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 | |
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| August | |
It is common to change our minds about things. We might decide we want spaghetti instead of tacos for dinner. We might even decide on spaghetti tacos (that is a thing). However, it becomes a little more complicated when the decision is regarding having children and permanent birth control has already been put in place. A common form of permanent birth is tubal ligation or as most people refer to it “tying your tubes.” In this procedure, the fallopian tubes are cut and tied. By doing so, eggs can no longer travel down the fallopian tubes and no sperm can climb up the fallopian tubes to reach the egg. This will prevent any contact from occurring between the two gametes.
Is it permanent?
You might have noticed we said “permanent.” For the most part that is true. Once a woman undergoes tubal ligation, she does not need to worry about an unwanted pregnancy from that point onwards. Is it possible to reverse this procedure? In fact, it is! This does not necessarily mean that you are guaranteed a pregnancy after reversal. In fact, only approximately 50-80% of women become pregnant after reversing the ligation.
Why might IVF not work after tubal ligation?
There are several reasons for this. One of them is that when trying to undo the procedure, the stumps left after the procedure are beyond repair and scarred. Another reason is the development of another condition such as pelvic inflammatory disease or endometriosis. Lastly, it might not have anything to do with your body. Your partner’s sperm count or motility could be very low. Yes, male factor infertility is a thing. Infertility is not only a woman’s problem.
Ectopic pregnancies might occur after the reversal procedure. This is when the egg implants itself in the fallopian tube rather than the uterus. The chances of this happening post-reversal is 10% and the consequences could be fatal. Age is another factor. Women in their 40s have lower chances of conceiving and IVF is not recommended. Even if there are no complications witht he reversal, low egg reserve may end up preventing a pregnancy. Nevertheless, IVF will increase the chances of a successful pregnancy after tubal ligation rather than trying to conceive naturally.
Our final thoughts
IVF is expensive and tubal ligation is essentially a surgery that will also cost money. When making these decisions, make sure you are financially planning ahead of time. Whether you think the risk is worth it is completely up to you. No one is able to gauge the benefit of taking risks regarding your fertility except you. You will know what choice is right and not another individual. IVF after tubal ligation is a complicated topic. Every woman’s body is different and as we have seen even with a successful reversal of the ligation, the development of certain conditions and as a woman ages, the chances of pregnancy may decrease. Make sure you confide in your reproductive endocrinologist to find what is best for you. If you have not had ligation done yet, and are not sure if you want it, also confide in your doctor and they can walk you through the pros and cons of the different options. It’s a tricky road to navigate, but not impossible!
References:
- “IVF After Tubal Ligation: University Reproductive Associates ….” https://www.uranj.com/blog/ivf-after-tubal-ligation. Accessed 18 Sep. 2020.
- “Tubal Reversal vs. IVF? | Shady Grove Fertility Blog.” 4 Feb. 2020, https://www.shadygrovefertility.com/blog/diagnosing-infertility/tubal-reversal-vs-ivf-0/. Accessed 18 Sep. 2020.
“Tubal Ligation | Johns Hopkins Medicine.” https://www.hopkinsmedicine.org/health/treatment-tests-and-therapies/tubal-ligation. Accessed 18 Sep. 2020.
Parents to be embarking on the surrogacy journey are often faced with the predicament of bonding with their unborn child. It might seem like forming a connection with your child growing inside another woman’s womb is difficult however, there are actually several different ways which you can enjoy feeling closer to your little precious baby.
Talk to them
It’s as simple as that. If you reside in the same city or country as your surrogate, you can plan visits to get some exclusive time to talk to your baby, so that they identify with your voice from early on. However, in many instances, Intended Parents are geographically miles apart from the surrogate and their baby, in which case it’s still fairly easy to converse with you child. Thanks to good technology, you can send plenty of voice notes to the surro-mama for relaying to the baby, including your favorite songs, bedtime stories, poems or lullabies. Listening to you repeatedly will help them familiarize themselves with your voice.
Baby’s preferences
Pregnant women often talk about their babies being most active at night when they lay down. Studies reveal that is probably because while you’re walking around or doing house chores, the movement lulls the baby to sleep. And when you’re sitting or lying down, the baby wakes up due to the lack of movement. This explains why newborns want to be “rocked” to sleep. Experiencing tiny things like these during your surrogacy journey might seem like a challenge but small steps and tips can really make you feel better connected.
Ask your surrogate about your baby’s preferences and activity times. Babies also respond to certain flavors favorably while inside. Ask the surro-mama what kind of cravings is the baby inducing? Does she crave sweets or more savory foods? That’s a good clue to finding out what your little one’s taste-buds (developed at week 13-15 already) enjoy more.
Decorate the nursery
Assemble difficult nursery furniture and pick out shades for the accent wall to foster a sense of anticipation and excitement for the new addition, arriving soon! Utilize this time proactively and get the nursery ready for the arrival of the stork and your little bundle of joy. Once the baby comes home, he/she might not be able to acknowledge your efforts right away as he/she makes messes on the spotless white rug you picked for the room, but trust me, it’s all the worth the effort.
Baby Registry
The importance of this cannot be emphasized enough. List down all the essential items you will need once the baby is here, which might seem like the entire inventory of BuyBuyBaby, however talk to your friends and family and discuss what items you’d need absolutely ready before the grand arrival. Picking out stuff you love and coordinating it with everything you’ve learned about the baby can help you feel even more emotionally connected.
Baby’s sense of smell
Your baby’s 5 senses begin developing inside the womb somewhere between weeks 16 to 21. Intended Parents can ask the surro-mama to start keeping a teddy-bear next to her during this timeframe to help the baby take in and familiarize himself/herself with some scents. Once the baby is born, the stuffed toy can travel to the IP’s home with them, serving as a transitional connection for the baby.
Birth of baby
When the moment you’ve been impatiently waiting for, for far more than 9 months finally arrives, try and let the baby confirm their senses as he/she struggles to touch the surro-mama’s face or hands. In all fairness, it’s what they’re most easily able to recognize so make sure to allow some time for the baby and surro-mama to spend together in physical contact just so the baby can ease into the life outside the womb. Be wary of whether your surrogate is emotionally ready to hold the baby or not and plan your post-birth activities accordingly.
Skin-to-skin contact
Spend lots of skin-to-skin time together. There’s nothing stronger than the power of touch while you hold your tiny miracle in your arms. Make sure to cradle and caress the baby abundantly, helping him/her acknowledge and recognize your touch.
Final Thoughts
Surrogacy is definitely not an easy journey, for either the Intended Parents or the Surrogate however employing certain behaviors and techniques can aid your and the baby’s transition from the womb to your home.
If you’ve decided to go the surrogacy path, we are here to help make the process as easy and stress-free for you as possible. Patriot Conceptions is one of LA’s leading surrogacy facilities with a vast pool of dedicated, loving and compassionate surrogates, and we are proud to partner with them in helping make surrogacy a blissful reality for you.