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:
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:
Google Play Store:
|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
|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.|
|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|