nonmaleficence patient safety & quality jan e. patterson ... · patient safety & quality...

Pediatrics Grand Rounds

25 March 2011

University of Texas Health Science

Center at San Antonio

1

Educating for Quality Improvement & Patient Safety

Patient Safety & QualityJan E. Patterson, MD MS


Ethical principles

Nonmaleficence

• First do no harm

• Obligation of physicians to patients to

prevent harm

Beneficence

• Obligation to provide the best care possible

Patient Safety & Quality as

Professional Responsibility

Objectives

• Describe the Quality & Patient Safety gap

• Identify quality improvement methods

• Identify some Joint Commission National

Patient Safety goals

• Define the role of teamwork and

communication in patient safety

Current Health Care

CDC, Natl Ctr Health Statistics

• Is the best the world has ever seen

– From 1900 to 2000, life expectancy increased from 49 to 77 years

– Since 1960, mortality from heart disease has decreased by 56%

– Since 1970, mortality from stroke has decreased by 70%


Institute of Medicine1999, To Err is Human

An estimated 44,000 to 98,000 people die each year from medical errors in healthcareMore than from breast cancer or AIDS or

motor vehicle accidents

2001, Crossing the Quality ChasmBetween the healthcare we have and the healthcare we

could have, lies not just a gap, but a chasm

2003, Follow-on Report, Patient SafetyErrors of Commission vs. Errors of Omission

The average number of deaths from medical errors is

roughly equal to the number of deaths that would occur if a

747 crashed EVERY DAY


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Brent James, 2008

What is quality?

Definitions - quality

• A degree or grade of excellence

• Medical quality – the degree to which

health care systems… increase the

likelihood for positive health outcomesAmerican College of Medical Quality

IOM’s definition:

• High quality medical care is characterized by the following attributes:

– Safe (no injury)

– Timely (no waiting)

– Efficient (no waste)

– Effective (evidence-based)

– Equitable (same quality for all)

– Patient-centered (best for patient)

Quality gap

• The quality gap… is the difference between what is scientifically sound and possible and the actual practice and delivery of health services.

Ken Kizer

Quality improvement:

• An interdisciplinary process designed to raise the standards of care delivery in order to maintain the outcomes of individuals and populationsAm. Coll. Medical Quality

• Focus on improving processes of care


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Why do we care about quality?

#1: Errors

• Diagnostic errors• Treatment errors• Failure of preventative care

• 42% of the general public reports experiencing a preventable error in their own or a family members’ care*

• Each error represents potential mortality or morbidity

*Blendon, NEJM 2002

#2: Variation in Care #3: Cost!!• Billions of dollars in unnecessary costs

• Adverse Drug Events (ADE)– $8750 / hospitalization

– $3-4 billion in costs / year

• ~ 50% of expenditures in hospitals is related to waste**

• Looming financial crisis:– Premiums rising for employers and patients

– Aging population with more chronic disease

** James et al 2006

Medicare Spending & Quality

Baicker & Chandra. Health Affairs Web Exclusive April 7, 2004

International Comparisons

Country

Infant

Mortality

Life

Expectancy

Per Capita

Expenditures

% GDP Spent

on

Healthcare

Sweden 2.8 80.6 $3,202 9.2%

Japan 3.2 81.4 $2,474 8.2%

Germany 4.1 79.0 $3,371 10.6%

Canada 4.6 80.3 $3,678 10.0%

UK 5.0 78.7 $2,760 8.4%

Italy 5.7 79.9 $2,514 9.0%

Greece 5.3 79.4 $2,453 9.1%

United States 6.4 78 $6,714 15.1%

Outcomes data – U.S. Census Bureau, International database 2007

Financial data – Org for Economic Cooperation & Development 2006


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The Quality “Players”and what they do…

Institute of Medicine

• Established in 1970 under the National Academies of Science

• Purpose is to provide independent… evidence-based advice

www.iom.edu

Agency for Healthcare Research & Quality (AHRQ)

• Mission is to improve the quality, safety, efficiency and effectiveness of health care…

