Two years ago, the Department of Health and Human Services released proposed regulations that would allow patients to obtain their clinical lab test results directly from the lab, rather than having to wait to receive the results from their health care provider. CDT and other consumer groups enthusiastically supported this proposed rule at the time of its release.
Yet an Administration largely characterized by increasing patient access to health information seems inexplicably unable to close the deal on this important access initiative. As a result, patients still must wait for their providers to contact them with test results.
Under the current regulations, known as the Clinical Laboratory Improvement Amendments (CLIA), laboratories are restricted from disclosing test results to patients directly. Instead, labs can only send the test results to health care providers, people authorized to receive test results under state law or other labs. Only a handful of states permit labs to send patients test results directly, and some of these states require the provider’s permission before patients can have the results. The HIPAA Privacy Rule reflects this restriction, exempting CLIA-regulated labs (which are the great majority of clinical labs) from patients’ existing right to access their health information.
This existing regime has put patients at risk. A 2009 study published in the Archive of Internal Medicine indicated that providers failed to notify patients (or document notification) of abnormal test results more than 7 percent of the time. The National Coordinator for Health IT recently put the figure at 20 percent. This failure rate is dangerous, as it could lead to more medical errors and missed opportunities for valuable early treatment.
The 2011 proposed regulations would modify CLIA to permit labs to send results directly to patients, and they would also modify the HIPAA Privacy Rule to give patients the right to access or receive their lab results. Contrary state laws would be preempted. Patients would have the ability to request their lab results in a particular form or format, as with their other health information; for example, patients could request a paper copy of their test results, or to have the results sent electronically to the their personal health records
Increasing the ability of patients to have direct access to all their medical information allows patients to more effectively manage their own health care and organize electronic copies of their own data – a major benefit of the health care system’s ongoing transition to digital records. Further, providing patients directly with a copy of their records can cut down on duplicate tests and may reduce the burden on providers to promptly route data to patients themselves. Most broadly, this expanded access gives patients the ability to be as engaged as they choose in their own health and care.
Importantly, although patients would no longer have to go to health care providers to receive their test results, this does not mean providers would be cut out of the conversation. Labs will almost certainly send providers the results as well as patients, so providers can still reach out to patients to explain or provide context to the test results. Further, patients are granted the choice as to whether to involve their providers by getting in touch with them for further information, context or analysis, and CDT is strongly supportive of this and other initiatives that give patients the ability to make their own decisions based on their own information.
We are far from the only ones: a year ago we joined a consensus letter drafted by Ann Waldo on behalf of O’Reilly Media and signed by 638 individuals and organizations[DM1] , all of which strongly support these important patient access provisions and urged HHS to stop delaying the release of a final rule.
The proposed regulations were a logical move for a health care system transitioning to digital records and increasingly focused on patient engagement, and finalizing them is long overdue. Patients deserve to enjoy greater access to and transparency of their records, not to mention they deserve to receive their test results more consistently. And they deserve it now. This delay cannot continue: HHS and OCR must move swiftly to finalize these important regulations.
Alice Leiter serves as policy counsel for the Center for Democracy and Technology. Deven McGraw is the director of the Health Privacy Project at the Center for Democracy & Technology.
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Laurie,
You are being a bad girl!
You should immediately go to your room, look up “ad hominem” argument and not come out until you can use it in a sentence.
Also, no soup for you!
Actually I wasn’t ‘trolling’ old posts… I was attempting to find information re: CLIA. My labs and xrays were done on 6/30/14.
I don’t think you have an office anywhere, nor do I think you are in the medical profession. I am sure you can be found squirming around in the mud under a large flat rock.
Trolling old posts?
Anxiety driven lab testing still burning a hole in your sleep patterns?
Yikes…. Angry doctor here? And you are ordering ‘stupid lab tests’ you say?’ Sounds like you need to get the H out of the medical profession. God help anyone who crosses your office threshold!
No need to do that work- it just became federal law due to the CLIA updates. Labs had 8 months to comply, which I believe puts us about 6 months out.
