September is a great time to perform an FDA Compliance quality assurance audit in your IVF Lab!
This blog post will provide you with a month’s schedule of specific quality assurance activities that will keep your IVF lab compliant with FDA Title 21 Code of Federal Regulations (CFR) Part 1271 and College of American Pathologist inspections. It will also provide background on FDA and CAP requirements.
FDA requires prospective egg and sperm donors to be tested for HIV, Hepatitis B and C, chlamydia, and gonorrhea, and for stored embryos, eggs, and sperm to be labeled so they don’t get mixed up. The FDA has the power to inspect and shut down IVF labs if they don’t meet the legal requirements.
Donated reproductive tissue (eggs or sperm) are regulated as human cells, tissues, and cellular and tissue-based products (HCT/Ps). Any establishment that performs one or more manufacturing steps for HCT/Ps (recovery, processing, storage, labeling, packaging or distribution of products) must register with FDA and list their HCT/Ps in accordance with Title 21 Code of Federal Regulations (CFR) Part 1271.
Reproductive HCT/P donors are required to be screened for risk factors that may increase the chances of transmitting a communicable disease.
Donor screening consists of reviewing the donor’s relevant medical records for risk factors for, and clinical evidence of, relevant communicable disease agents and diseases. These records include a current donor medical history interview to determine medical history and relevant social behavior, a current physical examination, and treatments related to medical conditions that may suggest the donor is at increased risk for a relevant communicable disease.
FDA Donor HCT/P Eligibility Determination: 3 Necessary Factors
Donor screening must document three items: donor medical history (ie risk factor assessment), physical exam and review of other relevant medical records, and donor infectious disease testing. After those items are reviewed by a physician or responsible person, a donor eligibility determination can be made. Donors can be deemed “eligible” for anonymous donation, or “ineligible” (and therefore the donation can only be directed, not anonymous). An ineligible directed reproductive tissue donor can provide semen, oocytes, or embryos, to a specific recipient, and who knows and is known by the recipient before donation, provided they are counseled appropriately and sign a waiver.
What is the IVF lab’s responsibility for maintaining FDA compliance?
Both FDA and CAP have specific requirements for IVF labs to follow. The IVF laboratory must be registered with FDA and have a procedure for reporting device-related adverse patient events, donor records must include a statement of eligibility or ineligibility and a summary of the records used to make the donor-eligibility determination, and there must be a written procedure for investigating donor infections or adverse events after reproductive donor cells/tissues are received or implanted.
Donor cells/tissues must be labeled with the following information in accordance with the intended use:
- Unique identification code
- Description of the type of cells/tissue(s)
- Expiration date (if any)
- Warnings (if any)
- Name and address of the establishment that made the eligibility determination and made the cells/tissue(s) available for distribution
Furthermore, for testing performed by clinical lab staff in Endocrinology or Andrology, prior to clinical use of each modified FDA-cleared or approved test and laboratory-developed tests (LDTs), the laboratory must perform a validation study and prepare a written assessment of each of the following test method performance specifications. Whenever available, reagents and supplies used in the collection, processing and cryopreservation of gametes and/or embryos should be cleared or approved by FDA for human use.
Lastly, the entire staff should be competent in FDA related skills and knowledge, and the IVF laboratory director or designee must interact with agencies FDA, as appropriate, for laboratory-related matters.
| FDA Related CAP Requirements | |
| GEN.20351: Adverse Patient Event Reporting | |
| RLM.12455: FDA Registration | |
| RLM.12510: Donor Cells/Tissues Labeling | |
| RLM.12587: Donor Infection/Adverse Events Investigation | |
| DRA.11450: Director Responsibility – Interaction with Government or Regulatory Interaction | |
| COM.40350: Validation of Test Performance Specifications | |
| RLM.03480: FDA-Cleared/Approved Reagents and Supplies |
One Month Schedule of FDA related IVF Lab QA Activities
Start each month by answering “In Progress” to each question, then assign this survey to junior staff using the “assign” button. This will document both continuing education and quality assurance activities.