• Fund research on quality, disseminate results, provide resources

• $372 million budget FY2009

www.ahrq.gov




• $372 million budget FY2009– NIH budget $29 Billion

www.ahrq.gov




• $372 million budget FY2009– NIH budget $29 Billion– NIDDK budget $1.7 Billion

www.ahrq.gov

Joint Commission

• Accreditation programs

– Hospitals

– Labs, ambulatory surgery, outpatient practices

• Required for hospital accreditation, and payment

• National Patient Safety Goals

www.jointcommission.org

http://www.nap.edu/catalog/9728.html





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National Committee for Quality Assurance (NCQA)

• Accreditation, Certification focusing on plans

• HEDIS – healthcare effectiveness data and information set– Breast cancer screening

– Cervical cancer screening

– Chlamydia screening

• > 90% plans of use HEDIS data as the basis of their reporting

http://www.ncqa.org/

National Quality Forum (NQF)

• Founded in 1996 by recommendation of a Presidential Advisory commission

• Charged with designing a strategy / framework for a national reporting system

• Goal is to develop collaborative consensus standards that have legal status

• Developed “Never Events”

Never Events

• Wrong patient / part / procedure

• Retained objects

• Death / disability related to drugs, device, air embolus

• Patient suicide

• Infant discharge to wrong person / abduction

• Maternal death / disability in low-risk patient

• Failure to diagnosis newborn hyperbilirubinemia

• Severe pressure ulcer

• Death / disability due to falls

• Assault on patient

Pay for Performance

• Financial incentives would be more likely to impact care

– Current fee for service system pays for episodes of care, not quality of care

• The goal is to provide a reward for higher quality

So what can YOU do to improve the quality of care you deliver?

Step 1: Decide what to improve

• Common problems

• High-impact problems

– Patient outcomes

– Cost

• High variability problems


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Step 1: Decide what to improve

• Common problems

• High-impact problems

– Patient outcomes

– Cost

• High variability problems

Step 2: Get the TEAM together

• Representation / knowledge of all the process

• Composition:– “Leaders” who can facilitate change– “Process owners”

• Ground rules: inclusive, open, consensus-driven

• Define Aim Statement – “SMART”

Step 2: Get the TEAM together

• Representation / knowledge of all the process

• Composition:– “Leaders” who can facilitate change– “Process owners”

• Ground rules: inclusive, open, consensus-driven

• Define Aim Statement – “SMART”

35

PI Team StagesStages of team development

–Forming – Create awareness

–Storming – Resolve conflict

–Norming – Cooperation

–Performing – Produce meaningful work

–Rewarding –

• See the improvement in health outcomes that are possible

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Developing an Aim Statement

• Purpose of the Aim Statement

– Define the scope of the project

– Become the cornerstone for all project efforts

– Rallies the team around clear goals

– Keeps the team’s action focused

• Transforms “We’ve got to do something about this!” to something actionable.

37

When Developing an Aim Statement

• Use the SMART method to develop your aim statement:

– Specific

– Measureable

– Actionable

– Realistic/Relevant

– Timely

Beware, it may take more than 1 meeting to develop an aim statement and may be revised mid-stream.


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Step 3: Define the process

• Deming’s 7 Why’s

– Goal is to map out and display the process

• Tools:

– Conceptual flow diagrams

– Cause and effect / Fishbone / Ishikawa diagrams

– Process mapping

Step 4: Decide what to change

• Find the leverage points in the process– Use “tally sheet” to help you outline the major

contributors to processes

– Pareto charts – graphically display weights or frequencies of occurrences

• Goal is typically to reduce variation / increase predictability around these points– Evidence-based or consensus guidelines may be a

helpful approach

Step 5: Measure the impact

• What has been the effect on your target outcome?

– Run charts

– Statistical process control charts

• What has been the effect on other parts of the system?

Step 5: Measure the impact

• What has been the effect on your target outcome?

– Run charts

– Statistical process control charts

• What has been the effect on other parts of the system?

Step 6: Repeat and monitor!

• Refine what has worked and what hasn’t worked

• Need to follow processes over time, as they will be impacted by other organizational changes

Step 6: Repeat and monitor!

