Medicare Oversight Entities Miss Opportunities to Address Patient Safety

Medicare’s system of hospital oversight missed opportunities to address patient safety in its response to alleged serious adverse events, such as medication and surgical errors, physical abuse by hospital staff, and patient suicide, according to a recent Office of Inspector General (OIG) report that examined the responses of state survey and certification agencies, Medicare accreditors, and CMS to allegations of adverse events in hospitals and identified opportunities for Medicare oversight entities to improve the quality of oversight and responses to adverse events.

OIG’s review of responses to adverse events in hosptitals was mandated by the Tax Relief and Health Care Act of 2006 (TRHCA), which requires OIG to study serious reportable events and their impact on Medicare beneficiaries and program costs. Over the past fews years, OIG”s annual Work Plans include the following reviews:

  • the type of information hospitals’ internal incident-reporting systems capture about adverse events and the extent to which hospital systems captured adverse events and reported the information to external patient-safety oversight entities;
  • adverse health care events among Medicare beneficiaries in inpatient hospital settings to estimate the national incidence of such events, identify types of adverse events experienced by beneficiaries in hospital settings, and assess the extent to which serious reportable events and other adverse events were preventable as determined by a panel of physicians with expertise in patient safety;
  • the following methods hospitals use to assess their utility: medical record reviews by both nurses and physicians, administrative data analysis using the Agency for Healthcare Research and Quality’s patient safety indicators and present-on-admission indicators, hospital incident reports, and interviews with Medicare beneficiaries or their representatives;
  • policies and practices of CMS and selected patient safety organizations for disclosing information about adverse health care events as well as associated protections intended to ensure patient privacy. The TRHCA requires that OIG recommend potential processes for public disclosure ofadverseevents that will ensure patient privacy and allow for root-cause analysis.

OIG found that:

  • Generally, state agency responses to complaints alleging serious adverse events were timely and often found problems. For 75 of the 95 alleged events in the OIG sample, state agencies conducted complaint surveys at hospitals within two days, as required. For 53 of the 95 alleged events, state agencies cited hospitals for federal deficiencies while investigating the events.
  • State agencies and CMS missed opportunities to incorporate patient safety principles in their responses. For complaint surveys at accredited hospitals, CMS directed state agencies to assess the CoPs on performance improvement in only 33 of the 78 surveys and the CoP on the hospital’s governing body in only 12. State agencies performed little longer term monitoring to verify that hospitals’ corrective actions resulted in sustained improvements. After completing complaint surveys, state agencies required the hospitals to submit performance data for only one of the 19 complaints that required corrective action plans. State agencies did not always disclose the nature of complaints to hospitals, thus limiting hospitals’ ability to learn from alleged events.
  • CMS informed the Joint Commission of few complaints, impeding the Joint Commission’s oversight of its accredited hospitals. CMS regional offices notified accreditors of only 28 of the 88 sampled complaints against accredited hospitals.
  • Hospitals investigated most complaints in OIG’s sample, finding state agency responses valuable but disruptive. Hospitals reported being aware of 87 of the complaints in the sample and investigated 75 of them, beginning two-thirds of their investigations before state agencies arrived to conduct their onsite complaint surveys. Hospitals’ investigations were multidisciplinary and often involved hospital leadership. Hospitals found that state agency responses lent urgency but also disrupted their own responses.
  • Hospital corrective actions resulted largely in training coupled with policy and process changes. Hospitals also took disciplinary actions, such as firing staff, in one-third of complaints resulting in corrective actions. For just under one-third of complaints resulting in corrective actions, the corrective 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

OIG recommended that CMS:

  • require that all immediate jeopardy complaint surveys evaluate compliance with the CoPs on quality assurance and performance improvement and should consider limiting the initial scope of the immediate jeopardy complaint survey to this CoP and the allegation itself;
  • require state agencies to monitor corrective actions for sustained and take action when hospitals’ corrective actions fail to yield effective and sustained improvements;
  • amend guidance on disclosure to explain the nature of complaints to hospitals thus providing them with opportunities to analyze and learn from alleged adverse events;
  • ensure that its regional offices follow its policy on notifying accreditors of complaints against accredited hospitals.