1. The Nature of Quality Improvement Donald M. Berwick, MD, MPP Institute for Healthcare Improvement Testimony to the Secretary’s Advisory Committee on Human Research Protections Washington, DC: March 27, 2008

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3. Aims Safety Effectiveness Patient-centeredness Timeliness Efficiency Equity 3

5. Does Improving Safety Save Money? 5 103 ICUs Working on Central Line Infections: 82% Reduction in Mean Rate 1,578 Lives Saved 81,020 Hospital Days Saved Over $165,000,000 in Costs Averted

6. Model for Improvement (Nolan, et al.) ActPlan StudyDo What are we trying to accomplish? How will we know that a change is an improvement? What changes can we make that will result in an improvement?

7. Ascension Health Mortality Reduction 7

8. 8,015 Donors in 2006 -- Another Recording Breaking Year! -- Collaborative Starts Here

9. IHS Diabetes Care & Outcomes Audit Source: IHS National Diabetes Program Statistics 1996-2007 A1C, % Mean A1C, 1996-2007 *p<0.0001 comparing mean A1C levels in FY96 and FY07 year

10. Average visit cycle time Patient experience

11. The “100,000 Lives Campaign” 11

12. Preventing Central Line Infections Hand hygiene Maximal barrier precautions Chlorhexidine skin antisepsis Appropriate catheter site and administration system care Daily review of line necessity and prompt removal of unnecessary lines 12

13. Central Line Associated Bloodstream Infections (CLABs) (from Rick Shannon, MD, West Penn Allegheny Health System) 13

14. The Campaign “Planks” -- Six Changes That Save Lives Deployment of Rapid Response Teams Delivery of Reliable, Evidence-Based Care for Acute Myocardial Infarction Medication Reconciliation Prevention of Central Line Infections Prevention of Surgical Site Infections Prevention of Ventilator-Associated Pneumonias 14

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16. Six Additional Planks Prevent Pressure Ulcers Reduce Methicillin-Resistant Staphylococcus Aureus (MRSA) Infection Prevent Harm from High-Alert Medications Reduce Surgical Complications (the Surgical Care Improvement Project (SCIP)) Deliver Reliable, Evidence-Based Care for Congestive Heart Failure Get Boards on Board 16

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18. Rapid Response Results: Benedictine Hospital 43% Reduction 18

19. “Informed Consent…” NOTICE TO OUR PATIENTS This hospital – our leaders, Board, and staff …. □does □does not make continual, informed changes in its processes of care, based on current and new science, to improve safety, effectiveness, patient-centeredness, timeliness, efficiency, and equity, for you. We continually measure our results and compare them to those of others. Our results over time are displayed below….

20. Conclusions “Quality improvement” is primarily a component of proper management, not the creation of new knowledge from research. Unlike researchers, clinicians and health care organizations have an obligation to improve quality. Ethical management requires continual improvement, ethically managed, but that is not a human subjects research issue.

21. What Could OHRP Do? Clarify that QI work was not meant to come under the Common Rule. Encourage health care leaders and clinicians to set standards and articulate guidelines for the ethical conduct of QI, but as a matter separate from “human subjects research.” Clarify that neither measurement nor learning nor comparison groups nor publication make a QI project “research.”