Patients to Have Right to Access Lab Test Result Data – Finally!

The lab test result data access rule is finally final. See the HHS presser and the final rule, which is scheduled to be published on Thursday.

What does this mean? In a nutshell, patients in all 50 states are now guaranteed the right to access the results of tests conducted by freestanding labs. (The right to test results from labs within hospitals, other health care facilities and physician offices has already been in place under HIPAA, and a handful of states have already guaranteed direct patient access to freestanding lab test results.) The compliance date for the rule is eight months out, in early October, in order to give labs time to put necessary processes into place.

What exact changes were made to the regs? This was a surgical strike. The Clinical Laboratory Improvement Amendments (CLIA) regulations were revised to permit labs to provide results to patients, and the HIPAA regulations were revised to eliminate lab test results from the (very short) list of records not covered by HIPAA’s patient access rule. Thus, if a patient asks, CLIA permits and HIPAA requires that a lab provide the results.

Is this significant? Yes, it is. This is a notable development because it was prompted not by legislation (the usual culprit when it comes to regulatory revisions) but by persistence on the part of patient advocacy groups and evolution in thinking within government. The final regulation has been a long time coming. It was originally published as a proposed rule more than two years ago — see e-patients.net post about the proposed rule. While it has been supported by many interested parties, including the Society for Participatory Medicine, there was significant opposition to the rule from organized medicine on the grounds that unmediated information could be misinterpreted by patients and could otherwise be problematic. The rule was held up in the final stage of review — at OMB, which reviews the projected cost burden of proposed regulations — for five months (that’s at least 2-3 months longer than expected).

Under HIPAA, health care providers have up to 30 days to respond to patient requests for health care records, and freestanding labs will now join imaging centers, physician offices, hospitals, clinics and other providers in complying with this requirement. Labs, like other providers, may charge patients for the cost of providing records. Given the 30-day response period, there should be plenty of time for physicians to contact patients directly about potentially worrisome test results.

Since most, if not all, of the data at issue here will be stored and transmitted electronically, it is possible — and perhaps even likely — that many test results will be transmitted to patients in less than 30 days. Some of the health care organizations that already facilitate delivery of this sort of information do it automatically and electronically.

That’s the vision of the future for the engaged patient: frictionless sharing of information. Coming soon to a lab near you.

David Harlow is a health care lawyer and consultant at The Harlow Group LLC, and chairs the Society for Participatory Medicine’s public policy committee. Check out his home blog, HealthBlawgYou should follow him on Twitter: @healthblawg.

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Posted in: medical records | policy issues | reforming hc | trends & principles

 

 

Comments

9 Responses to “Patients to Have Right to Access Lab Test Result Data – Finally!”

  1. Well done, David! Both the post and your effective advocacy!

    I can’t emphasize enough how important this is, and how harmful the establishment’s resistance has been. Despite physician concerns about whether “patients can handle it,” the unfortunate reality is that physicians pretty much work in a world that lacks reliable processes to guarantee that problems get noticed. A key part of the testimony on this was that patients have DIED when a lab result got misfiled.

    Another key element was testimony that despite those physician concerns, in places where patients have had access, patients have loved it and haven’t freaked out. Over and over, when physicians have said “We need control – patients are weak” they’ve been shown wrong by the evidence.

    Some related items:

    JAMA article, Dec. 2011: Should Patients Get Direct Access to Their Laboratory Test Results? An 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.”

    Nearly One-Third of Physicians Report Missing Electronic Notification of Test Results (from one of the authors of the above, but on a different angle – 29%+ of docs report missing some notifications.)
    “Our data suggest that PCPs using comprehensive EHRs are vulnerable to information overload, which might lead them to miss important information,” the study concludes.

    Physicians Frequently Fail to Inform Patients About Abnormal Test Results – Archives of Internal Medicine, 2009

    I applaud the government people involved in this – the Office for Civil Rights, which administers HIPAA, and ONC, which regulates health data – for this decision, which clearly is totally oriented around the patient’s needs, and totally evidence-based.

    And for those clinicians who resisted it: please, please, look at the evidence and as yourself about the patient harm that’s resulted from undelivered test results. Not to mention that every penny spent on those tests went in the toilet because nobody saw the results.

    The world of healthcare is changing for the better. Thanks to all who’ve done this work.

  2. David Harlow says:

    I cited the 2009 journal article in the S4PM comments and it was cited in the official commentary on the final rule.

  3. bev M.D. says:

    As a former lab director, I think the labs will be happy about this too. Not only was it kind of embarrassing to tell patients they couldn’t have their own information (and engendered ill-will), but, as you mention Dave, it will provide a sort of double check on the well-known problem of doctors missing results. I remember tying ourselves into knots trying to formulate a policy concerning the lab’s responsibility to notify doctors of significant post-discharge lab results (i.e. tests ordered before discharge but the result comes back after discharge.) Just think about the logistics involved – does the lab have to talk to the Dr. directly? What is significant? What to do with the doctor who complains we are bothering him on a weekend? On and on.

    Not that this policy will obviate those necessities – better office processes are still mandatory – but at least it will help. No one cares about YOUR results more than YOU.

  4. Sue Woods says:

    This is excellent, thank you David!
    30 days is too long, and release won’t shorten until it’s required. So ruling is 80% there. Peoples’ 30-day angst will drive down the time delay.

    The JAMA Commentary by Giardina & Singh are basically against test release, because of (1) patient worry, (2) more physician work and (3) lack of evidence. Yet Singh et. al. has done the research to show that test results are missed and patient safety is at risk.
    Really?

    The 2009 study in Archives of Internal Medicine shows that a small but significant number of electronic notifications to physicians about abnormal imaging tests go without review.
    Really?

    Yet the authors comments include no solutions related to sharing information with patients. In fact, they state, “This underscores the need for a multidisciplinary approach involving human-computer interaction and informatics.” [meaning: EHR-doctor solutions]
    Really?

    Link to paper:
    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2919821/

  5. I am thrilled with this, as I have asked for lab and imaging results be sent directly to me for years. Of course, I have always known that the answer for the labs was a big, fat NO, but continued to ask and pester to make a statement. When I was ill, I saw my doctor flipping back and forth 4-5 times looking for data, focusing on one measure only and thereby missing the trends that became apparent to me when I really looked through the labs. This move will empower the patient, and may trigger even more apps and such that teach the patient the impact of the values. Glad that I am considered a grown-up, at last!

  6. Jeff says:

    Although I haven’t had much resistance to my requests for medical records myself, I just want some clarification – if blood test results, for instance, are ready in a few days, both the independent lab or the doc has 30 days to provide a written copy?

    A verbal to me is never enough – have suffered late cancer diagnosis to information missed as well as threatening side effects that were glossed over…

    Thanks for all the good work!

  7. Deb says:

    Please advise what one should do when a doctor’s offices refuses to send test results upon the patient’s request.

  8. Deb says:

    I had an untrasound done on my thyroid at the hospital as prescribed by an ear, nose and throat doctor. I do not care to return to this doctor as he tried to get me to consent to surgery and testing not related to my reason for being there (guess I looked like a cash cow that day). A copy of the ultrasound result was sent to my primary care doctor, but their office refuses to send it to me, saying the doctor that ordered the test has to be the one to provide me with a copy. Is this true, are they allowed to have that policy?

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