Should Patients Get Direct Access to Their Laboratory Test Results?: Title and subTitle BreakAn Answer With Many Questions

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.^{1 - 2} 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).^{3 - 4}

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 Rights⁵ 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.

Patients have expressed interest in being involved in medical decision making and desire access to their health information.⁶ Patients want to be notified of their test results, including normal and abnormal results,^{6 - 7} in less time than current norms. Quiz Ref IDAlthough 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.⁸

Patients prefer direct telephone contact with their physicians for notification of their abnormal test results.^{6 - 7} 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.

Quiz Ref IDThe 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 notified of an abnormal test result, follow-up is worse because of the lack of clarity of who is responsible for follow-up.²

The proposal suggests that direct patient access to laboratory test results will decrease physician workload, reduce the number of patients not receiving notification of test results, and reduce the risk of loss of follow-up.⁵ Although clear evidence to support these claims is lacking, the idea of direct notification as a backup system is intuitively appealing. Quiz Ref IDUnencumbered access to health information may lead to better informed and engaged patients, who could then partner with their physicians to achieve true patient-centered care and better outcomes. However, in the absence of a time embargo, physicians are likely to be less enthusiastic about this approach for several reasons.

The proposal does not offer guidance to laboratories on releasing highly sensitive results such as human immunodeficiency virus, abnormal pathology, and genetic testing or provide physicians the opportunity to receive the result before the patient. In these scenarios, perhaps the best practice is face-to-face communication with the physician. Quiz Ref IDPhysicians have expressed concern that notification of test results outside of a patient-physician encounter would lack the level of explanation that a physician could provide⁹ and could engender unnecessary anxiety or confusion, especially if the results are difficult to interpret. Hypothetically, transmitting certain abnormal test results without context may place patients at risk for psychological harm. Special concerns remain for patients with cognitive limitations or mental health conditions.

It is also likely that many patients will contact their physicians between scheduled face-to-face encounters to help them interpret test results. This communication is of clear benefit if the physician has not yet contacted the patient regarding a clinically abnormal finding. Nevertheless, how patients would respond to abnormalities that are not clinically significant and what effect this will have on increased physician workload and potential for reimbursement remain to be seen.

The proposal also produces a new standard in patient-centered care that raises questions of authority and responsibility in the patient-physician encounter. Quiz Ref IDDirect patient access to test results challenges the traditional physician role as information gatekeeper and requires role adjustments and behavior changes by physicians and patients alike. Some physicians might be hesitant to encourage more egalitarian relationships with patients (including shared access to health information) for fear of identity loss. Because physicians' beliefs may influence their patients' adoption of new communication tools, understanding and addressing physician perspectives in this initiative is essential.

The proposed rule is consistent with the Health Information Technology for Economic and Clinical Health Act (HITECH), which prioritizes patients' rights to access health information stored in EHRs. The current policy of allowing state laws to limit patient access to test results could deter patient engagement, thereby contradicting the intention of transparency in health care reform. However, offering patients direct and potentially immediate access to laboratory results has potential consequences that must be addressed. Without involvement of physicians, delivery of abnormal test results will be a major concern. For example, patients having access to abnormal test results before physicians have had the opportunity to interpret and counsel patients may create unnecessary anxiety. Although direct patient notification of certain test results has been implemented in a small number of US health systems,^{3 - 4} there is limited evidence that it leads to better follow-up.^{8 ,10} How potentially immediate direct access to laboratory results will affect the workload and workflow of the currently overwhelmed health system and physicians is even less clear. To develop best practices in this area, the potential consequences and benefits of this approach should be subjected to rigorous evaluation.