Education and training in the changing environment of laboratory medicine pdf

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REFERENCE: Quality Assurance in the Pathology
Laboratory by MJ Bogusz, 2011 edwineiou

!  Laboratory Medicine is a canonical field
of study for degree courses in medicine
as well as for other courses directed at
healthcare professionals.
!  In the past several years, there has been
a tremendous upheaval in medical
curricula due to series of boosts coming
from either the great scientific
advancements or the new healthcare
organization and management
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!  Being a pervasive discipline, ML represents a
elevant field of study of either pre- or
postgraduation curricula.
!  Instrumental or methodological laboratory
technologies have widely exploited the
exponential progress of informatics and
chemometrics with a huge gain in terms of
analytic quality.
!  Incessant translation of relevant research
results into clinical advantage to patients,
mainly by the increasing availability of
predictive and diagnostic procedures.
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!  The more recent integrated concept of
medical pedagogy where instruction in
clinical disciplines starts early and
gradually forms the bulk of the basic
sciences and then progressively gains
importance during the last year. This
approach is believed to be highly effective
and is able to optimize the learning
abilities of the students.

edwineiou

!  From an academic point of view, LM
represents an area of teaching that
comprises disciplines such as clinical
biochemistry, clinical microbiology,
clinical pathology, and, more recently and
increasingly, molecular biology,
particularly for aspects of pathological
and clinical relevance.

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Course of Laboratory Medicine for
Undergraduate Students
!  Test Ordering
! Preanalytical Issues
!  Analytical Issues
!  Test Interpretation

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Medical Laboratory
Technicians (MLTs)
!   Also known as BIOMEDICAL TECHNICIANS.
!   The main work of MLTs is directed at examining
and analyzing biological samples.
!   In particular, MLTs analyze the physicochemical
composition of organic fluids; test for drug levels
in the blood, in order to assess the best
therapeutic regimen, and to ascertain how a
patient is responding to treatment; match and
prepare blood for transfusions; and look for
bacteria, parasites, and other microorganisms.
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Medical Laboratory
Technicians (MLTs)
!   MLTs prepare specimens for histology
examination, perform cell counts, and evaluate
possible cell abnormalities in blood and other body
fluids.
!   The work of MLTs is mainly performed with
automated and computerized instruments, cell
counters, and other sophisticated laboratory
equipment, including the more recent instruments
capable of performing arrays of tests mainly
directed at investigating alterations at genetic and
molecular levels. edwineiou

The Profession of Laboratory Technologist/
Technicians in the United States
!   There are two levels of clinical laboratory
personnel with technical qualifications:
technologist (higher) and technicians (lower).
!   The technologists are entitled to perform more
complex examinations, such as evaluating test
results, developing and modifying procedures,
establishing and monitoring programs, and
ensuring the accuracy of tests.
!   Technologists can supervise one or more clinical
laboratory technicians.
edwineiou

The Profession of Laboratory Technologist/
Technicians in the United States
!  The usual requirement for an entry-level
position as a clinical laboratory
technologist is a bachelor’s degree, with a
major in medical technology or one of the
life sciences.
!  Medical and clinical laboratory technicians
have either an associate degree from
community college or certificate from
hospital, technical school or armed forces.
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!  Agencies that accredit specific areas for
clinical laboratory workers include:
!  The National Accrediting Agency for
Clinical Laboratory Sciences
!  The Commission of Accreditation of Allied
Health Education Programs
!  The Accrediting Bureau of Health
Education Schools.

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!   Some states require laboratory personnel to be
licensed or certified.
!   Licensure of technologists often requires a
bachelor’s degree and the passing of an
examination, but requirements may vary by state
and specialty. Moreover, many employers prefer
applicants who are certified by a recognized
professional association.
!   Associations offering certification include the
Board of Registry of the American Society for
Clinical Pathology, American Medical
Technologists, the National Credentialing Agency
for Laboratory Personnel, and the Board of
Registry of the American Association of
Bioanalysts.
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!   Technicians can advance and become chief
medical technologists or clinical laboratory
technologists or laboratory managers.
!   Manufacturers also seek experienced
technologists to work in product development,
marketing and sales. CL technologists and
technicians held about 319,000 jobs in 2009.
!   A doctorate degree is usually needed to become a
laboratory director.
!   Federal regulation requires directors of
moderately complex laboratories to have either a
master’s degree or a bachelor’s degree, combined
with appropriate amount of training and
experience.
edwineiou

The Profession of Laboratory
Technician in Europe
!   Medical/Biomedical laboratory technician is the one
main recognized level of clinical laboratory personnel
with technical qualification which is listed among the
professions covered by Directive 2005/36/EC.

