With proper procedural steps and safeguards at a fertility clinic’s embryology lab, couples who undergo IVF should never receive the wrong embryos. This is why it is so important to follow IVF safeguards properly. When embryology labs are run by highly educated and skilled embryologists, unwarranted human errors should never occur. The strict protocols and safeguards for a highly-rated embryology lab will help to prevent embryo mix-ups from ever occurring.
Strict Embryo Transfer Protocol
In the past few months, the news has been covering a tragic story of a New York couple who underwent in vitro fertilization (IVF) and gave birth to two male babies from embryos that were not their own. According to a lawsuit, the couple was forced to give each child to his biological parents, which were also clients of the same fertility practice.
Unique Identification Numbers
At Fertility Centers of Illinois, every patient that has a fresh IVF or frozen embryo transfer (FET) cycle is assigned a unique accession number. The patients also have a unique MPI number assigned to them and used throughout their care at our clinics.
The unique accession number indicates that:
- The IVF cycle was performed at the Fertility Centers of Illinois Embryology Laboratory.
- The specific year the cycle was performed
- What number the patient falls within that year.
Every patient that has an IVF or FET cycle will also have a chart created with the assigned unique number. This chart contains information pertinent to their IVF or FET cycle. Information on the egg retrieval, semen preparation, insemination, embryo fertilization and development, embryo transfer, embryo thaw and cryopreservation will be entered in this chart. Information on who performed each procedure and verification data will also be entered in this chart. Patient demographic information, information on past infertility treatment, information on the current cycle including preimplantation genetic diagnosis (PGD) and lab results for infectious diseases is also entered on the patient chart. This information can also be found on the Artworks (electronic medical record) program.
Assigning Patient Incubators
Patients are also assigned their own incubator space where their gametes (eggs and sperm) and embryos (fertilized eggs) are kept until the completion of their cycle.
Patients are given two strips of a colored piece of tape that has their name, cycle date and incubator number. One strip is placed on the outside of the incubator; the other is placed on the inside of the incubator on the glass door. When assigning incubator tape colors, we make sure that no color is repeated on an incubator.
If and when two patients with similar names are in the laboratory at the same time, care is taken so mistakes are not made.
- First, a name alert sticker will be placed on the incubator to alert embryology staff to the issue.
- Second, these patients will be placed as far away from each other as possible so there is not confusion.
- Lastly, there is a name alert posted on the white board at the entrance to the laboratory. This is another way to alert the embryology staff to this issue. Incubator numbers are entered on the patient charts to allow the embryology staff to know where the gametes/embryos are located.
The Oocyte (Egg) Retrieval Process
During the oocyte retrieval process, our goal is to retrieve oocytes, fertilize them with sperm in vitro, and replace the embryos in the patient’s uterus in order to achieve pregnancy. The oocytes are retrieved via ultrasound-guided aspiration. The semen samples are collected by masturbation, by coitus with a seminal collection device or surgically.
The day before retrieval:
- The culture media is prepared.
- We verify the patient name, follicle number to be retrieved and time of retrieval from the posted schedule.
- We prepare the egg sheet by carefully transcribing patient information from the ARTWorks chart.
- We copy the patient stimulation sheet and attach to the egg sheet.
- We assign a tape color for the patient and affix the colored tape on the egg sheet, schedule and incubator.
- The Andrology Lab must also put the same color assigned on the tube containing the prepared sperm sample.
The day of egg retrieval:
- We identify the patient by verifying the patient’s name and DOB (date of birth) on the ID Bracelet put on by the Medical Assistant prior to the egg retrieval.
- We place prepared petri dishes under the blood gas funnel in the lab, making sure that the name on the dishes matches the patient in the room who is having eggs retrieved.
- We check the patient identification label on the egg sheet, which has the same information as on the ID Bracelet.
- We check the ARTworks “Cycle Plan” and make sure all the procedures marked actually match the information on the egg sheet and the IVF schedule.
