product recalls/alerts: two not-for-profit organizations
TRANSCRIPT
1
Product Recalls/Alerts:Two Not-For-Profit Organizations
Partnering for Patient Safetyby
Bea Haupt, J.D., CPHQRecall and Safety Manager,
Contract Administrator for Laboratory ServicesInova Health System
Third AnnualMaryland Patient Safety Conference
March 23, 2007
Agenda
1. Inova Health System at a Glance
2. Communication Challenges
3. Inova’s Two-Prong Approach to Alert Management
4. Inova-Noblis Patient Safety Collaboration
5. Implementation/Benefits of Automated Tracking System
6. Recall & Safety Manager
7. Summary
2
Inova at a Glance
Inova Alexandria Hospital Inova Fair Oaks Hospital Inova Mount Vernon Hospital Inova Fairfax Hospital
Inova Fairfax Hospital for Children - 5th busiestOB
Inova Heart & Vascular Institute - region’s only US News “America’s Best Hospitals” & Top 100 Magnet recognition for nursing leadership
Inova Loudoun Hospital
Inova at a Glance Specialized Services
Assisted Living (5 locations)
Blood Donor services
Inova Cancer services
US News Top 50 Life with Cancer
Hospital for Children
Nation’s Top 25
Pediatric specialization
International Adoption Emergency care centers
Long term careMental health & AddictionOrgan transplantationPhysician referralSleep disordersRegion’s only Level 1 TraumaLow vision centerWound healing center
3
Inova at a Glance Specialized Services cont’d
Inova Employees in Action Inova Partnership for Healthier Kids Inova Pediatric Clinic Inova OB Clinic Inova CATS Inova Healthsource Inova Kellar Center Inova Life with Cancer® and My Friend's House Forensic Assessment and Consultation Teams Ronald McDonald House Inova Childhood Immunization Program
Inova at a Glance
Licensed Hospital Beds 1,732 Licensed Nursing Home Beds 366 Participants in Health Promotion Programs 105,902 Inpatient admission 100,946 Outpatient surgeries 54,360 Outpatient visits 394,935 Births 20,550 Emergency room visits 373,737 Home health care visits 115,726 Employees 14,911 Physicians 2,991 Volunteers 2,487
4
Alert Structure No standards for structure and content of alerts
Alert Distribution Lack of standardized mechanisms for notifying hospitals of recalls; alerts often delayed Multiple alert sources resulted in duplicates
Communication Challenges(Pre-Automated Tracking System)
Communication Challenges(Pre-Automated Tracking System)
Alert Processing No uniformity in processing alerts across departments Lack of accountability for alert ownership and resolution
Management Oversight Minimal ability to monitor and report status Insufficient support for regulatory audits
Risk Delay in assessment of risk Prolonged exposure to defective products
5
Communication Challenges
Inova’s Two-Prong Approach toAlert Management
Patient Safety
Recall & SafetyManagerAutomated
Tracking System
6
Inova-NoblisPatient Safety Collaboration
• Jul. 2003 – Jan. 2004: Inova (along with two other healthsystems) acted as beta site for initial version of RASMASdeveloped by Noblis (formerly Mitretek Systems)
- Inova implemented system at primary hospital and provided recommendations to Noblis on improvements - Conducted joint analysis of manual versus automated processing at Inova to determine process improvements
• Jan. 2004 forward: Inova and Noblis continued to collaborateto enhance RASMAS and improve alert management process
- Coordination checklist for alert clinical impact - Collaborative article on innovation in alert management
Implementation/BenefitsAutomated Tracking System
Risk and Safety Management Alert System (RASMAS)
Inova Health SystemAccount Manager
Inova Hospital #1Facility Manager
Inova Hospital #2Facility Manager
Alert Coordinator 1
Alert Coordinator 2
Alert Coordinator 1
Alert Coordinator 2
Responders Responders
7
Implementation/BenefitsAutomated Tracking System
Phase 1 Phase 2 Phase 3
Alert Coordinator
Alert Responder
Alert Coordinator
Alertassignment to
responder
Alertassignmentcompletion
Alert closure
Implementation/BenefitsAutomated Tracking System
Organization
Process
Change Infrastructure
RASMASImplementation
• Identify management• Assemble cross-functional team• Train team
• Develop implementation plan• Introduce new technology• Manage implementation
• Define new process• Monitor and enhance process
Challenge:Coordinators managing
responders in otherdepartments
ExistingEnvironment
NewEnvironment
Challenge: Staffcomfort with newtechnology
Challenge: Staffresistance tochange
Change Organization
Change Process
8
Implementation/BenefitsAutomated Tracking System
• Gathers recalls and alerts from a widerange of paper and electronic sources
• Has review by clinical experts atNoblis to refine the alert for priorityand reliability
Implementation/BenefitsAutomated Tracking System
• Releases alerts to subscribers in asimple to read, standardized formatover the web
• Eliminates manual processes andimproves turn-around-times
• Provides the ability to track alerts
9
Implementation/BenefitsAutomated Tracking System
Implementation/BenefitsAutomated Tracking System
Time to Close AlertsTime to Close Alerts
10
Recall & Safety Manager
• Accountable for the oversight of the Risk andSafety Management Alert System (RASMAS)throughout Inova
• Analyze, facilitate and coordinate all recallsbetween appropriate senior leadership, physicians,department directors, staff and patients whennecessary
• Provide on-going education and serve as anadvocate for patient safety
• Meet with senior leadership and Patient SafetyCommittees on a quarterly basis
Recall & Safety Manager
• Alert Coordinator Checklist – Standardization of Working Alerts• Recall Blast List• Recall Executive Summaries• Material Messages – Quarterly Newsletter Published on Inova’s
Intranet• Terms and Conditions – Include Parties to be Notified
11
Improving the Recall Process forPatient Safety
Inova Health SystemMaterials Management participated in……..
What: Noblis Healthcare National Leaders Forum
When: June 14, 2006
Where: Omni Shoreham Hotel Washington, DC
• Product Recalls/Alerts – Increasing involume and complexity
• Communication Challenges –Alertdistribution/processing andmanagement oversight
• Recall/Alert Management – Improvedprocess using two-prong approach
• Partnering – Enhances patient safety
Summary
12
Bea HauptRecall and Safety Manager,
Contract Administrator for Laboratory ServicesInova Health System3300 Gallows Road
Falls Church, VA 22042
Phone: 703-776-3973Fax: 703-776-3982
Questions?