!   Laboratory technician falls under the “general system”
and a regulated profession, meaning that access to and
exercise of the profession are subordinate to the
possession of a specific qualification.

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!   Curricula:

!   Training at the post-secondary level, of at least 1 year, or
of an equivalent duration on a part-time basis, with the
condition of the successful completion of the secondary
course required to obtain entry to university or

!   The professional training with special structure
equivalent to the level of training that provides a
comparable level of responsibilities and functions.

!   The alternative is training at higher or university level, of
a duration of at least 3 years and not exceeding 4 years.

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Main Tasks, Attribution, and Duties of
Laboratory Technicians
!   Tasks include sampling, preparing, processing, testing,
measuring, recording and analyzing results in a series
of biological samples, including blood, urine, feces,
CSF, etc.

!   They also provide all the required technical support to
enable the laboratory to function effectively, with
constant observance of the correct procedures of
health and safety guidelines.
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!   Responsible for actions under their competence,
conduct laboratory analysis and research pertaining to
biomedical and biotechnology analysis, and, in
particular, biochemistry, microbiology and virology,
pharmacology/toxicology, immunology, CP, hematology,
and cytology and histopathology.

!   Responsible for the correct fulfillment of the analytical
procedures and of their work, in application of the
working protocols defined by the lab director/manager;
they will assess that the services supplied correspond to
the indicators and standards predefined by the lab
director/manager.

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!   They control and verify the correct operation of the
equipment employed and provide for its day-to-day
maintenance and the elimination of any small
inconveniences

!   They participate in programming and organizing the
work within the lab

!   They will contribute to the training of support personnel
and to the updating of their professional profiles and to
research.

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Activities performed in clinical
laboratories by technicians
!   Performing laboratory tests in order to produce reliable
and precise data in support of patients, physicians, and
scientific investigations;

!   Carrying out routine tasks accurately, and following
strict methodologies to perform analyses, fulfilling the
total quality system adopted by the laboratory, in order
to meet the regulatory and accreditation requirements;

!   Preparing specimens and samples for analysis;
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!   Constructing, maintaining, and operating standard
laboratory equipment, such as centrifuges, titrators,
pipetting machines, and pH meters;
!   Operating and maintaining automated laboratory
equipment, such as blood counters, clinical chemistry
analyzers, and immunometric analyzers;
!   Operating and maintaining advanced laboratory
instruments, such as gas and liquid chromatography
analyzers and mass spectrometers;
!   Operating and maintaining instruments for molecular
biology and cytogenic studies, such as polymerase chain
reaction (PCR) thermocyclers, denaturing high-
performance liquid chromatography (D-HPLC) analyzers,
and microarray equipment;
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!   Ensuring the laboratory is well stocked and resourced;

!   Recording and sometimes interpreting, results to be
shown to senior colleagues;

!   Using computers and performing mathematical
calculations for the preparation of graphs;

!   Keeping up to date with technical developments,
especially those that can save time and improve
reliability;

!   Demonstrating practical procedures, if working in
education;

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!   Conducting searches on identified topics relevant to the
research;

!   Following and ensuring strict safety procedures and
safety checks.

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Training of Laboratory
Technicians
!   When starting with university-based courses, the
student lab technician should learn some preliminary
concepts and practices dealing with pre-analytic,
analytic, and post-analytic phases of laboratory testing,
along with other important aspects of specimen
collection, handling, and transportation.

!   Preliminary phase dedicated to teaching some general
prerequisites for laboratories, safety regulations,
general and specific precautions.
edwineiou

!   When starting with university-based courses, the
student lab technician should learn some preliminary
concepts and practices dealing with pre-analytic,
analytic, and post-analytic phases of laboratory testing,
along with other important aspects of specimen
collection, handling, and transportation.