• Refine what has worked and what hasn’t worked

• Need to follow processes over time, as they will be impacted by other organizational changes


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PDSA Cycle

Plan

Do

Act

Study

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Performance Improvement ModelsName Explanation

Prospective Models used to design systems or prevent problems

PDCA / PDSA Plan-Do-Check-Act or Plan-Do-Study-Act: Four step improvement process that begins with planning the intervention, implementing the change, measuring results, and using the result to plan further improvements in the system.

DMAIC Define-Measure-Analyze-Improve-Control: A 5 phase methodology for improving an existing process, usually used as part of Six Sigma approach to improvement.

DMADV Define-Measure-Analyze-Design-Verify: A 5 phase methodology for designing a new process, usually used as part of a Six Sigma approach to product or service design.

Six Sigma An improvement strategy that seeks to identify and remove causes of defects within a process. This approach focuses on team preparation and charter, defining customer expectations, process mapping, and care ongoing measurement of results.

HFMEA Healthcare Failure Mode Effectiveness Analysis: Another engineering term that has been adopted by health care. This process analyzes a new process or product to determine potential point of weakness or failure prior to implementation.

Retrospective Model used to analyze past occurrences

Root Cause Analysis (RCA)

Examines an unexpected outcome or adverse even to identify the underlying system vulnerabilities that led to its occurrence. This process is often used to investigate sentinel events or other adverse health care events. The cause and effect diagram is a quality improvement tool often utilized as part of a root cause analysis.

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Plan

DoStudy

Act

How will we know that a change is an

improvement?

What changes can we make that will

result in improvement?

What are we trying to accomplish?

Rapid Cycle PDSA Performance Improvement Model

Plan

DoStudy

Act

Describe your intended change & list the tasks needed to set up this change test.

Describe what actually happened when you ran the change test.

Describe the results and how the measurement compares to your predictions of what should happen.

Based upon what you learned from measurement & your predictions, describe what modifications to the plan you will make for the next rapid cycle of change.

How will we know that a change is an improvement?

What changes can we make that will result in improvement?

What are we trying to accomplish?

Aim Statement

To reduce transfusion time from the "MD order” to the “Start Time" on 4 South from 6 hours to 2 hours or less by August 2009.

MD evaluates

Transfusion need

Blood Bank

Processes the

Blood/Blood

Product

Does patient

meet criteria?No

Informed Consent

obtained

MD Orders

Transfusion

Date/Time

Blood/Blood

Product is

transfused

Start Date/Time

Transfusion

Reaction?

Transfusion

Follow/up Testing

Is this an urgent order?

(Yes if surgical & after 10am the

day prior to surgery or if to be

given within 2 hours of the

transfuse order)

Schedule Urgent

Ward Collect by

RN/Super Tech

Schedule routine

Lab Collect

@ 5am or 11am

Transfusion Reaction

Investigation

Indicates data elements to be

captured for reporting.

Pre-Intervention

Transfusion Flow

Yes

Yes

No

Yes

Continue to

evaluate

Is there a specimen in the blood

bank drawn within the last 72

hours?

No

Yes

No

Definitions:

Routine – Transfusion scheduled at specific date/Time in the future

. – Lab Collect @ 5am or 11am

Urgent – After 10am the day prior to surgery or within 2 hours

. of the Transfuse Order

. – Ward Collect by RN/Super Tech

Emergent – Uncross-matched blood to be administered

Type & Screen

MD Order

PSA & RN

electronically notified

of MD Order

PSA Verifies if

Specimen in BB

Begin SF18

End

No

Yes

Ward Collect?

Type & Cross

ROUTINE/HOLD/STAT

MD Order

Phlebotomist, RN, Super Tech,

MD Collects Specimen

Yes

Lab Collect

5am & 11am

Page Transporter to pick up on

nursing unit & deliver to BB

NO

SF18 clocked

into BB

BB Tech verifies SF518 &

specimen information

BB tech spins specimen

(Approximately 8 min.)

