Direct Access Laboratory Testing

At the request of the board, the Council on Scientific Affairs investigated and developed policy regarding direct access laboratory testing of blood and bodily fluids, with support from the Office of General Counsel to assist the council in addressing liability concerns. In a comprehensive report to the board, the council noted unresolved concerns regarding other aspects of direct access laboratory testing.  To address these concerns, the board then forwarded the issue to the Council on Socioeconomics and the Board of Councilors for additional input.  The report of the two councils and the Board of Councilors was presented to the Board of Trustees in February 2005 and to the House of Delegates in May (BOT Report 11-A-05) with the following recommendations:

That the Texas Medical Association adopt as policy the position statement of the College of American Pathologists on direct access laboratory testing (from the testimony of CAP Secretary-Treasurer Jared N. Schwartz, MD, FCAP, to the Clinical Laboratory Improvement Advisory Committee in Atlanta, March 2003):

Patients are best served when laboratory tests are ordered by qualified physicians, a physician directs the course of a patient's diagnostic and therapeutic care, and a physician determines which clinical and anatomic laboratory services are appropriate. Individual pathologists, pathology groups, or laboratories should decide for themselves whether to accept requests for diagnostic laboratory studies directly from patients and should retain the right to refuse direct access laboratory testing requests. More information about risks and benefits of direct access laboratory testing is needed, such as data on whether direct access laboratory testing improves health and wellness or reduces morbidity or mortality rates. At this time, there is no evidence that demonstrates this benefit. Information on potential ill effects, such as patients lost to follow up for counseling and treatment, also is needed.

That the Texas Medical Association adopt the following additional policy regarding direct access laboratory testing:

To ensure maximum safety and quality, direct access laboratory testing should occur with the following stipulations:

a.   It should be confidential (not anonymous) with contact information provided by the patient. Anonymous testing should occur only with built-in assurances of patient follow up for counseling (e.g., patient must come back in person to claim results).
b.   It must be performed by a laboratory certified by the Clinical Laboratory Improvement Amendments.
c. If results are sent out, they should be provided concomitantly to the patient and the doctor of the patient's choice.  If the patient has no doctor, the laboratory physician should review the results with the patient.
d. Physician interpretation of the laboratory results should occur.
e. Appropriate informed consent should occur prior to testing.
f. Only tests licensed in the United States for diagnostic testing should be performed (e.g., no research tests).
g. Appropriate reflex/confirmatory testing should be performed. Repeat testing should be done if appropriate, with the patient contacted if additional blood specimens are needed.

There was some confusion noted in the floor debate, and BOT Report 11-A-05 was referred back to the Board of Trustees.  Subsequently, Michael E. Speer, MD, represented the board in direct discussions with the delegate who had moved for referral.  The board is pleased to report that issues on which referral was based have been resolved, as the delegate withdrew all objections to the proposed recommendations when Dr. Speer clarified that the board's recommendation is to adopt as policy the position statement of the College of American Pathologists.

Recommendation: Adoption of BOT Report 11-A-05 as originally submitted.

TMA House of Delegates: TexMed 2006