Making sense of HCFA’s restraint rules

Anything done unilaterally is a problem’

Probably nothing in recent memory has raised eyebrows and elevated administrative blood pressure quite like the Health Care Financing Administration’s (HCFA) Conditions of Participation (CoP) regarding seclusion and restraints. Even now, months after the CoP’s release, many health care professionals remain frustrated by its inherent ambiguities and unanswered questions: What exactly constitutes a restraint? Who can order them? What about chemical restraints?

Particularly vexing to most clinicians and hospital administrators is the requirement from both HCFA and the Joint Commission that a physician do a face-to-face assessment with the patient within an hour of implementation of restraint or seclusion. (See "Hospitals cry foul over ambiguity in HCFA’s new restraint standards," Hospital Peer Review, November 1999, p. 165.) "This new requirement is not clinically necessary because competent caregivers on the scene already are in constant dialogue with physicians about the patient’s condition," said Jonathan T. Lord, MD, chief operating officer of the Chicago-based American Hospital Association (AHA). "Given the short notice of this unexpected provision, most hospitals would not be able to hire enough staff to fulfill these requirements."

What can a small rural hospital do with an out-of-control patient and no physician standing by to do an assessment? For that matter, what can be done in a medically underserved urban area or a residential setting?

"It’s going to add expense at best and be difficult to comply with at worst," says Michael H. Allen, MD, immediate past president of the American Association of Emergency Psychiatry in Medford, MA. Allen is also associate director of behavioral health at Denver Health Medical Center, a large public hospital. "Some people will just get out of the business," he says. "Others will have to charge more. But we must improve staffing patterns to make this work."

Yet Allen agrees that where seclusions and restraints are involved, "whenever possible there should be a dialogue and choices about how the patient will be treated. It’s important to involve the consumer and discuss the treatment options. Anything done unilaterally is a problem," he maintains.

HCFA’s rules require the assessment by a physician or independent licensed practitioner within an hour of restraining the patient, a provision that caretakers argue is often impossible. The Oakbrook Terrace, IL-based Joint Commission on Accreditation of Healthcare Organizations (JCAHO) claims it wants to learn more about solutions to this dilemma. "Based on the review research, should the Joint Commission ultimately adopt a time frame that differs from HCFA’s requirement, the Joint Commission still would hold organizations that are subject to the HCFA regulations to whichever standard or regulation had the shorter time frame," it states in its written response to concerns raised by the National Alliance for the Mentally Ill (NAMI) in Arlington, VA.

What constitutes competency?

The Joint Commission’s draft also would require that "only competent, trained staff are involved in the use of restraint and seclusion" the JCAHO adds in the NAMI response. This means the organization would have to train and assess the competency of all staff, including physicians and midlevel providers, who are authorized to be involved in the use of restraint and seclusion.

But just how trained must staff be to qualify as competent?

According to the Joint Commission’s draft restraint standards, staff must have competence in:

• an understanding of how their own behavior can affect the behavior of the people being served;

• the use of de-escalation, mediation, and other non-physical intervention techniques;

• the safe use of restraint and seclusion, including physical holding techniques;

• recognizing and appropriately responding to signs of physical distress in individuals who are restrained and secluded.

Allen is not entirely opposed to this. "We could cut the rates of seclusion and restraint dramatically by training staff in de-escalation skills, offering food, toileting, oral medications, and helping people get into a better frame of mind," he says.

Currently, HCFA is exempting emergency rooms from the rules, and the Joint Commission has yet to make up its mind on this issue. So in some situations, a patient could be restrained by order of an ER physician. "However, we wouldn’t want to make a habit of classifying these patients as emergencies where reimbursements may be higher," says Allen. "We don’t want that to become an incentive for making restraints more attractive."

Vagaries in the standards persist and complicate the issue of compliance. What exactly constitutes a restraint — a raised bed rail? A shot of Valium? A prisoner in handcuffs?

HCFA has tried to address some of the more persistent questions on the definition of restraints in its Q&A paper related to "Hospital CoP for Patients’ Rights." The Q&A paper was designed to address the interim draft until HCFA issues its final rules. (The entire text of the paper is available on HCFA’s Web site: In the case of the bed side rail, HCFA notes that "if the side rail restricts the patient’s movement and the patient cannot remove it, the side rail is a restraint and must meet the requirements of the CoP."

In the case of the handcuffed prisoner, however, the situation would be covered by the criminal law and not subject to the HCFA standards.

"The key is assessing each patient and each situation," HCFA says in its Q&A paper on the subject of restraints. For instance, a gerichair with a tray across the front is not a restraint if the patient can lift the tray and get up at will. The same reasoning applies to a wheelchair strap.

However, if the patient can’t reach and release the strap, it becomes a restraint under the conditions of the CoP.

"Individual assessment is necessary," HCFA adds in the Q&A paper, "because what functions as a restraint for one patient may not do so for another."

HCFA’s position on chemical restraints takes careful reading. In general, HCFA defines a restraining drug as a medication that is used to control behavior or to restrict that patient’s freedom of movement. But in examples of the use of drugs for restraint, HCFA cites a patient on an acute medical/surgical unit who during recovery suddenly becomes agitated and aggressive. Since her condition until now has not indicated the need for sedatives, the use of drugs to calm her will require the assessment of a physician within an hour.

On a detox unit, however, if a patient becomes violent and aggressive, the staff can administer a PRN medication ordered by his physician to address this outburst. Since it is a conventional treatment for his medical condition, it is not affected by the HCFA standard and is not considered a restraint.

"The variation in the range of restraints is huge," says Allen. "Many facilities should be reducing the rate at which they use restraints. Patients are traumatized by this. Some end up with post-traumatic stress disorder. We need to be thinking about how this affects them afterward."