This is Part 1 of a two-part series. Part 2 covers backup capacity infrastructure, the CAP requirements that govern temperature-dependent equipment, and the year-end infrastructure checklist. This post covers the physical audit itself — what to prepare, how to safely handle tanks and canisters, how to reconcile your physical findings against your records, and what to do when things don’t match.

A cryostorage inventory audit is not a casual walkthrough. Done correctly, it is a systematic, dual-witnessed, documented process that confirms the identity, location, and compliance status of every specimen in your cryobank. Done carelessly, it creates the very risks it is supposed to prevent: labeling errors, thermal damage to samples, and documentation gaps that become compliance findings or patient safety events.

The procedure below is designed to be adapted into your lab’s SOPs. Every time-sensitive step is flagged. Every dual-witness requirement is noted.

Before You Touch a Tank: What to Gather First

A physical audit cannot begin until you have assembled the documentary baseline you will be reconciling against. Walking into a cryo room with a clipboard and no source data is not an audit — it is a tour.

Documents Required

Assemble the following before audit day:

– Cryosheets (paper and digital) — your current record of what is in each tank, organized by patient

– Tank maps — diagrams showing canister positions within each tank

– Canister and cane logs — records of what is loaded onto each cane within each canister

– EMR exports — patient-level and sample-level data from your electronic medical records system, including active versus inactive status and freeze/thaw history

– Billing ledger — to identify samples associated with active storage fee arrangements versus those with lapsed billing

– Consent forms — storage and disposition consents for each patient with samples in inventory

– Prior audit reports — if a previous audit was performed, its findings establish your baseline and flag any previously identified discrepancies that should have been resolved

 

Tools Required

– PPE: cryogenic gloves, face shield, and lab coat. Non-negotiable.

– Inventory tablets or audit sheets — pre-numbered paper audit reconciliation sheets are recommended even if you also use a tablet. Pre-numbering means every sheet is accounted for at the end of the audit; you cannot accidentally lose a page or quietly remove one without the gap being immediately obvious. This is a chain-of-custody control, not a bureaucratic formality.

– Barcode or RFID scanners — if your lab uses these for sample identification, have them charged and tested before audit day

– Discrepancy log forms — a dedicated form for recording mismatches, identity questions, and missing samples in real time, separate from the main audit sheets

– Tamper-evident seals — required if retagging is anticipated; see Section 4

Section I: Physical Inventory Reconciliation

The Goal

To verify that every specimen physically present in your cryobank matches a documented patient identity and a recorded storage location — and that every specimen documented in your records is physically present where it is supposed to be.

Tank-Level Procedure

Before opening any canister, complete a tank-level inspection for each storage vessel:

1. Assign a unique Tank Audit ID to this vessel for this audit cycle (e.g., AUDIT-2025-TANK-01).
2. Record: tank serial number, tank model, current LN₂ level, and monitoring system status.
3. Photograph the tank exterior label and log the image with the Tank Audit ID.
4. Note any physical damage, unusual condensation, frost patterns, or alarm history since the last audit.
5. Pull the tank map and confirm the number of canister positions occupied matches your records before proceeding to canister-level inspection.

Canister-Level Procedure

Work through each canister systematically. Do not open multiple canisters simultaneously.

Safe Canister Lift Procedure

Before beginning any lift, confirm PPE is in place — cryogenic gloves and face shield are required, not optional.

1. Identify the canister to be lifted using the tank map. Confirm the canister number on the tank map matches the canister handle label.
2. Using long-handled forceps or a specialized lifting hook, locate the canister handle within the tank neck and engage it carefully.
3. Unhook the canister from the bottom holder or spider assembly with a steady upward motion. Do not jerk or tilt.
4. Raise the canister slowly and vertically through the tank neck. Keep the canister within the neck of the tank for as long as the inspection allows.
5. **Do not lift the canister above the frost line** — the visible cold zone in the neck of the tank. Exposing canes to ambient temperature even briefly can compromise sample integrity. The frost line is your safety boundary.
6. Complete your canister-level inspection while the canister remains within the neck. Confirm: canister number, total cane count, and that all sample labels are legible, intact, and free of frost damage. Take and save an image of the top of the canister clearly showing all cane labels. 
7. Limit each lift to under 30 seconds. Return the canister to LN₂ before proceeding.
8. Allow a minimum of 3–5 minutes of re-equilibration time between consecutive lifts of the same canister. This allows samples to return to storage temperature before the next inspection pass. Follow your equipment manufacturer’s guidance if it specifies a different interval.
9. Cross-check the canister contents against the tank map before returning the canister to its position. Document any discrepancies immediately on the discrepancy log.
10. Re-secure the canister in the bottom holder and confirm it is seated correctly before moving to the next canister.

Sample-Level Verification

For samples requiring individual inspection, use a liquid nitrogen holding box — a small insulated vessel kept filled with LN₂ — to safely transfer canes from the canister for inspection without exposing them to ambient air.

Remove no more than 3–5 canes at a time into the holding box. Monitor LN₂ levels in the holding box continuously; refill before the level drops below the canes. Do not allow the holding box to run dry.

For each sample, confirm and record:

– Patient name or ID number

– Unique sample ID (straw or vial label)

– Date of cryopreservation

– Sample type (embryo, oocyte, sperm, or other)

– For embryos: stage and grade if labeled

– Straw or vial count per cane, and contents where labeled

– Physical location: Tank → Canister → Cane → Position

Return each cane to the canister promptly after verification. The total time any cane spends outside of LN₂ should be kept to an absolute minimum. Return all canes to the canister before replacing the canister in the tank. Do not leave canes in the holding box and move on to the next canister.

Retagging Protocol

If during audit you identify labels that are faded, illegible, inconsistent with current labeling standards, or non-standardized, retagging is required. This must be done under dual-witness conditions.

1. Both witnesses confirm the sample identity from all available source records before any new label is applied.
2. Create a new barcode or ID tag that matches the sample’s existing record exactly.
3. Preserve the original ID in the metadata and audit trail — do not discard the original identifier.
4. Apply tamper-evident seal if appropriate for your labeling system.
5. Record the retag event in the audit trail with both witness signatures, the original label description, the new label ID, and the date.

Performance Metrics: How Do You Know the Audit Was Successful?

Track the following metrics across audit cycles to measure improvement over time:

– % of inventory certified — the primary measure of cryobank integrity

– % of samples with valid consent — a measure of documentation compliance

– % of billing alignment — samples with active, matching storage fee agreements

– Number of unidentified materials — should trend toward zero across successive audits

– Time to reconcile per tank — efficiency metric that improves with process standardization

– Reduction in abandoned inventory — measures effectiveness of ongoing patient outreach programs

Tracking these metrics year over year turns the annual audit from a compliance exercise into a genuine quality improvement tool — one that tells you whether your processes are getting better, and where the remaining gaps are.

 

Closing Thoughts

A physical cryostorage audit is one of the most consequential things an IVF laboratory does. It is the process by which you confirm that the patients who entrusted you with their most irreplaceable biological material can trust that you actually know where it is, what condition it is in, and what will happen to it. Done with rigor and documented thoroughly, it is also one of your strongest demonstrations of compliance, quality, and institutional integrity.

December is the right time. The procedure is here. The rest is execution.

April Quality Audit: Temperature Dependent Backup Capacity 

The Infrastructure That Protects Everything

Every December, while most of the world is winding down, IVF laboratory directors are doing the opposite. The slower clinical pace between holiday closures creates a rare and genuinely useful window — one that experienced lab directors learn to protect fiercely. It is the time to reconcile cryostorage databases against physical tank contents, dispose of embryos that have reached their consent end-dates, restock reagents, archive a year’s worth of records, and make sure the infrastructure holding everything together is ready for the next year.

None of this is glamorous. But if you have ever arrived on a Monday morning to find a liquid nitrogen tank alarm screaming, or worse, discovered it silently failed overnight, you understand exactly why backup capacity planning is not a topic you put off until spring.

Part 1 of this series covers the step-by-step physical audit procedure. This post covers temperature dependent lab equipment infrastructure and the CAP requirements that govern it.

 

Why December Is the Right Time for This

The IVF lab calendar has a natural rhythm. Cycle volumes typically dip between Christmas and New Year’s, giving laboratories a brief reprieve from the relentless pace of retrievals, fertilization checks, transfers, and biopsies. This window is not a vacation — it is an operational gift.

 

December is the ideal time to:

– Physically audit every cryostorage tank against your database records

– Identify and process embryos designated for discard, donation, or transfer of custody

– Deep clean incubators, workstations, laminar flow hoods, and cryo storage areas

– Reconcile reagent and supply inventories and place orders for Q1

– Archive paper and electronic records from the closing year

And the best part: you are now fully prepared to test and document backup systems for all temperature-sensitive equipment

 

Backup Capacity: The Infrastructure That Protects Everything

Temperature-dependent equipment in an IVF laboratory includes liquid nitrogen dewars and vapor-phase tanks for long-term cryostorage, incubators for embryo and gamete culture, refrigerators and freezers for reagent and media storage, and warming blocks and heated stages used during procedures. Each of these represents a potential single point of failure. The question is not whether one will fail — it is whether your lab is prepared when it does.

 

Liquid Nitrogen Storage: The Highest Stakes

Cryopreserved embryos, oocytes, and sperm represent years of patient effort, significant financial investment, and in many cases a person’s only remaining path to biological parenthood. The vessels holding them are, at their core, insulated containers relying on liquid nitrogen to maintain temperatures around -196°C. Modern vapor-phase tanks are excellent. While all tanks are robust, they are not infallible.

