Lab management in a changing healthcare

environment

Johan Van Eldere

Laboratoriumgeneeskunde

contents

• The changing health care & medical lab

environment

– Evolution towards bigger labs

– POCT testing / trans mural medicine

• The role of the clinical biologist

The changing lab environment

• Evolution towards bigger labs

– economy of scale

– consolidation, integration & outsourcing

– driven by external factors :

• diagnostics is big business

– driven by internal developments

• technician shortage, budget, clinical & quality

demands

External factors : diagnostics is big business

Private companies are investing in diagnostics

• Global IVD market valued at $44 billion in 2011, growing yearly by

7.8% from 2011 to 2016.

– U.S. = biggest market (47% of the total IVD market in 2011).

– European region = 31% of the global IVD market (Germany : 23.24% - France :

16.89% - Italy : 16.41%

• “The merger of Carilion Labs and Greensboro, N.C.-based

Spectrum Laboratory Network forms a private company with more

than 2,600 employees and annual revenues of more than $300

million. "This is a business line that we expect to be able to grow

and to be more valuable and more profitable.” The merger creates a

company serving 37 hospitals and 14,000 physicians in eight mid-

Atlantic states.”

External factors : diagnostics is big business Private

companies are investing in diagnostics

• “Sonic Healthcare to Acquire Belgium’s

Second Largest Clinical Pathology

Laboratory”

• “Sonic said Belgium and the Netherlands

have a combined population of

approximately 27 million people, a factor

that meets Sonic’s criteria for growth in

stable and reliable laboratory markets”

The changing lab environment

• Evolution towards bigger labs

– driven by external factors :

• economy of scale, diagnostics is big business

– driven by internal developments

• technician shortage, budget, clinical & quality

demands

• Need for automation, informatisation and large

investments

Internal factors :

the battle for trained personnel

• Aging laboratory workforce – Major retirements waves started 5 yrs ago and will

continue for another 5 yrs & increasing staffing shortages in medical laboratories at medical & technical levels

– Fewer young recruits - Attractiveness of medical laboratories

• Trend towards employing less-trained technicians

– Less individual decisions, more automation

– introduction molecular techniques

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MLT’s leaving school

Internal factors :

Age distribution MLT’s hospital labs - Belgium

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MLT's in hospital labs

Van Eldere - unpublished

Internal factors : increasing demands

• Shorter turn-around time: same day reporting, point of

care testing, 24/7 availability

• Better, more reliable & clinically (therapeutically)

meaningful results (added value)

• Quality control: burden for small/medium sized labs

• “A major obstacle for independent laboratories to make a

significant contribution to risk management is the current

reimbursement system, which makes it economically impossible

for independent laboratories to support infection control programs

in healthcare institutions. “ » Yanagisawa H. Rinsho Byori. 2009 May;57(5):463-6

Internal factors : automation & new techniques

• New techniques become gold standard, automation

reduces costs, but capital investments too large for

small labs – Inpeco track UZLeuven

• Capital investment : 1,7 million €

– Interior refurbishing : 1,5 million €

– 1 year preparation – 1 year of adaptation

• savings of 3,8 FTE

– Microbiology

• MALDI-TOF : capital investment = 200,000 €

• full lab automation : capital investment : 1,7- 3,5 million €

The changing lab environment :

Perception of the lab in the hospital

• Lab perceived as a service provider : – by the hospital management : financially

• Soyez profitable et taisez-vous

– by other physicians : ” we think & interpret, you do ”

• Fractionation of laboratory department (Micro, hemato, immuno, chemistry, toxico, TDM etc) leads to reduced visibility – Lack of common objectives

• Juicy bits in separate department : genetics

• Not the best doctors are recruited – Pharmacists not fully accepted

Internal factors

Towards a changed reimbursement system ?

• Taskforce Perl: 2009

– advise the government on structural savings in

Rx and Biology (34,2 % of medical fees in 2009)

• Lump-sum and closed envelope systems

• Prescribing more adequately = more

funding for new technology ?

