Restraints
To Report or Not to Report – That is the Question
Since the Centers for Medicare and Medicaid Services (CMS) announced its final rule regarding the Conditions of Participation for Patient Rights in November 2006, there has been confusion over the expectations regarding the reporting of restraint deaths. In the past, reporting of deaths during the use of restraints was required for patients in behavioral settings, and in some states, in other hospital settings. The new rules have greatly expanded the expectations for all hospital settings.
Relevant Regulations
The final Conditions of Participation for Patient Rights were released on December 8, 2006, and can be found in the Federal Register. On page 71416, the discussion outlined the expectations for reporting, which include:
- Each death that occurs while a patient is in restraint or in seclusion
- Each death that occurs within 24 hours after the patient has been removed from restraint and seclusion
- Each death known to the hospital that occurs within 1 week after restraint (whether physical restraint or drugs used as a restraint) or seclusion, in cases in which it is reasonable to assume that use of restraint or placement in seclusion contributed, directly or indirectly, to a patient’s death
- For clarity, “reasonable to assume” has been defined as:
- Deaths related to restrictions of movement for prolonged periods of time
- Deaths related to chest compression, restriction of breathing, or asphyxiation
- Each death must be reported to CMS by telephone no later than the close of business the next business day following knowledge of the patient’s death.
- Staff must document in the patient’s medical record the date and time the death was reported to CMS.
Patient Examples
Based on the restraint reporting requirements, the following deaths would be reported to CMS:
- Death of patients on ventillators in the ICU that have been in restraints
- Patient deaths in the ED held in seclusion or restraint.
- Death of patients extubated and transferred to a medical unit within the last 24 hours.
- Death of a patient within one week of a “take down” that resulted in a chest injury, such as broken ribs that impaired breathing
Situations that would not need to be reported include:
- Death of a ventilated patient that only required alternatives to restraint or 1:1
- Patients receiving an injury during restraint or seclusion (but did not die)
- Death of a patient from AMI one week after restraints were removed and the patient extubated and discharged from the ICU
Path to Compliance and Recommendations from Compass Group
Achieving compliance rests in assuring that three things occur:
- Reportable deaths are identified.
- Reporting occurs within the established timeframe.
- Notification is documented appropriately.
Identifying Reportable Deaths
Screening all deaths for applicability can occur at the same time as staff screen patients for referral to the local coroner. Consider the modification of an existing death care checklist to include the following questions:
- Was the patient in restraint or seclusion at the time of death?
- Was restraint or seclusion used at any time during the admission?
Charts with answers in the affirmative are further reviewed by the supervisors to differentiate whether the patient met the 24-hour or 7-day expectations outlined above. The secondary screen eliminates the need to teach a large number of individuals precise criteria that will be infrequently used. Using supervisors to complete a secondary screen controls the number of individuals required to apply the criteria. It also increases the chance of compliance as nursing supervisors are commonly aware of all deaths in the organization.
Reporting Deaths Within 24 Hours
- Utilizing the death care checklist can also serve as a secondary check for assuring that all deaths are reported appropriately. The presence of a nursing supervisor as the double check mechanism can serve as a 24/7 resource for assuring prompt notification.
- Regardless of the method chosen for assuring notification, make sure that the phone number (and fax, if applicable) is available within the policy to provide quick reference to the correct number for use in reporting to the regional CMS office.
Notification Documentation
Documentation of notification can occur on the death care checklist as long as this remains a permanent part of the record. Documentation on a central resource also makes compliance monitoring easier.
Next Steps
To assure compliance in all areas of the organization, the following actions are recommended:
- Update policy to reflect expectations in all areas of the organization.
- Update any relevant documentation tools and checklists.
- Educate relevant groups on their roles and responsibilities relative to these expectations.










