MODULE 4

MANAGEMENT AND LEADERSHIP SKILLS

IN THE CLINICAL LABORATORY

Matthias ORTH

IFCC EMD - Committee on Clinical Laboratory Management (C-CLM)

 CONTENTS OF THIS MODULE*
Definitions of Laboratory Management
Definition of the tasks and skills of laboratory managers
Healthcare laboratories compared to analytical laboratories
Effect of recent changes in test kits and instruments on workload of
a laboratory manager
Challenges of being a leader in a healthcare laboratory
Addressing expectations of patients and healthcare professionals
in a world with less visible national boundaries

*) All pictures and images in this module are from Wikipedia, Google search images, unless otherwise noted.

IFCC EMD - Committee on Clinical Laboratory Management (C-CLM)

 LEARNING OBJECTIVES
By completing this module, participants will be able to:
Define their role as laboratory manager in the healthcare system of their
country
Evaluate their skills to counsel other physicians
Evaluate their skills to counsel patients (if legal in their country)
Participate in postgraduate continuous education activities (such as CME)
Describe the expectations of stakeholders of the skills and qualities of a
laboratory manager; and how to perform formalized feedback (such as
surveys, questionnaires, “suggestions, questions, praise and blame”)
activities.
IFCC EMD - Committee on Clinical Laboratory Management (C-CLM)
 Definition of Laboratory Management
Management is the specific organization of tasks and processes.
The verb "manage" originates
 from Italian maggiore (to handle, especially tools or a horse)
 derived from the Latin words manus (hand) and agere (to act)
 French word for housekeeping, ménagerie is derived from ménager ("to keep
house"), also encompasses taking care of domestic animals
 Meaning of manus is to lead by the hand
 meaning of mansion agree is “to do housekeeping for the proprietor”
current meaning of managing as to head, to lead, to be in charge of is a narrowing
down of the original meaning

IFCC EMD - Committee on Clinical Laboratory Management (C-CLM)

 12 Tips For Good Management
1) Learn management skills
2) Have a five-year plan for your lab
3) Set clear standards and expectations
4) Optimize your management style for each laboratory staff member
5) Listen to your laboratory staff members
6) Walk around the laboratory daily
7) Learn when to say no
8) Be prepared when small amounts of free time become available
9) Get to know the people at your institution who can help you
10) Get involved in your national (or even international) societies for exchange with peers
11) Attend annual meetings and visit the laboratories of your peers to get an idea of the
“state of the art”
12) Celebrate successes with your lab

IFCC EMD - Committee on Clinical Laboratory Management (C-CLM)

 Motivation to become a Laboratory Manager
• You chose this profession because you were fascinated with the world around
you and wanted to discover on a molecular level the ways in which life exists and
to assist other medical workers in the treatment of patients.
• You long to be at the heart of the lab — directing method evaluations, analyzing
data, being consultant for medical personnel and patients — but you find
yourself caught up in other tasks — ordering reagents, dealing with troubled
associates and students, attending yet another committee meeting, anything but
lab work.
• You have found that being the head of the lab is more than testing; it is about
managing a small business. Lab-management skills, while used every day by lab-
specialists, are not directly taught to young apprentices. Rather, they are learned
secondhand. While much is to be learned from this follow-by-example approach,
it has its limits. We have all heard horror stories of lab managers with poor
leadership and organization skills, but how can we keep from becoming a
character in one of these stories?
IFCC EMD - Committee on Clinical Laboratory Management (C-CLM)
 Laboratory Management should be learned
in a Purposeful Manner
 Some laboratory managers are promoted from ranks of
technical staff, or are Clinical Pathologists with little
management experiences. If an individual has the capacity
to learn the science of laboratory medicine, they can learn
good complimentary management skills, given the desire
and aptitude to do so.
 Management skills are important for career development.
Whether you work at the bench or away, the ability to
organize your work and supervise those under you is critical.

