Lab Quality ConfabSan Antonio, Texas6 November 2012

ROBERT L. MICHELEditor In Chief

THE DARK REPORTSpicewood, Texas

rmichel@darkreport.comph: 512-264-7103fax: 512-264-0969

Labs Need Lean, Process Improvement, QMS

Prospering in the Age of ACOS, Medical Homes, and Integrated Care

My Goals Today! One: Discuss new report

by Institute of Medicine and itsimplications for healthcare and labs.

Two: Demonstrate essential link between new healthcare goals and techniques of Lean, performance improvement.

Three: Identify useful strategies and action items for clinical labs and pathology groups.

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Big Development:IOM’s New Report!

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IOM’s Views “Americans would be better served

by a more nimble healthcare system that is consistently reliable and that constantly, systematically, and seamlessly improves.”

“In short, the country needs healthcare that learns by avoiding past mistakes and adopting newfound successes.”

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$2.2 Trillion Health System “By one estimate, almost 75,000

needless deaths could have been averted in 2005 if every state had delivered care on par with the best performing state.”

“Current waste diverts resources; the committee estimates $750 billion in unnecessary health spending in 2009 alone.”

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Business Intelligence Plays to Labs’ Strength

IOM says: “Decision support tools and knowledge

management systems can be included routinely in health care delivery to ensure that decisions are informed by the best evidence.”

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IOM’s New Operational Mindset

Healthcare delivery organizationsshould develop organizational cultures that encourage continuous improvement by incorporating: best practices, transparency,

open communication,

staff empowerment, coordination, teamwork, and mutual respect, and,

align incentives accordingly. 7

Great News for Lean Labs Advantage for labs already practicing

Lean and process improvement. Opportunity for all of you

here to “borrow frequently” from outside healthcare.

You have the encouragementand the endorsement the Institute of Medicine!

Let’s look at what IOM says…

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1

9

Laboratory

Informatics

2

10

Laboratory

Workflow

& Physician

Support

3

11

Reducing Lab

Errors—Internal &

External

4

12

Patients Can Readily

See Prices of their Lab

Tests

5

13

Labs Support Clinical Workflow

6

14

Labs Have Patient-

Friendly Services and

Access

7

15

Labs Implement

Continuous Improvement,

Drive Out Waste

Add It Up! Institute of Medicine tells providers

now time to adopt modern management methods and tools.

More use of informatics and real-timebusiness intelligence to eliminate waste, add value.

Mindset of continuous improvement. Clinical labs are complex organizations

and will benefit from taking these steps.

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Overlooked Lab Basics( Ignore at your peril! )

For hospitals, laboratory testing averages 5¢ of every $1.

Keep that fact in mind today! Lab test data typically represents 80%

of patient’s permanent health record. Lab test data typically plays a role

in 60% of the decisions to admit or discharge an inpatient.

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Healthcare Macro-Trends1. ObamaCare is BIG!

(Accountable Care Act)

2. Demographics are BIG!Silver Tsunami = Skyrocketing test volume

3. Chronic disease is BIG!

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Healthcare Macro-Trends4. Electronic Medical Records

5. Proactive Medicine

6. Personalized Medicine

7. Whole Human Genome Sequencing

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Source: Behavioral Risk Factor Surveillance System, CDC.

Age-adjusted percentage of adults aged ≥20 years who are obese, 2007

MMWR 58:1259-1263, 2009

Austin

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Why Integration of Clinical Care?

ACOs inspired by the care models used at: Kaiser Permanente Geisinger Health Mayo Clinic Intermountain Healthcare Cleveland Clinic

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For Laboratories… Laboratories must evolve to be

fully integrated in their community’s healthcare continuum.

Laboratories must integrate their information technology capabilities with each sector in healthcare.

Laboratories produce information and can only serve their customers by integrating access to this information.

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Use of targeted laboratory testing, including POCT, reduced cardiac readmission rates. Mortality from CAD declined 73%, number of patients meeting cholesterol goal went from 26% to 73%. 12,000 patients were enrolled in the Collaborative Cardiac Care Services (CCCS) program. 23

Engleberg Center for health Care Reform at Brookings/Dartmouth Institute 24

Lab Medicine’s Vital Role Concepts of personalized medicine

and genetic medicine require doctors to utilize laboratory tests.

Flood of new diagnostic technologies enables more clinically-useful lab tests.

More accurate and earlier disease detection.

Capabilities to help physicians select therapies that are most appropriate.

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Personalized and Precision Use these terms to guide decisions

about laboratory information technology. It is the lab test which informs physician

as to patient’s unique health status. Making lab test data—and pathologists’

interpretations—available to all caregivers will be critical success factor.

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Here at LQC Today… Lab Industry “First Movers” You have special skills and insights

for achieving high performance. Over seven years, Lab Quality Confab

only lab industry meeting devoted to Lean and process improvement.

That makes everyone here leaders in this sector of healthcare!

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Lean Labs’ Window of Opportunity The “Squeeze” is on! Need fewer errors. Need to test more with less money. Need to invest in genetic technology. Need to deliver knowledge

from raw test data.28

Coming: Age of QMS No lab will be able to meet these goals

using traditional management and workflow.

Quality Management Systems (QMS) are an integral part of the solution.

Think ISO 9001, ISO 15189, CSLI GP 22, to name a few.

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QMS as Global Standard As many as 100 nations are in the

process of making ISO 15189 their accedition/license standard for medical labs.

Expect the requirement for labs offering laboratory-developed tests (LDTs)to have a QMS in place.

Think about the FDA’s “Good Manufacturing Practices” (GMP) for medical devices.

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New QMS Resource

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• Looks at role of QMS in helping labs meet CLIA & CAP Accreditation.

• Based on presentations by Yost, Berte, Flaherty, Nichols, Serrano.

• Available for purchaseLQC registration desk.

Question for Your Lab… With all these developments,

shouldn’t your lab take steps now to implement a QMS?

Plenty of resources to help yoyuat this year’s Lab Quality Confab.

Case studies of ISO 15189 implementation.

Extended workshops in Lean skills and tools.

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Yes, It’s a Time of Change! Healthcare’s coming transformation

will unfold a pace unseen by this country since World War II.

Next cycle of change in healthcare is poised to fundamentally reshape the lab testing industry.

“Change Means Opportunity”Disruption of status quo in lab marketplace creates the opportunity for nimble lab organizations to prosper in new ways! 33

“In a chronically leaking boat, energy devoted to changing vessels is more productive than energy devoted to patching leaks.”

–Warren Buffett

Final Thoughts on Change…

“You miss 100% of the shots you never take!”

–Wayne Gretzky

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