Hospitals have long been required to report deaths associated with restraints. But, questions about when to report still linger. Mostly, these questions stem from a hesitancy to report deaths for fear of their potential impact on a hospital’s liability.

In the past, hospitals were only required to report deaths that occurred in behavioral health. However, the most recent requirements – in place since 2008 – expand the types of deaths that must be reported to the Centers for Medicare and Medicaid Services (CMS) regional office. The hospital must report to its CMS regional office each death that occurs:

• While a patient is in restraint or in seclusion
• Within 24 hours after the patient has been removed from restraint or seclusion
• Within 1 week after use of restraint or seclusion where it is reasonable to assume that the use of restraint or seclusion contributed directly or indirectly to the patient’s death. “Reasonable to assume” applies only to those deaths that occur on days 2-7 after restraint or seclusion has been discontinued. [42 CFR §482.13(g)]

Not surprisingly, regional offices have seen an increase in the number of reports from hospitals since the requirement went into effect. CMS understands that by using these criteria, the number of deaths in restraints will increase, primarily because many critically ill patients are intubated and in restraints at the time of death for unrelated reasons. However, the intent of CMS is to capture cases in which the cause of death is less certain or when there is a potentially causative relationship between the death and restraint. These are the cases that may trigger a complaint survey. And, if a survey does result from a restraint-associated death, it helps to be prepared.

“When should I expect surveyors to arrive if they are coming?”
This continues to be a common question amongst hospital quality leaders and managers. Though it cannot be answered with certainty, familiarity with the survey process can take some of the mystery out of preparing for such a visit when it does occur.

Surveyor procedures revised in July of 2009, outlined the timeline for processing reports received by the CMS regional offices. All death reports received as a requirement of 42 CFR §482.13(g) will be processed as follows:

• The report from the hospital will be received by the regional office and the worksheet completed.
• The regional office will evaluate the case to see if it might involve a violation of relevant standards.
• The regional office will authorize an on-site investigation if there appears to be a possible violation.
• Within 2 working days of receiving the report, the regional office will immediately notify the State agency to authorize a complaint survey.
• The State agency should complete the investigation within 5 working days of receipt of survey authorization from the regional office.

Depending on the day the report is submitted and the relative number of reports at the regional office, surveyors could arrive in as little as one day. Generally, surveyors will arrive within 10 days of the receipt by the regional office.

Preparing for Survey
If a complaint survey looms in your future, you can use the time between report and survey to address the issues that could have contributed to the death or restraint use. Even for events that seem to be unrelated to the use of restraints, it is important to take the following actions in anticipation of survey.

• Evaluate the actual event to assure that all documentation is available to surveyors.
• Examine the charts of other individuals restrained at the same time as the source patient.
• Update restraint and seclusion data, and make it available to the surveyors.
• Review current charts of patients in restraints. Coach staff members to ensure that records are completed accurately in real time. Pay attention to:
• Documentation of alternatives tried prior to restraint use
• Documentation of a physician order consistent with the requirements
• Documentation by the physician of the need for restraint
• Documentation of assessment and reassessment, including the ongoing assessment of the need for continuation of restraint
• Addition of restraint or seclusion to the patient’s care plan
• Assure that competencies for the use of restraints documented in the files of all appropriate staff members. If competency files are stored separate from other HR files, assure that these portions come together during survey.
• For patients in restraint for violent, self-destructive behaviors, assure that compliance with all applicable standards is documented and that documentation is easily accessible during survey.

During any visit by state surveyors, remember that all standards are written with the goal of establishing a minimum standard for patient safety. Therefore, surveyors expect 100% compliance, 100% of the time. And remember, if things do not go as planned, you can reach out to the team at Compass Clinical Consulting for questions or advice to survive the survey.

To find your CMS regional office, click here.