CLINICAL LAB SCIENEC

22
ESSENTIALS OF CLINICAL LABORATORY SCIENCE
Are the two levels of laboratory worker interchangeable, because some
employers believe that they are and hire workers based on that premise? Or,
regardless of level, should they be used for the same levels of tasks? These questions
may seem simple on the surface, but they are difficult to answer and vary
depending on the facility in which the worker is employed and, to an extent, on
state in which the worker is practicing. And to further complicate the nomenclature
used, in some areas of the country, a CLS/MT is called a CLS and a CLT/MLT
is called an MLT, to differentiate between the level that requires an associate’s
degree (MLT) and the one that requires a bachelor’s degree (CLS). In answer to
these questions, CLIA 88 regulations differentiate between levels of tests and
between the category of laboratory that will perform them, as laboratories are
classified as being qualified to perform “waived tests” only or moderate- and
high-complexity tests. In some cases, a procedure for one type of test may be of
a waived classification, while the same test using another methodology may fall
under another classification.
Laboratory classifications are based on the difficulty of the tests performed,
which is based on the complexity of the procedure, and laboratory personnel
standards differ for each of the categories of testing. More complex tests require
more training than do those that are of the waived variety. Each laboratory is
classified and receives a CLIA certificate stating the category for which it is classified.
There are five different certificates (Table 1-3).
Who Differentiates between CLS/MT and CLT/MLT?
Accreditation agencies that inspect health care facilities may review scope-ofpractice
requirements and determine what level of worker is assigned to various
tasks. The agencies and organizations listed on the next page observe scope of
practice policies.
Table 1-3 Types of Certificates Issued through CLIA 88 Regulations and
Activities Performed under Each Category of Certificate
Certificate
Certificate of Waiver
Certificate of Registration
Certificate of Compliance
Certificate of Accreditation
PPMP
Activity Permitted
Permits a laboratory to perform only CLIA-waived tests
Permits the laboratory to conduct moderate- or high-complexity
laboratory testing (or both) until the laboratory is determined
by survey to be in compliance with CLIA regulations
Issued to a laboratory holding a Certifi cate of Registration after
an inspection fi nds the laboratory to be in compliance with all
applicable CLIA regulations
Issued to a laboratory that has been accredited by a
CMS-approved accrediting organization
Issued to a laboratory in which a physician, mid-level
practitioner, or dentist performs no tests of complexity other
than the microscopy procedures; this certifi cate also permits
the laboratory to perform waived tests
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