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How the GENESIS process assures the accuracy of our patient specimens

IVF lab security and specimen ID accuracy

In Vitro Fertilization (IVF) and Intrauterine Insemination (IUI) are well-established, safe and effective treatment options for infertility. But sometimes patients are concerned about the journey their specimens take after retrieval and before transfer.

To set our patients’ minds at ease, our laboratory director, Dr. Alka Goyal, answers some pressing questions about how the laboratory staff at GENESIS assures accuracy in identifying patient eggs, sperm, and embryos.

It starts with proper labeling

Proper labeling and record keeping is a critical component of our lab activity. The security protocols that all staff at GENESIS must follow assure specimen ID accuracy and safeguard our patients against lab mix ups.

Before cycling, each patient has a unique label created for them containing their first and last name, date of birth (DOB), unique identifier number, partner information and date of procedure, among other details of the procedure.

These labels are placed on every page of the patient’s chart, as well as the lid of the incubator, which will hold their embryos for the duration of their culture. Each patient is assigned a separate incubator and dishes are labeled with their name and date of birth. Every step, from collection to insemination (assessment, biopsy, transfer, freezing of gametes or embryos) is witnessed and documented with a signature and time.

How do I know the frozen eggs, sperm or embryos are actually mine?

For the safety of our patients, only one patient’s specimen can be handled on the workbench at any moment in time. In addition, all of our patient gametes – whether eggs, sperm or embryos – are handled with a Chain of Custody protocol. This means that all specimens must be accurately identified by two people throughout each step of all tests and procedures. Every time a sample is touched, that information is logged.

What practices does GENESIS use for specimen accuracy when storing frozen eggs, sperm and embryos?

The holding unit is labeled using, at minimum, the patient’s first and last names, date of birth and the date of freeze. Every cryopreservation event is recorded on a cryopreservation sheet. The cryopreservation sheet also includes the storage location for the material, including the tank and canister. Every cryopreservation event is also recorded in our EMR and an Excel cryostorage database; which is on a computer server that is backed up every day.

What safeguards does GENESIS use for accuracy when specimens are removed from cryostorage for thawing, disposal or transfer to a patient?

When specimens are removed from cryostorage, the appropriate log record is accessed and the event is documented. The freeze label from the straw container is detached from the straw and attached to the thaw/ transfer sheet of the patient to ensure that the correct embryo is thawed. All these procedures are witnessed by two people.

When procedure dishes are prepared, each dish is labeled with the patient’s full name. Immediately before the transfer, the patient’s name and date of birth is again verified with the patient to ensure accuracy. The patient is also given a photograph of the embryo being transferred.

Our Lab Credentials

GENESIS maintains and operates three state-of-the-art laboratories licensed by the New York State Department of Health (NYSDOH) and the U.S. Food and Drug Administration (FDA). We are accredited by CAP (College of American Pathologist). In fact, we passed our 2023 inspection without any deficiencies at all. GENESIS is also proud to be a member in good standing with the Society for Assisted Reproductive Technology (SART).

Our Lab Director

Alka Goyal, PhD, HCLD/CC is the Director of Laboratories at GENESIS. She has been involved in the field of reproductive medicine for over 30 years. Dr. Goyal holds a High Complexity Laboratory Director’s license and a Clinical Consultant certification from the American Board of Bioanalysis. She also has the NYSDOH Laboratory Director certification , as well as lab director certification from CFAS (Canadian Fertility & Andrology Society). Dr. Goyal has also completed the GCSRT (Global Clinical Scholars Research Training Program) for Harvard Medical School, Boston.

Original post July 17, 2019
Updated February 16, 2024

If you would like to learn more about GENESIS Fertility New York or are ready to schedule an appointment, please speak with one of our representatives at 718-GENESIS.

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