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Building the right esoteric testing laboratory for Cleveland Clinic: Successes and Lessons Learned David Bosler, MD Head, Cleveland Clinic Laboratories Executive War College, 5/4/2011 Objectives Cleveland Clinic Health System, Lab Esoteric lab initiatives Molecular department Test Development Test Utilization

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Page 1: Building the right esoteric testing laboratory for ......Building the right esoteric testing laboratory for Cleveland Clinic: Successes and Lessons Learned David Bosler, MD Head, Cleveland

Building the right esoteric testing laboratory for Cleveland Clinic: Successes and Lessons Learned

David Bosler, MD Head, Cleveland Clinic Laboratories

Executive War College, 5/4/2011

Objectives

• Cleveland Clinic• Health System, Lab

•Esoteric lab initiatives• Molecular department• Test Development• Test Utilization

Page 2: Building the right esoteric testing laboratory for ......Building the right esoteric testing laboratory for Cleveland Clinic: Successes and Lessons Learned David Bosler, MD Head, Cleveland

Cleveland Clinic

• Founded in 1921 by four physicians: “To Act as a Unit”

• A nonprofit multispecialty academic medical center

•2,000 employed physicians and scientists

•4.2 million patient visits/year.

• Institute Model: centered on organ system and disease type

Cleveland Clinic Organization – Regional

• Main Campus Hospital, Cleveland, Ohio

• 180 acres, 50 buildings

• Family Health Centers• 17 centers across Northeast Ohio

• Nine Regional Hospitals

Page 3: Building the right esoteric testing laboratory for ......Building the right esoteric testing laboratory for Cleveland Clinic: Successes and Lessons Learned David Bosler, MD Head, Cleveland

Cleveland Clinic Organization – Beyond• Cleveland Clinic Florida

• Weston and West Palm Beach

• Lou Ruvo Center for Brain Health • Co-located in Las Vegas and Cleveland

• Cleveland Clinic Abu Dhabi• Under construction, scheduled completion:

end 2012

Cleveland Clinic’s Pathology and Laboratory Medicine Institute• Chair: Kandice Kottke-Marchant, MD, PhD

• 70+ pathologists, complete subspecialty-based practice

• Approx. 2,000 employees

• Approx. 20 million test results generated each year

• Departments• Main campus

– Anatomic Pathology – Clinical Pathology – Molecular Pathology

• Regional Pathology • Cleveland Clinic Florida• Cleveland Clinic Laboratories

Page 4: Building the right esoteric testing laboratory for ......Building the right esoteric testing laboratory for Cleveland Clinic: Successes and Lessons Learned David Bosler, MD Head, Cleveland

Cleveland Clinic Laboratories (Reference Lab)

• Expanding menu of routine and esoteric tests

• Mixture of regional physician outreach and hospital clients• New building

• 136,000 square feet• “Green” building, targeting

LEED Silver• Designed “from the bench

out” to support optimal laboratory work flow

Cleveland Clinic Laboratories (Reference Lab)

• Growth Plan• Leverage our core strengths

– Comprehensive subspecialty expertise– Breadth of test offerings in Clinical, Molecular and Anatomic

Pathology• Expand into key market of hospital referrals, value added niche• Integrated hospital-level affiliations

• Key Challenge • How to continue what we do well for our clients “across the

street”, and translate into successful service for referral clients nationally and internationally

Page 5: Building the right esoteric testing laboratory for ......Building the right esoteric testing laboratory for Cleveland Clinic: Successes and Lessons Learned David Bosler, MD Head, Cleveland

Creating a Department of Molecular Pathology

• Chair: Gary Procop, MD, MS

• Why a Molecular Department?– Fosters growth of in-depth

knowledge and expertise in all areas that require molecular testing

– Furthers medical investigation/innovation and education

Creating a Department of Molecular Pathology

•Design Philosophy– Centralized technical cores

ensure quality and operational efficiency

– Disease and expertise-based professional interpretation optimizes value to patient care

TechnicalCores

Hemepath

AP/Onc

Molecular Genetics

Pharmacogenetics

Page 6: Building the right esoteric testing laboratory for ......Building the right esoteric testing laboratory for Cleveland Clinic: Successes and Lessons Learned David Bosler, MD Head, Cleveland

Department of Molecular Pathology

Clinical Sections• Cytogenetics• Molecular Genetic Pathology• Molecular Hematopathology• Molecular Oncologic Pathology • Molecular Microbiology

Department of Molecular Pathology

Operational Cores• Polymerase chain reaction

(PCR)• Sequencing• Microarray • Epigenetics• Commercial assays

• Cytogenetics• Fluorescence in situ

hybridization (FISH) • Materials handling• Extraction

Page 7: Building the right esoteric testing laboratory for ......Building the right esoteric testing laboratory for Cleveland Clinic: Successes and Lessons Learned David Bosler, MD Head, Cleveland

Department of Molecular Pathology

Operational Cores Concept Yields Efficiencies:

