HospitalInspections.org

Based on policy and procedure review, medical record review, administrative document review, and interview, the facility failed to timely report, and document in the medical record, a restraint associated death for 1 of 1 patients meeting the reporting requirements (#1).

Findings included:

1. The facility's policy #5.02, Use of Restraints, effective date August 2013, indicated, "E. Injury or Death Potentially Related to Restraints: 1. The hospital will comply with all internal logging and reporting requirements of CMS and regulatory bodies. [Facility] will report the following to the CMS Regional Office, no later than the close of business on the next business day following knowledge of the event. Reporting will include: a. Death of a patient while in restraint. b. Death of a patient within 24 hours of removal of restraint. ...d. In a. & b. above, if the only restraints used were those applied exclusively to the wrists and are composed solely of soft, non-rigid, cloth-like materials, the deaths need not be reported to CMS, but instead recorded in an internal log. Log entries must be made no later than 7 days after the date of the death. e. Each entry in the internal log will include patient name, date of birth, date of death, name of attending physician responsible for care, medical record number, and diagnosis (es). f. Associate Administrators will notify the Quality Department of deaths meeting the above criteria. g. The Quality Department will be responsible for reporting to CMS and maintaining the internal log."

2. The medical record for patient #1 indicated bilateral soft wrist restraints were applied at 2147 hours on 09/25/14 because the patient was agitated and pulling at tubes and oxygen equipment. At 1100 hours on 09/26/14, a Soma safe enclosure bed was added due to confusion, agitation, and trying to get out of bed without supervision. The medical record indicated the bilateral soft wrist restraints were removed on 09/27/14 at 1700 hours. The Soma bed was utilized until the patient's death on 09/28/14 at 1724 hours. The medical record lacked documentation of the death being reported to CMS.

3. Review of the file of CMS Hospital Restraint/Seclusion Death Report Worksheets indicated 8 forms from September through December 2014, including the worksheet for patient #1. All of the forms indicated only soft wrist restraints were used except for patient #1, who also had the Soma bed used. Documentation indicated all 8 forms were submitted to CMS on 12/29/14.

4. At 10:00 AM on 01/13/15, staff member #1, the Medical Staff Quality Analyst, indicated he/she was responsible for reporting to CMS. He/she indicated he/she thought all deaths associated with restraints had to be reported, which he/she did, but indicated they were not reported within 24 hours. He/she confirmed patient #1 had soft wrist restraints and the Soma bed used and although the patient's death on 09/28/14 was not related to the restraints, it was not reported to CMS until 12/29/14. He/she indicated once the worksheet was sent to CMS, it became part of the patients's medical record, but the form was not yet in the medical record of patient #1 since it had just been submitted 12/29/14.

Based on policy and procedure review, medical record review, administrative document review, and interview, the facility failed to keep an internal restraint/death log or tracking system with all of the required information and failed to document in the patient's medical record, the logging of this information for 4 of 4 patients who died within 24 hours after removal from soft wrist restraints (#2, 3, 4, and 5) and whose charts were reviewed.

Findings included:

1. The facility's policy #5.02, Use of Restraints, effective date August 2013, indicated, "E. Injury or Death Potentially Related to Restraints: 1. The hospital will comply with all internal logging and reporting requirements of CMS and regulatory bodies. [Facility] will report the following to the CMS Regional Office, no later than the close of business on the next business day following knowledge of the event. Reporting will include: a. Death of a patient while in restraint. b. Death of a patient within 24 hours of removal of restraint. ...d. In a. & b. above, if the only restraints used were those applied exclusively to the wrists and are composed solely of soft, non-rigid, cloth-like materials, the deaths need not be reported to CMS, but instead recorded in an internal log Log entries must be made no later than 7 days after the date of the death. e. Each entry in the internal log will include patient name, date of birth, date of death, name of attending physician responsible for care, medical record number, and diagnosis (es). f. Associate Administrators will notify the Quality Department of deaths meeting the above criteria. g. The Quality Department will be responsible for reporting to CMS and maintaining the internal log."

2. Review of the medical records lacked documentation that the deaths were recorded in an internal log for the following:
A. Patient #2 had bilateral soft wrist restraints removed on 12/24/14 at 1945 hours and expired on 12/24/14 at 2115 hours.
B. Patient #3 had bilateral soft wrist restraints removed on 12/19/14 at 1755 hours and expired on 12/19/14 at 1834 hours.
C. Patient #4 had bilateral soft wrist restraints removed on 10/03/14 at 1700 hours and expired on 10/04/14 at 1636 hours.
D. Patient #5 had bilateral soft wrist restraints removed on 09/29/14 at 1200 hours and expired on 09/29/14 at 1435 hours.

3. Review of the file of CMS Hospital Restraint/Seclusion Death Report Worksheets indicated 8 forms, including forms for patients #2, 3, 4, and 5, from September through December 2014. The forms lacked the physician name and patient's medical record number. All of the forms indicated only soft wrist restraints were used. Documentation indicated all 8 forms were submitted to CMS on 12/29/14

4. At 10:00 AM on 01/13/15, staff member #1, the Medical Staff Quality Analyst, indicated he/she was responsible for reporting to CMS and maintaining the records. He/she indicated he/she thought all deaths associated with restraints had to be reported, which he/she did, but indicated they were not reported within 24 hours. Staff member #1 also indicated he/she kept all of the CMS Hospital Restraint/Seclusion Death Report Worksheets, but did not have an actual internal log. He/she indicated the worksheets became part of the patient's medical record after they were submitted to CMS. He/she confirmed they were not part of the medical record for the patients reviewed because the worksheets had just been submitted 12/29/14.