One of the trends in the healthcare industry is the advent of direct access testing (DAT). DAT represents a de-formalization of traditional healthcare, allowing consumers the opportunity to access the laboratory without having to consult a physician. While it appears unlikely that DAT will supplant traditional healthcare, it does appear that the characteristics which make DAT appealing will propel it to a significant role in the healthcare arena.

Without a Physician
DAT is a service that allows consumers to obtain laboratory-type testing without consulting a physician. It is defined as consumer-initiated testing of human specimens. However, it is up to the consumer to decide what tests should be performed. Laboratory personnel are not licensed to practice medicine; however, "laboratory results not explained to a patient (in writing or in conversation) establish a duty of patient care relationship that is enforced in a court of law."

Even when laboratories employ physicians to meet certain insurance requirements, the extent to which they can advise the patient is limited by both regulatory statutes and potential civil litigation.

However, test results often come with generic information about the test and what the results may mean. Consequently, customers are generally on their own to find a physician to study and evaluate the information to determine an appropriate response.  

Formats for DAT
Laboratories involved in DAT retain the same obligations that they have with traditional, physician-ordered tests. In general:

• tests should be performed properly,
• results should be reliable,
• results should be communicated properly to the individual ordering the test, and
• medical information is privileged.

There are essentially four formats for DAT. 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.

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.

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.

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.

Emergence
To a certain extent, DAT has evolved in concert with the development of point-of-care testing and technology. Cost-reduction efforts in the medical field included reduced hospitalization and general de-formalizationpatients were treated on an outpatient basis, often by an assistant or nurse (or even pharmacist). To this effect, the walk-in lab became an extension of outpatient treatment. Meanwhile, technological advances allowed for more reliable test methods that were, in many instances, easier to perform.

Consequently, more and more tests were adapted for use at home, as patients assumed new responsibilities for their healthcare. The FDA has approved numerous kits that allow the patient to either perform the test at home, or to collect the sample at home and mail it to the laboratory for testing. The most common home tests include: pregnancy indicators, ovulation predictors and blood glucose monitors, while home sample collection kits include tests that require a small sample of dried blood (e.g., HIV) or other specimen.

Acceptance
Given the dynamics of the World Wide Web, data is, in essence, available anywhere there is access to the Internet. Presently, no federal statutes restrict test ordering or release of results to patients. However, many states have introduced legislation to regulate DAT. States that presently have restrictions on DAT include California, Nevada, Utah, Missouri, Arkansas, Illinois, Mississippi, Michigan, New York, Maine, New Jersey, Maryland, Arizona, Oregon, Idaho, Wyoming, North Dakota, Iowa, Kentucky, Tennessee, Alabama, Georgia, Florida, South Carolina, North Carolina, Pennsylvania, Massachusetts, Rhode Island, Connecticut and Hawaii. Puerto Rico also has restrictions.

Advantages
Inherent in this form of healthcare are several advantages. Advocates of DAT point toward cost savings to the consumer, convenience, improved privacy and, most importantly, greater controls of one's own healthcare. The most highly touted advantage of DAT appears to be reduced cost to the consumer. Lab-sponsored Web sites indicate that customers can reduce their medial bills by 40 to 70 percent. Indeed, many employers have relied upon DAT as a low-cost option to screen workers for drug use (with a more formalized test for those who demonstrate positive results). Moreover, physicians will often refer patients who lack the ability to pay for healthcare to this type of testing due to its increased affordability. However, because most insurance plans do not pay for tests unless prescribed by a physician, the potential cost savings are not available to a large segment of the population. Thus, it appears that cost avoidance may in fact be less significant than the convenience and privacy of DAT.

For many customers, the issue of DAT has more to do with convenience than anything else. Within the framework of traditional healthcare, the patient would have to make an appointment (often necessitating an absence from work), spend time traveling to the physician's office, wait for the physician to become available, have the test performed and, in many cases, repeat the entire process several days later to receive the results.

With DAT, consumers can obtain laboratory evaluation with little or no interruption of their daily activities. No doubt, the primary advantages of the home pregnancy test kit and glucose monitoring devices are convenience. Other DATs that appeal because of convenience include mammograms, PSA screening, glucose monitoring and cholesterol testing.

For patients who are embarrassed or concerned with the stigma associated with certain tests (such as screenings for sexually transmitted diseases or drug use), the main advantage of DAT is privacy. Increased discretion is also of concern to many patients who fear that documentation in their medial files may result in denied health or life insurance, or even employment. In particular, a higher level of privacy is often appealing to patients in rural areas, who frequently have nonprofessional relationships with the only healthcare workers available. To this effect, the anonymous nature of DAT provides a vehicle whereby these individuals can determine their health status.

The advantages of DAT involve potentially reduced costs, greater convenience and increased privacy. The primary advantage of DAT, however, may be due to increased accessibility to healthcare services. Consumers who might avoid testing due to financial limitations, time constraints or embarrassment may find DAT more suitable for their circumstances. Thus, individuals who otherwise would be unaware or uninformed of medical issues may be inspired to seek additional medical help or treatment to resolve problems that were revealed vis a vis direct access to laboratory testing.

In addition to providing benefits for consumers, DAT also offers advantages for the laboratory. The primary advantages here include putting the labs in new, direct relationships with patients; increased business, and up-front payment for services rendered.