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P aul L . Epner

J une 2 1, 2016

DELIVERING ON THE VALUE

OF LABORATORY MEDICINE:A PATIENT-CENTERED APPROACH

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HEALTHCARE IS CHANGING

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CLINICAL LABORATORIES ARE CHANGING

How much do you agree or disagree with each of the following statements?

Answer OptionsStrongly

DisagreeDisagree

Neither

Agree nor

Disagree

AgreeStrongly

Agree

Rating

Average

Response

Count

The shift, FROM fee for service, e.g.

“clinical laboratory fee schedule”

reimbursed TO bundled, capitated or value-

based reimbursement, is commanding significant attention from our parent

organization.

18 27 131 142 84 3.61 402

Significant change in our laboratory will

occur as a direct result of this

reimbursement change.18 29 135 146 74 3.57 402

Our lab feels significant pressure to

demonstrate our value to our institution’s

senior leadership.

18 40 76 142 126 3.79 402

Our lab feels significant pressure to cut

costs.

15 25 85 130 147 3.92 402

answered question 402

skipped question 67

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J. K. Iglehart, “Health insurers and medical-imaging policy--a work in progress.,” The New England journal of medicine, vol.

360, no. 10, pp. 1030-7, Mar. 2009.

THE CU RRENT P ERSP ECTIVE ON CLINICAL LABS

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THE PUBLIC IS TOLD ABOUT OVER-TESTING

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And the

payers

promote a

narrow look at

the problem

Original reference: Stuebing, E.

A., & Miner, T. J. (2011).

Surgical vampires and rising

health care expenditure:

reducing the cost of daily phlebotomy. Archives of

Surgery (Chicago, Ill. : 1960),

146(5), 524–7.

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WHICH LEA DS TO A NA RROW F OCU S

To provide accurate, timely test resul ts at t he

l owest possible cost

Our m eas ur es evolv e f rom t hat f oc us

A nal y t i cal pr oc ess c ontr ol

Er r or l ogs s uch as m i ssi ng ID, hem ol ysi s, s hor t f il l s, i nt er face

er r or l ogs , i nc ompl ete r equi sit ions, unc oll ected s ampl es,

or der ent r y er ror s, l ost s peci mens, c ontam inated s peci mens

P r ol onged t ur n -around t ime (nar rowly defi ned)

Inc i dent r epor ts and c or rected r esul t r epor ts (r eact ive and

poor pr ox i es f or pat i ent outc omes)

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WE’VE TRIED REVERSING THE PRESSURE

BY SELLING OUR VALUE

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70% of medical decisions are driven by the

laboratory

“ 70% ” of the medical record contains laboratory data

Lic htenberg-2005

“ D ay without a lab”

Lewin-ACLA 2009

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OTHER APPROACHES ALSO FAILED

All approaches fail to articulate what’s broken; what

consequences exist with the current approach; and

what opportunities are being missed.

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EXAGGERATED FOCUS ON COST IS

INAPPROPRIATE

National Health Expenditure

(2014)

$ 3 , 0 00 billion

Medical Laboratory Expenditure

(2014)

$ 7 3 . 4 billion

M LE /NHE=2.4 %

OVER-TESTING IS NOT NECESSARILY THE

RIGHT FOCUS FOR PATIENTS EITHER

Ov er ut i li zati on i s c omm on (mean=20 .6 %) but v ari es

s y s t emati cal ly (n= 38)

by clinical setting – initial (43.9%) vs. repeat (7.4%)

By test volume – low volume tests (32.2%) vs. high (10.2%)

measurement – restricti ve (44.2%) vs. permissive (12.0%)

U nder ut i l izati on i s al s o wi despread, but under studi ed

(m ean= 4 4 . 8%), (n=8 )

Source: Zhi M, Ding EL, Theisen-Toupal J, Whelan J, ArnaoutR. The Landscape of Inappropriate Laboratory Testing: A 15-Year Meta-Analysis Szecsi PB, editor. PLoS ONE. 2013 November 15;8(11):e78962.

11(C) 2015 Paul Epner LLC

MALPRACTICE CASES POINT TO THE

REAL PROBLEM

12Source: T. GANDHI, A. KACHALIA, E.J. Thomas, A.L . Puopolo, C. Yoon, T. Brennan, and D. Studdert, “Missed and delayeddiagnoses in the ambulatory setting: A study of closed malpractice claims.,” Annals of internal medicine , vol. 145, 2006.

