When is inspection of the female genitalia necessary?

Which of the following is defined by the FDA as, "establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality characteristics"?

A) Quality improvement B) Process validation C) Documentation D) Assessment

Operation: The patient was brought to the operative suite, placed in supine position and general anesthesia was administered. His scrotum was shaved. He was then sterilely prepped and draped in the usual manner. A transverse incision across the right hemiscrotum was then made approximately 3.5 cm in length using electrocautery to further dissect this area. The right-sided fluid sac was then

exuded from the right hemiscrotum. It seems to be a right spermatocele. Using meticulous care and caution, the spermatocele was divided from the testicle and the vas deferens was identified. There as a moderate degree of difficulty as the spermatocele had separated the epididymis from the patient’s right testicle. So using meticulous care, this was divided free from his spermatocele. The spermatocele was handed off intact to the scrubbed personnel. Hemostasis was achieved. The epididymis was then re-attached to the testicle. The testicle was then replaced into the right hemiscrotum. The wound was closed using a #2-0 locking running chromic stitch and the superficial skin was closed in a horizontal mattress fashion. Patient tolerated the procedure well and was sent to recovery in satisfactory condition. Preoperative Diagnosis: Right hydrocele Postoperative Diagnosis: Right spermatocele Operation: Right spermatocelectomy Indications for Procedure: This 54-year-old male has a history of right-sided scrotal enlargement. Scrotal ultrasound preoperatively was consistent with right hydrocele. Pathology Report: spermatocele a. 55040 b. 55040, 54840 c. 54840 d. 54830