The American Society for Reproduction provides official guidance for disaster preparedness for IVF labs. They say: “The primary objective of an emergency action plan (the ‘‘Emergency Plan’’) should be to provide for the safety of program personnel and patients, fresh and cryopreserved human specimens, and critical equipment and records.”
Disaster preparedness is critical in the high-stakes environment of assisted reproductive technology (ART) laboratories; preparedness for emergencies is non-negotiable.
All IVF programs and clinics should have such a plan codified and in place to protect fresh and cryopreserved human specimens (embryos, oocytes, sperm) and to provide for continuation or cessation of patient care in the event of an emergency, pandemic, or natural disaster.”
Whether it’s an everyday accident or a major natural disaster, having a robust plan is essential to:
- Protect Laboratory Personnel and Patients: Ensuring the safety and well-being of everyone on-site is the top priority during any disruptive event.
- Preserve Cryopreserved Gametes and Embryos: Maintaining the viability of fresh and frozen human tissue is critical to patient care and outcomes.
- Safeguard Information and Equipment: Securing patient records, operational documents, and essential lab equipment ensures continuity of care and smooth recovery.
Once an IVF program has developed its written Emergency Plan, the plan should be distributed among the staff and reviewed biennially. All program personnel should familiarize themselves with the Emergency Plan regularly and, as appropriate, receive disaster preparedness training tailored to their job responsibilities. Practicing the Emergency Plan annually is essential to ensure staff are capable of executing their assigned tasks effectively during an emergency.
Key Takeaways for ART Lab Disaster Preparedness
- Make Logistical Arrangements:
- Identify alternative storage locations for cryopreserved specimens in case of evacuation.
- Develop a transportation plan for safely relocating gametes, embryos, and critical equipment.
- Reduce Labor Needs:
- Streamline emergency response tasks to minimize the number of staff required on-site during disasters.
- Assign clear roles and responsibilities in advance to avoid confusion.
- Conserve Supplies:
- Maintain an inventory of emergency supplies, such as backup media, supplements, and cryopreservation tools.
- Regularly inspect and restock supplies to ensure readiness during critical situations.
- Protect Embryologists and Gametes/Embryos:
- Prioritize the safety of laboratory personnel through proper training and protective measures.
- Implement safeguards for incubators, cryopreservation tanks, and culture equipment to withstand environmental threats.
- Protect Clinic and Patient Records:
- Ensure that patient information, financial records, and operational documents are securely stored and backed up digitally.
- Designate personnel to manage and transport records during an evacuation.
Practicing the Plan
A disaster preparedness plan is only as strong as the team executing it. Conduct annual drills and tabletop exercises to test readiness, identify weaknesses, and refine procedures. Training sessions tailored to specific roles help staff remain confident and prepared in the event of a real emergency.
A robust disaster plan ensures the safety of your team, the viability of critical specimens, and the continuity of patient care in the most challenging circumstances. Investing in preparation minimizes risks and demonstrates a commitment to excellence, even during emergencies.
Types of Disasters Requiring Action
Disasters can be categorized as internal or external, depending on their nature and impact:
Internal Disasters
Structural damage to the laboratory, such as impending collapse.
Fires causing direct damage or requiring evacuation.
Gas leaks or toxic chemical exposure.
Excessive heat above 100°F for extended periods, compromising equipment and specimen viability.
External Disasters
Earthquakes, floods, and other “Acts of God” that threaten the building or surrounding infrastructure.
Local or regional emergencies evaluated by the lab director for potential evacuation.
Disaster Response and Evacuation Plan
- Activation of the Plan
The disaster plan is activated at the direction of the laboratory director or supervisor.
The immediate goal is to ensure the safety of personnel, preserve critical specimens, and secure equipment. - Evacuation of Specimens and Equipment
Relocation Sites:
Collaborate with nearby fertility laboratories to pre-arrange alternative storage locations. Secure a letter of agreement with local labs confirming availability and access.
Ensure the chosen location has secure storage facilities, such as lockable doors, and assign constant supervision if security cannot be guaranteed.
Specimen and Equipment Handling:
Personnel: Only designated staff should handle and transport embryos and equipment.
Documentation: Assign a team member to remove records and documents critical to inventory and current cases.
Media and Supplies: Assign another team member to gather media, supplements, and equipment necessary to maintain embryo viability.
Transport of Equipment:
Small incubators and isolettes with backup power can be wheeled to temporary locations.
Larger equipment may require professional movers or coordination with manufacturers.
Tanks and dewars must be securely transported to avoid damage.
Emergency Freezing: If time permits, fresh embryos can be frozen and stored in LN₂ dewars for safer relocation.
- Returning to the Lab
An “All Clear” to return specimens and equipment is given after:
Assessing air quality and ensuring acceptable conditions.
Cleaning the lab thoroughly and replacing air filters.
Maintaining Continuity During Specific Disasters
Fire Response
Firefighters are authorized to rescue cryogenic tanks and other critical items if it is safe to do so.
Backup refrigerators and storage tanks should be pre-positioned in safe locations for temporary use.
Flooding or Hurricanes
Elevated storage areas should be identified to mitigate flood risks.
Longer-term relocation may be necessary; ensure all equipment is prepped for secure transport.
Earthquakes
Secure all equipment to prevent damage from tremors.
Relocate specimens and equipment to a pre-identified alternate site if the building’s structural integrity is compromised.
Snowstorms
Maintain an adequate supply of LN₂, media, and emergency power to handle prolonged access issues.
Ensure personnel and patients are kept informed of any delays or changes.
Tornadoes
Use designated interior safe rooms to protect staff and specimens during the storm.
Relocate specimens to secure areas only after the tornado threat has passed.
Documentation and Review
Record all actions taken during the disaster, including:
The timeline of specimen evacuation and return.
Conditions that prompted the evacuation.
Details of any equipment moved or damaged.
Post-incident, review the response with the team to identify improvements and update the disaster plan as needed.
Training and Preparedness
Regular Drills: Conduct drills to simulate specific disaster scenarios and test evacuation procedures.
Cross-Training: Ensure all designated personnel are trained in specimen handling, emergency freezing, and transport logistics.
Communication Plans: Maintain an updated list of contacts for local fertility labs, emergency services, and transportation providers.
World Embryologist Day, is a special day in the world of healthcare as we come together to celebrate World Embryologist Day. On this occasion, we take a moment to recognize and honor the remarkable achievements of embryologists worldwide. These dedicated professionals play a pivotal role in both clinical embryology and groundbreaking research that continually advances the industry. Today, we delve into the fascinating stories of a few pioneering embryologists who have transitioned from their “hands-on” roles to becoming visionary leaders in technology startups. Let’s explore how they are leveraging cutting-edge technologies to make a profound impact on millions of lives.
The Crucial Role of Embryologists in Family Building:
Embryologists are unsung heroes in the realm of assisted reproductive technology (ART). They skillfully work behind the scenes, performing crucial tasks like in vitro fertilization (IVF), embryo culture and grading, and cryopreservation, to name a few. The success of countless couples’ dreams of starting a family owes a great deal to the dedication and expertise of these professionals, and is celebrated on World Embryologist Day, the birthdate of the world’s first IVF baby, Louise Joy Brown.
As technology and research continually evolve, so do the opportunities for embryologists to expand their horizons beyond the confines of a laboratory. Many of them have ventured into the world of startups, where they now play pivotal roles in driving innovation and creating groundbreaking solutions.
Empowering through Technology Startups:
We had the privilege to interview some incredible embryologists who have embraced their passion for cutting-edge technology and translated it into fruitful roles as executives and CEOs in tech startups. Their journey from being “hands-on” working embryologists to driving innovation has been truly inspiring.
AI Driven Embryo Selection Advancements:
Daniella Gilboa, CEO at AIVF, a renowned embryologist, shared her experience of transitioning to the tech world. As the CEO of a fertility-focused startup, AIVF, she spearheads the development of AI-powered embryo selection algorithms. This technology revolutionizes the embryo screening process, significantly increasing the chances of a successful pregnancy while reducing emotional and financial burdens for couples undergoing IVF.
She says “I sometimes have flashbacks to my first week in an IVF lab. Which was overwhelming. About 20 years ago. It took me a couple of days to fall in love with this amazing profession. There’s a moment in time where it’s the embryologist, the patient and the physician, in the same room, just moments before embryo transfer. It’s this moment that encapsulates everything. It’s this moment when you know you can change people’s lives. I am honored to be an embryologist and more so, to lead the development of the next generation of IVF.”
