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Laboratory professionals may be most familiar with certification as it relates to professional organizations or non-
governmental agencies, such as the ASCP Board of Certification. In this instance, certification is a voluntary
process by which the ASCP Board of Certification grants recognition of competency to persons who have satisfied
predetermined qualifications, i.e., education, training and/or experience, and passage of a certifying examination.
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Health care personnel can be certified without being “licensed,” as is the case with many clinical laboratory
personnel.
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B. Licensure
The most well known type of occupational regulation is licensure. Licensure refers to the right bestowed by a
governmental agency or entity to engage in a legally defined occupational scope of practice.
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With specified
exceptions, this form of occupational regulation prohibits non-licensed individuals from providing certain services.
Its intent is to “assure the public that practitioners have met the qualifications and minimum competencies required
for practice.”
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Licensure can address the maintenance of a licensee’s skill through continuing education and/or
competency requirements. It can also “provide a universal benchmark for entry-level personnel.”
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State governments “license” hundreds of professions. One estimate indicates that more than 800 occupations
are licensed by one or more states.
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Among the healthcare occupations and professions licensed by states are
physicians, nurses, midwives, physician assistants, radiologic technicians, chiropractors, physical therapists,
and pharmacists. Among the non-health care related occupations regulated by the states are painters, general
contractors, school bus drivers, barbers, bartenders, dogcatchers, septic system installers, and insurance agents.
It is clear that laboratory operations, including testing, have a major role in assessing and managing patient health;
nevertheless, most states do not license laboratory practitioners. As of November 2009, 11 states and one territory
license laboratory personnel.
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These include: California, Florida, Hawaii, Louisiana, Montana, Nevada, New York,
North Dakota, Rhode Island, Tennessee, West Virginia, and Puerto Rico. The state of Georgia does not license
laboratory personnel but does specify personnel requirements that are more stringent than those required by the
Clinical Laboratory Improvement Amendments of 1988 (CLIA). Certification is utilized by every state that licenses
laboratory personnel to assess the initial competency of licensure candidates.
C. Complementary Aspects of Licensure and Certification
A careful examination of certification and licensure suggests that these regulations reinforce and complement one
another rather than duplicate or compete with each another. Licensure provides the mechanism to accept and
extend the concept of certification over time so that continued personnel competency is assured through periodic
self-assessment, competency evaluation, and continuing laboratory education skills. Therefore, licensure can be
the process through which laboratory personnel competency is continually maintained.
III. Justification for Licensure of Laboratory Personnel
Are the Clinical Laboratory Improvement Amendments’ Personnel Requirements Sufficient?
The Federal Centers for Medicare and Medicaid Services (CMS) regulates all laboratory testing (except research) performed
on patients in the United States through CLIA.
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CLIA provides a number of important patient protections, such as laboratory
personnel standards, proficiency testing (PT), quality assessment and control requirements, and cytology testing standards.
The level of personnel skill and training required by the CLIA regulations depends on the complexity level of the testing
performed.
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Complexity levels include waived, moderate and high complexity. In order to perform laboratory testing of waived,
moderate or high complexity tests, laboratory personnel must satisfy minimum standards for the level of testing they perform.