Course Materials & Disclosure

Hospice Education Network - Adverse Incident & Medical Device Events: Recognizing & Reporting

Adverse Incident & Medical Device Events: Recognizing & Reporting What You Need to Know and Do

Terri Maxwell PhD, APRN VP, Strategic Initiatives Weatherbee Resources Inc & Hospice Education Network Inc

• Course materials including handout(s) and conflict of interest disclosure statement are available to download with this course. • This presentation is for educational and informational purposes only. It is not intended to provide legal, technical or other professional services or advice.

Part I: Adverse Events and Incidents Reporting

Objectives

• Define adverse events, serious reportable events and adverse medication events • Describe the primary purpose of incidence reporting • Describe best practices in completing an Incident Report form

The Institute of Medicine (IOM) estimates that more than 1 million preventable adverse events occur each year in the U.S., of which 44,000 -98,000 are fatal.

IOM “To Err is Human”; 2000

Definition of Adverse Events

• Injuries related to medical management (in contrast to complications of disease). • Preventable adverse events are those that result from errors or equipment failures. • Errors of execution or • Errors of planning

Examples of Hospice Adverse Events/Incidents Patient Care Related: • Falls • Medication errors • Alleged abuse • Pressure ulcer • Burns • Oxygen-related • Wandering/elopement • Patient suicide

Examples of Hospice Adverse Events/Incidents Operations Related: • Contracted services • DME • Pharmacy • Respiratory • PT/OT • Theft • Vehicle accident • Property damage

Primary purpose of reporting

• Learn from the experience • Monitor progress in error prevention • Share lessons with others so that others can avoid mishaps • Hold hospitals and health care providers accountable for safe practices

Leap. LL. NEJM Vol 347(20): 2002

Importance of external reporting

• Alerts about new hazards (ex. new drugs or therapies) • Dissemination of information from a few to many as a way to prevent errors • Central analysis can identify trends and hazards that requires attention • Analysis can lead to recommendations for “best practices” for all to follow

Leap. LL. NEJM Vol 347(20): 2002

What about….Mandatory Reporting Systems? • Definition: reporting systems run by state departments of health that require hospitals to report serious accidents and threats to patient safety. • Not all states have public reporting systems and some disclose more than others. • 7 states have no public reporting of adverse events • Types of events that must be reported vary widely • The Veterans Administration has a system-wide reporting system

Incident reporting at the hospice level

• Ensure quality patient care • Document a factual record of the event • Alert administration

What Should an Incident Report Include?

• Detailed description of the incident • Stick to the facts • Leave out personal opinions or disparaging comments • Name of participants or staff involved • All actions taken • Conclusion • Follow-up

Best Practices for Incident Reporting • Have a standard process for reporting and educate staff • Designate a contact person • Set blame/bias aside • Trend and analyze safety issues • Committee review (including QAPI committee) • Provide feedback to staff

Adverse Events: What You Need to Know

• What the adverse events are that need to be reported (ex. falls, med errors, auto accident, potential abuse, blood/body fluid contamination) • Where to find your agency’s Adverse/Incident Report Policy, or whom to contact in your agency for more information • How this information applies to you in your role •How to file an incident report •Who do you go to if you think an incident has taken place?

Adverse Events: What You Need to Do

• Follow your hospice’s policy for incident reporting

• Ensure that the report is routed to the a supervisor for review of the incident

• Follow up as needed

When completing an incident report you should …

Describe: • Who was involved • Who witnessed the incident • What happened to cause the incident • When and where did the incident take place

How to Report?

• Hospice needs to have clearly defined policies and procedures that outline clear lines of accountability and responsibility • Timeframe for reporting • Paper or electronic submission • Who to send report to • Review/follow up

Focus Areas to Mitigate Risk

Staff Education and Training Infection Control Committee • Monitor and report infection trends including antibiotic dispensing • Report to QAPI committee

Focus Areas to Mitigate Risk Cont’d Pharmacy and Therapeutics Committee • Identify real and potential medication errors • Educate and monitor for adverse drug reactions • Recommend safe prescribing • Develop correction plans

Focus Areas to Mitigate Risk Cont’d Safety Committee • Monitor and educate re: current regulations (CoPs, Joint Commission Safety Standards, OSHA, etc). • Monitor all safety related issues/findings and actions required by all departments

Adverse Events and QAPI Conditions of Participation: §418.58 Hospices are required to collect and analyze patient care and administrative quality data and to use that data to identify, prioritize, implement, and evaluate performance improvement projects to improve the quality of services furnished to hospice patients. Integrate adverse event/incident reporting into your hospice’’’s QAPI program.