Gamete and Embryo Cryostorage Breakthroughs:
Cynthia Hudson, VP Clinical Strategy at TMRW Life Sciences formerly a hands-on embryologist, is now the VP of Clinical Strategy at TMRW, specializing in gamete and embryo cryostorage automation. She leads a team of researchers working on innovative automated cryostorage hardware and software. This breakthrough robotics technology has far-reaching implications for individuals facing fertility challenges and those considering delaying parenthood by freezing gametes for long term storage.
She says “There is so much demand for fertility care that it will take all of us, and more, to solve the access to care problem. My path went from working as an embryologist to designing technology for embryologists to use in the laboratory. If we can improve the efficiency, safety, and standard of care, we can help more people that need us.”
The Power of Precision: PGT Technologies
Among the remarkable stories of embryologists transitioning to leadership roles in technology startups, we find those who have embarked on a journey into the realm of Preimplantation Genetic Testing (PGT). PGT is a cutting-edge technology that enables embryologists to screen embryos for genetic abnormalities before they are replaced. At the heart of their mission lies the development of advanced PGT technologies that offer unparalleled precision in identifying genetic anomalies in embryos.
Charlene Alouf, PhD, HCLD, Medical Science Liaison, Genomic Prediction says “It has been an amazing transition – especially from someone with decades of experience that started during a very remedial time in IVF technology. I really have gotten to know so many in the field and that is 50% of the satisfaction!”
Sheela Ali, PhD, HCLD, VP of Science and Innovation, Progenesis, “I have spent the last 15 years dedicating my career to human IVF, many times sacrificing personal time to my work. I have such a strong passion for the field and an even stronger passion for the families we are helping build. My time as an embryologist and laboratory director were monumental in identifying gaps in automation and technology for our IVF field. I made the decision to use my experience, education and skills to help bridge the gap between new and emerging technologies and their proper availability and application in the IVF and Andrology laboratories by joining Progenesis. I find that the growth in my career has been exceptional as I broadened my reach by helping laboratories improve their practices, ultimately improving patient care and cycle outcomes. As the VP of Science and Innovation, with a single webinar, hands on workshop or conference, I address larger laboratory and clinical groups to maximize the positive impact, which ultimately translates to improved efficiencies. I can develop and grow the technology for the betterment of the patient and laboratory staff alike by assessing the current needs of the laboratory and clinicians. I am an advocate for progressive and improved laboratory practices and strive to propose solutions and workflows that will reduce hardships of my fellow embryologists and andrologists. I have been fortunate that the relationships I have built over the years with my peers are strong and supportive. It has been an exhilarating journey thus far and I look forward to continuously bringing the latest and greatest technologies to IVF laboratories.”
Global Professional Education Clinical Support In addition to the groundbreaking work of embryologists in technology startups, another essential aspect of the field is the Global Professional Education Clinical Support. Highly skilled embryologists, like Sourima Biswas Shivhare, of Cooper Surgical Fertility Solutions strive to strengthen the global community of embryologists and contribute to the continuous improvement of reproductive healthcare on a global scale.
She says “It has been liberating; in my current role, I am truly able to embrace my love and curiosity for the field and help the field move forwards. Let’s say there are tools in a true ‘clinical scientists’ toolbox, which aren’t ‘allowed’ to be utilized in the regular lab. This makes them obliged, due to their love for the field, to move out in the direction of roles that are conducive and nurturing of the true scientist. Bottom line, embryologists are being used/trained as technicians, not given the scope to nurture their brains. Having even the most basic understanding of the potential and the necessity for automation in the lab, in fact we should be training more brains than hands.”
On the Occasion of Word Embryologist Day 2023
On this World Embryologist Day, we celebrate the achievements of embryologists worldwide and the profound impact they have on countless lives. These passionate individuals not only excel in clinical embryology but are also instrumental in driving technological advancements that shape the future of reproductive healthcare.
As we applaud their dedication, let us also acknowledge the remarkable journey of those who have embraced leadership roles in technology startups. Their vision, paired with their expertise, has given rise to cutting-edge solutions that hold the promise of helping millions achieve their dreams of building a family.
Together, as a global community, we honor and appreciate the invaluable contributions of these exceptional individuals, and we look forward to a future where technology and human ingenuity continue to work hand in hand for the betterment of reproductive health worldwide. Happy World Embryologist Day!
Assisted reproductive technology (ART) has transformed the landscape of infertility treatment, providing a ray of hope to countless couples trying to conceive. In-vitro fertilization (IVF) is one of the most commonly used ART methods, accounting for over 99% of all ART cycles performed in the United States. However, despite the progress made in this field, disparities in IVF outcomes and access persist, and racial factors play a significant role in exacerbating these disparities.
What is DEI?
Diversity, equity, and inclusion (DEI) are crucial components of any healthcare system, including IVF clinics. DEI practices help ensure that all patients are treated equitably, regardless of their race, ethnicity, gender, sexual orientation, or socioeconomic status. By adopting DEI practices, IVF clinics can better serve and advocate for patients and their loved ones, leading to better outcomes and a higher quality of life.
One of the key benefits of DEI practices is that they promote patient-centered care. Patient-centered care is an approach to healthcare that places the patient at the center of their care experience. This approach emphasizes listening to patients’ needs and preferences, involving them in decision-making, and providing care that is respectful of their values, beliefs, and cultural background. When IVF clinics adopt DEI practices, they create an environment that is welcoming and supportive of all patients, which can improve patient satisfaction and outcomes.
Cultural sensitivity is another important aspect of DEI practices in IVF clinics. Cultural sensitivity refers to the ability to understand and appreciate the cultural backgrounds of patients and how these backgrounds may affect their healthcare experiences. For example, a patient from a different cultural background may have different beliefs about fertility treatment, and IVF clinics that are culturally sensitive can adapt their services to better meet these patients’ needs.
In addition to promoting patient-centered and culturally sensitive care, DEI practices can also improve health outcomes for patients. Studies have shown that patients who receive care that is culturally sensitive and responsive have better health outcomes than those who do not. For example, a study of African American women undergoing infertility treatment found that those who received culturally sensitive care had higher pregnancy rates than those who did not.
Finally, DEI practices can help IVF clinics attract and retain a diverse and talented workforce. When IVF clinics prioritize DEI, they create an environment that is welcoming and supportive of all employees, regardless of their background. This can help attract and retain employees who are representative of the communities they serve, which can improve the quality of care and outcomes for patients.
There are several reasons why racial disparities in IVF outcomes and access exist. One of the most significant factors is the cost of treatment. IVF is an expensive procedure that can cost tens of thousands of dollars per cycle, making it out of reach for many individuals and families, especially those without insurance coverage. Unfortunately, insurance coverage for infertility treatment is not mandated in most states, and even in states where it is mandated, the scope and extent of coverage may vary significantly. This lack of access to affordable IVF treatment disproportionately affects low-income individuals and people of color, who are more likely to be uninsured or underinsured.
Another factor contributing to disparities in IVF outcomes is the quality of care. Studies have shown that Black women have lower success rates with IVF, even after controlling for age, infertility diagnosis, and other confounding factors. This disparity may be due in part to differences in the quality of care provided to Black women. For example, Black women may be less likely to receive appropriate preconception counseling, have longer wait times for appointments, and receive lower-quality care during the IVF process.
Finally, there is a significant lack of diversity in the field of reproductive medicine. Black individuals and other people of color are significantly underrepresented in the field, both as patients and as practitioners. This lack of diversity may contribute to the disparities in care and outcomes seen in IVF treatment. For example, a study found that Black women who received care from Black physicians were more likely to have successful IVF outcomes than those who received care from non-Black physicians.
Disparities in IVF outcomes and access are complex and multifactorial, with racial factors playing a significant role. Addressing these disparities will require a comprehensive approach that includes addressing the cost of treatment, improving the quality of care provided, and increasing diversity in the field of reproductive medicine. Legislation such as the ACA presents an opportunity to expand coverage for infertility treatment and improve disparities in fertility prevention, but more needs to be done to ensure that all individuals have access to the care they need to build their families.
DEI and Inclusive and Accurate Medical Language
The use of medical language has a significant impact on the way we think about and understand health conditions. Historically, medical language has been focused on gender, with certain conditions and symptoms being attributed exclusively to either male or female bodies. However, this approach can be problematic as it ignores the fact that gender is not binary and fails to account for individuals whose gender identity does not align with their biological sex.
As such, a more inclusive and accurate approach to medical language would be to shift the focus from gender to anatomy, conditions, and symptoms. This means using language that describes specific body parts and functions, rather than assuming that certain conditions or symptoms are exclusive to one gender or another.
