DAT brings benefits and concerns.
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 to work.
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.
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 interpretation.
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 reporting.
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 die 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 overlooked.
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.
By Barbara Harty-Golder, MD, JD
Barbara Harty-Golder is a pathologist-attorney consultant in Chattanooga, TM 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.
|Printer friendly Cite/link Email Feedback|
|Title Annotation:||Liability and the lab; direct-access testing|
|Publication:||Medical Laboratory Observer|
|Date:||Jul 1, 2009|
|Previous Article:||Answering your questions.|
|Next Article:||"Boomers" change the medical lab landscape.|