Quality of Patient Care in the Laboratory
The laboratory is designed to provide the best possible patient care. The primary objectives are to maximize the viability of embryos and to make sure that no mishaps occur. To achieve these primary objectives, the laboratory has fine–tuned its procedures and created a work environment that is conducive to achieving high standards.
Further improvements are continuously made as new information emerges from published data and from the evaluation of our own results. The laboratory uses an “evidence-based” approach to introducing changes to its protocol: each change has to result in a measurable improvement in our hands in order to be adopted.
Significant efforts have been taken to adopt procedures that minimize the chances of human error. Particular attention is paid to patient identification. All publicly available details of reported incidents in patient identification have been carefully reviewed and used to strengthen the security of the patient identification process.
Patient identification is aided by allocating a different color code to each patient. The patient’s name is confirmed before oocyte collection and every time oocytes or embryos are moved into a different dish. Similarly, the name and the color code are confirmed before the insemination of oocytes and the freezing of embryos. The patients are requested to confirm their full name and date of birth before embryo transfer and the identification process is fully documented.
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Laboratory Standards
The laboratory is accredited by the Reproductive Laboratory Program of the College of American Pathologists (CAP) which was initiated by the American Society for Reproductive Medicine (ASRM). The accreditation program requires the Laboratory Director to be board certified and members of staff to participate in continuous medical education. It also involves rigorous annual inspections to ensure that the standards of quality are maintained and improved. Our commitment to excellence in combination with accreditation and certification ensures the high standards of our laboratory.
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The Laboratory Environment
The operation of the IVF Laboratory in many respects is similar to the operation of a neonatal intensive care unit since it requires exacting standards just like providing life support for premature babies. Therefore, the maintenance of laboratory instruments and equipment is of paramount importance. Everyday maintenance tasks are performed by the laboratory staff while additional technical and logistical support is provided by the Alta Bates Medical Center engineers. The benefits of affiliation with a major hospital include 24/7 on-site support by engineers for tasks that require such expertise. The combination of continuous maintenance by laboratory staff and ready availability of engineering support ensures the smooth operation of all instruments and equipment.
The Alta Bates Summit Medical Center also provides multiple levels of state of the art security to guarantee that only authorized personnel have access to the laboratory. Limiting access to authorized personnel is just one of the measures to maintain the security and cleanliness of the laboratory.
Authorized personnel must wear scrubs, shoe covers and surgical hats before entering the lab. The embryo laboratory is equipped with a HEPA air filtration system that creates positive pressure by pumping in clean air. The positive pressure prevents dust particles from entering the lab while the air inside the lab is continuously filtered.
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Preparation for IVF Cases
Upcoming IVF cases are discussed at regular meetings between clinical and laboratory staff. During these meetings all the relevant details of patient’s history are reviewed. Unusual cases are given extra time and effort including consultations with urologists or other specialists as appropriate. After a thorough review, an individualized treatment plan is formulated.
Petri dishes for the culture of oocytes and embryos are prepared in the laboratory based on the individualized treatment plan. The dishes are prepared 1 day ahead of the case to allow time for the embryo culture medium to reach temperature and pH equilibration. We engrave the patient’s name on the bottom of dishes which is a better form of identification than writing on the lid of the dish.
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Oocyte Recovery
Laboratory procedures associated with IVF cycles are performed at the Alta Bates Campus of the Medical Center. The oocytes are recovered in the operating room of the Surgery Department using standard ultrasound-guided aspiration. The embryologist uses a portable isolette to identify the eggs during the retrieval procedure allowing for instant communication between the clinician and the embryologist.
The isolette is a modified neonatal incubator that maintains body temperature and a gas phase resulting in physiologic pH levels. Thus it mimicks the environment inside the mother’s body. The use of the isolette for this purpose was described by Dr. Chetkowski and collaborators in 1983 while he was at UCLA (Dr. Chetkowski’s CV).
All work on eggs and embryos, with the sole exception of micromanipulation, is performed inside the controlled environment of the isolette.
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Semen Processing and Insemination
In most cases, semen samples for IVF are collected by ejaculation. In some forms of male factor infertility, however, there is no viable sperm in the ejaculate and it may be necessary to surgically to recover sperm from the epididymis or the testicles (What is MESA?). Semen samples are processed to concentrate or isolate the most viable sperm before insemination. Specimens with normal parameters are suitable for conventional insemination. This involves the overnight culture of the egg together with sperm. During that time sperm pass through the outside layers of the egg (including the zona) and penetrate the oocyte itself.
Sperm specimens which have low number of sperm or possibly reduced fertilizing capacity require microsurgical injection of sperm into the oocytes (What is ICSI?). In the most severe cases of male factor infertility, there may be no motile sperm available so that viable sperm cannot be selected on the basis of motility. In this situation, the most efficient way to select viable sperm, in our hands, is by the use of a stimulant (pentoxifylline) that induces motility. This sperm selection technique improves the success of ICSI.
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Fertilization Assessment and Embryo Culture
The fertilization of oocytes is assessed in the morning on the day following the insemination. At this time, we identify oocytes that contain two pronuclei (2PN)which is a sign of normal fertilization.
One of the two pronuclei contains the genetic information inherited from the oocyte and the other from the sperm. The union of the genetic information in the two pronuclei results in the unique genetic makeup of the embryo.
The fertilized oocytes are kept in culture and their development is assessed and recorded. The development of embryos in culture correlates with their potential to become a baby after transfer into the mother’s uterus. Therefore, the records of these observations are used to aid the selection of embryos for transfer or cryopreservation.
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Embryo Transfer
The embryos are usually transferred to the patient’s uterus either 2-3 days or 5-6 days after insemination. The transfer is a closely coordinated teamwork between the embryologist, the physician, ultrasound technician and the patient. The embryologist loads the embryos into a transfer catheter and the physician passes the catheter through the cervix and expels the embryos into the uterine cavity. The ultrasound technician assists the physician to visualize the passage of the location of the catheter inside the uterine cavity. The patient is requested to communicate any cramping she experiences during transfer. Finally, after the transfer catheter has been withdrawn, the embryologist confirms that the embryos have been expelled by rinsing the catheter.
The transfer can be an anxiety-provoking step for many patients. Therefore, we ensure that our patients receive emotional support from us as well as their partners or friends. We make a recommendation for the number of embryos to be transferred based on the patient’s individual circumstances. We also try to answer any questions you have before or after the transfer. At the conclusion of the transfer, we provide a printed report that gives full accounting of the fate of all oocytes and embryos and contains a picture of the transferred embryos.
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