Of 307 closed cases (ambulatory) studied because they alleged missed or delayed

diagnosis, 181 involved diagnostic errors that harmed patients

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Clinic ians are not always sure of what to order

(14 .7%)*

Clinic ians are not always sure of what to do with res ults (8 .3%)*

Clinic ians don’t always retrieve results

Clinic ian’s training curriculum indicates the

problems will persist (8 hours)**

UNMET NEEDS ARE NOT BEING

SUFFICIENTLY ADDRESSED

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*Hickner, J., Thompson, P. J., Wilkinson, T., Epner, P., et al. (2014). Primary Care Physicians’ Challenges in

Ordering Clinical Laboratory Tests and Interpreting Results. The Journal of the American Board of Family

Medicine, 27(2), 268–274.

**Smith, B. et al (submitted) Medical Student Education in Laboratory Medicine in United States Medical

Schools: A 2014 Status Report

What medical students are taught about the

diagnostic tests they will use

in practice ?

What diagnostic tests do doctors order in practice and are required

to interpret the test results by

themselves ?

A N E DUCATIONAL MISMATCH WITH

ME DICAL P RACTICE COMPETENCY

A nat om ic pa tho logy tests

R ad io logy tests

Clinical laboratory tests

Clin ic al labor ator y te sts

Provided courtesy of Dr. Michael Laposata, Vanderbilt University Medical Center

A n a t om ic pa thology tests

R ad io logy tests

Clin ic al labor ator y te sts

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SO WHAT DOES THIS

TELL US ABOUT DRIVING

LAB VALUE?

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Value = f(net outcomes)

= (delivered benefit - delivered harm)

D elivered benefit = clinical + financial

D elivered harm = clinical + financial

Value has both a technical and a personnel component

OR

Value = health outcomes achieved that matter to patients relative to the cost of achieving those

outc omes (Porter)

VALUE QUALIT Y

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More ac c urate, timely and lower cost diagnosis

More effec tive treatments with less wasted expense

More engaged and healthier populations

More effic ient and effec tive health systems

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TESTING-RELATED BENEFITS

T E STING-RELATED HARMS*

An inappropriate test is ordered

An appropriate test is not ordered

An appropriate test result is misapplied

An appropriate test is ordered, but a delay occurs

s omewhere in the total testing process

The result of an appropriately ordered test is

inaccurate

*Epner PL, Gans JE, Graber ML. When diagnostic testing leads to harm: a new outcomes -based

approach for laboratory medicine. BMJ Quality & Safety. 2013 August 16

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Oper at i onal ef fic ienc y i s f ocused on r educ ing c ost and

s y s t emati c er ror s

C l i ni c al ef fecti veness i s foc us ed on i m pr oving pat ient

out c om es

A FOCUS ON VALUE WOULD REQUIRE A

CHANGE IN PRIORITIES

Operational

Efficiency

Clinical

Effectiveness

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INTERVENTIONS EXIST THAT IMPROVE

TESTING-RELATED VALUE

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U t i l i zati on A ppropri atenes s

CPOE design and monitoring

Algorithms, clinical pathways, guidelines

Reflex testing

Data mining

Inter-physici an variance analysis

P r oc es s Robus tness

Process monitor

Discharge monitor

Int er pr etati on and A c tion A ppropri ateness

Interpretive comments

Data mining

EMR interface

Trigger tools

WE M UST M AKE IT EASIER TO ORDER THE

RIGHT TEST

S yn o n yms/ Conf oun ders

A lk al ine P hos b lood A lk a l ine phos phom onoes t er as e

A lk a l ine phos phohy dr o las e A lk a l ine pheny l phos phat as e

B HCG ( s er um qual i t a tiv e)B et a- Chor ion ic G onadotr op inB lood v s ur ine B et a HCG

Hem at o logy pr o f i le ; b lood c ount ; hem ogr am

CB C wi t h d i f f

CB C wi t h d i f f er entia lCB C wi t h d i f f er entia l and p la t e le t sCB C w/ di f f & P LTCB C di f f p l t s

Key Name

A lk al ine P hos phat as e

B et a HCG

Com plet e b lood

c ount wi t h di f f er ent ia l

Ab b revi at i o n ( s )

A LP, A lk P hos , A P, A K P

B HCG , HCG B ,

B et a- HCG

CB C

CB C d/ p

*Passiment E, Meisel J, Fontanesi J, Fritsma G, Aleryani S, Marques M. Decoding laboratory test names: a major challenge to appropriate patient care. J Gen Intern Med. 2013;28(3):453-458.

