| Policy Synopsis
The College of American Pathologists believes that the interpretation
of laboratory tests constitutes the practice of medicine, for which pharmacists
should not be licensed. The College also believes that no test is so simple
and straightforward to perform that erroneous results cannot occur and
that no incorrect test result is “risk free” or inconsequential
with regard to potential harm.
Policy
The College believes that the interpretation of laboratory tests, used
for the diagnosis, prevention, treatment, or assessment of human disease,
or for purposes of drug therapy management, constitutes the practice of
medicine, for which pharmacists should not be licensed. The College also
believes that no test is so simple and straightforward to perform that
erroneous results cannot occur and that no incorrect test result is “risk
free” or inconsequential with regard to potential harm. The College,
therefore, recommends that any legislation or regulation addressing the
ability of pharmacists to order, perform or evaluate laboratory tests
should be based on the following principles:
Except for individuals requesting a test for themselves as authorized
by state law, the ordering of clinical laboratory tests should be limited
to licensed physicians, licensed dentists, or licensed health care practitioners
under the supervision of a licensed physician or licensed dentist who
is providing treatment for the patient.
Diagnostic laboratory testing should only be performed by those individuals
who possess appropriate clinical education and training, and under the
supervision of licensed physicians, or consistent with moderate and high
complexity testing requirements under CLIA 88.
The interpretation of clinical laboratory tests is the practice of medicine
and should, therefore, be done solely by licensed physicians.
All clinical laboratory testing used for the diagnosis, prevention, treatment
or assessment of human disease, and laboratory testing for purposes of
drug therapy management should be subject to quality control and proficiency
testing.
When individuals perform any test on a person other than themselves,
it should be construed as the practice of laboratory medicine, subject
to all of the above listed principles, unless such test is approved by
the Food and Drug Administration as an “over-the-counter”
test that is available for use to the general public without a prescription
and used by a home health care attendant or caregiver under the supervision
of a licensed physician.
The College of American Pathologists offers this policy for consideration
by any government agency or legislature and for use by state pathology
societies for legislative or regulatory advocacy.
Revision History
Adopted May 2002
Revised November 2002
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