Avoidable vs. Unavoidable Pressure Ulcers: A Summary of the Federal Regulations

Pressure sores, also known as pressure ulcers and bed sores, develop in the elderly and infirm when range of motion is restricted and limited. Pressure sores can be devastating injuries, and are frequently the subject of litigation against nursing homes and hospitals. In most circumstances, a well developed plan of care can avoid these complications. This article discusses when pressure sores are deemed preventable under Federal Regulations.

This article was published in Medical Malpractice Law and Strategy  in September 2013.
Two Congressional acts - the Omnibus Budget Reconciliation Act of 1987 and the Balanced Budget Act of 1997- resulted in the promulgation of regulations that have had a significant impact on nursing home practices. Some commentators have concluded that these regulations have essentially created the standard of care in nursing home negligence cases. David R. Thomas, MD, The New F-tag 314: Prevention and Management of Pressure Ulcers, ]ournal of the American Medical Directors Association (JAMDA), 523-531 (2006).

In addition to the federal regulations adopted pursuant to these acts, Appendix PP of the Long Term Care Survey published by the American Health Care Association (AHCA) contains interpretive guidelines of nursing home regulations issued by the Center for Medicare and Medicaid Services (CMS). These guidelines, commonly referred to as "F-tags," are used by the government, long term care facilities and colleges and universities for training purposes. Long Term Care Survey, AHCA, "About This Manual," (2012). F-tags provide further information about accepted standards of care applicable to nursing homes.

And the Centers for Medicare and Medicaid Services requires nursing homes to prevent avoidable pressure sores. According to 42 CFR 483.25(c)(l), after a comprehensive assessment, a nursing home must ensure that "a resident who enters the facility without pressure sores does not develop pressure sores unless the individual's clinical condition demonstrates that they were unavoidable." Id.

The Attorney’s Role

Because these various guidelines and regulations exist, attorneys representing residents who develop pressure sores while admitted to nursing homes must be familiar with them so that they can distinguish avoidable from unavoidable pressure sores.

Since liability cannot be established if a pressure sore was unavoidable this knowledge is a prerequisite to screening these cases. Additionally, because the focal point of the debate between the plaintiff and defense experts in these cases is usually whether a pressure sore was unavoidable a thorough understanding of the regulations is helpful for deposing and cross-examining experts.

Avoidable or Not?

What are the criteria for deciphering whether a pressure sore is avoidable? "Avoidable" means that the nursing home resident developed a pressure ulcer and that the facility did not do one or more of the following: evaluate the resident's clinical condition and pressure ulcer risk factors; define and implement interventions that are consistent with resident needs, resident goals, and recognized standards of practice; monitor and evaluate the impact of the interventions; or revise the interventions as appropriate. Long Term  Care Survey, AHCA, Appendix PP FTag 314, pg. 230-231 (2012).

The Initial Evaluation

If a nursing home fails to identify a resident's risk factors, any pressure sore developing during that patient's admission will be deemed avoidable and, consequently, a breach of accepted standards of care. A nursing home must identify residents at risk for the development of pressure sores during the resident's initial assessment because "a resident at risk can develop a pressure ulcer within two to six hours of the onset of pressure." Id. pg. 326.

Conditions that increase the likelihood that a nursing home resident will develop pressure ulcers include: Impaired and decreased mobility and functional ability; including end-stage renal disease, thyroid disease and diabetes mellitus; Impaired diffuse or localized blood flow from conditions like arthrosclerosis or lower extremity arterial insufficiency; Resident refusal of some aspects of treatment, Cognitive impairment; Skin exposure to fecal and urinary incontinence; and A previous history of a healed pressure ulcer. Id. pg. 238

Pressure sore prevention is not just a nursing challenge. A comprehensive interdisciplinaty approach is needed to assess and monitor nursing home residents. Pressure Ulcers in the Long-Term Care Setting: Clinical Practice Guideline. American Medical Directors Association, pg. 2 (2008).