| Create or update a schematic map of all tank or canister eligibilities | Post up to date schematic in tank room(s). Download our editable template here! Tank-Schematic-1-1. |
| Review Tissue in Donor Canisters/ Tanks | Move all eligible donors to a single canister or tank. Update cryo records and log books. |
| Separate Sperm and Egg Bank Donor Binders | Particularly review shipping records to ensure that when donor tissue is received it is located in the correct binder, tank, and canister. |
| Take the FDA Survey in the ART Compass app and assign survey to staff | Review competency results and assign any needed remediation. Download the free ART Compass app Apple App Store: https://itunes.apple.com/us/app/art-compass/id1442048939?mt=8 Google Play Store: https://play.google.com/store/apps/details?id=com.artproficiencyapp |
| Update FDA Cryopreserved tissues eligibility forms | Copy language directly from HCTP and replace out of date language. |
| Review Summary of Records forms | Update out of date language by reviewing FDA Warning Letters (search for “fertility”). |
| Review Donor Risk Checklist / Questionnaire for updated risk questions | Update out-of-date language by reviewing FDA Warning Letters (search for “fertility”). |
| Review Requisitions for tissue type – anonymous, directed donor, and for future GC | Correct sperm freezing, egg cryo, and IVF requisitions so that IVF Lab can put an accurate FDA Cover sheet or sticker with each cryo record. |
| Review FDA eligibility form or stickers with each cryopreserved tissue by randomly selecting 10 GC transfers, 10 Egg Donor Embryos, and 10 Sperm Donor Embryos | Hold a staff meeting to ensure that each FDA eligibility status’ are used correctly. Goal of 100% compliance. Document staff/ lab meeting. |
| Review one full binder of sperm records and one full binder of embryo records for presence of FDA Eligibility sheets or stickers. If missing more than 3 per binder review all binders. | Replace or correct any FDA Eligibility sheets in each binder. |
| Read and sign off on all FDA related policies and procedures | Document each person for each Policy and Procedure. Assign them to staff and records annual sign offs in the ARTC Document control system. |
| Read FDA Warning Letters for fertility clinics. | Discussion deviations in a lab meeting and document meeting. |
| Review all tests and devices used and check for new FDA approved products. | Still using unapproved tests or devices? Are there any new tests of devices that can replace the unapproved ones? |
| Review any FDA reportable adverse donor or device events | Perform a Root Cause Analysis to determine the cause of any incidents. Notify the Laboratory Administrator and the Laboratory Director of the findings. Complete FORM FDA 3500 either in paper format or online at www.fda.gov/medwatch/report.htm |
| IVF Lab Director Responsibilities | Create a folder with evidence of compliance, such as records, reports, or responses to FDA. Make sure to notify FDA of any change in directorship! Update FDA Registration menu. |
| Audit companies that perform any manufacturing step for the IVF laboratory | Check the FDA website for current registration, possible FDA actions against contractors, and patient comments. Take action on any notification of defects or issue with supplies that may affect patient care and document actions. |
| Hold Mock FDA Inspection. | Are you ready for FDA to show up at your IVF Clinic? Review electronic medical records of donor tissue recipients and “provide recommendations” in a mock inspection. |
| September | FDA Audit |
| October | Staff Audit |
| November | Patient Satisfaction and Security |
| December | Space and Supplies |
| January | Preventative Maintenance, Air Quality, and Deep Clean |
| February | Biennial P&P Updates, Review, and Sign Off |
| March | General IVF lab CAP Inspection Preparations |
| April | |
| May | |
| June | |
| July | |
| August | |
Wait hold up. Isn’t a gestational carrier a surrogate? The answer to that question is yes-and-no. Both persons perform the same job: helping a couple have their miracle baby by carrying a child for them. However, a surrogate will be the biological mother of the child because she has donated her egg to make the baby she is carrying. A gestational carrier is not the biological mother of the child she is carrying.
Image by Brodie Vissers
Who requires a gestational carrier?
There are a variety of reasons for wanting to have a gestational carrier.
- The woman’s uterus is not able to carry a baby
- The woman may be experiencing certain disorders that hinder her ability to carry a child such as “extensive fibroids, scarring of the uterine cavity or adenomyosis” (Yale Medicine)
- The woman might have had several failed pregnancies, stillbirths, and miscarriages, which indicate another pregnancy might not yield good results.
- The woman has experienced complications while giving birth that is a cause for concern and may indicate another pregnancy could be fatal for the mother or baby.
What is the procedure for a gestational carrier?
It might differ slightly from one clinic to another. Essentially, it is the same. In this article, we will include what the process is like at Yale Medicine as described by the clinic itself! It begins with an evaluation of the gestational carrier. This evaluation is both psychological and physical. This is to ensure that the gestational carrier is ready to take on the overwhelming job of carrying another individual’s baby. The woman then undergoes a practice embryo transfer. By undergoing a practice run, the specialists are able to gain a better understanding of how the GC’s uterus will respond to the medications required to prepare the uterus for the transfer. Once the GC’s ovulation is aligned with the biological mother’s, the embryo is transferred and the hard part is essentially over! From there onwards it’s simply a regular pregnancy.
Gestational Carriers are Growing in Popularity
As the scientific field progresses, more and more gestational carriers are being used by infertile couples. In fact, the CDC has some data that can help put it into perspective!
- During the period of 1999 to 2013, 2% of all artificial reproductive technology cycles involved a gestational carrier. This equates to 30,927 cycles.
- The couples using a GC were often older.
- GC cycles had better rates of live pregnancy when compared to the cycles which did not have a GC.
- Multiple births were more common among GC cycles
How to Find a Gestational Carrier and Things to Keep in Mind
One of the first steps is finding a surrogacy agency. Steps after that involve choosing the GC and reviewing the abundant legal matters that surround the situation. These govern every aspect, from the extent of involvement of the intended parents during the pregnancy and whether the child will have contact with the GC when he or she grows up.
Knowing whether a GC is right for you is a conversation involving you, your partner, and your fertility doctor. People may have their own opinions about your use of a GC. They might see it as unnatural and belittle you for the choices you have made. At the end of the day, they don’t have all the information to be making claims about your fertility. Check out some of the articles we have referenced to explore more aspects of having a GC!
References:
- “Surrogacy: Who decides to become a gestational carrier ….” 5 Mar. 2020, https://www.health.harvard.edu/blog/surrogacy-who-decides-to-become-a-gestational-carrier-2020030519052. Accessed 18 Sep. 2020.
- “ART and Gestational Carriers | Key Findings | Assisted … – CDC.” 5 Aug. 2016, https://www.cdc.gov/art/key-findings/gestational-carriers.html. Accessed 18 Sep. 2020.
“Gestational Surrogacy > Condition at Yale Medicine.” https://www.yalemedicine.org/conditions/gestational-surrogacy/. Accessed 18 Sep. 2020.