Publications









Visit Elsevier's
Caring for the Ages Web Site
Get Your Free Subscription! Selected Articles 2001-2004

Caring for the Ages
Selected Articles from
December 2002;
Vol. 3, No. 12
LTC Staff Sensitized to Needs of Gay Elders
Time to Put Survey Reform into Action
OIG Cautions Drug Industry on Relationships with Physicians
Curbing Restraint-Related Litigation
2002 Research Roundup Incorporating Clinical Study Results into Daily Practice
Focusing in on the Critical Role of Nursing Home Owners & Administrators
A Daughter's Journal: Loneliness of the Long-Distance Caregiver
Power of the Pen in Long-Term Care
Previous Month's Articles
Following Month's Articles

Curbing Restraint-Related Litigation

by Jacqueline Vance, RNC

Restraint use poses some conundrums for medical directors and staff in long-term care. The idea is to restrain as little as possible, so that the only residents who are restrained are those who require a physical restraint to treat their condition and improve their functioning and well-being. The restraints used should be the least restrictive, and they should be used for the least amount of time possible. If you follow these precepts, you are likely to improve the quality of care at your facility and please surveyors. But that's not enough.

What about families and their legal representatives? By limiting the extent of restraint use, you reduce the risk of injury and falls. But, accidents still happen, and can lead to lawsuits--particularly if family members don't understand that when it comes to restraint use, less is more.

To protect yourself from litigation if there is an accident involving a restraint-free resident, you and your colleagues need to develop four key strategies: education, communication, documentation, and a clear care process that puts them all together.

Education

When making a decision to restrain or not restrain, the facility needs to make clear to physicians and nursing staff, as well as to the residents and their families: what constitutes a restraint, the improper use of a restraint, the role of the family or legal surrogate in restraint use, and what the benefits of not using restraints are (see box, right).

Educating Residents & Families

The primary goal of an education program is for the families and residents to come away with a clear understanding of:

  • The resident's rights to be free of restraints.
  • Who is the primary decision maker for the resident.
  • Basic aspects of federal and state regulations that apply to restraint use.
  • The fact that family members and surrogates may not dictate care that is not medically necessary.
  • The decision-making process in creating a plan of care for the resident.
  • The risks and negative effects of restraint use and the benefits of using alternatives to restraints.
  • The fact that successful lawsuits result more frequently from deaths due to improper use of restraints than from not using restraints.

Adapted from "Providing a Quality of Live While Avoiding Restraints" from the Wisconsin Department of Health and Family Services-Division of Supportive Living-Bureau of Quality Assurance.

The Centers for Medicare and Medicaid Services defines physical restraints under Interpretive Guidance in the State Operations Manual as: "any manual method or physical or mechanical device, material, or equipment attached or adjacent to the individual's body that the individual cannot remove easily which restricts freedom of movement or normal access to one's body."

According to the SOM, the resident has the right to be free from any physical or chemical restraints imposed a) for purposes of discipline (an action taken by the facility for the purpose of punishing or penalizing residents) or convenience (an action taken by the facility to control a resident's behavior or manage a resident's behavior with a lesser amount of effort by the facility, and not in the resident's best interest); or b) that is not required to treat the resident's medical symptoms.

Appropriate Requests

Although the resident or family may request that a restraint be used, it is the facility's responsibility to evaluate whether or not that request is appropriate. It should be viewed in the same light as a request for any other type of medical treatment. Family members or legal surrogates may say that they will sign a consent form relieving the facility of the responsibility for using a restraint. However, at issue is the improper use of restraints and not the fact that consent forms may have been signed. Signed consent forms do not free the facility from meeting the requirements for restraint use.

Many facilities insist that staff use consent forms, but there is no language in the federal regulations that requires written consents for the use of restraints. Although guidance at F Tags-F154 and F163(2) discuss being informed about care, treatment, and changes, this does not mean that a facility must obtain written consents from the resident or legal surrogate.

Whether or not consent forms are utilized by the facility, SOM transmittal 20 states that "the legal surrogate or representative cannot give permission to use restraints for the sake of discipline or convenience or when the restraint is not necessary to treat the resident's medical symptoms." It also states that "the facility may not use restraints in violation of the regulation solely based on a legal surrogate or representative's request or approval."

