Pressure Ulcers in Nursing Homes: Does Negligence Litigation Exceed Available Evidence?

   It's official. A crisis exists in nursing homes, fueled by critical staffing shortages that a recent General Accounting Office (GAO) report indicates are expected to become more serious as the population ages and the demand for nursing services increases.¹ Additionally, bankruptcies among skilled nursing facilities numbered around 2,000 in 1999 alone. According to the President of the American Health Care Association, this "…is just the tip of the iceberg."²

   Patient safety concerns were triggered following the release of the Institute of Medicine's 1999 report "To Err is Human: Building a Safer Health System."³ A recent Congressional investigation demonstrated that nearly 9,000 citations of abuse were issued over 2 years among the nation's 17,000 nursing homes starting in 1999.⁴ Among the abuses identified were "untreated bedsores."

   The lack of clarity regarding the natural history of pressure ulcers has led to the "criminalization" of this event, reported to be as high as 23% in skilled nursing care facilities and nursing homes.⁵ The occurrence of a pressure ulcer in a nursing home can trigger investigations of negligence, citations, fines, and accusations of abuse.

   Pressure ulcer litigation is a growing concern for nursing homes. The incidence of a pressure ulcer alone is used as defacto evidence of neglect on the part of a nursing home. These cases rely on disparate medical records from all treating facilities, testimony of employees of record (when available), and the interpretation of events by expert witnesses. A neat linear format is created by this attenuated reconstruction of events. However, a confluence of factors can lead to the occurrence of a pressure ulcer. Additionally, limited evidence is available regarding the effectiveness of specific prevention strategies. Knowing the outcome in a case being litigated, plus the limitations described above, weakens one's ability to objectively judge whether reasonable prevention strategies were employed in a timely manner or even whether prevention was possible.

   Pressure ulcers are a phenomenon, not a disease or even a discrete medical condition. Pressure ulcers - skin breakdown that occurs entirely as a result of exposure to a toxic combination of physical forces, such as pressure and shear - are more accurately described as an injury as used by the Institute of Medicine (IOM).³ Experienced clinicians know that this type of pressure ulcer is the exception rather than the rule. Instead, the incidence of pressure ulcers in nursing homes is more accurately described as an event, often associated with medically complicated residents who usually are frail and immobilized. Clinicians must continue efforts to understand pressure ulcers, learn which can be avoided, and find better ways to treat them. Criminalizing this event will never provide an environment that encourages funding of the basic research needed to comprehensively understand their natural history nor will it help people at risk for developing pressure ulcers or those responsible for patient care.

The Current Nursing Homes Oversight Environment

   The nursing home industry ranks high on the list of the most regulated industries by both state and federal oversight agencies. The federal government is a major stakeholder in the nursing home industry. In the year 2000, the federal government paid nursing homes an estimated $39 billion.⁶ Through the Centers for Medicare and Medicaid Services (CMS), the federal government performs an increasingly coordinated oversight role.
A heightened focus on improving systems to monitor, correct, and punish nursing homes that do not meet acceptable standards of care followed the release of the IOM report Improving the Quality of Care in Nursing Homes.⁷ The report outlined systemic elements of abuse and neglect throughout the nursing home industry. The end result of IOM assessment of the state of nursing home care was the 1987 Omnibus Budget Reconciliation Act (OBRA-87) (42 U.S.C. // 1320a et seq. and 42 U.S.C. //1396 et seq. as amended). The seminal aspect of this legislation is that federal standards were established by which every Medicare-certified nursing home would from that time be measured.

   Federal regulations mandate approximately 185 quality standards.⁸ The CMS, in July of 1999, instituted a program of measuring "quality indicators" that assess individual nursing home performance on 24 care dimensions.⁶ The United States Congress, following the creation of several initiatives designed to improve the quality of nursing homes, approved the expansion of the Medicare survey and certification budget by $8 million in 1999 and by $23.5 million in 2000.⁶ Among the initiatives were several organizational improvements made to the process of handling and responding to complaints from virtually anyone wishing to report an event or observation made within a nursing home. Additionally, reports that detail the findings of the annual surveys are available through the CMS On-Line Survey Certification and Reporting (OSCAR) system database.

   In 1997, the IOM again convened an expert committee that examined the "...means for assessing, overseeing, and improving the quality of long-term care..."⁹ The report, released in 1999, provided recommendations for federal and state policymakers to improve their regulations and standards used for measuring nursing home quality.