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S t udy 1 of 2 6 44 pati ents at 2 t erti ary c ar e hos pi tals of

w hi c h 1 0 9 5 had 2 0 33 t est res ul ts (l ab, r adiol ogy)

r et ur n af ter di schar ge

1 9 1 of r esul ts w ere pot ent ial ly act ionabl e (9 %)

6 1 % of r es pondent s w it h potenti all y ac ti onabl e r es ults

w er e unaw ar e of r esul ts

A s y s t emati c r evi ew2 f ound f ail ure to f oll ow- up was a

s i gni f i cant pr obl em f or i n - pat ients , f or i n - patients

bei ng di s c har ged and f or ED pat i ents.

WE MU ST ELIMINATE

“ORPHAN” TEST RESULTS

1C.L. Roy, E.G. Poon, A.S. Karson, Z. Ladak-Merchant, R.E. Johnson, S.M. Maviglia, and T.K. Gandhi, “Patient safetyconcerns arising from test results that return after hospital discharge.,” Annals of internal medicine, vol. 143, Jul. 2005.

2Callen, J., Georgiou, A., L i, J., & Westbrook, J. I. (2011). The safety implications of missed test results for hospitalised

patients: a systematic review. BMJ quality & safety, 20(2), 194–9.22

EVEN THE NEW YORKER IS AWARE OF THE

PROBLEM

The New Yorker, February 4, 2013, p. 56 23

For patients being treated with Plavix, there is a an opportunity

to reduce the risk for thrombosis by performing

pharmacogenomics testing to determine if Plavix is likely to be effective based on the patient’s genetic profile

At Vanderbilt alone, 6400 patients on medication x 60 adverse

events avoided per year x $25,000 per adverse event = an estimated s avings of $1.5 million

WE MUST DOCUMENT TESTING-RELATED

DIAGNOSTIC VALUE

Provided courtesy of Dr. Michael Laposata, Vanderbilt University Medical Center 24

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Di agnosis Detection: Repeat Serum Creatinine

Results (2009-2011)

5,324 lab orders placed for patients with an

abnormal creatinine not repeated within 90 days

2,565 total labs repeated within 90 days (48%)

1,311 abnormal results (51%)

1,078 New CKDs identified

Kanter – 2012 – “Reducing Diagnostic Errors By Closing The Loop On Outpatient Care”

MEASURE

VALUE

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Medi cation Monitoring: Annual Medication Monitoring

Results (2011)

Digoxin, ACE/ARB, Diuretics, Anti-convulsants combined

117,776 lab orders placed for patients missing appropriate annual medication monitoring labs

94,831 letters mailed (81%)

61,587 labs completed (65%)

10,022 abnormal results (16%)

Michael Kanter, MD “Reducing Diagnostic Errors By Closing The Loop On Outpatient Care.” Presented

at the 5 th International Diagnostic Error in Medicine conference, Baltimore, 2012.26

DIAGNOSTIC ERROR IS ONE OF OUR BEST

OPPORTUNITIES TO DELIVER VALUE

Di agnos t i c er ror s ar e defi ned as mi sdi agnos is , m i ssed

di agnos i s , or del ayed di agnosi s1

Di agnos t i c er ror s oc cur i n 1 0 -1 5% of c as es,2 w i t h more

t han 5 0 , 0 0 0 Dx E i n pr im ary c ar e and 4 0 - 80, 00 0 annual

deat hs i n hos pi t als 3

One i n t w ent y adul ts i n out pati ent s etti ngs experi ence a

di agnos t i c error annual ly4

Di agnostic Errors

Falls

Rx ErrorsWrong Site

S ur gery

1Graber, M. L . et al, “Diagnostic error in internal medicine,” Archives of internal medicine, vol. 165, July,

