Q What liability exists when students test their own
blood samples in the training lab?
A It is a time-honored tradition — recognized or not —
for students to run tests on their own blood samples in the training
lab. Sometimes this practice spills over into the “real world”
laboratory after graduation as well.
In general, pursuant to the requirements of CLIA, a
laboratory test may only be ordered by an “authorized person.” CLIA
leaves the definition of such persons up to the state, and these
definitions vary. Physicians, of course, are authorized in all states,
but depending on the locale, allied health professionals such as nurses
may also order tests. Some states have provisions for self-referral for
certain types of lab tests.
Implicit in the law is that these tests are done in
the ordinary course of healthcare as a part of medical evaluation and
treatment. In its broadest sense, that would encompass any testing for
medical purposes, even that of self-evaluation by a knowledgeable
patient. As a result, unless self-referral for the particular test is
provided for, no tests for clinical reasons should be done in the
medical laboratory unless there is a valid order from an authorized
person.
Student labs, however, are not generally in the
business of providing testing for medical diagnosis and treatment, and
valid medical orders are not required for running tests in training
situations. As a result, the laws regulating the ordering of lab tests
do not prohibit students from running tests on their own blood in the
student lab.
That does not mean, however, that permitting the
practice is a good idea. The student lab is intended for training
purposes, not for purposes of providing informal medical testing to
aspiring lab techs or their families. Any policy that permits medical
testing under the guise of student training can potentially run afoul of
statutes that regulate lab testing and ordering.
Defining policies for the use of the student lab in
advance and making certain students are aware of the rules is important.
After all, knowledge of and adherence to policies is critical to success
as a laboratorian in the “real world.” If self-testing is prohibited,
provide clear (and significant) consequences for violating the policy,
and be vigilant in enforcement. After all, adherence to policy and
respect for privacy, procedures, and regulations is at the heart of
laboratory medicine and should be taught to students early and often.
healthcare provider capable of assisting the patient if the results indicate
a need for treatment.
If and when students are permitted limited and
elective self-testing, make clear restrictions that apply. Testing
anyone other than themselves would be an abuse of the student laboratory
and put the test in question squarely in the “medical testing” legal
arena.
In the past, instructors have commonly requested
students' blood samples to run in the course of classroom and bench
training. Doing so, however, exposes the student to having medical
information generally known to classmates; and because sometimes such
tests result in unpleasant surprises for the individual concerned, this
practice is best avoided. If student blood samples are to be used for
class, a release from each student providing samples should be obtained,
and expectations of privacy detailed and enforced.
Liability, therefore, will depend on a combination of
relevant state laws (including those that relate directly to student
laboratories). Start by thoroughly researching the state laws and
administrative regulations, including those of the individual
institution, to determine what is permitted and what penalties are
attached to violations. In this day and age, the potential for
violations of privacy rights and inadvertent disclosure of medical
information are a cause for concern.
A worst-case scenario would be that a student tests a
relative's blood, obtains an erroneous result, and the relative fails to
get necessary care or has some adverse medical consequence. If it could
be established that it was common practice to permit students to run
such tests for such purposes, the school might become embroiled in a
malpractice suit and face regulatory scrutiny for unauthorized medical
testing. Such an outcome may be unlikely but not impossible.
Though the legal liabilities associated with
permitting limited self-testing by students are not crystal-clear,
permitting the practice is discouraged, because there is no clear
benefit to the school or the student that makes the risk worth assuming.
Medical tests are best done under the aegis of a healthcare provider
capable of assisting the patient if the results indicate a need for
treatment. Technologists are fully capable of running tests — but they
are not doctors.
Schools are advised to explore alternative sources of
blood samples that maintain anonymity and ensure the range of results
needed for adequate exposure to testing and results management.
Barbara Harty-Golder is a pathologist-attorney
consultant in Chattanooga, TN. She maintains a law practice with a
special interest in medical law. She writes and lectures extensively on
healthcare law, risk management, and human resource management.
