Are you up-to-date on the latest rules and regulations regarding patient restraint and seclusion? In January, new standards went into effect for all hospitals that participate in Medicare and Medicaid. These standards stem from a final rule on patients’ rights by the Centers for Medi­care & Medicaid Services (CMS)—part of the U.S. Department of Health and Human Services.

The final CMS rule:

• expands behavior management standards to acute medical and surgical care restraint
• revises key definitions
• increases flexibility as to who can perform 1-hour evaluations and monitor patients in restraint or seclusion. (The 1-hour evaluation rule stipulates that a patient must be evaluated face-to-face within 1 hour after restraint or seclusion is initiated to manage violent or self-destructive behavior.)
• expands staff training requirements for restraint application
• broadens documentation and reporting requirements regarding restraint and seclusion

This article summarizes the regulatory changes and discusses how they affect nurses and other healthcare workers.

Expanded behavior management standards
Previously, two standards addressed the use of restraint and seclusion—one applicable to acute medical and surgical care (such as medical care restraints), the other to behavior management. However, many patients have multiple diagnoses and behaviors, and hospitals have struggled to distinguish between the two uses. For example, if an Alzheimer’s patient becomes confused and physically attacks a staff member, which standard applies—the one for medical use or the one for behavior management?

To address this dilemma, CMS collapsed both standards into one universally applied standard. Consequently, the 1-hour evaluation, additional training standards, and death-reporting requirements—previously applicable only to restraint use in behavior management—now apply to restraint use in medical care as well.

Revision of key definitions
CMS also changed key definitions to provide clarity.

• It replaced the term behavior management with the more specific management of violent or self-destructive behavior.
• It clarified that seclusion can be used only to manage violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, staff members, or others.
• It revised the definition of restraint to exclude treatment devices common to medical and surgical care—including orthopedically prescribed devices, surgical dressings or bandages, protective helmets, and other methods that hold a patient physically for the purpose of conducting routine physical examinations or tests, protect the patient from falling out of bed, or allow the patient to engage in activities without the risk of physical harm.

Greater flexibility as to who can perform evaluations
Under the old CMS rule, when restraint or seclusion was initiated for behavior management, a physician or other licensed independent practitioner was required to see the patient and evaluate the need for this intervention within 1 hour. The new rule expands this requirement to cover restraint use in medical care and gives hospitals more flexibility as to who can perform the 1-hour evaluation. Now a registered nurse (RN) or physician assistant (PA) may perform it, unless a more restrictive state law supersedes the CMS rule. If an RN or a PA conducts the evaluation, the attending physician or other licensed independent practitioner responsible for the patient’s care must be consulted as soon as possible after the evaluation iscompleted. (When revising policies, facilities need to verify whether state law permits RNs and PAs to conduct these evaluations.)

Expansion of the 1-hour evaluation to restraint use for medical care applies only when restraints are used to manage violent or self-destructive behavior that jeopardizes the safety of the patient or others. It doesn’t apply, for instance, to a patient who wakes up after surgery and continually attempts to pull out a GI tube. It does apply to a patient who acts out violently toward himself or others despite medical treatment.

More flexibility in monitoring restrained or secluded patients
The old rule required that the condition of a restrained patient had to be assessed, monitored, and reevaluated continually. But many hospitals struggled to understand exactly what continually meant. Did it mean constantly? Periodically?

In the new rule, CMS deleted the word continually, instead deferring to hospitals to define monitoring in their policies. How­-ever, continual (meaning ongoing) monitoring is still required when restraint and seclusion are used simultaneously, when the patient requires face-to-face monitoring, or when audio and video equipment are used.

Expanded staff training requirements
Previously, all staff having direct patient contact were required to receive ongoing education and training in safe and proper use of restraints and seclusion. However, under this definition “all staff” arguably could include even nonclinical staff, such as dietary, housekeeping, and environmental services staff.

The new rule replaces “all staff” with more specific language. It mandates training only for staff members who apply restraints, implement seclusion, provide care for a restrained or secluded patient, or assess and monitor the condition of such a patient. It also increases staff training requirements.

Staff must be trained and able to demonstrate competency before they can apply restraints, implement seclusion, perform associated monitoring and assessment, or provide care for a restrained or secluded patient. They must demonstrate these competencies initially as part of orientation and subsequently on a periodic basis. Finally, individuals providing staff training must be qualified, as demonstrated by education, training, and experience in techniques used to address patients’ behaviors.

Hospitals need to review and, as needed, revise staff training policies to ensure they’re consistent with the new requirements. Training classes should be small enough to allow for hands-on training and should include only staff involved in applying restraints or seclusion and caring for restrained or secluded patients. Staff training and competencies must be documented in personnel files.

Broader documentation requirements
The old CMS rule stipulated that a restraint or seclusion order be made in accordance with a written modification to the patient’s plan of care. Fearing this could lead to loss of key information, CMS expanded documentation requirements and now requires that the following be documented in the patient’s medical record:

• 1-hour face-to-face medical and behavioral evaluation if restraint or seclusion is used to manage violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others
• description of the patient’s behavior and the intervention used
• alternatives or other less restrictive interventions attempted (as applicable)
• patient’s condition or symptoms that warranted use of restraint or seclusion
• patient’s response to the intervention, including the rationale for its continued use

Changes in death-reporting requirements
Previously, hospitals were required to report all deaths associated with use of restraint or seclusion for behavior management but not for medical care. However, hospitals sometimes struggled to determine whether to report a patient’s death because of difficulty distinguishing medical restraint from behavioral restraint. The new rule specifies that hospitals must report:

• each death that occurs in a patient who is in restraint or seclusion
• each death that occurs within 24 hours after a patient has been removed from restraint or seclusion
• each patient death known to the hospital that occurs within 1 week after restraint or seclusion if it’s reasonable to assume that restraint or seclusion contributed directly or indirectly to the death. Reasonable to assume includes (but isn’t limited to) deaths related to prolonged restriction of movement, chest compression, breathing restriction, or asphyxiation.

Also, staff must document in the patient’s medical record the date and time the death was reported to CMS. The person who makes the report must contact the CMS regional office. (For contact information, visit www.cms.hhs.gov/RegionalOffices.)

Immediate impact of the new rule
For nurses, the impact of the new rule depends on hospital size, staffing, services offered, and patient population served. Ask your supervisor whether your facility’s policies and protocols on patient restraint and seclusion have been revised. Also make sure you’re familiar with the expanded documentation requirements.

Hospital administrators need to review policies and procedures and revise them accordingly to assure they’re consistent with the new rule, if they haven’t already done so. They also must ensure that staff receive education and training not just in the rule itself but in any facility policies that have been revised to conform with it.

Selected references
71 Fed. Reg. 71378 (December 8, 2006).

42 C.F.R. § 482.13 (2006).

62 Fed. Reg. 66726 (December 19, 1997).

Jay P. Anstine, JD, is a Compliance Officer at Exempla Healthcare in Denver, Colo.