   The National Citizens Coalition for Nursing Home Reform (NCCNHR), an advocacy group founded in 1975, gives voice to a broad band of local groups and individuals interested in participating in the process of improving the care provided in nursing homes nationwide. This group provides a wide range of services to the public, including recommendations ranging from selecting a nursing home for a loved one to information about current restraint laws. Additionally, this group provides testimony to Congressional Committees, comments on regulatory drafts produced by CMS, and coordinates collective feedback to the federal government on proposed changes that would effect the nursing home industry.

   Additionally, under the federal Older Americans Act, each state must provide an Ombudsman Program. The role of an Ombudsman is to function as an advocate for nursing home residents and their families. This service is available to anyone who wishes to register a complaint or just receive advice about issues related to nursing home care.

   The creation of federally mandated regulations has provided plaintiff attorneys a mechanism for demonstrating negligence when the requirements set forth by OBRA-87 were arguably not met by a nursing home. As was demonstrated by Bennett et al¹⁰ in a review of voluntarily reported databases of pressure ulcer related litigation, the number of lawsuits filed after OBRA-87 increased. Bennett found that the median number of suits related to pressure ulcers filed after the publication of the OBRA-87 regulations in 1992 was nearly 10 times more than was reported for the same number of years (5) before the passage of OBRA-87. Bennett further reported that 38% (n = 66) of cases reviewed were filed against nursing homes.¹⁰

The Judicial Role in Ensuring Nursing Home Quality

   Despite the federal, state, and advocacy mechanisms in place to continuously monitor and maintain quality in nursing homes, the judicial arm of state governments participate in the process of nursing home oversight through the mechanism of negligence lawsuits.

   Historically, plaintiff firms did not view nursing home residents (or more likely, their appointed personal representatives) as viable clients. The reasoning was that the advanced age and deteriorating health status of nursing home residents does not usually create an economic loss to surviving family members; therefore, financial compensation was unlikely. However, several factors have now converged, making the possibility of recovering punitive damages much more likely. The attention the media has given to cases of nursing home abuse infuses in the public a generalized distrust of long-term care facilities. Additionally, CMS has focused on establishing more and better scrutiny of the performance of nursing homes. Also, a general lack of knowledge about aging and some of the related physical consequences exists among consumers, fostering unrealistic expectations for functional improvement of family members placed in nursing homes. Punitive damages are possible in an environment where unrealistic expectations, distrust, and lack of knowledge flourish.

   To recover punitive damages, negligence must first be proven and then that the nursing home's conduct was such that it warrants punishment. The requirements for this level of conduct vary according to each state's laws. The nursing home's conduct does not have to be demonstrated as intentional - rather, a pattern of "bad care" or misconduct can be used as evidence. Juries hearing cases requesting punitive damages may be presented with evidence relating to the nursing home's finances and income before deciding the amount of award.

   In order to establish negligence, plaintiff attorneys frequently cite OBRA-87 and the federal regulations 42 C.F.R. Part 483 // 1-75; 483/150-158; and 483 //400-480; Part 483.1(b) Scope. The overarching purpose of the Act and the associated federal regulations was to establish the guidelines and criteria that skilled nursing facilities and nursing facilities must meet in order to participate in Medicare and Medicaid and receive payment for services. More than 86% of nursing homes are Medicare certified.⁶ In negligence cases, OBRA-87 is used to establish a standard of care, against which any failure on the part of the nursing home to comply with all provisions is negligence per se. OBRA-87 and associated state regulations set out 15 broad categories such as resident rights, dietary services, and quality of life. They do not address individual resident needs, conditions, or wishes; therefore, the categories do not adapt well as a tool for judging specific patient experiences. The regulations that can be related to pressure ulcers do not effectively capture the nuances of functional status of patients who are often in transition from a completely healthy status to one of decline.