Times have changed, the release of test results to patients should be mandatory. Lay persons reading about testing anomalies don’t threaten the doctor/patient relationship, they improve it. My doctor just called and shot off a few out of range blood results, lipids, triglycerides, hemoglobin, testosterone. If I had a full copy, I could review them before meeting with him in a week. Using Wikipedia and by having discussions with family regarding similar anomalies in parents and siblings test results (e.g. familiar elevated hemoglobin) , I would be better prepared to discuss any preliminary test results with my doctor. Hoarding a patients test results is contraindicated doctors. According to Quest, California is a state which does not authorize patient release of test results. Here’s my opportunity to request that my States’ Assemblyman and Senator form a bill to change that to be more in line with thoughtful state law. My sole request means nothing though, so everyone reading this will have to do the same thing before any bill would be considered. So, do it now. Write your representative.
While I’m tempted to jump on board and agree that the forthcoming rule should pre-empt state law, I am humble enough to conclude that we should allow the laboratories of democracy (state legislatures) to work this out, no matter how frustrating it is.
If we have a diversity of state law, that means we can research the consequences. Does anyone have any ideas for cross-sectional research, or references to research that has already been done?
Hmm, I actually wrote up lab tests on my blog today, explaining how individuals could save money by going to independent lab companies instead of having hospitals handle the labs: http://theselfpaypatient.com/2013/09/23/hospital-bills-student-2000-for-lab-test-insurer-pays-375/
I’m pretty sure a few of the labs said they’d send the results directly to the patient. I’m wondering if that’s permitted because they’re the ones paying for it? First Choice Labs USA, to cite one of the companies I mention, says they’ll mail results to the patient and fax the physician: http://firstchoicelabsusa.com/
We began this process back in 2009 with a consensus letter outlining the steps we felt would be necessary to finally provide access to lab test results. It is thrilling to see that this might now happen.
Here is the original post:
http://goo.gl/TQAtpp
As a pathologist, I have no problem with releasing lab results directly to patients…for clinical pathology tests (chemistry, hematology, coag, etc) only.
I do not believe anatomic pathology results should be released to patients directly, as it could be potentially disastrous for a patient to receive a diagnosis of cancer without the benefit of having an immediate face-to-face conversation with his/her physician about the prognosis and next steps in their care.
Love it, two thumbs way up. As well as Adrian’s suggestions below.
legacyflyer – $300 /hr is reasonable for an informed and unbiased opinion from a licensed professional. I will easily save $75 and more on the imaging facility and EHR/PHR charges if I’m able to shop around for that service. Your independence has great value to me.
As far as the schedule, I expect different specialists will make various choices. Some will ask for a monthly retainer in return for giving me their cell phone. Others will simply look for patients from the web and post their availability on-line. All of these models are already operating to some extent.
What I particularly like about this scenario is that the physician will be working directly for me, that your specific reputation will be out on the ‘net as a result of various ratings and that your prices and terms will be posted as well.
Adrian,
In the first place, I will discuss your XRay/Imaging results with you – including comparison to priors. Obviously, I will not discuss lab results with you.
I earn $300 per hours as a (defense) expert witness so i guess that is my “fair market value”. Therefore my fee would be $5.00 per minute, $25 per 5 minutes and $75 per 15 minitues. Take as long as you like since the clock is running – just like your lawyer and accountant.
You can call up our office to schedule a time to talk to me – either in person or over the phone – just like my lawyer and accountant.
You are NOT free to call me on weekends or in the evenings – even though I work a fair number of them – just like my lawyer and accountant.
Have a nice day!
Absolutely would make me happy- I’m not asking for free services! Like Adrian also be happy to pay a reasonable amount for access to a quality patient portal that displays my results and offers these digital communication tools. Actually already do as I’m a patient of One Medical, though their portal leaves a huge amount to be desired. Ie I can only see my self entered history.
@legacyflier You’re On! How much do I have to pay you, per 15minutes, for you to have access to all of my health records via my state HIE and to give me your cell phone or a timely response the way my accountant and lawyer do?
I fully support the right of patients to receive their test results.
However, I will decline to explain what these reports mean without some system for compensation.
So now, you can find out that your cholesterol is elevated and you have coronary artery calcification, but you need to wait until your appointment to discuss what this means.
I have no problem with this. Will “Mad as Hell patient” like it?
Good news! The rule providing patients with direct access to lab data has officially advanced in the regulatory process – now at OMB (usually the last step before release) http://www.reginfo.gov/public/do/eoDetails?rrid=123422.