• Commercial assays core– Kit based assays allow step-wise

development of technologists’expertise

– Accomodates staffing growth• Materials handling core

– Dedicated reagent preparation and QC improves efficiency in other cores

– In-house production of control materials lowers materials cost

Lessons Learned:Career pathways for technologists improve satisfaction and retention

Cross training is a vital part of maintaining optimal staffing levels in each core

Focus on Test Development

Translating what we already do well to a growing reference laboratory mission:

• 2200+ tests– Extensive menu for hospital lab– Increased expectations for reference lab

• Ever increasing send out volumes and costs– CC physicians: increased utilization of high cost esoteric testing– Reference work: sending out tests increases turn around time,

unfavorable finance, and puts our reputation in the hands of others

Solution: Dedicated test development resources

Page 8: Building the right esoteric testing laboratory for ......Building the right esoteric testing laboratory for Cleveland Clinic: Successes and Lessons Learned David Bosler, MD Head, Cleveland

Center for Test Development

•Director: Tom Daly, MD• Purpose: pooled resource dedicated to test

development• Staffing

– 2 PhDs, 5 Technical– “Embedded” Development Techs outside CTD

4 in Chemistry5 in Molecular

Center for Test Development

•Equipment • Used for a variety of protein and

molecular assay development including:

– PCR – Sequencing – IHC – ELISA– FISH

Page 9: Building the right esoteric testing laboratory for ......Building the right esoteric testing laboratory for Cleveland Clinic: Successes and Lessons Learned David Bosler, MD Head, Cleveland

How are projects selected for development?

Section heads

TDSC

CTD

Development lab

CCML

PLMI staff

CC staff

Standardized RFP PrioritizationTDSC Progress oversight

IP review

Department

Chairs

PLMI ChairMarchant

AP ChairGoldblum

CP ChairHsi

Research ChairRubin

MP ChairProcop

Head CCL Bosler

Chair - CTDDaly

In Situ

Center for Test Development

CTD Development Phases• Feasibility• Validation• Transfer

Page 10: Building the right esoteric testing laboratory for ......Building the right esoteric testing laboratory for Cleveland Clinic: Successes and Lessons Learned David Bosler, MD Head, Cleveland

Center for Test Development

• Feasibility– CTD staff partners with laboratory medical director– Platform selection – Assay design & Development

• Transfer– Transfer packet – Observation of procedure in CTD by clinical lab– CTD available for trouble shooting prior to “go live”

Center for Test Development

Benefits of Design• Operational efficiency

– Specialized skill sets– Lack of clinical responsibilities eliminates conflict of priorities

• Strategic focus– Opportunity for institute level prioritization and tracking– Promotes coordination with reference laboratory efforts

Page 11: Building the right esoteric testing laboratory for ......Building the right esoteric testing laboratory for Cleveland Clinic: Successes and Lessons Learned David Bosler, MD Head, Cleveland

Impact of Development Efforts

CTD Developed, Launched

Sendout Test Volumes: 2008-2010

0

20,000

40,000

60,000

80,000

100,000

120,000

140,000

2008 2009 2010

An

nu

al

vo

lum

e

Other

Molecula

Focus on sendout testing yielded results in 2010

• 3-fold increase in the # of sendout tests brought in vs. 2009

• Initial focus on high-impact sendouts

Implemented tests as % of prior year sendout volume

• 2009 = 0.9%• 2010 = 17.2%

Other

Molecular

Page 12: Building the right esoteric testing laboratory for ......Building the right esoteric testing laboratory for Cleveland Clinic: Successes and Lessons Learned David Bosler, MD Head, Cleveland

Sendout Test Costs: 2008-2010

Implemented tests as % of prior year sendout costs

• 2009 = 0.3% • 2010 = 10.5%

Molecular testing is greater percentage of costs than of volume

$0

$2,000,000

$4,000,000

$6,000,000

$8,000,000

$10,000,000

$12,000,000

2008 2009 2010

An

nu

al vo

lum

e

OtherMoleculaOther

Molecular

Sendouts: Progress against the “top of the curve”

Tests with costs > $100K/yrTests with volumes > 1000/yr

Gray = brought in-house

Yellow = in active development

Page 13: Building the right esoteric testing laboratory for ......Building the right esoteric testing laboratory for Cleveland Clinic: Successes and Lessons Learned David Bosler, MD Head, Cleveland

Annual sendout totals: 2008-2010

Sendout volumes 2008-2010

0

1000

2000

3000

4000

5000

6000

7000

8000

9000

1 10 100 1000Rank

Ann

ual v

olum

e 2008

2009

2010

Sendout cost 2008-2010

$0

$200,000

$400,000

$600,000

$800,000

$1,000,000

$1,200,000

$1,400,000

1 10 100 1000Rank

Ann

ual c

ost 2008

20092010

Center for Test Development

Lessons Learned• Buy-in to community resource concept

– Overcome culture of development “silos”– Foster trust in process

No loss of medical control over assayCommunicate along the wayCelebrate successes

