By Caroline Fife, MD, FAAFP, CWS, co-editor of Today's Wound Clinic
Pressure ulcers are a serious cause of morbidity and cost across all healthcare settings in the United States.1 They are more likely to occur among the elderly, and because the US population age 65 years and older is expected to double within the next 25 years, the number of people with pressure ulcers also is expected to increase.2 Data suggest the incidence of skin breakdown can be reduced with the implementation of protocolized care. Driven in part by legislative initiatives, many institutions have developed pressure ulcer prevention protocols.3 It seems difficult to argue these initiatives can be anything other than good for patients. However, even though pressure ulcer prevention protocols may decrease the incidence of some types of skin breakdown, the frequency of litigation involving pressure ulcers is increasing. Why?
Reliable data now support two different pathophysiological processes at work that create the spectrum of skin breakdown we consider pressure ulcers. Friction and shear, often exacerbated by maceration from incontinence, lead to the development of the lesions termed Stage II pressure ulcers according to the National Pressure Ulcer Advisory Panel (NPUAP) classification system.4,5Such lesions occur from the outside in. Stage III and Stage IV pressure ulcers are the clinical manifestation of tissue damage resulting from excessive tissue deformation, including possible ischemic injury due to distortion of the vasculature.5 The tissues nearest to the bony prominence are thought to experience the most pressure, which then dissipates and spreads as the superficial layers are approached. In this way, the damage causing Stage III and Stage IV pressure occurs in the deeper tissue first and progresses toward the surface. In other words, deep pressure ulcers form from the inside out. Because most prevention protocols emphasize nursing efforts to reduce friction, shear, and moisture, the types of lesions they are most likely to impact are Stage II ulcers. Based on their different causative mechanism, the interventions most likely to mitigate the formation of deep tissue necrosis would include maintaining normal values regarding mean arterial pressure, arterial oxygen tension, and hemoglobin. To date, few if any prevention protocols have targeted the largely medical factors affecting Stage III and Stage IV pressure ulcers. This may explain why their incidence remains stubbornly predictable among the very ill.
Despite its failure to represent the current understanding of pressure ulcer pathogenesis, the NPUAP staging system has profound reimbursement implications.5 In the Deficit Reduction and Reconciliation Act (DRA) of 2005, Congress required the Centers for Medicare and Medicaid Services (CMS) to identify at least two high-cost or high-volume (or both) conditions that could “reasonably have been prevented through the application of evidence-based guidelines.” Pressure ulcers were one of the eight hospital-acquired conditions (HACs) Congress subsequently identified, although pressure ulcers did not make the list of “never events,” a common misperception. (The four “never events” include leaving an object in the patient, performing the wrong surgery, air embolism following surgery, and incompatible blood products.) If Stage III and Stage IV pressure ulcers occur during hospitalization, the additional DRG payment for these major comorbidities will not be made. However, Stage III and Stage IV pressure ulcers identified within 24 hours of admission are considered pre-existing and thus will contribute to the major comorbidity DRG.
The CMS requirement to identify pre-existing pressure ulcers present on admission drives institutions to mandate skin assessments before a specific temporal deadline. However, algorithms with rigid time factors for any assessment or intervention are problematic from a risk-management standpoint. If a pressure ulcer occurs and it is later determined that, for example, 25 hours elapsed (rather than 24) before the skin assessment was performed, a potentially persuasive case could be made by a plaintiff’s attorney that the hospital was negligent because its nurses failed to adhere to the hospital’s prevention protocol.
The goals of prevention protocols include identifying and mitigating risk factors for pressure ulcer formation in hopes of decreasing their incidence. Although many studies have shown the incidence of pressure ulcers can be reduced when proper quality care is consistently implemented,6,7 a group of patients remains in whom pressure ulcers do not appear to be preventable. This may be due in part to the failure to recognize the inside out pathologic process and properly address relevant risk factors. However, no current intervention strategy consistently and reproducibly decreases the incidence of all pressure ulcers to zero, nor do published data support the assumption that all pressure ulcers are preventable. Thus, the presence of pressure ulcer prevention protocols may perpetuate the myth that pressure ulcers are entirely preventable (otherwise, we wouldn’t call them prevention protocols).
