Advance for Administrators of the Laboratory published a recent article about direct access testing (DAT). Here is a link to my previous blog notes about DAT. Here is the link to the article and and below is an excerpt from it that describes the four categories of DAT, which the author refers to as formats:
(1) The first of these is the walk-in laboratory, where trained staff (typically a phlebotomist) is available to assist in sample collection. This method allows for better specimens and, because more complicated samples may be collected, the laboratory can conduct a broader range of tests. Results are reported in a variety of ways, depending upon the test and the policy of the testing lab.
(2) The second of the formats for DAT is the mail-order lab test. These tests usually involve a collection kit, where the patient collects his own sample. Typically, the tests which are susceptible to improper collection (e.g., blood hemolysis) may not be appropriate within this method. Results are often reported via phone or mail.
(3) The third laboratory format available to patients seeking self-diagnosis is in fact a de facto form of DAT. This arena involves blood donor processing facilities, where donated blood is screened for a variety of diseases, such as hepatitis and HIV. While donors are discouraged from donating blood to obtain free screening, it is likely that this in fact does occur. In this case, patients are typically notified by mail.
(4) The fourth and final format for DAT is the at-home test kit. In this case, it is up to the patient to collect the sample, perform the test, interpret the results, and determine the appropriate medical response. Obviously, this type of testing includes only those evaluations that are simple to perform and interpret.
We need a working definition for DAT in order to discuss the categories into which direct access testing can be divided. Let's see if the following works:
The process by which a healthcare consumer tests, or submits for analysis in a clinical laboratory, a biological specimen (e.g., blood, serum, cells, urine, stool) without using a trained healthcare practitioner (e.g., physician, nurse) as a known intermediary in the process.
Note my reference to a "known" physician intermediary. Because DAT is not legal in about half of the states absent a physician order, some web-enabled DAT services use a physician in the background as the test-ordering physician of record about whom the client may not even be aware.
I have a few minor quibbles with the four categories of DAT described above. First, I would exclude any lab testing that occurs in blood donor centers because the testing is merely the byproduct of blood donation and the consumer does not submit the specimen -- it is submitted by the blood collection agency. Second, I would add the category of blood testing by a consumer using any small analyzer such as a glucometer. This type of testing, although largely performed at home, is substantially different than a mail-in or home test kit. With these changes, we are back to four categories of DAT.