– Savings achieved are not invested in sector itself

– Demands will continue to rise

The changing lab environment :

consolidation of non-hospital labs in Belgium

• 1/ SONIC HEALTHCARE BENELUX – Medhold (AML-Riatol + Lab Van Waes) lab Rigo

in Genk, Lab Woestijn J. in Mouscron, Clinilab in Brussels and KBL-BML-UL in Merksem

• 2/ MEDINA – Clinical Lab Dendermonde, Medical Lab Medina in

Aalter, lab Torhout, MedianLab in Aalst, Medical and Veterinary Lab Oostakker, Lab ZOV Brakel

• 3/ CERBA EUROPEAN LAB – European network

– BARC group (Rudi Mariën), Medic Lab Aalst

The changing lab environment :

Evolution of the number of approved Clinical Biology

Labs Belgium (1990-2010)

Riziv-Inami

The changing lab environment :

Evolution of the number of approved Clinical

Biology Labs Belgium (2008-2013)

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WIV-ISP

The changing lab environment :

lab integration in UZLeuven

• Tertiary care teaching hospital

– 1900 beds, 100 ICU beds, 65.000 hospitalisations/yr

• University lab UZLeuven – 4000 m2 integrated laboratory organised around technical

platforms (production teams)

– (bio)chemistry, haematology, coagulation & haemostasis, metabolic

disorders, microbiology, immunology, hormonology, toxicology &

TDM, genetics.....

– 250 employees (150 FTE), 18 medical staff, 11

doctors/pharmacists in training

– 10,000 samples/day, 40.000 analyses/day, 14.000.000 analyses/yr

The changing lab environment :

lab integration in UZLeuven

PT1 : chemistry & haemato-analysers, haemato, 58 MLT - 48,86 FTE PT2 : special chemistry, toxicology, TDM, metabolic disorders

15 MLT - 10,94 FTE PT3 : ELISA, semi-automatic tests 19 MLT - 13,05 FTE PT4 : bacteriology, parasitology, mycology 29 MLT - 20,05 FTE CEMOL LabA (PT5) genetics & viral cultures 14 MLT - 10.55 FTE

PT6 (RIA-based tests, digestion & absorption 11 MLT - 8,05 FTE

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LIS : 9 collaborators - 8,1 FTE Logistics team : 25 collaborators - 21,65 FTE

Ordering-unit : 4 collaborators - 4 FTE Quality control : 3 collaborators - 2.5 FTE Process analysis : 3 collaborators – 2.5 FTE

POCT Secretariat

4 collaborators

3.5 FTE

The changing lab environment :

lab Integration & operational improvement

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vte MLT productie %prod 100 107 114 119 121 129 137 144 151 153 157 150 159

vte N-Medisch totaal %prod 100 105 110 115 118 124 130 136 144 141 145 138 140

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contents

• The changing health care & medical lab

environment

– Evolution towards bigger labs

– POCT testing / trans mural medicine

• The role of the clinical biologist

The role of the clinical biologist

• Operational excellence needed in view of

changing lab and reimbursement

environment

– Professionalization of lab management

• Towards a new role for the clinical

biologist

– Pathologists at interface lab- clinic = laboratory

medicine

The lab manager

• How to Become a Medical Laboratory Manager

– Medical Laboratory Managers often start as medical laboratory technicians or

technologists.

– take a certification exam or pursue professional licensure

– professional experience in a general medical or surgical hospital, are good preparation

for earning a master's degree or a Ph.D. in Medical Technology or in one of the life

sciences.

– federal regulations require that directors and managers of complex medical laboratories

hold a graduate degree or an undergraduate degree with a specified amount of on-the-

job experience.

• Skills Required for a Career in Medical Laboratory Management

– possess excellent organizational and leadership skills;

– adept with technology, including computer programs and laboratory equipmen

– learn new technologies quickly.

– knowledgeable in pathology, immunology and hematology

The lab manager

• Manager Medical Lab Salary (United States). The average

salary for a Manager Medical Lab is $63,692 per year. Most

people in this job have more than five years' experience in

related jobs

• Job Description for Manager Medical Lab

– Introduce new techniques and equipment and evaluates their effectiveness.

– Develop and enforce lab procedures for conducting tests and reporting

results.

– Supervise and organize the work of lab technicians, train new employees,

and help staff members resolve problems.

– Ensure health and safety regulations are followed

The clinical biologist

• Small labs with clinical biologist as lab manager

bound to disappear

• Clinical biologist wanting to grow into

management function should prepare & see this

as a career choice

• Clinical biologist at interface lab- clinic =

laboratory medicine

– Improved added value to laboratory tests derived from

appropriate test request and utilisation