Backup capacity for cryostorage means having sufficient additional tank volume available — either empty tanks kept on site or a documented arrangement with a nearby facility — to absorb the entire contents of your largest tank if an emergency transfer becomes necessary. It means having liquid nitrogen supply agreements that guarantee delivery even during weather disruptions or supplier shortages. It means alarm systems with redundant notification pathways: audible local alarms, remote monitoring, and after-hours phone escalation to someone who will actually answer.

 

Incubators: More Redundancy Than You Think You Need

Most IVF labs run multiple incubators, and experienced embryologists intuitively spread embryos across units to reduce risk concentration. But true backup capacity means having a plan for what happens if two incubators fail simultaneously — not just one. It means documenting the answer to: if we lost half our incubator capacity tonight, where would everything go, and who would make that call?

Backup incubators do not need to be identical to your primary units. A benchtop incubator maintained in working condition, properly calibrated, and stocked with appropriate gas concentrations can bridge a critical gap while a primary unit is repaired or replaced. The key is that it exists, it is ready, and your team knows how to use it under pressure.

 

Reagent Cold Chain: The Quietly Vulnerable Link

Reagents and culture media stored at 2–8°C or -20°C represent a supply chain vulnerability that does not always get the same attention as cryostorage. A refrigerator compressor failure on a Friday afternoon can render thousands of dollars of culture media unusable by Monday morning — and more importantly, delay or compromise cycle outcomes for patients already in stimulation.

Backup refrigeration capacity, even a single secondary unit designated for media overflow and emergency transfer, is a worthwhile investment. At minimum, your standard operating procedures should specify what happens to reagents if primary cold storage fails, including acceptable temperature excursion windows for each product category and the contact information for your media supplier’s emergency line.

 

What CAP Requires: A Practical Reference Table

The College of American Pathologists (CAP) reproductive laboratory accreditation checklist addresses backup capacity, storage, inventory, and disposition across several checklist items. The table below organizes the most relevant requirements with a plain-language explanation of what each one actually demands in practice — not just what it says.

 

CAP Checklist Item | Requirement Summary | What It Means in Practice |

**RLM.08575** Temperature-Dependent Equipment Failure Plan | Written plan for backup equipment covering: identification, capacity, location, transfer process, contact personnel, and patient notification. Annual evaluation required. Inter-lab agreement required if backup is offsite. | Your backup plan must be written, specific, and tested annually. A verbal understanding with another lab does not satisfy this requirement. Update contact lists every year.

**GEN.61900** Inventory Control | Effective supply inventory control system in operation. | Know what you have, where it is, and when it expires — for reagents, consumables, and specimens. An Inventory Audit reconciliation directly satisfies this. 

**RLM.12000** Cryostorage Inventory | Records available for current inventory of all specimens in cryobanks. | The database is not the inventory — the tank is. They must match. Discrepancies require investigation and documentation.

**RLM.12400** Long-Term Disposition | Written procedure for storage duration, informed consent, and long-term disposition of cryopreserved gametes and embryos. | All December discards and custody transfers must be performed under a current, signed consent with complete disposition records.

**RLM.03975** Specimen Handling and Disposition | Records allow tracking of disposition for all gametes and embryos handled or stored. | Every embryo discarded, donated, or transferred needs a complete chain-of-custody record. This is patient protection, not paperwork.

**RLM.08000** Specimen Handling | System to verify and maintain specimen identity throughout receipt, storage, processing, and disposition. | Identity verification must be active and documented at every step — not assumed.

**GEN.40506** Secured Specimen Storage | Original specimens maintained appropriately when not in possession of an authorized individual. | Storage conditions must be defined and met continuously. Backup capacity planning is the operational expression of this requirement.

**GEN.40507** Specimen Retention and Storage | Retention and storage conditions defined for each specimen type using chain-of-custody procedure. | Storage conditions are not optional or approximate. They are defined, documented, and your backup plan must maintain them.

**GEN.40509** Secured Records | Chain-of-custody and testing records retained for minimum two years in a limited-access secured area. | Year-end archiving moves completed cycle records to secure long-term storage. This is also when you confirm your retention schedule complies with applicable state law.

 

A Closer Look at RLM.08575

This checklist item deserves special attention because it is the most operationally specific — and the most likely to generate a finding if your plan exists only in someone’s head.

The CAP note attached to RLM.08575 specifies that procedures for backup equipment must address: equipment identification, capacity, physical location, the transfer process to maintain required temperature range, contact personnel, and patient notification. It explicitly covers emergent situations including disasters, and it requires timely notification of patients regarding the location and status of their cryopreserved cells and tissues if a transfer becomes necessary.

Two elements of this requirement routinely catch labs off guard. First, the annual evaluation is not optional — it requires physically verifying that backup equipment is functional and has adequate capacity, and confirming that the contact personnel list is current. People change roles, leave organizations, and update phone numbers. A contact list that was accurate eighteen months ago may not reach anyone at 2 a.m. during a power failure.

Second, if your backup equipment is located at another laboratory or if you have a storage agreement with another facility, a written inter-laboratory agreement is required. A handshake understanding with the lab down the street does not satisfy this requirement. The agreement must exist, be current, and be immediately accessible to the people who would need to act on it.

 

The Infrastructure Checklist

Use this as a working tool for your year-end review. Part 1 of this series provides the detailed physical inventory audit procedure.

Backup Equipment Plan (RLM.08575 Annual Evaluation)

[ ] Pull your written backup equipment plan and verify it names specific equipment with model, serial number, location, and confirmed capacity

[ ] Physically test each backup unit — power on, confirm temperature stability, verify gas supply if applicable

[ ] Confirm backup capacity is sufficient to receive the full contents of each corresponding primary unit

[ ] Update contact personnel list and verify every number reaches the right person after hours

[ ] Confirm inter-laboratory storage agreements are current, signed, and filed accessibly

[ ] Test alarm systems including remote monitoring and after-hours notification chains

[ ] Document the completed evaluation with date and signatures

 

Cryostorage Audit (RLM.12000)

[ ] Schedule physical tank audit — see Part 2 for full procedure

[ ] Confirm LN₂ levels and fill schedule through the holiday closure period

[ ] Document any discrepancies and initiate investigation per your deviation procedure

[ ] Confirm backup tank capacity and emergency transfer protocol is current

 

Reagent and Supply Inventory (GEN.61900)

[ ] Count all reagents, media, and consumables against inventory records

[ ] Flag and quarantine items past expiration or outside storage specifications

[ ] Identify critical items with lead times longer than your buffer stock can cover

[ ] Place Q1 orders before holiday supply chain delays take effect

[ ] Verify all cold storage equipment is functioning and recently calibrated

 

Disposition Workflows (RLM.12400, RLM.03975)

[ ] Pull list of embryos and gametes with approaching or past consent end-dates

[ ] Confirm informed consent documentation is complete before initiating any discard

[ ] Complete disposition records and obtain required witness signatures

[ ] Notify patients as required by consent documentation and applicable state law

 

Records and Archiving (GEN.40509)

[ ] Archive completed cycle records per your retention schedule

[ ] Confirm electronic records are backed up and access controls are current

[ ] Update any SOPs that changed during the year and retire obsolete versions

[ ] Document completion of annual inventory per GEN.61900 and RLM.12000

 

The Bigger Picture

An IVF laboratory is, at its core, a controlled environment sustained by infrastructure. Incubators, cryotanks, refrigerators, alarms, gas supplies, and backup systems are the unseen architecture that makes everything else possible. Embryologist skill, clinical protocol, and patient care all depend on that infrastructure functioning reliably — not just on a Tuesday afternoon, but at 3 a.m. on a holiday weekend when something unexpectedly fails.

That is not administrative housekeeping. That is risk management, quality assurance, and patient safety rolled into a to-do list.

The patients whose embryos are in your tanks are counting on you to make every effort to safeguard their precious cells.

Continue to Part 1: How to Perform a Physical Cryostorage Inventory Audit — a step-by-step procedure covering tank-level inspection, canister and cane verification, sample-level reconciliation, documentation requirements, and post-audit action pathways.

The cost of building a family in the United States was already difficult to defend. What is happening right now makes it worse, and the people absorbing the consequences are patients.

In the past eighteen months, IVF laboratories have seen a 5 to 6 percent tariff surcharge added by suppliers, followed by an 8 percent fuel surcharge layered on top. Those numbers are not abstract. They are passed through the system — into reagent costs, consumable budgets, cryostorage operations, and ultimately into what programs charge patients who are already spending money they often do not have on treatment that is still not covered by most insurance plans in this country.

The tariffs driving these increases are not accidents of the market. They are policy choices. And while the intended targets are geopolitical, the collateral damage lands squarely on clinical laboratories trying to run ethical, compliant, high-quality programs on margins that were never generous to begin with.

That is before we talk about what is happening globally. Supply chains that were already stressed from COVID-era disruptions are now contending with active geopolitical instability affecting shipping routes, port operations, and the sourcing of raw materials that go into the culture media, cryoprotectants, and sterile consumables that IVF laboratories cannot function without. Add severe weather events compounding freight delays and cold-chain risk, and you have a system operating with very little slack.\

Lab directors are not passive observers in this. We are the ones who have to build the emergency plans, validate the alternate products, document the substitutions in a way that satisfies CAP and CLIA requirements, and explain to clinical teams and patients why timelines are shifting or costs are changing. The regulatory infrastructure does not pause for supply disruptions. Neither does patient care.

Now there are media formulation changes driven by geopolitical pressures. How to protect your laboratory budget when suppliers add surcharges without meaningful notice. Emergency SOPs and continuity planning for ongoing supply chain instability. And for offsite laboratory directors, the real and rising costs of travel in an environment that is neither predictable nor cheap.

If you direct a laboratory, supervise a team, or carry responsibility for operational continuity in an ART program, this conversation is for you.

