# Presentation: 035249

## 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*

## Slide 2

## Aims

- Safety
- Effectiveness
- Patient-centeredness
- Timeliness
- Efficiency
- Equity

## Slide 4

## IMPROVING SAFETY AT SCALE

**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.)

## Ascension Health Mortality Reduction

## 8,015 Donors in 2006

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

**Collaborative **
**Starts Here**

## 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**

**Notes:**
We can have hope that this works.  We have seen through the Division of Diabetes Prevention and Treatment’s success that population based improvement in treatment of at least single conditions and its complications are possible.  The improvements that have occurred in the Mean A1C for our population is unmatched.  You won’t find another system in the world that can show similar numbers.

We can have hope.  We have enough money to improve, we are a system full of champions, and we have seen some success.

## Average visit cycle timePatient experience

**Notes:**
Our improvement in the health care can’t be achieved without improving our patient’s experience of care.  As such one of the measures that we are addressing in the collaborative is the cycle time that patients experience when they come into the clinic.  Teams are making substantial improvements in this and it is improving patient satisfaction.

## The “100,000 Lives Campaign”

##  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

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

## 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

## Slide 15

## 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

**Notes:**
58% of Medication Injuries Are Due to High-Alert Medications! – 5M americans with CHF/40% readmission rate after 60 days -- Over 126,000 hospitalized people are infected by MRSA annually (cost of 2.5B extra dollars to the health care system) -- 7% incidence in acute care within 5 days (Wittington) -- Surgical Site Infections/Adverse Cardiac Events/Deep Vein Thrombosis/Postoperative Ventilator Related Pneumonia -- 

## Rapid Response Results: Benedictine Hospital

- 43% Reduction

## “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.”