Have you ever been surprised to discover an abnormal test result? Surprised because the result either had not been communicated to you or communicated in an untimely manner?
The Department of Health and Human Services (HHS) has instituted a new federal rule which requires lab results be released directly to patients. This rule supersedes the Health Insurance Portability and Accountability Act (HIPAA) and the Clinical Laboratory Improvement Amendments (CLIA). In the United States, CLIA regulates clinical labs.
Prior to the amendment laws varied per state. Seven states and the District of Columbia required patients to have direct access to their data and lab results. Of the remaining states, 13 prohibited access and the remainder had no policy. The new federal rule will establish consistency throughout the medical community irrespective of where one lives.
Health Privacy Project
It is estimated by the Health Privacy Project that 7-26% of abnormal test results are not communicated to the patient via the doctor. Procedurally the labs will have 30 days to process a request by the patient to obtain lab results. The procedures between the doctors and laboratories will not change.
Proponents of the HHS rule cite transparency and ease of patient access as a result of the rule. Critics of the rule cite concern patients will receive results they may not be prepared to interpret prior to consulting with their doctor. However, critics also agree lab results are usually communicated to the ordering doctor within two to three days and under the new rule clinical labs have 30 days to process a patient request.
The new rule also affects the administration and cost to the clinical laboratories as each must institute administrative procedures to comply with the rule. Whether these costs or how the exact costs would be passed on to the patient is unclear at this juncture. Laboratory results can be ordered by either the patient, patient designee or patients personal representative and can be available in electronic form.
As always, it is best to be your own advocate whether obtaining results from your doctor or through a clinical lab.