Failure to Maintain Bed System Safety and Compliance with FDA Guidelines
Penalty
Summary
The facility failed to ensure that bed systems, including bed frames, mattresses, and bed rails, were regularly inspected and maintained in accordance with FDA guidelines and the facility's own policies and procedures. For three residents who used bilateral side rails, measurements of gaps in the bed systems were found to exceed the maximum allowable dimensions for several entrapment zones, specifically Zones 1, 2, and 4. These measurements were verified by the Central Supply Supervisor and were not within the 4.75-inch limit established by the FDA and referenced in the facility's Bed Safety policy. There was no documentation to show that corrective actions were taken to address these out-of-range measurements. For one resident, the Bed Safety Checklist showed Zone 1 and Zone 2 gaps measured 10.5 inches and 10 inches, respectively, both exceeding the recommended maximum. Another resident's checklist showed Zone 1 at 10.5 inches, Zone 2 at 10 inches, and Zone 4 at 5.5 inches, all above the allowable limits. A third resident had a Zone 2 gap of 9.5 inches, also exceeding the standard. In each case, the Central Supply Supervisor confirmed the measurements and acknowledged that there was no evidence of follow-up or correction. Additionally, interviews revealed that there was no regular schedule or log for bed maintenance, and the Maintenance Director, who was responsible for these tasks, was unavailable for interview. The residents involved had orders and care plans in place for the use of side rails as enablers to promote independence, bed mobility, or for seizure precautions. Informed consent was documented where appropriate, and residents or their representatives were aware of the risks and benefits of side rail use. However, despite these measures, the facility did not ensure that the physical safety standards for bed systems were met, as required by both internal policy and federal guidance. Facility leadership, including the Assistant Administrator and DON, verified and acknowledged the findings during the survey.