The 5 Rules of Restraint & Seclusion Small Practices Cannot Ignore (42 CFR § 482.13(e))

For small practices, compliance with the Medicare Conditions of Participation (CoPs) is often thought of in terms of documentation, billing, and patient rights. However, one of the most sensitive and heavily regulated areas is the use of restraint and seclusion. Under 42 CFR § 482.13(e), patients have the right to be free from unnecessary restraints or seclusion, and practices must meet strict requirements to ensure both patient safety and regulatory compliance.

Restraint and seclusion are high-risk interventions that, if misapplied, can result in serious harm to patients, civil monetary penalties, deficiency citations from CMS, and even loss of Medicare certification. Small practices may assume that restraint rules apply only to hospitals, but CMS expects all Medicare-participating facilities to follow these requirements whenever restraints or seclusion are used.

This article breaks down the five core rules of restraint and seclusion compliance, explains common pitfalls, provides a compliance checklist, and outlines best practices to help small practices remain aligned with CoPs while ensuring safe, dignified patient care.

Understanding Restraint & Seclusion Under § 482.13(e)

• Restraint: Any manual method, physical or mechanical device, or material that restricts a patient’s freedom of movement.

• Seclusion: The involuntary confinement of a patient alone in a room or area where they are physically prevented from leaving.

The regulation requires that both restraint and seclusion be used only when necessary to ensure the safety of the patient or others, and never as punishment, discipline, or convenience.

• Restraints and seclusion can only be applied when less restrictive interventions have failed and must use the least restrictive technique effective for safety (42 CFR § 482.13(e)(3)).

• They must never be used for staff convenience or as a substitute for proper staffing.

• Documentation must demonstrate attempts at alternatives such as verbal de-escalation, environmental adjustments, or patient redirection.

Example: A patient becoming agitated in a waiting room should first be managed with calming techniques or a private space before restraints are considered.

• Restraints and seclusion require a written order from a physician or licensed practitioner.

• Standing or PRN (“as needed”) orders are not allowed.

• Orders must specify the type of restraint, reason, duration, and must be incorporated into the patient’s written plan of care (42 CFR § 482.13(e)(4)).

• Orders are time-limited (e.g., 4 hours for adults, 2 hours for children/adolescents, and 1 hour for young children).

• Patients placed in restraints or seclusion for violent or self-destructive behavior must be seen face-to-face within one hour by a physician, licensed practitioner, or trained registered nurse to evaluate their situation and determine if restraint should continue (42 CFR § 482.13(e)(12)).

• If the attending physician did not issue the order, they must be consulted as soon as possible (42 CFR § 482.13(e)(7)).

Failure to obtain proper authorization is one of the most common causes of CoP citations.

• Patients placed in restraints or seclusion must be continuously monitored for physical and psychological well-being.

• Monitoring can be in-person or via trained staff observation, but it must be documented.

• Assessments must include circulation, breathing, hydration, nutrition, toileting, and comfort.

• Hospitals must also report any patient death occurring during restraint or seclusion, within 24 hours of removal, or within one week if related, to CMS by the next business day, or log such events if only soft wrist restraints were used (42 CFR § 482.13(g)(1)–(2)).

Compliance Tip: Create monitoring logs with time-stamped observations every 15 minutes to ensure audit readiness.

• After release, the patient must undergo a debriefing session with staff to discuss the event and prevent recurrence.

• Staff must document:

• Circumstances leading to restraint or seclusion.

• Alternative interventions attempted.

• Duration and type of restraint.

• Patient condition during and after.

• Documentation must be placed in the patient’s medical record and grievance log if the patient files a complaint.

• All staff who may be involved in restraint or seclusion must undergo initial and annual training.

• Training must cover:

• Recognizing escalation and applying alternatives.

• Safe application and removal of restraints.

• Monitoring requirements.

• CPR and emergency response.

• Training records must be available during CMS surveys.

