Q We are thinking of instituting direct-access testing
(DAT). What are the issues we need to deal with? Are there some states
that do not permit DAT?
A CLIA specifically leaves the regulation of DAT to
individual states, which means there is considerable variation among
states with respect to what, if any, DAT is allowed. Direct access
testing is permitted, at last count, in 34 states. Twenty of those
states have no regulation on the types of tests that can be ordered; the
remaining states place some restrictions of patient-ordered tests. In a
hybrid model, some states permit patients to call in for consultations
with laboratory staff physicians, who can then, in turn, order testing
without the benefit of an ongoing doctor-patient relationship.
Because state regulations are always subject to
change, check with your local legal counsel to determine what the law is
in your locale before embarking on such a project. If you will be
offering services in several states, this process becomes even more
complicated. In general, the state law of the locus of the draw will be
controlling — meaning that patients who live near state borders may
choose to cross state lines to obtain services if their own state law is
too restrictive. The details of licensing and regulation are too
specific and complex to detail in this column but are critical to any
successful business plan.
Federal and state laws regulating lab proficiency and
staffing will apply to DAT tests just as they do to physician-ordered
tests. In addition, some states have added requirements that test
results be given in clear, understandable language to patients when DAT
is used. An attorney can help sort through these requirements and may be
able to assist you in finding exemplars of language and forms from which
Aside from the attraction of easy ordering of lab
tests, many patients are attracted to DAT because of the sometimes
substantial savings DAT labs offer over other labs. This is often the
result of a cash-only advance payment that reduces revenue lost to
insurance processing and discounts, as well as bad debt. Consequently,
it may be possible to boost lab revenues by cutting prices; and if there
is a sufficient customer base, this can be an attractive way for labs to
supplement falling income.
Critical values and test results that are clearly linked to health problems of a serious and potentially acute nature
present particular risks.
DAT has also given rise to a variety of
Internet-based services that contract with local clinical laboratories
in various states to perform patient-ordered tests alongside traditional
physician-ordered lab services.
One major shift of liability for the lab that offers
DAT is that there is no longer an interpreting physician to guide the
patient in understanding and responding to test results. Having a
well-defined way of making certain that the patient understands the
importance of the reported result is necessary. Most DAT labs include a
disclaimer on the results forms, directing patients to take their
results to a physician and discuss them. One might argue, however, that
the premise of DAT is that an informed patient either knows how to
interpret data or will take the results to a physician for
Some states specifically name the laboratory director
responsible for communicating lab tests in the DAT setting. Part of any
legal discussion in setting up DAT should be to define what is known
under state law about the responsibilities for reporting and to what
extent interpretation might legitimately be considered part of
Critical values and test results that are clearly
linked to health problems of a serious and potentially acute nature
(e.g., elevated potassium, PSA) present particular
risks. In the hospital setting, the detection of a critically elevated
potassium level, for example, results in the immediate attention of a
physician to address the problem.
Communicating such information can be a challenge
when the patient may not understand the “see a doctor right away”
language really means “SEE A DOCTOR RIGHT AWAY!” Discussion with an
attorney can help create language that is specific and clear and, to the
extent possible, that indemnifies the lab when such situations arise. As
always, proper policies, documentation, and follow up will not only help
to protect the lab but also will help improve the care of the patient.
Appropriate personal contact can help underscore the need for physician
intervention in particularly critical situations and should not be
The driving forces for DAT have been economics and convenience. It
remains to be seen how this will affect the delivery of healthcare and
the legal risks of providing laboratory services.
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.
MLO’s “Liability and the Lab”is intended
to provide risk management and human resource management education; it
is not intended to provide specific legal advice. If you require legal
advice, the services of an attorney should be sought. Dr. Harty-Golder
welcomes your questions, which can be sent to her at
[email protected]. Unless otherwise noted as “confidential”
by readers, all queries will be considered for publication without
further notice to them. Names, institution, city, and state will be
removed before publication.