Dear SART/SRBT/ASRM/ABB Board Member:
We are writing to express profound concern regarding the proposed initiative, a SART/SRBT/ASRM-approved proposal seeking to eliminate the doctoral requirement for the Embryology Laboratory Director certification (ELD). This proposal aims to enable embryologists with a BS or MS degree and TS qualification to qualify for the ELD. We have summarized key points below as our response to this initiative, providing a comprehensive overview of our stance on this matter.
Clinic Shortage
An analysis of available data indicates only a limited number of job postings for laboratory directors, averaging one to two per month from sources like Indeed, LinkedIn, and the ASRM Career Center (reviewed monthly for 2023). This compares to more than thirty jobs per month for embryologists and over fifty jobs per month for reproductive endocrinologists. The data clearly shows there is a shortage of embryology positions, not laboratory directors. The limited availability of postings for IVF Laboratory Directors indicates a well-balanced equilibrium between the current workforce and the demand for these directorial roles. Conflicting numbers have also circulated regarding the creation of new IVF clinics, which is driving a perceived need for immediate new laboratory directors. As per SART data, there has been a modest increase of merely six SART Member clinics in the past four years, totaling 386 in the latest count. The CDC register was also examined. Their data indicates a total of 453 clinics, and this reflects a net decrease of three clinics since 2018. It appears that despite the emergence of numerous new clinics, a considerable number have shuttered, with aging physicians retiring or merging with other facilities/networks. What has been shown is an explosion in the number of ART cycles. The CDC reports a surge of more than 35% in ART cycles since 2018. This data aligns with the notion that the rise in cases, unaccompanied by a proportional increase in clinics, underscores a shortage of embryologists rather than laboratory directors.
According to the latest SRBT Salary survey, more than 60% of lab directors only have a single laboratory, with an additional 16% overseeing only one extra laboratory. This indicates that more than 75% of IVF laboratory directors are in charge of only one or two laboratories, with a minimal number overseeing four or five. This proposed initiative assumes that offsite directors are chosen solely due to onsite HCLD unavailability, contrary to the lack of job postings, which suggests otherwise. There may be a myriad of reasons why the strategy of employing an offsite director is adopted. A main one is the current enrollment of a highly skilled embryologist from their program in one of the non-traditional Ph.D. programs.
According to EVMS, over 50 students have either graduated, are currently enrolled, or are about to enroll in their PhD program alone. Many IVF programs are currently supporting highly skilled embryologists in Ph.D. programs. They are fostering individuals with extensive practical expertise to achieve advanced academic qualifications for future directorial roles. This approach, adopted by organizations like Medtech, CCRM, and Ovation, among others, ensures a steady supply of qualified professionals and signifies an industry-wide commitment to nurturing potential laboratory directors despite the absence of a current shortage in available positions. This could potentially explain why laboratory directors hold licenses for multiple labs—they might be occupying those positions while simultaneously mentoring their embryologists in a PhD program.
It should also be considered that these students have followed the current standards, invested significant financial resources, and devoted extensive time and effort to conquering the challenges inherent in these rigorous programs in their aim to attain their doctoral degrees. The introduction of an alternate pathway for the introduction of a non-doctoral pathway may undermine their dedication and hard-earned achievements, and this should not be overlooked.
Historical Perspective
Regarding the historical perspective of the non-doctoral ELD certification, it was not established to promote embryologists to become lab directors but to grandfather those already directing a lab before the HCLD designation. Without this designation, they were at risk of losing their jobs. Unlike in the past, non-traditional pathways now exist for any qualified embryologist to pursue their doctoral degree to qualify under the current rules for laboratory director certification. A prior ABB board elevated the ELD standard to include a doctoral component to align not only with other clinical and therapeutic laboratory requirements but also to establish legitimacy within our profession. It has been argued that a BS/MS-level candidate passing a TS exam is evidence of equivalence to a doctoral laboratory director. The passage of an exam where the majority of the subject material can be found in a single study guide does not provide proof of the candidate's capacity to understand complex concepts, apply critical thinking skills, and execute tasks relevant to the field at a level akin to that of someone holding a doctoral degree. The passage of this exam does not prove equivalence. Doctoral programs encompass a depth and breadth of knowledge. They bring a wealth of comprehensive expertise that is gained from years of academic study. No one is questioning that there are outstanding embryology supervisors, but there is a current pathway in the standards for them to become doctoral laboratory directors. If there are any issues with current PhD directors fulfilling their role, this should certainly be addressed, but compromising standards isn’t the solution.
