Improving the Quality of Care in the Nursing Home: Regulation and Litigation

Introduction

A recent General Accounting Office report notes that inadequate care or physical harm continues to affect one in five nursing home (NH) patients annually,¹ an unacceptably high figure. More than 20% of residents who have been in long-term care facilities for two or more years will develop at least one pressure ulcer.² In one study in patients with pain unassociated with cancer, 25% of NH patients received no analgesic medication at all.¹ Inadequate NH care results in patients suffering pain, loss of function, decreased quality of life, and a higher risk of premature death. The following case scenario illustrates the risks that older adults confront in the healthcare system.
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Case Presentation: Mrs. W

Mrs. W was 86 years of age, living independently in her one-story home following the death of her husband two years earlier, when on September 1 she tripped on a rug and fell. In the Emergency Room (ER), a hip fracture was diagnosed, and she was admitted for surgery. Her medical history included hypertension, type 2 diabetes, osteoarthritis, dementia, and a partial hearing deficit, for which she wore hearing aids. Medications on admission, brought by her daughter, included: glipizide 5 mg daily, lisinopril 5 mg daily, sertraline 25 mg daily, and aspirin. Over the past year, Mrs. W, previously independent and caring for her home and all of her personal needs, began to have difficulty with short-term memory. Recently, her daughter brought her to their family physician. He diagnosed Mrs. W with “mild dementia and depression,” and at that time sertraline was prescribed. Mrs. W underwent an uncomplicated open reduction internal fixation the following day after her fall. Pain management was provided via patient-controlled analgesia (PCA).

Forty-eight hours after surgery, Mrs. W became agitated, calling out for her mother. Haloperidol was ordered, but by the next day she became lethargic, and it was discontinued. Fortunately, the orthopedic resident, recognizing the degree of memory impairment present, discontinued the morphine PCA pump, ordering morphine to be given as needed by nursing. Five days after surgery on September 7, still lethargic but “stable,” Mrs. W was transferred to a NH and rehabilitation center. Discharge medications included all of those on admission, with the addition of oxycodone and acetaminophen for pain. The admission nursing assessment documented that Mrs. W was “bed-bound and in discomfort,” “deconditioned,” “pleasantly confused,” “depressed,” and “incapable of making medical decisions.” Physical assessment by the admitting nurse revealed that there was no evidence for skin breakdown and that a Foley catheter was in place. The Mini-Mental State Examination score was 22, with deficits in orientation, recognition, and recall. Physical therapy documented that Mrs. W required a two-person assist from bed to chair, and that the resulting motion caused considerable pain.

The Fall Risk Assessment placed Mrs. W at risk for falling. The Braden Scale was scored incorrectly. No points were given for altered nutrition, limited sensory perception (a typical finding in dementia), and potential for skin breakdown due to friction and shear. A formal skin prevention program was thus not initiated. The Minimum Data Set (MDS) triggered Resident Assessment Protocols (RAPs) for falls, altered cognition, pain, and depression. A falls prevention program and pain assessment sheet were initiated. Over the next several weeks, Mrs. W made little progress with the physical therapy program. At the therapist’s request, the attending physician increased the dosage of sertraline to 50 mg daily. Mrs. W continued to experience intermittent confusion. There were many days when she could not recognize her daughter, who visited frequently. Mrs. W had significant difficulty working with the physical therapist, due to “confusion and discomfort.” Nursing notes documented that Mrs. W would take in only 25-50% of her three meals daily. A dietary consult suggested protein supplements. This suggestion was never documented in the nursing notes, nor in the order sheet.