Current Cost Pressure Context Supplier surcharges have compounded over consecutive cycles: 5–6% tariff surcharge (2025) + 8% fuel charge (2026 add-on). Labs operating on fixed-cycle pricing or legacy contracts are most exposed. This session addresses both immediate mitigation and long-horizon planning.

Media Formulation Changes: What Suppliers Are Doing and Why

→ Overview of reported formulation adjustments by major culture media manufacturers in response to U.S. import tariffs on raw chemical constituents and packaging materials

→ Geopolitical drivers: tariff exposure on goods from key trading partners affecting BSA sourcing, amino acid precursors, and sterile consumables

→ Alternate product evaluation: process for qualifying a new media lot or product under CLIA/CAP standards without compromising clinical outcomes

▸ Internal validation requirements: KPIs, historical controls, minimum cycle threshold

▸ FDA 21 CFR Part 1271 implications for labs using donor tissue: documentation obligations when switching reagents in donor gamete processing workflows

▸Vendor change notification requirements: what suppliers are obligated to disclose vs. what labs must proactively investigate

→Discussion: Have members received formal notification of formulation or lot changes from suppliers? What QA documentation was provided?

Protecting the Laboratory Budget: Cost Escalation Strategies

5–6%: Tariff surcharge added 2025

+8%: Fuel/freight surcharge 2026

~14%” Compounded cost increase on goods

What is your lab’s exposure?

→ Auditing current vendor contracts: understanding surcharge clauses, escalation caps, and notice requirements for price changes

→ Renegotiation leverage: volume commitments, multi-year agreements, and group purchasing organization (GPO) participation as cost controls

→ Alternate sourcing: domestic vs. international suppliers; evaluating CE-marked products for U.S. lab use and regulatory acceptability under current CAP/CLIA frameworks

→ Strategic inventory practices: safety stock thresholds, shelf-life management, and capital exposure of pre-buying vs. just-in-time models

→ Communicating cost pressures upward: making the case to administration for budget adjustments with data-driven cost modeling

→ Discussion: How are members absorbing these costs? Are clinical fee structures being revisited at your institution?

Offsite Lab Directors: Travel Safety & Per Diem Frameworks

→ Current travel safety landscape for lab directors traveling to supervised sites: domestic considerations (airline reliability, airport disruption) and international medical travel advisory changes

→ Practical travel tips and protocols: documentation to carry (HCLD credential copies, site contracts, emergency contacts), health and safety precautions, and communication check-in expectations with home institution

→ Per diem rate structures for offsite lab direction: what is reasonable, what is defensible, and how to structure agreements to keep pace with rising travel costs

▸GSA rate benchmarks as a reasonable anchor point

▸Fuel surcharge pass-through: should directors be absorbing or billing these?

▸Contract language: building in annual cost-of-travel adjustments

→ Insurance considerations: professional liability coverage during offsite visits, travel medical insurance, and what gaps may exist in standard malpractice policies for remote or consulting directors

→ Discussion: Are members revisiting their offsite agreements in light of cost increases? What are standard practices in the group?

Emergency Plans & SOPs for Supply Chain Disruption

→ Elements of a robust supply chain continuity SOP: triggers for activation, decision tree for alternate sourcing, patient communication protocols during consumable shortages

→ Critical supply triage: identifying your non-negotiable consumables (culture media, oil, dishes, cryoprotectants, sperm prep reagents) vs. items with acceptable alternatives

→ Regulatory documentation: how to document supply chain substitutions in a way that satisfies CAP inspection requirements and CLIA compliance

▸QC records for alternative lot/product use

▸Cycle reporting: when do reagent changes need to be flagged?

→ Donor tissue workflows under shortage: FDA-regulated HCT/P documentation obligations do not pause during supply disruptions; what contingency plans must address

→ International supply chain exposure: labs sourcing from Europe or Asia and exposure to shipping delays, customs holds, and currency-driven price volatility

→ SOP review exercise: members share one gap identified in their current emergency supply plan; group problem-solves in real time

Running a high-performing IVF laboratory requires more than clinical expertise. It requires a carefully considered technology stack, built from tools that have been tested in real laboratory conditions and evaluated against real patient outcomes. This post is a practical guide to the platforms and products that form the operational backbone across my laboratories.

Every item on this list is something I use, have validated, and recommend based on direct experience. There are no sponsorships or affiliate arrangements here, just a working laboratory director sharing what actually works. Technology choices in an IVF laboratory are not just operational decisions, they have direct implications for patient-facing costs, and selecting the right tools can meaningfully reduce per-procedure expenses without compromising outcomes. 

As a bonus for my network: if you reach out to any of these vendors, mention my name and you should be able to access the same pricing I receive. The more labs I refer to the tools, companies, and people I LOVE the better discounts we ALL get. Consider it a professional courtesy from one lab to another.

Let’s get started! 

Cryostorage Management and Billing: Fertility Billing Solutions

I have moved away from automatic (reflexive) aneuploid embryo discard in my labs. Have you? We now reconfirm consent, and discard after the last euploid transfer, for the highest standard of safety. Changing policy in the lab can lead to chaos! Your billing department can be thrown for a sudden loop without the right billing management solutions.

Cryostorage management is one of the most administratively complex and legally exposed areas of an IVF practice, and it’s one that doesn’t get nearly enough attention in conversations about laboratory technology and safety. I turn to Fertility Billing Solutions (FBS) to manage abandoned specimens: embryos, eggs, and sperm left in storage by patients who have stopped communicating, which represent a genuine liability to me. Not to mention, financial losses from uncollected storage fees, compliance exposure from incomplete documentation, and a real moral burden on staff who are indefinitely stewarding specimens with no clear path to resolution. 

The system adapts to clinic-specific billing policies, whether you bill by cycle, specimen type, or storage date, and supports both monthly and annual billing options with transparent patient-facing views that reduce confusion and the support calls that come with it. Critically, FBS automates the outreach and documentation workflows that would otherwise fall to overburdened embryologists and administrative staff: digital audit trails, automated renewal reminders, consent pathway management, and collections. On the lab metrics side, the platform tracks specimen inventory by type, freeze method, and aneuploidy ratios over time, which is useful not just for storage reconciliation but for clinical audit support and patient counseling. Fertility Billing Solutions was developed during peak PGT-A adoption, and the system is built to intake per-embryo results at the chromosomal level. As practice patterns shift away from reflexive discard of aneuploid embryos, FBS supports informed storage management; most critically by flagging patients whose remaining frozen cohort consists entirely of aneuploid embryos.

Andrology

Every IVF laboratory runs on a stack of technology decisions, and the ones made in the andrology lab set the tone for everything downstream in an IVF cycle. After evaluating multiple semen preparation platforms, the ProteX™ Semen Collection Cup paired with the NovoSort® Sperm Preparation Device has become a cornerstone of our andrology workflow. The system is built around a simple but powerful idea: keep sperm in a single, controlled environment from collection through processing. The ProteX™ cup is polymer-coated for temperature stability and features a funnel design that limits reactive oxygen species (ROS) exposure — two variables that matter enormously for sperm DNA integrity. The NovoSort® device integrates directly with the cup, isolating motile sperm without tube transfers, which reduces both handling stress and contamination risk. Critically for our quality system, the entire process requires only one electronic witnessing (EW) label, compared to three for a laminar flow separation device and four for conventional density gradient preparation. That single label isn’t just a workflow convenience — it’s a meaningful cost reduction and a chain-of-custody simplification that compounds across hundreds of procedures per year. Our laboratory formally validated this transition, comparing outcomes across more than 2,000 MII oocytes and nearly 400 transfers between device generations. Fertilization rate improved from 67.5% to 75.0% (p<0.001) and utilization rate from 21.6% to 35.5% (p<0.001), while pregnancy outcomes remained statistically equivalent. Per-procedure cost savings of $35–$39 compared to our previous platform were an added confirmation that the right clinical choice and the right financial choice were the same choice. I will be presenting these data at the AAB / CRB conference May 5-8th, 2026. 

Environmental Monitoring Systems: Pharmawatch

Environmental monitoring is one of those infrastructure decisions that feels invisible when it’s working and catastrophic when it isn’t. After testing several alarm and monitoring systems, PharmaWatch™ has become our platform of choice for temperature, humidity, pressure, and liquid nitrogen storage monitoring across the lab. What sets it apart for an IVF setting is the combination of things it doesn’t require: no connection to your internal network, no IT setup, no manual data downloads. PharmaWatch™ runs entirely on secure multi-carrier cellular communication, which means your monitoring infrastructure is completely isolated from your clinic’s firewalls and IT systems — a meaningful security advantage in an era of increasing ransomware exposure in healthcare. Built-in battery backup keeps the system collecting and transmitting for up to five days through power or internet outages, which matters when you have cryostorage tanks full of irreplaceable samples. On the compliance side, the platform automatically generates FDA 21 CFR Part 11 and GxP-aligned audit documentation, and the OneClick™ reporting tool produces inspection-ready reports in seconds rather than hours. For a laboratory director managing CAP inspections and continuous regulatory readiness, that’s not a minor convenience! It’s hours of staff time recovered and a material reduction in our CAP Inspection preparation and audit anxiety.

Supply Chain: IVF Store

Supply chain is not a glamorous topic, but anyone who has run an IVF laboratory through a backorder, a sudden vendor discontinuation, or a tariff-driven price surge knows exactly how quickly it becomes the most urgent problem in the building. We are operating in an era of compounding global instability, geopolitical disruption, escalating trade policy volatility, and increasingly severe weather events are no longer background noise for laboratory directors; they are active variables in procurement planning. Culture media manufactured overseas, cryogenic supplies dependent on international shipping lanes, consumables sourced from single-country suppliers, all of it is vulnerable in ways that were largely theoretical a decade ago and are now routine operational risks. 

