Below is the draft of comments compiled by the American College of Embryology to be submitted to the California Department of Public Health. If you would like to edit the text of this document, you need to create an account and login. In order to leave your comments for considerations in the "Comments" section below you do not need to have an account on this site.

The purpose of licensing standards

The proposed rules state that “Many clinical embryologists are trained in the United Kingdom or Australia, and are unable to legally perform tests or examinations in California. They have asked that their board certification be recognized for licensure purposes in California. That is the purpose of these proposed licensing standards.”

Embryology practice is currently not regulated at the federal level nor, to the best of our knowledge, is it regulated on the State level in California. Therefore, it is not clear why clinical embryologists trained in the United Kingdom or Australia require special accommodations to practice embryology in California.

Even though British scientists were responsible for the birth of the first child following in vitro fertilization and embryo transfer, major breakthroughs responsible for the foundation of embryology practice in the United States were developed by scientists from other countries.  For example, intracytoplasmic sperm injection (ICSI) was developed by an Italian physician working in Belgium and vitrification was first successful in Italy.  Scientists and practitioners from Japan, Germany, South Korea, Russia, Hungary, China, Belgium, India, Georgia among many others, have been in the forefront of key developments in the field and are credited with significant contributions to clinical embryology.  

Therefore, ACE feels that any legislation in the area of embryology should address concerns of all internationally educated embryology practitioners, many of whom were recruited to the United States on H1 visa status, specifically to practice embryology in the United States and direct embryology laboratories. Many of these embryologists have, and continue to contribute to the success of the field in this country which has became their own. 

In summary, it is ACE’s position that legislation should be concerned with the needs of  embryology practitioners from all countries who currently work in the United States.    

Post-bachelor credit hours requirement

The proposed rules state that, ”A clinical embryologist applicant must have an earned doctorate degree in biological or clinical laboratory science with at least 30 semester hours of post-baccalaureate biology.”  

As does any specialty, Embryology or Reproductive Laboratory Science, requires specialized education and training.  

Therefore ACE does not endorse the premise that a certain number of credit hours in any discipline creates an educational foundation for the specialty, unless the respective courses have been accredited toward the degree in that specialty.  

Instead, education must be curriculum-based and relevant to the profession, as is education for other related fields.

For the same reason that 30 credit hours in biology do not create educational background in, for example, cytogenetics, and would not qualify an individual to be admitted to the licensing exam in that specialty, in the same manner it does not create a specialized background in embryology.  

As another example; a physician has earned many more credit hours in clinical medicine than a massage therapist, nonetheless, he or she would not be able to practice massage therapy without going through massage therapy school and only then after passing  taking an examination in that specialty.

Due to the variety of post-graduate educational backgrounds of current embryology practitioners, according to the proposed rules an individual with fewer credit hours of highly relevant postgraduate education will be at a disadvantage to an individual with more credit hours of less relevant education.

Furthermore, it would be extremely difficult to validate the relevance of random biology courses for embryology practice without referencing them against an existing accredited program of the same nature.

The first and only, accredited PhD level program in Reproductive Science became available only recently  from University of Kentucky and the first PhD will graduate in 2012.  

That program’s director, Dr. Doris Baker (see attached credentials supplement) is also a Chair of the American College of Embryology Education Committee and supervises creating a structured doctoral level online course in clinical embryology for ACE members. 

ACE proposes that any specific credit hours requirement  only be applied to future graduates of specialized doctoral level programs in reproductive laboratory science. However,  those individuals who entered  into clinical embryology before the field matured and were effectively contributing to creating this specialized knowledge must be able to grandfather as described below. 

Furthermore, since historically and uniquely for embryology, internationally -trained individuals represent a large percentage of the current embryology laboratory directors, it would be appropriate that their PhD models be acceptable regardless of the number of credit hours since they have served as the basis for their immigration, certification and current employment in the capacity of the embryology laboratory directors.

Approved internship programs

The proposed rules stipulate that “He or she must complete two years of post-doctorate training on human specimens in an ART facility approved by the American Association of Bioanalysts Board of Registry (AAB BOR) for board certification of embryologists, and then must complete at least two more years of practical experience in a facility.” 

The College supports the idea of Internship, which in fact was pioneered by ACE almost 2 years ago and the College developed accreditation criteria for such training facilities (see attached letter). 

In the current proposal, criteria for training facilities are absent and have to be clarified as well as the number of such facilities and number of trainees accepted every year.

Furthermore, it is not understood why a single private corporation would be placed in an exclusive position to approve a program for internship which may effectively give it the authority to control the market.                                                                                                                

It is also not clear why the proposed duration of training is fixed at 2 years. ACE proposes that the duration of training be dependent on the prior experience of the candidate. ACE has developed a respective model to define candidate readiness through the practical skills examination and has already administered such testing (video can be found on ACE web site).  

