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EDMUND G. BROWN JR.
Governor

State of California—Health and Human Services Agency
California Department of Public Health


AFL 20-21
March 11, 2020


TO:
All Hospitals and Critical Access Hospitals with Psychiatric or Rehabilitative Distinct Part Units

SUBJECT:
New Electronic Process for Hospitals to Report a Death Associated with Restraint or Seclusion
(This AFL supersedes AFL 14-15)

AUTHORITY:    ​Quality, Safety, & Oversight Group Letter 20-04 and Title 42 of the Code of Federal Regulations (CFR) Section 482.13(g)


​All Facilities Letter (AFL) Summary

This AFL notifies hospitals of changes the Centers for Medicare and Medicaid Services (CMS) has made to the reporting procedure for patient deaths associated with restraint and seclusion. CMS no longer accepts paper versions of form CMS-10455. Hospitals must use the new electronic process to complete and submit E-Form CMS-10455.

CMS has transitioned from a paper form to an electronic process for reporting deaths associated with restraint or seclusion. Effective January 1, 2020 the CMS Regional Office (RO) resource mailboxes stopped accepting paper versions the CMS-10455. CMS will only accept electronically submitted CMS-10455. If CMS receives a paper version of the CMS-10455, the CMS RO mailbox will trigger an automatic reply requesting the hospital use the electronic form to submit their death report. 

The new electronic process features automatic submission of the CMS-10455 to the CMS RO that ensures a more reliable report transmission and timely reporting of instances of death associated with restraints and/or seclusion. The E-Form also features enhanced categories to collect information related to the death associated with restraint and/or seclusion. CMS will use the enhanced categories of information being reported on the E-Form and the regulatory requirements in Title 42 CFR 482.13(g) to determine whether authorization of an onsite survey is warranted as well as to provide rationale for their decisions.

 

Reporting Requirements

Title 42 CFR 482.13(g), requires hospitals to report the following deaths associated with restraint and seclusion directly to CMS no later than the close of business on the next business day following knowledge of the patient's death and document in the patient's medical record the date and time the death was reported to CMS:

  • 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. “Reasonable to assume” in this context includes, but is not limited to, deaths related to restrictions of movement for prolonged periods of time, or death related to chest compression, restriction of breathing, or asphyxiation.

Hospitals must record deaths when no seclusion has been used and when the only restraints used on the patient are those applied exclusively to the patient's wrist(s), and which are composed solely of soft, non-rigid, cloth-like materials, in an internal log or other system:

  • Any death that occurs while a patient is in such restraints.
  • Any death that occurs within 24 hours after a patient has been removed from such restraints.

Entries into the internal log or other system must be documented as follows:

  • Each entry must be made not later than seven days after the date of death of the patient.
  • Each entry must document the patient's name, date of birth, date of death, name of attending physician or other licensed practitioner who is responsible for the care of the patient, medical record number, and primary diagnosis(es).
  • The information must be made available in either written or electronic form to CMS immediately upon request.

 

E-Form CMS-10455: Location and Resources

E-Form CMS-10455 is located on the CMS Report of a Hospital Death Associated With the Use of Restraint or Seclusion webpage. Hospitals can also access the form by entering the following URL in their browser:

https://restraintdeathreport.gov1.qualtrics.com/jfe/form/SV_5pXmjIw2WAzto8J 

The electronic process guides users through entering the reporting information. Hospitals have the option of downloading a PDF of the completed CMS-10455 from the submission confirmation page. 

The CMS training webpage for Form CMS-10455 contains informational resources, including a brief instructional video on how to complete and submit the electronic form. CDPH recommends that hospitals review the instructional video and resources. 

See CMS Quality, Safety & Oversight Group letter 20-04 for details about the new electronic form and process. If there are any questions or concerns regarding this information, contact CMS at QSOG_Hospital@cms.hhs.gov

 

Sincerely,

Original signed by Heidi W. Steinecker

Heidi W. Steinecker
Deputy Director

 

Resources

E-Form CMS-10455
CMS training webpage for E-Form CMS-10455
CMS Quality, Safety & Oversight Group letter 20-04

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