Type & Screen Processed

(Valid for 72 Hours)

Ø Accessioning

Ø Set up

Ø Resulting

Ø Pt history checked

(Approximately 45 min. if no antibodies)

Post-Intervention

Blood Administration Flow

PSA/RN verifies T&S

PSA/RN Starts NEW SF518 w/

copy of T&C MD order to Escort

Yes

Escort Picks up and Delivers

SF18 & T&C MD order to BB

SF18 & T&C MD order clocked

into BB

BB cross verifies T&S specimen

info with SF18 & T&C MD order

T&C performed

Results of T&C read

Results recorded in VISTA

Blood Product tagged w SF518

Routine Blood

Administration?

BB MT calls on

“to give” orders ONLY

Routine

w/in 4 hrs

Refer to T&S process

PSA notifies RN Blood

is ready

RN assesses schedule for

blood administration

If conditions ready for blood

administration, PSA calls escort

for priority blood pick up

No

If Type & Hold

Process ends

Stat

w/in 2 hrs

Hold

BB MT calls on Stat Blood

Administration orders

Process Ends

Escort Present MD “to give”

order to MT in BB

MT Verifies SF18, Blood

Product, Pt name & SS# with

MD order

If verification is correct, BB

issues blood product to

escort & both sign

Escort deliver blood product

to unit RN or pages RN

& RN signs off

RN verifies blood product

with 2nd

LVN, RN, MD

If verification correct,

RN hangs blood product

Process Ends


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Cause and Effect Diagram

In 2008, 58.8%

vaccination rate

Institution Vaccine & Side Effects

Logistics

Hard to contact everyone

Takes time to sway people

back to acceptance

Education

Afraid of getting flu from vaccine

Misconception about live vaccine

Placebo effect

Previous experience, cold or

other illness after vaccinated

Fear of side effectsLack of knowledge

All proceedings and records of the Quality/Risk Management Committee are confidential and all professional review actions and communications made to the Quality/Risk Management Committee are privileged under Texas and federal law.Tex. Occ. Code Ann. Chps 151 & 160; Tex Health And Safety Code § 161.032; and 42 U.S.C. 11101 § et seq.

Believe the vaccine is a guess

H1N1: How can they make it in 3 months

when usually takes a whole year?

Lack of time

Not educated about flu

Egocentric individuals (only effect self)

Not enough facts

H1N1 Risk Population is changing

Lack of trust in people

who make vaccine

Not priority to be

knowledgable about vaccine

TV always negative

Hard to overcome individual beliefs

Vocal people sway others

Only focuses on flu

during flu season

Have never had

the flu, so

not concerned

People

Object to putting substances

in their body

Core beliefPeer Pressure

Lack of interest

Past experience

Unit culture

Leadership

Lack of buy-in

Don’t give time to staff

Don’t believe

Don’t get it

Don’t encourage

Lack of interest by leader

Executive leadership

does not set example

Leader lacks leadership skills

Must go above and beyond

Lack of accountability

Lack of peer pressure at this level

No ramifications to leader

if staff not vaccinated

Lack audit/feedback

No ramifications to executive

leaders

Delay in shipments

Contaminated Blood Cultures on 8th Floor of UH

7.1%

6.6%

3.2%

5.3%

1.7%

4.7%

5.8%

3.2%

1.1%

3.0%

5.1%

8.1%

3.5%

9.4%

3.3%

2.3%

1.8%

2.8%

5.2%

3.0%

1.6%

2.6%

1.4%

3.6%

2.0%

1.1%

2.9%

CL

0.019

UCL

0.102

0.000

0.020

0.040

0.060

0.080

0.100

0.120

0.140

0.160

JulA

08

JulB

08

Aug

A 0

8

Aug

B 0

8

Aug

C 08

Sep

A 0

8

Sep

B 0

8

OctA 0

8

OctB 0

8

NovA

08

NovB

08

DecA

08

DecB

08

JanA

09

JanB

09

JanC

09

FebA 0

9

FebB 0

9

Mar

A 0

9

Mar

B 0

9

Apr

A 0

9

Apr

B 0

9

May

A 09

May

B 09

JunA

09

JunB

09

JulA

09

JulB

09

Aug

A 0

9

Aug

B 0

9

Aug

C 09

Sep

A 0

9

Sep

B 0

9

Two Week Intervals

% o

f B

loo

d C

ult

ure

s C

on

tam

inate

d

Pre-intervention Post-intervention

Challenges in quality improvement:

• Will there be more coordinated national direction?– HHS releases National Quality Strategy

• Change management is HARD!

