Disclosing Medical Errors in ART

February 2, 2012Carole 6 Comments »

The American Society for Reproductive Medicine has a Ethics Committee which issues recommendations regarding various ART medical practices. Most recently, they published “Disclosure of medical errors involving gametes and embryos”  If this link doesn’t work, you can download a PDF copy for yourself directly from www.asrm.org.

In this article, the Ethics Committee generally advocates for medical disclosure but describes two types of errors that may be managed differently. They make a distinction between errors that cause obvious harm to the patient such as mix-ups of wrong gametes cultured together or wrong embryos transferred and those that result in a loss in the “number or quality of gametes or embryos”. Specifically,

“A difference of opinion exists as to whether mistakes involving the number or quality of gametes or embryos should always be dis closed. According to one point of view, disclosure is discretionary if such errors do not harm the patients. According to another, ‘‘even trivial medical errors should be disclosed to patients, and decisions to withhold information need ethical justification’’ (3). We believe that the presumption should be to disclose, rather than not to disclose, mistakes that have potentially adverse effects for patients, even if the mistakes are seemingly minor. If, on the other hand, there is clearly no adverse effect, and if disclosure may unnecessarily compound the stress of patients, disclosure may be considered to not be obligatory.”

The potential problem with this two-pronged approach to disclosure is that someone within the organization must make a decision regarding whether patient harm has occurred. From a business perspective, it is never advisable to fully disclose because the patient may react in a manner that could harm your business. This being a fact, is it really sensible to expect that the business owner can set his self-interest aside or is it more likely that the bar for disclosure will be set high enough to avoid any adverse business effect?

Interestingly, the committee adds that “If the error is something that would or should be entered in the medical record, it should be disclosed.” By this standard, since the number and quality of embryos are charted on a daily basis in the patient’s medical chart, any loss due a lab mishap would clearly have to be disclosed.

The Ethics Committee also points out that the primary professional organizations such as the American Medical Association, the American College of Physicians, the American College of Obstetricians and Gynecologists and the Joint Commission on the Accreditation of Health Care Organizations all have standards of care that require disclosure of medical errors. They also remind us that we have a moral duty not to” lie, falsify records, or ask or require team or staff members to engage in deception or actions that prevent patients from being properly informed about their situation.”

Another ethical argument for full disclosure (if any more should be required) is that to not disclose is to cause patient harm by not respecting patient autonomy.  If patients are to be respected as autonomous individuals with the authority to make decisions about their medical care, patients must be given the information they need to make informed decisions.

The Ethics Committee also provides a blueprint for how to disclose errors to patients. Their recommendations include:

“Clinics should have a written policy regarding disclosure of medical errors which defines key events and terms, state who should be informed, how an investigation into root cause will be conducted and the timing and method of patient disclosure. statements about who should be informed, how further investigation will be conducted, and when and how information will be discussed with patients.”

Clinic policies should make clear that a culture of openness is encouraged and retribution against  “whistle blowers” will not be tolerated. Furthermore, clinic policies must include a method to convey to employees that consequences to the program and themselves are likely if errors are not disclosed or worse, steps are taken to “cover up”errors, for instance by creating false entries into the medical record.

Prevention of errors is the first line of defense against being in a position where disclosure of errors becomes an issue. Robust chain of custody and labeling protocols to insure gamete identification throughout the process and “time outs” to verify identity of patient or gametes at critical treatment junctions (like combining gametes, transferring embryos) are essential to proper patient care.

Specific recommendations regarding clinic policy in the ethics recommendation include:

“Clinic policy should include suggestions for facilitating the process of disclosure. For example, it is advisable for practitioners to: a) initiate the disclosure rather than waiting for the patient to ask and, b) regard disclosure as a process involving more than one discussion (1). Clinic personnel should also let the patient know what steps are being taken to prevent recurrences. Those who have studied disclosure of errors recommend that an apology and empathy can help; to express condolences is not necessarily to admit fault (6). Conversely, the lack of an apology may be distressing to the patients (5). Personnel should disclose what is known and what is uncertain and then provide updates if more is learned about the error (10).”

Patients interviewing prospective clinics should ask about whether they have a written policy regarding disclosure of medical errors. If their response does not satisfy you, you might be better served seeking treatment elsewhere.

I would be interested in hearing from patients  regarding these guidelines. Are there any situations in which they would rather not know about clinical errors in their care?

From embryologists, I would be interested in your experiences in the workplace. Do you feel that you can disclose errors without retribution? Is there a culture of openness where you work? Have you ever been asked not to disclose or to change the medical record to obscure a medical error? Is your workplace  a small business or part of a hospital system? Obviously, if commenting publicly, use an anonymous email account.

 

 

© 2012, Carole. All rights reserved.

6 Responses to this entry

  • Sam Says:

    As an infertility patient and a clinical researcher, I disagree that there are certain circumstances under which a medical error should not be disclosed.

    ART is elective medicine. IVF is extremely costly, time consuming and emotionally and physically challenging as well. Most IVF patients are self-pay like me and it isn’t cheap. As a savvy consumer I need to know and will actively seek out all information regarding my treatment course. I expect and I am owed complete disclosure of all factors that could potentially effect my outcome so I (and I alone) can make a judgement as to how to proceed with my dollars and my future treatment. It is my role as an educated consumer to decide if “there is clearly no adverse effect”. The idea that my doctor would withhold any information with the blessing of the ASRM’s Ethics Committee is appalling.

