Improving Patient Safety Through Adverse Event Reporting Kathy Schmitt, MPA Research Analysis and Data Section Manager Office of Community Health Systems Washington State Department of Health Good morning Today I will be talking about why we have an adverse event reporting program and I’ll spend some time talking about the specifics of the Washington program - how it works, what you’re required to report and when and how.

Improving Patient Safety Through Adverse Event Reporting Health care system is large, complex, fragmented Adverse Events are typically preventable medical errors that result in patient death or serious disability Adverse Event Reporting Systems Promote quality improvement in facilities Enhance open and honest conversations Support learning, sharing information, and identifying best practices Background on what led up to an adverse event reporting program As you know, the Health care system is large, complex, and often fragmented Just in Washington, we have more than 350,000 individual health professionals licensed in about 80 professions. Care is delivered in more than 94 hospitals, 176 ambulatory surgery facilities, and thousands of individual physician offices. The people involved, and the electronic information systems they use, often don’t talk to each other. At least not yet! IOM Report (1999)– To Err is Human – publically focused attention to issue of medical errors. Estimated the number of people dying in the US from medical errors equals a jumbo jet crash on every single day of the year. It said the health delivery community must act rapidly, decisively, and effectively. Since the report, there has been a lot of money and effort focused on reducing medical errors. Yet, even today, most national experts say there is little evidence errors have declined. The Institutes of Medicine (IOM) Report endorsed state reporting for adverse events. It said: Adverse events are preventable medical errors that result in patient death or serious disability Reporting laws promote quality improvement and a broader vision for patient safety Adverse event reporting systems help create open, honest conversations to identify improvements. The true strength of the adverse event reporting system is the focus on what can be learned from adverse events to change practices. 2

Improving Patient Safety Through Adverse Event Reporting Washington State Adverse Event Reporting System Law established in 2006 NQF – List of 29 adverse events Hospitals, Psychiatric Hospitals, Child Birth Centers, Department of Corrections Medical Facilities, and Ambulatory Surgery Facilities are required to report adverse events to DOH Quality Improvement Focus A 2006 state law requires that health care facilities ranging from hospitals to prisons notify the Department of Health when an adverse event has occurred. Our reporting system is based on a nationally accepted list of 29 types of serious events – the National Quality Forum. These are typically preventable and many should universally never occur in a medical facility. Hospitals, psychiatric hospitals, child birth centers, DOC medical facilities and Ambulatory surgery facilities are required to report adverse events Just as an FYI - At least 30 states have reporting systems. There is no single model and they vary greatly. Our state’s system is unique (or it was at the last time we scanned state systems). Our focus is on quality improvement rather than discipline. We believe there are more benefits in reforming systems than punishing individuals. The goal of the program is to help each facility understand what went wrong, determine the underlying causes (root cause analysis) and develop a plan to prevent errors from occurring again. Our approach has prompted facilities to look candidly at systems and care practices that put patients at risk.

Improving Patient Safety Through Adverse Event Reporting Reporting an Adverse Event Notify DOH within 48 hours of confirmation of event Electronic reporting form Paper reporting form – fax, email, mail Toll free hot line Complete a Root Cause Analysis and send to DOH within 45 days Quarterly Check-in Survey Health care facilities required to report to the adverse event program must notify the department with 48 hours of confirming the event. Confirmation happens through the internal QI process. Then the facility must complete a root cause analysis and send it to the department within 45 days. The root cause analysis is where the real learning happens. It is a system-based review of the medical error. We find out what happened, why it happened, and what can be done to prevent it from happening again. In 2010, we implemented a quarterly check-in survey. All facilities required to report adverse events are asked to respond to the survey, letting us know whether they had an event or not. This is our way to assure that all facilities required to report are participating in the program.

Improving Patient Safety Through Adverse Event Reporting Notification of Adverse Events Total of 1,360 events reported from June 2006 to June 2012 629 – Pressure Ulcers 370 – Surgical Events 233 – Falls 37 – Criminal Events 29 – Medication Errors 62 – Other Event Types Since 2006, we have been notified of 1,360 events. Only 34% of health care facilities(292 total) required to participate have reported an adverse event. 78/94 (83%) hospitals; 16/176 (10%) ASFs. 98% of all confirmed events reported to date were reported by hospitals. The number of events reported each year has remained steady. Around 200/year through 2009, around 250 per year since (due to change in threshold for reporting falls from death to death or serious disability) When we look at the data by error type, pressure ulcers account for 46% of all events reported. The second largest category includes surgical events, including retained foreign objects and procedures performed on the wrong body part. Death or serious disability (added in July 2009) from falls are the third highest. 5

Improving Patient Safety Through Adverse Event Reporting Changes in DOH Adverse Event Program Budget impacts WAC changes, effective 10/1/2012 Revised web-page Electronic notification form Compile and share findings from RCA’s Like many programs in state government, the Adverse Event Reporting program was hit hard by budget cuts over the past couple of years. At the beginning of this biennium (July 2011), we lost the nurse consultant position that provided technical consultation to facilities, reviewed root cause analyses, and convened patient safety stakeholders to share lessons learned. Much of the work called for in the original law is on hold. This includes a more comprehensive quality improvement program. However the law is still in effect and our work to improve systems has not stopped. We continue to receive notifications of events and root cause analyses. We continue to compile the notifications and publish quarterly reports on our web page. We recently revised the adverse event program rules to reflect changes to the NQF list and definitions of events. Our law requires us to follow the NQF, so when they make a change, we need to change our rules and documents. Not only did the NQF list of events change (3 retired, 4 new) but the threshold for reporting many events was intentionally lowered (from serious disability to serious injury) We expect to see an increase in the number of events reported. We recently revised the webpage to make the program as “self-service” as possible. We want the web-page to be a one stop shopping place for facilities to easily find all the information and resources needed to notify us of an event and conduct a root cause analysis and action plan. We recently implemented an electronic notification form to make reporting easier for facilities and to make data compilation easier for us. And finally, we are working on a way to contract with a patient safety organization (or 2) – at no cost – to gather and compile information from the root cause analyses so that we can start to look for patterns across the health care system and develop best practices to improve patient safety. Learning about the causes of events and sharing the solutions developed by health care facilities will help everyone improve systems. 6

Improving Patient Safety Through Adverse Event Reporting List of Adverse Events http://www.doh.wa.gov/Portals/1/Documents/Pubs/689003.pdf 2011 NQF Guidance http://www.doh.wa.gov/Portals/1/Documents/2900/NQF2011Update.pdf Adverse Events webpage http://www.doh.wa.gov/hsqa/AdverseEvents

Thank You! Kathy Schmitt, MPA Kathy.schmitt@doh.wa.gov 360-236-2869