64C-7.002. Collection Procedures for Newborn Screening

(1) Each live born infant shall be screened for those core and secondary conditions listed in the “Newborn Screening Disorders” list, February 3, 2020, unless the parent or guardian objects to the screening in accordance with Section 383.14(4), F.S. The “Newborn Screening Disorders,” February 3, 2020 is incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-12063.

(2) The infant’s blood shall be collected on a specimen card, DOH Form DH 677, (Revised 9/16), which is titled “Newborn Screening Specimen Collection Card,” and incorporated by reference. The form is available at https://www.flrules.org/Gateway/reference.asp?No=Ref-08548. The form may also be obtained through the State Public Health Laboratory located at 1217 North Pearl Street, Jacksonville, FL 32202. Forms may be ordered through the DOH website at http://www.floridahealth.gov/programs-and-services/childrens-health/newborn-screening/_documents/order-form-for-DH677.pdf.

(3) The laboratory order for a newborn screen may be submitted via the specimen card, DOH Form DH 677, or electronically to the State Public Health Laboratory. It is the responsibility of the submitting entity to complete all data fields on the specimen card or the electronic order that are required for identification, testing, result interpretation/reporting and billing of the specimen and/or patient.

(4) When a live birth occurs in a hospital, or licensed birth center, the responsible physician or healthcare practitioner, must:

(a) Ensure a satisfactory blood specimen is collected prior to the infant’s discharge from care. The specimen shall be collected within 48 hours of birth, but no earlier than 24 hours after birth.

(b) If the infant is discharged from the hospital or birth center before 24 hours after birth, a blood specimen shall be collected before discharge and a second newborn screening specimen shall be repeated after 24 hours and no later than 5 days after birth. At or before discharge, the hospital or birth center administrator or designee must provide a written notice to the parents, guardian, or other legally responsible party of the requirements for the newborn to be tested again within 5 days after birth. The primary responsibility for assuring repeat testing remains with the hospital or birth center; and,

(c) A pulse oximeter device must be used to test the oxygen level in the right hand and either foot. Newborns must be at least 24 hours of age or prior to hospital discharge to obtain the oxygen level. Pulse oximetry screening results must be documented on a specimen card, DOH Form DH 677, or submitted electronically to the State Public Health Laboratory. Testing procedures must be consistent with the American Academy of Pediatrics current screening algorithm as referenced in paragraph (5)(b), below.

(5) When a live birth occurs in a location outside of a licensed birth center and the infant is not admitted to a hospital following the birth, the professional person in attendance at the birth must:

(a) Obtain a satisfactory blood specimen within 48 hours of birth, but no earlier than 24 hours after birth; and,

(b) A pulse oximeter device must be used to test the oxygen level in the right hand and either foot. Newborns must be at least 24 hours of age to obtain the oxygen level. Pulse oximetry screening results must be documented on a specimen card, DOH Form DH 677, or submitted electronically to the State Public Health Laboratory. Testing procedures must be consistent with the American Academy of Pediatrics screening algorithm as described in “Strategies for Implementing Screening for Critical Congenital Heart Disease,” in Figure 1, page e1262, effective November 2011, incorporated by reference and available at http://pediatrics.aappublications.org/content/128/5/e1259.full, and https://www.flrules.org/Gateway/reference.asp?No=Ref-08549.

Rulemaking Authority 383.14(2) FS. Law Implemented 383.14 FS. History–New 10-25-79, Formerly 10D-76.03, Amended 12-5-84, Formerly 10J-8.03, Amended 3-29-92, 9-20-94, 3-28-96, Formerly 10J-8.003, Amended 4-1-08, 3-26-15, 8-20-17, 11-22-18, 8-30-20.