease (50%).
Similar conclusions have been drawn about the inability to prevent pressure ulcers among some critical care patients. Even when it is possible to implement prevention protocols, these interventions are often insufficient. While most experienced clinicians know that this is true, media and misguided institutional policies (including popular “get to zero” campaigns) may lead family members, patients and senior living residents to believe pressure ulcers are always preventable and their occurrence is evidence of substandard or negligent care.
The “X factors”
Real world evidence shows that the following factors are associated with the development of both DTIs and Stage 4 pressure ulcers, particularly among critical care patients5:
- Low mean arterial pressure
- Low diastolic blood pressure
- Low cardiac output
- Low arterial oxygen saturation
- Low serum albumin (causes a low oncotic pressure)
During hypotension, it is a normal physiological response for the body to shunt blood to the brain and kidneys, reducing perfusion to the skin. Thus, the body makes a “value judgment” to sacrifice soft tissue, losses from which it is possible to recover, in exchange for supporting cerebral and renal function, because losses to those organs may not be recoverable. Vasopressors accentuate the normal physiological reduction in peripheral perfusion.
Management of hemodynamic unstable patients
As recognition of the hemodynamic origin of pressure ulcers grows, some health care organizations are proactively evaluating hemodynamic data to identify the perfusion thresholds leading to DTIs and Stage 4 pressure ulcers, particularly among critical care patients. It seems likely that the medical community will identify a new generation of pressure ulcer mitigation strategies focused on maintaining, for example, specific levels of mean arterial pressure, diastolic blood pressure, serum albumin or hemoglobin. If the patient’s medical condition prevents maintenance of these thresholds, any subsequent pressure ulcers will be considered medically unpreventable.
While this ongoing research is highly relevant to the sickest of people, hospitals and senior living centers have noted a decrease in pressure ulcer formation from interventions as basic as ensuring adequate oral hydration among patients able to drink. Since oral hydration has a direct impact on blood pressure, this simple intervention can be powerful.
Communicating risk and setting expectations
Patients, senior living residents and families need to understand that not all pressure ulcers are preventable, and the likelihood of developing a pressure ulcer increases if the person is hemodynamically unstable. They also need to understand that once deep tissue has infarcted, severe pressure ulcers do not “progress” but rather “evolve” from the inside-out along a predictable course. Once a DTI occurs, there is no reliable evidence that this evolution can be stopped.
Risk mitigation strategies
Below are a few expert-vetted risk mitigation strategies your care team can consider:
- Avoid naming care protocols and policies prevention protocols; this implies that all pressure ulcers are preventable
- Do not use dogmatic language such as “must” when referring to interventions that may not be feasible depending on the patient or senior living resident’s status. Failure to perform some of these tasks (e.g., taking photographs at specific intervals) may be used as evidence of poor care, even though their relevance to prevention is unproven.
- Educate team members about why pressure ulcers are NOT considered “never events,” including why they should avoid using these terms in conversations with family or in the medical record.
- Make a note while documenting care for critically ill patients that they are at high risk for DTIs due to hemodynamic factors that cannot be adequately managed.
- Communicate risk and set expectations with families of critically ill patients or the frail elderly with hypotension due, for example, to acute infection. Medical interventions and the body’s own physiological responses may elect to sacrifice the skin (which can be repaired) in favor of the brain (which cannot).
- If a pressure ulcer occurs, discuss the risk factors and mitigation strategies involved with the patient or senior living resident and family, and document in the medical record.
- Explain the importance of oral hydration in reducing pressure ulcer formation with patients, senior living residents and families. Simple interventions, such as ensuring adequate oral fluid, vitamin, calorie and protein intake, can have a dramatic impact on pressure ulcer risk.
- Ensure accurate and complete documentation; historically, this has enabled clinicians and health care organizations to successfully defend severe pressure ulcer litigation (even when the ulcerations are visually disturbing, and the outcome was poor) because mitigation strategies were clearly documented and the severity of the patient’s condition and risks for DTIs/severe pressure ulcers were explained in the medical record.
Research has shown that severe pressure ulcers are not always preventable. Assessing a person’s risk for developing severe pressure injuries and maintaining best practices can help your team mitigate harm and malpractice claims.
1NPIAP Pressure Injury Stages
2CMS: 2022 ICD-10-CM
3CMS Quality Reporting Program Provider Training Section M: Skin Conditions (Pressure Ulcer/Injury)
4Multi-Site Study to Characterize Pressure Ulcers in Long-Term Care Under Best Practices, Laura Mosqueda, M.D., August 2010 (https://www.ojp.gov/library/publications/multi-site-study-characterize-pressure-ulcers-long-term-care-under-best)
5Alderden J, Rondinelli J, Cummins M, Pepper G, Whitney J. Risk factors for pressure injuries among critical care patients: a systematic review. Int J Nurs Stud 2017;71:97–114. https://www.sciencedirect.com/science/article/pii/S0020748917300858
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