Patient Safety Organizations and ACA Impact

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 • Providesfederal, 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 • 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” • Collection and analysis of PSWP • Web-based event reporting system • Aggregate analysis and benchmarks • May report event data to national database • Alerts based on aggregate findings • Secure collection of documents – RCAs, committee materials, etc. • Develop and disseminate information to drive improvement • Best practices, protocols, recommendations on specific topics

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

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

15. Working with a PSO - Sample Patient Safety and Quality Information Information Triaged by Provider Information Eligible to Become PSWP -Could improve safety, quality or outcomes of care -Assembled/developed solely for reporting to PSO 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 Provider PSES -Date and document incoming information -Internal analysis and collaboration -Prepare for reporting to PSO PSWP=Patient Safety Work Product PSES=Patient Safety Evaluation System PSO PSES -Conduct required activities -Provide feedback to provider members -Aggregate data for reporting to national event database (if PSO chooses)

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

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