Disclosure of medical errors and untoward events involving gametes and embryos: an Ethics Committee opinion (2024)

KEY POINTS

• The practice of reproductive medicine can involve medical errors and untoward events in which gametes and embryos are lost, damaged, or misdirected, as well as near misses in which errors are averted before producing any clinical impact. (Fig. 1)
• Fertility programs should have in place rigorous procedures to prevent the loss, damage, or misdirection of gametes and embryos and to ensure proper identification of all gametes, embryos, patients, and gamete donors.
• Clinics have an ethical obligation to disclose errors to all impacted patients out of respect for patient autonomy and fairness to patients.
• Clinics have an ethical obligation to disclose errors to all recipients, source patients, intended parents, gamete and embryo donors, and gestational carriers where the tissue was used improperly and/or without appropriate authorization, including in cases in which the wrong sperm is used for insemination or gametes or embryos are mistakenly switched, resulting in fertilization, embryo transfer, implantation, or the birth of a child with a different genetic parentage than intended as soon as the error is discovered.
• Clinics should address medical errors, untoward events, and near misses by conducting a root-cause analysis aimed at revealing any system failures and implementing procedural changes to reduce the risk of recurrence.
• Clinics should promote a culture of truth-telling and should establish written policies and procedures regarding the disclosure of errors and untoward events to patients.

The practice of reproductive medicine involves the retrieval, processing, transfer, and storage of human gametes as well as embryos. In vitro manipulation or handling of gametes and embryos creates opportunities for the loss, damage, or misdirection of gametes as well as embryos in the course of fertility care. Any instance in which gametes or embryos are lost, damaged, or misdirected constitutes an adverse event. ‘‘Near misses,’’ that is, possible errors averted before producing any clinical impact that reaches the patient, also occur. This document reviews the conditions under which it is ethically obligatory to disclose both medical errors and near misses involving gametes as well as embryos to patients. It also considers how and when disclosure might be done.

Medical errors are mistakes that have potentially negative consequences for patients (1–3). Harm can occur from something done to the patient (errors of commission) or from something not done (errors of omission). When harm has occurred, there is an ethical obligation for the error to be disclosed to the patient or patients involved. In the provision of fertility care, errors involving gametes and embryos may harm the intended recipients, patients, intended parents, gamete as well as embryo donors, and gestational carriers who supply these reproductive tissues. When errors are clinically relevant, fairness to patients, protection from harm, and respect for patient autonomy require open as well as honest disclosure of errors immediately on recognition, even though disclosure may be difficult for clinicians. The scope of disclosure also includes other health care providers who are involved in a fertility patient’s care, including treating physicians within the clinic’s practice or those independent of the clinic who provide necessary ancillary services, such as surgical sperm extraction. When applicable, hospital and practice administrators should be also informed. Shared knowledge of errors by all members of a patient’s health care team allows for any adjustments in the treatment plan to proceed in a coordinated and consistent manner.

With near misses, the possibility of harm is averted before it reaches the patient(s). Reasons for disclosure of near misses may include patient autonomy and the importance of assessing clinic procedures to reduce systemic possibilities for error. The American Society for Reproductive Medicine (ASRM) Ethics Committee believes that disclosure to the patient(s) should be considered in these cases but is not obligatory. Clinics should have policies in place to conduct root-cause analysis and implement corrective action or system improvements when medical errors as well as near misses occur to guard against system error, and they should periodically review these policies for adequacy as well as compliance.

Although medical error can occur at any point in the delivery of assisted reproductive care, this document focuses on two specific types of errors: errors that lead to gametes or embryos being lost or damaged, with the diminished reproductive opportunity that such errors may bring; and situations in which the gametes or embryos used in fertility care are not those originally intended for use in the patient(s) undergoing treatment, potentially leading to the birth of a child from an unintended gamete or embryo source. We believe that physicians, in the first instance, are ethically obligated to disclose errors that affect the number or quality of gametes or embryos, except in those instances in which the error’s impact is so clearly minimal that it could not possibly affect the patient’s interests, as discussed below. In the second instance, in which gametes or embryos are misdirected, the ethical obligation to disclose errors is immediate and without exception. Here the patients’ right to know is compelling; physicians are ethically obligated to disclose to patients, including any inadvertent gamete or embryo donors or other third-party patient participants any error as soon as discovered that could lead to a child being born from an unintended gamete or embryo source.

