Direct Access Testing: The Way of the Future

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.

What is Direct Access Testing for blood?

DAT is a service that allows is defined as consumer-initiated testing of human specimens. 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.

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-formalization patients 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.

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

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.

Document: Consumer Access to Laboratory Testing and Information
Classification: Position Paper
Date: July 2004
Status: Approved by ASCLS House of Delegates July, 2004

The traditional healthcare model in this country places the physician (or appropriate ordering provider) in control of determining what diagnostic and therapeutic monitoring (including laboratory tests) are performed on a patient. In addition, all results of tests and procedures are reported to the physician who assumes the responsibility of relaying the information to the patient. This model is reinforced by Medicare and Medicaid regulation and the laws of a number of states. The general public, however, was introduced to the concept of being directly involved in their own laboratory testing as early as the 1950's with the availability of over-the-counter urine glucose and ketone tests. As the number of diabetics continues to increase, these patients are encouraged to monitor closely their glycemic status in an attempt to decrease the incidence of complications. With diabetes mellitus leading the way, an expansion of over-the-counter testing technology, and a movement for more empowerment of consumers to take responsibility for their own healthcare, has created a major paradigm shift in healthcare, moving from a physician focus to a consumer focus1. One manifestation of this has been direct access testing (DAT) for laboratory services. DAT is also known by a variety of other names including consumer ordered tests, patient-directed testing, direct access to lab services, consumer driven testing, self-ordering, direct-to-consumer and consumer self-orders. It is characterized by the individual paying up-front and out-of-pocket for the service. As of 2004, most insurance companies and other payers are not offering reimbursement. Tests are usually purchased without physician consultation, and the consumer/patient is responsible for any follow up with their clinician2. This is in contrast to the over-the-counter home testing kits available for purchase in pharmacies and other retail outlets. DAT places the clinical laboratory professional in a direct provider relationship with that consumer/patient.

By Regina Goodrum, MT(ASCP); Elaine Miller, MT(ASCP); Randall Reeves, MS, MT(ASCP); and Hassan Aziz, PhD, CLS(NCA)

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.

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.

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-formalization patients 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.

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.

 

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