IFCC EMD - Committee on Clinical Laboratory Management (C-CLM)

 5 Main Categories of Laboratory Management
1. Planning allows a laboratory manager to know where the lab is going.
2. Organizing is also an important job for a laboratory manager as he or she
determines who is in charge of which department and technique, manages
the timelines and budgets for multiple departments, and keeps current with
research in the fields, technical innovations and expectations from medical
community (e.g. guidelines).
3. Leadership is extremely important for a lab manager, as it often sets the
environment and pace of the lab. Good leadership can inspire laboratory
staff members toward productivity and creativity and help members work
together.
4. Controlling a laboratory involves the evaluation of laboratory staff members
and projects progress, and the ability to correct problems as they arise.
5. Know the legal restrictions (and advantages) of a healthcare laboratory in
your country.
IFCC EMD - Committee on Clinical Laboratory Management (C-CLM)
 Laboratory Management: Marketplace Perspective
 Diagnostic laboratories operate in a dynamic environment
 Operational and strategic needs are changing, evolving, and expanding
 Consolidation of facilities and merging of institutions to profit from economies of scale
 Laboratories must be able to readily respond to increases in volume, assay menu changes,
and staffing challenges
 Laboratories must be focused on a multitude of short-term goals while not losing sight of
what is coming down the road
 Making the right decisions today for staffing, automation, instruments and IT to be prepared
for future needs
BUT
 Clinical laboratories belong to healthcare and must obey the specific legal and ethical limits
of healthcare
IFCC EMD - Committee on Clinical Laboratory Management (C-CLM)
Medical Act and the Clinical Laboratory
Federal legislations to safeguard the patients
 Restriction of practicing medicine to (licensed) physicians
 Medical Act in most countries include:
 Diagnosing illnesses
 Prescribing diagnostic examinations
 Using diagnostic techniques that are invasive or entail risks of injury
 Determining medical treatment
 Prescribing medications
 Providing clinical monitoring of the condition of patients whose state of health is
problematic
 Providing pregnancy care
 Conducting deliveries
 Deciding to use isolation measures

Fighting against quacksalvers – support of evidence based medicine

IFCC EMD - Committee on Clinical Laboratory Management (C-CLM)

 Healthcare vs. Business/Trade
 Services has to be performed in person, but some can be delegated
 Certain services may not be substituted
 Expansion of medical services not without limits (personal supervision of associates)
 Physician may not expand services by hiring employees (unlike a commercial firms)
 Prohibition of (exclusive) telemedicine
 Critical: (external) IT service provider essential in medical process
 Restrictions on advertising and access to tests
 Special laws for medical data protection
 Special ethical code for physicians
(see Declaration of Geneva)

primum non nocere, secundum cavere, tertium sanare

IFCC EMD - Committee on Clinical Laboratory Management (C-CLM)
 The challenge of Defining a Medical Laboratory
No quality assurance criteria need to be applied if laboratory tests are
performed by non-health care professionals allowing a free movement of
services under the consumer rights directive 2011/83/EU (example from
the European Community

Definition of a medical lab is different across countries (challenging if the

same test is performed using animal specimen, food stuff, lifestyle
samples and human medical samples!)

IFCC EMD - Committee on Clinical Laboratory Management (C-CLM)

 Current Challenges of the Medical Act

• Delegation of some defined procedures to other professions

(mainly due to financial restraints or by a shortage of skilled
professionals)
• Substitution of the work primarily reserved for physicians

Consequences for the necessary skills, both from the

perspective of the laboratory manager as well as from the per-
spective of the laboratory personnel!

IFCC EMD - Committee on Clinical Laboratory Management (C-CLM)

 Skills Necessary for the
Management of Laboratory
Is equivalent to the stakeholders’
perspective for expectations of a
laboratory manager.
Stakeholders perspectives those of:
• Patients
• Laboratory personnel
• Other healthcare workers
• Hospital administration
• And in some cases governmental
bodies
IFCC EMD - Committee on Clinical Laboratory Management (C-CLM)
 Skills of Laboratory Manager

• Manual skills

• Applied science
(Biochemistry, Biology, Physics, IT)

• Theoretical and applied knowledge

(Medicine, Mathematics)

IFCC EMD - Committee on Clinical Laboratory Management (C-CLM)

 Perception of Necessary Skills Dependent on the
Profession of the Laboratory Manager
Challenge: There are differences across different countries not only in the designation of the different
professions but also in the number, and proportion of distinct professions operating in laboratory medicine
including
• “Clinical Pathologists” (summarizing all physicians with a medical license and formal postgraduate
specialization in laboratory medicine, aka physician laboratory medicine specialists)
• “Scientific Biomedical Specialists” (non-medical laboratory medicine specialists with a university degree
such as a master’s degree or diploma and formal postgraduate specialization in laboratory medicine)
• “Non-scientific Biomedical Technologists” (laboratory medicine specialists without university degree or with
a bachelor’s degree)
Please note:
o the tasks of persons with a master’ degree but without formal postgraduate specialization differs between
countries
o In some countries a partial medical license can be given to scientific biomedical technologists