MEDICAL ERRORS LEADING TO GAMETES OR EMBRYOS BEING LOST OR DAMAGED

Medical errors in fertility practice involving gametes or embryos can be devastating to patients and clinic personnel, often raising legal, ethical, as well as practical concerns in their wake (4,5). This section discusses circumstances in which the error leads to the loss or damage of sperm, oocytes, or embryos intended to be used for reproduction.

Errors leading to the loss or damage of gametes or embryos can adversely affect the biologic and financial ability of individuals as well as couples to have children. Some errors may require the individual or couple to undergo additional treatment cycles, with their corresponding costs and burdens. Such would be the case when an error resulted in an insufficient number or inadequate quality of gametes or embryos available for fertilization or transfer. Examples include cryopreservation tank failures, laboratory accidents, and the misplacement of gametes or embryos. These may ultimately result in the inability of an individual or couple to have a genetically related child because the lost or damaged gametes or embryos represent the patients’ last remaining genetic material.

Some errors leading to the loss or damage of gametes or embryos clearly have no adverse clinical consequences for patients. Examples include a scenario in which a small portion of a semen sample is accidentally spilled in the laboratory but enough remains to provide a suitable specimen for insemination, or when atretic oocytes or noncleaving embryos are lost. Because the patient has not been harmed and disclosure may cause needless worry or mistrust, it may be argued that disclosure is not required in these cases. This argument defers to a clinician’s individual judgment about the nature of the harm and the value of disclosure in these situations.

However, there are compelling arguments in favor of the disclosure of all errors, even those with no clinical impact. These arguments raise concerns about deferring to physicians’ judgments about whether errors are of clinical consequence. Disclosing errors is difficult, and many physicians are reluctant to engage in disclosure discussions (6). Thus, physicians may be overly likely to justify nondisclosure on the basis that the error was of little clinical importance. Critics also question whether physicians are the best judges of the meaning of ‘‘harm’’ in such cases and argue that respect for patient autonomy means that patients should be informed about events that they might judge to be harmful to them (7). These concerns weigh in favor of disclosure in cases in which the error reached the patient but was judged to have been inconsequential by the physician. The ASRM Ethics Committee believes that the presumption should be in favor of disclosure of errors that have potentially adverse effects on patients, even when the errors are seemingly minor. On the other hand, when there is clearly no adverse effect and disclosure risks significantly compounding the stress of patients it is still recommended, but may not be obligatory.

Near misses involving the loss or damage of gametes or embryos involve events that do not impact the patient, either because of intervention from members of the clinical team or by chance alone. Examples are errors in the identification of gametes or embryos for disposal or errors in the management of preservation techniques that are identified by backup checking or other systems before the error reaches the patient. Although no harm is incurred, near misses are opportunities to consider process improvements and may indicate systemic difficulties that clinics need to address so that errors do not occur in the future. They also illustrate the importance of having effective and redundant systems to catch errors. Advocates of disclosure in these situations contend that it may encourage practitioners to recognize systemic errors and take remedial steps that may reduce the risks of harmful errors to subsequent patients (7). In cases of near misses, the ASRM Ethics Committee believes that disclosure to patients is not required but that clinics should have policies to identify near misses and to take steps to guard against them, including following best practices (8,9).

ERRORS INVOLVING MISDIRECTION OF GAMETES OR EMBRYOS

A second type of error, considerably less common, occurs when the gametes or embryos used in infertility treatment are not those originally intended for use in a particular patient. This might occur when the gametes or embryos of one person or couple are mistakenly used with the gametes or embryos of another person or mistakenly transferred. This would include inseminating a patient with the wrong sperm, creating an embryo using sperm, egg, or both from gamete sources other than the intended parents(s) or intended gamete donor(s), and transferring an embryo to the incorrect recipient, including embryos created with sperm or egg that did not come from the intended parent or gamete donor. Another example includes a scenario in which an aneuploid embryo is transferred after preimplantation genetic testing for aneuploidy, resulting in a failed embryo transfer or a spontaneous abortion. In addition, included in these types of errors is the unintentional transfer of an affected embryo after preimplantation genetic testing for monogenic conditions or translocations. Because there is no mandatory reporting for errors in reproductive medicine, the incidence of these errors is largely unknown. A survey study in 2008 found that of the 186 US fertility clinics that responded, 21% reported that they were aware of inconsistencies between the results of genetic analysis of embryo biopsies and later genetic testing of the resulting offspring. Of those who noted inconsistencies, 11% suspected this was because of a mix-up or mislabeling of biopsy samples (10).

