(a) There must be a written quality control program, which includes control bioassays, designed to check for:

1. (1) Cell culture media and contact materials for toxins;
2. (2) Inappropriate ionic concentration;
3. (3) Microbial contamination; or
4. (4) Other potential hazards to human gametes or embryos.

(b) Documentation.

1. (1) Quality control procedures. There must be documentation of all quality control procedures performed.
2. (2) Remedial action. There must be documentation of remedial actions when control procedures do not meet the laboratory’s criteria for acceptability.

3. (3) Culture medium. There must be documentation of the following on each batch of culture medium:

   1. (A) Date prepared;
   2. (B) Name of person who prepared the medium;
   3. (C) Osmolarity;
   4. (D) pH;
   5. (E) Method of sterilizations;
   6. (F) Expiration; and
   7. (G) Results of control procedures.