General PSO Update

1. General PSO Update AHRQ Annual Conference 2008 Amy Helwig, MD, MS William B Munier, MD, MBA Larry Patton 8 September 2008

2. Presentation Organization • Moderator – Amy Helwig • PSO Status – Bill Munier • PSO Operations – Larry Patton 2

3. Overview of PSO Sessions • Sunday • Common Formats Workshop • Monday • Confidentiality, PSWP, & the PSOs • General PSO Update • PSO Status • PSO Operations • Tuesday • 8 am – Common Format Mini I – Brookside A & B • 10 am – Common Fmt Mini II – Middlebrook • 1 pm – Common Fmt Mini III – Brookside A & B

4. Presentation Organization • Moderator – Amy Helwig • PSO Status – Bill Munier • PSO Operations – Larry Patton 4

5. Medical Errors in History “In my opinion, physicians kill as many people as we generals.” Napoleon Bonaparte

6. Progress? The only two “wins” we are sure of are: • Removal of concentrated KCl from the floors • Introduction of infusion devices to eliminate free-flow IVs in hospitals. Dennis O’Leary, CEO, Joint Commission – June 1, 2007

7. The Patient Safety and Quality Improvement Act of 2005 • Encourages formation of PSOs to improve the quality & safety of health care • AHRQ will administer rules for listing qualified PSOs • HHS Office for Civil Rights will be responsible for enforcing confidentiality

8. Rather than a patchwork of state-by-state protections, there will now be national uniform protections; that is, confidentiality & privilege for clinicians & entities performing patient safety activities

9. Proposed Patient Safety Regulation • PSOs will provide feedback to clinicians & health care organizations on improving safety • The Act does not relieve clinicians or health care organizations from meeting reporting requirements under Federal, state, or local laws • The proposed rule (NPRM) was published in the February 12th Federal Register; comment period ended April 14th • 150 comments received – many very detailed

10. Regulations Process 2007 2008 HHS Completes Draft Regulations OMB Reviews NPRM Published Comments Accepted HHS Revises OMB Review (of revisions) Final Rule Published

11. Patient Safety Organizations (PSOs)

12. Who Can be a PSO? • Eligible organizations: • Any public or private entity / component • Any for-profit or not-for-profit / component • Ineligible organizations: • Statute prohibits health insurance issuer or component of health insurance issuer • NPRM proposes prohibiting any public or private entity that regulates providers • e.g., The Joint Commission

13. Potential PSO Sponsors • Hospital associations • Hospital chains • Medical societies • Specialty societies • Group practices • Newly-created organizations • Others

14. PSO Activities • Collect, analyze patient safety (PS) data • Assist providers to improve quality & safety • Develop & disseminate PS information • Encourage culture of safety & minimize patient risk • Provide feedback to participants • Maintain confidentiality & security of data

15. Network of Patient Safety Databases (NPSD)

16. NPSD • Provides benchmarks & baselines for measurement • Disseminates results, best practices • Conducts analyses for the National Healthcare Quality Reports • Develops a web-based evidence-based management resource to support research • Provides technical assistance as needed

17. Common Formats • PSOs will collect, aggregate, & analyze information on quality & safety of care • Statute authorizes collection of this information in a standardized manner • Common Formats are now available • Allow aggregation of comparable data at local, PSO, & national level • Facilitate the exchange of information • Underlie the ability to compare & learn

18. Common Formats can provide a common language for patient safety reporting across the nation

19. Common FormatsDevelopment Cycle • Formats will not be subject to • Federal regulatory processes • NQF formal consensus process • Formats will • Be updated annually as guidance • Have tight version control • Formats are • Currently limited to the hospital setting • Planned for additional settings

20. Presentation Organization • Moderator – Amy Helwig • PSO Status – Bill Munier • PSO Operations – Larry Patton 20

21. PSOs: The Basics • Providers are NOT required to work with PSOs • Providers are NOT required to enter contracts with PSOs to obtain protections (but note HIPAA Privacy Rule requires business associate agreement if provider is a “covered entity” and shares PHI with a PSO) • While AHRQ will list PSOs for the Secretary, PSOs will not receive funding from AHRQ; AHRQ will provide technical assistance • AHRQ’s regulatory authority only extends to PSOs; AHRQ will not regulate providers that work with PSOs 21

22. PSOs: AHRQ Approach Streamlined process of simple attestation; spot checks to ensure compliance with requirements and entities are subject to penalties for false statements Expect marketplace will assess worth of a PSO; Proposed rule emphasizes transparency / disclosure to enable providers to make those decisions Proposed rule emphasizes technical assistance and a non-adversarial approach whenever possible to promoting compliance by PSOs with the criteria they must meet; but if a PSO fails to correct deficiencies, the NPRM gives AHRQ the authority to take action 22

23. Subpart B:PSO Portion of the Rule 3.102 - Process and Requirements for Initial and Continued Listing 3.104 - Secretarial Actions 3.106 - Security Requirements 3.108 - Correction of Deficiencies, Revocation, and Voluntary Relinquishment 3.110 - Assessment of PSO Compliance 3.112 - Submissions and Forms

24. PSOs: Listing Requirements 15 Statutory Requirements: 8 Patient Safety Activities (PSAs) 7 Criteria Initial listing – policies & procedures in place to perform 8 PSAs and will meet 7 criteria upon listing Seeking continued listing – are performing/will continue to perform all 8 PSAs and complying with/will continue to comply with 7 criteria 18 Statutory Requirements for Component PSOs 3 additional requirements

25. PSOs: Remaining a PSO • Listing is for 3-year renewable periods • BUT statute includes a requirement that every 24 months a PSO must demonstrate that it has bona fide contracts with more than 1 provider • Proposed rule would require 2 contracts to meet that test

26. Confidentiality The statute provides federal confidentiality and privilege protections to patient safety work product (PSWP) and specifies when disclosures are permitted Confidentiality and privilege protections continue after disclosure, with limited exceptions PSWP may contain protected health information (PHI) requiring covered providers to also comply with the HIPAA Privacy Rule requirements 26

27. Patient Safety Work Product PSWP is any data: Developed by a provider and reported to a PSO Developed by a PSO for the conduct of patient safety activities, or That identifies or constitutes deliberations of or the fact of reporting pursuant to a patient safety evaluation system Original provider records (e.g., medical, billing) are not PSWP Non-identifiable PSWP is not confidential or privileged 27

28. Confidentiality Protections: Implications for Providers The Patient Safety Act’s confidentiality protections have the potential to significantly expand provider-based patient safety initiatives The proposed rule does NOT impose specific requirements on providers; within the framework of rule, providers have great flexibility on how to operate and develop systems to meet their needs But there are a number of issues that providers need to consider 28

29. Confidentiality: Implications for Providers • External Reporting – Statute does not relieve a provider of obligations under other laws or regulations that require external reporting of information; those requirements must be met with information that is NOT protected (not PSWP) • Internal Use of PSWP within the legal entity of a provider is NOT a disclosure but consider: • Any holder of PSWP can make disclosures • Intersection with credentialing or disciplinary actions • If provider is covered entity, disclosures must meet HIPAA and Patient Safety Act requirements

30. Your questions?