Post egg retrieval:
- At the end of each egg retrieval procedure the reproductive endocrinologist who performed the egg retrieval walks into the lab to verify the name of the patient with the name on the culture dish.
- The reproductive endocrinologist also has a second person independently verify that the name on the culture dish used matches the name of the patient just retrieved. This individual signs the designated space on the egg sheet.
- Before performing any procedure on a patient’s eggs, sperm or embryos, we obtain a written or electronic request from an authorized person, generally a physician. We also obtain verification of informed consent.
Tubes containing sperm for insemination are clearly labeled with the color code designated for that patient, the patient’s and his or her partner’s names, and date processed. If the patient is using donor sperm; we label with the donor number along with sperm bank initials.
Only one patient insemination is ever performed at a time. We do not perform any other embryological procedure in the workstation while the insemination is taking place. The insemination is only performed after another embryologist verifies the patient name, specimen ID, and assigned color that corresponds to both the insemination dish and the tube containing the sperm. The embryologist documents the identity checks on the egg sheet.
Once oocytes have been recovered from follicular fluid and evaluated for maturity, they are inseminated with sperm so that IVF may occur or intracytoplasmic sperm injection (ICSI) is performed.
We record all observations on the patient’s egg sheet, including details of morphology and fertilization for each embryo, tech ID, and time and date of observation. Then we fill out the computerized fertilization report sheet and distribute, noting any unusual occurrences.
Disposition of Oocytes and Embryos
Oocytes that are not injected with sperm are disposed as hazardous waste in the appropriately labeled receptacles. All abnormal or not fertilized oocytes and embryos after culture is complete are kept in a basement of a special designated incubator (incubator # 20) for at least five days.
Great care is taken when discarding these oocytes and embryos to ensure that embryos are not accidentally discarded.
- Before discarding the dish, the embryologist uses a microscope to check what will be discarded.
- Using the daily task log, the embryology lab confirms that the patient has completed the culture before the embryos are discarded.
- Disposal of each oocyte and embryo is recorded on the patient’s egg sheet.
Upon completion of the IVF lab’s role in the cycle (after cryo determination is made on day 6/7), the egg sheet and accompanying records are reviewed and signed by the lab director or supervisors. The data is then entered into ArtWorks, the electronic medical record. The original copy of the egg sheet and accompanying records are filed in the IVF laboratory. Laboratory records are kept a minimum of five years.
The Embryo Transfer
Although it may seem obvious that correct identification of patient and embryos is vital, errors in communication can occur and could lead to a disastrous mistake, especially if there are patients with similar names undergoing treatment at the same time.
Fertility Centers of Illinois follows a routine discipline of identification in order to avoid the possibility of mistakes.
- We ensure that medical notes always accompany a patient who is being prepared for embryo transfer.
- The embryologist checks the name and date of birth verbally with the patient and compares it with the medical record.
- The embryologist confirms the information on the patient disposition sheet and sign.
- A second embryologist or physician verifies that the name on the dish matches the name of the patient undergoing the embryo transfer.
- The embryologist walks into the embryo transfer room and hands the catheter with the embryos and the syringe to the physician for transfer to the patient. The embryologist confirms the patient name and number of embryos transferred with the physician.
The Compassionate Fertility Doctor
It is important to work with a fertility doctor having over 38 years of clinical experience diagnosing infertility and designing customized IVF treatment plans for his patients.
Dr. Laurence A. Jacobs has two beautiful office located in Hoffman Estates IL and Buffalo Grove IL. Dr. Jacobs is the Senior Doctor at Fertility Centers of Illinois and has privileges in 10 fertility clinic locations and 2 IVF centers located in the Chicagoland area. After your initial consultation with Dr. Jacobs, you can choose from all convenient locations to pursue your customized IVF treatment plan.
Click the icon below to schedule your consultation with The Infertility Doctor – or – call 888.325.7389.