For example, instead of using terms like “male infertility” or “female infertility,” medical professionals can use terms like “sperm count” or “ovulation problems” to describe specific conditions or symptoms. Similarly, rather than using gendered terms like “menstrual cramps” medical professionals can use more specific language like “dysmenorrhea” to describe the symptoms.
By shifting the focus of medical language from gender to anatomy, conditions, and symptoms, we can ensure that all individuals receive accurate and inclusive healthcare. This approach also acknowledges that individuals may have a range of gender identities and expressions, and that these identities do not necessarily correspond to their biological sex.
It is important to note that shifts in medical language are not just a matter of political correctness, but rather a crucial step in providing equitable healthcare. Inaccurate or exclusionary medical language can lead to misdiagnosis, delayed treatment, and a lack of access to appropriate care for marginalized communities. In contrast, more inclusive and accurate medical language can help ensure that all individuals receive the care and support they need to maintain their health and well-being.
DEI and LGBTQIA+
Diversity, equity, and inclusion (DEI) practices can greatly improve fertility outcomes and create a more welcoming environment for LGBTQIA patients in several ways:
Access to Care: DEI practices ensure that all patients have equal access to fertility care, regardless of their gender identity or sexual orientation. This includes providing education and resources to LGBTQIA patients about their fertility options, as well as making fertility services more affordable and accessible.
Culturally Sensitive Care: Fertility clinics that adopt DEI practices can provide culturally sensitive care to LGBTQIA patients. This involves understanding the unique challenges that LGBTQIA individuals face when seeking fertility treatment and developing care plans that are tailored to their specific needs.
Inclusive Language: Fertility clinics that use inclusive language can create a more welcoming environment for LGBTQIA patients. This involves using gender-neutral language and avoiding assumptions about gender and sexual orientation.
Provider Diversity: DEI practices promote provider diversity, which is essential in creating a more welcoming and inclusive environment for LGBTQIA patients. Clinics should strive to hire providers who are representative of the diverse patient population they serve.
Patient Advocacy: Fertility clinics can serve as patient advocates by advocating for policies that promote DEI in healthcare. This includes supporting legislation that protects the rights of LGBTQIA patients, as well as advocating for insurance coverage for fertility treatments.
The table below gives a sample DEI plan, and provides space to record a point person on the executive team, DEI group members who might participate, and a strategy to include staff from the whole company.
| DEI Initiative by Department | Activities | Executive Staff | DEI Group Members | Strategy to include all staff |
| Human Resources | Recruiting – all levels | |||
| Talent Pipeline – Bridging the gap to local schools and Universities | ||||
| Diversity Survey: What is does the diverse make-up of your company look like? • Race • Gender More than two options (MANY options) • Religion • Age • Sexual orientation • Parental status • Marital status • Position • Disability (physical or otherwise) Equity: • Salary equity • Equitable promotions and raises • Diversity in leadership positions? Inclusion: Understanding the employee experience. • “I can voice a contrary opinion without fear of negative consequences” • “people from all backgrounds have equal opportunities to succeed ” • “perspectives like mine are included in the decision-making at my company” | ||||
| Marketing | Analyze your social media feeds for each clinic. Does your social media feed display a range of skin tones? A range of relationships? A spectrum of genders? | |||
| Your ads and creative content should show diversity. Captions and posts should use inclusive language. | ||||
| Amplify publications related to disparity in outcomes, eduction, or access. Show you care about these issues. | ||||
| “Like,” follow, and occasionally share (amplify) the content of diverse creators. | ||||
| Ask physicians and scientists to participate in diverse infertility events and share. Ask them to use inclusive language in social media posts. Educate them on inclusive language. | ||||
| Can you create sections on the IVF Clinic website that speaks to the lived experience of BIPOC, LGBTQI+. Can you use inclusive language whenever possible “Pregnant persons” People with a uterus” “Birthing person” “Chest Feeder”? | ||||
| Clinical | Change all paper or electronic forms to use inclusive language (LGBTQ, race, and ethnicities). Patient and Partner (instead of female and male) | |||
| Increase visual representation in waiting rooms, magazines, pictures, baby pictures | ||||
| Attendance at Men Having Babies or other diverse conferences or symposia | ||||
| Can you parse your SART data or EMRs and strategize for one abstract / publication a year on a topic related to diversity? What are the IVF success rates of BIPOC at your IVF clinic? What are the ethnic backgrounds of the internal donor egg banks? (Can you recruit more diverse backgrounds?) Do the patients reflect the diversity of the area surrounding your IVF clinic? Does your patient satisfaction surveys have queries for culturally sensitive and competent, or LGBTQI+ specific care? | ||||
| IVF Laboratory | Seminar on lab handling of HIV+ sperm and embryos. Education about SPAR processing. | |||
| Changes in lab protocols to accommodate egg donor splits for male:male couples. | ||||
| Coordinate with clinic for abstracts and papers related to DEI | ||||
| Internal Network | Mission, Vision, Contract with executive team | |||
| DEI newsletter, 2x per year posted on HR staff management platform and emailed to staff |
Competency Assessment vs Proficiency Testing. Do IVF Labs Need Both? Tl;DR – YES! We explain why.
“One thing worse than training employees and losing them… is not training them and keeping them.” -Ed Metcalf
Competency Assessment vs Proficiency Testing. Does my IVF lab need to perform both? The short answer is yes!
Learning Objectives
— What is the difference between proficiency testing and competency assessment?
— When do you need to perform PT?
— When do you need to perform CA?
— What are the 6 elements needed to perform a CAP level CA?
— When do you need to perform PT?
— Define the criteria for satisfactory proficiency testing (PT) performance.
— Describe the consequences of unsatisfactory performance of a PT event.
— Take the appropriate steps to investigate a PT failure.
— Discuss the advantages of standardization and digitization for documentation of training, performance, and corrective actions.
Until each staff member has documented training, followed by successful assessment of competency of that task, they should not be permitted to perform or result patient testing independently of their trainer. Embryologist training, competency acquisition and documentation of these activities for inspections hasn’t advanced in 40 years, until now. ART Compass is outsmarting the embryologist shortage, reducing non-conformance events, and helping you pass quality inspections, defeating CAPs number one most cited deficiency, staff-related checklist items- download our complete full length, peer reviewed study here, “Assuring quality in assisted reproduction laboratories: assessing the performance of ART Compass – a digital ART staff management platform.”
Whether you’re subject to CLIA, CAP or your local state DOH requirements, you will be required to provide proof (documentation) of both training AND competency for each employee, for each task that they perform. Documentation of all of these tasks can be organized through the use of advanced digital IVF lab management tools, like ART Compass. ART Compass helps savvy IVF lab directors keep track of what each staff members’ specific job junctions include, which they need to be trained in, and which tasks have been completed by each trainer.
Proficiency Testing
Before passage of the Clinical Laboratory Improvement Amendments of 1988 (CLIA), participation in proficiency testing (PT) was voluntary for many labs and the standards for these tests were not defined. With passage of CLIA ‘88, proficiency testing evolved from an educational self-assessment and improvement tool to the primary measure of continued reimbursement and licensure.
Proficiency testing determines the performance of individuals for specific tests or measurements. Performance on PT has been found to be an indicator of the quality of patient testing. By CLIA standards, clinical laboratories are required to enroll in a CMS-approved PT program for all regulated nonwaived testing, and their performance is compared to a target value using statutory criteria for acceptable performance. For nonregulated, nonwaived testing or for tests that have no formal PT available, CLIA requires alternative assessment, twice per year.
Failure of a single event (<80%, or <100% for immunohematology) requires an investigation to ensure that processes were followed correctly throughout all phases of testing: preanalytic, analytic, and postanalytic. This type of unsuccessful performance does not require that a response be returned to the PT program or to the facility’s accreditation agency. However, if two consecutive events or two out of three consecutive events for the same procedure receive an unsuccessful grading, consequences are more severe. The laboratory must take steps to discontinue the procedure. It is best to notify the accrediting agency of the voluntary discontinuance before the accrediting agency notifies the laboratory.
Next, the problem should be investigated, corrective action implemented, and two consecutive successful PT events must be performed. The events can be independently obtained through the ART Compass program. Finally, the accrediting agency must be notified of the corrective action and the intent to reinstate testing.
Embryology procedures fall under nonregulated, nonwaived testing. This requirement can be met by subscribing to a formal program, such as ART Compass, which offers testing for all embryology procedures. The target values in ARTC are determined two ways: by the mean of all peer participant responses after removal of outliers, and by IVF Lab Director consensus. Acceptable performance is considered to be 80%.
You may access a Proficiency Testing Policy and Procedure in ART Compass, by logging in online via a Chrome Browser and navigating to the green tab “Documents and Forms,” then click on the “Quality” folder. Use the “Show to” feature to select any individual who needs to read and review the policy.
