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Should Patients Be Able to Get Lab Results Electronically?

October 26, 2009
by David Raths
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The Oct. 20 meeting of ONC's Health IT Policy Committee Information Exchange Workgroup was able to shine a light on some barriers to the electronic exchange of laboratory data, and emphasize the issue's significance. For one, the current practice of writing and testing interfaces between labs and EHRs is time-consuming and expensive. CLIA (Clinical Laboratory Improvement Amendments) regulations require the labs to verify that each individual EHR implementation is configured correctly to exchange data. One speaker noted that for clinics adopting EHRs in her health system, implementing, testing and validating a lab interface takes from 10 to 14 weeks. Some speakers recommended that the EHR certification process require that systems use national lab standards and display lab results in a CLIA-compliant way. Others called for decreasing constraints on the labs and putting that onus on the EHR vendors.

The meeting also provided a venue for a consumer-focused organization to raise the issue of patient access to lab data. These activists see patient access to lab data as crucial to consumers being better able to manage their own health information in personal health records. The group is calling attention to federal regulations under the HIPAA Privacy Rule that treat test results differently from other protected health information. also notes that CMS regulations state that results can only be delivered to "authorized persons," which does not include the patient. The group proposes that the federal government treat the lab test data under HIPAA like all other data, and that the term "authorized person" should explicitly include the patient.

While the group notes that some state laws may restrict access to test results, removing federal barriers could have benefits. It claims that approximately 7 percent of lab results are never reported to the patient and that approximately 14 percent of labs and other tests are repeated because earlier results aren't available.

Some clinicians may balk at the idea of patients getting lab results directly. They have legitimate worries about patients freaking out after receiving abnormal test results directly from a lab without interpretation by a physician. But notes that under the HIPAA Privacy Rule, covered entities/providers generally have up to 30 days to respond to an individual's request for their information.

With so many other certification and standardization issues to grapple with, this may end up being a low priority for the feds. But with the definition of meaningful use likely to include gradually increasing patient access to their own health records, this may be a proposal that regulators take seriously.



Thanks to Dr. Feldbaum for his take on what is indeed a thorny issue. I have had the experience of dermatologists running tests and implying that if I never heard from them again, I should just assume everything is OK. That seems like a setup for a systemic failure to me. Patients should hear one way or the other the results of a lab test. The question remains, how to provide the context they need to understand the lab results if patients are going to get electronic copies.

Pete, here's the rub. Yes, you have directly or indirectly paid for the test (to the lab). Yes, you have every right to it in any format. My question is: have you paid for your primary care doc to educate you about interpreting tests? I used to say that it costs me $25 out of my pocket to order an XRAY. The lab would bill and get paid. The radiologist would bill and get paid. Still, the patient called me to discuss the results (free). Primary care docs want the responsibility of being your "medical home", but the insanity of our reimbursement system penalizes them too greatly. My group has tried for four years to hire a new primary care doctor (internist or family practice), but there are none available. There needs to be a new balance between patient rights and the ability of caring docs to meet them.

This is a very thorny question. Most patients are insufficiently trained to interpret lab results. I used to warn patients that to have all "normal" labs is statistically more "abnormal" than having a few out of range. With the internet readily available information to guide patients could be available (we could provide links with the results), but they will still lack context. Without a doubt, giving patients their lab data before the doctor has an opportunity to evaluate them and inform the patient will generate a massive number of phone calls or emails adding to the already overworked and underpaid plight of the primary care doc.
The flip side of the equation, however, needs attention. We miss labs. Sometimes they never arrive and sometimes they are misplaced. Sometimes we are unable to contact the patient immediately and often we just screw up. I told each and every patient who went for a test "No news is not good news. We will call you with your results normal or abnormal. If you don't hear from us in a week it is your responsibility to call." I dictated the statement and followed it by "this was dictated in front of the patient." It was my failsafe, but equally important was that it enlisted the patient in his/her care. This was an adequate solution at a time when there were few better choices. If the EMR/PHR is properly implemented patients properly educated monetary recognition is made for the primary doctor who fields inquiries and sensible legislation can be put in place I would be all for it.

So I'll be the guy jumping up and down and saying that Patients should be able to get them in any format, paper or electronic. They are consumers. As such they are either paying for the test or paying for the insurance which covers the test.
Its more of an issue about the relationship I have with my physician. When I get my results, I have time to read it, and form whatever question(s) I may have prior to the visit. It helps me manage my care better by understanding what is going on and making educated decisions about my care.
The days of blind trust or "you know best" are gone. I want to know, because I am paying for it, its my body and ultimately its my treatment option decisions.