Restraints: High-risk processes with significant exposure

The use of restraints and seclusion is among the most highly regulated and scrutinized clinical practices in healthcare. Federal regulators, accrediting bodies, and state agencies consistently identify restraint management failures as a source of serious patient harm, litigation exposure, and condition-level citations. Recent civil and criminal actions further underscore the risk when restraint use is not tightly governed, clinically justified, and continuously monitored. 

Why restraints represent high-risk clinical practice 

Under the Centers for Medicare & Medicaid Services Patients’ Rights Condition of Participation (42 CFR §482.13), patients have the right to be free from restraints or seclusion used for coercion, discipline, convenience, or retaliation. CMS considers restraints and seclusion to be high-risk, last-resort interventions, permitted only to ensure immediate physical safety and required to be discontinued at the earliest opportunity. 

CMS defines a restraint broadly as any manual, physical, or mechanical device that restricts a patient’s freedom of movement. This definition includes chemical restraints when medications are used to control violent or self-destructive behavior rather than to treat a medical condition. Because of the inherent risk of physical injury, psychological harm, and clinical deterioration, CMS requires 100% compliance with restraint-related regulatory standards. 

Key regulatory expectations 

Healthcare organizations must demonstrate consistent adherence to several foundational requirements, including: 

• Clear clinical justification for each restraint episode 
• Appropriate ordering authority, consistent with federal, state, and organizational policies 
• Time-limited orders renewed within age-based regulatory parameters 
• Face-to-face provider evaluation within one hour of initiating violent or self-destructive restraints 
• Ongoing monitoring and reassessment documentation with frequency based on restraint type 
• Competency-based staff training 
• Mandatory reporting of restraint-related injuries and deaths in accordance with CMS and state requirements 

Failure to meet these expectations exposes organizations to immediate jeopardy citations, condition-level deficiencies, corrective action plans, potential loss of CMS participation, and significant legal liability. 

Emerging risk signals: Recent legal and regulatory actions 

Recent regulatory and legal actions demonstrate that restraint-related failures are increasingly viewed as systemic patient rights and safety violations rather than isolated documentation issues. Civil litigation exposures such as wrongful death and negligence claims may occur when patients are in restraints for an extended period. Allegations commonly cite failures to recognize medical deterioration when behavior is incorrectly attributed to psychiatric causes. Additionally, organizations and clinicians may face criminal and fraud enforcement actions. Federal prosecutors have pursued criminal charges, including kidnapping and healthcare fraud, when restraints or chemical sedation are allegedly used to unlawfully detain patients or extend lengths of stay for financial gain. These cases signal heightened scrutiny when restraint use is perceived as coercive or inconsistent with medical necessity.  

Regulatory enforcement is also likely to follow. CMS inspections have linked prolonged restraint use, failure to discontinue restraints, missed provider evaluations, and incomplete monitoring to patient deaths. Such findings have resulted in condition-level deficiencies and immediate jeopardy determinations, placing organizations at risk for corrective action and loss of CMS participation.  

Common improvement opportunities 

Kodiak’s evaluations of restraint processes in healthcare organizations frequently identify recurring gaps in documentation, including:  

• Clinical rationale  
• Face-to-face evaluations  
• Required elements at initiation and routine intervals  
• Initial and discontinuation assessments  
• Monitoring and reassessment  

Chemical restraint use often lacks appropriate ordering. In addition, there is often a lack of defined documentation of chemical restraint use, or, when documentation is present, it does not follow the violent restraint requirements. 

Additionally, ordering deficiencies around authorization, order type, and timely renewal are often identified opportunities. Direct observation of the processes has noted: 

• Inappropriate physiological monitoring  
• Lack of dedicated and trained 1:1 staff 
• Failures to adequately assess the patient and precipitating events  

These are often the results of failing to follow organizational policy and procedures. 

Governance and risk management considerations 

Restraint oversight requires more than policy alignment—it demands operational reliability. Executive leaders and governing bodies should ensure restraint use is regularly reviewed through a risk-based lens, incorporating: 

• Targeted auditing of restraint documentation and order compliance 
• Monitoring of prolonged or repeat restraint episodes 
• Validation of staff competency and training effectiveness 
• Escalation pathways for atypical restraint patterns 
• Integration of restraint data into patient safety and compliance dashboards 

Organizations that proactively strengthen restraint governance increase patient safety, protect staff, and mitigate exposure to regulatory sanctions, litigation, and reputational damage. For more information on how Kodiak can work with you to strengthen your organization’s restraint processes and governance, contact our clinical risk and compliance experts today.