Senior living providers face unrelenting challenges—a burdensome regulatory environment, financial sustainability, COVID-19 preparedness, quality and safety performance, complex legal issues, and a workforce that is more stressed and vulnerable than ever before. Read on to learn how a deep dive into the medical records may have saved this LTC facility millions in CMS fines.

CMS Compliance

The Centers for Medicare and Medicaid Services (CMS) has indicated that now more than ever, they are taking necessary steps to ensure long-term care facilities are adequately meeting the needs of their residents through ongoing, focused site surveys. The stated purpose of a CMS survey of a skilled nursing facility (SNF) is to ensure that the SNF is in substantial compliance with Medicare’s Requirements of Participation. This is to presumably increase the likelihood of improved resident outcomes and quality of life. Substantial compliance is assessed when there are no conditions present that could cause more than minimal harm or actual harm to any resident.

CMS Immediate Jeopardy

When non-compliance exists, CMS has the authority to impose one or several enforcement remedies. These may include a Civil Money Penalty (CMP); denial of payment for new admissions, a targeted plan of correction, and/or termination from Medicare and Medicaid programs. According to CMS Memo #17-37-NH on CMPs, the remedies are “intended to promote a swift return to substantial compliance for a sustained period of time, preventing future non-compliance.”

When CMS deems a CMP is appropriate, they make a determination between a Per Day and Per Instance assessment. Per Day CMP is used to address non-compliance when a resident suffers actual serious harm at the immediate jeopardy (IJ) level, a resident was abused, or the facility had persistent deficient practices violating federal regulations. CMP assessments are not only impacted by the type of non-compliance. Factors such as the date the facility was determined to be out of compliance also affect assessments. Immediate jeopardy assessments often involve CMPs above 1 million dollars. When assessed, they significantly impact the already limited resources a long-term care facility needs to deliver quality resident care.

It goes without saying that long-term care facilities should be held accountable for providing substandard care to their residents. It is arguable, though, that the CMS survey process itself needs improvement. In our experience, however, many times, issues arise when the medical record documentation falls short and fails to substantiate the comprehensive and compassionate care rendered by the nursing home staff. In these instances, facilities are not only at risk for substantial sanctions from CMS but significant liability claims as well.

Med Law Case Study

We present a case in which our client, a mid-sized regional skilled nursing facility, faced an Immediate Jeopardy assessment by CMS related to wound care provided to one of their long-term residents over a ten-month period. Defense counsel for the SNF reached out to Med Law when the survey team was onsite, requesting an emergency medical record review to help defend the assessment and mitigate damages. Working alongside the Director of Informatics and VP of Clinical Operations for the facility, the Med Law team had remote access to the facility’s electronic medical record (EMR) within 2 hours. Over the next few days, Med Law nurse consultants diligently reviewed clinical documentation surrounding the resident’s 13 wounds, working with nursing administration to fill in the noteworthy documentation gaps.

Within days of initiating the review, Med Law consultants determined:

• The facility properly and thoroughly assessed and reassessed the resident’s risk of skin breakdown with rare exceptions.
• A comprehensive, person-centered care plan to address the resident’s risk for skin breakdown and actual pressure injuries was developed. Care plan updates and revisions were ongoing.
• Supportive interventions to promote healing of the resident’s existing wounds and prevent new wounds were noted throughout the record.
• Wound consultant notes, found outside the EMR, provided supportive evidence the resident’s physicians were closely monitoring his wounds and directing wound care.

Review Results

As a result of the collaborative efforts between the Med Law consultants and facility nursing administration, the teams identified significant documentation that supported proper care and treatment of the resident’s wounds for most of the original period of non-compliance. Unfortunately, issues remained regarding a lack of documentation to substantiate provider notification of symptoms consistent with wound infection for six days. The resident’s physician became aware of the wound changes during a follow-up wound evaluation. These findings were submitted to the CMS survey team for consideration in the Immediate Jeopardy assessment. The final calculation of CMPs was pending at the time of this post; however, given the duration of the initial period of non-compliance, the review findings likely saved the facility hundreds, if not millions of dollars in penalties.

Strong record-keeping equals a strong defense in regulatory and medical-legal matters. Accurate and clear documentation in the medical record supports the staff’s attempts to provide comprehensive, person-centered care to patients and residents. Given the intense regulatory oversight and volatile nature of litigation in the senior-care environment, it’s more important than ever that staff understand the importance of memorializing resident assessments and the overall care rendered in the medical records.