   An often cited nursing home care standard is that each client will achieve and maintain the "highest level of functioning" possible. Perhaps, more than any other factor, the language of this standard is responsible for encouraging unrealistic expectations on the part of the families of residents placed in nursing homes. A recent retrospective review of at-risk elderly patients sought to link pressure ulcer prevention processes utilized with the incidence of pressure ulcers. That study failed to "significantly associate prevention strategies with the decreased incidence of pressure ulcers...."¹⁶ The authors of the study commented that the results "...illustrate the multivariate nature of pressure ulcer development."¹¹

   Litigation involving alleged acts of medical malpractice and negligence in nursing homes can be conceptualized as another instrument or tool for ensuring good quality of care for the frail elderly residing in nursing homes. As a tool, this kind of litigation must be classified as a deterrent, costing guilty providers time, money, and reputation. This deterrent is used as recourse for events or injuries that have already occurred. Its strength as a deterrent depends entirely on its effectiveness in preventing future lapses in the provision of the highest quality of care possible. If serial prevalence numbers are any indication, that deterrent effect has failed. A weakness of this tool is its reliance on standards related to pressure ulcers that do not encompass an adequate description of "unavoidable."

   Implementation of OBRA-87 and the release of the Clinical Practice Guideline "Pressure Ulcers in Adults: Prediction and Prevention"¹² published by the American Geriatric Society, have impacted the nature and probably the frequency of lawsuits filed that allege negligence related to pressure ulcers. OBRA-87 requires that, "Based on the comprehensive assessment of a resident, the facility must ensure that (1)[a] resident who enters the facility without a pressure sore does not develop pressure sores unless the individual's clinical condition demonstrates that they were unavoidable; and (2)[a] resident having pressure sores receives necessary treatment and services to promote healing, prevent infection, and prevent new sores from developing."¹³ Not surprisingly, this language has fostered an increased interest on the part of plaintiff attorneys to pursue cases involving residents who developed pressure ulcers.

   The federal guidelines most often cited in pressure ulcer litigation cases are the two related Clinical Practice Guidelines produced by the Agency of Healthcare Research and Quality (AHRQ): Pressure Ulcers in Adults: Prediction and Prevention and Treatment of Pressure Ulcers.^5,14 Worth noting: of the 85 recommendations offered in the Treatment guideline, 73 or 87% are "C" rated. Similarly in the Prevention guideline, 21 of 26 or 81% are "C" rated. The rating of "C" for a AHRQ guideline recommendation is defined as follows: "This rating requires one or more of the following: (1) results of one controlled trial; (2) results of at least two case series/descriptive studies on pressure ulcers in humans; or (3) expert opinion."⁵ In the overview of the Treatment guideline, the authors indicate, "The intent of the panel was to recommend those interventions that were supported by at least one controlled trial. In reality, many well-established clinical practices have never been investigated experimentally."⁵ Not much has changed in the intervening years. In a recent review of the validity of the AHRQ guidelines, both pressure ulcer-related guidelines were judged to be "still valid."¹⁵ This may be interpreted as indicating that the guidelines have stood the test of time. However, review of the methodology for establishing that the guidelines were "still valid" reveals that this determination was made when neither the original contributors to the guidelines nor intervening published clinical research has advanced the science of pressure ulcer detection, prevention, or management. In the case of pressure ulcer science, today's standards reflect well-established clinical practices, not research, and not sensitivity to the combined impact of aging, illness, and wide range of quality-of-life priorities.

The Dilemma

   First, recognizing the nebulous nature of pressure ulcers is imperative. Bedsore is a term loaded with implied causal connotations. Generically, pressure ulcer refers to a group of untoward events associated with skin breakdown over bony prominences. In fact, bedsores or decubitus or pressure ulcers, as they are interchangeably called, are minimally defined. Currently, the term pressure ulcer can be applied to any cutaneous wound that was exposed to some undetermined amount and combination of physical factors, including pressure, shear, friction, and moisture. Unfortunately, that has meant that some wounds more appropriately ascribed to other categories such as vascular, arterial, or neuropathic ulcers fit the definition of a pressure ulcer and are documented as such. In terms of liability and charges of negligence, that lack of distinction and clarity has, and will continue to have, far-reaching consequences.

   One far-reaching but perhaps underrated consequence of successfully litigated pressure ulcer-related negligence suits is the impact they have on insurance costs to providers - a cost ultimately passed onto consumers. The Washington Times¹⁶ recently reported that insurance premiums for nursing homes are on the rise, with some insurance companies now declining coverage to nursing homes. The report attributed the rise in premiums to the high cost of negligence claims, with an estimated 21% of claims exceeding $500,000, according to a study completed by Aon Risk Consultant Inc.¹⁶

   Pressure ulcer prevalence serves as a quality indicator, a screening device that accomplishes a quick, nonspecific assessment of a particular setting. This, along with the many policies and standards written and disseminated to reduce their prevalence, is intended to protect the most vulnerable sector of the population, the frail elderly. However, both are blunt instruments. Although the overall reduction of the prevalence of pressure ulcers is a worthwhile and probably achievable goal, it will not be accomplished without a complete reevaluation of the multifaceted nature of this phenomenon.