!   Preliminary phase dedicated to teaching some general
prerequisites for laboratories, safety regulations,
general and specific precautions. As such, instructions
regard the following: safety, pre-analytic phase, sample
pre-processing and processing, analytic phase and post
analytic phase.

edwineiou

!   Before end of training, competence in the procedure of
validation of laboratory report is addressed and
explored in both analytical and clinical sides. In this
context, the MLT is trained to be (1)responsible for
completing/providing all the documents that are
prepared in his or her area of autonomy/responsibility
and that part of the analytical processes which the MLT
is responsible for; (2) cooperative in compliance with
standard indicators and predefined procedures as
established by the laboratory.

!   Also, bioinformatics are incorporated in the training
since the compelling tasks that laboratory medicine will
face in the coming years need strong support from
informatics.
edwineiou

POST GRADUATE TRAINING IN LABORATORY

MEDICINE
!   According to ELEFTHERIOS DIAMANDIS, a laboratory
scientist is not exactly a researcher or a teacher or a
manager or a medical consultant or an administrator or a
physician, but is supposed to be all these, altogether.
Therefore, he should be able to demonstrate knowledge and
skill regarding the specific scientific, technical, clinical,
organizational, and management aspects of this field.

!   Despite the heterogenous definitions of postgraduate
courses, the main aim is to develop a common formative
curriculum for all laboratory professionals, regardless of
their graduate backgrounds, to allow them to work efficiently
and profitably in a clinical laboratory.
edwineiou

The EC4 Register
!   The EC4 Register came under the direction of the
European Federation of Clinical Chemistry and
Laboratory Medicine (EFCC) in 2007, when EC4 merged
with the Federation of European Societies of Clinical
Chemistry and Laboratory Medicine (FESCC) to form
EFCC.
!   The title EC4 solely relates to the EC4 European
Rigester and the Register Commission and only applies
to countries within the EU.
!   The EC4 syllabus for postgraduate training is the basis
for the European register of Specialists in Clinical
Chemistry and Laboratory Medicine.
edwineiou

The EC4 Register
!   According to the EC4, training must involve dedicated
postgraduate study of at least 4 years, following a
comprehensive and appropriate university education of
at least 5 years. Postgraduate education should also
provide comprehensive knowledge of the biology of
diseases and the procedures and analytical techniques
used in a medical laboratory. It is important that there
should be a commitment to research and development.

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The EC4 Register
!   The main issues comprising this program include
!   knowledge of biochemistry, hematology, microbiology,
parasitology and immunology, genetics and the biology of
reproductive medicine
!   Pre-analytical conditions
!   Evaluation of results
!   Interpretation
!   laboratory management
!   Quality assurance management

edwineiou

POSTGRADAUTE EDUCATION IN THE

UNITED STATES
!   In 1995, four major pathology organizations, the
Association of Pathology Chairs, the College of
American Pathologists (CAP), the Academy of Clinical
Laboratory Physicians and Scientists (ACLPS), and the
American Society for Clinical Pathology (ASCP) formed
a conjoint committee to examine issues related to
optimal CP training, which culminated in the publication
of the GRAYLYN CONFERENCE REPORT.

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!   The task force concluded that after completing CP residency
training, the resident should have acquired enough skills to
direct and manage clinical laboratory services and be able to:

!   Serve as a consultant to physicians on cost-effective test
strategies and interpretation of results;
!   Select, evaluate, and apply laboratory instruments and
procedures appropriate to the screening, diagnostic, and
monitoring needs of clinical decision making
!   Plan, organize, staff and direct laboratory resources
!   Use the techniques of medical informatics to acquire and
manage data, translate data to clinically useful information, and
communicate that information in support of patient care and
educational programs
!   Play an influential role in medical staff and healthcare delivery
activities that reach beyond the confines of the laboratory
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!   The Accreditation Council for Graduate Medical
Education (ACGME) has mandated the development of a
defined curriculum for trainees in all medical
specialties, focused on six main areas of competency,
which include patient care, medical knowledge,
practice-based learning and improvement,
interpersonal and communication skills,
professionalism, and system-based practice.

!   In 2006, a curriculum in CP was further developed under
the auspices of the Academy of Clinical Laboratory
Physicians and Scientists (ACLPS) taking into account
newly designated and revised areas of residency core
competency

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!   The Goals of Training in CP:
!   Capacity of communicating test results
!   Knowledge and understanding of methods of diagnostic
test development, test utilization and assay interpretation
!   Understanding of methods and implementation of clinical
laboratory-based therapeutics, including minimally
manipulated and engineered cellular therapy
!   Skills to consult in these areas at the broader systems
level, and in the various extant healthcare delivery models
!   Understanding the role of research, in its broader
definition, in clinical decision making, test development,
knowledge generation, and continuing education.