In cases in which the gametes or embryos of one person or couple are misdirected to another, patients face not only the loss of gametes or embryos that would have enabled them to reproduce but also the possibility that the gametes or embryos received will result in a child intended for another individual or couple. In the latter case, patients face potential legal disputes to determine the child’s parentage and custody arrangements (11). Discovery of the error may occur shortly after the gametes are used or the embryos are transferred, or discovery may occur later. A particularly unfortunate scenario involves the discovery of the error after the child is born and has been raised for some time by the individual or couple and not by the child’s intended parent(s) (12).

Disclosure of any identified misdirection should take place immediately after discovery to all recipients, patients, and inadvertent donors, including gamete or embryo donors, whose tissue was used, regardless of whether harm has occurred or is judged minimal. Respect for patient autonomy requires disclosure even when the embryo did not implant or when the resulting pregnancy did not result in a live birth. Some might argue that the ethical duty to minimize harm justifies not telling the patients of the error because disclosure may be harmful, such as leading to a pregnancy termination or creating stress. We believe this view is misguided. Disclosure of the error will enable those most directly affected to decide on a course of action. When a pregnancy has been established, this course of action may involve continuing the pregnancy, making advance arrangements about parentage, and securing legal counsel to take steps to develop a workable solution for this unforeseen outcome. An alternative course of action may be a decision to terminate the pregnancy. The duty to disclose also holds when the child has been born and some time has elapsed before the error is discovered. Realizing the complexity of disclosure in such a case, careful assessment and planning should be undertaken, including the involvement of mental health and legal experts, but disclosure should take place as soon as possible.

ETHICAL JUSTIFICATION FOR DISCLOSING ERRORS

A fundamental principle of medical ethics is to respect patients by treating them as autonomous individuals. This means communicating with patients honestly and openly, as well as it includes the duty to provide patients with the information necessary to understand their diagnosis, course of treatment, and risks and benefits so they can make informed decisions. The ethical dictum of ‘‘First, do no harm’’ includes supporting the patient’s status as an autonomous individual.

Respect for patients means providing them with the information necessary to understand their situations and to make choices about future courses of treatment. Such information includes telling patients when physicians or other members of the medical team have made an error or mistake that affects the well-being or goals of the patient. In such cases, there is an ethical duty to disclose the mistake and take steps to prevent or minimize harmful effects, when possible. Disclosure also guards against an erosion of trust because failure to disclose ‘‘potentially involves deception and suggests the preservation of narrow professional interests over the well-being of patients’’ (2). It is important to remember that the nature of the physician-patient relationship is on the basis of confidence and trust, with the physician holding a privileged position in the relationship. When a physician fails to disclose an error, even a minimal or no harm error, the foundation of the physician-patient relationship is undermined, and the emphasis shifts away from patient-centered decision-making in favor of physician self-interest (7).

The principle of informed consent and the need for disclosure of mistakes are recognized directly or indirectly in the ethical statements of the American Medical Association, the American College of Physicians, the American Congress of Obstetricians and Gynecologists, the Joint Commission, and many other professional associations (13–16). In addition to a duty to disclose relevant information to patients, there is also an ethical and legal 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.

THE PROCESS OF DISCLOSING ERRORS

Clinic personnel may be reluctant to disclose errors for various reasons. They may be concerned about negative consequences to them or their practice, including concerns about losing patients, facing compensation demands, implicating other members of the medical team, being sued, harming the clinic’s reputation, and having complaints filed with medical licensing boards. Practitioners may also feel discomfort about admitting mistakes (3,7). Encouraging a climate of transparency and nonretribution, as well as fostering a culture of safety, is important to counteract this reluctance.

Although admitting a medical error might be difficult, disclosing, rather than hiding, the error is ethically and legally appropriate, both to avoid further harm to the patient(s) as well as to avoid the additional wrongs that an attempt at secrecy might entail. Practitioners who hide their errors may gamble that the errors will not be discovered. For example, a practitioner may try to keep secret the error of inseminating a patient with the wrong sperm, hoping that a pregnancy is not established. Yet such an act may further injure patients by depriving them of the opportunity to take corrective or other remedial action. It is recognized that ‘‘errors do not necessarily constitute improper, negligent, or unethical behavior, but failure to disclose them may’’ (17). Covering up an error may also lead to penalties for practitioners, including the loss of a physician’s medical license (18). Moreover, with contemporary forms of genetic testing, errors of misdirection are likely to be more frequently discovered, including following direct-to-consumer genetic testing.

