Product Recalls/Alerts: Two Not-For-Profit Organizations Partnering for Patient Safety

Transcription

1 Third Annual Maryland Patient Safety Conference March 23, 2007 Product Recalls/s: Two Not-For-Profit Organizations Partnering for Patient Safety by Bea Haupt, J.D., CPHQ Recall and Safety Manager, Contract Administrator for Laboratory Services Inova Health System Agenda 1. Inova Health System at a Glance 2. Communication Challenges 3. Inova s Two-Prong Approach to Management 4. Inova-Noblis Patient Safety Collaboration 5. Implementation/Benefits of 6. Recall & Safety Manager 7. Summary 1

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 busiest OB 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 care Mental health & Addiction Organ transplantation Physician referral Sleep disorders Region s only Level 1 Trauma Low vision center Wound healing center 2

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 3

4 Communication Challenges (Pre-) Structure No standards for structure and content of alerts Distribution Lack of standardized mechanisms for notifying hospitals of recalls; alerts often delayed Multiple alert sources resulted in duplicates Communication Challenges (Pre-) 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 4

5 Communication Challenges Inova s Two-Prong Approach to Management Patient Safety Automated Tracking System Recall & Safety Manager 5

6 Inova-Noblis Patient Safety Collaboration Jul Jan. 2004: Inova (along with two other health systems) acted as beta site for initial version of RASMAS developed 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 forward: Inova and Noblis continued to collaborate to enhance RASMAS and improve alert management process - Coordination checklist for alert clinical impact - Collaborative article on innovation in alert management Implementation/Benefits Risk and Safety Management System (RASMAS) Inova Health System Account Manager Inova Hospital #1 Facility Manager Inova Hospital #2 Facility Manager Coordinator 1 Coordinator 2 Coordinator 1 Coordinator 2 Responders Responders 6

7 Implementation/Benefits Phase 1 Phase 2 Phase 3 Coordinator Responder Coordinator assignment to responder assignment completion closure Implementation/Benefits Existing Environment Challenge: Staff comfort with new technology RASMAS Implementation Change Organization Organization Identify management Assemble cross-functional team Train team Change Infrastructure Develop implementation plan Introduce new technology Manage implementation Change Process Process Define new process Monitor and enhance process Challenge: Coordinators managing responders in other departments New Environment Challenge: Staff resistance to change 7

8 Implementation/Benefits Gathers recalls and alerts from a wide range of paper and electronic sources Has review by clinical experts at Noblis to refine the alert for priority and reliability Implementation/Benefits Releases alerts to subscribers in a simple to read, standardized format over the web Eliminates manual processes and improves turn-around-times Provides the ability to track alerts 8

9 Implementation/Benefits Implementation/Benefits Time to Close s Time to Close s 9

10 Recall & Safety Manager Accountable for the oversight of the Risk and Safety Management System (RASMAS) throughout Inova Analyze, facilitate and coordinate all recalls between appropriate senior leadership, physicians, department directors, staff and patients when necessary Provide on-going education and serve as an advocate for patient safety Meet with senior leadership and Patient Safety Committees on a quarterly basis Recall & Safety Manager Coordinator Checklist Standardization of Working s Recall Blast List Recall Executive Summaries Material Messages Quarterly Newsletter Published on Inova s Intranet Terms and Conditions Include Parties to be Notified 10

11 Improving the Recall Process for Patient Safety Inova Health System Materials Management participated in.. What: Noblis Healthcare National Leaders Forum When: June 14, 2006 Where: Omni Shoreham Hotel Washington, DC Summary Product Recalls/s Increasing in volume and complexity Communication Challenges distribution/processing and management oversight Recall/ Management Improved process using two-prong approach Partnering Enhances patient safety 11

12 Questions? Bea Haupt Recall and Safety Manager, Contract Administrator for Laboratory Services Inova Health System 3300 Gallows Road Falls Church, VA Phone: Fax: