May / June 2012
OIG Report Critical of CMS Handling of Serious Adverse Events
In late 2011, the Office of Inspector General (OIG) released a report that examined CMS’s response to serious adverse events in hospitals. The report, Adverse Events in Hospitals: Medicare’s Responses to Alleged Serious Events (Levinson, 2011), concludes that “Medicare’s system of hospital oversight missed opportunities to address patient safety in its response to alleged serious adverse events.”
The OIG also made specific recommendations for CMS to implement in order to improve serious event reporting, investigation, corrective processes, and, ultimately, patient safety.
The report is one of a series mandated by the Tax Relief and Health Care Act of 2006, which requires that the OIG report to Congress regarding the incidence of never events and adverse events among Medicare beneficiaries in hospitals. Medicare is charged with maintaining quality oversight of hospitals based on the Medicare Conditions of Participation (CoP), which are regulatory standards hospitals must meet to ensure minimum health and safety requirements under Medicare.
Medicare contracts with state survey and certification agencies (state agencies) to investigate complaints alleging noncompliance with the CoPs, including, as the highest priority, immediate jeopardy (IJ) complaints. IJ complaints represent the most serious adverse patient events and the greatest potential for patient harm, such as medication and surgical errors, physical abuse by hospital staff, and patient suicide.
Since there is no national database of adverse events to draw from for its evaluation, the OIG used a random sample of 95 alleged IJ complaints as a proxy for serious events to which Medicare responded. The data used in reviewing the complaints came from a variety of sources, including CMS, state survey agencies, hospital accreditors, and the associated hospitals.
OIG Report Results
The good news for CMS: The OIG found that state agency responses to IJ complaints were generally timely—within two days, as required—in 75 out of the 95 events. In addition, the OIG recognized that the state agencies did in fact find problems, citing hospitals for federal deficiencies for 53 of the 95 alleged events.
However, the rest of the OIG’s findings were quite negative. Specifically, the OIG found that state agencies and CMS:
• Frequently failed to review hospitals’ compliance with both the CoP on quality assessment and performance improvement (QAPI), which encompasses patient safety, and the CoP on the hospital’s governing board, which is responsible for ensuring QAPI at the hospital. CMS directed state agencies to assess the CoP on QAPI in only 33 of the 78 surveys and the CoP on the hospital’s governing body in only 12 instances.
• Informed The Joint Commission of only a few complaints (28 of 88), impeding The Joint Commission’s ability to oversee its accredited hospitals. This was contrary to CMS’s policy of notifying accreditors of all complaints against the hospitals they accredit.
• Performed little long-term monitoring to verify that hospitals’ corrective action plans resulted in sustained improvements. State agencies had required hospitals to submit plans of correction in response to 19 complaints, but the oversight was limited to ensuring acceptable plans were in place. CMS guidance requires that “hospitals should institute corrective actions that are effective and sustained.”
• Failed to disclose the nature of the complaints to the hospitals, thereby limiting the hospitals’ ability to learn from the alleged events. The OIG report points out that this type of limited disclosure by investigating surveyors can prevent hospitals from learning about alleged events, which may be “near misses” or “an event or situation that did not produce patient injury, but only because of chance.” Near misses are considered by patient safety experts to be important learning opportunities that can prevent recurrence.
The OIG also found that hospitals themselves investigated most of the adverse events in the sample (75) and that they found the state agency responses valuable but disruptive. In response to their internal investigations, hospitals’ corrective actions consisted primarily of training coupled with policy and process changes, but also included disciplinary actions such as firing staff as well as changes to devices, software, or work spaces designed to prevent adverse events by forcing staff into a course of action, rather than relying on their memory or adherence to procedures.
After the OIG presented its evaluation of the effectiveness of CMS and state agencies in responding to the IJ complaints in its sample, it reiterated how essential the responses of state agencies, CMS, and hospitals all are in ensuring that adverse events are addressed appropriately. In order to address the shortcomings pointed out above, the OIG recommends that CMS take the following actions:
• Require that all IJ complaint surveys evaluate compliance with the QAPI CoP. CMS identifies this CoP as central to patient safety and to a hospital’s ability to identify, track, analyze, and prevent adverse events. The OIG further suggests that CMS consider limiting the initial scope of the IJ complaint survey to this CoP and the allegation itself to enable surveyors to focus their initial efforts on investigating the complaints and how well the hospital addressed them.
• Ensure that state agencies monitor hospitals’ corrective actions for sustained improvements. After hospitals have implemented corrective actions, CMS should require state agencies to monitor the results—for example, by collecting and analyzing hospitals’ performance data or by revisiting hospitals. Furthermore, state agencies should take action when hospitals’ corrective actions fail to yield effective and sustained improvements.
• Amend guidance on disclosure by the survey teams to explain the nature of complaints to hospitals. The OIG recommends that CMS explore ways to improve communication with hospitals during complaint surveys, with the thought being that “to maximize the opportunities for hospitals to learn from the complaints being investigated, the hospitals must know something about the nature of the complaints,” and “a culture of learning—for example, learning from adverse events as well as from near misses—is a basic principle of patient safety.”
• Improve communication with accreditors. Specifically, CMS should ensure that state agencies comply with its policy on notifying accreditors of complaints against accredited hospitals (i.e., clarify its instructions and educate office staff on how and when to notify accreditors).
CMS Response to the OIG Report Findings
CMS concurred with the OIG report and its recommendations in a five-page response that lays out some changes CMS will make to improve performance and outcomes:
• Increase the prominence of the CoP on QAPI in complaint surveys.
• Enhance the monitoring of the efficacy of corrective actions.
• Improve communication with hospitals at the beginning of complaint surveys.
• Collaborate with regional offices to improve compliance with CMS’ policy to notify accreditation organizations of complaints.
Implications for Hospitals and Other Providers
This OIG report and recommendations crystallize precisely how patient safety and compliance are evolving. Gone are the days when a mere action plan can be submitted to a state survey agency and forgotten without being fully implemented and monitored for success, failure, or the need for modification. Hospitals can expect that following an initial acceptance of a plan of correction, the state agency may require progress reports on corrective action plan implementation.
A hospital should also ensure that its board of directors is fully informed of IJ complaints and adverse events as well as action plans and responses, and that the board is routinely informed about the status of the hospital’s quality improvement program. Board minutes should reflect the communication to the board and any suitable follow-up requested by the board to the CEO, chief operating officer, chief nursing officer, chief compliance officer, quality improvement director, or other appropriate personnel.
Finally, hospitals should carefully reflect on their disclosure obligations to The Joint Commission or other accreditation agencies. Hospitals should not put themselves in the unenviable position of having an adverse event reported to The Joint Commission by a state survey agency, which then triggers a Joint Commission visit or inquiry. Hospitals should carefully consider whether that information would best come from the hospital to The Joint Commission. ?
Renee Martin is a member of the healthcare law firm Tsoules, Sweeney, Martin & Orr, LLC, located in Exton, Pennsylvania. Martin is a member of the Editorial Advisory Board for Patient Safety & Quality Healthcare and may be contacted at