Surprisingly, there are no federal regulations that impede this growing trend of consumer ordering and purchasing of lab tests. Because no federal programs funds' are involved, the regulatory initiatives are left to the states. Currently, more than 30 states* allow DAT, with regulations varying widely. In Washington state, for example, there are no restrictions; New York and California have recently relaxed their regulations; yet, Idaho prohibits DAT altogether. Despite the "hands-off" policy of the federal government, the Clinical Laboratory Improvement Advisory Committee (CLIAC), affiliated with the Centers for Disease Control and Prevention, is starting to evaluate a possible role in DAT.
Direct Access Testing: A Retail Business
What is evident to the federal government, states, and medical community is that DAT changes the basic relationship of how patients receive their services from commercial laboratories. Heretofore, these laboratories have operated on a business-to-business level with hospitals, clinics and physician clients. With DAT, laboratories do business directly with customers. DAT is a retail business.
Results Direct: An Example of Responding to the 21st Century Patient Consequently, the leadership of Results (http://www.results-direct.com), a consumer-direct laboratory testing venture in Spokane, WA, established a task team to implement a wide range of programs, including a survey that would quantify interest in DAT, characterize target customers, identify key features for the DAT program, and create an implementation and monitoring plan. The company's success in this new industry is an example of a service meeting the needs of the informed, 21st century patient. Reporting the Results Direct experience is Lawrence Killingsworth, PhD, Chief Science and Technical Officer, Pathology Associates and Medical Laboratories, Sacred Heart Medical Center Laboratories, in Spokane, Washington. Dr. Killingsworth is presenting his report, "Direct Access Testing from Concept to Reality" during the 55th Annual Meeting of the American Association of Clinical Chemistry (AACC), being held July 20-24, 2003 at the Pennsylvania Convention Center, Philadelphia, PA. More than 16,000 attendees are expected.
What Do Today's Patients Want?
According to Killingsworth, Results Direct found the following results in its analysis:
Suggested Customer Procedures
Results Direct offers the following guidance for serving its patient base:
For patient safety and to put laboratory testing into a broader medical perspective, Results Direct attaches the following comment to all laboratory reports:
LAB TESTS PROVIDE USEFUL INFORMATION, BUT ARE NOT A SUBSTITUTE FOR A FULL MEDICAL EVALUATION. RESULTS WITHIN THE REFERENCE (NORMAL) RANGE DO NOT ENSURE HEALTH. RESULTS OUTSIDE THE REFERENCE RANGE MAY NOT INDICATE DISEASE. RESULTS DIRECT RECOMMENDS YOU CONSULT YOUR PHYSICIAN TO DISCUSS YOUR TEST RESULTS AS A PART OF A COMPLETE MEDICAL EXAMINATION.
Recommended DAT Test Menu
The Results Direct panel suggested that DAT include common medical tests with public understanding and "name recognition," tests for a wide range of common medical conditions, and those that can be offered at reasonable prices with rapid turn-around time. Those not recommended included HIV testing, tests requiring extensive clinical interpretation by specialists, and tumor markers not approved for screening.
In the case of Results Direct, their menu of available tests and pricing includes the following:
|Allergy(Adult Food Profile)||175.00|
|Blood Count (Complete CBC)||20.00|
|Cardiac Lipid/Cholesterol Panel||35.00|
|Cardiac Risk Comprehensive Panel||150.00|
|Health Panel (Men's and Women's)||125.00|
|Hepatitis Profile (A, B and C)||150.00|
|Pregnancy Test (Blood serum)||30.00|
|Urine Drug Screen (Take Home/cocaine or methamphetamines)||30.00|
Direct Access Testing is on the verge of tremendous expansion in providing laboratory services to the patient population. The Results Direct experience offers a template for the industry on how to meet customer needs and ensure that the end product - laboratory testing - is safe, reliable, and confidential.
*States and DAT
States with no limits on DAT:
AK, WA, MT, CO, NM, SD, NB, KS, OK, TX, MN, WI, LA, IN, OH, WV, VA, VT, NH, DE, DC
States with some limits on DAT:
CA, NV, UT, MO, AR, IL, MS, MI, NY, ME, NJ, MD, PR
States prohibiting DAT:
AZ, OR, ID, WY, ND, IA, KY, TN, AL, GA, FL, SC, NC, PA, MA, RI, CT, HI
Source: Centers for Disease Control and Prevention
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. AACC's members are specialists trained in the areas of laboratory testing, including genetic disorders, infectious diseases, tumor markers and DNA. Their primary professional commitment is utilizing tests to detect, treat and monitor disease.
***Editor's Note: To schedule an interview with Dr. Killingsworth, please contact Donna Krupa at 703-527-7357 (direct dial),703-967-2751 (cell) or firstname.lastname@example.org. Or contact the AACC Newsroom at: 215-418-2429 between 8:00 AM and 4:00 PM EST July 20-24, 2003.
AACC NEWSROOM OPENS
SUNDAY, JULY 20, 2003
@ 12:00 NOON
Pennsylvania Convention Center
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