Michigan Health & Safety Coalition Conference 29 March 2006

1. An Overview of the Agency for Healthcare Research and Quality&The Patient Safety and Quality Improvement ActWilliam B. Munier, MD Michigan Health & Safety Coalition Conference 29 March 2006

2. Today’s Agenda • Agency for Healthcare Research and Quality (AHRQ) • Center for Quality Improvement and Patient Safety (CQuIPS) • Patient Safety and Quality Improvement Act

3. AHRQ Mission • AHRQ is the lead Federal agency charged with improving the quality, safety, efficiency, and effectiveness of health care for all Americans • One of 12 agencies within DHHS • Supports health services research that will improve the quality of care and promote evidence-based decisionmaking

4. AHRQ Facts • Director: Carolyn Clancy, MD • Staff: Approximately 300 • FY 06 Budget: $318.7 million • Research comprises 80% of budget, invested in grants and contracts focused on improving health care

5. CQuIPS within AHRQ Office of theDirector Center for Primary Care, Prevention & Clinical Partnerships Office of Performance, Accountability, Resources & Technology Center for Quality Improvement & Patient Safety Office of Extramural Research, Education & Priority Populations Center for Delivery, Organizations & Markets Center for Financing, Access & Cost Trends Office of Communications & Knowledge Transfer Center for Outcomes & Evidence

6. CQuIPS • Patient safety – research, education and training, development and dissemination of information • National Healthcare Quality and Disparities Reports • National report on quality • National report on disparities • Disease-specific reports • State snapshots

7. Making the case • What’s the data • Turning data into information • Learning from others • Developing a QI plan • Moving the agenda forward

8. CQuIPS • Consumer Assessment of Healthcare Providers and Systems (CAHPS) • Quality improvement • Conducting and supporting user-driven research • Disseminating reports and information • Patient Safety and Quality Improvement Act – PL 109-41

9. PSQIA – PL 109-41 Purpose of Act • To provide for the improvement of patient safety • To reduce the incidence of events that adversely affect patient safety

10. Major Provisions of Act • Creates “Patient Safety Organizations” (PSOs) • Establishes “Network of Patient Safety Databases” (NPSD) • Mandates Comptroller General to study effectiveness of Act (by 2010) • Is a completely voluntary system

11. What is the Problem? • Providers fear that patient safety analyses can be used against them in court (malpractice) or in disciplinary proceedings • State laws offer inadequate protection (e.g., large providers cannot share analyses system-wide without risk) • Patient safety improvement is hampered by the inability to aggregate data; by analyzing large numbers of events, patterns of failures could be more rapidly identified

12. The Act Addresses These Issues • Authorizes creation of PSOs that enter into contracts with providers to assist them in analyzing threats to patient safety and correcting or preventing them • Requires PSOs to work with more than one provider so that PSOs can aggregate data across providers and with other PSOs • Provides Federal confidentiality protections for these analyses and significantly limits their use in criminal, civil, and administrative proceedings

13. Principal Implementation Strategies • Build on existing work • Sharp end infrastructure • Private sector resources • Previous conceptual work (JCAHO; NQF) • Coordinate DHHS/Federal efforts • Use IT to maximum extent practical • Keep it simple

14. Two Basic Tracks • Development and operation of PSOs • Fostering an operational “network of patient safety databases”

15. Supporting Activities • Public listening sessions (just concluded) • Developing regulations to govern the operations of the PSO program • Compiling an inventory of operational patient safety reporting systems • Scope, operations, and output of reporting systems • Patient safety incident definitions (data element level)

16. Issues Requiring Rulemaking • AHRQ: PSOs • Certification, operation, and revocation of certification • Office of Civil Rights: Confidentiality • The Act necessitates new confidentiality standards as well as guidance on how and when to assess civil monetary penalties

17. PSO Program • PSO certification processing system • Reviewing & accepting initial, subsequent PSO certifications • Certification statements • Optional narratives (under consideration) • Disclosures • Handling complaints; revoking acceptance of certification • Technical assistance • Collecting, analyzing reports • Providing strategies to improve patient safety • Annual meeting

18. Issues Requiring Clarification • The Act establishes two novel concepts: • Patient Safety Work Product • Patient Safety Evaluation System • To be protected, information must be considered “patient safety work product” and be in the “patient safety evaluation system” • Raises the issue of who & where patient safety reporting, analysis, etc. are carried out

19. NPSD Objectives • To generate information relevant to preventing harm to patients from health care (aggregate/analyze incident data; disseminate results) • To employ interoperable terms, definitions of patient safety incidents • To simplify task of reporting incidents • To provide benchmarking and trend reports • To share de-identified data for use in improving patient safety

20. Next Steps • Finish inventory of data elements, definitions & encoding schemes used currently to • Inform development of “common formats” • Provide technical assistance to PSOs • Consider options for fostering development of network of patient safety databases • Plan for inclusion of patient safety information on performance, trends AHRQ’s NHQR/DR

21. Discussion

22. For Additional Information: • http://www.ahrq.gov • William.Munier@ahrq.hhs.gov