Title: An act relating to the adverse health events and incident reporting system.

Brief Description: Modifying disclosure provisions under the adverse health events and incident reporting system.

Sponsors: Representatives Campbell, Hunt and Kenney; by request of Governor Gregoire.

Brief History:

Health Care & Wellness: 1/21/08, 1/31/08 [DPS].

HOUSE COMMITTEE ON HEALTH CARE & WELLNESS

Majority Report: The substitute bill be substituted therefor and the substitute bill do pass. Signed by 13 members: Representatives Cody, Chair; Morrell, Vice Chair; Hinkle, Ranking Minority Member; Alexander, Assistant Ranking Minority Member; Barlow, Campbell, Condotta, DeBolt, Green, Moeller, Pedersen, Schual-Berke and Seaquist.

Staff: Chris Blake (786-7392).

Background:

In 2006 the Legislature passed new requirements for the systemic notification and reporting of unsafe events that occur in medical facilities, including hospitals, ambulatory surgical facilities, childbirth centers, psychiatric hospitals, and correctional medical facilities. The unsafe events that are covered by the reporting program include adverse events and incidents. Adverse events are serious reportable events that have negative consequences for patient care as defined by the National Quality Forum and adopted by the Department of Health (Department) through rulemaking. There are two types of incidents: (1) acts that result in unanticipated injury to the patient that are not included in the definition of an adverse event; and (2) acts that could have caused unanticipated injury or required additional health services, but did not.

The new reporting program requires that medical facilities notify the Department about the occurrence of an adverse event within 48 hours of confirming that it happened. Within 45 days of the notification, the medical facility must file a detailed report related to the adverse event that includes a root cause analysis and a description of a corrective action plan or reasons for not adopting a corrective action plan. Medical facilities have the option of reporting the occurrence of an incident to an independent entity that the Department will contract with to collect and analyze data received through the reporting program.
   
Previous reporting standards required the Department to publicly disclose reports filed by hospitals in accordance with public disclosure requirements. Since adoption of the new notification and reporting system in 2006, public access has been limited to information contained in an annual report that states the number of adverse events and incidents by geographic location.

Summary of Substitute Bill:

The intent of the adverse events notification and reporting system is expanded to include the goal of assisting the public in making informed health care choices.

Notifications of adverse events are subject to public disclosure. Notifications of adverse events must contain the date of the event, the type of event, and any additional contextual information that the facility chooses to provide. Notifications and reports of adverse events may be amended within 60 days of submission.

The annual reports of the independent entity shall contain aggregated information reported on a geographic basis. It is clarified that the report shall include a summary of actions taken by facilities in response to adverse events and incidents. The report shall also include aggregated information for consumers and providers about best practices and prevention tools that medical facilities are implementing to prevent adverse events as well as other patient safety initiatives.

Substitute Bill Compared to Original Bill:

The substitute bill exempts notifications of incidents related to unanticipated injuries.

Notifications of adverse events submitted to the Department must include the date and type of adverse event as well as any contextual information that the medical facility chooses to provide.

The requirement that the Department report information to the Washington State Quality Forum that identifies individual facilities is removed. The requirement in current law that it be sent as aggregated data is restored.

The requirement that annual reports on adverse events contain information listed by individual medical facilities is removed, thus restoring the current law requirement that information be reported on a geographic basis. It is specified that the reporting of "outcomes" refers to the actions taken by medical facilities in response to an adverse event. Annual reports must contain information for consumers and providers about facilities' efforts to prevent adverse events.

Adverse event notifications and reports may be amended within 60 days of submission.

The definition of "incidents" is restored to current law so that it relates to unanticipated injuries to a patient, but not necessarily "serious" injuries.

Appropriation: None.

Fiscal Note: Available.

Effective Date of Substitute Bill: The bill takes effect 90 days after adjournment of session in which bill is passed, except section 5 which reinstates prior law related to exemptions from the Public Records Act after a scheduled expiration and takes effect July 1, 2009.

Staff Summary of Public Testimony:

(In support) The public has a right to know about errors that occur in hospitals. Prior law struck a balance between access to individual hospital information and internal hospital quality control mechanisms, but recent changes to the law have upset the balance. When medical errors occur, the public is best served by a setting that encourages medical facilities to acknowledge these events, address their causes, and prevent them in the future. Too much public scrutiny may discourage quality improvement efforts. This bill refines the adverse event reporting system by restoring prior disclosure law. This increases transparency and consumer knowledge.

(In support with amendments) There needs to be more work to reach the point where hospitals are comfortable with reporting adverse events.

(Opposed) None.

Persons Testifying: (In support) Representative Campbell, prime sponsor; Jonathan Seib, Office of the Governor; and Laurie Jinkins, Department of Health.

(In support with amendments) Lisa Thatcher, Washington State Hospital Association.

Persons Signed In To Testify But Not Testifying: None.