This All Facilities Letter (AFL) is being sent to notify hospitals of changes to the reporting procedures for patient deaths associated with the use of restraints or seclusion.

Previously, hospitals reported each death that occurred while a patient was in restraint or seclusion, each death that occurred within 24 hours after the patient was removed from restraint or seclusion, and each death known to the hospital that occurred within one week after restraint or seclusion of the patient.

As of November 2013, the new reporting form CMS 10455 (attached) modifies the reporting requirement related to hospital deaths associated with the use of restraint or seclusion. Hospitals are no longer required to report deaths to CMS if there was no use of seclusion and the only restraint was 2-point soft wrist restraints (CFR Section 482.13(g)). Hospital staff must now record the incident in an internal log or other system. In addition, the final rule replaced the previous requirement for reporting via telephone, with a requirement that allows submission of reports via telephone, facsimile, or mail. E-mail is not an acceptable means of reporting.

Hospitals must report the following deaths associated with restraint and seclusion directly to their CMS regional office no later than the close of business on the next business day following knowledge of the patient's death:

• Each death that occurs while a patient is in restraint or seclusion, excluding those in which only 2-point soft wrist restraints were used and the patient was not in seclusion at the time of death;

• Each death that occurs within 24 hours after the patient has been removed from restraint or seclusion, excluding those in which only 2-point soft wrist restraints were used and the patient was not in seclusion within 24 hours of their death; and

• Each death known to the hospital that occurs within one week after restraint or seclusion where it is reasonable to assume that use of restraint or placement in seclusion contributed directly or indirectly to a patient's death, regardless of the type(s) of restraint used on the patient during this time.

Hospitals must record in an internal hospital log or other system those deaths that occur in the circumstances listed below. Hospitals are not required to send reports of these deaths directly to the regional office:

• Each death that occurs while a patient is in restraint but not seclusion and the only restraints used on the patient were applied exclusively to the patient's wrist(s) and were composed solely of soft, non-rigid, cloth-like materials; and

• Each death that occurs within 24 hours after the patient has been removed from restraint, when no seclusion has been used and the only restraints used on the patient were applied exclusively to the patient's wrist(s) and were composed solely of soft, non-rigid, cloth-like materials.

The log entry must be made no later than seven days after the date of death of the patient. The log must include the information specified in 42 CFR Section 482.13(g)(4)(ii), which includes:

• Patient's name
• Date of birth
• Date of death
• Name of attending physician or other licensed independent practitioner who is responsible for the care of the patient
• Medical record number, and
• Primary diagnosis(es).

The following must also be documented in the patient's medical record for any patient whose death is associated with the use of restraint or seclusion:

• The date and time the death was reported to CMS for deaths required to be directly reported; and
• The date and time the death was recorded in the hospital's internal log or other system for deaths that are required to be logged and not directly reported to CMS.

The CMS 10455 form may be found at the Centers for Medicare and Medicaid website: (http://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/Downloads/CMS10455.pdf)

If you have additional questions, please contact Chelsea Driscoll, Chief, Policy Section, at Chelsea.Driscoll@cdph.ca.gov or (916) 552-8778.

Sincerely,

Original signed by Jean Iacino

Jean Iacino
Interim Deputy Director
Center for Health Care Quality

Attachments

Form CMS-10455

Hospital Restraint/Seclusion Death Reporting