IVF is as prone to errors as any other treatment because it is provided by a host of people working together – doctors, nurses, receptionist, ultrasonographers, lab technicians and embryologists. It requires lots of coordination, and there are few treatment processes for which a team approach is more important than for assisted reproduction. Close, continuous communication is required at many levels to ensure everything goes as planned.
Regular interaction is required to assure that infertile couples are adequately prepared, and that scans, blood tests, egg collections and embryo transfers are performed seamlessly. IVF offers a wide variety of mix-and-match treatment options, because there can be multiple sources of eggs, sperms, and uteri; and lots of different physicians are involved, including reproductive endocrinologists, urologists, anesthetists and counselors.
All of these can produce an environment of controlled chaos that must be managed. Important to the issues of patient safety and the integrity of an ART program are the ways in which a program handles the difficult issue of medical errors. Total freedom from error is only possible in theory. Response to errors, when they occur, reveals the integrity of the program and should be based on established processes.
IVF programs can be madhouses of activity, and the possibility of an error creeping in is every IVF clinic’s nightmare. There are two primary types of errors in IVF:
• One, in which the eggs or sperm are mistakenly used with the gametes of another person ; or the wrong embryo is transferred to a patient
• The second, which leads to the loss of sperm, eggs, or embryos (for example, because of a power failure as a result of which the incubator malfunctions).
IVF mix-ups are every patient’s and doctor’s nightmare, and lots of high profile cases have been described where this has happened. The trouble is that eggs, sperms, and embryos look exactly the same under the microscope ! Errors can be avoided by:
• Obsessive labeling
• Double witnessing, where a second person double checks the identity of all the dishes in the lab can help reduce this risk
• Electronic witnessing, using coding and RFID (radio frequency identification) technology has also been introduced to prevent gamete mix-ups.
If a mix-up does occur and is noticed, this must be brought to the doctor’s attention immediately. Even if the embryo has not been transferred, the patient should be informed, so they can decide on a course of action they are comfortable with.
The second type of error may or may not lead to a reduced chance of reproduction. A loss of part of a sperm specimen or improper handling of immature oocytes may not result in a dramatic change in the outcome of the cycle for the patient. Although there can be a difference of opinion about whether this should be disclosed, the ASRM Ethics committee states that it’s best to disclose even minor mistakes that have potentially adverse effects for patients.
"If, on the other hand, there is clearly no adverse effect and if disclosure may unnecessarily compound the stress of patients, disclosure may not be obligatory." However, the perception of dishonesty resulting from attempts to cover errors is often worse than the actual medical error.
Maintaining transparency is important
Good IVF clinics have policies and procedures in place that deal specifically with medical error. These should include definitions; statements about who should be informed, when, and how; and mechanisms for determining the cause of the error and preventing its repetition. Policies should encourage a culture of openness, address the ill effects of trying to cover up errors, and very importantly, include corrective actions to minimize future errors.
They should be based on the understanding that errors can and will occur, and that a better assessment of errors will improve the mechanisms for preventing and correcting them. This has a positive effect on staff morale, which further enhances safety. A mechanism for reporting both within the clinic and the laboratory allows for analysis of near misses. Incidents that do not result in harm should also be reported to allow process optimization that can prevent serious errors.
IVF care is a complex clinical process, and the clinical activity needs to be categorized into compartments. This allows us to depict them as flow diagrams that allow study of sources of error or risk. This promotes the ability to streamline the interaction of multiple complex tasks performed by different clinical and administrative units such as nursing, laboratory, and billing departments.
In addition to reducing effort, which in turn can decrease the sources of error, the process map gives all the staff members an overview of the complete treatment cycle, so that the right hand finally knows what the left hand is doing. This improves coordination and communication, and allows each staff member to put patients first. Because they can see the big picture, the staff is now no longer just focused on doing their individual job, but understands that their goal is to help the patient along her IVF journey.
Flow process diagrams allow us to assess the risk of error at each step in a clinical process. For example, what would happen if the lab did not report the estradiol value in a timely fashion to the doctor when he is timing the HCG trigger shot? The systematic evaluation of risk points can lead to an action plan that results in minimal errors in the future.
Establishing metrics and tracking provides a means for following the success of error reduction over time. Parameters can be as simple as checking to see what percentage of patients are phoned the day after egg collection to make sure they are comfortable and are not developing OHSS. Such simple proactive measures can help to make IVF safer for patients.
We use an EMR ( electronic medical record) to document that we have provided treatment correctly and safely. This allows team members to communicate with each other, and with the patient as well.
The laboratory is the last stop in the complex process of IVF treatment and laboratory personnel must confirm that all consents are current and complete for the intended treatments. In the absence of these documents (whether paper or electronic), the embryology laboratory should not perform the procedures.
Improving safety is not the responsibility of only the clinic staff. Thus, drug manufacturers have started to provide the medications which patients need to self-inject daily in pre-filled syringes, so that their chances of making a mistake in taking the injections is reduced.
The patient is the final line of defense against errors. Making sure the patient knows what is supposed to happen next is the best way of reducing errors. This is why we have created the free My Fertility Diary app (www.myfertilitydiary.com); it allows patients to track and monitor the progress of their IVF cycle. If they know what’s going on, they are empowered to speak up when the cycle does not progress as planned.