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Adverse Event Reporting – What’s Required

By November 14, 2019On the Radar

Recently we published an item highlighting the changes the Joint Commission made with their Sentinel Event Definitions.  We have received some questions on what reporting is required and are taking this opportunity to explain this further. Sentinel or adverse event reporting is not always required by accreditors or states. Reporting is encouraged and voluntary in many states and with The Joint Commission.  However, there are mandatory reporting requirements in some areas and this information is summarized below.

Reportable Events – Required or Voluntary

Background: In 2002, the National Quality Forum (NQF) published ‘Serious Reportable Events in Healthcare: A Consensus Report’ that provided a recommended list of standardized reportable events it hoped would be used as the basis of a national, state-based reporting system. In 2011, the list was updated, and national entities continued to utilize or adapt the list to shed light on serious reportable events and help prevent their reoccurrence. The 2011 update included 29 adverse events that are unambiguous, largely preventable, serious, as well as adverse. These events are indicative of a problem in a healthcare setting’s safety systems, or important for public credibility or accountability. The 29 events are organized into seven categories; six relate to the provision of care, such as surgical or invasive procedure, product or device, patient protection, care management, environmental, and radiologic, and the seventh category is for potential criminal events.

Current: To date there are 27 States that have Adverse Event reporting systems.  Many state reporting systems, like the Joint Commission, make serious event reporting or sentinel event reporting voluntary by the healthcare organization.

The States with Reportable Event systems include California, Colorado, Connecticut, the District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Maine, Maryland, Massachusetts, Minnesota, Nevada, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Utah, Vermont, and Washington.

Required: There are a few areas where reporting is either required by the healthcare organization or data is collected from claims information related to adverse events or injuries.  The Centers for Medicare and Medicaid Services (CMS) requires organizations to report any Death of a patient that was in restraints or had restraints applied in the 24 hours preceding the death.  Hospital Acquired Conditions and Communicable Diseases are required to be reported either into the National Healthcare Safety Network (NHSN) or to the State Agency.  CMS and Third-Party payors collect data on hospital acquired infections, injuries and other negative outcome events.

Accrediting Agencies: The Joint Commission, highly encourages healthcare organizations to report adverse events, serious reportable events or sentinel events. If the organization chooses not to report a sentinel event, they have a requirement that a Root Cause Analysis is completed within 45 days of the organization becoming aware of the event.

Summary: As we journey down the road to High Reliability, the goal of adverse event reporting systems is to identify, track, analyze and hopefully provide evidence-based practices that would lead to the prevention of future adverse events.  The struggle with standardizing event reporting systems continues today.  States, accrediting organizations and federal agencies all encourage organizations to report adverse events and sentinel events experienced within a given healthcare entity to continue our understanding of ways to improve and prevent patient harm.

 

For additional information:

Joint Commission – Sentinel Event https://www.jointcommission.org/sentinel_event.aspx

National Academy for State Health Policy: 2014 Guide to State Adverse Event Reporting Systems (Jan 2015) www.nashp.org

Agency for Healthcare Research and Quality: Never Events https://psnet.ahrq.gov/primer/never-events

CMS – Chapter 2 State Operations Manual – Survey and Certification process https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107c02.pdf

James Ballard

Author James Ballard

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