Furthermore, embryology programs in California are no different than anywhere else in the country. Therefore the rational for the requirement of training specifically in California as a licensure pre-requisite is not apparent and in ACE’s view creates an unnecessary burden for applicants.  

It is also not clear how current directors who work full time can fulfill the requirement of such an internship.  

Grandfathering

While strongly advocating differentiation of embryology practitioners based on educational background, ACE is not endorsing sudden changes, which would be disruptive for the industry, increasing the cost of operations in this difficult economical times without demonstrating a clear public benefit and disqualifying some current laboratory directors who have, and continue to, successfully operate IVF laboratories.  

Furthermore, Department of Health Services  issued (April 2004) unique to California Clinical Laboratory Law " All laboratories require a laboratory director who is a CA-licensed physician/surgeon, master or doctoral scientist, or master or doctoral bioanalyst. This includes registered laboratories performing waived tests. (BPC1209)(a)). ACE believes that society has a strong interest in securing protection of public health and safety in the most cost-beneficial manner available. In case of IVF clinical laboratories, if empirical analysis were to demonstrate, that work done in IVF labs directed by persons who do not have earned doctorates is at least equal in quality to the work done in doctoral-directed laboratories, one would have to conclude that unnecessary costs to the public were being generated through unnecessary compensation for director services, which are lower for non-doctoral than for doctoral directors. The doctoral directorship requirement denies to a substantial number of people the ability to advance to the highest levels of their profession and denies them a substantial portion of their potential life-time achievement.
California law regulating public health laboratories has a non-doctoral director requirement that has served California citizens well for over 50 yeas. To prevent disruption of the IVF laboratory workforce, IVF laboratory director personnel licensure bills should include grandfathering provision to allow individuals who have established careers as IVF Laboratory Directors to continue working at their current professional level.

The grandfathering provision as defined by ABB, CAP, ASRM and SART: The director of the embryology laboratory has proper qualifications through education and experience to provide direction and administration of the laboratory. The director of the embryology laboratory should have 2 years of documented experience in a laboratory performing in vitro fertilization or assisted reproductive technologies-related procedures. Directors of embryology laboratories who are not physicians or qualified doctoral scientists, but who were functioning as embryology directors on or before July 20, 1999 are considered in compliance with the personnel requirements. Effective January 1, 2006, all new laboratory directors should hold HCLD, ELD or equivalent certification. Directors in laboratories performing testing covered by CLIA must meet CLIA laboratory director requirement for high complexity testing.  

Therefore ACE recommends that, those who have been certified as HCLD, ELD or TS, with at least a bachelor degree be given opportunity to grandfather and continue to practice in their current capacity,  provided that they have practiced in the United States for several years.  

All those who grandfathered, would have to become enrolled in a structured continued education program based on an accredited post-graduate program in Reproductive Sciences or Embryology.    

Alternative pathways to licensure 

The proposed regulation seeks to appoint a single corporation to qualify and examine candidates and to choose approved training facilities. 

Even though historically this corporation was the first and only to provide certification in Embryology (ELD), this certification was not required to practice embryology and therefore it was not a cause for the concern. 

However, if such certification becomes the pathway to licensure, it would seem appropriate that additional pathways through a major organizations representing embryology practitioners be opened.  

This would be consistent with multiple routes of certification in other specialties.  

Miscellaneous comments  

Within  diagnostic laboratories that deal with human specimens, there are clear pre-analytical, analytical and post-analytical phases. At the end of the process the specimen is discarded as biological waste or stored, but in either case, the specimen is rendered non-viable. Diagnostic laboratory quality is measured in accuracy, sensitivity and specificity etc, according to the standards set by CLIA 88. 

On the other hand, human embryos do not become specimens at any stage of the process in the embryology laboratory. On the contrary, embryos are created with the intent to be transferred into the uterus to achieve pregnancy and all efforts are made to keep them viable. Embryology laboratory quality is measured in the percentage of embryos becoming live-born children.  

It has to be mentioned here that ACE model makes this measure of quality of an Embryology laboratory an important certification component, which is currently being  replaced by skills examination and internship.

Therefore, the similarity between a diagnostic testing laboratory and an embryology laboratory is only in the word “laboratory”, which makes the matter confusing.  The term “Embryology Facility” is much more appropriate. 

Since there is no current embryology regulation model in the United States, some lessons may be drawn from Great Britain, the birthplace of the human embryology laboratory.  

In that country, a separate entity, “The Human Fertilization and Embryology Authority” was established under the Department of Health to regulate issues unique to Embryology. 

This is also generally in line with ACE’s position that embryology cannot be regulated as a diagnostic testing laboratory, nor as a practice of medicine. Instead it has to be regulated as a separate and unique practice of embryology.