AACC: Better Quality and Patient-Friendliness Needed in Direct Testing

Noting the paradigm shift among consumers seeking greater control over their own healthcare, AACC has issued a position statement that emphasizes DTC test results must be accurate and easily understood—an area where laboratory medicine professionals play a vital role.

State laws have limited to physicians the ordering of lab tests, but as people have become more engaged in managing their own healthcare, this model has begun to change. Currently, 37 states and the District of Columbia permit consumers to order some or all of their laboratory tests without involvement of a physician. Individuals can also buy over-the-counter test kits or get laboratory services from non-traditional settings such as retail centers. These DTC lab tests can provide invaluable information to individuals about their health status in a timely and convenient manner. However, many healthcare providers and policymakers are concerned that some of these tests may be of questionable quality and value, or that consumers might not have enough background knowledge to make sound decisions based on their test results.

To enhance patient benefit, AACC urges the Centers for Medicare and Medicaid Services and the US Food and Drug Administration (FDA) to require that DTC testing providers disclose sufficient information about their products and services, enabling consumers to make well-informed decisions. These providers should provide: user-friendly descriptions of risks, benefits, and limitations of all tests offered; clear and understandable reports of test results, with enough information to assist in decision-making; prominent instructions to contact a qualified healthcare provider with any questions or concerns; and a comprehensive, public listing of tests offered and prices charged.

Laboratory medicine professionals are integral to this consumer-driven process. AACC encourages lab professionals to collaborate with federal agencies to inform the public about the costs, benefits, interpretation, and limitations of DTC tests. Likewise, consumers should consult qualified professionals in making decisions about their healthcare.

“DTC laboratory testing is a key element of ongoing efforts to empower people in decisions affecting their healthcare,” said AACC CEO Janet B. Kreizman, “AACC supports expanding consumer access to high-quality DTC testing services, and urges policymakers to ensure that these services have demonstrated clinical validity and utility and make a positive impact on patient outcomes.”

Related Links:
American Association for Clinical Chemistry (AACC)
AACC position statement on direct-to-consumer testing