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!  POSTGRADUATE EDUCATION IN
ITALY
!  Involves dedicated postgraduate study of 5 years,
following a university education of 6 years in
medicine, and 5 years in life sciences, chemistry,
or biotechnology.

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!  Educational goals
!  Interdisciplinary goals in the subarea of diagnostic
and therapeutic clinical services, including knowledge
of molecular pathology, physiopathology, general
pathology, immunology, and immunopathology;
!  Basic goals in clinical biochemistry, including
knowledge in analytical chemistry, biochemistry,
molecular biology, and medical statistics; and
!  Specific goals in clinical biochemistry, including
knowledge about the fundamental major organ and
system diseases, and their monitoring and prevention.
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!  Educational program:
!  Participation in diagnostic run for at least 1000
patients;
!  Attendance at the outpatient clinic(1 month),
emergency lab(1 month), hematology lab(3 months),
clinical cytology(2 months), protein lab (1 month),
clinical biochemistry separation lab (1 month), clinical
pharmacology and toxicology lab (2 weeks), cell
biology lab (1 month), microbiology and virology labs
(2 months), biochemistry, molecular biology and
genetics labs(11 months), attendance at analytical
chemistry lab (1 month);
!  Presentation of 1 seminar on lab medicine each year;
!  Participation in at least 3 clinical experimental
projects comparing inter-laboratory analytical
methods or Quality Assurance programs.
edwineiou

!  Postgraduate Education in the
United Kingdom
!  Curriculum encompasses a 5 year training but
entry is competitive and requires a medical
degree, plus 2 years of foundation training, or its
equivalent.
!  Curriculum is divided into four stages, and
progression through those stages is dependent on
successful annual assessment and completion of
the relevant stage of the MRCPath examination.
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!   In stage A (12 months), the trainee gathers a comprehensive
understanding of the principles and practice of chemical
pathology, under direct supervision.

!   In stage B (12-24 months), the trainee applies
knowledge and understanding to most of the day-to-day
issues, but still requires consultant input for complex
management and clinical aspects.
!   In stage C (12-24 months), the trainee undertakes
specialized training, and is largely responsible for his or
her practice.
!   In stage D (12 months), the trainee demonstrates a level
of clinical and professional judgment commensurate
with independent practice at the consultant level.
edwineiou

!  Curriculum content
!  Two aspects of good medical practice and core
chemical pathology which is developed through
demonstration of compliance with several
standards of good clinical care, maintenance of
good medical practice, teaching and training,
appraising and assessing, relationship with
patients, working with colleagues, health, and
probity.
!  Also contains hundreds of standards that
describe the scope of practice of the modern
profession of clinical biochemistry, encompassing
the knowledge required, the skills developed from
application of the knowledge, and the attitudes
developed as a result.
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!   Minimum requirement is a BSc Honors degree
!   4 years specialist postgraduate training is required for
registration as a clinical scientist with the Health
Professions Council.
!   In clinical biochemistry, 3-4 years required for the
completion of `Grade A Training.
!   Registration as a clinical scientist requires the Certificate
of Attainment of the Association of Clinical Scientists.
!   Standard for certification include the requirement to
demonstrate the following competencies: scientific
knowledge, clinical proficiency, technical training,
research and development, communication, problem
solving, and management.
edwineiou

!   The detailed content of the discipline-specific
curriculum is determined by the Association for
Clinical Biochemistry, and is completed by Grade A
trainees in a 3 year program.
!   The MRCPath examination is the professional
qualification that virtually concludes the training in
clinical biochemistry in the United Kingdom.
!   Study for the MRCPath examination takes place
during a period of approximately 5 years of higher
specialist training, which commences following the
completion of Grade A training.
!   Overall, the normal period of training for a clinical
scientist to complete their MRCPath is 8 years.
edwineiou

