CLINICAL LAB SCIENEC

10
ESSENTIALS OF CLINICAL LABORATORY SCIENCE
Procedures performed today often do not
require the use of animals to complete tests,
except in research laboratories, as the methodology
in hospital laboratories is much
more sophisticated and is becoming more
technically complex for most testing. The
laboratory has evolved and is evolving into
an even more sophisticated component of a
large medical delivery system, as shown in
Figure 1-1.
Lack of Recognition as a Profession
Even today, regardless of years of efforts by
FIGURE 1-1 A modern clinical laboratory in a large hospital.
Source: Delmar/Cengage Learning.
laboratory professionals, there is still a great
deal of confusion, particularly in the general
populace, as well as within health care facilities, with respect to the education,
training, and hierarchy of laboratory professionals. The National Labor Relations
Board (NLRB) bestowed professional status on medical laboratory technologists
in 1995, but this has done little to elevate the stature of the profession.
Many hospitalized patients and their families often erroneously assume that a
person in hospitals who collects, transports, and processes the blood and body
fluids is a “nurse” or some other unnamed medical worker. Few laypersons are
aware of the diversity and numbers of laboratory tests performed on a regular
basis. The duties of technologists and technicians are often the same in some
facilities and further confuse the picture. Additionally, some states require personnel
licensure to work in laboratories within these states, while others rely
on professional registries to test and certify the competency of those entering
the profession of laboratory medicine. California, as mentioned, has personnel
licensure for laboratory technicians and technicians, but recently adopted the
American Society for Clinical Pathology (ASCP) registry examination as the
instrument to measure the knowledge and competency of those entering the
medical laboratory profession.
States that have no personnel licensure requirements for laboratory workers
are now subject to CLIA regulations. The Clinical Laboratory Improvement
Amendments (CLIA) of 1988 are U.S. federal regulatory standards that apply to
all clinical laboratory testing performed on humans in the United States, except
for those tests performed in research laboratories with limited numbers and varieties
of tests performed. A separate regulatory entity was created for administering
the regulations legislated by CLIA 88. The Centers for Medicare and
Medicaid Services (CMS) has the primary responsibility for the operation of the
CLIA Program. In turn, CMS enforces implementation of the CLIA Program by
the Center for Medicaid and State Operations, Survey and Certification Group,
Division of Laboratory Services.
The CLIA Program sets standards and issues certificates for clinical laboratory
testing according to the requirements of CLIA 88. CLIA defines the clinical
laboratory as any facility that performs laboratory testing of specimens collected
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