(1) Congenital anomalies include major structural congenital defects, genetic disorders, and other congenital disorders.
    (2) Notifiable congenital anomalies include all those diagnosed in:
    (a) Infants who are born alive and have the anomaly diagnosed before their first birthday, including infants who at the time of death are so diagnosed, or
    (b) Fetuses that are not born alive, but completed 19 weeks of gestation. In the absence of a gestational age estimate, a congenital anomaly in a fetus that is not born alive must be reported if the fetus had a weight of at least 500 grams.
    (3) The reporting of congenital anomalies shall apply to each infant or fetus born, expelled or extracted in Florida on July 4, 1999, or later.
    (4) A licensed hospital or licensed practitioner as defined in Florida Statutes § 381.0031(2), shall report information regarding each congenital anomaly.
    (a) Each hospital licensed under Florida Statutes Chapter 395, shall report to the Department’s Florida Birth Defects Registry each congenital anomaly occurring in an infant admitted to the hospital. If a hospital reports a congenital anomaly to the Agency for Health Care Administration in its inpatient discharge data report pursuant to Fl. Admin. Code Chapter 59E-7, then it need not comply with the reporting requirements of Fl. Admin. Code R. 64D-3.035, for that anomaly.
    (b) Each licensed practitioner who diagnoses a congenital anomaly shall report it to the Department’s Florida Birth Defects Registry, except if the anomaly occurs in an infant admitted to a hospital licensed under Florida Statutes Chapter 395
    (c) Physician or hospital reports shall be made no sooner than the date of birth, expulsion or extraction, and no later than 60 days after the date on which the diagnosis was made, or the date of the birth, expulsion or extraction, whichever is later, except as indicated in Fl. Admin. Code R. 64D-3.035(4)(a)
    (d) Reports shall be sent to the Florida Department of Health, Division of Environmental Health, Florida Birth Defects Registry, 4052 Bald Cypress Way, Bin A-8, Tallahassee, Florida 32399-1720. Information on reporting formats can be obtained from the Florida Birth Defects Registry at the above address or on-line at: www.fbdr.org.
Rulemaking Authority Florida Statutes § 381.0011(2), 381.0031(8) FS. Law Implemented 381.0011, 381.0031 FS. History-New 11-20-06.