How Med Law Advisory Partners Can Help

Med Law Advisory Partners can help LTC organizations implement action plans to help mitigate risk for and effectively respond to regulatory assessments and liability claims. Our LTC Defense Preparedness Program identifies weaknesses in record-keeping systems and outlines ways to improve processes and defend standard of care claims.

If you would like more information on how our team can help your organization, we’d love to hear from you. Contact us to schedule a conversation. 

Founded by Alicia Davis, RN, LNCC, Med Law Advisory Partners (and former ALN Consulting) provides resources and expertise in the areas of safe opioid prescribing, medical malpractice, and post-acute care litigation, including COVID-19 claims. Alicia and her team have worked with government entities, healthcare systems, insurers, and senior-living operators for nearly 20 years, helping mitigate risk and manage medical-legal and healthcare fraud claims.

Originally published March 8, 2021. 

2016

In April 2016, the National Pressure Ulcer Advisory Panel or NPUAP announced a change in the terminology and the stages of pressure injuries. Though these stages continue to include both unstageable pressure injuries and deep tissue pressure injuries the new definitions do not specifically mention the Kennedy Terminal Ulcer. Over the years, however, multiple panels and advisory groups have documented the Kennedy Ulcer as an end of life phenomenon.

The unavoidable skin breakdown that occurs as part of the dying process, known as a Kennedy Ulcer, has been recognized by Ostomy Wound Management since a 2009 journal article. Also in 2009, an expert panel released a consensus statement known as SCALE or Skin Changes At Life’s End which identified skin organ compromise occurring at the end of life. The panel recognized that the ulcer is usually seen on the coccyx or sacrum but has been reported in other anatomical areas and is usually associated with imminent death.

This special classification was also mentioned by the Center for Medicare and Medicaid Services (CMS) in 2014 within its Quality Reporting Program Manual and its Continuity Assessment Record and Evaluations Data Set (CARE) for long-term care hospitals. The “Coding Tips” of the publication noted if an ulcer was part of the dying process, developing from six weeks to two to three days before death, it should not be coded as a pressure ulcer.

Click here for the full detailed staging guidelines.

ALN Consulting will continue to stay on top of these and other developments. Contact ALN Consulting if you have questions about a case and would like an initial consultation.

A thorough understanding of the development and treatment of pressure ulcers is critical when defending against these medical malpractice cases. Attorneys must stay up-to-date with the latest definitions, risk factors, and stages of pressure ulcers to help address the complicated claims in these cases. Studying the prevention and treatment of pressure ulcers allows for the strongest defense to be made. Pressure ulcer cases are rarely straightforward. Growing debate around the avoidability of pressure ulcers gives more room for defense teams to make defensible claims.

This portion originally published on November 18, 2015:

What is a Decubitus or Pressure Ulcer?

The term decubitus ulcer (from Latin decumbere, “to lie down”), pressure sore, bed sore, and pressure ulcer are often used interchangeably among patients, family, and medical staff. As the root of the name suggests, these ulcers occur at sites overlying bony structures that sustain more pressure when the person is recumbent. The National Pressure Ulcer Advisory Panel (NPUAP) and the most up to date literature refer to these type of ulcers as pressure ulcers, or an area of unrelieved pressure over a defined area, usually over a bony prominence, resulting in ischemia, cell death, and tissue necrosis.

Risk Factors for Pressure Ulcers

In a Long Term Care (LTC) setting surveyors follow the guidelines of F-tag #F314 which states that an admission assessment must be performed, along with an identification of patients who are at risk for pressure ulcers. There is no one formal risk assessment tool recommended, but many facilities use the Norton or Braden scales. Risk factors mentioned in #F314 include, but are not limited to:

• Impaired/decreased mobility and decreased functional ability;
• Co-morbid conditions, such as end stage renal disease, thyroid disease or diabetes;
• Drugs such as steroids that may affect wound healing;
• Impaired diffuse or localized blood flow;
• Resident refusal of some aspects of care and treatment;
• Cognitive impairment;
• Exposure of skin to urinary and fecal incontinence;
• Under nutrition, malnutrition, and hydration deficits;
• A healed ulcer. The history of a healed pressure ulcer and its stage (if known) is important since areas of healed Stage III and IV pressure ulcers are more likely to have recurrent skin breakdown; and
• Diabetic neuropathy, frailty, cognitive impairment.