Equivalency
Eliminating the doctoral mandate for an embryology lab director purely based on the absence of CLIA regulations appears illogical. This decision also diverges from the standards upheld in comparable therapeutic laboratories, all of which uniformly demand a doctoral qualification for oversight. Therapeutic laboratories, like those handling bone marrow for transplantation, share a complexity akin to embryology labs—they are therapeutic rather than diagnostic and necessitate a doctoral oversight. This similarity suggests that such labs could encounter comparable patient safety concerns in the absence of adequate oversight. Even in less complex clinical labs, a doctoral degree is mandated for oversight. This highlights the importance of expertise in maintaining standards. Doctoral laboratory directors possess the skill set to analyze data crucial for ensuring accuracy and precision in results—a proficiency essential in any laboratory setting. Setting a standard below that of other therapeutic or clinical laboratories undermines the importance of expertise in ensuring quality, precision, and safety in embryology procedures, potentially jeopardizing the standards upheld in our field.
Removing the doctoral requirement fails to serve the best interests of our field and our programs. Lowering the bar diminishes the standards essential for maintaining excellence and expertise in critical areas. It's a decision that contradicts the pursuit of quality patient care. This alteration sacrifices care, depth of knowledge, and specialized skills necessary to navigate the complexities of our field, ultimately compromising the level of care we offer.
Role as Clinical Advisor
Upholding the doctoral requirement is vital as doctoral-level laboratory directors also serve an important role as clinical advisors to the MDs and the practice due to their expertise and the unique skill set they bring to the field. This pivotal role and their extensive knowledge base allow them to serve as invaluable clinical advisors, particularly on intricate matters like interpreting genetic data, advising on the most effective treatment approaches, and ensuring the safe implementation of new techniques into clinical practice to benefit patient care. Their ability to bridge the gap between theoretical advancements and practical applications ensures a higher standard of precision and innovation in patient care. The consistency and depth of knowledge doctoral directors bring to the table cannot consistently be matched by BS or MS-level embryologists. Removing the doctoral requirement could potentially undermine the intricacies involved in these critical consultative roles, stripping away the depth of expertise needed for this consultative role, potentially limiting the scope and quality of advancements in embryology and its clinical applications, and ultimately compromising patient safety.
Removing the doctoral requirement could also heighten our exposure to liability by potentially diluting the specialized expertise necessary for crucial decision-making in such a complex area as embryology. Without the depth of knowledge that doctoral directors often bring, there might be gaps in understanding and judgment, potentially leading to errors or oversights in patient care. This could increase the risk of misinterpretation of critical data, improper implementation of new techniques, or inadequate consideration of evolving ethical standards. As a result, our programs could face heightened legal vulnerabilities due to compromised standards of practice and decision-making, impacting patient safety and potentially leading to legal repercussions.
A laboratory director's involvement in validating new technologies in the IVF laboratory is enriched by the comprehensive knowledge acquired during their doctoral program. The advanced education and training received in a doctoral program equip them with a deep understanding of reproductive biology, molecular techniques, and laboratory methodologies relevant to assisted reproductive technologies. This academic background enables laboratory directors to critically assess the scientific foundations of emerging technologies, ensuring that they align with established principles in reproductive medicine. Their research skills and analytical capabilities, honed during their doctoral studies, empower them to scrutinize data, evaluate experimental design, and validate the efficacy of new technologies. Moreover, the interdisciplinary nature of many doctoral programs equips laboratory directors with a holistic perspective, allowing them to consider not only the technical aspects but also the ethical, legal, and regulatory implications of adopting novel technologies in the dynamic field of IVF. Thus, the knowledge gained through their doctoral program significantly enhances the laboratory director's ability to contribute meaningfully to the validation of innovative technologies in the IVF laboratory.
Removing this requirement might also set a precedent for eroding other qualifications within our field. If the rationale diminishes the embryologist roles to mere technicians, it opens the door to argue that anyone, regardless of qualifications, could conduct these complex procedures. This shift could trivialize the expertise, training, and precision essential in embryology, potentially devaluing the field's standards and jeopardizing patient care.
Maintaining the doctoral requirement is essential for safeguarding the standards and integrity of our field and program. Lowering these standards by eliminating the requirement not only undermines the depth of expertise needed but also jeopardizes the quality of care, with inherent patient safety concerns, and affects the advancement of our field. Striving for excellence by upholding stringent qualifications ensures that our patients receive the highest level of expertise and care. Preserving these standards isn't just about tradition; it's about prioritizing patient safety, fostering innovation, and maintaining our commitment to providing the best possible care in the field of embryology and reproductive medicine. Our foremost obligation lies in advancing the field and ensuring optimal care for our patients. Removing the doctoral requirement from the embryology laboratory director role directly undermines our commitment to pursuing what's best, potentially compromising the standards vital for excellence and patient well-being.
Respectfully submitted,
