1. From Event Reporting to Patient Safety Organization Mark A. Keroack, MD, MPH SVP & Chief Medical Officer AHRQ Annual Meeting 9/27/2010

2. Before the 2008 PSO Rule UHC: a member owned alliance of 107 academic health centers (AHCs) and over 220 affiliates Patient Safety Net: UHC’s adverse event reporting and management system since 2002 Key lessons learned: – Standard taxonomy enables data mining – Learning community fosters innovation and disseminates solutions – Decentralized event management builds awareness and participation by unit managers ©2010 University HealthSystem Consortium2

3. Adapting to the Final Rule Component entity decision: – UHC Performance Improvement PSO Policies, procedures and training Separate physical security for PSO reports High reliability assessment for data security Two types of customers (30 of 80 now in PSO) No current consensus among PSO members on what goes into PSO space and when ©2010 University HealthSystem Consortium3

4. ©2010 University HealthSystem Consortium 4 UHC PSN ® Taxonomy HERF and PIF: Event Specific: Anesthesia** Blood ** Equipment and Devices* Fall* Healthcare- Associated Infection*** Medication & Other Substances* Perinatal** Pressure Ulcer* Surgical and other invasive procedure** *Direct Map **Edit ***Adopt AHRQ Event Date/Time* Demographics* Harm*** Interventions*** In both AHRQ CF and PSN (fields extracted for NPSD) Manager reviews, consultations and attached documents Incorporating the Common Formats Patient ADRs Anesthesia/Sedation Behavioral Care Coordination Complications of care Emergency Dept Equipment/devices Food/Nutrition Laboratory Test Maternal Medication Related Neonatal Radiology/Imaging Test Respiratory Care Skin Integrity Supply Surgery/Invasive Procedures Transfusion Other Unsafe Conditions: Environmental Issues Equipment Safety Medication Equipment and Counts Violation of Infection Control Inappropriate Staff Behavior Security Issues Regulatory Reporting Procedures Staff: Assault Exposure to Blood/Body Fluids Exposure to Chemicals/Drugs Injury Other Visitor Events: Assault Call to Medical Response Team Exposure to Blood/Body Fluids Exposure to Chemicals/Drugs Inappropriate Behavior Injury Other

5. Remaining Issues Role of the PPC Upcoming compliance review Incomplete reports and selective participation The larger federal agenda (CMS, CDC/NHSN) Upcoming challenges to the rule by plaintiffs ©2010 University HealthSystem Consortium5

6. The Real Value of PSOs Leveraging federal protections in order to: Convene organizations with a shared interest in safety Foster a climate of openness and disclosure Develop insights from submitted data – Aggregate event analysis – Root cause analysis Contributing to national learning (solutions as well as data) ©2010 University HealthSystem Consortium6

7. Aggregate Data Analysis – 1 Falls: Basic Surveillance Approach – 27,201 falls selected for 2008 – Peak numbers in 50-60 age group – Peak times 1-2 hours after meals – High rates of non-assessment in ED & Peds – Rethinking who is at risk and how to best deploy rounding resources ©2010 University HealthSystem Consortium7

8. Aggregate Data Analysis – 2 Epidural-IV Confusion: “Tip of the Iceberg” – 55 reports in literature 1968-2009 – 31 event reports in PSN (most low or no harm) – Both Epi to IV and IV to Epi – Hot spots in critical care and obstetrics – Lack of training, distractions, inexperienced staff listed as contributing factors – Labeling/alert approaches shared among sites, but definitive device solution still awaited – Analysis of low harm and near miss events builds awareness of issues ©2010 University HealthSystem Consortium8

9. © 2010 University HealthSystem Consortium 9 Aggregate Data Analysis – 3 Aggregate Data Analysis – 3 Mislabeled Specimen Rates Per 1000 Accessions Aggregate Performance (32 units in 12 sites over 1 month: 1.30 mislabelings / 1000 accessions (112 / 86,123) Hospital Performance: Mean: 1.45SD: 1.36 Median: 1.13Range: 0.00 – 5.80 Critical Care UnitsED Units Mislabeled Specimens: “Campaign approach”

10. Conclusions The PSO Final Rule has imposed some (so far manageable) constraints on PSN AHC involvement in PSOs is highly variable, and most remain uncertain about choosing one Enthusiasm among newly formed PSOs is high Continuing to demonstrate the value of PSOs by disseminating insights and solutions is critical for this young initiative ©2010 University HealthSystem Consortium10