A single port disruption, a new tariff schedule, or a regional climate event can ripple through a lab’s supply chain within weeks, and mid-cycle patients have no margin for error in a lab that wasn’t prepared. 

IVF Store has become our preferred purchasing partner precisely because consolidation is a form of resilience. Based in Alpharetta, Georgia, they supply IVF and andrology laboratories across the country with the full range of what a lab actually needs: media, oil, and consumables; ICSI and procedure supplies; cryopreservation products; andrology collection and processing supplies; semen analysis essentials; equipment sourcing; and calibration, servicing, and repair support. Fewer vendor relationships means fewer single points of failure, and a single point of contact staffed by people who understand laboratory workflow, rather than generalist procurement reps who don’t know the difference between an oil overlay and a density gradient, means faster problem-solving when disruptions hit. For a multi-site laboratory operation, supply chain simplification is not an efficiency play. It is risk management.

Preimplanation Genetic Testing (PGT): Progenesis 

Preimplantation genetic testing for aneuploidy (PGT-A) has become a standard offering in most IVF programs, and the platform you choose to deliver it matters both clinically and operationally. We love Previda® by Progenesis for chromosomal copy number analysis on biopsied embryos. Previda® screens for the full range of aneuploidies (monosomies, trisomies, and other copy number abnormalities) providing the chromosome-level information that informs embryo prioritization for transfer. It is important to be clear with patients about what PGT-A does and does not do: it evaluates chromosome copy number and is not designed to detect single-gene disorders, which require a separate PGT-M workflow. 

Clinically, PGT-A is most commonly indicated for patients of advanced maternal age, those with unexplained infertility, recurrent pregnancy loss, or a history of failed IVF cycles; populations where aneuploidy rates are elevated and the cost of transferring an abnormal embryo, in both human and financial terms, is high. Previda® fits cleanly into laboratory workflows and gives clinical teams the reporting clarity they need to counsel patients and make informed transfer decisions.

But Wait, There’s More!

This post covers the cryostorage billing, andrology, monitoring, cryostorage, supply chain, and PGT layers of our laboratory stack, but it is far from the complete picture. There are several exceptional products in our workflow that deserve their own dedicated treatment: electronic witnessing systems, electronic medical records platforms, time-lapse incubation, and the growing landscape of AI tools for embryo evaluation and selection, stimulation monitoring, and beyond. The technology available to IVF laboratories right now is genuinely remarkable, and the decisions made around these tools have direct implications for patient outcomes, laboratory efficiency, and regulatory readiness. We will be covering all of it in a follow-up post, stay tuned!

If any of these tools resonate with your laboratory’s needs, I encourage you to reach out directly to me at Carol@FertilityGuidanceTechnologies.com or to the companies referenced in this post. Every vendor listed here was selected based on validated data, operational experience, and patient outcome impact. I’m happy to share more about how any of them fit into a real laboratory workflow. The links to each company are embedded throughout this post. You can mention my name when you contact them for preferred pricing. Good technology decisions compound over time, and the IVF community is better served when we share what’s actually working.

About the Author

Carol Curchoe, PhD, HCLD, is a certified IVF Laboratory Director at Poma Fertility in Seattle, Washington, Reproductive Resource Center of Greater Kansas City, and Cryomate in Indianapolis, Indiana. She is also the Director of Science and Innovation at Progenesis. Most recently, she served as Chair of the Artificial Intelligence Special Interest Group at ASRM (2024–2025) and previously held a leadership role on the AI Special Interest Board of Directors (2023–2024). Prior to the formal establishment of the AI SIG, she was actively involved beginning in 2020 in the foundational efforts to organize and develop what became the official ASRM AI SIG. Her professional focus centers on technology development, education, quality assurance, and regulatory compliance within reproductive laboratories. She has dedicated her career to strengthening laboratory standards, building educational programming, and developing systems that improve clinical outcomes while ensuring adherence to evolving regulatory frameworks. She brings a strong understanding of operational oversight, governance, and the practical challenges faced by clinics and laboratories in implementing new technologies responsibly.

By Carol Lynn Curchoe, PhD, CLD, HCLD 

Published February 2025  •  Regulatory Affairs  •  IVF & Tissue Banking Compliance

Let’s be honest: the regulatory environment governing tissue banks and gamete storage facilities has never been more fractured, more demanding, or more consequential than it is right now. Between expanding state-level legislation, evolving FDA oversight, and increasingly nuanced international frameworks, the compliance landscape that fertility clinics and sperm banks operate in today looks almost nothing like it did even five years ago.

For those of us who have spent careers in this space, the sheer volume of requirements — and the way they layer, contradict, and occasionally harmonize across jurisdictions — is something that keeps lab directors and compliance officers up at night. If you’re operating a tissue bank that handles donor semen for significant intimate partner (SIP) use, known donation, or anonymous donation, this piece is for you. We’ll take a deep dive into the federal baseline, walk through the most demanding state requirements (with particular attention to Colorado, which has become a genuinely distinct regulatory environment), and touch on the international frameworks you’re likely navigating if you distribute or receive specimens across borders.

This isn’t an academic overview. This is operational guidance drawn from real compliance work.

The Federal Foundation: FDA and CLIA

Before we get into state-specific complexity, it’s worth reestablishing the federal baseline, because everything else layers on top of it. Tissue banks that collect, process, store, or distribute semen must be registered with the FDA as a human cells, tissues, and cellular and tissue-based products (HCT/P) establishment under 21 CFR Part 1271. This means donor screening, infectious disease testing, and record-keeping must conform to FDA requirements — not as a formality, but as an ongoing operational reality that FDA inspectors will verify.

FDA inspections aren’t particularly frequent for most tissue banks, but when they happen, they’re thorough. If you receive a Form 483 with observations, the clock starts ticking on your corrective action response. Timely, substantive responses matter — both for the immediate issue and for how the agency views your facility going forward. An internal corrective action log that’s reviewed regularly and linked to your quality management system isn’t optional; it’s what separates facilities that sail through re-inspections from those that don’t.

On the CLIA side, laboratories performing clinical testing in connection with tissue banking operations must maintain CLIA certification, and many facilities choose to work with an accreditation agency that performs routine inspections and reports directly to the state CLIA authority. Accreditation standards tend to be somewhat more prescriptive than the CLIA baseline, and the overlap with FDA requirements on things like specimen handling and documentation creates a meaningful compliance burden for labs that aren’t well-organized.

The takeaway on the federal level: get your quality assurance records, staff training logs, and SOPs into shape and keep them there. These aren’t inspection-time documents. They’re living operational records.

Colorado: The Most Demanding State Regulatory Framework in the Country

Let’s spend real time here, because Colorado deserves it. In the last several years, Colorado has enacted some of the most detailed, operationally specific requirements for gamete agencies, banks, and fertility clinics of any state in the nation. Whether you’re a Colorado-based entity or an out-of-state organization that ships to Colorado recipients or matches with Colorado-located medical providers, these rules apply to you in ways that are not always intuitive.

The Age Requirement and Its Effective Date

Effective January 1, 2025, Colorado requires that gamete donors must be at least 21 years of age at the time of consent. This isn’t simply a policy preference you can note and move on from — your procedure manual must explicitly describe the steps your entity takes to limit donations to donors who meet this threshold and to assess and monitor adherence to the age limit. For facilities that have historically worked with donors in the 18–20 age range, this represents a meaningful operational change that needs to flow through your SOPs, your intake screening process, and your staff training.

Donor and Recipient Education: More Than a Checkbox

Colorado is explicit that donor and recipient education is an obligation. Your SOP must describe, in detail:

• How educational materials are distributed to and discussed with donors and potential donors prior to gamete collection.
• How educational materials are distributed to gamete or embryo recipients prior to matching or the provision of gametes or embryos.

This isn’t about having a pamphlet on file. Regulators reviewing your SOPs during the application or inspection process will look for documented processes, not just the existence of materials. Who distributes them? When in the process? How is completion documented? These are the questions your procedures need to answer.

The 25-Family Limit: Good Faith Is Required, but Good Faith Has Teeth

Colorado caps the number of families that may be established using a single donor’s gametes at 25. This is not a soft guideline. Your procedures must describe:

• The methods used to ensure that gametes from a donor are not matched or provided to additional families once 25 or more families have been established.
• How potential donors are informed that they may request a lower family limit.
• How compliance with requests for lower family limits is verified and maintained.

The state recognizes the practical challenge of tracking live births across distributed recipient populations and has built in a good-faith standard, but the regulation specifies what good faith actually means:

• Sufficient record-keeping.
• Requiring recipients, as a condition of receiving donor gametes, to provide information on live births, and requesting this information from recipients.
• Using industry best practices or multiple commercially reasonable methods to account for the number or percentage of live births, whether reported or not.

The limit also comes with specific exclusions that must be tracked separately:

• Children conceived when the donor was known to the recipient parent(s) at the time of donation.
• Children conceived by the donor as a parent.
• Embryos transferred from one family to another.

Identity Disclosure: A Non-Negotiable in Colorado

This is where Colorado most sharply diverges from the practices that have been standard in anonymous donation programs for decades. Colorado requires that donors agree to identity disclosure — and for entities operating within the state, this means you may not match or collect gametes from a donor who does not agree to this disclosure.

For out-of-state entities, the requirement is framed differently but is equally binding: you must not match or provide gametes to a recipient parent or medical provider located in Colorado from a donor who has not agreed to identity disclosure. If you operate a national or international sperm bank and you distribute to Colorado, this means every donor whose samples might be shipped to Colorado recipients must have an identity disclosure consent on file.