2005.2Berner, E. S., & Graber, M. L, “Overconfidence as a cause

of diagnostic error in medicine,” American Journal of

Medicine , vol. 121, 2008, S2-S23.3Newman-Toker DE. Measuring Diagnostic Errors in

Primary Care - Invited Commentary. JAMA Internal

Medicine 2013 February 254Singh, H., Meyer, A. N. D., & Thomas, E. J, “The frequency

of diagnostic errors in outpatient care: estimations from three large observational studies involving US adult

populations.” BMJ Quality & Safety, 2014 27

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HOW MANY OF YOU HAVE ENCOUNTERED

DIAGNOSTIC ERRORS?

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INSTITUTE OF MEDICINE

WATER SCIENCE AND TECHNOLOGY BOARD

Improving Diagnosis

in Health Care

INSTITUTE OF MEDICINE

INSTITUTE OF MEDICINE

Yet…

• Diagnostic errors persist through all settings

of care and harm an unacceptable

number of patients

• In every r esearch area, diagnostic errors were

a consistent quality and safety challenge

Getting the right diagnosis is a key aspect of health

care: it provides an explanation of a patient’s

health problem and informs health care decisions

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INSTITUTE OF MEDICINE

Definition of Diagnostic Error

The failure to:

(a)establish an accurate and timely explanation of the patient’s health problem(s)

or

(b) communicate that explanation to

the patient

INSTITUTE OF MEDICINE

1A: Health care organizations should ensure that health care

professionals have the appropriate knowledge, skills,

resources, and support to engage in teamwork in the diagnostic process.

This includes:

• Interprofessional and intraprofessional teamwork.

• Collaboration among pathologists, radiologists, and

treating health care professionals to improve diagnostic testing.

RECOMMENDATION 1

INSTITUTE OF MEDICINE

1B: Health care professionals & organizations should partner with patients and their families as diagnostic team members.

They should:

Create env ironments where patients and their families can

learn and engage in the diagnostic process and share

feedback and concerns.

Ensure patient access to EHRs, including clinical notes and

diagnostic testing results.

Include patients and their families in efforts to improve the

diagnostic process.

RECOMMENDATION 1

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INSTITUTE OF MEDICINE

3A: Health IT vendors and ONC should work together with

users to ensure that health IT used in the diagnostic

process:

–Demonstrates usability

–Incorporates human factors knowledge

–Integrates measurement capability

–Fits well within clinical workflow

–Prov ides clinical decision support

–Facilitates the timely flow of information among patients

and clinicians

RECOMMENDATION 3

INSTITUTE OF MEDICINE

5: Health care organizations should:

Promote a non-punitive culture that values open discussion and feedback on diagnostic performance.

Design the work system to support patients, their

families, and health care professionals in the

diagnostic process.

Ensure effective and timely communication between diagnostic testing health care professionals

and treating health care professionals across all health care settings.

RECOMMENDATION 5

INSTITUTE OF MEDICINE

7A & 7B: CMS and other payers should:

Provide coverage for evaluation and management (E&M) activities,

including time spent by pathologists, radiologists, and others in

advising clinicians on diagnostic testing.

Reorient relative value fees to more appropriately value the time

spent with patients in E&M activities.

Modify documentation guidelines to improve the accuracy of

information in the EHR and to support decision making in

diagnosis.

Assess the impact of payment and care delivery models on the

diagnostic process & diagnostic error.

RECOMMENDATION 7

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The firs t step is the decision to change

Maintain foc us on operational efficiency, but make

c linic al effectiveness a comparable focus

Ens ure c ost analysis is based on systems cost not laboratory c ost

Learn how to tell the story

Grow the evidence-base – participate in ICE™

CALL TO ACTION

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ICE is a platform for soliciting and

promoting case studies of clinical

laboratories positively impacting

patient outcomes

• The ICE initiative demonstrates the value of

clinical laboratory physicians and scientists in

improving patient outcomes.

• It accomplishes this by providing training,

guidance and incentives for the collection of

evidence that will in turn link testing-related

interventions, regardless of where they occur, to

patient benefits.

• ICE then acts as a platform for the sharing of the

best practices that result.

