1. (a) Embryology laboratory director.

   1. (1) The embryology laboratory director shall be an individual with demonstrated knowledge of all laboratory aspects of assisted reproductive technology (ART).

   2. (2) To be acceptable as an embryology laboratory director, an applicant must fulfill both the following requirements:

      1. (A)

2. (i) Hold an earned doctorate degree (Ph.D.) from an accredited institution in a chemical, physical, or biological science as the major subject or an M.D. degree from an accredited institution.

   1. (ii) The laboratory director should have expertise and/or special training in biochemistry, cell biology, and physiology of reproduction with experience in experimental design, statistics, and problem solving/trouble shooting.

      1. (iii) The laboratory director should:
3. (a) (a) Be responsible for formulating laboratory policies and protocols; and

4. (b) (b) Communicate regularly with the medical director regarding patient progress and protocols as they affect the laboratory aspects of treatment; and

   1. (B)

      1. (i) Have two (2) years documented pertinent experience in a program performing IVF- or ART-related procedures.

         1. (ii) This experience should include:
5. (a) (a) Familiarity with laboratory quality control, inspection, and accreditation procedures; and
6. (b) (b) Detailed knowledge of tissue culture, ART, and andrology procedures performed in mammalian systems.

7. (b) Laboratory supervisor.

   1. (1) Education.

      1. (A) If the medical director is also the laboratory director, there should be a qualified, designated laboratory supervisor.
      2. (B) The embryology laboratory supervisor should have a bachelor’s or master’s degree in a chemical, physical, or biological science.

   2. (2) Experience.

      1. (A)

         1. (i) The embryology laboratory director or supervisor should have had a period of training of at least six (6) months and at least sixty (60) completed ART procedures in a program that performs at least one hundred (100) IVF procedures per year with a minimum annual ten percent (10%) IVF live birth rate per retrieval cycle.
         2. (ii) A procedure is defined as a combination of the:

8. (a) (a) Examination of:

   1. (1) (1) Follicular aspirates;
   2. (2) (2) Insemination; and
   3. (3) (3) Documentation of fertilization; and

9. (b) (b) Preparation for embryo transfer.

   1. (B) Satisfactory completion of this period of training should be documented by a signed letter from the laboratory director of the training program.

      1. (C) In lieu of formalized training, a similar experience with the director’s own program is sufficient, provided the program has:

         1. (i) Performed at least one hundred (100) total retrievals; and
         2. (ii) Had at least an annual ten percent (10%) live birth rate per retrieval cycle.
         3. (c) Laboratory technologists.

   2. (1) Education.

      1. (A) The embryology laboratory technologist should have an earned bachelor’s degree from an accredited institution with a physical, chemical, or biological science as the major subject.
      2. (B) Individuals without this educational requirement are acceptable provided they meet all the requirements in the subdivision (c)(2) of this section by January 1, 1992.

   3. (2) Experience.

      1. (A) The embryology laboratory technologists should have documented pertinent experience in tissue culture and sterile technique with evidence of completion of thirty (30) complete IVF procedures under continuous supervision of the laboratory director or supervisor.
      2. (B) Experience and documented training in tissue culture, sperm-egg interaction, or related areas of animal reproduction are desirable.
      3. (C) The embryology laboratory technologist works under the supervision of a laboratory director or supervisor.

      4. (D) Programs for the appropriate training of embryology laboratory technologists should be in place for each program with documentation of completion for each employee.

         1. (d) Laboratory staff.
   4. (1) Quantity of procedures. Each staff embryologist (including the embryology laboratory director or supervisor) should perform at least twenty (20) complete ART procedures a year.

   5. (2) Expertise. Among the embryology laboratory staff there should be one (1) or more persons with knowledge and experience in the following fields:

      1. (A) Preimplantation embryology;
      2. (B) Andrology; and
      3. (C) Pre-fertilization and post-fertilization events.

   6. (3) Knowledge of freeze-thaw. Before attempting human embryo freezing, at least one (1) member of the embryology laboratory staff should have:

      1. (A) Frozen in excess of two hundred fifty (250) animal embryos; and
      2. (B) Demonstrated the ability to freeze-thaw embryos with a survival/development rate of over fifty percent (50%).

10. (e) Consultant visits.

    1. (1) If the laboratory director is not physically present on a routine basis, consultant visits will be allowed.
    2. (2) These visits are to ensure compliance with all applicable laws and regulations as well as current standards of practice.

    3. (4) The visits should also:

       1. (A) Identify current problems;
       2. (B) Note trends; and
       3. (C) Make recommendations for correction and improvement.
    4. (5) The visits should be bimonthly at the least, while monthly visits are strongly recommended.

    5. (6)

       1. (A) Each visit should be documented with a consultant’s report.
       2. (B) In addition, relevant in-service educational programs should be provided during each visit.

Codification Notes: "M.D." means Doctor of Medicine. "Ph.D." means Doctor of Philosophy.