The procedural requirements around disclosure are detailed. Your SOP must address:

• How donors are provided information about disclosing identifying information, including full name, date of birth, permanent and current address, and medical history.
• How notarized or witnessed signed consent agreeing to identity disclosure is obtained.
• How consent to medical history disclosure is separately obtained.
• When in the donation process the declaration of disclosure is signed.
• The length of time the declaration is valid and whether it must be re-signed for each cycle.

Donor-Conceived Person (DCP) Rights and Information Access

Colorado’s framework is explicitly oriented toward the interests of donor-conceived persons. When a DCP reaches age 18, they have the right to request identifying information about their donor. Your procedure must address:

• What donor information is shared with a DCP and through what mechanism (e.g., secure portal, encrypted email, physical copies).
• How identity between the DCP and the associated donor record is verified, using methods that do not impede or prohibit communication. Verification may rely only on government-issued ID and the name and date of birth of the birth parent who received the donated gametes or embryos — entities may request but not require additional documentation.
• The defined timeline within which such requests must be fulfilled.

Record Retention: In Perpetuity, Not a Figure of Speech

Colorado’s record retention requirement is as close to absolute as regulations get. Identifying information and medical history for donors matched with or providing gametes to unknown recipients, family count data and the efforts to obtain it, and gamete screening and testing records must all be permanently maintained.

This has real implications for how your document management systems are structured. Electronic records systems that archive after a certain period, platforms that sunset older data, or paper records in facilities without long-term storage plans are all potential compliance failures waiting to happen. The records must also remain traceable to the associated gametes — a point that’s easy to underestimate until you’re trying to reconstruct a chain of custody years or decades later.

Traceability of Gamete Source Entities and Inter-Entity Transfers

For entities receiving gametes or embryos from another entity on or after July 1, 2024, Colorado requires permanent maintenance of the providing entity’s name, address, telephone number, and email address. For fertility clinics that collect gametes from donors matched by a separate gamete agency on or after that same date, the same information must be maintained for the matching agency.

This inter-entity traceability obligation extends to disclosure rights. When a DCP or parent/guardian requests information about the source entity for gametes received from another entity after July 1, 2023, your procedure must describe how you receive the request, verify the requestor’s connection to the gametes, share the required contact information, and fulfill the request within a defined timeline.

All of this contact information must also include your Colorado license number, and it must remain traceable to the specific gametes it relates to — not just stored somewhere in your records system.

Ovum Donor Cycle Limits

For entities that handle egg donors in addition to sperm donors, Colorado caps the total number of retrieval cycles at six in a donor’s lifetime. This requires active monitoring, not passive record review — your procedure must describe how you assess and track adherence to this limit across the donor’s entire donation history, including at other facilities.

There is a narrow exception for prior donors who provide informed consent to undergo additional cycles for families who have already conceived children with that donor. But this exception requires its own documented procedure: how you assess and monitor it, and how you establish a connection between the recipient parent(s) and the donor in those circumstances.

SOP Accuracy, Training, and the Employee Verification Requirement

Colorado specifies not just what your SOPs must cover, but how your facility must manage them. Your procedures must describe:

• How you ensure SOPs accurately reflect actual practices.
• How employees are trained to procedures and how evidence of that training is maintained.
• How periodic reviews verify that policies and procedures continue to reflect actual practices.

Your training plan must specifically include:

• Identification of which policies and procedures each employee role must be trained on.
• A requirement to verify training is completed before staff perform steps independently.
• Training record templates with spaces for dates, and signatures from both the employee and a supervisor or senior staff member — wet signatures or e-verifiable signatures required.

Business Continuity: The Bankruptcy and Dissolution Plan

One of the requirements that catches organizations off guard is Colorado’s mandate that entities maintain a written plan for bankruptcy, dissolution, or insolvency. At minimum, this plan must identify the types of records that will be transferred to a receiving entity, the timeframe for providing records to that entity, and the timeframe for providing required information to the state Department of Health. If your organization doesn’t have this plan drafted, it’s a gap that needs to be closed before your next compliance review.

Other State Regulatory Frameworks

Colorado may be the most demanding, but it isn’t the only state with meaningful compliance requirements. Here’s a working overview of what you’re dealing with in other key jurisdictions.

California

California requires annual registration with associated fees, and while the chance of a formal inspection is lower than in some other states, the registration process itself is substantive. All SOPs and consent forms are reviewed during the application process, which means your documents need to be in shape before you submit, not after. For facilities that operate in multiple states, California’s front-end SOP review is actually a useful forcing function for getting your procedures in order.

New York

New York has no registration fees but compensates with a robust oversight structure. SOPs are reviewed during the application process, and the frequency of inspections is determined by the nature and volume of the facility’s activities — which means high-volume operations should expect more scrutiny.

The most distinctive New York requirement is mandatory participation in an annual Tissue Bank Advisory Meeting. Your Medical Advisory Committee must consist of at least five members with expertise in human fertility, infectious disease, or related fields — and this committee composition needs to be documented and defensible, not just nominal.

Illinois, Delaware, and Oregon

These three states require annual registration with no fees and conduct no routine inspections. SOPs are not reviewed during registration. For multi-state operators, these are relatively low-friction jurisdictions — but that doesn’t mean you can neglect the underlying operational quality. Federal requirements and accreditation standards still apply fully.

Maryland

Maryland requires a one-time registration with no fees and no routine inspections. SOPs are not reviewed during registration. The administrative burden is minimal, but again, this is not a jurisdiction where you can cut operational corners — it simply means the state isn’t looking over your shoulder in the same way others are.

International Regulatory Frameworks

Canada

Canadian compliance for tissue and donor semen banking centers on registration and adherence to Health Canada guidelines covering donor screening, infectious disease testing, and traceability. Canadian requirements around traceability and infectious disease testing have significant operational overlap with FDA requirements, but they are not identical — particularly around the specific testing panels and documentation standards. If you’re importing or exporting specimens to Canada, your records and labeling need to satisfy both frameworks simultaneously.

United Kingdom

The Human Fertilisation and Embryology Authority (HFEA) is one of the more rigorous international regulatory bodies a tissue bank is likely to interact with. UK registration requires ongoing use of HFEA-mandated MD and CD forms to document and track donor and patient consent, gamete testing, and storage compliance. The HFEA code of practice covers donor suitability assessment, records management, and reporting obligations in considerable detail.

For US-based facilities distributing to UK clinics, the HFEA inspection framework and documentation requirements represent a genuinely separate compliance track that must be maintained in parallel with FDA and state requirements. HFEA inspections can be thorough, and the expectation that all gamete tracking, consent, and testing documentation is complete and immediately accessible is not aspirational — it’s a baseline expectation.

Israel

Israel has among the most detailed genetic testing requirements of any country for imported donor sperm. Sperm from donors whose samples are imported into Israel must include an expanded panel for pathogenic genetic variants and chromosomal microarray analysis (CMA). Where a recipient woman is a carrier of a recessive disease, targeted gene sequencing or whole exome sequencing is required for the donor.

Donors must sign informed consent permitting preservation of a sample — either in Israel or abroad — specifically for future genetic testing if required. This consent must be obtained proactively, before samples are shipped.

The family limit in Israel is set at 12, significantly lower than Colorado’s 25-family cap. A single exception exists: the bank director may authorize provision to an additional recipient only when all ampoules allocated to a prior recipient have been used, all treatment cycles have concluded without a live birth, and no embryos remain for that recipient. Each of these conditions must be documentable.

The Operational Infrastructure That Makes This Work

You can know every regulation in this article and still fail a compliance review if your operational infrastructure isn’t designed to support sustained adherence. Here’s what that infrastructure looks like in practice.

Centralized Compliance Registry

A centralized registry of all required licenses, registrations, and renewal dates is not a nice-to-have. It’s how you avoid discovering mid-inspection that a state registration lapsed eight months ago. The registry should include the regulatory body, the license type, the renewal date, the responsible staff member, and links to the applicable regulations so that annual reviews can check for changes in requirements, not just renewal of the same obligations.

Roles and Responsibilities

Compliance across this many jurisdictions requires clearly delineated ownership. In practice, that typically means:

• A Regulatory Compliance Officer who monitors requirements, manages renewal timelines, and coordinates inspection readiness.
• A Laboratory Technical Supervisor who ensures daily operations conform to CLIA, FDA, accreditation, and state standards, and who owns quality assurance protocols.
• A State Licensing Specialist who maintains state-specific documentation and maintains working relationships with state health departments.
• An International Liaison who manages relationships and compliance with HFEA in the UK, Health Canada, and other international regulators.

The Annual Tissue Advisory Meeting

For facilities subject to New York’s requirements (and as a best practice more broadly), the annual Tissue Bank Advisory Meeting is a critical governance touchpoint. A well-structured meeting reviews:

• Licensure and registration status across all jurisdictions.
• Regulatory changes since the prior meeting.
• Document retention compliance across electronic systems.
• Corrective actions from prior inspection cycles and their effectiveness.
• Annual and new staff training completion.
• Incidents, occurrences, and any non-conformances.
• Review of consent forms, donor selection criteria, and social history forms.
• Key performance indicators from the annual quality assurance review.

The Bottom Line

The regulatory environment for tissue banks and fertility clinics handling donor semen is not getting simpler. Colorado’s framework in particular represents what appears to be a leading edge of state-level regulation — detailed, donor-conceived person-oriented, and operationally demanding in ways that require genuine procedural infrastructure rather than checkbox compliance.

For organizations distributing nationally or internationally, the challenge is managing multiple overlapping frameworks simultaneously — FDA and CLIA as a baseline, state-specific licensing in each jurisdiction where you operate or distribute, and international bodies like the HFEA and Health Canada where applicable. Each of these has its own inspection cadence, its own documentation standards, and its own gap between the minimum required and what actually constitutes defensible compliance.

