Order Your Own Lab Tests without Direct Physician Access

EMBARGOED UNTIL JULY 30, 2001

Contact: Donna Krupa
703.527.7357 (direct dial to office through July 27th)
703.967.2751 (cell) or djkrupa1@aol.com

AACC Newsroom: Room Sl0lB
July 30-August 2, 2001, McCormick Place, Chicago
Tel: 312.791.6671

ABILITY TO ORDER YOUR OWN LAB TESTS WITHOUT DIRECT PHYSICIAN ACCESS AND VIEW YOUR SURGICAL BIOPSY ON LINE WITH YOUR MD

Internet and web breaking down barriers, allowing you first-hand access to your test results

CHICAGO-- Direct Access Testing (DAT) is the term used to describe the process by which an individual can order and pay for laboratory tests themselves via the Web, obtain the results anonymously on line, and conduct the entire transaction without obvious physician intervention. Because of new and forecasted web technology, communication channels between healthcare consumers and lab professionals will open up in ways never before imagined as they have begun to under DAT. Moreover, new, open and direct relationships between consumers and laboratories -- once separate by a physician gatekeeper -- are part of the sea change in being observed by one expert.

The expert is Bruce A. Friedman, MD, Professor of Pathology, University of Michigan Medical School. Dr. Friedman will present his observations and lead a discussion by a panel of experts about the impact of the internet and website-access on patient testing during the 53rd Annual Meeting of the American Association for Clinical Chemistry (AACC), being held July 30-August 2, 2001 in Chicago.

Background
In l999, 170,000 clinical laboratories in the United States performed 5.7 billion tests, according to the Institute of Medicine. Approximately 60 percent of the testing was conducted in hospitals, 30 percent was conducted by commercial laboratories and about 10 percent of the total was administered in doctors' offices.

Routine diagnostic tests include chemistry tests such as glucose and cholesterol, hematology tests such as white and red cell count, microbiology tests such as throat cultures, pregnancy and Pap smears. Non-routine tests include a host of other assays including genetic testing. Taken together, up to $40 billion is spent on lab testing each year.

It is also an industry characterized by third-party relationships. Physicians order tests for patients from the laboratories. The laboratories send the results to the physician and the physician reviews the results and places them in the medical context of the individual patient. With the web-enable processes relating to the clinical laboratory, the paradigm may not only shift, but be scuttled altogether.

Direct Access Testing (DAT)
Last February, Quest Diagnostics, Inc., the world's largest laboratory, opened storefront clinics in four states permitting people to order their own tests without the need for a physician order. (Quest had worked with each of the state's medical societies and regulators to secure permission to do so).

According to Friedman, the Quest imprimatur gives legitimacy to the DAT approach to testing and will become a part of mainstream medicine for this and two additional reasons:

The Process is Simple
-- The individual identifies the blood tests they are interested in having performed (hematology tests (white count, blood count, red blood cell, hemoglobin) or a chemistry panel: (a battery of liver and kidney tests). Alcohol and drugs-of-abuse test are expected to be available in the near future.
-- An individual locates a patient service center, goes to the center and has blood drawn.
-- The costs of the tests are paid by the client.
-- The client receives an individualized password and ID to use to log on to the laboratory web site to obtain the test results. The individual is anonymous.
-- When life-threatening diseases such as HIV are tested, it is expected that a counseling module will be built around the disclosure of the test results.

Confidentiality Concerns
Dr. Friedman believes that many people will be driven to DAT because they want a high level of confidentiality and fear that their health information could leak out , or be made available to employers or prospective employers, under FOIA (the Freedom of Information Act) or through mishaps (directly or indirectly).

For these reasons, Dr. Friedman believes that ten percent or even more of all lab testing will be done by DAT within the next five years.

The New Explosion: Lab Portals Within the Existing Healthcare System
Within the existing healthcare system, the enabling of lab test ordering and resulting on websites is expected to grow exponentially. Working through their physicians, patients are growing accustomed to reviewing their test results online after receiving instructions about how to do so from their doctor. This process allows patients to review their own test results and illustrative material about the relevance of tests for diagnosis, monitoring and treatment.

Dr. Friedman expects that managed care plans may find it economically advantageous to give patients "lab test accounts," in order for patients to order -- and monitor -- their own tests. For patients with chronic diseases, such as chronic anemia or a history of chronic liver disease, this approach makes sense from every perspective.

First, it allows patients to seize control over their own healthcare. By deciding whether or not to order a test because the patient is taking control of their health care and being pro-active. The convenience for the patients and efficiency gains are expected to help reduce healthcare costs from the demand side of the healthcare equation.

Second, it eliminates the need for a first-time visit to a physician for the primary purpose of obtaining lab orders. Once the patient orders their test, obtains their results on line, they can notify the physician of any irregularities. The results can then be brought with them to the doctor's office visit. This is expected to help reduce healthcare costs on the supply side of the healthcare equation.

Standard Panel of Tests Expected to Skyrocket from 20 to 200+
As the diagnostic testing industry becomes more sophisticated in the wake of the genome, Dr. Friedman foresees a radical new generation of tests emerging as a consequence of genomic and proteomic research. Whereas He predicts that the testing process will be driven by new research in basic science and testing methodologies and also the unique health considerations of the individual. Such new testing methods will allow for the development of more numerous and more complex lab tests, meaning that as many as 200 tests could become the norm when a patient is admitted to the hospital. Outpatient testing will also become more complex and challenging in terms of test result interpretation, requiring the use of computers to arrive at the proper diagnosis and therapy.

Cutting Edge: Bringing Surgical Biopsies to the Web for Patients to See
Michael J. Becich, MD and his colleagues at the University of Pittsburgh Medical Center (UPMC) are at the forefront of helping patients obtain first-hand knowledge about their health. They have developed a system that allows pathologists to post surgical biopsy images online for clinicians to review and share those visual findings with patients via the web.

Doing so has tremendous patient and consumer education benefits. Using visual aids, patients, in partnership with their physician, can observe benign tumors, aggressive tumors, identify which tumors require chemotherapy, see the margins for which tumor size requires surgical intervention, and receive referrals to URLs that provide in-depth, specific information.

Dr. Becich, an Associate Professor of Pathology at the University of Pittsburgh and Chairman of Pathology at UPMC-Shadyside is also a pioneer in the new era of "webization" of patient testing. His web page is among the most heavily traveled on the healthcare internet.

He and Dr. Friedman will be part of a four-member panel, led by Dr. Friedman to discuss the effects that the internet, the web and patient testing will have on creating a more open healthcare process.

The work of Dr. Becich is, according to Dr. Friedman, "another step in the democratization of our healthcare system."

-end-

Founded in 1948, the American Association for Clinical Chemistry (AACC) is the world's most prestigious professional association for clinical laboratorians, clinical and molecular pathologists, and others in related fields. Clinical laboratorians are specialists trained in all areas of human laboratory testing, including infectious and genetic diseases, DNA and the presence of tumor markers. The primary professional commitment of clinical laboratorians is the effective understanding and use of laboratory tests in order to detect, monitor and treat human diseases.

***
Editor's Note: For further information or to schedule an interview with Dr. Friedman or Dr. Becich, please contact Donna Krupa
at 703.527.7357; cell: 703.967.2751 or at djkrupa1@aol.com. Or log on to the AACC website at www.aacc.org.