It was all over the news in 2009 that in a tragic mix-up, a patient revealed that the fertility clinic where she underwent in vitro fertilization (IVF) transferred another couple's embryos into her uterus by mistake … and she recently delivered the baby!!! With proper procedural steps and safeguards at a fertility clinic’s embryology lab, that should NEVER happen! The following discussion about proper Embryology standard operating procedures outlines why a couple should never get the wrong embryos… if these IVF safeguards are followed properly.
UNIQUE IDENTIFICATION NUMBERS
Every patient that has a fresh IVF or frozen embryo transfer (FET) cycle will be assigned a unique accession number. The patients will also have a unique MPI number assigned to them and used throughout their care at our Fertility Centers of Illinois (FCI) IVF clinics. (FCI-Highland Park IVF and FCI-River North IVF)
The number indicates that the IVF cycle was performed at the FCI- Embryology Laboratory, in which year the cycle was performed and 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 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
Every patient will be assigned their own incubator space where their gametes (eggs and sperm) and embryos (fertilized eggs) are kept until the completion of their cycle.
Each patient will have two strips of a colored piece of tape that has their name, cycle date and incubator number.One strip will be placed on the outside of their incubator; the other will be 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 as possible so there is not confusion. Lastly, there will be 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.
OOCYTE (EGG) RETRIEVAL
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.
Oocytes are retrieved via ultra sound guided aspiration.
The semen samples will be collected by masturbation, by coitus with a seminal collection device, or surgically.
The Day before Retrieval
Prepare culture media; Aseptic techniques are required at all stages.
Verify the patient name, follicle number to be retrieved and time of retrieval from the posted schedule. Prepareegg sheet by carefully transcribing patient information from ARTWorks chart. We copy the patient stimulation sheet and attach to 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 use the same color assigned on the tube containing the prepared sperm sample.
Egg Retrieval Day
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 (ER). Place prepared petri dishes under blood gas funnel in the labmaking sure that name on dishes matches the patient in the room for retrieval.
Check the patient identification label on the egg sheet, which has the same information as on the ID Bracelet. Next, check the ARTworks ‘Cycle plan’ and make sure all the procedures marked match the information on the egg sheet and the IVF schedule.
At the end of each egg retrieval procedure the retrieval RE physician walks into the lab to verify the name of the patient with the name on the culture dish and get a second Independent Verification person that will verify that the name on the culture dish used matches the name of the patient just retrieved. This person is to sign the designated space on the egg sheet.
BEFORE PERFORMING ANY PROCEDURE ON PATIENT’S GAMETES (Eggs or Sperm):
The following must be performed: Obtaining written or electronic requests from an authorized person (usually a physician) before performing any procedure on patient’s gametes or embryos.
Verification of informed consent, which must be obtained before performing any procedures.
Tubes containing sperm for insemination are to be clearly labeled with the color code designated for that patient,patient’s names (patient and partner), date processed. If using donor sperm; label with donor number along with sperm bank initials.
Only one patient insemination is ever performed at a time. Do not perform any other embryological procedure in the workstation while the insemination is taking place! The insemination will only be performed after another embryologist verifies the patient name, specimen I.D, and assigned color that corresponds to both the insemination dish and the tube containing the sperm. Document the identity checks on the egg sheet.
INSEMINATION OF OOCYTES FOR IVF
Once oocytes have been recovered from follicular fluid and evaluated for maturity, they are inseminated with sperm so that in vitro fertilization may occur or ICSI (Intracytoplasmic Sperm Injection) is done.
RECORD OF EXAMINATIONS
Record all observations like details of morphology and fertilization for each embryo, including tech ID, time and date of observation on the patient’s egg sheet.
Fill out the computerized fertilization report sheet and distribute. Note any unusual occurrences.
DISPOSITION / DISPOSAL OF OOCYTES AND EMBRYOS
Oocytes not injected will be disposed as hazardous waste in the appropriately labeled receptacles. All abnormal or not fertilized oocytes and embryos after culture is complete must be kept in a basement of a special designated incubator (incubator # 20) for at least 5 days. During cleaning of this basement and finally discarding these embryos great care must be taken to each dish designated for discard.
The following actions must be taken:
Before discarding the dish use a microscope to check what will be discarded.
Confirm using the daily task log that the patient has completed culture before the embryos are discarded. Disposal of each oocyte and embryo will be recorded on the patient’s egg sheet. By following these actions, embryos are not accidently discarded.
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 will be reviewed and signed by the lab director or supervisors. The data is then entered into ArtWorks (electronic medical record). The original copy of the egg sheet and accompanying records is filed in the IVF laboratory. Laboratory records will be kept a minimum of five years.
Although it may seem obvious that correct identification of patient and embryos is vital, errors in communication do occur and may lead to a disastrous mistake, especially should there be patients with similar names undergoing treatment at the same time. Therefore, a routine discipline of identification is followed in order to avoid any possibility of mistakes:
1. Ensure that medical notes always accompany a patient who is being prepared for embryo transfer.
2. Identify the patient! The embryologist should check the name and Date of Birth verbally with the patient and compare with the medical record.
3. Confirm the information on the Patient Disposition sheet and sign.
4. Have a second embryologist/MD verify that the name on the dish matches the name of the patient having the embryo transfer.
5. Walk into the embryo transfer room and hand the catheter with the embryos and the syringe to the physician for transfer to the patient. Confirm with the physician the patient name and number of embryos transferred.
Embryology labs are run by highly trained and highly educated embryologists, but unwanted human errors can occur. The routine critical procedural steps and safeguards for a highly- rated embryology lab, as outlined above, with all the checks and balances and double checks, should however be able to prevent serious disastrous embryo mix ups from ever occurring.
Laurence A. Jacobs, M.D.