The facilities that navigate this well share a few things in common: they treat their SOPs as living documents rather than static filings, they invest in compliance infrastructure before inspections rather than scrambling during them, and they recognize that regulatory requirements in reproductive medicine increasingly reflect the interests of the donor-conceived people whose lives begin from this work.

That’s not a burden to resent. It’s a responsibility to take seriously.

This article is intended for informational purposes for regulatory and compliance professionals in the reproductive medicine and tissue banking industries. It does not constitute legal advice. Regulatory requirements change frequently; always verify current requirements with the relevant regulatory authority or qualified legal counsel.

The College of American Pathologists (CAP) has released its updated checklists for 2024, bringing several significant changes across various accreditation programs. Staying informed about these revisions is crucial for laboratories to maintain compliance and ensure a smooth accreditation process. This blog post summarizes the key substantive changes found in the Common, Director Assessment, Reproductive Laboratory, and Laboratory General checklists.

Common Checklist (COM) Updates

The Common Checklist, which applies to all laboratories, sees several key clarifications and new additions. One notable change is to COM.01200, where the activity menu must now be accurate for all related information, not just test activities. Additionally, laboratories subject to CLIA regulations must now explicitly list patient-specific results on the CAP Activity Menu, a change from the previous wording of “reported to.”

New qualifications for technical supervisors have been added for the specialties of Cytogenetics and Transfusion Medicine (COM.01400), and a new requirement (GEN.41096) has merged with the existing COM.22950 from 2023.

Director Assessment (DRA) Checklist: Focus on Qualifications and Remote Oversight

The Director Assessment Checklist introduces new requirements for high-complexity testing directors. A key change in DRA.10100 mandates that a doctoral degree holder must have at least 20 continuing education (CE) credit hours covering director responsibilities*. However, the This is a shift from the previous one-year laboratory training requirement. The same requirement has also been updated for moderate-complexity laboratory directors, who must now have board certification and at least one year of experience in directing or supervising nonwaived testing.

The checklist also introduces new rules for remote oversight. DRA.10432 and DRA.10433 are new requirements specifying on-site visit frequencies for laboratories, both inside and outside the US, respectively. A new requirement under DRA.10435 directs laboratories to have a specific policy for the frequency of on-site visits if the director’s activities are conducted remotely.

Reproductive Laboratory (RLM) Checklist: Enhanced Cryopreservation and Personnel Rules

The Reproductive Laboratory Checklist now includes a greater emphasis on back-up plans for temperature-dependent equipment. RLM.03955 has been revised to require process plans for utilizing back-up equipment, including protocols for emergent situations and an annual assessment of the equipment’s functionality. This is a significant update from the prior focus on simply having a plan.

Regarding personnel, a key change in RLM.10250 has removed “physical” from the list of acceptable bachelor’s degrees for embryology laboratory personnel, refining the qualifications for these roles. A new clause (RLM.10166) was added for Department of Defense laboratories, clarifying the process for evaluating the equivalency of qualifications for directors trained outside the US.

Laboratory General (GEN) Checklist: Extensive Revisions to Quality Control and Safety

The Laboratory General Checklist has undergone the most extensive changes, particularly concerning proficiency testing (PT), equipment maintenance, and safety.

Equipment and Maintenance:

• GEN.20180 now explicitly requires instrument maintenance and cleaning to be performed according to manufacturer instructions.
• A new requirement, GEN.20450, mandates a policy for preventive maintenance on instruments not in use for extended periods.
• Conversely, the requirement for inspecting refrigerators and freezers every six months for cleanliness (GEN.20665) has been removed.

Proficiency Testing (PT):

• Several new requirements have been added to reinforce best practices for PT.
• GEN.50505 requires PT results to be reported in accordance with the PT program’s instructions.
• GEN.50555 now mandates that laboratory policies for handling PT samples define acceptable testing conditions.
• The requirement for corrective action plans has been strengthened with GEN.50875, which states that the plan must now address all PT results that are not perfect, and GEN.50850, which specifies that the plan must be documented and approved by the director.
• The requirements for on-site reviews of PT results (GEN.51500 and GEN.51600) have been revised to include the process for evaluating and documenting the results.

Safety:

• The entire requirement for emergency eyewash and shower equipment (GEN.70010) has been replaced by two new ones (GEN.70020 and GEN.70030), which now explicitly require the equipment to be accessible, inspected, and maintained per ANSI standards, with specific instructions for weekly activations and visual examinations.
• The requirement for a chemical hygiene plan (GEN.60500) has been deleted.

By understanding these changes, laboratory professionals can proactively update their policies and procedures to align with the latest CAP standards, ensuring continued compliance and quality.

High Complexity Laboratory Director, 20 Continuing Education Requirements

* At the end of June 2025, the Centers for Medicare & Medicaid Services (CMS), which oversees the Clinical Laboratory Improvement Amendments (CLIA) program, announced it was suspending enforcement of its decision to require, as a condition for eligibility to serve as a High Complexity Laboratory Director, 20 continuing education (CE) credits in laboratory practice that cover CLIA laboratory director responsibilities.

To be consistent with this new CLIA requirement, earlier this year the American Board of Bioanalysis (ABB) mandated the same 20 CE credits for candidates seeking to sit for High Complexity Laboratory Director examinations (including HCLD, BCLD, PHLD, ELD and ALD). In light of CMS/CLIA’s decision to suspend enforcement of the 20 CE credit requirement, ABB decided to suspend this requirement from ABB’s eligibility criteria for high complexity laboratory director certification until such time that CMS decides to enforce this requirement. ABB also believes that its General Knowledge examination for laboratory directors covers this subject matter.

As a result, individuals who previously applied for HCLD, BCLD, PHLD, ELD, and ALD certification after December 28, 2024, do not have to meet this requirement.

Also consistent with CLIA regulations, ABB announced an alternative pathway for candidates whose doctoral degrees may not be in a chemical, biological, clinical or medical laboratory science, or medical technology. Under this pathway, applicants may qualify to take the HCLD, BCLD, PHLD, ELD, and ALD examinations by completing 16 credit hours of doctoral level coursework in a chemical, biological, clinical or medical laboratory science, or medical technology. This adjustment is intended to broaden access while ensuring candidates have the necessary academic preparation for high-complexity laboratory oversight.

Finally, the revised CLIA regulations did not have a provision to “grandfather” Clinical Consultants. Therefore, to qualify as a Clinical Consultant, all previously qualified laboratory directors would have to “requalify” as laboratory directors under the December 28, 2024, rules that require directors to have 20 CE credits in laboratory practice that cover laboratory director responsibilities. Since CLIA enforcement of that requirement has been suspended, individuals who qualified as Clinical Consultants before December 28, 2024, do not have to earn the 20 CE credits to continue to qualify as Clinical Consultants.

Tips for Performing Your CAP Self-Inspection

Performing a comprehensive self-inspection will help you achieve:

• Ongoing compliance with the CAP checklist requirements
• A continual state of readiness for your next on-site CAP inspection
• Improved laboratory performance and better patient care

1. Prepare

• Formalize a self-inspection procedure.
• View the Laboratory Data Report on e-LAB Solutions™ for accuracy.
• Notify the CAP of any demographic and/or test activity changes.
• Confirm that proficiency testing (PT) is being performed for each required analyte.
• Review the Laboratory Activity Menu with PT Options (or the Missing PT Enrollment) Reports for required PT program enrollment vs. alternate performance assessment.
• Notify CAP of any Activity Menu changes that may affect PT enrollment.
• Determine the date that the inspection will occur (this should be unannounced).
• Select a team to perform the unannounced inspection.
  • Involve a variety of staff levels.
  • Include a mix of supervisory staff, non-supervisory staff, residents, and fellows.
  • Consider using a sister facility and cross-discipline lines for a fresh, unbiased perspective.
• Encourage staff and inspectors to complete inspector education. To access the courses:

1. Go to cap.org and log in to e-LAB Solutions Suite with your individual user ID and password.
2. Select CAP Accreditation, CAP Accreditation Resources, Inspector Resources, Online Inspector Training.
3. Register for the Team Leader or Team Member training session.

2. Conduct

• Review previously cited deficiencies and proficiency testing performance.
• Check deficiency responses against current practice.
• Ensure compliance with each applicable checklist question, including any new CAP requirements.
• Communicate with a variety of staff levels.
• Include all personnel involved in the testing process, such as: phlebotomists, accessioning/processing techs, bench techs, and supervisors/managers.
• As you perform the self-inspection, consider how you would respond to the following if the supervisor or laboratory director was not present:
  • Are you prepared to explain a certain procedure or practice?
  • Do you know where various policies are located?
  • Do you know where quality control and instrument maintenance records are located?

3. Improve

• Conduct a summation conference.
• Review cited deficiencies.
• Develop and document a corrective action plan with appropriate staff members.
• Demonstrate implementation of the plan with a review of follow-up corrective action taken to ensure compliance.
• Self-inspection documentation must be readily accessible for the next on-site inspection.

Need assistance? Call 800-323-4040 or 847-832-7000 or email accred@cap.org.

 

IVF Clinics take the safe transport of reproductive tissue seriously—for our patients’ protection and peace of mind.

Whether you’re coordinating a ship-in or ship-out, transporting embryos, eggs, or sperm requires 6–8 weeks and careful planning across multiple steps.

We’ve created a clear, patient-friendly infographic to guide your team and your patients through the entire process—from signing consents to confirming tissue arrival.

 Featuring recommended couriers (Cryofuture)

 Step-by-step timeline

 Critical reminders to avoid delays

 Final note: Tissue must be on-site before any IUI, IVF, or FET cycle begins

 Download and share with your staff and patients to ensure a seamless experience.

