1. (a)

   1. (1) The facility shall maintain a sufficient number of personnel to provide effective patient care and all other related services to an in vitro fertilization program.
   2. (2) There shall be written personnel policies and procedures which shall be made available to personnel.
   3. (3) Provisions shall be made for orientation and continuing education programs for personnel.

2. (b)

   1. (1) Each employee shall have a health file.

   2. (2) The file shall document at least:

      1. (A) Annual testing for tuberculosis;
      2. (B) Documentation of other tests required by the facility; and
      3. (C) Certification of current training in CPR techniques for all personnel involved in surgical/invasive procedures.

3. (c)

   1. (1) Written job descriptions shall:

      1. (A) Be developed for each employee classification; and
      2. (B) Include as a minimum the responsibilities or actual work to be performed in each classification.
   2. (2) In addition, the job descriptions shall include the physical, educational, and licensing or certification requirements for each job classification.
   3. (3) These job descriptions shall be included in the policy and procedure manual for the facility.

4. (d) Personnel records shall:

   1. (1) Be maintained for each employee; and

   2. (2) Contain no less than:

      1. (A) Current and background information covering qualifications for employment;
      2. (B) Records of all required health examinations; and
      3. (C) Evidence of current registration, verification, or licensure of personnel subject to statutory regulation.

5. (e)

   1. (1) An in vitro fertilization program must include, as a minimum, personnel with the following expertise.

   2. (2) A single individual may fulfill the requirement for expertise in one (1) or more areas:

      1. (A)

6. (i) An individual with training and experience in reproductive endocrinology, particularly in the use of ovulation-inducing agents and the hormonal control of the menstrual cycle.

   1. (ii) The Department of Health would accept an individual who has completed a board-approved fellowship in reproductive endocrinology for fulfillment of this requirement;

      1. (B)

         1. (i) An individual with expertise in pelvic reparative (infertility) surgery, as well as experience in laparoscopic and ultrasound-guided oocyte retrieval techniques.
         2. (ii) This combined expertise is necessary not only for the performance of the oocyte retrieval procedures, but also to ensure that the infertile couple is offered the most appropriate treatment modality;

      2. (C)

         1. (i) A director of the embryology laboratory.
         2. (ii) See also embryology laboratory personnel section, 20 CAR § 48-115.
         3. (iii) This laboratory director must have personal experience in the organization and maintenance of a basic or clinical embryology laboratory, as well as in tissue culture techniques;
      3. (D) An ultrasonographer (or obstetrician-gynecologist with specialized training and experience in gynecologic sonography) who provides the monitoring of follicular development and supervises ultrasound-directed oocyte retrieval;

      4. (E)

         1. (i) Each program must have a designated overall program director.
         2. (ii) If the overall program director is not a licensed physician, there must be a designated medical director who is responsible for the clinical aspects of the treatment program;

      5. (F)

         1. (i) An individual experienced in male reproduction (andrology) with special competence in semenology.
         2. (ii) If this individual is not a urologist, then there should be available consultant urologist services with expertise in reproductive surgery.
         3. (iii) This individual should also be involved, when indicated, in recommending the most appropriate treatment options for the couple;

      6. (G)

         1. (i) In addition to the laboratory director, there should be a minimum of one (1) other embryology technologist.
         2. (ii) Every embryologist should have a working knowledge of sterile technique and cell tissue culture;

      7. (H) If gamete and/or embryo cryopreservation is offered, there should be an individual with:

         1. (i) Specialized training in cryobiology; and
         2. (ii) Experience in gamete and cryopreservation techniques; and
      8. (I) If oocyte micromanipulation is offered, there should be an individual with specialized training in gamete biology and experience in micromanipulation techniques.

Codification Notes: "CPR" means cardiopulmonary resuscitation.