Should Patients Get Direct Access to Their Laboratory Test Results?
Authors: Traber Davis Giardina, Hardeep Singh
Journal: JAMA (2011)

IN THE OUTPATIENT SETTING, BETWEEN 8% AND 26% OF abnormal test results, including those suspicious for malignancy, are not followed up in a timely manner. Despite the use of electronic health records (EHRs) to facilitate communication of test results, follow-up remains a significant safety challenge. In an effort to mitigate delays, some systems have adopted a time-delayed direct notification of test results to patients (ie, releasing them after 3 to 7 days to allow physicians to review them). On September 14, 2011, the Department of Health and Human Services jointly with the Centers for Medicare & Medicaid Services, the Centers for Disease Control and Prevention, and the Office for Civil Rights proposed a rule allowing patients to access test results directly from the laboratory by request (paper or electronic). The proposal will affect 39 states and territories in which either no current laws regulate direct test-result delivery to patients, or the practice is banned outright by state law. The rule ensures that all Clinical Laboratory Improvement Amendments (CLIAs) and CLIA-exempt clinical laboratories abide by Health Insurance Portability and Accountability Act (HIPAA) regulations, thus standardizing patients’ rights to access protected health information. The rule does not specify a waiting period before sending results or specify which types of tests would require physician review first. Although the new rule could be considered a monumental step forward to improve the safety of test-result follow-up, there is lack of consensus in the literature about best practices in direct patient notification of abnormal results. To our knowledge, there is also no empirical evidence as to how physicians in systems that currently perform direct notification have perceived and adapted to this strategy. In this commentary, we consider patient and clinician perspectives on the potential effects of this approach and lay groundwork for issues to consider in the implementation of this proposed rule. Patient Perspectives Patients have expressed interest in being involved in medical decision making and desire access to their health information. Patients want to be notified of their test results, including normal and abnormal results, in less time than current norms. Although prompt direct notification of test results might help patients make decisions about their care, adequate data to support this idea are lacking. To our knowledge, only one US study has evaluated the effectiveness of direct notification (mailing of bone density test results in this case), but the study included a follow-up telephone call by a nurse educator. Patients who received this intervention were more likely to perceive timely reporting than patients who received usual care, but the effect on actual treatment received after 3 months was minimal. Patients prefer direct telephone contact with their physicians for notification of their abnormal test results. However, in the proposed new rule, this patient-centered approach to delivery of abnormal test results is not addressed. More importantly, questions remain as to whether patients will know what’s best to do when they receive the results. Although several Web sites offer explanations of laboratory test results, such results are often interpreted within a patient’s individual context and personalized goals. It is unlikely that patients will receive any coaching or personalized information on interpretation of results directly from the laboratory. The proposal also raises questions about patient responsibility for follow-up. Proponents of this strategy could argue that direct access to test results may empower patients to actively plan follow-up. Currently, however, it is unknown what effect dual patient-clinician notification might have on follow-up rates if physicians more explicitly share the ownership of patients’ test results and shift responsibility for initiating follow-up care to patients. For example, when both the primary care practitioners and the ordering clinician are no-