Regardless of any individual’s risk score, the nursing staff is responsible for the creation of a resident specific care plan that addresses each risk factor and the extent to which the factors can be modified, stabilized or removed.

Staging of Pressure Ulcers

An important facet of caring for a patient with pressure ulcers is assessment and re-assessment of the stage, size, and appearance. If a pressure ulcer exists upon admission, or develops during residency, the stage of the ulcer should be documented. Nursing staff should not use the following staging system for ulcers that are not a result of pressure, such as ulcers and wounds called arterial ulcers (the result of blockage in the arteries with inadequate blood flow to the limbs), venous insufficiency ulcers (known as “stasis ulcers”), and diabetic ulcers. These ulcers should be documented, reported to the physician, and monitored, but not staged using the NPUAP International Classification System. For use along with the below NPUAP definitions of each stage, artistic renditions of the skin layers of these stages, as well as pictures for reference can be found at: http://www.npuap.org/wp-content/uploads/2014/08/Updated-10-16-14-Quick-Reference-Guide-DIGITAL-NPUAP-EPUAP-PPPIA-16Oct2014.pdf

Stage I: Nonblanchable Erythema: Intact skin with non-blanchable redness of a localized area usually over a bony prominence. Darkly pigmented skin many not have visible blanching; its color may differ from the surrounding area.

The area may be painful, firm, soft, warmer or cooler as compared to adjacent tissue. Stage I may be difficult to detect in individuals with dark skin tones. May indicate “at risk” individuals (a heralding sign of risk).

Stage II: Partial Thickness Skin Loss: Partial thickness loss of dermis presenting as a shallow open ulcer with a red pink wound bed, without slough. May also present as an intact or open/ruptured serum-filled blister.

Presents as a shiny or dry shallow ulcer without slough or bruising. ⃰ Stage II should not be used to describe skin tears, tape burns, perineal dermatitis, maceration or excoriation.

Stage III: Full Thickness Skin Loss: Full thickness loss of tissue. Subcutaneous fat may be visible, but bone, tendon, or muscle are not exposed. Slough may be present but does not obscure the depth of tissue loss. May include undermining and tunneling.

The depth of a Stage III pressure ulcer varies by anatomical location. The bridge of the nose, ear, occiput and malleolus do not have subcutaneous tissue and a Stage III can be shallow. In contrast, areas of significant adiposity can develop extremely deep Stage III pressure ulcers. Bone/tendon is not visible or directly palpable.

Stage IV: Full Thickness Tissue Loss: Full thickness tissue loss with exposed bone, tendon or muscle. Slough or eschar may be present on some parts of the wound bed. Often include undermining and tunneling.

The depth of a Stage IV pressure ulcer varies by anatomical location. The bridge of the nose, ear, occiput and malleolus do not have subcutaneous tissue and these ulcers can be shallow. Stage IV ulcers can extend into muscle and/or supporting structures (e.g. fascia, tendon or joint capsule) making osteomyelitis possible. Exposed bone/tendon is visible or directly palpable.

Unstageable: Depth Unknown: Full thickness tissue loss in which the base of the ulcer is covered by slough (yellow, tan, gray, green or brown) and/or eschar (tan, brown or black) in the wound bed.

Until enough slough and/or eschar is removed to expose the base of the wound, the true depth, and therefore stage, cannot be determined. Stable (dry, adherent, intact without erythema or fluctuance) eschar on the heels serves as ‘the body’s natural (biological) cover’ and should not be removed.

Suspected Deep Tissue Injury (SDTI): Depth Unknown: Purple or maroon localized area of discolored intact skin or blood-filled blister due to damage of underlying soft tissue from pressure and/or shear. The area may be preceded by tissue that is painful, firm, mushy, boggy, warmer or cooler as compared to adjacent tissue.

Deep tissue injury may be difficult to detect in individuals with dark skin tones. Evolution may include a thin blister over a dark wound bed. The wound may further evolve and become covered by thin eschar. Evolution may be rapid exposing additional layers of tissue even with optimal treatment.