On World Embryologist Day, we recognize the silent guardians of early human development—embryologists—whose hands guide the first few days of every IVF-conceived life. Behind each embryo transfer, every pregnancy test, and every hopeful smile is an immense weight of responsibility carried by IVF laboratory professionals.

The IVF laboratory is not just a workplace; it is a living, breathing ecosystem—delicately balanced, highly sensitive, and deeply complex. Embryologists are its caretakers. When everything goes right, they remain invisible. But when success rates falter, the microscope turns inward—on them, their tools, their decisions, and the entire microenvironment they manage.

The Complexity of IVF Laboratory Systems

The culture system in an IVF lab depends on a constellation of interdependent variables: temperature, gas flow, media composition, embryo handling, light exposure, consumables, and air quality. Each detail can make or break a patient’s chance at success. This is why embryologists must be more than technicians—they must be scientists, detectives, and engineers rolled into one.

Recognizing When Something’s Wrong

Embryologists are often the first to notice subtle patterns: a reduced blastulation rate here, a lower-than-expected fertilization rate there. These aren’t just statistics—they’re signals. Signals that trigger urgent, comprehensive reviews. Because even one failed cycle carries emotional and financial weight for patients. And for embryologists, each failure feels deeply personal.

The Pressure of Root Cause Analysis

When success metrics drop, embryologists initiate a process many industries call Root Cause Analysis (RCA)—a structured investigation that spans clinical protocols, patient biology, and lab systems. It’s an emotionally charged process, demanding objectivity under pressure and teamwork across disciplines. Every possibility must be evaluated—from sperm quality to CO₂ calibration.

Embryology KPIs: The Daily Pulse

Embryologists track dozens of KPIs daily: normal fertilization rates (2PN), abnormal fertilization events (1PN, 3PN), cleavage timing, blastulation progression, embryo morphology, and even PGT results. These metrics are not just numbers—they are the heartbeat of the laboratory and the first indicators that something may be amiss.

Under the Microscope: Patient Biology and Lab Systems

Is it the stimulation protocol? Sperm fragmentation? A pH fluctuation in the culture dish? A cracked incubator seal? Embryologists leave no stone unturned. They check air quality logs, incubator readouts, lot numbers of oil overlays, and even the arrangement of dishes inside the incubator.

Silent Threats: VOCs, Temperature, and Technique

The threat is often invisible. A new piece of furniture releasing formaldehyde. A micro-pause in temperature stability. Even the gentle pressure of ICSI injection that’s just a bit too forceful. Embryologists must maintain vigilance in the face of such minute but impactful variables.

The Human Element: Responsibility Beyond Reagents

On this World Embryologist Day, it’s important to recognize that behind the protocols and SOPs are real people who shoulder extraordinary responsibility. They are the first responders when a cycle fails. They revisit every action, every annotation, every decision. They carry not only scientific precision—but emotional resilience.

Constant Vigilance, Continuous Improvement

Modern IVF labs operate with internal and external QA programs, staff audits, and witnessing systems. But even the best systems rely on the eyes and minds of skilled embryologists. When trouble arises, they are the ones who synthesize clinical data, patient histories, environmental records, and their own instincts to formulate a recovery strategy.

Why Troubleshooting is a Core Embryologist Skill

Troubleshooting isn’t a separate task—it’s embedded in every action an embryologist takes. Every embryo they culture, every pipette they handle, every incubator they load—carries the weight of performance and outcome. It’s a career defined not only by successes, but by how effectively problems are identified and solved.

A Day to Honor the Invisible Architects of Life

Today, we thank embryologists not just for the miracle of life they help create, but for the integrity, precision, and care with which they troubleshoot, adapt, and recover. The IVF lab is a high-stakes environment where even minor misalignments can derail hope. Embryologists are the ones who ensure that doesn’t happen.

So here’s to the embryologists—the unseen hands behind life, the calm in the face of chaos, the quiet force ensuring science meets success. You carry more than samples. You carry the trust of thousands. Happy World Embryologist Day July 25, 2025.

Oocyte Maturation 

In Vitro Maturation (IVM) was developed as an alternative to traditional IVF due to the adverse outcomes of ovarian hyperstimulation syndrome and the costs

associated with the administration of FSH. The treatment also has the potential to overcome other causes of infertility such as male factor, gamete donation and poor response to stimulation, and also has profound benefits for women undergoing oocyte or embryo cryopreservation with an estrogen-sensitive tumor or with a prothrombotic medical condition. IVM consists of collecting immature (ie. Geminal Vesicle or GV) oocytes and applying FSH and HCG in the culture media. 

In vitro maturation of immature oocytes from an unstimulated cycle is an emerging technology. One of the safest ways to prevent OHSS is to not stimulate the ovaries. During an in vitro maturation of oocytes cycle, the immature eggs are retrieved from ovaries that are barely stimulated or completely unstimulated.  The eggs are maturated in defined culture media for 24 to 48 hours and fertilized through IVF or ICSI. 4 IVM is an experimental technique that consists of the in vitro conversion of oocytes at the GV stage to oocytes at the metaphase II stage. This technology must include nuclear and cytoplasmic maturation of the oocyte and give rise to embryos that have a developmental potential that is similar to embryos obtained from standard IVF or from spontaneously in vivo matured oocytes. A few IVM practitioners advocated for “rescue IVM” in IVF conventional settings to prevent severe OHSS. “Rescue IVM” is when the physician has come to the conclusion that a safe conventional IVF cycle cannot be done so they change the treatment direction to an IVM protocol to the cycle instead. If the aspiration happens prior to the follicle selection, then OHSS risk can be eliminated. 

Though IVM shows promising results, it is not a mainstream for fertility treatment. Mainly because there are difficulties retrieving eggs from immature ovaries that are not stimulated, and a lower chance of live births compared to conventional IVF, and there is an increased rate of abnormalities in meiotic spindles and chromosomes from immature eggs. 

Sperm Preparation for ART

When sperm is ejaculated it is surrounded by fluid. A typical ejaculate contains cells, debris, dead and damaged sperm, and healthy, motile sperm. Healthy sperm is critical to the success of ART procedures and so we use sperm preparation techniques to separate functional spermatozoa for IUI, IVF, and ART and for cryopreservation. In the IVF lab there are essentially 4 techniques we use commonly; Swim-up, Swim-down, Sucrose and Ficoll-400 density gradient techniques. Each lab finds that one of these techniques will yield more motile, live and normal looking sperm for their procedures. 

Companies like ZyMot sell specialty devices for sperm separation that can be very expensive. The idea is that they simulate the cervical and uterine pathways that sperm must navigate to naturally fertilize an egg. By mimicking this natural selection method, sperm can be isolated without the use of chemicals or centrifugation that may damage the sperm. Instead they use microfluidic technology to isolate healthy sperm by laminar flow, which creates gradients through channels. These devices have been tested in randomized controlled trials, which is the gold standard of medical research.  

Data shows that up to 25% of semen specimens from men with an undetectable burden of viral RNA (HIV particles in their blood) are HIV positive. Each semen sample must be tested because those results are not consistent. HIV is detected in some samples and not others form the same man, even when HIV is not detected in the blood. SPAR stands for special program of assisted reproduction. They have developed highly sensitive techniques to detect the viral load in semen samples viruses like HIV, CMV, and Hepatitis C, and special procedures to wash the semen samples. This allows the sperm to be used for IVF to decrease or virtually eliminate the risk of transmitting the infection. These specimens can only be used for IVF, they are not appropriate for intrauterine insemination. 

ICSI was developed for men with poor sperm quality and quantity. Low sperm count, sperm motility, and abnormal morphology can be indications for ICSI. Abnormal morphology (shape of sperm) has been linked to poor fertilization. Fertilization can now be achieved for men where it previously seemed impossible. It is now used exclusively in some clinics, and it is especially important for couples who want to have their embryos genetically tested. One of the reasons why it is so widely used now, is so that the embryologists can look at the eggs and know the quality and maturation right after the egg retrieval. In conventional IVF, the egg quality and maturity is essentially a mystery because the eggs are surrounded by cells until the day after the fertilization. Fertilization rates are generally higher after ICSI compared to conventional IVF. The more embryos you have the better the chance of pregnancy!

One variation of ICSI is called “PICSI” which stands for physiological ICSI, and uses a specialized dish coated in a substance called hyaluronan.  Healthy sperm are attracted to that enzyme and stick to it, they are later used to inject the egg with. 

Sperm DNA Fragmentation Testing 

DNA fragmentation can be caused by a variety of factors such as infection, chemotherapy, radiotherapy, smoking, drug use, or advanced age. SDF is linked to impaired fertilization, poor embryo quality, increased spontaneous abortion rates and reduced pregnancy rates after assisted reproduction. Currently, there seems to be insufficient evidence to support the routine use of SDF in male factor evaluation nevertheless the importance of DNA fragmentation in spermatozoa has been acknowledged in the latest American Urological Association (AUA) and European Association of Urology (EAU) guidelines on male infertility. Several strategies have been proposed to minimize the influence of abnormal chromatin integrity on ART outcomes. Obesity, smoking, toxins, pollutants, and Bisphenol A (BPA). They include: intake of oral antioxidants, varicocele ligation, frequent ejaculation and sperm sorting. 

In vitro gametogenesis (IVG)

A new process called in vitro gametogenesis (IVG) is currently being developed, and if successful, it will completely transform the way humans think about reproduction.