Nutritional Needs

A comprehensive initial assessment of a resident must also address the possibility of under-nutrition and hydration deficits. Id. Nursing homes are required by 42 CFR 483.250)(1) to conduct a comprehensive assessment to ensure that a resident "maintains acceptable parameters of nutritional status such as body weight and protein levels." Under 42 CFR 483.25(j), nursing homes must provide residents with sufficient fluid intake to maintain proper hydration and health. Before implementing a nutrition plan, however, a nursing home must assess a resident's nutritional status and determine: 1) the severity of any existing nutritional compromise; 2) the rate of weight loss and/or appetite decline of a resident; and 3) the probable causes of these things. Long Term Care Survey, AHCA, Appendix :p F-Tag 314, pg. 241 (2012). Finally, current standards of practice recommend weighing the resident on admission or readmission (to establish baseline weight)." Long Term Care Survey, supra, F-Tag 325, pg. 416.

If a resident is found to be nutritionally compromised on admission, and at risk for developing a pressure sore, a nursing home's nutrition plan should allow for protein intake of approximately 1.2-1.5 grams per kilogram of body weight. Id. at 241. Hydration deficits also have to be addressed in patients who are at risk for developing pressure sores. Id. at 242. The failure to maintain acceptable parameters of a resident's nutritional status after admission to a nursing home is a breach of accepted standards of care if that failure was avoidable. The criterion for determining an avoidable breach of acceptable parameters of a resident's nutritional status is as follows: "Avoidable means the resident did not maintain acceptable parameters of nutritional status and that the facility did not do one or more of the following: evaluate the resident's clinical condition and nutritional risk factors; define and implement interventions that are consistent with resident needs, resident goals and recognized standards of practice; monitor and evaluate the impact of the interventions; or revise the interventions as appropriate." Long Term Care Survey, supra, F-Tag 325, pg. 412.

Accepted standards of care require nursing home residents to be weighed weekly for the first four weeks during a nursing home admission, and monthly thereafter. Long Term Care Survey, supra, F-Tag 325, pg. 416. A weight loss of 5% of body weight in one month is significant, and a weight loss in a resident greater than 5% in one month is a severe weight loss. Id. at 421. Monitoring the dietary aspects of care plan is necessary for residents with impaired or at-risk nutritional status. Id. at 431. Monitoring efforts must include identifying and reporting information about a resident's nutritional status. Id. If a resident's nutritional needs are not being met, the use of nutritional supplements should be considered. Id. at 429.

Skin Condition

In addition to monitoring a resident's dietary needs and compliance with a nutrition plan, nursing homes must monitor a patient's skin condition at least daily, and all changes in
a resident's skin must be documented. Long Term Care Survey, supra, FTag 314, pg. 248.

Relieving Pressure

If an initial nursing home assessment establishes that a resident is at risk for developing pressure sores, accepted standards of care require the facility to implement a repositioning plan. If an at-risk resident is able to change positions independently, accepted standards of care require a nursing home: 1) to provide any assistive devices necessary; 2) to educate the resident about why repositioning is necessary and how to do this; 3) to encourage the resident to change positions regularly; and 4) to monitor the resident's frequency of repositioning. Long Term Care Survey, supra, F-Tag 314, pg. 245.

Alternatively, if a resident is dependent on staff for repositioning, the nursing home staff must implement a plan that repositions that patient at least every two hours, but more frequently if it appears that this is insufficient to protect a patient's skin integrity. Id. Static pressure redistribution devices in the form of a foam or gel mattress may be required if this will reduce the risk of developing a pressure ulcer. Id. at 247. Finally, accepted standards of care may require a nursing home to elevate a patient's heels and elbows to avoid pressure sores in at-risk patients. Id.

Conclusion

Understanding the regulatory framework relative to the prevention of pressure sores enables attorneys to discern whether their client's clinical condition on admission to a
nursing home increased the risk of the development of a pressure sore. Attorneys armed with the relevant regulations and F-Tags can then determine whether a nursing home appropriately anticipated a potential pressure sore problem and whether it developed an appropriate plan of care to prevent the development of skin breakdown. Finally, knowledge of the federal regulations and interpretive guidelines aids in determining whether medical personnel properly monitored a patient and intervened to revise the patient's care plan in response to a developing problem.