Paths of Action
Creating Smarter Oversight and Accountability in IVF
Improving IVF safety in California (and eventually beyond) requires a coordinated approach involving law, regulation, clinics, and public awareness. This page outlines clear, achievable steps toward systems that protect families, support providers, and significantly reduce preventable risk.
1. Legislative Action
Why This Matters
Currently, IVF is governed by a patchwork of federal reporting requirements and voluntary accreditation programs, but there is no enforceable state law that sets uniform safety standards for how IVF clinics handle, track, and verify embryos. In the U.S., clinics report success rates under the Fertility Clinic Success Rate and Certification Act, but adverse events and errors are not tracked in a comprehensive public system. CDC
What We Propose
Working with California legislators, we aim to support laws that:
Require clinics to report serious errors to a designated oversight body
Set minimum licensing and safety standards for all IVF providers
Define clear protocols for handling, labeling, and storing embryos
Support genetic identity verification prior to transfer
Establish consequences for non-compliance that are proportionate and enforceable
These policies won’t undermine quality care, they support consistency and accountability.
2. Establish a State Oversight Division
Why This Matters
Federal reporting systems like the CDC’s ART surveillance track outcomes, but no state agency currently inspects and enforces safety practices in IVF clinics directly. Multiple federal agencies influence aspects of reproductive care (CDC, FDA, CMS), and professional groups provide guidance, but enforcement authority remains decentralized. Reproductive Facts
What We Propose
A dedicated division within California’s Department of Public Health focused on Assisted Reproductive Technology (ART) could:
License and inspect IVF clinics regularly
Maintain a centralized database for reported errors and procedural issues
Create a patient complaint portal tied to enforcement authority
Publish summaries of compliance trends to inform families and policymakers
Oversight with transparency builds public confidence without overburdening providers.
3. Independent Accreditation and Certification
Why This Matters
Voluntary accreditation by organizations like the College of American Pathologists (CAP) and The Joint Commission helps clinics adopt best practices. However, not all clinics pursue or maintain these accreditations, and self-regulation alone leaves variability in standards. ASRM
What We Propose
California could require IVF clinics to be accredited by recognized bodies as a condition of their operating license. Accreditation standards would include:
Uniform protocols for embryo tracking
Verification steps and documentation controls
Certification requirements for all personnel handling gametes and embryos
This creates consistency without presuming malfeasance.
4. Transparency and Reporting Standards
Why This Matters
Published clinic success rates help families compare outcomes, but currently there is no requirement to publicly report safety data such as mix-ups, storage incidents, or near misses. CDC
What We Propose
California oversight could include:
Publicly accessible clinic safety and compliance records
Mandatory reporting of significant errors to a registry
Encouraging voluntary reporting of “near misses” so the industry can learn from patterns
Transparent reporting helps patients make informed choices and highlights systemic improvements.
5. Statewide Genetic Verification Support
Why This Matters
Misidentification errors in IVF occur when sample handling fails. Peer-reviewed analyses show that lab errors often stem from mislabeling, documentation mistakes, or human factors. Springer
What We Propose
While genetic verification prior to transfer is not yet universal practice, requiring this step (or offering funding to help clinics implement it) could significantly reduce risk. The state could:
Encourage DNA confirmation of embryo identity before transfer
Provide grants or assistance for smaller clinics adopting this technology
Work with standards bodies to set clear, consistent protocols
This doesn’t replace human checks, it reinforces them.
6. Education and Public Awareness
Why This Matters
Families often don’t realize the variability in safety practices across clinics. Public demand for accountability is a powerful driver of change. STAT
What We Do
Hope Without Harm will:
Share personal and expert stories in media and public forums
Host informational workshops and webinars
Publish resources explaining what patients can ask and expect from clinics
Knowledge is leverage. Informed families help shape better systems.
7. Pilot Programs and Collaborative Innovation
Why This Matters
Policy change is easier when there are clear examples of what works.
What We Propose
Partner with willing clinics to pilot:
Biometric verification systems
Automated electronic tracking for embryo handling
Error-reporting and near-miss learning systems
Measuring and publishing results builds evidence that can drive broader adoption.
8. California as a National Model for Reform
California’s leadership in medicine and public health makes it well-positioned to pioneer IVF safety reforms that respect innovation while protecting families.
By demonstrating practical, data-informed oversight in one state, we can help shape broader conversations across the U.S.
Sources & Further Reading
CDC National ART Surveillance System: Federal reporting requirements for IVF success rates and clinic data. CDC
Fertility Clinic Success Rate and Certification Act: Primary U.S. law requiring IVF clinic reporting. Wikipedia
ART Oversight Landscape: Federal/state regulatory snapshot including CDC, FDA, and professional standards. Reproductive Facts
Human Error in IVF Labs: Analysis of error modes in clinical IVF. Springer
Need for Transparency and Regulation: Commentary by reproductive medicine experts about oversight needs. STAT