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Restraint on Restraints

02.15.07 written by

By Cathy A. Sloane, Esq.
Published in the March/April 2007 Issue of
MD News Magazine

On February 6, 2007, new regulations on the use of patient restraints and seclusion went into effect for hospitals as a condition of participation in the Medicare and Medicaid programs. The long-anticipated final rule modifies the interim regulations in place since 1999.

In development of the final rule, the Centers of Medicare and Medicaid Services (CMS) reviewed more than 4000 public comments from the healthcare community, patient advocacy groups, accrediting bodies, and private citizens. Many commenters applauded the ongoing work to protect patients’ rights to be free from the inappropriate use of restraint or seclusion even when they disagreed with specific requirements of the interim restraint rules. In stark contrast, a few letters were quite disturbing in their conceptualization of patient shackles as wholly appropriate and a “time-honored” standard of care. The final rule reflects CMS’ efforts to reconcile the many ideas for improvement of the regulations while determining the best, most reasonable approaches for ensuring patient health and safety.

As hospitals implement the new rule requirements, physicians can expect to see the following changes:

  • One Standard. The new rule no longer distinguishes between restraint for “acute medical and surgical care” and the application of restraint for “behavior management.” Never intending to target anyone patient population, specifically patients on psychiatry units, the final rule has one standard that applies to all patients regardless of location in the hospital. Restraint or seclusion may only be imposed to ensure the immediate safety of the patient, a staff member, or others, and restraint or seclusion must be discontinued at the earliest possible time. Seclusion may only be used for the management of violent or self-destructive behavior.
  • Face-to-Face Patient Evaluations. The requirement that a physician must see the patient and evaluate the need for restraint or seclusion within an hour after the initiation of restraint was a lightning rod for public comment. The new rule clarifies that a patient must be evaluated face-to-face within an hour of restraint or seclusion when the purpose is to manage “violent or self-destructive behavior.” 
  • The final rule further expands the categories of practitioners who may conduct this 1-hour face-to-face evaluation to include trained registered nurses (RN) and physician assistants (PA). An onsite visit by a physician within one hour of restraint or seclusion is no longer required if the evaluation is performed by another recognized practitioner. When a trained RN or PA conducts the 1-hour evaluation, the attending physician or other licensed independent practitioner (LIP) treating the patient must be consulted as soon as possible after the evaluation to assure continued medical oversight

A patient restrained for reasons other than violent or self-destructive behavior does not require the 1-hour face-to-face evaluation, but the patient must be monitored by a recognized practitioner at intervals determined by hospital policy. How quickly the restrained patient needs to be seen by the attending physician or other LIP is left to the medical judgment of the physician. 

  • Training. The final rule requires more rigorous training for healthcare workers with a focus on demonstrated competencies. As a minimum requirement, physicians and other LIP must have a “working knowledge” of hospital policy on use of restraint and seclusion. If the physician is directly involved with the application of restraint or the implementation of seclusion, additional training may be required by the hospital.
  • Reporting Patient Deaths. Hospitals are now required to report to CMS each patient death that occurs while the patient is in restraint or seclusion; each death that occurs within 24 hours after removal of the restraint or seclusion; and each death that occurs within one week after restraint or seclusion when it is reasonable to assume that the use of restraint or placement in seclusion contributed directly or indirectly to the death.

In summary, the final rule recognizes the legitimate use of restraint and seclusion and applies one standard across all care settings; broadens the categories of practitioners who can perform face-to-face evaluations; strengthens training requirements; and mandates reporting of patient deaths. The final rule informs the public and provider community of minimum requirements for patient safety and provides a basis for legal action if requirements are not met. Physicians should obtain a copy of the hospital’s policy and become familiar with its specific provisions.

For additional information, see 42 CFR §482.13

NOTE: This general summary of the law should not be used to solve individual problems since slight changes in the fact situation may require a material variance in the applicable legal advice.