Case Example: A behavioral health clinic was cited after surveyors discovered staff had not been retrained on restraint protocols for over two years. Corrective actions required immediate retraining, competency testing, and reporting to CMS.

A small rural clinic serving behavioral health patients was investigated after multiple complaints were filed regarding its use of physical restraints. During a CMS survey, inspectors discovered that staff frequently applied restraints to patients who were verbally agitated but not physically threatening themselves or others.

Key Findings

• No documented alternatives attempted: Records showed that verbal de-escalation or environmental modifications were not attempted before restraints were applied.

• Standing orders used: Physicians had left standing orders authorizing restraint use “as needed,” which directly violated the time-limited order requirement under § 482.13(e).

• Lack of continuous monitoring: Patients placed in restraints were not consistently monitored; in some cases, logs showed gaps of over an hour between staff observations.

• Missing debriefings: After restraints were removed, staff failed to conduct or document patient debriefings.

Consequences

• The clinic received deficiency citations under § 482.13(e) for improper restraint practices.

• CMS required submission of a corrective action plan, including:

• Immediate elimination of all standing orders for restraints.

• Mandatory retraining of staff in de-escalation techniques and proper documentation.

• Implementation of 15-minute monitoring logs.

• Appointment of a compliance officer to oversee restraint and seclusion cases.

• Beyond regulatory penalties, the clinic suffered community trust issues, as patients and families expressed fear of mistreatment.

Lessons Learned

This case underscores that:

• Restraints must only be used as a last resort, after less restrictive alternatives fail.

• Standing or PRN orders are never allowed.

• Continuous monitoring and detailed documentation are essential to protect both patients and the practice.

• A culture of patient dignity and de-escalation must be prioritized over convenience.

1. Improper Orders

• Accepting PRN orders instead of time-limited ones.

• Solution: Educate providers and enforce electronic alerts in EHR systems.

2. Lack of Continuous Monitoring

• Failing to document frequent checks.

• Solution: Use pre-formatted logs and assign dedicated monitoring staff.

3. Using Restraints for Convenience

• Applying restraints when patient behavior is inconvenient but not dangerous.

• Solution: Implement strong de-escalation protocols.

4. Training Gaps

• New hires, or long-term staff, not retrained annually.

• Solution: Incorporate restraint competency into mandatory annual training.

5. Failure to Debrief

• Skipping debrief sessions with patients.

• Solution: Create a mandatory debrief form that must be completed before case closure.

Building a Culture of Patient-Centered Compliance

Beyond rules and checklists, successful small practices must foster a culture where restraint and seclusion are recognized as extraordinary interventions. Key strategies include:

• Encouraging staff to escalate concerns early before situations require restraint.

• Involving patients and families in care planning to identify triggers and alternatives.

• Regularly reviewing incidents in staff meetings to learn from patterns.

• Creating accountability by assigning a compliance officer to oversee restraint practices.

Under 42 CFR § 482.13(e), restraint and seclusion compliance is non-negotiable. For small practices, building a program around the **five rules of last resort use, physician’s orders, continuous monitoring, documentation and debriefing, and staff training **is essential to protecting patients and surviving CMS audits.

By developing clear policies, training staff, and prioritizing patient dignity, small practices can not only avoid citations but also transform their approach to care. In doing so, they align compliance with compassion, ensuring that restraint and seclusion remain interventions of absolute last resort.

To further strengthen your compliance posture, consider using a compliance regulatory tool. These platforms help track and manage requirements, provide ongoing risk assessments, and keep you audit-ready by identifying vulnerabilities before they become liabilities, demonstrating a proactive approach to regulators, payers, and patients alike.

1. 42 CFR § 482.13(e) – Condition of Participation: Patient Rights (Restraint & Seclusion). Legal Information Institute

2. Centers for Medicare & Medicaid Services (CMS) – Interpretive Guidelines on Patient Rights

3. Office of Inspector General (OIG) – Compliance Guidance for Individual and Small Group Practices