    They also may be setting themselves up for some potential litigation. (Although I am sure ASRM has several lawyers on their Ethics Committee.) I, for one, would not hesitate to contact a lawyer if I felt I had been mislead so that I would continue a faulty treatment course based on incomplete or misleading information from my doctor. While the ASRM EC seems to hedge their bets by instructing their membership not to falsify medical records, what’s to prevent them from keeping incomplete records? By not capturing the data or disclosing it to patients they are limiting their liability.

  • Carole Says:

    And more about medical disclosures http://www.washingtonpost.com/blogs/ezra-klein/post/when-doctors-lie/2012/02/08/gIQAH8CfzQ_blog.html.
    And an in depth ethical analysis of lying to patients http://www.bioetica.uchile.cl/doc/honesty.htm /mail/?ui%3D2%26ik%3Dabc300b914%26view%3Datt%26th%3D13562bd8f318a784%26attid%3D0.1%26disp%3Dsafe%26realattid%3Df_gyfy3aw10%26zw&sig=AHIEtbSvlmh2-75qwubkiJSdO5x3rmrDfA&pli=1Plenty to think about and discuss here. Are there such things as white lies? If so, when are they justified?

  • ConservativePOV Says:

    I suspect I am in a small minority, but here is another POV for you. For uber-conservatives, (pro-life, life begins at conception, etc.) it’s already an enormous leap just to do IVF. There are all sorts of concerns over creating lives that you know will not survive in culture. These things weigh heavily enough on my mind even now after a sucessful pregnancy. To add to that burden a mistake someone made in the lab; let’s say they dropped and destroyed a viable embryo; I just don’t think there is a therapist gifted enough to get me past that much guilt and animosity. Please just tell me I have one fewer today than yesterday.

  • Carole Says:

    Dear ConservativePOV,
    Thanks for your comment. Your point of view is not that unusual in my experience in several regards. I recently had a very interesting conversation with a couple who had grave misgivings about using PGD with IVF even though this was the only medical route they could take to try to ensure that their next child wouldn’t have the genetic disease that claimed their naturally conceived son at 10 days of life. They also believe life begins at conception. In the end, they decided to proceed with IVF, despite their misgivings. So you wouldn’t be the first (or the last) to struggle with their personal faith and whether they should be using medical interventions.
    The other perhaps even more interesting point you made is that you would prefer not to know the truth in some circumstances. What troubles me about this view (and you are also not alone in this opinion) is that you have to allow someone else to decide what you should know and what you shouldn’t know. From the other side, I have never felt that omniscient to know what is best to keep from a patient so it is easier for me to simply describe mishaps in the lab in a simple straightforward manner because it is easier from my perspective (coverups are hard). Also the truth does not take anything away from you. It does not assume that you are too naive, stupid or foolish to understand and handle the truth. It does, however, put me at some risk of making you unhappy. In healthcare, I have seen some instances in my career of managing patient expectations and patient information to an extent that made me feel highly uncomfortable. IMO, I think a better plan for all concerned is to dispel the myth of perfect healthcare and give patients a very realistic picture of their risks, benefits and alternatives (informed consent, anyone?) and then be honest if things occasionally don’t go as planned. Unfortunately, in this highly litigious age, my insistence on truth is looked upon by some of my colleagues with either amusement at my naivete or alarm. As has been said before, “in healthcare, we cater to all levels of denial”. In any case, the whole topic of the ethics of medical disclosure is fascinating to me and I appreciate your participation in the discussion.

  • Rachel Says:

    An interesting post!

    I am a patient whose embryos suffered what I believe was an embryology lab error. We had 10 vitrified embryos, and wanted to thaw (or warm, I guess) two — we were told on transfer day that it had taken eight thaws to get us two. Of course I was upset and thought we just had poor quality embryos, despite the fact that they were excellent quality when they were frozen…

    Months later I got the paper work, which recorded that there were four embryos left. How did 10 – 8 = 4? I called and was told that they “weren’t sure” whether one of the receptacles (vials? straws?) had embryos in it or not! There was, apparently., some kind of a lab accident, and they don’t know how many were destroyed. That’s why it had taken eight embryos to get me two to transfer.

    I understand that accidents happen. But I’m angry because I wasn’t told what happened, and was instead led to believe that I just had embryos that couldn’t survive thaw. I’m angry because I have never received either a clear explanation of what happened, or an apology (I also don’t understand how they can just not know how many embryos I have!). And I’m angry at myself because I have never demanded any of the above, because I am so intimidated by these people who control the very lives of my longed-for children — I don’t want them to be mad at me, I don’t want them to know that I am mad at them. There is so much helplessness bound up in infertility.

    I believe that they embryologists in this lab are decent people, but they should have told me what happened, immediately and clearly. I shouldn’t have had to sleuth it out from paperwork months later.

  • Carole Says:

    Dear Rachel,
    I am sorry that you had this experience. Clearly, you should have been informed on the day of thaw that the lab was having difficulty with the thaw and were having trouble recovering embryos from your straws. Obviously, I don’t know the root cause of this problem but technical problems like this are more likely to happen when technicians are not properly trained or aren’t given much training time before they are required to perform the procedure “for real” for patients. I have encountered pressure to get procedures “on line” as quickly as possible because it was the new thing that the program wanted to market to attract patients. Vitrification in general and egg freezing in particular are the newest procedures that are most vulnerable to this kind of market pressure. Experiences like yours are why I feel that more regulation and oversight is necessary because some programs have weak leaders who allow market pressures to override their professional ethics and these programs do not serve patients well. Yes, there is an investment cost to the program to develop effective accurate written protocols, a step-wise training program and there is short-term program cost in paying technical staff to train rather than doing chargeable tasks but it pays off in the long run. I wish you all the best going forward. Carole

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