ART errors are fortunately a rare occurrence. but humans are fallible and mistakes are inevitable. We, as infertility specialists, must be vigilant in reviewing existing risk management systems and consider other options to minimize/eliminate these events. ART programs should work to emphasize honesty and transparency to improve quality of care. “To err is human, but we can work together to build a safer healthcare system”
The errors made in ART can range from mild to severe, which may or may not affect the outcome of the cycle.
Where are the errors made? You may think they are limited only to core embryology but these errors are present almost everywhere across various categories.
|Communication||Inter-departmental communication problems|
|Documents/Records||Incorrect or incomplete documentation|
|Equipment and supplies||Failure of a piece of equipment, including computers, or supply item.|
|External||A problem that has occurred outside the clinic (e.g. transport of cryodevices)|
|Facilities||A problem with infra- structure, such as HVAC.|
|Human||An error involving performance of tasks outside of the documented protocol or a mistake or oversight, which was most likely the direct result of a human action.|
|Patient problem/complaint||A problem with a specific patient or a complaint from a patient.|
|QA/QC/Statistical out- of-range values||A problem not directly attributed to a specific cause, such as transient drop in fertilization or pregnancy|
Much can be learnt from the analysis of errors. All adverse events should be evaluated to assess whether improvements can be made, to reduce the likelihood of similar events occurring in the future. Errors that do not result in harm also represent an important opportunity to identify system improvements that have the potential to prevent adverse events.
Examples of some errors made in the lab and their severity
|Communication||None/Minimal||Had to remind the nurse regarding the official time out on patient SJ. She initially told me that she was bringing down “Joshi” I confirmed with her that the full name was “Saloni Joshi”||Speak to the OT staff to use full names at all times|
|Human||None/Minimal||When preparing to do an embryo transfer I saw that the culture dish was properly labelled, but the transfer dish was mislabelled with an incorrect first name. This dish had the proper number of embryos in it at the proper stages of development and the correct last name||To have the lab sheet in the vicinity at all times during labelling or transferring gametes/embryos|
|Human||Moderate||“Priya” (a new embryologist) was handling the dishes of a patient during fertilization assessment. There were 14 oocytes in the dish, 12 fertilized. The 8 ICSI ferts were moved to the culture dish, but, before the remaining 4 eggs could be moved, the original dish was accidentally flipped over. 2 of the remaining oocytes were found, but 2 were not recovered.||To induct Priya regarding the protocols of the lab. To assure and make her comfortable in the “new place” so she is less nervous and less likely to make errors.|
|Equipment||Moderate||During a busy day, the bench top incubator started beeping, it was observed that the tri gas cylinder was empty. The lab technician was immediately alerted and cylinder was changed||Not to open the incubator while the cylinders were being changed. To tell the lab technician to have a spare cylinder ready and attached for auto switch.|
|Human||Significant||A patient was scheduled for a thaw and on the day of the thaw her cryo paperwork could not be found in the usual place. The record in the electronic database was checked and the remaining embryos and location was not mentioned. Precious time was lost in looking for the cryotop. It was found in a random location after one hour of stressful search.||To be careful to file all sheets serial wise once the cycle is completed. Also entries to be double checked weekly by the team member.|
|Equipment||Significant||I was using a 150um stripper tip to strip the eggs of a patient. I individually picked up each egg from their original drops and moved them through a wash drop and then to a culture drop. When I expelled the media into the culture drop, no eggs emerged. I examined the pipet under the microscope and could see no eggs in it, but could see a particle of plastic lodged in the tip. I flushed the pipet using a needle and syringe but still found no eggs. The drop I had expelled the media into was then re-examined and 7 ruptured zonas could be seen.||If it was done by a trainee / junior embryologist , they were asked to practise more before denuding patient eggs.|
Next steps: When errors have been made, we can either choose to ignore them or use them to improve. Best practices in case of errors would be:
– Acknowledge them
– Understand why they happened and get to the source of the problem
– Work on improving the processes involved
Depending on the type and severity of the problem, it should be decided whether the error needs to be:
a) Discussed within the laboratory team and rectified – This includes, but is not limited to, paperwork not filed or entered in the software, not able to find oocyte during denudation, discrepancy in grading;
b) Discussed with the clinician – This is when the error is intradepartmental. This includes reduction in fertilization rate or pregnancy rate, embryos cannot be located, incorrect information related to the patient, etc.
