Bogdan Solnica1, Milena
Dabrowska2, Grazyna Sypniewska3 *
- Jagiellonian University Medical College , Cracow;
- Medical University, Bialystok;
- Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz,
Poland
Corresponding author's
address
* odes@cm.umk.pl;
grazynaodes@interia.pl
Laboratory diagnostics is the medical discipline devoted to
obtain, explore and employ knowledge about using various techniques
for the analysis of body fluids composition and properties of cells
and tissues, and interpretation of the results in relation to
health and disease. It should be stressed that laboratory
diagnostics or laboratory medicine is both the clinical discipline
and the separate medical science. These two fields of laboratory
diagnostics are tightly bound as in the case of other clinical
sciences.
Laboratory tests are used in various stages of the diagnostic
process in all fields of clinical medicine, being along with
imaging studies, electrophysiological and other procedures the main
source of information on the health status of the patient. It is
estimated that laboratory results can be the basis of 60% -70% of
medical decisions (1). In addition to routine diagnostics in
symptomatic patients, laboratory tests are used for screening,
treatment monitoring and medical jurisprudence. Thus, laboratory
diagnostics generating around 10% of all healthcare costs is
crucial for the healthcare decision-making process, contributing to
improved outcomes and cost savings (1-4).
Advances in medical sciences and clinical practice cause the
continuous increase in demand for laboratory testing related to
their panel, the quantity and availability. Meeting this
demand is possible thanks to the big methodological and
technological progress in laboratory medicine over the past 20-30
years. This progress has brought the measuring picomole
concentrations of various substances in body fluids and testing on
the cellular and subcellular level, including genetic material.
Moreover, the analytical quality has significantly improved
together with an increase in laboratory efficiency and decrease in
turn-around time (5,6).
However, despite this progress, a fundamental question still
remains valid - how to properly perform laboratory tests, and
ensure their accessibility, the adequate turn-around time, and the
appropriate analytical quality? In other words - how should the
laboratorians perform their work well?
Automation, consolidation, integration and centralization of
laboratory procedures and manufactured on an industrial scale
ready-to-use reagents have completely changed the nature of the
work in diagnostic laboratories. Currently, the laboratory staff
members must be familiar with often complex preanalytical phase of
performed tests, analytical methodology and advanced measurement
techniques and equipment, various electronic devices and
information systems, which they use in daily practice. The
automation of measuring systems developing very dynamically
requires continuous updating of knowledge of analytical methodology
and features of particular analyzers (maintenance and calibration,
monitoring measurement system and electronics, trouble-shooting or
error recognition, corrective action and others). Thus, the
contemporary laboratorian should be also an expert in the field of
advanced measurement techniques and equipment.
The remaining professional knowledge and skills have also become
more complex. The preanalytical phase properly established for the
continuously increasing number of performed tests should be based
on the knowledge of interfering factors influencing the obtained
results (7). This knowledge is necessary for advisory functions
including explaining the causes of erroneous results, which
sometimes are obtained in laboratories. Moreover, the required
qualifications must include an appropriate body of knowledge of the
pathophysiology and diagnostics of diseases, allowing validation of
the results before reporting and advisory functions offered by
laboratories.
There are two key factors determining the respective competence
of laboratory staff - professional training and appropriate human
resources management. The required scope of the knowledge and
skills is very wide and such high level of professional
qualifications is not necessary for every diagnostician employed in
given laboratory. According to the common organizational approach
there are at least two categories of laboratory staff. Laboratory
technicians familiar with analytical methodology and equipment are
the operators of the analyzers and are responsible for the proper
performing of tests. They are not involved in the validation of the
results or the consultative and advisory functions of the
laboratory. The next group comprises laboratory diagnostitians,
which should be familiar with the preanalytical and analytical
phase as well as with the patophysiological, and diagnostic context
of performed tests and obtained results. Their duties usually
include supervising the work of technicians, validating the
obtained results and releasing the lab reports and the contact with
physicians ordering the tests (5,8). This contact is very
important and useful for both laboratory diagnosticians and
physicians and should have an organizational and technical support.
The exchange of information is often helpful for validation of the
results and their interpretation particularly in the case of
erroneous results. On the other hand, doctors benefit of getting
sometimes assistance in interpreting the results or in the
appropriate choice of laboratory tests. Currently, the laboratory
service includes the advisory and consultative functions and
laboratory diagnosticians should be partners for physicians in the
diagnostic process. To achieve this, they must have an appropriate
level of professional qualifications including sufficient medical
knowledge. Particularly important is that laboratory staff members'
qualifications must be in line with current scientific and
technological bases of laboratory medicine. Thus, laboratory
diagnostics is the medical profession based on advanced analytical
technologies, diagnostic expertise and medical knowledge.
Properly organized pre- and postgraduate training in all fields of
laboratory medicine should ensure the acquisition of appropriate
professional knowledge and skills by laboratorians (5,9). The
syllabus for pre-graduate and post-graduate training in clinical
chemistry and laboratory medicine should be similar to the syllabus
prepared by EC4 committee (10,11). Moreover, laboratory
diagnosticians should also have the ability of continuous updating
professional knowledge and skills in order to raise qualifications
through constant participation in training courses and medical
research. They should have the ability of management in the area of
laboratory medicine, taking individual and collective
responsibility for their own profession along with its economic and
social aspects. In order to meet these tasks, the main standards of
pre- and postgraduate education for laboratory diagnosticians
should ensure that:
- the study program includes basic and clinical science as well
as laboratory professional training
- the basic contents are medically oriented, practical and
adjusted to the needs of clinical training
- the educational facility is adequately equipped with
laboratories, which must meet the quality standards for scientific
and medical diagnostics laboratories
- the clinical diagnostics training should be carried out in
hospital facilities by physicians familiar with laboratory
medicine
Learning effects for the postgraduate education include advanced
knowledge from the specialist field of laboratory medicine as well
as skills and attitude to head specialist laboratories and be a
consultant in the areas of diagnostic practice, prognosis and
treatment monitoring.
Laboratory diagnostics or laboratory medicine is also a clinical
science of a specific nature resulting from its location "across"
all other clinical disciplines. Laboratory tests are an essential
diagnostic tool, or the subject of numerous experimental, clinical
and epidemiological studies. Laboratory medicine by its nature
integrates the basic science, technical performance and clinical
context for patient decision making but as the science provides a
general rules of selection of tests for specific research tasks.
Laboratory medicine creates also the rules of analysis and
interpretation of the results and for evaluation of the diagnostic
performance of laboratory tests. The scientific nature of
laboratory diagnostics is best reflected in the evidence-based
laboratory medicine (EBLM). According to the classical
definition EBLM is the conscientious, explicit, and judicious use
of current best evidence in making well-informed medical decisions
(12,13). Thus, all clinical practice guidelines developed for the
use of laboratory tests should be based on EBLM rules. On the other
hand, EBLM serves the basis of studies designed to evaluate the use
of laboratory tests in defined clinical settings. It provides
also useful tools to assess the study design, reliability of
data and quality of systematic revyewing and metaanalyses (14).
Alltogether, laboratory medicine is the clinical science using
advanced research tools and providing data relevant for clinical
practice, published in highly valued scientific journals.
It should be emphasized that progress in laboratory diagnostics,
as in other clinical disciplines, is made not only through clinical
studies, but also in daily practice. Diagnostic laboratories are a
source of information that properly selected and analyzed can have
high scientific value. For this reason, the institutions performing
research in the field of laboratory medicine, in addition to
co-operation with clinical units should be integrated with
diagnostic laboratories. Separation of such institutions lowers the
quality of both research and routine laboratory testing.
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