1. PATIENT SAFETY ORGANIZATION (PSO) Rich Zink zinkr@purdue.edu April 22, 2016 1

2. 1999 - IOM “To Err is Human” preventable medical errors report 2005 - Patient Safety and Quality Improvement Act (PSQIA) January 19, 2009 - Patient Safety Rule effective Creation of PSOs –Administered by the Agency for Healthcare Research and Quality (AHRQ) –Privilege and confidentiality protections to promote shared learning to enhance quality & safety nationally PSO PROGRAM OVERVIEW PATIENT SAFETY ORGANIZATIONS 2 Agency for Healthcare Research and Quality (AHRQ) https://pso.ahrq.gov/about

3. FOCUS OF OUR COLLABORATIVE 3 Association for the Advancement of Medical Instrumentation (AAMI) Patient Safety Week Email Campaign, March 14 – 16. KNOWLEDGE SHARING QUALITY & SAFETY

4. Patient Safety Work Product (PSWP) –Any quality data and analysis, oral statement – assembled or developed by a provider for reporting to a PSO, and are reported to the PSO or which constitute the deliberations or analysis of a PSES Patient Safety Evaluation System (PSES) –The collection and management of information for reporting to or by a PSO Privilege and Confidentiality –PSWP beyond the reach of federal and state courts, even if subpoenaed –Information not subject to discovery –PSQIA places the burden on providers and others not to disclose PSWP, without permission PSO PROTECTIONS FOR DATA AND PROVIDERS RCHE PURDUE PSO 4 Agency for Healthcare Research and Quality (AHRQ) https://pso.ahrq.gov/faq/definitions https://pso.ahrq.gov/sites/default/files/wysiwyg/OnDemand%20Webinar %20Slides%20-%20June%2010%202015.pdf

5. Patient Safety Work Product (PSWP) –Any quality data and analysis, oral statement – assembled or developed by a provider for reporting to a PSO, and are reported to the PSO or which constitute the deliberations or analysis of a PSES Patient Safety Evaluation System (PSES) –The collection and management of information for reporting to or by a PSO Privilege and Confidentiality –PSWP beyond the reach of federal and state courts, even if subpoenaed –Information not subject to discovery –PSQIA places the burden on providers and others not to disclose PSWP, without permission PSO PROTECTIONS FOR DATA AND PROVIDERS PATIENT SAFETY ORGANIZATIONS 5 Agency for Healthcare Research and Quality (AHRQ) https://pso.ahrq.gov/faq/definitions

6. CMS/CCIIO HHS Notice of Benefits and Payment Parameters for 2017 Final Rule A Qualified Health Plan (QHP) issuer contracted with hospitals > 50* beds is required to engage with either: 1.AHRQ PSO Program – “Utilize a PSO” 2.Or alternative evidence-based initiative such as Hospital Engagement Networks (HENs) Effective date: Beginning on or after January 1, 2017 * (3) ADJUSTMENT – The Secretary may by regulation adjust the number of beds described in paragraph (1)(A) AFFORDABLE CARE ACT (ACA) SEC. 1311(h) 6

7. PATIENT SAFETY ORGANIZATIONS 7 HospitalPSO Patient Safety Evaluation System (PSES) Patient Safety Work Product (PSWP) Patient Safety Evaluation System (PSES) Patient Safety Work Product (PSWP) Data Aggregation Data Analysis Reporting Incident Near Miss Unsafe Condition

8. Filed for and granted listing February 9, 2015 as; –Regenstrief Center for Healthcare Engineering at Purdue University Patient Safety Organization (RCHE Purdue PSO) Initial focus on medication safety –In Scope: Medication incident, near miss and unsafe condition Incorrect patient, medication, dose, route, timing, rate, form, concentration, etc. –Out of scope: Falls, HAI, medical device failure, wrong site surgery, etc. Complimentary/Extension of REMEDI Central Self-Attestation –8 Patient Safety Activities –7 PSO Criteria –3 Component Criteria (Part of Purdue University) RCHE PURDUE PSO 8

9. Organization focused on improving patient safety Shared knowledge and best practices Compliments vendor reporting / Benchmarking at named level Clinical alarm safety (TJC NPSG.06.01.01) TJC Sentinel Events –Alert 54: Safe use of health information technology –Alert 50: Medical device alarm safety in hospitals –Alert 42: Safely implementing health information and converging technologies Research opportunities REMEDI CENTRAL – VALUE 9 Reduction of risk of patient harm using device data to prevent and predict BEFORE AN EVENT OCCURS

10. All of the REMEDI Central Value plus… Event, Near Miss, and Unsafe Condition Analysis Reports & Advisories (both data and clinical perspectives) Enhanced patient/consumer confidence ACA Section 1311(h) Linked device and event data (outcome measurement) Privilege and confidentiality protections RCHE PURDUE PSO– VALUE 10 Reduction of risk of patient harm using incident data to prevent and predict AFTER AN EVENT OCCURS

11. Sign PSO agreement Sign Business Associate Agreement (BAA) Pay fee: $X,000/ 2-year term* * Introductory pricing: Fee and term likely to change Submit Reports –Unsafe Conditions –Near Misses –Incidents –Other PSWP REQUIREMENTS TO JOIN RCHE PURDUE PSO 11

12. Questions? Thank you! REMEDI CENTRAL & RCHE PURDUE PSO 12