Focus On: Patient Access to Lab Test Results: Labs Have Flexibility in Developing Policies Under New Access Rule
Clinical and anatomic pathology laboratories have flexibility as to how to set up policies and procedures to respond to patient requests under a new rule requiring labs to provide patients with access to their completed test reports, say industry experts. In a March 25, 2014, webinar co-sponsored by G2 Intelligence and the American Clinical Laboratory Association (ACLA), a key staff person from the Centers for Medicare and Medicaid Services (CMS) and the legal counsel to ACLA addressed key issues raised by the new rule. The new rule becomes effective April 7, though laboratories will not be required to comply until Oct. 6, 2014. As of April 7, a lab subject to the Clinical Laboratory Improvement Amendments may provide patients with a copy of a completed test report. As of Oct. 6, a lab that is subject to the rule must do so. The rule applies to laboratories that are considered “covered entities” under the Health Insurance Portability and Accountability Act (HIPAA)—in other words, any labs that performed covered electronic transactions, such as transmitting health care claims to a health plan, according to Karen Dyer, MT(ASCP), deputy director of the Division of Laboratory Services at CMS. The rule is expected to […]
- Since patients have access to test results without the benefit of provider interpretation, there is a potential for them to panic and act upon results that appear to be abnormal. Dyer notes labs will not be required to interpret test results for patients and should continue to refer patients back to the referring physician for interpretation. Peter Kazon, Esq., senior counsel with Alston & Bird, suggests that labs have a policy that results not be released to the patient any sooner than 48 hours after they have been sent to the physician. This gives the physician a chance to address any potential concerns about abnormal results before the patient receives the results.
- Reference laboratories do not have contact with the patient, and many feel this rule should not apply to them. According to Dyer, reference labs that are covered entities under HIPAA will be require to provide access to completed test reports.
- Labs have 30 days to respond to a request, but in some cases, it may not be possible to meet that time frame (i.e., testing takes longer or labs have to retrieve archived records). Dyer notes that labs may request, in writing, a one-time 30-day extension and the request must provide the patient with a reason for the delay. In rare cases when tests will not be completed and available within the time frame and the individual still wants the report, the lab must provide access to the existing information in its designated record set at the time, minus the test report requested. Test reports are not considered part of the designated record set until they are complete.
- Under HIPAA, individuals have a broad right of access to any or all of their information contained in a designated record set with a very limited exception. There is an exception if a licensed health care professional has determined, based on professional judgment, that the access requested is reasonably likely to endanger the life or physical safety of the individual or another person.
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