On November 15, Mrs. W became agitated, anxious, and combative when the certified nursing assistants (CNAs) attempted to transfer her from bed to chair. Her temperature was 99.1 degrees F. Her physician was called, and he ordered a urinalysis. Ciprofloxacin 250 mg twice daily was initiated. The urine culture report revealed “no growth.” Over the next several days, Mrs. W became more agitated and combative. Her physician was called and ordered haloperidol 0.5 mg to be given twice daily, as well as every 4 hours as needed. On November 21, a CNA documented several red areas on the patient’s buttocks, bilaterally. Over the next several weeks, Mrs. W was intermittently confused and agitated, at times “crying out in pain.” Oxycodone and acetaminophen were given on average three times daily. Although the nursing notes documented that Mrs. W was in pain, a formal pain assessment was not documented. The effectiveness of pain management was noted on only two occasions. On December 12, a nursing note documented “several red areas on the buttocks, ? early skin ulcer.” A skin care plan was initiated on December 16. Several interventions were documented, including weekly skin inspections, turning and repositioning every two hours, nutritional supplements, and topical interventions. The following day, the facility was cited by the state for a deficiency in staffing levels.

The next documentation of the skin findings was dated December 26: “Stage II ulcer, measuring 3 cm by 2.5 cm, with depth of .4 cm, left buttock. Stage III ulcer, measuring 3.5 cm by 2.5 cm, with depth of .5 cm, right buttock. Both oozing green foul-smelling fluid.” Mrs. W’s attending physician was informed and ordered the following: “a wound care nurse evaluation, dressing changes as per the wound care nurse, turning and repositioning every two hours, and daily inspection of the wounds.” A low-air loss mattress was ordered on December 29 but was not put in place until December 31. On that same day, the attending physician’s nurse practitioner (NP) examined Mrs. W. As she was in her wheelchair, the NP did not examine her buttocks, but rather wrote: “Patient with pressure ulcers, under the good care of wound nurse. Dementia being treated. Appetite poor. Occasional choking with food. Suggest dietary consult and swallowing study.” There was no written order, however, for the latter suggestions.

On January 2, at 1100 hours, Mrs. W attempted to exit her wheelchair. The nursing notes documented: “Patient tried to get out of wheelchair, lap buddy not fastened. Immediately put back in the wheelchair. Patient stated ‘it hurts.’ No obvious injury.” Several hours later Mrs. W, now in bed, was found to be unarousable. Orders were obtained for transfer to the local hospital ER. In the ER, Mrs. W was febrile (101.5 degrees F), lethargic, dehydrated, and crying out in pain. Multiple flexion contractures were noted. Hip x-rays revealed a nondisplaced intertrochanteric left hip fracture. The BUN was elevated at 75 mg/dL. The white cell count was elevated at 15,000/µL with a left shift. Skin examination revealed a grade IV ulcer of the coccyx, with necrotic foul-smelling tissue and the sacral bone visible. A chest x-ray revealed bilateral lower-lobe infiltrates. Mrs. W was admitted to the hospital and started on antibiotics. Orthopedics evaluated Mrs. W, noting that treatment of the ulcer would be needed prior to surgical fixation of the hip. Pain medication was initiated. Vascular surgery was consulted, and the wound was debrided. Surgical repair was scheduled for the next day, but within several hours Mrs. W’s condition worsened, and she developed respiratory failure. Faced with the need to intubate, her daughter made the difficult decision to withhold further aggressive measures, and Mrs. W died later that evening.
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Overview of the NH Industry

There are currently 17,000 NHs in the United States, with 1.8 million beds, 1.6 million residents, and 2.4 million discharges each year. Sixty-five percent of NHs are proprietary, 25% voluntary nonprofit, and 10% government-controlled. Over 20% of NH residents require assistance with one or two activities of daily living (ADL), and 75% require assistance with three or more ADL.³ Unfortunately, this increased level of functional dependence has occurred at the same time that the NH environment has experienced financial constraints and lack of resources. Not surprisingly, NH patients are at high risk for complications, including infections, and especially pressure ulcers, falls, malnutrition, dehydration, incontinence, behavioral disturbances associated with dementia, and polypharmacy.