Competency Assessment
Embryologist competency assessment is an ongoing, continuous process of monitoring individuals’ abilities to perform their specific job functions.
Once training has been completed and documented in ART Compass, you will assess each staff member’s clinical decision-making ability to successfully perform these tasks using our robust suite of subjective “surveys.” This is their competency, where you assess if the training was successful and staff are able to perform each assigned task correctly.
You may access a Competency Assessment Policy and Procedure in ART Compass, by logging in online via a Chrome Browser and navigating to the green tab “Documents and Forms,” then click on the “Quality” folder. Use the “Show to” feature to select any individual who needs to read and review the policy.
CAP Requirements for Competency Assessment:
ART Compass contains a robust suite of tools for staff management, including a Staff-Quality Audit and subjective competency assessments for each embryology procedure, as well as objective surveys for topics of interest such as Media and pH, FDA regulations, HIPAA Compliance, PPE and Bloodborne Pathogens and much more! Two ART Compass digital tools, a conventional checklist and our Competency Assessment 2.0 document capture module (use your phone camera to record evidence) will guide your competency evaluations and document evidence of completion for all required procedural steps.
To fully demonstrate successful competency all 6 of the following elements must be documented for each employee, for each task:
Direct observation of routine patient testing — Watch (and snap a picture!) as employee performs routine work processes and procedures, including; patient preparation, specimen handling, processing, and testing.
Monitoring the recording and reporting of test results — Review worksheets, computer printouts, or manual test logs for results or entries that are incorrect or incomplete. The worksheets, logs, and printouts should be compared to final test reports, evaluated turnaround times, and for compliance with policies and procedures.
Review of intermediate test results, records, and proficiency testing results — Review testing documentation, to include test results or worksheets, documentation forms, QC logs, proficiency testing documentation, and other applicable documentation for completion of proper policies and procedure. Documentation of review will include follow up of corrective action related to problems in the laboratory.
Direct observation of instrument maintenance and function checks — Watch employee perform instrument maintenance and function checks as compared to documentation for completeness and correctness of process and expected outcome.
Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples — Assessment of previously tested samples; internal blind samples or external proficiency testing samples.
Assessment of problem-solving skills — Include review of problem logs, incident reports, and QC failures; Review corrective actions employed to resolve the problem. Personnel interviews (staff narrative) may also be included for documentation.
PT Failure: Now What?
Unsatisfactory PT performance makes up approximately 3.2% of all CMS survey deficiencies. Inappropriate PT enrollment makes up 1.8%, and failure to perform alternative assessment of nonregulated testing makes up 6% of deficiencies (Yost, 2011). The suggested steps for investigating PT failure are:
- Survey Materials: On receipt of the survey materials, verify that they were received in acceptable condition. Should any unacceptable conditions or criteria be noted, notify the PT program as soon as possible for shipment of replacement samples. Ensure that the samples are stored according to the manufacturers’ instructions until analysis.
- Clerical Error: Errors of this type are the most commonly reported and may be of various types. They include typographical errors as well as errors related to interpretation, transcription, transposition, misidentification, answer-form coding, miscalculation, or acceptance of a nonlinear result. Manual entry offers more chance for transcription or transposition errors. Electronic entry still allows for incorrect keystrokes and/or options to be submitted.
- Technical Problems: The most common assumption when assessing technical issues is that the reagent and/or instrumentation reported an inaccurate result. This may be exhibited by the quality control value falling out of the acceptable range for the analyte and the run being accepted. Quality control results that demonstrate excessive repeats, shifts, or trends may also affect PT results and should be carefully scrutinized in the investigation.
- Method Problems: These types of errors include instrument problems, maintenance issues, or faulty reagents and/or standards. Verify that the instrument was within performance guidelines the day of PT. Were there repairs or component replacements recently done that could have affected the PT results?
- Could the error have affected patient testing? If so, document the actions taken to ensure that the patient testing reported at the time of the unsatisfactory PT was valid or whether amendment is needed. It is necessary to notify providers if any inaccurate results were reported.
- The final steps of the investigation are to determine the problem(s) and summarize the findings in your documentation. Include any supporting documents for the findings. These may include proficiency report records, instrument data, quality control records, calibration records, maintenance logs, and any other records found to be of assistance. Document the corrective action taken to remedy the problem and that steps that will be taken to prevent the problem from recurring.
Documenting PT performance in ARTC
A logical approach and use of a standardized investigation forms may be a reassurance that possible critical steps in the investigative process were not overlooked, and variables were examined for the root cause of unsatisfactory proficiency testing performance. You can find free resources in ART Compass to troubleshoot failed or unsatisfactory PT events. 1. In the surveys module of ARTC you will find The IVF Lab Digital Playbook -> Investigation of Proficiency Testing Results. 2. Access ARTC online, navigate to the green tab “Documents and Forms” and assign the “Investigation of Proficiency Testing Results”to a staff member.
Embryo Selection has been proposed as one of the top Infertility research priorities. Healthcare professionals, people with fertility problems and infertility researchers (healthcare funders, healthcare providers, healthcare regulators, research funding bodies and researchers) were brought together in an open and transparent process resulting in an article that was published in Human Reproduction in November 2020 outlining the top future infertility-related research priorities. The initial survey was completed by 388 participants from 40 countries, and 423 potential research questions were submitted. Fourteen clinical practice guidelines and 162 Cochrane systematic reviews identified a further 236 potential research questions.
The top 10 infertility research priorities for the four areas of male infertility, female and unexplained infertility, medically assisted reproduction and ethics, access and organization of care for people with fertility problems were identified. These top ten research priorities in each topic area outline the most pressing clinical needs as perceived by healthcare professionals, people with fertility problems and others, to assist research funding organizations and researchers to develop their future research agenda.
This post discusses research priority #4: What is the optimal method of embryo selection in IVF cycles?
- An article was published in Human Reproduction in November 2020 outlining the top future infertility-related research priorities. The top ten ART research priorities are;
- What are the causes of implantation failure?
- What is the optimal treatment for women undergoing IVF who are poor responders to increase live birth rates?
- What is the optimal method of sperm selection in IVF cycles?
- In couples with unexplained infertility, does IUI increase live birth rates when compared with other ARTs, including IVF?
- In couples with unexplained infertility, what is the optimal number of IUI cycles before moving to IVF?
- What is the optimal method of embryo selection in IVF cycles?
- What are the factors that affect cycle to cycle variability in the number and quality of oocytes produced in an IVF cycle?
- What is the optimal time interval between ovulation and IUI?
- What is the emotional and psychological impact on children born using donor gametes?
- What is the emotional and psychological impact of repeated fertility treatment failure?
- Why is Embryo Selection a research priority?
- The primary goal of embryo selection is to produce a live birth from a single embryo transfer and to minimize detrimental outcomes, like implantation failure, miscarriage, or birth defects.
- Noninvasive imaging (microscopy) systems for gametes and embryos is the primary grading and selection method
- Common:
There are three techniques for imaging live, transparent specimens.
Phase contrast passes light through the sample, so the image is light and dark based on the DENSITY of the sample. HMC (Hofmann Modulation Contrast) and DIC are very similar- both are rendering an image based on the rate of change in the optical path- the slope. However, they do it different ways. In HMC a filter is used to amplify certain signals- in this case, the signal is light that has refracted as it passed through the sample. In DIC light is split into parallel beams and directed at the specimen, then they are further affected as they pass through the specimen, then recombined and analyzed on the other side. DIC relies on waves of light interfering (or not) with each other. The major problem with phase contrast is that it produces “halos” of light. The major problem with DIC is that orientation of the sample matters a lot (so swimming sperm- as they change their orientation- would not be good to view with it). Additionally, you must use glass coverslips/ slides or plates with the same refractive index – whereas with HMC you can use a plastic dish, PVP etc all having different refractive indices than the sample.
- Rare:
- Polscope. Visualize meiotic spindle placement and formation with polarized light. Now we predict the position of the spindle by positioning the 1st polar body at 12 on the clock when we do our ICSI injections. But the spindle is not always there, and we can damage the chromosome apparatus during the injection causing the second polar body to not be able to extrude from the egg, and failed fertilization. If the spindle has not formed when we inject the egg usually dies. So the method we have now works for 90% of eggs. We don’t usually have access to this specialized microscope.
