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Types of Regulation

Types of Regulation. State Regulation : Medical licensing Federal Regulation : CDC, FDA, CMS/CLIA Professional Self-Regulation : CAP, SART. Federal Regulation. Center for Disease Control (CDC): Complete annual reporting

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Types of Regulation

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  1. Types of Regulation • State Regulation: Medical licensing • Federal Regulation: CDC, FDA, CMS/CLIA • Professional Self-Regulation: CAP, SART

  2. Federal Regulation • Center for Disease Control (CDC): Complete annual reporting • Food and Drug Administration (FDA): Screening and testing of reproductive tissues, patient testing • Centers for Medicare and Medicaid Services/ Clinical Laboratory Improvement Act(CMS/CLIA): Ensure quality lab testing

  3. Self-Regulation • College of American Pathologists (CAP)- onsite/self-inspection, proficiency testing • American Society for Reproductive Medicine (ASRM)- ethical guidelines • Society for Assisted Reproductive Technology (SART)- affiliate of ASRM involved in cycle reporting

  4. Society for Assisted Reproductive Technology • 393 practices, >90% clinics in US • What does SART do? • Data collection • Practice guidelines and standards • Government interaction • Quality assurance • Research

  5. SART Reporting • Patient Health History: age, height, weight, gravidity, known diagnoses, previous ART treatments • Current ART Treatment Information: types of medication/stimulation, complications • Cycle Information: retrieval details, andrology, micromanipulation and fertilization • Transfer and Outcome: Embryo morphology, number transferred, cryopreservation, treatment outcome • Delivery: Pregnancy outcome, delivery date, number born, weight, gender, birth defects

  6. Treatment Outcome • Not Pregnant • Biochemical: positive hCG by blood test • Clinical Intrauterine Gestation: one or more gestational sacs confirmed by ultrasound • Ectopic pregnancy: gestational sac outside of uterine cavity • Heterotopic: clinical intrauterine gestation and ectopic pregnancy • Unknown

  7. 55% 50% 56% 59% 10% 37% 2 20% 0% 67% 67% 100% 100% 33% 60% 2.5 50% 0% 50% 17% 20% 20% 17% 27% 2.2 0% 0%

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