Example of Vendor Supported QAPI Reporting and Analysis

 Source:Source: Deyta Deyta’’’s Quality’s Quality Navigator Navigator

Part II: Recognizing and Reporting Adverse Medical Device Events

Learning Objectives

• Define “Adverse Medical Device Event” • Describe when to report an adverse medical device event • Explain what an employee should do if he/she witnesses or discovers an incident resulting in death or serious injury that may have been caused or contributed by a medical device.

What is a Medical Device?

Anything used in treatment or diagnosis that is not a drug or biologic.

Definition of a device can be found in FD&C Act, Section 201(h).

The Safe Medical Devices Act

• Enacted in 1996 • Requires health care providers to document and report any deaths or serious injuries to patients or employees that were caused or contributed to by a medical device.

When to Report? • Death • Serious injury • Minor injuries • Close calls • Patient and staff adverse events

“Serious Injury”

Life-Threatening Injury or Illness

results in permanent impairment / damage to body function / structure

requires medical or surgical intervention to preclude permanent impairment / damage to body function / structure.

Caused by or Contributed to:

The device may Malfunction have been a factor Improper/inadequate in the death or device design serious injury Manufacture problem due to: Labeling problem User error Device failure

Reporting Goals

• Patient safety • Staff safety • Methods: • Recognize an adverse event may be device related • Accurate event reporting • Education • Improved device design

CDRH Reporting Programs

Voluntary Mandatory MedWatch - User Facilities - Reporting by (such as hospitals healthcare and hospices) professionals and - Report deaths and consumers serious injuries - Report actual or - Manufacturers potential product - Report deaths, problems serious injuries, and malfunctions

Immediate Action Plan

• Ensure patient safety • Minimize and preserve equipment/ device damage • Notify physician

Reporting a Medical Device Event

• Complete and submit an incident report to your supervisor within 24 hours of witnessing or discovering the incident • Outcome on the report must be listed as “Serious Injury” or “Death” • Type of incident must be listed as “Adverse Medical Device Event”

Reporting a Medical Device Event cont.d Describe the • The medical device incident including: involved • How it may have caused or contributed to an adverse outcome • Patient status

Reporting a Medical Device Event cont.d Within 10 days after • The manufacturer of discovery of the device- the device involved or related death or serious • The FDA if the injury, a report of the manufacturer is not incident must be sent to: known or if the event involves a device- related death

Reporting a Medical Device Event cont.d Agencies: • are not expected to evaluate or investigate the triggering event; • are required to fill out information that is reasonably known to them; • must make at least an initial determination as to whether the event is required to be reported.

A Surveyor Will Look For

• Your hospice’’’s Incident Reporting Policies

• Staff knowledge (like asking staff questions about what they know and would do in case of an adverse event)

• Documentation of adverse events (incident reports)

A Surveyor Will Look For

• Incident Reports, with follow-up actions and outcomes

• Training records of employees and volunteers (for up to 3 years)

• Committee minutes pertaining to safety standards and QAPI

Summary Know & Do Know • What constitutes an adverse event • How and when to report an adverse event/incident • What your hospice’s policy is regarding incident reporting and your role in reporting Do • Document events concisely, accurately and factually • Recognize your role in recognizing and reporting adverse events to help ensure the safety of patients, family members, and hospice staff

Additional Resources

• Adverse Event Reporting System (AERS) - data base that contains information regarding adverse events and medication errors reported to the FDA: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInf • FDA Med Watch - The FDA Safety Information and Adverse Event Reporting Program: http://www.fda.gov/Safety/MedWatch/default.htm • National Quality Forum (NQF) Serious Reportable Events: http://www.qualityforum.org/Topics/SREs/Serious_ Reportable_Events.aspx • “H.R. 5866--112th Congress: Medical Device Patient Safety Act.” www.govtrack.us/congress/bills/112/hr58

Faculty Contact information:

Terri Maxwell PhD, APRN [email protected]

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