IFCC EMD - Committee on Clinical Laboratory Management (C-CLM)

 Perception of Necessary Skills Dependent on the
Profession of the Laboratory Manager
Challenge: There are differences across different countries in the number, and
proportion of distinct professions operating in laboratory medicine.
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IFCC EMD - Committee on Clinical Laboratory Management (C-CLM)

 Perception of Necessary Skills Dependent on the
Profession of the Laboratory Manager
Challenge: There are differences across different countries in the number, and
proportion of distinct professions operating in laboratory medicine.
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IFCC EMD - Committee on Clinical Laboratory Management (C-CLM)

 The Medical Act in the Medical Laboratory
and Necessary Skills
• Complex processes in a medical laboratory could be
dissected in many small segments of work
(“Taylorismus”)
• Many of these small segments could be performed from
persons who are trained for this particular work
(irrespective of educational background)
BUT:
Medical practice –irrespective of the discipline -- requires
both the science of medicine (i.e. detailed knowledge of
anatomy, physiology and biochemistry as well the
underlying diseases and their treatment) and the craft (or
art) of medicine (i.e. competence in its applied practice
including the Social Sciences)
IFCC EMD - Committee on Clinical Laboratory Management (C-CLM)
 Specific Situation of Laboratory Medicine
Medical discipline with the second most patient contacts (after General
Practioners)
• Results of laboratory tests trigger many medical decisions
• Majority of laboratory tests performed are time-critical
BUT:
• Personal encounters of laboratory personnel with patients are infrequent
• Laborator testing is sometimes regarded as a commodity (no
acknowledgement on services received), not an individually-tailored
medical service
• Difficulty to reach intensive personal involvement of associates with
patients
IFCC EMD - Committee on Clinical Laboratory Management (C-CLM)
 Shift from Manual Workload to
Counseling in Last Decades
Focus has shifted from the analytical phase to the preanalytical and post-
analytical phases.
 Well-being of the patient by
• counseling of other physicians and patients
• In selecting adequate tests
• Interpreting the results by the Clinical Pathologist
 Reason for the different perception of the necessary skills of a laboratory
manager from higher standardization
 Evolution in the laboratory
 Supply of test kits
 Advances in technology
Clinical Chemistry 50:12
 Advances in instrument design 2415–2458 (2004)

IFCC EMD - Committee on Clinical Laboratory Management (C-CLM)

 Shift from manual workload to
Counseling in Recent Decades
IVD-companies offer nearly perfect diagnostic systems for many areas of the clinical
laboratory. Technical chores such as:
 Preparation of reagents
 Tedious adjustments of instruments
previously regularly performed by highly qualified professionals in the laboratory and
overseen by the laboratory manager nearly completely shifted to IVD-companies
 With use of CE/FDA marked reagents, even many tasks of test evaluation need
no longer be repeated by Clinical Pathologist but can be relied on evaluation
performed by IVD-companies.

FDA
clinical validity

CLIA
safety and effectiveness of
test system

IFCC EMD - Committee on Clinical Laboratory Management (C-CLM)

 “Brain-to-Brain Loop”
in-vitro testing process was named “Brain-to-Brain Loop”
Loop runs from clinical question over selecting the adequate test(s) and
obtaining the patient’s sample over to the analytical process and to the
post-analytical steps with determining medical treatment, prescribing
medications and other substances, providing clinical monitoring of the
condition of patients, providing pregnancy care and deciding to use
isolation measures –
typical elements of Medical Act

With the exception of very few tests,

it is obvious that all other tests need
medical interpretation

IFCC EMD - Committee on Clinical Laboratory Management (C-CLM)