• Things that work in one place often don’t work in others

• Still need to find the right combination of tools / policy directives to support QI work


Patient Safety

Definition•The prevention of harm to patients, where harm can occur through commission and omission• Safety and quality cannot be separated•Requires a commitment by all stakeholdersto a culture of safety and improved information systems

The Joint

• The Joint Commission

–Accreditation of healthcare organizations

–Accreditation standards

–National Patient Safety Goals


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National Patient Safety Goal #2(Now a Standard)

• Improve the effectiveness of communication between caregivers– For verbal or telephone orders, or for phone reporting of

critical test results, verify the complete order or test result “read-back.”

– Standardize a list of abbreviations not to be used throughout the organization

– Measure, assess, improve the timeliness or reporting and receipt of clinical tests

– Implement a standardized approach to “hand off” communications www.txhima.org/www/journals/jvol12a5.htm

Unapproved Abbreviations

See Unapproved list at: Institute for Safe Medication Practices (ISMP)

Educating for Quality Improvement & Patient SafetyEducating for Quality Improvement & Patient Safety

National Patient Safety Goal #3• Improve the safety of using medications

– Identify and annually review a list of look-alike/sound alike drugs used in the organization, and take action to prevent errors

(Now a Standard)

– Label all medications, medication containers (syringes, medicine cups) on and off the sterile field in preop and other procedural settings

– Reduce the likelihood of patient harm associated with the use of anticoagulation therapy


Look Alike

Institute for Safe Medication Practices (ISMP)

Tall Man Letters

ISMP Newsletter 7-10-10

http://www.txhima.org/www/journals/jvol12a5.htm


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National Patient Safety Goal #7

• Comply with hand hygiene guidelines

• Implement practices to prevent healthcare-associated infections due to multiply drug-resistant organisms in acute care hospitals

• Implement best practices for preventing catheter-related bloodstream infections

• Implement best practices for preventing surgical site infections


15 million central venous catheter (CVC) days

Total number of days of exposure to CVCs

Avg rate: 3.2 per 1000 catheter days

Range 1.5 – 6.8 per 1000 catheter days

~ 80,000 CVC-related BSIs each year

Mortality 10-35%

Cost per BSI: $25,000

70% of nosocomial BSI related to CVCs


Intravascular Catheter-Related Infections (BSIs)

Prevention: Team Approach

• Pronovost et al. NEJM 2006;355:2725

• 5 evidence-based interventions• Hand hygiene• Chlorhexidine skin prep• Maximal barrier precautions• Avoid femoral site• Removal of line ASAP

• 66% decrease in catheter BSIs

103 ICUs; 1,981 ICU months in Michigan375,757 catheter daysFunded by AHRQ


Team-Based Approach

Pronovost et al. NEJM 2006

Patient Safety Goal #13(Now a Standard)

• Encourage the active involvement of patients and their families in the patient’s care as a patient safety strategy

– Define the ways in which the patient and the patient’s family can report concerns about safety and encourage them to do so


• Cost of low health literacy

– $100 to $200 billion


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Organizational Culture Change for Patient Safety

Hospital administration support and buy-in

Multidisciplinary teams

Physician champions

Nurse and other staff empowerment

Caregivers feel comfortable speaking up about perceived problems with care

Unit ownership and accountability

Process measures/bundles

Surveillance and reporting

Outcomes


Center for Patient Safety & Health Policy• Integrate quality and safety concepts into our everyday

work to increase quality and safety of clinical care

– Implement quality and safety through project-based

learning at levels of UTHSCSA

• Integrate quality improvement efforts into health

services/outcomes research and health policy

• Train the next generation of health professionals to

incorporate quality improvement practices in their work

• Initiatives

• Clinical Safety & Effectiveness course – faculty & staff

• Interprofessional course in quality & safety - UME

• GME training


nonmaleficence patient safety & quality jan e. patterson ... · patient safety & quality...

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