!  Postgraduate Education in Other European
Countries
!   Netherlands. They are enlisted in the Register of
Recognized Clinical Biochemists, supervised by the
Netherlands Society of Clinical Chemistry. Training as a
clinical biochemist consists of a 4 year period in a hospital
laboratory; it is not a specific university education.
!   France. Clinical biochemistry is taught in both the regular
medical and pharmacy curricula, but medical teaching is
more oriented toward the interpretation of laboratory
findings than toward test performance. The practice of this
profession is only open to physicians and pharmacists,
provided they have graduated in medical biology after 4
years of specialized training through a particular type of
residency called the “internat.” edwineiou

Countries
!  Spain. Clinical biochemistry was first established as
independent specialty in 1978. It is one of several
clinical laboratory sciences specialties, together with
hematology, microbiology, immunology, and general
laboratory science. Graduates in medicine, pharmacy,
chemistry, and biological sciences can enter
postgraduate training in clinical chemistry after a
nationwide examination. Training in an accredited
clinical chemistry is for a duration of 4 years. A
continuing education program is organized by the
Spanish Society for Clinical Biochemistry and
Molecular Pathology. edwineiou

Countries
!  Croatia. The model, an undergraduate education in
clinical chemistry, consisting of 4 years of specific
university education, which provides for all
requirements to maintain the high quality of the
profession. Postgraduate education is regulated by the
laws issued by the Ministry of Health and the Ministry of
Science and Technology. There is a compulsory
program of lifelong continuing education, recognized
by the Croatian Chamber of Medical Biochemists.

edwineiou

Countries
!   Macedonia. The specialization in medical biochemistry/
clinical chemistry is only for physicians and pharmacists.
!   Russia. Specialized education of clinical laboratory
physicians who work as medical technologists, heads of
laboratories, or heads of laboratory divisions is conducted
during various forms of postgraduate training, namely,
internship, primary specialization courses, advanced study
courses, graduate clinical studies, and postgraduate
fellowship. Such education is offered at departments for
clinical laboratory diagnostics, which are located within the
institutes for advanced medical studies in medical institutes.
edwineiou

!  Postgraduate Education in Other Non-
European Countries
!  Canada. The training of medical biochemists is
regulated by the Royal College of Physicians and
Surgeons of Canada, by means of a residency program
of 4 years duration, following graduation from medical
school and completion of the required internship. The
training of clinical biochemists is regulated by the
Canadian Academy of Clinical Biochemistry through
certification process incorporating written and oral
examinations, approximately 1 year apart. Training
programs are 2 or 3 years duration and entry to these
programs requires a PhD and some postgraduate
research experience. edwineiou

European Countries
!  Australia. Education of clinical biochemists occurs
after the student has attained a basic degree in science
and is employed in the clinical laboratory. In the case
of medical graduates, professional education is carried
on under the auspices of the Royal College of
Pathologists of Australia. Recognition is conferred by
the membership and fellowship examinations of the
Australian Association of Clinical Biochemists.
Currently, there are no formal recognition requirements
for laboratory scientists within Australia.
edwineiou

European Countries
!  Taiwan. The Taiwan Society of Clinical Pathologists
developed guidelines for postgraduate education and
certification of laboratory medicine. Curriculum for CP
includes clin chem, clin microscopy, parasitology, clin
hematology, clin microbiology, clin virology,
immunohematology and blood banking, clinical
serology and immunology and issues on lab
management. In recent years, the board examination
has also emphasized the subjects of molecular biology
and laboratory informatics. Recertification requires at
least 100 credit hours of continuing education.
edwineiou

European Countries
!  Japan. The program encompasses emergency tests,
blood transfusion, and microbiology. Along with these,
it is also required to acquire knowledge on how to reply
to consultations from physicians, on laboratory
workflow, and on interpretation of laboratory data at
reverse clinical laboratory conferences.

edwineiou

!  Conclusions
!   The field of laboratory diagnostics is undergoing remarkable
changes in organization and complexity, providing a variety
of new opportunities and risks. The education, skill, and
expertise required for laboratory professionals to stay
abreast of this continuously evolving scenario now embrace
a variety of technical, scientific, and organizational issues.
Translating into practice the new insights from basic and
innovative sciences requires the construction of a new and
complex core curriculum for laboratory professionals, where
the integration of different areas of diagnostics within the
same laboratory service is ultimately aimed at improving
quality, efficiency, efficacy, and safety throughout the entire
testing process. Laboratory professionals are expected to
include several technical and consultative capacities that
would fall within rather different diagnostic areas.

edwineiou

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