   The level of veracity for many of the commonly held recommendations related to pressure ulcers (ie, turn patients every 2 hours) has not been consistently borne out by controlled clinical trials. Because many treatments associated with pressure ulcers are so ingrained into the standards of care, randomized clinical trials are difficult to construct and implement for fear of denying patients basic levels of care.

   Assumptions related to the incidence of pressure ulcers are continually being codified by oversight agencies. The American Health Care Association (AHCA) reported recently that CMS, through contractors at the American Institutes for Research (AIR), is developing guidance for nursing home surveyors intended to sharpen their ability to identify the specific scope and severity levels of noncompliance. Pressure ulcers were included as an example of a "critical observation" that point surveyors to possible deficiencies.¹⁷ Pressure ulcers have become inextricably linked to poor quality of care. Studies have associated the presence of pressure ulcers with less than optimal staffing levels.¹⁸ The Centers for Medicare and Medicaid Services has identified pressure ulcers as a quality indicator, deeming only those wounds that have a documented pattern of failed interventions to be considered "unavoidable." The impact of these regulatory perspectives is to give credence to the position that nearly all pressure ulcers are avoidable and that under all circumstances they represent a noxious outcome. That the development of this type of wound can be categorized as neglect simply in the absence of success for some ill-defined progression of interventions belies the "...multivariate nature of pressure ulcer development."¹¹

Pressure Ulcers: Avoidable or Unavoidable?

   This seemingly simple question has been addressed in multiple forums¹⁹ without any defining conclusions that support the establishment of two clear and concise categories of ulcers - those that could have been avoided and those that could not. Further, although rarely stated, both pressure ulcer-related AHRQ practice guidelines caution generalizing the recommendations offered to all patients. "The recommendations may not be appropriate for use in all circumstances. Decisions to adopt any particular recommendation must be made by the practitioner in light of available resources and circumstances presented by individual patients."^5,14
As the nursing home industry continues to experience continued and growing demand for its services and the pool of qualified providers shrinks, practical answers to the question of causality will demand answers. The AHRQ's pressure ulcer prevention clinical practice guideline acknowledged that prevention measures can be costly and therefore recommends targeting at-risk patients only. Further, the guideline indicates that a Stage I ulcer need not progress to the deeper layers of tissue.¹⁴ Implicit in both those statements are two critical assumptions. The first is that clinicians have the ability to consistently predict who will develop a pressure ulcer and when; the second is that all pressure ulcers progress from a Stage I to Stage IV. Regarding the first assumption, understanding that, to date, no diagnostic tool(s) exists for clinicians to prospectively identify patients with an impaired ability to mount normal responses to the mechanical forces implicated in pressure ulcer development is important. Individual patient tolerance to mechanical forces (much like vital signs) varies and is influenced by exposure to and number of stresses exerted. The expectation of a favorable outcome for early intervention or prevention is contingent not only on the timeliness of treatment, but also on the individual patient's ability to initiate physiological repair responses. The second assumption of the guideline statement regarding the progression of pressure ulcers probably evolved as an unintended consequence of standard staging nomenclature. Staging systems were originally designed to establish a uniform means of communicating the character and anatomical structures affected by a pressure ulcer. In 1989, the National Pressure Ulcer Advisory Panel (NPUAP) sponsored a Consensus Development Conference from which a sequential format of describing pressure ulcers from Stage I through Stage IV emerged. An inexact interpretation of the staging system concluded that the sequence referred to the wound's progression rather than a simple description of the type of tissue affected. This has facilitated ascribing negligence in cases where pressure ulcer documentation records an increase in stage over time. Staging a wound is completely dependent upon visual observation. Damage to deeper tissues, as would be expected in cases involving shearing forces and/or diminished blood flow, cannot be observed. In these wounds, the outer skin layer is breached only in the late phases of the wound's development. Determining the full extent of the wound is possible only after either a sinus tract appears that formed to release exudates created in a deep tissue abscess or the skin becomes necrotic following an interruption in blood flow resulting from damaged deeper tissue.