The process of IVG creates sperm and egg cells in a lab from just about any adult cell. IVG uses skin or blood cells to reverse engineer a special type of cells called induced pluripotent stem cells (iPSCs). Essentially, iPSCs are adult cells that have been genetically reprogrammed into an embryonic state, meaning they have the potential to transform into any type of cell: kidney cells, muscle tissue, sperm, or eggs.

IPSCs can be used to create the necessary components for reproduction: eggs and sperm. They’re also at the forefront of all sorts of important research, including disease treatment, transplant science, and cutting-edge drug development.

In the hypothetical human IVG process, an individual would provide a skin biopsy. A lab would then reprogram those skin cells to create induced pluripotent stem cells, which would then be used to create eggs or sperm.

Today, we still need a man and a woman to make a baby. Reproduction still requires testes to make sperm and ovaries to produce eggs. 

In 2016, a team of scientists at Tokyo University of Agriculture in Japan helped a female mouse successfully give birth to 26 pups, using eggs created from skin cells.

In 2018, Japanese scientists were able to generate immature human eggs, using induced pluripotent stem cells derived from human blood cells. These incomplete eggs would not be viable for fertilization, but they do represent a major step toward the development of a successful human IVG process.

Oocyte Activation 

A small percentage of individuals continue to face repeated fertilization failure, even with normal sperm parameters and a good ovarian response and multiple ICSIs. Normally, when the sperm binds an egg a cascade of events occurs that results in oscillating waves of calcium ions in the egg. This is called egg activation! If this is missing or deficient in a patient it results in zygotes that arrest and cleavage stage defects. Calcium ionophores are the molecules that increase the concentration of calcium ions, and when artificially applied to an egg can activate the egg so that fertilization can occur.

A meta-analysis by Murugesu et al. (2017) included fourteen studies, and found activation with calcium ionophore increased fertilization, embryo cleavage, blastocyst and implantation rates, as well as overall clinical pregnancy rate per embryo transfer (OR=3.48) and live birth rate (OR=3.44). Calcium ionophore treatment may be especially helpful for patients with specific conditions, such as a condition called globozoospermia, which is when the sperm lacks a feature called the acrosome, or if previous, unexplained failed fertilization occurred.

https://www.fertstert.org/article/S0015-0282(17)30488-0/pdf

DHEA – de hydro epi andro sterone. 

One of the hottest topics in IVF right now is the use of DHEA to rejuvenate ovarian function, because currently up to 1 in 4 IVF cycles are characterized by poor ovarian response. “Poor responders” suffer from Diminished Ovarian Reserve (DOR) resulting in fewer oocytes and decreased rates of pregnancy. Some studies claim that use of DHEA supplementation improves pregnancy chances in women with Diminished Ovarian Reserve by reducing aneuploidy—chromosome number abnormalities in embryos. DHEA, according to some reports, has been very successful in increasing the number and quality of eggs, reducing the risks of miscarriages and shortening the time to pregnancy. 

Endometrial Receptivity Assays 

The Endometrium must be prepared with progesterone for the embryo to implant. The typical metric is to look for a think “triple line” pattern. ERA testing determines if the endometrium is “genetically” receptive or not at the time of sampling, by analyzing a few hundred genes that get turned on or off and are known to be important for true endometrial receptivity. When your lining looks ready after but is not expressing the right genes and therefore the right proteins, your “window of implantation” is displaced. ERA testing can find your personalized window of implantation in case of displacement, and will allow a personalized timing for embryo transfer. 3 in every 10 patients have a displaced window of implantation. Use of the ERA test in one study, resulted in a 73% pregnancy rate in patients with previous implantation failure.

https://www.researchgate.net/scientific-contributions/2068756675_M_Ruiz-Alonso

Millions of babies have been born through Assisted Reproductive Technologies (ART), however, only 30% of IVF cycles succeed in a clinical pregnancy. Aside from increasing the success rate, there are other goals for continued improvement across the IVF  industry; to simply get patients pregnant faster, reduce treatment dropout, or to reduce embryo wastage. Innovations in Artificial Intelligence (AI) will drive ART that is more reproducible, standardized, efficient, and less costly. Artificial intelligence and big data: Companies are using “big data” and predictive analytics to help fertility doctors recommend the best course of treatment based on what’s worked for patients with similar demographics. Others are using artificial intelligence to predict which embryo will create a viable pregnancy, instead of relying on scientist’s (occasionally) subjective judgment.⁠

Nanotechnology helps sperm swim: Male Infertility issues contribute to about half of all cases of infertility. One major cause is low sperm motility, or the sperm’s inability to swim to the egg. Nano-tech motors can slip over a sperm’s tail to propel it next to an egg.⁠

Creating “Three-person” embryos: The goal of so-called three-person IVF is to create embryos that have nuclear DNA from a woman and her partner but with healthy mitochondrial DNA from an egg donor. Three-person embryos have been created for two reasons, to correct inherited mitochondrial disorders or as an attempt to reverse the biological clock of older women. ⁠

Freeze all Vs. Fresh Transfer

A suggestion originated in the early 2000s that the high hormone levels derived from a stimulated IVF cycle would encourage a non-receptive, out-of-phase endometrium, the concept arose that adopting a freeze-all approach would not only minimize the risk of ovarian hyper response syndrome, but maybe even improve pregnancy rates in the general IVF population.

The latest clinical meta-analysis of fresh vs frozen transfers, now involving 5379 eligible subjects and 11 trials, found eFET associated with a higher live birth rate only in hyper-responders. There was no outcome difference between fresh and frozen in normal responders, nor in the cumulative live birth rate of the two overall groups. Now, here is where it gets complicated. 

The CDC described the increase in the number of elective FET cycles between 2007 and 2016 as ‘dramatic’, rising steeply from almost zero to more than 60,000 cycles per year. In its summary of US activity for 2016 the CDC seems unequivocal – at least, based on its observational registry data – that rates of pregnancy and live birth are higher after frozen transfers than after fresh. Yet the (published, peer reviewed or randomized clinical trial) so far has not shown a large difference. It seems to be a case where the clinical trials have not caught up with clinical practice, and because there is clear evidence that for hyper responders outcomes are better, many clinics are now relying on a freeze all strategy to reduce this poor outcome.   

1. Devroey P, Polyzos NP, Blockeel C. An OHSS-free clinic by segmentation of IVF treatment. Hum Reprod 2011; 26: 2593–2597.
2. Wong KM, Van Wely M, Mol F, et al. Fresh versus frozen embryo transfers in assisted reproduction. Cochrane Database Syst Rev. 2017 Mar 28;3:CD011184. doi: 10.1002/14651858.CD011184.pub2.
3. Roque M, Haahr T, Geber S. Fresh versus elective frozen embryo transfer in IVF/ICSI cycles: a systematic review and meta-analysis of reproductive outcomes. Hum Reprod Update 2019; 25: 2-14.
4. CDC. Assisted Reproductive Technology: National Summary Report. 2016.

Embryo Retained in Catheter 

Thaw Biopsy Revit 

Personalized Genomic Medicine 

Anticoagulants; Asprin, Lovenox, Heparin 

C4M2 mutation is found on the Annexin 5 which keeps the blood thin enough for pregnancy to progress successfully. When mutated, the gene fails to work adequately causing blood clotting, which eventually leads the body to abort the fetus.

Antiphospholipid syndrome (APS) is a systemic autoimmune disease characterized by production of antibodies – antiphospholipid antibodies (aPL) – that “attack” the person’s own body, resulting in blood clots and/or pregnancy complications.

For APS patients with a history of pregnancy complications only:

oral low-dose aspirin (LDA), which prevents clots by blocking platelet aggregation.

subcutaneous injections of prophylactic, low-dose heparin (an anticoagulant drug that prevents the clotting ability of the blood).

• Prevents the formation of blood clots in the embryo and placenta
• Increases the production of cellular substances important to successful embryo implantation in the uterine lining
• Increases insulin-like growth at the site of the embryo’s implantation
• Increases production of protein assisting in binding the early embryo in the uterine lining
• Effects suppression on the immunologic cause of recurrent miscarriage
• https://www.ebiomedicine.com/article/S2352-3964(16)30280-8/fulltext

MTHFR 

People differ in how much folate or folic acid they need for their health – based on the activity of “the MTHFR gene”. A mutation in this gene causes very low activity of the MTHFR protein in the body. This results into a highly reduced ability of the body to convert folic acid into a usable form and can lead to accumulation of the amino acid homocysteine – which is toxic to the body.

The biggest reason why knowing your MTHFR gene result is because it is involved in creating healthy DNA for both you and your future child. Active folate is directly involved in the synthesis of new DNA. And while we have a constant demand for the production of new and healthy DNA, you can imagine that demand for this hugely increases during pregnancy, when you are growing a new life! 

Issues with not enough healthy DNA available for both mother and growing child can result in issues with pregnancy, fetal growth, and general childhood development.

It is also used by the body to prevent levels of a substance in the body called homocysteine from climbing too high, which can be related to blood clots and increased risk of blot clot formation during pregnancy.

It is also important to create molecules called ‘methyl groups’, which act as instruction manuals for your DNA and cells, telling them the correct way to ‘behave’, so they do not do anything unwanted (e.g. cause disease or dysfunction within the body). We need healthy levels of these methyl groups to methylate/instruct your DNA, and without it cells are uncontrolled and can start to cause problems.

Formation of red blood cells, white blood cells, and platelets, which are all vital for both the health of the mother during pregnancy and also for the health of the child during pregnancy and after birth as they begin to rapidly grow and come into contact with bacteria and pathogens to strengthen their immune system.

As you can see, addressing and supporting your MTHFR genes during your preconception phase is the best way to healthily support both your body once you fall pregnant, and the growth and development of your new baby.

Knowing your MTHFR gene result and supporting your folate levels where needed is a key step in preconception, and both should not be undervalued!