This rule is being amended to update the “Newborn Screening Conditions” list to add new conditions for which each live born infant will be screened. This rule amendment also specifies certain collection procedures.

 

DEPARTMENT OF HEALTH

Division of Children's Medical Services

RULE NO.:RULE TITLE:

64C-7.002Collection Procedures for Newborn Screening

PURPOSE AND EFFECT: This rule is being amended to update the “Newborn Screening Conditions” list to add new conditions for which each live born infant will be screened. This rule amendment also specifies certain collection procedures.

SUMMARY: Infants will be screened for additional conditions and procedures for collection are updated.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: Based on the SERC checklist, this rulemaking will not have an adverse impact or regulatory costs in excess of $1 million within five years as established in s.120.541(2)(a), F.S.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 383.14(2) FS

LAW IMPLEMENTED: 383.14 FS, 383.145 FS

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Emily Reeves, Program Director, Newborn Screening Follow-up Program, [phone] or [e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

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 ConditionsDisorders” list, August 22, 2023,February 3, 2020, unless the parent or guardian objects to the screening in accordance with sSection 383.14(4), F.S. The “Newborn Screening ConditionsDisorders,” August 22, 2023,February 3,2020 is incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-##### 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 05/2023Revised 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-##### https://www.flrules.org/Gateway/reference.asp?No=Ref-08548. The form may also be obtained through the Bureau of 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/ 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)     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.

(b) renumbered (e) No change.

(c) renumbered (f) No change.

(5) No change.

Rulemaking Authority 383.14(2) FS. Law Implemented 383.14, 383.145 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,_____.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Emily Reeves, BSN, RN, CPN, Program Director, Newborn Screening

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Joseph A. Ladapo, MD, PhD,

State Surgeon General, Department of Health

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: April 25, 2024

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: June 8, 2023