They don’t.
I don’t disagree with your points at all, but these are all solvable problems. And not all that need to be solved by you- if HHS really does care about patient access and “engagement”, then their should be a reimbursement code for educating/interpreting directly to patients.
If you are transparent about how you approach the roles in a doctor-patient relationship and run your practice then I entirely agree that it is on me to find a different provider if I take issue with it The trouble is that none of this is transparent until after I’ve experienced all of the so called “whiny” issues that have absolutely delayed my care or caused repeat lab tests and an expensive imaging study.
I do now make healthcare decisions based in part upon access to my electronic data including lab results. Thankfully I live in a part of the country where I have this choice, there are two healthcare systems in my city that offer it.
Bingo
Catchy name.
If you are paying me to be your doctor then you picked me. That usually is because you want or need something from me as your doctor.
If that is not the case then we have no relationship and the rest of your whining post is of no concern of mine. And if you are looking to be a “customer” instead of a “patient” then you will be unhappy with any physician sooner or later.
As your doctor I will tell you what I think about the matter of concern.
I am in a practice (like most) that sends X Ray reports to the ordering physician. We will, at the patients request, provide the patient with copies of films/images and reports but this is not routine.
Unlike many of my fellow Radiologists, I actually like talking to patients. I am the one that the nurses will “grab” to talk to a patient about contrast reactions or other issues.
During a typical day, I read in excess of 100 cases. I don’t have the time to talk to more than a few of these patients. And there is no mechanism to charge for this time. If we started giving the reports directly to the patients we could be inundated with calls and questions that we wouldn’t have time to deal with.
For some reason I can’t reply to MGs comment directly, but regardless:
if you think my points were unrelated its because you didn’t understand them. I will try again.
1. The disruption point was that the argument for those industries was the same as the one you are making for lab results- the task at hand is too complicated for the lay person. The point is that the products themselves changed to allow for the lay person to participate, and that we didn’t entirely understand the full spectrum of “problems’ the lay person was trying to solve. I don’t think you understand the “task at hand” given you completely ignored my argument that we want to do more with this data than self interpret. We want second opinions when we can’t get into your office for another month, we need it for a referral because you never got around to sending it before an appointment, we need it to catch mistakes like the earlier commentor did when her husband’s liver enzymes skyrocketed. And we want to self interpret when results are obvious.
2. Point is that the current evidence you point to is bad to the extent that it was gathered in an information and power asymmetric system. We pay lip service to patient centeredness and engagement, if you look at the way the typical hospital or clinic is run its still about the provider. The Open Notes study is the only one I am aware of that was a truly meaningful intervention because it put actual power in the patient’s hands. And the outcomes were very significant.
3, Dr. Google is an example everyone uses of why self interpretation is dangerous and bad. My argument is that it has overall been good, and raised literacy and engagement more than any superficial hospital patient engagement plan. Ie related to both 1 and 2, its a classic example of disruption, and given its in the top 3 most common uses of the Internet, I’d argue pretty great evidence that people want to be engaged in their health and health care.
4. This point is in summary of all of the above- we need to design for the end user being a consumer for a different problem than the current lab results try to solve for providers before we start claiming engagement has failed.
I don’t disagree with the rest of your assessments that we haven’t seen major successes in this area, and I think there is absolutely a need to design for human behavior when it comes to inelastic price demand and the healthcare corollary to 401Ks; individuals investing in insurance, prevention, and chronic disease management.
Are you worried because you are a radiologist that typically does not do this type of interpretation direct to patients? I’m not sure that would change just because somebody is able to access their imaging result, the portal they use to access the results could make it very clear who they should contact with questions, ie the ordering provider. I also know a few radiologists who would be pretty happy it if changed….
That said, aren’t these precisely the sort of questions we would WANT engaged patients to ask to buy into and adhere to any treatment plan, especially that last CAD example??
I think all patients should have access to their lab reports, X-Ray reports (I am a Radiologist), etc.
However, I am not looking forward to answering a whole bunch of patient’s questions like:
– What is a granuloma?
– Isn’t diverticulosis the same as diverticulitis?
– You say I have coronary artery calcification – am I going to have a heart attack?