Many of these complications result in claims of negligent care as a result of inadequate or inappropriate care, and so it is essential that the NH provide for quality diagnostic, preventive, and treatment strategies. Caring for NH residents has thus become increasingly complex and challenging, and yet, internists and family physicians, who typically provide medical care, devote no more than two hours—and usually less—per week to care of NH patients. Studies have confirmed the correlation of quality of care to total nursing hours and the ratio of professional nurses to nonprofessional nursing staff. In 2001, an Institute of Medicine (IOM) report recommended increasing nursing staff levels to improve the quality of care in the NH.⁴ As a result, Congress has debated the merits of mandatory minimum staffing ratios. Until now, the Centers for Medicare & Medicaid Services has declined instituting a regulation such as this but has called for additional research in this area. Certainly, if higher staffing ratios are mandated, the financial support for such an undertaking will be extremely difficult. Further difficulty is found in the area of recruiting and maintaining staff, especially CNA staff, the bulk of the NH workforce. Turnover rates for registered nurses and licensed practical nurses occur at more than 50% a year.⁵ Higher caregiver staff turnover has been shown to be associated with a higher rate of hospitalization of NH residents.

Negligence in the NH

Studies have documented mistakes in diagnosis, inappropriate diagnostic and therapeutic interventions, and poor preventive care practices in the NHs. In a frequently cited study of NHs in Maryland, only 11% of patients with the four most common types of infections were found to have received even a minimal evaluation, such as simply obtaining a urine sample to rule out a urinary tract infection.⁵ Between March 2001 and August 2002, 86% of all NH facilities in Texas had at least one violation that could result in more than minimal harm, and staffing levels fell below standards.⁶ Failure to establish care plans for the prevention of pressure ulcers, failure to properly treat ulcers once established, and failure to provide adequate nutrition and hydration were the most common violations noted.

NH Regulation

The regulatory structure for NHs is daunting as a result of an IOM report and resulting enactment of federal regulations more than a decade ago⁷ and the passage of the Omnibus Budget Reconciliation Act of 1987 (OBRA ‘87), resulting in far-reaching reforms initiated in 1992 involving NH law and practice, an acknowledgment of patients, families, and the medical establishment that care provided in the NH was deficient in many respects. The resulting legislation has standardized patient assessment and quality of care to a large degree. Since 1992, however, litigation against NHs has increased. The reason is clear: Relative “standards” have been established, and far too often these standards are not met in caring for patients. Surveys of NHs are mandated every 15 months. However, it is unclear whether or not the process engenders lasting improvement of deficiencies of care found. The survey process has been criticized for being inconsistent, the surveyors often too subjective, and trivial issues more often cited than more important quality issues.

Quality of Care
Assessment of “quality of care,” essential in proving medical causation, is more elaborate and codified as a result of legislation and a regulatory structure that insists upon a comprehensive assessment in a uniform manner for all patients.⁸ The federal regulations stemming from OBRA ‘87 established much needed quality-of-care standards for the NH industry.⁹ The Act requires a periodic comprehensive assessment of all NH residents, establishes minimal staffing requirements, and fosters residents’ rights by limiting the use of restraints and psychoactive medications. These requirements are now used as “benchmarks” in measuring quality of care in the NH and have been used to prove negligence on the part of the NH. The MDS¹⁰ is a five-page document that drives NH care in a powerful way and triggers a RAP, which is in essence a codified care plan for each problem triggered.

The MDS is basically a guideline, only useful if done correctly and followed appropriately. It reflects the status of the patient at the time of the signature and must be updated when there is a change in the patient’s condition, and then quarterly. Unfortunately, recent surveys have shown that only a minority of physicians ever review the MDS or related care plans!¹¹ An incomplete or inaccurate MDS or nursing assessment can result in the omission of an important care plan, as was the case with Mrs. W, and this finding can be very helpful in proving poor quality of care. Measuring quality of care in a NH is a difficult task. In an effort to improve quality, a new set of quality indicators, based on MDS items, has been initiated nationally. NHs can now compare their performance with regional national norms to help guide their efforts to improve the quality of care (see https://www.cms.gov). Nursing progress notes reflect the day-to-day condition of a given patient. There are no standards. There is no format. Often, one will find more information in the nursing progress notes than in a flow sheet, so it is imperative that the expert witness ensure that what appears to be missing in a flow sheet is not documented in the progress notes.

