The Nature of Quality Improvement

1
The Nature of Quality Improvement

• Donald M. Berwick, MD, MPP
• Institute for Healthcare Improvement
• Testimony to the
• Secretarys Advisory Committee on Human Research
  Protections
• Washington, DC March 27, 2008

2
(No Transcript)
3
Aims

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

4
(No Transcript)
5
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

6
Model for Improvement (Nolan, et al.)
7
Ascension Health Mortality Reduction
8
8,015 Donors in 2006 -- Another Recording
Breaking Year! --
Collaborative Starts Here
9
IHS Diabetes Care Outcomes Audit
Mean A1C, 1996-2007
A1C,

year
Source IHS National Diabetes Program Statistics
1996-2007
plt0.0001 comparing mean A1C levels in FY96 and
FY07
10
Average visit cycle timePatient experience
11
The 100,000 Lives Campaign
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

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

15
(No Transcript)
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

17
(No Transcript)
18
Rapid Response Results Benedictine Hospital
43 Reduction
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
  patient care 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
  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.