Particularly because these would all be “freebies”
I suspect many other doctors feel the same way.
I guess the answer is yes. We try very hard to write the office visit note and document the encounter with the patient, in a way in which it is open, educational and has personal value to them. I have always in my 25+ years in medicine tried very hard to be a medical home and family for patients.
I know you all feel better now.
My pleasure.
You are throwing in all kinds of different topics including ones that have little to nothing to do with one another.
Disruptions to driving a car and typing on a keyboard were improved through mechanical modifications which improved efficiency, ease, and simplicity to the user. Quite a different task than something that what is being discussed here.
I admire your optimism and maybe if the healthcare payment system was set up differently then there would be an opportunity here both to really improve patient engagement/activation & an opportunity for outside companies to really jump here.
I just look at what has happened with 401ks and what an abject policy failure they have been. In fact, the pendulum has swung back the other way for companies to take a more active role including auto enrollment in a 401k upon employment, annual bump up in the savings rate, etc.
As for the patient engagment/activation market on the whole, it still pretty lukewarm at best from an opportunity and investment standpoint. It is almost exactly where it was 4-5 years ago with the only difference being now that Stage 2/3 MU requirements and increasing thresholds are forcing the hands of hospitals and payers/self-funded employers are increasingly desperate to pay more than lip-service to the growing number of people enrolled in CDHP plans and new enrollees who will come in via the exchanges.
You do realize this argument has been made about every single industry before it was massively disrupted? Driving ones own car was considered too complicated. It was once laughable to imagine people doing their own “typesetting”.
I think we have no idea what the true potential of medical/health literacy and patient engagement could be in this country because the entire system has been set up so any care and any information is administered by the “professionals”. Do you know what my “patient engagement” training was in medical school? A bunch of one liners I could say to patients to make them feel heard and understood. Note- not training around how to ACTUALLY hear and understand them, how to trick them into feeling that way “wasting” as little encounter time as possible. And this was at a medical school that receives national awards for including this in the curriculum.
Everyone likes to hate on Dr. Google. But I bet its done FAR more good than harm educating people and bringing up the state of health literacy around the world, despite a great deal of the information out there being crap.
Give the average person a typical lab result printout or provider note, and of course its going to be unintelligible. They were designed for people with years of training. Do you really think thats what any consumer friendly company would design if the goal was to increase patient understanding and engagement?
As I said to MD as Hell, refer to the Open Notes study.
Truly appreciate this article, but there is no haze to the beaurocracy in this case. There are only state and national medical societies that are working harder to be at the table when regulations are made than all of you. Behind every stupid thing that comes out of government (or in this case, good thing that’s not getting out), there is a powerful group of stupid or self serving people outside of government pushing it to happen. And in this case its even worse because there is always the shroud of patient protection to wrap the arguments in. Whenever I hear somebody use that line to argue for restricting patient access to data, I wonder who will finally have the guts to point out the emperor is wearing no clothes.
Sometimes I wonder if the medical profession will completely destroy itself before people like Leslie and Alan have a chance to build it back up again. Losing the confidence of the public is a dangerous thing for a profession.
Go look at the studies on medical literacy and or financial literacy. Didn’t say that this data shouldn’t be available to those that want it as soon as their physician gets it but the impact to common lay people is vastly overrated as is patient activation/engagement.
I’d say its highly dependent on the person and the lab ordered. Lets please stop pretending that because many things in medicine are too complicated for even the well informed lay person, all things are.
Per my comment above, there are many other reasons to want access to lab data quickly that have nothing to do with self interpretation.
MD as HELL- thanks but we are perfectly capable of defining what our “job” is in taking care of our ill loved ones or ourselves. I’m pretty sure that we have the bigger reason to get it right.
YOU are the one with a job- last time I checked I’m not paid to be a patient, I pay YOU to be my doctor. Healthcare and the “profession” that owns it has gotten this so backwards compared to every other industry in the world.
There are also many other reasons to need access to a lab test or other study result that have nothing to do with interpreting it myself. Maybe I’m tired of waiting weeks for an appointment only to have it be entirely wasted because the results didn’t reach my provider or the one that i was referred to, and I had no way of knowing. Maybe I want a second opinion (or a FIRST opinion) when I can’t get into your office for over a month. Maybe your office forgets to call me with the results yet again, I personally despise the “no news is good news” practice since a good portion of the time there is actually something wrong but the office just doesn’t call.