Communication

Nevertheless, communication with residents and families about the plan of care might just save you from a lawsuit, even if a patient is injured in a fall. Gerald B. Hickson, MD, of Vanderbilt University Medical Center in Nashville, TN, was recently quoted in a newsletter from the National Patient Safety Foundation. When asked why people file suits, his answer was, "the single greatest error in health care is the failure to communicate. Money is important, but families have to be motivated by something more."

When families feel out of the loop, they often believe someone is "hiding something." In short, don't get sued just because a family or surrogate didn't know what you were doing nor the right way to do it.

If a consent form is one method of communication, make sure the legal representative understands what is being signed. Ask the family or legal surrogate to repeat the information given to them. There may be documentation in the medical record about conversations with the family or legal surrogate, but should there be litigation, they may say that they didn't understand what the health care team was saying. Repetition of this information is a clear way to ensure they understand. Make sure that this step is documented in the medical record.

Injury Reduction

One of the most common reasons for the use of restraints in nursing homes is the archaic belief that restraints prevent falls. This idea has become ingrained. Furthermore, acute-care practices may mislead families about what constitutes good "safe" care. After all, they may say, "they tied dad down in the hospital."

Surprisingly, family members can look directly at a loved one who is restrained and not even notice whether they are uncomfortable, withdrawn, depressed, or perhaps even suffering. The only thing they see is that their loved one is "safe." Our job is to break through those traditional ideas.

Many studies show that reducing restraints reduces the risk of injury due to falls. The Commonwealth National Restraint Minimization Project looked into interventions at 16 nursing facilities in order to reduce restraint use. One conclusion was that falls may increase slightly when restraints are removed, but serious injuries decrease to a much greater extent. This finding is consistent with other studies that have shown that removing restraints, in most cases, reduces the risk of serious injury.

Restraints have been found in some cases to increase the incidence of accidents such as strangulation and entrapment. Restraint use can also reduce independence, functional capacity, and quality of life. Residents who are restrained may lose autonomy, dignity, and self respect, and may also show symptoms of withdrawal, depression, or reduced social contact.

High Expectations

In nursing homes, there will always be falls that cannot be prevented. One cannot expect otherwise. Unfortunately, family members or legal surrogates may not be aware of this. Perhaps we have let them set their expectations too high. Perhaps we have not told them of the risks involved with restraint use, the reasons we have chosen not to restrain, our regulatory requirements, or even our restraint-evaluation process.

It is our responsibility to educate residents and their families about restraint use and about the specifics of their care. This is especially necessary if a resident has been identified as a fall risk and their restraint evaluation shows that they would be at greater risk for injury if they were to be restrained. One good approach to getting the family to agree to not using restraints is to involve them in devising alternative strategies.

Essential Documentation

Good documentation is extremely important in risk management. If you want to show what you have done, you need to document the results of the entire process. This includes what was said to families and staff, everything related to the decision making process (assessment, root cause analysis, etc.) and everything related to the monitoring process, especially when there is a need to re-evaluate or modify the interventions in place.

If a resident does fall, accurate and comprehensive documentation of the event in chronological order, including the health care staff's response, is invaluable. Poor documentation leads to allegations of poor practice. Illegible, incomplete, or confusing documentation may be impossible to defend in court and may have a negative impact on a lawsuit's outcome.

Proving Compliance

The Interpretive Guidelines make it clear that a facility cannot meet its burden of proving compliance with the restraint requirements unless it has engaged in a systematic process of evaluation and care planning that addresses certain identified issues (42 C.F.R. 483.25(h)(2). HCFA Ex. 1 at 8-10). This regulation provides that a long-term care facility must ensure that each resident receives adequate supervision and assistance devices to prevent accidents.

The regulation does not make a facility strictly liable for accidents that may occur to its residents. A facility is obligated to take measures that are designed, to the extent that is practicable, to assure that residents do not sustain accidents that are reasonably foreseeable.

Howard Sollins, an attorney with Ober, Kaler, Grimes, and Shriber in Baltimore agrees with the need for a systematic care process. "The facility's best protection is to identify residents at risk for falls, to demonstrate that steps are taken to reduce the risk of falls, including through improving the physical function of residents, and being able to demonstrate that the facility has an effective care planning and quality assurance process."

