CMS Pushed to Improve Reporting on Adverse Events

A new Office of Inspector General report criticizes the Centers for Medicare & Medicaid Services for failing to notify accreditation agencies, such as the Joint Commission, in two out of three sampled cases involving serious adverse events in hospitals. These include immediate jeopardies such as medication and surgical errors, physical abuse by hospital staff, and patient suicide.

"CMS regional offices notified accreditors of only 28 of the 88 sampled complaints against accredited hospitals," the report says.

In an interview with HealthLeaders Media, Patricia Kurtz, director of federal relations for the Joint Commission, which accredits most of the nation's hospitals, said the agency was pleased at the OIG's findings and had been concerned about the lack of notification from CMS.

"We want to know about these because it gives us the overarching picture of performance of the entities we're accrediting. And we use these on the next survey," she says.

Kurtz says that in her seven years at the organization, the commission "has asked many times for CMS to send us this information on a timely basis." While about three of the 10 regional offices have been reliable, she says, the others have been less so. "some we don't hear from on a timely basis. I wouldn’t say we’re ignored, rather it is probably not high on their list of priorities."

However, the OIG report notes that CMS' policy explicitly state the obligation to notify accreditation agencies in the event of serious adverse events that could affect accreditation status.

Additionally, the OIG found that CMS and the state agencies that conduct investigations on CMS' behalf have "missed numerous other opportunities to incorporate patient safety principles" such as requiring longer term monitoring.

For example, the state agencies that conduct complaint investigations on behalf of CMS were not directed by the federal agency to assess the hospitals' adherence to CMS' conditions of participation in more than half of the adverse event cases. And state agencies conducting these surveys for CMS "required the hospital to submit performance data for only one of the 10 complaints that required corrective action plans," the OIG report says.

Nor do the state agencies review hospitals' compliance with conditions of participation on quality assessment, performance improvement, or the hospital's governing body.

The state agencies perform "little longer term monitoring to verify that hospitals' corrective actions resulted in sustained improvements, and sometimes failed to disclose the nature of the complaints to hospitals, thereby limiting hospitals' ability to learn from alleged events," the report says.

In a five-page response, CMS administrator Donald Berwick, MD, concurred with the OIG report and its recommendations.

Of note, Berwick wrote, the agency will "improve the ability of surveyors to identify problems in a hospital's compliance with the CMS regulatory requirement that every hospital have an effectively functioning internal quality assessment and performance improvement system."

Among the OIG report's other findings were these:

• Hospitals took one or more corrective actions in response to each of 64 complaints. But hospitals took disciplinary actions, such as firing staff, in just one-third of complaints resulting in corrective actions.
• And for just under one-third of complaints resulting in corrective actions, the actions included changes to devices, software, or workspaces designed to prevent adverse events by "forcing staff into a course of action, rather than relying on their memory or adherence to procedures."
• Hospitals reported being aware of 87 of the complaints in the sample and investigating 75 of them, beginning two-thirds of their investigations before state agencies arrived. However, the OIG says, "hospitals found that state agency responses lent urgency but also disrupted their own responses."

The OIG recommends the following changes in practice:

• CMS should require that all immediate jeopardy complaint surveys evaluate compliance with the CMS' Condition of Participation on quality assurance and performance improvement.
• CMS should ensure that state agencies monitor hospitals' corrective actions for sustained improvements. After hospitals have implemented corrective actions, CMS should require state agencies to collect and analyze hospitals' performance data and/or revisit the hospitals, and state agencies should take action when hospitals' corrective actions fail to yield effective and sustained improvements.
• CMS should improve disclosure to explain the nature of complaints to hospitals.
• CMS should ensure that regional offices follow policy on notifying accreditors of complaints.