- MSOME and IMSI. Expensive experimental systems that require extended handling of the sperm, potential to cause more oxidative damage, lack of agreement on what marker of any indicates sperm DNA damage (vacuoles, cytoplasmic droplet)
- Time lapse monitoring. Expensive and most labs do not have it. Incubation system where the embryos are placed and grown continuously and monitored. Right now, we take embryos from their little culture chamber and inspect them at set time points. Usually at fertilization, day 3, and then 5/6/7. Time lapse can record things we miss in between those checks. Positive selection criteria include the positioning of the pronuclei and a small organelle called the nucleoli inside them, number of blastomeres, the absence of multinucleation, early cleavage to the two-cell stage, and a low percentage of cell fragments in embryos.
- Genetic screening selection techniques like PGT-A are peaking in several countries
- New controversy: polygenic trait selection of embryos
- There have been and continue to be many many controversies in genetic testing of embryos: namely, mosaic embryos and “segmental aneuploidy” embryos can self correct and make healthy pregnancies 30% of the time.
- Algorithmic and artificial intelligence scoring generated by computers is gradually enhancing our selection process, these are becoming more widely used.
- EMA by AiVF is a multi-module integrated platform that combines AI, computer vision, and big data to improve the success rates in patients undergoing IVF treatment. Its genetic evaluation tool can determine if the given embryo is genetically suitable for transfer by avoiding an invasive biopsy. AiVF has the largest embryo database in the world and the platform offers objective and automatic tools. One groundbreaking study from AiVF, tested the effectiveness of EMATM, AiVF’s multi-module integrated platform, which combines AI, computer vision, and big data. According to the study, EMATM detected significant differences between aneuploid and euploid embryos during the first five days of embryonic development. This was based on a retrospective study involving 2,500 embryos with PGT-A results – 1,000 euploid (genetically normal) embryos and 1,500 aneuploid (genetically abnormal) embryos. Aneuploid embryos were significantly more likely to reach each specific embryo developmental event later than euploid embryos and the time gaps between developmental milestones were also statistically longer in aneuploid embryos.
- In general, lack of video imaging systems for continuous monitoring and single step embryo culture systems, as well as lack of data handling methodologies, are holding these back from widespread deployment.
- The race has been on to find metabolomic markers for embryo selection
- What is the embryo using for energy and growth, and what are its waste products?
- The metabolomic profiling of embryo culture media has been performed through proton nuclear magnetic resonance (1H NMR). Researchers have discovered that the metabolomics profile is correlated with embryo reproductive potential. From the proton NMR spectrum, alanine, pyruvate, and glucose levels were reduced in the culture media of embryos that resulted in pregnancy. Glutamate levels were found to be higher compared to embryos that failed to implant, possibly due to its generation from α-ketoglutarate and ammonium, thereby lowering the potentially toxic ammonium to developing embryos. A sensitivity ― the ability to identify true implantations/pregnancies ― of 88.2 percent and a specificity ― the ability to correctly predict no implantations/pregnancies ― of 88.2 percent was achieved through 1H NMR
- Protein markers from the embryo culture medium
- Not too many have been discovered, but surely there are more. Healthy embryos will be producing characteristic proteins as they go about their work growing.
- In one study by Noci et al., soluble human leukocyte antigen-G (sHLA-G) was isolated and considered as a possible protein marker of embryo reproductive potential. The presence of sHLA-G shows no correlation with embryo morphology, and the lack of sHLA-G in culture media has a negative predictive value. In another study in which sHLA-G-positive embryos were transferred, implantation and pregnancy rates were 44 percent and 75 percent, respectively, compared to 14 percent and 23 percent of transferred sHLA-G-negative embryos.
- A protein biomarker that has been found to be upregulated and increased during embryo maturation into the blastocyst stage is a Day 5 secretome ― a set of proteins secreted from the cell ― resembling ubiquitin. Ubiquitin has been implicated in the turnover of key signaling molecules during implantation
- Other non-embryonic genomic markers (cumulus cells) have potential
- The cumulus cells (CCs) that surround the oocyte from fertilization until implantation have been analyzed and gene-profiled to gauge embryo potential: the likelihood of an embryo to implant and lead to a successful pregnancy. Several genes expressed in CCs have been correlated with predicting pregnancy, including cyclooxygenase 2 (COX2), steroidogenic acute regulatory protein (STAR), and pentraxin 3 (PTX3). Two upregulated biomarkers have been identified in the CCs of successful pregnancies, BCL2L11 and PCK1, which are involved in apoptosis of abnormal cells and gluconeogenesis.
Interested in Embryologist Training and KPI management? Book a one on one meeting with ART Compass today! Missed our Digital Staff Management and Novel KPI Webinar? Catch the replay, anytime, on demand!!
“One thing worse than training employees and losing them… is not training them and keeping them.” -Ed Metcalf
IVF labs have been affected by unprecedented workforce shortages, and are at the forefront of a great wave of pending retirements. Less skilled and experienced staff means there is more room for grave errors to occur, and less people than ever to lead the training of new staff. Until each staff member has documented training, followed by successful assessment of competency of that task, they should not be permitted to perform or result patient testing independently of their trainer. Embryologist training, competency acquisition and documentation of these activities for inspections hasn’t advanced in 40 years, until now. ART Compass is outsmarting the workforce shortage, reducing non-conformance events, and helping you pass quality inspections, defeating CAPs number one most cited deficiency, staff related checklist items.
Whether you’re subject to CLIA, CAP or your local state DOH requirements, you will be required to provide proof (documentation) of both training AND competency for each employee, for each task that they perform. Documentation of all of these tasks can be organized through the use of advanced digital IVF lab management tools, like ART Compass. ART Compass helps savvy IVF lab directors keep track of what each staff members’ specific job functions include, which ones they will need to be trained on, and which tasks have been completed by each trainer. Competency assessment is an ongoing, continuous process of monitoring individuals’ abilities to perform their specific job functions.
When Embryologist Training is Complete- Maintain Competencies and KPIs
Once training has been completed and documented in ART Compass, you will assess each staff member’s ability to successfully perform these tasks using our robust suite of subjective “surveys”. This is competency, where you will assess if the training was successful and if staff can perform each assigned task correctly. ART Compass contains competency assessments for every embryology procedure. To fully demonstrate successful competency all 6 of the CAP Checklist items must be documented for each employee, for each task.
Our webinar will detail the ART Compass platform to standardize competency assessment, ART lab training, and reduce new staff on-boarding time and much more, including discussion of the KPIs or the future – in a fully digital embryology lab!
How can ART Compass Help?
ART Compass is a mobile application for the assisted reproductive technology (ART) industry that puts physicians, administrators, and lab staff on the “same page” as their patients. It is a LIMS , a patient portal, and a laboratory quality management system. It documents IVF staff clinical decision-making, streamlines reporting, and automates data analysis.
Apple App Store:
https://itunes.apple.com/us/app/art-compass/id1442048939?mt=8
Google Play Store:
https://play.google.com/store/apps/details?id=com.artproficiencyapp
We achieve this unprecedented level of information management, starting in the heart of any clinical practice: the IVF (in vitro fertilization) laboratory. The IVF laboratory is responsible for creating the patient’s embryos, reporting their quality, status, and genetic results to both patients and physicians.
ART Compass takes the pain out of managing dozens of parameters for automated regulatory reporting, simplifying the quality control workflow for labs, saving time and money, all while simultaneously improving patient care by providing direct and timely access to hundreds of data points pertaining to each patient’s IVF cycle.
Physicians go on to use this information to make clinical care decisions, such as which embryo to transfer. Administrators use this information to track pregnancy and success rates for their clinic. Patients have a secure and HIPAA compliant portal to view their frozen embryo inventory, and IVF cycle information, and direct access to physicians and laboratory staff.
www.artcompass.io
While you are here… check out the entire ARTC digital Playbook…
| September | FDA Audit |
| October | Staff Audit |
| November | Patient Satisfaction and Security |
| December | Space and Supplies |
| January | PMs, Air Quality, and Deep Clean |
| February | Biennial P&P Updates, Review, and Sign Off |
| March | |
| April | |
| May | |
| June | |
| July | |
| August |
Why do IVF Clinics Belong to SART? SART member clinics must meet the highest standards of professionalism and patient care in IVF. Not every IVF clinic can belong to SART! IVF clinics that display a SART member badge have met rigorous criteria. They take pride in the transparency and stringency that allows them to display the SART member logo.
SART member IVF Clinics are committed to the highest standards of quality. IVF Clinics that display the SART membership logo provide the highest standards of contemporary infertility care (meaning, they follow best practices in IVF). SART members eligible to display the SART logo include more than 380 member practices, representing more than 85 percent of the ART clinics in our country.
- SART is the primary organization of professionals dedicated to the practice of IVF, or assisted reproductive technology (ART).
- SART IVF clinics are committed to the highest quality standard of care. All SART member IVF clinics are required to advertise truthfully.