Legal Interventions

Since the passage of OBRA in 1987, there has been an increase in litigation involving substandard care in nursing homes. One reason for this is the feeling that the regulations have set a new standard of care. In addition, there has been a public recognition that poor care leads to bad, and sometimes severe, outcomes, even leading to premature death. Plaintiff lawyers, in order to support a claim, have increasingly sought out physicians and nurse specialists to ensure that the care provided has been substandard, and has in fact led to poor outcomes.

Standards of Care
An expert witness has the responsibility to offer an opinion that is scientifically sound, relevant to the case at hand, and unbiased. Furthermore, as a result of a 1993 Supreme Court ruling on Daubert v Merrell Dow Pharmaceuticals,¹² and adopted by many state courts, the opinion must rest on “reliable science.” Many “standards,” however, are open to interpretation. Complicating this is the lack of evidence-based support for many nursing interventions, especially relating to falls and pressure ulcers. For example, despite best efforts, a good falls prevention program has not been shown to prevent all falls, and the use of expensive low-pressure mattresses has not been shown to reduce pressure ulcer risk. Some experts will argue that there is no real “standard,” that medicine is an art, not an exact science. Yet, those same experts will quote exacting statistics regarding survival! Expert witnesses play an essential role in determining medical negligence under our system of jurisprudence. Expert witness testimony, by and large, helps to establish not only the standards of care germane to a medical causation suit, but also whether those standards were met.

Using federal regulation “benchmarks” as reasonable standards will often be successful in proving medical causation because these benchmarks derive from extensive literature review and the input of medical experts. Negligence law utilizes the fictional “reasonable man” standard to evaluate whether the conduct of the defendant was negligent. The law of medical negligence defines the standard of care as “the degree of care which a reasonably prudent health-care provider would exercise in same or similar circumstances.”¹³ An expert witness is to establish standards of care applicable to a particular case, compare the applicable standards of care with the facts of the case, and interpret whether the evidence indicates a deviation from those standards. However, it is critical for the expert witness to know and consider alternative acceptable standards and treatment options in order for the expert to avoid being myopic or too much of an advocate for the plaintiff.

Medical Causation
In proving causation, an expert witness must describe the standards of care relevant to a given case, identify breeches in those standards, and render an opinion as to whether those breaches are the most likely cause of pain, suffering, injury, or death. Negligence, as it relates to causation, is defined as the doing or failure to do something that a person of ordinary prudence would do or not do in similar circumstances. Negligent medical conduct is the doing or failure to do something that a reasonably prudent healthcare provider would or would not do in similar circumstances. Black’s Law Dictionary defines the plaintiff’s requirement in proving negligence. In relation to NH care, these elements include: (1) The existence of a NH’s duty to the patient; (2) the applicable standard of care and its violation; (3) the resulting injury; and (4) a causal connection between the violation (an act or omission) and resulting harm. In preparation for showing a causal link, I have found the principles set forth in Frye v United States¹⁴ helpful in that endeavor. The Frye test permits an opinion of medical causation by expert testimony based on the medical literature, reasoned methodology, and generally accepted scientific principles. Proving general acceptance lies with the party offering disputed expert testimony but has been applied too restrictively in some courts.

Does the NH Chart Reflect the Care Rendered?
The medical record reflects care given. It is imperative that the entire record be reviewed. Often, what appears to be an omission (eg, a missing flow sheet) might be found in a progress note. Demonstrating that a MDS is incomplete, a RAP is missing, a pressure ulcer flow sheet is not consistent, or a nursing progress note is incomplete only matters if the resulting care, as reflected in the record, does not meet reasonable standards and directly resulted in injury.