Closing Thoughts

Restraint reduction continues to advance in long-term care, and the general public should be made aware of this. Many studies have demonstrated the negative impact of restraints, but, as noted earlier, people still falsely believe that restraints prevent falls. We must get the word out beyond physicians and nursing home staff. The move towards restraint-free care in nursing homes should be encouraged, not punished.

Nevertheless, until the general public understands the benefits of not using restraints, nursing facility staff need to protect themselves. By putting good care processes in place, you help ensure quality of care and may save yourself the pain and cost of litigation. Doing so requires educating staff, residents, and families. And, as well as explaining the plan of care and the reasons for it, you must clearly document all that you do.

What the Legal Experts Say

Fear of liability is not a good reason to use restraints. Nevertheless, liability is a concern for facilities with restraint reduction programs. The legal issues are less defined than the regulatory issues. It appears that there is no clear, statutory law in the area of "non-restraint" use. However, due to data from recent studies, plaintiff attorneys can no longer rely on the fictitious notion that restraints prevent falls and fall-related injuries. Physical restraints are no longer being viewed as the definitive treatment to prevent falls.

Attorney Howard Sollins notes that restraints "are not permitted unless medically justified" and "falls may well occur" after attempting other means of addressing a problem. Some believe this may provide a defense against allegations of deficiencies or negligence, but "even without restraints," he points out, "there is an expectation that the facility will take reasonable and appropriate steps to prevent falls."

As more defense attorneys become aware of research-based practice and expert witnesses who can testify about the negative effects of physical restraint use, settlement and court decisions in fall-related injury cases are leading to new trends in litigation regarding physical restraints.

Although lawsuits are still being won for physical restraint use that has led to harmful outcomes, fewer lawsuits are won for harmful outcomes from not using restraints.

However, this depends on whether the facility's documentation supports the education, assessments, and informed decision that was applied to the process of not restraining. According to Mary K. Robbins- Kralapp, RN, NHA, an attorney and Director of Quality Assurance and Corporate Compliance at Ingham Regional Medical Center in Lansing, MI, "it is critical to make sure there is adequate and appropriate documentation in the medical record that reflects the restraint decision process. Although the outcomes of litigation often depend on how well and what the lawyer is articulating, good documentation is key to winning a case."

Ms. Robbins-Kralapp added that litigation of this sort is extending beyond the nursing home. "We are now seeing lawsuits related to falls without restraint usage in assisted living facilities, domiciliaries, and even the acute-care hospital setting."

Often, hindsight bias comes into play when litigation is involved. Knowing the outcome of an event can influence how that event is assessed. Hindsight bias, as defined in the Institute of Medicine Report To Err is Human--Building a Safer Health System, means that things that were not seen or understood at the time of the accident seem obvious in retrospect.

The report also points out that hindsight bias may mislead a reviewer into simplifying the cause and overlooking multiple contributing factors. Given that the information about an accident is spread over many participants, none of whom may have complete information, hindsight bias makes it easy to arrive at a simple solution or to blame an individual, but difficult to determine what really went wrong.

Ms. Robbins-Kralapp observes that it's always easier to correct a problem once it has occurred. However, in this litigious society, if you are honest in your root-cause analysis findings, it may be turned against you. "It's an awful predicament," she acknowledges.

She recommends that an investigation be launched as soon as an untoward event takes place, and this should be done with the viewpoint of a plaintiff's attorney in mind. "Get statements and affidavits from the staff and compile a complete summary of the event. Prepare yourself now, while everyone's memory is fresh, so that down the road, if the event does come to litigation, you are prepared for it."

Mr. Sollins adds that an effective quality-assurance program should take into account state laws that may permit certain internal quality-assurance reports to be used without their being turned into discoverable material that may be used in civil litigation against the nursing home. However, the facility needs to understand the kind of process that must be followed to take this need for confidentiality into consideration.


This article originally appeared in Caring for the Ages, December 2002; Vol. 3, No. 12, p. 7-8. Caring for the Ages is an official publication of the American Medical Directors Association, published by Elsevier. This article may not be reproduced in any form, print or electronic, without permission.

The opinions expressed by the authors are their own
and not necessarily those of AMDA or of Elsevier.

back to top

Print Version     11000 Broken Land Parkway, Suite 400 Columbia, MD 21044
    Phone: (410) 740-9743 - Toll free: (800) 876-2632
    Fax: (410) 740-4572 - E-mail: webmaster@amda.com