c) Discussed with the clinical and the next steps on how to handle and disclose to the patient should be decided – This is if a significant error has occurred, which will affect the patient’s cycle. For instance, wrong samples used for insemination, power failure leading to error in equipment which resulted in poor embryo development, embryo mismatch, etc.
A tightly woven collaboration between embryologist and clinician is crucial in developing a patient’s treatment plan, e.g. ICSI versus conventional insemination, number of embryos to transfer, review of genetic results after PGD for embryo selection for transfer, design of contingency plans for cases in which sperm may not be available from testicular biopsy.
A team approach will be especially advantageous when sub-optimal outcomes are encountered. The best response to these stressful times is a conjoint investigation into the outcome data and what it may reflect. Consideration of both laboratory factors, e.g. supplies, equipment or personnel, and patient-related factors, e.g. female age, ovarian reserve, severity of male factor, trajectory of ovarian stimulation, progesterone level at retrieval – all factors that could have influenced a poor or unexpected outcome – is vital in productive analysis and resisting and assigning blame or deficiency.
‘Witnessing’ is one of the most important steps which should be incorporated in your lab on a daily basis. Witnessing is important in intradepartmental and interdepartmental procedures like OPU, embryo transfer, taking the sperm in the ICSI dish for injection, loading embryos for embryo transfer and so on. During OPU and ET, the nurse should ask the patient to call out her full name loudly and the same should be confirmed by the nurse and embryologist. Similarly, while loading the embryos for embryo transfer, the embryologist must reiterate the full name of the patient along with the number of embryos he or she is loading into the catheter.
During embryology procedures like loading the sperm or moving the embryos onto the embryo transfer dish or for vitrification, the working embryologist should call out the name loudly and get it witnessed by a fellow embryologist. This small addition in your daily laboratory routine will go a long way and will be beneficial in minimizing errors.
A fundamental principle of medical ethics is to respect patients by treating them as autonomous individuals. This means dealing with patients honestly and openly, and includes the duty to provide patients with information necessary to understand their diagnosis, course of treatment, and risks and benefits so they can make completely known and well-informed decisions. The ethical dictum of ‘‘first do no harm’’ includes harm to the patient’s status as an autonomous individual.
Principles of open and honest communication with patients have special significance in reproductive medicine. Fertility treatments are often stressful, and patients may be particularly sensitive to the statements of their health-care providers. In addition, errors in reproductive medicine may affect the couple’s ability to have a child. In such situations, where the errors are particularly serious— like embryos mistakenly transferred to the wrong patient—the error may lead to the birth of a different child than was intended. Such births can lead to significant emotional turmoil and bring along with them burdens of parentage or custody lawsuits, that can adversely affect all involved parties, including the children. (1)
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 and facing compensation demands. Encouraging a climate of transparency and no retribution is important to counteract this reluctance.
Admitting a medical error might be difficult, however, disclosing rather than hiding the error is ethically and legally appropriate, both to avoid further harm to the patient and to avoid the additional wrongs that an attempt at secrecy might entail. Practitioners who hide their error may gamble that the error 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. 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’’.
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. Clinic personnel should also let the patient know what steps are being taken to prevent recurrences.
The best ethical practice is for programs to have in place rigorous procedures 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 prompt identification and disclosure of errors to patients (1)
A. Errors in the laboratory can be avoided by 1. Training and validating the new entrant 2. Have good communication between personnel in the laboratory 3. Adherence to strict SOP
A. Yes, if it is error which effects the cycle of the patient.
A. The embryologist and clinician need to have an open discussion before they address the patient. Usually, it would be better If both the clinician and embryologist break the news to the patient.