Direct Access Laboratory Testing: 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. 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; (b) It must be performed by a laboratory certified by the Clinical Laboratory Improvement Amendments. The results should be provided to the patient, and the laboratory physician should review the results with the patient. The responsibility for subsequent actions are solely that of the patient; (c) Appropriate informed consent should occur prior to testing; (d) Only tests licensed in the United States for diagnostic testing should be performed (e.g., no research tests); and (e) Appropriate reflex/confirmatory testing should be performed. Repeat testing should be done if appropriate, with the patient contacted if additional blood specimens are needed (Amended BOT Rep. 15-A-06; amended CHCQ Rep. 2-A-16).
Last Updated On
October 07, 2016