- All SART member IVF clinics accurately report outcomes so that you, the patient, can trust your provider.
- All SART IVF clinics work with nationally accredited laboratories to assure the best possible reproductive environments.
Why else do IVF Clinics Belong to SART?
The IVF Laboratory: A commitment to the Highest Standards of Quality
The success of individual IVF cycles depends on the quality of the embryology laboratory. IVF Laboratories that proudly display the SART membership logo must be inspected and accredited by one of the premier IVF lab accreditation agencies; College of American Pathologists (CAP), Joint Commission (JCO), or New York State Tissue Bank certification for ART laboratories (NYSTB). Accreditation means that the embryology, andrology, and endocrinology lab are certified as compliant with the Clinical Laboratory Improvement Amendments (CLIA) regulations (CLIA’88). The CLIA88 regulations are federal level regulations, which resulted from a Congressional examination and investigation of testing performed in physician office laboratories. The United States Department of Health and Human Services office define these regulations for all laboratory testing for assessment of human health, or the diagnosis, prevention, or treatment of disease. CLIA applies to every laboratory and testing site in the United States, including IVF clinics. Fulfilling these requirements means that the IVF Lab Director is certified as a High Complexity Laboratory Director (HCLD) or American Board of Bioanalysis Embryology Laboratory Director (ABB- ELD). As of 2006 this certification is required of all lab directors. Accreditation promotes the quality and safety of IVF laboratory services to give physicians and patients confidence in the services the IVF Laboratory provides.
Research and Technology
SART doctors and scientists are leaders on the cutting edge of IVF and infertility medical technology and scientific advances. They are continually researching new breakthroughs for infertility treatment, and are recognized for excellence in infertility research and IVF technology development nationally and internationally. Member IVF practices must report (annually) their data to SART. These data include hundreds of parameters, including; how many IVF cycles are started, patient demographics, IVF success rates per cycle, and many other data points. Reporting these data is a rigorous task that takes dedicated highly trained embryologists and medical personal. SART member clinics notify SART within 3 days of any medicated IVF cycle being started, before the outcome of that cycle can be known. This ensures a commitment to the highest standards of data collection. The SART Clinic Outcome Reporting System (CORS) database collects data to fulfill the federal Fertility Clinic Success Rate and Certification Act of 1992 (Public Law 102-493). The SART CORS database has informed over 165 highly impactful scientific studies. SART member IVF Clinics make data available for research and publications that have transformative power through continued participation in SART. SART IVF Clinic members are encouraged to use the national SART CORS database to ask powerful retrospective research questions. SART CORS publications have; validated elective single embryo transfers, illuminated powerful links between SART and state birth registries, and yielded prediction models that inform contemporary clinical IVF practice.
IVF Practice and Ethical Guidelines
SART IVF member clinics provide information and treatments that are up-to-date. SART is an affiliate society of the American Society for Reproductive Medicine (ASRM). ASRM ethical guidelines define what actions are morally right and cover every aspect of infertility and IVF treatment. They protect IVF patients, honor the trust between clinicians and infertility patients, anticipate harms and the possible consequences of IVF treatment, avoid undue intrusion, define informed consent, and provide for privacy and confidentiality. ASRM practice committee guidelines provide evidence-based outcomes for IVF, opinions on IVF best practices, diagnoses’, treatments, testing, and risk reduction. The embryologists and reproductive endocrinologists of SART member IVF clinics participate in continuing medical education and certification, to ensure the most up to date treatments are offered to IVF patients.
The ARTC Digital Lab Playbook February Quality Audit focuses on documenting the biennial IVF lab policy and procedures review. When should IVF Lab policies be updated? What elements make an effective policy? How should they be reviewed? What is sufficient evidence that each policy has been reviewed?! This month’s quality audit answers all of these questions and more!
IVF Lab Policy and Procedure Review
This quality management process ensures policies and procedures are up-to-date, and that all staff members who must comply with your policy or monitor their implementation have been throughly trained. It may be useful for your organization to develop a communication strategy that identifies everyone who needs to be aware and comply with the policy. Scheduled review dates ensure continuous improvement when:
A gap/need is identified.
A serious or critical incident has occurred, requiring an urgent review.
Changes occur in the operating environment
Changes in laws, regulations, government policies, or CAP.
There are several objectives to policy and procedure review and sign off. The CAP All Common checklist, COM.10200 says that the laboratory director must review and approve all new technical policies and procedures, as well as substantial changes to existing documents, before implementation. A paper or electronic signature review of records is required, but a secure electronic signature is highly recommended. When a policy or procedure is discontinued, a paper or electronic copy must be retained for at least two years, with a record of the initial date of use, and retirement date.
With respect to procedures, the CAP says that a complete procedure manual should be available in a paper-based, electronic, or web-based format at the workbench or in the work area. A schedule should be developed where roughly 1/24 of all technical policies and procedures are reviewed monthly, in order to minimize the burden on the laboratory and reviewer(s).
After review, a paper or electronic signature must be recorded at the level of each policy or procedure. A single signature on a Title Page or Index is not sufficient to record that each policy or procedure has been carefully reviewed.
According to CAP general requirement GEN.20375, IVF laboratories must have a document control system to manage policies, procedures, and forms that are subject to CAP accreditation. All of these objectives are easily met by the documents and forms control module in ART Compass.
Effective policies clearly state:
Purpose: A statement that explains the goal(s) the policy is intended to achieve.
Findings: Brief statements of fact and /or statistics that outline the issue being addressed and support the need for the policy.
Definitions: Detailed explanations of the key terms in the policy.
Provisions: The main policy provisions state the prohibitions and/or requirements of the
policy and identify the parties to whom the provisions apply.
Exemptions: Any exemptions or exceptions to the prohibitions or requirements that are necessary to achieve the purpose of the policy.
Enforcement: An Enforcement section identifies the parties responsible for enforcement, outlines the enforcement procedures, any penalties or fines that may be imposed, and any appeal process.
Implementation: The implementation section states the effective date for the policy and the steps to
disseminate and publicize the policy.
One Month Schedule of Annual Policy and Procedure Updates, Review, and Sign Off related IVF Lab QA Activities
The lab director or quality manager should start each month’s Quality Audit by answering “In Progress” to each question, then assign this survey to junior staff using the “assign” function. This will document both continuing education and quality assurance activities. As embryologists perform or learn about these activities, they can mark them as “complete”.
| Research and Analysis | Analyze CAP Checklist to determine if new policies need to be written or existing policies updated. Cap Checklist Management Tools are available in ART Compass. |
| Distribution | The policies and procedures has been distributed to those expected to implement it and follow up feedback will be sought to ensure the policy is understood and applied. Use the “Assign” function in ART Compass! |
| Dates | Check that policies and procedures include the implementation date when the policy becomes active, dates and notes about changes or edits, and end use dates. |
| Review Schedule | Policy includes a review date – recommended 1/24 per month to completion every two years. |
| Supporting Documents | Supporting documents, such as forms, checklists or guidelines that will assist staff to implement policy have been developed. |
| Policy Scope | The scope of the policy lists all staff positions with responsibility for implementing the policy. |
| Critical or Panic Values | Policies identify what constitutes a breach of the policy and what the consequences are, and/or panic values that require immediate notification of a physician. |
| Sign Off! | IVF Lab Director, Medical Director and Technologists acknowledge they have read and understand the policies and procedures, supporting documents, and checklists. All employees can record their sign off on each P&P in ART Compass. |
The CAP requires various policies. Do you have a policy to address each of the following?
| GEN.20310 | Written QM policy and processes for performing a root cause analysis or investigation of non-conforming events |
| GEN.20340 | Written policy for the handling of recalls and notifications |
| GEN.20374 | The laboratory has a policy for ensuring compliance with applicable national, federal, state (or provincial), and local laws and regulations. |
| GEN.20377 | Written policy for retention of records, specimens, and slides |
| GEN.20450 | The laboratory follows a written policy for the management and correction of laboratory records, including quality control data, temperature logs, and intermediate test results or worksheets. |
| GEN.26791 | The laboratory has a written policy that addresses compliance with the CAP terms of accreditation. |
| GEN.40492 | The laboratory has a written policy regarding correction of information on specimen labels. |
| GEN.40506 | Written policy defining criteria for storage of and access to specimens collected by chain-of-custody procedures |
| GEN.40509 | Written policy addressing restricted access to secured records and record retention. |
| GEN.40935 | Personnel receiving verbal or phone orders read back the entire order to verify accuracy of transcription. |
| GEN.41304 | There is a written policy to ensure that patient data are accessible in a timely manner only to those individuals who are authorized to review test results. |
| GEN.41345 | Written policy defining test reporting turnaround time and process for communication of delays in turnaround time |
| GEN.43325 | Written policy defining mechanism for data protection |
| GEN.54200 | Written policy for continuing laboratory education |
| GEN.59980 | The laboratory has a written policy for restricting access to the laboratory to authorized individuals. |
| GEN.74400 | There is a written policy that prohibits smoking, vaping, eating, gum chewing, drinking, application of cosmetics and lip balm, manipulation of contact lenses, and mouth pipetting in all technical work areas. |
| GEN.77300 | The laboratory has a policy to protect personnel from excessive noise levels. |
| September | FDA Audit |
| October | Staff Audit |
| November | Patient Satisfaction and Security |
| December | Space and Supplies |
| January | PMs, Air Quality, and Deep Clean |
| February | Biennial P&P Updates, Review, and Sign Off |
| March | General IVF lab CAP Inspection Preparations |
| April | |
| May | |
| June | |
| July | |
| August |
The ARTC Digital Lab Playbook January Quality Audit focuses on documenting the IVF lab deep cleaning, preventative maintenance, and air quality. Most IVF labs appear to “shut down” for the week between Christmas and New Year. But we never really close! We are hard at work behind the scenes, ensuring that every instrument we use in the IVF lab and even the environment itself is strictly maintained to provide the best patient care.