The unfounded assertion that all pressure ulcers are preventable is pervasive. The August 2012 issue of Consumer Reports included “Bedsores” in their list of “8 Things That Should Never Happen in a Hospital,” stating that, “frequent repositioning and special pads, cushions, and mattresses can prevent them [italics ours].” See www.consumerreports.org/cro/magazine/2012/08/how-safe-is-your-hospital/i...
Hospital prevention protocols similarly reinforce the misperception that pressure ulcers are reliably prevented by interventions such as repositioning and managing incontinence. Although these interventions may decrease outside in (Stage II) pressure ulcer, data are not convincing that they prevent Stage III and Stage IV pressure ulcers. If Stage III or Stage IV pressure ulcers occur, the prevention protocol has failed, and someone must account for this failure.
This is not a trivial matter. Plaintiff’s attorneys have successfully argued that pressure ulcers are a form of elder abuse, sometimes positioning pressure ulcer lawsuits within statutory exceptions to monetary damage caps that apply to medical malpractice claims in some states. The legal risks of pressure ulcers are not limited to civil penalties. In a worrisome trend toward criminalization of adverse events, family members, and even a nursing home operator, have been convicted of manslaughter (and are currently serving prison sentences) for patient deaths indirectly attributed to pressure ulcers. Healthcare and legal professionals need to provide the potential for criminal penalties from pressure ulcer formation substantially more attention.
How can institutions implement prevention protocols designed to decrease the risk of skin breakdown among patients without increasing the risk of litigation among caregivers? The following are some considerations: 1) Calling these algorithms prevention protocols may perpetuate the misconception that (all) pressure ulcers are preventable or that if skin breakdown occurs, the protocol or the caregivers failed. Therefore, we recommend that the algorithms not include the word prevention in the title; 2) Including rigid time factors for specific interventions, or rigid language (eg, “must”) may set up the institution and its clinical staff for failure, even if circumstances beyond the control of the caregivers intervene.
Therefore, we recommend that words be carefully chosen to guide but not mandate evaluations or interventions within a specific time frame; 3) Implementing nursing interventions that primarily mitigate risk factors for Stage II pressure ulcers may do little to reduce Stage III and Stage IV pressure ulcers, which form via different pathophysiological mechanisms. It is necessary to acknowledge at least two distinct processes are at work and that the specified protocol may be capable of limiting only certain types of ulcerations.
The goals of pressure ulcer prevention protocols are laudable — ie, to provide the best possible care for patients and to limit preventable skin breakdown. However, if drafted without attention to detail and recognition of their potential medical-legal effect, pressure ulcer prevention protocols can unnecessarily increase the risk of litigation. Care should be taken to ensure they are developed with a realistic understanding of what sort of skin breakdown such protocols may be able to prevent and an up-front appreciation of the potential legal implications of the words used.
1. Gupta S, Ichioka S. Optimal use of negative pressure wound therapy in treating pressure ulcers.Int Wound J. 2012;9(suppl 1):8–16.
2. Lyder CH, Ayello EA. Pressure ulcers: a patient safety issue. In: Hughes RG (ed). Patient Safety and Quality. An Evidence-based Handbook for Nurses. Bethesda, MD: Agency for Healthcare Research and Quality;2008.
3. Jankowski IM, Nadzam DM. Identifying gaps, barriers, and solutions in implementing pressure ulcer prevention programs. J Comm J Qual Patient Saf. 2011;37:253–264.
4. Hanson D, Langemo DK, Anderson J, Thompson P, Hunter S. Friction and shear considerations in pressure ulcer development. Adv Skin Wound Care. 2010;23:21–24.
5. Kottner J, Balzer K, Dassen T, Heinze S. Pressure ulcers: a critical review of definitions and classifications. Ostomy Wound Manage. 2009;55:22–29.
6. Agency for Healthcare Research and Quality. Interdisciplinary, comprehensive skin care program significantly reduces hospital-acquired pressure ulcers. Available at:www.innovations.ahrq.gov/content.aspx?id=2326. Accessed July 24, 2012.
7. Niederhauser A, VanDeusen Lukas C, Parker V, Ayello EA, Zulkowski K, Berlowitz D. Comprehensive programs for preventing pressure ulcers: a review of the literature. Adv Skin Wound Care. 2012;25(4):167–188.