Some studies suggest that patients are less likely to take legal action when they are informed honestly about mistakes (2). If one does not disclose and the patient later learns of the error, then the patient ‘‘is likely to be more hostile as well as suit-prone’’ because of the perceived violation of the practitioner’s obligations to the patient (3). Disclosure is also important whether the clinic uses it as an opportunity to prevent future similar mistakes or to improve the quality of care (19). Clinicians should, however, be prepared for negative consequences from disclosure, such as loss of patients to other clinics, expectations of compensation, or the initiation of a legal suit.

Health care workers may not know how or when to inform patients (20). As such, clinics should develop written policies advising how to disclose important clinical events to patients, which helps to foster a culture of safety (6,21). Such policies should include definitions of key events and terms, 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 reflect a culture of encouraging disclosure of and discussion about errors in the clinic itself. A culture of openness includes conveying to the medical team awareness of the harm that can come from hiding errors, of the consequences of secrecy to staff members, and of policies in place to minimize errors. These policies can help clinics that educate trainees convey best practices for the disclosure of medical errors within the context of a supportive environment.

Clinic policy should include suggestions for facilitating the process of disclosure. For example, it is advisable for practitioners to initiate the disclosure rather than wait for the patient to ask, and to regard disclosure as a process involving more than one discussion (2). Clinic personnel should also let the patient know what steps are being taken to prevent recurrences; patients want to know that the health care system will learn from the error and prevent it from happening again (22). Those who have studied the disclosure of errors recommend that an apology and empathy can help; to express condolences is not necessarily to admit fault (19). Conversely, the lack of an apology may be distressing to the patients (18). Personnel should disclose what is known and what is uncertain and then provide updates if more is learned about the error (23).

As part of a culture of safety, it is important for written policies to include rigorous procedures to prevent the loss or damage of gametes and embryos and to ensure proper identification of all gametes, embryos, as well as patients. This should include robust, redundant identification methods. When an error is identified, clinics may choose to distinguish between individual errors and system errors. Recognizing system errors can help lessen the odds of a similar systemic mistake in the future (7). Conducting root-cause analyses of errors can provide the opportunity to better understand why the error occurred, with the goal of improving health care in general. This can be part of the culture of encouraging disclosure and discussion about errors in the clinic itself.

We conclude that the best ethical practice is for programs to have rigorous procedures in place to prevent errors. To prepare for the possibility that errors may occur despite these procedures, programs should foster an environment of truth-telling that will allow for the prompt identification and disclosure of errors to patients. It is recommended that clinics have written policies and procedures that outline how to reduce medical errors as well as disclose them should they occur.

ACKNOWLEDGMENTS

This report was developed under the direction of the Ethics Committee of the American Society for Reproductive Medicine (ASRM) as a service to its members and other practicing clinicians. Although this document reflects appropriate management of a problem encountered in the practice of reproductive medicine, it is not intended to be the only approved standard of practice or to dictate an exclusive course of treatment. Other plans of management may be appropriate, taking into account the needs of the individual patient, available resources, and institutional or clinical practice limitations. The Ethics Committee and the Board of Directors of the ASRM have approved this report.

This document was reviewed by ASRM members, and their input was considered in the preparation of the final document. The following members of the ASRM Ethics Committee participated in the development of this document: Sigal Klipstein, M.D.; Deborah Anderson, Ph.D.; Kavita Shah Arora, M.D., M.B.E.; Tolulope Bakare, M.D.; Katherine Cameron, M.D.; Marcelle Cedars, M.D.; Susan Crockin, J.D.; Ruth Farrell, M.D.; Jessica Goldstein, R.N.; Mandy Katz-Jaffe, Ph.D.; Jennifer Kawwass, M.D.; Edward Martinez, M.D.; Joshua Morris, M.D., M.A.; Gwendolyn Quinn, Ph.D.; Robert Rebar, M.D.; Chevis N Shannon, Dr.PH., M.P.H., M.B.A.; Hugh Taylor, M.D.; Sean Tipton, M.A.; and Julianne Zweifel, Ph.D. The Ethics Committee acknowledges the special contribution of Ruth Farrell, M.D., and Mandy Katz-Jaffe, Ph.D., in the preparation of this document. All committee members disclosed commercial and financial relationships with manufacturers or distributors of goods or services used to treat patients. Members of the Committee who were found to have conflicts of interest on the basis of the relationships disclosed did not participate in the discussion or development of this document. 

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