Preventative Maintenance
IVF lab equipment must be properly installed, maintained, and calibrated to protect the quality of patient embryos. A great preventive maintenance routine includes cleaning, monitoring and repairs, and timely replacement of any component that shows signs of failure. A proactive and preventative approach allows the IVF Lab to predict potential problems, plan to move precious samples to properly functioning equipment, optimize maintenance schedules (e.g. equipment calibrations), and ensure that the lab can pivot when critical equipment is being repaired or replaced.
The future of IVF lab management includes assistance from Artificial Intelligence systems. In the realm of quality control and assurance, this is called predictive maintenance: knowing how to target future issues or failures before they happen, enabled by continuous monitoring of equipment, historical data, and development of predictive algorithms.
The IVF lab typically has numerous highly sophisticated instruments that need to be maintained, among them are; benchtop incubators, box incubators, warmers, heated surfaces for microscopes, isolettes, laminar flow hoods, pipettors, timers, thermometers, analytical balances, micromanipulators, inverted microscopes, water purifiers, and heating and ventilation systems with sophisticated filtration and pressure requirements.
The CAP generally requires preventative maintenance to be performed and documented.
| COM.30550 Instrument/Equipment Performance Verification | The performance of all instruments and equipment is verified prior to initial use, after major maintenance or service, and after relocation to ensure that they run according to expectations. |
| COM.30600 Maintenance/Function Checks | Appropriate maintenance and function checks are performed and records retained for all instruments (eg, analyzers) and equipment (eg, centrifuges) following a defined schedule, at least as frequent as specified by the manufacturer. |
| COM.30675 Instrument and Equipment Records | Instrument and equipment maintenance, function check, performance verification, and service and repair records (or copies) are promptly available to, and usable by, the technical staff operating the equipment. |
The CAP requires specific instrument preventative maintenance to be performed and documented.
| COM.30680 Microscope Maintenance | Microscopes are clean, adequate (eg, low, high dry and oil immersion lenses as appropriate for the intended use), optically aligned, and properly maintained with records of preventive maintenance at least annually. |
| COM.30700 Thermometric Standard Device | Thermometric standard devices must be recalibrated, re-certified, or replaced prior to the date of expiration of the guarantee of calibration or they are subject to requirements for non-certified thermometers. |
| COM.30820 Quantitative Pipette Accuracy and Reproducibility | Pipettes used for quantitative dispensing (eg, adjustable volume, micropipettes, dilutors, and analytic instruments with integral automatic pipettors) are checked for accuracy and reproducibility initially and according to the manufacturer’s recommended interval, or at least annually if not specified, and the results are recorded. |
| COM.30860 Analytical Balance Maintenance | Analytical balances are cleaned, serviced and checked at least annually by qualified service personnel. |
Air Quality and VOCs
New car smell, paint, dyer sheets, perfume, pine tree, and orange zest all have one thing in common; Volatile Organic Compounds (VOCs). Not all VOCs smell good, not all smell bad, and some have no odor at all. VOCs are nasty compounds like benzene, isopropanol and pentane, as well as particulate matter, carbon monoxide, nitrous oxide, sulphur dioxide and heavy metals. People have organs systems to combat these environmental stressors, lungs, spleen, kidneys, liver, antioxidants that can mop up free radicals and prevent major damage to cells. However, eggs, sperm, and embryos have been removed from the body and don’t have their own antioxidant systems.
Construction materials like MDF, PVC flooring, paints and adhesives, are the major source of VOCs indoors, while the compressed gasses that run our incubators are the major source of benzene, isopropanol and pentane; city air and natural disasters such as wildfires and heat waves bring the noxious gases and heavy metals. Laboratory plasticware, which is made from a variety of plastics like polyethylene, polystyrene, polycarbonate, polypropylene, and acrylic, release VOCs. All of these are bad for embryo development, and air quality unrefutably has been shown to impact pregnancy outcomes. Particle monitors and VOC counters are now important instruments for quality control. New laminar flow hoods and extensive “inline” gas filtration units for incubators, as well as standalone or ceiling / roof mounted air filtration systems with HEPA and VOC filters, and airflows and airlocks that maintain positive pressure are necessary for modern clean room IVF lab design. Currently, it has been generally recommended that IVF laboratories maintain total VOC levels below 400 to 800 ppb.
Deep Clean
The IVF lab must be kept clean and sterilized, but without the use of harsh cleansers and soaps, or disinfectants like ethanol that might emit harmful VOCs. Good practice points are to leave a specific pair of shoes for lab use only, wear clean scrubs that are put on in a clean room, always wear PPE to catch hair shedding (heads and beards!).
| GEN.42750 Computer Facility Maintenance | The computer facility and equipment are clean, well-maintained and adequately ventilated with appropriate environmental control. |
| GEN.61500 Environment Maintenance | Floors, walls and ceilings are clean and well-maintained. |
| GEN.61600 Environment Maintenance | Bench tops, cupboards, drawers and sinks are clean and well-maintained. |
One Month Schedule of Preventative Maintenance, Air Quality, and Deep Clean related IVF Lab QA Activities
The lab director or quality manager should start each month’s Quality Audit by answering “In Progress” to each question, then assign this survey to junior staff using the “assign” function. This will document both continuing education and quality assurance activities. As embryologists perform or learn about these activities, they can mark them as “complete”.
| Dust, starting at top of hoods and lab shelves and moving to floor level – clean all microscopes, wipe all electronics, cords, incubator and hood tops and stands, stools and chairs. Legs of tables and hoods. | Dust accumulation should be cleared quarterly and a deep dive undertaken once a year. Fine dust filters should be used. Low lint scrubs should be worn, and care should be taken to dispose Swifter cleaning cloths outside of the laboratory trash can. |
| Clean and sterilize all incubators and water trays | EmbryoSafe, Oosafe, IVF Prime, H2O2. Record name and date of cleaning. |
| Wipe all hoods and incubators | EmbryoSafe, Oosafe, IVF Prime, H2O2. Record name and date of cleaning. |
| Wipe outside of dewars and dewars roller stands | EmbryoSafe, Oosafe, IVF Prime, H2O2. Record name and date of cleaning. |
| Check Generator maintenance records | Schedule generator maintenance |
| Air Filters | PM air handling system and replace HEPA and other filters. Life Aire |
| Replace VOC in line filters, Carbon filters on top of hoods | Coda® Xtra Inline® Filters Unique VOC removing filter technology should be replaced every 3-6 months. |
| Purified Water System | Specify types and purity of water used, PM must include CFU |
| Alarms, O2 alarms | Smart-Vue (thermofisher) CO2/temp monitor system for incubators, Oceasoft, TempGenius, Pharma Watch |
| Pipettes | Sterilize and Calibrate |
| Thermometers | Sterilize and Calibrate, InnoCal Solutions, a division of Cole Parmer |
| Gas manifolds | PM |
| Incubators | Pharma Watch, Smart-Vue (thermofisher) CO2/temp monitor system for incubators |
| Isolettes | Use a double loop of tape or suction cup to remove glass |
| Microscopes | Sterilize and Calibrate – PM, Kohler, Objectives, Lasers |
| Analytical Balance | PM |
| Anti Vibration Tables | https://www.newport.com/c/microscope-isolation-platforms |
| Hoods | PM, Sterilize and Calibrate: ENV Services |
| VOC Detectors | Graywolf PPB and RAE Systems PPB, VOC and particle meters from CooperSurgical |
| Lab Pens | The Maverick Embryologist’s list of favorites: Pilot G-2 Ultra Fine 0.38mm, 0.5mm, Pilot G2 0.7 mm , Small sharpie extra fine point, not ultra. Paper Mate ink joy gel 0.5, Tul Retractable Gel Pens 0.5mm Needle Point in blue, Zebra F-301 Ballpoint Stainless Steel Retractable Pen, Fine Point, 0.7mm, Black Ink, Pentel EnerGel RTX Retract, Pentel Energel Needle Tip 0.3. |
| Order Spare Parts | CI-2 micropipette connector Narashige for connecting to a glass micropipette, Mouth pieces at the IVFStore |
| September | FDA Audit |
| October | Staff Audit |
| November | Patient Satisfaction and Security |
| December | Space and Supplies |
| January | PMs, Air Quality, and Deep Clean |
| February | Biennial P&P Updates, Review, and Sign Off |
| March | General IVF lab CAP Inspection Preparations |
| April | |
| May | |
| June | |
| July | |
| August |
The ART Compass platform makes managing space and supplies easy! In December we focus on tissue inventory, supplies management, and discard workflows! December is a great time for most IVF labs to prepare for the coming year’s IVF cycles by performing inventory of both embryos (visually comparing what is in the tank to what is in the cryostorage database) and reagents and supplies, disposing of embryos that are not usable or no longer needed out of tanks, deep cleaning the lab, organizing storage spaces, and archiving records to make space for the next year’s cycles!