   Pressure ulcers do not occur in a vacuum. They arise as a result of several factors, both patient- and provider-centered. Knowledge of environmental factors or the physical forces that participate in the formation of pressure ulcers has been well documented in the current standards of care. What is lacking is an understanding of how the complexity and variability of individual patient conditions can be accounted for in the assessment of pressure ulcer risk and the likelihood that they can be avoided.

  Pressure ulcers have evolved to the status of marker or red flag, signaling a need that adjustments to the system may be required. However, they also may be a marker for patients with diminishing reserves, incapable of mounting a "normal" response when exposed to physical forces. Using diminishing reserves as a marker for "unavoidable" ulcers requires knowing the exact combination of clinical values that will consistently result in a patient's inability to avoid damage from the same physical forces tolerated the week before, or even perhaps, the day before. Contributing factors and the confluence of circumstances that cause breakdown on individual patients are not always immediately evident nor are they generally documented.

   Consideration must be given to the observation that nursing home residents have a continually increasing statistical likelihood of developing pressure ulcers the longer they remain in a nursing home.²⁰ Is it reasonable to assume that care standards diminish over that period, or is causality more subtle, related to a resident's eroding capacity to respond to the environment?

What Can Providers Do Today?

   To suggest better documentation, increased staffing ratios, more rigorous continuing education at all provider levels, as well as nonstop lobbying for research funding is tempting. All of these and more have been suggested before, with little systemic change to the industry. Instead, a change in perspective may offer real hope for advancement. Consider the occasional adjustments made naturally in the stock market that serve to maintain a realistic relationship between stock prices and their value. Using the analogy of the stock market, a new perspective (or price) of the known causal trajectory of pressure ulcers and the assignment of culpability (value) placed on providers could dramatically change pressure ulcer dialogue. Clinicians must be able to prospectively answer the question of when ulcers are unavoidable.

   The AHRQ clinical guidelines for pressure ulcers, at the time of their development and again following their more recent review,¹⁵ demonstrated a startling lack of rigorous research to support the recommendations. Despite this, the CMS, and individual state regulators, have designated pressure ulcers as a generic quality indicator. Although regulatory language generally allows for the "unavoidable" pressure ulcer, that category of wound is defined retrospectively through the documentation of a sequenced set of failed interventions. In an expanding marketplace already reporting scarce resources, regulations that demand untargeted use of those resources can only create conflict.

   Providers of nursing home care today who perform due diligence by successfully coordinating all the interdependent aspects that define quality care for their charges can forge the way toward a better understanding of the circumstances under which pressure ulcers cannot be avoided. Currently, conventional wisdom states that thorough documentation of pressure ulcers involves recording appearance, size, and characteristics. Many nursing homes have established protocols that require photographs, at some given frequency, of these wounds. Most available pressure ulcer risk tools summarize a patient's general mental condition, activity/mobility level, and continence status. These certainly provide a basis for patient-centered factors but do not begin to capture the complexity of how those factors and more combine to confound efforts to prevent the occurrence or worsening of pressure ulcers. A dramatic shift in focus is needed to expand the scope of record to capture patient-centered as well as environmental factors. Documentation that puts pressure ulcer-related factors into the context of the individual patient, instead of focusing all efforts on describing the appearance of wounds, would provide reviewers a record that reflects the environment and conditions under which a pressure ulcer occurred.

   Another readily accessible but underutilized approach to avoiding accusations of negligence related to pressure ulcers is to involve family members as partners in care. Simply reporting untoward events after they occur will never foster a sense of trust among family members. Instead, the status or appearance of an existing or developing wound should be freely discussed. Available options and their consequences for the resident should be continually reviewed with family members. Allow the family the opportunity to see the damage and answer questions regarding treatment options and consequences.
Finally, nursing home providers, caregivers, and citizen groups must play an active role in demanding that funding sources be directed to this issue. In the zeal to protect nursing home residents, inference and habit have dictated regulatory policy. Only through a rigorous and strategically directed set of research efforts will clinicians advance the science of pressure ulcers so that scarce resources can be more effectively utilized.

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13. 42 C.F.R. Code of Federal Regulations/483.25(1998).

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20. Brandeis GH, Morris JN, Nash DJ, Lipsitz LA. The epidemiology and natural history of pressure sores in elderly nursing home residents. JAMA. 1990;264:2905-2909.