Joe Plandowski has emailed me to correct a portion of my blog note of yesterday (see: UC Berkeley "Adjusts" Its Freshman Genetic Testing Program). Here is his comment:
I don't believe [the following] statement [from your note] is totally correct; "He and his other team members appear to have been blissfully unaware of the CLIA regulations whereby only licensed labs can release test results to individuals." As I understand it, there are only a handful of states where individuals can directly order lab tests and receive lab results. In all the rest of the states the tests are ordered by a physician and the results are returned to that physician. Only the ordering physician can release test results to the patient. When I ran labs years ago this was always a problem.Patients would call for results and we could not release them. Patients would argue it was their blood/urine/whatever specimen and they were paying to have the test(s) run so why couldn't they get the results?Also, all labs other than research labs in this country that test patient specimens and release those test results to physicians or patients, where allowed by the state, must be CLIA registered. Last time I looked, there were about 180,000 CLIA registered labs. Of that total, about 110,000 such labs are in physician office practices. Commercial labs occupy about 5,000 of the total and hospitals have about 8,000 of the registered labs. There are more CLIA lab registrations for hospital labs than there are hospitals because some hospitals have multiple registrations (ex - Cleveland Clinic has 4 CLIA registrations).
Joe is correct. I conflated the two separate issues of (1) CLIA certification of labs and (2) the release of test results directly to a patient, the latter being controlled by state regulations. Here is a brief summary of the CLIA regulations (see: Clinical Laboratory Improvement Amendments).
The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). In total, CLIA covers approximately 200,000 laboratory entities. The Division of Laboratory Services, within the Survey and Certification Group, under the Center for Medicaid and State Operations (CMSO) has the responsibility for implementing the CLIA Program.The objective of the CLIA program is to ensure quality laboratory testing.
So, here are the salient take-home points:
- Research labs are not required to be CLIA certified, presumably because they are not pursuing the diagnosis of disease in humans. Some research labs obviously do perform tests on humans, as in the case of drug trials, but these tests are part of a project and the results are not released to the subjects.
- CLIA regulations are quality-driven and apply to those labs performing tests on humans for the diagnosis of disease. Physicians order their tests from such labs.
- As emphasized by Joe above, there are a set of states where individuals can directly order lab tests and receive lab results. California is not one of them. The ASCP has determined that direct-access-testing (DAT) is allowed in some form in 34 states. In all the rest of them, the tests are ordered by a physician and the results are returned to that physician. Only the ordering physician can release test results to the patient.
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