Adverse Events Frequently Asked Questions

Frequently Asked Questions

What is an adverse event?

Adverse events are medical errors health care facilities could and should have avoided. The National Quality Forum (NQF) defines an adverse event as a preventable, serious and unambiguous occurrence or error at a healthcare facility that is universally or largely preventable and should never occur. The Department of Health uses the NQF 2011 Update to identify 29 reportable events and provides guidance on defining these events.

What types of healthcare facilities are required to report adverse events?

State law requires hospitals, psychiatric hospitals, child birthing centers, Department of Corrections medical facilities and ambulatory surgical facilities to report to the department when an adverse event occurs.

What adverse event information is available to the public?

Adverse events reported to the department are aggregated and published as quarterly reports. Facilities may also provide additional information about specific events by submitting a contextual information form, which does not contain any patient or staff identifiers. The department may not release root cause analysis or any other documents that contain confidential information such as patients or staff members involved in any event.

How does my facility determine if a medical error is an adverse event?

Review the list of 29 reportable events. The NQF 2011 Update provides specification and guidance in defining reportable events. More information about reporting an adverse event is on the Resources webpage.

What does state law require of healthcare facilities if they identify an adverse event?

Facilities must notify the Department of Health Adverse Event Reporting Program within 48 hours of confirming an event. The notification form lists the information facilities must provide to the department. This form lists the available methods for reporting.

After our office confirms receipt of this notification facilities must then complete and submit a root cause analysis to the department within 45 days. For conducting and preparing a root causes analysis, see the Resources webpage for guidance.

How does my facility report an adverse event to the Department of Health?

Notification can be completed in one of the following ways:

• Complete the electronic form or
• Complete and submit the paper notification form by email, or
• Complete and submit the paper notification form by fax to 360-236-2830, or
• You may also mail the notification form to our office:

Department of Health, Community Health Systems, Adverse Event
P.O. Box 47853
Olympia, WA 98504-7853

Please be aware that mailing the notification form may delay our ability to confirm receipt of your adverse event information.

What is the required reporting time for reporting an adverse event?

A healthcare facility must report an event to the department within 48 hours of confirming the event. The facility may also provide contextual information at that time. Facilities must submit a root analysis within 45 days after confirmation of an event.

What is contextual information? Does a facility have to complete this form when reporting an adverse event?

When reporting an adverse event a facility may want to provide more information about the occurrence without listing any patient or staff identifiers. The Contextual Information Form is an optional document and is not required when reporting an event. Contextual Information is published with the Quarterly Reports.

What is a root cause analysis (RCA)?

A root cause analysis (RCA) is system-based review of an adverse event. It is a tool used to determine what happened, why it happened and what can be done to prevent it from happening again. The RCA is intended to be used for quality improvement. Facilities must submit a RCA within 45 days of confirming an adverse event. Information in the RCA is confidential and the department will not release content from it. More guidance in conducting and preparing a RCA is on the Resources webpage.

How do I conduct a root cause analysis? Are there more resources that are helpful?

There is a step-by-step guide to assist facilities in completing the root cause analysis. More information and guidance on conducting and preparing a root cause analysis is on the Resources webpage.

Are there any other reporting responsibilities of the facilities?

Yes, the department implemented a quarterly check-in survey for facilities that do not have an adverse event to report. Facilities are asked to notify the department every three months whether or not they had an adverse event. The department emails the survey link to each facility after the end of each reporting quarter.

What is the check-in survey?

The department implemented a check-in survey requesting facilities to notify our office every quarter as to whether they had an adverse event. The check-in survey is emailed to each designated facility contact 15 days after the end of the reporting (calendar) quarter. The survey consists of only one question. Survey responses are due within 30 - 45 days after the end of the reporting quarter. Facilities must notify us every quarter if contact information has changed.

Our office conducts direct follow-up with facilities that do not respond to the check-in survey. The results of the survey are reported in the Quarterly Reports.

What are the consequences of not reporting an adverse event? Will adverse event reporting affect my licensing survey?

The law requires healthcare facilities to report when one of the 29 adverse events occurs. Facilities must conduct a root cause analysis and send those findings to the department. The Adverse Event Program is separate from healthcare professions and facilities licensing programs.

The department may cite a healthcare facility when conducting a licensing survey or investigation if:

• It identifies a possible adverse event and the facility failed to follow the adverse event requirements, or
• It receives a complaint about an adverse event and the findings of the investigation determine citations.
• In either case, the department will direct the facility to follow the adverse event reporting guidelines.

Why are facilities required to report if they are not cited for an event?

The intent of the law is to create a system for enhancing accountability and transparency. It is not based on an approach of blame, shame or punishment. Policymakers hope to foster a culture of learning and enhancing patient safety. The reporting law drives quality improvement in facilities as part of a statewide patient safety vision.

Whom do I contact for consultation on definitions or for a site visit?

The Adverse Event Patient Safety Office position was eliminated in the 2011-2013 biennial budget. Facility staff members should consult the guidance provided on the Resources webpage.

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