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INCREASING CLINICAL

EFFECTIVENESS - 2015

TOP SUBM ISSIONSFrom Order to Result: Helping the

Patient Get the Right Test

Jessie Conta, Seattle Children's

Hospital

The Future of Transfusion Medicine at

UnityPoint Health

Carol Collingsworth, Unity Point

Health

How Technology Contributed

Dramatically to Decreasing HAI's and Delivering High Value Outcomes

Denise Geiger, Mather Hospital

Central Ohio Primary Care and Local

Specialty Group Working Hand in Glove for Better Patient Outcomes

Rebecca Burk, Central Ohio Urology

Group

2016 Submissions Came from Eight

Countries

• Canada (1)

• Ethiopia (2)

• India (1)

• Italy (2)

• Turkey (2)

• Uganda (1)

• United Kingdom (5)

• United States (9)

INCREASING CLINICAL

EFFECTIVENESS - 2016

TOP SUBM ISSIONSHigh sensitivity cardiac troponin I at

presentation enables early safe discharge of patients

Clare Ford, Royal Wolverhampton

NHS Trust

Improving Stat Protime Turn Around

to Improve Emergency Department Patient Throughput

Susan Traub, Kaiser Permanente

South Sacramento Medical Center

GeneXpert MTB/RIF® assay for the

diagnosis of smear-negative pulmonary tuberculosis

Mulualem Tadesse, Jimma University

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2016-17 ICE Details

• Submission period: June – October 2016

• Web-based resources from CLMA and CDC

Webinars

Reading list

Published scoring criteria

Library of accepted submissions

• International panel of rev iewers

• Opportunities to promote the best work

The CLMA-led Innovative Program has

At tracted Important Part ners

KnowledgeLab – Executive War College EuroMedLab

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ICE 2015-16 Reviewers

• Julian H Barth, M D

• Consultant in Chemical Pathology & M etabolic M edicine, Leeds

General Infirmary

• Julie A. Gayken

• S enior Director of Laboratory S ervices (Ret ired),

HealthPartners/Regions Hospital

• M ichael J Hallworth FRCPath

• Consultant Biochemist (ret ired), Royal S hrewsbury Hospital

• Brian R. Jackson, M D, MS

• V ice President , Chief M edical Informat ics Officer, ARUP

Laboratories

ICE 2015-16 Reviewers

• M ichael Kanter, M .D.

• Regional M edical Director of Quality & Clinical Analysis, S outhern

California Permanente M edical Group

• M ary Nix, MS, PMP

• Health S cient ist Administrator, Agency for Healthcare Research

and Quality (AHRQ)

• Rick Panning, M BA, MLS(ASCP)CM

• S enior Administrat ive Director, HealthPartners and Park Nicollet

Care Group Laboratories

• Tim S kelton, M D, PhD

• M edical Director Core Laboratory & Laboratory Informat ics, Lahey

Hospital & M edical Center

CDC Seeks & Offers Help

• Reduction in blood culture contamination

• Reduction in blood sample hemoly sis in ED’s.

• Pre-analy tical practices that improv e urine culture

results

• Timely and accurate reporting of critical v alues

• Improv ed laboratory test selection using clinical

decision support (especially due to confusing lab

test names)

• Laboratory triggers that improv e patient safety

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Drive improved outcomes

Measure your impact

Submit your ICE abstract

I nc reased patient-c enteredness

Rapid, accurate and cost-effective diagnosis and

monitoring

Patient engagement and empowerment

I nc reased effectiveness of our c are delivery system

Reduc ed healthc are burden in our communities

Expanded, dis seminated and utilized evidence

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IN SUMMARY, WE CAN PROVIDE TESTING-

RELATED VALUE IN MANY WAYS

The c linic al lab’s mis s ion s h o ul d not j us t b e:

To provide accurate, timely, low cost test results

Although nec es s ary, it is not s uffic ient

The c linic al lab’s mis s ion s h o ul d be:

To rapidly and efficiently enable the accurate diagnos is of conditions , the selection of appropriate treatments and the effective

monitoring of health status*

F I N AL THOUGHT: THE GOAL

* Epner, Paul, “Impact of Laboratory Services on Diagnostic Errors,” ThinkLab ‘1151

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QUESTIONS?