 Medical Interpretation

• Medical interpretation goes far beyond “normal – abnormal test result” and – as a part of
the Medical Act – has to be done by a physician.
• Physician not only knows the limits of the analytical part (i.e. the testing process) but also
experienced in the consequences of a certain test result in context of
1. other diseases
2. certain therapies and
3. clinical course of the disease
• These tasks can be done by a medical laboratory specialist focused on certain specialties
of Clinical Pathology only (such as Endocrinology or Hemostasieology)
OR
• by a medical laboratory specialist covering all subjects of in vitro testing (i.e. Hematology,
Clinical chemistry, Immunology, Laboratory Genetics and often Microbiology)

IFCC EMD - Committee on Clinical Laboratory Management (C-CLM)

 Skills of Generalists vs. Specialists
in Laboratory Medicine
• Depending on local situations medical laboratory specialists and medical laboratory
generalists can counsel adequately.
• Advantages of generalists: expert of in vitro diagnostics who oversees the whole test spectrum
in Clinical Pathology – but skills have to cover the whole spectrum of laboratory medicine
• In certain situations in particular very complex patients / university hospital setting, two or even
more laboratory specialists might be more appropriate for optimum treatment of patient
• Academic Biomedical Specialists often participate in clinical rounds and share their advice,
similar to nurse consultants or pharmacist consultants. In hospitals with clinical rounds, there is
long tradition of sharing knowledge between different professions with mutual respect.
• Extensive social skills are needed from the laboratory manager so that all professions involved
can give input to the benefit of the patient while legal issues such as accepting different
responsibilities of the professions involved have been taken into account

IFCC EMD - Committee on Clinical Laboratory Management (C-CLM)

 Syllabi of Laboratory Managers
(Generalist vs. Specialist)

IFCC EMD - Committee on Clinical Laboratory Management (C-CLM)

 Legal Issues of Substitution

Laboratory Manager has to be aware of legal issues which are currently

absolute roadblocks to move certain areas of laboratory medicine to
nonqualified practitioners or lay persons:
In particular
• Blood transfusions
• Genetic testing
• Dealing with contagious diseases in many countries are restricted
to physicians only
• Certain diagnostic kits can only be exclusively obtained by a
physician’s prescription

IFCC EMD - Committee on Clinical Laboratory Management (C-CLM)

 Skills and Qualities Needed
as a Laboratory Manager
• Wide array of improvements in the last years in:
• Preanalytical processes (such as electronic orders, diagnostic pathways, barcode
coding of primary samples, robot-assisted aliquoting, permanent temperature control
of reagents and samples, automatic checks for clots, hemolysis, lipemia and icterus)
• Analytical processes (in particular by using highly standardized techniques with low
Intra- and inter-assay variation)
• Post-analytical processes (such as auto validation and sending reports electroni-
cally directly in the health record)
• Improvements and time savings allow many Clinical Pathologists to spend less time with
the analytical processes.
• Allow assigning more of their time being a partner to the other physicians (and to patients)
for selecting and interpreting laboratory tests and advising therapies.

IFCC EMD - Committee on Clinical Laboratory Management (C-CLM)

 Skills and Qualities Needed
as a Laboratory Manager
Extensive practical and theoretical medical expertise are essential for
these tasks, with a special focus on
1. Medical knowledge
2. Practical experiences
3. Laboratory management skills
and less than in previous times on analytical techniques.

Changed perception of the necessary skills of laboratory manager by

stakeholders

IFCC EMD - Committee on Clinical Laboratory Management (C-CLM)

 Skills and Qualities Needed
as a Laboratory Manager
However, despite many technological improvements
 Manual work can be still the cornerstone of a laboratory
manager in some specialty testing such as in:
• Cytology
• Malaria microscopy
• Microbiology
• Hemostasieology
• Complex toxicology testing
• Autoimmune disease testing

IFCC EMD - Committee on Clinical Laboratory Management (C-CLM)

 Necessary Skills Dependent
of Healthcare System
Basically, patients` well-being should be universally definable
situation complicated due to federal systems of healthcare:

Heterogeneous healthcare systems, as well as the different

allocation of resources e.g. to laboratory medicine in different
countries, result in differences in role of physicians, and
scientific biomedical specialists and non-scientific biomedical
technologists in the medical laboratory.