Please read the Open Notes study and educate yourself.
I am glad that you have 31 years of vast ED experience. I hope and pray that I never grace your ED. As a nurse with experience of 30 years in patient safety as well as the spouse of that guy dying who has won the John Eisenberg Lifetime Achievement Award in Patient Safety it truly saddens me you attitude that you are better than your patients. Some day, you will realize that you really are no better, and in fact some of your patients know quite a bit more. My job is to make sure my husband gets the best care possible out there. And if that means knowing his lab values before they are released than that is what I will do. Perhaps it would have helped when one of his physicians forgot to look and one of his liver functions was more than 10x the normal value. Did that do my any good. It sure as hell did. It alerted us to the fact that there was a new drug drug interaction. See, believe it or not nurses can figure that out. As for being happier than my grandparents, I am much happier, they were concentration camp survivers. I think its time you hang up your shingle. As a very good friend has said relating to pateint safety although a cynical mantra, his hope for the future is to ” teach the young, regulate the old and hope everyone else retires or dies off”. Right now I have more important things to do, as I suppose you do. After all, there are patients waiting who need to look up to you because without you they would be lost.
Thanks for the great article, Alice and Deven! Any thoughts on why it’s taking so long for this rule to be implemented?
What, if any, is the case to be made against it?
I am sorry for your husbands situation. The truth is, you knowing the labs does not help one bit. It is not your job to know ahead. It does your husband no good. It actually does you no good. If you think it does, then I believe you are focusing on the wrong role for you in his illness.
That last sentence in your post is a little unnecessary. I am a 31 year ER doc. No disgrace am I . I sanctimoniously think I have a larger view of this issue.
The frenetic pursuit of what masquerades as “healthcare” is folly for the vast majority of people. They have been stampeded by fear into a system of perpetual anxiety.
Take a breath! You are not happier than your grandparents. Why not?
Patients should get access to the lab results if they desire but how many of them would know how to put them in any kind of context if just supplied a number, basic ‘normal’ range, and a descriptive criteria like ‘Normal’ or ‘Abnormal/Out of range’
20%-30%?
Lab on a chip and its iPhone app. The day draws nigh when I can pee in a cup in my bathroom and prick my finger for a drop or two of blood and hit those samples against some inexpensive probes to immediately get the full panel UA and hematological results that now are intermediated through an ordering physician and lab vendor. No one seriously proposes I need to go to the doctor to get my pulse, BP, height, and weight checked, notwithstanding that I might need MD as Hell to correctly interpret and Bless my BMI and BP.
Thanks to all for weighing in, and thanks in particular to the medical professionals who weighed in in support of this provision. The proposed rule included the access provisions patients deserve – but two years later, the rule still hasn’t been released by the Administration. We wrote this post to try to pry it out of the bureaucratic haze. It’s the right thing to do!
This thread is a microcosm of our health IT confusion in the US. There are so many commercial parties and perspectives behind the scenes. Transparency,, as usual, is in short supply.
e-patient Dave gets it. Is my doctor working for me or part of some inscrutable provider institution? Is the lab just a contractor to that provider, like a transcription service in the old days, or does the lab have a responsibility directly to the patient?
I agree with Deven and signed Ann Waldo’s letter for a very simple reason: all information about me needs to be accessible to me so that I can have a choice of medical advisors. I have a right to advice independent of the particular commercial interests of the “provider” that ordered a sampling of my blood. The test result can be accessible immediately from the provider’s EHR via Blue Button Plus or directly from the lab’s system via Blue Button Plus.
There are reasonable arguments to be made either way. Privacy is protected when only the site that took or ordered the sample knows who I am but was the sample taken by the lab or the provider? There’s a lot of commercial interest in control of the provider-lab-patient relationship.
I could go on and decompose the commercial interests in ordering the tests, the importance of screening tests as providers compete to do them and provide the follow-up, the changes as we go from fee-for-service to value based insurance payments, the lack of price transparency to both doctors and patients when tests are ordered…
But I’ll stop here and offer a simple principle: it’s my body, my blood sample and everything about it is mine first and foremost. Your IT limitations and commercial complexities have no standing.