On April 8, 2016, the NPUAP will hold the 2016 Staging Consensus Conference at the Hilton Rosemont/Chicago O’Hare Hotel. Attendees will have the unique opportunity to provide input on the future of the staging system as it is now, including the possibility of doing away with the staging system altogether. Find out more here: http://www.npuap.org/events/2016-staging-consensus-conference/

Prevention Strategies

For prevention of pressure ulcer development, the 2014 NPUAP Quick Reference Guide recommends the following interventions (not an all-inclusive listing):

• Avoid positioning the individual on an area of erythema whenever possible.
• Keep the skin clean and dry.
• Do not massage or vigorously rub skin that is at risk of pressure ulcers.
• Develop and implement an individualized continence management plan.
• Protect the skin from exposure to excessive moisture with a barrier product.
• Consider using a skin moisturizer to hydrate dry skin in order to reduce risk of skin damage.
• Consider the need to control moisture and temperature when selecting a support surface.
• Do not apply heating devices directly on skin surfaces or pressure ulcers.
• Consider applying a polyurethane foam dressing to bony prominences.
• Assess the skin for signs of pressure ulcer development at each dressing change or at least daily. Use a finger or disc method to assess whether the skin is blanchable. A transparent disc is used to apply pressure equally over an area or erythema can help the nurse observe for blanching.
• Screen, assess and care plan for nutritional issues. Follow dietary requirements for offering or providing the correct amount of hydration, calories and protein. Keep in mind that “offer” or “provide” does not mean “consume” and no individual can be forced to eat or drink. If there is a risk of malnutrition or dehydration, alternatives should be provided to the individual and decision makers in the family (e.g. IV fluids, tube feedings).
• Reposition all individuals at risk of, or with existing pressure ulcers, unless contra-indicated. Consider a pressure redistribution support surface when determining the frequency of repositioning. (Other considerations when determining frequency are tissue tolerance, level of activity and mobility, general medical condition, overall treatment objectives, skin condition, and comfort).
• Document frequency, position, and outcome of repositioning plan.
• Teach individuals ‘pressure relief lifts’ or other pressure relieving maneuvers as appropriate.
• Add assessments of skin folds in obese individuals.

Most nurses are familiar with a standard of turning patients “Q2” or every 2 hours to prevent pressure ulcers. The current recommendations in the 2014 NPUAP Reference Guide do not prescribe a frequency that applies to every patient, but instead recommends that the staff take into account the above considerations and develop an individual plan based on the risk factors and patient condition.

Treatment Plans and Wound Healing

NPUAP treatment recommendations are based on scientific principles and the opinion of experts in the field. These recommendations include (but are not limited to):

• Complete comprehensive initial assessment and reassessment. Wound assessments should be documented, and deterioration should be addressed immediately. Existing pressure ulcers should be reassessed at least weekly.
• There should be some pressure ulcer healing within two weeks, with adjustment of expectations for healing in the presence of multiple factors that impair wound healing.
• Reevaluate the plan if the pressure ulcer does not show signs of healing within two weeks.
• Assess and treat pain.
• Cleanse the pressure ulcer and surrounding skin at the time of each dressing change. Cleanse with potable water or normal saline, or aseptic technique when the wound healing is compromised. Consider cleansing solutions with suspected or confirmed infection.
• Debride devitalized tissue within the wound bed or edge of pressure ulcers when appropriate, and when the presence of biofilm is confirmed or suspected. Do not debride stable, hard, dry eschar in ischemic limbs.
• Assess for and treat infection.
• Select a wound dressing based on the ability to keep the wound bed moist, need to address bacterial bioburden, nature and volume of wound exudate, condition of the tissue in the ulcer bed, condition of periulcer skin, ulcer size, depth, and location, presence of tunnelling and/or undermining, and goals of the individual with the ulcer.
• Use hydrocolloid dressings for clean Stage II pressure ulcers in body areas where they will not roll or melt.
• Use care in removing film dressings on fragile skin.
• Consider hydrogel dressings on shallow, minimally exuding pressure ulcers.
• Consider alginate dressings for the treatment of moderately and heavily exuding ulcers.
• Consider foam dressings on exuding Stage II and shallow Stage III ulcers.
• Consider silver-impregnated dressings for pressure ulcers that are clinically infected or heavily colonized but avoid prolonged use.
• Avoid gauze dressings for open pressure ulcers.