• Plan resources for implementation– “Throughput” limited by staffing of clinical lab– Increasing clinical lab head count can be difficult in resource

constrained environment

Page 14: Building the right esoteric testing laboratory for ......Building the right esoteric testing laboratory for Cleveland Clinic: Successes and Lessons Learned David Bosler, MD Head, Cleveland

Test Development Status Test Development Status

Center for Test Development

Next Steps• How to approach the “tail” of the send out curve?• Laboratory “Centers of Excellence”

– Comprehensive offerings in focused areas, building on strengths– Engage CC clinical faculty

Ensures needs are metImproves clinical utility of diagnostic algorithms

Page 15: Building the right esoteric testing laboratory for ......Building the right esoteric testing laboratory for Cleveland Clinic: Successes and Lessons Learned David Bosler, MD Head, Cleveland

Test Utilization Review

Before…• “If one of our docs orders it, run it!”

Now…• Service line cost initiatives

– Mandates to reduce cost, recognition for savings – Driving efficiency and cost throughout the enterprise– Cultural shift makes timing right for test utilization

review

Test Utilization Committee• Chair: Gary Procop, MD, MS

– Inclusive membershipWrote letter of invitation to each Department ChairInterdisciplinary membersHigh-level leadership

Test Utilization Review

Initial Steps: Inpatient “Hard Stops”• 10 tests identified for limitation based on frequency (no more than 1 per 24 hours)

– Medical Leadership, staff engaged – Implemented trial as “soft stops” (could push through)– Converted to hard stops 08/2010

• 78 additional hard stops implemented 11/2010

Bosler, David

Page 16: Building the right esoteric testing laboratory for ......Building the right esoteric testing laboratory for Cleveland Clinic: Successes and Lessons Learned David Bosler, MD Head, Cleveland

Test Utilization Review: Calls to Client Services Regarding Hard Stops

10 Hard Stops

8/24/2010

+ 78 Hard Stops

11/16/2010

Reduced Laboratory Test OrdersReduced Laboratory Test Orders

Completed Laboratory Test Orders per Patient Day

5.9 5.96.0

5.9

6.3

5.4

5.85.5

5.15.4

5.35.05.25.45.65.86.06.26.4

Apr-10May-10

June-10July-10

Aug-10Sep-10

Oct-10Nov-10

Dec-10Jan-11

Feb-11

# pe

r pat

ient

day BEFORE AFTER

Data from 4 inpatient floorsData from 4 inpatient floors

9% reduction in completed orders/patient day9% reduction in completed orders/patient day

Estimated at $670K annualized savingsEstimated at $670K annualized savings

Page 17: Building the right esoteric testing laboratory for ......Building the right esoteric testing laboratory for Cleveland Clinic: Successes and Lessons Learned David Bosler, MD Head, Cleveland

Hard Stop Fire Hard Stop Fire ““Revenue AvoidanceRevenue Avoidance””

Less inpatient Less inpatient ““revenuerevenue”” for lab medicine after hard stops initiatedfor lab medicine after hard stops initiated

This is a good thing! Lab realization rate being remodeled to aThis is a good thing! Lab realization rate being remodeled to account ccount for this changed practicefor this changed practice

Revenue Avoidance (Gross)

$64,410

$46,904

$39,998 $39,612$43,104

$46,702$51,972

$0

$10,000

$20,000

$30,000

$40,000

$50,000

$60,000

$70,000

Aug 30 - Oct 4 Oct 5 - Nov 3 Nov 4 - Nov 30 Dec 1 - Dec 31 Jan 1 - Jan 31 Feb 1 - Feb 28 Mar 1 - Mar 31

Gross Revenue

Hard Stops

Test Utilization Review

Lessons Learned• Be aware of institutional trends and tie initiatives to

them• Foster inclusive membership in utilization review

committee• Engage ordering physicians early and often• Target early “wins” by building consensus on non-

controversial items• Track progress and use metrics to showcase

successes

Page 18: Building the right esoteric testing laboratory for ......Building the right esoteric testing laboratory for Cleveland Clinic: Successes and Lessons Learned David Bosler, MD Head, Cleveland

Test Utilization Review

Next Steps Underway:• Once daily limitation for broader portion of menu

(~1000 tests approved, awaiting implementation)• Extend duration of hard stop interval for certain tests

based on established guidelines (eg HbA1c)• Implement consideration of utilization limits as part

of new test implementation

Top 10 most expensive genetics tests• Applies to inpatient and outpatient• Make “Lab order” only• Deemed users list• Non-deemed users must

– Obtain a consult from deemed user– Contact Laboratory Genetics Counselor– Contact designated Laboratory Faculty

Building the right esoteric testing lab…

What has helped us:• Molecular Department

– “Critical mass”– Expansion in growing area

• Dedicated development resources– Creates efficiencies– Allows strategic input

• Utilization Review– Capitalizes on cost focus– Bridge building yields results

Page 19: Building the right esoteric testing laboratory for ......Building the right esoteric testing laboratory for Cleveland Clinic: Successes and Lessons Learned David Bosler, MD Head, Cleveland