Resistance to this has come largely from the medical community, who worry that patients won’t be able to interpret the results, and may be unnecessarily alarmed, or who don’t want patients calling them about results at times when they are not free to discuss the result further. Frankly, I read a survey once that indicated most patients would prefer to get results from their physicians (can’t seem to remember where I saw that) – and nothing in the proposed rule would change the ability of patients to continue to get lab results from the professionals who have ordered the tests. But for patients who don’t want to wait for a medical professional to have time to communicate the result, or who prefer to take a more active role in their care, or for any other reason – the proposed rule gives them options. I agree – why should anyone be against that?
So does MD as hell wait until he has heard from his physician to review his results. That is the most ridiculous statement I have ever heard. It is obvious from a very insecure, non patient centered physician without an ounce of compassion. Has he heard the term “shared decision”? Is he still assuming that the letter MD stand for major deity? As an RN for 30 years and the wife of a stage IV metastatic prostate cancer patient who is in the end of his life that is frankly insulting. I cannot use the results to prescribe treatment, however I can use them to understand where we are in the process until we see the physician next week, next month or are able to speak to them. Is MD as hell available within 2 hours for every patient when the results are available? What a disgrace to the medical profession.
Alice and Deven,
Who has resisted changing this?
MD Like a Stump,
Do you really have nothing better to do with your time?
Who said anything about free?
MD as HELL,
First, it’s fine with me if you want to be a “nothing about me without you” practice. As long as you make that clear, I have no problem with that.
Second, why would you not want me to see the results first? Is it a billing issue? Presuming we have a good partnership doc-pt relationship, I’d still turn to you for interpretation. What’s the problem with me seeing the numbers before then?
Whaaaaaa.a.a.aa.a.a.a.aaaaa….Sounds like you just want free healthcare.Sounds like you just want free healthcare.Sounds like you just want free healthcare.Sounds like you just want free healthcare.Sounds like you just want free healthcare.Sounds like you just want free healthcare.Sounds like you just want free healthcare…. Waaaaaaa.a.a.a…..
Alan you are consistently ahead of other providers in your openness in sharing information with patients. I wish I lived near you so I could be under your care.
CLIA actually does specify that labs must release results directly to patients, except that it leaves individual states the rights to override it. Most leave it up to the provider, and most providers don’t even know how to make it accessible to patients since its not an obvious box or anything you can tick on a lab ordering form. Which is bizarre to me given how much Quest has put into consumer technologies like the Gazelle app which is meant to provide results direct to consumer.
I would be HAPPY to order my own lab tests if the law would let me!! Oh, what professional societies consistently oppose direct to consumer lab testing?
Or perhaps if I didn’t have to wait weeks to months to receive anxiety provoking results, or was never contacted at all despite many calls to your office, we would all feel less angst about hearing the results from providers.
And who said we don’t want to pay for the tests or your services in ordering them and explaining the results?
Such a simple solution. Have done this for two decades. Just put on the requisition form to the lab: copy labs to patient
The labs are then required by law to do that.
CLIA by the way has nothing to do with release of labs to patients.
In fact if anything having the patient aware of their labs will increase your role as the subject matter expert and eliminate your role as a transcriptionist but it can be hard when the power shifts and roles change
. I don’t know a single doctor where I work (large teaching hospital) who doesn’t want their patients to be as involved as possible in their care (oncology unit) and we have noticed that patients who can see their own lab results are much more engaged in their treatment. The open notes project last year really proved this (even with a homeless population).
The best workflow is to have the provider see them first and release them to patients as quickly as possible but for most labs there really isn’t any reason for the doctor to control the flow..
As to providing the “meaning” to a number – I would challenge you on that.. it is very easy to write an algorithm that would alert patients of when they need further advice from you. (IE an 80 y/o kidney function test results might be a crisis level for a 20 y/o)
I am not ordering your stupid lab tests if I do not provide the meaning, in my opinion. of the results. It was my opinion that decided to order them. It was your opinion to come see me.
Sounds like you just want free healthcare.
Go order yuour own tests.
So glad to see the authors raising this important issue. Couldn’t agree more; the rules on lab results are a serious hindrance to patients taking a more active role in coordinating their care.
Hope HHS takes action soon. Thanks for this post!