Deficiencies in Mrs. W’s Care

Federal regulation tag CFR483.25 notifies that “each resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well being, in accordance with the comprehensive assessment and plan of care.” Several studies have found the mortality rate to be as high as 60% for all persons who develop pressure ulcers within one year of hospital discharge.² Thus, careful skin assessment and pressure ulcer prevention is an essential NH task. In proving bad outcomes as a result of care given in a NH, it is incumbent upon the expert witness to show that a decline in well-being was avoidable or that failure to reach the highest practicable well-being occurred directly as a result of substandard care. Often, poor care results from an inaccurate or incomplete assessment, and thus a deficient plan of care. For example, the failure to assess Mrs. W as being at high risk for pressure ulcers and the resulting failure to monitor her for same resulted in a very advanced pressure ulcer.

Federal regulations clearly require that a patient entering a NH without a pressure ulcer will not experience one, and that the facility “must ensure” that each resident obtain “optimal improvement” or will “not deteriorate within the limits of a resident’s right to refuse treatment, and within the limits of recognized pathology and the normal aging process.” (Federal regulation CFR 483.25[c].) Was the pressure ulcer avoidable? When discovered, was it treated properly? Was further decline unavoidable? The “cause in fact” was an omission of preventive care, including an inaccurate initial skin assessment, lack of a skin care plan, failure to monitor for signs of skin breakdown, an avoidable delay in discovering the ulcer, failure to provide adequate nutrition, failure to follow a physician’s order (for a wound care nurse), failure to consistently turn and reposition (shown in studies to be effective), and failure to provide Mrs. W with a pressure-reduction mattress in a timely fashion. The facts underlying the expert opinion supporting the theory must be established. Therefore, the expert must show, in the case of Mrs. W, a reasonable likelihood that omissions by the NH led to sepsis and death. One need not indicate other possible causes, as certainly there are many. However, the expert must exclude other reasonable hypotheses with the fair amount of certainty. Further deficiencies are obvious: the misuse of an atypical antipsychotic (haloperidol) without first examining Mrs. W for other causes of confusion; poor pain management without determining the true etiology of Mrs. W’s pain; an insufficient examination by the NP; failure to follow up on a swallowing study; and misuse of the lap buddy in a patient already documented to be at risk for falls.

Burden of Proof
Medical causation must be shown with a reasonable degree of medical probability, not possibility. A preponderance of the evidence must be at least 51%.¹⁵ The preponderance of evidence clearly establishes that the nursing staff did not follow well-established guidelines for pressure ulcer prevention and care, and that the omission of this care resulted in the development and progression of the pressure ulcer, sepsis, and death.

Summary

Failure to prevent or properly treat pressure ulcers and failing to provide adequate nutrition and hydration are among the most common NH violations leading to harm. Patients have a basic right and should expect humane care consistent with established standards. Sadly, families have had to seek civil judgments as a way of forcing NHs to provide better care. Physicians, nurses, and NH administrators must work together to establish “best practices’’ with comprehensive care planning, continuous updates, and consistent communication between residents, family members, staff, and physicians. Unfortunately, wrongful death litigation is “too little, too late,” and exacting a monetary price for the loss of a loved one does not bring him or her back, nor erase the pain and suffering that that person experienced. Legislation has improved care to some extent, but NH patients still need every deterrent tool possible to avoid complications resulting from inadequate and substandard care. Litigation, as difficult and costly as it may be, has served to improve the care given to our patients.

The author reports no relevant financinal relationships. Dr. Dupee is Chief of Geriatric Services, Tufts Medical Center, and Associate Clinical Professor, Tufts University School of Medicine, Boston, MA.

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12. William Daubert v Merrell Dow Pharmaceuticals Inc. (92-102), 509 U.S. 579 (1993).

13. Black’s Law Dictionary. 6th ed. St Paul, MN: West Publishing Co; 1991.

14. Frye v United States, 293 F 1013(1923).

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