patient access to laboratory results

What is the Patient’s Right With Respect to Laboratory Testing Orders?

I was recently in Arizona for a meeting and being there made me think of an email that I had received the day before I flew out. Apparently, the Arizona House of Representatives recently passed legislation (HB 2645) allowing direct lab test ordering by patients without a physician’s request or written authorization. This bill would still need to be signed into law to go into effect but I was still surprised to read about this bill.

Interested parties worked together to have the original bill amended with the stipulation that the laboratory would have the authority to decide which tests (or none) that patients may order. In some states, such a law I believe already exists (but don’t quote me on that…I tried finding confirming this but was not successful). But this begs the question, who takes responsibility for the test results? Currently, the Arizona bill states that test results would go to the person who provided the sample if a physician did not order the test. It would be their responsibility to consult with a physician for test result interpretation and required care and no physician would be liable for not acting on the test results if s/he did not order them.

So what is your opinion on patients self-ordering lab tests for themselves? Would this lead to patients second guessing their physicians if they want a lab test based on information that they personally gathered but that their physician disagrees with? Or would this make it easier for both the patient and physician in cases of routine testing? Are there implications that we have not thought of?

As an AP/CP resident, I’m not quite sure where I fall on this issue. Sure, having been “raised” in a training environment where vestiges of a previously patriarchal ethos and bias remain, it is difficult to imagine patients, and not physicians, choosing what tests to order. After all, hopefully, four years of medical school and multiple years of residency and eventual fellowship, should help inform these decisions more than internet searches and anecdotal stories can. But I have always been a patient advocate first. And I am always willing to take a step back to think about questions from the patient’s point of view and try to set aside my own biases, if doing so will improve patient care and safety.

But as with every human being, I’m cognizant that I do have biases. And as a resident who has had to navigate what we know as CP call, I understand that physicians, too, often have difficulty knowing what tests to order and what they should be looking for in a “good test” to provide them with the appropriate answers that they and their patients seek. I’m sure we’ve all dealt getting pages where we had to shut down what I like to refer to as “shotgun” ordering – multiple tests that are ordered hoping to find an answer in those cases where there is no differential or a very exhaustive one. Especially since without a targeted differential, test results may be difficult to interpret. Additionally, I’ve often seen other issues such as duplicate orders when a panel along with specific additional tests that are (unknowingly) included in the panel are ordered or the wrong test(s) ordered altogether. So it does pay to have another set of informed eyes look over test orders.

As a pathology resident, and even one with extensive lab and research experience prior to medical school, I can admit that I learn more and more each time I’m on a CP rotation about how to gauge the analytic and clinical validity of specific lab tests. Just because a test exists, doesn’t always mean that we should use it or always order it for every patient. This is the role I feel that we fill for referring physicians and patients. We develop and make sure tests are conducted properly, safely, and efficaciously. We also serve as a resource with knowledge on which tests, specimen sources and other analytic parameters, and patient populations are appropriate. We can also identify and troubleshoot when false positives or negatives are suspected as well as provide an interpretation of the test results within the context of clinical patient history that we can access through the EMR. But that is within the confines of the walls of the medical culture and environment, which I admit is not perfect and has areas that we can still work on to improve.

But when it comes to patients ordering tests outside the purview of direct medical care, I’m not sure what my stance is. In this country, patient autonomy is king. As physicians, we don’t always have to agree with our patient’s decisions, but we do need to respect them. We cannot arbitrarily subjugate patients to the dictatorship of a patriarchal perspective (at least not in this modern day), even within a patient care setting. So, at least in my mind, a grey zone exists in the context of a patient who is willing to pay or who can get his/her insurance to pay (although that is entirely another issue) for a specific test not ordered by their physician. But I do worry that this could set up complications for evidence-based patient care. There are multiple levels of implications that I’m sure we have not even thought of – not only for the physician who has to decide what to do when their patient brings in results from a test that they personally ordered without physician authorization but also for the patient to not feel as if they are falling through the cracks of our healthcare system if physicians decide to not act on these test results. I can imagine that there are medicolegal issues that are significant as well but I humbly admit that these are definitely beyond my expertise to comment on at this time. However, I do know that I believe that patients have a right to access their test results directly and not have to go through their provider if they choose not to.

I wrote this post not to necessarily push readers to one viewpoint or another but more so to provoke thought. So, how do you think this bill will affect healthcare in Arizona or set a precedent for other states to follow and what is your stance? I can honestly say, I’m still thinking it over…

This post is an edited version of one that appeared on 2/27/15.

-Betty Chung, DO, MPH, MA is a third year resident physician at Rutgers – Robert Wood Johnson University Hospital in New Brunswick, NJ.

Management and Administration Housekeeping Items

A few items relevant to your interests have crossed the editor’s desk over the past few days.

1. As we mentioned several months ago, laboratories need to provide lab results to patients (or their representative) when requested to do so. The Privacy Rule amendments went into effect on October 6, 2014. Is your lab compliant? Read the regulations to be sure.

2. The Draft Guidance for the FDA regulation of LDTs has been published. You can read them here and here. The FDA will accept comments about the draft for the next 110 days.

New Rule Gives Patients More Access

Yesterday the Obama Administration and the Department of Health and Human Services implemented a regulation that amends the Clinical Laboratory Improvement Amendments of 1988 and the Health Insurance Portability and Accountability Act of 1996 in regards to reporting of patient results. Basically, the new regulations state that patients (or their personal representatives) can receive lab results directly from the laboratory. In most cases the laboratory has 30 days to comply with the request. This regulation goes into effect 3/31/14 and laboratories must comply by 9/27/14.

So what does this mean for laboratory professionals? The language of the final rule gives laboratories a lot of flexibility in terms of dealing with a request for information. In a nutshell:

Individual laboratories can set up systems to receive, process, and respond to requests for results however they choose to do so.
If a state law is different than the federal regulation, laboratories must comply with the “more stringent” law, with “more stringent” meaning “greater rights of access.” For example, the federal regulation requires results to be given within 30 days of the request; if state law requires those results be given with 15 days, then the laboratory should follow the state law.
Laboratories need to have “verification of identity” policies in place. There is no mandate that requires specific forms of identification.
Laboratories that currently have patient portals in place may continue to use them.
Laboratories CANNOT require patients to make requests only through their providers; mechanisms must be in place for a patient to make requests directly to the laboratory. However, laboratories CAN require patients to make these requests directly to the laboratory.
Laboratories can recoup the costs of providing results to patients, but the fees must be cost-based and reflect labor, supplies, postage, and preparation of an explanation of PHI. Laboratories CANNOT charge fees that reflect the cost of searching and retrieving information, nor can they charge fees for costs associated with verification, documentation, liability insurance, maintaining systems, etc. It should be noted that laboratories cannot withhold future lab results if a patient chooses not to pay the fee.
Laboratories must provide results in the form (electronic or paper) requested by the individual if readily producible. This could be a MS Word or Excel document or PDF as well as access to an electronic portal.
Laboratories are required to reasonably safeguard information (electronic or paper).
Laboratories are not required to include test interpretations but may do so if desired.
Providers are encouraged, but not required, to tell patients they have access to their laboratory results directly from the laboratory.