IFCC EMD - Committee on Clinical Laboratory Management (C-CLM)

 Necessary Skills Dependent of
Laboratory Size and Test Menu

Definition of the necessary skills of laboratory manager is dependent on

size and kind of the laboratory:
• complexity and the volume of testing differ markedly between
laboratories
• level of direct intervention by the clinical pathologists is different
between laboratories of differing sizes and in different countries
personal contact between clinical pathologists and patients occurs on a
regular basis in some countries and is rare or even non-existing in
other countries

IFCC EMD - Committee on Clinical Laboratory Management (C-CLM)

 Necessary Skills Dependent of
Local Settings

• Healthcare and Medical Act challenged by the increasing specialization in

medicine as well as the increasing percentage of part-time employees
(when the Medical Act was defined there was perception of a single one polyvalent
physician (“personal physician”) being responsible around the clock of his/her
patients, working by himself without or with only little assistance from coworkers)
• Challenge arises when position of a laboratory manager is split between two
part-time employees
• Good social skills are necessary to demonstrate as well the unique
personalities of both part-time laboratory managers as to allow the mutual
compensation for each other

IFCC EMD - Committee on Clinical Laboratory Management (C-CLM)

 Detailed knowledge of anatomy, physiology and biochemistry

Knowledge of underlying diseases and their treatment

Practical skills in laboratory work (e.g. Microscopy)

Applied practice in medicine including the Social Sciences

Continuing efforts in research

Basics of economical knowledge and of legal issues

Continuing efforts in development (including CPD and CME)

Continuing efforts in innovation and technology

Good medical practice

IFCC EMD - Committee on Clinical Laboratory Management (C-CLM)
 Direct Access of Patients to Biomedical
Specialists (Non-Medical Laboratory Specialists)
• Patients not interested in result of a certain laboratory test but want to get the
answer what (medical) consequences of the test results incur to them
• Test results without medical interpretation are without use
• Unethical to offer laboratory testing without qualified medical post-analytical
interpretation
• Patient’s safety relies on medical knowledge / skills of the non-medical laboratory
specialist (oxymoron)
• Invasive sampling (like phlebotomy / bone marrow puncture / spinal tap) precedes
testing process
• For sampling physician’s supervision or even the direct sampling by the physician
is mandatory (except for saliva and urine)

IFCC EMD - Committee on Clinical Laboratory Management (C-CLM)

Laboratory Testing is Used Under Different Settings
for Precise Medical Decisions

GP OP IP OP GP

Prognosis

Treatment
Symptoms Diagnosis Monitoring
(optimisation)

Medical decision made by

Clincial Pathologist POCT DCT (direct to consumer testing)

IFCC EMD - Committee on Clinical Laboratory Management (C-CLM)

 Direct Access of Patients to Biomedical
Specialists (Non-Medical Laboratory Specialists)
• Definition of the skills necessary for a laboratory manager in countries with
direct patient access is very challenging
• In particular, legal issues make it nearly impossible to impose definitions
for the necessary skills.
• To hit on an expedient: limited setting in which non-medical laboratory
specialist with proof of the necessary knowledge and skills are allowed to
run a specialized laboratory (such as basic clinical chemistry tests only,
doing capillary blood counts only, doing malaria smears only)
• Comparable situation to a registered nurse who is allowed to perform a
small spectrum of medical services (performing vaccinations or
prescribing certain drugs)
IFCC EMD - Committee on Clinical Laboratory Management (C-CLM)
 Evidence Based Medicine

Lab
Tests

POCT

Animal
testing,
DTCT Food
testing
IFCC EMD - Committee on Clinical Laboratory Management (C-CLM) 38
 How to Maintain Necessary Skills

Willingness of life-long learning

• In many countries, formal programs such as CPD (continuing
professional development) and CME (continuing medical education)
track the scope and the success of the participation in such a program
• In countries with voluntary CPD/CME programs only, laboratory manager
has to participate in such programs out of her/his own personal initiative

IFCC EMD - Committee on Clinical Laboratory Management (C-CLM)

 SUMMARY
 In last decades high level of standardization of the tests used in
clinical laboratory and improvements of the IVD vendors
 Less effort is needed now for the analytical processes than previously
 Skills of the Clinical Pathologists have to focus more on fundamental
contents of the Medical Act, i.e. the diagnosing and the counseling of
physicians and patients
 Ongoing adoption of the syllabus for post-graduate education in
Clinical Pathology as well as of life-long learning by CPD-CME
programs to ensure high standards and achieve the patients’ wellbeing

IFCC EMD - Committee on Clinical Laboratory Management (C-CLM)