Disclosing Medical Errors in ART

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, Fertility Lab Insider. All rights reserved.

©2012 Fertility Lab Insider. All Rights Reserved.



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