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Pinnacle Fertility FDA Compliance

 

Our Commitment to FDA Compliance at Pinnacle Fertility

Upholding the Highest Standards in Fertility Care
At Pinnacle Fertility, we understand that trust is the foundation of our relationship with our patients. Adhering to the stringent rules and regulations set by the FDA, we are dedicated to providing safe and effective fertility treatments.

FDA Requirements for Donors – We adhere to all FDA requirements as a part of our commitment to maintaining the highest standards of safety and compliance in our egg donation process. For further details on our adherence to FDA requirements, you can refer to the FDA’s guidelines here.

FDA Requirements for Egg Donors

  • Donor Physical Examination: All potential egg donors at our facility undergo a detailed physical examination. This thorough evaluation is designed to ensure that they are fit and suitable for the egg donation process.
  • Donor Questionnaire: To participate, egg donors fill out a detailed questionnaire regarding their medical and personal history.
    Infectious Disease Testing Protocol: Our protocol involves conducting rigorous tests for infectious diseases at an FDA-approved laboratory. These crucial tests are administered in the thirty (30) days prior to or within seven (7) days following the collection of eggs.
  • Criteria for Anonymous Donor Eligibility: For egg donors who choose to remain anonymous, adherence to FDA standards for tissue eligibility is a strict requirement.
  • Guidelines for Directed Donations: In situations involving directed (known) egg donors, there might be instances where the donated tissue does not meet standard eligibility criteria. In such cases, the tissue may still be eligible to be utilized, provided the tissue is appropriately labeled, and recipients must provide informed consent before use.

FDA Requirements for Donor Embryos

  • Infectious Disease Testing for Oocyte and Sperm Sources: Pursuant to applicable FDA requirements, we conduct infectious disease testing on both the oocyte (egg) and sperm sources. This includes testing for CMV (Cytomegalovirus) and HTLV (Human T-Lymphotropic Virus) types I and II, with IgM and IgG testing on the both sources at an FDA-approved laboratory.
  • Use of Ineligible Embryos: Embryos that are deemed ineligible may still be eligible to be utilized. In such cases, the tissue must be appropriately labeled, and recipients must provide informed consent before use.

FDA Requirements for Non-Identified (Anonymous) Sperm Donors

  • Donor Physical Examination: Each potential sperm donor undergoes a thorough physical exam designed to ensure that they are fit and suitable for sperm donation.
  • Donor Questionnaire: Sperm donors are required to complete a detailed questionnaire regarding their medical and personal history.
  • Medical History Review: A comprehensive review of the sperm donor’s medical history is conducted to assess any potential health risks.
    Infectious Disease Laboratory Tests: We perform infectious disease testing at an FDA-approved laboratory, including tests for CMV and HTLV types I and II IgM and IgG, within seven (7) days before or after sperm acquisition at an FDA-approved laboratory.
  • Six-Month Quarantine with Repeat Testing: Donated sperm is quarantined for six 6) months, followed by repeat infectious disease testing.
  • Eligibility for Tissue Use: Sperm donors must meet the eligibility criteria to use tissue as per FDA standards.

FDA Requirements for Directed (Known) Sperm Donors

  • Donor Physical Examination: Similar to anonymous sperm donors, potential directed sperm donors also undergo a comprehensive physical examination.
  • Donor Questionnaire: To participate, sperm donors are also required to fill out a detailed questionnaire regarding their medical and personal history.
  • Infectious Disease Laboratory Tests: Infectious disease testing, including CMV and HTLV types I and II IgM and IgG, is conducted within seven (7) days of sperm acquisition at an FDA-approved laboratory.
  • Use of Ineligible Sperm: In cases where the donated sperm tissue is ineligible, it may still be used, provided the tissue is appropriate labeled and recipients must provide informed consent before use.

Stringent Donor Screening and Testing
Our donor screening process is thorough and complies with applicable FDA requirements. We conduct extensive medical, genetic, and psychological evaluations designed to ensure donors are tested for infectious diseases to protect the health and safety of our patients.

FDA Female Donor Testing Includes

  1. CT/NG NAT – Chlamydia/Gonorrhea Nucleic Acid Test
  2. HBcAb, Total – Total Hepatitis B Core Antibody Test
  3. HBsAg – Hepatitis B Surface Antigen Test
  4. HCV Ab – Hepatitis C Antibody Test
  5. HIV-1/HCV/HBV Ultrio NAT – HIV/Hepatitis C/Hepatitis B Nucleic Acid Test
  6. HIV-1/2 Plus O EIA – HIV-1/2 Plus O Enzyme Immunoassay
  7. T. pallidum, IgG (Syphilis) – Syphilis IgG Antibody Test
  8. West Nile Virus, RNA – West Nile Virus RNA Test
  9. TSE/CJD

FDA Male Donor Testing Includes

  1. CMV, Total w/ reflex to IgM/IgG – Cytomegalovirus Total Antibodies with Reflex to IgM and IgG
  2. CT/NG NAT – Chlamydia/Gonorrhea Nucleic Acid Amplification Test
  3. HBcAb, Total w/ reflex to IgM – Hepatitis B Core Antibody Total with Reflex to IgM
  4. HBsAg w/ reflex to HBV DNA Quant – Hepatitis B Surface Antigen with Reflex to Hepatitis B Virus DNA Quantification
  5. HCV Ab w/ rfx to HCV RNA Quant – Hepatitis C Antibody with Reflex to Hepatitis C Virus RNA Quantification
  6. HIV-1/HCV/HBV Ultrio NAT – HIV-1/Hepatitis C/Hepatitis B Virus Ultrio Nucleic Acid Test
  7. HIV-1/2 Plus O EIA w/reflex to HIV-1, Quant – HIV-1/2 Plus O Enzyme Immunoassay with Reflex to HIV-1 Quantification
  8. HTLV I/II Ab – Human T-Lymphotropic Virus Types I/II Antibody
  9. T. pallidum, IgG (Syphilis) – Treponema pallidum IgG (Syphilis Antibody)
  10. West Nile Virus, RNA – West Nile Virus RNA Test
  11. TSE/CJD

Record-Keeping Standards
We maintain complete records of all procedures, donor information, and patient interactions. Our record-keeping practices are designed to be transparent and compliant with applicable FDA standards, providing an extra layer of safety and reassurance.

Adherence to Tissue Handling and Storage Protocols
We utilize cutting-edge technology for the handling, processing, and storage of reproductive tissues. We follow applicable FDA guidelines designed to ensure the highest quality and safety of these materials.

Quality Control and Assurance
Our facilities have robust quality control and assurance systems. We conduct regular audits and staff training designed to ensure that all equipment and procedures meet or exceed applicable FDA standards.

Conforming to Labeling and Packaging Guidelines
We adhere to applicable FDA requirements for labeling and packaging of reproductive tissues, which are designed to ensure accurate identification and minimizing the risk of mix-ups.

Prioritizing Patient Safety
We are committed to promptly reporting any adverse events in accordance with applicable FDA regulations. This practice is designed to meet applicable safety standards and contribute to national safety monitoring.

Certification and Compliance
Pinnacle Fertility is FDA-registered for processing of reproductive tissue and also complies with the standards of professional fertility organizations such as American Society for Reproductive Medicine (ASRM), reaffirming our commitment to excellence in fertility care.