Avoidable vs. Unavoidable, and Defense of Pressure Ulcers

In the defense of pressure ulcer claims, a legal nurse consultant (LNC) can be the most important member of your defense team in sorting through the many and varied recommendations regarding pressure ulcers, especially in light of so many of the recommendations being suited to individualized care plans and the many factors of each individual patient. There are few “cut and dry” recommendations which apply universally.

In certain populations, the NPUAP and CMS have acknowledged that not all pressure ulcers are avoidable. The NPUAP defines an unavoidable pressure ulcer as “one that develops even though the provider has evaluated the patient’s clinical condition and pressure ulcer risk factors; defined and implemented preventive interventions consistent with the patient’s need and goals, and formulated with recognized standards of practice; monitored and evaluated the impact of the interventions; and revised care as appropriate.” F-tag #F314 describes an avoidable pressure ulcer as one that developed after the facility did not do one or more of the above interventions. Of particular interest to many in defense, is the growing literature and research backing the existence of unavoidable tissue injury or organ failure such as skin failure associated with the natural dying process. There are many terms which address such skin failure, such as SCALE (skin changes at life’s end), the Kennedy Terminal Ulcer (KTU), and Trombley-Brennan Terminal Tissue Injury. The VCU Pressure Ulcer Summit was held in March 2014 to redefine pressure ulcer prevention. The group agreed that most of these unavoidable ulcers at the end of life were not caused by pressure/shearing forces alone, and hypothesized they had underlying etiologies related to insufficient perfusion.

Important takeaways when defending a pressure ulcer case are:

• There are no “black and white” preventative and treatment measures. If the nursing staff regularly documents assessment and re-assessment, and tailors a plan which is implemented for each individual, as well as non-compliance by the patient in the treatment plan, this documentation can be the cornerstone of your defense.
• The patient may have diabetes which leads to “non-modifiable fixed deficits that can lead to non-preventable pressure ulcers.”
• Non-reversible peripheral neuropathy is a significant causative factor in development of pressure ulcers of the feet.
• Malnutrition present on admission can be a very high risk factor for pressure ulcer development.
• Incontinence of bowel and bladder requires dedication by nursing staff and can be complicated by medical problems such as C. diff and urinary tract infections.
• Obesity upon admission is a hurdle for facilities in many facets of health maintenance, especially in skin health. The barrier of noncompliance with nutritional dietary items, and the moisture involved in skin folds makes the obese patient a high risk for skin alteration.
• Arterial insufficiency can lead to amputations, but the misdiagnosis of an arterial ulcer for a pressure ulcer places an impossible preventative and treatment burden on the nursing staff. Without adequate blood flow to the limbs, and considering the treatments of elevation compression wraps adding to the pressure risk, this patient population is at high risk of unavoidable ulcers. Venous insufficiency can be clearly seen in most cases by lack of hair on lower extremities, with more darkly pigmented skin and edema. It complicates the management of pressure ulcers to a degree that is unrelated to the intervention given by nursing staff.

References

1. Iyer, Patricia W. (2006). Nursing Home Liability and Its Consequences. In Nursing Home Litigation: Investigation and Case Preparation, 2^nd (pp. 270-279). Tucson, AZ: Lawyers and Judges Publishing Co, Inc.
2. Brindle, Creehan, Black, & Zimmerman. (2015). The VCU Pressure Ulcer Summit: Collaboration to Operationalize Hospital-Acquired Pressure Ulcer Prevention Best Practice Recommendations. J Wound Ostomy Continence Nursing, 2015:00(0):1-7.
3. Haesler, Emily. (2014). National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel and Pan Pacific Pressure Injury Alliance. Prevention and Treatment of Pressure Ulcers: Quick Reference Guide. Cambridge Media: Perth, Australia. Retrieved October 8, 2015
4. Kirman, C., Geibel, J. (2015). Pressure Ulcers and Wound Care. Retrieved October 8, 2015 from Medscape web site.
5. Lee, K. (2015). All the World’s a “Stage”: Pressure Ulcers – Prediction, Prevention and Treatment: A Review of the NPUAP 2014 Guidelines. [Presentation].
6. Sharpe, J. N. (2015). Preventable vs. Non-Preventable Pressure Ulcers – Evaluation and Defense. [Presentation].