Current through Reg. 50, No. 187; September 24, 2024
(1) Each live born infant shall be screened
for those core and secondary conditions listed in the "Newborn Screening
Conditions" list, August 22, 2024, unless the parent or guardian objects to the
screening in accordance with section
383.14(4), F.S.
The "Newborn Screening Conditions," August 22, 2024, is incorporated by
reference and available at
https://www.flrules.org/Gateway/reference.asp?No=Ref-16664.
(2) The infant's blood shall be collected on
a specimen card, DOH Form DH 677, (Revised 05/2023), 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-16665.
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
https://floridanewbornscreening.com/medical-professionals/order-supplies/.
(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. For enrollment into electronic laboratory
ordering, contact NBSOrderServicesTeam@flhealth.gov.
(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) Ensure 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 are completed and legible.
(c) Report critical congenital heart disease
(CCHD) screening information on the specimen card or through the web
portal.
(d) Ensure specimens are
received at the Bureau of Public Health Laboratory - Jacksonville within three
days of collection. Specimens should be mailed or transported as soon as
properly dried (3 - 4 hours), and no later than 24 hours after
collection.
(e) 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,
(f) 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,
383.145
FS.
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.