What do the CAP guidelines say about “space and supplies”, ie. cryostorage, physical storage, and reagents traceability and inventory?
Specimen Storage and Disposition
| GEN.40506: Secured Specimen Storage | The original specimens (in the original container) and appropriately labeled aliquots are maintained in an appropriate manner when not in the possession of an authorized individual. |
| GEN.40507: Specimen Retention and Storage | Specimen retention and storage conditions are defined for each type of specimen tested by the laboratory using a chain-of-custody procedure. |
| RLM.08000: Specimen Handling | There is a system to verify and maintain the identity of the specimen throughout receipt, storage, processing, and disposition. |
| RLM.12400: Specimen Storage/Long-Term Disposition | There is a written procedure regarding the length of storage, informed consent and long-term disposition of cryopreserved gametes or embryos. |
| RLM.03975: Specimen Handling and Disposition | Records allow for the tracking of the disposition for gametes or embryos handled or stored. |
Records and Inventory
| GEN.40509: Secured Records | The chain-of-custody collection records, security logs, and testing records are retained for an appropriate period of time, no less than two years and following applicable laws and regulations, in a limited-access, secured (locked) area that is only accessible to authorized laboratory personnel. |
| GEN.61900: Inventory Control | There is an effective supply inventory control system in operation. |
| RLM.12000: Inventory | Records are available for the current inventory of all specimens that have been stored in its cryobanks. |
Embryo Cryostorage Inventory
A precise inventory is maintained for all embryos in storage by IVF laboratory staff. Once a year, the embryo inventory should be visually checked and confirmed with the embryo database. Patients who no longer wish to store their frozen embryos have several options. Frozen embryos may be discarded as medical waste. They may be donated for research studies, quality control or training of junior embryologists. When embryos are donated for lab use, they are thawed, studied scientifically, and then discarded after a few days. Typical research topics include new techniques for freezing or thawing embryos, new embryo culture methods, PGT-A or genetics studies and more!
Make some space! Embryo Discards
Embryo discards tend to pile up during the year. To discard frozen embryos, a consent form is typically signed (by both partners) and notarized or witnessed by IVF clinic staff. Many labs have a 30-60-day “cool down” waiting period, before at least two embryologists are needed to fulfill the patients’ wishes to discard embryos. Because multiple people are needed to properly locate the embryos in the storage tank and carefully confirm the identity, this is a time consuming a laborious process often superseded by the day–to–day demands of running an embryology lab. The embryologists will typically sign and date the consent form and other storage documents, attesting that they performed and witnessed the disposition according to the patients’ wishes and these should be kept permanently in the laboratory files. It is a good practice to provide written confirmation of the disposal of the embryos to the physician and patient chart.
Reagents and Supplies Inventory
Inventory control is vital to deliver quality IVF services. A carefully managed inventory ensures that the right quantities of reagents and consumables are available at the right time and place. It prevents waste from expired reagents (over-ordering), duplicate orders, or improper storage. All purchased supplies, reagents, and consumables should be included in the laboratory inventory. Information in the inventory should include lot number, date received, date put into use, expiration date, and special storage requirements. Inventory control management includes monitoring the physical storage environment (temperature, humidity, exposure to sunlight), keeping stock levels consistent with procedure numbers, conducting physical inventories, and disposing of expired products in a timely manner. You will want to ensure that the SDS and 510K folders in ART Compass are up-to date.
Tips to manage Space and Supplies
Designate a Place for Everything
Make sure everything in your lab has a specific place. Designate specific, clearly-labeled storage locations for each reagent or category of reagents to ensure that newly-delivered items can easily be found by all embryologists. Create a schedule to go through your reagents and remove expired and obsolete reagents from your storage space.
Label Everything
Establish a consistent labeling system that all embryologists and lab techs use to label aliquots and shared solutions. Don’t forget to also label shelves and cupboards, which can remind people of where items belong and help keep storage areas organized.
Create an Ordering Information Spreadsheet in ART Compass.
Keep an updated lab inventory and ensure all lab members update the LQMS module in ART Compass when receiving new items. A basic lab inventory spreadsheet can be created under “Documents and Forms” containing reagent names and ordering information (i.e. vendor, catalog number, price, etc.) Lot numbers and expiration dates may be included for good laboratory practice.
For larger IVF labs, create and maintain an ordering spreadsheet where embryologists can add items and quantities they need ordered for a given week. A designated member, such as the IVF supervisor, can then order these items in bulk for the entire lab.
One Month Schedule of Space and Supplies (Tissue Discards, Cryostorage, and Supplies Inventory) related IVF Lab QA Activities
The lab director or quality manager should start each month’s Quality Audit by answering “In Progress” to each question, then assign this survey to junior staff using the “assign” function. This will document both continuing education and quality assurance activities. As embryologists perform or learn about these activities, they can mark them as “complete”
| Check Consents and Disposition Directives, Perform Tissue Discards | Witnessing this procedure is non negotiable! Don’t forget, you can use the image archive function in ART Compass to record any part of this process., and permanently amend it to the patient record. |
| Prepare to Ship Tissues to long term storage. | Long term fertility preservation samples, and other types of samples for long term storage can be prepared now for transfer in the new year. Long term storage facilities include: Reprotech, Cryopoint, Fairfax Cryobank, California Cryobank, Ovation, TMRW. |
| Review Discard Policy and Process. Pull 10 discards to ensure the process has been followed. | A few good process points: Store tissue discards in a separate binder. Scan tissue discards into a separate (digital) folder. Don’t forget to mark tissue as “discarded” in cryostorage so the patient is not billed! |
| Review previous year’s cycle numbers, gas and dewar costs, and forecast needs for coming year. Review dewar and cryostorage options for coming year. | Calculate how fast you will fill up space: High capacity tank options are MVE 6000, Vitrostash among others. |
| Make or update a list of all supplies and reagents | Log into the web version of ARTC. Navigate to the white tab, LQMS. Update reagents list and then record lot #, expiration date, date into stock and into service. Use your phone’s camera to image product invoices, certificates of analysis and store them permanently. |
| Update the SDS folder in ART Compass with current safety data sheets. | Log into the web version of ARTC. Navigate to the green tab, Documents and Forms. We have pre-populated your SDS folder with Vitrolife, Fujifilm/Irvine Scientific and Cooper products! |
| Count pieces in storage, check expiration dates, discard expired products. | Take an inventory of plastics, reagents, and other stocks! Discard expired reagents. |
| Update the 510K folder in ART Compass with products that have FDA approval. Discontinue use of products when a suitable approved device is available. | Log into the web version of ARTC. Navigate to the green tab, Documents and Forms. We have pre-populated your SDS folder with Vitrolife, Fujifilm/Irvine Scientific and Cooper products! |
| Update Standing Orders for the new year. |
| September | FDA Audit |
| October | Staff Audit |
| November | Patient Satisfaction and Security |
| December | Space and Supplies |
| January | Preventative Maintenance, Air Quality, and Deep Clean |
| February | Biennial P&P Updates, Review, and Sign Off |
| March | General IVF lab CAP Inspection Preparations |
| April | |
| May | |
| June | |
| July | |
| August |