1. Patient Safety Organizations and ACA Impact Kelly Court WHA Chief Quality Officer August 23, 2013

2. Webinar Agenda Patient Safety Organizations Background Recent Developments Participation Requirements Next Steps Q&A

3. PSO Background Patient Safety and Quality Improvement Act (PSQIA) of 2005 and final regulations issued November, 2008 established Patient Safety Organizations (PSO’s) and the process by which they are governed. A PSO must be “listed” by DHHS and commit to: – Undertake efforts to improve patient safety and quality of health care – Develop and implement processes for voluntary and confidential reporting of adverse events and providing feedback to members

4. PSO Background Provides federal, state, and local protection from discovery of Patient Safety Work Product; if collected for and reported to or by a PSO – Reported events and trend analysis – Root cause analyses and peer review of events – Recommendations regarding analyses – Culture surveys PSO are subject to strict confidentiality requirements which includes fines for breaches PSO are subject to HIPAA privacy requirements

5. PSO Background AHRQ manages the listing process for PSO’s: http://www.pso.ahrq.gov/listing/psolist.htm http://www.pso.ahrq.gov/listing/psolist.htm Currently 70 PSO’s listed by AHRQ Typical PSOs – State hospital associations – Technology vendors – Large health systems – Specialty societies/organizations

6. AHRQ Common Formats AHRQ developed a common data dictionary, paper forms and technical requirements to submit data to PSO’s – Hospitals (Acute Care) – v1.2 – Skilled Nursing – beta – Readmissions – beta – Outpatient Services – research phase – Surveillance module (IT “trigger tool”) – research phase https://www.psoppc.org/web/patientsafety/commonformats

7. AHRQ Common Formats Hospitals (Acute Care) – v1.2 – Blood or Blood Product – Device or Medical/Surgical Supply, including HIT – Fall – Healthcare-associated Infection – Medication or Other Substance – Perinatal – Pressure Ulcer – Surgery or Anesthesia – Venous Thromboembolism

8. Recent Development Affordable Care Act http://www.gpo.gov/fdsys/pkg/PLAW-111publ148/html/PLAW-111publ148.htm Section 1311(h) Quality Improvement (1) Enhancing patient safety “Beginning on January 1, 2015, a qualified health plan may contract with (A) a hospital with greater than 50 beds only if such hospital (i) utilizes a patient safety evaluation system as described in part C of Title IX of the Public Health Service Act; …. or (B) a healthcare provider only if such provider implements such mechanisms to improve healthcare quality as the Secretary may by regulation require.“

9. Recent Development Affordable Care Act Jan. 1, 2015, qualified health plans in insurance exchanges may not contract with a hospital of >50 beds unless that hospital has a patient safety evaluation system (PSES) PSES Definition: –“Patient safety evaluation system means the collection, management, or analysis of information for reporting to or by a PSO.” Patient Safety and Quality Improvement Act, Final Rule, Section 3.20. Final rule pending- we do not know all the details

10. Patient Safety Evaluation System (PSES) – What a Hospital Would Need to Do Defines (in writing) what information is included and excluded: – Common inclusions: Safety event reports, root cause, meeting minutes, quality analysis, HAC’s, investigative materials (Patient Safety Work Product) – Common exclusions: disciplinary action, just culture, state reporting mandates Defines staff that have access to PSES information Defines how information is reported to a PSO Defines how information may be removed from the PSES Defines committees and structures supporting the PSES – Patient safety committee, RM plan, PI plan, P&P’s Defines how information is identified as Patient Safety Work Product (PSWP)

11. Submitting Information to PSO Examples of Patient Safety Work Product that could be submitted to the PSO Patient safety events (“incident/occurrence reports”) – using AHRQ Common Formats – Manual entry – Electronic upload from an existing system Analyses and reports related to patient safety events Investigative documents (root cause analyses) Committee materials – minutes, findings, etc.

12. What a PSO Does – “Patient Safety Activities” 1.Collection and analysis of PSWP a)Web-based event reporting system b)Aggregate analysis and benchmarks c)May report event data to national database d)Alerts based on aggregate findings e)Secure collection of documents – RCAs, committee materials, etc. 2.Develop and disseminate information to drive improvement a)Best practices, protocols, recommendations on specific topics

13. What a PSO Does – “Patient Safety Activities” 4.Promote culture of safety a)Culture of safety surveys and recommendations b)Culture training 5.Preserve confidentiality of PSWP a)Strict P/P for HIPAA compliance b)Strict P/P to maintain member confidentiality 6.Preserve security of PSWP a)Secure website b)Encrypted data transfer c)P/P to not mix PSWP with other projects d)P/P related to staff training and physical security

14. What a PSO Does – “Patient Safety Activities” 6.Efforts to improve patient safety and quality 7.Provision of feedback to participants a)Improvement collaboratives b)RCA reviews and critiques c)“Safe Tables” – peer discussion of events and actions d)Improvement toolkits e)Recommendations based on data submitted

15. Working with a PSO - Sample Patient Safety and Quality Information Information Not Eligible to Become PSWP -Collected/developed for purpose other than for reporting to PSO -Claims, medical records -Accreditation/regulatory survey info. -Other record keeping requirements Information Eligible to Become PSWP -Could improve safety, quality or outcomes of care -Assembled/developed solely for reporting to PSO Provider PSES -Date and document incoming information -Internal analysis and collaboration -Prepare for reporting to PSO PSO PSES -Conduct required activities -Provide feedback to provider members -Aggregate data for reporting to national event database (if PSO chooses) Information Triaged by Provider PSWP=Patient Safety Work Product PSES=Patient Safety Evaluation System

16. Benefits to PSO Membership Compliance with ACA requirement if >50 beds (tentative) Legal protection of patient safety material Broader aggregation of events that can be relatively rare Access to national and state improvement content Peer sharing and learning Access to online event reporting if still on paper

17. Downsides to PSO Membership Time to catalog and document your Patient Safety Evaluation System (PSES) Adherence to your PSES If information is entered into the PSO it cannot be removed for other purposes Time to create data feeds if already using an electronic reporting system Cost associated with membership (not yet determined) Similar peer-to-peer sharing is protected under the state statute (WI 146.38)

18. Be Cautious Don’t feel pressured to join a PSO until your legal counsel has a good understanding of the benefits and limitations Don’t feel pressured by an existing PSO to “join quickly before the end of 2014”

19. Next Steps and Timetable WhatHospitalsWHABy When Complete survey re: possible interest XSept 6 th Evaluate feedback from data vendors XSept 6 th Federal interpretation of ACA ruleOctober? WHA decision to proceedXOctober- December Create policies/procedures and seek AHRQ listing X4 th quarter 2013 Contracting to join WHA PSOXXBegin 1 st quarter 2014

20. Question and Answer Kelly Court kcourt@wha.orgkcourt@wha.org – 608-274-1820