The Nature of Quality Improvement

Donald M. Berwick, MD, MPP

Institute for Healthcare ImprovementTestimony to the

Secretary’s Advisory Committee on Human Research Protections

Washington, DC: March 27, 2008

2

Aims

• Safety

• Effectiveness

• Patient-centeredness

• Timeliness

• Efficiency

• Equity

3

IMPROVING SAFETY AT SCALE

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

Model for Improvement (Nolan, et al.)

Act Plan

Study Do

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?

CareScience Observed minus Expected Mortality Rate per 100 DischargesAscension Health System

-0.9000

-0.8000

-0.7000

-0.6000

-0.5000

-0.4000

-0.3000

Apr

-03

May

-03

Jun-

03

Jul-0

3

Aug

-03

Sep

-03

Oct

-03

Nov

-03

Dec

-03

Jan-

04

Feb-

04

Mar

-04

Apr

-04

May

-04

Jun-

04

Jul-0

4

Aug

-04

Sep

-04

Oct

-04

Nov

-04

Dec

-04

Jan-

05

Feb-

05

Mar

-05

Apr

-05

May

-05

Jun-

05

Jul-0

5

Aug

-05

Sep

-05

Oct

-05

Nov

-05

Dec

-05

Obs

erve

d m

inus

Exp

ecte

d R

ate

per 1

00 D

isch

arge

s

Actual Monthly Difference p-bar (Center Line for Difference) LCL UCL

Baseline

1,038 Mortalities Avoided (Year 2)

374 Mortalities Avoided(9 mos. of Year 3)

1,412 Mortalities Avoided Since Baseline Period

Ascension Health Mortality ReductionAscension Health Mortality Reduction

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400

450

500

550

600

650

700

750

Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec

Org

an D

onors

1999 2000 2001 2002 2003 20042005 2006

8,015 Donors in 2006-- Another Recording Breaking Year! --

Collaborative Starts Here

IHS Diabetes Care & Outcomes Audit

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7.5

8

8.5

9

9.5

10

'96 '97 '98 '99 '00 '01 '02 '03 '04 '05 '06 '07

Source: IHS National DiabetesProgram Statistics 1996-2007

A1C,

%

Mean A1C, 1996-2007

*p<0.0001 comparing mean A1C levels in FY96 and FY07

year

Average visit cycle timePatient experience

0

20

40

60

80

100

120

140

160

Min

ute

s

The “100,000 Lives Campaign”

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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

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

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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

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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

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Rapid Response Results: Benedictine Hospital

43% Reduction

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“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….

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 patient care quality.

• Ethical management requires continual improvement, ethically managed, but that is not a human subjects research issue.

What Could OHRP Do?

• Clarify that QI work was not meant to come under IRB jurisdiction 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 “human subjects research.”